10-Q

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 1, 2022, the registrant had 50,074,277 shares of common stock outstanding.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, since they are interim statements, the accompanying condensed financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC. In the opinion of management, the unaudited condensed financial statements and notes thereto include all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. The operating results presented in these unaudited condensed financial statements are not necessarily indicative of the results that may be expected for any future periods.

Use of Estimates

The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to determining the standalone selling prices of performance obligations associated with license and collaboration arrangements, accrued research and development expenses and stock-based compensation expenses. The Company bases these estimates on historical experience, knowledge of current events and actions it may undertake in the future, and on various other assumptions that are believed to be reasonable. Actual results may differ materially from these estimates and assumptions. Although the impact of the COVID-19 pandemic to the Company’s business and operating results presents additional uncertainty, the Company continues to use the best information available to update its critical accounting estimates.

Cash, Cash Equivalents and Restricted Cash

The following table presents a reconciliation of cash, cash equivalents and restricted cash to the amounts shown in the unaudited condensed statements of cash flows (in thousands):


	June 30, 2022		June 30, 2021
Cash and cash equivalents	$	290,147	$	426,047
Restricted cash included in other assets		1,876		1,875
Total cash, cash equivalents and restricted cash	$	292,023	$	427,922

Concentration of Credit Risk

Substantially all of the Company’s cash, cash equivalent and marketable securities are held at two financial institutions. Due to the financial strength of the depository institutions, the Company believes these financial institutions represent minimal credit risk. Cash amounts held at financial institutions are insured by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. At June 30, 2022, cash, cash equivalents and marketable securities totaling $818.0 million are either not subject to FDIC insurance, or exceed the FDIC insured limit. The Company’s cash, cash equivalents and marketable securities are invested in short term, high credit quality securities, and as a result, the Company believes represent a minimal credit risk.

Net Loss Per Share

Basic net loss per share is computed by dividing the net loss available to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share assumes the conversion, exercise or issuance of all potential common stock equivalents, unless the effect of inclusion would be anti-dilutive. For purposes of this calculation, common stock equivalents include the Company’s stock options, restricted stock units (RSUs) and performance stock units (PSUs). The Company excluded stock options to purchase common stock, RSUs and PSUs from the number of shares used to calculate diluted shares outstanding because the inclusion of these potentially dilutive securities would have been antidilutive.

Historical outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following:


	Six Months Ended June 30,
	2022		2021
Common stock options		6,266,363		5,406,931
RSUs		893,536		192,281
PSUs		234,284		188,518
Total		7,394,183		5,787,730

3. Marketable Securities

The Company invests its excess cash in marketable securities, including debt instruments of financial institutions, corporations with investment grade credit ratings, commercial paper and government agencies.

At June 30, 2022, marketable securities consisted of the following (in thousands):


	Maturity	Amortized		Unrealized
	in Years	Cost		Gains		Losses			Fair Value
U.S. Treasuries	2 years or less	$	348,544	$	—	$	(5,372	)	$	343,172
U.S. Government agency securities	2 years or less		87,115		—		(839	)		86,276
Non-U.S. Government agency securities	2 years or less		13,643		—		(184	)		13,459
Corporate debt securities	2 years or less		51,944		—		(461	)		51,483
Commercial paper	Less than 1		33,749		—		—			33,749
Total marketable securities		$	534,995	$	—	$	(6,856	)	$	528,139

At December 31, 2021, marketable securities consisted of the following (in thousands):


	Maturity	Amortized		Unrealized
	in Years	Cost		Gains		Losses			Fair Value
U.S. Treasuries	2 years or less	$	305,763	$	1	$	(1,006	)	$	304,758
U.S. Government agency securities	2 years or less		151,047		—		(180	)		150,867
Non-U.S. Government agency securities	2 years or less		23,787		—		(49	)		23,738
Corporate debt securities	2 years or less		74,391		5		(56	)		74,340
Total marketable securities		$	554,988	$	6	$	(1,291	)	$	553,703

The Company segments its portfolio based on the underlying risk profiles of their current securities being held. The Company regularly reviews the securities in an unrealized loss position and evaluates the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, current and expected future economic conditions. As of June 30, 2022 and December 31, 2021, the Company did not record an allowance for credit loss related to its investment portfolio.

4. Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Fair value should maximize the use of observable inputs and minimize the use of unobservable inputs. The Company determines the fair value of financial assets and liabilities using three levels of inputs as follows:

Level 1 — Observable inputs such as quoted prices in active markets for identical assets or liabilities at the measurement date;

Level 2 — Inputs (other than quoted market prices included in Level 1) that are either directly or indirectly observable, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the instrument’s anticipated life; and

Level 3 — Unobservable inputs for assets or liabilities and include little or no market activity.

A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

The Company measures fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, prepaid and other current assets, accounts payable, and accrued liabilities, approximate fair value due to the short-term nature of these items.

The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used for such measurements were as follows (in thousands):


	Fair Value Measurements at June 30, 2022 Using:
	Level 1		Level 2		Level 3		Total
Money market funds	$	139,838	$	—	$	—	$	139,838
U.S. Treasuries		343,172		—		—		343,172
U.S. Government agency securities		—		86,276		—		86,276
Non-U.S. Government securities		—		13,459		—		13,459
Corporate debt securities		—		51,483		—		51,483
Commercial paper		—		183,272		—		183,272
Total cash equivalents and marketable securities	$	483,010	$	334,490	$	—	$	817,500


	Fair Value Measurements at December 31, 2021 Using:
	Level 1		Level 2		Level 3		Total
Money market funds	$	232,813	$	—	$	—	$	232,813
U.S. Treasuries		304,758		—		—		304,758
U.S. Government agency securities		—		150,867		—		150,867
Non-U.S. Government securities		—		23,738		—		23,738
Corporate debt securities		—		77,400		—		77,400
Commercial paper		—		191,130		—		191,130
Total cash equivalents and marketable securities	$	537,571	$	443,135	$	—	$	980,706

7. License and Collaboration Agreements

Zai Repotrectinib Agreement

In July 2020, the Company entered into a license agreement (the Zai Repotrectinib Agreement) with Zai Lab (Shanghai) Co., Ltd. (Zai), pursuant to which the Company granted Zai exclusive rights to develop and commercialize products containing the Company’s drug candidate, repotrectinib (the Repotrectinib Products), in Mainland China, Hong Kong, Macau and Taiwan (collectively, the Zai Territory or Greater China). The Company retains exclusive rights to, among other things, develop, manufacture and commercialize the Repotrectinib Products outside the Zai Territory. The Company will supply or have supplied to Zai the Repotrectinib Products for use in the Zai Territory pursuant to a supply agreement for agreed upon consideration, except that Zai has the right, at its election, to package and label the Repotrectinib Products in or outside the Zai Territory for use in the Zai Territory.

Pursuant to the terms of the Zai Repotrectinib Agreement, the Company received an upfront cash payment of $25.0 million in 2020 and is eligible to receive up to $151.0 million in development and sales milestone payments, consisting of up to $46.0 million of development milestones and up to $105.0 million of sales milestones. In addition, during the term of the Zai Repotrectinib Agreement, Zai is obligated to pay the Company tiered percentage royalties ranging from mid-to-high teens on annual net sales of the Repotrectinib Products in the Zai Territory, subject to adjustments in specified circumstances.

Zai is responsible for conducting the development and commercialization activities in the Zai Territory related to the Repotrectinib Products at Zai’s own expense, subject to limited exceptions pursuant to which the Company may be responsible for the cost. The Company is responsible for global clinical studies of the Repotrectinib Products, including the portions that may be conducted in the Zai Territory, at the Company’s expense, except that Zai will participate in global clinical studies of the Repotrectinib Products through clinical trial sites in the Zai Territory as agreed as of the effective date of the Zai Repotrectinib Agreement and may, at Zai’s election, participate in future global clinical studies of the Repotrectinib Products through clinical trial sites in the Zai Territory, in each case at Zai’s expense.

The Zai Repotrectinib Agreement will continue in effect until expiration of the last royalty term for a Repotrectinib Product in any region in the Zai Territory, where the royalty term for a Repotrectinib Product in a region continues until the later of (i) the date of the last-to-expire valid claim within Company’s patent rights that covers the Repotrectinib Product in such region in the Zai Territory; (ii) the expiry of the regulatory exclusivity for such Repotrectinib Product in such region; or (iii) the close of business of the day that is exactly 10 years after the date of the first commercial sale of such Repotrectinib Product in such region. Subject to the terms of the Zai Repotrectinib Agreement, Zai may terminate the Zai Repotrectinib Agreement for convenience by providing written notice to the Company, which termination will be effective following a prescribed notice period. In addition, the Company may terminate the Zai Repotrectinib Agreement under specified circumstances if Zai or certain other parties challenge the Company’s patent rights. Either party may terminate the Zai Repotrectinib Agreement for the other party’s uncured material breach of the Zai Repotrectinib Agreement, with a customary notice and cure period, for the other party’s insolvency or if the other party acquires a third party and the acquired party is engaged in activities with a competing product that is not divested or discontinued within a specified period. After termination (but not natural expiration), other than certain terminations by Zai for cause, the Company is entitled to retain a worldwide and perpetual license from Zai to exploit the Repotrectinib Products.

Revenue Recognition

The Company determined that two performance obligations existed: (1) the exclusive license, bundled with the associated know-how and (2) the Company’s initial obligation to supply repotrectinib for clinical development in the Zai Territory.

The total transaction price of $25.7 million was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company developed assumptions that require judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies.

The Company delivered the license and technical know-how to Zai in the third quarter of 2020 to satisfy this performance obligation, and accordingly the Company recognized license revenue of $25.0 million in the third quarter of 2020. The $0.7 million in consideration allocable to the clinical supply performance obligation was recognized when clinical trial material was shipped by the Company and Zai obtained control of the goods upon delivery, over the period of the obligation. In the second quarter of 2021, the Company recognized $5.0 million of revenue upon the achievement of certain development milestones. The upfront payment received in 2020 and the development milestone payments received in 2021 were subject to foreign tax withholdings, which was recorded as general and administrative expense.

For the three months ended June 30, 2022, the Company did not recognize any revenue associated with the clinical supply performance obligation. For the three months ended June 30, 2021, the Company recognized $0.2 million of revenue associated with the clinical supply performance obligation. For each of the six months ended June 30, 2022 and 2021, the Company recognized $0.4 million of revenue associated with the clinical supply performance obligation.

The Company assessed and determined that there is no significant financing component associated with the Zai Repotrectinib Agreement.

Zai Elzovantinib Agreement

On January 10, 2021, the Company entered into a license agreement with Zai, which was amended on March 31, 2021 (the Zai Elzovantinib Agreement), pursuant to which the Company granted Zai exclusive rights to develop and commercialize products containing the Company’s drug candidate, Elzovantinib (the Elzovantinib Products), in the Zai Territory. The Company retains exclusive rights to, among other things, develop, manufacture and commercialize the Elzovantinib Products outside the Zai Territory.

Pursuant to the terms of the Zai Elzovantinib Agreement, the Company received an upfront cash payment of $25.0 million in the first quarter of 2021 and is eligible to receive up to $336.0 million in development and sales milestone payments, consisting of up to $121.0 million of development milestones and up to $215.0 million of sales milestones. In addition, during the term of the Zai Elzovantinib Agreement, Zai is obligated to pay the Company tiered percentage royalties ranging from mid-teens to low twenties on annual net sales of the Elzovantinib Products in the Zai Territory, subject to adjustments in specified circumstances.

Zai is responsible for conducting the development and commercialization activities in the Zai Territory related to the Elzovantinib Products at Zai’s own expense, subject to limited exceptions pursuant to which the Company may be responsible for the cost. The Company is responsible for global clinical studies of the Elzovantinib Products, including the portions that may be conducted in the Zai Territory, at the Company’s expense, except that Zai will participate in global clinical studies of the Elzovantinib Products through clinical trial sites in the Zai Territory as agreed as of the effective date of the Zai Elzovantinib Agreement and may, at Zai’s election subject to specified exceptions, participate in future global clinical studies of the Elzovantinib Products through clinical trial sites in the Zai Territory, in each case at Zai’s expense.

The Zai Elzovantinib Agreement will continue in effect until expiration of the last royalty term for a Elzovantinib Product in any region in the Zai Territory, where the royalty term for a Elzovantinib Product in a region continues until the later of (i) the expiry of the last-to-expire valid claim within Company’s patent rights that covers the Elzovantinib Product in such region in the Zai Territory; (ii) the expiry of the regulatory exclusivity for such Elzovantinib Product in such region; or (iii) the close of business of the day that is exactly 10 years after the date of the first commercial sale of such Elzovantinib Product in such region. Subject to the terms of the Zai Elzovantinib Agreement, Zai may terminate the Zai Elzovantinib Agreement for convenience by providing written notice to the Company, which termination will be effective following a prescribed notice period. In addition, the Company may terminate the Zai Elzovantinib Agreement under specified circumstances if Zai or certain other parties challenge the Company’s patent rights. Either party may terminate the Zai Elzovantinib Agreement for the other party’s uncured material breach of the Zai Elzovantinib Agreement, with a customary notice and cure period, for the other party’s insolvency or if the other party acquires a third party and the acquired party is engaged in activities with a competing product that is not divested or discontinued within a specified period. After termination (but not natural expiration), other than certain terminations by Zai for cause, the Company is entitled to retain a worldwide and perpetual license from Zai to exploit the Elzovantinib Products.

Revenue Recognition

The Company determined that two performance obligations existed: (1) the exclusive license, bundled with the associated know-how and (2) the Company’s initial obligation to supply elzovantinib for clinical development in the Zai Territory.

The total transaction price of $25.9 million was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company developed assumptions that require judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies.

The Company delivered the license and technical know-how to Zai in the first quarter of 2021 to satisfy this performance obligation, and accordingly the Company recognized license revenue of $25.0 million in the first quarter of 2021. The upfront payment received was subject to foreign tax withholdings, which was recorded as general and administrative expense. The $0.9 million in consideration allocable to the clinical supply performance obligation is recognized when clinical trial material has been shipped by the Company and Zai obtains control of the goods upon delivery, over the period of the obligation. For the three and six months ended June 30, 2022, the Company recognized $0.1 million associated with the clinical supply performance obligation under the Zai Elzovantinib Agreement. The Company did not recognize any revenue associated with the clinical supply performance obligation for the three and six months ended June 30, 2021.

The Company assessed and determined that there is no significant financing component associated with the Zai Elzovantinib Agreement.

LaNova License Agreement

On May 4, 2022, the Company entered into a license agreement (the LaNova License Agreement) with LaNova Medicines Limited (LaNova) for an exclusive, royalty-bearing license to intellectual property related to LM-302, a clinical stage anti-Claudin18.2 antibody drug conjugate (the LaNova Product), on a worldwide basis excluding Greater China and South Korea (the Company Territory). Under the LaNova License Agreement, the Company has the exclusive right to research, develop, use, register, offer for sale, import and otherwise commercialize the LaNova Product in the Company Territory and non-exclusive rights to manufacture the LaNova Product worldwide in support of activities in the Company Territory.

Pursuant to the LaNova License Agreement, the Company paid LaNova an upfront cash payment of $25.0 million in June 2022, which was recorded as research and development expense in the second quarter of 2022 because the technology has not yet achieved regulatory approval. The Company may be obligated to pay milestone payments, which include up to $195.0 million in development and regulatory milestones and up to $880.0 million in sales milestones, and tiered royalty payments based on percentages (ranging from the mid-single digits to the mid-teens) of net sales (subject to customary deductions).

MD Anderson Collaboration Agreement

On June 23, 2022, the Company entered into a five-year strategic collaboration agreement (the MD Anderson Collaboration Agreement) with The University of Texas M.D. Anderson Cancer Center (MD Anderson). Under the terms of the MD Anderson Collaboration Agreement, the Company will provide funding and support for preclinical and clinical studies to be conducted by MD Anderson in several solid tumors, including non-small cell lung cancers, gastrointestinal malignancies and endocrine cancers (the Studies). Pursuant to the MD Anderson Collaboration Agreement, the Company will provide total funding in an amount of $10.0 million for the performance of the Studies, such funding to be provided in increments of $1.0 million on a twice-yearly basis. The Studies will be overseen by a joint steering committee, which will provide technical, scientific, clinical and regulatory guidance, discuss and approve study budgets, and monitor the progress of the Studies. As of June 30, 2022, the Company has not made any funding to MD Anderson.

8. Commitments and Contingencies

Operating Leases

The Company leases office and laboratory space under lease agreements with remaining lease terms ranging from 14 months to 21 months. One of the leases contains an option to extend the lease for five years, which was not included in the determination of the lease term as it was not reasonably certain that the Company would exercise this option.

As of June 30, 2022, the Company recorded $4.6 million as right-of-use (ROU) assets, $4.0 million as current operating lease liabilities and $0.9 million as non-current operating lease liabilities on its balance sheet. As of December 31, 2021, the Company recorded $5.2 million as ROU assets, $3.6 million as current operating lease liabilities and $2.0 million as non-current operating lease liabilities on its balance sheet.

Operating lease costs were $1.0 million and $0.6 million for the three months ended June 30, 2022 and 2021, respectively, and $2.0 million and $1.0 million for the six months ended June 30, 2022 and 2021, respectively. Variable lease costs representing the Company’s share of the operating expenses and utility costs of the leased properties were $0.4 million and $0.3 million for the three months ended June 30, 2022 and 2021, respectively, and $0.8 million and $0.6 million for the six months ended June 30, 2022 and 2021, respectively. Cash paid for amounts included in the measurement of operating lease liabilities was $1.0 million and $0.6 million for the three months ended June 30, 2022 and 2021, respectively, and $2.0 million and $1.0 million for the six months ended June 30, 2022 and 2021, respectively.

The Company’s operating leases had a weighted-average remaining lease term of 15 months and 18 months as of June 30, 2022 and December 31, 2021, respectively, and a weighted-average discount rate of 5.5% and 7.0% as of June 30, 2022 and December 31, 2021, respectively.

Maturities of operating lease liabilities as of June 30, 2022 were as follows (in thousands):


2022 (remaining)	$	2,100
2023		2,940
2024		54
Total future minimum lease payments		5,094
Less: amounts representing interest		(157	)
Total lease liability	$	4,937

In May 2021, the Company entered into a lease agreement with HCP Callan Road, LLC for office and laboratory space for the Company’s future corporate headquarters, delivered in two phases. The term of the lease is approximately 11 years and nine months with an option by the Company to extend for an additional five years, and is currently expected to commence in May 2023. The lease term has an initial abatement period with respect to each phase and the initial base rent payable upon the Company's occupancy of both phases will be approximately $1.0 million per month following the end of the abatement period for each phase, which amount will increase by 3% per year over the lease term. The Company is also responsible for the payment of its share of the operating expenses for the building. Pursuant to the terms of the lease agreement, the landlord will provide the Company with a tenant improvement allowance of up to $220 per square foot. As of June 30, 2022, total aggregate future lease commitments under the lease were approximately $165.9 million. As of June 30, 2022, the Company had not taken control of the space. Accordingly, no ROU asset or lease liability related to the lease has been recorded.

In connection with the lease, the Company is required to maintain a letter of credit for the benefit of the landlord in the amount of $1.8 million, which was delivered in May 2021 and is included in other assets in the Company’s condensed balance sheets.

Legal Proceedings

Between June 24, 2022 and June 29, 2022, four complaints were filed in federal court by purported stockholders of the Company regarding the Merger. The first complaint was filed on June 24, 2022 in the United States District Court for the Southern District of New York and is captioned O’Dell v. Turning Point Therapeutics, Inc., et al., Case No. 1:22-cv-05352. The second and third complaints were filed on June 27, 2022 in the United States District Court for the Southern District of New York and are captioned Hopkins v. Turning Point Therapeutics, Inc., et al., Case No. 1:22-cv-05433 and Whitfield v. Turning Point Therapeutics, Inc., et al., Case No. 1:22-cv-05439. The fourth complaint was filed on June 29, 2022 in the United States District Court for the District of Delaware and is captioned Kent v. Turning Point Therapeutics, Inc. et al., Case No. 1:22-cv-00879. The aforementioned four complaints are collectively referred to as the “Complaints.” The Complaints name as defendants the Company and each member of the Company’s Board of Directors (the Board) (collectively, the Turning Point Defendants). The Complaints allege violations of

Section 14(d) and Section 14(e) of the Securities Exchange Act of 1934, as amended (the Exchange Act), as well as Rule 14a-9 and Rule 14d-9 promulgated thereunder, against all Turning Point Defendants and assert violations of Section 20(a) of the Exchange Act against the members of the Board. The Complaints collectively seek, among other relief, (i) injunctive relief preventing the consummation of the transactions contemplated by the Merger Agreement; (ii) rescission and/or rescissory damages in the event the transactions contemplated by the Merger Agreement are consummated, (iii) an award of plaintiffs’ expenses and attorneys’ fees; and (iv) disclosure of certain information requested by the plaintiffs.

Each of the Turning Point Defendants intend to vigorously defend these actions. The Company believes that the Complaints are without merit and has not recorded an expense related to the outcome of these litigations because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.

Between June 28, 2022 and July 11, 2022, the Company had also received four stockholder demand letters and one draft complaint, which generally seek that certain allegedly omitted information in the Schedule 14D-9 be disclosed. On July 8, 2022, the Company also received a letter from a purported stockholder seeking to inspect certain books and records of the Company pursuant to Section 220 of the Delaware General Corporation Law.

9. Stockholders’ Equity

At the Market Offering

In August 2020, the Company entered into an Open Market Sale AgreementSM with Jefferies LLC (ATM facility), under which the Company may offer and sell, from time to time, at its sole discretion, up to $250.0 million shares of the Company’s common stock. As of June 30, 2022, the Company had not yet sold any shares of common stock under the ATM facility.

2019 Equity Incentive Plan

The Company’s 2019 Equity Incentive Plan (the Plan) provides for the grant of stock options, restricted stock and other equity awards of the Company’s common stock to employees, officers, consultants and directors. In addition, the number of shares of common stock available for issuance under the Plan will be automatically increased on the first day of each calendar year through January 1, 2029, by an amount equal to 4% of the outstanding number of shares of the Company’s common stock on December 31 of the preceding calendar year or such lesser amount as determined by the Board. On January 1, 2022, the Company added 1,983,306 shares to the Plan. At June 30, 2022, the Plan had 3,516,795 total shares available for issuance.

Stock Options

Stock options expire within a period of not more than ten years from the date of grant. Initial option grants to employees typically vest 25% on the first anniversary of the original vesting date and monthly thereafter over a three-year period and expire three months after employee termination. Subsequent option grants to employees and grants to non-employees typically vest monthly over a four-year period.

The following table summarizes stock option activity under the Plan for the periods presented:


	Outstanding Options			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value (in thousands)
Balance as of December 31, 2021		5,418,467		$	47.17		7.5	$	91,794
Options granted		1,854,914		$	35.24
Options exercised		(230,813	)	$	35.78
Options forfeited or cancelled		(776,205	)	$	61.52
Balance as of June 30, 2022		6,266,363		$	42.28		7.6	$	235,281

Options vested and exercisable as of June 30, 2022		3,183,310		$	32.24		6.2	$	147,763

The weighted-average grant-date fair value of options granted to employees was $20.85 and $48.45 for the three months ended June 30, 2022 and 2021, respectively, and $23.73 and $77.86 for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, total unrecognized compensation expense related to unvested options was $106.3 million, which is expected to be

recognized over a weighted-average term of 2.8 years. The total intrinsic value of stock options exercised was $5.0 million and $10.4 million during the three months ended June 30, 2022 and 2021, respectively, and $6.2 million and $54.7 million during the six months ended June 30, 2022 and 2021, respectively.

The fair value of the stock options granted during the three and six months ended June 30, 2022 and 2021 was estimated at the date of grant using the Black-Scholes option-pricing model using the following assumptions:


	Three Months Ended June 30,						Six Months Ended June 30,
	2022			2021			2022			2021
Risk-free interest rate		2.83	%		1.05	%		2.17	%		0.80	%
Volatility		76.8	%		79.9	%		76.1	%		80.4	%
Expected term (in years)		6.08			5.98			6.08			6.04
Dividend yield		—			—			—			—

Restricted Stock Units

The following table summarizes restricted stock unit activity under the Plan for the periods presented:


	Restricted Stock Units Outstanding			Weighted Average Grant Date Fair Value		Aggregate Intrinsic Value (in thousands)
Balance as of December 31, 2021		358,760		$	89.09	$	17,113
Granted		712,582		$	34.87
Vested		(38,666	)	$	120.98
Forfeited		(139,140	)	$	62.12
Outstanding as of June 30, 2022		893,536		$	48.67	$	67,239

As of June 30, 2022, total unrecognized compensation related to RSUs granted was $38.4 million, which is expected to be recognized over a weighted-average period of approximately 3.2 years. The total fair value of RSUs vested during the three and six months ended June 30, 2022 was $0.3 million and $1.4 million, respectively. There were no RSUs vested during the three and six months ended June 30, 2021.

Performance Stock Units

The Company grants PSUs that vest based on the achievement of certain predefined Company-specific performance criteria. The fair value of PSUs is estimated based on the closing price of the Company’s common stock on the date of grant. The Company recognizes expense in proportion to the number of PSUs that are deemed probable of vesting, based on the Company’s evaluation of the respective performance-based criteria, at each reporting date.

The following table summarizes performance stock unit activity under the Plan for the periods presented:


	Performance Stock Units Outstanding			Weighted Average Grant Date Fair Value		Aggregate Intrinsic Value (in thousands)
Balance as of December 31, 2021		204,759		$	120.34	$	9,767
Granted		107,747		$	37.74
Vested		—		$	—
Forfeited		(78,222	)	$	99.45
Outstanding as of June 30, 2022		234,284		$	89.33	$	17,630

As of June 30, 2022, the Company does not estimate that the achievement of any performance-based criteria is probable. To date, there have been no PSUs that have vested and the Company has not recognized any stock-based compensation expense related to the PSUs.

2019 Employee Stock Purchase Plan

The Company adopted an employee stock purchase plan in 2019 (the ESPP). The ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to 15% of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the ESPP. Under the ESPP, eligible employees may purchase shares of the Company’s common stock at 85% of the lower of the fair market value of the common stock at the commencement date of each offering period or the date of purchase. Each offering period is 24 months, with new offering periods commencing every six months on the dates of June 11 and December 11 of each year. Each offering period consists of four six-month purchase periods (each a Purchase Period) during which payroll deductions of the participants are accumulated under the ESPP. The last business day of each Purchase Period is referred to as the “Purchase Date.” Purchase Dates are every six months on the dates of June 10 and December 10 of each year. As of June 30, 2022, a total of 169,127 shares of common stock were available for purchase under the ESPP.

Pursuant to the terms of the Merger Agreement, except for the offering period in existence under the ESPP on the date of the Merger Agreement, no new ESPP offering was authorized or commenced, including the offering period scheduled to commence on June 11, 2022. As a result, the Company recognized $2.7 million of stock-based compensation expense in June 2022 representing the total remaining unrecognized compensation under the ESPP, consisting of $2.0 million in research and development expenses and $0.7 million in general and administrative expenses.

Modifications to Outstanding Equity Awards

On March 30, 2021, Sheila Gujrathi, M.D. and Jacob M. Chacko, M.D. resigned from the Board, effective immediately, to focus on other endeavors. Dr. Gujrathi also resigned from her position as Chair of the Board and Dr. Chacko resigned from each committee of the Board for which he was a member. In connection with the foregoing, the Board approved an amendment to the option awards held by Drs. Gujrathi and Chacko to provide that (i) all shares subject to such option awards are fully vested and exercisable as of the resignation date and (ii) the post-resignation exercise period shall be extended to September 30, 2022.

The Company determined that the modification to extend the term of vested stock options was a Type I modification pursuant to ASC 718, Compensation – Stock Compensation (ASC 718). The acceleration of the vesting of the unvested stock options was deemed a Type III modification pursuant to ASC 718, because without Board approval, these stock options would have been forfeited on the date of resignation. As a result of these modifications the Company recognized $5.6 million of stock-based compensation expense in the first quarter of 2021 in general and administrative expenses in the condensed statements of operations and comprehensive loss.

Stock-Based Compensation Expense

Stock-based compensation expense recognized is presented in the condensed statements of operations and comprehensive loss as follows (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Research and development	$	9,728	$	6,980	$	16,975	$	12,982
General and administrative		7,583		6,315		15,425		17,591
Total stock-based compensation expense	$	17,311	$	13,295	$	32,400	$	30,573

Common Stock Reserved for Future Issuance

Common stock reserved for future issuance consisted of the following:


	June 30,
	2022
Options to purchase common stock		6,266,363
PSUs outstanding		234,284
RSUs outstanding		893,536
Shares available for issuance under the Plan		3,516,795
Shares available for purchase under ESPP		169,127
Total		11,080,105

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes included in this Quarterly Report on Form 10-Q (Quarterly Report) and the audited financial statements and notes thereto as of and for the year ended December 31, 2021 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the Securities and Exchange Commission (SEC) on February 28, 2022.

Unless the context requires otherwise, references in this Quarterly Report to “we,” “us,” and “our” refer to Turning Point Therapeutics, Inc.

This Quarterly Report includes forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are subject to the “safe harbor” created by those sections, that involve a number of risks, uncertainties and assumptions. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “estimate,” “predict,” “potential,” “continue,” “likely,” or “opportunity,” the negative of these words or other similar words. Similarly, statements that describe our plans, strategies, intentions, expectations, objectives, goals or prospects and other statements that are not historical facts are also forward-looking statements. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Readers of this Quarterly Report are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the time this Quarterly Report was filed with the SEC. These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business, and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, without limitation, the risk factors identified in our SEC reports, including this Quarterly Report. In addition, past financial or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Except as required by law, we undertake no obligation to update publicly or revise our forward-looking statements.

Promptly following the completion of the Offer, Purchaser will merge with and into our company (the Merger), with our company continuing as the surviving corporation and as a wholly owned subsidiary of Bristol-Myers Squibb. The Merger Agreement contemplates that the Merger will be effected pursuant to Section 251(h) of the Delaware General Corporation Law, which permits completion of the Merger without a vote of our stockholders upon the acquisition by Purchaser of a majority of the aggregate voting power of our common stock. As a result of the Merger, we will cease to be a publicly traded company.

The Merger Agreement contains customary representations and warranties. The Merger is anticipated to close in the third quarter of 2022, subject to the satisfaction or waiver of certain closing conditions, including, among others, that the number of Shares tendered in the Offer represent a majority of the Shares outstanding at the time of the expiration of the Offer. The Merger Agreement provides Bristol-Myers Squibb and us with certain termination rights and, under certain circumstances, may require us to pay Bristol‑Myers Squibb a termination fee of $138.0 million.

For additional information related to the Merger Agreement, refer to the Solicitation/Recommendation Statement on Schedule 14D-9 we filed with the SEC on June 17, 2022, together with the exhibits and annexes thereto and as amended or supplemented from time to time. Please also see “Item 1A. Risk Factors—Risks Related to Our Pending Acquisition by Bristol-Myers Squibb.

We are a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment. We have developed a macrocycle platform from which we designed our current pipeline of proprietary small, compact tyrosine kinase

inhibitors (TKIs) with rigid structures that have the potential to bind to their targets with greater precision and affinity than other kinase inhibitors. Our drug discovery approach integrates tumor biology with structure-based drug design to develop a new generation of orally available proprietary agents that we believe will have the potential to address important unmet medical needs for patients.

Our lead drug candidate, repotrectinib, is being evaluated in an ongoing Phase 1/2 clinical trial called TRIDENT-1 for the treatment of patients with ROS1+ advanced non-small cell lung cancer (NSCLC) and patients with NTRK+ advanced solid tumors. The U.S. Food and Drug Administration (FDA) has granted repotrectinib breakthrough therapy designations (i) for the treatment of patients with ROS1+ metastatic NSCLC who have not been treated with a ROS1 TKI; (ii) for the treatment of patients with ROS1+ metastatic NSCLC who have been previously treated with one ROS1 TKI and who have not received prior platinum-based chemotherapy; and (iii) for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK TKIs, with or without prior chemotherapy, and have no satisfactory alternative treatments. In addition, the FDA has granted repotrectinib orphan drug designation for the treatment of advanced NSCLC with adenocarcinoma histology; and four fast track designations for the treatment of patients with: (1) ROS1+advanced NSCLC who have not been previously treated with a ROS1 TKI; (2) ROS1+ advanced NSCLC who have been previously treated with one prior line of platinum-based chemotherapy and one prior line of a ROS1 TKI; (3) ROS1+ advanced NSCLC who have been previously treated with one prior ROS1 TKI and who have not received prior platinum-based chemotherapy; and (4) NTRK+ advanced solid tumors who have been previously treated with one prior line of chemotherapy and one or two prior TRK TKIs.

Our multi-cohort Phase 2 registrational portion of TRIDENT-1 is ongoing at sites in North America, Europe and the Asia-Pacific regions. The Phase 2 portion of TRIDENT-1 is a registrational trial for potential approval in ROS1+ advanced NSCLC and NTRK+ advanced solid tumors. In the second quarter of 2021 we reached enrollment of 50 patients pooled from the Phase 1 and Phase 2 portions of the TRIDENT-1 study in EXP-1 and in the first quarter of 2022 we reached enrollment of 60 patients from the Phase 2 portion of the TRIDENT-1 study in EXP-4 and 40 patients from the Phase 2 portion of the TRIDENT-1 study in EXP-6. Enrollment is ongoing in all cohorts in the study. We reported topline blinded independent central review (BICR) data from all of the ROS1+ NSCLC cohorts from the Phase 1/2 TRIDENT-1 study in April 2022. The primary objective of the TRIDENT-1 study is to determine the confirmed objective response rate (cORR) based on BICR as assessed by RECIST 1.1, and the key secondary objectives include duration of response (DOR), progression free survival (PFS) and intracranial activity.

As of the February 11, 2022 data cutoff date, the data include the following findings:

We discussed the BICR data with the FDA at a pre-new drug application (NDA) meeting in June 2022 and received positive feedback in July 2022 that the FDA agreed with our plan to provide data for ROS1+ TKI-naïve and TKI-pretreated advanced NSCLC patients with at least six months of follow-up from the first post-baseline scan at the time of NDA submission. We also plan on providing a detailed update, including intracranial activity, from the ROS1+ advanced NSCLC cohorts of the TRIDENT-1 study at an upcoming medical conference in the second half of 2022. We also anticipate reporting additional data from patients with NTRK+ advanced solid tumors in the second half of 2022. We plan to conduct a pre-NDA meeting with the FDA in the first quarter of 2023 to discuss topline BICR results from 40 patients from the NTRK+ TKI-pretreated patient cohort (EXP-6) and at least 30 patients from the NTRK+ TKI-naïve patient cohort (EXP-5) with responders having at least six months of follow-up.

In addition to the TRIDENT-1 study, we are also conducting our Phase 1/2 CARE study of repotrectinib in pediatric and young adult patients with ALK+, ROS1+ or NTRK+ advanced solid tumors and our Phase 1b/2 TRIDENT-2 study of repotrectinib in combination with trametinib in KRAS mutant G12D advanced solid tumors.

Elzovantinib, our MET/SRC/CSF1R inhibitor, is currently being evaluated in our ongoing Phase 1 SHIELD-1 clinical trial, in patients with advanced solid tumors harboring genetic alterations in MET. The FDA has granted elzovantinib orphan drug designation for the treatment of gastric cancer, including gastroesophageal junction adenocarcinoma and fast track designation for the treatment of patients with MET amplified advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma after prior chemotherapy. Our Phase 1 SHIELD-1 clinical trial is designed to evaluate the overall safety profile, pharmacokinetics and preliminary efficacy of elzovantinib and includes a dose-finding portion followed by dose expansion in multiple cohorts of MET alterations and tumor types.

We have completed enrollment into the 60 mg QD to 60 mg BID intermediate dose level cohort within the dose escalation portion of SHIELD-1. In parallel, we continue to enroll patients in the Phase 1 dose expansion portion of the study at 40 mg QD to 40 mg BID. We anticipate providing a clinical data update from the Phase 1 SHIELD-1 study in the second half of 2022. We also anticipate initiating the planned Phase 2 portion of SHIELD-1 in the second half of 2022 pending feedback from the FDA on data from the intermediate dose level.

In October 2021 we entered into a clinical trial collaboration agreement with EQRx, Inc. (EQRx) to evaluate elzovantinib in combination with aumolertinib (EQ143), EQRx’s drug candidate targeting EGFR, in patients with EGFR mutant MET-amplified advanced NSCLC. Our investigational new drug (IND) submission for our planned Phase 1b/2 SHIELD-2 combination study of elzovantinib and aumolertinib was cleared by the FDA in January 2022 and we initiated the study in June 2022. Preclinical data suggest the combination of MET and EGFR inhibition has the potential to increase anti-tumor activity based on complementary mechanisms. It is estimated that 15% to 20% of patients who progress on a first-line EGFR inhibitor develop MET amplification as the basis of acquired resistance.

The Phase 1 dose-finding portion of our Phase 1/2 SWORD-1 clinical trial of our RET inhibitor, TPX-0046, in patients with advanced solid tumors harboring RET genetic alterations is ongoing at sites in North America and the Asia-Pacific regions. The trial is designed to enroll TKI-naïve and TKI-pretreated patients with RET-altered non-small-cell lung, thyroid, and other advanced cancers in multiple cohorts to assess safety, tolerability, pharmacokinetics and preliminary clinical activity of TPX-0046, in a Phase 1 dose-finding portion, followed by multiple Phase 1 dose expansion cohorts after determination of the recommended Phase 2 dose. We are continuing to further characterize the pharmacokinetics, safety, and efficacy profile of TPX-0046 before determining the recommended Phase 2 dose.

Our fourth drug candidate, TPX-0131, is a next-generation ALK inhibitor. TPX-0131 has been designed with a compact macrocyclic structure and in preclinical studies has been shown to potently inhibit wildtype ALK and numerous ALK mutations, in particular the clinically observed G1202R solvent front mutation, L1196M gatekeeper mutation and G1202R/L1196M compound mutation. Additionally, preclinical in vivo studies have shown that TPX-0131 has significant brain tissue penetration after repeat oral dosing supporting the potential to cross the blood-brain barrier.

We initiated our Phase 1/2 FORGE-1 study of TPX-0131 in patients with locally advanced or metastatic TKI-pretreated ALK-positive NSCLC in the second quarter of 2021. The study endpoints include safety and tolerability, determination of the maximum tolerated dose and/or the recommended Phase 2 dose, and objective response rate by RECIST 1.1. The dose-finding portion of the

Phase 1/2 FORGE-1 study is ongoing. We anticipate providing early interim data from initial patients treated in the dose-finding portion of the FORGE-1 study in the fourth quarter of 2022 or early 2023.

On May 4, 2022, we entered into a license agreement (the LaNova License Agreement) with LaNova Medicines Limited (LaNova) for an exclusive, royalty-bearing license to intellectual property related to LM-302, a clinical stage anti-Claudin18.2 antibody drug conjugate (the LaNova Product), on a worldwide basis excluding Greater China and South Korea (the Company Territory). Under the LaNova License Agreement, we have the exclusive right to research, develop, use, register, offer for sale, import and otherwise commercialize the LaNova Product in the Company Territory and non-exclusive rights to manufacture the LaNova Product worldwide in support of activities in the Company Territory.

Pursuant to the LaNova License Agreement, we paid LaNova an upfront cash payment of $25.0 million in June 2022 and may be obligated to pay milestone payments, which include up to $195.0 million in development and regulatory milestones and up to $880.0 million in sales milestones, and tiered royalty payments based on percentages (ranging from the mid-single digits to the mid-teens) of net sales (subject to customary deductions).

As part of the LaNova License Agreement, we also obtained the right of first negotiation for an exclusive license to develop, use, manufacture and commercialize other products containing components of the LaNova Product. In addition, we have the option to collaborate with LaNova on up to three additional antibody drug conjugate programs, initiated or proposed by either us or LaNova.

LM-302, now designated TPX-4589, is a potentially first-in-class anti-Claudin18.2 ADC that suppresses cell proliferation of gastric and pancreatic cell lines with nanomolar potency in preclinical models. It also has demonstrated efficacy in gastric and pancreatic cancer xenograft models. TPX-4589 is currently in Phase 1 clinical trials in both the United States and China, and the FDA has granted TPX-4589 three orphan drug designations for the treatment of pancreatic cancer, for the treatment of gastric cancer, including cancer of the gastroesophageal junction, and for the treatment of cholangiocarcinoma. The Phase 1 clinical trial in the United States is designed to evaluate the overall safety profile, pharmacokinetics, and preliminary efficacy and immunogenicity of TPX-4589 and includes a dose-finding portion followed by dose expansion in subjects with Claudin18.2+advanced solid tumors who have progressed or are intolerant to standard therapy or for whom standard therapy is not available. We anticipate providing additional guidance on the clinical development plan for TPX-4589 by early 2023, as well as presenting preclinical data at an upcoming medical conference by early 2023.

We will continue to engage in business development efforts to expand our portfolio where we can leverage our deep expertise in drug development and clinical trial execution in oncology. Our focus is to actively explore opportunities for acquisitions, partnerships, collaborations and license agreements for targeted therapy product candidates that would complement our strategic goals and research and development pipeline. We have evaluated a number of preclinical and clinical assets and platforms and continue to actively review opportunities.

In June 2022, we entered into a five-year strategic collaboration agreement (the MD Anderson Collaboration Agreement) with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”). Under the terms of the MD Anderson Collaboration Agreement, we will provide funding and support for preclinical and clinical studies to be conducted by MD Anderson in several solid tumors, including non-small cell lung cancers, gastrointestinal malignancies and endocrine cancers (the Studies). The initial focus of the Studies will be repotrectinib, and additional studies will include elzovantinib or TPX-0131. Pursuant to the MD Anderson Collaboration Agreement, we will provide total funding in an amount of $10.0 million for the performance of the Studies, such funding to be provided in increments of $1.0 million on a twice-yearly basis. The Studies will be overseen by a joint steering committee, which will provide technical, scientific, clinical and regulatory guidance, discuss and approve study budgets, and monitor the progress of the Studies.

Our approach to the discovery of new and potentially differentiated small-molecule drug candidates is to use a methodology anchored by our significant structure-based drug design expertise that exploits innovative protein-ligand interactions, coupled with a disciplined chemistry approach and deep enabling biology. We anticipate our internal and external exploration of oncology candidates will continue to include kinase targets and other oncogenic signaling proteins and pathways that address high unmet medical need. We currently have four internal discovery programs targeting aberrant GTPase signaling known to drive genomically defined cancers with significant unmet medical need. The most advanced programs target KRAS G12D and the p21 activated kinase, or “PAK” family. We are targeting the identification of two development candidates in the second half of 2022 with a goal to achieve at least one new IND

per year beginning in 2023. We anticipate providing details on our other two GTPase signaling discovery programs in the second half of 2022.

We have experienced disruptions to our business operations as a result of the COVID-19 pandemic. Due to the continued evolving and uncertain global impacts of the COVID-19 pandemic, including the omicron variant and future potential variants, we cannot precisely determine or quantify the impact this pandemic will have on our ongoing business, operations and financial performance. For our ongoing and planned clinical trials, while we anticipate and have experienced some temporary delays or disruptions due to the COVID-19 pandemic, in particular with respect to activation of additional clinical trial sites and patient enrollment, we continue to work closely with our contract research organizations (CROs) and clinical sites as we navigate and seek to mitigate the impact of COVID-19 on our clinical studies and current timelines. Measures we have taken in response to COVID-19, include where feasible, conducting remote clinical trial site activations and data monitoring, enabling patients to have routine tests conducted closer to home, allowing trial sites to evaluate certain patients remotely, in compliance with their local procedures, and direct-to-patient study drug shipping. In addition, we believe our current supply and plans for supply will be sufficient to meet our anticipated clinical development needs for our drug candidates through 2022. However, depending on the length and ultimate impact of the COVID-19 pandemic, and available manufacturing capacity at our suppliers, our suppliers could be adversely impacted, which may result in delays or disruptions in our current or future supply chain.

We will continue to assess the duration, scope and severity of the COVID-19 pandemic and the existing and potential impacts on our business, operations and financial performance, and we will continue to work closely with our third-party vendors, CROs, collaborators and other parties in order to seek to advance our drug candidates as quickly as possible, while making the health and safety of our employees and their families, healthcare providers, patients and communities a top priority. Please refer to our Risk Factors in Part II, Item IA of this Quarterly Report for further discussion of risks related to the COVID-19 pandemic.

Since our inception, we have incurred significant operating losses. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our drug candidates. As of June 30, 2022, we had an accumulated deficit of $714.3 million. For the six months ended June 30, 2022 and for the year ended December 31, 2021, we incurred net losses of approximately $197.5 million and $236.6 million, respectively. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.

To date, our operations have been financed primarily through the sale of common stock and convertible preferred stock. At June 30, 2022, we had $818.3 million of cash, cash equivalents and marketable securities.

In August 2020, we entered into an Open Market Sale AgreementSM with Jefferies LLC (ATM facility) under which we may offer and sell, from time to time, at our sole discretion, up to $250.0 million shares of our common stock. As of June 30, 2022, we had not yet sold any shares of our common stock under the ATM facility.

We will not generate revenue from product sales until we successfully complete clinical development and obtain regulatory approval for our drug candidates. If we obtain regulatory approval for any of our drug candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing and distribution.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. The COVID-19 pandemic and ongoing geopolitical events continue to evolve and have already resulted in a significant disruption of global financial markets. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and further disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the pandemic or geopolitical actions. If such further disruption occurs, we could experience an inability to access additional capital. If we fail to raise capital or enter into such agreements we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our drug candidates.

