Dear Stockholders of Werewolf Therapeutics, Inc.:

On August 21, 2026, Werewolf Therapeutics, Inc., a Delaware corporation (“Werewolf”), Ambros Therapeutics, Inc., a Delaware corporation (“Ambros”), and Wave Atlantis Merger Sub, Inc., a Delaware corporation (“Merger Sub”), entered into an Agreement and Plan of Merger (as amended from time to time, the “Merger Agreement”), pursuant to which Merger Sub will merge with and into Ambros (the “Merger”), with Ambros surviving the Merger as a wholly owned subsidiary of Werewolf. In connection with the Merger, Werewolf will change its name to “Ambros Therapeutics, Inc.” The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.

Upon the terms and subject to the conditions set forth in the Merger Agreement, (i) immediately prior to the effective time of the Merger (the “Effective Time”), all issued and outstanding shares of Ambros’ preferred stock, par value $0.00001 per share (“Ambros Preferred Stock”), will be converted into shares of Ambros’ common stock, par value $0.00001 per share (“Ambros Common Stock” and, together with Ambros Preferred Stock, “Ambros Capital Stock”) and (ii) at the Effective Time, (a) each outstanding share of Ambros Common Stock (excluding shares held by stockholders who have exercised and perfected appraisal rights for such shares) will be converted into the right to receive a number of shares of Werewolf’s common stock, par value $0.0001 per share (“Werewolf Common Stock”), equal to the Exchange Ratio (as defined below), subject to any election pursuant to the terms of the Merger Agreement to receive pre-funded warrants to acquire Werewolf Common Stock with an exercise price of $0.001 per share (“Merger Pre-Funded Warrants”) in lieu of any shares of Werewolf Common Stock in excess of the Beneficial Ownership Limitation (as defined in the Merger Agreement); (b) each outstanding share of Ambros Common Stock underlying any restricted stock award agreement or other similar agreement with Ambros outstanding as of immediately prior to the Effective Time that is unvested or is subject to a repurchase option or a risk of forfeiture (“Ambros Restricted Stock”) will be converted into the right to receive a number of shares of Werewolf Common Stock equal to the Exchange Ratio that will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture and other applicable terms and conditions (each such share of Werewolf Common Stock, a share of “Assumed Restricted Stock”) and (c) each outstanding and unexercised option to acquire Ambros Common Stock (“Ambros Option”) granted by Ambros including, without limitation, under the Ambros Therapeutics, Inc. 2024 Equity Incentive Plan, as amended (the “Ambros 2024 Plan”), as of immediately prior to the Effective Time will be assumed and converted into an option to acquire Werewolf Common Stock (each, an “Assumed Option”) on the same vesting and exercisability terms and conditions as were applicable under the Ambros 2024 Plan and option agreement applicable to such Ambros Option, with appropriate adjustments to reflect the Exchange Ratio, as determined in accordance with the Merger Agreement.

In addition, prior to the Effective Time, Werewolf expects to declare a distribution to holders of record of outstanding shares of Werewolf Common Stock of one contingent value right (each, a “CVR”) for each outstanding share of Werewolf Common Stock held by such stockholder, less applicable withholding taxes, each representing the right to receive contingent payments upon the occurrence of certain events, subject to and in accordance with the terms and conditions of the Contingent Value Rights Agreement (the “CVR Agreement”), the form of which is attached to the accompanying proxy statement/prospectus as Annex B. The record date for such distribution is expected to be the close of business on the business day prior to the date on which the Effective Time occurs, and the payment date is expected to be three business days after the Effective Time. For more information, see the section entitled “Agreements Related to the Merger—CVR Agreement.”

On August 21, 2026, concurrently with the execution and delivery of the Merger Agreement, Werewolf entered into a securities purchase agreement (as amended from time to time, the “Subscription Agreement”) with certain investors, pursuant to which such investors have agreed to purchase, immediately prior to the Effective Time, shares of Werewolf Common Stock and pre-funded warrants to purchase shares of Werewolf Common Stock with an exercise price of $0.001 per share (“PIPE Pre-Funded Warrants” and, together with the Merger Pre-Funded Warrants, the “Werewolf Pre-Funded Warrants”) for an aggregate purchase price of $150.0 million (the “Concurrent PIPE Financing”).

The exchange ratio derived from the valuation framework in the Merger Agreement (the “Exchange Ratio”) ascribes to Ambros an equity value of $500.0 million, ascribes to Werewolf an equity value of $47.5 million, subject to adjustment to the extent Werewolf’s net cash as of closing (as determined pursuant to the Merger Agreement) is more or less than its target net cash amount of $30.0 million, and includes in the aggregate valuation of the combined company the amount of proceeds actually received in the Concurrent PIPE Financing. Assuming Werewolf’s net cash as of closing will be $[  ], each share of Ambros Common Stock is currently estimated to be entitled to receive approximately [  ] shares of Werewolf Common Stock. This estimated Exchange Ratio does not give effect to the proposed Reverse Stock Split (as defined below) and is subject to adjustment as described in more detail in the section entitled “The Merger Agreement—Merger Consideration—Exchange Ratio” in the accompanying proxy statement/prospectus.

Immediately after the Merger, based solely on the estimated Exchange Ratio as described in the accompanying proxy statement/prospectus, pre-merger equity holders of Werewolf, other than those participating in the Concurrent PIPE Financing, are expected to own approximately [6.4]% of the combined company, pre-merger Ambros equity holders are expected to own approximately [72.0]% of the combined company and investors in the Concurrent PIPE Financing are expected to own approximately [21.6]% of the combined company, in each case, calculated on a fully diluted basis, using the treasury stock method.

