As filed with the Securities and Exchange Commission on July 9, 2025.

Registration No. 333-288222

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

_________________________________________

TO
FORM S-4
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

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HELIX ACQUISITION CORP. II*
(Exact name of registrant as specified in its charter)

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For Co-Registrants, see “Table of Co-Registrants” on the following page.

Helix Acquisition Corp. II
200 Clarendon Street, 52nd Floor
Boston, MA 02116
Telephone: (857) 702-0370
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

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Maples Fiduciary Services (Delaware) Inc.
4001 Kennett Pike, Suite 302
Wilmington, Delaware 19807
+1 (302)-338-9130
(Name, address, including zip code, and telephone number, including area code, of agent for service)

_________________________________________

Copies to:

_________________________________________

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective and all other conditions to the transactions contemplated by the Business Combination Agreement described in the included proxy statement/prospectus have been satisfied or waived.

If the securities being registered on this form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box. ☐

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting 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 7(a)(2)(B) of the Securities Act. ☐

If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:

____________

*           Prior to the consummation of the Business Combination described herein, the Registrant intends to effect a deregistration under Section 206 of the Companies Act (As Revised) of the Cayman Islands and a domestication under Section 388 of the Delaware General Corporation Law, pursuant to which the Registrant’s jurisdiction of incorporation will be changed from the Cayman Islands to the State of Delaware. All securities being registered will be issued by Helix Acquisition Corp. II (after its domestication as a corporation incorporated in the State of Delaware), the continuing entity following the Domestication, which will be renamed “BridgeBio Oncology Therapeutics, Inc.”

The Registrant and Co-Registrant hereby amend this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant and Co-Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the SEC, acting pursuant to said Section 8(a), may determine.

TABLE OF CO-REGISTRANTS

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(1)      The Co-Registrant has the following principal executive office:

TheRas, Inc.
256 E. Grand Avenue, Suite 104
South San Francisco, CA 94080
Telephone: (650) 405-4770

(2)      The agent for service for the Co-Registrant is:

Aaron Chan
TheRas, Inc.
256 E. Grand Avenue, Suite 104
South San Francisco, CA 94080
Telephone: (650) 405-4770

The information in this preliminary proxy statement/prospectus is not complete and may be changed. These securities may not be issued until the registration statement filed with the U.S. Securities and Exchange Commission is effective. This preliminary proxy statement/prospectus is not an offer to sell these securities and does not constitute the solicitation of an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

“PIPE Investments”). Existing BBOT Stockholders (other than Cormorant and investors who were existing Helix Shareholders) subscribed for approximately $25 million of the PIPE Investments, existing Helix Shareholders (other than Cormorant and investors who were existing BBOT Stockholders) subscribed for approximately $85 million of the PIPE Investments, investors who were both existing shareholders of Helix and BBOT (other than Cormorant) subscribed for approximately $22.9 million of the PIPE Investments, Cormorant subscribed for an aggregate of $75 million of PIPE Investments, and investors who were neither existing BBOT Stockholders nor existing Helix Shareholders subscribed for $53 million of the PIPE Investments. The obligations of the PIPE Investors to consummate the PIPE Investments are conditioned upon, among other things: (i) the PubCo Common Stock, including the PIPE Shares, having been approved for listing on Nasdaq, subject only to official notice of issuance; (ii) the satisfaction or waiver of the conditions to closing set forth in Article IX of the Business Combination Agreement; (iii) the Business Combination Agreement not having been amended, modified or supplemented, and no condition having been waived in any manner that would materially adversely affect the economic benefits the PIPE Investors reasonably expect to receive under the Subscription Agreements; (iv) no subscription agreement, side letter, or other agreement or understanding with any other PIPE Investor having been amended, modified, or waived in any manner that benefits such other PIPE Investor unless each PIPE Investor has been offered the same benefits; (v) Helix having received not less than $200 million in cash from the PIPE Investments; and (vi) no BBOT Material Adverse Effect or Helix Material Adverse Effect (each as defined and further described in the section entitled “The Business Combination — Representations and Warranties”) having occurred. Conditions (i) and (ii) above are for the benefit of all parties to the Subscription Agreements and subject to waiver by all parties to the Subscription Agreements, and conditions (iii) through (vi) above are for the benefit of and subject to waiver by each PIPE Investor individually. For more information, see “Proposal No. 1 — The Business Combination Proposal — Ancillary Agreements — Subscription Agreements.”

In connection with entering into the Business Combination Agreement, on February 28, 2025, Helix entered into non-redemption agreements with certain shareholders (the “Non-Redemption Agreements” and such shareholders, the “Non-Redeeming Shareholders”), pursuant to which, among other things, the Non-Redeeming Shareholders irrevocably and unconditionally agreed, for the benefit of Helix, that neither they nor their controlled affiliates will exercise any redemption rights under the Helix Articles with respect to the 450,900 Helix Class A Shares collectively held by the Non-Redeeming Shareholders as of the date of the Non-Redemption Agreement (the “NRA Shares”) at any meeting of the Helix Shareholders. Assuming a Redemption Price of approximately $10.72, which is estimated using an assumed Closing Date of July 31, 2025, the NRA Shares will represent approximately $4.8 million in retained funds in the Trust Account. The Sponsor and Cormorant are not parties to the Non-Redemption Agreements. Each of the Non-Redeeming Shareholders also agreed (i) not to transfer directly or indirectly the NRA Shares held by it until earlier of (x) the Closing Date, (y) the termination of the Business Combination Agreement in accordance with its terms and (z) the termination of the Non-Redemption Agreement in accordance with its terms; and (ii) to vote its NRA Shares in favor of the Business Combination Agreement, the Domestication and Merger and each other proposal brought by the Helix in connection with the Business Combination and in favor of any proposal brought by Helix to adjourn or postpone the EGM. The Non-Redemption Agreements do not provide for any consideration to be paid by Helix or BBOT to the Non-Redeeming Shareholders in connection with such agreements. For more information, see “Proposal No. 1 — The Business Combination Proposal — Ancillary Agreements — Non-Redemption Agreements.”

In connection with the execution of the Business Combination Agreement, on February 28, 2025, the Sponsor, certain directors and officers of Helix, certain investment vehicles managed by Cormorant Asset Management, LP (“Cormorant”), each holding Helix Class A Shares, and the independent directors and an advisor of Helix each holding Class B Shares (collectively with the Sponsor and Cormorant, the “Helix Insiders”) entered into a support agreement with Helix and BBOT (the “Helix Support Agreement”), pursuant to which the Helix Insiders agreed (i) to vote, at any meeting of the shareholders of Helix, and in any action by written consent of the shareholders of Helix, all of such Helix Insiders’ Helix Class A Shares and Helix Class B Shares in favor of the Business Combination Agreement and each other proposal presented by Helix in this proxy statement/prospectus, and against certain competing proposals or competing transactions, and in favor of any proposal sought by Helix to extend the deadline by which Helix must consummate its initial business combination, (ii) to certain non-solicitation limitations with respect to certain competing transactions, (iii) to irrevocably waive, to the fullest extent permitted by law and the Helix Articles, the anti-dilution provisions of the Helix Articles that would have Helix Class B Shares convert to Helix Class A Shares at a ratio of greater than one-for-one, and (iv) to refrain from selling, assigning or transferring any Helix Ordinary Shares except to certain permitted transferees, until the earliest of (A) the Merger Effective Time, (B) such date and time as the Business Combination Agreement is terminated in accordance with its terms, (C) the liquidation of Helix, (D) the written agreement of each of the terminating Helix Insiders, Helix and BBOT with respect to terminating the rights and

obligations under the Helix Support Agreement of a specific Helix Insider or a subset of Helix Insiders and (E) the written agreement of all Helix Insiders, Helix and BBOT to terminate the Helix Support Agreement in its entirety. Pursuant to the Helix Support Agreement, each of Cormorant and its permitted transferees irrevocably and unconditionally agreed not to submit any Helix Class A Shares owned by it for redemption in connection with the Business Combination, and the Sponsor and Helix Insiders agreed to comply with their non-redemption obligations as specified in the letter agreement they entered into with Helix in connection with Helix’s initial public offering. Additionally, Sponsor agreed (x) to forfeit to Helix the Sponsor Forfeited Shares and (y) if the Minimum Cash Condition is not met, and provided that Helix has used good faith efforts to meet the Minimum Cash Condition then, effective as of and subject to the Closing, to surrender and forfeit a number of shares of PubCo Common Stock equal to (A) 3,360,000 multiplied by (B) one minus the number resulting from dividing (a) the actual Helix Closing Cash by (b) $400 million (such shares, the “Sponsor Contributed Shares”). No consideration has been or will be paid by Helix or BBOT to the Helix Insiders in connection with such agreements. For more information, see “Proposal No. 1 — The Business Combination Proposal — Ancillary Agreements — Helix Support Agreement.”

Concurrently with and immediately prior to the signing of the Business Combination Agreement, BBOT obtained and delivered to Helix the written consent of a sufficient number of shares of BBOT Common Stock required to approve the Business Combination Agreement, each ancillary agreement to which BBOT is a party, and the Business Combination (the “BBOT Written Consent”).

Additionally, concurrently with and immediately prior to the signing of the Business Combination Agreement, Helix, BBOT, and certain stockholders of BBOT (the “BBOT Supporting Stockholders”), including affiliates of Cormorant, entered into a support agreement (the “BBOT Support Agreement”). Pursuant to the BBOT Support Agreement, each BBOT Supporting Stockholder (A) agreed that each existing investor rights agreement of BBOT will automatically terminate upon the Closing, (B) agreed to refrain from making any proposal or offer that would constitute a competing proposal that would reasonably be expected to materially impede, interfere with, delay, postpone or adversely affect the Merger and (C) waived and agreed not to exercise any rights of appraisal or rights to dissent it may have in connection with the Merger. The BBOT Support Agreement also prohibits the BBOT Supporting Stockholders from, among other things, selling, assigning or transferring any capital stock of BBOT held by the BBOT Supporting Stockholders except to certain permitted transferees, until the earliest of (a) the Merger Effective Time, (b) such date and time as the Business Combination Agreement is terminated in accordance with its terms; and (c) the written agreement of all BBOT Supporting Stockholders, Helix and BBOT to terminate the agreement in its entirety. For more information, see “Proposal No. 1 — The Business Combination Proposal — Ancillary Agreements — BBOT Support Agreement.”

In connection with the Closing, pursuant to the Business Combination Agreement, the Helix Insiders will enter into a lock-up agreement with PubCo (the “Lock-Up Agreement”), pursuant to which the Helix Insiders will agree not to transfer (except for certain permitted transfers) the shares of PubCo Common Stock held by each such person (the “Lock-Up Shares”) immediately following the Closing Date until one year after the later of (i) the filing of the Form 10 Information (as defined in Rule 144(i)(3) of the Securities Act) with the SEC and (ii) the Closing Date (the “Lock-Up Period”). The bylaws of PubCo (“PubCo Bylaws”) will also provide that all BBOT Stockholders (“Lock-Up Holders”) who receive shares of PubCo Common Stock from PubCo as consideration pursuant to the Merger, or upon the settlement or exercise of warrants, stock options, restricted stock units or other equity awards assumed, continued, or substituted by PubCo pursuant to the Business Combination Agreement (provided that the lock-up does not apply to shares acquired in the Domestication or PIPE Investment, or in the public market or pursuant to a transaction exempt from registration under the Securities Act that occurs on or after the Closing), will not be permitted to transfer such shares of PubCo Common Stock (except for certain permitted transfers) following the Closing as follows: (i) Lock-Up Holders who are employed at BBOT and held a position below the level of Vice President immediately prior to Closing (the “Employee Lock-Up Holders”) will be subject to lock-up during the period beginning on the Closing Date and ending on the day that is the six month anniversary of the Closing Date (the “Employee Lock-Up Period”) and (ii) Lock-Up Holders who are not Employee Lock-Up Holders will be subject to lock-up during the Lock-Up Period. If any lock-up obligation under the PubCo Bylaws is waived or repealed by PubCo’s Board of Directors, the PubCo Board will be required to also waive or repeal (as applicable) any lock-up obligation of each party under the Lock-Up Agreement. For more information, see “Proposal No. 1 — The Business Combination Proposal — Ancillary Agreements — Lock-Up Agreement and Provisions of PubCo Bylaws.”

Additionally, in connection with the Closing, the Helix Insiders, certain BBOT Stockholders and PubCo will enter into an amended and restated registration rights agreement (“A&R Registration Rights Agreement”), which will provide customary demand and piggyback registration rights. The PIPE Investors also have registration rights

pursuant to the terms of the Subscription Agreements. Helix estimates that approximately 63.8 million shares of PubCo Common Stock will be subject to registration rights pursuant to the A&R Registration Rights Agreement and Subscription Agreements immediately following the Closing, representing approximately 78.5% of the total issued and outstanding shares of PubCo Common Stock following the Business Combination, assuming the Minimum Cash Condition Redemptions Scenario (as defined below), the surrender and forfeiture of 307,867 Sponsor Forfeited Shares and no surrender and forfeiture of Sponsor Contributed Shares by the Sponsor, and that an aggregate of approximately $260.9 million of PIPE Investments are funded at the Closing. For more information, see “Proposal No. 1 — The Business Combination Proposal — Ancillary Agreements — A&R Registration Rights Agreement.”

BBOT is a clinical-stage biotechnology company with the mission of transforming the lives of patients with cancers driven by RAS and PI3Kα, the two most frequently mutated oncogenes. Cormorant, an affiliate of the Sponsor and Bihua Chen, Helix’s Chairwoman and Chief Executive Officer, and investor in Helix, is an investor in BBOT; there is one Cormorant designee serving on BBOT’s board of directors (the “BBOT Board”) and Cormorant has the right to have one non-voting board observer attend all meetings of the BBOT Board. In light of potential conflicts of interest with respect to the Business Combination as a result of Cormorant’s existing ownership interest in BBOT and the fact that a Cormorant designee was serving as a director of BBOT (such conflicts are described more fully in the section entitled “— Interests of the Sponsor, Cormorant, and Helix’s Officers and Directors in the Business Combination”), the Helix Board formed the Transaction Committee, comprised of two independent and disinterested members of the Helix Board, Mark McKenna and John Schmid. The Transaction Committee was empowered to, among other things, act as a disinterested body of the Helix Board as appropriate for the purpose of exploring and evaluating the Business Combination; to engage and oversee one or more financial advisors, investment banking firms and accounting firms in connection with the Business Combination as the as the Transaction Committee deemed necessary or advisable in connection with fulfilling its responsibilities and to perform such other services and deliver such opinions as the Transaction Committee in its discretion requests, including providing an opinion, all at the expense of Helix; consult with, advise, and oversee management, on behalf of the Helix Board, in connection with due diligence activities relating to BBOT, the evaluation of the Business Combination, and discussions and/or negotiations concerning potential terms and conditions of the Business Combination; engage and oversee separate legal counsel if the Transaction Committee determines it is necessary or advisable to do so; and review the Business Combination and, if the Transaction Committee determines it is advisable and in the interests of Helix and its Public Shareholders, recommend to the Helix Board that the Helix Board approve the Business Combination. The Transaction Committee engaged separate counsel, Latham & Watkins, LLP (“Latham”) to represent the Transaction Committee. The Transaction Committee also engaged Lincoln International LLC (“Lincoln”) to provide an opinion to the Transaction Committee as to the fairness, from a financial point of view, to the Helix Unaffiliated Shareholders (defined as the holders of Helix Ordinary Shares other than (i) the Sponsor, (ii) officers, directors or affiliates of Helix, (iii) holders of Helix Class A Shares who elect to redeem their shares prior to or in connection with the Business Combination, and (iv) holders of Dissenting Shares (as defined in the Business Combination Agreement) of the Aggregate Merger Consideration to be paid by Helix in the Merger pursuant to the Business Combination Agreement.

On February 27, 2025, the Transaction Committee received an opinion from Lincoln as to the fairness, from a financial point of view, to the Helix Unaffiliated Shareholders of the Aggregate Merger Consideration to be paid by Helix in the Merger pursuant to the Business Combination Agreement, a copy of which is attached hereto as Annex M. For more information, see “Proposal No. 1 — The Business Combination Proposal — Background of the Business Combination”, “Proposal No. 1 — The Business Combination Proposal — Interests of Helix’s Sponsor, Directors and Officers in the Business Combination” and “Proposal No. 1 — The Business Combination Proposal — Opinion of Lincoln International LLC.”

After careful consideration, the Helix Board, based in part upon the unanimous recommendation of the Transaction Committee, has unanimously determined that the Business Combination is fair, advisable, and in the best interests of Helix and its shareholders, unanimously approved the Business Combination and unanimously recommends that shareholders vote “FOR” the adoption of the Business Combination Agreement, and approval of the transactions contemplated thereby, including the Domestication and Merger, and “FOR” all other proposals presented to Helix’s shareholders in this proxy statement/prospectus. The Business Combination was not structured to require the approval of at least a majority of Helix’s unaffiliated shareholders because such a vote is not required under Cayman Islands law. When you consider the recommendation of the proposals herein by the Helix Board, you should keep in mind that the Sponsor, Cormorant, and Helix’s directors and officers and their affiliates have interests in the Business Combination that may conflict with your interests as a shareholder. See the section entitled “Interests of the Sponsor, Cormorant, and Helix’s Directors and Officers” for a further discussion of these considerations.

Immediately following the Closing, assuming the redemption of 5,236,672 Public Shares at approximately $10.72 per share (estimated using an assumed Closing Date of July 31, 2025), or approximately 34% of the Public Shares subject to redemption, which represents the estimated maximum number of Public Shares that can be redeemed while still satisfying the $400 million Minimum Cash Condition (the “Minimum Cash Condition Redemptions Scenario”), and without giving effect to any dilutive instruments, such as the exercise of the PubCo Options, it is expected that (i) Public Shareholders (excluding Cormorant) will own approximately 13.3% of PubCo Common Stock outstanding at that time, (ii) the Sponsor and Cormorant will own approximately 22.2% of PubCo Common Stock outstanding at that time (which includes 4,172,133 Founder Shares (after reflecting the surrender and forfeiture of 307,867 Sponsor Forfeited Shares and no surrender and forfeiture of Sponsor Contributed Shares), 509,000 Private Placement Shares, 2,400,000 Public Shares, 6,998,042 PIPE Shares, and 3,950,427 shares issued upon the conversion of BBOT capital stock held by Cormorant), (iii) Helix’s directors (other than Ms. Chen) and advisor will own less than 1% of PubCo Common Stock outstanding at that time, (iv) BBOT Stockholders other than Cormorant will own approximately 43.0% of PubCo Common Stock outstanding at that time, and (v) the PIPE Investors other than Cormorant will own approximately 21.4% of PubCo Common Stock outstanding at that time. The Public Shareholders (excluding Cormorant) currently own 68.1% of the issued and outstanding Helix Ordinary Shares prior to the Business Combination. Accordingly, Public Shareholders, as a group, will experience immediate dilution as a consequence of the Business Combination. As redemptions increase, the overall percentage ownership held by the Sponsor, Cormorant and other Helix Insiders, BBOT Stockholders and the PIPE Investors will increase as compared to the overall percentage ownership and voting percentage held by Public Shareholders, thereby increasing dilution to Public Shareholders. For more information on the percentage of the issued and outstanding shares of PubCo Common Stock immediately following the Closing that are expected to be held by securityholders, in various redemptions scenarios, see “Questions and Answers About the Business Combination — What equity stake will current Helix Shareholders and BBOT Stockholders hold in PubCo immediately after the Closing?” and for more information about dilution to Public Shareholders, see “Dilution.”

Pursuant to the Business Combination Agreement, Public Shareholders who do not redeem their Public Shares will receive one share of PubCo Common Stock for each Helix Class A Share held by them immediately prior to the Domestication. While Helix cannot be certain of the price such Public Shareholders paid for their Public Shares, assuming they purchased their Public Shares for $10.00 per share, which was the price of the Helix Class A Shares sold in Helix’s IPO, the effective purchase price paid per share of PubCo Common Stock issued to each Public Shareholder at Closing would be $10.00. In connection with Helix’s IPO, the Sponsor paid an aggregate of $25,000 for the Founder Shares, or approximately $0.006 per share. In connection with the Business Combination, assuming the Minimum Cash Condition Redemptions Scenario and assuming the surrender and forfeiture of 307,867 Sponsor Forfeited Shares and no surrender and forfeiture of Sponsor Contributed Shares, an aggregate of 4,172,133 Founder Shares held by the Sponsor and an additional 120,000 Founder Shares held by Helix’s independent directors and advisor will be voluntarily converted on a one-for-one basis into Helix Class A Shares immediately prior to the Domestication, which will then automatically convert at the effective time of the Domestication into an equal number of shares of PubCo Common Stock, valued at approximately $10.72 per share, which is the assumed per share price used in the Business Combination pursuant to the Business Combination Agreement. The Sponsor also purchased 509,000 Helix Class A Shares at a price of $10.00 per share in a private placement that occurred simultaneously with the closing of the Helix IPO; such shares will automatically convert at the effective time of the Domestication into an equal number of shares of PubCo Common Stock valued at approximately $10.72 per share, which is the assumed per share price used in the Business Combination pursuant to the Business Combination Agreement. Cormorant purchased an aggregate of 2,400,000 Helix Class A Shares in the IPO at a price of $10.00 per share, and such shares will automatically convert at the effective time of the Domestication into an equal number of shares of PubCo Common Stock valued at approximately $10.72 per share, which is the assumed per share price used in the Business Combination pursuant to the Business Combination Agreement. Cormorant will also receive an estimated 3,950,427 shares of PubCo Common Stock in the Business Combination upon the exchange of BBOT capital stock held by Cormorant pursuant to the terms of the Business Combination Agreement, and the BBOT Stockholders (excluding Cormorant) will receive an estimated 34,954,950 shares of PubCo Common Stock in the Business Combination, excluding an estimated 4,113,979 shares of PubCo Common Stock issuable upon the exercise of PubCo Options, each of which is equal to $461,051,546 divided by approximately $10.72, the assumed Redemption Price for the Public Shares estimated using an assumed Closing Date of July 31, 2025. The PIPE Investors (which includes Cormorant) will purchase an estimated 24,343,757 shares of PubCo Common Stock, which is equal to approximately $260.9 million divided by approximately $10.72, the assumed Redemption Price for the Public Shares estimated using an assumed Closing Date of July 31, 2025. As a result of the low price the Sponsor paid for the Founder Shares, the Sponsor may realize a positive rate of return on its investment even if the market price per share of PubCo

Common Stock is below $10.00 per share after Closing, in which case the Public Shareholders may experience a negative rate of return on their investment. See “Questions and Answers about the Business Combination — What is the effective purchase price attributed to the PubCo Common Stock to be received by Public Shareholders, the Sponsor, Cormorant, Helix officers and directors, and the BBOT Stockholders at the Closing?”

Compensation to be Received by the Sponsor, Cormorant, and Helix’s Officers and Directors in Connection with the Business Combination and PIPE Investment:    Assuming the Minimum Cash Redemptions Scenario, the Sponsor will receive (i) 4,172,133 shares of PubCo Common Stock upon the exchange of 4,172,133 Helix Class B Shares (assuming the surrender and forfeiture of 307,867 Sponsor Forfeited Shares and no surrender and forfeiture of Sponsor Contributed Shares), which were initially purchased prior to the Helix IPO for approximately $0.006 per share and (ii) 509,000 shares of PubCo Common Stock upon the exchange of 509,000 Helix Class A Shares, which were initially purchased in a private placement that closed concurrently with the Helix IPO for $10.00 per share. Cormorant will receive (i) 2,400,000 shares of PubCo Common Stock upon the exchange of 2,400,000 Helix Class A Shares, which were initially purchased in the Helix IPO for $10.00 per share, (ii) an estimated 6,998,042 shares of PubCo Common Stock, which is equal to Cormorant’s $75 million PIPE Investment divided by approximately $10.72, the assumed Redemption Price for the Public Shares estimated using an assumed Closing Date of July 31, 2025, and (iii) an estimated 3,950,427 shares of PubCo Common Stock upon the exchange of BBOT capital stock, which is determined by reference to the estimated Conversion Ratio using the assumed Redemption Price of approximately $10.72, the assumed Redemption Price for the Public Shares estimated using an assumed Closing Date of July 31, 2025. Helix’s independent directors and its advisor will each receive 30,000 shares of PubCo Common Stock upon the exchange of 30,000 Helix Class B Shares held by them, which shares were issued to them as consideration for services rendered to Helix. The securities to be issued to the Sponsor, Cormorant, and Helix’s officers and directors may result in a material dilution of the equity interests of non-redeeming Public Shareholders. See “Dilution”, “The Business Combination — Interests of Helix’s Sponsor, Cormorant and Directors and Officers in the Business Combination”, “The Business Combination — Compensation to be Received by the Sponsor, Cormorant, and Helix’s Officers and Directors in Connection with the Business Combination and PIPE Investment” and “Information About Helix — Executive and Director Compensation.”

The Sponsor, Cormorant, and Helix’s officers and directors will also be reimbursed for loans, advances, and out-of-pocket expenses incurred by them related to identifying, negotiating, investigating and completing the Business Combination. No such loans, advances, or out-of-pocket expenses are outstanding as of the date of this proxy statement/prospectus. In addition, Helix has agreed to pay the Sponsor $6,458 per month for office space, utilities, secretarial and administrative support services provided to members of the Helix management team. Additionally, the Sponsor, Cormorant, and Helix’s officers and directors will be entitled to continued indemnification and the continuation of directors’ and officer’s liability insurance after the Business Combination.

Helix’s independent directors are not members of the Sponsor and are not affiliates of Cormorant. None of the funds in the Trust Account will be used to compensate our officers or directors. Except for administrative services fees paid or to be paid to the Sponsor, no compensation of any kind, including finder’s and consulting fees, have been paid or will be paid to the Sponsor, Cormorant, officers and directors, or any of their respective affiliates, for services rendered prior to or in connection with the completion of the Business Combination. However, these individuals will be reimbursed for any out-of-pocket expenses incurred in connection with activities on our behalf such as identifying potential target businesses and performing due diligence on suitable business combinations, as discussed above. The reimbursement of expenses and advances to the Sponsor, Cormorant, and Helix’s officers and directors may result in a material dilution of the equity interests of non-redeeming Public Shareholders. Further, Bihua Chen, Helix’s Chairwoman and Chief Executive Officer, is expected to serve as a director of PubCo after the Closing, and as such, in the future, Ms. Chen may receive compensation for her service as a director of PubCo. See “Dilution”, “The Business Combination — Interests of Helix’s Sponsor, Cormorant and Directors and Officers in the Business Combination”, “The Business Combination — Compensation to be Received by the Sponsor, Cormorant, and Helix’s Officers and Directors in Connection with the Business Combination and PIPE Investment” and “Information About Helix — Executive and Director Compensation.”

Potential conflicts of interest in connection with the Business Combination:    There may be actual or potential material conflicts of interest between or among (i) the Sponsor, Cormorant, Helix officers and directors, BBOT officers and directors and (ii) unaffiliated security holders of Helix. Such conflicts of interest may include a material conflict of interest arising in determining whether to proceed with the Business Combination, the shares to be issued to the Sponsor, Cormorant, and Helix’s officers and directors in connection with the Business Combination,

and the reimbursement of loans and advances. See the section entitled “The Business Combination — Interests of the Sponsor, Cormorant, and Helix’s Directors and Officers in the Business Combination” and “The Business Combination — Interests of the BBOT Officers and Directors in the Business Combination” for more information.

In order to finance transaction costs in connection with the Business Combination, the Sponsor, Cormorant, and Helix’s officers and directors may, but are not obligated to, loan Helix funds as may be required (“Working Capital Loans”). If Helix completes the Business Combination, Helix would repay any such Working Capital Loans out of the proceeds of the Trust Account released to Helix without interest, or, at the lender’s discretion, up to $1,500,000 of such Working Capital Loans may be convertible into PubCo Common Stock, at a price of $10.00 per share, at the Closing. If Helix liquidates without completing a business combination, any such Working Capital Loans would be repaid only out of funds held outside the Trust Account, if any. Except for the foregoing, the terms of such Working Capital Loans, if any, have not been determined and no written agreements exist with respect to such loans. As of March 31, 2025, Helix had no outstanding borrowings under Working Capital Loans.

If Helix does not complete the Business Combination with BBOT or another initial business combination by February 13, 2026, which date is 24 months after the closing of its IPO, or by such earlier liquidation date as the Helix Board may approve (the “completion window”), Helix will (i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the Public Shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account, including interest earned on the funds held in the Trust Account (less taxes payable and up to $100,000 of interest to pay dissolution expenses), divided by the number of then issued and outstanding Public Shares, which redemption will completely extinguish Public Shareholders’ rights as shareholders (including the right to receive further liquidating distributions, if any), subject to our obligations under Cayman Islands law to provide for claims of creditors and subject to the other requirements of applicable law. The Sponsor and Helix’s officers, directors, and advisor have no rights to liquidating distributions from the Trust Account with respect to any Founder Shares and any Public Shares held by them if Helix fails to complete an initial business combination within the completion window, although they will be entitled to liquidating distributions from assets outside the Trust Account.

Helix’s Class A Shares are listed on Nasdaq under the symbol “HLXB.” On February 27, 2025, the last trading day before announcement of the execution of the Business Combination Agreement, the closing price of the Helix Class A Shares was $10.80. As of June 30, 2025, the closing price of the Helix Class A Shares was $10.65. Helix has applied for listing, to be effective at Closing, of the PubCo Common Stock on the Nasdaq Global Market under the symbol “BBOT”. It is a condition to BBOT’s and Helix’s obligations to consummate the Business Combination that the PubCo Common Stock to be issued in connection with the Business Combination Agreement, including the Aggregate Merger Consideration and the PIPE Shares, is approved for listing on Nasdaq, subject only to official notice of issuance. Additionally, it is a condition to the obligations of the parties to the Subscription Agreements to consummate the PIPE Investments that the PubCo Common Stock, including the PIPE Shares, has been approved for listing on Nasdaq, subject only to official notice of issuance. Helix and BBOT believe that Helix will satisfy the initial listing requirements of the Nasdaq Global Market at the Closing, but there can be no assurance such listing condition will be met. If such listing condition is not met, the Business Combination may not be consummated unless such condition is waived by BBOT and Helix, and the PIPE Investments may not be consummated unless such condition is waived by the PIPE Investors. The Nasdaq listing condition may be waived by BBOT and Helix, with respect to the Business Combination, and by the PIPE Investors, with respect to the PIPE Investment, at any time prior to the Closing, including after the deadline for submitting redemption requests or the EGM. If BBOT and Helix, on the one hand, and/or the PIPE Investors, on the other hand, waive such condition, Helix intends to file a Current Report on Form 8-K within four business days of such event, however you should know that given such timing you may not be notified before the deadline for submitting redemption requests or the EGM. It is important for you to consider that, at the time of the deadline for submitting redemption requests or the EGM, PubCo may not have received from Nasdaq either confirmation of the listing of the PubCo Common Stock or confirmation that approval will be obtained prior to the consummation of the Business Combination, and you will not be notified prior to the deadline for submitting redemption requests or the EGM if PubCo has not yet received such approval or confirmation. As a result, you may be asked to vote to approve the Business Combination and the other proposals included in this proxy statement/prospectus without knowing whether the PubCo Common Stock will be listed on Nasdaq or another securities exchange and, further, it is possible that such listing may never be achieved and the Business Combination could still be consummated if such condition is waived.

Helix is, and PubCo will be, an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected to comply with certain reduced public company reporting requirements. Investing in PubCo’s Common Stock involves a high degree of risk. See “Risk Factors” beginning on page 25 of the accompanying proxy statement/prospectus for a discussion of information that should be considered in connection with an investment in PubCo’s Common Stock.

This proxy statement/prospectus provides you with detailed information about the Business Combination and other matters to be considered at the EGM. Helix encourages you to carefully read this entire document. You should also carefully consider the risk factors described in “Risk Factors” beginning on page 25.

When you review the information included in the accompanying proxy statement/prospectus and consider the Helix Board’s recommendation to vote in favor of the proposals described therein, you should keep in mind that the Sponsor, Cormorant, and Helix’s officers and directors have interests in the Business Combination that may conflict with your interests as a shareholder. For instance, the Sponsor, Cormorant and Helix’s officers and directors will benefit from the completion of a business combination and may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidating Helix. See the sections entitled “The Business Combination — Interests of Sponsor, Cormorant, and Helix’s Directors and Officers in the Business Combination” and “Beneficial Ownership of Securities” in the accompanying proxy statement/prospectus for a further discussion.

NEITHER THE SEC NOR ANY STATE SECURITIES REGULATORY AGENCY HAS APPROVED OR DISAPPROVED THE TRANSACTIONS DESCRIBED IN THIS PROXY STATEMENT/PROSPECTUS, PASSED UPON THE MERITS OR FAIRNESS OF THE BUSINESS COMBINATION OR PASSED UPON THE ADEQUACY OR ACCURACY OF THE DISCLOSURE IN THIS PROXY STATEMENT/PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY CONSTITUTES A CRIMINAL OFFENSE.

This proxy statement/prospectus is dated [•], and is first being mailed to Helix Shareholders on or about [•].

State of Delaware so as to migrate to and domesticate as a Delaware corporation in accordance with the Helix Articles, Section 388 of the DGCL, and Part XII of the Cayman Companies Act. The Domestication is intended to be effected on the date that is one business day prior to the effective time of the Merger, including the filing with the Secretary of State of the State of Delaware a certificate of domestication with respect to the Domestication, together with the proposed new certificate of incorporation of PubCo (the “PubCo Charter”). Upon the effectiveness of the Domestication, Helix will become a Delaware corporation and will change its corporate name to “BridgeBio Oncology Therapeutics, Inc.” and all outstanding securities of Helix will convert into securities of PubCo, as described in more detail in the accompanying proxy statement/prospectus. We refer to this proposal as the “Domestication Proposal.”

The full text of the resolution to be considered and, if thought fit, passed and approved is as follows:

“RESOLVED, as a special resolution, that Helix be de-registered in the Cayman Islands pursuant to article 49 of the amended and restated memorandum and articles of association of Helix and Part XII of the Cayman Islands Companies Act (As Revised) and transferred by way of continuation to Delaware as a corporation under the laws of the state of Delaware.”

(3)    Proposal No. 3 — The Stock Issuance Proposal — To consider and vote upon a proposal to approve, by ordinary resolution, including for purposes of complying with the applicable provisions of Nasdaq Listing Rules 5635(a), (b) and (d), the issuance or potential issuance of (i) shares of PubCo Common Stock to the shareholders of Helix in the Domestication and stockholders of BBOT in the Merger pursuant to the Business Combination Agreement, (ii) shares of PubCo Common Stock to the PIPE Investors in the PIPE Investment pursuant to the Subscription Agreements, and (iii) any other issuances of PubCo Common Stock and securities convertible into or exercisable for PubCo Common Stock pursuant to subscription, purchase or similar agreements Helix has entered, or may enter, into prior to Closing. We refer to this proposal as the “Stock Issuance Proposal.”

The full text of the resolution to be considered and, if thought fit, passed and approved is as follows:

“RESOLVED, as an ordinary resolution, that, for the purposes of complying with the applicable provisions of Nasdaq Listing Rules 5635(a), (b) and (d), the issuance or potential issuance of (i) shares of PubCo Common Stock to the shareholders of Helix in the Domestication and stockholders of BBOT in the Merger pursuant to the Business Combination Agreement, (ii) shares of PubCo Common Stock to the PIPE Investors in the PIPE Investment pursuant to the Subscription Agreements, and (iii) any other issuances of PubCo Common Stock and securities convertible into or exercisable for PubCo Common Stock pursuant to subscription, purchase or similar agreements Helix has entered, or may enter, into prior to Closing, be approved in all respects.”

(4)    Proposal No. 4 — Organizational Documents Proposal — To consider and vote upon a proposal to approve, by special resolution, the PubCo Charter and the proposed new bylaws (the “PubCo Bylaws” and, together with the PubCo Charter, the “PubCo Organizational Documents”) of PubCo in connection with the Business Combination. We refer to this proposal as the “Organizational Documents Proposal”. The form of each of the PubCo Charter and the PubCo Bylaws is attached to the accompanying proxy statement/prospectus as Annex I and Annex J, respectively.

The full text of the resolution to be considered and, if thought fit, passed and approved is as follows:

“RESOLVED, as a special resolution, that the amended and restated memorandum and articles of association of Helix currently in effect be amended and restated by the deletion in their entirety and the substitution in their place of the proposed new PubCo Charter and the PubCo Bylaws (in the form attached to the proxy statement/prospectus of the meeting as Annex I and Annex J, respectively) including, without limitation, the authorization of the change in authorized share capital as indicated therein, in each case effective upon the effectiveness of the Domestication.”

(5)    Proposal No. 5 — The Advisory Organizational Documents Proposals — To consider and vote upon the following six separate proposals (collectively, the “Advisory Organizational Documents Proposals”) to approve an ordinary resolution on a non-binding and advisory basis only the following material differences between the Helix Articles and the PubCo Organizational Documents:

•        Proposal No. 5A: Authorized Shares — A proposal to amend the Helix Articles to authorize the change in the authorized capital stock of Helix from (i) 500,000,000 Helix Class A Shares, 50,000,000 Helix Class B Shares and 5,000,000 preference shares, par value $0.0001 per share, to (ii) 500,000,000 shares of PubCo Common Stock and 10,000,000 shares of undesignated preferred stock.

•        Proposal No. 5B: Exclusive Forum Provision — A proposal to amend the Helix Articles to authorize adopting Delaware as the exclusive forum for certain stockholder litigation.

•        Proposal No. 5C: Adoption of Supermajority Vote Requirement to Amend the Proposed Organizational Documents — A proposal to amend the Helix Articles to approve provisions requiring the affirmative vote of at least (i) two-thirds of the outstanding shares of capital stock entitled to vote to adopt, amend or repeal the Proposed Bylaws and (ii) a majority of PubCo’s then outstanding common stock (except where a lower threshold is provided by the DGCL) for amendments to the PubCo Charter.

•        Proposal No. 5D: Removal of Directors — A proposal to amend the Helix Articles to approve provisions permitting the removal of a director only for cause and only by the affirmative vote of not less than two-thirds of the outstanding shares entitled to vote at an election of directors, voting together as a single class.

•        Proposal No. 5E: Action by Written Consent of Stockholders — A proposal to amend the Helix Articles approve provisions requiring stockholders to take action at an annual or special meeting and prohibiting stockholder action by written consent in lieu of a meeting.

•        Proposal No. 5F: Other Changes In Connection With Adoption of the proposed PubCo Organizational Documents — A proposal to amend the Helix Articles to authorize (1) changing the corporate name from “Helix Acquisition Corp. II” to “BridgeBio Oncology Therapeutics, Inc.”, (2) making PubCo’s corporate existence perpetual, and (3) removing certain provisions related to Helix’s status as a blank check company that will no longer be applicable upon consummation of the Business Combination.

The full text of the resolution to be considered and, if thought fit, passed and approved is as follows:

“RESOLVED, as six separate ordinary resolutions on a non-binding and advisory basis only, that the following governance provisions contained in the Proposed Governing Documents be and are hereby approved and adopted:

•        Proposal No. 5A — to amend the Helix Articles to authorize the change in the authorized capital stock of Helix from (i) 500,000,000 Helix Class A Shares, 50,000,000 Helix Class B Shares and 5,000,000 preference shares, par value $0.0001 per share, to (ii) 500,000,000 shares of PubCo Common Stock and 10,000,000 shares of undesignated preferred stock.

•        Proposal No. 5B — to amend the Helix Articles to authorize adopting Delaware as the exclusive forum for certain stockholder litigation.

•        Proposal No. 5C — to amend the Helix Articles to approve provisions requiring the affirmative vote of at least (i) two-thirds of the outstanding shares of capital stock entitled to vote to adopt, amend or repeal the Proposed Bylaws and (ii) a majority of PubCo’s then outstanding common stock (except where a lower threshold is provided by the DGCL) for amendments to the PubCo Charter.

•        Proposal No. 5D — to amend the Helix Articles to approve provisions permitting the removal of a director only for cause and only by the affirmative vote of not less than two-thirds of the outstanding shares entitled to vote at an election of directors, voting together as a single class.

•        Proposal No. 5E — to amend the Helix Articles approve provisions requiring stockholders to take action at an annual or special meeting and prohibiting stockholder action by written consent in lieu of a meeting.

•        Proposal No. 5F — to amend the Helix Articles to authorize (1) changing the corporate name from “Helix Acquisition Corp. II” to “BridgeBio Oncology Therapeutics, Inc.”, (2) making PubCo’s corporate existence perpetual, and (3) removing certain provisions related to Helix’s status as a blank check company that will no longer be applicable upon consummation of the Business Combination.”

(6)   Proposal No. 6 — The Incentive Plan Proposal — To consider and vote upon a proposal to approve, by ordinary resolution, the BridgeBio Oncology Therapeutics, Inc. 2025 Stock Option and Incentive Plan (the “PubCo Incentive Plan”). We refer to this proposal as the “Incentive Plan Proposal”.

The full text of the resolution to be considered and, if thought fit, passed and approved is as follows:

“RESOLVED, as an ordinary resolution, that the BridgeBio Oncology Therapeutics, Inc. 2025 Stock Option and Incentive Plan, in the form attached to the proxy statement/prospectus of the meeting as Annex K, be adopted and approved.”

(7)    Proposal No. 7 — The ESPP Proposal — To consider and vote upon a proposal to approve, by ordinary resolution, the BridgeBio Oncology Therapeutics, Inc. 2025 Employee Stock Purchase Plan (the “ESPP”). We refer to this proposal as the “ESPP Proposal.”

The full text of the resolution to be considered and, if thought fit, passed and approved is as follows:

“RESOLVED, as an ordinary resolution, that the BridgeBio Oncology Therapeutics, Inc. 2025 Employee Stock Purchase Plan, in the form attached to the proxy statement/prospectus of the meeting as Annex L, be adopted and approved.”

(8)    Proposal No. 8 — Director Election Proposal — To consider and vote upon a proposal to approve, by ordinary resolution, the election of eight directors to serve on the PubCo board of directors until their respective successors are duly elected and qualified. We refer to this proposal as the “Director Election Proposal”.

The full text of the resolution to be considered and, if thought fit, passed and approved is as follows:

“RESOLVED, as an ordinary resolution, that the persons named below be elected to serve on the PubCo board of directors until their respective successors are duly elected and qualified, effective upon the consummation of the Business Combination.”

(9)    Proposal No. 9 — The Adjournment Proposal — To consider and vote upon a proposal to approve, by ordinary resolution, the adjournment of the EGM to a later date or dates, if necessary or desirable (the “Adjournment Proposal”). The full text of the resolution to be considered and if thought fit, passed and approved is as follows:

The full text of the resolution to be considered and, if thought fit, passed and approved is as follows:

“RESOLVED, as an ordinary resolution, that the EGM be adjourned to a later date or dates, if the Helix Board deems it necessary or desirable, be approved.”

Approval of each of the Business Combination Proposal, the Domestication Proposal, the Stock Issuance Proposal and the Organizational Documents Proposal is a condition to consummating the Business Combination. We refer to such proposals, collectively, as the “Condition Precedent Proposals”.

Only holders of record of Helix Class A Shares and Helix Class B Shares (together, the “Helix Ordinary Shares”) at the close of business on June 30, 2025 (the “Record Date”) are entitled to notice of and to vote at and to have their votes counted at the EGM and any adjournment of the EGM.

This proxy statement/prospectus and accompanying proxy card is being provided to Helix’s shareholders in connection with the solicitation of proxies to be voted at the EGM and at any adjournment of the EGM. Whether or not you plan to attend the EGM, all of Helix’s shareholders are urged to read this proxy statement/prospectus, including the Annexes and the documents referred to herein, carefully and in their entirety. You should also carefully consider the risk factors described under the heading “Risk Factors” beginning on page 25 of this proxy statement/prospectus.

After careful consideration, the Helix Board, based in part upon the unanimous recommendation of the Transaction Committee, has unanimously determined that the Business Combination is fair, advisable, and in the best interests of Helix and its shareholders, unanimously approved the Business Combination and unanimously recommends that shareholders vote “FOR” the adoption of the Business Combination Agreement, and approval of the transactions contemplated thereby, including the Domestication and Merger, and “FOR” all other proposals presented to Helix’s shareholders in this proxy statement/prospectus. The Business Combination was not structured to require the approval of at least a majority of Helix’s unaffiliated shareholders because such a vote is not required under Cayman Islands law. When you consider the recommendation of the proposals herein by the Helix Board, you should keep in mind that the Sponsor, Cormorant, and Helix’s directors and officers and their affiliates have interests in the Business Combination that may conflict with your interests as a shareholder. See the section entitled “Interests of the Sponsor, Cormorant, and Helix’s Directors and Officers” for a further discussion of these considerations.

Pursuant to the Helix Articles, a holder of Helix Class A Shares initially issued in Helix’s initial public offering (the “Public Shares”, and such holder, a “Public Shareholder”), other than the Sponsor, Cormorant, and the Helix Insiders, may request that Helix redeem all or a portion of his, her, or its Public Shares for cash if the Business Combination is consummated. As a holder of Public Shares, you will be entitled to receive cash for any Public Shares to be redeemed only if you:

(i)     hold Public Shares;

(ii)    submit a written request to Continental Stock Transfer & Trust Company (“Continental”), Helix’s transfer agent, including the legal name, phone number and address of the beneficial owner of the Public Shares for which redemption is requested, that Helix redeem all or a portion of your Public Shares for cash; and

(iii)   tender or deliver your Public Shares (and share certificates (if any) and other redemption forms) to Continental, physically or electronically through The Depository Trust Company (“DTC”).