To date, we have not generated any revenue from product sales. If our development efforts for our drug candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales. If we enter into license or collaboration agreements for any of our drug candidates or intellectual property, such as our license agreements with Zai Lab (Shanghai) Co., Ltd. (Zai) that we executed in July 2020 (the Zai Repotrectinib Agreement) and January 2021, which was amended in March 2021 (the Zai Elzovantinib Agreement, and together with the Zai Repotrectinib Agreement, the Zai License Agreements), we may generate revenue in the future from payments as a result of such license or collaboration agreements. Under the Zai License Agreements, we recognized $0.1 million and $5.2 million of revenue for the three months ended June 30, 2022 and 2021, respectively, and $0.5 million and $30.4 million of revenue for the six months ended June 30, 2022 and 2021, respectively. Unless and until we are able to generate revenue from future product sales, we expect that our revenue, if any, will be derived primarily from the Zai License Agreements, as well as any collaborations or additional license agreements that we may enter into in the future. We cannot provide assurance as to the timing of future milestone or royalty payments or that we will receive any of these payments at all. We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of our drug candidates. We may never succeed in obtaining regulatory approval for any of our drug candidates.

We expense research and development costs to operations as incurred. Nonrefundable advance payments for services in advance of the performance of the related research and development activities are recorded as prepaid assets and recognized as expense in the period when the services are performed. Costs incurred in obtaining technology licenses are charged to research and development expenses if the technology licensed has not reached technological feasibility and has no alternative future use.

Our direct research and development expenses are tracked on a program-by-program basis and consist primarily of external costs, such as fees paid to consultants, central laboratories, contractors, CMOs and CROs in connection with our preclinical and clinical development activities. We allocate indirect expenses, such as employee salaries, fringe benefits, facilities, travel and other miscellaneous expenses, based on an estimated percentage of time worked on programs.

The table below summarizes our research and development expenses incurred by development program for the periods presented (in thousands):

Drug candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase substantially in connection with our ongoing and planned clinical and preclinical development activities in the near term and in the future. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our drug candidates.

The successful development of our drug candidates is highly uncertain. This is due to the numerous risks and uncertainties, including the following:

A change in the outcome of any of these variables with respect to the development of our drug candidates may significantly impact the costs and timing associated with the development of our drug candidates. We may never succeed in obtaining regulatory approval for any of our drug candidates.

Research and development activities are central to our business model. There are numerous factors associated with the successful commercialization of any of our drug candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs.

General and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation expense, for personnel in executive, finance, legal, commercial and other administrative functions. General and administrative expenses also include professional fees for legal, patent, accounting and tax-related services, insurance costs, recruiting costs, travel expenses and facility-related costs.

We anticipate that our general and administrative expenses will continue to increase as a result of transaction costs associated with the pending acquisition by Bristol-Myers Squibb, as well as increased payroll, expanded infrastructure and higher consulting, legal, accounting and investor relations costs, and director and officer insurance premiums associated with being a public company.

Other income, net consists of interest earned on cash, cash equivalents and our marketable securities.

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes. We evaluate these estimates and assumptions on an ongoing basis. We base our estimates on historical experience, knowledge of current events and actions we may undertake in the future, and on various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ materially from these estimates and assumptions.

There have been no significant changes to our critical accounting policies and use of estimates from our disclosure reported in “Critical Accounting Policies, Significant Judgements and Estimates” in the section titled “Management's Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, except as described in Note 2 to the interim unaudited condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q.

The following table summarizes our results of operations for the three months ended June 30, 2022 and 2021 (in thousands):

Revenue recognized during the three months ended June 30, 2022 was $0.1 million from the sale of clinical supply to Zai for supporting the Phase 1 clinical trial for elzovantinib in the Zai Territory. Revenue recognized during the three months ended June 30, 2021 was $5.2 million, consisting of $5.0 million earned upon the achievement of development milestones under the Zai Repotrectinib Agreement and $0.2 million from the sale of clinical supply to Zai for supporting the TRIDENT-1 Phase 2 clinical trials in the Zai Territory.

Research and development expenses increased $42.1 million to $86.8 million during the three months ended June 30, 2022 compared to $44.7 million during the three months ended June 30, 2021. The increase was primarily attributable to a $25.0 million

charge in the second quarter of 2022 for an upfront payment to LaNova for the in-licensing of its intellectual property that has not yet achieved regulatory approval, increased activities related to the ongoing clinical trials for the Phase 2 registrational portion of TRIDENT-1, discovery efforts and higher personnel-related expenses due to an increase in headcount. We expect that our research and development expenses will continue to increase in future periods with the advancement of our clinical programs and additional future clinical trials and discovery efforts.

General and administrative expenses increased $20.5 million to $37.7 million during the three months ended June 30, 2022 compared to $17.2 million during the three months ended June 30, 2021. The increase was primarily attributable to $17.7 million of transaction costs incurred in the second quarter of 2022 in connection with the pending acquisition by Bristol-Myers Squibb, primarily for outside legal and external financial advisory fees, and higher personnel-related expenses as a result of increased employee headcount, facility-related costs and professional fees, including those associated with product launch readiness.

Other income, net increased $0.9 million to $1.3 million during the three months ended June 30, 2022 compared to $0.4 million during the three months ended June 30,2021, primarily due to higher overall yields on our marketable securities and money market funds.

The following table summarizes our results of operations for the six months ended June 30, 2022 and 2021 (in thousands):

Revenue recognized during the six months ended June 30, 2022 was $0.5 million from the sale of clinical supply to Zai for supporting the TRIDENT-1 Phase 2 clinical trials and the Phase 1 clinical trial for elzovantinib in the Zai Territory. Revenue recognized during the six months ended June 30, 2021 was $30.4 million, consisting of $25.0 million related to an upfront payment received under the Zai Elzovantinib Agreement, $5.0 million earned upon the achievement of development milestones under the Zai Repotrectinib Agreement and $0.4 million from the sale of clinical supply to Zai for supporting the TRIDENT-1 Phase 2 clinical trials in the Zai Territory. We recognized the upfront payment as license revenue upon the delivery to Zai of the license and the associated technical know-how under the Zai Elzovantinib Agreement.

Research and development expenses increased $55.9 million to $141.8 million during the six months ended June 30, 2022 compared to $85.9 million during the six months ended June 30, 2021. The increase was primarily attributable to a $25.0 million charge in the second quarter of 2022 for an upfront payment to LaNova for the in-licensing of its intellectual property that has not yet achieved regulatory approval, increased activities related to the ongoing clinical trials for the Phase 2 registrational portion of TRIDENT-1, discovery efforts and higher personnel-related expenses due to an increase in headcount. We expect that our research

and development expenses will continue to increase in future periods with the advancement of our clinical programs and additional future clinical trials and discovery efforts.

General and administrative expenses increased $20.8 million to $58.0 million during the six months ended June 30, 2022 compared to $37.2 million during the six months ended June 30, 2021. The increase was primarily attributable to $17.7 million of transaction costs incurred in the second quarter of 2022 in connection with the pending acquisition by Bristol-Myers Squibb, primarily for outside legal and external financial advisory fees, and higher personnel-related expenses as a result of increased employee headcount, facility-related costs and professional fees, including those associated with product launch readiness, partially offset by a decrease in stock-based compensation expense of $2.2 million. During the six months ended June 30, 2021, we recorded a one-time charge of $5.6 million as stock-based compensation expense associated with the resignations of two board members and foreign tax withholding expenses of $1.6 million related to the upfront payment and development milestone payments received from Zai under the Zai License Agreements.

Other income, net increased $0.8 million to $1.8 million during the six months ended June 30, 2022 compared to $0.9 million during the six months ended June 30,2021, primarily due to higher overall yields on our marketable securities and money market funds.

At June 30, 2022, we had $818.3 million of cash, cash equivalents and marketable securities. Based on our current and anticipated level of operations, we believe that our cash, cash equivalents and marketable securities as of June 30, 2022 will be sufficient to fund current operations for at least one year from the date that this Quarterly Report is filed with the SEC. Our cash, cash equivalents and marketable securities include money market funds, government agency securities, corporate debt, commercial paper and U.S. treasuries. We maintain established guidelines relating to diversification and maturities of our investments to preserve principal and maintain liquidity.

Since inception, our operations have been financed primarily through the sale of common stock and convertible preferred stock. Through June 30, 2022, we received net proceeds of approximately $1.3 billion from the issuance of common stock and convertible preferred stock and through stock option exercises.

In August 2020, we entered into the ATM facility, under which we may offer and sell, from time to time, at our sole discretion, up to $250.0 million shares of our common stock. As of June 30, 2022, we had not yet sold any shares of our common stock under the ATM facility.

On May 4, 2022, we entered into the LaNova License Agreement with LaNova. Pursuant to the LaNova License Agreement, we paid LaNova an upfront cash payment of $25.0 million in June 2022 and may be obligated to pay milestone payments, which include up to $195.0 million in development and regulatory milestones and up to $880.0 million in sales milestones, and tiered royalty payments based on percentages (ranging from the mid-single digits to the mid-teens) of net sales (subject to customary deductions).

On June 23, 2022, we entered into the MD Anderson Collaboration Agreement, pursuant to which we will provide total funding in an amount of $10.0 million for the performance of certain preclinical and clinical studies to be conducted by MD Anderson, such funding to be provided in increments of $1.0 million on a twice-yearly basis. As of June 30, 2022, we have not made any funding to MD Anderson.

Since inception, we have primarily devoted our resources to build infrastructure, conduct research and development, including clinical trials, perform business and financial planning, and raise capital. To fund future operations, we will need to raise significant additional capital.

Additionally, we are subject to a variety of specified liquidity and capitalization restrictions under the Merger Agreement. Unless we obtain Bristol-Myers Squibb’s prior written consent (which consent may not be unreasonably withheld, delayed or conditioned) and except (i) as required or expressly contemplated by the Merger Agreement, (ii) as required by applicable laws or (iii)

as set forth in the confidential disclosure schedule we delivered to Bristol-Myers Squibb, we may not, among other things and subject to certain exceptions and aggregate limitations, incur additional indebtedness, issue additional shares of our common stock outside of our equity incentive plans, repurchase shares of our common stock, pay dividends, acquire or dispose of material assets or property, amend, modify or enter into material contracts or make certain additional capital expenditures.

Without taking into account the planned acquisition by Bristol-Myers Squibb, the amount and timing of future funding requirements will depend on many other factors, including the timing and results of our ongoing development activities, the potential expansion of our current development programs, potential new development programs and related general and administrative support. We may seek to obtain additional financing in the future through equity or debt financings or other sources, such as potential collaboration agreements. We cannot make assurances that anticipated additional financing will be available to us on favorable terms, or at all. The COVID-19 pandemic and ongoing geopolitical events continue to evolve and have already resulted in a significant disruption of global financial markets. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and further disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the pandemic or geopolitical actions. If such further disruption occurs, we could experience an inability to access additional capital, which could in the future negatively affect our capacity to fund research and development programs, including discovery research, preclinical and clinical development activities and activities to support commercialization. Although we have previously been successful in obtaining financing through our equity securities offerings, there can be no assurance that we will be able to do so in the future.

The following table summarizes our sources and uses of cash and cash equivalents for each of the periods presented (in thousands):

Net cash used in operating activities was approximately $163.6 million in the six months ended June 30, 2022, primarily due to spending on ongoing research and development activities related to the Phase 2 registrational portion of TRIDENT-1, the Phase 1 clinical trial for elzovantinib, the Phase 1/2 clinical trial for TPX-0046, the Phase 1/2 clinical trial for TPX-0131, discovery efforts, payments made for professional services in connection with the pending acquisition by Bristol-Myers Squibb and other general and administrative activities. In addition, we paid an upfront cash payment of $25.0 million to LaNova in the six months ended June 30, 2022.

Net cash used in operating activities in the six months ended June 30, 2021 was approximately $58.1 million, primarily due to spending on the Phase 2 registrational portion of TRIDENT-1, the Phase 1 clinical trial for elzovantinib, the Phase 1/2 clinical trial for TPX-0046 and the Phase 1/2 clinical trial for TPX-0131. Cash used to fund operations was partially offset by a $25.0 million upfront payment received under the Zai Elzovantinib Agreement and $5.0 million of development milestone payments received under the Zai Repotrectinib Agreement.

Net cash provided by investing activities was approximately $16.5 million in the six months ended June 30, 2022, consisting of approximately $18.5 million from the maturities (net of purchases) of marketable securities, partially offset by approximately $2.0 million for the purchases of property and equipment. Net cash used in investing activities was approximately $87.2 million in the six months ended June 30, 2021, consisting of approximately $86.3 million for the purchases (net of maturities) of marketable securities and approximately $0.9 million for the purchases of property and equipment .

Net cash provided by financing activities was approximately $9.4 million and $19.0 million in the six months ended June 30, 2022 and 2021, respectively, from the sale of common stock to employees under our equity compensation plans.

During the six months ended June 30, 2022, there were no material changes to our contractual obligations and commitments as set forth in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2021.

We are exposed to market risks in the ordinary course of our business. These risks primarily relate to equity price risk and interest rate fluctuations. Substantially all of our cash, cash equivalents and marketable securities are held at two financial institutions. Due to the financial strength of the depository institutions, we believe these financial institutions represent a minimal credit risk. Cash amounts held at financial institutions are insured by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. At June 30, 2022, cash, cash equivalents and marketable securities totaling $818.0 million are either not subject to FDIC insurance, or exceed the FDIC insured limit. Our cash, cash equivalents and marketable securities are invested in short term, high grade securities, and as a result, we believe represent a minimal credit risk. If a 10% change in interest rates were to have occurred on June 30, 2022, this change would not have had a material effect on the fair value of our investment portfolio as of that date.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our President and Chief Executive Officer (our principal executive officer) and Executive Vice President and Chief Financial Officer (our principal financial officer), as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

As of June 30, 2022, we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2022.

There has been no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. In addition, we have not experienced any material impact to our internal controls over financial reporting as a result of the COVID-19 pandemic, including from employees working remotely. We are continually monitoring and assessing the impact of the COVID-19 pandemic on our internal controls over financial reporting.

Between June 24, 2022 and June 29, 2022, four complaints were filed in federal court by purported stockholders of ours regarding the Merger. The first complaint was filed on June 24, 2022 in the United States District Court for the Southern District of New York and is captioned O’Dell v. Turning Point Therapeutics, Inc., et al., Case No. 1:22-cv-05352. The second and third complaints were filed on June 27, 2022 in the United States District Court for the Southern District of New York and are captioned Hopkins v. Turning Point Therapeutics, Inc., et al., Case No. 1:22-cv-05433 and Whitfield v. Turning Point Therapeutics, Inc., et al., Case No. 1:22-cv-05439. The fourth complaint was filed on June 29, 2022 in the United States District Court for the District of

Delaware and is captioned Kent v. Turning Point Therapeutics, Inc. et al., Case No. 1:22-cv-00879. The aforementioned four complaints are collectively referred to as the “Complaints.” The Complaints name as defendants us and each member of our board of directors (collectively, the Turning Point Defendants). The Complaints allege violations of Section 14(d) and Section 14(e) of the Exchange Act, as well as Rule 14a-9 and Rule 14d-9 promulgated thereunder, against all Turning Point Defendants and assert violations of Section 20(a) of the Exchange Act against the members of our board of directors. The Complaints collectively seek, among other relief, (i) injunctive relief preventing the consummation of the transactions contemplated by the Merger Agreement, (ii) rescission and/or rescissory damages in the event the transactions contemplated by the Merger Agreement are consummated, (iii) an award of plaintiffs’ expenses and attorneys’ fees, and (iv) disclosure of certain information requested by the plaintiffs.

Each of the Turning Point Defendants intend to vigorously defend these actions. We believe that the Complaints are without merit and have not recorded an expense related to the outcome of these litigations because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.

Between June 28, 2022 and July 11, 2022, we had also received four stockholder demand letters and one draft complaint, which generally seek that certain allegedly omitted information in the Schedule 14D-9 be disclosed. On July 8, 2022, we also received a letter from a purported stockholder seeking to inspect certain of our books and records pursuant to Section 220 of the Delaware General Corporation Law.

We face many risks and uncertainties, as more fully described in this section under the heading “Risk Factors.” Some of these risks and uncertainties are summarized below. The summary below does not contain all of the information that may be important to you, and you should read this summary together with the more detailed discussion of these risks and uncertainties contained in “Risk Factors.”

Investing in our common stock involves a high degree of risk. In addition to the information included or incorporated by reference in this Quarterly Report and in our other public filings, you should carefully consider the risks described below in evaluating our company. Our business, financial condition or results of operations could be harmed by any of these risks. The risks and uncertainties described below are not the only ones we face. Additional risks not currently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations, including as a result of the potential acquisition by Bristol-Myers Squibb. We have marked with an asterisk (*) those risk factors that reflect changes from the risk factors previously disclosed in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on February 28, 2022.

We may not complete the pending transactions with Bristol-Myers Squibb within the time frame we anticipate, or at all, which could have an adverse effect on our business, financial results and/or operations.*

On June 2, 2022, we entered into an Agreement and Plan of Merger (the Merger Agreement) with Bristol-Myers Squibb Company, a Delaware corporation (Bristol-Myers Squibb), and Rhumba Merger Sub Inc., a Delaware corporation and a wholly owned subsidiary of Bristol-Myers Squibb (Purchaser). Pursuant to the Merger Agreement, and upon the terms and subject to the conditions thereof, Purchaser commenced a cash tender offer on June 17, 2022 (the Offer) to acquire all of the issued and outstanding shares of our common stock at a price per share of $76.00 to the seller in cash, without interest, subject to any applicable withholding of taxes. Following the completion of the Offer, Purchaser will merge with and into our company (the Merger), with our company surviving as a wholly owned subsidiary of Bristol-Myers Squibb, and each outstanding share of our common stock (other than shares of common stock held by us as treasury stock, or owned by Bristol-Myers Squibb, Purchaser or any other direct or indirect wholly owned subsidiary of Bristol-Myers Squibb, or irrevocably accepted for purchase in the Offer, or held by stockholders who are entitled to demand, and who properly demand, appraisal rights under Delaware law) will be converted into the right to receive $76.00 per share in cash, without interest, subject to any withholding of taxes required by applicable law.

The failure to complete the Merger may adversely affect our business, financial results and/or operations.*

The completion of the Merger will be conditioned on (1) at least a majority of the shares of our outstanding common stock having been validly tendered into and not withdrawn from the Offer, (2) receipt of certain regulatory approvals, including expiration of the respective waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the German Act Against Restraints of Competition, (3) there being no restraint enjoining, making illegal or otherwise prohibiting the transactions contemplated by the Merger Agreement, (4) the accuracy of certain representations and warranties that we made and compliance by us with certain covenants contained in the Merger Agreement, subject to customary qualifications, (5) there not having been a “Material Adverse Effect” (as defined in the Merger Agreement) with respect to us, and (6) other customary conditions. In addition, the Merger Agreement may be terminated under certain specified circumstances, including, but not limited to, a change in the recommendation of our board of directors or a termination of the Merger Agreement by us to enter into an agreement for a “Superior Proposal,” as defined in the Merger Agreement. As a result, we cannot assure you that the transactions with Bristol-Myers Squibb will be completed, or that, if completed, it will be exactly on the terms set forth in the Merger Agreement or within the expected time frame.

If the Merger is not completed within the expected time frame or at all, we may be subject to a number of material risks. The price of our common stock may decline to the extent that current market prices reflect a market assumption that the Merger will be completed. The failure to complete the Merger also may result in negative publicity and negatively affect our relationship with our stockholders, employees, collaborators, vendors, suppliers, regulators and other business partners. We may also be required to devote significant time and resources to litigation related to any failure to complete the merger or related to any enforcement proceeding commenced against us to perform our obligations under the Merger Agreement.

The announcement and pendency of the transactions with Bristol-Myers Squibb could adversely affect our business, financial results and/or operations.*

Our efforts to complete the transactions contemplated in the Merger Agreement could cause substantial disruptions in, and create uncertainty surrounding, our business, which may materially adversely affect our results of operation and our business. Uncertainty as to whether the transactions will be completed may affect our ability to recruit prospective employees or to retain and motivate existing employees. Employee retention may be particularly challenging while the transactions are pending because employees may experience uncertainty about their roles following the Merger. A substantial amount of our management’s and employees’ attention is being directed toward the completion of the transactions and thus is being diverted from our day-to-day operations. Uncertainty as to our future could adversely affect our business and our relationship with collaborators, vendors, suppliers, regulators and other business partners. For example, vendors, suppliers, collaborators and other counterparties may defer decisions concerning working with us, or seek to change existing business relationships with us. Changes to or termination of existing business relationships could adversely affect our results of operations and financial condition, as well as the market price of our common stock. The adverse effects of the pendency of the transactions could be exacerbated by any delays in completion of the transactions or termination of the Merger Agreement.

While the Merger Agreement is in effect, we are subject to restrictions on our business activities.*

While the Merger Agreement is in effect, we are subject to restrictions on our business activities, generally requiring us to conduct our business in the ordinary course, consistent with past practice, and subjecting us to a variety of specified limitations absent Bristol-Myers Squibb’s prior consent. These limitations include, among other things, restrictions on our ability to acquire other businesses and assets, dispose of our assets, make investments, enter into certain contracts, repurchase or issue securities, pay dividends, make capital expenditures, take certain actions relating to intellectual property, amend our organizational documents and incur indebtedness. These restrictions could prevent us from pursuing strategic business opportunities, taking actions with respect to our business that we may consider advantageous and responding effectively and/or timely to competitive pressures and industry developments, and may as a result materially and adversely affect our business, results of operations and financial condition, our stock price and our perceived acquisition value, regardless of whether the Merger is completed.

The Merger Agreement limits our ability to pursue alternative transactions, which could deter a third party from proposing an alternative transaction.*

The Merger Agreement contains provisions that, subject to certain exceptions, limit our ability to, directly or indirectly, (i) solicit, initiate or knowing facilitate or knowing encourage (including by way of furnishing non-public information) any inquiries regarding, or the marking of any proposal or offer that constitutes, or could reasonably be expected to lead to, an acquisition proposal, (ii) engage in, continue or otherwise participate in any discussions or negotiations regarding, or furnish to any other person any non-public information relating to or for the purpose of knowing encouraging or facilitating, an acquisition proposal or any proposal or offer that could reasonably be expected to lead to an acquisition proposal, or (iii) enter into any letter of intent, acquisition agreement, agreement in principle of similar agreement with respect to an acquisition proposal or any proposal or offer that could reasonably be expected to lead to an acquisition proposal. It is possible that these or other provisions in the Merger Agreement, including a termination fee of $138.0 million payable to Bristol-Myers Squibb under certain circumstances, might discourage a potential competing acquirer that might have an interest in acquiring all or a significant part of our outstanding common stock from considering an acquisition or might result in a potential competing acquirer proposing an overall lower per-share consideration amount than it might otherwise have proposed to offer.

If the Merger occurs, our stockholders will not be able to participate in any upside to our business.*

Upon the consummation of the Merger, our stockholders will receive $76.00 in cash, without interest, subject to any applicable withholding of taxes, per share of our common stock owned by them but will not receive any shares of Bristol-Myers Squibb common stock. As a result, if our business following the Merger performs well, our current stockholders will not receive any additional consideration, and will therefore not receive any benefit from the performance of our business.

Additional lawsuits may be filed against us and the members of our board of directors arising out of the proposed Merger, which may delay or prevent the proposed Merger.*

Additional putative stockholder complaints, including stockholder class action complaints, and other complaints may be filed against us, our board of directors, Bristol-Myers Squibb, Bristol-Myers Squibb’s board of directors, and others in connection with the transactions contemplated by the Merger Agreement. The outcome of litigation is uncertain, and we may not be successful in defending against any such future claims. Lawsuits that may be filed against us, our board of directors, Bristol-Myers Squibb, or Bristol-Myers Squibb’s board of directors could delay or prevent the consummation of the Merger, divert the attention of our management and employees from our day-to-day business, and otherwise adversely affect us financially.

We have incurred, and will continue to incur, direct and indirect costs as a result of the pending transactions with Bristol-Myers Squibb.*

We have incurred, and will continue to incur, significant costs and expenses, including fees for professional services and other transaction costs, in connection with the pending transactions with Bristol Myer Squibb. We must pay a material portion of these costs and expenses whether or not the Merger is completed. There are a number of factors beyond our control that could affect the total amount or the timing of these costs and expenses, any of which could materially and adversely affect our business, prospects, financial condition and results of operations. Many of the expenses that will be incurred, by their nature, are difficult to estimate accurately.

The following risk factors do not take into account the planned acquisition by Bristol-Myers Squibb and assume that we remain a stand-alone company except as otherwise noted.

Risks Related to the Discovery and Development of Our Drug Candidates and Regulatory Approval

We are highly dependent on the success of our lead drug candidate, repotrectinib, which is currently in a Phase 2 potentially registrational clinical trial, and our other drug candidates which are in early clinical development. We have not successfully completed late-stage clinical trials or obtained regulatory approval for any drug candidate. We may never obtain approval for any of our drug candidates or achieve or sustain profitability.*

Our future success is highly dependent on our ability to obtain regulatory approval for, and then successfully commercialize, our lead product candidate, repotrectinib, and our other drug candidates which are in earlier stages of development. We currently have no products that are approved for sale. Our Phase 2 registrational portion of our TRIDENT-1 clinical trial for our lead drug candidate, repotrectinib, is ongoing and our other drug candidates currently in clinical trials are only in Phase 1 studies. There can be no assurance that repotrectinib or our other drug candidates in development will achieve success in their clinical trials or obtain regulatory approval.

Our ability to generate product revenues, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of repotrectinib or other drug candidates in development. The success of our drug candidates, including repotrectinib, will depend on several factors, including the following:

Many of these factors are beyond our control, and it is possible that none of our drug candidates will ever obtain regulatory approval even if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our drug candidates, which would materially harm our business. For example, our business could be harmed if results of our clinical trials of repotrectinib or our other drug candidates vary adversely from our expectations.

Our assumptions about the EXP-1 cohort to support a potential NDA for the treatment of patients with ROS1+ metastatic NSCLC who have not been treated with a ROS1 TKI may not be accurate. We held a pre-NDA meeting with the FDA in June 2022 after which we received feedback on next steps toward a potential NDA submission for repotrectinib, including the planned patient follow-up within the ROS1+advanced NSCLC patient cohorts. The FDA’s guidance at that meeting may be subject to change, including on the basis of the detailed study results from the ROS1+ advanced NSCLC cohorts of the TRIDENT-1 study. A change in the assumptions or FDA requirements for NDA acceptance for filing and approval may delay our development timelines.

Drug development involves a lengthy and expensive process. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of repotrectinib or our other drug candidates.*

We currently have five drug candidates in clinical development, and the risk of failure is high. We are unable to predict when or if our drug candidates will prove effective or safe in humans or will obtain marketing approval. Before obtaining marketing approval from regulatory authorities for the sale of any drug candidate, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our drug candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to the outcome. A failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim or preliminary results of a clinical trial do not necessarily predict final results. In particular, the small number of patients and limited geographies in our early clinical trials may make the results of these trials less predictive of the outcome of later clinical trials. Although we have observed encouraging preliminary objective response rates (ORRs) in the Phase 1 portion of our ongoing TRIDENT-1 clinical trial of repotrectinib, the primary objectives were to determine the safety, tolerability and maximum tolerated dose of repotrectinib and to determine a recommended Phase 2 dose and not to demonstrate efficacy. The assessments of efficacy from this portion of the clinical trial were not designed to demonstrate statistical significance and may not be predictive of the results of further clinical trials of repotrectinib. Additionally, the early interim data we reported from the Phase 2 portion of TRIDENT-1 in August 2020, January 2021 and October 2021 was only physician assessed data from subsets of patients and may not be predictive of the final results of the trial. Furthermore, the topline data we reported in April 2022 from the Phase 1 and Phase 2 portions of the TRIDENT-1 study may be subject to change following a more comprehensive review of the data and results, and as patient enrollment and treatment continues and more patient data become available. The preliminary interim data we reported from both our elzovantinib Phase 1 SHIELD-1 clinical trial in October 2020 and October 2021 and our TPX-0046 Phase 1 SWORD-1 clinical trial in April 2021, were only physician assessed data from patients enrolled in the dose escalation portions of each trial and may not be predictive of the final results of the trials or of any further trials of elzovantinib or TPX-0046.

We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to obtain marketing approval or commercialize our drug candidates, including:

Our product development costs will increase if we experience delays in preclinical studies or clinical trials or in obtaining marketing approvals. We do not know if any of our planned preclinical studies or clinical trials will begin in a timely basis or at all. We do not know whether any of our ongoing clinical trials will need to be restructured or will be completed on schedule, or at all. For example, the FDA may place a partial or full clinical hold on any of our clinical trials for a variety of reasons. In February 2018, we received a Deficiency–Potential Hold Issues letter from the FDA stating that the number of patients treated in the Phase 1 portion of TRIDENT-1 exceeded the protocol-specified dose escalation enrollment plan. Additionally, the Development Safety Update Report (DSUR) and the Investigator’s Brochure (IB) had not been updated with available clinical safety information. Following discussion with the FDA, our IND was placed on partial clinical hold pending the submission of an amended protocol, an updated DSUR and updated IB. The partial clinical hold was removed on June 29, 2018 after the requested documents were revised and TRIDENT-1 resumed patient enrollment.

Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our drug candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our drug candidates and may harm our business and results of operations.

Any delays in the commencement or completion, or termination or suspension, of our ongoing, planned or future clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.*

Before we can initiate clinical trials of a drug candidate in any indication, we must submit the results of preclinical studies to the FDA or comparable foreign regulatory authorities along with other information, including information about the drug candidate’s chemistry, manufacturing and controls and our proposed clinical trial protocol, as part of an IND or similar regulatory filing.

Before obtaining marketing approval from the FDA or comparable foreign regulatory authorities, for the sale of repotrectinib or any other drug candidate in any indication, we must conduct extensive clinical studies to demonstrate safety and efficacy. Clinical testing is expensive, time consuming and uncertain as to outcome. In addition, we expect to rely in part on preclinical, clinical and quality data generated by our CROs and other third parties for regulatory submissions for our drug candidates. While we have or will have agreements governing these third parties’ services, we have limited influence over their actual performance. If these third parties do not make data available to us, or, if applicable, make regulatory submissions in a timely manner, in each case pursuant to our agreements with them, our development programs may be significantly delayed and we may need to conduct additional studies or

collect additional data independently. In either case, our development costs would increase. We will require the acceptance by the FDA of an IND prior to initiating any clinical trials in the United States for any future combination studies of any of our drug candidates, or for any of our future potential drug candidates. The FDA may require us to conduct additional preclinical studies for any drug candidate before it allows us to initiate clinical trials under any IND, which may lead to additional delays and increase the costs of our preclinical development programs.

Any delays in the commencement or completion of our ongoing, planned or future clinical trials could significantly affect our product development costs. We do not know whether our planned trials will begin on time or at all, or be completed on schedule, if at all. The commencement and completion of clinical trials can be delayed for a number of reasons, including delays related to:

We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs/ECs of the institutions in which such trials are being conducted, by a Data Monitoring Committee for such trial or by the FDA. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a pharmaceutical, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to IRBs/ECs for reexamination, which may impact the costs, timing or successful completion of a clinical trial.

Certain of our scientific advisors or consultants who have received compensation from us are investigators for our clinical trials. Under certain circumstances, we may be required to report some of these relationships to the FDA. Although we believe our existing relationships are within the FDA’s guidelines, the FDA may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA and may ultimately lead to the denial of marketing approval of repotrectinib or other drug candidates. If we experience delays in the completion of, or termination of, any clinical trial of repotrectinib or any other drug candidate, the commercial prospects of such drug candidate will be harmed, and our ability to generate product revenues will be delayed. Moreover, any delays in completing our clinical trials will increase our costs, slow down our development and approval process and jeopardize our ability to commence product sales and generate revenues, which may harm our business, financial condition, results of operations and prospects significantly.

If we experience delays or difficulties in enrolling patients in our ongoing or planned clinical trials, our receipt of necessary regulatory approval could be delayed or prevented.*

We may not be able to initiate or continue our ongoing or planned clinical trials for our drug candidates if we are unable to identify and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA. In addition, some of our competitors may have planned or ongoing clinical trials or expanded access programs for approved and/or investigational drugs that would treat the same patients as repotrectinib or our other drug candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in our competitors’ clinical trials or expanded access programs. This is relevant for our development of repotrectinib for the treatment of patients with ROS1+ advanced NSCLC, NTRK+ advanced solid tumors and KRAS mutant G12D advanced solid tumors; development of elzovantinib for the treatment of patients with MET+ advanced solid tumors and EGFR mutant MET-amplified advanced NSCLC; development of TPX-0046 for the treatment of patients with RET+ advanced solid tumors; development of TPX-0131 for the treatment of patients with ALK+ NSCLC; and development of TPX-4589 for the treatment of patients with Claudin18.2+ advanced solid tumors, indications for which approved and/or investigational drugs are competing for clinical trial participants. Patient enrollment is also affected by other factors, including:

Our inability to enroll and retain a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs, which would cause the value of our company to decline and limit our ability to obtain additional financing.

The COVID-19 pandemic has and could adversely impact our business in the future, including our ongoing and planned clinical trials.*

Our business could be materially adversely affected by the effects of health epidemics. Health epidemics, such as the ongoing COVID-19 pandemic in the United States and in other countries in which we have planned or active clinical trial sites and where our third party manufacturers operate, has impacted and could impact our business and clinical trials in the future, including:

Such disruptions could impede, delay, limit or prevent completion of our ongoing clinical trials and preclinical studies or commencement of new clinical trials and ultimately lead to the delay or denial of regulatory approval of our product candidates, which would seriously harm our operations and financial condition and increase our costs and expenses. Measures we have taken in response to COVID-19, include where feasible, conducting remote clinical trial site activations and data monitoring, enabling patients to have routine tests conducted closer to home, allowing trial sites to evaluate certain patients remotely, in compliance with their local procedures and direct-to-patient study drug shipping. Such greater dependency on electronic monitoring could prove to be less reliable and could increase data privacy and cybersecurity risks. However, despite these efforts, we have experienced some temporary delays or disruptions due to the COVID-19 pandemic, in particular with respect to activation of additional clinical trial sites and patient screening and enrollment. We may also experience delays or disruptions in trial data collection and analysis. These delays could have an adverse impact on our timelines and our business. If patients drop out of our trials, miss scheduled doses or follow-up visits or otherwise fail to follow trial protocols, or if our trials are otherwise disputed due to COVID-19 or actions taken to slow its spread, the integrity of data from our trials may be compromised or not accepted by the FDA or other regulatory authorities, which would represent a significant setback for the applicable program and could have an adverse impact on our business. The COVID-19 pandemic could also affect the business of the FDA, EMA or other health authorities, which could result in delays in meetings related to planned or completed clinical trials and ultimately of reviews and approvals of our product candidates. The global COVID-19 pandemic continues to evolve. The extent to which the COVID-19 pandemic may impact our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. Additionally, although we are currently not aware of any material impacts on our supply chain of our current or potential product candidates as a result of the COVID-19 pandemic, some of our third-party manufacturers which we use for the supply of materials for product candidates or other materials necessary to manufacture product to conduct preclinical tests and clinical trials and CROs that we may utilize may be impacted by COVID-19, and should they experience continued disruptions, such as temporary closures or suspension of services, we would likely experience delays in advancing clinical trials. Accordingly, while we have not yet experienced material adverse effects to our business as a result of the COVID-19 pandemic, the ultimate impact of the COVID-19 pandemic or a similar health epidemic is highly uncertain and could have negative impact our business, financial condition and operating results.

Adverse side effects or other safety risks associated with repotrectinib, elzovantinib or our other drug candidates could delay or preclude approval, cause us to suspend or discontinue clinical trials or abandon further development, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.

Results of clinical trials of our drug candidates could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by our drug candidates could result in the delay, suspension or termination of clinical trials by us or the FDA for a number of reasons. Additionally, due to the high mortality rates of the cancers for which we are initially pursuing development and the pretreated nature of many patients in our clinical trials of our drug candidates, a material percentage of patients in these clinical trials may die during a trial, which could impact development of our drug candidates. If we elect or are required to delay, suspend or terminate any clinical trial, the commercial prospects of our drug candidates will be harmed and our ability to generate product revenues from this drug candidate will be delayed or eliminated. Serious adverse events observed

in clinical trials could hinder or prevent market acceptance of our drug candidates. Any of these occurrences may harm our business, prospects, financial condition and results of operations significantly.

Moreover, if our drug candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect to abandon or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for our drug candidates, if approved. We may also be required to modify our study plans based on findings in clinical trials of our drug candidates. Many drugs that initially showed promise in early stage testing have later been found to cause side effects that prevented further development. In addition, regulatory authorities may draw different conclusions or require additional testing to confirm these determinations. Zai has rights to develop and commercialize products containing repotrectinib and products containing elzovantinib within Greater China. If serious adverse events occur during any clinical trials Zai conducts with respect to repotrectinib or elzovantinib, the FDA and other regulatory authorities may delay, limit or deny approval of repotrectinib or elzovantinib or require us to conduct additional clinical trials as a condition to marketing approval, which would increase our costs.

It is possible that as we test our drug candidates in larger, longer and more extensive clinical trials, including with different dosing regimens, or as the use of our drug candidates becomes more widespread following any regulatory approval, illnesses, injuries, discomforts and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients. If such side effects become known later in development or upon approval, if any, such findings may harm our business, financial condition, results of operations and prospects significantly.

In addition, if any of our drug candidates receive marketing approval, and we or others later identify undesirable side effects caused by treatment with such drug, a number of potentially significant negative consequences could result, including:

Any of these events could prevent us from achieving or maintaining market acceptance of our drug candidates, if approved, and could significantly harm our business, financial condition, results of operations and prospects.

Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data.*

From time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials, such as the preliminary interim and topline data from the Phase 1 and Phase 2 portions of our repotrectinib TRIDENT-1 clinical trial, and the preliminary interim data from our elzovantinib Phase 1 SHIELD-1 clinical trial and from the Phase 1 portion of our TPX-0046 Phase 1/2 SWORD-1 clinical trial. The interim updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. For our TRIDENT-1 data updates in August 2020, January 2021 and October 2021, we reported preliminary safety and efficacy data as assessed by trial investigators, or physician assessment, using standard RECIST 1.1 criteria. We also reported topline BICR data from all of the ROS1+NSCLC cohorts from the Phase 1/2 TRIDENT-1 study in April 2022. The topline data from TRIDENT-1,

including related findings and conclusions, are subject to change following a more comprehensive review of the data related to the trial, and as the trial continues to enroll, treatment continues and more patient data becomes available.

We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, preliminary and topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. In addition, we may report interim analyses of only certain endpoints rather than all endpoints. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse changes between interim data and final data could significantly harm our business and prospects. Further, additional disclosure of interim data by us or by our competitors in the future could result in volatility in the price of our common stock.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular drug candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is typically selected from a more extensive amount of available information. You or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug, drug candidate or our business. If the preliminary or topline data that we report differ from late, final or actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, repotrectinib or any other drug candidates may be harmed, which could harm our business, financial condition, results of operations and prospects.

If we are unable to successfully develop companion diagnostic tests for our drug candidates that require such tests, or experience significant delays in doing so, we may not realize the full commercial potential of these drug candidates.*

We are developing or plan to develop, either by ourselves or with collaborators, companion diagnostic tests for our drug candidates for certain indications. To be successful, we or our collaborators will need to address a number of scientific, technical, regulatory and logistical challenges. We have no prior experience with medical device or diagnostic test development. If we choose to develop and seek FDA approval for companion diagnostic tests on our own, we will require additional personnel. We may rely on third parties for the design, development and manufacture of companion diagnostic tests for our therapeutic drug candidates that require such tests. If these parties are unable to successfully develop companion diagnostics for these therapeutic drug candidates, or experience delays in doing so, we may be unable to enroll enough patients for our current and planned clinical trials, the development of these therapeutic drug candidates may be adversely affected, these therapeutic drug candidates may not obtain marketing approval, and we may not realize the full commercial potential of any of these therapeutics that obtain marketing approval. We have developed a prototype companion diagnostic that is being used as a clinical trial assay to confirm the presence of ROS1+ or NTRK+ gene fusions in patients in the Phase 2 portion of TRIDENT-1. We are also enrolling patients into the Phase 2 portion of TRIDENT-1 based on the results of select laboratory developed tests (LDTs) and other tests used by the clinical sites. There is no guarantee that the results obtained from such LDTs or other tests will be consistent with the results obtained from our prototype companion diagnostic. Any inconsistency may result in inclusion of patients with false positive test results that could adversely impact the results of the clinical trial and adversely impact the development and approval of a companion diagnostic. We have selected a diagnostic partner to support development of the companion diagnostic and submission of a pre-market approval application to the FDA. In May 2019, the FDA approved an Investigational Device Exemption (IDE) for use of this clinical trial assay in the Phase 2 portion of TRIDENT-1 and the assay was CE-marked under the In-Vitro Diagnostic Medical Device Directive in Europe (a CE Mark is a mandatory conformity marking for certain products sold within the European Economic Area). An approved companion diagnostic may be required in order to obtain marketing approval of repotrectinib in patients with ROS1+ advanced NSCLC and patients with NTRK+ advanced solid tumors. Any failure to successfully develop this companion diagnostic may prevent us from ultimately seeking approval for repotrectinib in patients with ROS1+ advanced NSCLC and patients with NTRK+ advanced solid tumors. As a result, our business, results of operations and financial condition could be materially harmed.

The failure to obtain required regulatory clearances or approvals for any companion diagnostic tests that we may pursue may prevent or delay approval of any of our drug candidates. Moreover, the commercial success of any of our drug candidates that require a companion diagnostic will be tied to the receipt of any required regulatory clearances or approvals and the continued availability of such tests.

In connection with the clinical development of our drug candidates for certain indications, we may work with collaborators to develop or obtain access to companion diagnostic tests to identify appropriate patients for our drug candidates. We may rely on third

parties for the development, testing and manufacturing of these companion diagnostics, the application for and receipt of any required regulatory clearances or approvals, and the commercial supply of these companion diagnostics. The FDA and foreign regulatory authorities regulate companion diagnostics as medical devices that will likely be subject to analytical and clinical validation studies in conjunction with the clinical trials for drug candidates, and which will require separate regulatory clearance or approval prior to commercialization. This process could include additional meetings with health authorities, such as a pre-submission meeting and the requirement to submit an IDE. In the case of a companion diagnostic that is designated as “significant risk device,” such as the clinical trial assay we are using in the Phase 2 portion of TRIDENT-1, approval of an IDE by the FDA and IRB is required before such diagnostic is used in conjunction with the clinical trials for a corresponding drug candidate. In May 2019, the FDA approved an IDE for the clinical trial assay we are using in the Phase 2 portion of TRIDENT-1. We or our third-party collaborators may fail to obtain the required regulatory clearances or approvals in the United States or in relevant geographies outside the United States, which could prevent or delay approval of our drug candidates in such geographies. In addition, the commercial success of any of our drug candidates that require a companion diagnostic will be tied to and dependent upon the receipt of required regulatory clearances or approvals and the continued ability of such third parties to make the companion diagnostic commercially available to us on reasonable terms in the relevant geographies.

We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we focus on research programs and drug candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other drug candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and drug candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular drug candidate, we may relinquish valuable rights to that drug candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such drug candidate.

We may not be successful in our efforts to design additional potential drug candidates.

A key element of our strategy is to apply our knowledge and our understanding of the structure, biology and activity of kinase inhibitors to design drug candidates. The therapeutic design and development activities that we are conducting may not be successful in developing drug candidates that are useful in treating cancer or other diseases. Our research programs may initially show promise in identifying potential drug candidates, yet fail to yield drug candidates for clinical development for a number of reasons, including:

Research programs to identify and design new drug candidates require substantial technical, financial and human resources. We may choose to focus our efforts and resources on a drug discovery program or potential drug candidate that ultimately proves to be unsuccessful. We may also pursue opportunities to acquire or in-license additional businesses, technologies or drug candidates to complement or augment our existing drug discovery and development pipeline. If we are unable to identify or design suitable drug candidates for preclinical and clinical development, we will not be able to obtain revenues from the sale of products in future periods, which likely would result in significant harm to our financial position and adversely impact our stock price.

The development and commercialization of pharmaceutical products are subject to extensive regulation, and we may not obtain regulatory approvals for repotrectinib or any other drug candidates, on a timely basis or at all.

The clinical development, manufacturing, labeling, packaging, storage, recordkeeping, advertising, promotion, export, import, marketing, distribution, adverse event reporting, including the submission of safety and other post-marketing information and reports, and other possible activities relating to our drug candidates are subject to extensive regulation. Marketing approval of drugs in the United States requires the submission of an NDA to the FDA and we are not permitted to market any drug candidate in the United States until we obtain approval from the FDA of the NDA for that product. An NDA must be supported by extensive clinical and preclinical data, as well as extensive information regarding pharmacology, chemistry, manufacturing and controls.