Shares of Werewolf Common Stock are currently listed on The Nasdaq Capital Market (“Nasdaq”) under the symbol “HOWL.” Werewolf and Ambros plan to prepare, and Ambros plans to file, an initial listing application for the combined company with Nasdaq. After completion of the Merger, it is expected that the common stock of the combined company will trade on Nasdaq under the symbol “AMBX.” It is a condition to the consummation of the Merger that Werewolf will receive confirmation from Nasdaq that the combined company has been approved for listing on Nasdaq, but there can be no assurance such listing condition will be met or that Werewolf will obtain such confirmation from Nasdaq. If such listing condition is not met or if such confirmation is not obtained, the Merger will not be consummated unless the condition is waived. The Nasdaq condition set forth in the Merger Agreement is not expected to be waived by the applicable parties.

Werewolf will hold a virtual special meeting of its stockholders in connection with the Merger (the “Special Meeting”) on [ ], 2026 at [ ] a.m. Eastern Time, unless postponed or adjourned to a later date. Werewolf and Ambros cannot complete the Merger unless Werewolf’s stockholders approve the Nasdaq Stock Issuance Proposal, the Nasdaq Change of Control Proposal, the Reverse Stock Split Proposal and the Name Change Proposal (each as defined below and, together, the “Required Proposals”). The Werewolf board of directors (the “Werewolf Board”) is providing this proxy statement/prospectus to solicit your proxy to vote on the Required Proposals and related matters. At the Special Meeting, Werewolf will ask its stockholders to:

amendment and the abandonment of such amendment to be mutually agreed by Werewolf and Ambros or, if the Nasdaq Stock Issuance Proposal or the Nasdaq Change of Control Proposal is not approved by Werewolf’s stockholders, determined solely by Werewolf (the “Reverse Stock Split Proposal”);

As described in the accompanying proxy statement/prospectus, certain Werewolf stockholders who in the aggregate owned approximately [ ]% of the outstanding shares of Werewolf Common Stock as of [  ], 2026, and certain Ambros stockholders who in the aggregate owned approximately [ ]% of the outstanding shares of Ambros Common Stock on an as-converted basis as of [  ], 2026, are parties to stockholder support agreements with Werewolf and Ambros, respectively, whereby such stockholders have agreed to vote in favor of certain matters related to the Merger, subject to the terms of the Support Agreements (as defined in the accompanying proxy statement/prospectus). Following the effectiveness of the registration statement on Form S-4 of which the accompanying proxy statement/prospectus is a part and pursuant to the terms of the Merger Agreement, Ambros stockholders holding a sufficient number of shares of Ambros Capital Stock to adopt the Merger Agreement and approve the Merger and related transactions will be asked to execute written consents providing for such adoption and approval.

Your vote is very important. Werewolf and Ambros cannot complete the Merger unless Werewolf’s stockholders approve the Required Proposals (unless related conditions under the Merger Agreement are waived, which the parties to the Merger Agreement do not expect to waive). Whether or not you plan to virtually attend the Special Meeting, we urge you to please promptly complete, sign, date and return the accompanying proxy card in the enclosed postage-paid envelope or authorize the individuals named on the accompanying proxy card to vote your shares by calling the toll-free telephone number or by using the internet as described in the instructions included with the accompanying proxy card. If your shares are held in the name of a bank, broker, trustee or other nominee, please follow the instructions on the voting instruction card furnished by such bank, broker, trustee or other nominee. You may change or revoke your proxy at any time before it is voted at the Special Meeting.

The Werewolf Board has unanimously (i) determined that the transactions contemplated by the Merger Agreement (the “Transactions”) are fair to, advisable and in the best interests of Werewolf and its stockholders, (ii) approved and declared advisable the Merger Agreement and the consummation by Werewolf of the Transactions and (iii) recommended, upon the terms and subject to the conditions set forth in the Merger Agreement, that Werewolf’s stockholders vote to approve the Required Proposals.

The accompanying proxy statement/prospectus provides a detailed description of the Merger, the Merger Agreement and related matters. We urge you to read the accompanying proxy statement/prospectus, including its annexes, carefully and in their entirety, including the section entitled “Risk Factors,” beginning on page 24 of the accompanying proxy statement/prospectus, for a discussion of the risks relating to the Merger.

Sincerely,

[Signature to be inserted]

Daniel J. Hicklin, Ph.D.

President and Chief Executive Officer

Werewolf Therapeutics, Inc.

Neither the United States Securities and Exchange Commission nor any state securities commission has approved or disapproved of the Merger or the securities to be issued in the Merger or determined that the disclosure in the accompanying proxy statement/prospectus is accurate or adequate. Any representation to the contrary is a criminal offense.

The accompanying proxy statement/prospectus is dated [ ], 2026 and is first being mailed to Werewolf’s stockholders on or about [ ], 2026.

 

Dear Stockholder of Werewolf Therapeutics, Inc.:

On August 21, 2026, Werewolf Therapeutics, Inc., a Delaware corporation (“Werewolf”), Ambros Therapeutics, Inc., a Delaware corporation (“Ambros”), and Wave Atlantis Merger Sub, Inc., a Delaware corporation (“Merger Sub”), entered into an Agreement and Plan of Merger (as amended from time to time, the “Merger Agreement”), pursuant to which Merger Sub will merge with and into Ambros (the “Merger”), with Ambros surviving the Merger as a wholly owned subsidiary of Werewolf. In connection with the Merger, Werewolf will change its name to “Ambros Therapeutics, Inc.” The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.