Holders must complete the procedures for electing to redeem their Public Shares in the manner described above prior to 5:00 p.m., Eastern Time, on July 31, 2025 (two business days before the scheduled date of the EGM) in order for their Helix Class A Shares to be redeemed.

Holders of Public Shares (other than the Sponsor, Cormorant, and the Helix Insiders) may elect to redeem all or a portion of their Public Shares regardless of if or how they vote in respect of the Business Combination Proposal and regardless of whether they hold Public Shares on the Record Date. If the Business Combination is not consummated, the Public Shares will be returned to the respective holder, broker or bank.

If the Business Combination is consummated, and if a Public Shareholder (other than the Sponsor, Cormorant, and the Helix Insiders) properly exercises its right to redeem all or a portion of the Public Shares that it holds, including timely delivering such shares to Continental, Helix will redeem such Public Shares for a per-share price, payable in cash, equal to the pro rata portion of the funds held the trust account established at the consummation of Helix’s IPO (the “Trust Account”) (including interest earned on the funds held in the Trust Account not previously released to Helix to pay its taxes, net of taxes payable), calculated as of two business days prior to the consummation of

the Business Combination (the “Redemption Price”). For illustrative purposes, as of the Record Date, this would have amounted to approximately $10.68 per issued and outstanding Public Share. Prior to exercising redemption rights, Public Shareholders should verify the market price of the Helix Class A Shares, as they may receive higher proceeds from the sale of their Public Shares in the public market than from exercising their redemption rights if the market price per share is higher than the Redemption Price. Helix cannot assure shareholders that they will be able to sell their Public Shares in the open market, even if the market price per share is higher than the Redemption Price stated above, as there may not be sufficient liquidity in the Helix Class A Shares when Public Shareholders wish to sell their shares. If a Public Shareholder exercises its redemption rights in full, then it will be electing to exchange his, her or its Public Shares for cash and will no longer own Public Shares. See “Extraordinary General Meeting — Redemption Rights” for a detailed description of the procedures to be followed if you wish to redeem your Public Shares for cash.

Notwithstanding the foregoing, a Public Shareholder, together with any affiliate of such Public Shareholder or any other person with whom such Public Shareholder is acting in concert or as a “group” (as defined in Section 13(d)(3) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), will be restricted from redeeming his, her or its Public Shares with respect to more than an aggregate of 20% of the Public Shares without Helix’s prior consent. Accordingly, if a Public Shareholder, alone or acting in concert or as a group, seeks to redeem more than 20% of the Helix Class A Shares, then any such shares in excess of that 20% limit would not be redeemed for cash without Helix’s prior consent.

On February 28, 2025, Helix entered into Non-Redemption Agreements with Non-Redeeming Shareholders, pursuant to which, among other things, each Non-Redeeming Shareholder irrevocably and unconditionally agreed, for the benefit of Helix, that neither it nor its controlled affiliates will exercise any redemption rights under the Helix Articles with respect to the NRA Shares at any meeting of the Helix Shareholders. Assuming a Redemption Price of approximately $10.72, which is estimated using an assumed Closing Date of July 31, 2025, the NRA Shares will represent approximately $4.8 million in retained funds in the Trust Account. The Non-Redemption Agreements do not provide for any consideration to be paid by Helix or BBOT to the Non-Redeeming Shareholders in connection with such agreements. The Sponsor and Cormorant are not parties to the Non-Redemption Agreements.

Under the Business Combination Agreement, the obligations of the parties to consummate the Business Combination are subject to the satisfaction or waiver of certain closing conditions of the respective parties, including, without limitation: (i) the aggregate cash proceeds available for release to Helix from the trust account established in connection with Helix’s initial public offering (the “Trust Account”) in connection with the Business Combination (net of the amount required to be paid to redeeming Public Shareholders, but for the avoidance of doubt, prior to the payment of any transaction expenses), together with the aggregate cash proceeds actually received from the PIPE Investments (as defined below) (such amount, the “Helix Closing Cash”), equaling no less than $400 million (the “Minimum Cash Condition”); (ii) the PubCo Common Stock to be issued in connection with the Business Combination Agreement, including the Aggregate Merger Consideration and the PIPE Shares (as defined below), having been approved for listing on the Nasdaq Global Market (“Nasdaq”), subject to official notice of issuance; (iii) this registration statement having been declared effective by the Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended (the “Securities Act”), no stop order suspending the effectiveness of this registration statement being in effect, and no proceedings for purposes of suspending the effectiveness of this registration statement having been initiated or threatened in writing by the SEC; and (iv) the approval and adoption of the Business Combination Agreement and transactions contemplated thereby by the requisite vote of the holders of Helix Ordinary Shares (such holders, the “Helix Shareholders” and such vote the “Helix Shareholder Approval”) and BBOT Stockholders (the “BBOT Stockholder Approval”). The Minimum Cash Condition described above is for the benefit of BBOT only and is subject to waiver by BBOT. Conditions (ii) through (iv) above are for the benefit of both Helix and BBOT and are subject to waiver by Helix or BBOT. As of the date of this proxy statement/prospectus, the Minimum Cash Condition has not been satisfied. The parties intend to satisfy the Minimum Cash Condition through the PIPE Investment and through amounts released to us from the Trust Account. In the event the Minimum Cash Condition is not satisfied as a result of redemptions of Public Shares which reduce the amount available to be released to us from the Trust Account, BBOT may, in its sole discretion, waive the Minimum Cash Condition. If BBOT waives the Minimum Cash Condition, Helix intends to file a Current Report on Form 8-K within four business days of such event, however such condition may be waived at any time prior to the Closing, including after the deadline for submitting redemption requests or the EGM, and, given such timing, you may not be notified before the deadline for submitting redemption requests or the EGM. For more information, see “Proposal No. 1 — The Business Combination Proposal — The Business Combination Agreement — Conditions to Closing.”

Only holders of record of Helix Ordinary Shares at the close of business on the Record Date are entitled to notice of and to have their votes counted at the EGM and any adjournment of the EGM.

Pursuant to the Helix Articles and Cayman Islands law, the approval of each of the Business Combination Proposal, Stock Issuance Proposal, Incentive Plan Proposal, ESPP Proposal, Director Election Proposal and Adjournment Proposal requires an ordinary resolution, being the affirmative vote of the holders of a majority of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

Pursuant to the Helix Articles and Cayman Islands law, the approval of the Organizational Documents Proposal requires a special resolution, being the affirmative vote of holders of a majority of at least two-thirds of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

Pursuant to the Helix Articles and Cayman Islands law, the approval of each of the Advisory Organizational Documents Proposals requires an ordinary resolution on a non-binding and advisory basis only, being the affirmative vote of holders of a majority of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

Pursuant to the Helix Articles, the approval of the Domestication Proposal requires a special resolution, being the affirmative vote of holders of a majority of at least two-thirds of the issued and outstanding Helix Class B Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM. The holders of the Helix Class A Shares will have no right to vote on the Domestication Proposal, in accordance with Article 48 of the Helix Articles.

In connection with Helix’s IPO, the Sponsor and Helix’s officers, directors, and advisor entered into a letter agreement with Helix (the “Insider Letter”), pursuant to which they agreed to waive their redemption rights with respect to their Founder Shares and Public Shares in connection with the completion of an initial business combination. Such redemption rights waiver was provided at the time of the IPO without any separate consideration paid. Additionally, pursuant to the Helix Support Agreement, the Sponsor and each of Helix’s independent directors and advisor who hold Founder Shares agreed not to redeem any Helix Ordinary Shares held by them in connection with the Business Combination, and Cormorant also agreed to waive its redemption rights with respect to any Helix Ordinary Shares it holds, including the 2,400,000 Helix Class A Shares purchased in the IPO. Such redemption rights waiver was provided without any separate consideration paid in connection with providing such waiver. The Helix Insiders collectively own 7,509,000 Helix Ordinary Shares, or approximately 31.9% of the issued and outstanding Helix Ordinary Shares as follows: (i) the Sponsor owns 4,480,000 Helix Class B Shares and 509,000 Helix Class A Shares; (ii) the Helix independent directors and an advisor each own 30,000 Helix Class B Shares, for an aggregate of 120,000 Helix Class B Shares; and (iii) Cormorant owns an aggregate of 2,400,000 Helix Class A Shares.

Your vote is very important. Whether or not you plan to attend the EGM, please vote as soon as possible by following the instructions in the accompanying proxy statement/prospectus to make sure that your shares are represented at the EGM. If you hold your shares in “street name” through a bank, broker or other nominee, you will need to follow the instructions provided to you by your bank, broker or other nominee to ensure that your shares are represented and voted at the EGM. The transactions contemplated by the Business Combination Agreement will be consummated only if the Condition Precedent Proposals are approved at the EGM, and if the other conditions to Closing are satisfied or waived. Each of the Condition Precedent Proposals is cross-conditioned on the approval of each other Condition Precedent Proposal. The Advisory Organizational Documents Proposals, Director Election Proposal, Incentive Plan Proposal, and ESPP Proposal are each conditioned on the approval of the Condition Precedent Proposals. The Adjournment Proposal is not conditioned upon the approval of any other proposal set forth in the accompanying proxy statement/prospectus.

If you sign, date and return your proxy card without indicating how you wish to vote, your proxy will be voted “FOR” each of the proposals presented at the EGM. If you fail to return your proxy card or fail to instruct your bank, broker or other nominee how to vote, and do not attend the EGM in person, the effect will be, among other things, that your shares will not be counted for purposes of determining whether a quorum is present at the EGM and will not be voted. If a valid quorum is established, any such failure to vote or to provide voting instructions will have no effect on the outcome of any proposal in the accompanying proxy statement/prospectus. An abstention will be counted towards the quorum requirement; broker non-votes cast on a “routine” matter will be counted as present for

purposes of establishing a quorum, while broker non-votes cast on a “non-routine” matter will not be counted toward the quorum requirement. We do not expect any of the matters being presented at the EGM to constitute “routine” matters. Abstentions and broker non-votes will not count as a vote cast at the EGM and otherwise will have no effect on a particular proposal because each proposal requires the affirmative vote of a particular number of votes cast and an abstention and a broker non-vote is not a vote cast. If you are a shareholder of record and you attend the EGM and wish to vote in person, you may withdraw your proxy and vote in person.

Your attention is directed to the remainder of the proxy statement/prospectus following this notice (including the Annexes and other documents referred to herein) for a more complete description of the Business Combination and related transactions and each of the proposals. You are encouraged to read this proxy statement/prospectus carefully and in its entirety, including the Annexes and other documents referred to herein. If you have any questions or need assistance voting your Helix Ordinary Shares, please contact Sodali & Co. (“Sodali”), our proxy solicitor, by email at HLXB.info@investor.sodali.com. Individuals may also call Sodali toll free at (800) 662-5200; banks and brokers can call (203) 658-9400. This notice of EGM and the proxy statement/prospectus are available at https://www.cstproxy.com/helixacquisitionii/2025.

Thank you for your participation. We look forward to your continued support.

Important Notice Regarding the Availability of Proxy Materials for the EGM to be held on August 4, 2025: This notice of EGM and the related proxy statement will be available at https://www.cstproxy.com/helixacquisitionii/2025.

IF YOU RETURN YOUR PROXY CARD SIGNED AND WITHOUT AN INDICATION OF HOW YOU WISH TO VOTE, YOUR PROXY CARD WILL APPOINT BIHUA CHEN AND CALEB TRIPP AS YOUR PROXY TO VOTE YOUR SHARES IN THEIR DISCRETION. BIHUA CHEN AND CALEB TRIPP WILL VOTE ANY UNDIRECTED PROXIES IN FAVOR OF EACH OF THE PROPOSALS. TO EXERCISE YOUR REDEMPTION RIGHTS, YOU MUST (1) SUBMIT A WRITTEN REQUEST TO CONTINENTAL AT LEAST TWO BUSINESS DAYS PRIOR TO THE SCHEDULED VOTE AT THE EGM, WHICH REQUEST MUST INCLUDE THE LEGAL NAME, PHONE NUMBER AND ADDRESS OF THE BENEFICIAL OWNER OF THE PUBLIC SHARES FOR WHICH REDEMPTION IS REQUESTED, THAT YOUR PUBLIC SHARES BE REDEEMED FOR CASH, AND (2) TENDER OR DELIVER YOUR PUBLIC SHARES (AND SHARE CERTIFICATES (IF ANY) AND OTHER REDEMPTION FORMS) TO CONTINENTAL, PHYSICALLY OR ELECTRONICALLY USING THE DEPOSITORY TRUST COMPANY’S DWAC (DEPOSIT/WITHDRAWAL AT CUSTODIAN) SYSTEM, IN EACH CASE, IN ACCORDANCE WITH THE PROCEDURES AND DEADLINES DESCRIBED IN THE ACCOMPANYING PROXY STATEMENT/PROSPECTUS. IF THE BUSINESS COMBINATION IS NOT CONSUMMATED, THEN THE PUBLIC SHARES WILL NOT BE REDEEMED FOR CASH. IF YOU HOLD THE SHARES IN STREET NAME, YOU WILL NEED TO INSTRUCT THE ACCOUNT EXECUTIVE AT YOUR BANK OR BROKER TO WITHDRAW THE SHARES FROM YOUR ACCOUNT IN ORDER TO EXERCISE YOUR REDEMPTION RIGHTS. SEE “THE EXTRAORDINARY GENERAL MEETING — REDEMPTION RIGHTS” IN THE ACCOMPANYING PROXY STATEMENT/PROSPECTUS FOR MORE SPECIFIC INSTRUCTIONS.

The accompanying proxy statement/prospectus is dated [•], 2025 and is first being mailed to shareholders on or about [•], 2025.

ABOUT THIS DOCUMENT

This document, which forms part of a registration statement on Form S-4 filed with the Securities and Exchange Commission (the “SEC”) by Helix and BBOT, constitutes a prospectus of Helix under Section 5 of the Securities Act of 1933, as amended (the “Securities Act”), with respect to the shares of PubCo Common Stock to be issued under the Business Combination Agreement if the Business Combination described herein is consummated. This document also constitutes a notice of meeting and a proxy statement of Helix under Section 14(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) with respect to the EGM of Helix at which Helix Shareholders will be asked to consider and vote upon proposals to approve the Business Combination by the adoption of the Business Combination Agreement, among other matters.

You should rely only on the information contained or incorporated by reference into this proxy statement/prospectus. No one has been authorized to provide you with information that is different from that contained in, or incorporated by reference into, this proxy statement/prospectus. This proxy statement/prospectus is dated as of the date set forth on the cover hereof. You should not assume that the information contained in this proxy statement/prospectus is accurate as of any date other than that date. Neither the mailing of this proxy statement/prospectus to Helix Shareholders nor the issuance by PubCo of PubCo Common Stock in connection with the Business Combination will create any implication to the contrary.

Information contained in this proxy statement/prospectus regarding Helix has been provided by Helix and information contained in this proxy statement/prospectus regarding BBOT has been provided by BBOT.

This proxy statement/prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities, or the solicitation of a proxy, in any jurisdiction to or from any person to whom it is unlawful to make any such offer or solicitation in such jurisdiction.

TABLE OF CONTENTS

FREQUENTLY USED TERMS

Unless otherwise stated or unless the context otherwise requires, the terms “we”, “us”, “our” and “Helix” refer to Helix Acquisition Corp. II and the terms “PubCo,” “combined company” and “post-combination company” refer to PubCo. (f/k/a Helix Acquisition Corp. II as of immediately following the consummation of the Business Combination) and its subsidiaries following the consummation of the Business Combination.

In this document:

“A&R Registration Rights Agreement” means the Amended and Restated Registration Rights Agreement, which will be entered into by and between the Helix Insiders, certain BBOT Stockholders and PubCo in connection with the Closing.

“Adjournment Proposal” means the proposal to approve, by ordinary resolution, the adjournment of the EGM to a later date or dates, if necessary or desirable.

“Advisory Organizational Documents Proposals” means the six proposals to be considered at the EGM to approve an ordinary resolution on a non-binding advisory basis and as required by applicable SEC guidance, certain material differences between the Helix Articles and the PubCo Organizational Documents.

“Aggregate Merger Consideration” means consideration to be issued to BBOT Stockholders in connection with the Merger, to be determined by dividing (a) the Equity Value by (b) the Redemption Price. For purposes of this proxy statement/prospectus, the Aggregate Merger Consideration that is estimated to be issued to BBOT Stockholders is 43,233,290 shares of PubCo Common Stock

“Aggregate Fully Diluted BBOT Shares” means the sum, without duplication of (a) BBOT Common Stock plus (b) the aggregate number of shares of BBOT Common Stock that are issuable upon, or subject to, the exercise or settlement of BBOT Options (whether or not then vested or exercisable), in each case, that are outstanding immediately prior to the Merger Effective Time, plus (c) BBOT Preferred Stock (on an as-converted to BBOT Common Stock basis) that are issued and outstanding immediately prior to the Merger Effective Time. For purposes of this proxy statement/prospectus, the Aggregate Fully-Diluted BBOT Shares is deemed to be 484,114,644 shares, which represents the BBOT fully-diluted common stock as of May 7, 2025.

“Alternative Proposal” means any inquiry, proposal or offer for, or an indication of interest in entering into, an Alternative Transaction, communicated to BBOT or any of its representatives.

“Alternative Transaction” means any of the following transactions (in a single transaction or series of transactions) involving BBOT, on the one hand, or Helix, on the other hand, as applicable and in each case other than the Business Combination: (A) any direct or indirect merger, consolidation, share exchange, business combination, reconsolidation, recapitalization, reorganization, liquidation, dissolution, or other similar transaction, or (B) any direct or indirect sale, lease, license, exchange, transfer, option or other disposition of (x) all or a material portion of the assets or properties of BBOT or the Business, on the one hand, or Helix, on the other hand, as applicable, or (y) any class or series of the capital stock or other equity interests or debt securities or profit interests of BBOT, on the one hand, or Helix, on the other hand.

“BBOT” means TheRas, Inc. (d/b/a BridgeBio Oncology Therapeutics), a Delaware Corporation.

“BBOT Board” means the board of directors of BBOT.

“BBOT Common Stock” means the shares of common stock of BBOT.

“BBOT Disclosure Schedules” means the disclosure schedules of BBOT to the Business Combination Agreement.

“BBOT Option” means each outstanding and unexercised option to purchase shares of BBOT Common Stock.

“BBOT Preferred Stock” means the shares of preferred stock of BBOT.

“BBOT Series B Financing” means the Series B preferred stock financing of BBOT on April 30, 2024.

“BBOT Special Committee” means the special committee of the BBOT Board.

“BBOT Stockholder Approval” means the requisite vote by BBOT Stockholders to approve and adopt the Business Combination Agreement and transactions contemplated thereby.

“BBOT Stockholders” means the holders of BBOT Common Stock and BBOT Preferred Stock.

“BBOT Support Agreement” means the certain BBOT Support Agreement, dated as of February 28, 2025, by and between Helix, BBOT and the BBOT Supporting Stockholders.

“BBOT Supporting Stockholders” means certain stockholders of BBOT, including affiliates of Cormorant, who are parties to the BBOT Support Agreement.

“BBOT Written Consent” means the written consent of a sufficient number of shares of BBOT Common Stock required to approve the Business Combination Agreement, each ancillary agreement to which BBOT is a party and the Business Combination.

“BridgeBio Pharma” means BridgeBio Pharma, Inc., and its affiliates.

“Business Combination” means, collectively, the Merger, the Domestication and the other transactions contemplated by the Business Combination Agreement.

“Business Combination Agreement” means the Business Combination Agreement, dated as of February 28, 2025 (as amended by Amendment No. 1 to the Business Combination Agreement, dated as of June 17, 2025, and as it may be further amended, restated, supplemented or otherwise modified from time to time) by and among Helix, Merger Sub, and BBOT.

“Business Combination Proposal” means the proposal to be considered at the EGM to approve and adopt the Business Combination Agreement and the transactions contemplated by the Business Combination Agreement.

“Cayman Companies Act” means the Companies Act (as revised) of the Cayman Islands.

“Class B Share Conversion” means the election by each holder of the Helix Class B Shares, pursuant to the terms of the Sponsor Support Agreement, to convert each Helix Class B Share, on a one-for-one basis, into one Helix Class A Share.

“Closing” means the closing of the Business Combination.

“Closing Date” means the date the Closing occurs.

“Code” means the U.S. Internal Revenue Code of 1986, as amended.

“completion window” means the time in which Helix has to complete its initial business combination pursuant to the terms of the Helix Articles, which is until the date that is 24 months from the closing of Helix’s IPO, or February 13, 2026.

“Condition Precedent Proposals” means the Business Combination Proposal, the Domestication Proposal, the Stock Issuance Proposal and the Organizational Documents Proposal, the approval of each of which is a condition to consummating the Business Combination.

“Consideration Ratio” means the number of shares of PubCo Common Stock to be issued in exchange for issued and outstanding BBOT capital stock upon the Merger, and is equal to the quotient obtained by dividing (x) the Aggregate Merger Consideration by (y) the Aggregate Fully Diluted BBOT Shares. Assuming that the Aggregate Fully Diluted BBOT Shares on the Closing Date is 484,114,644 shares, which represents the BBOT fully-diluted common stock as of May 7, 2025, and that the Redemption Price is approximately $10.72, which is estimated using an assumed Closing Date of July 31, 2025, the Estimated Consideration Ratio is approximately 0.0889 shares of PubCo Common Stock for every outstanding share of BBOT capital stock on an as-converted basis.

“Continental” means Continental Stock Transfer & Trust Company, Helix’s transfer agent.

“Cormorant” means certain investment vehicles managed by Cormorant Asset Management, LP.

“DGCL” means the Delaware General Corporation Law.

“Director Election Proposal” means the proposal to be considered at the EGM to approve, by ordinary resolution, the election of eight directors to serve on the PubCo Board.

“Domestication” means the domestication of Helix as a Delaware corporation, in which Helix will de-register from the Register of Companies in the Cayman Islands and transfer by way of continuation out of the Cayman Islands and into the State of Delaware so as to migrate to and domesticate as a Delaware corporation in accordance with the Helix Articles, Section 388 of the DGCL and Part XII of the Cayman Companies Act.

“Domestication Effective Time” means the effective time of the Domestication.

“Domestication Proposal” means the proposal to be considered at the EGM to approve, by special resolution, the Domestication.

“DTC” means The Depository Trust Company.

“EGM” means the extraordinary general meeting of Helix’s shareholders, to be held virtually at 10:00 a.m., Eastern Time, on August 4, 2025. The EGM will be a virtual meeting conducted via live webcast at https://www.cstproxy.com/helixacquisitionii/2025. For the purposes of Cayman Islands law and the amended and the Helix Articles, the physical location of the EGM will be at the offices of White & Case LLP at 1221 Avenue of the Americas, New York, New York 10020.

“Employee Lock-Up Holder” means a Lock-Up Holder who was employed at BBOT and held a position below the level of Vice President immediately prior to the Closing.

“Employee Lock-Up Period” means the period beginning on the Closing Date and ending on the day that is the six-month anniversary of the Closing Date.

“Equity Value” means the sum of $461,051,546.

“ESPP” means the BridgeBio Oncology Therapeutics, Inc. 2025 Employee Stock Purchase Plan.

“ESPP Proposal” means the proposal to be considered at the EGM to approve, by ordinary resolution, the ESPP.

“Exchange Act” means the Securities Exchange Act of 1934.

“Founder Shares” means the Helix Class B Shares held by the Sponsor and Helix’s independent directors and advisor.

“Helix” means Helix Acquisition Corp. II (which prior to the Domestication is an exempted company incorporated under the laws of the Cayman Islands and after the Domestication will be a corporation incorporated under the laws of the State of Delaware).

“Helix Articles” means Helix’s amended and restated memorandum and articles of association.

“Helix Board” means the board of directors of Helix.

“Helix Class A Shares” means the Class A ordinary shares of Helix, par value $0.0001 per share.

“Helix Class B Shares” means the Class B ordinary shares of Helix, par value of $0.0001 per share.

“Helix Closing Cash” means the aggregate cash proceeds available for release to Helix from the Trust Account (net of amount to be paid to redeeming Public Shareholders, but for the avoidance of doubt, prior to the payment of any transaction expenses), together with the aggregate cash proceeds actually received from the PIPE Investments.

“Helix Insiders” means the Sponsor, certain directors and officers of Helix, Cormorant, and the independent directors and an advisor of Helix.

“Helix Ordinary Shares” means, collectively, the Helix Class A Shares and Helix Class B Shares.

“Helix Shareholders” means the holders of Helix Ordinary Shares.

“Helix Shareholder Approval” means the requisite vote by Helix Shareholders to approve and adopt the Business Combination Agreement and transactions contemplated thereby.

“Helix Support Agreement” means that certain Helix Support Agreement, dated as of February 28, 2025 (as it may be amended or supplemented time to time), by and between Helix, Helix Insiders and BBOT.

“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

“Incentive Plan Proposal” means the proposal to be considered at the EGM to approve, by ordinary resolution, the PubCo Incentive Plan.

“Latham” means Latham & Watkins, LLP.

“Leerink Partners” means Leerink Partners LLC.

“Lincoln” means Lincoln International LLC.

“Lock-Up Agreement” means the lock-up agreement to be entered into in connection with the Closing pursuant to the Business Combination Agreement by the Helix Insiders and PubCo, pursuant to which the Helix Insiders will agree not to transfer (except for certain permitted transfers) the Lock-Up Shares during the Lock-Up Period.

“Lock-Up Holders” means the BBOT Stockholders who receive shares of PubCo Common Stock from PubCo as consideration pursuant to the Merger, or upon the settlement or exercise of warrants, stock options, restricted stock units or other equity awards assumed, continued, or substituted by PubCo pursuant to the Business Combination Agreement.

“Lock-Up Period” means the duration immediately following the Closing Date until one year after the later of (i) the filing of the Form 10 Information (as defined in Rule 144(i)(3) of the Securities Act) with the SEC and (ii) the Closing Date.

“Lock-Up Shares” means the shares of PubCo Common Stock held by signatories to the Lock-Up Agreement.

“Merger” means the merger of Merger Sub with and into BBOT and BBOT surviving the merger as a wholly-owned subsidiary of Helix.

“Merger Effective Time” means the effective time of the Merger.

“Merger Sub” means Helix II Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Helix.

“Minimum Cash Condition” means the condition that the Helix Closing Cash must equal no less than $400 million.

“Morgan Stanley” means Morgan Stanley & Co. LLC.

“Nasdaq” means the Nasdaq Stock Market, LLC.

“Non-Redeeming Shareholders” means the Helix Shareholders who entered into Non-Redemption Agreements with Helix.

“Non-Redemption Agreements” means the Non-Redemption Agreements, dated February 28, 2025, by and between Helix and the Non-Redeeming Shareholders, pursuant to which, among other things, the Non-Redeeming Shareholders agreed to refrain from exercising their redemption rights with respect to the NRA Shares.

“NRA Shares” means the 450,900 Helix Class A Shares collectively held by the Non-Redeeming Shareholders as of the date of the Non-Redemption Agreements.

“Oppenheimer” means Oppenheimer & Co, Inc.

“Organizational Documents Proposal” means the proposal to be considered at the EGM to approve, by special resolution, the PubCo Organizational Documents.

“Outside Date” means October 31, 2025; provided, that if the SEC has not declared effective the registration statement, of which this proxy statement/prospectus forms a part, on or prior to September 30, 2025, the Outside Date will be automatically extended to December 31, 2025.

“PIPE Investments” means the subscription for approximately $260.9 million of PIPE Shares pursuant to the Subscription Agreements.

“PIPE Investors” means certain qualified institutional buyers, institutional accredited investors and other accredited investors who entered into the Subscription Agreements with Helix.

“PIPE Shares” means the approximately $260.9 million of PubCo Common Stock to be purchased as part of the PIPE Investments.

“Placement Agents” means, collectively, Leerink Partners, Morgan Stanley, Cantor, and Oppenheimer.

“PubCo” means Helix after the consummation of the Domestication, which will be named BridgeBio Oncology Therapeutics, Inc.

“PubCo Bylaws” means the proposed new bylaws of PubCo, to take effect upon the Domestication.

“PubCo Charter” means the proposed new certificate of incorporation of PubCo, to take effect upon the Domestication.

“PubCo Common Stock” means PubCo’s common stock, par value $0.0001 per share.

“PubCo Incentive Plan” means the BridgeBio Oncology Therapeutics, Inc. 2025 Stock Option and Incentive Plan.

“PubCo Option” means an option of PubCo containing the same terms, conditions, vesting and other provisions as are currently applicable to such BBOT Options, provided that each PubCo Option will be exercisable for the number of shares of PubCo Common Stock equal to the Consideration Ratio multiplied by the number of shares of BBOT common stock subject to the BBOT Option as of immediately prior to the Merger Effective Time, rounded down to the nearest whole share, at an exercise price equal to the per share exercise price of the BBOT Option divided by the Consideration Ratio, rounded up to the nearest whole cent.

“PubCo Organizational Documents” means, collectively, the PubCo Charter and PubCo Bylaws.

“Public Shareholder” means a holder of Public Shares.

“Public Shares” means the Helix Class A Shares initially issued in Helix’s initial public offering (whether they are purchased in the initial public offering or thereafter in the open market).

“Public Shares subject to redemption” means the Public Shares held by Public Shareholders other than Cormorant and the Non-Redeeming Shareholders.

“Redemption Price” means the per-share price, payable in cash, equal to the pro rata portion of the funds held the Trust Account (including interest earned on the funds held in the Trust Account not previously released to Helix to pay its taxes, net of taxes payable), calculated as of two business days prior to the consummation of the Business Combination) at which each Public Share may be redeemed in connection with the Business Combination, pursuant to the Helix Articles.

“Record Date” means June 30, 2025.

“SEC” means the Securities and Exchange Commission.

“Securities Act” means the Securities Act of 1933, as amended.

“Sodali” means Sodali & Co.

“SPAC” means a special purpose acquisition company.

“Sponsor” means Helix Holdings II LLC, a Cayman Islands limited liability company.

“Sponsor Contributed Shares” means the number of shares of PubCo Common Stock equal to (A) 3,360,000 multiplied by (B) one minus the number resulting from dividing (a) the actual Helix Closing Cash by (b) $400 million to be contributed by the Sponsor if the Minimum Cash Condition has not been met and Helix has used good faith efforts to meet the Minimum Cash Condition.

“Sponsor Forfeited Shares” means the Helix Class B Shares to be forfeited by the Sponsor to Helix, equal to the quotient of the difference between (a) the Redemption Price multiplied by 4,600,000 less (b) $46,000,000 divided by the Redemption Price.

“Subscription Agreements” means the subscription agreements, dated February 28, 2025, by and between Helix and the PIPE Investors.

“Stock Issuance Proposal” means the proposal to be considered at the EGM to approve, by ordinary resolution, including for purposes of complying with the applicable provisions of Nasdaq Listing Rules 5635(a), (b) and (d), the issuance or potential issuance of (i) shares of PubCo Common Stock to the Helix Shareholders in the Domestication and BBOT Stockholders in the Merger pursuant to the Business Combination Agreement, (ii) shares of PubCo Common Stock to the PIPE Investors in the PIPE Investment pursuant to the Subscription Agreements and (iii) any other issuances of PubCo Common Stock and securities convertible into or exercisable for PubCo Common Stock pursuant to subscription, purchase or similar agreements Helix has entered, or may enter, into prior to the Closing.

“Surviving Corporation” means BBOT after the Merger.

“Transaction Committee” means the Transaction Committee of the Helix Board.

“Trust Account” means the trust account established in connection with Helix’s initial public offering.

“Underwriting Agreement” means the Underwriting Agreement, dated February 8, 2024, by and between Helix and Leerink Partners.

“U.S. GAAP” means the accounting principles generally accepted in the United States of America.

“Working Capital Loans” means any loans provided by the Sponsor, Cormorant and Helix’s officers and directors to finance transaction costs in connection with the Business Combination.

FINANCIAL STATEMENT PRESENTATION

Helix

The historical unaudited condensed consolidated financial statements of Helix as of and for the three months ended March 31, 2025 and the historical audited financial statements of Helix as of and for the years ended December 31, 2024 and 2023 were prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and are denominated in U.S. dollars.

BBOT

The historical unaudited condensed financial statements of BBOT as of and for the three months ended March 31, 2025 and the historical audited financial statements of BBOT as of and for the years ended December 31, 2024 and 2023 were prepared in accordance with U.S. GAAP and are denominated in U.S. dollars.

Rounding and Negative Amounts

Certain numerical information and other amounts and percentages in this proxy statement/prospectus, including financial data, have been rounded. Accordingly, in certain instances, the sum of the numbers in a column or a row in tables may not conform exactly to the total figure given for that column or row or the sum of certain numbers presented as a percentage may not conform exactly to the total percentage given.

In preparing the audited and unaudited historical financial statements of Helix and BBOT, most numerical figures are presented in thousands. For the convenience of the reader of this proxy statement/prospectus, certain numerical figures in this proxy statement/prospectus are rounded to the nearest thousand. As a result of this rounding, certain numerical figures presented herein may vary slightly from the corresponding numerical figures presented in Helix’s and BBOT’s financial statements.

The percentages presented in the textual financial disclosure in this proxy statement/prospectus are derived directly from the financial information contained in Helix’s and BBOT’s financial statements. The percentages derived from Helix’s and BBOT’s financial statements may be computed using the numerical figures expressed in thousands in its financial statements. Therefore, such percentages are not calculated on the basis of the financial information in the textual disclosure that has been subjected to rounding adjustments in this proxy statement/prospectus.

In tables, negative amounts are shown between parentheses. Otherwise, negative amounts may also be shown by “—” before the amount.

Currency Presentation

The financial statements of Helix and BBOT are measured and presented using United States dollars.

References to “$,” “US$” and “U.S. dollar” each refer to the United States dollar.

MARKET AND INDUSTRY DATA

Helix and BBOT are responsible for the disclosure contained in this proxy statement/prospectus. However, information contained in this proxy statement/prospectus concerning the market and the industry in which BBOT competes, including its market position, general expectations of market opportunity, size and growth rates, is based on information from various third-party sources, on assumptions made by BBOT based on such sources and BBOT’s knowledge of the markets for its services and solutions. This information and any estimates provided herein involve numerous assumptions and limitations, and third-party sources generally state that the information contained in such source has been obtained from sources believed to be reliable. The industry in which BBOT operates is subject to a high degree of uncertainty and risk. As a result, the estimates and market and industry information provided in this proxy statement/prospectus are subject to change based on various factors, including those described in “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors — Risks Related to BBOT and the Business Combination” and elsewhere in this proxy statement/prospectus.

Industry publications, research, studies and forecasts generally state that the information they contain has been obtained from sources believed to be reliable, but that the accuracy and completeness of such information is not guaranteed. Although Helix and BBOT have not independently verified the accuracy or completeness of third-party information, Helix and BBOT believe the industry and market information included in this proxy statement/prospectus is reliable. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and uncertainties as the other forward-looking statements in this proxy statement/prospectus. These forecasts and forward-looking information are subject to uncertainty and risk due to a variety of factors, including those described under “Risk Factors.” These and other factors could cause results to differ materially from those expressed in any forecasts or estimates.

Notwithstanding anything in this proxy statement/prospectus to the contrary, Helix and BBOT are responsible for all disclosures in this proxy statement/prospectus.

QUESTIONS AND ANSWERS ABOUT THE BUSINESS COMBINATION

The questions and answers below highlight only selected information from this proxy statement/prospectus and only briefly address some commonly asked questions about the EGM and the proposals to be presented at the EGM, including with respect to the Business Combination. The following questions and answers do not include all the information that is important to Helix Shareholders. Shareholders are urged to read carefully this entire proxy statement/prospectus, including the Annexes and the other documents referred to herein, to fully understand the Business Combination and the voting procedures for the EGM.

Q:     Why am I receiving this proxy statement/prospectus?

A:     You are receiving this proxy statement/prospectus because you are a shareholder of Helix and you are entitled to vote at the EGM to approve the matters set forth herein. This document serves as:

•        a proxy statement of Helix to solicit proxies for the EGM to vote on the proposals set forth herein; and

•        a prospectus of Helix to offer PubCo Common Stock to Helix Shareholders and BBOT Stockholders (other than the BBOT Consenting Stockholders) in the Business Combination.

Helix Shareholders are being asked to consider and vote upon, among other proposals, a proposal to approve and adopt the Business Combination Agreement and approve the Business Combination. Helix is proposing to consummate the Business Combination with BBOT. Helix, Merger Sub and BBOT have entered into the Business Combination Agreement, the terms of which are described in this proxy statement/prospectus. A copy of the Business Combination Agreement is attached hereto as Annex A. Helix urges its shareholders to read the Business Combination Agreement in its entirety.

THE VOTE OF HELIX SHAREHOLDERS IS IMPORTANT. HELIX SHAREHOLDERS ARE URGED TO SUBMIT THEIR PROXIES AS SOON AS POSSIBLE AFTER CAREFULLY REVIEWING THIS PROXY STATEMENT/PROSPECTUS AND CAREFULLY CONSIDERING EACH OF THE PROPOSALS BEING PRESENTED AT THE EGM.

Q:     What proposals are Helix Shareholders being asked to vote on?

A:     At the EGM, Helix is asking holders of Helix Ordinary Shares to consider and vote upon the following proposals:

•        the Business Combination Proposal;

•        the Domestication Proposal;

•        the Stock Issuance Proposal;

•        the Organizational Documents Proposal;

•        the Advisory Organizational Documents Proposals;

•        the Incentive Plan Proposal;

•        the ESPP Proposal;

•        the Director Election Proposal; and

•        the Adjournment Proposal (if presented).

If Helix’s shareholders do not approve each of the Condition Precedent Proposals, then unless certain conditions in the Business Combination Agreement are waived by the applicable parties to the Business Combination Agreement, the Business Combination Agreement could be terminated and the Business Combination may not be consummated. See “Proposal No. 1 — The Business Combination Proposal,” “Proposal No. 2 — The Domestication Proposal,” “Proposal No. 3 — The Stock Issuance Proposal” and “Proposal No. 4 — The Organizational Documents Proposal” and “The Business Combination,” of this proxy statement/prospectus, respectively.

Helix will hold the EGM to consider and vote upon these proposals. This proxy statement/prospectus contains important information about the Business Combination and the other matters to be acted upon at the EGM. Helix Shareholders should read it carefully.

After careful consideration, the Helix Board has determined that each of the Business Combination Proposal, the Domestication Proposal, the Stock Issuance Proposal, the Organizational Documents Proposal, the Advisory Organizational Documents Proposals, the Incentive Proposal, the ESPP Proposal, the Director Election Proposal and the Adjournment Proposal, if presented, are fair, advisable, and in the best interests of Helix and its shareholders and unanimously recommends that you vote or give instruction to vote “FOR” each of those proposals.

The existence of financial and personal interests of one or more of Helix’s directors may result in a conflict of interest on the part of such director(s) between what he or they may believe is in the best interests of Helix and its shareholders and what he or they may believe is best for himself or themselves in determining to recommend that shareholders vote for the proposals. In addition, the Sponsor, Cormorant, and Helix’s officers have interests in the Business Combination that may conflict with your interests as a shareholder. See “Proposal No. 1 — The Business Combination Proposal– Interests of the Sponsor, Cormorant, and Helix’s Directors and Officers in the Business Combination” for a further discussion of these considerations.

Q:     Are the proposals conditioned on one another?

A:     Yes. The Business Combination is conditioned on the approval of each of the Condition Precedent Proposals at the EGM. Each of the Condition Precedent Proposals is cross-conditioned on the approval of each other Condition Precedent Proposal. The Advisory Organizational Documents Proposals, Director Election Proposal, Incentive Plan Proposal, and ESPP Proposal are each also conditioned on the approval of the Condition Precedent Proposals. The Adjournment Proposal is not conditioned upon the approval of any other proposal set forth in the accompanying proxy statement/prospectus.

Q:     I am a holder of Public Shares. Why am I receiving this proxy statement/prospectus?

A:     Upon consummation of the Business Combination, and without any action on the part of any party or any other person, each outstanding Helix Class A Share (excluding Public Shares validly submitted for redemption and the Sponsor Forfeited Shares, but including Helix Class A Shares issued upon the Class B Share Conversion) will be reclassified as one share of PubCo Common Stock. This proxy statement/prospectus includes important information about PubCo and the business of PubCo and its subsidiaries following consummation of the Business Combination. Helix urges you to read the information contained in this proxy statement/prospectus carefully.

Q:     Why is Helix proposing the Business Combination?

A:     Helix was incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or other similar business combination with one or more businesses.

On February 13, 2024, Helix consummated its initial public offering of 18,400,000 Helix Class A Shares, including the issuance of 2,400,000 Helix Class A Shares as a result of the underwriter’s exercise in full of its over-allotment option. The Helix Class A Shares were sold at a price of $10.00 per share, generating gross proceeds to Helix of $184,000,000. Simultaneously with the IPO, the Sponsor purchased 509,000 Helix Class A Shares at a purchase price of $10.00 per share, generating gross proceeds to Helix of $5,090,000. A total of $184,000,000, comprised of the net proceeds from the IPO and the sale of the private placement shares to the Sponsor, was placed in the Trust Account and invested in U.S. government securities, within the meaning set forth in Section 2(a)(16) of the Investment Company Act of 1940, as amended (the “Investment Company Act”), with a maturity of 185 days or less or in money market funds meeting certain conditions under Rule 2a-7 under the Investment Company Act which invest only in direct U.S. government treasury obligations. Since the IPO, Helix’s activity has been limited to the evaluation of business combination target companies.

BBOT is a clinical-stage biotechnology company with the mission of transforming the lives of patients with cancers driven by RAS and PI3Kα, the two most frequently mutated oncogenes. The Helix Board considered a wide variety of factors in connection with its evaluation of the Business Combination, including the evaluation and recommendation of the Transaction Committee as well as the Transaction Committee’s and Helix Board’s review of the results of the due diligence conducted by Helix management and its advisors. As a result, the

Transaction Committee and the Helix Board concluded that the Business Combination with BBOT would present a unique business combination opportunity and is in the best interests of Helix and its shareholders. The Transaction Committee and the Helix Board also considered certain potentially material negative factors as well as certain potential conflicts of interest in arriving at that conclusion. These factors are discussed in greater detail in the section entitled “Proposal No. 1 — The Business Combination Proposal — The Transaction Committee’s and the Helix Board’s Reasons for the Approval of the Business Combination,” as well as in the section entitled “Risk Factors”.

Q:     What will happen in the Business Combination?

A:     The Business Combination is structured as follows:

(A)    Immediately prior to the Domestication, (1) Helix will effect the redemption of the Public Shares that are validly submitted for redemption and not withdrawn, (2) the Sponsor will surrender to Helix the Sponsor Forfeited Shares, and (3) the Class B Share Conversion will occur, whereby each holder of each issued and outstanding Helix Class B Share (other than the Sponsor Forfeited Shares) will irrevocably and unconditionally elect to convert, on a one-for-one basis, each Helix Class B Share held by it into one Helix Class A Share.

(B)    The Domestication is intended to occur one business day prior to the Closing, whereby Helix will de-register in the Cayman Islands and transfer by way of continuation out of the Cayman Islands and into the State of Delaware so as to migrate to and domesticate as a Delaware corporation. In connection with the Domestication, Helix will change its name to “BridgeBio Oncology Therapeutics, Inc.”

(C)    At the effective time of the Domestication, each outstanding Helix Class A Share (excluding Public Shares validly submitted for redemption and the Sponsor Forfeited Shares, but including Helix Class A Shares issued upon the Class B Share Conversion) will be reclassified as one share of PubCo Common Stock.

(D)    On the day of the Closing, the Sponsor will surrender and forfeit the Sponsor Contributed Shares, if any, and the Merger will occur. At the Merger Effective Time, each share of BBOT’s capital stock that is issued and outstanding as of immediately prior to the Merger Effective Time (excluding treasury shares and dissenting shares) will be automatically canceled and converted into the right to receive a corresponding number of shares of PubCo Common Stock equal to the Consideration Ratio (see “Consideration” below).

(E)    Additionally, at the Merger Effective Time, each outstanding and unexercised BBOT Option will become a PubCo Option containing the same terms, conditions, vesting and other provisions as are currently applicable to such BBOT Options, provided that each PubCo Option will be exercisable for the number of shares of PubCo Common Stock equal to the Consideration Ratio multiplied by the number of shares of BBOT common stock subject to the BBOT Option as of immediately prior to the Merger Effective Time, rounded down to the nearest whole share, at an exercise price equal to the per share exercise price of the BBOT Option divided by the Consideration Ratio, rounded up to the nearest whole cent.

Q:     What are the reasons for the structure and timing of the Business Combination, the PIPE Investment, and the Non-Redemption Agreements?

A:     Helix was incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or other similar business combination with one or more businesses. Following the completion of Helix’s IPO, at the direction of the Helix Board, Helix’s management and directors commenced a search for potential business combination targets, leveraging Helix’s and Cormorant’s network of biotech company founders and executives, investment bankers, private equity firms and hedge funds and numerous other business relationships, as well as the prior experience and network of Helix’s management and directors. Helix conducted preliminary due diligence on, and entered into confidentiality agreements with, 50 companies from February 2024 through February 2025, including BBOT. Helix management ultimately decided not to pursue continued discussions with such alternate targets because Helix concluded that these other target businesses were not suitable business combination opportunities for Helix based on, among other factors, its due diligence indicating that the target businesses did not meet the criteria Helix had established at the time of its IPO, and instead Helix focused its efforts on BBOT.