FDA approval of an NDA is not guaranteed, and the review and approval process is an expensive and uncertain process that may take several years. The FDA also has substantial discretion in the approval process. The number and types of preclinical studies and clinical trials that will be required for NDA approval varies depending on the drug candidate, the disease or the condition that the drug candidate is designed to treat and the regulations applicable to any particular drug candidate. For example, if successful, we believe that the Phase 2 portion of TRIDENT-1 may be sufficient to support FDA approval of an NDA for repotrectinib, but the FDA may disagree with the sufficiency of our data and require additional clinical trials. Additionally, depending upon the results of the Phase 2 portion of TRIDENT-1, we may choose to seek Subpart H Accelerated Approval for repotrectinib, which would require completion of a confirmatory trial or trials to validate the clinical benefit of the drug. Despite the time and expense associated with preclinical studies and clinical trials, failure can occur at any stage. The results of preclinical and early clinical trials of repotrectinib or any other drug candidate may not be predictive of the results of our later-stage clinical trials.

Clinical trial failure may result from a multitude of factors including flaws in trial design, dose selection, placebo effect, patient enrollment criteria and failure to demonstrate favorable safety or efficacy traits, and failure in clinical trials can occur at any stage. Companies in the pharmaceutical industry frequently suffer setbacks in the advancement of clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Based upon negative or inconclusive results, we may decide, or regulators may require us, to conduct additional clinical trials or preclinical studies. In addition, data obtained from clinical trials are susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may further delay, limit or prevent marketing approval.

The FDA could delay, limit or deny approval of a drug candidate for many reasons, including because they:

Generally, public concern regarding the safety of pharmaceutical products could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling, or require us to undertake other activities that may entail additional costs. We have not obtained FDA approval for any product. This lack of experience may impede our ability to obtain FDA approval in a timely manner, if at all, for repotrectinib or any of our other drug candidates.

If we experience delays in obtaining approval or if we fail to obtain approval of repotrectinib or our other drug candidates, our commercial prospects will be harmed and our ability to generate revenues will be materially impaired which would adversely affect our business, prospects, financial condition and results of operations.

A breakthrough therapy designation by the FDA for repotrectinib may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that repotrectinib will receive marketing approval.*

The FDA has granted breakthrough therapy designations to repotrectinib (i) for the treatment of patients with ROS1+ metastatic NSCLC who have not been treated with a ROS1 TKI; (ii) for the treatment of patients with ROS1+ metastatic NSCLC who have been previously treated with one ROS1 TKI and who have not received prior platinum-based chemotherapy; and (iii) for the treatment of

patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK TKIs, with or without prior chemotherapy, and have no satisfactory alternative treatments. We may also seek breakthrough therapy designation for other indications or for some of our other drug candidates. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens.

Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our drug candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a breakthrough therapy designation for a drug candidate may not result in a faster development process, review or approval compared to other drugs and does not assure ultimate approval by the FDA. In addition, even though we received breakthrough therapy designation for certain indications for repotrectinib and even if one or more of our other drug candidates qualify as breakthrough therapies, the FDA may later decide that the drugs no longer meet the conditions for qualification or may decide that the time period for FDA review or approval will not be shortened.

A fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process for our drug candidates.*

The FDA has granted fast track designations to repotrectinib for the treatment of patients with (i) ROS1+ advanced NSCLC who have not been previously treated with a ROS1 TKI; (ii) ROS1+ advanced NSCLC who have been previously treated with one prior line of platinum-based chemotherapy and one prior line of a ROS1 TKI; (iii) ROS1+ advanced NSCLC who have been previously treated with one prior ROS1 TKI and who have not received prior platinum-based chemotherapy; and (iv) NTRK+ advanced solid tumors who have been previously treated with one prior line of chemotherapy and one or two prior TRK TKIs. The FDA has also granted fast track designation to elzovantinib for the treatment of patients with MET amplified advanced or metastatic gastric cancer or GEJ adenocarcinoma after prior chemotherapy. We may also seek fast track designation for other indications or for some of our other drug candidates. If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for fast track designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular drug candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even though we have received four fast track designations for repotrectinib, and one fast track designation for elzovantinib, or even if we receive fast track designation for other indications or for our other drug candidates, we may not experience a faster development process, review or approval. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

Our failure to obtain marketing approval in foreign jurisdictions would prevent our drug candidates from being marketed abroad, and any approval we are granted for our drug candidates in the United States would not assure approval of drug candidates in foreign jurisdictions.

In order to market and sell our products in the European Union (EU) or other jurisdictions outside the United States, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. Zai is responsible for obtaining marketing approval for repotrectinib and elzovantinib in Greater China. The approval procedure varies among countries and jurisdictions and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country. We may not be able to submit for marketing approvals and may not receive necessary approvals to commercialize our products in any market.

Even if we obtain marketing approval for repotrectinib or any of our other drug candidates, the terms of approvals and ongoing regulation of our products may limit how we manufacture and market our products and compliance with such requirements may involve substantial resources, which could materially impair our ability to generate revenue.

Even if marketing approval of a drug candidate is granted, an approved product and its manufacturer and marketer are subject to ongoing review and extensive regulation, which may include the requirement to implement a REMS or to conduct costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product. We must also comply with requirements concerning advertising and promotion for any of our drug candidates for which we obtain marketing approval.

Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling. Thus, we will not be able to promote any products we develop for indications or uses for which they are not approved. In addition, manufacturers of approved products and those manufacturers’ facilities are required to ensure that quality control and manufacturing procedures conform to cGMPs, which include requirements relating to quality control and quality assurance as well as the corresponding maintenance of records and documentation and reporting requirements. We and our contract manufacturers could be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with cGMPs.

Accordingly, assuming we obtain marketing approval for one or more of our drug candidates, we and our contract manufacturers will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control. If we are not able to comply with post-approval regulatory requirements, we could have the marketing approvals for our products withdrawn by regulatory authorities and our ability to market any future products could be limited, which could adversely affect our ability to achieve or sustain profitability. As a result, the cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition.

We may not be able to obtain or maintain orphan drug designation or exclusivity for our drug candidates.*

Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as “orphan drugs.” Under the Orphan Drug Act, the FDA may designate a drug candidate as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States, or if the disease or condition affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making a drug product available in the United States for the type of disease or condition will be recovered from sales of the product.

Orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. Additionally, if a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity. This means that the FDA may not approve any other applications to market the same drug or biological product for the same indication for seven years, except in certain circumstances, including proving clinical superiority (i.e., another product is safer, more effective or makes a major contribution to patient care) to the product with orphan exclusivity. Competitors, however, may receive approval of different products for the indication for which the orphan product has exclusivity, or obtain approval for the same product but for a different indication than that for which the orphan product has exclusivity. In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

We have obtained orphan drug designations in the United States for use of repotrectinib in treatment of NSCLC with adenocarcinoma histology and for use of elzovantinib in treatment of gastric cancer, including gastroesophageal junction adenocarcinoma. We may apply for similar designations in other geographies or for our other drug candidates in the future. Orphan drug status does not ensure that we will receive marketing exclusivity in a particular market, and we cannot assure you that any future application for orphan drug designation in any other geography or with respect to any other drug candidate will be granted. Orphan drug designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval process.

We have incurred significant operating losses since our inception and have not generated any revenue from product sales. We expect to incur continued losses for the foreseeable future and may never achieve or maintain profitability.*

Investment in drug discovery and development is a highly speculative undertaking and involves a substantial degree of risk. We are a clinical-stage precision oncology company that was formed in 2013 and commenced operations in 2014. We have no approved products for commercial sale and have not generated any revenue from product sales. We continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we have never been profitable and have incurred losses in each year since inception. For the six months ended June 30, 2022 and for the year ended December 31, 2021, we reported net losses of approximately $197.5 million and $236.6 million, respectively. As of June 30, 2022, we had an accumulated deficit of $714.3 million.

Since our inception, we have focused substantially all of our efforts and financial resources on the research and development of our lead drug candidate, repotrectinib, and our other drug candidates. To date, we have funded our operations primarily with proceeds

from sales of shares of our common stock and convertible preferred stock. From inception through June 30, 2022, we received an aggregate of $1.3 billion in net proceeds from such sales. As of June 30, 2022, our cash, cash equivalents and marketable securities were $818.3 million.

We expect to incur increasing levels of operating losses for the foreseeable future, particularly as we advance repotrectinib, and our other drug candidates through clinical development. Our prior losses, combined with expected future losses, have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital. We expect our research and development expenses to significantly increase in connection with our drug discovery activities and our ongoing and planned clinical trials, and any other clinical trials or development activities we may choose to pursue. In addition, if we obtain marketing approval for repotrectinib or any of our other drug candidates, we will incur significant sales, marketing and outsourced manufacturing expenses in connection with the commercialization of these drug candidates. As a result, we expect to continue to incur significant and increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if at all. Even if we do become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis.

Our ability to become profitable depends upon our ability to generate revenue. To date, we have not generated any revenue from product sales and we do not know when, or if, we will generate any such revenue. If we enter into license or collaboration agreements for any of our drug candidates or intellectual property, such as the Zai License Agreements, we may generate revenue in the future from payments as a result of such license or collaboration agreements. Unless and until we are able to generate revenue from future product sales, we expect that our revenue, if any, will be derived primarily from the Zai License Agreements, as well as any collaborations or additional license agreements that we may enter into in the future. We do not expect to generate significant revenue unless and until we obtain marketing approval for, and begin to sell, repotrectinib or another drug candidate. Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to:

To become and remain profitable, we must succeed in designing, developing and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials for our drug candidates, designing additional drug candidates, establishing arrangements with third parties for the manufacture of clinical supplies of our drug candidates, obtaining marketing approval for our drug candidates and manufacturing, marketing and selling any products for which we may obtain marketing approval. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.

In cases where we are successful in obtaining regulatory approval to market one or more of our drug candidates, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for

the product, the ability to obtain coverage and reimbursement, and whether we own the commercial rights for that territory. If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved.

Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses we will incur or when, or if, we will be able to achieve profitability. If we decide to or are required by the FDA or other regulatory authorities to perform studies or clinical trials in addition to those currently expected, or if there are any delays in establishing appropriate manufacturing arrangements for, in initiating or completing our current and planned clinical trials for, or in the development of, any of our drug candidates, our expenses could increase materially and profitability could be further delayed.

Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

We will require substantial additional funding. If we are unable to raise capital on favorable terms when needed, we could be forced to delay, reduce or eliminate our research or drug development programs or any future commercialization efforts.*

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance our lead drug candidate, repotrectinib, elzovantinib, and our other drug candidates through clinical development and further develop our pipeline. We expect increased expenses as we continue our research and development, initiate additional clinical trials, and seek marketing approval for repotrectinib and our other drug candidates. In addition, if we obtain marketing approval for any of our drug candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. Furthermore, we expect to continue to incur significant costs associated with operating as a public company.

In addition, our drug candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for sale for at least the next several years, if ever, and such funds, if raised, may not be sufficient to enable us to continue to implement our business strategy. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. Adequate additional financing may not be available to us on favorable terms, or at all. In addition, the COVID-19 pandemic and ongoing geopolitical events continue to evolve and have already resulted in a significant disruption of global financial markets. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and further disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the pandemic or geopolitical actions. If such further disruption deepens, we could experience an inability to access additional capital. Further, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. If we are unable to raise capital when needed or on favorable terms, we could be forced to delay, reduce or eliminate our research and development programs, our commercialization plans or other operations. We believe that our existing cash and cash equivalents and marketable securities as of June 30, 2022 will be sufficient to enable us to fund our operating expenses for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Changes beyond our control may occur that would cause us to use our available capital before that time, including changes in and progress of our drug development activities and changes in regulation. Our future capital requirements will depend on many factors, including:

We will require additional capital to complete our planned clinical development programs for our current drug candidates to obtain regulatory approval. Any additional capital-raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our current and future drug candidates, if approved.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates.*

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We do not currently have any committed external source of funds. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. In August 2020, we entered into an Open Market Sale AgreementSM with Jefferies LLC (ATM facility), under which we may offer and sell, from time to time, at our sole discretion, up to $250.0 million shares of our common stock. As of June 30, 2022, we had not yet sold any shares of our common stock under the ATM facility.

If we raise additional funds through additional collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to third parties to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

We rely, and intend to continue to rely, on third parties to conduct our clinical trials and perform some of our research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased costs or we may be unable to obtain regulatory approval, each of which may have an adverse effect on our business, financial condition, results of operations and prospects.

We do not have the ability to independently conduct all aspects of our preclinical testing or clinical trials ourselves. As a result, we are dependent on third parties to conduct our ongoing and planned clinical trials and other studies of repotrectinib and our other drug candidates. The timing of the initiation and completion of these studies and trials will therefore be partially controlled by such third parties and may result in delays to our development programs. Specifically, our CROs, clinical investigators and consultants play

a significant role in the conduct of these trials and the subsequent collection and analysis of data. However, we will not be able to control all aspects of their activities. Nevertheless, we are responsible for ensuring that each clinical trial is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs and other third parties does not relieve us of our regulatory responsibilities. We and our CROs are required to comply with GCP requirements, which are regulations and guidelines enforced by the FDA for drug candidates in clinical development. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, clinical trial investigators and clinical trial sites. If we or any of our CROs or clinical trial sites fail to comply with applicable GCP requirements, the data generated in our clinical trials may be deemed unreliable, and the FDA, EMA and comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA will determine that our clinical trials comply with GCPs. In addition, our clinical trials must be conducted with product produced under cGMP regulations. Our failure or the failure of third parties on whom we rely to comply with these regulations may require us to stop and/or repeat clinical trials, which would delay the marketing approval process.

There is no guarantee that any such CROs, clinical trial investigators or other third parties on which we rely will devote adequate time and resources to our development activities or perform as contractually required. If any of these third parties fail to meet expected deadlines, adhere to our clinical protocols or meet regulatory requirements, otherwise perform in a substandard manner, or terminate their engagements with us, the timelines for our development programs may be extended or delayed or our development activities may be suspended or terminated. If our clinical trial site terminates for any reason, we may experience the loss of follow-up information on subjects enrolled in such clinical trial unless we are able to transfer those subjects to another qualified clinical trial site, which may be difficult or impossible. In addition, certain of our scientific advisors or consultants who receive compensation from us are clinical trial investigators for our clinical trial. Although we believe our existing relationships are within the FDA’s guidelines, if these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation of the trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of any marketing application we submit by the FDA. Any such delay or rejection could prevent us from commercializing repotrectinib or any other drug candidates.

Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors for whom they may also be conducting clinical trials or other pharmaceutical product development activities that could harm our competitive position. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for repotrectinib or any other drug candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our products.

Manufacturing pharmaceutical products is complex and subject to product loss for a variety of reasons. We contract with third parties for the manufacture of our drug candidates for preclinical testing and clinical trials and expect to continue to do so for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.*

We do not have any manufacturing facilities. We produce in our laboratory very small quantities of small molecules for evaluation in our research programs. We rely, and expect to continue to rely, on third parties for the manufacture of our drug candidates for preclinical and clinical testing, for the supply of third-party drug product for our planned and ongoing combination clinical trials, as well as for commercial manufacture if any of our drug candidates obtain marketing approval. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. We rely heavily on manufacturers in China for starting materials for our drug candidates. Any delays or interruptions in the supply of starting materials for the manufacture of any of our drug candidates could delay, prevent or impair our development or commercialization efforts. We believe we currently have sufficient supply or plans for supply to meet our anticipated clinical development needs for repotrectinib, elzovantinib, TPX-0046, TPX-0131 and TPX-4589 through 2022. However, depending on the length and ultimate impact of the COVID-19 pandemic, and available manufacturing capacity at our supplier, our supply could be adversely impacted, which may result in delays or disruptions in our current or future supply chain.

We may be unable to establish any agreements with third-party manufacturers or to do so on favorable terms. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

We have only limited supply arrangements in place with respect to our drug candidates, and these arrangements do not extend to commercial supply. We acquire many key materials on a purchase order basis. As a result, we do not have long-term committed arrangements with respect to our drug candidates and other materials. If we obtain marketing approval for any of our drug candidates, we will need to have established an agreement for commercial manufacture with a third party.

Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside of the United States. Our failure, or the failure of our third-party manufacturers and suppliers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of drug candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products. In addition, our third-party manufacturers and suppliers are subject to numerous environmental, health and safety laws and regulations, including those governing the handling, use, storage, treatment and disposal of waste products, and failure to comply with such laws and regulations could result in significant costs associated with civil or criminal fines and penalties for such third parties. Based on the severity of regulatory actions that may be brought against these third parties in the future, our clinical or commercial supply of drug and packaging and other services could be interrupted or limited, which could harm our business.

Our drug candidates and any products that we may develop may compete with other drug candidates and products for access to manufacturing facilities. As a result, we may not obtain access to these facilities on a priority or timely basis or at all. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

For later-stage clinical trials and potential commercialization, we need to take steps to increase the scale of production of our drug candidates. In scaling up the manufacturing process for our drug candidates, even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in our drug candidates or in the manufacturing facilities in which our drug candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.

Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval. We do not currently have arrangements in place for redundant supply. If our current contract manufacturers for preclinical and clinical materials cannot perform as agreed, we may suffer delays or disruptions in our current or future supply chain and our clinical trials may be adversely impacted as a result. If our current third-party manufacturers cannot perform as agreed, we may also be required to replace such manufacturers and we may be unable to replace them on a timely basis or at all. Although we believe that there are several potential alternative manufacturers who could manufacture our drug candidates, we may incur added costs and delays in identifying and qualifying any such replacement manufacturer or be able to reach agreement with any alternative manufacturer. Further, our third-party manufacturers may experience manufacturing or shipping difficulties due to resource constraints or as a result of natural disasters, labor disputes, unstable political environments, or public health epidemics such as the COVID-19 outbreak.

Our current and anticipated future dependence upon others for the manufacture of our drug candidates or products may adversely affect our future profit margins and our ability to commercialize any products that obtain marketing approval on a timely and competitive basis.

We may enter into collaborations with third parties for the development and commercialization of our drug candidates. If those collaborations, including, without limitation, our license arrangements with Zai for the development and commercialization of repotrectinib and elzovantinib in Greater China, are not successful, we may not be able to capitalize on the market potential of these drug candidates.*

We currently have and may in the future seek third-party collaborators for the development and commercialization of some of our drug candidates on a selected basis. Our likely collaborators for any collaboration arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies. For example, we have granted to Zai, a China and U.S.-based commercial stage biopharmaceutical company, rights to develop and commercialize products containing repotrectinib and products containing elzovantinib, in Greater China. Consequently, our ability to generate any revenues from repotrectinib or elzovantinib in Greater China depends on our ability to maintain our collaborations with Zai. We have limited control over the amount and timing of resources that Zai will dedicate to these efforts. We face significant competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for any future collaboration we may seek, will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.

To the extent we have, and if we do enter into any further such arrangements with any third parties, we will likely have limited control over the amount and timing of resources that our collaborators dedicate to the development or commercialization of our drug candidates. Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities and efforts to successfully perform the functions assigned to them in these arrangements. Collaborations involving our drug candidates, such as our collaborations with Zai, pose numerous risks to us, including the following:

If our collaborations, such as our license arrangements with Zai, our clinical collaboration with EQRx, Inc., our license arrangements with LaNova, or any future license or collaboration we may enter into, if any, are not successful, our business, financial condition, results of operations, prospects and development and commercialization efforts may be adversely affected. Any termination or expiration of either of the Zai License Agreements, or any other license or collaboration we may enter into, if any, could adversely affect us financially or harm our business reputation, development and commercialization efforts.

We may explore new licensing arrangements, strategic collaborations and acquisitions that may never materialize or may fail.*

We have been continuously exploring a variety of potential business development opportunities in an effort to expand our product candidate portfolio. At the current time, we cannot predict what form such a strategic collaboration might take. We are likely to face significant competition in seeking appropriate strategic collaborators, and these strategic collaborations can be complicated and time-consuming to negotiate and document. We may not be able to negotiate strategic collaborations on acceptable terms, or at all. We are unable to predict when, if ever, we will enter into any additional strategic collaborations because of the numerous risks and uncertainties associated with establishing strategic collaborations.

The incidence and prevalence for target patient populations of our drug candidates have not been established with precision. If the market opportunities for our drug candidates are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue potential and ability to achieve profitability will be adversely affected.

The total addressable market opportunity for repotrectinib and our other drug candidates will ultimately depend upon, among other things, the diagnosis criteria included in the final label for each such drug candidate if our drug candidates are approved for sale for these indications, acceptance by the medical community and patient access, drug and any related companion diagnostic pricing and their reimbursement. The number of patients in our targeted commercial markets and elsewhere may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our drugs, or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our business.

Even if any of our drug candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

If any of our drug candidates receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. For example, current cancer treatments, such as existing targeted therapies, chemotherapy, and radiation therapy, are well established in the medical community, and doctors may continue to rely on these treatments. If our drug candidates do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of our drug candidates, if approved for commercial sale, will depend on a number of factors, including:

We have no experience as a company in commercializing products and we may have to invest significant resources to develop these capabilities. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate revenue.*

We do not have a sales infrastructure and are only in the very early stages of building a marketing infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any product for which we obtain marketing approval, we will need to establish sales, marketing and distribution capabilities, either ourselves or through collaboration or other arrangements with third parties.

We plan to build our own focused, specialized sales and marketing organization in the United States. Outside of the United States, in addition to our existing repotrectinib and elzovantinib licenses to Zai for Greater China, we plan to selectively establish partnerships in markets outside the United States to support the commercialization of drug candidates for which we obtain marketing approval and that can be commercialized with such capabilities.

There are risks involved with establishing our own sales and marketing capabilities. For example, recruiting and training a sales force is expensive and time-consuming and could delay any product launch. If the commercial launch of a drug candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. These efforts are expected to be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our products on our own include:

As a result of any potential partnerships in markets outside of the United States, including our license arrangements with Zai and LaNova, or if we are unable to establish our own sales and marketing capabilities in the United States and instead enter into arrangements with third parties to perform these services, our product revenues and our profitability, if any, are likely to be lower than if we were to market and sell any products that we develop ourselves. In addition, we may not be successful in entering into arrangements with third parties to market and sell our drug candidates or may be unable to do so on terms that are acceptable to us. We likely will have little control over such third parties, and any of these third parties may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing any of our drug candidates for which we receive marketing approval.

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

The development and commercialization of pharmaceutical products is highly competitive. We face competition with respect to our current drug candidates, and will face competition with respect to any drug candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for which we are developing our drug candidates. Some of these competitive products and therapies are based on scientific approaches that are similar to our approach,

and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

There are a large number of pharmaceutical and biotechnology companies developing or marketing targeted treatments for cancer that would be competitive with the drug candidates we are developing, if our drug candidates are approved. Many of these companies are developing cancer therapeutics that are also kinase inhibitors.

If we are successful in developing repotrectinib, we expect that repotrectinib will compete against approved drugs, including: crizotinib, which is marketed by Pfizer Inc. under the name Xalkori for the treatment of ROS1+and ALK+ NSCLC; entrectinib, which is marketed by F. Hoffman La Roche AG under the name Rozlytrek, for the treatment of ROS1+ NSCLC and TRK+ solid tumors; and larotrectinib, which is marketed by Bayer AG under the trade name Vitrakvi, for the treatment of TRK+ solid tumors. We also expect that repotrectinib will compete against other compounds which are currently in late-stage clinical development, including TKIs in Phase 2 or later clinical development for the treatment of ROS1+NSCLC at companies including against Pfizer Inc. (lorlatinib), Novartis Pharmaceuticals Corporation (ceritinib), Betta Pharmaceuticals Co., Ltd. (ensartinib), Exelixis, Inc. (cabozantinib) and AnHeart Therapeutics Company (taletrectinib) and TKIs in Phase 2 or later clinical development for the treatment of TRK+ solid tumors at companies including Bayer AG (selitrectinib), Exelixis, Inc. (cabozantinib) and AnHeart Therapeutics Company (taletrectinib).

If we are successful in developing elzovantinib, we expect that elzovantinib will compete against capmatinib, which is marketed by Novartis Pharmaceutical Corporation under the name Tabrecta; tepotinib, which is marketed by Merck KGaA under the name Tepmetko; savolitinib, which is marketed in China by AstraZeneca PLC and Hutchison China MediTech Limited under the name Orpathys; and amivantamab, which is marketed by Johnson & Johnson under the name Rybrevant. Capmatinib, tepotinib and savolitinib are indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. We also expect that elzovantinib will compete against Xalkori (crizotinib) and other compounds which are in Phase 2 or later clinical development for the treatment of MET+ tumors at companies including Exelixis, Inc. (cabozantinib), Apollomics, Inc. (APL-101), Haihe Biopharma Co., Ltd (glumetinib), Servier (Sym015), AbbVie Inc. (telisotuzumab vedotin) and Aveo Oncology (ficlatuzumab).

If we are successful in developing TPX-0046, we expect that TPX-0046 will compete against selpercatinib, which is marketed by Eli Lilly and Company under the names Retevmo and Retsevmo for the treatment of NSCLC, medullary thyroid cancer and other types of thyroid cancer in patients with RET gene alterations; and pralsetinib, which is marketed by F. Hoffman La Roche AG and Blueprint Medicines Corporation under the name Gavreto for the treatment of NSCLC, medullary thyroid cancer and other types of thyroid cancer in patients with RET gene alterations, and are both in development for the treatment of other RET+ cancers, and other approved multi-kinase inhibitors with RET activity that are being evaluated in clinical trials including cabozantinib (Exelixis, Inc.), lenvatinib (Eisai Inc.), sorafenib (Bayer AG), sunitinib (Pfizer Inc.) and vandetinib (Sanofi Genzyme). We also expect TPX-0046 will compete against compounds which are in Phase 2 or later clinical development for the treatment of RET+ tumors at companies including Helsinn Group (HM06).

If we are successful in developing TPX-0131, we expect that TPX-0131 will compete against approved drugs, including: alectinib, which is marketed by F. Hoffman La Roche AG under the name Alecensa for the treatment of ALK+ NSCLC; brigatinib, which is marketed by Takeda Pharmaceutical Company Limited under the name Alunbrig for the treatment of ALK+ NSCLC; ceritinib, which is marketed by Novartis Pharmaceuticals Corporation under the name Zykadia for the treatment of ALK+ NSCLC; crizotinib, which is marketed by Pfizer Inc. under the name Xalkori for the treatment of ROS1+ and ALK+ NSCLC; and lorlatinib, which is marketed by Pfizer Inc. under the names Lorbrena and Lorviqua for the treatment of ALK+ NSCLC. We also expect that TPX-0131 will compete against other compounds which are currently in late-stage clinical development, including TKIs in Phase 2 or later clinical development for the treatment of ALK+ NSCLC at companies including against Betta Pharmaceuticals Co., Ltd. (ensartinib).

Many of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining marketing approvals and marketing and selling approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific, management and sales and marketing personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are approved for broader indications or patient populations, are more

convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other marketing approval for their products more rapidly than any approval we may obtain for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products. Generic products are currently on the market for some of the indications that we are pursuing, and additional products are expected to become available on a generic basis over the coming years. If our drug candidates achieve marketing approval, we expect that they will be priced at a significant premium over any competitive generic products. The key competitive factors affecting the success of our drug candidates are likely to be their efficacy, safety, scope and limitations of marketing approval, and availability of reimbursement.

Even if we are able to commercialize any drug candidates, the products may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which would harm our business.

The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drug products vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our drug candidate to other available therapies. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a drug candidate in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues, if any, we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more drug candidates, even if such drug candidates obtain marketing approval.

Our ability to commercialize any drug candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from third-party payors, including government healthcare programs, private health insurers and other organizations. Third-party payors decide which medications they will pay for and establish reimbursement levels.

A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage and reimbursement may not be available for any product that we commercialize and, even if these are available, the level of reimbursement may not be satisfactory. Reimbursement may affect the demand for, or the price of, any drug candidate for which we obtain marketing approval. Obtaining and maintaining coverage and adequate reimbursement for our products may be difficult. We may be required to conduct expensive pharmacoeconomic studies to justify coverage and reimbursement or the level of reimbursement relative to other therapies. If coverage and adequate reimbursement are not available or reimbursement is available only to limited levels, we may not be able to successfully commercialize any drug candidate for which we obtain marketing approval.

Additionally, we are developing or plan to develop, either by ourselves or with collaborators, in vitro companion diagnostic tests for our drug candidates for certain indications. We, or our collaborators, will be required to obtain coverage and reimbursement for these tests separate and apart from the coverage and reimbursement we seek for our product candidates, once approved. While we have not yet developed any companion diagnostic test for our product candidates, if we do, there is significant uncertainty regarding our ability to obtain coverage and adequate reimbursement for the same reasons applicable to our product candidates.

There may also be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or similar regulatory authorities outside of the United States. Moreover, eligibility for coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including research, development, intellectual property, manufacture, sale and distribution expenses. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies, but also have their own methods and approval process apart from Medicare determinations. Our inability to promptly obtain coverage and adequate reimbursement rates from third-party payors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related to the testing of our drug candidates in human clinical trials and will face an even greater risk if we commercialize any products that we may develop. If we cannot successfully defend ourselves against any claims that our drug candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

Our current product liability insurance coverage for the United States and certain other jurisdictions may not be adequate to cover all liabilities that we may incur. We likely will need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of our drug candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Risks Related to Marketing of Our Drug Candidates and Other Legal Compliance Matters

Any drug candidate for which we obtain marketing approval will be subject to ongoing enforcement of post-marketing requirements and we could be subject to substantial penalties, including withdrawal of our product from the market, if we fail to comply with all regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

Any drug candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include, but are not limited to, restrictions governing promotion of an approved product, submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, and requirements regarding drug distribution and the distribution of samples to physicians and recordkeeping.

The FDA and other federal and state agencies, including the Department of Justice, closely regulate compliance with all requirements governing prescription drug products, including requirements pertaining to marketing and promotion of drugs in accordance with the provisions of the approved labeling and manufacturing of products in accordance with cGMP requirements. For example, the FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. Although physicians may prescribe products for off-label uses as the FDA and other regulatory agencies do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued. Companies may only share truthful and not misleading information that is otherwise consistent with a product’s FDA approved labeling. Violations of such requirements may lead to investigations alleging violations of the FDCA and other statutes, including the False Claims Act and other federal and state healthcare fraud and abuse laws as well as state consumer protection laws. Our failure to comply with all regulatory requirements, and later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, may yield various results, including:

Non-compliance by us, our licensee Zai or any other collaborator with regulatory requirements, including safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population can also result in significant financial penalties.

Our relationships with customers, healthcare providers, and third-party payors may be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil and administrative penalties, contractual damages, reputational harm and diminished profits and future earnings.*

Healthcare providers, including physicians, and third-party payors will play a primary role in the recommendation and prescription of any drug candidates for which we obtain marketing approval. Our current and future arrangements with healthcare providers, third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we research, market, sell and distribute any products for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional integrity reporting and oversight obligations, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs, which could have a material adverse effect on our business, results of operations, financial condition and prospects.

Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and decrease the prices we may obtain.*

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our drug candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any drug candidates for which we obtain marketing approval.

For example, the ACA was passed in March 2010 and substantially changed the way healthcare is financed by both governmental and private insurers, and continues to significantly impact the U.S. pharmaceutical industry.

With regard to pharmaceutical products, the ACA, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees and taxes on manufacturers of certain branded prescription drugs and a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

There have been executive, judicial and Congressional challenges to repeal or replace certain aspects of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA such as removing penalties, starting January 1, 2019, for not complying with the ACA’s individual mandate to carry health insurance and eliminating the implementation of certain ACA-mandated fees. Additionally, on June 17, 2021 the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Thus, the ACA will remain in effect in its current form. Further, prior to the U.S. Supreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and the healthcare reform measures of the Biden administration will impact the ACA.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals for spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction, triggering the legislation’s automatic reduction to several government programs. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, starting in 2013, and due to subsequent legislative amendments to the statute, will remain in effect through 2030, except for a temporary suspension from May 1, 2020 through March 31, 2022 due to the COVID-19 pandemic, unless additional Congressional action is taken. Under current legislation the actual reduction in Medicare payments will vary from 1% in 2022 to up to 3% in the fiscal year of this sequester. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These laws may result in additional reductions in Medicare and other healthcare funding.

Further, there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. At the federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives. However, several lawsuits have been brought against the U.S. Department of Health and Human Services (HHS) challenging various aspects of the rules implemented during the Trump administration. As a result, the Biden administration and HHS have delayed the implementation or published rules rescinding some of these Trump-era policies. In addition, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. No legislation or administrative actions have been finalized to implement these principles. In addition, Congress is considering drug pricing as part of the other reform initiatives. In addition, at the state level, individual states have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

We expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our drug candidates, if any, may be. It is also possible that additional governmental action is taken in response to the COVID-19 pandemic.

Governments outside of the United States tend to impose strict price controls, which may adversely affect our revenues, if any.

In some countries, particularly some countries in the EU, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our drug candidate to other available therapies. If reimbursement of our products is unavailable

or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU member states, and parallel trade, i.e., arbitrage between low-priced and high-priced member states, can further reduce prices. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any products, if approved in those countries. In the EU the regulation of pricing and reimbursement varies widely between individual member states. Some member states prohibit the marketing of products prior to a reimbursement price being agreed, some member states may require the completion of additional studies to assess cost-effectiveness against currently available therapies. Price controls or profit controls are in place in a number of member states.

Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain drug candidates and products outside of the United States and require us to develop and implement costly compliance programs.

If we expand our operations outside of the United States, we must dedicate additional resources to comply with numerous laws and regulations in each jurisdiction in which we plan to operate. The Foreign Corrupt Practices Act (FCPA) prohibits any U.S. individual or business from paying, offering, authorizing payment or offering anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of such third party in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the company, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.

Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If we expand our presence outside of the United States, it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing or selling certain drug candidates and products outside of the United States, which could limit our growth potential and increase our development costs.

The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.

We are subject to stringent and changing obligations related to data protection and privacy. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; a disruption of our business operations; reputational harm; loss of revenue or profits; loss of sales; and other adverse business consequences.*

In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (commonly known as processing) personal data and other confidential information, including proprietary business information, trade secrets, intellectual property, and data we collect about trial participants in connection with clinical trials, and sensitive third-party data. Our data processing activities may subject us and potential collaborators to federal, state and foreign data protection and privacy laws and regulations. In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), govern the collection, use, disclosure and protection of health-related and other personal data and could apply to our operations or the operations of our collaborators. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the HIPAA, as amended by HITECH. We could be subject to penalties if we obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

In addition, the California Consumer Privacy Act of 2018 (CCPA) imposes obligations on covered businesses. These obligations include, but are not limited to, providing specific disclosures in privacy notices and affording California residents certain rights related to their personal data. The CCPA allows for statutory fines for noncompliance (up to $7,500 per violation) and a private

right of action for certain data breaches. Although the CCPA exempts some data processed in the context of clinical trials, the CCPA may increase compliance costs and potential liability with respect to other personal data we maintain about California residents. In addition, it is anticipated that the California Privacy Rights Act of 2020 (CPRA), effective January 1, 2023, will expand the CCPA. Additionally, the CPRA establishes a new California Privacy Protection Agency to implement and enforce the CPRA, which could increase the risk of enforcement. Other states have also enacted data privacy laws. For example, Virginia passed the Consumer Data Protection Act (CDPA), Colorado passed the Colorado Privacy Act (CPA) and Utah passed the Utah Consumer Privacy Act (UCPA), all of which differ from the CPRA and become effective in 2023. If we become subject to new data privacy laws, at the state level, the risk of enforcement action against us could increase because we may become subject to additional obligations, and the number of individuals or entities that can initiate actions against us may increase (including individuals, via a private right of action, and state actors). The CCPA, CPRA, CDPA, CPA and UCPA may impact our business activities and exemplify the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information.

Outside the United States, an increasing number of laws, regulations, and industry standards apply to data protection and privacy. For example, the European Union’s General Data Protection Regulation (EU GDPR) and the United Kingdom’s GDPR (UK GDPR) impose strict requirements for processing personal data. For example, under the EU GDPR, government regulators may impose temporary or definitive bans on data processing, as well as fines of up to 20 million euros or 4% of annual global revenue, whichever is greater. Further, the EU GDPR also provides for private litigation related to the processing of personal data that can be brought by classes of data subjects or consumer protection organizations authorized at law to represent the data subjects’ interests. Additionally, certain jurisdictions have enacted data localization laws and cross-border personal data transfer laws, which could make it more difficult to transfer information across jurisdictions (such as transferring or receiving personal data that originates in the EU or in other foreign jurisdictions). For example, the EU GDPR increases our responsibility and liability in relation to personal data that we process. In addition, the GDPR prohibits the transfer of personal data to countries outside of the EEA, such as the United States, which are not considered by the European Commission to provide an adequate level of data protection. Switzerland and the United Kingdom have adopted similar restrictions. U.S. companies had been able to rely on the Privacy Shield and the standard contractual clauses for compliantly transferring personal data, both of which were struck down by the Court of Justice of the European Union in July 2020. In June 2021, the European Commission released a set of “Standard Contractual Clauses” that are designed to be a valid mechanism by which entities can transfer personal data out of the EEA to jurisdictions that the European Commission has not found to provide an adequate level of protection. Currently, these Standard Contractual Clauses are a valid mechanism to transfer personal data outside of the EEA. The Standard Contractual Clauses, however, require parties that rely upon that legal mechanism to comply with additional obligations, such as conducting transfer impact assessments to determine whether additional security measures are necessary to protect the at-issue personal data. If we cannot implement a valid compliance mechanism for cross-border data transfers, we may face increased exposure to regulatory actions, substantial fines, and injunctions against processing or transferring personal data from Europe or other foreign jurisdictions. The inability to import personal data to the United States could significantly and negatively impact our business operations, including by limiting our ability to conduct clinical trial activities in Europe and elsewhere; limiting our ability to collaborate with parties that are subject to such cross-border data transfer or localization laws; or requiring us to increase our personal data processing capabilities and infrastructure in foreign jurisdictions at significant expense.

Compliance with U.S. and international data protection and privacy laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. Failure to comply with U.S. and international data protection and privacy laws and regulations could result in government enforcement actions (which could include civil, criminal, and administrative penalties), private litigation and/or adverse publicity and could negatively affect our operating results and business. Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose the information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection and privacy laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time consuming to defend and could result in adverse publicity that could harm our business.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.

We are subject to numerous foreign, federal, state and local environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources, including any available insurance.

In addition, our leasing and operation of real property may subject us to liability pursuant to certain of these laws or regulations. Under existing U.S. environmental laws and regulations, current or previous owners or operators of real property and entities that disposed or arranged for the disposal of hazardous substances may be held strictly, jointly and severally liable for the cost of investigating or remediating contamination caused by hazardous substance releases, even if they did not know of and were not responsible for the releases.

We could incur significant costs and liabilities which may adversely affect our financial condition and operating results for failure to comply with such laws and regulations, including, among other things, civil or criminal fines and penalties, property damage and personal injury claims, costs associated with upgrades to our facilities or changes to our operating procedures, or injunctions limiting or altering our operations.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations, which are becoming increasingly more stringent, may impair our research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

We are subject to certain U.S. and certain foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.

U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations prohibit, among other things, companies and their employees, agents, CROs, legal counsel, accountants, consultants, contractors and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of these laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We also expect our non-U.S. activities to increase over time. We expect to rely on third parties for research, preclinical studies and clinical trials and/or to obtain necessary permits, licenses, patent registrations and other marketing approvals. We can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

Our business may be adversely impacted by the consequences of Russia’s invasion of Ukraine.*

Economic, political and social conditions resulting from Russia’s invasion of Ukraine could materially disrupt our clinical trials, increase our costs and may disrupt planned clinical development activities. To the extent the conflict between Ukraine and Russia adversely impacts our ability to enroll patients or complete enrollments in process or adversely impacts the ability of our suppliers to produce and distribute supplies that we need for our clinical trials, the timing for completing our clinical trials may be adversely impacted. In addition, the United States, United Kingdom and European Union governments, among others, have instituted various sanctions and export-control measures in response to the invasion, including comprehensive financial sanctions, targeted at Russia or designated individuals and entities with business interests and/or government connections to Russia or those involved in Russian military activities. Governments have also enhanced export controls and trade sanctions targeting Russia’s imports of goods. The duration and intensity of this conflict and its economic impact on our European operations is uncertain at this time, but it is possible that our business, results of operations and financial condition could be materially and adversely affected.

If we are unable to obtain and maintain sufficient patent protection for our drug candidates, or if the scope of the patent protection is not sufficiently broad, third parties, including our competitors, could develop and commercialize products similar or identical to ours, and our ability to commercialize our drug candidates successfully may be adversely affected.

Our success depends in large part on our ability to protect our proprietary technologies that we believe are important to our business, including pursuing, obtaining and maintaining patent protection in the United States and other countries intended to cover

the composition of matter of our drug candidates, the methods of use, related technologies and other inventions that are important to our business. Although we own patents in the United States and foreign countries, we cannot be certain that the claims in our other U.S. pending patent applications, corresponding international patent applications and patent applications in certain foreign countries will be considered patentable by the USPTO, courts in the United States or by the patent offices and courts in foreign countries, nor can we be certain that the claims in our patents will not be found invalid or unenforceable if challenged. In addition to patent protection, we also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. If we do not adequately pursue, obtain, maintain, protect or enforce our intellectual property, third parties, including our competitors, may be able to erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability.

To protect our proprietary position, we file patent applications in the United States and abroad related to our drug candidates that we consider important to our business. The patent application and approval process is expensive, time-consuming and complex. We may not be able to file, prosecute and maintain all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, depending on the terms of any future license agreements to which we may become a party, we may not have the right to control the preparation, filing, and prosecution of patent applications, or to maintain the patents, covering technology licensed from third parties. Therefore, these patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.

Furthermore, the patent position of biotechnology and pharmaceutical companies generally is highly uncertain. No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United States or in many foreign jurisdictions. The standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably. In addition, the determination of patent rights with respect to biological and pharmaceutical products commonly involves complex legal and factual questions, which have in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Thus, we cannot offer any assurances about which, if any, patents will issue, the breadth of any such patents, whether any patents will be found invalid and unenforceable or will be threatened by third parties or whether any patents will effectively prevent others from commercializing competing technologies and drug candidates.

Our pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until at least one patent issues from such applications. Assuming the other requirements for patentability are met, currently, the first to file a patent application is generally entitled to the patent. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Since patent applications in the United States and most other countries are confidential for a period of time after filing, and some remain so until issued, we cannot be certain that we were the first to file for patent protection for the inventions covered by pending patent applications. In addition, we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, collaborators, CROs, contract manufacturers, hospitals, independent treatment centers, consultants, independent contractors, suppliers, advisors and other third parties; however, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. Furthermore, if third parties have filed patent applications related to our drug candidates or technology, we may not be able to obtain our own patent rights to those drug candidates or technology.

Moreover, because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, our patents or pending patent applications may be challenged in the courts or patent offices in the United States and abroad. For example, we may be subject to a third-party pre-issuance submission of prior art to the USPTO or become involved in post-grant review procedures, oppositions, derivations, revocation, reexaminations, inter partes review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party rights. Moreover, we may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge priority of invention or other features of patentability. Such challenges may result in loss of exclusivity or in our patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products or limit the duration of the patent protection of our technology and products. Such challenges also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, and prospects.

In addition, given the amount of time required for the development, testing and regulatory review of new drug candidates, our patents protecting such drug candidates might expire before or shortly after such drug candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Moreover, some of our patents and patent applications may in the future be co-owned with third parties. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

Our pending and future patent applications may not result in patents being issued that protect our drug candidates, in whole or in part, or which effectively prevent others from commercializing competitive products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. In addition, the laws of foreign countries may not protect our rights to the same extent or in the same manner as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment of the human body more than United States law does.

Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us or otherwise provide us with any competitive advantage. Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued and its scope can be reinterpreted after issuance. Consequently, we do not know whether any of our drug candidates will be protectable or remain protected by valid and enforceable patents. Our competitors and other third parties may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. Our competitors and other third parties may also seek approval to market their own products similar to or otherwise competitive with our products. Alternatively, our competitors or other third parties may seek to market generic versions of any approved products by submitting abbreviated NDAs to the FDA during which process they may claim that patents owned by us are invalid, unenforceable or not infringed. In these circumstances, we may need to defend or assert our patents, or both, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid or unenforceable, or that our competitors are competing in a non-infringing manner. Thus, even if we have valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

Furthermore, future patents may be subject to a reservation of rights by one or more third parties. For example, to the extent the research resulting in future patent rights or technologies is funded in the future in part by the U.S. government, the government could have certain rights in any resulting patents and technology, including a non-exclusive license authorizing the government to use the invention or to have others use the invention on its behalf for non-commercial purposes. If the U.S. government then decides to exercise these rights, it is not required to engage us as its contractor in connection with doing so. These rights may also permit the government to disclose our confidential information to third parties and to exercise march-in rights to use or allow third parties to use our licensed technology. The government may also exercise its march-in rights if it determines that action is necessary because we failed to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S. industry. In addition, our rights in such government-funded inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States. Any exercise by the government of aforementioned proprietary rights could harm our competitive position, business, financial condition, results of operations, and prospects.

Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involves both technological and legal complexity and is therefore costly, time consuming and inherently uncertain. Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Patent reform legislation in the United States and other countries could increase those uncertainties and costs. For example, the Leahy-Smith America Invents Act (the Leahy-Smith Act) signed into law in September 2011, includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. For example, the Leahy-Smith Act allows third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. In addition, the Leahy-Smith Act has transformed the U.S. patent system from a “first-to-invent”

system to a “first-to-file” system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. The Leahy-Smith Act could make it more difficult to obtain patent protection for our inventions and increase the uncertainties and costs surrounding the prosecution of our or our collaboration partners’ patent applications and the enforcement or defense of our or our collaboration partners’ issued patents, all of which could harm our business, results of operations, financial condition and prospects.

In addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained. Additionally, there have been recent proposals for additional changes to the patent laws of the United States and other countries that, if adopted, could impact our ability to enforce our proprietary technology. Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

We may become involved in lawsuits or administrative disputes to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors and other third parties may infringe, misappropriate or otherwise violate our patents, trademarks, copyrights, trade secrets or other intellectual property. To counter infringement, misappropriation or other violations, we may be required to file infringement, misappropriation or other violation claims, which can be expensive and time consuming and divert the time and attention of our management and business and scientific personnel. In addition, many of our adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we can.

Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe, misappropriate or otherwise violate their patents or their other intellectual property, in addition to counterclaims asserting that our patents are invalid or unenforceable, or both. In patent litigation in the United States, counterclaims challenging the validity, enforceability or scope of asserted patents are commonplace. Similarly, third parties may initiate legal proceedings against us seeking a declaration that certain of our intellectual property is non-infringed, invalid or unenforceable. The outcome of any such proceeding is generally unpredictable.

In any patent infringement proceeding, there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our patent claims do not cover the invention. An adverse outcome in a litigation or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors, and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. If a defendant were to prevail on a legal assertion of invalidity or unenforceability of our patents covering one of our drug candidates, we could lose at least a part, and perhaps all, of the patent protection covering such a drug candidate. Competing drugs may also be sold in other countries in which our patent coverage might not exist or be as strong. If we lose a foreign patent lawsuit, alleging our infringement of a competitor’s patents, we could be prevented from marketing our drugs in one or more foreign countries. Any of these occurrences could adversely affect our competitive business position, business prospects and financial condition. Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common stock. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings.

Furthermore, third parties may also raise invalidity or unenforceability claims before administrative bodies in the United States or foreign authorities, even outside the context of litigation. Such mechanisms include re-examination, inter partes review, post-grant review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation, cancellation or amendment to our patents in such a way that they no longer cover and protect our drug candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or written description. Grounds for an unenforceability assertion could be an allegation that someone connected with the prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution of the patent. With respect to the validity of our patents, for example, we cannot be certain that there is no invalidating prior art of which we, our licensors, our patent counsel and the patent examiner were unaware during prosecution. Moreover, it is possible that prior art may exist that we are aware of but do not believe is relevant to our current or future patents, but that could nevertheless be determined to render our patents invalid. If a third party were to prevail on a legal assertion of invalidity or unenforceability, we could lose at least part, and perhaps all, of the patent protection on one or more of our drug candidates. Any such loss of patent protection could have a material adverse impact on our business, financial condition, results of operations and prospects.

We may not be able to effectively enforce our intellectual property and proprietary rights throughout the world.*

Filing, prosecuting and defending patents with respect to our drug candidates in all countries throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. The requirements for patentability may differ in certain countries, particularly in developing countries. In addition, any future intellectual property license agreements may not always include worldwide rights. Consequently, competitors and other third parties may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may obtain patent protection, but where patent enforcement is not as strong as that in the United States and where our ability to enforce our patents to stop infringing activities may be inadequate. These products may compete with our products in such territories and in jurisdictions where we do not have any patent rights or where any future patent claims or other intellectual property or proprietary rights may not be effective or sufficient to prevent them from competing with us, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Moreover, our ability to protect and enforce our intellectual property and proprietary rights may be adversely affected by unforeseen changes in foreign intellectual property laws. Additionally, the laws of some countries outside of the United States and Europe do not afford intellectual property protection to the same extent as the laws of the United States and Europe. Many companies have encountered significant problems in protecting and defending intellectual property and proprietary rights in certain foreign jurisdictions. The legal systems of some countries, including, for example, India, China and other developing countries, do not favor the enforcement of patents and other intellectual property or proprietary rights, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement, misappropriation or other violation of our patents or other intellectual property or proprietary rights. For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. Consequently, we may not be able to prevent third parties from practicing our inventions in certain countries outside the United States and Europe. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected. Proceedings to enforce our intellectual property and proprietary rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and resources from other aspects of our business, could put our patents, trademarks or other intellectual property and proprietary rights at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Furthermore, while we intend to protect our intellectual property and proprietary rights in major markets for our products, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our products. Accordingly, our efforts to protect our intellectual property and proprietary rights in such countries may be inadequate.

Geo-political actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the maintenance, enforcement or defense of our issued patents or those of any current or future licensors. For example, the United States and foreign government actions related to Russia’s invasion of Ukraine may limit or prevent filing, prosecution and maintenance of patent applications in Russia. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia. If such an event were to occur, it could potentially have a material adverse effect on our business. In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees from the United States without

consent or compensation. Consequently, we would not be able to prevent third parties from practicing our inventions in Russia or from selling or importing products made using our inventions in and into Russia. Accordingly, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.

If we are sued for infringing, misappropriating or otherwise violating intellectual property or proprietary rights of third parties, such litigation or disputes could be costly and time consuming and could prevent or delay us from developing or commercializing our drug candidates.

Our commercial success depends, in part, on our ability to develop, manufacture, market and sell our drug candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and other proprietary rights of third parties. If any third-party patents, patent applications or other proprietary rights are found to cover our drug candidates or any related companion diagnostics or their compositions, methods of use or manufacturing, we may be required to pay damages, which could be substantial, and we would not be free to manufacture or market our drug candidates or to do so without obtaining a license, which may not be available on commercially reasonable terms, or at all.

We may in the future become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property or proprietary rights with respect to our drug candidates and technologies we use in our business. Our competitors or other third parties may assert infringement claims against us, alleging that our drug candidates are covered by their patents. We cannot be certain that we do not infringe existing patents or that we will not infringe patents that may be granted in the future. Furthermore, because patent applications can take many years to issue and may be confidential for 18 months or more after filing, and because patent claims can be revised before issuance, there may be applications now pending which may later result in issued patents that may be infringed by the manufacture, use or sale of our drug candidates. If a patent holder believes our drug candidate infringes its patent rights, the patent holder may sue us even if we have received patent protection for our technology. Moreover, we may face patent infringement claims from non-practicing entities that have no relevant drug revenue and against whom our own patent portfolio may thus have no deterrent effect.

There is a substantial amount of intellectual property litigation in the biotechnology and pharmaceutical industries, and we may become party to, or threatened with, litigation or other adversarial proceedings regarding intellectual property or proprietary rights with respect to our drug candidates, including post-grant proceedings before the USPTO. Third parties may assert infringement, misappropriation or other claims against us based on existing or future intellectual property or proprietary rights. The outcome of intellectual property litigation and other disputes is subject to uncertainties that cannot be adequately quantified in advance. The pharmaceutical and biotechnology industries have produced a significant number of patents, and it may not always be clear to industry participants, including us, which patents cover various types of products or methods of using or manufacturing products. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. If we were sued for patent infringement, we would need to demonstrate that our drug candidates, products or methods of use, manufacturing or other applicable activities either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and we may not be successful in doing so. However, proving invalidity or unenforceability is difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by patents. Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, or enforceability. Even if we are successful in these proceedings, we may incur substantial costs and the time and attention of our management and business and scientific personnel could be diverted in pursuing these proceedings, which could significantly harm our business and operating results. In addition, we may not have sufficient resources to bring these actions to a successful conclusion.

If we are found to infringe, misappropriate or otherwise violate a third party’s intellectual property or proprietary rights and we are unsuccessful in demonstrating that such intellectual property or proprietary rights are invalid or unenforceable, we could be forced, including by court order, to cease developing, manufacturing or commercializing the infringing drug candidate or product. Alternatively, we may be required to obtain a license from such third party in order to use the infringing technology and continue developing, manufacturing or marketing the infringing drug candidate. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain such a license, it could be granted on non-exclusive terms, thereby giving our competitors and other third parties access to the same technologies licensed to us. In addition, we could be found liable for significant monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed such third-party patent rights. A finding of infringement could prevent us from commercializing our drug candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business, financial condition, results of operations and prospects.

We may be subject to claims by third parties asserting that our employees or consultants or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.

Some of our employees and consultants are currently or have been previously employed at universities or at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. These employees and consultants may have executed proprietary rights, non-disclosure and non-competition agreements, or similar agreements, in connection with such other current or previous employment. Although we try to ensure that our employees and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of third parties. Litigation may be necessary to defend against such claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property or personnel or sustain damages. Such intellectual property could be awarded to a third party, and we could be required to obtain a license from such third party to commercialize our technology or products. Such a license may not be available on commercially reasonable terms or at all. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to our management. Any of the foregoing would have a material adverse effect on our business, financial condition, results of operations and prospects.

In addition, while it is our policy to require our employees, consultants and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own, which may result in claims by or against us related to the ownership of such intellectual property. In addition, such agreements may not be self-executing such that the intellectual property subject to such agreements may not be assigned to us without additional assignments being executed, and we may fail to obtain such assignments. In addition, such agreements may be breached. Accordingly, we may be forced to bring claims against third parties, or defend claims that they may bring against us to determine the ownership of what we regard as our intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to our senior management and scientific personnel, which would have a material adverse effect on our business, financial condition, results of operations and prospects.

In the course of testing our drug candidates, we have entered into agreements with third parties to conduct clinical testing, which provide that improvements to our drug candidates may be owned solely by a party or jointly between the parties. If we determine that rights to such improvements owned solely by a third party are necessary to commercialize our drug candidates or maintain our competitive advantage, we may need to obtain a license from such third party in order to use the improvements and continue developing, manufacturing or marketing the drug candidates. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain such a license, it could be granted on non-exclusive terms, thereby giving our competitors and other third parties access to the same technologies licensed to us. Failure to obtain a license on commercially reasonable terms or at all, or to obtain an exclusive license, could prevent us from commercializing our drug candidates or force us to cease some of our business operations, which could materially harm our business. If we determine that rights to improvements jointly owned between us and a third party are necessary to commercialize our drug candidates or maintain our competitive advantage, we may need to obtain an exclusive license from such third party. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such improvements, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners of our intellectual property in order to enforce such intellectual property against third parties, and such cooperation may not be provided to us. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

The term of our patents may be inadequate to protect our competitive position on our products.

Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. Depending upon the timing, duration and other factors relating to any FDA marketing approval we receive for any of our drug candidates, one or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984 (Hatch-Waxman Amendments). We expect to seek extensions of patent terms in the United States and, if available, in other countries where we are prosecuting patents. In the United States, the Hatch-Waxman Amendments permit a patent term extension of up to five years beyond the normal expiration of the patent, limited to the approved indication (or any additional indications approved during the period of extension), as compensation for patent term lost during the regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to an approved drug is eligible for the extension and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended, and the application for the extension must be submitted prior to the expiration of the patent. However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available for our patents, may refuse to grant

extensions to our patents, or may grant more limited extensions than we request. We may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements. If we are unable to obtain patent term extension or the term of any such extension is less than we request, our competitors and other third parties may be able to obtain approval of competing products following our patent expiration and take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case. Any of the foregoing would have a material adverse effect on our business, financial condition, results of operations and prospects.

Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent offices, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other government fees on any issued patent are due to be paid to the USPTO and patent offices in foreign countries in several stages over the lifetime of the patent. The USPTO and patent offices in foreign countries require compliance with a number of procedural, documentary, fee payment and other requirements during the patent application process. In the future, we may rely on licensing partners to pay these fees due to U.S. and non-U.S. patent agencies and to comply with these other requirements with respect to any future licensed patents and patent applications. While an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of a patent or patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our competitors and other third parties might be able to enter the market with similar or identical products of technology, which would have a material adverse effect on our business, financial condition, results of operations and prospects.

If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.

While we have filed patent applications or obtained patents with respect to our four drug candidates, we also rely on proprietary know-how and trade secret protection and confidentiality agreements to protect proprietary know-how or trade secrets that are not patentable or that we elect not to patent. We seek to protect our trade secrets and proprietary know-how in part by entering into non-disclosure and confidentiality agreements with parties who have access to such knowledge, such as our employees, consultants, independent contractors, advisors, contract manufacturers, CROs, hospitals, independent treatment centers, suppliers, collaborators and other third parties. We also enter into confidentiality and invention or patent assignment agreements with employees and certain consultants. However, we cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary know-how. Additionally, our confidentiality agreements and other contractual protections may not be adequate to protect our intellectual property from unauthorized disclosure, third-party infringement or misappropriation. Any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts in the United States and certain foreign jurisdictions are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent such third party, or those to whom they communicate such technology or information, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third party, our business, financial condition, results of operations and prospects our business and competitive position could be materially harmed.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.

Risks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business

Our future success depends on our ability to retain key employees and to attract, retain and motivate qualified personnel.

We are highly dependent on the development and managerial expertise of Athena Countouriotis, M.D., our President and Chief Executive Officer, as well as the other principal members of our management, scientific and clinical team. Although we have entered into employment agreements with our executive officers, each of them may terminate their employment with us at any time.

Our industry has experienced a high rate of turnover in recent years. Our ability to compete in the highly competitive pharmaceuticals industry depends upon our ability to attract, retain and motivate highly skilled and experienced personnel with scientific, clinical, regulatory, manufacturing and management skills and experience. We conduct our operations in the greater San Diego area, a region that is home to many other pharmaceutical companies as well as many academic and research institutions, resulting in fierce competition for qualified personnel. We may not be able to attract or retain qualified personnel in the future due to the intense competition for a limited number of qualified personnel among pharmaceutical companies. Many of the other pharmaceutical companies against which we compete have greater financial and other resources, different risk profiles and a longer history in the industry than we do. Our competitors may provide higher compensation, more diverse opportunities and/or better opportunities for career advancement. Any or all of these competing factors may limit our ability to continue to attract and retain high quality personnel, which could negatively affect our ability to successfully develop and commercialize our drug candidates and to grow our business and operations as currently contemplated.

We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.*

As of June 30, 2022, we had 267 full-time employees. We expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of clinical development, clinical operations, manufacturing, regulatory affairs, commercial and, if any of our drug candidates receives marketing approval, sales, marketing and distribution. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth and with developing sales, marketing and distribution infrastructure, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources.

If we are not able to effectively manage growth and expand our organization, we may not be able to successfully implement the tasks necessary to further develop and commercialize repotrectinib, our other pipeline drug candidates or any future drug candidates and, accordingly, may not achieve our research, development and commercialization goals.

Our internal information technology systems, or those of our third-party CROs or other vendors, contractors or consultants, may fail or suffer security breaches, loss or leakage of data and other disruptions, which could result in a material disruption of our development programs, compromise confidential information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.*

We are increasingly dependent upon information technology systems, infrastructure and data to operate our business. In the ordinary course of business, we collect and otherwise process personal data and other confidential information, including proprietary business information, trade secrets, intellectual property, and data we collect about trial participants in connection with clinical trials, and sensitive third-party data. It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We also have outsourced elements of our operations to third parties, and as a result we manage a number of third-party CROs, vendors, and other contractors and consultants who have access to our confidential information. Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place.

Despite the implementation of security measures, given their size and complexity and the increasing amounts of confidential information that they maintain, our internal information technology systems and those of our third-party CROs, vendors and other contractors and consultants are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war and telecommunication and electrical failures, as well as security incidents or breaches from inadvertent or intentional actions by our employees, third-party CROs, vendors, contractors, consultants, business partners and/or other third parties, or from cyber-attacks by malicious third parties (including the deployment of harmful malware, ransomware, denial-of-service attacks, supply chain attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information), which may compromise our system infrastructure, or that of our third-party CROs, vendors and other contractors and consultants, or lead to data leakage. Ransomware attacks, including by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe – particularly for companies like ours that are engaged in critical infrastructure or manufacturing – and can lead to significant interruptions in our operations, loss of data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments. Similarly, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our information technology systems or the third-party information technology systems that support us.

The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. During times of war and other major conflicts, we and the third parties upon which we rely may be vulnerable to a heightened risk of these attacks, including cyber-attacks that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products. For example, we may have operations and third parties upon which we rely to support our business located in unstable regions and regions experiencing (or expected to experience) geopolitical or other conflicts, including through the use of cyber-attacks. We may not be able to anticipate all types of security threats, nor may we be able to implement preventive measures effective against all such security threats. The techniques used by cyber criminals change frequently, may not be recognized until launched and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations or hostile foreign governments or agencies. Changes in how our employees work and access our systems during the current COVID-19 pandemic could lead to additional opportunities for bad actors to launch cyber-attacks or for employees to cause inadvertent security risks or incidents. To the extent that any accidental or intentional disruption or security breach were to result in a material loss of, or damage to, our data or applications, or those of our third-party CROs, vendors and other contractors and consultants, or inappropriate disclosure of confidential or proprietary information, we could incur liability and reputational damage and the further development and commercialization of repotrectinib or any other drug candidates could be delayed. The costs related to significant security breaches or disruptions could be material and exceed the limits of the cybersecurity insurance we maintain against such risks. The effects of a security breach or disruption could be further amplified during the current COVID-19 pandemic. If the information technology systems of our third-party CROs, vendors and other contractors and consultants become subject to disruptions or security breaches, we may have insufficient recourse against such third parties and we may have to expend significant resources to mitigate the impact of such an event, and to develop and implement protections to prevent future events of this nature from occurring.

While we have not experienced any such system failure, accident or security breach to date, we cannot guarantee that our data protection efforts and our investment in information technology will prevent significant breakdowns, data leakages, breaches in our systems, or those of our third-party CROs, vendors and other contractors and consultants, or other cyber incidents that could have a material adverse effect upon our reputation, business, operations or financial condition. For example, if such an event were to occur and cause interruptions in our operations, or those of our third-party CROs, vendors and other contractors and consultants, it could result in a material disruption of our programs and the development of our drug candidates could be delayed. In addition, the loss of clinical trial data for repotrectinib or any other drug candidates could result in delays in our marketing approval efforts and significantly increase our costs to recover or reproduce the data. Furthermore, significant disruptions of our internal information technology systems or those of our third-party CROs, vendors and other contractors and consultants, or security breaches could result in the loss, misappropriation and/or unauthorized access, use, or disclosure of, or the inability to access, confidential information (including trade secrets or other intellectual property, proprietary business information and personal data), which could result in government enforcement actions (for example, investigations, fines, penalties, audits, and inspections) and financial, legal, business and reputational harm to us. For example, any such event that leads to unauthorized access, use, or disclosure of personal data, including personal data regarding our clinical trial subjects or employees, could harm our reputation directly, compel us to comply with federal and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, and otherwise subject us to liability under laws and regulations that protect the privacy and security of personal data, which could result in significant legal and financial exposure and reputational damages that could potentially have an adverse effect on our business.

We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Our company is located in San Diego, California, an area prone to wildfires and earthquakes. These and other natural disasters could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. Any disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, could have a material adverse effect on our business.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

We have incurred substantial losses during our history and do not expect to become profitable in the near future, and we may never achieve profitability. Unused U.S. federal net operating losses for the tax years beginning before January 1, 2018, will carry forward to offset future taxable income, if any, until such unused losses expire. Under current law, unused U.S. federal net operating losses generated in tax years beginning after December 31, 2017, will not expire and may be carried forward indefinitely but the deductibility of such federal net operating losses in taxable years beginning after December 31, 2020, is limited to 80% of taxable income. In addition, both our current and our future unused losses and other tax attributes may be subject to limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Code) if we undergo an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in our equity ownership by certain stockholders over a three-year period. We have experienced ownership changes in the past and we may also experience additional ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations. Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes. In addition, at the state level, there may be periods during which the use of net operating losses or other tax attributes is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. As a result, even if we attain profitability, we may be unable to use all or a material portion of our net operating losses and other tax attributes, which could adversely affect our future cash flows.

We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.

From time to time, we may consider strategic transactions, such as acquisitions of companies, businesses or assets and out-licensing or in-licensing of products, drug candidates or technologies. Additional potential transactions that we may consider include a variety of different business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments. Any such transaction may require us to incur non-recurring or other charges, may increase our near term or long-term expenditures and may pose significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial results. For example, these transactions may entail numerous operational and financial risks, including:

Our portfolio of marketable securities is subject to market, interest and credit risk that may reduce its value.*

The value of our investments may decline due to increases in interest rates, downgrades of the bonds and other securities included in our portfolio and instability in the global financial markets that reduces the liquidity of securities included in our portfolio. In addition, the COVID-19 pandemic and ongoing geopolitical events have and may continue to adversely affect the financial markets in some or all countries worldwide. Each of these events may cause us to record charges to reduce the carrying value of our investment portfolio or sell investments for less than our acquisition cost. Although we attempt to mitigate these risks through diversification of our investments and continuous monitoring of our portfolio’s overall risk profile, the value of our investments may nevertheless decline.

Our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

We are exposed to the risk of fraud or other misconduct by our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (i) FDA regulations or those of comparable foreign regulatory authorities, including those laws that require the reporting of true, complete and accurate information, (ii) manufacturing standards, (iii) federal and state health and data privacy, security, fraud and abuse, government price reporting, transparency reporting requirements, and other healthcare laws and regulations in the United States and abroad, (iv) sexual harassment and other workplace misconduct, or (v) laws that require the true, complete and accurate reporting of financial information or data. Such misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. We maintain a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or person performing similar functions, as well as a disclosure program and other applicable policies and procedures, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional integrity reporting and oversight obligations, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

The trading price of our common stock has been and may in the future be volatile and fluctuate substantially, which could result in substantial losses.*

Our stock price is volatile. For example, the closing price of our common stock since April 17, 2019 through June 30, 2022, has ranged from a low of $24.32 to a high of $141.30. The stock market in general and the market for smaller pharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price for our common stock may be influenced by many factors, including:

Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock.

Provisions of our amended and restated certificate of incorporation and amended and restated bylaws may delay or discourage transactions involving an actual or potential change in our control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock. Among other things, our amended and restated certificate of incorporation and amended and restated bylaws:

The amendment of any of these provisions, with the exception of the ability of our board of directors to issue shares of preferred stock and designate any rights, preferences and privileges thereto, would require approval by the holders of at least 66-2/3% of our then-outstanding common stock.

In addition, as a Delaware corporation, we are subject to Section 203 of the Delaware General Corporation Law. These provisions may prohibit large stockholders, in particular those owning 15% or more of our outstanding voting stock, from merging or combining with us for a certain period of time. A Delaware corporation may opt out of this provision by express provision in its

original certificate of incorporation or by amendment to its certificate of incorporation or bylaws approved by its stockholders. However, we have not opted out of this provision.

These and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by our then-current board of directors, including delay or impede a merger, tender offer or proxy contest involving our company. The existence of these provisions could negatively affect the price of our common stock and limit opportunities for you to realize value in a corporate transaction.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation provides that, to the fullest extent permitted by law and subject to the court’s having personal jurisdiction over the indispensable parties named as defendants, the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf, (ii) any action or proceeding asserting a breach of fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders, (iii) any action or proceeding asserting a claim against us or any of our current or former directors, officers or other employees arising out of or pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or bylaws; (iv) any action or proceeding to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; (v) any action or proceeding as to which the Delaware General Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware and (vi) any action asserting a claim against us or any of our directors, officers or other employees that is governed by the internal affairs doctrine. These provisions would not apply to suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims.

These choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees and may discourage these types of lawsuits. Furthermore, the enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable or unenforceable. If a court were to find the choice of forum provisions contained in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving such action in other jurisdictions, all of which could seriously harm our business.

We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company we have incurred and will continue to incur significant legal, accounting and other expenses. The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of The Nasdaq Global Select Market and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations have increased our legal and financial compliance costs and have made some activities more time-consuming and costly. For example, these rules and regulations have made it more difficult and more expensive for us to obtain and maintain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified members of our board of directors.

We are evaluating these rules and regulations, and cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us.

We are required to comply with certain aspects of Section 404 of the Sarbanes-Oxley Act. Section 404 of the Sarbanes-Oxley Act requires public companies to, among other things, conduct an annual review and evaluation of their internal controls over

financial reporting. Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate financial statements on a timely basis is a costly and time-consuming effort that requires frequent evaluation. Our failure to maintain the effectiveness of our internal controls in accordance with the requirements of the Sarbanes-Oxley Act could have a material adverse effect on our business. We could lose investor confidence in the accuracy and completeness of our financial reports, which could have an adverse effect on the price of our common stock. In addition, if our efforts to comply with new or changed laws, regulations and standards differ from the activities intended by regulatory or governing bodies, regulatory authorities may initiate legal proceedings against us and our business may be harmed.

Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.

We have never declared or paid cash dividends on our capital stock. We currently intend to retain all of our future earnings, if any, to finance the growth and development of our business. In addition, the terms of any future debt agreements we may enter into may preclude us from paying dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.

New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could adversely affect our business operations and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. For example, the Biden administration and Congress have proposed various changes, which if enacted could have a material impact on our business, cash flow, financial condition, or results of operations. In addition, it is uncertain if and to what extent various states will conform to federal tax laws. Future tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about us, our business or our market, our stock price and trading volume could decline.

The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our common stock or publish inaccurate or unfavorable research about our business, our common stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our common stock price and trading volume to decline.

Our business could be negatively affected as a result of actions of activist stockholders, and such activism could impact the trading value of our securities.

Stockholders may, from time to time, engage in proxy solicitations or advance stockholder proposals, or otherwise attempt to effect changes and assert influence on our board of directors and management. Activist campaigns that contest or conflict with our strategic direction or seek changes in the composition of our board of directors could have an adverse effect on our operating results and financial condition. A proxy contest would require us to incur significant legal and advisory fees, proxy solicitation expenses and administrative and associated costs and require significant time and attention by our board of directors and management, diverting their attention from the pursuit of our business strategy. Any perceived uncertainties as to our future direction and control, our ability to execute on our strategy, or changes to the composition of our board of directors or senior management team arising from a proxy contest could lead to the perception of a change in the direction of our business or instability which may result in the loss of potential business opportunities, make it more difficult to pursue our strategic initiatives, or limit our ability to attract and retain qualified personnel and business partners, any of which could adversely affect our business and operating results. If individuals are ultimately elected to our board of directors with a specific agenda, it may adversely affect our ability to effectively implement our business strategy and create additional value for our stockholders. We may choose to initiate, or may become subject to, litigation as a result of the proxy contest or matters arising from the proxy contest, which would serve as a further distraction to our board of directors and management and would require us to incur significant additional costs. In addition, actions such as those described above could cause significant fluctuations in our stock price based upon temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our business.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because pharmaceutical companies have experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

Furnish the exhibits required by Item 601 of Regulation S-K (§ 229.601 of this chapter).

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

CERTAIN INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY [***], HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE THE REGISTRANT HAS DETERMINED THAT IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

This License Agreement (this “Agreement”) is made as of May 4, 2022 (the “Effective Date”), by and between Turning Point Therapeutics, Inc., a corporation organized and existing under the laws of the State of Delaware, with offices located at 10628 Science Center Drive, Suite 200, San Diego, California 92121, United States of America (“TPTX”), and LaNova Medicines Limited, a limited liability company organized and existing under the laws of the People’s Republic of China, with offices located at 999 Cailun Road, Building 1, F5, Pudong District, Shanghai, China, 201203 (“LaNova”). LaNova and TPTX may be referred to in this Agreement individually as a “Party” and together as the “Parties”.

WHEREAS, LaNova is a biopharmaceutical company designing and developing novel molecule, targeted oncology therapies, and controls rights to a pharmaceutical product candidate comprising an antibody-drug conjugate targeting Claudin18.2 (as further defined below, the “Licensed Molecule”);

WHEREAS, TPTX is a pharmaceutical company having experience in the development and commercialization of pharmaceutical products; and

WHEREAS, LaNova wishes to grant to TPTX, and TPTX wishes to be granted from LaNova, an exclusive license to develop and commercialize the Product in the Field in the TPTX Territory and non-exclusive, worldwide license to manufacture the Product for the purpose of development and commercialization in the TPTX Territory (each, as defined below), and LaNova desires to grant to TPTX, and TPTX desires to be granted by LaNova, the first right to negotiate for a license or collaboration with respect to up to three (3) additional antibody-drug conjugate products, all in accordance with the terms and conditions of this Agreement.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

The following initially capitalized terms, whether used in the singular or plural, have the respective meanings set forth below:

1.3 “Adverse Event” means any unwanted or harmful medical occurrence in a patient or subject who is administered a Product, whether or not considered related to such Product, including any undesirable sign (including abnormal laboratory findings of clinical concern).

1.4 “Affiliate” means, with respect to a specified Person, any entity that directly or indirectly controls, is controlled by or is under common control with such Person. As used in this Section 1.4, “control” (and, with correlative meanings, the terms “controlled by” and “under common control with”) means, in the case of a corporation, the ownership of more than fifty percent (50%) of the outstanding voting securities thereof or, in the case of any other type of entity, an interest that results in the ability to direct or cause the direction of the management and policies of such entity or the power to appoint more than fifty percent (50%) of the members of the governing body of the entity or, where ownership of more than fifty percent (50%) of such securities or interest is prohibited by law, ownership of the maximum amount legally permitted.

1.5 “Agreement” has the meaning set forth in the preamble to this agreement.

1.7 “Ancillary Agreements” means, collectively, the Pharmacovigilance Agreement, Clinical Supply Agreement, and any and all other written agreements between TPTX and LaNova with respect to the Product contemplated under this Agreement.

1.9 “Annual Net Sales Milestone Event” has the meaning set forth in Section 9.3(a).

1.10 “Annual Net Sales Milestone Payment” has the meaning set forth in Section 9.3(a).

1.11 “Anti-Corruption Laws” has the meaning set forth in Section 11.5(a)(i).

1.12 “Applicable Laws” means all statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority that may be in effect from time to time and applicable to the relevant activities contemplated by this Agreement.

1.13 “Business Day” means a day other than Saturday, Sunday or any day on which banks located in San Diego, California or Shanghai, PRC are authorized or obligated to close. Whenever this Agreement refers to a number of days, such number will refer to calendar days unless Business Days are specified.

1.14 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31st, June 30th, September 30th and December 31st.

1.15 “Calendar Year” means each twelve (12) month period commencing on January 1st.

1.17 “cGMP” means all applicable current Good Manufacturing Practices including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent Applicable Laws in any relevant country or region, each as may be amended and applicable from time to time.

1.18 “Change of Control” means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than fifty (50%) of the total voting power of all of the then outstanding voting securities of such Party; (b) a merger, consolidation, recapitalization, or reorganization of such Party is consummated which results in shareholders or equity holders of such Party immediately prior to such transaction, no longer owning at least fifty (50%) of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (c) there is a sale or transfer to a Third Party of all or substantially all of such Party’s consolidated assets taken as a whole, through one or more related transactions.

1.19 “Chemotherapy” means cytotoxic anti-cancer drugs that belong to one of the following categories: alkylating agents, antimetabolites, anti-tumor antibiotics, topoisomerase inhibitors, mitotic inhibitors, corticosteroids, and proteasome inhibitors. For clarity, chemotherapy does not include targeted cancer therapies that use drugs or substances that block the growth and spread of cancer by interfering with specific targets.

1.21 “Clinical Supply Agreement” has the meaning set forth in Section 7.1(b).

1.22 “Clinical Supply Cutoff Date” has the meaning set forth in Section 7.1(a).

1.23 “Clinical Trial” means any clinical trial of a Product in human subjects as defined in 21 C.F.R. §312.21, as amended from time to time, or a similar clinical trial as prescribed by the Regulatory Authorities in any jurisdiction outside the U.S.

1.24 “CMO(s)” means any Third Party contractor manufacturing organization(s).

1.26 “Commercialization” or “Commercialize” means all activities directed to marketing, distribution, promoting or selling of pharmaceutical products (including importing and exporting activities in connection therewith), but excluding activities directed to Manufacturing. “Commercializing” and “Commercialized” have the correlative meanings.

1.27 “Commercialization Plan” means the written plan for the Commercialization of the Product in the TPTX Territory, as prepared and updated by TPTX from time to time.

1.28 “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective, the level of reasonable, diligent, good faith efforts that biotechnology or pharmaceutical companies typically devote to product candidates or products owned by them that are at a similar stage in their development or product life and are of similar market potential, taking into account efficacy, safety, approved labeling, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the product, the likelihood of regulatory approval, the profitability of the product, and other relevant technical, legal, scientific and medical factors. For purposes of this Section 1.28, “biotechnology or pharmaceutical companies” means companies in the biotechnology or pharmaceutical industry (as applicable) of a size and stage of development similar to that of such Party, including having human pharmaceutical product candidates or products in a similar stage of development to the Product.

1.29 “Committee(s)” means the JSC, JDC, JMC or any subcommittee established by the JSC, as applicable.

1.30 “Competing Activities” means, with respect to a Party, any and all activities prohibited by such Party under Section 2.6(a).

1.31 “Competitive Infringement” means, with respect to a Licensed Patent or a Joint Patent, either of the following: (a) any activity in the TPTX Territory that (i) is conducted by a Person (other than any Person authorized by TPTX in accordance with this Agreement), (ii) infringes or would reasonably be expected to infringe any Licensed Patent or Joint Patent and (iii) involves the development, registration, use, sale, offer for sale or import of [***]; or (b) receipt of any notice alleging that a Third Party’s manufacture, use, or sale of a product that [***] in the TPTX Territory does not infringe any Licensed Patent or Joint Patent, or that such Licensed Patent or Joint Patent is invalid or unenforceable. Notwithstanding the foregoing, Competitive Infringement shall not include any activities involving [***].

1.33 “Control” or “Controlled” means, with respect to any Know-How, Patents or other subject matters, that a Party has the legal authority or right (whether by ownership, license or otherwise, after taking into account the provisions of this Agreement regarding ownership of Improvements, but without taking into account any license granted by one Party to the other Party pursuant to this Agreement) to grant a license, sublicense, access or right to use (as applicable) under such Know-How, Patents, or subject matters, on the terms and conditions set forth herein, in each case without breaching the terms of any agreement with a Third Party. Notwithstanding the foregoing, in the event of a Change of Control of a Party, any Know-How, Patent, and such

other subject matter Controlled by any Affiliate of such Party that was not an Affiliate of such Party immediately prior to such Change of Control transaction will not be Licensed Know-How, Licensed LaNova Territory Technology or Licensed Manufacturing Technology (in the case of LaNova) or TPTX IP (in the case of TPTX) except to the extent any such Know-How, Patent, or such other subject matter (a) is also Controlled by such Party or its Affiliate existing immediately prior to such Change of Control transaction, or (b) is generated or used by such Affiliate in the Development, use, Manufacture or Commercialization of the Licensed Molecule or Product after such transaction.

1.34 “Cost of Goods” means the cost of Manufacturing the Product. Cost of Goods shall be a “standard cost” per unit (calculated annually), comprised of the following elements calculated with internal cost accounting methods in accordance with the GAAP: (a) [***], (b) [***], (c) [***], (d) [***], (e) [***], (f) [***], (g) [***], and (h) [***]. To the extent that the Product is Manufactured by one or more CMOs and supplied to a Party by such CMO(s), Cost of Goods shall be the actual invoice price paid by a Party to such CMO(s) for the Manufacture and supply of the Product, [***].

1.37 “Data” means any and all results of research, preclinical studies, including in vitro and in vivo studies, clinical trials and other testing of any composition of matter, product candidate or product, and any and all other data related to the development, manufacture or commercialization of any composition of matter, product candidate or product, including biological, chemical, pharmacological, toxicological, pharmacokinetic, preclinical, clinical, CMC, analytical, quality control, mechanical, software, electronic and other data, results and descriptions.

1.39 “Development” or “Develop” means research and preclinical and clinical drug or biological development activities, including test method development, toxicology, formulation, quality assurance/quality control development, statistical analysis, preclinical and clinical studies and regulatory affairs, and regulatory activities, including filing for, obtaining and maintaining approval and registration, but excluding activities directed to Manufacturing. “Developing” has the correlative meaning.

1.40 “Development Milestone Event” has the meaning set forth in Section 9.2(a).

1.41 “Development Milestone Payment” has the meaning set forth in Section 9.2(a).

1.44 “Effective Date” has the meaning set forth in the preamble in this Agreement.

1.45 “EMA” means the European Medicines Agency, or any successor agency thereto.

1.48 “FDA” means the United States Food & Drug Administration, or any successor agency thereto.

1.49 “Field” means all prophylactic, palliative, therapeutic and/or diagnostic uses in connection with all human and veterinary diseases and disorders.

1.50 “First Commercial Sale” means, with respect to the Product, the first arm’s length sale of such Product to a Third Party in a country of the TPTX Territory by TPTX, its Affiliate(s) or Sublicensee(s) for use or consumption in such region following Regulatory Approval. [***].

1.51 “GAAP” means U.S. Generally Accepted Accounting Principles, consistently applied.

1.52 “GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable (a) as set forth in the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the TPTX Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts

50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws in the region in the TPTX Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

1.53 “Generic/Biosimilar Product” means, with respect to the Product that has received Regulatory Approval in a country within the TPTX Territory and is being marketed and sold by TPTX or any of its Affiliates or Sublicensees in such country, any pharmaceutical/biologic product that: (a) is sold in such country under an independent marketing authorization by a Third Party that is not a Sublicensee of TPTX or its Affiliates and did not purchase or acquire such product in a chain of distribution that included TPTX or any of its Affiliates or Sublicensees; and (b) has received such marketing authorization as a “generic medicinal product,” “biosimilar,” “bioequivalent,” “similar biological medicinal product,” or similar designation by the applicable Regulatory Authority in such country, pursuant to an approval process in accordance with the then-current rules and regulations in such country, whereby the “reference medicinal product,” “reference listed product” or similar designation used in such marketing authorization in such country relies upon or references such Product.

1.56 “GLP” means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the U.S. Food and Drug Administration as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the region in the TPTX Territory, each as may be amended and applicable from time to time.

1.57 “Governmental Authority” means any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, region, state or local authority or any political subdivision thereof, or any association of countries.

1.58 “GSP” means all applicable Good Supply Practice standards, including, as applicable, as set forth in the then current good supply practice standards promulgated or endorsed by the FDA as defined in Good Supply Practice for Pharmaceutical Products or the equivalent Applicable Laws in the region in the TPTX Territory, each as may be amended and applicable from time to time.

1.61 “IND” means an investigational new drug application or equivalent application filed with the applicable Regulatory Authority, which application is required to commence Clinical Trials in the applicable jurisdiction.

1.64 “Indication” means a specific disease, disorder or condition which is recognized by the applicable Regulatory Authority in a given country or jurisdiction as a disease, disorder or condition; [***].

1.65 “Invention” means any process, method, composition of matter, article of manufacture, discovery or finding, patentable or otherwise, that is invented, discovered or generated as a result of a Party (or the Parties jointly) exercising its (their) rights or carrying out its (their) obligations under this Agreement, including all rights, title and interest in and to the intellectual property rights therein.

1.66 “Joint Development Committee” or “JDC” has the meaning set forth in Section 3.2(b).

1.68 “Joint Manufacturing Committee” or “JMC” has the meaning set forth in Section 3.2(b).

1.70 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 3.2(a).

1.71 “Know-How” means any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data.

1.73 “LaNova Acquisition Party” has the meaning set forth in Section 2.6(b)(i).

1.75 “LaNova Excluded Products” has the meaning set forth in Section 2.6(b)(i).

1.77 “LaNova Territory” means Mainland China, Hong Kong, Taiwan, Macau, and South Korea.

1.78 “Licensed Know-How” means any and all Know-How Controlled by LaNova or its Affiliates as of the Effective Date or during the Term, including LaNova’s joint ownership interest in any Know-How within the Joint Inventions, that is necessary or reasonable useful (and with respect to Development only, actually used by or on behalf of LaNova or its Affiliates) for the Development, use or Commercialization of the Product (including the Licensed Molecule contained therein) in the Field in the TPTX Territory.

1.80 “Licensed LaNova Territory Technology” means any and all Patents and Know-How Controlled by LaNova or its Affiliates as of the Effective Date or during the Term that is necessary or reasonably useful (and with respect to Development only, actually used by or on behalf of LaNova or its Affiliates) for the Development or use of the Product (including the Licensed Molecule contained therein) in the LaNova Territory.

1.81 “Licensed Manufacturing Technology” means any and all Know-How Controlled by LaNova or its Affiliates as of the Effective Date or during the Term that is necessary or reasonably useful for the Manufacture of the Product (including the Licensed Molecule contained therein).

1.82 “Licensed Molecule” means LaNova’s ADC referred to as [***], comprised of an antibody with the [***] Sequence that [***].

1.83 “Licensed Patents” means any and all Patents in the TPTX Territory Controlled by LaNova or its Affiliates as of the Effective Date or during the Term, including LaNova’s interest in any Joint Patents in the TPTX Territory, that are necessary or reasonably useful for the Development, use, or Commercialization of the Product (including the Licensed Molecule contained therein) in the Field in the TPTX Territory, including any such Patents that claim the Licensed Molecule or the Product (including the composition of matter, formulation or method of use thereof). Schedule 1.83 contains a list of all Licensed Patents as of the Effective Date.

1.84 “Licensed Technology” means the Licensed Know-How and Licensed Patents.

1.86 “[***] Patent Family” means (a) the Patents listed under “[***] Patent Family” in Schedule 1.83 (as may be updated from time to time in accordance with Section 13.3(c)), (b) any substitutions, divisions, continuations, continuations-in-part (but only to the extent that they cover the same invention claimed in the foregoing), reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like, and any provisional applications, of any such Patents described in (a) or (b), and (c) any foreign or international equivalent in the TPTX Territory of any of the Patents described in (a) or (b).

1.87 “[***] Sequence” means the sequence of the [***] referred to as [***], as specified in Schedule 1.87.

1.89 “[***] Patent Family” means (a) the Patents listed under “[***] Patent Family” in Schedule 1.83 (as may be updated from time to time in accordance with Section 13.3(c)), (b) any substitutions, divisions, continuations, continuations-in-part (but only to the extent that they cover the same invention claimed in the foregoing), reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like, and any provisional applications, of any such Patents described in (a) or (b), and (c) any foreign or international equivalent in the TPTX Territory of any of the Patents described in (a) or (b).

1.92 “MAA” means (a) a Marketing Authorization Application (as more fully defined in 21 C.F.R. §314.5, et seq.) or a Biologics License Application (as more fully defined in 21 C.F.R. §601.2), as applicable, submitted to the FDA or (b) the equivalent application(s) filed with any Regulatory Authority in any jurisdiction outside the U.S. for approval to market and sell a new drug or biologic in such jurisdiction; in each case, including all amendments and supplements to any of the foregoing.

1.93 “MAA Approval” means (a) with respect to an MAA for the Product submitted to the FDA, the approval of such MAA by the FDA; or (b) with respect to an MAA for a Product filed with the applicable Regulatory Authority in any jurisdiction outside the U.S., the approval of such MAA by such Regulatory Authority.

1.95 “Manufacture” or “Manufacturing” or “Manufactured” means all operations involved in the manufacturing, filling and finishing, quality control testing (including in-process, release and stability testing, if applicable), storage, releasing, packaging, and labeling.

1.96 “Manufacturing Technology Transfer” has the meaning set forth in Section 4.2(b).

1.97 “Manufacturing Technology Transfer Plan” has the meaning set forth in Section 4.2(a).

1.98 “Milestone Events” means Development Milestone Events or Annual Net Sales Milestone Events.

1.99 “Milestone Payments” means Development Milestone Payments or Annual Net Sales Milestone Payments.

The transfer of a Product to an Affiliate, Sublicensee, or other Third Party (i) in connection with the Development or testing of a Product (including the conduct of clinical studies), (ii) for purposes of distribution as promotional samples, (iii) for indigent or similar public support or compassionate use programs, or (iv) by and between TPTX and its Affiliates or Sublicensees will not, in any case, be considered a Net Sale of a Product under this Agreement. Subject to the foregoing, any sales income received by TPTX, its Affiliates or Sublicensees for the Product prior to or after Regulatory Approval will be Net Sales and subject to the Royalty Payments under Section 9.4(a).

Net Sales will also include and be deemed to have been made with respect to the Product used by TPTX or any Affiliate, for its own commercial purposes, or transferred to any Third Party for less than what the transferee is then charging in normal arms-length sales transactions; and Net Sales in all such cases will be deemed to have been made at the prices therefor at which the Product is then being sold to the customers of such user or transferor (or of TPTX, if an Affiliate is a user but not a seller) in arms-length sales transactions. For clarity, in the event the Product is sold in an arms-length transaction to a governmental agency, a group purchase entity or any other entity having the bargaining power to negotiate the purchase price below normal retail price in transactions of lesser volume, Net Sales will be calculated based on the actual price negotiated and agreed to for such agency or entity and not be based on the price charged in other arms-length sales transactions.

To the extent that TPTX or any of its Affiliates, or Sublicensees, provides to the purchasing Third Party discounts or allowances that are applicable to purchases of the Product and one or more other products (such as in a “bundled sale” arrangement), such discounts and allowances will be allocated between the Product (for purposes of the deductions used in calculating Net Sales as above) and such other products in an equitable and commercially reasonable manner that does not

unfairly or inappropriately bias the level of discounting against the Product (as compared to the other products).

1.103 “NMPA” means the National Medical Products Administration, formerly known as the China Food and Drug Administration, and local or provincial counterparts thereto, and any successor agency(ies) or authority thereto having substantially the same function.

1.104 “Party” or “Parties” has the meaning set forth in the preamble to this Agreement.