Upon the terms and subject to the conditions set forth in the Merger Agreement, (i) immediately prior to the effective time of the Merger (the “Effective Time”), all issued and outstanding shares of Ambros’ preferred stock, par value $0.00001 per share (“Ambros Preferred Stock”), will be converted into shares of Ambros’ common stock, par value $0.00001 per share (“Ambros Common Stock” and, together with Ambros Preferred Stock, “Ambros Capital Stock”) and (ii) at the Effective Time, (a) each outstanding share of Ambros Common Stock (excluding shares held by stockholders who have exercised and perfected appraisal rights for such shares) will be converted into the right to receive a number of shares of Werewolf’s common stock, par value $0.0001 per share (“Werewolf Common Stock”), equal to the Exchange Ratio (as defined below), subject to any election pursuant to the terms of the Merger Agreement to receive pre-funded warrants to acquire Werewolf Common Stock with an exercise price of $0.001 per share (“Merger Pre-Funded Warrants”) in lieu of any shares of Werewolf Common Stock in excess of the Beneficial Ownership Limitation (as defined in the Merger Agreement); (b) each outstanding share of Ambros Common Stock underlying any restricted stock award agreement or other similar agreement with Ambros outstanding as of immediately prior to the Effective Time that is unvested or is subject to a repurchase option or a risk of forfeiture (“Ambros Restricted Stock”) will be converted into the right to receive a number of shares of Werewolf Common Stock equal to the Exchange Ratio that will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture and other applicable terms and conditions (each such share of Werewolf Common Stock, a share of “Assumed Restricted Stock”); and (c) each outstanding and unexercised option to acquire Ambros Common Stock granted by Ambros (“Ambros Option”) including, without limitation, under the Ambros Therapeutics, Inc. 2024 Equity Incentive Plan, as amended (the “Ambros 2024 Plan”), as of immediately prior to the Effective Time will be assumed and converted into an option to acquire Werewolf Common Stock (each, an “Assumed Option”) on the same vesting and exercisability terms and conditions as were applicable under the Ambros 2024 Plan and option agreement applicable to such Ambros Option, with appropriate adjustments to reflect the Exchange Ratio, as determined in accordance with the Merger Agreement.

In addition, prior to the Effective Time, Werewolf expects to declare a distribution to holders of record of outstanding shares of Werewolf Common Stock of one contingent value right (each, a “CVR”) for each outstanding share of Werewolf Common Stock held by such stockholder, less applicable withholding taxes, each representing the right to receive contingent payments upon the occurrence of certain events, subject to and in accordance with the terms and conditions of the Contingent Value Rights Agreement (the “CVR Agreement”), the form of which is attached to the accompanying proxy statement/prospectus as Annex B. The record date for such distribution is expected to be the close of business on the business day prior to the date on which the Effective Time occurs, and the payment date is expected to be three business days after the Effective Time. For more information, see the section entitled “Agreements Related to the Merger—CVR Agreement.”

On August 21, 2026, concurrently with the execution and delivery of the Merger Agreement, Werewolf entered into a securities purchase agreement (as amended from time to time, the “Subscription Agreement”) with certain investors,

pursuant to which such investors have agreed to purchase, immediately prior to the Effective Time, shares of Werewolf Common Stock and pre-funded warrants to purchase shares of Werewolf Common Stock with an exercise price of $0.001 per share (“PIPE Pre-Funded Warrants” and, together with the Merger Pre-Funded Warrants, the “Werewolf Pre-Funded Warrants”) for an aggregate purchase price of $150.0 million (the “Concurrent PIPE Financing”).

The exchange ratio derived from the valuation framework in the Merger Agreement (the “Exchange Ratio”) ascribes to Ambros an equity value of $500.0 million, ascribes to Werewolf an equity value of $47.5 million, subject to adjustment to the extent Werewolf’s net cash as of closing (as determined pursuant to the Merger Agreement) is more or less than its target net cash amount of $30.0 million, and includes in the aggregate valuation of the combined company the amount of proceeds actually received in the Concurrent PIPE Financing. Assuming Werewolf’s net cash as of closing will be $[  ], each share of Ambros Common Stock is currently estimated to be entitled to receive approximately [   ] shares of Werewolf Common Stock. This estimated Exchange Ratio does not give effect to the proposed Reverse Stock Split (as defined below) and is subject to adjustment as described in more detail in the section entitled “The Merger Agreement—Merger Consideration—Exchange Ratio” in the accompanying proxy statement/prospectus.

Notice is hereby given that Werewolf will hold a virtual special meeting of stockholders (the “Special Meeting”) on [ ], 2026 at [ ]:00 a.m. Eastern Time, unless postponed or adjourned to a later date. The Special Meeting will be held exclusively online via webcast. You will be able to attend the Special Meeting by visiting [ ] (the “Special Meeting Website”) and using the 16-digit control number included in your proxy card or the voting instruction form provided by your bank, broker, trustee, nominee or other holder of record if you hold your shares of Werewolf Common Stock in “street name.”

The following proposals (the “Proposals”) will be presented at the Special Meeting:

Werewolf has fixed the close of business on [ ], 2026 as the record date for the Special Meeting (the “Record Date”). Only Werewolf stockholders of record as of 5:00 p.m. Eastern Time on the Record Date are entitled to notice of, and to vote at, the Special Meeting.

The approval of each of the Required Proposals is required to complete the Merger. If any of the Required Proposals is not approved by Werewolf’s stockholders, the Merger will not be consummated (unless related conditions under the Merger Agreement are waived, which the parties to the Merger Agreement do not expect to waive). In addition, each of the Equity Incentive Plan Proposal, the ESPP Proposal and the Auditor Ratification Proposal is conditioned on completion of the Merger, and none of the actions contemplated by those Proposals will be effected if the Merger is not consummated.

Whether or not you plan to virtually attend the Special Meeting, we urge you to please promptly complete, sign, date and return the accompanying proxy card in the enclosed postage-paid envelope or authorize the individuals named on the accompanying proxy card to vote your shares by calling the toll-free telephone number or by using the internet as described in the instructions included with the accompanying proxy card. If your shares are held in the name of a bank, broker, trustee or other nominee, please follow the instructions on the voting instruction card furnished by such bank, broker, trustee or other nominee. You may change or revoke your proxy at any time before it is voted at the Special Meeting.