Cormorant was initially introduced to BBOT in January 2024 by Neil Kumar, CEO of BridgeBio Pharma, a publicly traded biopharmaceutical company, in the context of a potential spinout of BBOT from BridgeBio Pharma. Prior to April 2024, BBOT was a majority-owned subsidiary of BridgeBio Pharma. In April 2024, Cormorant invested $35 million in the BBOT Series B Financing. At the time of Cormorant’s Series B investment, Helix did not consider BBOT to be a potential Helix target, as all of its programs were preclinical without imminent clinical catalysts. As a result of its Series B investment, Cormorant currently holds approximately 9.2% of the issued and outstanding equity securities of BBOT on a fully-diluted basis, has appointed a designee to the board of directors of BBOT, and has board observer rights. In late 2024, in light of the clinical data from the Phase 1 ONKORAS-101 study for BBO-8520, which is BBOT’s first program targeting KRAS, the most mutated oncogene (see “Information about BBOT”), emerging at an accelerated timeline, Helix’s management team started considering BBOT as a potential target candidate because BBOT’s product candidates were further along in development and BBOT satisfied more of Helix’s key criteria for a business combination target. Helix learned that BBOT was considering raising additional financing in 2025, including “crossover” (or mezzanine) financing or potentially a traditional initial public offering. On December 16, 2024, members of the Helix management team engaged in preliminary discussions with Dr. Wallace of BBOT regarding a potential business combination. However, until the execution of the letter of intent on January 16, 2025, there was no agreement, arrangement, or understanding between BBOT and Cormorant, Ms. Chen, or Helix to enter into a business combination with Helix, and no agreement, arrangement, or understanding between Helix and Ms. Chen or Cormorant with respect to determining whether to explore a potential business combination with BBOT or to proceed with the Business Combination. The terms of the Business Combination Agreement are the result of extensive negotiations between the representatives of Helix and BBOT, each in consultation with its advisors, which occurred between December 2024 and February 2025.

Helix and BBOT pursued both the PIPE Investment and Non-Redemption Agreements in order to provide additional capital to fund BBOT’s operations, research and development, and administration after the Business Combination is completed.

Concurrently with the execution of the Business Combination Agreement, on February 28, 2025, Helix entered into Subscription Agreements with 17 PIPE Investors, subscribing for an aggregate of approximately $260.9 million of PubCo Common Stock. Existing BBOT Stockholders (other than Cormorant and investors who were existing Helix Shareholders) subscribed for approximately $25 million of the PIPE Investments, existing Helix Shareholders (other than Cormorant and investors who were existing BBOT Stockholders) subscribed for approximately $85 million of the PIPE Investments, investors who were both existing shareholders of Helix and BBOT (other than Cormorant) subscribed for approximately $22.9 million of the PIPE Investments, Cormorant subscribed for an aggregate of $75 million of PIPE Investments, and investors who were neither existing BBOT Stockholders nor existing Helix Shareholders subscribed for $53 million of the PIPE Investments.

Additionally, concurrently with the execution of the Business Combination Agreement, on February 28, 2025, Helix entered into Non-Redemption Agreements with Non-Redeeming Shareholders, pursuant to which the Non-Redeeming Shareholders agreed not to redeem an aggregate of 450,900 NRA Shares at any meeting of Helix Shareholders. Assuming a Redemption Price of approximately $10.72, which is estimated using an assumed Closing Date of July 31, 2025, the NRA Shares will represent approximately $4.8 million in retained funds in the Trust Account. The Non-Redemption Agreements do not provide for any consideration to be paid by Helix or BBOT to the Non-Redeeming Shareholders in connection with such agreements. The Sponsor and Cormorant are not parties to the Non-Redemption Agreements.

As contemplated by the Business Combination Agreement, the structure and timing of the Business Combination, PIPE Investment, and Non-Redemption Agreements are consistent with common practice in initial business combination transactions consummated by special purpose acquisition companies. In addition, the timing for the consummation of the Business Combination provided for in the Business Combination Agreement, Subscription Agreements, and Non-Redemption Agreements, which was effectively as soon as reasonably practicable following the execution of the Business Combination Agreement, was determined and agreed by the parties in light of general business considerations weighing in favor of consummating the transaction promptly and the deadline for Helix to complete an initial business combination pursuant to the Helix Articles.

For more information, see “Proposal No. 1 — The Business Combination Proposal — Background of the Business Combination.”

Q:     What will Helix Shareholders receive in the Business Combination?

A:     Upon the Domestication, each outstanding Helix Class A Share (excluding Public Shares validly submitted for redemption and the Sponsor Forfeited Shares, but including Helix Class A Shares issued upon the Class B Share Conversion) will be reclassified as one share of PubCo Common Stock.

Q:     What will BBOT Stockholders receive in the Business Combination?

A:     At the Merger Effective Time, each share of BBOT’s capital stock that is issued and outstanding as of immediately prior to the Merger Effective Time (excluding treasury shares and dissenting shares) will be automatically canceled and converted into the right to receive a corresponding number of shares of PubCo Common Stock equal to the Consideration Ratio.

The Aggregate Merger Consideration to be issued to BBOT Stockholders in connection with the Merger will be determined by dividing (a) the Equity Value by (b) the Redemption Price. The Consideration Ratio is equal to the quotient obtained by dividing (x) the Aggregate Merger Consideration by (y) the Aggregate Fully Diluted Shares. Accordingly, assuming that the Aggregate Fully Diluted BBOT Shares on the Closing Date is 484,114,644 shares, which represents the BBOT fully-diluted common stock as of May 7, 2025, and that the Redemption Price is approximately $10.72, which is estimated using an assumed Closing Date of July 31, 2025, the Estimated Consideration Ratio is approximately 0.0889 shares of PubCo Common Stock for every outstanding share of BBOT capital stock on an as-converted basis.

Additionally, at the Merger Effective Time, each outstanding and unexercised BBOT Option will become a PubCo Option containing the same terms, conditions, vesting and other provisions as are currently applicable to such BBOT Options, provided that each PubCo Option will be exercisable for the number of shares of PubCo Common Stock equal to the Consideration Ratio multiplied by the number of shares of BBOT common stock subject to the BBOT Option as of immediately prior to the Merger Effective Time, rounded down to the nearest whole share, at an exercise price equal to the per share exercise price of the BBOT Option divided by the Consideration Ratio, rounded up to the nearest whole cent.

In considering the recommendation of the Helix Board to vote in favor of approval of the proposals set forth in this proxy statement/prospectus, unaffiliated Helix Shareholders should keep in mind that the Sponsor, Cormorant, and Helix’s directors and officers and entities affiliated with them, have interests in such proposals that are different from, or in addition to, those of unaffiliated Helix Shareholders. See “Proposal No. 1 — The Business Combination Proposal — Interests of the Sponsor, Cormorant, and Helix’s Directors and Officers in the Business Combination” and “Certain Relationships and Related Persons Transactions” for more information.

Q:     Will Helix and BBOT obtain new financing in connection with the Business Combination and are there any arrangements to help ensure that Helix will have sufficient funds to consummate the Business Combination and that PubCo has sufficient funds to operate BBOT’s business following the Closing?

A:     In connection with entering into the Business Combination Agreement, on February 28, 2025, Helix entered into the Subscription Agreements with certain qualified institutional buyers, institutional accredited investors, and, other accredited investors, including Cormorant and other existing shareholders of Helix pursuant to which, among other things, Helix agreed to issue and sell to the PIPE Investors, and the PIPE Investors agreed to subscribe for and purchase an aggregate of approximately $260.9 million of PubCo Common Stock, at a purchase price equal to the Redemption Price. Existing BBOT Stockholders (other than Cormorant and investors who were existing Helix Shareholders) subscribed for approximately $25 million of the PIPE Investments, existing Helix Shareholders (other than Cormorant and investors who were existing BBOT Stockholders) subscribed for approximately $85 million of the PIPE Investments, investors who were both existing shareholders of Helix and BBOT (other than Cormorant) subscribed for approximately $22.9 million of the PIPE Investments, Cormorant subscribed for an aggregate of $75 million of PIPE Investments, and investors who were neither existing BBOT Stockholders nor existing Helix Shareholders subscribed for $53 million of the PIPE Investments.

The obligations of the PIPE Investors to consummate the PIPE Investments are conditioned upon, among other things: (i) the PubCo Common Stock, including the PIPE Shares, having been approved for listing on Nasdaq, subject only to official notice of issuance; (ii) the satisfaction or waiver of the conditions to closing set forth in Article IX of the Business Combination Agreement; (iii) the Business Combination Agreement not having been amended, modified or supplemented, and no condition having been waived in any manner that would materially

adversely affect the economic benefits the PIPE Investors reasonably expect to receive under the Subscription Agreements; (iv) no subscription agreement, side letter, or other agreement or understanding with any other PIPE Investor having been amended, modified, or waived in any manner that benefits such other PIPE Investor unless each PIPE Investor has been offered the same benefits; (v) Helix having received not less than $200 million in cash from the PIPE Investments; and (vi) no BBOT Material Adverse Effect or Helix Material Adverse Effect having occurred. Conditions (i) and (ii) above are for the benefit of all parties to the Subscription Agreements and subject to waiver by all parties to the Subscription Agreements, and conditions (iii) through (vi) above are for the benefit of and subject to waiver by each PIPE Investor individually. For more information, see “Proposal No. 1 — The Business Combination Proposal — Ancillary Agreements — Subscription Agreements.”

Additionally, in connection with entering into the Business Combination Agreement, on February 28, 2025, Helix entered into the Non-Redemption Agreements with the Non-Redeeming Shareholders, pursuant to which, among other things, the Non-Redeeming Shareholders irrevocably and unconditionally agreed, for the benefit of Helix, that neither they nor their controlled affiliates will exercise any redemption rights under Helix’s Articles with respect to the 450,900 NRA Shares at any meeting of the Helix Shareholders. Assuming a Redemption Price of approximately $10.72, which is estimated using an assumed Closing Date of July 31, 2025, the NRA Shares will represent approximately $4.8 million in retained funds in the Trust Account. Each of the Non-Redeeming Shareholders also agreed (i) not to transfer directly or indirectly the NRA Shares held by it until earlier of (x) the Closing Date, (y) the termination of the Business Combination Agreement in accordance with its terms and (z) the termination of the Non-Redemption Agreement in accordance with its terms; and (ii) to vote its NRA Shares in favor of the Business Combination Agreement, the Domestication and Merger and each other proposal brought by the Helix in connection with the Business Combination and in favor of any proposal brought by Helix to adjourn or postpone the EGM. The Non-Redemption Agreements do not provide for any consideration to be paid by Helix or BBOT to the Non-Redeeming Shareholders in connection with such agreements. The Sponsor and Cormorant are not parties to the Non-Redemption Agreements. For more information, see “Proposal No. 1 — The Business Combination Proposal — Ancillary Agreements — Non-Redemption Agreements.”

Under the Business Combination Agreement, the obligations of the parties to consummate the Business Combination are subject to the satisfaction or waiver of certain closing conditions of the respective parties, including, without limitation, the Helix Closing Cash equaling no less than $400 million. As of the date of this proxy statement/prospectus, the Minimum Cash Condition has not been satisfied. The parties intend to satisfy the Minimum Cash Condition through the PIPE Investment and through amounts released to us from the Trust Account. In the event the Minimum Cash Condition is not satisfied as a result of redemptions of Public Shares which reduce the amount available to be released to us from the Trust Account, BBOT may, in its sole discretion, waive the Minimum Cash Condition. If BBOT waives the Minimum Cash Condition, Helix intends to file a Current Report on Form 8-K within four business days of such event, however such condition may be waived at any time prior to the Closing, including after the deadline for submitting redemption requests or the EGM, and, given such timing, you may not be notified before the deadline for submitting redemption requests or the EGM. For more information, see “Proposal No. 1 — The Business Combination Proposal — The Business Combination Agreement — Conditions to Closing.”

Q:     What equity stake will current Helix Shareholders and BBOT Stockholders hold in PubCo immediately after the Closing?

A:    The following tables illustrate estimated ownership levels in PubCo, immediately following the consummation of the Business Combination, based on varying levels of redemptions by Public Shareholders. In the following tables, the No Redemptions Scenario and Minimum Cash Condition Redemptions Scenario each assume that the $400.0 million Minimum Cash Condition is satisfied through a combination of the approximately $260.9 million PIPE Investments and retained funds in the Trust Account. The 75% Redemptions Scenario and Full Redemptions Scenario each represent redemptions in excess of the amount required to meet the Minimum Cash Condition and assume that BBOT, in its sole discretion, waives the Minimum Cash Condition. In the event the Minimum Cash Condition is not satisfied as a result of redemptions of Public Shares which reduce the amount available to be released to us from the Trust Account, BBOT may, in its sole discretion, waive the Minimum Cash Condition. If BBOT waives the Minimum Cash Condition, Helix intends to file a Current Report on Form 8-K within four business days of such event, however such condition may be waived at any time prior to the Closing, including after the deadline for submitting redemption requests or the EGM, and, given such timing, you may not be notified before the deadline for submitting redemption requests or the EGM.

The following table excludes the dilutive effect of PubCo Options and shares of PubCo Common Stock that will initially be available for issuance under the PubCo Incentive Plan and ESPP.

____________

*        Less than 1%.

**      Assumes that BBOT, in its sole discretion, waives the Minimum Cash Condition and no additional equity financing is obtained. The Full Redemptions Scenario represents the redemption of all Public Shares held by Public Shareholders (excluding Cormorant) other than the 450,900 shares that are subject to Non-Redemption Agreements.

(1)      Amount comprises the unredeemed Public Shares in a variety of redemptions scenarios, excluding 2,400,000 shares held by Cormorant which are presented in the row labeled “Sponsor and Cormorant”. This amount reflects the assumed redemption of 0 shares under the No Redemptions Scenario, 5,236,672 shares redeemed under the Minimum Cash Condition Redemptions Scenario, 11,661,825 shares redeemed under the 75% Redemptions Scenario, and 15,549,100 shares redeemed under the Full Redemptions Scenario.

(2)      Amount includes 4,172,133 Founder Shares held by the Sponsor, 509,000 Helix Class A Shares held by Sponsor, 2,400,000 Helix Class A Shares held by Cormorant, 6,998,042 shares purchased by Cormorant as part of the PIPE Investment, and 3,950,427 shares from BBOT ownership held by Cormorant. This amount includes the following forfeitures:

•        Sponsor Forfeited Shares: 307,867 shares surrendered and forfeited under all redemptions scenarios.

•        Sponsor Contributed Shares: 570,331 shares surrendered and forfeited under the 75% Redemptions Scenario and 915,387 shares surrendered and forfeited under the Full Redemptions Scenario.

(3)      Amount includes 30,000 Founder Shares held by each of Helix’s independent directors and advisor.

(4)      Amount includes 38,905,377 shares of PubCo Common Stock issued to BBOT Stockholders less 3,950,427 shares that will be held by Cormorant, which are presented in the row labeled “Sponsor and Cormorant”. The amounts in the table do not include the potentially dilutive shares that could be issued, specifically 4,113,979 PubCo Options issued to BBOT optionholders.

(5)      Amount includes the estimated shares of PubCo Common Stock to be issued to the PIPE Investors of 24,343,757, using the Estimated Redemption Price of approximately $10.72 per share, less the 6,998,042 shares to be purchased by Cormorant as part of the PIPE Investment (which are presented in the row labeled “Sponsor and Cormorant”).

The following table shows possible sources of dilution and the extent of such dilution that non-redeeming Public Shareholders could experience in connection with the closing of the Business Combination. In an effort to illustrate the extent of such dilution, the table below assumes the exercise of all PubCo Options for cash, which will each be exercisable for one share of PubCo Common Stock at a price of approximately $10.72 per

share (based on the Estimated Consideration Ratio). The table excludes shares of PubCo Common Stock that will initially be available for issuance under the PubCo Incentive Plan and ESPP, as such shares will not be outstanding on the Closing Date.

____________

*        Less than 1%.

**      Assumes that BBOT, in its sole discretion, waives the Minimum Cash Condition and no additional equity financing is obtained. The Full Redemptions Scenario represents the redemption of all Public Shares held by Public Shareholders (excluding Cormorant) other than the 450,900 shares that are subject to Non-Redemption Agreements.

(1)      Amount comprises the unredeemed Public Shares in a variety of redemptions scenarios, excluding 2,400,000 shares held by Cormorant which are presented in the row labeled “Sponsor and Cormorant”. This amount reflects the assumed redemption of 0 shares under the No Redemptions Scenario, 5,236,672 shares redeemed under the Minimum Cash Condition Redemptions Scenario, 11,661,825 shares redeemed under the 75% Redemptions Scenario, and 15,549,100 shares redeemed under the Full Redemptions Scenario.

(2)      Amount includes 4,172,133 Founder Shares held by the Sponsor, 509,000 Helix Class A Shares held by Sponsor, 2,400,000 Helix Class A Shares held by Cormorant, 6,998,042 shares purchased by Cormorant as part of the PIPE Investment, and 3,950,427 shares from BBOT ownership held by Cormorant. This amount includes the following forfeitures:

•        Sponsor Forfeited Shares: 307,867 shares surrendered and forfeited under all redemptions scenarios.

•        Sponsor Contributed Shares: 570,331 shares surrendered and forfeited under the 75% Redemptions Scenario and 915,387 shares surrendered and forfeited under the Full Redemptions Scenario.

(3)      Amount includes 30,000 Founder Shares held by each of Helix’s independent directors and advisor.

(4)      Amount includes 38,905,377 shares of PubCo Common Stock issued to BBOT Stockholders less 3,950,427 shares that will be held by Cormorant, which are presented in the row labeled “Sponsor and Cormorant”. The amounts in the table do not include the potentially dilutive shares that could be issued, specifically 4,113,979 PubCo Options issued to BBOT optionholders.

(5)      Amount includes the estimated shares of PubCo Common Stock to be issued to the PIPE Investors of 24,343,757, using the Estimated Redemption Price of approximately $10.72 per share, less the 6,998,042 shares to be purchased by Cormorant as part of the PIPE Investment (which are presented in the row labeled “Sponsor and Cormorant”).

Share ownership presented in the two tables above is only presented for illustrative purposes and does not necessarily reflect what PubCo’s share ownership will be after the Closing. Helix and BBOT cannot predict how many of the Public Shareholders will exercise their right to have their Public Shares redeemed for cash. As a result, the redemption amount and the number of Public Shares redeemed in connection with the Business Combination may differ from the amounts presented above, and therefore the ownership percentages of Public Shareholders may also differ if the actual redemptions are different from these assumptions. The Public Shareholders that do not elect to redeem their Public Shares will experience immediate dilution as a result of the Business Combination. The Public Shareholders currently own approximately 68.1% of the issued and outstanding Helix Ordinary Shares. As noted in the above table, even if no Public Shareholders redeem their Public Shares in the Business Combination, the Public Shareholders’ ownership will decrease from approximately 68.1% of the Helix Ordinary Shares prior to the Business Combination to owning approximately 18.5% of the total outstanding PubCo Common Stock at the Closing. As redemptions increase, the overall percentage ownership held by the Sponsor, Cormorant and other Helix Insiders, BBOT Stockholders and the PIPE Investors will increase as

compared to the overall percentage ownership and voting percentage held by Public Shareholders, thereby increasing dilution to Public Shareholders. For more information about the consideration to be received in the Business Combination, these scenarios, and the underlying assumptions, see “Unaudited Pro Forma Combined Financial Information.” See also “Risk Factors — The Public Shareholders will experience immediate dilution as a consequence of the issuance of PubCo Common Stock as consideration in the Business Combination and due to future issuances of equity awards to BBOT employees, directors, or consultants. Having a minority share position may reduce the influence that our current shareholders have on the management of PubCo.”

Q:     What is the effective purchase price attributed to the PubCo Common Stock to be received by the Public Shareholders, the Sponsor, Cormorant, the other Helix Insiders, and the BBOT Stockholders at Closing?

A.     Pursuant to the Business Combination Agreement, Public Shareholders who do not redeem their Public Shares will receive one share of PubCo Common Stock for each Helix Class A Share held by them immediately prior to the Domestication. While Helix cannot be certain of the price such Public Shareholders paid for their Public Shares, assuming they purchased their Public Shares for $10.00 per share, which was the price of the Helix Class A Shares sold in Helix’s IPO, the effective purchase price paid per share of PubCo Common Stock issued to each Public Shareholder at Closing would be $10.00. In connection with Helix’s IPO, the Sponsor paid an aggregate of $25,000 for the Founder Shares, or approximately $0.006 per share. In connection with the Business Combination, assuming the surrender and forfeiture of 307,867 Sponsor Forfeited Shares and no surrender and forfeiture of Sponsor Contributed Shares, an aggregate of 4,172,133 Founder Shares held by the Sponsor and an additional 120,000 Founder Shares held by Helix’s independent directors and advisor will be voluntarily converted on a one-for-one basis into Helix Class A Shares immediately prior to the Domestication, which will then automatically convert at the effective time of the Domestication into an equal number of shares of PubCo Common Stock, valued at approximately $10.72 per share, which is the assumed per share price used in the Business Combination pursuant to the Business Combination Agreement. The Sponsor also purchased 509,000 Helix Class A Shares at a price of $10.00 per share in a private placement that occurred simultaneously with the closing of the Helix IPO; such shares will automatically convert at the effective time of the Domestication into an equal number of shares of PubCo Common Stock valued at approximately $10.72 per share, which is the assumed per share price used in the Business Combination pursuant to the Business Combination Agreement. Cormorant purchased an aggregate of 2,400,000 Helix Class A Shares in the IPO at a price of $10.00 per share, and such shares will automatically convert at the effective time of the Domestication into an equal number of shares of PubCo Common Stock valued at approximately $10.72 per share, which is the assumed per share price used in the Business Combination pursuant to the Business Combination Agreement. Cormorant will also receive an estimated 3,950,427 shares of PubCo Common Stock in the Business Combination upon the exchange of BBOT capital stock held by Cormorant pursuant to the terms of the Business Combination Agreement, and the BBOT Stockholders (excluding Cormorant) will receive an estimated 34,954,950 shares of PubCo Common Stock in the Business Combination, excluding an estimated 4,113,979 shares of PubCo Common Stock issuable upon the exercise of PubCo Options, which is equal to $461,051,546 divided by approximately $10.72, the assumed Redemption Price for the Public Shares estimated using an assumed Closing Date of July 31, 2025. The PIPE Investors (which includes Cormorant) will purchase an estimated 24,343,757 shares of PubCo Common Stock, which is equal to approximately $260.9 million divided by approximately $10.72, the assumed Redemption Price for the Public Shares estimated using an assumed Closing Date of July 31, 2025. As a result of the low price the Sponsor paid for the Founder Shares, the Sponsor may realize a positive rate of return on its investment in the Founder Shares even if the market price per share of PubCo Common Stock is below $10.00 per share after Closing, in which case the Public Shareholders may experience a negative rate of return on their investment. Based on the closing price of $10.65 per Helix Class A Share on June 30, 2025, the Sponsor may receive potential profits of approximately $10.64 per Founder Share, and accordingly may make a substantial profit on its investment in the Founder Shares at a time when shares of PubCo Common Stock may have lost significant value. On the other hand, if Helix liquidates without completing a business combination during the completion window, the Sponsor will lose its investment in Helix.

For information about conflicts of interest with respect to the Sponsor, Cormorant and the other Helix Insiders, see “Proposal No. 1 — The Business Combination Proposal — Interests of the Sponsor, Cormorant, and Helix’s Directors and Officers in the Business Combination”. For information about the compensation of the Sponsor and our officers and directors, see “Information About Helix — Executive and Director Compensation”. For information about the securities owned by the Sponsor, Cormorant and other Helix Insiders, including transfer restrictions and required surrender and forfeitures, see “Beneficial Ownership of Securities” and “Certain Relationships and Related Persons Transactions”.

Q:     Who is the Sponsor?

A.     Helix Holdings II, LLC, the Sponsor, is a Cayman Islands limited liability company. The Sponsor was formed prior to the IPO for the purpose of acting as the sponsor of Helix. It is responsible for organizing, directing, and managing the business and affairs of Helix from its incorporation, through the consummation of the IPO, the negotiation of the Business Combination Agreement, until the consummation of the Business Combination. The Sponsor’s activities included identifying and negotiating terms with the underwriter of Helix’s IPO, other third-party service providers such as Helix’s auditors and legal counsel, and Helix’s directors and officers, and searching for and negotiating with potential business combination targets. Other than its investment in Helix and its work on behalf of Helix, the Sponsor is not engaged in any business. The Sponsor made an initial investment of $25,000 to cover certain pre-IPO expenses, in exchange for the issuance of Founder Shares, or approximately $0.006 per share. In connection with the closing of the IPO, the Sponsor purchased 509,000 Helix Class A Shares at a price of $10.00 per share, for an aggregate purchase price of $5,090,000.

The Sponsor owns 21.2% of our issued and outstanding Helix Ordinary Shares as of the date of this proxy statement/prospectus. Three investment vehicles managed by Cormorant Asset Management, LP are each managing members of the Sponsor, and Bihua Chen is the managing member of each such investment vehicle. The Sponsor is exclusively “controlled” for CFIUS purposes by Ms. Chen, who is a U.S. citizen, and thus we do not believe that the Sponsor is a “foreign person” as defined in the CFIUS regulations. Ms. Chen is the beneficial owner of 31.4% of the issued and outstanding Helix Ordinary Shares as of the date of this proxy statement/prospectus, which includes shares directly held by the Sponsor and by Cormorant, of which Ms. Chen is the managing member.

The Sponsor is an affiliate of Cormorant, a leading life sciences focused investment firm with over $3 billion in assets under management as of December 31, 2024. Our Chairperson and Chief Executive Officer, Bihua Chen, founded Cormorant and is the managing member of Cormorant. Since its inception in 2013, Cormorant has focused on the healthcare industry and invests, throughout their growth cycle, in companies that discover and develop therapeutic drugs or medical technology. Cormorant is an active life-science investor with investments in over 100 privately held, life science-focused companies over this period. Of these investments, over 50 have completed initial public offerings. Notable successes include Prometheus Biosciences, Inc., Turning Point Therapeutics, Inc., and MyoKardia, Inc., each of which has been acquired for more than $4 billion. Other notable successes include BridgeBio Pharma and Apellis Pharmaceuticals Inc., each of which is a public company with a market capitalization greater than $1 billion.

An affiliate of Cormorant founded Helix Acquisition Corp. (“Helix I”), a special purpose acquisition company (a “SPAC”) organized for purposes similar to those of Helix, which raised $115 million in an initial public offering of ordinary shares in October 2020. On April 5, 2022, Helix I completed its initial business combination with MoonLake Immunotherapeutics AG (Nasdaq: MLTX) (“MoonLake”), a clinical-stage biopharmaceutical company focused on creating next-level therapies for inflammatory diseases. Ms. Chen was Chairwoman and Chief Executive Officer of Helix I. Prior to the extraordinary general meeting of Helix I shareholders to approve the business combination with MoonLake, holders of 8,080,845 Helix I Class A ordinary shares, or approximately 70.3% of Helix I’s redeemable public shares, exercised their right to redeem those shares for cash at a price of approximately $10.00444 per share for an aggregate of approximately $80.8 million. MoonLake’s shares are listed on Nasdaq under the symbol “MLTX”. On June 30, 2025, the closing sale price of MLTX’s ordinary shares was $47.20.

Past performance by our management team, including with respect to Cormorant and Helix I, is not a guarantee of success with respect to the Business Combination with BBOT. You should not rely on the historical record of the performance of our management team or businesses associated with them, including Cormorant and Helix I as indicative of our future performance of an investment in Helix or BBOT or the returns we will, or are likely to, generate going forward.

For information about conflicts of interest with respect to the Sponsor and Cormorant, see “Proposal No. 1 — The Business Combination Proposal — Interests of the Sponsor, Cormorant, and Helix’s Directors and Officers in the Business Combination”. For information about the compensation of the Sponsor and our officers and directors, see “Information About Helix — Executive and Director Compensation”. For information about the securities owned by the Sponsor and Cormorant, including transfer restrictions and required surrender and forfeitures, see “Beneficial Ownership of Securities” and “Certain Relationships and Related Persons Transactions”.

Q:     Why was the Transaction Committee formed?

A:     Cormorant, an affiliate of the Sponsor and Bihua Chen, Helix’s Chairwoman and Chief Executive Officer, and investor in Helix, is an investor in BBOT; there is one Cormorant designee serving on the BBOT Board and Cormorant has the right to have one non-voting board observer attend all meetings of the BBOT Board. In light of potential conflicts of interest with respect to the Business Combination as a result of Cormorant’s existing ownership interest in BBOT and the fact that a Cormorant designee was serving as a director of BBOT (such conflicts are described more fully in the section entitled “— Interests of the Sponsor, Cormorant, and Helix’s Officers and Directors in the Business Combination”), the Helix Board formed the Transaction Committee, comprised of two independent and disinterested members of the Helix Board, Mark McKenna and John Schmid. The Transaction Committee was empowered to, among other things, act as a disinterested body of the Helix Board as appropriate for the purpose of exploring and evaluating the Business Combination; to engage and oversee one or more financial advisors, investment banking firms and accounting firms in connection with the Business Combination as the as the Transaction Committee deemed necessary or advisable in connection with fulfilling its responsibilities and to perform such other services and deliver such opinions as the Transaction Committee in its discretion requests, including providing an opinion, all at the expense of Helix; consult with, advise, and oversee management, on behalf of the Helix Board, in connection with due diligence activities relating to BBOT, the evaluation of the Business Combination, and discussions and/or negotiations concerning potential terms and conditions of the Business Combination; engage and oversee separate legal counsel if the Transaction Committee determines it is necessary or advisable to do so; and review the Business Combination and, if the Transaction Committee determines it is advisable and in the interests of Helix and its Public Shareholders, recommend to the Helix Board that the Helix Board approve the Business Combination. The Transaction Committee engaged separate counsel, Latham, to represent the Transaction Committee. The Transaction Committee also engaged Lincoln to provide an opinion to the Transaction Committee as to the fairness, from a financial point of view, to the Helix Unaffiliated Shareholders of the Aggregate Merger Consideration to be paid by Helix in the Merger pursuant to the Business Combination Agreement, a copy of which is attached hereto as Annex M.

Q:     Did the Helix Board or Transaction Committee obtain a third-party opinion in determining whether or not to proceed with the Business Combination?

A:     Yes. On February 27, 2025, the Transaction Committee received an opinion from Lincoln as to the fairness, as of such date, from a financial point of view to the Helix Unaffiliated Shareholders of the Aggregate Merger Consideration to be paid by Helix in the Merger pursuant to the Business Combination Agreement, which was based on and subject to the assumptions made, procedures followed, matters considered and limitations and qualifications on and scope of the review undertaken by Lincoln, as set forth in such opinion, as more fully described in the subsection “The Business Combination — Opinion of Lincoln International LLC”. A copy of Lincoln’s opinion is attached hereto as Annex M.

Q:     Has the announcement of the Business Combination affected the trading price of the Helix Class A Shares?

A:     On February 27, 2025, the last trading day before announcement of the execution of the Business Combination Agreement, the closing price of the Helix Class A Shares was $10.80. As of June 30, 2025, the closing price of the Helix Class A Shares was $10.65.

Q:     Are there material differences between my rights as a Helix Shareholder and my rights as a PubCo stockholder?

A:     Yes, there are certain material differences between your rights as a Helix Shareholder and your rights as a PubCo stockholder. Please read the sections entitled “Description of PubCo Securities” and “Comparison of Corporate Governance and Shareholder Rights.”

Q:     Do I have redemption rights?

A:     If you are a holder of Public Shares, you have the right to demand that Helix redeem such shares for a pro rata portion of the cash held in Helix’s Trust Account (including interest earned on the Trust Account not previously released to Helix to pay its taxes, net of taxes payable). These rights to demand redemption of the Public Shares are sometimes referred to herein as “redemption rights.” In connection with Helix’s IPO, the Sponsor and Helix’s officers, directors, and advisor entered into the Insider Letter with Helix, pursuant to which they agreed to waive their redemption rights with respect to their Founder Shares and any Public Shares held by them in connection with the completion of an initial business combination. Such redemption rights waiver was provided at the time

of the IPO without any separate consideration paid. Additionally, pursuant to the Helix Support Agreement, the Sponsor and each of Helix’s independent directors and advisor who hold Founder Shares agreed not to redeem any Helix Ordinary Shares held by them in connection with the Business Combination, and Cormorant also agreed to waive its redemption rights with respect to any Helix Ordinary Shares it holds, including the 2,400,000 Helix Class A Shares purchased in the IPO. Such redemption rights waiver was provided without any separate consideration paid in connection with providing such waiver.

The closing price of the Helix Class A Shares on June 30, 2025, the Record Date, was $10.65. The cash held in the Trust Account on the Record Date was approximately $196.51 million ($10.68 per Public Share). Prior to exercising redemption rights, Helix Shareholders should verify the market price of the Helix Class A Shares as they may receive higher proceeds from the sale of their Public Shares in the public market than from exercising their redemption rights if the market price per share is higher than the Redemption Price. Helix cannot assure shareholders that they will be able to sell their Public Shares in the open market, even if the market price per share is higher than the Redemption Price, as there may not be sufficient liquidity in the Helix Class A Shares when Public Shareholders wish to sell their shares.

Notwithstanding the foregoing, a holder of Public Shares, together with any affiliate or any other person with whom he, she or it is acting in concert or as a partnership, syndicate or other group, will be restricted from seeking redemption with respect to more than 20% of the issued and outstanding Public Shares. Accordingly, all Public Shares in excess of 20% held by a shareholder, together with any affiliate of such holder or any other person with whom such holder is acting in concert or as a “group” (as defined under Section 13 of the Exchange Act), will not be redeemed.

Q:     Will my ability to exercise redemption rights be impacted by how I vote on the Business Combination Proposal?

A:     No. You may exercise your redemption rights irrespective of whether you vote your Public Shares for or against the Business Combination Proposal, Domestication Proposal, Stock Issuance Proposal, Organizational Documents Proposal, Advisory Organizational Documents Proposals, Incentive Plan Proposal, ESPP Proposal, Director Election Proposal and Adjournment Proposal, or any other proposal described by this proxy statement/prospectus and regardless of whether you hold Public Shares on the Record Date. As a result, the Business Combination Agreement can be approved by shareholders who will redeem their Public Shares and no longer remain shareholders, leaving shareholders who choose not to redeem their Public Shares holding shares in a company with a less liquid trading market, fewer shareholders, less cash and the potential inability to meet the listing standards of Nasdaq.

Q:     How do I exercise my redemption rights?

A:     If you are a holder of Public Shares and wish to exercise your redemption rights, you must, prior to 5:00 p.m. Eastern Time, on July 31, 2025 (two business days prior to the scheduled vote at the EGM), (A) submit a written request to Continental that Helix redeem all or a portion of your Public Shares for cash, which request must include the legal name, phone number and address of the beneficial owner of the Public Shares for which redemption is requested, and (B) tender or deliver your Public Shares (and share certificates (if any) and other redemption forms) to Continental physically or electronically using the DTC’s DWAC System. Any holder of Public Shares (other than the Sponsor, Cormorant, and the Helix Insiders) will be entitled to demand that such holder’s Public Shares be redeemed for a full pro rata portion of the amount then in the Trust Account (including interest earned on the Trust Account not previously released to Helix to pay its taxes, net of taxes payable) (which, for illustrative purposes, was approximately $196.51 million, or $10.68 per Public Share, as of June 30, 2025).

Any request for redemption, once made by a holder of Public Shares, may be withdrawn at any time up to the deadline for submitting redemption requests and thereafter, with Helix’s consent, until the Closing. If you tender or deliver your Public Shares (and share certificates (if any) and other redemption forms) for redemption to Continental and later decide to withdraw such request prior to the deadline for submitting redemption requests, you may request that Continental return the shares (physically or electronically). You may make such request by contacting Continental at the address listed at the end of this section.

Any written demand of redemption rights must be received by Continental prior to the redemption deadline. No demand for redemption will be honored unless the holder’s Public Shares have been delivered (either physically or electronically) to Continental prior to the deadline for submitting redemption requests.

If the redemption demand is properly made as described above, then, if the Business Combination is consummated, Helix will redeem these Public Shares for a pro rata portion of funds deposited in the Trust Account. If you exercise your redemption rights, then you will be exchanging your Public Shares for cash and will not be entitled to PubCo Common Stock upon consummation of the Business Combination.

Q:     What are the U.S. federal income tax consequences of exercising my redemption rights?

A:     The U.S. federal income tax consequences of a Public Shareholder exercising redemption rights depends on the particular facts and circumstances. Because the Domestication will occur after the redemption of Public Shares held by U.S. holders (as defined in Material U.S. Federal Income Tax Considerations — U.S. Holders” below) that exercise redemption rights, U.S. holders exercising redemption rights should not be subject to the potential tax consequences of Section 367(b) of the Internal Revenue Code of 1986, as amended (the “Code”), as a result of the Domestication. Please see the section entitled “Material U.S. Federal Income Tax Considerations — U.S. Holders — Tax Consequences to U.S. Holders of Helix Class A Shares Exercising Redemption Rights” and “— Non-U.S. Holders — Tax Consequences to Non-U.S. Holders of Helix Class A Shares Exercising Redemption Rights.”

If you are a holder of Helix Class A Shares contemplating exercising your redemption rights, you are urged to consult your tax advisor to determine the tax consequences thereof.

Q:     What are the U.S. federal income tax consequences of the Domestication?

A:     Subject to the limitations and qualifications described in “Material U.S. Federal Income Tax Considerations” below, the Domestication should qualify as a tax-deferred reorganization within the meaning of Section 368(a)(1)(F) of the Code. Due to the absence of direct guidance on the application of Section 368(a)(1)(F) of the Code to a corporation holding only investment-type assets, such as Helix, this result is not entirely clear. In general, and subject to the PFIC rules and the rules under Section 367(b) of the Code discussed below, if the Domestication so qualifies, a U.S. holder should not recognize any gain or loss for U.S. federal income tax purposes in connection therewith.

In the case of an inbound transaction involving a foreign corporation, such as the Domestication, that qualifies as a reorganization within the meaning of Section 368(a)(1)(F) of the Code, U.S. holders of Helix Class A Shares will be subject to Section 367(b) of the Code and as a result:

•        a U.S. holder whose Helix Class A Shares have a fair market value of less than $50,000 on the date of the Domestication, and who on the date of the Domestication owns (actually and constructively) less than 10% of the total combined voting power of all classes of stock of Helix entitled to vote and less than 10% of the total value of all classes of stock of Helix, will generally not recognize any gain or loss on the exchange of Helix Class A Shares for PubCo Common Stock and will generally not be required to include any part of Helix’s earnings in income pursuant to the Domestication;

•        a U.S. holder whose Helix Class A Shares have a fair market value of $50,000 or more on the date of the Domestication, and who on the date of the Domestication owns (actually and constructively) less than 10% of the total combined voting power of all classes of stock of Helix entitled to vote and less than 10% of the total value of all classes of stock of Helix will generally recognize gain (but not loss) on the exchange of Helix Class A Shares for PubCo Common Stock pursuant to the Domestication. As an alternative to recognizing gain, such U.S. holders may file an election to include in income as a dividend the “all earnings and profits amount” (as defined in Treasury Regulations Section 1.367(b)-2(d)) attributable to their Helix Class A Shares, provided certain other requirements are satisfied; and

•        a U.S. holder who on the date of the Domestication owns (actually and constructively) 10% or more of the total combined voting power of all classes of stock of Helix entitled to vote or 10% or more of the total value of all classes of stock of Helix will generally be required to include in income as a dividend the “all earnings and profits amount” (as defined in Treasury Regulations Section 1.367(b)-2(d)) attributable to its Helix Class A Shares on the exchange of Helix Class A Shares for PubCo Common Stock pursuant to the Domestication. Any such U.S. holder that is a corporation may, under certain circumstances, effectively be exempt from taxation on a portion or all of the deemed dividend pursuant to Section 245A of the Code.

Furthermore, if the Domestication qualifies as a reorganization under Section 368(a)(1)(F) of the Code, a U.S. holder of Helix Class A Shares may, in certain circumstances, still recognize gain (but not loss) upon the exchange of its Helix Class A Shares for the PubCo Common Stock pursuant to the Domestication under the “passive foreign investment company,” or PFIC, rules of the Code. Proposed Treasury Regulations with a retroactive effective date have been promulgated under Section 1291(f) of the Code which generally require that a U.S. person who disposes of stock of a PFIC must recognize gain equal to the excess, if any, of the fair market value of PubCo Common Stock received in the Domestication over the U.S. Holder’s adjusted tax basis in the corresponding Helix Class A Shares surrendered in exchange therefor, notwithstanding any other provision of the Code. Because Helix is a blank check company with no current active business, we believe that Helix may be classified as a PFIC for U.S. federal income tax purposes. As a result, these proposed Treasury Regulations, if finalized in their current form, may require a U.S. holder of Helix Class A Shares to recognize gain on the exchange of such shares for PubCo Common Stock pursuant to the Domestication, unless such U.S. holder has made certain tax elections with respect to such U.S. holder’s Helix Class A Shares. The tax on any such gain so recognized would be imposed at the rate applicable to ordinary income and an interest charge would apply based on complex rules designed to offset the tax deferral to such U.S. holder on the undistributed earnings, if any, of Helix. It is not possible to determine at this time whether, in what form, and with what effective date, final Treasury Regulations under Section 1291(f) of the Code will be adopted. For a more complete discussion of the potential application of the PFIC rules to U.S. holders as a result of the Domestication, see the discussion in the section titled “Material U.S. Federal Income Tax Considerations — U.S. Holders — PFIC Considerations.”

Additionally, the Domestication may cause non-U.S. holders (as defined in “Material U.S. Federal Income Tax Considerations — Non-U.S. Holders — Tax Consequences to Non-U.S. Holders of the Ownership and Disposition of PubCo Common Stock received in the Business Combination” below) to become subject to U.S. federal withholding taxes on any dividends paid in respect of such non-U.S. holder’s shares of PubCo Common Stock after the Domestication.

The tax consequences of the Domestication are complex and will depend on your particular circumstances. For a more complete discussion of the U.S. federal income tax considerations of the Domestication, see the section entitled “Material U.S. Federal Income Tax Considerations” If you are a U.S. holder exchanging Helix Class A Shares in the Domestication, you are urged to consult your tax advisor to determine the tax consequences thereof.

Q:     Do I have appraisal or dissenters’ rights if I object to the proposed Business Combination?

A:     Helix Shareholders do not have appraisal or dissenters’ rights in connection with the Business Combination under the Cayman Companies Act. However, Helix Shareholders are still entitled to exercise the rights of redemption as set out in the subsection entitled “Extraordinary General Meeting — Redemption Rights” and the Helix Board has determined that the redemption proceeds payable to Helix Shareholders who exercise such redemption rights represents the fair value of those Helix Ordinary Shares. See the section entitled “Appraisal Rights and Dissenters’ Rights” for more information.

Q:     What happens to the funds deposited in the Trust Account after consummation of the Business Combination?

A:     As of June 30, 2025, the Record Date, there was approximately $196.51 million in the Trust Account. Upon consummation of the Business Combination, the funds in the Trust Account will be used to pay holders of the Public Shares who properly exercise redemption rights, to fund PubCo’s or its subsidiaries’ working capital, growth and general corporate purposes and to pay fees and expenses incurred in connection with the Business Combination.

Q:     What underwriting and placement agency fees are payable in connection with the Business Combination?

A:     Pursuant to the Underwriting Agreement, dated February 8, 2024 (the “Underwriting Agreement”), by and between Helix and Leerink Partners LLC (“Leerink Partners”), Leerink Partners was paid an upfront cash underwriting discount of $0.10 per Public Share, or $1,840,000 in the aggregate, paid upon the closing of the Initial Public Offering (the “Upfront Discount”). In addition, Leerink Partners is entitled to a deferred fee of $0.30 per Public Share, or $5,520,000 in the aggregate (the “Deferred Discount”). The Deferred Discount will become payable from the amounts held in the Trust Account solely in the event that Helix completes a business combination, subject to the terms of the Underwriting Agreement. On February 5, 2025, Helix and Leerink Partners entered into an agreement to reduce the fee payable to Leerink Partners for acting as a Placement Agent in connection with the PIPE Investment. The Deferred Discount and the terms of the Underwriting Agreement were not modified.

The following table illustrates the effective underwriting discount on a percentage basis for Public Shares at each redemption level identified below:

____________

*        Assumes that BBOT, in its sole discretion, waives the Minimum Cash Condition and no additional equity financing is obtained. The Full Redemptions Scenario represents the redemption of all Public Shares held by Public Shareholders (excluding Cormorant) other than the 450,900 shares that are subject to Non-Redemption Agreements.

(1)      Amount comprises the unredeemed Public Shares in a variety of redemptions scenarios, excluding 2,400,000 shares held by Cormorant which are presented in the row labeled “Public Shares held by Cormorant”. This amount reflects the assumed redemption of 0 shares under the No Redemptions Scenario, 5,236,672 shares under the Minimum Cash Condition Redemptions Scenario, 11,661,825 shares redeemed under the 75% Redemptions Scenario, and 15,549,100 shares redeemed under the Full Redemptions Scenario.