1.105 “Patents” means (a) all national, regional and international patents and patent applications, including any provisional patent application, (b) any patent application claiming priority from such patent application or provisional patent applications, including divisions, continuations, continuations-in-part, additions, (c) any patent that has issued or in the future issues from any of the foregoing patent applications, including any utility or design patent or certificate of invention, and (d) re-issues, renewals, extensions, substitutions, re-examinations or restorations, registrations and revalidations, and supplementary protection certificates and equivalents to any of the foregoing.

1.106 “Person” means any individual, sole proprietorship, corporation, joint venture, limited liability company, partnership, limited partnership, limited liability partnership, trust or any other private, public or governmental entity.

1.107 “Pharmacovigilance Agreement” has the meaning set forth in Section 6.11(a).

1.108 “Phase 1 Clinical Study” means a Clinical Trial of the Product conducted in healthy human subjects or patients with the disease or condition under study to generate information on product safety and tolerability (as a primary purpose), and as applicable pharmacological activity or pharmacokinetics, as more fully described in, 21 C.F.R. §312.21(a) (as amended from time to time) with respect to a Clinical Trial in the U.S. or equivalent law or regulation with respect to a Clinical Trial in any jurisdiction outside the U.S.

1.109 “Phase 2 Clinical Study” means a Clinical Trial of the Product following one or more Phase 1 Clinical Studies conducted in the target patient population for an Indication under study to evaluate the safety, efficacy, and dose-ranging of the Product, which Clinical Trial is prospectively designed to generate data that is sufficient (if successful) to commence a Phase 3 Clinical Study or to file for accelerated MAA Approval, as more fully described in 21 C.F.R. §312.21(b) (as amended from time to time) with respect to a Clinical Trial in the U.S. or equivalent law or regulation with respect to a Clinical Trial in any jurisdiction outside the U.S.

1.110 “Phase 3 Clinical Study” means a Clinical Trial of the Product following one or more Phase 2 Clinical Studies conducted with a defined dose or set of defined doses of the Product on sufficient numbers of human patients, which Clinical Trial is prospectively designed to demonstrate with statistical significance that the Product is safe and effective for use in the Indication under study and to support the filing for MAA Approval of the Product for such Indication, as more fully described in 21 C.F.R. §312.21(c) (as amended from time to time) with respect to a Clinical Trial in the U.S. or equivalent law or regulation with respect to a Clinical Trial in any jurisdiction outside the U.S.

1.111 “PMDA” means the Japanese Pharmaceutical and Medical Device Administration or any successor agency thereto.

1.112 “PRC” means the People’s Republic of China, including mainland China, Hong Kong Special Administration Region, Macau Special Administration Region, and Taiwan.

1.115 “Prosecution” means, with respect to a Patent, the filing, preparation, prosecution (including conducting all correspondence and interactions with any patent office and seeking, conducting and defending all any interferences, inter partes reviews, reissue proceedings, reexaminations, and oppositions and similar proceedings), and maintenance thereof, including obtaining patent term extensions, regulatory exclusivity, supplemental protection certificates, or their equivalents with respect thereto. When used as a verb, “Prosecute” and “Prosecuting” mean to engage in Prosecution. “Prosecution”, “Prosecute”, and “Prosecuting” exclude any enforcement action with respect to a Patent.

1.117 “Regulatory Approval” means, with respect to the Product in a region or a country, the approvals from the necessary Governmental Authority to import, market and sell such Product in such region (but excluding pricing approvals and reimbursement approvals).

1.118 “Regulatory Authority” means any applicable Governmental Authority responsible for granting Regulatory Approvals for the Product, including the FDA, EMA, NMPA, and any corresponding national or regional regulatory authorities.

1.119 “Regulatory Exclusivity” means marketing or data exclusivity rights conferred by the applicable Regulatory Authority under Applicable Law in a country or jurisdiction on the holder of an approved MAA for a pharmaceutical product in such country or jurisdiction to prevent Third Parties from Commercializing such Product (other than Patent rights), including regulatory data exclusivity, orphan drug exclusivity, new chemical entity exclusivity and pediatric exclusivity.

1.120 “Regulatory Submissions” means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Product.

1.125 “ROFN Data Package” means, with respect to each ROFN Program, a summary of all results of Development activities conducted by or on behalf of LaNova or its Affiliates with respect to such ROFN Program [***].

1.126 “ROFN Development Candidate” has the meaning set forth in Section 2.7.

1.136 “Senior Executive” means (a) with respect to LaNova, its Chief Executive Officer (or one of his or her direct reports having authority to agree to a final resolution of a disputed matter under this Agreement) and (b) with respect to TPTX, its Chief Executive Officer (or one of his or her direct reports having authority to agree to a final resolution of a disputed matter under this Agreement).

1.139 “Sublicensee” means a Third Party or Affiliate of TPTX that was granted a sublicense by TPTX under any of the rights or licenses described in Section 2.1. For clarity, a Third Party or any Affiliate of TPTX that was granted a sublicense by a Sublicensee will also be deemed a Sublicensee.

1.140 “Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon). For clarity, Taxes includes VAT.

1.142 “Technical Assistance Period” has the meaning set forth in Section 4.3(a).

1.146 “Third Party” means an entity other than (a) TPTX and its Affiliates or (b) LaNova and its Affiliates.

1.147 “Third Party Infringement Claim” has the meaning set forth in Section 13.3(f).

1.149 “TPTX Acquisition Party” has the meaning set forth in Section 2.6(b)(ii).

1.152 “TPTX IP” means any and all Know-How and Patents Controlled by TPTX or its Affiliates (a) as of the Effective Date or (b) at any time during the Term that are, in each case, (i) not Improvements and (ii) actually used by or on behalf of TPTX or its Affiliates for conducting the Global Studies.

1.154 “Transition Period” has the meaning set forth in Section 14.10(b)(iv).

1.156 “U.S. Dollars” or “$” means United States dollars, the lawful currency of the U.S.

1.157 “Valid Claim” means (a) a claim of an issued and unexpired Patent included within the Licensed Patents (including any Patent to the extent covering any of LaNova’s Sole Inventions, but excluding any Patent to the extent covering any of TPTX’s Sole Inventions or Joint Patents, in the TPTX Territory) that has not been permanently revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is not appealable or is not appealed within the time allowed for appeal, and has not been abandoned, disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise or (b) a claim of a pending Patent application included within the Licensed Patents (including any Patent covering an Improvement and any Joint Patent) in the TPTX Territory that (i) would cover the Licensed Molecule or Product (including the composition of matter, formulation, or method of use thereof) in the TPTX Territory if such claim was to issue, (ii) has not been pending for more

than [***] years from its filing date, and (iii) (A) has not been cancelled, withdrawn or abandoned or (B) finally rejected by an administrative agency action from which no appeal can be taken or that has not been appealed within the time allowed for appeal.

2.1 License Grant to TPTX. Subject to the terms and conditions of this Agreement, LaNova hereby grants to TPTX:

(a) an exclusive (even as to LaNova and its Affiliates), royalty-bearing license, with the right to grant sublicenses (solely in accordance with Section 2.3), under the Licensed Technology to Develop, use, register, sell, offer for sale, import, and otherwise Commercialize the Product (including the Licensed Molecule contained therein) in the Field in the TPTX Territory;

(b) a non-exclusive, royalty-bearing, and worldwide license, with the right to grant sublicenses (solely in accordance with Section 2.3), under the Licensed Manufacturing Technology to Manufacture and have Manufactured the Product (including the Licensed Molecule contained therein), solely for use in the Development, use, registration, sale, offer for sale, import, or other Commercialization of the Product (including the Licensed Molecule contained therein) in the Field in the TPTX Territory; and

(c) to the extent that the Global Studies will be conducted [***] under the Global Development Plan in accordance with Section 5.2(b), a non-exclusive license, with the right to grant sublicenses (solely in accordance with Section 2.3), under [***] solely for the purpose of conducting such Development Activities (as defined below) in accordance with the Global Development Plan in such country or region [***].

(a) General. TPTX has the right, without LaNova’s consent or approval, to grant sublicenses under the licenses granted in Section 2.1 solely as follows: (i) from and after the Effective Date, to its Affiliates (except that such sublicense will automatically terminate from and after the time that such entity ceases to be an Affiliate of TPTX), CROs or CMOs; and (ii) from and after the [***] anniversary of the Effective Date, to any Third Party, in each case of (i) and (ii), for the sole purpose of performing TPTX’s obligations or exercising TPTX’s rights with respect to the Product in accordance with this Agreement.

(b) Restrictions. Each sublicense will be subject to a written agreement that is consistent with the terms and conditions of this Agreement as applicable to the scope of the sublicense granted, and TPTX will remain fully responsible for compliance by its Sublicensees with the terms and conditions of this Agreement applicable to such Sublicensees. TPTX may fulfill any of its obligations under this Agreement itself or through its Affiliates, subcontractors and Sublicensees, provided, however that TPTX will remain directly responsible for all its obligations under this Agreement, regardless of whether any such obligation is delegated, subcontracted or sublicensed to any of its Affiliates, subcontractors, or Sublicensees. Any breach of the terms or conditions of this Agreement by any Affiliate, subcontractor, or Sublicensee of TPTX will be deemed a direct breach by TPTX of such terms or conditions, which breach will be subject to the opportunity to cure following notice of breach. TPTX will, prior to engaging any Third Party as a Sublicensee, enter into a written agreement with such Sublicensee containing terms and conditions that: (i) require such Sublicensee to protect and keep confidential any Confidential Information of the Parties, including in accordance with Article 10; and (ii) do not impose any payment obligations or liability on LaNova. TPTX will provide a true copy of the complete executed agreement with each Sublicensee to LaNova within [***] days after the execution of such sublicense agreement, or where such sublicense agreement will not become effective until regulatory clearance is obtained, within [***] days after the date on which such sublicense agreement becomes effective; provided that TPTX will be permitted to redact commercially sensitive terms of any such agreement which terms are not necessary for LaNova to confirm TPTX’s compliance with its obligations hereunder.

2.4 License Grant to LaNova. Subject to the terms and conditions of this Agreement, TPTX hereby grants to LaNova an exclusive, fully paid-up and royalty free, license, with the right to grant sublicenses (through multiple tiers), under the TPTX IP to the conduct its obligations (if any) with respect to the Global Studies [***] pursuant to Section 5.2.

2.5 No Implied Licenses; Negative Covenant. Except as set forth herein, nothing in this Agreement grants any license or other intellectual property interest of either Party to the other Party, by implication or otherwise, under any Know-How, trademarks, Patents of the other Party. Each Party may not, and may not permit any of its Affiliates or sublicensees to, practice any Patent or Know-How licensed to it by the other Party outside the scope of the licenses granted to it under this Agreement.

(i) Non-Compete by TPTX. Except as provided in Section 2.6(b) below or otherwise expressly contemplated under this Agreement (including any transaction between the Parties as contemplated in Sections 2.7 and 2.8), TPTX will not, and will cause its controlled Affiliates and require its Sublicensees not to, engage in (independently or for or with any Third Party) any clinical Development, use or Commercialization of any TPTX Competing Product in the Field in the TPTX Territory other than the Licensed Molecule and the Product in the Field in the TPTX Territory as permitted under this Agreement. Such obligations will commence as of the Effective Date and continue [***].

(ii) Non-Compete by LaNova. Except as provided in Section 2.6(b) below or otherwise expressly contemplated under this Agreement (including any transaction between the Parties as contemplated in Sections 2.7 and 2.8), LaNova will not, and will cause its Affiliates and require its licensees and sublicensees with respect to the Licensed Molecule or the Product not to, engage in (independently or for or with any Third Party) any clinical Development, use or Commercialization in the Field in the TPTX Territory of any LaNova Competing Product (including through any license or grant of rights to any Third Party with respect to any LaNova Competing Product or to any antibody incorporated in a LaNova Competing Product), other than the Licensed Molecule and the Product as permitted under the Retained Rights. Such obligations will commence as of the Effective Date and continue [***]

(iii) For clarity, a breach by a Party of its obligations under this Section 2.6(a) will constitute a material breach by such Party of this Agreement.

(i) Change of Control of LaNova. LaNova will not be in breach of the restrictions set forth in Section 2.6(a) if LaNova undergoes a Change of Control with a Third Party (such Third Party, together with its pre-Change of Control Affiliates, the “LaNova Acquisition Party”) that is (either directly or through any Third Party) clinically Developing, using or Commercializing one or more LaNova Competing Products prior to such Change of Control [***]. LaNova Competing Products being Commercialized by the LaNova Acquisition Party prior to the Change of Control are referred to herein as “LaNova Excluded Products.” The LaNova Acquisition Party may continue to Commercialize such LaNova Excluded Products in the TPTX Territory following the Change of Control; provided that LaNova and the LaNova Acquisition Party (A) institute, implement, and maintain commercially reasonable technical and administrative safeguards to ensure the applicable requirements set forth in Section 2.6(a) are met and the Development, use and Commercialization activities with any such LaNova Excluded Product are segregated from the Development, Manufacture, use, Commercialization and other exploitation of the Product, including by creating “firewalls” to prevent disclosure of non-public plans or non-public information relating to the Licensed Technology or the Product or any Confidential Information of TPTX, to any personnel (including sales teams) of LaNova, its

Affiliates or LaNova Acquisition Party (and its Affiliates), who are conducting any activities with such LaNova Excluded Products and (B) limit the disclosure of any Confidential Information of TPTX to personnel (including sales teams) of the LaNova Acquisition Party (or its Affiliates) on a need-to-know basis and only those personnel not working on such LaNova Excluded Products.

(ii) Change of Control of TPTX. If TPTX undergoes a Change of Control with a Third Party (such Third Party, and together with such TPTX Acquiror’s pre-Change of Control Affiliates, the “TPTX Acquisition Party”) that is (either directly or through any Third Party) Developing or Commercializing one or more TPTX Competing Products prior to such Change of Control [***] or is performing any Competing Activities at the closing of such transaction, TPTX will promptly (but no later than [***] days following such closing) provide written notice to LaNova of such Change of Control (which notification will also identify and describe in reasonable detail the applicable Competing Activities). LaNova will have the right to terminate this Agreement with an immediate effect upon written notice to TPTX at any time after twelve (12) months following such closing unless, by the end of such twelve (12)-month period, TPTX or TPTX Acquisition Party has (A) divested, or caused their respective Affiliate to have divested, whether by license or otherwise, its interest in all such TPTX Competing Products or (B) terminated the corresponding performance of any Competing Activities with respect to all such TPTX Competing Products, and provided LaNova with written confirmation of such divestment or termination. [***].

2.7 Rights of First Negotiation. Subject to the terms and conditions of this Agreement, LaNova hereby grants to TPTX the first right to negotiate (each, a “ROFN”) to obtain an exclusive license to Develop, use, Manufacture, and Commercialize (and participate in the Development in collaboration with LaNova if mutually agreed by the Parties), (a) [***]; (b) [***]; or (c) [***] (each (a), (b), and (c), a “ROFN Program”). LaNova will promptly provide TPTX with written notice (each, a “ROFN Offer Notice”) within a reasonable period after LaNova selects a development candidate for any ROFN Program (each such development candidate specified in a ROFN Offer Notice, a “ROFN Development Candidate”) and provides the applicable ROFN Data Package to TPTX. [***]. TPTX will have [***]

days following the later of (A) LaNova’s delivery of each such ROFN Offer Notice and provision of such ROFN Data Package and [***] to the extent such data or information does not exist or is otherwise unavailable, LaNova’s delivery of written notice to TPTX that such data or information is non-existent or unavailable (the “ROFN Exercise Period”) [***]. With respect to each ROFN Program, (i) [***], and (ii) [***]. Notwithstanding anything to the contrary herein, the ROFN will automatically expire and LaNova will not have any further obligations to TPTX under this Section 2.7, upon the [***]. For clarity, nothing in this Section 2.7 will restrict LaNova from [***]. LaNova will, through the JSC (or JDC or other applicable Committee), keep TPTX reasonably informed about each of the ROFN Programs.

2.8 Additional ADC Programs. The Parties may collaborate on up to three (3) programs for the identification, discovery, research or development of any ADC (other than the Licensed Molecule or Product) using any proprietary technology of LaNova or its Affiliates (each, an “Additional ADC Program”), which programs may be initiated or proposed by either Party to the other Party, as contemplated by this Section 2.8. [***]. The Parties may, through the JSC (or JDC or other applicable Committee), discuss possible Additional ADC Programs of interest. During the [***] months following the Effective Date, LaNova will in good faith discuss and

negotiate with TPTX for the grant to TPTX of an exclusive license in the Field and in the TPTX Territory, which may include a collaboration with LaNova if agreed by the Parties, for up to three (3) such Additional ADC Programs. [***].

3.1 Alliance Managers. Within [***] days following the Effective Date, each Party will appoint (and notify the other Party of such appointment) a representative to act as its alliance manager regarding Development and Manufacture of the Product in the TPTX Territory and in the LaNova Territory under this Agreement (each such individual appointed, an “Alliance Manager”). The Alliance Managers will serve as the primary contact points between the Parties and will (a) facilitate the flow of information; (b) otherwise promote communication, coordination and collaboration between the Parties by providing single points of contact for communication by and between the functions/subject matter experts for seeking consensus both internally within each Party’s respective organization, including facilitating review of external corporate communications, and raising cross-Party or cross-functional disputes in a timely manner; and (c) manage the JSC (and any other Committee) meetings by (i) calling meetings; (ii) preparing and issuing minutes of each such meeting within [***] Business Days thereafter; and (iii) preparing and circulating an agenda for the upcoming meeting, in each case at the direction of and in consultation with the then-current chairperson. Each Party may remove and replace its Alliance Manager at any time by written notice to the other Party.

(a) Joint Steering Committee. Within [***] days following the Effective Date, LaNova and TPTX will establish a joint steering committee (“Joint Steering Committee” or “JSC”) to oversee the Development and Manufacture of the Product in the Field in the TPTX Territory and in the LaNova Territory, to resolve any disputes of the JDC, JMC (each, as defined below) or any other subcommittee of the JSC and to serve as a forum for the exchange and discussion of information with respect thereto.

(b) Joint Development Committee; Joint Manufacturing Committee. Within [***] days following the Effective Date, LaNova and TPTX will establish as subcommittees of the JSC (i) a joint development committee (“Joint Development Committee” or “JDC”) to review and oversee the Development of the Product in the Field in the TPTX Territory and the LaNova Territory and to serve as a forum for the exchange and discussion of information with respect thereto, and (ii) a joint manufacturing committee (“Joint Manufacturing Committee” or “JMC”) to oversee the Manufacture of the Product in the Field in the TPTX Territory and, with respect to Global Studies, in the LaNova Territory and to serve as a forum for the exchange and discussion of information with respect thereto.

(1) establishing the JDC and the JMC pursuant to Section 3.2 and such other subcommittees as necessary or advisable to undertake any of the responsibilities of the JSC delegated to such subcommittee by the JSC or to further the purpose of this Agreement;

(2) overseeing and managing the strategic direction of the collaboration between the Parties with respect to the Product in the Field pursuant to this Agreement;

(3) reviewing and monitoring the progress of Development, Manufacturing and regulatory activities with respect to the Product in the Field in the TPTX Territory and the LaNova Territory and recommendations from the JDC, JMC or other subcommittee of the JSC with respect to any such matter;

(4) resolving any matter within the authority of the JDC, JMC or other subcommittee of the JSC on which the applicable Committee cannot reach a decision as to such matter; and

(5) undertaking such other matters as are specifically assigned to the JSC in this Agreement.

(1) developing and reviewing Development and regulatory strategy for the Product in the TPTX Territory and the LaNova Territory;

(2) reviewing and commenting on all clinical development activities proposed to be conducted by or on behalf of TPTX or LaNova with respect to the Product;

(3) reviewing and commenting on the Global Development Plan or any amendment thereto, as applicable, and reviewing and discussing any changes in the scope or direction of the Development work with the Product to be performed under this Agreement that would be a material deviation from the Global Development Plan;

(4) reviewing and commenting on the Global Studies of the Product proposed to be conducted by or on behalf of the Parties;

(5) serving as the principal means by which TPTX keeps LaNova reasonably informed regarding TPTX’s Development plans, efforts and results with respect to the Product in the TPTX Territory;

(6) serving as the principal means by which LaNova keeps TPTX reasonably informed regarding LaNova’s Development plans, efforts and results with respect to the Product in the Field in the LaNova Territory; and

(7) undertaking such other matters as are specifically assigned to the JDC in this Agreement.

(1) reviewing and commenting on all Manufacturing activities proposed to be conducted by or on behalf of TPTX or LaNova with respect to the Product; and

(2) undertaking such other matters as are specifically assigned to the JMC in this Agreement.

(d) Membership. Each Committee will be composed of [***] representatives of each of LaNova and TPTX. Each Party will appoint its initial [***] Committee representatives by written notice to the other Party within [***] days of the Effective Date. Either Party may remove and replace its respective Committee representatives at any time with prior written notice to the other Party; provided that each Party will ensure that, at all times during the existence of a Committee, such Party’s Committee representatives (initial or replacement) have appropriate expertise and sufficient seniority within the applicable Party to make recommendations and decisions arising within the scope of the applicable Committee’s responsibilities. With respect to the JSC, each Party will ensure that at all times during the existence of the JSC, such Party’s JSC representatives (initial or replacement) (i) have the authority to bind such Party with respect to matters within the purview of the JSC, and (ii) at least [***] of each Party’s JSC representatives is a member of such Party’s senior management.

(e) Meetings. Each Committee will meet at least [***], or more or less often as otherwise agreed to by the Parties. Responsibility for chairing Committee meetings will alternate between the Parties. The chair for any Committee meeting will not have any greater authority than any other representative of either Party on such Committee. All Committee meetings may be conducted by telephone, video-conference, or in person; provided, however, that each Committee will meet in person at least [***], unless the Parties mutually agree to meet by alternative means. Unless otherwise agreed by the Parties, all in-person meetings for a Committee will be held on an alternating basis between the facilities of each Party. Each Party will bear its own personnel and travel costs and expenses relating to participation in Committee meetings. Upon each Party’s invitation, a reasonable number of additional representatives of such Party may attend Committee meetings in a non-voting capacity.

(f) Minutes. The chair of each Committee meeting will be responsible for ensuring definitive minutes of such Committee meeting are prepared and will circulate a draft of the minutes of such meeting to all members of such Committee for comments within [***] days after such meeting. Such minutes will provide a description, in reasonable detail, of the discussions at the meeting and will document all actions and determinations approved by the Committee at such meeting. The Parties will promptly discuss any comments on such minutes and finalize the minutes no later than the date of the next applicable Committee meeting.

(g) Decision-Making. Decisions of a Committee will be made by unanimous vote, with each Party’s representatives on such Committee collectively having one vote. No vote of a Committee may be taken unless at least one of each Party’s representatives is present for such Committee vote. Notwithstanding any other provision of this Agreement to the contrary, no Committee will have decision-making authority whatsoever with regard to [***]. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JDC, JMC or other subcommittee of the JSC, the applicable Committee cannot reach a decision as to such matter, such Committee will bring the matter to the attention of the JSC for resolution. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the JSC cannot reach a decision as to such matter within [***] days after such matter was brought to the JSC for resolution, then:

(i) subject to Section 3.2(g)(ii), LaNova will have final decision-making authority for matters relating to [***];

(ii) if TPTX reasonably believes [***], the matter shall be referred to the Parties’ respective Alliance Managers, who will promptly meet and attempt in good faith to resolve such matter within [***] days. If such Alliance Manager are unable to resolve such matter within such [***] day period, then, at the written request of either Party, the matter will be referred to the Parties’ respective Senior Executives, who will promptly meet and attempt in good faith to resolve such matter within [***] days. If such Senior Executives are unable to resolve such matter within such [***] day period, then the [***].

(iii) subject to Section 3.2(g)(iv), TPTX will have final decision-making authority for matters relating to [***];

(iv) if LaNova reasonably believes [***] (A) [***], (B) [***], or (C) [***], the matter shall be referred to the Parties’ respective Alliance Managers, who will promptly meet and attempt in good faith to resolve such matter within [***] days. If such Alliance Manager are unable to resolve such matter within such [***] day period, then, at the written request of either Party, the matter will be referred to the Parties’ respective Senior Executives, who will promptly meet and attempt in good faith to resolve such matter within [***] days. If such Senior Executives are unable to resolve such matter within such [***] day period, then [***]. For clarity, TPTX will have final decision-making authority [***], and LaNova will have final decision-making authority [***].

(v) A Party’s Senior Executive, in the exercise of his or her decision-making authority, will give good faith consideration to, and take into account, the other Party’s position. Notwithstanding any other provision of this Article 3 to the contrary, neither any Committee, including the JSC, nor a Senior Executive in the exercise of the foregoing decision-making authority, will have the right: (A) to modify or amend the terms and conditions, or waive any term or condition, of this Agreement; (B) to determine any issue in a manner that would conflict with the terms and conditions of this Agreement; (C) to make any determination that a Party is in breach (or not) of this Agreement; or (D) to make a decision that is expressly stated to require the mutual written agreement or mutual written consent of the Parties. The Parties intend that all matters within the scope of a Committee’s decision-making authority will be resolved by the Parties in accordance with this Section 3.2(g), and no matter within the scope of a Committee’s authority will be subject to the dispute resolution provisions set forth in Section 15.4.

3.3 Scope of Governance. Notwithstanding the creation of a Committee, each Party will retain the rights, powers and discretion granted to it hereunder, and not Committee will be delegated or vested with rights, powers or discretion unless such delegation or vesting is expressly provided herein. No Committee will have the power to amend or modify this Agreement, and no decision of a Committee will be in contravention of any terms and conditions of this Agreement. It is understood and agreed that issues to be formally decided by a Committee are only those specific issues that are expressly provided in this Agreement to be decided by such Committee.

4.1 Licensed Know-How Transfer. LaNova will, within [***] days after LaNova’s receipt of the Technology Access Fee, disclose or make available to TPTX all Licensed Know-How that exists as of such date (the “Licensed Know-How Transfer”). During the Term, LaNova shall provide or make available to TPTX as promptly as practicable any additional Licensed Know-How, to the extent that such Licensed Know-How comes to LaNova’s attention (or is reasonably requested by TPTX) and has not previously been provided or made available to TPTX.

(a) The Parties (through the JSC or JMC) will establish and approve a plan and budget pursuant to which LaNova will perform technology transfer with respect to the Licensed Manufacturing Technology (as may be amended, the “Manufacturing Technology Transfer Plan”). The Manufacturing Technology Transfer Plan will describe the Licensed Manufacturing Technology and any and all other subject matter to be transferred hereunder, including the anticipated timelines for completing such transfers.

(b) Upon request from TPTX, which may be made at any time [***] Clinical Study, LaNova will, within [***] days after LaNova’s receipt of such request and in accordance with the Manufacturing Technology Transfer Plan (including the budget therein), disclose or make available, or cause its CMO(s) to disclose or make available, to TPTX or its designee(s) all Licensed Manufacturing Technology that exists as of such date (the “Manufacturing Technology Transfer,” and together with the Licensed Know-How Transfer, the “Technology Transfer”). [***].

(a) LaNova will conduct and provide to TPTX or its designee(s) reasonable technical support with respect to such Technology Transfer (such conduct and technical support, “Technical Assistance”) (i) [***] and (ii) [***]. During the Technical Assistance Period, LaNova will provide Technical Assistance up to [***] hours to TPTX [***], provided that, [***].

Any additional Technical Assistance in excess of such [***] hours reasonably requested by TPTX and agreed by LaNova during or following the Technical Assistance Period will be provided by LaNova at a cost of [***] U.S. Dollars ($[***]) per full-time equivalent per [***]. If applicable, LaNova will invoice TPTX for the Technical Assistance provided under this Section 4.3 at the rates set forth in this Section 4.3, and TPTX will pay all such amounts within [***] days after receipt of an applicable invoice from LaNova.

(b) TPTX acknowledges that it may need to directly engage LaNova’s existing CMO(s) to perform services necessary to complete the Manufacturing Technology Transfer contemplated by Section 4.2. [***].

5.1 Diligence and Responsibilities. Each Party will be responsible for, and will use Commercially Reasonable Efforts to conduct, all Development activities of the Product in the Field to be conducted by such Party in accordance with the Global Development Plan [***]. Each Party will perform such obligations under the Global Development Plan in a professional manner, and in compliance in all respects with the Global Development Plan and the requirements of Applicable Laws, GCP, and cGMP. [***].

(i) General. The Parties will, subject to the JDC’s review and comment, prepare and agree upon an initial global development plan consistent with Schedule 5.2(a) within [***] days after the Effective Date (as may be extended by written agreement of the Parties) and update such agreed global development plan annually (such global development plan, as initially agreed and as amended in accordance with this Section 5.2(b), the “Global Development Plan”). The Global Development Plan will be focused on the objective of achieving Regulatory

Approval for the Product in the applicable territory, while taking into consideration potential development and commercial impacts on the Product in the other Party’s respective territory. Each Party will keep the JDC regularly and fully informed of the status, progress, and results of its Development and registration efforts.

(a) TPTX will [***], be solely responsible for and have decision-making authority for performance of any Local Study (including handling relevant Regulatory Submissions for any Local Studies) in the TPTX Territory at its own cost, as applicable, in accordance with Article 6. Each such Local Study will be conducted in accordance with a study protocol approved by any relevant Regulatory Authority and Applicable Laws in the TPTX Territory.

(c) Each Party will have the final say with respect to the Local Study in its respective territory taking into account regulatory considerations in such territory.

5.4 Development Reports. Each Party would keep the JDC regularly and reasonably informed of the status, progress, and results of its development and registration efforts. At least within [***] Business Days before each regularly scheduled JDC meeting, each Party will provide the JDC with a written report detailing its Development Activities and the results thereof, including the Local Studies, covering subject matter at a level of detail reasonably requested by the other Party and sufficient to enable the other Party to determine such reporting Party’s compliance with its obligations pursuant to Sections 5.1 and 5.2. Through the JDC, each Party will keep the other Party reasonably informed on the Development of the Product conducted by or on behalf of such Party. In addition, each Party will make available to the other Party such additional information about its Development Activities with respect to the Product as may be reasonably requested by the other Party from time to time. All updates and reports provided by a Party pursuant to this Section 5.4 will be the Confidential Information of such Party.

5.5 Records. Each Party will maintain appropriate records in either tangible or electronic form of all significant Development, Manufacture (in the case of TPTX, after the Manufacturing Technology Transfer), regulatory or Commercialization of a Product, in each case in accordance with its usual documentation and record retention practices. Such records will be in sufficient detail to properly reflect, in a good scientific manner, all significant work done, and the results of studies and trials undertaken and, further, will be at a level of detail appropriate for patent and regulatory purposes. Each Party will document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines. Upon a Party’s reasonable request, the other Party will, and will cause its Affiliates and, in the case of TPTX, Sublicensees, to provide to the first Party copies of such records of Development, Manufacture (in the case of TPTX, after the Manufacturing Technology Transfer), regulatory and Commercialization activities to the extent necessary for the Development, Manufacture (in the case of TPTX, after the Manufacturing Technology Transfer), and

Commercialization of the Product in the other Party’s respective territory, including for patent and regulatory purposes. All such records, reports, information and data of a Party provided to the other Party will be the Confidential Information of the providing Party.

5.6 Clinical Trial Audits. Each Party or its representatives may conduct an audit of the other Party, its Affiliates, licensees or sublicensees, or any subcontractors (including Clinical Trial sites) engaged by such other Party or its Affiliates, licensees or sublicensees to perform such other Party’s obligations under any Global Development Plan, in each case, to ensure that the applicable Clinical Trials are conducted in compliance with the Global Development Plan, GCP, and Applicable Laws; provided that in the event any such audit of subcontractors or Clinical Trial sites engaged by such other Party or its Affiliates, licensees or sublicensees requires such other Party’s assistance, such other Party will provide the Party or its representatives with such assistance, to the extent reasonable. Each Party may conduct such audit no more than [***] (unless an additional audit is warranted for cause) upon [***] days’ prior written notice to the other Party. No later than [***] days after the completion of such audit, the auditing Party will provide the other Party with a written summary of the auditing Party’s findings of any deficiencies or other areas of remediation that the auditing Party identifies during any such audit. The audited Party will use Commercially Reasonable Efforts to respond or remediate any such deficiencies within [***] days following such Party’s receipt of such report. Without limiting the foregoing, each Party has the right to be present at any such audit conducted by the other Party pursuant to this Section 5.6 of any of such Party’s licensees, sublicensees, subcontractors or Clinical Trial sites. With respect to any Clinical Trial in the Global Study or Local Study, if the Parties acting reasonably and in good faith agree that any deficiencies with respect to a Clinical Trial site identified pursuant to an audit (each, a “Deficient Site”) may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from the conduct of any such Clinical Trial at such Deficient Site, then the Party not controlling the Deficient Site will notify the other Party of such Deficient Site and the Parties will discuss and attempt to agree upon a remediation plan for such Deficient Site. If the Parties cannot agree to such a remediation plan for a Deficient Site, then the Party controlling the Deficient Site will promptly remove such Deficient Site from such Clinical Trial and replace such Deficient Site with a new Clinical Trial site (a “Replacement Site”) in its respective territory, and such Party will be solely responsible for the costs of such replacement (unless not permitted by Applicable Law or for ethical reasons). Any such Replacement Site will be compliant in all respects with Applicable Law.

6.1 Transfer of Ongoing Phase 1 Study. LaNova will transfer all responsibilities for the ongoing Phase 1 Clinical Study with respect to the Product in the U.S. (as further specified in Schedule 6.1) to TPTX promptly following the Effective Date. Prior to transfer of such responsibilities to TPTX, LaNova shall (and it hereby does) transfer and assign to TPTX all right, title and interest in and to the IND filed in LaNova’s name in the U.S., free and clear of any and all liens and encumbrances, and shall file with the FDA any documentation necessary or useful to transfer such IND to TPTX.

6.2 TPTX’s Responsibilities. Subject to Section 6.1, TPTX will be responsible for (a) all regulatory activities leading up to and including the obtaining of the Regulatory Approval for the Product from the Regulatory Authority [***] in the TPTX Territory, at its sole cost and expense, except as set forth in the Global Development Plan; and (b) seek, secure, hold, and maintain all Regulatory Approvals and associated pricing and reimbursement approvals. TPTX will use Commercially Reasonable Efforts to obtain Regulatory Approvals and associated pricing and reimbursement approvals for the Product in the TPTX Territory in accordance with the Global Development Plan, at its sole cost and expense, [***]. TPTX will keep LaNova promptly informed (and in any event within [***] hours for any significant matter) of regulatory developments related to the Product in the TPTX Territory and will promptly notify LaNova in writing of any decision by any Regulatory Authority in the TPTX Territory regarding a Product.

6.3 LaNova Responsibilities. LaNova will be responsible for (a) all regulatory activities leading up to and including the obtaining of the Regulatory Approval for the Product from the Regulatory Authority [***] in the LaNova Territory, at its sole cost and expense, except as set forth in the Global Development Plan; and (b) [***]. LaNova will keep TPTX promptly informed (and in any event within [***] hours for any significant matter) of regulatory developments related to the Product in the LaNova Territory and will promptly notify TPTX in writing of any decision by any Regulatory Authority in the LaNova Territory regarding a Product.

6.4 Review of Regulatory Submissions. Except to the extent prohibited by Applicable Law, each Party will provide to the other Party for review and comment drafts of all Regulatory Submissions in its respective territory (i.e. the TPTX Territory or the LaNova Territory, as applicable) for the Product no later than [***] days prior to the planned submission. Such Party will respond to the other Party within [***] days and shall incorporate any comments received from the other Party on such Regulatory Submissions and will consider in good faith any comments received from such other Party on such Regulatory Submissions. In addition, each Party will notify the other Party of any material Regulatory Submissions for the Product related thereto submitted to or received from any Regulatory Authority in its respective territory (i.e. the TPTX Territory or the LaNova Territory, as applicable) and will provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment, or correspondence is not in English, then, in addition to a copy thereof in its original language, (a) each Party will also provide the other Party with an English summary thereof within the corresponding timelines as set forth in this Article 6 at its cost; and (b) upon the other Party’s reasonable request, provide such other Party with an English translation thereof at its cost.

6.5 Notice of Meetings. Each Party will provide the other Party with notice of any meeting or discussion with any Regulatory Authority in the TPTX Territory related to any Product, when possible, no later than [***] Business Days after receiving notice thereof. At the notifying Party’s request, the other Party will reasonably cooperate with the notifying Party in preparing for any such meeting or discussion. The notifying Party will provide to the other Party a written summary of such meeting or discussion in English promptly following the issuance or approval of the corresponding official minutes by the applicable Regulatory Authority.

6.6 Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of a Party relating to any Product, then such Party will notify the other Party of such contact, inspection, or notice or action within [***] Business Days after receipt of such notice (or, if action is taken without notice, within [***] Business Days of TPTX becoming aware of such action).

6.7 Cooperation. Each Party will reasonably cooperate with the other Party in obtaining any Regulatory Approvals for a Product in the other Party’s respective territory by providing, to the extent reasonably requested by the other Party, access to Regulatory Approvals, Regulatory Submissions, clinical data, and other data, information, and documentation relating to the Product pursuant to Article 5. In addition, upon the other Party’s reasonable request, the other Party will, and will cause its Affiliates and licensees or sublicensees, as applicable (to the extent permitted in such licensees’ or sublicensees’ agreement with such Party), to provide to such other Party copies of such records of Development, Manufacturing, and Commercialization activities to the extent necessary or reasonably useful to obtain Regulatory Approval of the Product in such other Party’s respective territory, except to the extent prohibited by Applicable Law in an applicable jurisdiction.

6.8 No Harmful Actions. If either Party believes that the other Party is taking or intends to take any action with respect to a Product that could have a material adverse impact upon the regulatory status of the Product outside its respective territory, such Party has the right to bring the matter to the attention of the JDC and the Parties will discuss in good faith to resolve such concern.

6.9 Notification of Threatened Action. Each Party will, within [***] Business Day, notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Third Party, which would reasonably be expected to affect the safety or efficacy claims of any Product or the continued marketing of any Product (as to LaNova’s notification obligation, only to the extent it would reasonably be expected to affect the TPTX Territory). Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action with respect to the TPTX Territory.

(a) TPTX hereby grants to LaNova the right of reference to all Regulatory Submissions pertaining to the Product in the Field submitted by or on behalf of TPTX or its Affiliates (and all data contained or referenced therein), with the right to grant further rights of reference to LaNova’s licensees and their sublicensees with respect to Products. LaNova and its Affiliates (and any licensee or sublicensee to whom it or they may grant a further right of reference) may use the right of reference to TPTX’s Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining the Regulatory Approval of the Product in the LaNova Territory.

(b) LaNova hereby grants to TPTX the right of reference to all Regulatory Submissions pertaining to the Product in the Field submitted by or on behalf of LaNova or its Affiliates (to the extent included in the definition of Licensed Know-How) (and all data contained or referenced therein), with the right to grant further rights of reference to Sublicensees. TPTX and its Affiliates (and any Sublicensee to whom it may grant a further right of reference) may use such

right of reference to LaNova’s Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining the Regulatory Approval of the Product in the TPTX Territory.

(a) TPTX and LaNova will generate and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Product, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Pharmacovigilance Agreement”). Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The Pharmacovigilance Agreement will be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.

(b) Each Party will be responsible for complying with all Applicable Laws governing Adverse Events for all Clinical Trials performed by such Party, including the Local Studies, Global Studies, and [***].

(c) [***] will hold and control the global safety database for the Product and for the exchange by the Parties, in English, of any information which a Party becomes aware of concerning any Adverse Event experienced by a subject or patient being administered the Product, including any such information received by either Party from any Third Party (subject to receipt of any required consents from such Third Party). It is understood that each Party and its Affiliates, licensees and sublicensees has the right to disclose such information if disclosure is reasonably necessary to comply with Applicable Laws or requirements of any applicable Regulatory Authority. [***].

6.12 Safety and Regulatory Audits. With respect to any inspection of a Party or its Affiliates, licensees or sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Product, each Party will notify the other Party of such inspection (a) no later than [***] Business Days after such Party receives notice of such inspection or (b) within [***] Business Day after the completion of any such inspection of which such Party did not receive prior notice. To the extent required by Applicable Law, each Party will permit Governmental Authorities outside of its respective territory to conduct inspections of such Party or its Affiliates, licensees or sublicensees (including Clinical Trial sites) relating to the Product, and will ensure that all such Affiliates, licensees or sublicensees permit such inspections. Following any such regulatory inspection related to the Product, such Party will provide the other Party with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) within [***] days of such Party receiving the same, and (ii) in the event that such findings, notice, or report is in a language other than English, a written English summary of any material finding, notice, or report of a

Governmental Authority related to such inspection (to the extent related to the Product) within [***] days after receiving the same.

6.13 Remedial Actions. Each Party will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the TPTX Territory and LaNova Territory, as applicable. TPTX has sole discretion with respect to any matters relating to any Remedial Action in the TPTX Territory, including the decision to commence such Remedial Action and the control over such Remedial Action and LaNova has sole discretion with respect to any matter relating to any Remedial Action in the LaNova Territory, including the decision to commence such Remedial Action and the control over such Remedial Action. The cost and expenses of any Remedial Action in the TPTX Territory or the LaNova Territory will be borne solely by the Party with sole discretion; provided, however, that to the extent a Remedial Action in the TPTX Territory results from the failure of the Product supplied by LaNova to comply with applicable specifications or product warranties (as set forth in the Clinical Supply Agreement (as defined below)) or any Applicable Law, including cGMP requirements, then LaNova will reimburse TPTX for the reasonable cost and expense of such Remedial Action after consultation with LaNova. Each Party will, and will ensure that its Affiliates, licensees and sublicensees will, maintain adequate records to permit the Parties to trace the distribution and use of the Product in the TPTX Territory and the LaNova Territory.

(a) During the period commencing on the Effective Date and ending on the earlier of (i) [***], and (ii) [***], the “CMO Agreement”, and such date, the “Clinical Supply Cutoff Date”), LaNova will be solely responsible for the Manufacture of the Licensed Molecule and the Product and supply of such materials to TPTX for clinical use. TPTX will pay LaNova [***]. In the event that TPTX has not, as of the Clinical Supply Cutoff Date, [***]. [***].

(b) Within [***] days following the Effective Date (or such longer period as mutually agreed upon by the Parties), the Parties will negotiate in good faith and enter into a supply agreement and, a related quality agreement with respect to the Manufacture and clinical supply of the Licensed Molecule and Product by LaNova to TPTX on commercially reasonable

terms (such agreement, once mutually executed, as may be amended, the “Clinical Supply Agreement”). [***].

(c) The Clinical Supply Agreement will include other customary terms for the clinical supply of pharmaceutical products, including [***]. TPTX will (i) [***]; and (ii) [***].

7.2 TPTX Manufacturing. From and after [***], TPTX will be solely responsible for the Manufacture the Licensed Molecule and the Product for the TPTX Territory by itself or via a qualified CMO. Following TPTX’s execution of the CMO Agreement, upon LaNova’s written request, TPTX will consider in good faith Manufacturing the Product for use by LaNova, its Affiliates and licensees in the LaNova Territory. Within [***] days following the execution of the CMO Agreement (or such longer period as mutually agreed upon by the Parties), the Parties will negotiate in good faith and enter into a commercial supply agreement and, a related quality agreement with respect to the Manufacture and commercial supply of the Licensed Molecule and Product by TPTX to LaNova for the LaNova Territory on commercially reasonable terms, which commercial supply agreement, if any, would provide for [***].

8.1 General. TPTX will be solely responsible for, and use Commercially Reasonable Efforts to Develop the Product in the Field and file for Regulatory Approval in the Major Market Countries and to Commercialize the Product in each Major Market Country in which Regulatory Approval is obtained, at its sole cost and expense.

8.2 Commercialization Plan. The Commercialization Plan will contain a high-level overview of the significant Commercialization activities with the Product in the TPTX Territory. TPTX will, no later than [***] days after the first submission of an MAA for the Product in the TPTX Territory, deliver an initial Commercialization Plan to the JSC for review, comment, and discussion. Thereafter, on [***], TPTX will propose updates or amendments to the Commercialization Plan to reflect changes in such plans, including [***]

[***]. In preparing the initial Commercialization Plan and any updates or amendments thereto, TPTX will provide LaNova (through the JSC) with an opportunity to comment and TPTX will consider any LaNova’s comments in good faith in finalizing the initial Commercialization Plan and any updates or amendments thereto. [***]

8.3 Product Trademarks. TPTX will have the right to brand the Product in the TPTX Territory using trademarks, logos, and trade names that it determines appropriate for the Product (such trademarks, logos, and trade names, the “Product Marks”). Without LaNova’s prior written consent, TPTX may not use any trademark Controlled by LaNova or its Affiliates (including their corporate names) to brand the Product. TPTX will own all rights in the Product Marks in the TPTX Territory and will register and maintain the Product Marks in the TPTX Territory that it determines reasonably necessary. To the extent requested by a Party and commercially practicable, the Parties will cooperate with respect to developing and implementing a global branding strategy, subject to separate discussion and agreement. If the Parties do not agree upon a global branding strategy, each Party will have the right to brand the Product in its respective territory in a manner that it determines appropriate in its sole discretion.