The accompanying proxy statement/prospectus provides a detailed description of the Merger and the Merger Agreement, in addition to certain other matters. We urge you to read the accompanying proxy statement/prospectus and its annexes carefully and in their entirety.

The Werewolf Board has unanimously (i) determined that the transactions contemplated by the Merger Agreement (the “Transactions”) are fair to, advisable and in the best interests of Werewolf and its stockholders, (ii) approved and declared advisable the Merger Agreement and the consummation by Werewolf of the Transactions and (iii) recommended, upon the terms and subject to the conditions set forth in the Merger Agreement, that Werewolf’s stockholders vote to approve the Required Proposals.

Sincerely,

[Signature to be inserted]

Daniel J. Hicklin, Ph.D.

President and Chief Executive Officer

Werewolf Therapeutics, Inc.

 

Watertown, Massachusetts

[ ], 2026

You may request copies of this proxy statement/prospectus and any of the documents included in this proxy statement/prospectus or other information concerning Werewolf Therapeutics, Inc., a Delaware corporation (“Werewolf”), without charge, by telephone or written request directed to:

Werewolf Therapeutics, Inc.

303 Wyman Street, Suite 300

Waltham, Massachusetts 02451

Attention: Corporate Secretary

Tel: (617) 952-0555

You may request copies of this proxy statement/prospectus and any of the documents included in this proxy statement/prospectus or other information concerning Ambros Therapeutics, Inc., a Delaware corporation (“Ambros”), without charge, by telephone or written request directed to:

Ambros Therapeutics, Inc.

4435 Eastgate Mall, Suite No. 100

San Diego, CA 92121

Attention: Corporate Secretary

Tel: (949) 508-0173

In order for you to receive timely delivery of the documents in advance of the virtual special meeting of Werewolf’s stockholders to be held on [ ], 2026 (the “Special Meeting”), your request for such information must be received no later than five business days prior to the date of the Special Meeting: [ ], 2026.

The proxy statement/prospectus is also available in the “Investor” section of Werewolf’s website at https://investors.werewolftx.com/. The information on Werewolf’s website is not part of this proxy statement/prospectus. References to Werewolf’s website in this proxy statement/prospectus are intended to serve as textual references only.

This document, which forms part of a registration statement on Form S-4 (File No. 333-[ ]) filed with the United States Securities and Exchange Commission (the “SEC”) by Werewolf constitutes a prospectus of Werewolf under Section 5 of the Securities Act of 1933, as amended (the “Securities Act”), with respect to the shares of Werewolf’s common stock, par value $0.0001 per share (“Werewolf Common Stock”), to be issued (or reserved for issuance) to the equity holders of Ambros, pursuant to the Merger Agreement (as defined below). This document also constitutes a proxy statement of Werewolf under Section 14(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

As used in this proxy statement/prospectus, except where otherwise stated or indicated by the context, all references to “Werewolf” are to Werewolf Therapeutics, Inc. and all references to “Ambros” are to Ambros Therapeutics, Inc., in each case, prior to the consummation of the Merger (as defined below).

You should rely only on the information contained in this proxy statement/prospectus. No one has been authorized to provide you with information that is different from that contained in this proxy statement/prospectus, and, if given or made by any person, such information must not be relied upon as having been authorized. This proxy statement/prospectus is dated [ ], 2026. You should not assume that the information contained in this proxy statement/prospectus is accurate as of any date other than that date. Neither Werewolf’s mailing of this proxy statement/prospectus to Werewolf’s stockholders, nor the issuance of Werewolf Common Stock in connection with the Merger, will create any implication to the contrary.

This proxy statement/prospectus does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in any jurisdiction to or from any person to whom it is unlawful to make any such offer or solicitation in such jurisdiction. Information contained in this proxy statement/prospectus regarding Werewolf has been provided by Werewolf and information contained in this proxy statement/prospectus regarding Ambros (and the combined company post-closing) has been provided by Ambros. See the section entitled “Where You Can Find More Information” of this proxy statement/prospectus.

Werewolf and Ambros have proprietary rights to trademarks, trade names and service marks appearing in this proxy statement/prospectus that are important to their respective businesses. Solely for convenience, the trademarks, trade names and service marks may appear in this proxy statement/prospectus without the ® and TM symbols, but any such references are not intended to indicate, in any way, that Werewolf or Ambros forgo or will not assert, to the fullest extent under applicable law, their rights or the rights of the applicable licensors to these trademarks, trade names and service marks. All trademarks, trade names and service marks appearing in this proxy statement/prospectus are the property of their respective owners.

This proxy statement/prospectus contains expressions of opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements” within the meaning of the federal securities laws. All statements, other than statements of historical fact, included herein regarding Werewolf’s, Ambros’ or the combined company’s strategy, future operations, financial position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements. Words such as “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “design,” “designed to,” “engineered,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “promise,” “project,” “should,” “target,” “will” or “would,” or the negative of these words or other similar expressions, are intended to identify forward-looking statements. All forward-looking statements are present expectations or forecasts of future events and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Discussions containing these forward-looking statements may be found, among other places herein, in the sections entitled “Information Regarding Werewolf,” “Information Regarding Ambros,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations of Werewolf” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations of Ambros” of this proxy statement/prospectus. In addition to the factors discussed in the section entitled “Risk Factors” of, and elsewhere in, this proxy statement/prospectus, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements:

The foregoing list is not exhaustive. Although these forward-looking statements are based on assumptions that the management of Werewolf and Ambros, as applicable, believed were reasonable when made, Werewolf and Ambros caution you that forward-looking statements are not guarantees of future performance and that actual results of operations, financial condition and liquidity and industry developments may differ materially from statements made in or suggested by the forward-looking statements contained in this proxy statement/prospectus.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this proxy statement/prospectus. Except as required by applicable law, neither Werewolf nor Ambros undertakes to update these forward-looking statements to reflect facts, circumstances, assumptions or events that occur after the date the forward-looking statements are made. In the event that a party does update any forward-looking statement, no inference should be made that the parties will make additional updates with respect to that statement, related matters or any other forward-looking statements.