(2)      Represents the product of (i) the sum of Unredeemed Public Shares (excluding Cormorant) plus Public Shares held by Cormorant and (ii) the assumed Redemption Price. Uses approximately $10.72 as the assumed Redemption Price for the Public Shares estimated using an assumed Closing Date of July 31, 2025.

Additionally, Helix engaged Leerink Partners, Morgan Stanley & Co. LLC (“Morgan Stanley”), Cantor Fitzgerald & Co. (“Cantor”) and Oppenheimer & Co. Inc. (“Oppenheimer”, together with Leerink Partners, Morgan Stanley, and Cantor, the “Placement Agents”) to act as Placement Agents of the PIPE Investment and Helix engaged Leerink as its lead capital markets advisor and Cantor as a capital markets advisor. Leerink Partners, Morgan Stanley and Cantor are entitled to be paid an aggregate fee at the Closing equal to the greater of (i) 4.125% of the gross proceeds received or to be received from the sale of PIPE Shares (other than with respect to any proceeds from existing investors of BBOT or any affiliate, subsidiary, related party or portfolio company of Helix or Cormorant, or from certain other excluded investors) or (ii) $5 million. Helix agreed to allocate 40% of such fees to Leerink Partners, 40% of such fees to Morgan Stanley, and 20% of such fees to Cantor. Helix also agreed to pay Oppenheimer at Closing a fee equal to $0.05 per certain of the PIPE Shares, provided that the fees Helix pays to Leerink Partners, Morgan Stanley and Cantor will be reduced pro-rata among Leerink Partners, Morgan Stanley and Cantor by the amount of fees Helix pays to Oppenheimer.

Q:     What happens if the Business Combination is not consummated?

A:     If Helix does not complete the Business Combination for whatever reason, Helix would search for another target business with which to complete a Business Combination. If Helix does not complete an initial business combination within the 24 months from the closing of its IPO, or by such earlier liquidation date as the Helix Board may approve (the “completion window”), Helix will (i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the Public Shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account, including interest earned on the funds held in the Trust Account (less taxes payable and up to $100,000 of interest to pay dissolution expenses), divided by the number of then issued and outstanding Public Shares, which redemption will completely extinguish Public Shareholders’ rights as shareholders (including the right to receive further liquidating distributions, if any), subject to our obligations under Cayman Islands law to provide for claims of creditors and subject to the other requirements of applicable law.

Q:     What interests do the Sponsor, Cormorant, and Helix’s officers and directors have in the Business Combination?

A:     The Sponsor, Cormorant, and Helix’s officers and directors have interests in the Business Combination that are different from or in addition to (and which may conflict with) the interests of unaffiliated Helix Shareholders. Further, Helix’s officers and directors have additional fiduciary or contractual obligations to other entities pursuant to which such officer or director is or will be required to present a business combination opportunity to such entity, which are set forth in more detail in the section titled “Information Related to Helix — Conflicts of Interest”. We believe there were no such opportunities that were not presented as a result of the existing fiduciary or contractual obligations of our officers and directors to other entities. The Helix Board was aware of and considered these interests, among other matters, in evaluating and negotiating the Business Combination and Business Combination Agreement and in recommending to our shareholders that they vote in favor of the proposals to be presented at the EGM, including the Business Combination Proposal. Helix Shareholders should take these interests into account in deciding whether to approve the proposals presented at the EGM, including the Business Combination Proposal. These interests include, among other things:

•        the fact that the Sponsor holds 4,480,000 Founder Shares which were initially purchased for an aggregate of $25,000, and such shares will have a significantly higher value at the time of the Business Combination, estimated at approximately $47.7 million based on the closing price of $10.65 per Helix Class A Share on Nasdaq on June 30, 2025. Helix estimates that, at the Closing, the Sponsor will hold an aggregate of 4,172,133 shares of PubCo Common Stock issued upon the conversion of such Founder Shares (assuming the Minimum Cash Condition Redemptions Scenario and the surrender and forfeiture of 307,867 Sponsor Forfeited Shares and no surrender and forfeiture of Sponsor Contributed Shares), which if unrestricted and freely tradeable, would be valued at approximately $44.4 million, based on the $10.65 closing price of the Helix Class A Shares on June 30, 2025. However, given that such shares of PubCo Common Stock will be subject to certain restrictions, including those described elsewhere in this proxy statement/prospectus, Helix believes such shares have less value;

•        the fact that each of Helix’s independent directors and its advisor holds 30,000 Founder Shares, which shares were transferred to such persons by the Sponsor in connection with their service to Helix, and such shares will have value at the time of the Business Combination, estimated at approximately $319,500 based on the closing price of $10.65 per Helix Class A Share on Nasdaq on June 30, 2025. Helix estimates that, at the Closing, Helix’s independent directors and its advisor will hold 30,000 shares of PubCo Common Stock each, which if unrestricted and freely tradeable, would be valued at approximately $319,500, based on the $10.65 closing price of the Helix Class A Shares on June 30, 2025. However, given that such shares of PubCo Common Stock will be subject to certain restrictions, including those described elsewhere in this proxy statement/prospectus, Helix believes such shares have less value;

•        the fact that, as a result of the low purchase price paid for the Founder Shares, if the Business Combination is completed, the Sponsor and Helix’s independent directors and advisor are likely to be able to make a substantial profit on their investment in Helix even at a time when the PubCo Common Stock has lost significant value. Accordingly, the economic interests of the Sponsor and Helix’s independent directors and advisor diverge from the economic interests of Public Shareholders because the Sponsor and Helix’s independent directors and advisor will realize a gain on its investment from the completion of any business combination while Public Shareholders will realize a gain only if the post-closing trading price exceeds $10.00 per share;

•        the fact that the Sponsor holds 509,000 Helix Class A Shares, initially purchased for $10.00 per share in a private placement that occurred simultaneously with the closing of the Helix IPO, which will then automatically convert at the effective time of the Domestication into an equal number of shares of PubCo Common Stock. Helix estimates that, at the Closing, if unrestricted and freely tradeable, such shares would be valued at approximately $5.4 million, based on the $10.65 closing price of the Helix Class A Shares on June 30, 2025. However, given that such shares of PubCo Common Stock will be subject to certain restrictions, including those described elsewhere in this proxy statement/prospectus, Helix believes such shares have less value;

•        the fact that certain investment vehicles managed by Cormorant purchased an aggregate of 2,400,000 Helix Class A Shares in the IPO at a price of $10.00 per share, and such shares will automatically convert at the effective time of the Domestication into an equal number of shares of PubCo Common Stock.

Helix estimates that, at the Closing, if unrestricted and freely tradeable, such shares would be valued at approximately $25.6 million, based on the $10.65 closing price of the Helix Class A Shares on June 30, 2025. However, given that such shares of PubCo Common Stock will be subject to certain restrictions, including those described elsewhere in this proxy statement/prospectus, Helix believes such shares have less value;

•        the fact that certain investment vehicles managed by Cormorant, which are affiliates of Bihua Chen and the Sponsor, are stockholders of BBOT and will receive an estimated 3,950,427 shares of PubCo Common Stock in the Merger pursuant to the Business Combination Agreement, using approximately $10.72 as the assumed Redemption Price for the Public Shares estimated using an assumed Closing Date of July 31, 2025. Helix estimates that, at the Closing, if unrestricted and freely tradeable, such shares would be valued at approximately $42.1 million, based on the $10.65 closing price of the Helix Class A Shares on June 30, 2025. However, given that such shares of PubCo Common Stock will be subject to certain restrictions, including those described elsewhere in this proxy statement/prospectus, Helix believes such shares have less value;

•        the fact that certain investment vehicles managed by Cormorant, which are affiliates of Bihua Chen and the Sponsor, will purchase an estimated 6,998,042 shares of PubCo Common Stock in the PIPE Investment, which is equal to $75 million divided by approximately $10.72, the assumed Redemption Price for the Public Shares estimated using an assumed Closing Date of July 31, 2025. Helix estimates that, at the Closing, if unrestricted and freely tradeable, such shares would be valued at approximately $74.5 million, based on the $10.65 closing price of the Helix Class A Shares on June 30, 2025, and such shares will not be subject to a lock-up;

•        the fact that Sponsor, Cormorant, and Helix’s directors and advisor who own Helix Ordinary Shares have each waived their right to redeem any Helix Ordinary Shares held by them in connection with the shareholder vote to approve the Business Combination;

•        the fact that, if Helix were to liquidate rather than complete an initial business combination, the Sponsor and Cormorant will lose their entire investment in Helix, which totals approximately $29,115,000 as of the date of this proxy statement/prospectus, comprising the $25,000 purchase price for the Founder Shares, the $5,090,000 purchase price for the Helix Class A Shares purchased by Sponsor in a private placement concurrently with the IPO, and the $24 million purchase price for the Helix Class A Shares purchased by certain investment vehicles managed by Cormorant in the IPO, because the Sponsor and Cormorant have waived their redemption rights with respect to such shares. The potential loss of this investment may have incentivized Sponsor and its affiliates to pursue a business combination transaction on unfavorable terms in order to avoid a liquidation;

•        the fact that, if the Trust Account is liquidated, including in the event Helix is unable to complete an initial business combination within the Combination Period, the Sponsor has agreed that it will be liable to Helix if and to the extent any claims by a third party for services rendered or products sold to Helix, or a prospective target business with which Helix has entered into a written letter of intent, confidentiality or other similar agreement or business combination agreement, reduce the amount of funds in the Trust Account to below the lesser of (i) $10.00 per Public Share and (ii) the actual amount per Public Share held in the Trust Account as of the date of the liquidation of the Trust Account, if less than $10.00 per Public Share due to reductions in the value of the trust assets, less taxes payable and up to $100,000 of interest to pay dissolution expenses; provided that such obligation will not apply to any claims by a third party who executed a waiver of any and all rights to seek access to the Trust Account (whether or not such waiver is enforceable), any claims by Helix’s independent registered public accounting firm, or any claims under the indemnity of the underwriters of the IPO against certain liabilities, including liabilities under the Securities Act;

•        the fact that Bihua Chen, Helix’s Chairwoman and Chief Executive Officer and an affiliate of the Sponsor and Cormorant, who has the right to attend meetings of the BBOT Board as a non-voting observer on behalf of Cormorant, and Raymond Kelleher, a current Cormorant designee on the BBOT Board, are expected to be directors of PubCo after the Closing. As such, in the future, Ms. Chen and Dr. Kelleher may receive fees for their service as director, which may consist of cash or stock-based awards, and any other remuneration that the PubCo Board determines to pay to its non-employee directors;

•        the fact that, pursuant to the A&R Registration Rights Agreement, the Sponsor, Cormorant, and Helix’s independent directors and advisor will have customary registration rights, including demand and piggy-back rights, subject to cooperation and cut-back provisions with respect to the PubCo Common Stock following the consummation of the Business Combination. Helix estimates that the Sponsor, Cormorant, and Helix’s independent directors and advisor will hold an aggregate of 18,149,602 shares of PubCo Common Stock subject to registration rights, assuming the Minimum Cash Condition Redemptions Scenario, the surrender and forfeiture of 307,867 Sponsor Forfeited Shares and no surrender and forfeiture of Sponsor Contributed Shares, and using a Redemption Price of approximately $10.72;

•        the fact that the Helix Articles contain a waiver of the corporate opportunity doctrine, and there could have been business combination targets that would have been appropriate for a combination with Helix but were not offered due to a Helix director’s duties to another entity. Helix does not believe that the waiver of the corporate opportunity doctrine in the Helix Articles interfered with its ability to identify an acquisition target; and

•        the continued indemnification of former and current directors and officers of Helix, the Sponsor and Cormorant and the continuation of directors’ and officer’s liability insurance after the Business Combination.

In addition, as a result of multiple business affiliations, our directors and officers have fiduciary, contractual or similar legal obligations to other entities, which may require our directors and officers to present a business combination opportunity to such other entity and only present it to us if such entity rejects the opportunity, subject to his or her fiduciary duties under Cayman Islands law. We believe, however, that there were no such corporate opportunities presented to our directors and officers which were not presented to Helix, and therefore that our directors’ and officers’ additional fiduciary, contractual, or similar legal obligations to other entities did not impact our search for a business combination target. For more information, see “Information About Helix — Conflicts of Interest.”

The Helix Board formed the Transaction Committee, comprised of two independent and disinterested members of the Helix Board, Mark McKenna and John Schmid. The Transaction Committee was empowered to, among other things, act as a disinterested body of the Helix Board as appropriate for the purpose of exploring and evaluating the Business Combination; to engage and oversee one or more financial advisors, investment banking firms and accounting firms in connection with the Business Combination as the as the Transaction Committee deemed necessary or advisable in connection with fulfilling its responsibilities and to perform such other services and deliver such opinions as the Transaction Committee in its discretion requests, including providing an opinion, all at the expense of Helix; consult with, advise, and oversee management, on behalf of the Helix Board, in connection with due diligence activities relating to BBOT, the evaluation of the Business Combination, and discussions and/or negotiations concerning potential terms and conditions of the Business Combination; engage and oversee separate legal counsel if the Transaction Committee determines it is necessary or advisable to do so; and review the Business Combination and, if the Transaction Committee determines it is advisable and in the interests of Helix and its Public Shareholders, recommend to the Helix Board that the Helix Board approve the Business Combination. The Transaction Committee engaged separate counsel, Latham, to represent the Transaction Committee. The Transaction Committee also engaged Lincoln to provide an opinion to the Transaction Committee as to the fairness, from a financial point of view, to the Helix Unaffiliated Shareholders of the Aggregate Merger Consideration to be paid by Helix in the Merger pursuant to the Business Combination Agreement, a copy of which is attached hereto as Annex M.

Q:     What interests do the BBOT directors and officers have in the Business Combination?

A:     BBOT’s directors and officers have interests in the Business Combination that are different from, or in addition to, those of the Helix Shareholders generally. These interests include, among other things, the interests listed below:

•        Dr. Kelleher, a member of the BBOT Board, is a Managing Director of Cormorant. In light of his relationship with both BBOT and Cormorant and to avoid any potential conflicts of interest, Dr. Kelleher was recused from the BBOT Board vote with respect to the Business Combination. Additionally, Ms. Chen was a board observer to BBOT, but did not attend any meetings of the BBOT Board or of the BBOT Special Committee related to the Business Combination.

•        In connection with the closing of the Business Combination, Dr. Wallace is expected to receive a cash payment in the amount of $3,000,000.

•        Upon the completion of the Business Combination, the following persons are expected to be appointed Executive Officers of PubCo: Drs. Wallace, Beltran and Ben. For a description of these arrangements see “Executive and Director Compensation of BBOT.”

•        In connection with the Business Combination, it is anticipated that the PubCo Board will adopt a new non-employee director compensation policy to govern PubCo effective as of the Closing. It is anticipated that the new non-employee director compensation policy will provide for annual cash retainers and certain equity awards that will be granted following the Business Combination. Ms. Doig, Ms. Chen, Mr. Bauer, and Drs. McCormick, Kumar, Kelleher and Tipirneni will be subject to this policy.

•        Certain of BBOT’s directors are holders of, and/or are affiliated with entities that are holders of, BBOT equity interests and in such capacity will be entitled to receive the Aggregate Merger Consideration payable to all holders of such equity interests pursuant to the terms of the Business Combination Agreement. Additionally, certain of BBOT’s directors are affiliated with entities that are PIPE Investors.

Q:     What conditions must be satisfied to complete the Business Combination?

A:     Under the Business Combination Agreement, the obligations of the parties to consummate the Business Combination are subject to the satisfaction or waiver of certain closing conditions of the respective parties, including, without limitation: (i) the Helix Closing Cash equaling no less than $400 million; (ii) the PubCo Common Stock to be issued in connection with the Business Combination Agreement, including the Aggregate Merger Consideration and the PIPE Shares, having been approved for listing on Nasdaq, subject to official notice of issuance; (iii) this registration statement having been declared effective by the SEC under the Securities Act, no stop order suspending the effectiveness of this registration statement being in effect, and no proceedings for purposes of suspending the effectiveness of this registration statement having been initiated or threatened in writing by the SEC; and (iv) Helix Shareholder Approval and BBOT Stockholder Approval. The Minimum Cash Condition described above is for the benefit of BBOT only and is subject to waiver by BBOT. Conditions (ii) through (iv) above are for the benefit of both Helix and BBOT and are subject to waiver by Helix or BBOT. For more information, see “Proposal No. 1 — The Business Combination Proposal — The Business Combination Agreement — Conditions to Closing.”

Under the Subscription Agreement, the obligations of the PIPE Investors to consummate the PIPE Investments are conditioned upon, among other things: (i) the PubCo Common Stock, including the PIPE Shares, having been approved for listing on Nasdaq, subject only to official notice of issuance; (ii) the satisfaction or waiver of the conditions to closing set forth in Article IX of the Business Combination Agreement; (iii) the Business Combination Agreement not having been amended, modified or supplemented, and no condition having been waived in any manner that would materially adversely affect the economic benefits the PIPE Investors reasonably expect to receive under the Subscription Agreements; (iv) no subscription agreement, side letter, or other agreement or understanding with any other PIPE Investor having been amended, modified, or waived in any manner that benefits such other PIPE Investor unless each PIPE Investor has been offered the same benefits; (v) Helix having received not less than $200 million in cash from the PIPE Investments; and (vi) no BBOT Material Adverse Effect or Helix Material Adverse Effect having occurred. Conditions (i) and (ii) above are for the benefit of all parties to the Subscription Agreements and subject to waiver by all parties to the Subscription Agreements, and conditions (iii) through (vi) above are for the benefit of and subject to waiver by each PIPE Investor individually. For more information, see “Proposal No. 1 — The Business Combination Proposal — Ancillary Agreements — Subscription Agreements.”

Q:     When do you expect the Business Combination to be completed?

A:     It is currently expected that the Business Combination will be consummated in the third quarter of 2025. This date depends, among other things, on the approval of the proposals to be put to Helix Shareholders at the EGM. However, such meeting could be adjourned if the Adjournment Proposal is adopted by Helix’s shareholders at the EGM and Helix elects to adjourn the EGM to a later date or dates, if necessary or desirable. If the Adjournment Proposal is not approved, and a quorum is present, the Helix Board will not have the ability to adjourn the EGM to a later date in order to solicit further votes or take other steps to cause the conditions to the Business Combination to be satisfied, for example. In such event, the Business Combination would not be completed. For a description of the conditions for the completion of the Business Combination, see “Proposal No. 1 — The Business Combination Proposal.”

Q:     Following the Business Combination, will Helix’s securities continue to trade on a stock exchange?

A:     Helix will effect the Domestication from the Cayman Islands to Delaware, after which each outstanding Helix Class A Share (excluding Public Shares validly submitted for redemption and the Sponsor Forfeited Shares, but including Helix Class A Shares issued upon the Class B Share Conversion) will be reclassified as one share of PubCo Common Stock. It is a condition to the closing of the Business Combination and the obligations of the PIPE Investors to consummate the PIPE Investments that the PubCo Common Stock, including the PIPE Shares, be approved for listing on Nasdaq, subject to official notice of issuance. Under the Business Combination Agreement and Subscription Agreement, this condition is for the benefit of both Helix and BBOT, on the one hand, and Helix and the PIPE Investors, on the other, and is subject to waiver by both parties to the agreement.

Helix has applied for listing, to be effective at Closing, of the PubCo Common Stock on the Nasdaq Global Market under the symbol “BBOT”. However, it is important for you to consider that, at the time of the deadline for submitting redemption requests or the EGM, PubCo may not have received from Nasdaq either confirmation of the listing of the PubCo Common Stock or confirmation that approval will be obtained prior to the consummation of the Business Combination, and you will not be notified prior to the deadline for submitting redemption requests or the EGM if PubCo has not yet received such approval or confirmation. As a result, you may be asked to vote to approve the Business Combination and the other proposals included in this proxy statement/prospectus without knowing whether PubCo’s securities will be listed on Nasdaq or another securities exchange and, further, it is possible that such listing may never be achieved and the Business Combination could still be consummated if such condition is waived. Please see the subsection entitled “The Business Combination — Listing of PubCo’s Common Stock on Nasdaq” for additional information.

Q:     What do I need to do now?

A:     Helix urges you to read carefully and consider the information contained in this proxy statement/prospectus, including the annexes, and to consider how the Business Combination will affect you as a Helix Shareholder. Shareholders should then vote as soon as possible in accordance with the instructions provided in this proxy statement/prospectus and on the enclosed proxy card.

Q:     Who is entitled to vote at the EGM?

A:     Helix has fixed June 30, 2025 as the Record Date for the EGM. If you were a shareholder of Helix at the close of business on the Record Date, you are entitled to vote on matters that come before the EGM. However, a shareholder may only vote his, her or its shares if he, she or it is present in person or is represented by proxy at the EGM.

Q:     How many votes do I have?

A:     Helix’s shareholders are entitled to one vote at the EGM for each Helix Ordinary Share held of record as of the Record Date. As of the close of business on the Record Date for the EGM, there were 23,509,000 Helix Ordinary Shares issued and outstanding, of which 18,400,000 were Public Shares.

Q:     How do I vote?

A:     The EGM will be held at 10:00 a.m., Eastern Time, on August 4, 2025. The EGM will be a virtual meeting conducted via live webcast at https://www.cstproxy.com/helixacquisitionii/2025. For the purposes of Cayman Islands law and the Helix Articles, the physical location of the EGM will be the offices of White & Case LLP, Helix’s legal counsel, at 1221 Avenue of the Americas, New York, NY 10020.

If you are a holder of record of Helix Ordinary Shares on the Record Date, you may vote at the EGM or by submitting a proxy for the EGM. You may submit your proxy by completing, signing, dating and returning the enclosed proxy card in the accompanying pre-addressed postage paid envelope. Any shareholder wishing to attend the meeting should register for the EGM by 5:00 p.m., Eastern Time, on July 25, 2025, by contacting Sodali using one of the contact methods set forth below under the question “Who can help answer my questions?”.

Q:     If my shares are held in “street name,” will my broker, bank or nominee automatically vote my shares for me?

A:     No. Your broker, bank or nominee cannot vote your shares unless you provide instructions on how to vote in accordance with the information and procedures provided to you by your broker, bank or nominee.

Q:     What constitutes a quorum?

A:     A quorum of Helix’s shareholders is necessary to hold a valid meeting. The presence, in person or by proxy, of one or more shareholders holding one-third of the issued and outstanding Helix Ordinary Shares entitled to vote at such meeting constitutes a quorum at the EGM. In the absence of a quorum, the EGM shall stand adjourned to the same time and place seven days hence, or to such other time and place as determined by the directors. There are 23,509,000 Helix Ordinary Shares outstanding as of the Record Date, and therefore, as of the Record Date for the EGM, 7,836,334 Helix Ordinary Shares would be required to achieve a quorum.

Q:     What vote is required to approve each proposal at the EGM?

A:     The following votes are required for each proposal at the EGM:

•        Business Combination Proposal:    Approval of the Business Combination Proposal requires an ordinary resolution, being the affirmative vote of holders of a majority of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

•        Domestication Proposal:    Approval of the Domestication Proposal requires a special resolution, being the affirmative vote of at least two-thirds of the holders of issued and outstanding Helix Class B Shares who, being present in person or represented by proxy and entitled to vote thereon at the EGM, vote at the EGM. The holders of the Helix Class A Shares will have no right to vote on the Domestication Proposal, in accordance with Article 48 of the Helix Articles.

•        Stock Issuance Proposal:    Approval of the Stock Issuance Proposal requires an ordinary resolution, being the affirmative vote of the holders of a majority of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

•        Organizational Documents Proposal:    Approval of the Organizational Documents Proposal requires a special resolution, being the affirmative vote of the holders of a majority of at least two-thirds of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

•        Advisory Organizational Documents Proposals:    Approval of each Advisory Organizational Documents Proposal requires an ordinary resolution on a non-binding and advisory only basis, being the affirmative vote of the holders of a majority of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM. The shareholder votes regarding these proposals are advisory in nature, and are not binding on Helix, the Helix Board, BBOT or PubCo Board.

•        Incentive Plan Proposal:    Approval of the Incentive Plan Proposal requires an ordinary resolution, being the affirmative vote of the holders of a majority of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

•        ESPP Proposal:    Approval of the ESPP Proposal requires an ordinary resolution, being the affirmative vote of the holders of a majority of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

•        Director Election Proposal:    Approval of the Director Election Proposal requires an ordinary resolution, being the affirmative vote of the holders of a majority of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

•        Adjournment Proposal:    Approval of the Adjournment Proposal requires an ordinary resolution, being the affirmative vote of the holders of a majority of the issued and outstanding Helix Ordinary Shares, who, being present in person or by proxy and entitled to vote thereon at the EGM, vote at the EGM.

As of the date hereof, the Sponsor, Cormorant and other Helix Insiders collectively own approximately 31.9% of the issued and outstanding Helix Ordinary Shares. The Helix Insiders have agreed to vote all Helix Ordinary Shares they own in favor of all of the proposals being presented at the EGM. The existence of financial and personal interests of one or more of Helix’s directors may result in a conflict of interest on the part of such director(s) between what he, she or they may believe is in the best interests of Helix and its shareholders and

what he, she or they may believe is best for himself, herself or themselves in determining to recommend that shareholders vote for the proposals. In addition, the Sponsor, Cormorant, and Helix’s officers have interests in the Business Combination that may conflict with your interests as a shareholder. See the section of this proxy statement/prospectus entitled “Proposal No. 1 — The Business Combination Proposal — Interests of the Sponsor, Cormorant, and Helix’s Directors and Officers in the Business Combination”.

The Business Combination was not structured to require the approval of at least a majority of Helix’s unaffiliated shareholders because such a vote is not required under Cayman Islands law.

Q:     What happens if a substantial number of the Public Shareholders vote in favor of the proposals herein and exercise their redemption rights?

A:     Public Shareholders are not required to vote in respect of the Business Combination Proposal and Merger Proposal in order to exercise their redemption rights. Accordingly, the Business Combination may be consummated even though the funds available from the Trust Account and the number of Public Shareholders are reduced as a result of redemptions by Public Shareholders.

In the event of significant redemptions, with fewer Public Shares and Public Shareholders, the trading market for PubCo Common Stock may be less liquid than the market for Helix Class A Shares was prior to the Business Combination, and PubCo may not be able to meet the listing standards for Nasdaq or another national securities exchange. If the net proceeds of the Business Combination and the PIPE Investments are less than BBOT anticipates, including as a result of redemptions of Public Shares, and the Minimum Cash Condition is waived by BBOT, BBOT may need to make adjustments to its business plans in light of available capital resources and BBOT may need to seek additional funds earlier than BBOT anticipates. See “Risk Factors — BBOT may require additional capital to finance its operations. If BBOT is unable to raise such capital when needed, or on acceptable terms, BBOT may be forced to delay, reduce or eliminate one or more of its research and drug development programs, future commercialization efforts, product development or other operations.”

The table below presents the Trust Account value per share to a Public Shareholder that elects not to redeem its shares across a range of varying redemptions scenarios. This Trust Account value per share includes the per share cost of the Deferred Discount and PIPE placement agent fees.

____________

(1)      This scenario assumes that no Public Shares are redeemed. This scenario also assumes payment of the Deferred Discount of approximately $5.5 million using the funds in the Trust Account.

(2)      This scenario assumes that 5,236,672 Public Shares, or approximately 34% of the Public Shares subject to redemption, are redeemed for an aggregate payment of approximately $55.3 million (based on the estimated per-share redemption price of approximately $10.57 per share) from the Trust Account based on funds in the Trust Account as of March 31, 2025, which is a redemptions scenario that could occur. This scenario also assumes payment of the Deferred Discount of approximately $5.5 million using the funds in the Trust Account.

(3)      This scenario assumes that 11,661,825 Public Shares, or 75% of the Public Shares subject to redemption, are redeemed for an aggregate payment of approximately $123.2 million (based on the estimated per-share redemption price of approximately $10.57 per share) from the Trust Account based on funds in the Trust Account as of March 31, 2025, which is a redemptions scenario that could occur. This scenario also assumes payment of the Deferred Discount of approximately $5.5 million using the funds in the Trust Account. Also assumes that BBOT, in its sole discretion, waives the Minimum Cash Condition and no additional equity financing is obtained.

(4)      This scenario assumes that 15,549,100 Public Shares held by the Public Shareholders are redeemed for an aggregate payment of approximately $164.3 million (based on the estimated per-share redemption price of approximately $10.57 per share) from the Trust Account based on funds in the Trust Account as of March 31, 2025, which is a redemptions scenario that could occur. This scenario also assumes payment of the Deferred Discount of approximately $5.5 million using the funds in the Trust Account. Also assumes that BBOT, in its sole discretion, waives the Minimum Cash Condition and no additional equity financing is obtained. The Full Redemptions Scenario represents the redemption of all Public Shares held by Public Shareholders (excluding Cormorant) other than the 450,900 shares that are subject to Non-Redemption Agreements.

Q:     Can I vote at the EGM if I sell my Helix Class A Shares before the EGM?

A:     The Record Date for the EGM is earlier than the date of the EGM and earlier than the date that the Business Combination is expected to be completed. If you transfer your Helix Class A Shares after the applicable Record Date, but before the EGM, unless you grant a proxy to the transferee, you will retain your right to vote at the EGM.

Q:     May I change my vote after I have mailed my signed proxy card?

A:     Yes. Shareholders may send a later-dated, signed proxy card to Sodali at the address set forth at the end of this section, so that it is received prior to the vote at the EGM, or attend the EGM in person and vote. Shareholders also may revoke their proxy by sending a notice of revocation to Helix’s Chief Executive Officer, which must be received prior to the vote at the EGM. However, if your shares are held in “street name” by your broker, bank or another nominee, you must contact your broker, bank or other nominee to change your vote.

Q:     What happens if I fail to take any action with respect to the EGM?

A:     If you fail to take any action with respect to the EGM and the Business Combination is approved by shareholders and consummated, you will become a stockholder of PubCo. However, if you fail to take any action with respect to the EGM, you will nonetheless be able to elect to redeem your Public Shares in connection with the Business Combination, provided you follow the instructions in this proxy statement/prospectus for redeeming your shares. If you fail to take any action with respect to the EGM and the Business Combination Proposal is not approved, you will continue to be a shareholder of Helix.

Q:     What should I do with my share certificates?

A:     Those shareholders who do not elect to have their Helix Class A Shares redeemed for their pro rata share of the funds in the Trust Account should not submit their share certificates now. After the consummation of the Business Combination, PubCo will send instructions to Helix Shareholders regarding the exchange of their Helix Class A Shares for PubCo Common Stock. Helix Shareholders who exercise their redemption rights must deliver their share certificates to the Transfer Agent (either physically or electronically) prior to the deadline for submitting redemption requests described above.

Q:     What should I do if I receive more than one set of voting materials?

A:     Shareholders may receive more than one set of voting materials, including multiple copies of this proxy statement/prospectus and multiple proxy cards or voting instruction cards. For example, if you hold your shares in more than one brokerage account, you will receive a separate voting instruction card for each brokerage account in which you hold shares. If you are a holder of record and your shares are registered in more than one name, you will receive more than one proxy card. Please complete, sign, date and return each proxy card and voting instruction card that you receive in order to cast a vote with respect to all of your Helix Ordinary Shares.

Q:     What is the recommendation of the Helix Board?

A:     The Helix Board believes that the Business Combination Proposal and the other proposals to be presented at the EGM are fair, advisable, and in the best interests of Helix’s shareholders and recommends that Helix Shareholders vote “FOR” the approval of the Business Combination Proposal, “FOR” the approval of the Domestication Proposal, “FOR” the approval of the Stock Issuance Proposal, “FOR” the approval of the Organizational

Documents Proposal, “FOR” the approval of each of the Advisory Organizational Documents Proposals, “FOR” the approval of the Incentive Plan Proposal, “FOR” the approval of the ESPP Proposal, “FOR” the approval of the Director Election Proposal and “FOR” the approval of the Adjournment Proposal, if presented.

The existence of financial and personal interests of one or more of Helix’s directors may result in a conflict of interest on the part of such director(s) between what he or they may believe is in the best interests of Helix and its shareholders and what he or they may believe is best for himself or themselves in determining to recommend that shareholders vote for the proposals. In addition, the Sponsor, Cormorant, and Helix’s officers have interests in the Business Combination that may conflict with your interests as a shareholder. See “Proposal No. 1 — The Business Combination Proposal — Interests of Sponsor and Directors and Officers in the Business Combination”.

Q:     How do the Sponsor, Cormorant and Helix’s officers and directors intend to vote?

A:     The Sponsor, Cormorant, and Helix’s officers and directors have agreed to vote in favor of all the proposals being presented at the EGM. No consideration has been or will be paid by Helix or BBOT to the Helix Insiders in connection with such agreements. The Sponsor, Cormorant, and other Helix Insiders collectively own approximately 31.9% of the issued and outstanding Helix Ordinary Shares.

The existence of financial and personal interests of one or more of Helix’s directors may result in a conflict of interest on the part of such director(s) between what he or they may believe is in the best interests of Helix and its shareholders and what he or they may believe is best for himself or themselves in determining to recommend that shareholders vote for the proposals. In addition, the Sponsor, Cormorant, and Helix’s officers have interests in the Business Combination that may conflict with your interests as a shareholder. See “Proposal No. 1 — The Business Combination Proposal — Interests of Sponsor and Directors and Officers in the Business Combination”.

Q:     Do the Sponsor, Cormorant, and Helix’s officers and directors expect to purchase Public Shares from Public Shareholders or take other actions to incentivize non-redemption?

A:     Other than the Non-Redemption Agreements entered into concurrently with the signing of the Business Combination Agreement (which do not provide any consideration to the Non-Redeeming Shareholders in connection with their Non-Redemption Agreements), the Sponsor, Cormorant, and Helix’s officers and directors do not have any plans at this time to purchase Public Shares from Public Shareholders or to take any other actions to incentivize non-redemption. However, at any time prior to the EGM, during a period when they are not then aware of any material nonpublic information regarding Helix or its securities, the Sponsor, Cormorant, and Helix’s officers and directors or their affiliates may purchase Public Shares in privately negotiated transactions or in the open market, although they are under no obligation to do so. There is no limit on the number of Public Shares that such persons may purchase in such transactions, subject to compliance with applicable law and Nasdaq rules. However, other than as expressly stated herein, they have no current commitments, plans or intentions to engage in such transactions and have not formulated any terms or conditions for any such transactions. None of the funds in the Trust Account will be used to purchase Public Shares in such transactions. Such purchases may include a contractual acknowledgment that such shareholder, although still the record holder of Helix’s shares, is no longer the beneficial owner thereof and therefore agrees not to exercise its redemption rights.

In the event that the Sponsor, Cormorant, and Helix’s officers and directors or their affiliates purchase shares in privately negotiated transactions from Public Shareholders who have already elected to exercise their redemption rights, such selling shareholders would be required to revoke their prior elections to redeem their shares. The purpose of such transaction could be to increase the likelihood of obtaining shareholder approval of the Business Combination or satisfy the Minimum Cash Condition, where it appears that such requirement would otherwise not be met. Helix expects any such purchases will be reported pursuant to Section 13 and Section 16 of the Exchange Act to the extent such purchasers are subject to such reporting requirements.

In addition, if such purchases are made, the public “float” of Helix Class A Shares and the number of beneficial holders of Helix Class A Shares may be reduced, possibly making it difficult to obtain or maintain the quotation, listing or trading of Helix’s securities on Nasdaq.

In the event the Sponsor, Cormorant, and Helix’s officers and directors or their affiliates were to purchase Public Shares from Public Shareholders, such purchases would be structured in compliance with the requirements of Rule 14e-5 under the Exchange Act. To the extent that the Sponsor, Cormorant, and Helix’s officers and

RISK FACTORS

Risks Related to BBOT and the Business Combination

Unless the context otherwise requires, references in this subsection “— Risks Related to BBOT and the Business Combination” to “we”, “us”, and “our” generally refer to BBOT in the present tense or PubCo from and after the Business Combination.

Risks related to BBOT’s financial position and need for additional capital

BBOT has a limited operating history, has not completed any clinical trials, has no products approved for commercial sale and has not generated any revenue, which may make it difficult for investors to evaluate BBOT’s current business and likelihood of success and viability.

BBOT is a biopharmaceutical company with a limited operating history upon which investors can evaluate its business and prospects. BBOT was incorporated in August 2016 and commenced significant operations as an independent entity starting in May 2024, has never completed a clinical trial, has no products approved for commercial sale and has never generated any revenue. Drug development is a highly uncertain undertaking and involves a substantial degree of risk. To date, BBOT has devoted substantially all of its resources to research and development activities, including with respect to BBO-8520, BBO-10203 and BBO-11818, and its discovery programs, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital and providing general and administrative support for these operations.

BBOT has not yet demonstrated its ability to successfully complete clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful product commercialization. As a result, it may be more difficult for investors to evaluate BBOT’s likelihood of success and viability.

In addition, BBOT may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by biopharmaceutical companies at BBOT’s stage of development in rapidly evolving fields. BBOT also expects that, as BBOT advances its product candidates, BBOT will need to transition from a company with a research and development focus to a company capable of supporting commercial activities. BBOT has not yet demonstrated an ability to successfully overcome such risks and difficulties, or to make such a transition. If BBOT does not adequately address these risks and difficulties or successfully make such a transition, its business will suffer.

BBOT has incurred significant net losses in each period since its inception, and expects to continue to incur significant net losses for the foreseeable future.

BBOT incurred significant net losses in each reporting period since its inception, has not generated any revenue to date and has financed its operations principally through private placements of securities. BBOT’s net losses were $22.1 million and $15.4 million for the three months ended March 31, 2025 and 2024, respectively, and $74.3 million and $64.7 million for the years ended December 31, 2024 and 2023, respectively. As of March 31, 2025, BBOT had an accumulated deficit of $244.6 million. BBOT has not yet completed any clinical trials. As a result, BBOT expects that it will be several years, if ever, before BBOT generates revenue from product sales. Even if BBOT succeeds in receiving marketing approval for and commercializing one or more product candidates, BBOT expects that it will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.

BBOT expects to continue to incur significant and increasing expenses and increasing operating losses for the foreseeable future. The net losses BBOT incurs may fluctuate significantly from quarter to quarter such that a period-to-period comparison of BBOT’s results of operations may not be a good indication of future performance. The size of future net losses will depend, in part, on the pace of development activities and the rate of future growth of expenses and BBOT’s ability to generate revenue. BBOT’s prior losses and expected future losses have had and will continue to have an adverse effect on working capital, BBOT’s ability to fund the development of its product candidates and its ability to achieve and maintain profitability and the performance of its stock.

BBOT’s ability to generate revenue and achieve profitability depends significantly on its ability to achieve its objectives relating to the discovery, development and commercialization of its product candidates.

BBOT relies on its team’s expertise in chemistry, structure-based drug design, oncology drug development, business development and patient-driven approach to develop its product candidates. BBOT’s business depends significantly on the success of its approach and the development and commercialization of the product candidates that BBOT discovers with this approach. BBOT has no products approved for commercial sale and does not anticipate generating any revenue from product sales for the next several years, if ever. BBOT’s ability to generate revenue and achieve profitability depends significantly on its ability to achieve several objectives, including:

•        successful and timely completion of preclinical and clinical development of BBO-8520, BBO-10203, BBO-11818 and any future product candidates from BBOT’s discovery programs, and any other future programs;

•        maintaining current and establishing new relationships with contract research organizations (“CROs”) and clinical sites for the clinical development of BBO-8520, BBO-10203, BBO-11818 and any future product candidates from BBOT’s current or future discovery programs;

•        timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which BBOT successfully completes clinical development;

•        developing an efficient and scalable manufacturing process for BBOT’s product candidates, including the production of finished products that are appropriately packaged for sale if BBOT’s product candidates obtain marketing approvals;

•        maintaining current and establishing new commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for BBOT’s product candidates, if approved;

•        successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators;

•        maintaining an acceptable safety profile following any marketing approval of BBOT’s product candidates;

•        commercial acceptance of BBOT’s product candidates by patients, the medical community and third-party payors, including the willingness of physicians to use BBOT’s product candidates, if approved, in lieu of (or in conjunction with) other approved therapies;

•        satisfying any required post-marketing approval commitments to applicable regulatory authorities;

•        identifying, assessing and developing new product candidates;

•        obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the U.S. and internationally;

•        defending against third-party interference or infringement claims, if any, with respect to BBOT’s intellectual property rights;

•        entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize BBOT’s product candidates;

•        obtaining coverage and adequate reimbursement by third-party payors for BBOT’s product candidates, if approved;

•        addressing any competing therapies and technological and market developments; and

•        attracting, hiring and retaining qualified personnel.

BBOT may never be successful in achieving its objectives and, even if it does, may never generate revenue that is significant or large enough to achieve profitability. If BBOT does achieve profitability, BBOT may not be able to sustain or increase profitability on a quarterly or annual basis. BBOT’s failure to become and remain profitable would decrease the value of the company and could impair BBOT’s ability to maintain or further its research and development efforts, raise additional necessary capital, grow its business and continue its operations.

BBOT may require additional capital to finance its operations. If BBOT is unable to raise such capital when needed, or on acceptable terms, BBOT may be forced to delay, reduce or eliminate one or more of its research and drug development programs, future commercialization efforts, product development or other operations.

Since inception, BBOT has used substantial amounts of cash to fund its operations, and its expenses will increase substantially in the foreseeable future in connection with its ongoing activities, particularly as BBOT continues the research and development of, initiates additional clinical trials of, and seeks marketing approval for, its product candidates. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Even if one or more of BBOT’s product candidates or any future product candidates that BBOT develops is approved for commercial sale, BBOT anticipates incurring significant costs associated with sales, marketing, manufacturing and distribution activities. BBOT’s expenses could increase beyond expectations if BBOT is required by the FDA, the EMA or other regulatory authorities to perform clinical trials or preclinical studies in addition to those that BBOT currently anticipates. Other unanticipated costs may also arise. Because the design and outcome of BBOT’s clinical trials, including its planned and anticipated clinical trials, are highly uncertain, BBOT cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of its product candidates or any future product candidates that it develops. BBOT has initiated Phase 1 clinical trials of BBO-8520, BBO-10203 and BBO-11818. BBOT is not permitted to market or promote any product candidate before it receives marketing approval from the FDA, EMA or any comparable foreign regulatory authorities. BBOT will also incur additional costs associated with operating as a public company. Accordingly, BBOT may need to obtain additional funding in order to continue its operations.

BBOT estimates that the net proceeds from the Business Combination and the PIPE Investments, together with its existing cash, cash equivalents and short-term marketable securities as of the date of this proxy statement/prospectus, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into 2027 in all four Redemptions Scenarios. If the net proceeds of the Business Combination and the PIPE Investments are less than BBOT anticipates, including as a result of redemptions of Public Shares, and the Minimum Cash Condition is waived by BBOT, BBOT may need to make adjustments to its business plans in light of available capital resources and BBOT may need to seek additional funds earlier than BBOT anticipates. Advancing the development of BBO-8520, BBO-10203 and BBO-11818 and BBOT’s discovery programs will require a significant amount of capital. BBOT’s existing cash, cash equivalents and marketable securities will not be sufficient to fund all of BBOT’s product candidates through regulatory approval, and BBOT may need to raise additional capital to complete the development and commercialization of its product candidates. BBOT’s estimate as to how long it expects its existing cash, cash equivalents and marketable securities to fund its operations does not include potential product revenue and is based on assumptions that may prove to be wrong, and BBOT could use its available capital resources sooner than currently expected. Changing circumstances, some of which may be beyond BBOT’s control, could cause BBOT to consume capital significantly faster than currently anticipated, and BBOT may need to seek additional funds.

BBOT may be required to obtain further funding through public or private equity financings, debt financings, collaborative agreements, licensing arrangements or other sources of financing, which may dilute BBOT’s stockholders or restrict its operating activities. BBOT does not have any committed external source of funds. Adequate additional financing may not be available to BBOT on acceptable terms, or at all. BBOT’s ability to raise additional funds may be adversely impacted by general economic conditions, both inside and outside the U.S., including disruptions to, and instability and volatility in, the credit and financial markets in the U.S. and worldwide, including heightened inflation, interest rate and currency rate fluctuations, and economic slowdown or recession as well as concerns related to public health emergencies, natural disasters or geopolitical events, including civil or political unrest or military conflicts. In addition, market instability and volatility, high levels of inflation and interest rate fluctuations may increase BBOT’s cost of financing or restrict BBOT’s access to potential sources of future liquidity. To the extent that BBOT raises additional capital through the sale of equity or convertible debt securities, each investor’s ownership interests will be diluted, and the terms may include liquidation or other preferences that adversely affect each investor’s rights as a stockholder. Debt financing may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect BBOT’s business. If BBOT raises additional funds through upfront payments or milestone payments pursuant to strategic collaborations with third parties, BBOT may have to relinquish valuable rights to its product candidates or grant licenses on terms that are not favorable to BBOT. In addition, BBOT may seek additional capital due to favorable market conditions or strategic considerations even if BBOT believes it has sufficient funds for its current or future operating plans.

BBOT’s failure to raise capital as and when needed or on acceptable terms would have a negative impact on its financial condition and its ability to pursue its business strategy, and BBOT may have to delay, reduce the scope of, suspend or eliminate one or more of its research or drug development programs, clinical trials or future commercialization efforts.