8.4 No Diversion. Each of LaNova and TPTX hereby covenants and agrees that (a) it will not, and will ensure that its Affiliates, licensees and sublicensees will not, directly or indirectly, promote, market, distribute, import, sell or have sold the Product, including via internet or mail order, outside its respective territory; (b) with respect to any country or region outside its respective territory, it will not, and will ensure that its Affiliates and their respective sublicensees will not: (i) unless otherwise agreed by the Parties in writing, establish or maintain any branch, warehouse or distribution facility for the Product in such countries, (ii) engage in any advertising or promotional activities relating to the Product that are directed primarily to customers or other purchaser or users of the Product located in such countries, (iii) solicit orders for the Product from any prospective purchaser located in such countries, or (iv) sell or distribute the Product to any Person in such Party’s respective territory who intends to sell or has in the past sold the Product in such countries; (c) if a Party receives any order for any Product from a prospective purchaser reasonably believed to be located in a region or country outside its respective territory, such Party will promptly refer that order to the other Party, and such Party will not accept any such orders; (d) neither Party will deliver or tender (or cause to be delivered or tendered) the Product into a country or region outside its respective territory; and (e) each Party will not, and will ensure that its Affiliates and their respective sublicensees will not, knowingly restrict or impede in any manner the other Party’s exercise of its exclusive rights to Commercialize the Product in the other Party’s respective territory. For purposes of this Agreement, TPTX’s territory will mean the TPTX Territory and LaNova’s territory will mean the LaNova Territory.

8.5 Medical Affairs. Each Party will be solely responsible, at its sole cost and expense, for conducting medical affairs activities with respect to the Product in its respective territory, including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), publications, congress presentations and posters, published manuscripts, activities performed in connection with patient registries and post-approval trials, and other medical programs and communications, including

educational grants, research grants (including conducting investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to other activities that do not involve the promotion, marketing, sale, or other Commercialization of the Product, all of which will be conducted in accordance with Applicable Law. Each Party will update the JSC at each regularly scheduled JSC meeting regarding such Party’s medical affairs activities. All updates and reports generated pursuant to this Section 8.5 will be the Confidential Information of Party that prepared such updates and reports.

8.6 Southeast Asia. If TPTX, in its sole discretion, determines to Commercialize the Product in the Field in any market in Southeast Asia through a Third Party, TPTX will notify LaNova reasonably in advance and, if LaNova has an existing or prospective partner that commercializes one or more pharmaceutical product(s) in Southeast Asia (or otherwise knows of any such Third Party), LaNova will promptly notify TPTX in writing, and TPTX will, for no longer than [***] days, consider and discuss in good faith [***].

9.1 Upfront Payment. In partial consideration of the licenses and rights granted by LaNova to TPTX hereunder, TPTX will pay to LaNova the one-time, non-refundable and non-creditable amount of twenty-five million U.S. Dollars ($25,000,000) (the “Technology Access Fee”) within [***] days of the Effective Date.

(a) In partial consideration of the rights granted herein, when the Product first achieves the Milestone Events set forth below (each such event, a “Development Milestone Event”), TPTX will pay to LaNova the corresponding one-time, non-refundable and non-creditable Development milestone payments (each such payment, a “Development Milestone Payment”) within [***] days after TPTX’s receipt of invoice from LaNova. TPTX will promptly (but in all events within [***] days) notify LaNova in writing upon the first achievement of each Development Milestone Event:

For clarity, (i) each Development Milestone Payment will be payable on the first occurrence of the corresponding Development Milestone Event, and (ii) none of the Development Milestone Payments will be payable more than once. [***].

(a) In partial consideration of the rights granted herein, TPTX will pay to LaNova the following one-time, non-refundable and non-creditable milestone payments (each such payment, an “Annual Net Sales Milestone Payment”) for the achievement of the corresponding Annual Net Sales events in the TPTX Territory set forth below (each such event, an “Annual Net Sales Milestone Event”) within [***] days after TPTX’s receipt of invoice from LaNova. TPTX will notify LaNova in writing of the first achievement of each Annual Net Sales Milestone Event promptly (but in all events within [***] days) [***] in which such Annual Net Sales Milestone Event is achieved.

(b) For clarity (i) each Annual Net Sales Milestone Payment will be payable on the first occurrence of the corresponding Annual Net Sales Milestone Event, and (ii) none of the Annual Net Sales Milestone Payments will be payable more than once. If the Annual Net Sales in a given Calendar Year exceed more than one (1) applicable threshold, then all corresponding Annual Net Sales Milestone Payments will be payable.

(a) Royalty Payment. During the Royalty Term [***], TPTX will pay to LaNova tiered royalties as calculated by multiplying the applicable royalty rate set forth in the table below by the corresponding amount of incremental, aggregated

Annual Net Sales of the Product in the TPTX Territory in a Calendar Year (a “Royalty Payment”). The tiered royalty rates on Annual Net Sales will be as set forth below:

(b) Royalty Term. The Royalty Payments under this Section 9.4 will be payable [***] in the TPTX Territory from the First Commercial Sale of the Product in such country until the latest to occur of: (i) the expiration of the last-to-expire Valid Claim in such country covering the composition of matter of the Product or method of use of the Product for the Indication for which Regulatory Approval has been granted in such country; (ii) the expiration of all Regulatory Exclusivity in such country; or (iii) ten (10) years after the date of the First Commercial Sale of the Product in such country (the “Royalty Term”).

(i) [***] during the Royalty Term [***] in the TPTX Territory where there is no Valid Claim covering [***],

[***] the royalties payable for the Product in such country [***] will be reduced by [***] percent ([***]%) of the royalties otherwise payable to LaNova with respect to such country during such [***] under Section 9.4(a). If such royalty reduction applies to any country in the TPTX Territory, it will be calculated by determining the portion of total Net Sales in the TPTX Territory of the Product in a [***] that is attributable to the country in which such reduction applies, and by determining the total royalties for the TPTX Territory without reduction, and then reducing by [***] percent ([***]%) the applicable portion (based on Net Sales) of the total royalties attributable to the country in which such reduction applies.

(ii) If, [***] a Generic/Biosimilar Product in any country in the TPTX Territory [***] causes a reduction in sales of the Product by [***] percent ([***]%), royalties payable for the Product in such country [***] will be reduced to [***] percent ([***]%) of the royalties otherwise payable to LaNova with respect to such country during such Calendar Quarter under Section 9.4(a). Such reduction shall be calculated in the same manner as described in the last sentence of Section 9.4(c)(i).

(iii) If, [***] TPTX is required to obtain [***] licenses under Patents of Third Parties (excluding Sublicensees) that are reasonably necessary for the Commercialization or use of the Product in a country in the TPTX Territory (each such license, a “Third Party License”), [***] percent ([***]%) of the royalties actually paid by TPTX under such Third Party License in connection with the sale of the Product in such country [***] will be creditable against the royalties payable to LaNova with respect [***] under Section 9.4(a); provided, however, that in no event will the royalties owed by TPTX to LaNova be reduced under this Section 9.4(c)(iii) by more than [***] percent ([***]%) of the royalties otherwise payable to LaNova with respect to such country [***] under Section 9.4(a) as a result of any and all such credits in the aggregate. [***].

(d) Royalty Estimate and Royalty Reports. Following the First Commercial Sale of the Product for which royalties are due pursuant to this Section 9.4, and continuing for so long as royalties are due hereunder:

(i) TPTX will, within [***] days [***], provide LaNova with a good faith estimate of the royalties due [***].

(ii) TPTX will, within [***] days [***], provide LaNova with a royalty report (in a template agreed to by the Parties) showing[***]:

(1) the gross sales and Net Sales of the Product sold by TPTX, its Affiliates and Sublicensees [***] reporting period and supporting gross-to-net calculations;

(2) the Royalty Payments in United States Dollars which has accrued hereunder with respect to such Net Sales, with supporting calculations showing the applicable royalty rate applied and any royalty reduction taken; and

(3) the rate of exchange with supporting calculations, determined in accordance with Section 9.5(b), used by TPTX in determining the amount of United States Dollars payable hereunder.

(e) Royalty Payment. After the receipt of each royalty report provided by TPTX under Section 9.4(d) above, LaNova will issue to TPTX an invoice for the undisputed amount of Royalty Payment set forth therein. TPTX will pay to LaNova the royalties [***] within [***] days after the receipt of the invoice from LaNova. If no royalty is due [***] following commencement of the reporting obligation, TPTX will so report.

(a) Mode of Payment. All payments to be made under this Agreement will be made in U.S. Dollars and will be paid by electronic transfer in immediately available funds to such bank account as designated in writing by LaNova. All payments will be free and clear of any transfer fees or charges.

(b) Currency Exchange Rate. All payments under this Agreement will be payable in U.S. Dollars. The rate of exchange to be used in computing the amount of currency equivalent in U.S. Dollars for calculating Net Sales [***] (for purposes of both the royalty calculation and whether a Net Sales milestone has been achieved) will be made at the average exchange rate as published by the Wall Street Journal [***], or such other source as the Parties may agree in writing.

(c) Payment Timeline. Except as otherwise provided in this Agreement, all payments to be made by one Party to the other Party under this Agreement will be due within [***] days following such Party’s receipt of an invoice from the other Party.

(a) TPTX will keep, and will require its Affiliates and Sublicensees to keep (all in accordance with the GAAP), for a period not less than [***] years from the end of the Calendar Year to which they pertain, complete and accurate records in sufficient detail to properly reflect Net Sales and to enable any Milestone Payment payable hereunder to be determined.

(b) Upon the written request of LaNova, TPTX will permit, and will cause its Affiliates and Sublicensees to permit, an independent certified public accounting firm of nationally recognized standing selected by LaNova, at LaNova’s expense, to have access during normal business hours upon reasonable prior written notice to TPTX to such records of TPTX or its Affiliates as may be reasonably necessary to inspect and verify the accuracy of the payments (including the basis of the calculations thereof) hereunder for any Calendar Year ending not more than the preceding [***] years. Such inspections may not be conducted more frequently than [***] per year. No accounting period of TPTX may subject to inspection more than [***] by LaNova. If such accounting firm concludes that an underpayment was made, then TPTX will pay the amount due within [***] days of the date LaNova delivers to TPTX such accounting firm’s written report so concluding. If such accounting firm concludes that an overpayment was made, then such overpayment will be credited against any future payment due to LaNova hereunder (if there is no future payment due, then LaNova will promptly refund such overpayment to TPTX). The accounting firm will provide to each Party a copy of the report at the same time, which report will include the methodology and calculations used to determine the findings. LaNova will bear the full cost of such audit unless such inspection concludes an underpayment by TPTX of more than [***] percent ([***]%) of the amount otherwise payable for that inspected period, in which case TPTX will pay the actual fees and expenses charged by the accounting firm for such inspection.

(c) LaNova will treat all financial information subject to review under this Section 9.6 in accordance with the confidentiality provisions of Article 10, and, prior to commencing such audit, will cause its accounting firm to enter into a confidentiality agreement with TPTX obligating it to treat all such financial information in confidence pursuant to such confidentiality provisions. Such accounting firm will not disclose TPTX’s Confidential Information to LaNova, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by TPTX or the amount of payments to or by TPTX under this Agreement.

(d) TPTX will include in each relevant sublicense granted by it a provision requiring any Sublicensee to maintain records of sales of the Product made pursuant to such sublicense, and to grant access to such records by an accounting firm to the same extent and under the same obligations as required of TPTX under this Agreement. LaNova will advise TPTX in advance of each audit of any such Sublicensee with respect to the Net Sales of the Product either by LaNova or its designated auditor under the terms of such Sublicensee agreement. LaNova will provide TPTX with a summary of the results received from the audit and, if TPTX so requests, a copy of the audit report. LaNova will pay the full costs charged by the accounting firm, unless such inspection concludes an underpayment by TPTX of [***] percent ([***]%) or more of the amount otherwise payable for that inspected period, in which case TPTX will pay the actual fees and expenses incurred by LaNova for such inspection.

9.7 Interest. Each Party will pay interest on any amounts overdue under this Agreement from the day payment was initially due at the prime or equivalent rate per annum quoted by The Wall Street Journal on the [***] Business Day after such payment is due, plus [***] basis points; provided, however, that in no case will such interest rate exceed the highest rate permitted by Applicable Laws. The payment of such interest will not foreclose a Party from exercising any other rights it may have because any payment is overdue.

(a) Responsibility. Any and all Taxes imposed on TPTX or with respect to TPTX’s business operations or activities hereunder, including any VAT, consumption, transfer, sales, use or other such Taxes relating to the transactions contemplated herein (but for clarity, excluding any Taxes imposed or calculated on the income of LaNova, its Affiliates or Sublicensees), will be borne solely by TPTX, and TPTX will timely pay, and indemnify and hold harmless, LaNova from and against all such Taxes, including any penalties or interest associated therewith. Any and all Taxes imposed on LaNova or with respect to LaNova’s business operations or activities hereunder, including any VAT, consumption, transfer, sales, use or other such Taxes relating to the transactions contemplated herein (but for clarity, excluding any Taxes imposed or calculated on the income of TPTX, its Affiliates or Sublicensees), will be borne solely by LaNova, and LaNova will timely pay, and indemnify and hold harmless, TPTX from and against all such Taxes, including any penalties or interest associated therewith. Notwithstanding anything to the contrary in this Agreement, all amounts stated herein are inclusive of any transfer, documentary, sales, use, stamp, consumption, goods and services VAT or other similar Taxes.

(c) Cooperation. The Parties acknowledge and agree that it is their mutual objective and intent to minimize, to the extent feasible under the Applicable Laws, any Taxes payable in connection with this Agreement, and will reasonably cooperate with each other in good faith in accordance with Applicable Laws to minimize any Taxes in connection with this Agreement, including by claiming any exemption from any required Taxes or withholdings (or additional Taxes or double taxation) and seeking any refund of Taxes paid or withheld, under any Applicable Law or regulation or treaty from time to time in force. For the aforementioned purpose, TPTX will cooperate with LaNova to provide documents and sign templated Technology Transfer Contract proposed and required by local authority for deduction of added-value tax in PRC (by

way of example and without limitation, such documents set forth in Schedule 9.8(b)). To the extent there is any conflict between the terms of such tax documentation and the terms of this Agreement, the terms of this Agreement will control. [***].

10.1 Confidential Information. Except as expressly provided in this Agreement, each Party agrees that, during the Term and for [***] years thereafter, such Party (the “Receiving Party”) will keep confidential and will not publish or otherwise disclose and will not use for any purpose, other than as expressly provided for in this Agreement, any information furnished to it by or on behalf of the other Party (the “Disclosing Party”) pursuant to this Agreement or under that Mutual Non-Disclosure Agreement between the Parties dated [***] (“MNDA”) (“Confidential Information”), whether before or after the Effective Date, and whether in written, electronic, oral, visual, graphic or any other form. The Receiving Party may use Confidential Information only to the extent required to exercise its rights or perform its obligations under this Agreement. The Receiving Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own, but no less than reasonable care, to ensure that its, and its Affiliates’, employees, agents, consultants and other representatives (“Representatives”) do not publish or disclose or make any unauthorized use of the Confidential Information of Disclosing Party. The Receiving Party will promptly notify the Disclosing Party upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information by the Receiving Party, its Affiliates or their respective Representatives. Notwithstanding the foregoing, Confidential Information will not include information that the Receiving Party can prove by competent evidence:

(a) was already known by the Receiving Party, other than under an obligation of confidentiality, prior to the time of receiving such information from the Disclosing Party, as evidenced by its pre‑existing written records;

(b) is, as of the Effective Date, or thereafter becomes, generally known or available to the public, other than through any act or omission of the Receiving Party in breach of this Agreement;

(c) was subsequently lawfully disclosed to the Receiving Party on a non‑confidential basis by a Third Party, as a matter of right (i.e., without breaching any obligation such Third Party may have to the Disclosing Party); or

(d) is independently discovered or developed by the Receiving Party, independently of the activities undertaken by the Receiving Party pursuant to this Agreement and without the use of or reference to Confidential Information furnished by the Disclosing Party, as evidenced by the Receiving Party’s contemporaneously-maintained written records.

10.2 Permitted Disclosures. Notwithstanding the provisions of Section 10.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:

(b) enforcing the Receiving Party’s rights under this Agreement or performing its obligations under this Agreement;

(d) complying with applicable court orders, Applicable Law, or the listing rules of any exchange on which the Receiving Party’s securities are traded;

(e) disclosure in regulatory filings that the Receiving Party has the right to make under this Agreement;

(f) disclosure to the Receiving Party’s Affiliates, to actual or potential licensees or sublicensees (including Sublicensees), and to the Receiving Party’s Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential licensee or sublicensee, or Representative agrees to be bound by terms of confidentiality and non-use at least as stringent as those set forth in this Article 10; and

(g) disclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by reasonable obligations of confidentiality and non-use.

Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 10.2(c) or Section 10.2(d), it will, except where impracticable, (i) give reasonable advance notice to the Disclosing Party of such required disclosure, (ii) use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts, and (iii) cooperate with any lawful efforts by the Disclosing Party, at the Disclosing Party’s request and expense, to contest such disclosure, to obtain a protective order for the Confidential Information required to be disclosed, or to secure other confidential treatment of such Confidential Information. Disclosure by the Receiving Party of Confidential Information in accordance with any of the foregoing provisions of this Section 10.2 will not, in and of itself, cause the information so disclosed to cease to be treated as Confidential Information under this Agreement, except to the extent that, by virtue of disclosure by the Receiving Party in full compliance with this Section 10.2, such information

becomes generally known or available. In any event, the Receiving Party agrees to take all reasonable action to avoid disclosure of Confidential Information hereunder.

10.3 Confidential Terms. Except as otherwise provided in this Article 10, each Party agrees not to disclose to any Third Party the terms of this Agreement without the prior written consent of the other Party, except that each Party may disclose the terms of this Agreement that are made public in accordance with Section 10.6 or to the extent such disclosure is permitted under Section 10.2.

10.4 Use of Names. Except as expressly permitted by this Agreement, neither Party will mention or otherwise use the name, logo or trademark of the other Party or any of its Affiliates in any publication, press release, marketing and promotional material or other form of publicity in connection with this Agreement or activities hereunder without the prior written approval of such other Party. The restrictions imposed by this Section 10.4 will not prohibit either Party from (a) making any disclosure identifying the other Party or its Affiliates to the extent required in connection with the exercise of such Party’s rights or the performance of such Party’s obligations under this Agreement and (b) making any disclosure identifying the other Party or its Affiliates that is required by Applicable Law or the rules of a stock exchange on which the securities of such Party are listed.

10.5 Publication of Product Information. Each Party recognizes that the publication, such as by public oral presentation, manuscript or abstract, of the results of development activities, including Clinical Trials, with respect to the Product may be beneficial to both Parties provided such publications are subject to reasonable controls to protect Confidential Information of each Party. Accordingly, each Party will have the right to review and comment on any material proposed for public oral presentation or publication by the other Party that includes Data or results of such other Party, its Affiliates’ and, in the case of TPTX, Sublicensees’ development activities and/or includes Confidential Information of such Party. Before any such material is submitted for publication, each Party will deliver a complete copy to the other Party at least [***] days prior to submitting the material to a publisher or initiating any other disclosure. Such other Party will review any such material and give its comments to the Party within [***] days of the delivery of such material to such other Party. With respect to public oral presentation materials and abstracts, each Party will make reasonable efforts to expedite review of such materials and abstracts, and will return such items as soon as practicable to the other Party with appropriate comments, if any, but in no event later than [***] days from the date of delivery to such Party. Each Party will comply with the other Party’s request to delete references to such other Party’s Confidential Information in any such material. In addition, if any such publication contains patentable subject matter, then at the non-publishing Party’s request, the publishing Party will either delete the patentable subject matter from such publication or delay any submission for publication or other public disclosure for a period of up to an additional [***] days so that appropriate Patent applications may be prepared and filed. LaNova shall coordinate with TPTX on the publication or presentation of any materials with respect to the Product by LaNova outside the LaNova Territory prior to any such publication or presentation, and any such publications or presentations shall be subject to TPTX’s review and prior approval.

(a) The Parties have agreed upon the content of a joint press release which will be issued substantially in the form attached hereto as Schedule 10.6(a), and the release of which the Parties will coordinate in order to accomplish the same promptly upon execution and delivery of this Agreement. Except to the extent already disclosed in a press release or other public communication issued in accordance with this Agreement, no public announcement concerning this Agreement, its subject matter or the transactions described herein will be made, either directly or indirectly, by either Party or its Affiliates, except as may be required by Applicable Law (including disclosure requirements of the U.S. Securities and Exchange Commission (“SEC”)), judicial order, or stock exchange or quotation system rule without first obtaining the approval of the other Party and agreement upon the nature, text and timing of such announcement, which approval and agreement will not be unreasonably withheld or delayed. The Party desiring to make any such voluntary public announcement will provide the other Party with a written copy of the proposed announcement in reasonably sufficient time prior to public release to allow the other Party to comment upon such announcement prior to public release. In the case of press releases or other public communications required to be made by Applicable Law, judicial order or stock exchange or quotation system rule, the Party making such press release or public announcement will provide to the other Party a copy of the proposed press release or public announcement in written or electronic form upon such advance notice as is practicable under the circumstances for the purpose of allowing the notified Party to review and comment upon such press release or public announcement. Under such circumstances, the releasing Party will not be obligated to delay making any such press release or public communication beyond the time when the same is required to be made. Neither Party will be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement or any amendment hereto that has already been publicly disclosed by such Party or by the other Party, in accordance with this Section 10.6(a); provided that such information remains accurate as of such time and provided the frequency and form of such disclosure are reasonable.

(b) Each Party may make public statements regarding this Agreement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, provided that any such public statement or press release: (i) is not inconsistent with prior public disclosures or public statements made in accordance with Section 10.6(a) or as permitted by Section 10.3; and (ii) does not reveal (A) information regarding the terms of this Agreement that have not previously been disclosed in accordance with Section 10.6(a) or as permitted by Section 10.3 or (B) non‑public information about the other Party.

(c) The Parties will coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with any securities authority or with any stock exchange on which securities issued by a Party or its Affiliate are traded, and each Party will use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided that each Party will ultimately retain control over what information to disclose to any securities authority or stock exchange, as the case may be, to the extent such Party determines, on the advice of legal counsel, that disclosure is reasonably necessary to comply with Applicable Law, including disclosure requirements of the SEC, or with the requirements of any stock exchange on which securities issued by a Party or its Affiliates are

traded, and provided, further, that the Parties will use their reasonable efforts to file redacted versions with any governing bodies which are consistent with redacted versions previously filed with any other governing bodies.

10.7 Prior Non-Disclosure Agreements. Upon execution of this Agreement, the terms of this Article 10 will supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties, including the MNDA and that certain Confidential Non-Binding Term Sheet dated [***]. Any information disclosed under such prior agreements by LaNova will be deemed disclosed by LaNova under this Agreement, and any information disclosed under such prior agreements by TPTX will be deemed disclosed by TPTX under this Agreement.

11.1 Representations and Warranties of Each Party. Each Party represents and warrants to the other Party as of the Effective Date that:

(a) it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder;

(b) (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms;

(c) it is not a party to any agreement that would prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under this Agreement; and

(d) all consents, approvals and authorization from all Governmental Authorities or other Third Parties required to be obtained by such Party in connection with execution of this Agreement have been obtained.

11.2 Additional Representations and Warranties of LaNova. LaNova represents and warrants to TPTX that as the Effective Date:

(a) LaNova is the sole owner of the Licensed Patents and it has the right under the Licensed Technology to grant the licenses to TPTX as purported to be granted pursuant to this Agreement;

(d) neither LaNova nor any of its Affiliates is a party to any license or similar agreement under which it has granted or agreed to grant a license to any Third Party to any Licensed Technology that would conflict with the rights or licenses granted to TPTX under this Agreement;

(e) LaNova and its Affiliates and their employees, consultants and contractors involved in the Development of the Licensed Molecule and the Product are not, and have not been, debarred or disqualified by any Regulatory Authority as of the Effective Date, and have complied in all material respects with all Applicable Laws in connection with the Development of the Licensed Molecule and the Product;

11.3 Additional Representations and Warranties of TPTX. TPTX represents and warrants to LaNova that as of the Effective Date:

(a) there are no legal claims, judgments or settlements against or owed by TPTX or its Affiliates, or pending or, to TPTX’s or its Affiliates’ actual knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, anti-bribery or corruption violations, including under any Anti-Corruption Laws; and

(b) TPTX and its Affiliates are not, and have not been, debarred or disqualified by any Regulatory Authority.

11.4 Covenants of Each Party. Each Party covenants to the other Party that in the course of performing its obligations or exercising its rights under this Agreement, it will, and will cause its Affiliates, Sublicensees to, comply with the Global Development Plan, all agreements referenced herein, all Applicable Laws, including as applicable, cGMP, GCP, GLP, and GSP standards, and will not employ or engage any party who has been debarred by any Regulatory Authority, or, to such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority. Without limiting the foregoing, (a) TPTX will conduct its obligations with respect to Global Studies under the Global Development Plan in strict adherence with the study design set forth in the protocol for such Global Studies and as set forth in the Global Development Plan, each as may be amended from time to time, and (b) TPTX will only engage Clinical Trial sites under the Global Development Plan that conduct all Clinical Trials in compliance with Applicable Laws,

including GCP and the ICH Guidelines, and are approved by the applicable Governmental Authority.

(a) Notwithstanding anything to the contrary in the Agreement, each Party hereby covenants to each other that:

(i) it will not, in the performance of this Agreement, perform any actions that are prohibited by local and other anti-corruption laws (including the provisions of the U.S. Foreign Corrupt Practices Act, the U.K. Anti-Bribery Law, and the Anti-Corruption Act of the PRC, collectively “Anti-Corruption Laws”) that may be applicable to such Party to this Agreement;

(ii) it will not, in the performance of this Agreement, directly or indirectly, make any payment, or offer or transfer anything of value, or agree or promise to make any payment or offer or transfer anything of value, to a government official or government employee, to any political party or any candidate for political office or to any other Third Party with the purpose of influencing decisions related to either Party or its business in a manner that would violate Anti-Corruption Laws;

(iii) it will, on request by the other Party, verify in writing that to the best of such Party’s knowledge, there have been no violations of Anti-Corruption Laws by such Party or persons employed by or subcontractors used by such Party in the performance of the Agreement, or will provide details of any exception to the foregoing; and

(iv) it will maintain records (financial and otherwise) and supporting documentation related to the subject matter of the Agreement in order to document or verify compliance with the provisions of this Section 11.5, and upon request of the other Party, upon reasonable advance notice, will provide a Third Party auditor mutually acceptable to the Parties with access to such records for purposes of verifying compliance with the provisions of this Section 11.5. Acceptance of a proposed Third Party auditor may not be unreasonably withheld or delayed by either Party. It is expressly agreed that the costs related to the Third Party auditor will be fully paid by the Party requesting the audit, and that any auditing activities may not unduly interfere with the normal business operations of Party subject to such auditing activities. The audited Party may require the Third Party auditor to enter into a reasonable confidentiality agreement in connection with such an audit.

(b) To its knowledge as of the Effective Date and during the Term, neither TPTX nor any of its subsidiaries nor any of their Affiliates, directors, officers, employees, distributors, agents, representatives, sales intermediaries or other Third Parties acting on behalf of TPTX or any of its subsidiaries or any of their Affiliates:

(i) has taken or will take any action in violation of any applicable anticorruption law, including the U.S. Foreign Corrupt Practices Act (15 U.S.C. § 78 dd-1 et seq.); or

(ii) has corruptly, offered, paid, given, promised to pay or give, or authorized or will corruptly, offer, pay give, promise to pay or give or authorize, the payment or gift of anything of value, directly or indirectly, to any Public Official (as defined in Section 11.5(d) below), for the purposes of:

(1) influencing any act or decision of any Public Official in his official capacity;

(2) inducing such Public Official to do or omit to do any act in violation of his lawful duty;

(4) inducing such Public Official to use his or her influence with a government, governmental entity, or commercial enterprise owned or controlled by any government (including state-owned or controlled veterinary or medical facilities) in obtaining or retaining any business whatsoever.

(c) As of the Effective Date, none of the officers, directors, employees, of TPTX or of any of its Affiliates or agents acting on behalf of TPTX or any of its Affiliates, in each case that are employed or reside outside the U.S., are themselves Public Officials.

(d) For purposes of this Section 11.5, “Public Official” means (i) any officer, employee or representative of any regional, federal, state, provincial, county or municipal government or government department, agency or other division; (ii) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including any state-owned or controlled veterinary or medical facility; (iii) any officer, employee or representative of any public international organization, such as the African Union, the International Monetary Fund, the United Nations or the World Bank; and (iv) any person acting in an official capacity for any government or government entity, enterprise or organization identified above.

(a) Notwithstanding anything to the contrary in the Agreement, each Party hereby covenants to each other that:

(i) it will conduct its activities under this Agreement in compliance with applicable export controls and trade and economic sanctions laws and regulations (collectively, “Export Controls”); and

(ii) it shall not, directly or indirectly, export, reexport, transfer, divert, or release any materials, technology, or software (each an “item”) to any prohibited country, territory, entity, individual, or for any prohibited end-use, unless authorized pursuant to Export Controls.

(b) Each Party has the right to terminate this Agreement effective immediately in the event that the other becomes a party with whom such Party is prohibited from dealing

pursuant to Export Controls, or such Party otherwise reasonably determines that its obligations to comply with Export Controls preclude performance.

11.7 NO OTHER REPRESENTATIONS OR WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL SUCH REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

12.1 By TPTX. TPTX will indemnify, defend and hold harmless LaNova and its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “LaNova Indemnitee(s)”). from and against all losses, liabilities, damages and expenses (including reasonable attorneys’ fees and costs) (individually and collectively, “Losses”) incurred by them in connection with any claims, demands, actions or other proceedings by any Third Party (individually and collectively, “Claims”) arising after the Effective Date to the extent arising from (a) the Development, Manufacture (after the Manufacturing Technology Transfer), Commercialization or other exploitation of the Product in the TPTX Territory by or under authority of TPTX, (b) the Manufacture of the Product in the LaNova Territory by or under authority of TPTX (other than by LaNova on behalf of TPTX), (c) the conduct of the Global Studies and Local Studies, whether in or outside the TPTX Territory, by or under authority of TPTX, (d) the gross negligence or willful or intentional misconduct of TPTX or any of its Affiliates, Sublicensees or other TPTX Indemnitee (as defined below), or (e) TPTX’s breach of any of its representations, warranties, or covenants made in or pursuant to this Agreement in each case (a) through (e), except to the extent such Losses arise from, are based on, or result from any activity or occurrence for which LaNova is obligated to indemnify the TPTX Indemnitees pursuant to Section 12.2.

12.2 By LaNova. LaNova will indemnify, defend and hold harmless TPTX and its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “TPTX Indemnitee(s)”), from and against all Losses incurred by them in connection with any Claims to the extent arising from (a) the Development, Manufacture, Commercialization or other exploitation of the Licensed Molecule or the Product in the LaNova Territory by or under authority of LaNova (other than by or under authority of TPTX pursuant to this Agreement), (b) the conduct of the Global Studies and Local Studies, whether in or outside the LaNova Territory, by or under authority of LaNova (other than by or under authority of TPTX pursuant to this Agreement), (c) the gross negligence or willful or intentional misconduct of LaNova or any of its Affiliates or other LaNova Indemnitee, or (d) LaNova’s breach of any of its representations, warranties, or covenants made in or pursuant to this Agreement, in each case (a) through (d) above, except to the extent such Losses arise from, are based on, or result from any activity or occurrence for which TPTX is obligated to indemnify the LaNova Indemnitees pursuant Section 12.1.

12.3 Procedure. A Party that intends to claim indemnification under this Article 12 (the “Indemnitee”) with respect to any Claim will: (a) notify the other Party (the “Indemnitor”) in writing of such Claim as soon as reasonably practicable after it receives notice of such Claim (it being understood that the Indemnitee’s failure to deliver written notice of such Claim to the Indemnitor within a reasonable time after the Indemnitee receives notice of such Claim, will relieve the Indemnitor of its indemnification obligations under Section 12.1 or 12.2, as applicable, with respect to such Claim only to the extent such failure is prejudicial to the Indemnitor’s ability to defend such Claim); (b) permit the Indemnitor to assume direction and control of the defense of the Claim (including the right to settle the claim solely for monetary consideration) using counsel reasonably satisfactory to the Indemnitee; and (c) cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of the Claim, as requested by the Indemnitor (at the expense of the Indemnitor). If the Indemnitor does not assume control of such defense within [***] days after receiving notice of the Claim from the Indemnitee, the Indemnitee will control such defense and, without limiting the Indemnitor’s indemnification obligations, the Indemnitor will reimburse the Indemnitee for all documented costs, including reasonable attorney fees, incurred by the Indemnitee in defending itself within [***] days after receipt of any invoice therefor from the Indemnitee. The Party not controlling such defense may participate therein at its own expense. The Party controlling such defense will keep the other Party advised of the status of such Claim and the defense thereof and will consider recommendations made by the other Party with respect thereto. The Indemnitee will not agree to any settlement of such Claim without the prior written consent of the Indemnitor, which will not be unreasonably withheld, delayed or conditioned. The Indemnitor will not agree to any settlement of such Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnitee from all liability with respect thereto, that imposes any liability or obligation on the Indemnitee or that acknowledges fault by the Indemnitee; in each case, without the prior written consent of the Indemnitee.

12.4 Insurance. Each Party, at its own expense, will obtain and maintain, during the Term and for [***] years thereafter, reasonable insurance, including commercial general liability insurance, worker’s compensation insurance and product liability insurance, at levels adequate to cover its obligations hereunder and consistent with industry standards. Each Party will furnish to the other Party on request certificates issued by the insurance company setting forth the amount of the liability insurance (or evidence of self-insurance). It is understood that such insurance will not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 12 or otherwise.

12.5 LIMITATION OF LIABILITY. SUBJECT TO AND WITHOUT LIMITING (A) THE INDEMNIFICATION OBLIGATIONS OF EACH PARTY WITH RESPECT TO CLAIMS UNDER SECTION 12.1 OR 12.2, (B) LIABILITY AS A RESULT OF A BREACH OF ARTICLE 10, (C) LIABILITY FOR MISAPPROPRIATION OR INFRINGEMENT OF INTELLECTUAL PROPERTY OWNED OR CONTROLLED BY THE OTHER PARTY, OR (D) LIABILITY FOR BREACH OF COVENANTS UNDER SECTION 2.6, NEITHER PARTY OR ANY OF ITS AFFILIATES WILL BE LIABLE TO THE OTHER PARTY UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, MULTIPLIED OR CONSEQUENTIAL DAMAGES OR FOR LOST PROFITS (EVEN IF

(a) As between the Parties, (i) LaNova will remain the sole and exclusive owner of all Licensed Technology, and (ii) TPTX will remain the sole and exclusive owner of all TPTX IP.

(b) Ownership of all Inventions (other than any Invention that is an Improvement) will be allocated based on inventorship, as determined in accordance with the rules of inventorship under the U.S. patent laws. All Improvements, whether invented, discovered, generated, conceived, reduced to practice, or made solely by either Party, its Affiliates, or its or its Affiliates’ employees, agents, or independent contractors, or jointly by both Parties, their Affiliates, or their or their Affiliates’ employees, agents or independent contractors, will be the [***]. A Party will own all Inventions [***] that are invented, discovered, generated, conceived, reduced to practice, or made solely by it, its Affiliates, or its or its Affiliates’ employees, agents or independent contractors (“Sole Inventions”), and (i) LaNova’s Sole Inventions will be included in the Licensed Technology (if within the scope of such definition) and included in the licenses and rights granted to TPTX by LaNova hereunder; and (ii) TPTX’s Sole Inventions (which, for clarity, are not Improvements) will be included in the TPTX IP (if within the scope of such definition) and included in the licenses and rights granted to LaNova by TPTX hereunder. The Parties will jointly own all Inventions (other than Improvements) that are made jointly by a Party (including its Affiliate, or its or its Affiliate’s employees, agents or independent contractors) together with the other Party (including such other Party’s Affiliates, or its or its Affiliate’s employees, agents or independent contractors) (“Joint Inventions”). Patents claiming the Joint Inventions will be referred to as “Joint Patents.” Each Party will own an undivided equal interest in the Joint Inventions and Joint Patents, without a duty of accounting or an obligation to seek consent from the other Party for the exploitation or license of the Joint Inventions or Joint Patents (subject to the licenses granted to the other Party under this Agreement).

13.2 Disclosure of Inventions. Each Party will promptly disclose to the other Party all Inventions, including all invention disclosure or other similar documents submitted to such Party by its or its Affiliates’ employees, agents, or independent contractors relating to such Inventions, and will also promptly respond to reasonable requests from the other Party for additional information relating to such Inventions.

(i) As between the Parties, TPTX will have the first right, but not the obligation, to Prosecute the [***] Patent Family, at its sole cost and expense and using counsel of its own choice. TPTX will consult with LaNova as to the Prosecution of the Patents included in the [***] Patent Family (each, an “[***] Patent”) reasonably prior to any deadline or action with any patent office in the TPTX Territory, will furnish to LaNova copies of all relevant drafts and documents reasonably in advance of such consultation, and will consider in good faith all reasonable requests or suggestions of LaNova with respect to such drafts or with respect to strategies for Prosecuting any such [***] Patent. TPTX will keep LaNova reasonably informed of progress with regard to the Prosecution of such [***] Patent Family and will provide to LaNova copies of all material patent office submissions within a reasonable amount of time (but not more than [***] days) following submission thereof by TPTX.

(ii) In the event that TPTX desires to abandon or cease the Prosecution of any [***] Patent, TPTX will provide reasonable prior written notice to LaNova of such intention to abandon or cease such Prosecution (which notice will be given no later than [***] days prior to the next deadline for any action that must be taken with respect to any such Patent in the relevant patent office in the TPTX Territory). In such case, at LaNova’s request, LaNova shall have the right, but not the obligation, to assume responsibility for Prosecution of any such [***] Patents. Upon such assumption, LaNova shall control the Prosecution of such [***] Patents subject to the same terms and conditions set forth in this Section 13.3(b) as applicable to TPTX, using counsel of LaNova’s choice at its cost and expense.

(i) TPTX will, and will instruct and cause its patent counsel to, Prosecute, in any [***] Patent, claims solely directed to the composition of matter comprising anti-Claudin18.2 ADC products or the formulation and/or method of use thereof; and

LaNova shall update Schedule 1.83 from time to time, including at TPTX’s request, to incorporate, on a Patent-by-Patent basis, any Licensed Patents not previously included within the [***] Patent Family or [***] Patent Family, including any Licensed Patents that claim Improvements, based on the applicable claimed subject matter.

(d) Prosecution of Joint Patents. As between the Parties, (i) LaNova will have the first right, but not the obligation, to control and manage the Prosecution of all Joint Patents in the LaNova Territory, and (ii) TPTX will have the first right, but not the obligation, to control and manage the Prosecution of all Joint Patents in the TPTX Territory, in each case (i) and (ii), at the Prosecuting Party’s sole cost and expense and by counsel of its own choice. Each such Prosecuting Party will consult with the other Party as to the Prosecution of Joint Patents reasonably prior to any deadline or action with any patent office, will furnish to the other Party copies of all relevant drafts and documents reasonably in advance of such consultation, and will consider in good faith all reasonable requests or suggestions of the other Party with respect to such drafts or with respect to strategies for Prosecuting any such Joint Patents. The Parties will attempt in good faith to reach mutual agreement as to all matters concerning strategies for Prosecuting Joint Patents. Each such Prosecuting Party will keep the other Party reasonably informed of progress with regard to the Prosecution of Joint Patents, will provide to the other Party copies of all material patent office submissions within a reasonable amount of time (but not more than [***] days) following submission thereof by such Prosecuting Party. In the event that the Prosecuting Party desires to abandon or cease the Prosecution of any Joint Patent in any country in the Prosecuting Party’s respective territory, the Prosecuting Party will provide reasonable prior written notice to the other Party of such intention to abandon (which notice will, to the extent possible, be given no later than [***] days prior to the next deadline for any action that must be taken with respect to any such Joint Patent in the relevant patent office). In such case, at the other Party’s sole discretion, upon written notice to the Prosecuting Party from the other Party, the other Party may elect to

continue the Prosecution of any such Joint Patent, at its sole cost and expense and by counsel of its own choice.

(e) Cooperation. Each Party will cooperate with the other Party in connection with all activities relating to the Prosecution of the Licensed Patents and Joint Patents undertaken by such other Party pursuant to this Section 13.3, including: (i) executing all papers and instruments, or requiring its employees or contractors, to execute such papers and instruments, so as to effectuate the ownership of Inventions set forth in Section 13.1, and Patents claiming such Inventions, and to enable the other Party to Prosecute the Licensed Patents or Joint Patents as permitted by this Section 13.3; and (ii) promptly informing the other Party of any matters coming to such Party’s attention that may affect the Prosecution of any Licensed Patent or Joint Patent. Each Party will also promptly provide to the other Party all information reasonably requested by such other Party with regard to such Party’s activities pursuant to this Section 13.3.

(f) Defense of Third Party Infringement Claims. If the Product or a Party becomes the subject of a Third Party’s claim or assertion of infringement of the Patents of a Third Party relating to the Manufacture of the Licensed Molecule or the Product or to the Commercialization of the Product in the Field in the TPTX Territory (each, a “Third Party Infringement Claim”), the Party first becoming aware of the Third Party Infringement Claim will promptly notify the other Party in writing. [***] will have the sole right to control the defense of any Third Party Infringement Claim involving alleged infringement of Third Party rights by [***] activities at its own expense and by counsel of its own choice, and [***] will have the right, at its own expense, to be represented in any such action by counsel of its own choice. [***] will have the sole right to control the defense of any Third Party Infringement Claim involving alleged infringement of Third Party rights by [***] activities at its own expense and by counsel of its own choice, and [***] will have the right, at its own expense, to be represented in any such action by counsel of its own choice. Neither Party will enter into any settlement of any Third Party Infringement Claim: (i) in a manner that would diminish the rights or interests of the other Party with respect to the Product without the written consent of such other Party, which will not be unreasonably withheld; or (ii) that would impose any cost, obligation, or liability on the other Party, or admit the invalidity or unenforceability of any Patent that is Controlled by the other Party, without such other Party’s prior written consent, which may be withheld in such other Party’s sole discretion.

(a) Notice. Each Party will promptly notify the other Party in writing of any alleged or threatened infringement of any Licensed Patent or Joint Patent of which it becomes aware or of any action or threatened action seeking a declaratory judgment of non‑infringement of a Licensed Patent or Joint Patent of which it becomes aware.

(i) LaNova Enforcement Rights. As between the Parties, LaNova will have the sole right, but not the obligation, to bring and control any action or proceeding with respect to [***]. With

respect to any such action or proceeding brought or controlled by LaNova, [***].

(ii) TPTX Enforcement Rights. As between the Parties, TPTX will have the first right, but not the obligation, to bring and control any action or proceeding with respect to (A) [***], or (B) [***]. With respect to any such action or proceeding brought or controlled by TPTX, TPTX will consult with LaNova and consider in good faith all reasonable requests or suggestions of LaNova with respect to LaNova’s interests in the [***] Patent Family or [***] Patent Family, as applicable, and take into account such requests or suggestions to the extent possible [***]. LaNova will have the right, but not the obligation, to be represented in any such action or proceeding to protect its interests therein, at its own expense and by counsel of its own choice. If TPTX fails to bring any such action or proceeding within (Y) [***] days following a written request by LaNova to do so, or (Z) [***] days before the time limit, if any, under Applicable Laws for the filing of such action or proceeding, whichever comes first, then LaNova will have the right to bring and control any such action or proceeding, at its own expense and by counsel of its own choice, [***].

(c) Joint Patents. Neither Party will have the right to bring or control any action or proceeding to enforce any Joint Patent without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed.

(d) Cooperation. In the event a Party brings an infringement action in accordance with this Section 13.4 (such Party, the “Enforcing Party”), the other Party will cooperate fully, at the Enforcing Party’s request and expense, including, if required to bring such action, the furnishing of a power of attorney or being named as a party. The Enforcing Party will not enter into any settlement or compromise of any action under this Section 13.4: (i) in a manner that would diminish the rights or interests of the other Party with respect to the Product without the written consent of such other Party, which will not be unreasonably withheld, conditioned or delayed; (ii) that would impose any cost or liability on the other Party without the written consent of such other Party; or (iii) that would admit the invalidity or unenforceability of any Patent that is Controlled by the other Party, without such other Party’s prior written consent, which may be withheld in such other Party’s sole discretion.

(e) Recoveries. Except as otherwise agreed by the Parties in connection with a cost-sharing arrangement, any recovery as a result of any action or proceeding pursuant to Section 13.4, whether by way of settlement or otherwise, will first be used first to reimburse

Enforcing Party for its documented, out-of-pocket costs and expenses (including court, attorneys’ and professional fees) incurred in connection with such action or proceeding, and then to reimburse the other Party for its documented, out-of-pocket costs and expenses (including court, attorneys’ and professional fees) incurred in connection with such action or proceeding (to the extent not previously reimbursed by the Enforcing Party), and any remainder of the recovery after reimbursement of the litigation costs and expenses of the Parties (“Remainder”), will be retained by the Enforcing Party; provided, however, that:

(f) Patent Marking. TPTX will mark (or cause to be marked) the Product marketed and sold in the TPTX Territory hereunder with appropriate Licensed Patent numbers or indicia to the extent required by Applicable Law.

(a) Term. The term of this Agreement will be effective as of the Effective Date and, unless terminated earlier in accordance with this Article 14, will continue in effect until the expiration of the last Royalty Term with respect to the Product in any country in the TPTX Territory (the “Term”, and the date of such expiration with respect to such country, the “Expiration Date”).

(b) Expiration of Royalty Term. [***], upon the expiration of the Royalty Term for the Product in a given country, the licenses granted by LaNova to TPTX under Section 2.1 of this Agreement in such country with respect to the Product in the Field in the TPTX Territory will become fully paid-up, perpetual, irrevocable, sublicensable (through multiple tiers) and royalty-free.