For additional information regarding factors that could cause actual results to differ materially from those described in the forward-looking statements, please see the section entitled “Risk Factors” in this proxy statement/prospectus, as well as the reports filed by Werewolf with the SEC, as described in the section entitled “Where You Can Find More Information” of this proxy statement/prospectus.

The following answers are intended to briefly address some commonly asked questions that Werewolf’s stockholders may have regarding the transactions contemplated by the Merger Agreement (the “Transactions”). You should read carefully the remainder of this proxy statement/prospectus because the information in this section does not provide all the information that might be important to you with respect to the Transactions. Additional important information is also contained in the annexes to this proxy statement/prospectus and elsewhere. See the section entitled “Where You Can Find More Information” of this proxy statement/prospectus.

Upon the terms and subject to the conditions set forth in the Merger Agreement, (i) immediately prior to the Effective Time, all issued and outstanding shares of Ambros’ preferred stock, par value $0.00001 per share (“Ambros Preferred Stock”), will be converted into shares of Ambros’ common stock, par value $0.00001 per share (“Ambros Common Stock” and, together with Ambros Preferred Stock, “Ambros Capital Stock”) and (ii) at the Effective Time, (a) each outstanding share of Ambros Common Stock (excluding shares held by stockholders who have exercised and perfected appraisal rights for such shares) will be converted into the right to receive a number of shares of Werewolf’s common stock, par value $0.0001 per share (“Werewolf Common Stock”), equal to the exchange ratio derived from the valuation framework in the Merger Agreement (the “Exchange Ratio”), subject to any election pursuant to the terms of the Merger Agreement to receive pre-funded warrants to acquire Werewolf Common Stock with an exercise price of $0.001 per share (“Merger Pre-Funded Warrants”) in lieu of any shares of Werewolf Common Stock in excess of the Beneficial Ownership Limitation (as defined in the Merger Agreement); (b) each outstanding share of Ambros Common Stock underlying any restricted stock award agreement or other similar agreement with Ambros outstanding as of immediately prior to the Effective Time that is unvested or is subject to a repurchase option or a risk of forfeiture (“Ambros Restricted Stock”) will be converted into the right to receive a number of shares of Werewolf Common Stock equal to the Exchange Ratio that will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture and other applicable terms and conditions (each such share of Werewolf Common Stock, a share of “Assumed Restricted Stock”) and (c) each outstanding and unexercised option to acquire Ambros Common Stock granted by Ambros (“Ambros Option”) including, without limitation, under the Ambros Therapeutics, Inc. 2024 Equity Incentive Plan, as amended (the “Ambros 2024 Plan”), as of immediately prior to the Effective Time will be assumed and converted into an option to acquire Werewolf Common Stock (each, an “Assumed Option”) on the same vesting and exercisability terms and conditions as were applicable under the Ambros 2024 Plan and option agreement applicable to such Ambros Option, with appropriate adjustments to reflect the Exchange Ratio, as determined in accordance with the Merger Agreement.

In addition, prior to the Effective Time, Werewolf expects to declare a distribution to holders of record of outstanding shares of Werewolf Common Stock of one contingent value right (each, a “CVR”) for each outstanding share of Werewolf Common Stock held by such stockholder, each representing the right to receive contingent payments upon the occurrence of certain events, subject to and in accordance with the terms and conditions of the Contingent Value Rights Agreement (the “CVR Agreement”), the form of which is attached to the accompanying proxy statement/prospectus as Annex B. The record date for such distribution is expected to be the close of business on the business day prior to the date on which the Effective Time occurs, and the payment date is expected to be three business days after the Effective Time. For more information, see the section entitled “Agreements Related to the Merger—CVR Agreement.”

On August 21, 2026, concurrently with the execution and delivery of the Merger Agreement, Werewolf entered into a securities purchase agreement (as amended from time to time, the “Subscription Agreement”) with certain investors, pursuant to which such investors have agreed to purchase, immediately prior to the Effective Time,

shares of Werewolf Common Stock and pre-funded warrants to purchase shares of Werewolf Common Stock with an exercise price of $0.001 per share (“PIPE Pre-Funded Warrants” and, together with the Merger Pre-Funded Warrants, the “Werewolf Pre-Funded Warrants”) for an aggregate purchase price of $150.0 million (the “Concurrent PIPE Financing”).

Pursuant to the CVR Agreement, during the period beginning at the Effective Time and ending on the third anniversary of the Closing (the “CVR Period”), each CVR holder will be entitled to receive, on a pro rata basis, one hundred percent of the Net Proceeds (as defined in the CVR Agreement) actually received by Werewolf or its affiliates in respect of the Legacy Assets pursuant to any Legacy Asset Agreement (as defined in the CVR Agreement), in each case net of Permitted Deductions (as defined in the CVR Agreement). The “Legacy Assets” consist of Werewolf’s conditionally activated INDUKINE programs referred to as WTX-124 and WTX-330, together with all related clinical and preclinical assets, to the extent still owned by Werewolf as of the Closing. For a period of twelve months after the Effective Time, Werewolf will engage a Legacy Asset Consultant (as defined in the CVR Agreement), mutually agreed by Werewolf and Ambros, to oversee, market and negotiate the disposition of the Legacy Assets, subject to Ambros’ prior written approval of any definitive disposition agreement before the Effective Time (or Werewolf’s prior written approval after the Effective Time).

If the aggregate Net Proceeds for a given annual CVR payment period (together with any amounts carried forward from prior periods) are less than $1,000,000, no payment is made for that period; instead, such Net Proceeds are carried forward and aggregated with subsequent periods until either the $1,000,000 threshold is reached or the CVR Period expires, at which point payment (if any) is made regardless of whether the threshold has been met.