Risks related to BBOT’s product development, regulatory approval and commercialization

BBOT’s future prospects are substantially dependent on the advancement of its product candidates. If BBOT is unable to advance its product candidates through development, obtain regulatory approval and ultimately commercialize such product candidates, or experience significant delays in doing so, BBOT’s business will be materially harmed.

BBOT has initiated Phase 1 clinical trials of BBO-8520, BBO-10203 and BBO-11818. BBOT’s ability to generate product revenue, which BBOT does not expect will occur for many years, if ever, will depend heavily on the successful clinical development and eventual commercialization of one or more product candidates. BBOT is not permitted to market or promote any product candidate before BBOT receives marketing approval from the FDA, EMA or any comparable foreign regulatory authorities, and BBOT may never receive such marketing approvals.

The success of BBOT’s product candidates will depend on several factors, including the following:

•        successful and timely completion of preclinical studies;

•        submission of INDs in the U.S. and CTAs and/or comparable applications outside the U.S. for regulatory authority review and agreement to proceed with BBOT’s clinical trials;

•        successful initiation and completion of clinical trials;

•        successful and timely patient selection and enrollment in and completion of clinical trials;

•        maintaining and establishing relationships with CROs and clinical sites for the clinical development of BBOT’s product candidates both in the U.S. and internationally;

•        maintaining and growing an organization of scientific, medical and other professionals who can develop and commercialize BBOT’s product candidates;

•        the frequency and severity of adverse events in clinical trials;

•        obtaining positive data that support demonstration of efficacy, safety and tolerability profiles and durability of effect for BBOT’s product candidates that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval;

•        the timely receipt of marketing approvals from applicable regulatory authorities;

•        the timely identification, development and approval of companion diagnostic tests, if required;

•        the extent of any required post-marketing approval commitments to applicable regulatory authorities;

•        the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of BBOT’s product candidates;

•        obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the U.S. and internationally;

•        the protection of BBOT’s rights in its intellectual property portfolio;

•        establishing sales, marketing and distribution capabilities and the successful launch of commercial sales of BBOT’s product candidates if and when approved for marketing, whether alone or in collaboration with others;

•        maintaining an acceptable safety profile following any marketing approval;

•        commercial acceptance by patients, the medical community and third-party payors, including the willingness of physicians to use BBOT’s product candidates, if approved, in lieu of (or in conjunction with) other approved therapies;

•        BBOT’s ability to compete with other therapies; and

•        BBOT’s ability to address any potential delays resulting from factors related to public health emergencies, natural disasters or geopolitical events.

BBOT does not have complete control over many of these factors, including certain aspects of preclinical and clinical development and the regulatory submission process, potential threats to BBOT’s intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future collaborator. If BBOT is not successful with respect to one or more of these factors in a timely manner or at all, BBOT could experience significant delays or an inability to successfully commercialize any product candidates from its lead programs, which would materially harm its business. If BBOT does not receive marketing approvals for such product candidates, BBOT may not be able to continue its operations.

BBOT’s preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of any of its product candidates, which would prevent or delay development, regulatory approval and commercialization.

Before obtaining marketing approval from the FDA, EMA or other comparable foreign regulatory authorities for the sale of BBOT’s product candidates, BBOT must demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that its product candidates are both safe and effective for use in each target indication. Preclinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and the ultimate outcome is uncertain. Failure can occur at any time during the preclinical study and clinical trial processes, there is a high risk of failure, and BBOT may never succeed in developing marketable products.

BBOT may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent receipt of marketing approval or BBOT’s ability to commercialize its product candidates, including:

•        failure of BBOT’s product candidates in preclinical studies or clinical trials to demonstrate safety and efficacy;

•        receipt of feedback from regulatory authorities that requires BBOT to modify the design of its clinical trials;

•        negative or inconclusive clinical trial results that may require BBOT to conduct additional clinical trials or abandon certain research, discovery and/or drug development programs;

•        the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated, particularly if there are other trials enrolling the same or overlapping precisely targeted patient populations, or participants dropping out of these clinical trials at a higher rate than anticipated;

•        third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to BBOT in a timely manner, or at all;

•        the suspension or termination of BBOT’s clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that BBOT’s product candidates have undesirable adverse events or other unexpected characteristics or risks;

•        the cost of clinical trials of BBOT’s product candidates being greater than anticipated;

•        the supply or quality of BBOT’s product candidates or other materials necessary to conduct clinical trials of BBOT’s product candidates being insufficient or inadequate; and

•        regulators revising the requirements for approving BBOT’s product candidates.

If BBOT is required to conduct additional clinical trials or other testing of its product candidates beyond those that BBOT is currently contemplating, if BBOT is unable to successfully complete clinical trials of its product candidates or other testing in a timely manner, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, BBOT may incur unplanned costs, be delayed in seeking and obtaining marketing approval, if BBOT receives such approval at all, receive more limited or restrictive marketing approval, be subject to additional post-marketing testing requirements or have the drug removed from the market after obtaining marketing approval.

BBOT’s discovery and development activities are focused on precision oncology to treat RAS-dependent cancers, which is a rapidly evolving area of science, and the approach BBOT is taking to discover and develop drugs may never lead to approved or marketable products.

The discovery and development of precision oncology therapeutics for patients with RAS-dependent cancers is an emerging field, and the scientific discoveries that form the basis for BBOT’s efforts to discover and develop product candidates are evolving. The scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. Although BBOT believes, based on BBOT’s preclinical work and clinical trials to date, that BBOT’s product candidates can inhibit RAS, clinical results may not confirm this hypothesis or may only confirm it for certain tumor types. The patient populations for BBOT’s product candidates are limited to those with KRAS and PI3Ka mutations and HER2 amplification and may not be completely defined but are substantially smaller than the general treated cancer population, and BBOT will need to screen and identify these targeted patients. Successful identification of patients is dependent on several factors, including evaluation of patient biopsies and blood samples, which may require the use of companion diagnostic tests. Furthermore, even if BBOT is successful in identifying patients, BBOT cannot be certain that the resulting patient populations for each mutation will be large enough to allow BBOT to successfully obtain approval for each mutation type and commercialize BBOT’s product candidates and achieve profitability. BBOT does not know if its approach of focusing on treating patients with RAS-dependent cancers will be successful, and if its approach is unsuccessful, BBOT’s business will suffer.

Any delays in the commencement or completion, or any termination or suspension, of BBOT’s current, planned or future clinical trials could result in increased costs to BBOT, delay or limit BBOT’s ability to generate revenue and adversely affect BBOT’s commercial prospects.

Before BBOT can initiate clinical trials of any product candidate in any indication, BBOT must submit the results of preclinical studies to the FDA, EMA or other comparable foreign regulatory authorities along with other information, including information about the product candidate’s chemistry, manufacturing and controls and its proposed clinical trial protocol, as part of an IND or similar regulatory submission under which BBOT must receive authorization to proceed with clinical development. The FDA, EMA or other comparable foreign regulatory authorities may require BBOT to conduct additional preclinical studies for any product candidate before they allow BBOT to initiate clinical trials under any IND, CTA or comparable application which may lead to additional delays and increase the costs of BBOT’s preclinical development programs.

Before obtaining marketing approval from the FDA of BBO-8520, BBO-10203, BBO-11818 or of any other future product candidate in any indication, BBOT must conduct extensive clinical studies to demonstrate safety and efficacy. Clinical testing is expensive, time consuming and uncertain as to outcome. In addition, BBOT expects to rely in part on preclinical, clinical and quality data generated by BBOT’s CROs and other third parties for regulatory submissions for BBOT’s product candidates. While BBOT has or will have agreements governing these third parties’ services, BBOT has limited influence over their actual performance. If these third parties do not make data available to BBOT, or, if applicable, make regulatory submissions in a timely manner, in each case pursuant to BBOT’s agreements with them, BBOT’s development programs may be significantly delayed and BBOT may need to conduct additional studies or collect additional data independently. In either case, BBOT’s development costs would increase. BBOT has initiated Phase 1 clinical trials of BBO-8520, BBO-10203 and BBO-11818. An IND submission must become effective prior to initiating any clinical trials in the U.S. for any of BBOT’s future product candidates.

BBOT could also encounter delays if a clinical trial is suspended or terminated by BBOT, by the independent institutional review board (IRB) or independent ethics committee (IEC) of the institutions in which such trials are being conducted, by a data safety monitoring board for such trial or by the FDA or foreign regulatory authorities. 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 BBOT’s clinical protocols, inspection of the clinical trial operations or trial site by the FDA or foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse events, 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 BBOT may need to amend clinical trial protocols to comply with these changes. Amendments may require BBOT to resubmit its clinical trial protocols to IRBs/IECs for reexamination, which may impact the costs, timing or successful completion of a clinical trial.

Further, if BBOT is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, BBOT’s development plans may be impacted. For example, in December 2022, with the passage of the Food and Drug Omnibus Reform Act (FDORA), Congress required sponsors to develop and submit a diversity action plan for each Phase 3 clinical trial or any other “pivotal study” of a new drug or biological product. Although these diversity action plans are not required to be submitted until after the FDA finalizes its guidance on the topic, such plans are meant to encourage the enrollment of more diverse patient populations in late-stage clinical trials of FDA-regulated products. Similarly, the regulatory landscape related to clinical trials in the European Union (EU) recently evolved. The EU Clinical Trials Regulation (CTR), which was adopted in April 2014 and repealed the EU Clinical Trials Directive, became applicable on January 31, 2022. While the Clinical Trials Directive required a separate CTA to be submitted in each member state, to both the competent national health authority and an IEC, the CTR introduces a centralized process and only requires the submission of a single application to all member states concerned. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state.

Certain of BBOT’s current or future scientific advisors or consultants who receive compensation from BBOT may become investigators for BBOT’s future clinical trials. Under certain circumstances, BBOT may be required to report some of these relationships to the FDA. Although BBOT expects any such relationships to be within the FDA’s guidelines, the FDA may conclude that a financial relationship between BBOT 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 BBOT’s marketing applications by the FDA and may ultimately lead to the denial of marketing approval of BBOT’s product candidates. If BBOT experiences delays in the completion of, or any termination or suspension of, any clinical trial of any product candidate, the commercial prospects of such product candidate will be harmed, and BBOT’s ability to generate product revenue will be delayed. Moreover, any delays in completing BBOT’s clinical trials will increase BBOT’s costs, slow down BBOT’s development and approval process and jeopardize BBOT’s ability to commence product sales and generate revenue, which may harm BBOT’s business, financial condition, results of operations and prospects significantly.

The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of BBOT’s clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities.

BBOT will be required to demonstrate with substantial evidence through well-controlled clinical trials that BBOT’s product candidates are safe and effective for use in the target population before BBOT can seek marketing approvals for their commercial sale. Preclinical and clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the preclinical study and clinical trial processes; there is a high risk of failure and BBOT may never succeed in developing marketable products.

The results of preclinical studies may not be predictive of the results of clinical trials of BBOT’s product candidates, and the results of early clinical trials may not be predictive of the results of later-stage clinical trials. Although product candidates may demonstrate promising results in preclinical studies and early clinical trials, they may not prove to be safe or effective in subsequent clinical trials. Favorable results from certain animal studies may not accurately predict the results of other animal studies or of human trials, due to the inherent biologic differences in species, the differences between testing conditions in animal studies and human trials, and the particular goals, purposes, and designs of the relevant studies and trials. Similarly, certain of BBOT’s hypotheses regarding the potential clinical and therapeutic benefits of its product candidates compared to other approved products and product candidates or molecules in development are based on observations from the preclinical studies and early clinical trials that BBOT has completed, and results from such preclinical studies and early clinical trials are not necessarily predictive of the results of later preclinical studies or clinical trials.

There is typically an extremely high rate of attrition from the failure of product candidates proceeding through preclinical studies and clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. Likewise, early, smaller-scale clinical trials may not be predictive of eventual safety or effectiveness in large-scale pivotal clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs. A number of companies in the biopharmaceutical

industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy, insufficient durability of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that commence preclinical studies and clinical trials are never approved as products. The development of BBOT’s product candidates and its stock price may also be impacted by inferences, whether correct or not, that are drawn between the success or failure of preclinical studies or clinical trials of BBOT’s competitors or other companies in the biopharmaceutical industry, in addition to BBOT’s own preclinical studies and clinical trials.

In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differences in and adherence to the dose and dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. Patients treated with BBOT’s product candidates may also be undergoing surgical, radiation and chemotherapy treatments and may be using other approved products or investigational new drugs, which can cause adverse events that are unrelated to BBOT’s product candidates. As a result, assessments of efficacy can vary widely for a particular patient, and from patient to patient and site to site within a clinical trial. This subjectivity can increase the uncertainty of, and adversely impact, BBOT’s clinical trial outcomes.

Any preclinical studies or clinical trials that BBOT conducts may not demonstrate the safety and efficacy necessary to obtain regulatory approval to market BBOT’s product candidates. If the results of BBOT’s ongoing or future preclinical studies and clinical trials are inconclusive with respect to the safety and efficacy of BBOT’s product candidates, if BBOT does not meet the clinical endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with BBOT’s product candidates, BBOT may be prevented or delayed in obtaining marketing approval for such product candidates.

BBOT does not know whether any clinical trials BBOT conducts will demonstrate consistent or adequate efficacy and safety sufficient to obtain approval to market any of BBOT’s product candidates.

In addition to BBO-8520, BBO-10203 and BBO-11818, BBOT’s prospects depend in part upon discovering, developing and commercializing additional product candidates from BBOT’s discovery programs, which may fail in development or suffer delays that adversely affect their commercial viability.

BBOT’s future operating results are dependent on its ability to successfully discover, develop, obtain regulatory approval for and commercialize BBO-8520, BBO-10203 and BBO-11818 and future product candidates from BBOT’s discovery programs. A research candidate can unexpectedly fail at any stage of development. The historical failure rate for research candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care and other unpredictable variables. The results from preclinical testing or early clinical trials of a product candidate may not be predictive of the results that will be obtained in later stage clinical trials of the product candidate.

The success of other research candidates that BBOT may develop will depend on many factors, including the following:

•        generating sufficient data to support the initiation or continuation of preclinical studies and clinical trials;

•        obtaining regulatory permission to initiate clinical trials;

•        contracting with the necessary parties to conduct clinical trials;

•        successful enrollment of patients in, and the completion of, clinical trials on a timely basis;

•        the timely manufacture of sufficient quantities of a product candidate for use in clinical trials;

•        adverse events in clinical trials; and

•        addressing any delays resulting from factors related to public health emergencies, natural disasters or geopolitical events.

Even if BBOT successfully advances any research candidates into preclinical and clinical development, their success will be subject to all of the preclinical, clinical, regulatory and commercial risks described elsewhere in this “Risk Factors” section. Accordingly, there can be no assurance that BBOT will ever be able to discover, develop, obtain regulatory approval of, commercialize or generate significant revenue from any product candidates.

BBOT’s approach to the discovery and development of product candidates is unproven, and BBOT may not be successful in its efforts to use and expand its approach to build a pipeline of product candidates with commercial value.

A key element of BBOT’s strategy, which is unproven, is to use and expand BBOT’s expertise in chemistry, structure-based drug design and patient-driven approach to build a pipeline of product candidates and progress these product candidates through clinical development. Although BBOT’s research and development efforts to date have resulted in the discovery of and initiation of clinical development of BBO-8520, BBO-10203 and BBO-11818, such product candidates and any other product candidates BBOT may develop may not be safe or effective as cancer therapeutics, and BBOT may not be able to develop any other product candidates. For example, the potential product candidates that BBOT has identified or identifies in the future may not generate acceptable clinical data, including as a result of being shown to have unacceptable toxicity or other characteristics that indicate that they are unlikely to be product candidates that will receive marketing approval from the FDA, EMA or other regulatory authorities or achieve market acceptance. If BBOT does not successfully develop and commercialize product candidates, BBOT will not be able to generate product revenue in the future, which would result in significant harm to BBOT’s financial position and adversely affect its business.

The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If BBOT is ultimately unable to obtain regulatory approval of its product candidates, BBOT will be unable to generate product revenue and its business will be substantially harmed.

Obtaining approval by the FDA, EMA and other comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that BBOT’s data are insufficient for approval and require additional preclinical, clinical or other data. In addition, the U.S. Supreme Court’s July 2024 decision to overturn prior established case law giving deference to regulatory agencies’ interpretations of ambiguous statutory language has introduced uncertainty regarding the extent to which FDA’s regulations, policies and decisions may become subject to increasing legal challenges, delays, and/or changes. Even if BBOT eventually completes clinical testing and receives approval for its product candidates, the FDA, EMA and other comparable foreign regulatory authorities may approve BBOT’s product candidates for a more limited indication or a narrower patient population than BBOT originally requested or may impose other prescribing limitations or warnings that limit the product candidate’s commercial potential. Even if approved, BBOT may be required to conduct additional studies to verify or confirm the clinical benefits of its products. BBOT has not submitted for, or obtained, regulatory approval for any product candidate, and it is possible that none of BBOT’s product candidates will ever obtain regulatory approval. Further, development of BBOT’s product candidates and/or regulatory approval may be delayed for reasons beyond its control.

Applications for BBOT’s product candidates could fail to receive regulatory approval for many reasons, including the following:

•        the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of BBOT’s clinical trials;

•        the FDA, EMA or other comparable foreign regulatory authorities may determine that BBOT’s product candidates are not safe and effective, are only moderately effective or have undesirable or unintended adverse events, toxicities or other characteristics that preclude BBOT obtaining marketing approval or prevent or limit commercial use;

•        the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which BBOT seeks approval;

•        the FDA, EMA or other comparable foreign regulatory authorities may disagree with BBOT’s interpretation of data from preclinical studies or clinical trials;

•        the clinical data of the clinical trial may fail to meet the level of statistical significance required to obtain approval of BBOT’s product candidates by the FDA, EMA or other comparable foreign regulatory authorities;

•        BBOT may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that BBOT’s product candidates’ risk-benefit ratios for their proposed indications are acceptable;

•        the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which BBOT contracts for clinical and commercial supplies;

•        the FDA, EMA or other comparable regulatory authorities may fail to approve companion diagnostic tests required for BBOT’s product candidates;

•        BBOT may not obtain or maintain adequate funding to complete its clinical trials in a manner that is satisfactory to the FDA, EMA or other comparable foreign regulatory authorities; and

•        the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering BBOT’s clinical data insufficient for approval.

This lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in BBOT failing to obtain regulatory approval to market any of its product candidates, which would significantly harm BBOT’s business, results of operations and prospects.

BBOT may not be able to submit INDs, CTAs or comparable applications to commence clinical trials on the timelines BBOT expects, and even if BBOT is able to, the FDA, EMA or any comparable foreign regulatory authority may not permit BBOT to proceed.

BBOT’s research and development efforts to date have resulted in the initiation of clinical development of BBO-8520, BBO-10203 and BBO-11818. BBOT may not be able to submit INDs for any future product candidates it may identify on the timelines it expects, or such submissions may not take effect on the timeline that BBOT anticipates, or at all. For example, BBOT may experience manufacturing delays or other delays with IND-enabling studies. Moreover, BBOT cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that could cause BBOT or regulatory authorities to suspend or terminate clinical trials. Additionally, even if the FDA agrees with the design and implementation of the clinical trials set forth in an IND, BBOT cannot guarantee that the FDA will not change its requirements in the future. These considerations also apply to new clinical trials BBOT may submit as amendments to existing INDs or to a new IND. Any failure to submit INDs, CTAs or comparable applications on the timelines BBOT expects or to obtain regulatory approvals for BBOT’s planned clinical trials may prevent BBOT from initiating or completing its clinical trials or commercializing its product candidates on a timely basis, if at all.

BBOT’s product candidates may cause significant adverse events, toxicities or other undesirable adverse events when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.

If BBOT’s product candidates are associated with undesirable adverse events or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or investigational new drugs, BBOT may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable adverse events or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Treatment-related adverse events could also affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Any of these occurrences may prevent BBOT from achieving or maintaining market acceptance of the affected product candidate and may harm BBOT’s business, financial condition and prospects significantly. There have been, and it is likely that there will be additional, adverse events associated with the use of BBOT’s product candidates as is typically the case with oncology drugs. Results of BBOT’s studies or trials could reveal a high and unacceptable severity and prevalence of these or other adverse events. In such an event, BBOT’s trials could be suspended or terminated and the FDA, EMA or comparable foreign regulatory authorities could order BBOT

to cease further development of or deny approval of BBOT’s product candidates for any or all targeted indications. Drug-related adverse events could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm BBOT’s business, financial condition and prospects significantly.

In addition, BBOT’s product candidates may be used in populations for which safety concerns may be particularly scrutinized by regulatory authorities. BBOT’s product candidates may be studied in combination with other therapies, which may exacerbate adverse events associated with the therapy. Patients treated with BBOT’s product candidates may also be undergoing surgical, radiation and chemotherapy treatments, which can cause adverse events that are unrelated to BBOT’s product candidates but may still impact the success of BBOT’s clinical trials. The inclusion of critically ill patients in BBOT’s clinical trials may result in deaths or other adverse medical events due to other therapies or medications that such patients may be using or due to the gravity of such patients’ illnesses.

If significant adverse events are observed in any of BBOT’s current or future clinical trials, BBOT may have difficulty recruiting patients to the clinical trials, patients may drop out of BBOT’s trials, or BBOT may be required to abandon the trials or its development efforts of that product candidate altogether. BBOT, the FDA, EMA, other comparable foreign regulatory authorities or an IRB may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse events. Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have later been found to cause adverse events that prevented their further development. Even if the adverse events do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable adverse events may inhibit market acceptance due to its tolerability versus other therapies. Any of these developments could materially harm BBOT’s business, financial condition and prospects. Further, if any of BBOT’s product candidates obtain marketing approval, toxicities associated with such product candidates previously not seen during clinical testing may also develop after such approval and lead to a requirement to conduct additional clinical safety trials, additional contraindications, warnings and precautions being added to the drug label, significant restrictions on the use of the product or the withdrawal of the product from the market. BBOT cannot predict whether its product candidates will cause toxicities in humans that would preclude or lead to the revocation of regulatory approval based on preclinical studies or early-stage clinical trials.

Interim, preliminary and topline data from BBOT’s preclinical studies and clinical trials that BBOT announces or publishes from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.

BBOT expects to publicly disclose interim, preliminary or topline data from its clinical trials in the future. These interim updates are anticipated to be based on preliminary analyses of then-available data, and the results and related findings and conclusions may be subject to change following a more comprehensive review of the data related to the particular study or trial. For example, BBOT may report responses in certain patients that are unconfirmed at the time and which do not ultimately result in confirmed responses to treatment after follow-up evaluations. BBOT also makes assumptions, estimations, calculations and conclusions as part of its analyses of data, and BBOT may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, preliminary or topline results that BBOT reports may differ from future results of the same studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Interim, preliminary and topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the interim, preliminary or topline data previously published. As a result, interim, preliminary and topline data should be viewed with caution until the final data are available. In addition, BBOT may report interim analyses of only certain endpoints rather than all endpoints. Interim, preliminary and topline data from clinical trials 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, preliminary or topline data and final data could significantly harm BBOT’s business and prospects. Further, additional disclosure of interim, preliminary or topline data by BBOT or by its competitors in the future could result in volatility in the price of BBOT’s common stock.

In addition, the information BBOT chooses to publicly disclose regarding a particular study or trial is typically selected from a more extensive amount of available information. Investors may not agree with what BBOT determines is the material or otherwise appropriate information to include in its public disclosures, and any information BBOT determines not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or BBOT’s business. If the interim, preliminary or

topline data that BBOT reports differs from late, final or actual results, or if others, including regulatory authorities, disagree with the conclusions reached, BBOT’s ability to obtain approval for, and commercialize, any of its product candidates may be harmed, which could harm BBOT’s business, financial condition, results of operations and prospects.

If BBOT experiences delays or difficulties in the enrollment or maintenance of patients in clinical trials, BBOT’s regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.

BBOT may not be able to initiate or continue clinical trials for its product candidates if BBOT is unable to locate and enroll a sufficient number of eligible patients to participate in these trials to such trial’s conclusion as required by the FDA, EMA or other comparable foreign regulatory authorities. Patient enrollment is a significant factor in the timing of clinical trials. BBOT’s ability to enroll eligible patients may be limited or may result in slower enrollment than anticipated. BBOT utilizes profiling of patients’ tumors to identify suitable patients for recruitment into its clinical trials. For these clinical trials, BBOT seeks patients who carry specific gene mutation or amplification that its product candidates are designed to precisely target. BBOT cannot be certain (i) how many patients will have the requisite mutation or amplification that qualify for inclusion in its clinical trials, (ii) that the number of patients enrolled in each program will suffice for regulatory approval or (iii) if regulatory approval is obtained, whether each specific mutation or amplification will be included in the approved drug label. Additionally, BBOT faces competition, including from large pharmaceutical companies with significantly more resources than BBOT, for enrollment of BBOT’s targeted patient populations, which may impact BBOT’s ability to successfully recruit patients for its clinical trials. If BBOT’s strategies for patient identification and enrollment prove unsuccessful, BBOT may have difficulty enrolling or maintaining patients appropriate for its product candidates.

Patient enrollment may be affected if BBOT’s competitors have ongoing clinical trials for programs that are under development for the same indications as BBOT’s product candidates, and patients who would otherwise be eligible for BBOT’s clinical trials instead enroll in clinical trials of its competitors’ programs. Patient enrollment for BBOT’s current or future clinical trials may be affected by other factors, including:

•        size and nature of the patient population;

•        severity of the disease under investigation;

•        availability and efficacy of approved drugs for the disease under investigation;

•        patient eligibility criteria for the trial in question as defined in the protocol, including biomarker-driven identification and/or certain highly-specific criteria related to stage of disease progression, which may limit the patient populations eligible for BBOT’s clinical trials to a greater extent than competing clinical trials for the same indication that do not have a biomarker-driven patient eligibility criteria;

•        perceived risks and benefits of the product candidate under study;

•        clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved or other product candidates being investigated for the indications BBOT is investigating;

•        clinicians’ willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in BBOT’s clinical trials;

•        patient referral practices of physicians;

•        the ability to monitor patients adequately during and after treatment;

•        proximity and availability of clinical trial sites for prospective patients; and

•        the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage cancer patients, will not survive the full terms of the clinical trials.

BBOT’s inability to enroll a sufficient number of patients for its clinical trials would result in significant delays or may require BBOT to abandon one or more clinical trials altogether. Enrollment delays in BBOT’s clinical trials may result in increased development costs for its product candidates and jeopardize its ability to obtain marketing approval

for the sale of its product candidates. Furthermore, even if BBOT is able to enroll a sufficient number of patients for its clinical trials, BBOT may have difficulty maintaining participation in its clinical trials through treatment and any follow-up periods.

BBOT has limited resources and is currently focusing its efforts on the development of BBO-8520, BBO-10203 and BBO-11818 in particular indications and advancing its discovery programs. As a result, BBOT may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.

BBOT is currently focusing its resources and efforts on its lead product candidates, BBO-8520 a KRAS inhibitor for KRASG12C NSCLC, BBO-10203 a PI3Kα:RAS breaker for PIK3CAmut BC, HER2amp BC, KRASmut NSCLC, KRASmut PDAC, and KRASmut CRC, and BBO-11818 a Pan-KRAS inhibitor for KRASG12X NSCLC, KRASG12X PDAC, KRASG12X CRC, and on advancing BBOT’s discovery programs. As a result, because BBOT has limited resources, BBOT may forgo or delay pursuit of opportunities for other indications or with other product candidates that may have greater commercial potential. BBOT’s resource allocation decisions may cause BBOT to fail to capitalize on viable commercial products or profitable market opportunities. BBOT’s spending on current and future research and development activities for BBO-8520, BBO-10203 and BBO-11818 and BBOT’s discovery programs may not yield any commercially viable products. If BBOT does not accurately evaluate the commercial potential or target markets for BBO-8520, BBO-10203 and BBO-11818 or any future product candidates identified through BBOT’s discovery programs, BBOT may enter into collaboration, licensing or other strategic arrangements with the effect of relinquishing valuable rights in cases in which it would have been more advantageous for BBOT to retain sole development and commercialization rights. In addition, given the similar approaches being utilized by BBOT’s lead product candidates, negative developments for one candidate in the pipeline may have negative implications for other candidates in the pipeline.

BBOT currently relies on third parties to supply and manufacture preclinical and clinical drug supplies, and BBOT intends to rely on third parties to produce commercial supplies of any approved product, which increases the risk that BBOT will not have sufficient quantities of these product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair BBOT’s development or commercialization efforts.

BBOT does not own or operate manufacturing facilities for the production of preclinical, clinical or commercial supplies of the product candidates that BBOT is developing or evaluating in its drug development programs. BBOT has limited personnel with experience in drug manufacturing and lacks the resources and the capabilities to manufacture any of BBOT’s product candidates on a preclinical, clinical or commercial scale. BBOT relies on third parties for supply of its preclinical and clinical drug supplies (including key active pharmaceutical ingredients, or API, drug product, and starting and intermediate materials), and BBOT’s strategy is to outsource to third parties all manufacturing of BBOT’s product candidates and products from preclinical development through clinical trials and commercialization, if any product candidates are approved.

In order to conduct clinical trials of product candidates, BBOT will need to have them manufactured in potentially large quantities, particularly for later-stage trials. BBOT’s third-party manufacturers may be unable to successfully increase the manufacturing capacity for any of its clinical drug supplies (including API, drug product, and key starting and intermediate materials) in a timely or cost-effective manner, or at all. In addition, quality issues may arise during scale-up activities and at any other time. If these third-party manufacturers are unable to successfully scale up the manufacture of BBOT’s product candidates in sufficient quality and quantity, the development, testing and clinical trials of that product candidate may be delayed or infeasible, and regulatory approval or commercial launch of that product candidate may be delayed or not obtained.

In addition, some of BBOT’s third-party suppliers (including suppliers of key active pharmaceutical ingredients, or API, drug product, and starting and intermediate materials) are currently BBOT’s sole source of supplies and, as a result, an issue with one of these suppliers may more significantly impact or delay BBOT’s development or commercial plans, as discussed further under the risk factor titled, “Some of the third parties upon whom BBOT currently relies for the supply of the active pharmaceutical ingredients, drug product and starting materials used in BBOT’s product candidates are BBOT’s sole source of supply, and the loss of any of these suppliers could delay BBOT’s development efforts and harm BBOT’s business”.

BBOT’s use of new third-party manufacturers or suppliers also increases the risk of delays in production or insufficient supplies of BBOT’s product candidates (and the key API, drug product, and starting and intermediate materials for such product candidates) as BBOT transfers its manufacturing technology to these manufacturers or suppliers and as they gain experience manufacturing or producing BBOT’s product candidates (and the key API, drug product, and starting and intermediate materials for these product candidates).

Even after a third-party manufacturer has gained significant experience in manufacturing BBOT’s product candidates (or the key API, drug product, and starting and intermediate materials for such product candidates), or even if BBOT believes it has succeeded in optimizing the manufacturing process, there can be no assurance that such manufacturer will supply or produce sufficient quantities of BBOT’s product candidates (or the key API, drug product, and starting and intermediate materials for such product candidates) in a timely manner or continuously over time, or at all. BBOT may be delayed if BBOT needs to change the manufacturing process used by a third party. Further, if BBOT changes an approved manufacturing process, then BBOT may be delayed if the FDA or a comparable foreign authority needs to review the new manufacturing process before it may be used.

Reliance on third-party manufacturers for preclinical, clinical and commercial supplies entails risks, including:

•        reliance on the third party for regulatory compliance and quality assurance;

•        the possible breach of the manufacturing or master services agreement by the third party;

•        the possible misappropriation of BBOT’s proprietary information, including trade secrets and know-how; and

•        the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for BBOT.

While BBOT has entered into master services agreements with its current suppliers under which work is performed on an as-needed basis pursuant to quotations or proposals, BBOT does not currently have any agreements with third-party manufacturers for long-term commercial supply. In the future, BBOT may be unable to enter into agreements with third-party manufacturers for commercial supplies of any of BBOT’s product candidates, or may be unable to do so on acceptable terms. Even if BBOT is able to establish and maintain arrangements with third-party manufacturers for commercial supply, reliance on third-party manufacturers entails risks, including those described above.

Third-party manufacturers may not be able to comply with cGMP requirements or similar regulatory requirements outside the United States. BBOT’s failure, or the failure of its third-party manufacturers, to comply with applicable requirements could result in sanctions being imposed on BBOT, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and/or criminal prosecutions, any of which could significantly and adversely affect supplies of BBOT’s product candidates.

BBOT’s future product candidates and any products that BBOT may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP requirements particularly that use chromatography or purification technology necessary for the manufacture of BBO-10203, and that might be capable of manufacturing for BBOT.

BBOT is also unable to predict how changing regulatory requirements, global economic conditions or ongoing geopolitical conflicts, trade policy, and related global economic sanctions, or potential global health concerns will affect BBOT’s third-party suppliers and manufacturers. Any negative impact of such matters on BBOT’s third-party suppliers and manufacturers may also have an adverse impact on BBOT’s results of operations or financial condition. For example, in 2024, there was Congressional activity related to interactions with Chinese biopharmaceutical companies, including the introduction of the BIOSECURE Act. Although the BIOSECURE Act has not been passed by Congress, if this bill is re-introduced and is passed, or if similar laws are passed in the future, they would have the potential to restrict the ability of U.S. biopharmaceutical companies like BBOT to purchase services or products from, or otherwise collaborate with, certain Chinese biotechnology companies “of concern” without losing the ability to contract with, or otherwise receive funding from, the U.S. government. Some of BBOT’s sole source suppliers are companies in China, including some named in these bills, and it is possible some of BBOT’s contractual counterparties could be impacted by the legislation described above.

If the third parties that BBOT engages to supply any materials or manufacture product for its preclinical tests and clinical trials should cease to continue to do so for any reason, BBOT likely would experience delays in advancing these tests and trials while BBOT identifies and qualifies replacement suppliers or manufacturers, and BBOT may be unable to obtain replacement supplies on terms that are favorable to BBOT or at all. In addition, if BBOT is not able to obtain adequate supplies of its product candidates or the substances used to manufacture them, it will be more difficult for BBOT to develop its product candidates and compete effectively.

BBOT’s current and anticipated future dependence upon others for the manufacture of BBOT’s product candidates (or the key API, drug product, and starting and intermediate materials for such product candidates) may adversely affect BBOT’s future profit margins and ability to develop product candidates and commercialize any products that receive marketing approval on a timely and competitive basis.

BBOT faces substantial competition which may result in others discovering, developing or commercializing products before or more successfully than BBOT does.

The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary and novel products and product candidates. BBOT’s competitors have developed, are developing or may develop products, product candidates and processes competitive with BBOT’s product candidates. Any product candidates that BBOT successfully develops and commercializes will compete with existing therapies and new therapies that may become available in the future. BBOT believes that a significant number of product candidates are currently under development, and may become commercially available in the future, for the treatment of conditions for which BBOT is currently attempting and may in the future attempt to develop product candidates. In addition, BBOT’s product candidates may need to compete with drugs physicians use off-label to treat the indications for which BBOT seeks approval. This may make it difficult for BBOT to replace existing therapies with BBOT’s product candidates.

In particular, there is intense competition in the field of oncology. BBOT has competitors both in the U.S. and internationally, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, emerging and start-up companies, universities and other research institutions. BBOT also competes with these organizations to recruit and retain qualified scientific and management personnel, which could negatively affect BBOT’s level of expertise and BBOT’s ability to execute its business plan. BBOT will also face competition in establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, BBOT’s programs.

For BBO-8520, there are currently two KRASG12C inhibitors approved by the FDA for use in KRASG12C mutant advanced or metastatic NSCLC.

For BBO-10203, there is one PI3Kα inhibitor approved by the FDA for the treatment of HR+ / HER2- advanced or metastatic PIK3CAmut breast cancer.

For BBO-11818, there are no pan-KRAS inhibitors approved by the FDA for the treatment of KRASG12X mutant lung, colorectal, or pancreatic cancers.

Many of BBOT’s competitors, either alone or with their collaborators, have significantly greater financial resources, established presence in the market, and expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products than BBOT. Large pharmaceutical and biotechnology companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and manufacturing biotechnology product candidates. These companies also have significantly greater research and marketing capabilities than BBOT and may also have product candidates that have been approved or are in late stages of development, and collaborative arrangements in BBOT’s target markets with leading companies and research institutions. Established pharmaceutical and biotechnology companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that BBOT develops obsolete. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies, as well as in acquiring technologies complementary to, or necessary for, BBOT’s programs. As a result of all of these factors, BBOT’s competitors may succeed in obtaining approval from the FDA, EMA or other comparable foreign regulatory authorities or in discovering, developing and commercializing product candidates in BBOT’s field before BBOT does.

BBOT’s potential commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer or less severe adverse events, are more convenient, have a broader label, are marketed more effectively, are more widely reimbursed or are less expensive than any products that BBOT may develop. Physicians may be more willing to prescribe competitors’ products for various reasons, and may rely on guidelines related to treatment of patients issued by medical societies, industry groups or other organizations, which may not include, and may never include, BBOT’s products. BBOT’s competitors also may obtain marketing approval from the FDA, EMA or other comparable foreign regulatory authorities for their products more rapidly than BBOT may obtain approval for its product candidates, which could result in competitors establishing a strong market position before BBOT is able to enter the market, or make BBOT’s development and marketing more complicated. Even if the product candidates BBOT develops achieve marketing approval, they may be priced at a significant premium over competitive products if any have been approved by then, resulting in reduced competitiveness. Technological advances or products developed by BBOT’s competitors may render BBOT’s technologies or product candidates obsolete, less competitive or not economical. If BBOT is unable to compete effectively, BBOT’s opportunity to generate revenue from the sale of products BBOT may develop, if approved, could be adversely affected.

BBOT’s product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

Even if BBOT’s product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, third-party payors and others in the medical community. The degree of market acceptance of any of BBOT’s approved product candidates will depend on a number of factors, including:

•        the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments;

•        the timing of market introduction of the product candidate as well as competitive products;

•        the clinical indications for which a product candidate is approved;

•        restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a Risk Evaluation and Mitigation Strategy (REMS), if any, which may not be required of alternative treatments and competitor products;

•        the potential and perceived advantages of BBOT’s product candidates over alternative treatments;

•        the cost of treatment in relation to alternative treatments;

•        the availability of coverage and adequate reimbursement by third-party payors, including government authorities;

•        willingness of physicians to use BBOT’s product candidates, if approved, in lieu of (or in conjunction with) other approved therapies;

•        the availability of an approved product candidate for use as a combination therapy;

•        relative convenience and ease of administration;

•        the willingness of the target patient population to try new therapies and undergo required diagnostic screening to determine treatment eligibility and of physicians to prescribe these therapies and diagnostic tests;

•        the effectiveness of sales and marketing efforts;

•        unfavorable publicity relating to BBOT’s product candidates; and

•        the approval of other new therapies for the same indications.

If any of BBOT’s product candidates are approved but do not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, BBOT may not generate or derive sufficient revenue from that product candidate and BBOT’s financial results could be negatively impacted.

The market opportunities for any product candidates BBOT develops, if approved, may be limited to certain smaller patient subsets and may be smaller than BBOT estimates them to be.

When cancer is detected early (referred to as localized disease), conventional treatments, which include chemotherapy, hormone therapy, surgery and radiation therapy and/or selected targeted therapies, may be adequate to cure the patient in many cases. However, once cancer has spread to other areas (advanced or metastatic disease), cancer treatments may not be sufficient to provide a cure but often can significantly prolong life without curing the cancer. First-line therapies designate treatments that are initially administered to patients with advanced or metastatic disease, while second- and third-line therapies are administered to patients when the prior therapies lose their effectiveness. The FDA, EMA and other regulatory bodies often approve cancer therapies for a particular line of treatment. Typically, drug approvals are initially granted for use in later lines of treatment, but with additional evidence of significant efficacy from clinical trials, biopharmaceutical companies can successfully seek and gain approval for use in earlier lines of treatment.

In most instances, BBOT plans to initially seek approval of BBO-8520, BBO-10203 and BBO-11818 and any other future product candidates for previously treated patients with advanced or metastatic cancer where at least one prior therapy has limited clinical benefit or where tumors have developed resistance to such therapy. For those product candidates that prove to be sufficiently safe and effective, if any, BBOT would potentially expect to seek approval ultimately as a first line therapy. There is no guarantee that BBOT’s product candidates, even if approved for previously treated patients, would be approved for an earlier line of therapy, and prior to any such approvals BBOT may have to conduct additional clinical trials that may be costly, time-consuming and subject to risk.

BBOT’s projections of both the number of people who have the cancers BBOT is targeting, as well as the subset of people with these cancers in a position to receive a particular line of therapy and who have the potential to benefit from treatment with BBOT’s product candidates, are based on BBOT’s beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research, and may prove to be incorrect. Further, new data and studies may change the estimated incidence or prevalence of the cancers that BBOT is targeting, especially if new therapies that are approved while BBOT advances its product candidates affect the treatment paradigm and/or the size of the target population. The potentially addressable patient population for BBOT’s product candidates may be limited or may not be amenable to treatment with BBOT’s product candidates. Consequently, even if BBOT’s product candidates are approved, the number of patients that may be eligible for treatment with BBOT’s product candidates may turn out to be much lower than expected. In addition, BBOT has not yet conducted market research to determine how treating physicians would expect to prescribe a product that is approved for multiple tumor types if there are different lines of approved therapies for each such tumor type. Even if BBOT obtains significant market share for its products, if approved, if the potential target populations are small, BBOT may never achieve profitability without obtaining regulatory approval for additional indications.

Any product candidates BBOT develops may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.

Patients rely on insurance coverage by third-party payors (third-party payors include Medicare and Medicaid (government payors) and commercial insurance companies such as Blue Cross Blue Shield, Humana, Cigna, etc.), to pay for products. The availability and extent of coverage and adequate reimbursement by third-party payors, including government health administration authorities, private health coverage insurers, managed care organizations and other third-party payors is essential for most patients to be able to afford expensive treatments. Sales of any of BBOT’s product candidates that receive marketing approval will depend substantially, both in the U.S. and internationally, on the extent to which the costs of such product candidates will be covered and reimbursed by third-party payors. No uniform policy exists for coverage and reimbursement in the U.S. If reimbursement is not available, or is available only to limited levels, BBOT may not be able to successfully commercialize its product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow BBOT to establish or maintain pricing sufficient to realize an adequate return on BBOT’s investment. Further, it is possible that a third-party payor may consider BBOT’s product candidates as substitutable with competitor products and offer to reimburse patients only for the less expensive competitor product. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which BBOT obtains marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, BBOT may not successfully commercialize any product candidate for which BBOT obtains marketing approval.

There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the U.S., for example, principal decisions about reimbursement for new products are typically made by the Center for Medicare & Medicaid Services (CMS), an agency within the U.S. Department of Health and Human Services (HHS). CMS decides whether and to what extent a new product will be covered and reimbursed under Medicare, and private third-party payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. However, one third-party payor’s determination to provide coverage for a product candidate does not assure that other payors will also provide coverage for the product candidate. As a result, the coverage determination process is often time-consuming and costly. Factors payors consider in determining reimbursement are based on whether the product is: (i) a covered benefit under its health plan; (ii) safe, effective and medically necessary; (iii) appropriate for the specific patient; (iv) cost-effective; and (v) neither experimental nor investigational. This process will require BBOT to provide scientific and clinical support for the use of BBOT’s products to each third-party payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

As federal and state governments implement additional health care cost containment measures, including measures to lower prescription drug pricing, BBOT cannot be sure that its products, if approved, will be covered by private or public payors, and if covered, whether the reimbursement will be adequate or competitive with other marketed products. Such other actions by federal and state governments and health plans may put additional downward pressure on pharmaceutical pricing and health care costs, which could negatively impact coverage and reimbursement for BBOT’s products if approved, BBOT’s revenue, and its ability to compete with other marketed products and to recoup the costs of its research and development. For further discussion, see “— Current and future legislation may increase the difficulty and cost for BBOT to obtain reimbursement for its product candidates;” and “— The prices of prescription pharmaceuticals in the U.S. and foreign jurisdictions are the subject of considerable legislative and executive actions and could impact the prices BBOT obtains for its products, if and when licensed for marketing.”

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. Further, such payors are increasingly challenging the price, examining the medical necessity and reviewing the cost effectiveness of medical product candidates. There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs. Third-party payors may limit coverage to specific product candidates on an approved list, known as a formulary, which might not include all FDA-approved drugs for a particular indication. BBOT may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and cost effectiveness of its products. Nonetheless, BBOT’s product candidates may not be considered medically necessary or cost effective. BBOT cannot be sure that coverage and reimbursement will be available for any product that BBOT commercializes and, if reimbursement is available, what the level of reimbursement will be.

In addition, companion diagnostic tests require coverage and reimbursement separate and apart from the coverage and reimbursement for their companion pharmaceutical or products. Similar challenges to obtaining coverage and reimbursement, applicable to pharmaceutical or products, will apply to companion diagnostics. Additionally, if any companion diagnostic provider is unable to obtain reimbursement or is inadequately reimbursed, that may limit the availability of such companion diagnostic, which would negatively impact prescriptions for BBOT’s product candidates, if approved.