14.2 Termination for Mutual Agreement. This Agreement may be terminated by the Parties’ mutual written agreement.

14.3 Termination for Convenience. TPTX has the right to terminate this Agreement in its entirety for any or no reason upon one hundred eighty (180) days’ prior written notice to LaNova.

(a) This Agreement may be terminated in its entirety at any time during the Term upon sixty (60) days’ (or thirty (30) days’ with respect to any payment breach) written notice identifying the material breach in reasonable detail, by either Party if the other Party is in material breach of this Agreement and, if such breach is curable, such breach has not been cured within sixty (60) days (or [thirty (30) days with respect to any payment breach) of such written notice (“Cure Period”), or if such breach is not susceptible to cure within the Cure Period, the breaching Party fails to deliver to the non-breaching Party within the Cure Period a written plan that is reasonably calculated to resolve such material breach within a specified period (not to exceed twelve (12) months) and does not cure such material breach within the period specified in such plan.

(b) If the alleged breaching Party reasonably and in good faith disagrees as to whether there has been a material breach, the Party that disputes that there has been a material breach may contest the allegation in accordance with Article 15. It is understood and acknowledged that, during the pendency of such a Dispute, the Cure Period shall be extended by the period of time of such pendency, all of the terms and conditions of this Agreement shall remain in effect, and the Parties shall continue to perform all of their respective obligations under this Agreement; provided that for any Dispute over payment, such tolling of the Cure Period will only apply with respect to the payment of the disputed amounts and not with respect to any undisputed amounts.

14.5 Termination for Insolvency. Each Party has the right to terminate this Agreement upon delivery of written notice to the other Party in the event that (a) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization under the Chapter 7 of the United States of Bankruptcy Code or other similar Applicable Law or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (b) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within ninety (90) days of its filing, or (c) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.

14.6 Termination for Patent Challenge. Except to the extent the following is unenforceable under the laws of a particular jurisdiction, LaNova may terminate this Agreement in its entirety (a) immediately upon written notice to TPTX if TPTX or any of its Affiliates or Sublicensees commences a legal, administrative or other action challenging the validity, enforceability, or scope of any Licensed Patent or (b) within thirty (30) days’ written notice to TPTX if TPTX or its Affiliates or Sublicensees commences a legal, administrative or other action challenging the validity, enforceability or scope of any Patent (other than any Licensed Patent) owned or Controlled by LaNova or its Affiliates anywhere in the world, unless such action is withdrawn during such thirty (30)-day period. Notwithstanding the foregoing, if TPTX promptly terminates the sublicense agreement of any Sublicensee that commences a legal action challenging

14.7 the validity, enforceability or scope of any Licensed Patents anywhere in the world, LaNova will not have the right to terminate this Agreement under this Section 14.6.

14.8 Termination for Acquisition of Third Party by a Party. Each Party has the right to terminate this Agreement to the extent permitted under and in accordance with Section 2.6(b)(ii).

14.9 Election to Terminate. If either Party has the right to terminate under Sections 14.3 through 14.6, it may at its sole option, elect either to (a) terminate this Agreement and pursue any legal or equitable remedy available to it, or (b) maintain this Agreement in effect and pursue any legal or equitable remedy available to it.

(a) Upon the termination of this Agreement for any reason, all rights and licenses granted by either Party to the other Party herein will immediately terminate and all such rights will revert back to the granting Party, and all sublicenses of such rights and licenses will also terminate, except as provided in this Section 14.10(a) and Sections 14.10(b)(i) and 14.12. Upon termination of this Agreement, if a Sublicensee is then in good standing under its sublicense agreement with TPTX, then the sublicense held by such Sublicensee shall automatically become a direct license under the Licensed Technology granted by LaNova that is the same scope as the sublicense granted by TPTX on the same terms and conditions set forth in this Agreement, and Section 14.10(b) below will not apply to such Sublicensee. Termination of this Agreement for any reason will not release either Party of any obligation or liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination. Notwithstanding anything herein to the contrary, termination of this Agreement by a Party will be without prejudice to other remedies such Party may have at law or equity. At the Disclosing Party’s election, except to the extent necessary or appropriate to enable exercise of rights or performance of obligations under the circumstances described in Sections 14.10(b) or 14.12, the Receiving Party will return (at Disclosing Party’s expense) or destroy all tangible materials comprising, bearing, or containing any Confidential Information of the Disclosing Party relating to the Product that are in the Receiving Party’s or its Affiliates’ or Sublicensees’ possession or control and provide written certification of such destruction (except to the extent any information is the Confidential Information of both Parties or to the extent that the Receiving Party has the continuing right to use the Confidential Information under this Agreement); provided that the Receiving Party may retain one copy of such Confidential Information for its legal archives. Notwithstanding anything to the contrary set forth in this Agreement, the Receiving Party will not be required to destroy electronic files containing such Confidential Information that are made in the ordinary course of its business information back-up procedures pursuant to its electronic.

(b) Upon termination of this Agreement by LaNova pursuant to Section 14.4, 14.5, 14.6, or 14.8, the following additional provisions will apply:

(i) Extension of License to LaNova. The licenses granted by TPTX to LaNova pursuant to Section 2.4 will automatically be extended to include the TPTX Territory.

(ii) Regulatory Materials; Data. TPTX will, and will cause its Affiliates to the maximum extent permitted by Applicable Laws at the time of any such termination,

promptly (A) assign all Regulatory Submissions and Regulatory Approvals and pricing and reimbursement approvals of the Product to LaNova, and (B) assign all data generated by or on behalf of TPTX or its designee while conducting Development or Commercialization activities under this Agreement to LaNova or its designee, including non-clinical and clinical studies conducted by or on behalf of TPTX on the Product and all pharmacovigilance data (including all Adverse Event database information) on the Product.

(iii) Trademarks. TPTX will, and will cause its Affiliates, to promptly transfer and assign to LaNova, solely upon termination of this Agreement all Product Marks.

(iv) Transition Assistance. TPTX will, and will cause its Affiliates, to provide assistance, solely upon termination of this Agreement, as may be reasonably necessary or useful for LaNova or its designee to commence or continue Developing or Commercializing the Product in the TPTX Territory for a period of at least [***] days after the effective date of such termination (the “Transition Period”) to the extent TPTX is then performing or having performed such activities, including transferring or amending as appropriate, upon request of LaNova, any agreements or arrangements with Third Party to Develop and Commercialize the Product in the TPTX Territory. To the extent that any such contract between TPTX and a Third Party is not assignable to LaNova or its designee, then TPTX will reasonably cooperate with LaNova to arrange to continue to and provide such services from such entity.

(c) Ongoing Clinical Trial. If at the time of such termination LaNova is entitled to transition services, any Clinical Trials for the Product are being conducted by or on behalf of TPTX, then, at LaNova’s election on a Clinical Trial-by-Clinical Trial basis: (i) TPTX will, and will cause its Affiliates to, (A) continue to conduct such Clinical Trial during the Transition Period or another period of time as determined by LaNova after the effective date of such termination at LaNova’s cost, and (B) after such period, to (I) fully cooperate with LaNova to transfer the conduct of all such Clinical Trial to LaNova or its designee or (II) continue to conduct such Clinical Trials, at LaNova’s cost, for so long as necessary to enable such transfer to be completed without interruption of any such Clinical Trials and (C) LaNova will assume any and all liability and costs for such Clinical Trial after the effective date of such termination, and (ii) TPTX will, and will cause its Affiliates and Sublicensees to, orderly wind down the conduct of any such Clinical Trial which is not assumed by LaNova under Section 14.10(c)(i).

(d) Inventory. At LaNova’s election and request, TPTX will, within [***] days following the termination, (i) transfer to LaNova or its designee all inventory of the Product then in possession or control of TPTX; provided that LaNova will pay TPTX a price equal to TPTX’s costs for such inventory, or (ii) (A) continue to Commercialize all inventory of the Product then in possession or control of TPTX during the Transition Period and make the corresponding payments due to LaNova under this Agreement as though this Agreement had not been terminated and (B) after the Transition Period, transfer to LaNova or its designee any remaining inventory of the Product to LaNova or its designee at a price equal to TPTX’s costs for such remaining inventory.

14.11 Other Remedies. Termination or expiration of this Agreement for any reason will not constitute a waiver or release of, or otherwise be deemed to prejudice or adversely affect, any

rights, remedies or claims, whether for damages or otherwise, that a Party may have hereunder or that may arise out of or in connection with such termination or expiration.

14.12 Specific Effects of Termination for Convenience by TPTX. Upon termination of this Agreement by TPTX pursuant to Section 14.3, the following additional provisions will apply:

(a) If requested in writing by LaNova no later than [***] days following the effective date of such termination, TPTX shall grant to LaNova a non-exclusive, worldwide, sublicensable (through multiple tiers), royalty-bearing (only as applicable under Section 14.12(b)) license (and/or rights of reference) under all Patents, Product Marks and Know-How owned by TPTX or its Affiliates that are necessary for and then being used by TPTX for the Development, use, Manufacture, or Commercialization of the Product, including all Regulatory Submissions and Regulatory Approvals and Data generated by or on behalf of TPTX while conducting Development, use, Manufacture, or Commercialization of the Product in the TPTX Territory under this Agreement.

(b) If termination is effective [***] of the Product in the TPTX Territory, in consideration for the license granted under Section 14.12(a), if any, LaNova shall pay TPTX a royalty of [***] percent ([***]%) on Net Sales of the Product in the TPTX Territory by LaNova or its Affiliates or licensees for a period of [***] years after the effective date of such termination (with the definition of Net Sales and the terms of Sections 9.4(d), 9.4(e), 9.5, 9.6, 9.7, and 9.8, revised as appropriate for payment of royalties by LaNova to TPTX for Net Sales in the TPTX Territory, applicable to such royalty payments).

(c) TPTX will, and will cause its Affiliates and Sublicensees, to provide assistance, solely upon such termination of this Agreement, as may be reasonably necessary or useful for LaNova or its designee to commence or continue Developing or Commercializing the Product in the TPTX Territory up to [***] hours at no cost to LaNova. Any additional assistance reasonably requested by LaNova in excess of such [***] hours will be provided by TPTX at a cost of [***] U.S. Dollars ($[***]) per full-time equivalent per Calendar Year to the extent TPTX is then performing or having performed such activities, including transferring or amending as appropriate, upon request of LaNova, any agreements or arrangements with Third Parties to Develop and Commercialize the Product in the TPTX Territory. To the extent that any such contract between TPTX and a Third Party is not assignable to LaNova or its designee, then TPTX will reasonably cooperate with LaNova to arrange to continue to and provide such services from such entity.

14.13 Survival. Termination or expiration of this Agreement will not affect any rights or obligations of the Parties under this Agreement that have accrued prior to the date of termination or expiration. The following provisions will survive the termination or expiration of this Agreement for any reason: Articles 1, 10, 12, 15 and 16 and Sections 2.5, 5.5 (solely as required under Applicable Laws), 9.6 (solely for [***] years after the Calendar Year in which termination occurs), 11.7, 13.1, 13.3(d), 13.3(e) (solely with respect to Joint Patents), 13.4(c), 14.1(b) (solely as to any licenses that become perpetual thereunder prior to termination or expiration) and 14.10-14.13.

15.1 General. The Parties recognize that a claim, dispute or controversy may arise relating to this Agreement or to the breach, enforcement, interpretation or validity of this Agreement (a “Dispute”). Any Dispute, including Disputes that may involve the Affiliates of any Party, will be resolved in accordance with this Article 15.

15.2 Continuance of Rights and Obligations during Pendency of Dispute Resolution. If there are any Disputes in connection with this Agreement, including Disputes related to termination of this Agreement under Article 14, all rights and obligations of the Parties will continue until such time as any Dispute has been resolved in accordance with the provisions of this Article 15.

15.3 Escalation. Any Dispute will be referred to the Senior Executives for attempted resolution. In the event the Senior Executives are unable to resolve such Dispute within [***] days of such Dispute being referred to them, then, upon the written request of either Party to the other Party, the Dispute will be subject to arbitration in accordance with Section 15.4.

(a) If the Parties fail to resolve the Dispute through escalation to the Senior Executives under Section 15.3, and a Party desires to pursue resolution of the Dispute, the Dispute will be submitted by either Party for final resolution by arbitration under the Rules of Arbitration of the International Chamber of Commerce (“ICC Rules”), excepted as modified herein. Any disputes concerning the propriety of the commencement of the arbitration or the scope or applicability of this agreement to arbitrate will be finally settled by the arbitral tribunal. The arbitration will be conducted by a tribunal of three (3) arbitrators, each with at least [***] years of pharmaceutical industry experience. Within [***] days after initiation of arbitration, each Party will nominate one (1) arbitrator and the two (2) Party-nominated arbitrators will nominate a third arbitrator, who will serve as the chairperson of the tribunal, within [***] days of the second arbitrator’s appointment. The seat of arbitration will be [***] and the language of the proceedings, including all communications, will be English.

(b) The Parties agree that any award or decision made by the arbitral tribunal will be final and binding upon them and may be enforced in the same manner as a judgment or order of a court of competent jurisdiction, and the Parties undertake to carry out any award without delay. The arbitral tribunal will render its final award or decision within [***] months from the date on which the request for arbitration by one of the Parties wishing to have recourse to arbitration is received by the ICC Secretariat. The arbitral tribunal will resolve the Dispute by applying the provisions of this Agreement and the governing law set forth in Section 16.1.

(c) By agreeing to arbitration, the Parties do not intend to deprive any court of its jurisdiction to issue, at the request of a Party, a pre-arbitral injunction, pre-arbitral attachment or other order to avoid irreparable harm, maintain the status quo, preserve the subject matter of the Dispute, or aid the arbitration proceedings and the enforcement of any award. Without prejudice to such provisional or interim remedies in aid of arbitration as may be available under the

jurisdiction of a competent court, the arbitral tribunal has full authority to grant provisional or interim remedies and to award damages for the failure of any Party to the dispute to respect the arbitral tribunal’s order to that effect.

(d) EACH PARTY HERETO WAIVES: (I) ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY, AND (II) ANY CLAIM FOR ATTORNEY FEES, COSTS AND PREJUDGMENT INTEREST.

(e) The arbitrators will be authorized to award compensatory damages, but will not be authorized to (i) award non-economic damages, (ii) award punitive damages or any other damages expressly excluded under this Agreement, or (iii) reform, modify or materially change this Agreement or any other agreements contemplated hereunder; provided, however, that the damage limitations described in clauses (i) and (ii) will not apply if such damages are statutorily imposed. Each Party will bear its own attorney’s fees, costs, and disbursements arising out of the arbitration, and will pay an equal share of the fees and costs of the administrator and the arbitrators; provided, however, that the arbitrators will be authorized to determine whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), or the fees and costs of the administrator and the arbitrators.

(f) Notwithstanding anything in this Section 15.4, in the event of a Dispute with respect to (i) the validity, scope, enforceability or ownership of any Patent or other intellectual property rights, (ii) a matter for which this Agreement assigns decision-making to the Parties or to the JDC or requires the consent of one or both of the Parties, (iii) the necessity of obtaining a Third Party license by TPTX in the TPTX Territory in accordance with Section 9.4(c)(iii), or (iv) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory, and such Dispute is not resolved in accordance with Section 15.3, such Dispute will not be submitted to an arbitration proceeding in accordance with this Section 15.4, unless otherwise agreed by the Parties in writing, and instead, either Party may initiate litigation in a court of competent jurisdiction in any country in which such rights apply.

16.1 Governing Law. This Agreement will be governed by and construed in accordance with the laws of [***] without reference to any rules of conflict of laws. The United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement and is expressly and entirely excluded.

16.2 Force Majeure. Neither Party will be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, pandemics, epidemics, quarantines, or other acts of God or any

other deity (or orders of any Governmental Authority related to any of the foregoing), or acts, omissions or delays in acting by any Governmental Authority. The affected Party will notify the other Party of such force majeure circumstances as soon as reasonably practical, the JSC, JDC or JMC, as applicable, will review and discuss any such matter and the affected Party will promptly undertake Commercially Reasonable Efforts necessary to cure such force majeure circumstances.

16.3 Assignment. Neither Party may assign this Agreement to a Third Party without the other Party’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed); except that (a) subject to Section 2.6, either Party may make such an assignment without such consent to a Third Party successor to substantially all of the business or assets of such Party to which this Agreement relates (whether by merger, sale of stock, sale of assets, exclusive license or other transaction), and (b) either Party may assign this Agreement without such consent to an Affiliate; provided that the assigning Party shall provide prompt written notice to the other Party of any such assignment. For clarity, each Party may exercise, discharge, or delegate any obligations and exercise any rights hereunder through any of its Affiliates without the consent of the other Party, provided that each Party will remain responsible for the performance by its Affiliates of such Party’s obligations or the exercise by its Affiliates or such Party’s rights under this Agreement. Any attempted assignment or transfer in violation of this Section 16.3 will be null and void. Subject to the foregoing, this Agreement will be binding on and inure to the benefit of the Parties and their respective successors and permitted assigns.

16.4 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein will not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties will in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.

16.5 Notices. All notices which are required or permitted hereunder will be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice will be deemed to have been given: (a) when delivered if personally delivered; (b) if sent by email, upon electronic confirmation of receipt; (c) on the Business Day after dispatch if sent by nationally-recognized overnight courier; or (d) on the fifth Business Day following the date of mailing if sent by mail.

16.6 Entire Agreement; Amendments. The Agreement contains the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, with regard to the subject matter hereof (including the licenses granted hereunder) are superseded by the terms of this Agreement. Neither Party is relying on any representation, promise, nor warranty not expressly set forth in this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto. To the extent there is any conflict between the terms of any Ancillary Agreement (including the Pharmacovigilance Agreement, the Clinical Supply Agreement or related quality agreement), and the terms of this Agreement, the terms of such Ancillary Agreement will control solely with respect to the primary subject matters thereof, and the terms of this Agreement will control otherwise.

16.7 Headings. The captions to the several Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the Sections of this Agreement.

16.8 Independent Contractors. It is expressly agreed that LaNova and TPTX will be independent contractors and that the relationship between the two Parties will not constitute a partnership, joint venture or agency. Neither LaNova nor TPTX has the authority to make any

statements, representations or commitments of any kind, or to take any action, which will be binding on the other Party, without the prior written consent of the other Party.

16.9 Waiver. The waiver by either Party of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, will not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.

16.10 Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement will be construed against the drafting Party will not apply.

16.11 Construction. Except where the context expressly requires otherwise, (a) the use of any gender herein will be deemed to encompass references to either or both genders, and the use of the singular will be deemed to include the plural (and vice versa), (b) the words “include”, “includes” and “including” will be deemed to be followed by the phrase “without limitation”, (c) the word “will” will be construed to have the same meaning and effect as the word “shall” (and vice versa), (d) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person will be construed to include the person’s successors and assigns, (f) the words “herein”, “hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Sections, Schedules, or Exhibits will be construed to refer to Sections, Schedules or Exhibits as described in this Agreement, (h) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder “agree”, “consent” or “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or Section, section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or” where applicable.

16.12 Cumulative Remedies. Unless otherwise expressly set forth herein, no remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Applicable Laws.

16.13 Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. Each Party will be entitled to rely on the delivery of executed facsimile copies of counterpart execution pages of this Agreement and such facsimile copies will be legally effective to create a valid and binding agreement among the Parties.

16.14 Language. This Agreement is in the English language only, which language will be controlling in all respects, and all versions hereof in any other language will be for accommodation only and will not be binding upon the Parties. All communications and notices to be made or given pursuant to this Agreement, and any dispute proceeding related to or arising hereunder, will be in the English language.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

TURNING POINT THERAPEUTICS ANNOUNCES PIPELINE EXPANSION, LICENSING OF TPX-4589 (LM-302), A CLINICAL STAGE ANTI-CLAUDIN18.2 ANTIBODY DRUG CONJUGATE FOR GASTROINTESTINAL CANCERS, FROM LANOVA MEDICINES

Strategic expansion of Turning Point Precision Oncology Portfolio and Scientific Capabilities

Agreement Includes Potential Broader Scope to Collaborate on up to Three Additional ADC Programs from LaNova Pipeline

SAN DIEGO, May 5, 2022 – Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, announced today that it has entered into an exclusive license agreement with LaNova Medicines Limited (“LaNova”) to develop and commercialize LM-302, a novel antibody drug conjugate (ADC) targeting Claudin18.2 in the US and rest of the world excluding Greater China and South Korea. Claudin18.2 is a protein expressed in many gastrointestinal cancers, including gastric, gastroesophageal junction and pancreatic cancer. LM-302, which going forward will be identified as TPX-4589, is currently in Phase 1 clinical trials in both the U.S. and China.

Under the terms of the licensing agreement, LaNova will receive an upfront payment of $25 million and will be eligible to receive up to an additional $195 million in development and regulatory milestone payments; in addition, LaNova is eligible to receive commercial sales milestones, and tiered royalties ranging from mid-single digit to mid-teens percentages on net sales (subject to customary deductions). As part of the agreement, both parties agree to potentially broaden the partnership by collaborating on up to three additional ADC programs from the LaNova pipeline.

TPX-4589 (LM-302) is a potentially first-in-class anti-Claudin18.2 ADC discovered by LaNova that suppresses cell proliferation of gastric and pancreatic cell lines with nanomolar potency in preclinical models. It also has demonstrated efficacy in gastric and pancreatic cancer xenograft models.

“We are excited to announce our first in-license as a company and strategically expand our clinical stage portfolio, specifically within GI tumors. Claudin18.2 is continuing to emerge as an important target,” said Athena Countouriotis, M.D., President and Chief Executive Officer of Turning Point. “We chose TPX-4589 based on it potentially being a first-in-class ADC to target Claudin18.2 and its preclinical data which show the potential to target tumors with low and high expression levels, which we believe could be an important differentiator versus other investigational therapies.”

“LaNova Medicines is focused on discovery and development of innovative medicines in oncology. We are very pleased to partner with Turning Point for LM-302, an innovative drug molecule with the potential as a novel treatment for gastric and pancreatic cancers. This partnership is an example of our discovery and development capabilities and our ambition for global innovation and patients,” said Dr. Crystal Qin, Chairman and CEO of LaNova Medicines.

It is estimated that the annual incidence of gastric and gastroesophageal junction cancers in the U.S. and EU5 is approximately 27,000 and 50,000, respectively1. The estimated annual incidence of pancreatic cancer in the U.S. and EU5 is approximately 60,000 and 70,000, respectively1. Approximately 65% of patients in pancreatic2, gastric and gastroesophageal junction3 cancers have tumors that express Claudin18.2.

Turning Point will host a webcast and conference call on May 5, 2022 at 6 p.m. ET / 3 p.m. PT to discuss this announcement. Athena Countouriotis, M.D., President and Chief Executive Officer, will host the virtual event for investors and will be joined by Kumar Srinivasan, Chief Business Officer.

The event will be accessible through the “Investors” section of www.tptherapeutics.com or by dialing (844) 256-2297 (in the United States) or (236) 714-3006 (outside the U.S.) using conference ID 8780394. A replay will be available shortly after the live event through the “Investors” section of www.tptherapeutics.com.

About Turning Point Therapeutics Inc.
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes elzovantinib, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer; and, TPX-4589 (LM-302), a novel ADC targeting Claudin18.2 being studied in a Phase 1 study in

gastrointestinal cancers. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.

About LaNova Medicines Ltd
LaNova Medicines is a privately-held China-based global biotech company incorporated in 2019. The company is committed to the discovery, development and, in the future, commercialization of novel biological drugs with “First-in-class” or “Best-in-class” potential in the areas of tumor associated antigens and immuno-oncology in tumor microenvironment to address significant unmet medical needs.

Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements in this press release include statements regarding, among other things, the potential for TPX-4589 (LM-302) to be a first-in-class anti-Claudin18.2 ADC candidate, and the efficacy, safety and therapeutic potential of TPX-4589 (LM-302). These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point Therapeutics’ business and the other risks described in Turning Point Therapeutics’ filings with the SEC, including its annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 28, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

1US: SEER database accessed January 2022; EU5: GLOBALCAN database accessed January 2022

2Woll at al., Int. J. Cancer:134, 731–739 (2014); Park et al., J Clin Oncol 38: 2020

3Arnold et al., Clinical and Translational Oncology (2020) 22:2357–2363; Dottermusch et al., Virchows Archiv (2019) 475:563–571

This Strategic Collaboration Agreement (“Agreement”), effective as of the 23rd day of June, 2022 (“Effective Date”), is entered into by and between The University of Texas M. D. Anderson Cancer Center, with a place of business located at 1515 Holcombe Blvd., Houston, TX 77030, USA (“MD Anderson”), a member institution of The University of Texas System (“System”) and Turning Point Therapeutics, Inc., with a place of business located at 10628 Science Center Drive, Suite 200, San Diego, CA 92121 (“Company”) (MD Anderson and Company each a “Party” and collectively the “Parties”).

Whereas, Company is a pharmaceutical development company involved in the field of research, development and marketing of pharmaceutical products, including the sponsorship of clinical trials.

Whereas, MD Anderson is a comprehensive cancer research, treatment, and prevention center, with scientists and technicians in substantive fields relating to cancer research.

Whereas, the Parties hereby wish to establish a collaboration, as further described herein (“Collaboration”) under which the Company desires to provide funding and support for one or more research studies to be conducted by MD Anderson pursuant to this Agreement (each such study a “Study,” and one or more of such Studies the “Studies”).

Now therefore, in consideration of the premises and the mutual covenants and conditions hereinafter recited, the Parties do hereby agree as follows:

1.1 The Parties intend that the scope of the Collaboration will consist of preclinical and clinical Studies designed to expand the science, clinical treatment and potential of precision oncology, the details of which are to be mutually agreed upon by the Parties and the JSC (as defined in Section 1.5). In consultation with Company, MD Anderson agrees to design the Studies and use reasonable efforts to conduct the work detailed under each Study Order. Studies may be changed as agreed upon by the JSC. Responsibility for IND filing and monitoring will be agreed upon by the JSC and may vary by Study.

1.2 The Agreement is a Collaboration agreement which shall govern the performance of Studies by MD Anderson and one or more Principal Investigator(s) on basis of Study specific documents (“Study Orders”) as agreed upon by the Parties. This Agreement shall apply to all Studies performed by MD Anderson and the MD Anderson principal investigator(s) responsible for the performance of such Studies (“Principal Investigator(s)”) upon execution of Study Orders during the term of this Agreement. Each Study Order shall be substantially in the form attached as Exhibit I to this Agreement and shall detail the specifics of the Study to be performed under such Study Order including, without limitation, (i) the detailed Protocol or workscope, (ii) the Principal Investigator, (iii) a study budget, (iv) a description of the clinical, pre-clinical or research stage molecule which is the subject of the Study, which will be provided by Company to MD Anderson pursuant to such Study Order (“Study Drug”) or any Proprietary Materials to be provided by the Parties, (v) if applicable, description of the Data, reports and any other work product or deliverables (vi) timelines for completion of the Study and (vii) any project-specific resources or support provided by

Company. In the event of any conflict of terms of this Agreement and the terms of a Study Order, the terms of this Agreement shall govern, unless the Study Order specifically and expressly supersedes this Agreement with respect to a specific term, and then only with respect to the particular Study Order and specific term. Once a Study Order for a Study is signed by both parties, it will automatically be deemed to be attached hereto and incorporated herein. If there is any discrepancy or conflict between the terms contained in a Protocol/workscope and this Agreement and/or the relevant Study Order, the terms of the Protocol/workscope shall govern and control with respect to clinical and/or scientific matters and the terms of the Agreement and/or the relevant Study Order shall govern and control with respect to all other matters, including but not limited to, legal and financial matters.

1.3 Company agrees to provide funding in an amount of Ten Million US dollars ($10,000,000) for the performance of the Studies under the applicable Study Order(s) during the term of this Agreement (collectively, “Collaboration Funding”). Company’s Study Drugs, repotrectinib, TPX-0022, and TPX-0131, shall be the subject of initial Studies to be conducted pursuant to initial Study Orders executed by the Parties pursuant to this Agreement. MD Anderson agrees that all costs for the conduct of all Studies under this Collaboration, with the sole exception of any costs to supply Company’s Study Drug or Proprietary Materials, are included in the Collaboration Funding. MD Anderson shall use the Collaboration Funding solely to conduct the applicable Study and MD Anderson shall be responsible for managing cash flow between payments. It is understood and agreed that the Collaboration Funding shall cover all administrative, IRB review, patient recruitment, and all other fees, costs and expenses of MD Anderson and any of its Study Team Members for the conduct of the Studies or the provision of equipment or services to facilitate the Studies, and that no other form of compensation shall be paid to MD Anderson in connection with the Studies except as otherwise may be mutually agreed upon by the Parties in writing. If the Parties extend the term by mutual agreement as set forth herein, the Parties shall negotiate in good faith the amount of any future Study funding commitments, as applicable to such extended term.

1.4 Ten Million US dollars, which represents full payment for all Studies performed by MD Anderson during the term of this Agreement and pursuant to this Agreement, shall be due and payable to MD Anderson within [***] days of Company’s receipt of twice-yearly invoices to [***] as follows. MD Anderson shall issue its first invoice for an upfront payment of One Million US dollars ($1,000,000) on the Effective Date. MD Anderson shall issue the remaining nine (9) invoices, each in the amount of One Million US dollars ($1,000,000), on the nine (9) succeeding half-year and full-year anniversaries of the Effective Date, each to be issued upon delivery by MD Anderson of a twice-yearly Collaboration or Study-progress report.

MD Anderson represents, and Company acknowledges, that the compensation being paid to MD Anderson under this Agreement constitutes the fair market value of the services to be provided hereunder. MD Anderson represents that the Collaboration Funding is based on the fair market value of the activities to be performed for the Studies, and it provides an accurate breakdown of all Study costs, including all Study start-up costs and overhead, if any. Company shall not be obligated to make any payments in connection with the Studies except as explicitly set forth in this Agreement, including any Study Order referencing this Agreement.

Neither MD Anderson nor Principal Investigator shall seek or accept reimbursement from any third-party payor for any Study items or procedures supplied by or paid for by Company under this Agreement. MD Anderson acknowledges that Company may be obligated to disclose all payments made hereunder, including the provision of non-monetary items of value, as may be required under applicable law,

regulations and guidelines, including the Physician Payments Sunshine Act, passed as Section 6002 of the 2010 Patient Protection and Affordable Care Act.

No amounts paid under this Agreement are intended to be for, nor shall they be construed as, an offer or payment made in exchange for any explicit or implicit agreement to purchase, prescribe, recommend, or provide a favorable formulary status, for any Company product or service. Any such compensation will be consistent with fair market value in arms-length transactions and will not be determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the Parties for which payment may be made in whole or in part under Medicare, Medicaid or other Federal health care programs.

1.5 The Parties will establish a Joint Steering Committee (“JSC”) of equal representation, comprised of [***] representatives (employees, directors or consultants who are each subject to confidentiality and non-use obligations no less stringent than those terms set forth herein) from each Party, with the representatives of each Party collectively having one vote on all matters to be decided upon by the JSC. Each Party can appoint and replace its representatives in the JSC at its own discretion through timely written notice to the other Party.

1.6 The JSC will have meetings (either in person, by teleconference or via electronic means) at least [***]. At least [***] meeting per year will be conducted in person or by videoconference (including the kick-off meeting). The JSC will decide on matters by unanimous vote provided, however, that no action may lawfully be taken at any meeting unless at least [***] representatives of each Party (including for this purpose any proxy representative appointed as provided below) are present at the meeting. If a member of the JSC is unable to attend a meeting, he or she may appoint, in writing, a proxy to participate and vote in his or her stead.

1.7 The main task of the JSC will be to oversee the Collaboration. In order to achieve the objectives of the Collaboration, the JSC will oversee each Study under the Collaboration. The JSC will provide technical, scientific, clinical, and regulatory guidance to the Studies and will be responsible for monitoring progress of these Studies. In addition the JSC will be responsible for discussing and approving a study budget for each Study Order and coordinating resolution of problems arising in the Studies or in the Collaboration as a whole. Additional representatives can be invited by the JSC on a case by case basis should discussion of certain topics require so, provided that such representatives will be subject to an obligation of confidentiality and non-use at least as strict as Section 4 below. In the event a Study is terminated early, then, in relation to any funds allocated to such Study, the Parties shall promptly discuss and agree upon a replacement of that Study with a new study of similar scope that is of mutual scientific interest to the Parties and that is approved by the JSC, and that will be funded by the Collaboration Funding. If there is any Collaboration Funding remaining at the expiration or termination of this Agreement and all Study Orders, it may be allocated to additional studies, research or tests as agreed to by the JSC and if the JSC cannot agree to any such studies, research or tests, it will be returned to Company promptly following budget reconciliation procedures described in Section 7.6.

1.8 In the event of any matter to which the JSC cannot reach resolution, or in the event of any dispute arising as to any matter subject to JSC responsibility, such matter will be escalated to the executive management of MD Anderson and Company for good faith resolution. If such executive management team cannot resolve the dispute within [***] days of first being notified of such dispute, such matter shall be escalated to the chief executive officer/president of MD Anderson and Company for good faith resolution.

2.1 Each clinical Study shall be subject to review and approval of the Study protocol (“Protocol”) as required by MD Anderson’s Institutional Review Board (“Institutional Review Board” or “IRB”) and/or any relevant authorities prior to commencement of the Study.

2.2 The scope of the Study to be performed shall be set forth in the Protocol(s) referenced in the Study Order, which shall be incorporated by reference into such Study Order. These Protocol(s) shall be considered final after being agreed to by MD Anderson and Company; for clinical Studies, including approval by MD Anderson’s IRB. The Principal Investigator for a clinical Study shall submit the Protocol and reports of the ongoing conduct of the clinical Study to the IRB as required by the IRB, obtain written approval from the IRB, and inform the IRB of Study closure. No change to or deviation from the Protocol, Consent, or Authorization will be made without prior written approval from Company and written approval by the IRB except when such change is either required by the IRB or is necessary to eliminate apparent immediate hazard to Study subjects, in which case MD Anderson agrees to promptly document such deviation and notify Company and the IRB as soon as reasonably possible.

2.3 MD Anderson represents that each Principal Investigator shall use reasonable efforts to conduct a Study in accordance with (a) the terms and conditions of this Agreement and the relevant Study Order, (b) the provisions of the Protocol, (c) applicable Good Clinical Practice requirements as incorporated by FDA regulations (“GCP”), (c) the ethical principles of the Declaration of Helsinki, and (d) any and all applicable orders and mandates of relevant authorities and IRB and applicable MD Anderson policies.

2.4 MD Anderson and Company shall comply, and shall ensure that its Study Team Members (in the case of MD Anderson) or employees (in the case of Company) complies, with all federal, state, and local laws and regulations as well as ethical codes applicable to such Party in the conduct of each such Study, including any anti-bribery and anti-corruption laws, rules, regulations applicable to either Party, including the US Anti-Kickback Law and the US Foreign Corrupt Practices Act, each as amended from time to time.

2.5 MD Anderson and/or Principal Investigator shall forward to Company evidence of approval of each clinical Study by MD Anderson’s IRB, and with respect to Studies for which MD Anderson serves as “sponsor” within the meaning of such term under applicable laws and regulations, evidence of approval of the Study by relevant regulatory authorities (or exemption from such regulatory authority/ies review and approval).

2.6 MD Anderson shall, as sponsor of a clinical Study, be responsible for complying with all applicable laws, regulations and guidelines governing adverse events for all clinical Studies. During the course of a clinical Study at MD Anderson, MD Anderson and/or Principal Investigator shall promptly notify Company of any (a) serious and unexpected adverse reactions and/or serious and unexpected adverse events arising from or relating to the use of Study Drug, and/or, if applicable, pregnancies, within the timelines stipulated in the Protocol, or if such is not stipulated in the Protocol, promptly following MD Anderson or Principal Investigator becoming aware of such event and (b) actual or suspected research misconduct or fraud by Principal Investigator or any of its employees, agents or contractors involved in the conduct of Study activities (“Study Team Member(s)”) in connection with the Study. To the extent permitted by applicable law, in connection with clinical Studies involving Study Drug provided by or proprietary to Company, Principal Investigator will promptly notify Company of any of his/her communication with a regulatory agency concerning the Study (including communications that are reasonably likely to impact the Study) and if feasible, will permit Company to review and comment in advance upon Principal Investigator’s communication to a regulatory authority concerning the Study.

2.7 Each Party represents that: (a) it has not been debarred by the FDA pursuant to its authority under Sections 306(a) and (b) of the U.S. Food, Drug, and Cosmetic Act (21 U.S.C. § 335(a) and (b)) and is not the subject of any investigation or proceeding which may result in debarment by the FDA, and to the extent applicable, it shall not use any Principal Investigator or Study Team Member in the performance of a Study that has been so debarred or subject to any such investigation or proceeding, and; (b) it is not included in the List of Excluded Individuals/Entities (maintained by the U.S. Department of Health and Human

Services Office of Inspector General) or the List of Parties Excluded from Federal Procurement and Non-procurement maintained by the U.S. General Services Administration, and is not the subject of any investigation or proceeding which may result in inclusion in any such list, and to the extent applicable, it shall not use any Principal Investigator or Study Team Member in the performance of a Study that is so included or the subject of any such investigation or proceeding. Each Party agrees to promptly notify the other Party in writing if it becomes aware of any such debarment, exclusion, investigation or proceeding of such Party or, to the extent applicable, any Principal Investigator or Study Team Member.

2.8 MD Anderson and Company shall comply with all applicable federal, state and local laws pertaining to confidentiality and disclosure of all information or records obtained and reviewed in the course of the Study, and shall permit access to such information or records only as authorized by a relevant Study subject, the IRB, and as authorized by law. Each Party agrees to comply with all provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) regulations (45 C.F.R. Parts 160 and 164) as to the protection and security of Protected Health Information (“PHI”). Prior to participation of each subject in a Study, MD Anderson will ensure that (a) it has obtained a signed written informed consent document from the subject (“Consent”) and (b) it has obtained a signed, written, HIPAA authorization that adequately discloses the circumstances under which the subject’s personal data might be disclosed, as applicable, and documents the subject’s express written authorization for use and disclosure of the subject’s PHI for Study purposes, as applicable, pursuant to the HIPAA regulations (“Authorization”). Company will only obtain, access, use and disclose the individually identifiable health information of any Study Subject in accordance with and to the extent permitted by the IRB, Consent and the Authorization document and in accordance with this Agreement and applicable laws.

2.9 During the term of a Study and for [***] years thereafter, MD Anderson will promptly notify Company upon identifying any aspect of a Protocol, including information discovered during site monitoring visits, or Study results that may adversely affect the safety, well-being, or medical care of the Study subjects, or that may affect the willingness of Study subjects to continue participation in a Study, influence the conduct of the Study, or that may alter the IRB’s approval to continue the Study. MD Anderson will promptly notify the IRB of any such events. If any such events occur or if Study subject safety or medical care could be directly affected by Study results, then notwithstanding any other provision of this Agreement, MD Anderson will send Study subjects a written communication about such information.

3.1 MD Anderson shall provide reasonably necessary personnel, facilities, and resources to accomplish its responsibilities under this Agreement and the relevant Study Order.

3.2 After receipt by Company of (a) a copy of the final complete Protocol, Consent, and Authorization, (b) evidence of IRB approval of the Study, and (c) Curriculum Vitae of the Investigator and any sub-investigators, Company agrees to promptly provide, or arrange to provide, MD Anderson with the required quantities of the Study Drug agreed to under a Study that will be utilized and required in accordance with the provisions of the Protocol applicable to the Study, and/or support services to the extent required for the conduct of a Study as specified in the Protocol and the applicable Study Order. Any Study Drug provided by Company will be used solely in accordance with the applicable Study, the Protocol, and all applicable laws, regulations and guidelines. MD Anderson will not use such Study Drug outside of the scope of the Study, and MD Anderson shall maintain exclusive control of the Study Drug and handle, store, and dispose of the Study Drug in accordance with applicable laws, regulations and guidelines and in the manner outlined in the Protocol. MD Anderson shall use the Study Drugs solely for the purpose of conducting the Study in strict adherence to the Protocol and for no other use or purpose. MD Anderson will maintain, or cause Principal Investigator to maintain, records on the receipt and disposition of the Study Drug, including dates, quantity, and use by subjects. MD Anderson will not transfer the Study Drug to any third party for any purpose. Company agrees that Study Drug shall comply with the labelling requirements in Exhibit II, attached hereto and as may be amended from time to time.

3.3. Use of Proprietary Materials. From time to time during the term, either Party (the “Transferring Party”) may supply the other Party (the “Receiving Party”) with proprietary materials of the Transferring Party (other than Study Drug) (“Proprietary Materials”) for use in the Study as further listed in the Study Order. In connection therewith, each Receiving Party hereby agrees that: (a) the Receiving Party will not use the Proprietary Materials for any purpose other than exercising its rights or performing its obligations hereunder; (b) it will use such Proprietary Materials only in compliance with all applicable laws, regulations and guidelines; (c) it will not transfer any such Proprietary Materials to any third party without the prior written consent of the Transferring Party; (d) it will not acquire any rights of ownership, or title in or to such Proprietary Materials as a result of such supply by the Transferring Party; and (e) upon the expiration or termination of this Agreement or the applicable Study Order, if requested by the Transferring Party in writing, it will destroy or return any such Proprietary Materials that are not the subject of the grant of a continuing license hereunder.

3.4 Nothing in this Agreement shall be construed to limit the freedom of either Party or of any Principal Investigator or Study Team Member to engage in similar clinical trials or research performed independently under other grants, contracts, or agreements with parties other than the other Party.

4.1 In conjunction with each Study, the Parties may wish to disclose confidential information to each other. For purposes of this Agreement, “Confidential Information” means confidential, non-public information, know-how, and data (technical or non-technical) that is disclosed in writing, orally, graphically, in machine readable form, or in any other manner by or on behalf of a disclosing Party or its Affiliates (as defined in this Agreement) to a receiving Party or its Affiliates for purposes of this Agreement or any Study Order. Confidential Information may be disclosed in any form (including. oral, written, graphic, electronic or sample) by or on behalf of disclosing Party or its Affiliates. Exchanges of Confidential Information directly between the Affiliates are also covered by this Agreement. “Affiliates” means any individual, company, partnership or other entity which directly or indirectly, at present or in the future, controls, is controlled by, or is under common control of a Party, and “control” means direct or indirect beneficial ownership of at least fifty per cent (50%) of the voting share capital in such company or other business entity, or to hold the effective power to appoint or dismiss members of the management.

4.2 Without disclosing Party’s prior written consent, receiving Party will: (a) not use any Confidential Information, or any part thereof, for any purpose other than in connection with performing obligations or exercising rights as contemplated by this Agreement (the “Purpose”); (b) restrict the dissemination of Confidential Information to individuals within its own organization and disclose the Confidential Information only to those of its officers, employees, agents, representatives, contractors, scientific and/or institutional review board members, and Affiliates who have a legitimate need to know the Confidential Information for the Purpose, who will be bound by confidentiality and non-use commitments no less restrictive than those of this Agreement, and who will have been made aware of the confidential nature of the Confidential Information; (c) protect the Confidential Information by using the same degree of care, but not less than a reasonable degree of care, to prevent the unauthorized use, dissemination, or publication of the Confidential Information as receiving Party uses to protect its own confidential information of a like nature; (d) preserve the confidentiality of the Confidential Information, not disclose it to any third party, except as expressly permitted herein, and take all necessary and reasonable precautions to prevent such information from being accessible to any third party; (e) not combine any part of or the whole of the Confidential Information with any other information except as required for the Purpose; and (f) promptly notify the disclosing Party upon becoming aware of any unauthorized use or disclosure of the Confidential Information. The foregoing obligations will exist for a period of [***] years from the date of completion of the last Study in relation to which the Confidential Information is disclosed or used.

4.3 The obligations of confidentiality and non-use listed in this Section 4 will not apply to information: (a) which is in the public domain or public knowledge at the time of disclosure, or which subsequently enters the public domain through no fault of receiving Party; (b) which was rightfully in the possession of receiving Party at the time of disclosure by disclosing Party; (c) which is independently developed by receiving Party without use of or reference to disclosing Party’s Confidential Information; or (d) which the receiving Party receives legally from any third party and which is not subject to an obligation of confidentiality.

4.4 Notwithstanding the foregoing, a receiving Party may disclose specific Confidential Information of the disclosing Party to the extent such disclosure is required by order of a court or government agency having competent jurisdiction; provided, however, that receiving Party will use reasonable efforts to, the extent authorized by applicable law to, promptly notify disclosing Party in writing prior to the disclosure of any of disclosing Party’s Confidential Information and use reasonable efforts to cooperate with disclosing Party to allow disclosing Party to contest and avoid such disclosure, and provided, further, that receiving Party will disclose only that portion of such Confidential Information that it is legally required to disclose. In addition, a receiving Party may also disclose Confidential Information of disclosing Party to the extent it is required to be disclosed (a) in order to obtain informed consent from patients or subjects who may wish to enroll in the Study, provided, however, that the information will be disclosed only to the extent necessary and will not be provided in answer to unsolicited inquiries by telephone or to individuals who are not eligible to be Study subjects; or (b) to a Study subject for the safety or well-being of the Study subject.

4.5 For the purposes of this Section 4, any combination of features disclosed to the receiving Party will not be deemed to be within the foregoing exceptions merely because individual features are. Moreover, specific disclosures made to the receiving Party will not be deemed to be within the foregoing exceptions merely because they are embraced by general disclosures.