CVR payment amounts, if any, will be paid to the Rights Agent for distribution to CVR holders. If no such proceeds are received during the CVR Period, holders of the CVRs will not receive any payment under the CVR Agreement. There can be no assurance that any CVR holders will receive any CVR payments.

The right to the contingent payments contemplated by the CVR Agreement is a contractual right only and is non-transferable, except through a permitted transfer as specified in the CVR Agreement. The CVRs will be issued in book-entry form, are not evidenced by a certificate or other instrument and are not registered with the SEC. The CVRs do not have any voting or dividend rights and do not represent any equity or ownership interest in Werewolf, Ambros or any of their respective affiliates. No interest will accrue on any amounts payable in respect of the CVRs.

Further, holders of record of outstanding shares of Werewolf Common Stock as of the close of business on the last business day prior to the day on which the Effective Time occurs will receive one CVR for each outstanding share of Werewolf Common Stock held by such holder on such date, as described in more detail in the section entitled “Agreements Related to the Merger—CVR Agreement” in this proxy statement/prospectus.

The Holder of each outstanding share of Ambros Restricted Stock will be converted into the right to receive a number of shares of Assumed Restricted Stock.

The Holder of each Ambros Option granted by Ambros including, without limitation, under the Ambros 2024 Plan, as of immediately prior to the Effective Time will be assumed and converted into an Assumed Option on the same vesting and exercisability terms and conditions as were applicable under the Ambros 2024 Plan and option agreement applicable to such Ambros Option, with appropriate adjustments to reflect the Exchange Ratio, as determined in accordance with the Merger Agreement.

For a more complete description of the treatment of Ambros Capital Stock in the Merger, please see the sections entitled “The Merger Agreement—Merger Consideration” and “The Merger Agreement—Treatment of Ambros Options and Ambros Restricted Stock.”

Werewolf and Ambros cannot complete the Merger unless Werewolf’s stockholders approve the Required Proposals (as defined below). Werewolf is holding the Special Meeting for its stockholders to vote on the Required Proposals as well as other related matters. Information about the Special Meeting, the Merger and the proposals to be considered by Werewolf’s stockholders at the Special Meeting is contained in this proxy statement/prospectus.

This document constitutes both a proxy statement of Werewolf and a prospectus of Werewolf. It is a proxy statement because the Werewolf board of directors (the “Werewolf Board”) is using this document to solicit proxies from Werewolf’s stockholders. This document is also a prospectus because Werewolf, in connection with the Merger, is offering shares of Werewolf Common Stock in exchange for outstanding securities of Ambros.

For more details on the reasons for the Merger, see the sections entitled “The Merger—Werewolf’s Reasons for the Merger” and “—Ambros’ Reasons for the Merger” of this proxy statement/prospectus.

Effective as of the Effective Time, the Werewolf Board will appoint the following Ambros designees: Prisca Di Martino, Trit Garg, M.D., Joseph P. Hagan, Matthew Hammond, Ph.D., John C. Jacobs, Keith A. Katkin and Scott Robertson to the board of directors of the combined company, and concurrently therewith, all of Werewolf’s current directors will resign from their positions as members of the Werewolf Board, effective as of the Effective Time.

For the factors considered by the Werewolf Board in reaching its decision to approve the Merger Agreement, see the section entitled “The Merger—Werewolf’s Reasons for the Merger” of this proxy statement/prospectus.

Each holder of Werewolf Common Stock is entitled to cast one vote on each matter properly brought before the Special Meeting for each share of Werewolf Common Stock that such holder owned of record as of the Record Date.

If you fail to submit a proxy or vote during the Special Meeting, this will have no effect on the Proposals.

If you vote to “ABSTAIN,” this will have no effect on the Proposals.

See the section entitled “Information About the Special Meeting—Vote Required; Treatment of Abstentions, Broker Non-Votes and Failure to Vote” of this proxy statement/prospectus. 

See the section entitled “Information About the Special Meeting—Vote Required; Treatment of Abstentions, Broker Non-Votes and Failure to Vote” of this proxy statement/prospectus.

The deadline for voting by telephone or the internet as a stockholder of record is [ ] a.m. Eastern Time, on [ ], 2026 (the day before the Special Meeting).

If a Werewolf stockholder’s shares are held in “street name” by a bank, broker or other nominee, that stockholder should check the voting form used by that firm to determine how to vote. You may not vote shares held in “street name” by returning a proxy card directly to Werewolf or by voting on the Special Meeting Website during the Special Meeting unless you obtain a valid proxy from your bank, broker or other nominee. Follow the instructions from your bank, broker or other nominee included with these proxy materials, or contact your bank, broker or other nominee to request a proxy form.

If your shares are held by a bank, brokerage firm or other nominee, you are considered the beneficial owner of shares held in “street name,” and your bank, brokerage firm or other nominee is considered the stockholder of record with respect to those shares. Your bank, brokerage firm or other nominee will send you, as the beneficial owner, a package describing the procedure for voting your shares. You should follow the instructions provided by them to vote your shares. You are invited to attend the Special Meeting; however, you may not vote your shares during the Special Meeting without the control number included on your vote instruction form.

Broker non-votes, if any, will have no effect on the Nasdaq Stock Issuance Proposal, the Nasdaq Change of Control Proposal, the Authorized Share Increase Proposal, the Reverse Stock Split Proposal, the Name Change Proposal, the Equity Incentive Plan Proposal, the ESPP Proposal, the Director Nomination Proposal or the Adjournment Proposal. Broker non-votes, if any, will be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the Special Meeting.

If your shares are held in “street name” by a bank, broker or other nominee, you should follow the instructions of your bank, broker or other nominee regarding the change or revocation of voting instructions.