Outside the U.S., the commercialization of therapeutics is generally subject to extensive governmental price controls and other market regulations, and BBOT believes the increasing emphasis on cost containment initiatives in Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of therapeutics such as BBOT’s product candidates. In many countries, particularly the countries of the EU, medical product prices are subject to varying price control mechanisms as part of national health systems. In these countries, pricing negotiations with governmental authorities can take considerable time after a product receives marketing approval. To obtain reimbursement or pricing approval in some countries, BBOT may be required to conduct a clinical trial that compares the cost-effectiveness of BBOT’s product candidate to other available therapies. In general, product prices under such systems are substantially lower than in the U.S. Other countries allow companies to fix their own prices for products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that BBOT is able to charge for its product candidates. Accordingly, in markets outside the U.S., the reimbursement for BBOT’s products may be reduced compared with the U.S. and may be insufficient to generate commercially reasonable revenue and profits.

If BBOT is unable to establish or sustain coverage and adequate reimbursement for any product candidates from third-party payors, the adoption of those products and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market or sell those product candidates, if approved. Coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which BBOT receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

BBOT’s business entails a significant risk of product liability and if BBOT is unable to obtain sufficient insurance coverage such inability could have an adverse effect on BBOT’s business and financial condition.

BBOT’s business exposes BBOT to significant product liability and other risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. Product liability and other claims or incidents, such as cyber incidents and breaches, could delay or prevent completion of BBOT’s development programs. If BBOT succeeds in marketing products, such claims could result in an FDA, EMA or other regulatory authority investigation of the safety and effectiveness of BBOT’s products, manufacturing processes and facilities or BBOT’s marketing programs. FDA, EMA or other regulatory authority investigations could potentially lead to a recall of BBOT’s products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for BBOT’s products, injury to BBOT’s reputation, costs to defend the related litigation, a diversion of management’s time and BBOT’s resources and substantial monetary awards to trial participants or patients. BBOT currently has product liability and other insurance that BBOT believes is appropriate for its stage of development and may need to obtain higher levels prior to advancing BBOT’s product candidates into later stages of development or marketing any of BBOT’s product candidates, if approved. Any insurance BBOT has or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trial, product liability, and other types of insurance (such as cyber insurance) are becoming increasingly expensive and difficult to obtain. As a result, BBOT may be unable to obtain sufficient insurance at a reasonable cost to protect BBOT against losses caused by product liability or other claims or incidents, including data breach and incidents, that could have an adverse effect on BBOT’s business and financial condition.

Certain of BBOT’s product candidates are novel, complex and difficult to manufacture. BBOT could experience manufacturing problems that result in delays in BBOT’s development or commercialization or otherwise harm BBOT’s business.

The manufacturing processes BBOT’s third-party contract manufacturing organizations (“CMOs”) use to produce its product candidates are complex, novel and have not been validated for commercial use. Several factors have caused and may cause future production interruptions, including restrictions on certain manufacturing operations and shortages in on-site personnel at BBOT’s CMOs’ manufacturing facilities, equipment malfunctions, facility contamination, raw material shortages or contamination, natural disasters, disruption in utility services, human error or disruptions in the operations of BBOT’s suppliers, including historical disruptions, which could reoccur in connection with any future global pandemic or health emergency.

Several of BBOT’s small molecule product candidates are particularly complex and difficult to manufacture, in some cases due to the number of steps required, the process complexity and the toxicity of end or intermediate-stage products. BBOT’s product candidates require processing steps that are more complex than those required for most small molecule drugs. As a result, assays of the finished product may not be sufficient to ensure that the product is consistent from lot-to-lot or will perform in the intended manner. Accordingly, BBOT’s CMOs must employ multiple steps to control the manufacturing process to assure that the process is reproducible and the product candidate is made strictly and consistently in compliance with the process. Problems with the manufacturing process, even minor deviations from the normal process, could result in product defects or manufacturing failures that result in lot failures, product recalls, product liability claims or insufficient inventory to conduct clinical trials or supply commercial markets. BBOT may encounter problems achieving adequate quantities and quality of clinical-grade materials that meet the FDA, the EMA or other applicable standards or specifications with consistent and acceptable production yields and costs.

In addition, the FDA, the EMA and other foreign regulatory authorities may require BBOT to submit samples of any lot of any approved product together with the protocols showing the results of applicable tests at any time. Under some circumstances, the FDA, the EMA or other foreign regulatory authorities may require that BBOT not distribute

a lot until the agency authorizes its release. Slight deviations in the manufacturing process, including those affecting quality attributes and stability, may result in unacceptable changes in the product that could result in lot failures or product recalls. Lot failures or product recalls could cause BBOT to delay clinical trials, which could be costly to BBOT and otherwise harm BBOT’s business, financial condition, results of operations and prospects.

BBOT’s CMOs also may encounter problems hiring and retaining the experienced scientific, quality assurance, quality-control and manufacturing personnel needed to operate BBOT’s manufacturing processes, which could result in delays in production or difficulties in maintaining compliance with applicable regulatory requirements.

Any problems in BBOT’s CMOs’ manufacturing process or facilities could result in delays in planned clinical trials and increased costs, and could make BBOT a less attractive collaborator for potential partners, including larger biotechnology companies and academic research institutions, which could limit access to additional attractive development programs. Problems in BBOT’s manufacturing process could also restrict BBOT’s ability to meet potential future market demand for any products that may be approved.

Certain of BBOT’s product candidates are under development for the treatment of patient populations with significant comorbidities that may result in deaths or serious adverse or unacceptable side effects and require BBOT to abandon or limit its clinical development activities.

Patients in certain of BBOT’s ongoing and planned clinical trials of product candidates in genetically driven cancers, as well as patients who may undergo treatment with other product candidates that BBOT may develop, may also receive chemotherapy, radiation, and/or other high dose or myeloablative treatments in the course of treatment of their disease, and may therefore experience side effects or AEs, including death, that are unrelated to BBOT’s product candidates. While these side effects or AEs may be unrelated to BBOT’s product candidates, they may still affect the success of BBOT’s clinical trials. The inclusion of critically ill patients in BBOT’s clinical trials may also result in deaths or other adverse medical events due to underlying disease or to other therapies or medications that such patients may receive. Any of these events could prevent BBOT from advancing its product candidates through clinical development, and from obtaining regulatory approval, and would impair BBOT’s ability to commercialize its product candidates. Any inability to advance BBOT’s product candidates through clinical development may harm BBOT’s business, financial condition, results of operations and prospects.

Risks related to regulatory approval and other legal compliance matters

BBOT may be unable to obtain U.S. or foreign regulatory approval and, as a result, may be unable to commercialize its product candidates.

BBOT’s product candidates are and will continue to be subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing, marketing and distribution of drugs. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process must be successfully completed in the U.S. and in many foreign jurisdictions before a new drug can be approved for marketing. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. BBOT cannot provide any assurance that any product candidate BBOT may develop will progress through required clinical testing and obtain the regulatory approvals necessary for BBOT to begin selling them.

BBOT does not have experience conducting, managing or completing large-scale or pivotal clinical trials nor managing the regulatory approval process with the FDA, EMA or any other regulatory authority. The time required to obtain approvals from the FDA, EMA and other regulatory authorities is unpredictable and requires successful completion of extensive clinical trials which typically takes many years, depending upon the type, complexity and novelty of the product candidate. The standards that the FDA and its foreign counterparts use when evaluating clinical trial data can change during drug development, which makes it difficult to predict with any certainty how such standards will be applied. BBOT may also encounter unexpected delays or increased costs due to new government regulations, including future legislation or administrative action, changes in applicable FDA, EMA or other regulatory policy during the period of drug development, clinical trials and regulatory review, or significant changes to FDA personnel during the regulatory review.

Applications for BBOT’s product candidates could fail to receive regulatory approval for many reasons, including the following:

•        the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of BBOT’s clinical trials;

•        the FDA, EMA or other comparable foreign regulatory authorities may determine that BBOT’s product candidates are not safe and effective or have undesirable or unintended adverse events, toxicities or other characteristics that preclude BBOT obtaining marketing approval or prevent or limit commercial use;

•        the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which BBOT seeks approval;

•        the FDA, EMA or other comparable foreign regulatory authorities may disagree with BBOT’s interpretation of data from preclinical studies or clinical trials;

•        BBOT may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that BBOT’s product candidates’ risk-benefit ratios for their proposed indications are acceptable;

•        the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which BBOT contracts for clinical and commercial supplies; and

•        the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering BBOT’s clinical data insufficient for approval.

Any delay or failure in seeking or obtaining required approvals would have a material and adverse effect on BBOT’s ability to generate revenue from any particular product candidates BBOT is developing and for which BBOT is seeking approval. Furthermore, any regulatory approval to market a drug may be subject to significant limitations on the approved uses or indications for which BBOT may market, promote and advertise the drug or the labeling or other restrictions. In addition, the FDA has the authority to require a REMS plan as part of approving a New Drug Application (NDA), or after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug. These requirements or restrictions might include limiting prescribing to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria, distribution through controlled distribution channels, and requiring treated patients to enroll in a registry. These limitations and restrictions may significantly limit the size of the market for the drug and affect reimbursement by third-party payors.

BBOT is also subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process varies among countries, and generally includes all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions. Moreover, the time required to obtain approval may differ from that required to obtain FDA approval.

BBOT plans to develop certain of its current product candidates and potentially future product candidates in combination with other therapies, which would expose BBOT to additional risks.

BBOT plans to develop certain of its current product candidates in combination with one or more currently approved cancer therapies or therapies in development and may pursue a similar strategy for future product candidates. For example, the ongoing Phase 1 trial of BBO-8520 is evaluating BBO-8520 both as a monotherapy and in combination with pembrolizumab. Even if any of BBOT’s current or future product candidates were to receive marketing approval or be commercialized for use in combination with other existing therapies, BBOT would continue to be subject to the risks that the FDA, EMA or other comparable foreign regulatory authorities could revoke approval of the therapy used in combination with any of BBOT’s product candidates, or safety, efficacy, manufacturing or supply issues could arise with these existing therapies. In addition, it is possible that existing therapies with which BBOT’s product candidates are approved for use could themselves fall out of favor or be relegated to later lines of treatment. This could result in the need to identify other combination therapies for BBOT’s product candidates or BBOT’s own products being removed from the market or being less successful commercially.

BBOT may also evaluate its current or future product candidates in combination with one or more other cancer therapies that have not yet been approved for marketing by the FDA, EMA or comparable foreign regulatory authorities. BBOT will not be able to market and sell any product candidate in combination with any such unapproved cancer therapies that do not ultimately obtain marketing approval.

If the FDA, EMA or other comparable foreign regulatory authorities do not approve or withdraw their approval of these other therapies, or if safety, efficacy, commercial adoption, manufacturing or supply issues arise with the therapies BBOT chooses to evaluate in combination with any of its current or future product candidates, BBOT may be unable to obtain approval of or successfully market any one or all of the current or future product candidates BBOT develops. Additionally, if the third-party providers of therapies or therapies in development used in combination with BBOT’s current or future product candidates are unable to produce sufficient quantities for clinical trials or for commercialization of BBOT’s current or future product candidates, or if the cost of combination therapies are prohibitive, BBOT’s development and commercialization efforts would be impaired, which would have an adverse effect on BBOT’s business, financial condition, results of operations and growth prospects.

BBOT has conducted and intends to continue conducting certain of its clinical trials globally. However, the FDA and other foreign equivalents may not accept data from such trials, in which case BBOT’s development plans may be delayed, which could materially harm BBOT’s business.

BBOT has conducted and intends to continue conducting certain of its clinical trials globally. The acceptance by the FDA or other regulatory authorities of study data from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to good clinical practice (GCP) regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP requirements, and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements.

In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of BBOT’s business plan, and which may result in BBOT’s product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.

Conducting clinical trials outside the U.S. also exposes BBOT to additional risks, including risks associated with:

•        additional foreign regulatory requirements;

•        foreign exchange fluctuations;

•        compliance with foreign manufacturing, customs, shipment and storage requirements;

•        cultural differences in medical practice and clinical research;

•        diminished protection of intellectual property in some countries; and

•        interruptions or delays in BBOT’s trials resulting from geopolitical events, including civil or political unrest or military conflicts.

Obtaining and maintaining regulatory approval of BBOT’s product candidates in one jurisdiction does not mean that BBOT will be successful in obtaining regulatory approval of its product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of BBOT’s product candidates in one jurisdiction does not guarantee that BBOT will be able to obtain or maintain regulatory approval in any other jurisdiction. For example, even if the FDA or EMA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the marketing of the product candidate in those countries. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the U.S., including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the U.S., a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that BBOT intends to charge for its products is also subject to approval.

Obtaining foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for BBOT and could delay or prevent the introduction of BBOT’s products in certain countries. If BBOT or any future collaborator fails to comply with the regulatory requirements in international markets or fails to receive applicable marketing approvals, BBOT’s target market will be reduced and BBOT’s ability to realize the full market potential of BBOT’s product candidates will be harmed.

Further, BBOT could face heightened risks with respect to obtaining marketing authorization in the United Kingdom (U.K.) as a result of the withdrawal of the U.K. from the EU, commonly referred to as Brexit. The U.K. is no longer part of the European Single Market and EU Customs Union. As of January 1, 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) became responsible for supervising medicines and medical devices in Great Britain, comprising England, Scotland, and Wales under domestic law, whereas under the terms of the Northern Ireland Protocol, Northern Ireland is currently subject to EU rules. The U.K. and EU have, however, agreed to the Windsor Framework, which fundamentally changes the existing system under the Northern Ireland Protocol, including with respect to the regulation of medicinal products in the U.K. Once implemented, the changes introduced by the Windsor Framework will make the MHRA responsible for approving all medicinal products destined for the U.K. market (i.e., Great Britain and Northern Ireland), and the EMA will no longer have any role in approving medicinal products destined for Northern Ireland.

In addition, foreign regulatory authorities may change their approval policies and new regulations may be enacted. For instance, the EU pharmaceutical legislation is currently undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020. The European Commission’s proposal for revision of several legislative instruments related to medicinal products (potentially reducing the duration of regulatory data protection, revising the eligibility for expedited pathways, etc.) was published on April 26, 2023. The proposed revisions remain to be agreed and adopted by the European Parliament and European Council and the proposals may therefore be substantially revised before adoption, which is not anticipated before early 2026. The revisions may however have a significant impact on the pharmaceutical industry and BBOT’s business in the long term.

Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, may force BBOT to restrict or delay efforts to seek regulatory approval in the U.K. for its product candidates, which could significantly and materially harm BBOT’s business. Further, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Also, regulatory approval for BBOT’s product candidates may be withdrawn. If BBOT fails to comply with the applicable regulatory requirements, BBOT’s target market will be reduced, BBOT’s ability to realize the full market potential of its product candidates will be harmed, and BBOT’s business, financial condition, results of operations and prospects could be harmed.

Even if BBOT’s product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.

Any regulatory approvals that BBOT may receive for its product candidates will require the submission of reports to regulatory authorities and ongoing surveillance to monitor the safety and efficacy of the product candidate, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements and regulatory inspection. For example, the FDA may require a REMS in order to approve BBOT’s product candidates, which could entail requirements for a medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In

addition, if the FDA, EMA or foreign regulatory authorities approve BBOT’s product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for BBOT’s product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with current good manufacturing practices (cGMP) and GCP for any clinical trials that BBOT conducts post-approval. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA, EMA and other regulatory authorities for compliance with cGMP regulations and standards. The PREVENT Pandemics Act, which was enacted in December 2022, clarifies that foreign drug manufacturing establishments are subject to registration and listing requirements even if a drug or biologic undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the U.S. prior to being imported or offered for import into the U.S. If BBOT or a regulatory authority discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory authority may impose restrictions on that product, the manufacturing facility or BBOT, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. In addition, failure to comply with FDA, EMA and other comparable foreign regulatory requirements may subject BBOT to administrative or judicially imposed sanctions, including:

•        delays in or the rejection of product approvals;

•        restrictions on BBOT’s ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;

•        restrictions on the products, manufacturers or manufacturing process;

•        warning or untitled letters;

•        civil and criminal penalties;

•        injunctions;

•        suspension or withdrawal of regulatory approvals;

•        product seizures, detentions or import bans;

•        voluntary or mandatory product recalls and publicity requirements;

•        total or partial suspension of production;

•        imposition of restrictions on operations, including costly new manufacturing requirements;

•        revisions to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings;

•        imposition of a REMS, which may include distribution or use restrictions; and

•        requirements to conduct additional post-market clinical trials to assess the safety of the product.

The FDA, EMA and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of BBOT’s product candidates. BBOT cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. If BBOT is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if BBOT is not able to maintain regulatory compliance, BBOT may lose any marketing approval that BBOT may have obtained and BBOT may not achieve or sustain profitability.

The FDA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.

If any of BBOT’s product candidates are approved and BBOT is found to have improperly promoted off-label uses of those products, BBOT may become subject to significant liability. The FDA, EMA and other regulatory authorities strictly regulate the promotional claims that may be made about prescription products, such as BBOT’s product candidates, if approved. In particular, a product may not be promoted in the U.S. for uses that are not approved

by the FDA as reflected in the product’s approved labeling, or in other jurisdictions for uses that differ from the labeling or uses approved by the applicable regulatory authorities. While physicians may prescribe products for off-label uses, the FDA, EMA and other regulatory authorities actively enforce laws and regulations that prohibit the promotion of off-label uses by companies, including promotional communications made by companies’ sales forces with respect to off-label uses that are not consistent with the approved labeling, and a company that is found to have improperly promoted off-label uses may be subject to significant civil, criminal and administrative penalties. If BBOT is found to have promoted such off-label uses, BBOT may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If BBOT cannot successfully manage the promotion of its product candidates, if approved, BBOT could become subject to significant liability, which would materially adversely affect BBOT’s business and financial condition.

If BBOT is required by the FDA, EMA or comparable regulatory authority to obtain clearance or approval of a companion diagnostic test in connection with approval of any of BBOT’s product candidates or a group of therapeutic products, and BBOT does not obtain or BBOT faces delays in obtaining clearance or approval of a diagnostic test, BBOT may not be able to commercialize the product candidate and BBOT’s ability to generate revenue may be materially impaired.

If BBOT is required by the FDA, EMA or a comparable regulatory authority to obtain clearance or approval of a companion diagnostic test in connection with approval of any of BBOT’s product candidates, such companion diagnostic test would be used during BBOT’s more advanced phase clinical trials as well as in connection with the commercialization of BBOT’s product candidates. To be successful in developing and commercializing product candidates in combination with these companion diagnostics, BBOT or its collaborators will need to address a number of scientific, technical, regulatory and logistical challenges. According to FDA guidance, if the FDA determines that a companion diagnostic device is essential to ensuring the safe and effective use of a novel therapeutic product or new indication, the FDA generally will not approve the therapeutic product or new therapeutic product indication if the companion diagnostic is not also approved or cleared. In certain circumstances (for example, when a therapeutic product is intended to treat a serious or life-threatening condition for which no satisfactory available therapy exists or when the labeling of an approved product needs to be revised to address a serious safety issue), however, the FDA may approve a therapeutic product without the prior or contemporaneous marketing authorization of a companion diagnostic. In this case, approval of a companion diagnostic may be a post-marketing requirement or commitment.

Co-development of companion diagnostics and therapeutic products is critical to the advancement of precision medicine. Whether initiated at the outset of development or at a later point, co-development should generally be conducted in a way that will facilitate obtaining contemporaneous marketing authorizations for the therapeutic product and the associated companion diagnostic. If a companion diagnostic is required to identify patients who are most likely to benefit from receiving the product, to be at increased risk for serious adverse events as a result of treatment with a particular therapeutic product, or to monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness, then the FDA has required marketing approval of all companion diagnostic tests essential for the safe and effective use of a therapeutic product for cancer therapies. Various foreign regulatory authorities also regulate in vitro companion diagnostics as medical devices and, under those regulatory frameworks, will likely require the conduct of clinical trials to demonstrate the safety and effectiveness of any future diagnostics BBOT may develop, which BBOT expects will require separate regulatory clearance or approval prior to commercialization in those countries.

The approval of a companion diagnostic as part of the therapeutic product’s labeling limits the use of the therapeutic product to only those patients who express the specific genomic alteration or mutation alteration that the companion diagnostic was developed to detect. If the FDA, EMA or a comparable regulatory authority requires clearance or approval of a companion diagnostic for any of BBOT’s product candidates, whether before, concurrently with approval, or post-approval of the product candidate, BBOT and/or future collaborators, may encounter difficulties in developing and obtaining clearance or approval for these companion diagnostics. The process of obtaining or creating such diagnostic is time consuming and costly. The FDA previously has required in vitro companion diagnostics intended to select the patients who will respond to a product candidate to obtain pre-market approval (PMA), simultaneously with approval of the therapeutic candidate. The PMA process, including the gathering of preclinical and clinical data and the submission and review by the FDA, can take several years or longer. It involves a rigorous pre-market review during which the sponsor must prepare and provide FDA with reasonable assurance of the

device’s safety and effectiveness and information about the device and its components regarding, among other things, device design, manufacturing, and labeling. After a device is placed on the market, it remains subject to significant regulatory requirements, including requirements governing development, testing, manufacturing, distribution, marketing, promotion, labeling, import, export, record-keeping, and adverse event reporting.

Any delay or failure by BBOT or third-party collaborators to develop or obtain regulatory clearance or approval of a companion diagnostic could delay or prevent approval or continued marketing of BBOT’s related product candidates. Further, in April 2020, the FDA issued guidance on developing and labeling companion diagnostics for a specific group of oncology therapeutic products, including recommendations to support a broader labeling claim rather than individual therapeutic products. BBOT will continue to evaluate the impact of this guidance on BBOT’s companion diagnostic development and strategy. This guidance and future issuances from the FDA, EMA and other regulatory authorities may impact BBOT’s development of a companion diagnostic for BBOT’s product candidates and could result in delays in regulatory clearance or approval or a change in the determination for whether or not a companion diagnostic is still required for BBOT’s product candidates. BBOT may be required to conduct additional studies to support a broader claim or more narrowed claim for a subset population. Also, to the extent other approved diagnostics are able to broaden their labeling claims to include any of BBOT’s future approved product candidates’ covered indications, BBOT may no longer need to continue its companion diagnostic development plans or BBOT needs to alter those companion diagnostic development strategies, which could adversely impact BBOT’s ability to generate revenue from the sale of BBOT’s companion diagnostic test.

Additionally, BBOT may rely on third parties for the design, development and manufacture of companion diagnostic tests for BBOT’s product candidates. If BBOT enters into such collaborative agreements, BBOT will be dependent on the sustained cooperation and effort of its future collaborators in developing and obtaining clearance or approval for these companion diagnostics. It may be necessary to resolve issues such as selectivity/specificity, analytical validation, reproducibility, or clinical validation of companion diagnostics during the development and regulatory clearance or approval processes. Moreover, even if data from preclinical studies and early clinical trials appear to support development of a companion diagnostic for a product candidate, data generated in later clinical trials may fail to support the analytical and clinical validation of the companion diagnostic. BBOT and its future collaborators may encounter difficulties in developing, obtaining regulatory clearance or approval for, manufacturing and commercializing companion diagnostics similar to those BBOT faces with respect to its product candidates themselves, including issues with achieving regulatory clearance or approval, production of sufficient quantities at commercial scale and with appropriate quality standards, and in gaining market acceptance. If BBOT is unable to successfully develop companion diagnostics for its product candidates, or experiences delays in doing so, the development of BBOT’s product candidates may be adversely affected, BBOT’s product candidates may not obtain marketing approval, and BBOT may not realize the full commercial potential of any of its product candidates that obtain marketing approval. As a result, BBOT’s business, results of operations and financial condition could be materially harmed. In addition, a diagnostic company with whom BBOT contracts may decide to discontinue selling or manufacturing the companion diagnostic test that BBOT anticipates using in connection with development and commercialization of product candidates or BBOT’s relationship with such diagnostic company may otherwise terminate. BBOT may not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic test for use in connection with the development and commercialization of BBOT’s product candidates or do so on commercially reasonable terms, which could adversely affect and/or delay the co-development or commercialization of BBOT’s companion diagnostic and therapeutic product candidates.

Where appropriate, BBOT plans to pursue approval from the FDA, EMA or comparable foreign regulatory authorities through the use of accelerated approval pathways. If BBOT is unable to obtain such approval, BBOT may be required to conduct additional preclinical studies or clinical trials beyond those that BBOT contemplates, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals. Even if BBOT receives accelerated approval from the FDA, EMA or comparable regulatory authorities, if BBOT’s confirmatory trials do not verify clinical benefit, or if BBOT does not comply with rigorous post-marketing requirements, the FDA, EMA or such other regulatory authorities may seek to withdraw accelerated approval.

Where appropriate, BBOT plans to pursue accelerated development strategies in areas of medical need. BBOT may seek an accelerated approval pathway for one or more of its product candidates from the FDA, EMA or comparable foreign regulatory authorities. Under the accelerated approval provisions in the Federal Food, Drug, and Cosmetic Act, and the FDA’s implementing regulations, the FDA may grant accelerated approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon

a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit. If such post-approval studies fail to confirm the drug’s clinical benefit, the FDA may withdraw its approval of the drug.

With passage of FDORA in December 2022, Congress modified certain provisions governing accelerated approval of drug and biologic products. Specifically, the new legislation authorized the FDA to require a sponsor to have its confirmatory clinical trial underway before accelerated approval is awarded, require a sponsor of a product granted accelerated approval to submit progress reports on its post-approval studies to the FDA every six months (until the study is completed), and use expedited procedures to withdraw accelerated approval of an NDA after the confirmatory trial fails to verify the product’s clinical benefit. Further, FDORA requires the FDA to publish on its website the rationale for why a post-approval study is not appropriate or necessary whenever it decides not to require such a study upon granting accelerated approval.

In the EU, a “conditional” marketing authorization may be granted in cases where all the required safety and efficacy data are not yet available. A conditional marketing authorization is subject to conditions to be fulfilled for generating missing data or ensuring increased safety measures. A conditional marketing authorization is valid for one year and has to be renewed annually until fulfillment of all relevant conditions. Once the applicable pending studies are provided, a conditional marketing authorization can become a “standard” marketing authorization. However, if the conditions are not fulfilled within the timeframe set by the EMA, the marketing authorization will cease to be renewed.

Prior to seeking accelerated approval, BBOT will seek feedback from the FDA, EMA or comparable foreign regulatory authorities and will otherwise evaluate BBOT’s ability to seek and receive such accelerated approval. There can be no assurance that after BBOT’s evaluation of the feedback and other factors BBOT will decide to pursue or submit an NDA for accelerated approval or any other form of expedited development, review or approval. Similarly, there can be no assurance that after subsequent feedback from the FDA, EMA or comparable foreign regulatory authorities, BBOT will continue to pursue or apply for accelerated approval or any other form of expedited development, review or approval, even if BBOT initially decides to do so. Furthermore, if BBOT decides to submit an application for accelerated approval or any other form of expedited development, review or approval, there can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. The FDA, EMA or other comparable foreign regulatory authorities could also require BBOT to conduct further studies prior to considering BBOT’s application or granting approval of any type. A failure to obtain accelerated approval or any other form of expedited development, review or approval for BBOT’s product candidate would result in a longer time period to commercialization of such product candidate, could increase the cost of development of such product candidate and could harm BBOT’s competitive position in the marketplace.

BBOT may seek certain designations for its product candidates, including Breakthrough Therapy, Fast Track and Priority Review in the U.S., and PRIME (priority medicines) in the EU, but BBOT might not receive such designations, and even if BBOT does, such designations may not lead to a faster development or regulatory review or approval process.

BBOT may seek certain designations for BBO-8520, BBO-10203 and BBO-11818 or future product candidates that could expedite review and approval by the FDA, such as Breakthrough Therapy or Fast Track designation for its product candidates, or priority review for its marketing applications for its candidates. A Breakthrough Therapy product is defined as a product that is intended, alone or in combination with one or more other products, to treat a serious condition, and preliminary clinical evidence indicates that the product 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 products that have been designated as Breakthrough Therapies, early and frequent

interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development. Sponsors may also have greater interactions with the FDA and the FDA may initiate review of sections of the NDA of a product candidate with Breakthrough Therapy designation before the application is complete. This rolling review may be available if the FDA determines, after preliminary evaluation of data submitted by the sponsor, that a product with Breakthrough Therapy designation may be effective.

BBOT may also seek Fast Track designation for one or more of its product candidates. The FDA may designate a product for Fast Track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. Like with Breakthrough Therapy designation, sponsors with Fast Track products may have greater FDA interactions and the FDA may initiate review of sections of a Fast Track product’s NDA before the application is complete if it determines, after its preliminary data evaluation, that the product may be effective.

BBOT may also seek a priority review designation for one or more of its product candidates. If the FDA determines that a product candidate intended to treat a serious condition and, if approved, offers a significant improvement in safety or effectiveness, the FDA may designate the product candidate for priority review. A priority review designation shortens the goal for the FDA to review an application within six months, rather than the standard review period of ten months.

These designations require a sponsor to submit an application for review and approval by the FDA. Accordingly, even if BBOT believes that one of its product candidates meets the criteria for these designations, the FDA may disagree and instead determine not to make such designation. Further, even if BBOT receives a designation, such as the Fast Track designation BBOT has received for BBO-8520 for the treatment of adult patients with previously treated, KRASG12C-mutated metastatic non-small cell lung cancer, the receipt of such designation for a product candidate may not result in a faster development or regulatory review or approval process compared to products considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if BBOT’s product candidates qualify for these designations, the FDA may later decide that the product candidates no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

In the EU, BBOT may seek PRIME for some of its product candidates in the future. PRIME is a voluntary program launched by the EMA that is aimed at enhancing the scientific and regulatory support for the development and accelerated assessment of new product candidates that target an unmet medical need. PRIME is aimed to offer early and proactive support to sponsors to optimize the generation of robust data on the product’s benefits and risks and enable accelerated regulatory assessment of new marketing applications. To be eligible for PRIME, a product candidate must meet the eligibility criteria in respect to its potential to offer a major therapeutic advantage over existing treatments, or benefit patients who do not have any treatment options. The benefits of PRIME include the appointment of a Committee for Medicinal Products for Human Use rapporteur to provide continued support and help to build knowledge ahead of a marketing authorization application, early dialogue and scientific advice at key development milestones, and the potential to qualify products for accelerated review, meaning reduction in the review time for an opinion on approvability to be issued earlier in the application process. PRIME enables an applicant to request parallel EMA scientific advice and health technology assessment advice to facilitate timely market access. BBOT may apply for PRIME and it may not be granted. Even if BBOT receives PRIME designation for any of its product candidates, the designation may not result in a materially faster development process, review or approval compared to conventional EMA procedures. Further, obtaining PRIME designation does not assure or increase the likelihood of EMA’s grant of a marketing authorization.

BBOT may not be able to obtain orphan drug designation or obtain or maintain orphan drug exclusivity for its product candidates and, even if BBOT does, that exclusivity may not prevent the FDA, EMA or other comparable foreign regulatory authorities, from approving competing products.

Regulatory authorities in some jurisdictions, including the U.S. and the EU, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product candidate as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the U.S., or a patient population greater than 200,000 in the U.S. where there is no reasonable expectation that the cost of researching and developing the drug will be recovered

from sales in the U.S. BBOT’s target indications may include diseases with large patient populations or may include orphan indications. There can be no assurances that BBOT will be able to obtain orphan designation for its current product candidates or candidates BBOT may discover and develop in the future.

In the U.S., 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. In addition, if a product candidate that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product candidate is entitled to orphan drug exclusivity. Orphan drug exclusivity in the U.S. provides that the FDA may not approve any other applications, including a full NDA, to market the same drug for the same indication for seven years, except in limited circumstances. The applicable exclusivity period is 10 years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified.

Even if BBOT obtains orphan drug designation for a product candidate, BBOT may not be able to obtain or maintain orphan drug exclusivity for that product candidate. BBOT may not be the first to obtain marketing approval of any product candidate for which BBOT has obtained orphan drug designation, if applicable, for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the U.S. may be limited if BBOT seeks 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 BBOT is unable to ensure that BBOT will be able to manufacture sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Further, even if BBOT obtains orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties may be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug with the same active moiety for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care or the manufacturer of the product with orphan exclusivity is unable to maintain sufficient product quantity. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the product candidate any advantage in the regulatory review or approval process or entitles the product candidate to Priority Review.

The FDA and Congress may further reevaluate the Orphan Drug Act and its regulations and policies. This may be particularly true in light of a decision from the Court of Appeals for the 11th Circuit in September 2021 finding that, for the purpose of determining the scope of exclusivity, the term “same disease or condition” means the designated “rare disease or condition” and could not be interpreted by the FDA to mean the “indication or use.” Thus, the court concluded, orphan drug exclusivity applies to the entire designated disease or condition rather than the “indication or use” for which a product is approved. On January 23, 2023, the FDA announced that, in matters beyond the scope of that court’s order, the FDA would continue to apply its existing regulations tying orphan drug exclusivity to the uses or indications for which the orphan drug was approved. BBOT does not know if, when, or how the FDA or Congress may change the orphan drug regulations and policies in the future, and it is uncertain how any changes might affect BBOT’s business. Depending on what changes the FDA may make to its orphan drug regulations and policies, BBOT’s business could be adversely impacted.

Current and future legislative and regulatory reform measures and cost containment initiatives may increase the difficulty and cost for BBOT to obtain adequate reimbursement for its product candidates and may adversely affect the prices we may set.

Current and future legislation and regulations may increase the difficulty and cost for us to commercialize our drugs, if approved, and affect the prices we may obtain, including changes in coverage and reimbursement policies in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates, if approved, profitably. If any such changes were to be imposed, they could adversely affect the operation of our business.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. In addition, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their commercial products, which has resulted in several Congressional inquiries and proposed and enacted state and federal 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 pharmaceutical products. Congress has indicated that it will continue to seek new legislative measures to control drug costs.

In the U.S. and some foreign jurisdictions, there have been and continue to be a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, prevent or delay marketing approval of BBOT’s product candidates, restrict or regulate post-approval activities and affect BBOT’s ability to profitably sell any products for which BBOT obtains marketing approval. BBOT expects that current laws, 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 BBOT may receive for any approved products. If reimbursement of BBOT’s products is unavailable or limited in scope, BBOT’s business could be materially harmed.

These laws and other healthcare reform measures may result in additional reductions in Medicare and other healthcare funding and otherwise affect the reimbursement BBOT may obtain for any of its product candidates for which BBOT may obtain regulatory approval or the frequency with which any such product is prescribed or used. BBOT expects that the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in coverage and payments from private payors. Accordingly, the implementation of cost containment measures or other healthcare reforms may prevent BBOT from being able to generate revenue, attain profitability or commercialize its product candidates.

At the U.S. state level, individual states are increasingly aggressive in passing legislation and implementing 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.

In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription product and other health care programs. These measures could reduce the ultimate demand for BBOT’s products, once approved, or put pressure on product pricing. In addition, in some countries, including member states of the EU, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take a significant amount of time after the receipt of marketing approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. 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 distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices, and in certain instances render commercialization in certain markets infeasible or disadvantageous from a financial perspective. In some countries, BBOT or its collaborators may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of BBOT’s products to other available products in order to obtain or maintain reimbursement or pricing approval. Publication of discounts by third party payors or government authorities may lead to further pressure on the prices or reimbursement levels. If reimbursement of BBOT’s products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, the commercial launch of BBOT’s products could be delayed, possibly for lengthy periods of time, BBOT or its collaborators may not launch at all in a particular country, BBOT may not be able to recoup its investment in one or more products, and there could be a material adverse effect on BBOT’s business.

BBOT is or may become subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure to comply with such requirements could subject BBOT to significant fines and penalties, which may have a material adverse effect on BBOT’s business, financial condition or results of operations.

There are multiple privacy and data security laws that may impact BBOT’s business activities in the U.S. and in other countries where BBOT conducts trials or where BBOT may do business in the future. These laws are evolving and may increase both BBOT’s obligations and its regulatory risks in the future. In the health care industry generally, for example, under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), HHS has issued regulations to protect the privacy and security of protected health information (PHI) used or disclosed by specific covered entities including certain healthcare providers, health plans and healthcare clearinghouses. BBOT is not currently

classified as a covered entity or business associate under HIPAA. Thus, BBOT is not directly subject to HIPAA’s requirements or penalties. The healthcare providers, including certain research institutions from which BBOT may obtain patient or subject health information, may be subject to privacy, security, and breach notification requirements under HIPAA. Additionally, any person may be prosecuted under HIPAA’s criminal provisions either directly or under aiding-and-abetting or conspiracy principles. Consequently, depending on the facts and circumstances, BBOT could face criminal penalties if BBOT knowingly receives individually identifiable health information from a HIPAA covered entity, business associate or subcontractor that has not satisfied HIPAA’s requirements for disclosure of individually identifiable health information. In addition, BBOT may maintain sensitive personally identifiable information, including health and genetic information, that BBOT receives throughout the clinical trial process, in the course of BBOT’s research collaborations, and directly from individuals (or their healthcare providers) who may enroll in patient assistance programs if BBOT chooses to implement such programs. As such, in addition to risks and obligations related to HIPAA, BBOT also may be subject to various state and federal laws regulating the use or disclosure of this information or requiring notification of affected individuals and state regulators in the event of a breach of personal information, which is a broader class of information than the health information protected by HIPAA.

Furthermore, certain health privacy laws, data breach notification laws, consumer protection laws and genetic information laws may apply directly to BBOT’s operations and/or those of BBOT’s collaborators and may impose restrictions on BBOT’s collection, use and dissemination of individuals’ health information. Individuals from whom BBOT or its collaborators may obtain health information, as well as the healthcare providers who may share this information with BBOT, may have statutory or contractual rights that limit the ability to use and disclose the information. BBOT may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws. Claims that BBOT has violated individuals’ privacy rights or breached its contractual obligations, even if BBOT is not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm BBOT’s business.

Additionally, the collection and use of personal data, including data concerning health, in the EU is governed by the General Data Privacy Regulation (GDPR), which extends the geographical scope of EU data protection law to non-EU entities under certain conditions and imposes substantial obligations upon companies and new rights for individuals.

Brexit may adversely impact BBOT’s ability to obtain regulatory approvals for its product candidates in the EU, result in restrictions or imposition of taxes and duties for importing BBOT’s product candidates into the EU, and may require BBOT to incur additional expenses in order to develop, manufacture and commercialize BBOT’s product candidates in the EU.

Disruptions at the FDA, the SEC and other government agencies or comparable regulatory authorities caused by funding shortages or global health concerns, in addition to substantial uncertainty regarding the new U.S. presidential administration’s initiatives and staffing cuts and how these might impact the FDA, its implementation of laws, regulations, policies and guidance, and its personnel, could hinder government agencies’ ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which BBOT’s business operations rely, including timely reviews, which could negatively impact BBOT’s business.

The ability of the FDA or comparable foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes that may otherwise affect the FDA’s or comparable foreign regulatory authorities’ ability to perform routine functions. In addition, government funding of the SEC and other government agencies or comparable foreign regulatory authorities on which BBOT’s operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies, including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would harm BBOT’s business. Changes and cuts in FDA staffing could result in delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.

Similar consequences would also result in the event of another significant shutdown of the federal government. For example, over the last several years, the U.S. federal government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If a prolonged government shutdown occurs, or if geopolitical or global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process BBOT’s regulatory submissions, which could materially adversely affect BBOT’s business, financial condition, results of operations and prospects. Such changes could significantly impact the ability of the FDA to timely review and take action on BBOT’s regulatory submissions, which could have a material adverse effect on BBOT’s business, including INDs placed on clinical holds or delayed new drug approvals. Further, in BBOT’s operations as a public company, future government shutdowns or substantial leadership, personnel, and policy changes could impact BBOT’s ability to access the public markets and obtain necessary capital in order to properly capitalize and continue BBOT’s operations. If the FDA is constrained in its ability to engage in oversight and implementation activities in the normal course, BBOT’s business may be negatively impacted.

With the change in the U.S. presidential administration in 2025, there is substantial uncertainty as to whether and how the new administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over BBOT’s product candidates and any products for which BBOT obtains approval. This uncertainty could present new challenges and/or opportunities as BBOT navigates development and approval of BBOT’s product candidates. Some of these efforts have manifested to date in the form of personnel cuts and measures that could impact the FDA’s ability to hire and retain key personnel, which could result in delays or limitations on BBOT’s ability to obtain guidance from the FDA on BBOT’s product candidates in development and obtain the requisite regulatory approvals in the future. There remains general uncertainty regarding future activities. The new administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect BBOT or create a more challenging or costly environment to pursue the development of new therapeutic products. Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to BBOT’s operations. If BBOT becomes negatively impacted by future governmental orders, regulations, policies or guidance as a result of the new administration, there could be a material adverse effect on BBOT and its business.

If BBOT’s product candidates are licensed for marketing and receive federal healthcare reimbursement, any relationships BBOT may have with healthcare providers will be subject to applicable healthcare fraud and abuse laws and regulations, which could expose BBOT to criminal and civil penalties and exclusion from participation in government healthcare programs.

Healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any products for which BBOT is able to obtain marketing approval. Any arrangements BBOT has with healthcare providers, third-party payors and customers will subject BBOT to broadly applicable fraud and abuse and other healthcare laws and regulations. The laws and regulations may constrain the business or financial arrangements and relationships through which BBOT conducts clinical research, markets, sells and distributes any products for which BBOT obtains marketing approval. These include the following:

•        Anti-Kickback Statute.    The federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward or in return for, either the referral of an individual for or the purchase, lease or order of a good, facility, item or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid. Violations are subject to civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs. In addition, a claim including items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act.

•        False Claims Laws.    The federal false claims and civil monetary penalties laws, including the federal civil False Claims Act, impose criminal and civil penalties, including through civil whistleblower or qui tam actions against individuals or entities for, among other things, knowingly presenting or causing to be presented false or fraudulent claims for payment by a federal healthcare program or making a false statement or record material to payment of a false claim or avoiding, decreasing or concealing an obligation to pay money to the federal government, with potential liability including mandatory treble damages and

significant per-claim penalties. Pharmaceutical companies can be held liable under the False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.

•        HIPAA.    HIPAA imposes criminal and civil liability for, among other things, executing a scheme or making materially false statements in connection with the delivery of or payment for health care benefits, items or services. Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations on covered entities and their business associates that perform certain functions or activities that involve the use or disclosure of protected health information on their behalf, including mandatory contractual terms and technical safeguards, with respect to maintaining the privacy, security and transmission of individually identifiable health information.

•        The U.S. Federal Physician Payments Sunshine Act.    The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to payments or transfers of value made to physicians, other healthcare providers and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members.

•        Price Reporting Laws.    Certain federal and state laws including U.S. federal government price reporting laws, which require manufacturers to calculate and report complex pricing metrics in an accurate and timely manner to government programs.

•        Analogous State and Foreign Laws.    Analogous state and foreign fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, can apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors and are generally broad and are enforced by many different federal and state agencies as well as through private actions.

The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the EU. Infringement of these laws could result in substantial fines and imprisonment. Payments made to physicians in certain EU Member States must be publicly disclosed. Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and/or the regulatory authorities of the individual EU Member States. These requirements are provided in the national laws, industry codes or professional codes of conduct applicable in the EU Member States. BBOT’s failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

Efforts to ensure that any business arrangements BBOT has with third parties and BBOT’s business generally will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that BBOT’s 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 BBOT’s operations are found to be in violation of any of these laws or any other governmental regulations that may apply to BBOT, BBOT may be subject to significant civil, criminal and administrative penalties, damages, fines, individual imprisonment, additional reporting requirements and oversight if BBOT becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of BBOT’s operations.

Defending against any such actions in connection with these laws can be costly and time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business are found not to be in compliance with applicable laws or regulations, they may be subject to significant criminal, civil, or administrative sanctions, including exclusions from government-funded healthcare programs. If any of the above occur, our ability to operate our business and our results of operations could be adversely affected.

BBOT’s employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

BBOT is exposed to the risk that its employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage or may have engaged in fraud, misconduct or other improper activities. Misconduct by these parties could include failures to comply with FDA, EMA or comparable foreign regulatory authority regulations, provide accurate information to the FDA, EMA or comparable foreign regulatory authorities, comply with federal and state health care fraud and abuse laws and regulations, accurately report financial information or data or disclose unauthorized activities to BBOT. In particular, research, sales, marketing and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to BBOT’s reputation. BBOT has adopted a code of conduct and engages contractors that agree to undertake certain measures with respect to their employees, but it is not always possible to identify and deter misconduct by these parties, and the precautions BBOT takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting BBOT 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 BBOT, and BBOT is not successful in defending itself or asserting its rights, those actions could have a significant impact on BBOT’s business, including the imposition of significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of BBOT’s operations.

BBOT’s business activities may be subject to the U.S. Foreign Corrupt Practices Act (FCPA) and similar anti-bribery and anti-corruption laws of other countries in which BBOT operates, as well as U.S. and certain foreign export controls, economic sanctions, import, and trade and national security laws and regulations. Compliance with these legal requirements could limit BBOT’s ability to compete in foreign markets and subject BBOT to liability if BBOT violates them.