4.6 All Confidential Information disclosed to receiving Party pursuant to this Agreement will be and remain the disclosing Party’s property. Nothing contained herein will be construed as granting to receiving Party any proprietary right on or in relation to any part of or the whole of the Confidential Information, or any right to use any of the Confidential Information except for purposes of this Agreement and the Collaboration. Receiving Party will return to disclosing Party all documents and other materials which constitute Confidential Information, as well as all copies thereof, promptly upon written request or upon termination of this Agreement (whichever is earlier); provided, however, that receiving Party may keep one copy of the Confidential Information received under this Agreement in its secure files in accordance with the terms of this Agreement for the sole purpose of maintaining a record of the Confidential Information received hereunder and for compliance with this Agreement and/or applicable laws, regulations and guidelines and that, with respect to electronic copies of any Confidential Information of a disclosing Party, the receiving Party shall use reasonable efforts to delete and make unavailable all electronic copies of any disclosing Party Confidential Information, and any which are not so deleted shall remain subject to the terms of this Agreement for so long as they are retained provided, that the receiving Party shall not be required to return or destroy copies of the disclosing Party’s Confidential Information made in routine back-up of its information technology systems in the ordinary course of business if access to such copies is limited to members of the receiving Party’s or its Affiliates’ information technology and legal departments.

4.7 MD Anderson will not disclose any Protected Health Information to Company under this Agreement and Company will not require MD Anderson to disclose any Protected Health Information. Notwithstanding the foregoing, if Company comes into knowledge or possession of any “Protected Health Information” (as such term is defined under HIPAA) by or through MD Anderson or any information that could be used to identify any Study subject or other MD Anderson patients or research subjects, Company will maintain any such Protected Health Information or other information confidential in accordance with laws and regulations as applicable to MD Anderson, including without limitation HIPAA, will use any such Protected Health Information solely to the extent permitted by (1) applicable laws, regulations and guidelines, (2) the IRB and the (3) Consent and Authorization of the patient/research subject, and will not use or disclose any such Protected Health Information or other information in any manner that would constitute a violation of any applicable laws or regulations if such use or disclosure was made by MD Anderson.

4.8 Improper use or disclosure of the Confidential Information by receiving Party may cause substantial irreparable harm to disclosing Party that is not adequately compensable by money damages and for which disclosing Party may not have an adequate remedy at law. Therefore, in the event of a breach, threatened breach, or intended breach of the confidentiality and non-use terms of this Agreement by receiving Party, in addition to any other rights and remedies available to it at law or in equity, disclosing Party will be entitled to seek preliminary and final injunctions enjoining and restraining such breach, threatened breach, or intended breach.

5.1 Oral reports and/or interim written status reports of the progress of the Studies will be provided by the Principal Investigator to Company no less than [***] per [***] months during the course of a Study, or of a shorter frequency if specified in the applicable Study Order. Significant developments arising out of Studies will be communicated promptly to Company.

5.2 As applicable to and appropriate for a Study, Company or Company’s representatives may monitor and inspect the conduct of a Study in accordance with Good Clinical Practice requirements of FDA Regulations, and may visit MD Anderson for the purpose of such monitoring , and Company may review and copy (to the extent permitted by the applicable Consent and/or Authorization form) documents, records, data, information and materials relating to the Study. MD Anderson and the Principal Investigator shall reasonably cooperate with the Company and make appropriate Study Team Members reasonably available to explain and discuss records and documentations related to the Study. For Company inspections of MD Anderson, MD Anderson shall submit a written response to Company for all nonconformances within [***] days after receipt of the inspection report from Company. MD Anderson will complete all reasonable corrective actions for each nonconformance within [***] days after the receipt of the inspection report. Any such monitoring visits shall be scheduled in coordination with MD Anderson and/or Principal Investigator during normal administrative business hours, and shall be subject to compliance with MD Anderson’s reasonable measures for confidentiality, safety and security, and shall also be subject to compliance with generally applicable premises rules at MD Anderson.

5.3 In addition to the above, MD Anderson and Principal Investigator shall, during a Study, permit inspections by legal and regulatory authorities with respect to such Study. To the extent permitted by law and if practicable, MD Anderson shall notify Company of such inspection within [***] hours of becoming aware of the inspection or plans for an inspection and MD Anderson shall reasonably cooperate with such legal and regulatory authorities, comply with audit requirements and make appropriate Study Team Members available to explain and discuss records and documentations related to the Study. To the extent permitted by applicable law, Company shall have the right to be present at inspections of MD Anderson’s facilities or operations or of MD Anderson to the extent they are directly related to a Study and shall have the opportunity to provide review and comment on any responses that may be required. MD Anderson shall promptly remedy all deficiencies noted during such inspection. Company may not direct the manner in which MD Anderson fulfills its obligations to permit inspection by governmental entities. It shall not be a breach of this Agreement for MD Anderson to comply with the demands and requests of any governmental entity in accordance with MD Anderson’s judgment or to fail to inform and consult with Company before complying with any such demand or request if MD Anderson is not permitted by law to inform or consult with Company before complying with such demand or request.

5.4 Notwithstanding any provision of this Section 5, to the extent that MD Anderson is the holder of an Investigational New Drug Application (“IND”) or other applicable regulatory application or approval for a Study, the provisions of Section 5.2 and 5.3 shall not apply, and MD Anderson shall have the sole responsibility for initiating, conducting, monitoring, auditing, and reporting for such Study, provided that MD Anderson agrees to consider in good faith Company’s request to access Study documentation and records relevant to the applicable Study Drug and documentation and facilities applicable to the Study, and provided that Company shall be subject to compliance with MD Anderson’s reasonable measures for confidentiality, safety and security, and shall also be subject to compliance with generally applicable premises rules at MD Anderson.

6.1. “Invention” means any invention or discovery, whether patentable or not, that is conceived or invented by a Party, including through MD Anderson’s or Study Team Member’s performance of the Study, either solely or jointly with others, in the conduct of and arising from the performance of a Study or as a result of the use of Company’s Confidential Information provided hereunder or Study Drug that is the subject of a given Study.

6.2 Each Party will retain all right, title and interest in and to its own Background IP and no license to use such Background IP is granted to the other Party except for MD Anderson’s use of Study Drug in a Study as set forth in Section 3.2 above and in the Protocol and each Party’s use of the other Party’s Proprietary Material as set forth in Section 3.3 above. “Background IP” means all intellectual property of a Party that: (a) is owned or controlled by such Party before the Effective Date; or (b) is generated by such Party outside the scope of and independently from this Agreement and which is not an Invention under this Agreement.

6.3 MD Anderson will provide to Company a reasonably detailed written disclosure of each Invention promptly after a written invention disclosure report for such Invention is received by MD Anderson’s Office of Technology Commercialization.

6.4 Inventorship of Inventions will be determined in accordance with United States patent law. Ownership of Inventions will be subject to the provisions set forth in Section 6.5 below.

6.5 All Inventions shall be solely owned by Company, unless otherwise specified in a Study Order that involves the use of Proprietary Materials of MD Anderson for a preclinical Study and which does not involve the use of Company’s Study Drug or Company’s Proprietary Materials. Inventions shall be deemed Company’s Confidential Information. To the extent MD Anderson has any rights to Inventions, MD Anderson agrees to assign and hereby assigns to Company any and all rights, title and interest that MD Anderson may acquire by operation or law or otherwise, in and to the Inventions and all intellectual property rights therein. MD Anderson shall take reasonable actions and execute, cause to be executed and deliver, at Company’s expense, all such further documents as may be necessary to effectuate and perfect the ownership provisions of this Section 6.5. MD Anderson certifies that all Study Team Members have assigned or assigns to MD Anderson as a condition of their employment or engagement, all right, title and interest in and to Inventions. MD Anderson shall retain a non-exclusive, royalty-free license to:

(1) publish the general scientific findings from research related to Inventions as permitted by and in accordance with Section 11 below; and

(2) use Inventions for non-commercial patient care, internal non-commercial research, teaching, and academic purposes.

6.6 MD Anderson shall record and maintain complete data and records, and all such data and results generated in the conduct of and as a result of conducting the Studies (“Data”) shall be promptly disclosed in writing by MD Anderson to Company and (with the exception of original laboratory notebooks and medical records, which shall be excluded from the definition of Data and be solely owned by MD Anderson) will be solely owned by Company and deemed Company’s Confidential Information, subject to MD Anderson’s right to use the Data for internal non-commercial research purposes, internal non-commercial academic purposes, non-commercial patient care, and publication in accordance with Section 11 of this Agreement. The Parties will keep the Data confidential until publication of the Data by MD Anderson in accordance with Section 11. Company shall promptly provide MD Anderson with a copy of any Data generated by, or on behalf of Company in connection with a Study..

6.7 Patent Rights. Company shall have the sole right to prepare, file, prosecute, maintain, enforce and defend all U.S. and foreign patents, registrations and other forms of intellectual property in any Invention but nothing herein will obligate Company to take any such actions.

7.1 The term of this Agreement shall be five (5) years following the Effective Date or until the Studies are completed, whichever is later, unless terminated earlier in accordance with the provisions hereof.

7.2 Either Party may terminate (i) a Study Order immediately upon written notice to the other Party if (a) the JSC determines that enrollment for such Study does not proceed as anticipated by the Study design and the JSC is unable to mutually agree to amend the Study so that the Study meets the intended timelines, or (b) the Protocol is amended and such amendment materially changes the scientific and medical merit of the Study or (ii) a Study Order as may be set forth in the applicable Study Order.

7.3 Either Party will have the right to terminate this Agreement if the other Party commits a material breach of the Agreement and fails to cure such breach within thirty (30) days of receiving notice from the non-breaching Party of such breach. Any expiration or termination of this Agreement will not affect any then existing Study Orders, and any then outstanding Study Orders will continue after the expiration or earlier termination of this Agreement in accordance with their respective provisions. Upon any expiration or termination of this Agreement, provisions of this Agreement that are incorporated by reference into any then outstanding Study Orders will survive termination of this Agreement and will continue to apply to such Study Orders until termination or expiration of each such Study Orders in effect at the time this Agreement expires or is terminated.

7.4 A Party may terminate a Study Order: (a) if the other Party commits a material breach of this Agreement or the Study Order and fails to cure such breach within thirty (30) days of receiving notice from the non-breaching Party of such breach; or (b) due to health and safety concerns related to the Study Drug or procedures in the Study (including regulatory holds due to the health and safety of the Study Subjects). The Parties agree that any termination of a Study Order shall allow for: (i) the wind down of the Study to ensure the safety of Study Subjects; and (ii) Company’s final reconciliation of Data related to the Study in addition to Company’s final monitoring visit. All reasonable fees associated with the wind-down activities and final monitoring visit shall be paid from the Collaboration Funding. Termination of one or more Study Orders will not automatically result in the termination of this Agreement or termination of any other Study Orders.

7.5 In case any regulatory or legal authorization necessary for the conduct of the Study is (i) finally rejected or (ii) withdrawn, the relevant Study Order shall terminate automatically at the date of receipt of such final rejection. Termination or cancellation of this Agreement or a Study Order will not affect the rights and obligations of the Parties that have accrued prior to termination, and any provisions of this Agreement or a particular Study Order that by their nature extend beyond expiration or termination will survive the expiration or termination of this Agreement and/or that particular Study Order.

7.6 In the event the Parties cannot reach agreement on a new Principal Investigator pursuant to Section 13.1 or such new Principal Investigator does not agree to the terms of this Agreement and the relevant Study Order, either Party may terminate such Study Order upon notice to the other Party.

7.7 Within [***] days following the expiration or early termination of the Agreement and/or last Study Order hereunder (whichever is later), the Parties shall promptly conduct a financial reconciliation of all funds paid under this Agreement and all work done under the Studies (including any replacement Study referred to in Section 1.7) to determine the disposition of the remaining, if any, Collaboration Funding. Within [***] days of such accounting and true-up, the Parties shall mutually agree upon any true-up amount of unpaid Collaboration Funding due to MD Anderson for completed performance of the Study Order activities and any non-cancellable obligations, which amount shall paid to MD Anderson within [***] days of the accounting and true-up and receipt of an invoice by Company or in the case there is Collaboration

Funding remaining, any such unused Collaboration Funding held by MD Anderson shall be returned by MD Anderson to Company within [***] days of the accounting.

7.8 In the event of termination of a Study under this Section 7, (a) Principal Investigator will immediately stop enrolling subjects in the Study and, if medically feasible, cease conducting Study procedures and treatment with Study Drugs or use of Proprietary Materials, (b) MD Anderson and/or Principal Investigator will (i) furnish Company all Study Data for that Study as of the effective date of Study termination and (ii) return to Company all remaining Study Drugs and Proprietary Materials that were furnished to MD Anderson for that Study in accordance with Company’s written instructions, except for records or samples that MD Anderson and/or Principal Investigator is required by law to retain. MD Anderson shall provide written notice to Company of its intention to destroy Study Drugs. Institution will have the right to destroy expired Study Drug after [***] days of the Study Drug’s expiration date, unless otherwise agreed to by the Parties. Within [***] of termination of this Agreement or completion of a Study (whichever comes first), Principal Investigator will submit final written reports to Company as specified in the Protocol. After termination of this Agreement or suspension of a clinical Study at MD Anderson for any reason, all Parties shall continue activities under this Agreement for such clinical Study solely as deemed necessary by mutual agreement of the Parties based on reasonable medical judgment to protect the health of subjects participating in a Study.

7.9 Sections 1.7 (the last sentence), 2.4, 2.6 – 2.9, 3.3(e), 3.4, 4, 5.3, 6, 7.3 (last sentence), 7.4 (last three sentences), 7.5 (last sentence), 7.7, 7.8, 7.9, 8, 11, 12 and 14 will survive any expiration or termination of this Agreement.

8.1 Company agrees to defend, indemnify, and hold harmless MD Anderson, System, each Principal Investigator and its/their regents, trustees, officers, directors, staff, employees, students, faculty members, and its/their affiliates and contracted clients and other parties as may be listed on a Study Order (“MD Anderson Indemnified Party/ies”) from and against any and all liability, losses, damages, costs, and expenses (“Indemnified Losses”) incurred in connection with any claim or lawsuit brought by a third party (a “Claim”) to the extent arising out of or resulting from (i) Company’s use of the Study Data or results of the Study; (ii) Company’s negligence in connection with a Study or this Agreement; (iii) any bodily injury, including death, to a Study subject directly caused by the Study Drug used as required by the Protocol; and (iv) defects in the Study Drug. The completion or termination of a Study shall not affect Company’s obligation to indemnify with respect to any claim or suit based upon the aforementioned Indemnified Losses. Notwithstanding the foregoing, Company will not be responsible for any Indemnified Losses to the extent that they arise from the negligence, intentional misconduct, or malpractice of the MD Anderson Indemnified Parties or the failure of any of the MD Anderson Indemnified Parties to adhere to the material terms of this Agreement, the Protocol (other than permitted deviations for health and safety reasons) or any written instructions by Company or its designee or to comply with any applicable laws, regulations and guidelines it being understood that the proper administration of the Study Drug in accordance with the Protocol (including permitted deviations for health and safety reasons) shall not constitute negligence, intentional misconduct, or malpractice for the purposes of this Agreement.

8.2 To the extent authorized by the constitution and laws of the State of Texas, MD Anderson, MD Anderson shall indemnify, defend and hold harmless Company and its directors, officers, staff, agents, employees, independent contractors and affiliates (collectively “Company Indemnified Party”): from and against any and all Indemnified Losses resulting from (i) any negligent or intentional act or omission of any MD Anderson Indemnified Parties, or (ii) the failure of any MD Anderson Indemnified Parties to adhere to the material terms of the Agreement, the Protocol (other than permitted deviations for health and safety reasons), any reasonable written instructions from Company or its designee or to comply with any applicable laws, regulations and guidelines. The completion or termination of a Study shall not affect MD Anderson’s obligation to indemnify with respect to any claim or suit based upon the aforementioned Indemnified Losses. Notwithstanding the foregoing, MD Anderson will not be responsible for any Indemnified Losses to the extent that they arise from the negligence, intentional misconduct, or malpractice of Company.

8.3 Subject to the statutory duties of the Texas State Attorney General, any Indemnified Party shall: (a) notify the indemnifying Party in writing as soon as is reasonably possible after receipt of notice of any and all claims, lawsuits, and demands, or any action, suit, or proceeding giving rise to the right of indemnification; (b) permit the indemnifying Party to retain counsel to represent the named Indemnified Party; and (c) permit the indemnifying Party to retain control of any such claims, lawsuits, and demands, including the right to make any settlement, except that the indemnifying Party shall not make any settlement or take any other action which would be deemed to confess wrongdoing by any of the Indemnified Parties without the prior written consent of the applicable Indemnified Party.

9.1 This Agreement does not obligate any of the Parties to provide medical treatment, except to the extent required by applicable law, nor does this Agreement obligate either Party to provide reimbursement for medical treatment if a Study subject requires medical treatment for physical illness or injury sustained as a direct result of the treatment of such Study subject in accordance with this Agreement and the Protocol, except to the extent required by applicable law, and except to the extent such injury is in connection with an indemnifiable claim in Section 8.2.

10.1 During the term of any Study Order under this Agreement, Company shall maintain in full force and effect general liability insurance for its liabilities arising from the Study with limits of not less than $[***] per occurrence and $[***] annual aggregate. Company shall provide MD Anderson with evidence of such insurance upon written request.

10.2 MD Anderson is self-insured pursuant to The University of Texas Professional Medical Liability Benefit Plan under the authority of Chapter 59, Texas Education Code. MD Anderson has and will maintain in force during the term of this Agreement adequate insurance or financial resources to cover its obligations pursuant to this Agreement. MD Anderson will provide Company with evidence of such insurance upon written request.

11.1 MD Anderson and/or Principal Investigator shall have the [***] right to publish or publicly disclose, either in writing or orally, the Data and results of the Study/ies and shall use reasonable efforts to submit the results of each Study for publication within [***] months after completion of such Study, subject to Company’s prior review of any such publications as set forth in Section 11.2. If MD Anderson has not published Study results by [***] months from the completion of a Study, Company shall also have the right to publish or publicly disclose, either in writing or orally, the Data and results of the particular Study. Each Party’s publications will be developed in accordance with accepted scientific practice and its respective internal policies and practices.

11.2 MD Anderson or Principal Investigator, as applicable, shall provide Company with a copy of any such proposed publication at least [***] days prior to submission for publication (including abstracts) or presentation. Within such [***] day period, Company shall review such proposed publication for any Confidential Information of Company or patentable Data. MD Anderson and/or Principal Investigator shall remove Confidential Information of Company that has been so identified (other than Study Data), provided that Company agrees to act in good faith when requiring the deletion of Company Confidential Information such that the deletion of such Company Confidential Information will not have a significant impact upon MD Anderson’s or Principal Investigator’s right to publish pursuant to general biomedical industry standards for manuscript submissions. If, during the review period, Company requests a delay of the publication to allow patent applications to be filed on any Inventions disclosed or contained in the disclosures, then MD Anderson will defer any such publication for an additional period of [***] days in order to permit the filing of a patent application.

11.3 MD Anderson and/or Principal Investigator shall give Company acknowledgment for its sponsorship of a Study in all applicable Study publications. Authorship and acknowledgements for Study publications shall be determined by MD Anderson in accordance with applicable customary scientific standards.

11.4 The “sponsor” of a Study, within the regulatory meaning of such term, shall register the Study if required by, and in accordance with, Section 801 of the Food and Drug Administration Amendments Act of 2007 on www.clinicaltrials.gov and on any other database required by laws or regulations in accordance with applicable standards regarding scope, form and content and in accordance with ICMJE guidelines such that the Study will be eligible for publication in those publications.

12.1 Except as expressly set forth in this Agreement, each Party agrees that it will not at any time during the term of this Agreement or following termination of this Agreement use any name of the other Party or any other names, insignia, mark(s), symbol(s), or logotypes associated with the other Party or any variant or variants thereof.

12.2 Except as expressly set forth in this Agreement, to the extent required by law or regulation, or to the extent necessary for MD Anderson for the recruitment of subjects to any Study hereunder, the Parties agree to make no public presentations about any Study Drug or any Study conducted under this Agreement, and to issue no news releases about any Study Drug or any Study. Any advertisements directed at recruitment of study subjects for a Study must comply with all applicable laws, rules, regulations (including the need for IRB review), and the confidentiality obligations herein, and shall not include the trademarked insignia, symbol(s), or logotypes, or any variant or variants thereof, of the other Party. Except as required by law or for regulatory purposes, neither Party will use the name (including trademark or other identifier) of the other Party or such other Party’s employee or staff member (except in an acknowledgment of sponsorship) in publications, advertising, press releases, or for any other commercial purpose without the written approval of the other Party. Company will not state or imply in any publication, advertisement, or other medium that any product or service bearing any of Company’s names or trademarks and/or manufactured, sold, or distributed by Company has been tested, approved, or endorsed by MD Anderson. Notwithstanding any other provision of this Agreement, MD Anderson and its researchers and employees will have the right, without Company’s approval, to acknowledge Company and Company’s involvement with a Study in scientific or academic publications and communications describing the Study or reporting the results of the Study if required by applicable law.

12.3 Either Party may use the name of the other Party in any document filed with any governmental authority or regulatory agency applicable to a Study, and to comply with any applicable legal or regulatory requirements. Further, each Party is permitted to disclose the other Party’s name, the title of the Study, the name of the Principal Investigator, and an overall Study budget amount projected to be paid/actual total amount paid for conducting the Study, provided that this information is presented together as part of mandatory disclosure in accordance with and to the extent required applicable law.

12.4. Notwithstanding anything to the contrary, Company shall be permitted to issue a joint press release in connection with this Agreement at a mutually agreed upon time and in the format agreed to in writing by the Parties, as attached hereto as Exhibit III (any deviations from Exhibit III shall require the prior written approval of each Party). For MD Anderson, such review shall include prior written approval by MD Anderson’s public relations team. Each Party may disclose the existence and terms of this Agreement, or information relating to a Study, to the extent required by applicable law, regulations or guidelines, including the rules of any stock exchange or quotation system on which such Party’s securities are listed.

13.1 If a designated Principal Investigator is terminated from a Study, or in the event of the death or other non-availability of the Principal Investigator, MD Anderson shall use reasonable efforts to designate a duly qualified person to act as new Principal Investigator, subject to the reasonable agreement of Company. If the Parties are unable to agree on a new Principal Investigator or if the new Principal Investigator is unwilling to agree to the terms and conditions of this Agreement and the relevant Study Order, either Party shall be entitled to terminate the respective Study Order in accordance with Section 7.5.

14.1 Warranties. Except as expressly provided herein, neither Party makes ANY WARRANTIES, EXPRESS OR IMPLIED, CONCERNING THE DATA OR RESULTS OF ANY STUDY OR THE STUDY DRUG, OR OF THE MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF SUCH DATA, RESULTS OR STUDY DRUG. EXCEPT FOR DAMAGES ARISING FROM A BREACH OF CONFIDENTIALITY OBLIGATIONS HEREUNDER,

NEITHER PARTY SHALL BE LIABLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES SUFFERED BY THE OTHER PARTY AS A RESULT OF PERFORMANCE OF ANY STUDY UNDER THIS AGREEMENT. Notwithstanding the foregoing, Company represents and warrants that each Study Drug hereunder shall have been manufactured in accordance with applicable current Good Manufacturing Practices in the United States and that it has not received any written claim that use of any Study Drug in the performance of a Study would infringe the intellectual property rights of any third party. COMPANY REPRESENTS THAT THERE ARE NO KNOWN MANUFACTURING DEFECTS. MD Anderson represents and warrants and Company acknowledges that the development and dissemination of scientific knowledge is a fundamental component of MD Anderson’s mission, and that MD Anderson makes no representations, warranties, or guarantees with respect to any specific results of the Studies.

14.2 Assignment. This Agreement and/or any Study Order may not be assigned by either Party without the prior written consent of the other Party, except that Company may assign this Agreement and/or any Study Order without consent to an affiliate or to a third party in connection with a merger, sale or other similar transaction. This Agreement and any Study Order inures to the benefit and is binding upon the successors and permitted assigns of the parties. Any assignment or attempt to assign, or any delegation or attempt to delegate, not in accordance with this Section shall be void and without effect.

14.3 Independent Contractors. MD Anderson and Company shall be independent parties and nothing contained in this Agreement shall be construed or implied to create an agency or partnership. No Party shall have the authority to agree to or incur expenses on behalf of another except as may be expressly authorized by this Agreement or a Study Order.

14.4 Notices. Any notice or communication required or permitted to be given or made under this Agreement by one of the Parties hereto to the other shall be in writing and shall be deemed to have been sufficiently given or made for all purposes on the date of mailing by certified mail, postage prepaid, overnight courier service, and/or fax to be followed by mailed original addressed to such other Party at its respective address as referenced in the Study Order.

14.5 Severability. If any one or more of the provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby.

14.6 Entirety. This Agreement represents the entire agreement of the Parties with respect to the subject matter hereof and it expressly supersedes all previous written and oral communications between the Parties. No amendment, alteration, or modification of this Agreement or any Study Orders attached hereto shall be valid unless executed in writing by authorized signatories of all Parties.

14.7 Waiver. The failure of any Party hereto to insist upon strict performance of any provision of this Agreement or to exercise any right hereunder will not constitute a waiver of that provision or right.

14.8 Force Majeure. In the event that performance of the obligations of a Party hereunder are prevented by events beyond their reasonable control, including, but not limited to, acts of God, regulations or acts of any governmental authority, war, civil commotion, strikes, or other labor disturbances, epidemics, fire, earthquakes, storms or other catastrophes of a similar nature, the affected Party will promptly notify the other Party of such event using the procedure defined herein, and the Parties shall be relieved of their respective obligations hereunder to the extent that the performance of such obligations is actually prevented thereby. During the existence of any such condition, the affected Party shall, nevertheless, use its best efforts to remove the cause thereof and resume performance of its obligations hereunder. The period of performance shall be extended for the Party who is unable to perform due to Force Majeure reasons by a

period of time equal to the length of the period during which the Force Majeure reason exists or for a longer period if required to meet the requirements of the Study Protocol.

14.9 Counterparts. It is understood that this Agreement may be executed in one or more counterpart copies, each of equal dignity, which when joined, shall together constitute one Agreement. In the event of execution by exchange of facsimile or electronic signed copies, the Parties agree that, upon being signed by both Parties, this Agreement shall become effective and binding and that facsimile or .pdf signed copies will constitute evidence of this Agreement.

14.10 Export Control. Notwithstanding any other provision of this Agreement, it is understood that the Parties are subject to, and shall comply with, applicable United States laws, regulations, and governmental requirements and restrictions controlling the export of technology, technical data, computer software, laboratory prototypes, and other commodities, information and items (individually and collectively, “Technology and Items”), including without limitation, the Arms Export Control Act, the Export Administration Act of 1979, relevant executive orders, and United States Treasury Department embargo and sanctions regulations, all as amended from time to time (“Restrictions”) and that the Parties’ obligations hereunder are contingent on compliance with applicable Restrictions.

14.11 Notice of State Agency. MD Anderson is an agency of the State of Texas and under the constitution and the laws of the State of Texas possesses certain rights and privileges, is subject to certain limitations and restrictions, and only has such authority as is granted to it under the constitution and laws of the State of Texas. Notwithstanding any provision hereof, nothing in this Agreement is intended to be, nor will it be construed to be, a waiver of the sovereign immunity of the State of Texas or a prospective waiver or restriction of any of the rights, remedies, claims, and privileges of the State of Texas. Moreover, notwithstanding the generality or specificity of any provision hereof, the provisions of this Agreement as they pertain to MD Anderson are enforceable only to the extent authorized by the constitution and laws of the State of Texas; accordingly, to the extent any provision hereof conflicts with the constitution or laws of the State of Texas or exceeds the right, power or authority of MD Anderson to agree to such provision, then that provision will not be enforceable against MD Anderson or the State of Texas.

In witness whereof, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives to be effective as of the Effective Date.

This Study Order (“Study Order”), effective as of the ___ day of ___ 202_ (“Effective Date”), is entered into by and between The University of Texas M. D. Anderson Cancer Center, with a place of business located at 1515 Holcombe Blvd., Houston, TX 77030, USA (“MD Anderson”), a member institution of The University of Texas System (“System”) and Turning Point Therapeutics, Inc. with a place of business located at 10628 Science Center Drive, Suite 200, San Diego, CA 92121 (“Company”). (MD Anderson and Company each a “Party” and collectively the “Parties”). This Study Order is a part of, and is subject to, the terms and conditions of the Strategic Collaboration Agreement entered into between MD Anderson and Company dated ___ 2022 (“Agreement”).

to workscope (if pre-clinical) or IRB approved Protocol No. [Insert Protocol number] which may be attached hereto in Appendix 1 to this Study Order and is incorporated herein.

2. _______ is the Principal Investigator (as defined in the Agreement) for the Study which will be conducted at MD Anderson.

4. The parties may further exchange the following Proprietary Materials (other than Study Drug) with each other in connection with the Study:

[if applicable, INSERT Material transfer terms and restrictions depending on nature of Proprietary Materials]

5. Term: This Study Order will continue until the Study is completed, which is expected to be ________ (__) months after the Effective Date, or until terminated early as provided in the Agreement.

Any notice or other formal communication related to this Agreement must be in writing and will be deemed given only if: (a) delivered in person; or (b) sent by internationally recognized overnight delivery service or air courier guaranteeing next day delivery. Until a change of address is communicated, as provided below, all notices and other communications must be sent to the Parties at the following addresses or facsimile numbers:

All notices will be effective and will be deemed delivered: (a) if by personal delivery, delivery service or courier, on the date of delivery; and (b) if by electronic facsimile communication, on the date of transmission of the communication. Either Party may change its notice address by sending notice of the change to the other Party in the manner set forth above.

In witness whereof, the Parties hereto have caused this Study Order to be executed by their duly authorized representatives to be effective as of the Effective Date.

I confirm that I have received a copy of the Agreement under which this Study Order is issued, and that I have read and understand the Agreement and this Study Order.

Note: Study Drug that is shipped to MD Anderson and not labeled as described above will be deemed unacceptable for use and will be destroyed or returned to Company at its cost.

Company shall ensure that Re-test and/or expiration dating information shall be provided to MD Anderson with each lot of Study Drug. Study Drug may be quarantined by MD Anderson until such information is provided.

MD Anderson and Turning Point Therapeutics announce strategic alliance to advance precision cancer therapies

HOUSTON and SAN DIEGO ― The University of Texas MD Anderson Cancer Center and Turning Point Therapeutics, Inc., today announced a strategic research and development alliance to expand the evaluation of two of Turning Point's investigational small molecules focusing on precision medicine targets well known in oncology.

The initial focus of the alliance will be Turning Point’s lead drug candidate, repotrectinib, a next-generation kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors that is currently being studied in a registrational Phase 1/2 study (TRIDENT-1). Alliance studies also will include elzovantinib (TPX-0022), a kinase inhibitor targeting MET, CSF1R and SRC, which is currently being studied in a Phase 1 trial of patients with advanced solid tumors harboring genetic alterations in MET (SHIELD-1).

The planned focus of the alliance will include monotherapy and potential combinations with other agents – including chemotherapy, immunotherapies and other targeted agents.

"This agreement embodies our commitment to further advancing our innovative macrocyclic programs and complementing our development efforts through collaborative alliances with those who share our vision for breakthrough science," said Homa Yeganegi, senior vice president and global product development lead at Turning Point Therapeutics. "We look forward to working with MD Anderson to strengthen our scientific and clinical understanding of our multi-targeted compounds in several tumor types with the goal of speeding delivery of new cancer treatments to patients."

The alliance brings together MD Anderson's clinical trial infrastructure and expertise with Turning Point's differentiated targeted oncology pipeline. Under the terms of the alliance’s agreement, which spans a five-year period, collaborative preclinical and clinical studies will be conducted in several solid tumors, including non-small cell lung cancers, gastrointestinal malignancies and endocrine cancers.

“There is a major unmet need to develop effective next-generation targeted therapies for cancer patients with oncogene-driven solid tumors, particularly those with mutations that render them resistant to our current therapies,” said John V. Heymach, M.D., Ph.D., chair of Thoracic/Head & Neck Medical Oncology at MD Anderson. "Our alliance with Turning Point represents an important opportunity to work toward advancing new treatment options for patients using novel inhibitors that target multiple driver mutations with the most characterized resistance patterns in common cancers."

The collaborative studies will be overseen by a joint steering committee. Turning Point will provide funding, study materials and other ongoing support throughout the term of the alliance.

TURNING POINT THERAPEUTICS AND MD ANDERSON announce STRATEGIC ALLIANCE TO ADVANCE PRECISION CANCER THERAPIES

HOUSTON and SAN DIEGO, June [XX], 2022 – Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, and The University of Texas MD Anderson Cancer Center today announced a strategic research and development alliance to expand the evaluation of two of Turning Point's investigational small molecules focusing on precision medicine targets well known in oncology.

The planned focus of the alliance will include monotherapy and potential combinations with other agents – including chemotherapy, immunotherapies and other targeted agents.

"This agreement embodies our commitment to further advancing our innovative macrocyclic programs and complementing our development efforts through collaborative alliances with those who share our vision for breakthrough science," said Homa Yeganegi, Senior Vice President and Global Product Development Lead at Turning Point Therapeutics. "We look forward to working with MD Anderson to strengthen our scientific and clinical understanding of our multi-targeted compounds in several tumor types with the goal of speeding delivery of new cancer treatments to patients."

“There is a major unmet need to develop effective next-generation targeted therapies for cancer patients with oncogene-driven solid tumors, particularly those with mutations that render them resistant to our current therapies,” said John V. Heymach, M.D., Ph.D., Chair of Thoracic/Head & Neck Medical Oncology at MD Anderson. "Our alliance with Turning Point represents an important opportunity to work toward advancing new treatment options for patients using novel inhibitors that target multiple driver mutations with the most characterized resistance patterns in common cancers."

The collaborative studies will be overseen by a joint steering committee. Turning Point will provide funding, study materials and other ongoing support throughout the term of the alliance.

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 52 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is No. 1 for cancer in U.S. News & World Report’s “Best Hospitals” rankings. It has been named one of the nation’s top two hospitals for cancer since the rankings began in 1990. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors.

Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes elzovantinib, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer; and TPX-4589 (LM-302), a novel ADC targeting Claudin18.2 which is being studied in a Phase 1 study in gastrointestinal cancers. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “plans,” “will,” “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding, among other things, Turning Point Therapeutics’ ability to advance its macrocyclic programs and speed delivery of new cancer treatments to patients. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point Therapeutics’ business and the other risks described in Turning Point Therapeutics’ filings with the Securities and Exchange Commission (SEC), including its quarterly report on Form 10-Q filed with the SEC on May 10, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

This Amendment No. 1 to Executive Employment Agreement (“Amendment”) between Turning Point Therapeutics, Inc. with its principal place of business at 10628 Science Center Drive, Suite 200, San Diego, CA 92121 (“Turning Point”) and Mohammad Hirmand, M.D. (“Executive”) is entered into between Turning Point and Executive effective as of May 20, 2022 (the “Amendment Effective Date”).

Whereas, Turning Point and Executive are parties to an agreement entitled Executive Employment Agreement having an effective date of October 30, 2019 (the “Agreement”); and

Whereas, Turning Point and Executive desire to amend the Agreement as described in this Amendment. Capitalized terms not defined in this Amendment shall have the meaning ascribed such terms in the Agreement.

Now, Therefore, Turning Point and Executive agree to amend the Agreement as follows:

“Duties and Location. Executive shall perform such duties as are customarily associated with the position of Executive Vice President and Chief Medical Officer and such other duties as are assigned to Executive by the CEO. Executive’s primary office location shall be the Company’s headquarters located in San Diego, California; provided that Executive shall be permitted to work remotely so long as (a) such arrangement does not materially interfere with Executive’s performance of Executive’s duties and responsibilities hereunder and (b) Executive will travel to and work from the Company’s headquarters from time to time as mutually agreed by the parties. Subject to the terms of this Agreement, the Company reserves the right to reasonably require Executive to perform Executive’s duties at places other than Executive’s primary office location from time to time and to require reasonable business travel.”

In Witness Whereof, the parties hereto have executed this Amendment by their respective duly authorized signatories below to take effect on and as of the Amendment Effective Date.

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

In connection with the Quarterly Report of Turning Point Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

This certification accompanies the Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.

(1) The Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Delaware	46-3826166
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
10628 Science Center Drive, Ste. 200 San Diego, California	92121
(Address of principal executive offices)	(Zip Code)


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value per share	TPTX	The Nasdaq Stock Market LLC


		Page
PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements (unaudited)	3
	Condensed Balance Sheets	3
	Condensed Statements of Operations and Comprehensive Loss	4
	Condensed Statements of Stockholders’ Equity	5
	Condensed Statements of Cash Flows	6
	Notes to Unaudited Condensed Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	30
Item 4.	Controls and Procedures	30
PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	30
Item 1A.	Risk Factors	31
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	79
Item 3.	Defaults Upon Senior Securities	79
Item 4.	Mine Safety Disclosures	79
Item 5.	Other Information	79
Item 6.	Exhibits	80
SIGNATURES		81


	June 30,			December 31,
	2022			2021
Assets	Unaudited
Current assets:
Cash and cash equivalents	$	290,147		$	427,879
Marketable securities		528,139			553,703
Prepaid and other current assets		13,381			10,880
Total current assets		831,667			992,462
Property and equipment, net		5,046			3,822
Right-of-use lease assets		4,583			5,158
Other assets		2,039			2,021
Total assets	$	843,335		$	1,003,463
Liabilities and stockholders' equity
Liabilities:
Current liabilities:
Accounts payable	$	7,934		$	5,656
Accrued expenses and other current liabilities		25,568			25,300
Accrued compensation		11,874			12,503
Current portion of operating lease liabilities		4,047			3,630
Total current liabilities		49,423			47,089
Operating lease liabilities, long-term		890			1,949
Commitments and contingencies (Note 8)
Stockholders' equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at June 30, 2022 and December 31, 2021, zero shares outstanding at June 30, 2022 and December 31, 2021		—			—
Common stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 49,885,036 and 49,582,638 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively		5			5
Additional paid-in capital		1,514,191			1,472,421
Accumulated other comprehensive loss		(6,914	)		(1,274	)
Accumulated deficit		(714,260	)		(516,727	)
Total stockholders' equity		793,022			954,425
Total liabilities and stockholders’ equity	$	843,335		$	1,003,463


	Three Months Ended June 30,						Six Months Ended June 30,
	2022			2021			2022			2021
Revenue	$	119		$	5,164		$	548		$	30,369
Operating expenses:
Research and development		86,788			44,650			141,838			85,913
General and administrative		37,695			17,171			58,009			37,162
Total operating expenses		124,483			61,821			199,847			123,075
Loss from operations		(124,364	)		(56,657	)		(199,299	)		(92,706	)
Other income, net		1,276			384			1,766			929
Net loss		(123,088	)		(56,273	)		(197,533	)		(91,777	)
Unrealized loss on marketable securities, net of tax		(1,522	)		(22	)		(5,640	)		(208	)
Comprehensive loss	$	(124,610	)	$	(56,295	)	$	(203,173	)	$	(91,985	)
Net loss per share, basic and diluted	$	(2.48	)	$	(1.14	)	$	(3.98	)	$	(1.87	)
Weighted-average common shares outstanding, basic and diluted		49,702,860			49,204,425			49,657,426			49,063,298


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


	Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Capital		Income (Loss)			Deficit			Equity
Balance at December 31, 2021		49,582,638	$	5	$	1,472,421	$	(1,274	)	$	(516,727	)	$	954,425
Issuance of common stock under equity incentive plans		81,835		—		396		—			—			396
Stock-based compensation expense		—		—		15,089		—			—			15,089
Net loss		—		—		—		—			(74,445	)		(74,445	)
Other comprehensive loss		—		—		—		(4,118	)		—			(4,118	)
Balance at March 31, 2022		49,664,473		5		1,487,906		(5,392	)		(591,172	)		891,347
Issuance of common stock under equity incentive plans		187,644		—		7,863		—			—			7,863
Issuance of common stock under employee stock purchase plan		32,919		—		1,111		—			—			1,111
Stock-based compensation expense		—		—		17,311		—			—			17,311
Net loss		—		—		—		—			(123,088	)		(123,088	)
Other comprehensive loss		—		—		—		(1,522	)		—			(1,522	)
Balance at June 30, 2022		49,885,036	$	5	$	1,514,191	$	(6,914	)	$	(714,260	)	$	793,022


Exhibit Number		Description
2.1+	Agreement and Plan of Merger, dated as of June 2, 2022, by and among the Registrant, Bristol-Myers Squibb Company and Rhumba Merger Sub Inc. (incorporated by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K (File No. 001-38871), filed with the SEC on June 3, 2022).

3.1	Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-38871), filed with the SEC on April 22, 2019).

3.2	Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-38871), filed with the SEC on April 22, 2019).

4.1	Form of Common Stock Certificate of the Registrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-230428), filed with the SEC on April 8, 2019).

10.1*	License Agreement, dated May 4, 2022, by and between the Registrant and LaNova Medicines Limited.

10.2*	Strategic Collaboration Agreement, dated June 23, 2022, by and between the Registrant and The University of Texas M.D. Anderson Cancer Center.

10.3†	Amendment No. 1 to Executive Employment Agreement, effective as of May 20, 2022, by and between the Registrant and Mohammad Hirmand, M.D.

31.1	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2	Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**	Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2**	Certification of Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS	XBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH	Inline XBRL Taxonomy Extension Schema Document
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document
104	Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101

+	Schedules omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule to the SEC upon request.

†	Indicates management contract or compensatory plan.

*	Certain portions of this exhibit (indicated by “[***]”) have been omitted as the Registrant has determined the omitted information is not material and is the type that the Registrant treats as private or confidential.

**	This certification shall not be deemed filed for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.


	TURNING POINT THERAPEUTICS, INC.

Date: August 8, 2022	By:	/s/ Athena Countouriotis
		Athena Countouriotis, M.D.
		President & Chief Executive Officer (Principal Executive Officer)

Date: August 8, 2022	By:	/s/ Paolo Tombesi
		Paolo Tombesi
		Executive Vice President & Chief Financial Officer (Principal Financial Officer)


Development Milestone Events	Development Milestone Payments (USD, millions)
1. [***]	$[***]


Development Milestone Events	Development Milestone Payments (USD, millions)
2. [***]	$[***]
3. [***]	$[***]
4. [***]	$[***]
5. [***]	$[***]
6. [***]	$[***]
7. [***]	$[***]
8. [***]	$[***]
9. [***]	$[***]
10. [***]	$[***]
11. [***]	$[***]


Development Milestone Events	Development Milestone Payments (USD, millions)
[***]
12. [***]	$[***]
13. [***]	$[***]
14. [***]	$[***]
15. [***]	$[***]
16. [***]	$[***]
17. [***]	$[***]
18. [***]	$[***]
19. [***]	$[***]
20. [***]	$[***]


Development Milestone Events	Development Milestone Payments (USD, millions)
21. [***]	$[***]
22. [***]	$[***]
23. [***]	$[***]
24. [***]	$[***]
Total Development Milestone Payments	$[***]


Annual Net Sales Milestone Events based upon Annual Net Sales of the Product in the TPTX Territory	Annual Net Sales Milestone Payments (U.S. Dollars)
Annual Net Sales equal to or greater than [***]	$[***]
Annual Net Sales equal to or greater than [***]	$[***]
Annual Net Sales equal to or greater than [***]	$[***]
Annual Net Sales equal to or greater than [***]	$[***]
Annual Net Sales equal to or greater than [***]	$[***]
Annual Net Sales equal to or greater than [***]	$[***]
Annual Net Sales equal to or greater than [***]	$[***]


Royalty rate based on portion of Annual Net Sales of the Product	Royalty Payments
Annual Net Sales less than or equal to [***]	[***]%
Annual Net Sales greater than [***]	[***]%
Annual Net Sales greater than [***]	[***]%
Annual Net Sales greater than [***]	[***]%
Annual Net Sales greater than [***]	[***]%
Annual Net Sales greater than [***]	[***]%
Annual Net Sales greater than [***]	[***]%


Address:	F5, Building 1, No. 999 Cailun Road, Pudong District, Shanghai, China
Attn:	LaNova Medicines Limited: [***]
Email:	[***]


Address:	10628 Science Center Drive Suite 200 San Diego, CA 92121, USA
Attn:	President & Chief Executive Officer
Email:	[***]


LaNova Medicines Limited	Turning Point Therapeutics, Inc.
By: /s/ Crystal Qin	By: /s/ Athena Countouriotis
Name: Crystal Qin	Name: Athena Countouriotis
Title: CEO	Title: President & Chief Executive Officer
Date: May 4, 2022	Date: May 4, 2022


The University of Texas M. D. Anderson Cancer Center		Turning Point Therapeutics, Inc.
Date: 6/23/2022		Date: 6/23/2022
/s/ Chris McKee		/s/ Athena Countouriotis
Name: Chris McKee Title: SrVP, Strategy & Business Dev.		Name: Athena Countouriotis, M.D. Title: President and CEO


The University of Texas M. D. Anderson Cancer Center	Turning Point Therapeutics, Inc.
Date: ______________________________	Date: ___________________________
___________________________________ Name	_________________________________ Name
Function:	Function:


Contact: Clayton Boldt, Ph.D.	Office: 713-792-9518	CRBoldt@MDAnderson.org
Contact: Adam D. Levy, Ph.D.	Office: 858-867-6366	IR@TPTherapeutics.com