If you properly sign your proxy card but do not mark the boxes showing how your shares should be voted on a matter, the shares represented by your properly signed proxy will be voted “FOR” each of the Proposals.

Please review the information in the section entitled “The Reverse Stock Split Proposal—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split” for a more complete description of the material U.S. federal income tax consequences of the Reverse Stock Split to a U.S. holder of Werewolf Common Stock.

Additionally, the Werewolf website address is werewolftx.com, which is used to distribute important information about Werewolf. At the “Investors” tab of that website (under the link “SEC Filings”), Werewolf makes available, free of charge, its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements, ownership reports on Forms 3, 4 and 5 and any amendments to those reports as soon as practicable after they are electronically filed with the SEC.

Information from the Werewolf website is not incorporated by reference into this proxy statement/prospectus.

Banks and Brokers Call: [ ]

Stockholders Call Toll Free: [ ]

The combined company will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus, you should carefully consider the material risks described below before deciding how to vote your shares of Werewolf Common Stock. You should also read and consider the other information in this proxy statement/prospectus. Please see the section entitled “Where You Can Find More Information” of this proxy statement/prospectus for further information.

Consummation of the Merger is subject to certain closing conditions, a number of which are not within Werewolf’s or Ambros’ control. Any failure to satisfy these required conditions to closing may prevent, delay or otherwise materially adversely affect the completion of the transaction. Werewolf and Ambros cannot predict with certainty whether or when any of the required closing conditions will be satisfied or if another uncertainty may arise and cannot assure you that it will be able to successfully consummate the Merger as currently contemplated under the Merger Agreement or at all.

Werewolf’s and Ambros’ efforts to complete the Merger could cause substantial disruptions in, and create uncertainty surrounding, their businesses, which may materially adversely affect their results of operations and business. Uncertainty as to whether the Merger will be completed in a timely manner or at all could adversely affect Werewolf’s and Ambros’ businesses and their relationships with employees, collaborators, vendors, manufacturers, regulators and other business partners. Changes to, or termination of, existing business relationships could adversely affect Werewolf’s and Ambros’ results of operations and financial condition, as well as the market price of Werewolf Common Stock. The adverse effects of the pendency of the transaction could be exacerbated by any delays in completion of the transaction or termination of the Merger Agreement.

Before the Merger can be completed, Werewolf’s stockholders must approve the Required Proposals and Ambros’ stockholders must adopt the Merger Agreement and approve the Merger and the related transactions. Failure to obtain these required stockholder approvals may result in a material delay in, or the abandonment of, the Merger.

Even if the Merger Agreement is adopted by, and the Transactions are approved by, Ambros’ stockholders and the Required Proposals are approved by Werewolf’s stockholders, other specified conditions must be satisfied or, to the extent permitted by applicable law, waived to complete the Merger. These conditions are set forth in the Merger Agreement and described further in the section entitled “The Merger Agreement—Mutual Conditions to Completion of the Merger” of this proxy statement/prospectus. Werewolf and Ambros cannot assure you that all of the conditions to the consummation of the Merger will be satisfied or waived. If the conditions are not satisfied or waived, the Merger may not occur or the Effective Time may be delayed. Any delay in completing the Merger may materially adversely affect the timing and benefits that are expected to be achieved from the Merger.

The market price of Werewolf Common Stock is subject to significant fluctuations. Market prices for securities of pharmaceutical, biotechnology and other life science companies have historically been particularly volatile. In addition, the market price of Werewolf Common Stock will likely be volatile based on whether stockholders and other investors believe that Werewolf can complete the Merger or otherwise raise additional capital to support its operations if the Merger is not consummated and another strategic transaction cannot be identified, negotiated and consummated in a timely manner, if at all. The volatility of the market price of Werewolf Common Stock has been and may be exacerbated by low trading volume. Additional factors that may cause the market price of Werewolf Common Stock to fluctuate include those described under the section entitled “—Risks Related to Werewolf” below.

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of Werewolf Common Stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies.

Directors and executive officers of Werewolf and Ambros have interests in the Merger that are different from, or in addition to, the interests of other stockholders generally. These interests with respect to Werewolf’s directors and executive officers may include, among others, the acceleration of vesting and other treatment of Werewolf Options, potential change-in-control severance, bonus and continued health coverage benefits for certain executive officers under their retention arrangements, and special retention bonuses and salary increases approved for certain employees in anticipation of the Transactions.

Further, the current members of the Ambros Board will continue as directors of the combined company after the Effective Time, and, following the Closing, non-employee directors of the combined company will be eligible to be compensated pursuant to the combined company’s then-effective non-employee director compensation policy.

The Werewolf Board and the Ambros Board were aware of and considered those respective interests, among other matters, in reaching their respective decisions to approve and adopt the Merger Agreement and to recommend the approval of the Required Proposals to Werewolf’s stockholders and recommend the adoption of the Merger Agreement and the approval of the Transactions to Ambros’ stockholders, respectively. These interests, among other factors, may have influenced the directors and executive officers of each company to support or approve the Merger.

If the combined company is unable to realize the full strategic and financial benefits currently anticipated from the Merger, Werewolf’s and Ambros’ stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

After the completion of the Merger, Werewolf’s current stockholders will generally own a smaller percentage of the combined company than the percentage of Werewolf they owned prior to the Merger. Immediately after the Merger, based solely on the estimated Exchange Ratio as described in this proxy statement/prospectus, pre-merger equity holders of Werewolf, other than those participating in the Concurrent PIPE Financing, are expected to own approximately [6.4]% of the combined company; pre-merger Ambros equity holders are expected to own approximately [72.0]% of the combined company; and investors in the Concurrent PIPE Financing are expected to own approximately [21.6]% of the combined company, in each case, calculated on a fully diluted basis, using the treasury stock method. In addition, the Chief Executive Officer of Ambros will serve as the Chief Executive Officer of the combined company following the completion of the Merger.