BBOT’s business activities may be subject to the FCPA and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which BBOT operates. The FCPA generally prohibits companies and their employees and third-party intermediaries from offering, promising, giving or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. BBOT’s business is heavily regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally, in many other countries, hospitals are owned and operated by the government, and doctors and other hospital employees would be considered foreign officials under the FCPA. The biotechnology and pharmaceutical industries have historically presented a heightened risk profile for FCPA enforcement. There is no certainty that all of BBOT’s employees, agents or contractors, or those of BBOT’s affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in fines, criminal sanctions against BBOT, its officers or employees, disgorgement, and other sanctions and remedial measures, and prohibitions on the conduct of BBOT’s business. Any such violations could include prohibitions on BBOT’s ability to offer its products in one or more countries and could materially damage BBOT’s reputation, brand, international activities, ability to attract and retain employees and business, prospects, operating results and financial condition.

In addition, BBOT’s business activities (including conduct of clinical trials) and products may be subject to U.S. and foreign export controls, economic sanctions, import and trade and national security laws and regulations. Governmental regulation of the import or export of BBOT’s products, or BBOT’s failure to obtain any required import or export authorization for its products, when applicable, could harm BBOT’s international or domestic sales and adversely affect revenue. Compliance with applicable regulatory requirements regarding the conduct of clinical trials and export of BBOT’s products may create delays in the introduction of BBOT’s products in international markets or, in some cases, prevent the export of BBOT’s products to some countries altogether. Furthermore, U.S. export

control laws and economic sanctions prohibit certain transactions and the shipment of certain products and services to countries, governments, and persons targeted by U.S. sanctions. If BBOT fails to comply with export and import regulations and such economic sanctions, penalties could be imposed, including fines and/or denial of certain export privileges and reputational harm.

Moreover, any new export controls, import restrictions, economic sanctions, national security policy, new legislation or shifting approaches in the enforcement or scope of existing regulations, or in the countries, persons, or products targeted by such regulations, could result in decreased use of BBOT’s products by, or in BBOT’s decreased ability to export its products to, existing or potential customers with international operations, in addition to adversely affecting cross-border operations and transactions. Any decreased use of BBOT’s products or limitation on BBOT’s ability to export or sell its products, or import materials for its products, would likely adversely affect BBOT’s business. For instance, the U.S. Department of Justice has issued a final rule prohibiting certain covered data transactions (including for human ‘omic and personal health data) and establishing data security requirements for restricted transactions involving China, Russia, and other countries of concern on national security grounds. More recently, tariffs have been proposed on products from Canada, China, Mexico and potentially other countries, which could have the effect of disrupting, and increasing costs associated with, BBOT’s supply chain of materials and other imports needed for its operations and business in the United States. The course of trade relations between the United States and other countries is difficult to predict, including how operations, transactions, products, and services may be impacted by the respective trade policies of the United States and other countries (including those in retaliation). If BBOT is unable to conduct transactions, obtain or use services, or export or sell products or services to third parties, including vendors, customers, and partners in other countries, BBOT’s business, liquidity, financial condition, or operations would be materially and adversely affected.

If BBOT fails to comply with applicable environmental, health and safety laws and regulations, BBOT could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of BBOT’s business.

BBOT is subject to numerous 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. BBOT’s operations involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. BBOT’s operations also produce hazardous waste products. BBOT generally contracts with third parties for the disposal of these materials and wastes. BBOT cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from BBOT’s use of hazardous materials, BBOT could be held liable for any resulting damages, and any liability could exceed BBOT’s resources. BBOT also could incur significant costs associated with civil or criminal fines and penalties.

Although BBOT maintains workers’ compensation insurance to cover BBOT for costs and expenses BBOT may incur due to injuries to its employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. BBOT does not maintain insurance for environmental liability or toxic tort claims that may be asserted against BBOT in connection with BBOT’s storage or disposal of biological, hazardous or radioactive materials. Compliance with applicable environmental, health and safety laws and regulations is expensive, and current or future environmental regulations may impair BBOT’s business, prospects, financial condition or results of operations.

Risks related to BBOT’s business

BBOT’s success is highly dependent on BBOT’s ability to attract, hire and retain highly skilled executive officers and employees, and BBOT may experience difficulties in managing the future growth of BBOT’s organization.

BBOT currently has a small team focused on research and development of RAS-pathway targeted small molecules. To succeed, BBOT must recruit, hire, retain, manage and motivate qualified clinical, scientific, technical, financial and management personnel, and BBOT faces significant competition for experienced personnel. Personnel with the required skills and experience may be scarce or may not be available at all. In addition, competition for these skilled personnel is intense and recruiting and retaining skilled employees is difficult, particularly for a development-stage company such as BBOT. Even if BBOT is successful in identifying, attracting, hiring and retaining qualified employees, recent market changes, including labor shortages, and rising inflation have increased employee-related costs substantially, which may negatively affect BBOT’s operating results.

BBOT is highly dependent on the principal members of its management and scientific and medical staff. If BBOT does not succeed in attracting and retaining qualified personnel in these positions, it could adversely affect BBOT’s ability to execute its business plan and harm its operating results. In particular, the loss of one or more of BBOT’s executive officers could be detrimental if BBOT cannot recruit suitable replacements in a timely manner.

Many of the other biotechnology companies that BBOT competes against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than BBOT does. They also may provide higher compensation, more diverse opportunities and better prospects for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what BBOT has to offer. If BBOT is unable to continue to attract and retain high-quality personnel, the rate and success at which BBOT can discover, develop and commercialize its product candidates will be limited and the potential for successfully growing BBOT’s business will be harmed.

Additionally, BBOT relies on its clinical advisory board and other scientific and clinical advisors and consultants to assist BBOT in formulating its research, development and clinical strategies. Most of these advisors and consultants are not BBOT’s employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability. In addition, these advisors and consultants typically will not enter into non-compete agreements with BBOT. If a conflict of interest arises between their work for BBOT and their work for another entity, BBOT may lose their services. Furthermore, BBOT’s advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with BBOT’s. In particular, if BBOT is unable to maintain consulting or employment relationships with other scientific and clinical advisors, or if they provide services to BBOT’s competitors, BBOT’s development and commercialization efforts will be impaired and BBOT’s business will be significantly harmed. For example, if BBOT is no longer able to access its network of physician-scientists, BBOT’s ability to define and characterize patients’ needs for future product candidate development may be negatively affected.

In order to successfully implement BBOT’s development and commercialization plans and strategies, and as BBOT grows as a public company, BBOT expects to need significant additional managerial, operational, financial, sales, marketing and other personnel. Future growth will impose significant added responsibilities on members of management, including:

•        identifying, recruiting, integrating, maintaining, retaining and motivating BBOT’s current and additional employees;

•        managing BBOT’s internal development efforts effectively, including the preclinical, clinical, FDA, EMA and other comparable foreign regulatory authorities’ review process for BBO-8520, BBO-10203 and BBO-11818 and BBOT’s discovery programs, while complying with any contractual obligations to contractors and other third parties;

•        managing increasing operational and managerial complexity; and

•        improving BBOT’s operational, financial and management controls, reporting systems and procedures.

BBOT currently relies, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services, including key aspects of research, clinical development and manufacturing. There can be no assurance that the services of independent organizations, advisors and consultants will continue to be available to BBOT on a timely basis when needed, or that BBOT can find qualified replacements. In addition, if BBOT is unable to effectively manage its outsourced activities or if the quality or accuracy of the services provided by third-party service providers is compromised for any reason, BBOT’s preclinical studies and clinical trials may be extended, delayed or terminated, and BBOT may not be able to obtain marketing approval for any of its product candidates or otherwise advance its business. There can be no assurance that BBOT will be able to manage its existing third-party service providers or find other competent outside contractors and consultants on economically reasonable terms, or at all.

If BBOT is not able to effectively expand its organization by hiring new employees and/or engaging additional third-party service providers, BBOT may not be able to successfully implement the tasks necessary to further develop and commercialize BBO-8520, BBO-10203 and BBO-11818 or any future product candidate from BBOT’s discovery programs and, accordingly, may not achieve its research, development and commercialization goals.

BBOT’s reliance on a limited number of employees who provide various administrative, research and development, and other services across BBOT’s organization presents operational challenges that may adversely affect BBOT’s business.

As of June 13, 2025, BBOT had 66 full-time employees, upon whom BBOT relies for various administrative, research and development, and other services. The small size of BBOT’s team may limit BBOT’s ability to devote adequate personnel, time, and resources to support BBOT’s operations or research and development activities, and the management of financial, accounting, and reporting matters. If BBOT’s team fails to provide adequate administrative, research and development, or other services across BBOT’s organization, its business, financial condition, and results of operations could be harmed.

BBOT’s internal computer systems, or those of any of BBOT’s CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or suffer actual or suspected security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of BBOT’s proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to BBOT’s brand and material disruption of BBOT’s operations, and potentially significant delays in BBOT’s delivery to market.

Despite the implementation of security measures, policies and procedures in an effort to protect systems that store BBOT’s data, given their size and complexity and the increasing amount of information maintained on BBOT’s internal information technology systems and external processing and storage systems (i.e., cloud), and those of BBOT’s third-party CROs, other contractors (including sites performing BBOT’s clinical trials) and consultants, these systems 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 breaches from inadvertent or intentional actions by BBOT’s employees, 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, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information), which may compromise BBOT’s system infrastructure or lead to the loss, destruction, alteration or dissemination of, or damage to, BBOT’s data. The risk of a security breach or disruption through cyber-attacks has generally increased as the number, intensity and sophistication of attempted attacks from around the world have increased. For example, companies have experienced an increase in phishing and social engineering attacks from third parties. Also, a majority of BBOT’s employees are working remotely. As a result, BBOT may have increased cybersecurity and data security risks, due to increased use of home wi-fi networks and virtual private networks, as well as increased disbursement of physical machines. While BBOT implements IT controls to reduce the risk of a cybersecurity or data security breach, there is no guarantee that these measures will be adequate to safeguard all systems.

To the extent that any disruption or security breach were to result in a loss, destruction, unavailability, alteration or dissemination of, or damage to, BBOT’s data (including confidential information and personal data) or applications, or for it to be believed or reported that any of these occurred, BBOT could incur liability and reputational damage and the development and commercialization of BBOT’s product candidates could be delayed. There can be no assurance that BBOT’s data protection efforts, annual security assessments and investment in information technology, or the efforts or investments of CROs, consultants or other third parties, will prevent significant breakdowns or breaches in systems or other cyber incidents that cause loss, destruction, unavailability, alteration or dissemination of, or damage to, BBOT’s data that could have a material adverse effect upon BBOT’s reputation, business, operations or financial condition. For example, if such an event were to occur and cause interruptions in BBOT’s operations, it could result in a material disruption of BBOT’s programs and the development of BBOT’s product candidates could be delayed. In addition, the loss of clinical trial data for BBOT’s product candidates could result in delays in BBOT’s marketing approval efforts and significantly increase BBOT’s costs to recover or reproduce the data, as well as claims or investigations from regulators or other third parties. Furthermore, significant disruptions of BBOT’s internal information technology systems or security breaches could result in the loss, misappropriation, and/or unauthorized access, use, or disclosure of, or the prevention of access to, data (including trade secrets or other confidential information, intellectual property, proprietary business information, and personal data), which could result in financial, legal, business, and reputational harm to BBOT, including significant expenses, remediation costs, litigation, disputes, claims by third parties and regulatory actions or investigations. For example, any such event that leads to unauthorized access, use, or disclosure

of personal data, including personal data regarding BBOT’s clinical trial subjects or employees, could harm BBOT’s reputation directly, compel BBOT to comply with federal and/or state breach notification laws and foreign law equivalents, subject BBOT to financial exposure related to investigation of the incident (including cost of forensic examinations), subject BBOT to mandatory corrective action, and otherwise subject BBOT to liability under laws and regulations that protect the privacy and security of data, which could result in significant legal and financial exposure and reputational damages that could potentially have a material adverse effect on BBOT’s business.

Notifications, follow-up actions, claims and investigations related to a security incident could impact BBOT’s reputation and cause BBOT to incur significant costs, including legal expenses and remediation costs. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in BBOT’s regulatory approval efforts and significantly increase BBOT’s costs to recover or reproduce the lost data. BBOT expects to incur significant costs in an effort to detect and prevent security incidents, and BBOT may face increased costs and requirements to expend substantial resources in the event of an actual or perceived security breach. BBOT also relies on third parties to manufacture its product candidates, and similar events relating to their computer systems could also have a material adverse effect on BBOT’s business. To the extent that any disruption or security incident were to result in a loss, destruction or alteration of, or damage to, BBOT’s data (including personal data), or inappropriate disclosure of confidential or proprietary information, BBOT could be exposed to litigation and governmental investigations, the further development and commercialization of BBOT’s product candidates could be delayed, and BBOT could be subject to significant fines or penalties for any noncompliance with certain state, federal and/or privacy and security laws from countries outside of the U.S.

BBOT’s insurance policies may not be adequate to compensate BBOT for the potential losses arising from any such disruption in or, failure or security breach of BBOT’s systems or third-party systems where information important to BBOT’s business operations or commercial development is stored. In addition, such insurance may not be available to BBOT in the future on economically reasonable terms, or at all. Further, BBOT’s insurance may not cover all claims made against BBOT and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.

BBOT’s operations are vulnerable to interruption by flood, fire, earthquakes, power loss, telecommunications failure, terrorist activity, pandemics and other events beyond BBOT’s control, which could harm BBOT’s business.

BBOT’s corporate headquarters are located in South San Francisco, California. BBOT has not undertaken a systematic analysis of the potential consequences to its business and financial results from a major flood, fire, earthquake, power loss, telecommunications failure, terrorist activity, pandemic or other disasters and BBOT does not have a recovery plan for such disasters. In addition, BBOT does not carry sufficient insurance to compensate for actual losses from interruption of BBOT’s business that may occur, and any losses or damages incurred by BBOT could harm BBOT’s operations and financial condition and increase costs and expenses.

BBOT has never commercialized a product candidate as a company before. If BBOT is unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market BBOT’s product candidates, BBOT may not be able to successfully sell or market its product candidates that obtain regulatory approval.

BBOT has never commercialized a product and currently does not have and has never had a significant marketing or sales team. In order to commercialize any product candidates, if approved, BBOT must build marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services for each of the territories in which BBOT may have approval to sell or market its product candidates. BBOT may not be successful in accomplishing these required tasks.

Establishing an internal sales or marketing team with technical expertise and supporting distribution capabilities to commercialize BBOT’s product candidates will be expensive and time-consuming and will require significant attention of BBOT’s executive officers to manage. Any failure or delay in the development of BBOT’s internal sales, marketing and distribution capabilities could adversely impact the commercialization of any of BBOT’s product candidates that BBOT obtains approval to market if BBOT does not have arrangements in place with third parties to provide such services on its behalf. Alternatively, if BBOT chooses to collaborate, either globally or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to augment BBOT’s own sales force and distribution systems or in lieu of BBOT’s own sales force and distribution systems, BBOT will be required to negotiate and enter into arrangements with such third parties relating to the

proposed collaboration and such arrangements may prove to be less profitable than commercializing the product on BBOT’s own. If BBOT is unable to enter into such arrangements when needed, on acceptable terms or at all, BBOT may not be able to successfully commercialize any of its product candidates that receive regulatory approval, or any such commercialization may experience delays or limitations. If BBOT is unable to successfully commercialize its approved product candidates, either on its own or through collaborations with one or more third parties, BBOT’s future product revenue will suffer, and BBOT may incur significant additional losses.

A variety of risks associated with marketing BBOT’s product candidates internationally could materially adversely affect BBOT’s business.

BBOT may seek regulatory approval of its product candidates outside of the U.S. and, accordingly, BBOT expects that it will be subject to additional risks related to operating in foreign countries if BBOT obtains the necessary approvals, including:

•        differing regulatory requirements and reimbursement regimes in foreign countries, such as the lack of pathways for accelerated drug approval, may result in foreign regulatory approvals taking longer and being more costly than obtaining approval in the U.S.;

•        foreign regulatory authorities may disagree with the design, implementation or results of BBOT’s clinical trials or BBOT’s interpretation of data from preclinical studies or clinical trials;

•        approval policies or regulations of foreign regulatory authorities may significantly change in a manner rendering BBOT’s clinical data insufficient for approval;

•        the impact of pandemics or other public health emergencies, natural disasters and geopolitical events on BBOT’s ability to produce its product candidates and conduct clinical trials in foreign countries;

•        unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

•        economic weakness, including inflation, or political instability in particular foreign economies and markets;

•        compliance with legal requirements applicable to privacy, data protection, information security and other matters;

•        compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

•        foreign taxes, including withholding of payroll taxes;

•        foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;

•        difficulties staffing and managing foreign operations;

•        complexities associated with managing multiple payor reimbursement regimes and government payors in foreign countries;

•        workforce uncertainty in countries where labor unrest is more common than in the U.S.;

•        potential liability under the FCPA or comparable foreign regulations;

•        challenges enforcing BBOT’s contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.;

•        production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

•        business interruptions resulting from geopolitical events, including war and terrorism, trade policies, treaties and tariffs.

These and other risks associated with international operations may materially adversely affect BBOT’s ability to attain or maintain profitable operations.

Changes in tax law could adversely affect BBOT’s business and financial condition.

The rules dealing with U.S. federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service, the U.S. Treasury Department and other applicable tax authorities. Changes to tax laws (which changes may have retroactive application) could adversely affect BBOT or holders of BBOT common stock. In recent years, many such changes have been made and changes are likely to continue to occur in the future. Future changes in tax laws could have a material adverse effect on BBOT’s business, cash flow, financial condition or results of operations.

BBOT’s ability to utilize its net operating loss carryforwards and certain other tax attributes to offset future taxable income may be limited.

BBOT’s federal net operating loss (NOL) carryforwards may be unavailable to offset future taxable income because of restrictions under U.S. tax law. Under the Tax Cut and Jobs Act, as amended by the Coronavirus Aid, Relief, and Economic Security Act, BBOT’s federal NOLs may be carried forward indefinitely, but for taxable years beginning after December 31, 2020, the deductibility of federal NOL carryforwards generated in tax years beginning after December 31, 2017 is limited to 80% of BBOT’s current year taxable income. As of December 31, 2024, BBOT had available federal NOL carryforwards of approximately $60.1 million and available state NOL carryforwards of approximately $12.2 million.

In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a cumulative change in the corporation’s ownership by “5-percent shareholders” that exceeds 50 percentage points (by value) over a rolling three-year period), the corporation’s ability to use its pre-change NOL carryforwards and certain other pre-change tax attributes to offset its post-change taxable income may be limited. Similar rules may apply under state tax laws. BBOT may have experienced such ownership changes in the past, and BBOT may experience ownership changes in the future as a result of shifts in BBOT’s stock ownership, some of which are outside BBOT’s control. However, BBOT does not expect that the transactions contemplated herein will cause an “ownership change” within the meaning of Section 382. BBOT has not conducted any studies to determine annual limitations, if any, that could result from such changes in the ownership. There is also a risk that due to regulatory changes, such as suspensions on the use of NOL carryforwards, or other unforeseen reasons, BBOT’s existing NOL carryforwards could expire or otherwise be unavailable to offset future income tax liabilities. Because BBOT’s ability to utilize BBOT’s NOL carryforwards, which could have a material adverse effect on BBOT’s cash flows and results of operations.

If the Business Combination does not qualify as a “reorganization” within the meaning of Section 368 of the Code, the Business Combination may be a taxable event, which would be taxable to holders of BBOT capital stock.

The U.S. federal income tax consequences of the Business Combination will depend primarily upon whether it qualifies as a “reorganization” within the meaning of Section 368 of the Code. Each of BBOT and Helix intends that the Business Combination should qualify as a “reorganization” for U.S. federal income tax purposes. Further, in the Merger Agreement, each of Helix, Merger Sub and BBOT agrees not to take any action that could reasonably be expected to prevent, impair or impede such qualification. Based on customary assumptions and representations from Helix, Merger Sub and BBOT, as well as certain covenants, undertakings and statements of intention (which we assume will be realized) by Helix, Merger Sub and BBOT and in the opinion included as Exhibit 8.3 hereto, it is the opinion of Goodwin Procter LLP that the Business Combination should qualify as a “reorganization” within the meaning of Section 368(a) of the Code. However, neither Helix nor BBOT intends to or has sought any rulings from the IRS regarding the U.S. federal income tax consequences of the Business Combination. If any of the tax opinion representations and assumptions is incorrect, incomplete or inaccurate, or is violated or not fulfilled, the validity of the opinion described above may be affected and the tax consequences of the Business Combination could differ from those described in this proxy statement/prospectus. Further, an opinion of counsel represents counsel’s best legal judgment but is not binding on the IRS or any court, and there can be no certainty that the IRS will not challenge the conclusions reflected in such opinion or that a court would not sustain such a challenge. Accordingly, no assurance can be given that the IRS will not assert, or that a court will not sustain, a position contrary to the intended U.S. federal income tax treatment of the Business Combination. If the Business Combination were determined not to qualify as a “reorganization” within the meaning of Section 368 of the Code, then, for U.S. federal income tax purposes, the

Business Combination would produce taxable income for holders of BBOT capital stock who exchange such stock for Helix stock in the Business Combination. You are urged to consult your tax advisor regarding the tax consequences of the Business Combination to you.

If BBOT engages in future acquisitions or strategic partnerships, this may increase BBOT’s capital requirements, dilute BBOT’s stockholders, cause BBOT to incur debt or assume contingent liabilities, and subject BBOT to other risks.

From time to time, BBOT evaluates various acquisition opportunities and strategic partnerships, including licensing or acquiring complementary products, product candidates, intellectual property rights, technologies or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:

•        increased operating expenses and cash requirements;

•        the assumption of additional indebtedness or contingent liabilities;

•        the issuance of BBOT’s equity securities;

•        assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel;

•        the diversion of BBOT’s management’s attention from its existing programs and initiatives in pursuing such a strategic merger or acquisition;

•        retention of key employees, the loss of key personnel and uncertainties in BBOT’s ability to maintain key business relationships;

•        risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products, product candidates and marketing approvals; and

•        BBOT’s inability to generate revenue from acquired technology and/or products sufficient to meet BBOT’s objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

In addition, if BBOT undertakes acquisitions or pursues partnerships in the future, BBOT may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense.

Adverse events in the field of oncology or the biopharmaceutical industry could damage public perception of BBOT’s current or future product candidates and negatively affect BBOT’s business.

The commercial success of BBOT’s products, if approved, will depend in part on public acceptance of the use of targeted cancer therapies. While a number of targeted cancer therapies have received regulatory approval and are being commercialized, BBOT’s approach to targeting cancer cells carrying tumor causing mutations, including oncogenic RAS pathway mutations, is novel and unproven. Adverse events in clinical trials of BBOT’s product candidates, or post-marketing activities, or in clinical trials of others developing similar products or that are related to approved targeted therapies, particularly those targeting oncogenic RAS pathway mutations, including sotorasib and adagrasib and the resulting publicity, as well as any other adverse events in the field of oncology that may occur in the future, could result in a decrease in demand for any product that BBOT may develop. If public perception is influenced by claims that the use of cancer therapies is unsafe, whether related to BBOT therapies or those of BBOT’s competitors, BBOT’s product candidates or products, if approved, may not be accepted by the general public or the medical community.

Future adverse events in oncology or the biopharmaceutical industry could also result in greater government regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of BBOT’s products. Any increased scrutiny could delay or increase the costs of obtaining marketing approval for BBOT’s current or future product candidates.

Risks related to BBOT’s intellectual property

Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require BBOT to cease using the related technology or to attempt to license rights from the prevailing party.

Derivation proceedings provoked by third parties or brought by BBOT or declared by the U.S. Patent and Trademark Office (USPTO) may be necessary to determine the priority of inventions with respect to one or more of BBOT’s patents or patent applications or those of BBOT’s future licensors. An unfavorable outcome may require BBOT to cease using the related technology or to attempt to license rights to it from the prevailing party. BBOT’s business could be adversely affected if the prevailing party does not offer BBOT a license on commercially reasonable terms. BBOT’s defense of derivation proceedings may fail and, even if successful, may result in substantial costs and distract BBOT’s management and other employees. In addition, the uncertainties associated with such proceedings could have a material adverse effect on BBOT’s ability to raise the funds necessary to continue BBOT’s clinical trials and development programs, license necessary technology from third parties or enter into development or manufacturing partnerships that would help BBOT bring its product candidates to market.

If BBOT is unable to obtain, maintain and enforce patent protection for its technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, BBOT’s competitors could develop and commercialize technology and products similar or identical to BBOT’s, and BBOT’s ability to successfully develop and commercialize its technology and product candidates may be adversely affected.

BBOT’s success depends in large part on its ability to obtain and maintain protection of the intellectual property rights BBOT owns (either solely and jointly with others), or may in the future license from third parties (in particular, worldwide patents relating to any proprietary technology and product candidates BBOT develops). BBOT seeks to protect its proprietary position by filing patent applications in the U.S. and select other countries related to its technologies and product candidates that are important to its business and by in-licensing intellectual property related to such technologies and product candidates. BBOT does not yet have issued patents for all of its most advanced product candidates in all markets in which BBOT may commercialize them, but BBOT continues to actively pursue patent protection for its technology and product candidates in certain jurisdictions around the world. However, BBOT cannot guarantee that patents will be granted with respect to any of its pending patent applications or with respect to any patent applications BBOT may file in the future, nor can BBOT be sure that any patents that may be granted to BBOT in the future will be commercially useful in protecting BBOT’s products, or the methods of use or manufacture of those products. If BBOT is unable to obtain and maintain meaningful patent protection in jurisdictions important to BBOT’s business for its product candidates, their respective components, formulations, combination therapies, methods used to manufacture them and methods of treatment, or other proprietary technologies, BBOT’s business, financial condition, results of operations and prospects could be adversely affected.

The patent prosecution process is expensive, time-consuming and complex, and BBOT may not be able to file, prosecute, maintain or defend all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that BBOT will fail to identify patentable aspects of its research and development output before it is too late to obtain patent protection. Moreover, in some circumstances involving technology that BBOT may license from third parties, BBOT may not have the sole right to control the preparation, filing and prosecution of patent applications or to maintain, enforce and defend the in-licensed patents. Therefore, any in-licensed patents and applications may not be prepared, filed, prosecuted, maintained, defended and enforced in a manner consistent with the best interests of BBOT’s business.

The patent rights of pharmaceutical and biotechnology companies, like BBOT, generally are highly uncertain, involve complex legal and factual questions and have been the subject of much litigation in recent years. No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents, particularly those related to oncology, has emerged in the U.S. The relevant patent laws and their interpretation outside of the U.S. are also uncertain. Various courts, including the U.S. Supreme Court, have rendered decisions that affect the scope of patent eligibility of certain inventions or discoveries relating to biotechnology. These decisions conclude, among other things, that abstract ideas, natural phenomena and laws of nature are not themselves patent eligible subject matter. Precisely what constitutes a law of nature or abstract idea is uncertain, and certain aspects of BBOT’s technology could be considered ineligible for patenting under applicable law. In addition, the scope of patent protection outside the U.S. is uncertain, and laws of foreign countries may not protect BBOT’s rights to the same extent as the laws of the U.S. or vice versa. For example, European patent law precludes the patentability of methods of treatment of the human body

by surgery or therapy. BBOT cannot predict whether the patent applications BBOT is currently pursuing will issue as patents that protect BBOT’s technology and product candidates, in whole or in part, in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from competitors. Changes in either the patent laws or interpretation of the patent laws in the U.S. or other countries may diminish the value of BBOT’s patents and its ability to obtain, protect, maintain, defend and enforce BBOT’s patent rights, narrow the scope of BBOT’s patent protection and, more generally, affect the value or narrow the scope of BBOT’s patent rights.

Further, third parties may have intellectual property rights relating to BBOT’s product candidates of which BBOT is unaware. For example, third parties may have blocking patents that could be used to prevent BBOT from commercializing its product candidates and practicing its proprietary technology. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the U.S. and other jurisdictions are typically not published until 18 months after filing, or in some cases are not published at all. Therefore, neither BBOT nor its future licensors can know with certainty whether either BBOT or its future licensors were the first to make the inventions claimed in the patent applications BBOT owns or any patents or patent applications BBOT may own or in-license in the future, or that either BBOT or any of its future licensors were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of BBOT’s owned and future in-licensed patent rights are uncertain. For example, currently unpublished patent applications may later publish and limit BBOT’s ability to obtain valid and enforceable patents.

Moreover, any issued patents BBOT does obtain or in-license may be challenged, invalidated, or circumvented. BBOT or its future licensors may be subject to a third-party pre-issuance submission of prior art to the USPTO, or to a foreign patent office, or become involved in opposition, derivation, revocation, reexamination, inter partes review, post-grant review or interference proceedings challenging BBOT’s 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, BBOT’s patent rights, allow third parties to commercialize BBOT’s technology or product candidates and compete directly with BBOT, without payment to BBOT, or result in BBOT’s inability to manufacture or commercialize drugs without infringing third-party patent rights. If the breadth or strength of protection provided by any patents BBOT obtains and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with BBOT to license, develop or commercialize current or future product candidates. Moreover, BBOT’s competitors may independently develop similar technologies that are outside the scope of the rights granted under any issued patents BBOT may obtain. For these reasons and others, BBOT may face competition with respect to its product candidates.

Additionally, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if BBOT’s owned and any future in-licensed patent applications issue as patents, they may not issue in a form that will provide BBOT with any meaningful protection, prevent competitors from competing with BBOT, or otherwise provide BBOT with any competitive advantage. The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and any patents BBOT does obtain may be challenged in the courts or patent offices in the U.S. and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit BBOT’s ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of BBOT’s technology and product candidates. Such challenges also may result in substantial cost and require significant time from BBOT’s management and employees, even if the eventual outcome is favorable to BBOT. Furthermore, BBOT’s competitors may be able to circumvent any patents BBOT obtains or in-licenses in the future by developing similar or alternative technologies or products in a non-infringing manner. For these reasons, even if BBOT is successful in obtaining patents or in-licensing patents in the future, BBOT’s patent portfolio may not provide BBOT with sufficient rights to exclude others from using or commercializing technology and products similar or identical to any of BBOT’s technology and product candidates for any period of time.

Patent terms may not protect BBOT’s competitive position for an adequate amount of time.

Issued patents can provide protection for varying periods of time, depending, for example, upon the type of patent, the date of filing of the patent application, the date of patent issuance and the legal term of patents in the countries in which they are obtained. However, patents have a limited lifespan. In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. The term of a patent outside of the U.S. varies in accordance with the laws of the foreign jurisdiction. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering BBOT’s

product candidates are obtained, once the patent life has expired, BBOT may be open to competition from competitive products, including generics. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are approved for use or commercialized.

Changes to patent laws in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing BBOT’s ability to protect its products.

Changes in either the patent laws or interpretation of patent laws in the U.S. or other jurisdictions could increase the uncertainties and costs surrounding the prosecution of BBOT’s owned and any future in-licensed patent applications and the maintenance, enforcement or defense of any issued patents BBOT may obtain or in-license.

In addition, the patent positions of companies in the development and commercialization of pharmaceuticals and biopharmaceuticals are particularly uncertain. For example, the USPTO regularly revises its policies and procedures for patent examination. Future political changes may impose new difficulties in obtaining patent protection. This combination of events has increased uncertainty with respect to the validity and enforceability of patents once obtained. Similarly, foreign courts and patent offices have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted. BBOT cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by U.S. and foreign legislative bodies. Those changes may materially affect BBOT’s patents or patent applications and BBOT’s ability to obtain patent protection in the future.

BBOT may become involved in lawsuits to protect or enforce its patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.

Competitors and other third parties may infringe, misappropriate or otherwise violate patents or other intellectual property that BBOT owns or licenses. As a result, BBOT or its future licensors may need to file infringement, misappropriation or other intellectual property claims, which can be expensive and time-consuming. Any claims BBOT asserts against others could provoke them to assert counterclaims against BBOT alleging that BBOT infringes, misappropriates or otherwise violates their intellectual property rights. BBOT’s ability to stop third parties from making, using, selling, offering to sell, or importing products that infringe BBOT’s intellectual property will depend in part on the extent to which BBOT obtains and enforces patent claims that cover BBOT’s technology, inventions, and improvements.

Furthermore, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability. In a patent infringement proceeding, the perceived infringers could counterclaim that the patents BBOT or its licensors have asserted are invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are common. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion include an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may institute such claims before administrative bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions, such as opposition proceedings in the European Patent Office. The outcomes of allegations of invalidity or unenforceability are unpredictable. With respect to validity, for example, even if BBOT is successful in obtaining patents or in-licensing patents, BBOT cannot be certain that there is no invalidating prior art of which the patent examiner and BBOT or its future licensing partners were unaware during prosecution.

An adverse result in any such proceeding could put one or more of the patents that BBOT may own or in-license in the future at risk of being invalidated or interpreted narrowly, and could put any of BBOT’s present or future owned or in-licensed patent applications at risk of not yielding an issued patent. A court may also refuse to stop the third party from using the technology at issue in a proceeding, for example, on the basis that BBOT owned or in-licensed patents do not cover that technology. Furthermore, if the breadth or strength of protection provided by BBOT’s patent applications and any future patents is threatened, regardless of the outcome, it could dissuade companies from collaborating with BBOT to license, develop or commercialize current or future products, diagnostic tests or services.

In addition, interference or derivation proceedings provoked by third parties or brought by BBOT or declared by the USPTO may be necessary to determine the priority of inventions with respect to BBOT’s patent applications or any future patents. An unfavorable outcome could require BBOT to cease using the related technology or to attempt to license rights to it from the prevailing party. BBOT’s business could be adversely affected if the prevailing party does not offer BBOT a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and BBOT’s competitors gain access to the same technology. BBOT’s defense of litigation or interference or derivation proceedings may fail and, even if successful, may result in substantial costs and distract BBOT’s management and other employees. In addition, the uncertainties associated with litigation could have a material adverse effect on BBOT’s ability to raise funds as needed to continue BBOT’s clinical trials and discovery programs, license necessary technology from third parties, or enter into development partnerships that would help BBOT bring its product candidates to market.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of BBOT’s confidential information or trade secrets could be compromised by disclosure during litigation. Any of the foregoing could allow third parties to develop and commercialize competing technologies and products and have a material adverse impact on BBOT’s business, financial condition, results of operations and prospects.

Third parties may allege that BBOT is infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on BBOT’s business.

BBOT’s commercial success depends upon its ability and the ability of its collaborators to develop, manufacture, market and sell BBOT’s product candidates and use its proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third parties. There is considerable patent and other intellectual property litigation in the pharmaceutical and biotechnology industries. BBOT has been and may in the future be threatened with, and may in the future become party to, adversarial proceedings or litigation regarding intellectual property rights with respect to BBOT’s technology and product candidates, including interference proceedings, post grant review, inter partes review and derivation proceedings before the USPTO and similar proceedings in foreign jurisdictions. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, including BBOT’s competitors, exist in the fields in which BBOT is pursuing product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that BBOT’s technologies or product candidates may be subject to claims that they infringe the patent rights of third parties. BBOT’s competitors and others may have significantly larger and more mature patent portfolios than BBOT has. In addition, future litigation may be initiated by patent holding companies or other third parties who have no relevant product or service revenue and against whom BBOT’s future patents, if any, may provide little or no deterrence or protection. Competitors may also assert that BBOT’s product candidates infringe their intellectual property rights as part of a business strategy to impede BBOT’s successful entry into those markets.

The legal threshold for initiating litigation or contested proceedings is low, so that even lawsuits or proceedings with a low probability of success might be initiated and require significant resources and management attention to defend. The risks of being involved in such litigation and proceedings may increase if and as BBOT’s product candidates near commercialization and as BBOT gains greater visibility as a public company. Third parties may assert infringement claims against BBOT based on existing patents or patents that may be granted in the future, regardless of merit. Even if BBOT believes third-party intellectual property claims are without merit, there is no assurance that a court would find in BBOT’s favor on questions of infringement, validity, enforceability or priority. Because patent applications can take many years to issue, pending patent applications may result in issued patents that BBOT’s product candidates infringe. For example, there may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the discovery, use or manufacture of BBOT’s product candidates or technologies. BBOT may not be aware of all such intellectual property rights potentially relating to its technology and product candidates, or BBOT may incorrectly conclude that third-party intellectual property is invalid or that BBOT’s activities and product candidates do not infringe the intellectual property rights of third parties. Thus, BBOT does not know with certainty that its technology and product candidates, or its development and commercialization thereof, do not and will not infringe, misappropriate or otherwise violate any third party’s intellectual property rights. Parties making claims against BBOT may also obtain injunctive or other equitable relief. For example, if any third-party patents were held to cover the manufacturing process of BBOT’s product candidates, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block BBOT’s ability to commercialize such product candidates. In the event of a successful claim of infringement against BBOT, BBOT may also have to pay substantial damages, including

treble damages and attorneys’ fees for willful infringement, indemnify customers, collaborators or other third parties, seek new regulatory approvals, and redesign BBOT’s infringing products, which may not be possible or practical. If BBOT is found to infringe, misappropriate or otherwise violate a third party’s intellectual property rights, BBOT may be required to obtain a license from such third party to continue developing, manufacturing and marketing its technology and product candidates. However, BBOT may not be able to obtain any required license on commercially reasonable terms or at all. Even if BBOT were able to obtain a license, it could be non-exclusive, thereby giving BBOT’s competitors and other third parties access to the same technologies licensed to BBOT, and could require BBOT to make substantial licensing and royalty payments. Claims that BBOT has misappropriated the confidential information, trade secrets or other intellectual property rights of third parties could have a similar material adverse effect on BBOT’s business, financial condition, results of operations and prospects.

If BBOT is unable to obtain licenses from third parties on commercially reasonable terms, BBOT’s business could be adversely affected.

It may be necessary for BBOT to use the patented or proprietary technology of third parties to commercialize its products, in which case BBOT would be required to obtain a license from the third parties. The in-licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to in-license or acquire third-party intellectual property rights that BBOT may consider attractive or necessary. These established companies may have a competitive advantage over BBOT due to their size, cash resources and greater clinical development and commercialization capabilities. Furthermore, companies that perceive BBOT to be a competitor may be unwilling to sell, assign or license rights to BBOT. In addition, BBOT expects that competition for the in-licensing or acquisition of third-party intellectual property rights for product candidates that are attractive to BBOT may increase in the future, which may mean fewer suitable opportunities for BBOT as well as higher acquisition or licensing costs. If BBOT is unable to license such technology, or if BBOT is forced to license such technology on unfavorable terms, such as substantial licensing or royalty payments, BBOT’s business could be materially and adversely affected. If BBOT is unable to obtain a necessary license, the third parties owning such intellectual property rights could seek an injunction prohibiting BBOT’s sales or BBOT may be unable to otherwise develop or commercialize the affected product candidates, which could materially harm BBOT’s business. Even if BBOT is able to obtain a license, it may be non-exclusive, thereby giving BBOT’s competitors access to the same technologies licensed to BBOT.

If BBOT is unable to obtain rights to required third-party intellectual property rights, BBOT may be required to expend significant time and resources to redesign its technology, product candidates, or the methods for manufacturing they nor to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis. If BBOT is unable to do so, BBOT may be unable to develop or commercialize the affected technology and product candidates, which could harm BBOT’s business, financial condition, results of operations, and prospects significantly.

If BBOT fails to comply with its obligations in any future intellectual property licenses with third parties that BBOT may enter into, or otherwise experiences disruptions to its business relationships with future licensors, BBOT could lose intellectual property rights that are important to BBOT’s business.

BBOT may in the future enter into licensing and funding arrangements with third parties that may impose, among other things, diligence, development, and commercialization timelines, milestone payment, royalty, insurance and other obligations on BBOT. If BBOT fails to comply with those obligations, BBOT’s counterparties may have the right to terminate these agreements, in which event BBOT might not be able to develop, manufacture or market, or may be forced to cease developing, manufacturing or marketing, any product that is covered by these agreements or may face other penalties under such agreements, or BBOT’s counterparties may require BBOT to grant them certain rights. Such an occurrence could materially adversely affect the value of any product candidate being developed under any such agreement. Termination of these agreements or reduction or elimination of BBOT’s rights under these agreements, or restrictions on BBOT’s ability to freely assign or sublicense its rights under such agreements when it is in the interest of BBOT’s business to do so, may result in BBOT having to negotiate new or reinstated agreements with less favorable terms, cause BBOT to lose its rights under these agreements, including its rights to important intellectual property or technology, which would have a material adverse effect on BBOT’s business, financial condition, results of operations, and prospects, or impede, delay or prohibit the further development or commercialization of, one or more product candidates that rely on such agreements.

For example, disputes may arise regarding intellectual property that is or becomes subject to a licensing agreement, including:

•        the scope of rights granted under the license agreement and other matters of contract interpretation;

•        whether and the extent to which BBOT’s technology and processes infringe the intellectual property rights of the licensor that are not subject to the licensing agreement;

•        whether BBOT’s licensor or its licensor had the right to grant the license agreement;

•        whether third parties are entitled to compensation or equitable relief, such as an injunction, for BBOT’s use of the intellectual property rights without their authorization;

•        BBOT’s involvement in the prosecution of licensed patents and BBOT’s licensors’ overall patent enforcement strategy;

•        the amounts of royalties, milestones or other payments due under the license agreement;

•        the sublicensing of patent and other rights under collaborative development relationships;

•        BBOT’s diligence obligations under the license agreement and what activities satisfy those diligence obligations;

•        the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by BBOT’s licensors and by BBOT and its partners; and

•        the priority of invention of patented technology.

If BBOT does not prevail in such disputes, BBOT may lose any or all of its rights under such license agreements.

In addition, intellectual property license agreements are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what BBOT believes to be the scope of its rights to the relevant intellectual property or technology, or increase what BBOT believes to be its financial or other obligations under the relevant agreement, either of which could have a material adverse effect on BBOT’s business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that BBOT may license prevent or impair BBOT’s ability to maintain its licensing arrangements on commercially acceptable terms, BBOT may be unable to successfully develop and commercialize the affected technology and product candidates, which could have a material adverse effect on BBOT’s business, financial condition, results of operations and prospects.

BBOT’s future licensors may rely on third-party consultants or collaborators or on funds from third parties such that BBOT’s licensors are not the sole and exclusive owners of the patents and patent applications BBOT may in-license. If other third parties have ownership rights to patents and/or patent applications BBOT may in-license, they may be able to license such patents to BBOT’s competitors, and BBOT’s competitors could market competing products and technology. In addition, BBOT may need the cooperation of any such co-owners of BBOT’s in-licensed patents in order to enforce such patents against third parties, and BBOT may not receive such cooperation. This could have a material adverse effect on BBOT’s competitive position, business, financial condition, results of operations and prospects.

Despite BBOT’s efforts, BBOT’s future licensors might conclude that BBOT has materially breached its license agreements and might therefore terminate the license agreements, thereby removing BBOT’s ability to develop and commercialize product candidates and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying intellectual property fails to provide the intended exclusivity, competitors could seek regulatory approval for and market products and technologies identical to BBOT’s. This could have a material adverse effect on BBOT’s competitive position, business, financial condition, results of operations and prospects.

If BBOT is unable to adequately protect its proprietary technology or obtain and maintain patent protection for its technology and products or if the scope of the patent protection obtained is not sufficiently broad, BBOT’s competitors could develop and commercialize technology and products similar or identical to BBOT’s, and BBOT’s ability to successfully commercialize its technology and products will be impaired.

BBOT’s commercial success will depend in part on its ability to obtain and maintain proprietary or intellectual property protection in the United States and other countries for its product candidates, and its core technologies, including its novel target discovery technology and other know-how. BBOT seeks to protect its proprietary and intellectual property position by, among other methods, filing patent applications in the United States and abroad related to its proprietary technology, inventions and improvements that are important to the development and implementation of its business. BBOT also relies on trade secrets, know-how and continuing technological innovation to develop and maintain its proprietary and intellectual property position.

BBOT may not be able to protect its intellectual property and proprietary rights throughout the world.

Third parties may attempt to develop and commercialize competitive products in foreign countries where BBOT does not have any patent protection and/or where legal recourse may be limited. This may have a significant commercial impact on BBOT’s foreign business operations.

Filing, prosecuting, and defending patents on product candidates in all countries throughout the world would be prohibitively expensive. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the U.S., and even where such protection is nominally available, adequate judicial and governmental enforcement of such intellectual property rights may be lacking. Consequently, BBOT may not be able to prevent third parties from practicing BBOT’s inventions in all countries outside the U.S., or from selling BBOT’s inventions in such countries or importing products made using BBOT’s inventions into the U.S. or other jurisdictions. Competitors may use BBOT’s technologies in jurisdictions where BBOT has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where BBOT does obtain patent protection or future licenses but enforcement is not as strong as that in the U.S. These products may compete with BBOT’s products, and BBOT’s patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to pharmaceutical and biotechnology products, which could make it difficult for BBOT to stop the infringement of any patents BBOT does obtain or in-license or marketing of competing products in violation of BBOT’s intellectual property and proprietary rights generally. In addition, certain jurisdictions do not protect, to the same extent as the U.S. or at all, inventions that constitute new methods of treatment.

Proceedings to enforce BBOT’s intellectual property and proprietary rights in foreign jurisdictions could result in substantial costs and divert BBOT’s efforts and attention from other aspects of BBOT’s business, could put any patents BBOT obtains at risk of being invalidated or interpreted narrowly, could put BBOT’s patent applications at risk of not issuing, and could provoke third parties to assert claims against BBOT. BBOT may not prevail in any lawsuits that BBOT initiates, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, BBOT’s efforts to enforce its intellectual property and proprietary rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that BBOT develops or licenses.

BBOT works with third-party contractors located in China to develop certain of BBOT’s intellectual property. On December 1, 2020, the Chinese government implemented a new Export Control Law which regulates the export of certain technologies outside of China. As currently implemented, BBOT does not believe the Export Control Law applies to its product candidates, and BBOT does not expect it to impact BBOT’s business; however the Export Control Law could be amended in the future in a way that could adversely affect BBOT’s business.

Many countries, including India, China and certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. 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 patents. If BBOT does obtain

or in-license patents and BBOT or any of its licensors are forced to grant a license to third parties with respect to any patents relevant to BBOT’s business, BBOT’s competitive position may be impaired and BBOT’s business, financial condition, results of operations, and prospects may be adversely affected.

Intellectual property rights do not necessarily address all potential threats.

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

•        others may be able to make products that are similar to BBOT’s product candidates or utilize similar technology but that are not covered by the claims of the patents that BBOT licenses or may own;

•        BBOT or its licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that BBOT licenses or owns now or in the future;

•        BBOT or its licensors or collaborators, might not have been the first to file patent applications covering certain of BBOT’s or their inventions;

•        others may independently develop similar or alternative technologies or duplicate any of BBOT’s technologies without infringing BBOT’s owned or licensed intellectual property rights;

•        it is possible that BBOT’s present or future pending patent applications (whether owned or licensed) will not lead to issued patents;

•        issued patents that BBOT holds rights to may be held invalid or unenforceable, including as a result of legal challenges by BBOT’s competitors or other third parties;

•        BBOT’s competitors or other third parties might conduct research and development activities in countries where BBOT does not have patent rights and then use the information learned from such activities to develop competitive products for sale in BBOT’s major commercial markets;

•        BBOT may not develop additional proprietary technologies that are patentable;

•        the patents of others may harm BBOT’s business; and

•        BBOT may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

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

BBOT may be subject to claims challenging the inventorship or ownership of its patents and other intellectual property.

BBOT or its future licensors may be subject to claims that current or former employees, collaborators, CROs, universities or other third parties have an interest in BBOT’s owned or future in-licensed patents and patent applications, trade secrets or other intellectual property as an inventor, co-inventor, owner or co-owner. For example, BBOT or its future licensors may have inventorship or ownership disputes that arise from conflicting obligations of employees, consultants, CROs or others who are involved in developing BBOT’s product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership of any future owned or in-licensed patents, trade secrets or other intellectual property. If BBOT or its licensors fail in defending any such claims, BBOT may be required to pay monetary damages and BBOT may also lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to BBOT’s product candidates. Even if BBOT is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Additionally, if residents of other countries can claim inventorship of BBOT’s patents and patent applications, BBOT may be required to fulfill additional obligations. For example, some countries, including China, require a patent owner to provide remuneration to inventors who assign rights to inventions

developed during course of their employment. Litigation may be necessary to defend against claims based on foreign inventors. Any of the foregoing could have a material adverse effect on BBOT’s business, financial condition, results of operations and prospects.

BBOT may not identify relevant third-party patents or pending patent applications or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect BBOT’s ability to develop and market its product candidates.

BBOT is developing certain product candidates in highly competitive areas and cannot guarantee that any patent searches or analyses that BBOT may conduct, including the identification of relevant patents or pending patent applications, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can BBOT be certain that it has identified each and every third-party patent and pending patent application in the U.S. and abroad that is or may be relevant to or necessary for the commercialization of BBOT’s product candidates in any jurisdiction. For example, U.S. patent applications filed before November 29, 2000 and certain U.S. patent applications filed after that date that will not be filed outside the U.S. remain confidential until patents issue. Patent applications in the U.S. and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patents or pending patent applications covering BBOT’s product candidates could have been or may be filed in the future by third parties without BBOT’s knowledge. Additionally, patents and pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover BBOT’s product candidates or the manufacturing or use of BBOT’s product candidates. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. BBOT’s interpretation of the relevance or the scope of a patent or a pending patent application may be incorrect, which may negatively impact BBOT’s ability to market its product candidates. BBOT may incorrectly determine that BBOT’s product candidates are not covered by a third-party patent or pending patent application or that BBOT is otherwise free to operate in relation to its product candidates. BBOT may also incorrectly predict whether a third party’s pending application will issue with claims of relevant scope, or incorrectly determine the expiration date of any patent in the U.S. or abroad that BBOT considers relevant. Any failure by BBOT to identify and correctly interpret relevant patents or pending patent applications may negatively impact BBOT’s ability to develop and market its product candidates.

If BBOT fails to identify or correctly interpret relevant patents, BBOT may be subject to infringement claims or otherwise be forced to obtain licenses to relevant patents or pending patent applications, which may require BBOT to pay significant royalties, license fees or other payments. BBOT cannot guarantee that it will be able to successfully settle or otherwise resolve any infringement claims. If BBOT fails in any such dispute, in addition to being forced to pay damages, potentially including in the form of future royalties, which may be significant, BBOT may be temporarily or permanently prohibited from commercializing any of its product candidates that are held to be infringing. BBOT might, if possible, also be forced to redesign product candidates so that BBOT no longer infringes the third-party intellectual property rights. Any of these events, even if BBOT were ultimately to prevail, could require BBOT to divert substantial financial and management resources that BBOT would otherwise be able to devote to its business and could adversely affect BBOT’s business, financial condition, results of operations and prospects.

Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit BBOT’s exclusive rights and limit BBOT’s ability to contract with non-U.S. manufacturers.

Inventions contained within BBOT in-licensed patents and patent applications have been, and BBOT may in the future develop, acquire, or license intellectual property rights that have been generated through the use of U.S. government funding or grants. Pursuant to the Bayh-Dole Act of 1980, the U.S. government has certain rights in inventions developed with government funding. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require BBOT to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (1) adequate steps have not been taken to commercialize the invention; (2) government action is necessary to meet public health or safety needs; or (3) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). If the U.S. government exercises its “march-in” rights in any future intellectual property rights that are generated through the use of U.S. government funding or grants, BBOT could be forced to license or sublicense intellectual property developed by BBOT or that BBOT may license on terms unfavorable to

BBOT, and there can be no assurance that BBOT would receive compensation from the U.S. government for the exercise of such rights. The U.S. government also has the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require BBOT to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the U.S. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the U.S. or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit BBOT’s ability to contract with non-U.S. product manufacturers for products covered by such intellectual property. Any exercise by the government of any of the foregoing rights could harm BBOT’s competitive position, business, financial condition, results of operations and prospects.

BBOT may be subject to claims by third parties asserting that BBOT’s employees, consultants or contractors have wrongfully used or disclosed confidential information of such third parties, or that they have wrongfully used or disclosed alleged trade secrets of their current or former employers, or that BBOT has misappropriated their intellectual property, or that they own what BBOT regards as its own intellectual property.

Many of BBOT’s employees, physician-scientist partners, consultants and contractors are or were previously employed at or engaged by universities or other pharmaceutical or biotechnology companies, including BBOT’s competitors or potential competitors. Many of them executed proprietary rights, non-disclosure and/or non-competition agreements in connection with such previous employment or engagement. Although BBOT tries to ensure that the individuals who work for BBOT do not use the intellectual property rights, proprietary information, know-how or trade secrets of others in their work for BBOT, BBOT may be subject to claims that BBOT or they have, inadvertently or otherwise, used, infringed, misappropriated or otherwise violated the intellectual property rights, or disclosed the alleged trade secrets or other proprietary information, of these former employers, competitors or other third parties. BBOT may also be subject to claims that BBOT has improperly used or obtained such trade secrets. Litigation may be necessary to defend against these claims. Any litigation or the threat of litigation may adversely affect BBOT’s ability to hire employees or engage consultants and contractors. A loss of key personnel or their work product could hamper or prevent BBOT from developing and commercializing products and product candidates, which could harm BBOT’s business.

In addition, while it is BBOT’s policy to require its employees, physician-scientist partners, consultants and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to BBOT, BBOT may be unsuccessful in obtaining such an agreement from each party who in fact develops intellectual property that BBOT regards as its own. BBOT’s intellectual property assignment agreements with them may not be self-executing or may be breached, and BBOT may be forced to bring claims against third parties, or defend claims they may bring against BBOT, to determine the ownership of what BBOT regards as its intellectual property. Additionally, assignment agreements and related agreements may be interpreted under the laws of a foreign country, which may be unpredictable. Such claims could have a material adverse effect on BBOT’s business, financial condition, results of operations, and prospects.

If BBOT fails in prosecuting or defending any such claims, BBOT may be required to pay monetary damages, and BBOT may also lose valuable intellectual property rights or personnel, which could have a material adverse effect on BBOT’s competitive position and prospects. Such intellectual property rights could be awarded to a third party, and BBOT could be required to obtain a license from such third party to commercialize BBOT’s technology or products, which license may not be available on commercially reasonable terms, or at all, or such license may be non-exclusive. Even if BBOT is successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to BBOT’s management and employees.

If BBOT is unable to protect the confidentiality of its trade secrets and other proprietary information, BBOT’s business and competitive position would be adversely affected.

In addition to seeking patents for some of BBOT’s technology and product candidates, BBOT also relies on trade secrets and confidentiality agreements to protect its unpatented know-how, technology and other proprietary information to maintain BBOT’s competitive position. BBOT seeks to protect its trade secrets and other proprietary

technology, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as BBOT’s employees, consultants, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties. BBOT cannot guarantee that it has entered into such agreements with each party that may have or has had access to its trade secrets or proprietary technology. Despite these efforts, any of these parties may breach the agreements and disclose BBOT’s proprietary information, including its trade secrets, unpublished patent applications or other confidential research, and BBOT may not be able to obtain adequate remedies for such breaches. Detecting the disclosure or misappropriation of a trade secret and 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 inside and outside the U.S. are less willing or unwilling to protect trade secrets. If any of BBOT’s trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, BBOT would have no right to prevent them, or those to whom they communicate such trade secrets, from using that technology or information to compete with BBOT.

Furthermore, BBOT expects that, over time, BBOT’s trade secrets, know-how and proprietary information may be disseminated within the industry through independent development, the publication of journal articles and the movement of personnel to and from academic and industry scientific positions. Consequently, without costly efforts to protect BBOT’s proprietary technology, BBOT may be unable to prevent others from exploiting that technology, which could affect BBOT’s ability to expand in domestic and international markets. If any of BBOT’s trade secrets were to be disclosed to or independently developed by a competitor or other third party, BBOT’s competitive position would be materially and adversely affected.

BBOT also seeks to preserve the integrity and confidentiality of its data and trade secrets by maintaining physical security of its premises and physical and electronic security of its information technology systems. These security measures may be breached or otherwise accessed in an unauthorized manner, and BBOT may not have adequate remedies for any breach.

If BBOT’s trademarks and trade names are not adequately protected, BBOT may not be able to build name recognition in its markets of interest and BBOT’s business may be adversely affected.

If BBOT’s trademarks and trade names are not adequately protected, BBOT may not be able to build name recognition in its markets of interest and BBOT’s business may be adversely affected. BBOT’s trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. As a means to enforce BBOT’s trademark rights and prevent infringement, BBOT may be required to file trademark claims against third parties or initiate trademark opposition or cancellation proceedings. This can be time-consuming and expensive, particularly for a company of BBOT’s size. In addition, in an infringement proceeding, a court may decide that a trademark of BBOT’s is not valid or is unenforceable, or may determine another trademark is not infringing BBOT’s trademarks. BBOT may not be able to protect its rights to these trademarks and trade names or may be forced to stop using these trademarks or trade names, which BBOT needs to build name recognition among potential collaborators or customers in BBOT’s markets of interest. At times, competitors may adopt trademarks or trade names similar to BBOT’s, thereby impeding BBOT’s ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trademark or trade name infringement claims brought by owners of other registered trademarks or trade names that incorporate variations of BBOT’s trademarks or trade names. Over the long term, if BBOT is unable to successfully register its trademarks and trade names and establish name recognition based on its trademarks and trade names, BBOT may not be able to compete effectively and BBOT’s business may be adversely affected. BBOT’s efforts to enforce or protect its proprietary rights related to trademarks and trade names may be ineffective and could result in substantial costs and diversion of resources and could adversely impact BBOT’s financial condition or results of operations.

Trademark applications BBOT may file in the future may not proceed to registration and/or may be opposed by third parties. Even if such applications proceed to registration, third parties may challenge BBOT’s use of such trademarks or seek to invalidate BBOT’s registration in the future. Other companies in BBOT’s industry may be using trademarks that are similar to BBOT’s and may in the future allege that the use of BBOT’s trademarks in connection with BBOT’s products infringes or otherwise violates their trademark rights. Trademark-granting authorities may decide to investigate BBOT’s trademarks on their own initiative if they believe that there may be potential issues to be resolved. In addition, failure to maintain BBOT’s trademark registrations, or to obtain new trademark registrations in the future, could limit BBOT’s ability to protect and enforce its trademarks and impede BBOT’s marketing efforts in the countries in which BBOT operates. Over the long term, if BBOT is unable to establish brand recognition based on its trademarks and trade names, then BBOT may not be able to compete effectively and BBOT’s business may be adversely affected.

If BBOT does not obtain patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation, which if granted could extend the term of BBOT’s marketing exclusivity for any product candidates BBOT may develop, BBOT’s business may be materially and adversely affected.

In the U.S., the term of a patent that covers an FDA-approved drug may be eligible for limited patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, permits a patent term extension of up to five years beyond the expiration date of the patent. The length of the patent term extension is related to the length of time the drug is under regulatory review. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. In addition, the patent term of only one patent applicable to an approved drug may be extended, and only those claims covering the approved drug, a method for using it or a method for manufacturing it may be extended. Similar provisions are available in Europe and certain other non-U.S. jurisdictions to extend the term of a patent that covers an approved drug. While, in the future, if and when BBOT’s product candidates receive FDA approval, BBOT expects to apply for patent term extensions on any patents that issue covering those product candidates, there is no guarantee that the applicable authorities will agree with BBOT’s assessment of whether such extensions should be granted and, even if granted, the length of such extensions. BBOT may not be granted patent term extension either in the U.S. or in any foreign country, even where BBOT obtains a patent that is eligible for patent term extension, if, for example, an applicable government authority determines that BBOT fails to exercise due diligence during the testing phase or regulatory review process, fails to apply within applicable deadlines, fails to apply prior to expiration of relevant patents or otherwise fails to satisfy applicable requirements. Moreover, the term of extension, as well as the scope of patent protection during any such extension, afforded by the governmental authority could be less than BBOT requests. If BBOT obtains such an extension, it may be for a shorter period than BBOT had sought. If BBOT is unable to obtain any patent term extension or the term of any such extension is less than BBOT requests, BBOT’s competitors may obtain approval of competing products following the expiration of BBOT’s patent rights, and BBOT’s business, financial condition, results of operations and prospects could be materially and adversely affected.

Furthermore, for any patents BBOT may in-license in the future, BBOT may not have the right to control prosecution, including filing with the USPTO, of a petition for patent term extension under the Hatch-Waxman Act. Thus, if a patent BBOT in-licenses in the future is eligible for patent term extension under the Hatch-Waxman Act, BBOT may not be able to control whether a petition to obtain a patent term extension is filed or whether the requested extension is obtained from the USPTO.

Also, there are detailed rules and requirements regarding the patents that may be submitted to the FDA for listing in the Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. BBOT may be unable to obtain or in-license patents covering BBOT’s product candidates that contain one or more claims that satisfy the requirements for listing in the Orange Book. Even if BBOT or its future licensors submit a patent for listing in the Orange Book, the FDA may decline to list the patent, or a manufacturer of generic drugs may challenge the listing. If one of BBOT’s product candidates is approved and a patent covering that product candidate is not listed in the Orange Book, a manufacturer of generic drugs would not have to provide advance notice to BBOT of any abbreviated new drug application filed with the FDA to obtain permission to sell a generic version of such product candidate.

Risks related to BBOT’s dependence on third parties

BBOT relies on third parties to conduct its preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research and studies.

BBOT utilizes and depends upon independent investigators and collaborators, such as medical institutions, CROs, CMOs, and strategic partners (collectively, partners) to conduct and support its preclinical studies and clinical trials under agreements with BBOT and plans to continue to do so for future preclinical studies and clinical trials. These third parties have had and will continue to have a significant role in the conduct of BBOT’s preclinical studies and clinical trials and the subsequent collection and analysis of data. For example, BBOT’s partners contribute highly enabling technologies and services that include, among others: (i) clinical conduct support from CROs, (ii) support for BBOT’s translational research efforts, (iii) crystallography to enable structure-based drug discovery, (iv) biochemical and cell-based assays to guide lead generation and optimization, and (v) patient-derived, cell and xenograft models to translate BBOT’s findings to the clinical setting.

These third parties are not BBOT’s employees, and except for remedies available to BBOT under BBOT’s agreements with such third parties, BBOT has limited ability to control the amount or timing of resources that any such third party will devote to BBOT’s preclinical studies or clinical trials. The third parties BBOT relies on for these services may also have relationships with other entities, some of which may be BBOT’s competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on BBOT’s behalf. Some of these third parties may terminate their engagements with BBOT at any time. BBOT also has to negotiate budgets and contracts with CROs, clinical trial sites and CMOs and BBOT may not be able to do so on favorable terms, which may result in delays to BBOT’s development timelines and increased costs. If BBOT needs to enter into alternative arrangements with, or replace or add any third parties, it would involve substantial cost and require extensive management time and focus, or involve a transition period, and may delay BBOT’s drug development activities, as well as materially impact BBOT’s ability to meet its desired clinical development timelines.

BBOT’s heavy reliance on these third parties for such drug development activities reduces BBOT’s control over these activities. As a result, BBOT has less direct control over the conduct, timing and completion of preclinical studies and clinical trials and the management of data developed through preclinical studies and clinical trials than would be the case if BBOT were relying entirely upon its own staff. Nevertheless, BBOT is responsible for ensuring that each of its studies and trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and BBOT’s reliance on third parties does not relieve BBOT of its regulatory responsibilities. For example, BBOT remains responsible for ensuring that each of its clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires BBOT to comply with GCP standards, regulations for conducting, recording and reporting the results of clinical trials to assure that data and reported results are reliable and accurate and that the rights, integrity and confidentiality of trial participants are protected. The EMA also requires BBOT to comply with similar standards. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators and trial sites. If BBOT or any of its CROs fail to comply with applicable GCP requirements, the clinical data generated in BBOT’s clinical trials may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require BBOT to perform additional clinical trials before approving BBOT’s marketing applications. There can be no assurance that upon inspection by a given regulatory authority, such regulatory authority will determine that any of BBOT’s clinical trials substantially comply with GCP regulations. In addition, BBOT’s clinical trials must be conducted with product produced under current cGMP regulations and require a large number of test patients. BBOT’s failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients, may require BBOT to repeat clinical trials, which would delay the regulatory approval process. Moreover, BBOT’s business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct BBOT’s clinical trials in accordance with regulatory requirements or BBOT’s stated protocols, or if these third parties need to be replaced, BBOT will not be able to obtain, or may be delayed in obtaining, marketing approvals for its product candidates and will not be able to, or may be delayed in efforts to, successfully commercialize its product candidates. As a result, BBOT’s financial results and the commercial prospects for its product candidates would be harmed, its costs could increase and its ability to generate revenue could be delayed.

BBOT’s manufacturing process needs to comply with FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of BBOT’s clinical programs and suspension or withdrawal of any regulatory approvals.

In order to commercially produce BBOT’s products either at a third party’s facility or in any BBOT facility, BBOT will need to comply with the FDA’s cGMP regulations and guidelines. BBOT may encounter difficulties in achieving quality control and quality assurance and may experience shortages in qualified personnel. BBOT is subject to inspections by the FDA and comparable foreign regulatory authorities to confirm compliance with applicable regulatory requirements. Any failure to follow cGMP or other regulatory requirements or delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or storage of BBOT’s precision medicines as a result of a failure of BBOT’s facilities or the facilities or operations of third parties to comply with regulatory requirements or pass any regulatory authority inspection could significantly impair BBOT’s ability to develop and commercialize its product candidates, including leading to significant delays in the availability of BBOT’s product candidates for its clinical trials or the termination of or suspension of a clinical trial, or the delay or prevention of a filing or approval of marketing applications for BBOT’s product candidates. Significant non-compliance could also result in the imposition

of sanctions, including warning or untitled letters, fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approvals for BBOT’s product candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could damage BBOT’s reputation and business.

If BBOT’s third-party manufacturers use hazardous materials in a manner that causes injury or violates applicable law, BBOT may be liable for damages.

BBOT’s research and development activities involve the controlled use of potentially hazardous substances, including chemical materials, by BBOT’s third-party manufacturers. BBOT’s manufacturers are subject to federal, state and local laws and regulations in the U.S. and local laws in other foreign jurisdictions governing the use, manufacture, storage, handling and disposal of medical and hazardous materials. Although BBOT believes that its manufacturers’ procedures for using, handling, storing and disposing of these materials comply with legally prescribed standards, BBOT cannot completely eliminate the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, BBOT may incur liability or local, city, state, federal or foreign authorities may curtail the use of these materials and interrupt BBOT’s business operations. In the event of an accident, BBOT could be held liable for damages or penalized with fines, and the liability could exceed BBOT’s resources. BBOT does not have any insurance for liabilities arising from medical or hazardous materials. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair BBOT’s research, development and production efforts, which could harm BBOT’s business, prospects, financial condition or results of operations.

If BBOT decides to establish collaborations but is not able to establish those collaborations on commercially reasonable terms, BBOT may have to alter its development and commercialization plans.

BBOT’s drug development programs and the potential commercialization of its product candidates may require additional cash to fund expenses. BBOT may seek to selectively form collaborations to expand its capabilities, potentially accelerate research and development activities and provide for commercialization activities by third parties. Any of these relationships may require BBOT to incur non-recurring and other charges, increase near- and long-term expenditures, issue securities that dilute existing stockholders, or disrupt BBOT’s management and business.

BBOT faces significant competition in seeking appropriate collaborators and the negotiation process is time-consuming and complex. Whether BBOT reaches a definitive agreement for a collaboration depends, among other things, upon BBOT’s 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. Those factors may include the design or results of preclinical studies or clinical trials, the likelihood of approval by the FDA, EMA or comparable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing drugs, the existence of uncertainty with respect to BBOT’s ownership of intellectual property and industry and market conditions generally. The potential collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such collaboration could be more attractive than the one with BBOT for its product candidate. Further, BBOT may not be successful in its efforts to establish a collaboration or other alternative arrangements for product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view them as having the requisite potential to demonstrate safety and efficacy.

In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Even if BBOT is successful in entering into a collaboration, the terms and conditions of that collaboration may restrict BBOT from entering into future agreements on certain terms with potential collaborators.

If and when BBOT seeks to enter into collaborations, BBOT may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If BBOT is unable to do so, BBOT may have to curtail the development of a product candidate, reduce or delay its development program or one or more of its discovery programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase its expenditures and undertake development or commercialization activities at its own expense. If BBOT elects to increase its expenditures

to fund development or commercialization activities on its own, BBOT may need to obtain additional capital, which may not be available to BBOT on acceptable terms or at all. If BBOT does not have sufficient funds, BBOT may not be able to further develop its product candidates or bring them to market and generate product revenue.

BBOT may enter into collaborations with third parties for the development and commercialization of product candidates. If those collaborations are not successful, BBOT may not be able to capitalize on the market potential of these product candidates.

If BBOT enters into any collaboration arrangements with any third parties for the development and commercialization of its product candidates, BBOT will likely have limited control over the amount and timing of resources that BBOT’s collaborators dedicate to the development or commercialization of BBOT’s product candidates. BBOT’s ability to generate revenue from these arrangements will depend on its collaborators’ abilities and efforts to successfully perform the functions assigned to them in these arrangements. Collaborations involving BBOT’s product candidates would pose numerous risks to BBOT, including the following:

•        collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected;

•        collaborators may deemphasize or not pursue development and commercialization of BBOT’s product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as a result of a business combination or sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities;

•        collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

•        collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with BBOT’s product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than BBOT’s;

•        a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of BBOT’s product relative to other products;

•        BBOT may grant exclusive rights to its collaborators that would prevent BBOT from collaborating with others;

•        collaborators may not properly obtain, maintain, defend or enforce BBOT’s intellectual property rights or may use BBOT’s proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate BBOT’s proprietary information and intellectual property or expose BBOT to potential litigation or other intellectual property related proceedings;

•        disputes may arise between the collaborators and BBOT that result in the delay or termination of the research, development or commercialization of BBOT’s product candidates or that result in costly litigation or arbitration that diverts management attention and resources;

•        collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates;

•        collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all;

•        collaborators may not provide BBOT with timely and accurate information regarding development progress and activities under the collaboration or may limit BBOT’s ability to share such information, which could adversely impact BBOT’s ability to report progress to its investors and otherwise plan development of BBOT’s product candidates;

•        collaborators may own or co-own intellectual property covering BBOT’s products or product candidates that result from BBOT collaborating with them, and in such cases, BBOT would not have the exclusive right to develop or commercialize such intellectual property; and

•        a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.

Some of the third parties upon whom BBOT currently relies for the supply of the active pharmaceutical ingredients, drug product and starting materials used in BBOT’s product candidates are BBOT’s sole source of supply, and the loss of any of these suppliers could delay BBOT’s development efforts and harm BBOT’s business.

The API, drug product and starting materials used in BBOT’s product candidates are currently supplied to BBOT primarily from sole-source suppliers pursuant to quotations or proposals issued on an as-needed basis under master services agreements entered into between BBOT and the corresponding suppliers in the ordinary course, on terms customary in the industry for similarly-situated biopharmaceutical companies. BBOT’s ability to successfully develop its product candidates, and to ultimately supply its commercial products in quantities sufficient to meet the market demand, depends in part on BBOT’s ability to obtain the API, drug product and starting materials for these products in accordance with regulatory requirements and in sufficient quantities for clinical testing and commercialization.

In addition, BBOT does have arrangements in place for a redundant or second-source supply of API, drug product or starting materials in the event any of BBOT’s current suppliers of such API, drug product or starting materials ceases its operations for any reason, although manufacturing with such second-source supply is currently expected to begin in 2026. Although BBOT believes such second-source supply or other alternative second-source supplies could be made available to it on the timelines necessary to operate in accordance with BBOT’s current business plans, if any of BBOT’s current or planned third-party suppliers or manufacturers ceases its operations for any reason or is unable or unwilling to supply API, drug product or starting material in sufficient quantities, on the timelines necessary, or at acceptable prices, to meet BBOT’s needs, it could impede, delay, limit or prevent BBOT’s development efforts, which could harm BBOT’s business, results of operations, financial condition and prospects.

For all of BBOT’s product candidates, BBOT intends to identify and qualify additional manufacturers to provide such API, drug product and starting materials prior to or after submission of an NDA to the FDA and/or an MAA to the EMA. BBOT is not certain, however, that its single-source suppliers will be able to meet BBOT’s demand for their products, either because of the nature of BBOT’s agreements with those suppliers, BBOT’s limited experience with those suppliers or BBOT’s relative importance as a customer to those suppliers. It may be difficult for BBOT to assess their ability to timely meet BBOT’s demand in the future based on past performance. While BBOT’s suppliers have generally met BBOT’s demand for their products on a timely basis in the past, they may subordinate BBOT’s needs in the future to their other customers.

Establishing additional or replacement suppliers for the API, drug product and starting materials used in BBOT’s product candidates, if required, may not be accomplished within the timeframes required to avoid delays in BBOT’s development and commercialization efforts. When BBOT finds a replacement supplier, such replacement supplier would need to be qualified and may require additional regulatory inspection or approval, which could result in delays. While BBOT seeks to maintain adequate inventory of the API, drug product and starting materials used in its product candidates, any interruption or delay in the supply of components or materials, or BBOT’s inability to obtain such API, drug product or starting materials from alternate sources at acceptable prices in a timely manner could impede, delay, limit or prevent BBOT’s development efforts, which could harm BBOT’s business, results of operations, financial condition and prospects.

Risks related to operating as a public company following the Business Combination

There may not be an active trading market for PubCo Common Stock, which may make it difficult to sell shares of PubCo Common Stock.

An active trading market PubCo Common Stock may not develop or be sustained following the closing of the Business Combination. If an active trading market for PubCo Common Stock does not develop or is not sustained, you may not be able to sell your shares at an attractive price or at all. Furthermore, an inactive market may also impair PubCo’s ability to raise capital by selling shares of PubCo Common Stock in the future, and may impair PubCo’s ability to enter into strategic collaborations or acquire companies or products by using shares of PubCo’s common stock as consideration.

The market price of PubCo Common Stock may be volatile, and investors could lose all or part of their investment.

The trading price of Helix Class A Shares has been, and PubCo Common Stock is likely to be, highly volatile and subject to wide fluctuations in response to various factors, many of which PubCo cannot control. The stock market in general, and pharmaceutical and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

Broad market and industry factors may negatively affect the market price of PubCo’s common stock, regardless of its actual operating performance. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this proxy statement/prospectus, these factors include, without limitation:

•        the timing and results of INDs, preclinical studies and clinical trials of BBOT’s product candidates or those of BBOT’s competitors;

•        the success of competitive products or announcements by potential competitors of their product development efforts;

•        regulatory actions with respect to BBOT’s products or product candidates or BBOT’s competitors’ products or product candidates;

•        actual or anticipated changes in BBOT’s growth rate relative to its competitors;

•        regulatory or legal developments in the U.S. and other countries;

•        developments or disputes concerning BBOT’s patent applications, issued patents, or other proprietary rights;

•        the recruitment or departure of key personnel;

•        announcements by BBOT or its competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;

•        actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

•        fluctuations in the valuation of companies perceived by investors to be comparable to BBOT;

•        market conditions in the pharmaceutical and biotechnology sector;

•        changes in the structure of healthcare payment systems;

•        share price and volume fluctuations attributable to inconsistent trading volume levels of PubCo Common Stock;

•        announcement or expectation of additional financing efforts;

•        sales of PubCo Common Stock by PubCo, its insiders or its other stockholders;

•        expiration of market stand-off or lock-up agreements;

•        the impact of any public health emergencies, natural disasters, or geopolitical events, including civil or political unrest or military conflicts; and

•        general economic, political, industry and market conditions.

The realization of any of the above risks or any of a broad range of other risks, including those described in this “Risk Factors” section, could have a dramatic and adverse impact on the market price of PubCo Common Stock.

If securities or industry analysts do not publish research or reports, or if they publish adverse or misleading research or reports, regarding BBOT, BBOT’s business or BBOT’s market, PubCo’s stock price and trading volume could decline.

The trading market for PubCo Common Stock may be influenced by the research and reports that securities or industry analysts publish about BBOT, BBOT’s business or BBOT’s market. If any of the analysts who cover BBOT issue adverse or misleading research or reports regarding BBOT, BBOT business model, intellectual property, stock performance or market, or if BBOT’s operating results fail to meet the expectations of analysts, BBOT’s stock price would likely decline. If one or more of these analysts cease coverage of BBOT or fail to publish reports on BBOT regularly, BBOT could lose visibility in the financial markets, which in turn could cause the PubCo Common Stock price or trading volume to decline.

BBOT’s operating results may fluctuate significantly, which makes BBOT’s future operating results difficult to predict and could cause BBOT’s operating results to fall below expectations or guidance.

BBOT’s quarterly and annual operating results may fluctuate significantly in the future, which makes it difficult for BBOT to predict its future operating results. From time to time, BBOT may enter into license or collaboration agreements or strategic partnerships with other companies that include development funding and significant upfront and milestone payments and/or royalties, which may become an important source of BBOT’s revenue. These upfront and milestone payments may vary significantly from period to period and any such variance could cause a significant fluctuation in BBOT’s operating results from one period to the next.

In addition, BBOT measures compensation cost for stock-based awards made to employees at the grant date of the award, based on the fair value of the award, as determined by the BBOT Board, and recognizes the cost as an expense over the employee’s requisite service period. As the variables that BBOT uses as a basis for valuing these awards change over time, BBOT’s underlying stock price and stock price volatility, the magnitude of the expense that BBOT must recognize may vary significantly.

Furthermore, BBOT’s operating results may fluctuate due to a variety of other factors, many of which are outside of BBOT’s control and may be difficult to predict, including the following:

•        the timing and cost of, and level of investment in, research and development activities relating to BBOT’s programs, which will change from time to time;

•        BBOT’s ability to enroll patients in clinical trials and the timing of enrollment;

•        the cost of manufacturing BBOT’s current product candidates and any future product candidates, which may vary depending on FDA, EMA or other comparable foreign regulatory authority guidelines and requirements, the quantity of production and the terms of BBOT’s agreements with manufacturers;

•        expenditures that BBOT will or may incur to acquire or develop additional product candidates and technologies or other assets;

•        the timing and outcomes of preclinical studies and clinical trials for BBO-8520, BBO-10203 and BBO-11818 and any product candidates from BBOT’s discovery programs, or competing product candidates;

•        the need to conduct unanticipated clinical trials or trials that are larger or more complex than anticipated;

•        competition from existing and potential future products that compete with BBO-8520, BBO-10203 and BBO-11818 or any of BBOT’s discovery programs, and changes in the competitive landscape of BBOT’s industry, including consolidation among BBOT’s competitors or partners;

•        any delays in regulatory review or approval of BBO-8520, BBO-10203 and BBO-11818 or product candidates from any of BBOT’s discovery programs;

•        the level of demand for any of BBOT’s product candidates, if approved, which may fluctuate significantly and be difficult to predict;

•        the risk/benefit profile, cost and reimbursement policies with respect to BBOT’s product candidates, if approved, and existing and potential future products that compete with BBO-8520, BBO-10203 and BBO-11818 or any of BBOT’s discovery programs;

•        BBOT’s ability to commercialize BBO-8520, BBO-10203 and BBO-11818 or product candidates from any of BBOT’s discovery programs, if approved, inside and outside of the U.S., either independently or working with third parties;

•        BBOT’s ability to establish and maintain collaborations, licensing or other arrangements;

•        BBOT’s ability to adequately support future growth;

•        potential unforeseen business disruptions that increase BBOT’s costs or expenses;

•        future accounting pronouncements or changes in BBOT’s accounting policies; and

•        the changing, volatile and instable global economic and political environment.

The cumulative effect of these factors could result in large fluctuations and unpredictability in BBOT’s quarterly and annual operating results. As a result, comparing BBOT’s operating results on a period-to-period basis may not be meaningful. Investors should not rely on BBOT’s past results as an indication of future performance. This variability and unpredictability could also result in BBOT failing to meet the expectations of industry or financial analysts or investors for any period. If BBOT’s revenue or operating results fall below the expectations of analysts or investors or below any forecasts BBOT may provide to the market, or if the forecasts BBOT provides to the market are below the expectations of analysts or investors, the price of BBOT’s common stock could decline substantially. Such a stock price decline could occur even when BBOT has met any previously publicly stated guidance BBOT may provide.

BBOT’s principal stockholders own a significant percentage of PubCo’s stock and can exert significant control over matters subject to stockholder approval.

Following the Business Combination, holders of 5% or more of PubCo’s capital stock and their respective affiliates will collectively beneficially own in excess of 45% of the outstanding PubCo Common Stock, assuming the Minimum Cash Condition Redemptions Scenario. In addition, several of BBOT’s directors following the Business Combination, including Frank McCormick, Michelle Doig, Neil Kumar, Raymond Kelleher and Bihua Chen are affiliated with certain of PubCo’s large stockholders. BBOT’s principal stockholders, acting together or on their own, could exert significant control over matters requiring stockholder approval. For example, they may be able to impact elections of directors, amendments of PubCo’s Organizational Documents or approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for PubCo’s common stock that investors may feel are in their best interest as one of PubCo’s stockholders. The interests of this group of stockholders may not always coincide with each investor’s interests or the interests of other stockholders and they may act in a manner that advances their best interests and not necessarily those of other stockholders, including seeking a premium value for their common stock, and might affect the prevailing market price for BBOT’s common stock.

Future sales, or the perception of future sales, by PubCo or its stockholders in the public market could cause the market price for PubCo’s securities to decline.

The sale of PubCo’s securities in the public market, or the perception that such sales could occur, could harm the prevailing market price of PubCo’s securities. These sales, or the possibility that these sales may occur, also might make it more difficult for PubCo to sell equity securities in the future at a time and at a price that BBOT deems appropriate.

Shares of PubCo Common Stock reserved for future issuance under its equity incentive plans will become eligible for sale in the public market once those shares are issued, subject to provisions relating to various vesting agreements, lock-up agreements and, in some cases, limitations on volume and manner of sale applicable to affiliates under Rule 144, as applicable. The compensation committee of PubCo’s board of directors may determine the exact number of shares to be reserved for future issuance under PubCo’s equity incentive plans at its discretion. PubCo expects to file registration statements on Form S-8 under the Securities Act to register shares of common stock or securities convertible into or exchangeable for shares of common stock issued pursuant to its equity incentive plans. Any such Form S-8 registration statements will automatically become effective upon filing. Accordingly, shares registered under such registration statements will be available for sale in the open market.

In the future, BBOT may also issue its securities in connection with investments or acquisitions. The number of shares of BBOT’s common stock issued in connection with an investment or acquisition could constitute a material portion of BBOT’s then-outstanding shares of common stock. Any issuance of additional securities in connection with investments or acquisitions may result in additional dilution to BBOT’s stockholders.

Raising additional capital may cause dilution to PubCo’s existing stockholders, restrict BBOT’s operations or require BBOT to relinquish rights to its technologies or product candidates.

Until such time, if ever, as BBOT can generate substantial product revenues, BBOT expects to finance its cash needs through a combination of public and private equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements. To the extent that BBOT raises additional capital through the sale of equity or convertible debt securities, BBOT’s stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of BBOT’s stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on BBOT’s ability to incur additional debt, limitations on BBOT’s ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact BBOT’s ability to conduct its business. If BBOT raises additional funds through future strategic partnerships and alliances and licensing arrangements with third parties, BBOT may have to relinquish valuable rights to its technologies or product candidates or grant licenses on terms unfavorable to BBOT.

BBOT will have increased costs as a result of operating as a public company, and BBOT’s management will devote substantial time to related compliance initiatives.

As a public company, BBOT will incur significant legal, accounting and other expenses. BBOT will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, and the Dodd-Frank Wall Street Reform and Protection Act, as well as rules adopted, and to be adopted, by the SEC and Nasdaq. In addition, changing laws, regulations and standards relating to corporate governance and public disclosure, including those related to climate change and other environmental, social and governance focused disclosures, are creating uncertainty for public companies, increasing legal and financial compliance costs, and making some activities more time-consuming. BBOT will have to hire additional accounting, finance, and other personnel in connection with becoming a public company. BBOT’s management and other personnel will devote a substantial amount of time to these compliance initiatives and BBOT cannot accurately predict or estimate the amount or timing of additional costs BBOT may incur to respond to these requirements.

In addition, as a public company BBOT will be required to incur additional costs and obligations in order to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act. Under these rules, BBOT will be required to maintain effective disclosure and financial controls and to make a formal assessment of the effectiveness of BBOT’s internal control over financial reporting.

BBOT has identified a material weakness in its internal controls over financial reporting. If BBOT is unable to maintain effective internal controls over financial reporting and disclosure controls and procedures, the accuracy and timeliness of its financial and operating reporting may be adversely affected, and confidence in its operations and disclosures may be lost.

In connection with the preparation and audit of BBOT’s financial statements for the years ended December 31, 2024 and 2023, BBOT’s management identified a material weakness in BBOT’s internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of its annual or interim financial statements will not be prevented or detected on a timely basis. The material weakness is as follows:

•        BBOT does not have sufficient full-time accounting personnel, (i) to enable appropriate reviews over the financial close and reporting process, (ii) to allow for an appropriate segregation of duties, (iii) to perform an effective risk assessment process, and (iv) with the requisite experience and technical accounting knowledge to identify, review and resolve complex accounting issues under U.S. GAAP.

As a private company, BBOT was not required to perform an evaluation of internal control over financial reporting as of December 31, 2024 and 2023 in accordance with the provisions of the Sarbanes-Oxley Act of 2002. Had such an evaluation been performed, additional control deficiencies may have been identified by BBOT’s management, and those control deficiencies could have also represented one or more material weaknesses.

BBOT intends to take certain steps, such as recruiting additional personnel, in addition to utilizing third-party consultants and specialists, to supplement its internal resources, to enhance its internal control environment and plans to take additional steps to remediate the material weakness. Although BBOT intends to complete this remediation process as quickly as possible, it cannot at this time estimate how long it will take. BBOT cannot assure you that the measures it takes will be sufficient to remediate the control deficiencies that led to its material weakness in internal control over financial reporting or that it will prevent or avoid potential future material weaknesses.

If BBOT is not able to maintain effective internal control over financial reporting and disclosure controls and procedures, or if material weaknesses are discovered in future periods, it may be unable to accurately and timely report its financial position, results of operations, cash flows or key operating metrics, which could result in late filings of annual or quarterly reports under the Exchange Act, restatements of financial statements or other corrective disclosures, an inability to access equity or debt capital or commercial lending markets, or other material adverse effects on its business, reputation, results of operations, financial condition or liquidity. BBOT’s investors could lose confidence in BBOT’s reported financial information, the market price of BBOT’s common stock could decline, and BBOT could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.

Incorrect estimates, including those related to the size of BBOT’s addressable patient populations and markets, or assumptions by management in connection with the preparation of BBOT’s financial statements could adversely affect BBOT’s reported assets, liabilities or expenses.

BBOT’s projections of both the number of people who have the diseases its product candidates are targeting, as well as the subset of people with such disease who have the potential to benefit from treatment with any of BBOT’s product candidates, are based on estimates.

The total addressable market opportunity will ultimately depend upon, among other things, the diagnosis criteria included in the final label, and, if BBOT’s product candidates are approved for sale for these indications, acceptance by the medical community and patient access, product pricing and reimbursement. The number of patients with RAS-dependent cancers may turn out to be lower than expected, patients may not be otherwise amenable to treatment with BBOT’s products, or new patients may become increasingly difficult to identify or gain access to. BBOT may not be successful in its efforts to identify additional product candidates. Assumptions made by management in connection with the preparation of BBOT’s financial statements could adversely affect BBOT’s reported assets, liabilities or expenses if BBOT’s estimates of the addressable patient populations and markets are incorrect.

BBOT’s disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

As a public company, BBOT will be subject to the periodic reporting requirements of the Exchange Act. BBOT has designed its disclosure controls and procedures to reasonably assure that information BBOT must disclose in reports BBOT files or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. BBOT believes that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

These inherent limitations include the fact that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in BBOT’s control system, misstatements due to error or fraud may occur and not be detected.

BBOT does not intend to pay dividends on BBOT common stock so any returns will be limited to the value of BBOT’s stock.

BBOT has never declared or paid any cash dividends on its common stock. BBOT currently anticipates that BBOT will retain future earnings for the development, operation and expansion of BBOT’s business and does not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to any appreciation in the value of their stock.

Risks Related to Helix and the Business Combination

Unless the context otherwise requires, references in this subsection “— Risks Related to Helix and the Business Combination” to “we”, “us”, and “our” generally refer to Helix in the present tense or PubCo from and after the Business Combination.

The Sponsor, Cormorant, Helix’s Directors and Officers and their affiliates have interests in the Business Combination and the proposals described in this proxy statement/prospectus that are different from, or in addition to and/or in conflict with, those of the Helix Shareholders generally.

When you consider the recommendation of the Helix Board in favor of approval of the Business Combination Proposal and the other proposals included herein, you should keep in mind that the Sponsor, Cormorant, and Helix’s directors and officers have interests in such proposals that are different from, in addition to and/or in conflict with, those of the Helix Shareholders generally. These interests include, among other things:

•        the fact that the Sponsor holds 4,480,000 Founder Shares which were initially purchased for an aggregate of $25,000, and such shares will have a significantly higher value at the time of the Business Combination, estimated at approximately $47.7 million based on the closing price of $10.65 per Helix Class A Share on Nasdaq on June 30, 2025. Helix estimates that, at the Closing, the Sponsor will hold an aggregate of 4,172,133 shares of PubCo Common Stock issued upon the conversion of such Founder Shares (assuming the Minimum Cash Condition Redemptions Scenario and the surrender and forfeiture of 307,867 Sponsor Forfeited Shares and no surrender and forfeiture of Sponsor Contributed Shares), which if unrestricted and freely tradeable, would be valued at approximately $44.4 million, based on the $10.65 closing price of the Helix Class A Shares on June 30, 2025. However, given that such shares of PubCo Common Stock will be subject to certain restrictions, including those described elsewhere in this proxy statement/prospectus, Helix believes such shares have less value;

•        the fact that each of Helix’s independent directors and its advisor holds 30,000 Founder Shares, which shares were transferred to such persons by the Sponsor in connection with their service to Helix, and such shares will have value at the time of the Business Combination, estimated at approximately $319,500 based on the closing price of $10.65 per Helix Class A Share on Nasdaq on June 30, 2025. Helix estimates that, at the Closing, Helix’s independent directors and its advisor will hold 30,000 shares of PubCo Common Stock each, which if unrestricted and freely tradeable, would be valued at approximately $319,500, based on the $10.65 closing price of the Helix Class A Shares on June 30, 2025. However, given that such shares of PubCo Common Stock will be subject to certain restrictions, including those described elsewhere in this proxy statement/prospectus, Helix believes such shares have less value;