While the Merger Agreement is in effect, each party is generally prohibited from, among other things, soliciting competing proposals or, except in certain limited circumstances set forth in the Merger Agreement, cooperating with persons making unsolicited acquisition proposals. The Werewolf Board or Ambros Board, as applicable, may take certain actions in response to an unsolicited competing proposal if it determines in good faith, after consultation with its outside financial advisor and outside legal counsel, that the unsolicited competing proposal constitutes, or is reasonably likely to result in, a superior competing proposal and, after consultation with its outside legal counsel, that failure to take such action would be inconsistent with the fiduciary duties of the Werewolf Board or Ambros Board, as applicable. In addition, Werewolf’s current directors and executive officers have entered into support agreements concurrently with the execution of the Merger Agreement, and as an inducement to Ambros’ willingness to enter into the Merger Agreement, by which they have agreed to vote all of their shares of Werewolf Common Stock in favor of the Required Proposals, subject to certain limited exceptions. Ambros’ officers, directors and certain stockholders, collectively representing the votes required to approve the Merger on behalf of Ambros’ stockholders, have also entered into support

agreements obligating them to vote their shares of Ambros Capital Stock in favor of the adoption of the Merger Agreement and against any competing proposals, and concurrently with the execution of the Merger Agreement, certain executive officers, directors and other stockholders of Ambros entered into lock-up agreements (“Ambros Lock-Up Agreements”).

The Merger Agreement further provides for the payment of termination fees, if the Merger Agreement is terminated under specified circumstances, and such termination fees may discourage third parties from submitting competing proposals that may be superior to the Transactions. A termination fee of $20.0 million may become payable by Ambros to Werewolf if the Merger Agreement is terminated by (a) Werewolf following certain specified events relating to a change in the recommendation of the Ambros Board or certain other actions by Ambros relating to an acquisition proposal, (b) by Ambros concurrently with Ambros’ entry into a definitive agreement with respect to a superior offer, subject to certain requirements set forth in the Merger Agreement, or (c) in certain circumstances following termination of the Merger Agreement if an acquisition proposal with respect to Ambros had been made prior to such termination and Ambros enters into or consummates an acquisition transaction within 12 months following such termination. A termination fee of $1.9 million may become payable by Werewolf to Ambros if the Merger Agreement is terminated by (a) Ambros following certain specified events relating to a change in the recommendation of the Werewolf Board or certain other actions by Werewolf relating to an acquisition proposal or (b) in certain circumstances following termination of the Merger Agreement if an acquisition proposal with respect to Werewolf had been made prior to such termination and Werewolf enters into or consummates an acquisition transaction within 12 months following such termination.

See the section entitled “The Merger Agreement—Termination and Termination Fees” of this proxy statement/prospectus.

These provisions could discourage a potential competing acquirer from considering or proposing an acquisition or merger, even if it were prepared to pay consideration with a higher value than that implied by the merger consideration in the Merger.

Ambros Capital Stock is privately held and is not traded on any public market. The lack of a public market makes it difficult to determine the fair market value of Ambros Capital Stock. Because the percentage of Werewolf’s equity to be issued to Ambros’ securityholders was determined based on negotiations between the parties, it is possible that the value of Werewolf Common Stock to be issued to Ambros’ securityholders will be more or less than the fair market value of Ambros Capital Stock.

Putative stockholder complaints, including stockholder class action complaints, and other complaints may be filed against Werewolf, the Werewolf Board, Ambros, the Ambros Board and others in connection with the Transactions. The outcome of litigation is uncertain, and Werewolf or Ambros may not be successful in defending against any such future claims. Lawsuits that may be filed against Werewolf, the Werewolf Board, Ambros or the Ambros Board could delay or prevent the Merger, divert the attention of Werewolf’s and Ambros’ management and employees from their day-to-day business and otherwise adversely affect Werewolf and Ambros financially.

The Exchange Ratio is based on a formula set forth in the Merger Agreement and will not be adjusted based on changes in the trading price of Werewolf Common Stock. Therefore, if before the completion of the Merger the market price of Werewolf Common Stock declines from the market price on the date of the Merger Agreement, Ambros stockholders could receive merger consideration with a value substantially lower than the value calculated by the parties when the Exchange Ratio formula was established. Similarly, if the market price of Werewolf Common Stock increases before the completion of the Merger, Ambros stockholders could receive merger consideration with substantially higher value

for their shares of Ambros Capital Stock. The Merger Agreement does not include a price-based termination right. Werewolf and Ambros cannot predict the trading price of Werewolf Common Stock at the Closing. See the section entitled “The Merger Agreement—Merger Consideration” of this proxy statement/prospectus.

Conditions to Werewolf’s or Ambros’ obligations to complete the Merger may be waived, in whole or in part, to the extent permitted by law, in certain circumstances unilaterally or by agreement of Werewolf and Ambros. In the event of a waiver of a condition, the Werewolf Board will evaluate the materiality of any such waiver to determine whether amendment of this proxy statement/prospectus and re-solicitation of stockholder approval is necessary. In the event that the Werewolf Board, in its own reasonable discretion, determines any such waiver is not significant enough to require recirculation of this proxy statement/prospectus and re-solicitation of its stockholders, it will have the discretion to complete the Merger without seeking further stockholder approval, which decision may have a material adverse effect on the Werewolf stockholders. For example, it is a condition to the consummation of the Merger that Werewolf will receive confirmation from Nasdaq that the combined company has been approved for listing on Nasdaq. If Werewolf and Ambros agree to waive this requirement and their respective boards of directors elect to proceed with the Closing, Nasdaq may notify the combined company of its determination to delist the combined company’s securities based upon the failure to satisfy the initial inclusion criteria in the Nasdaq application. The combined company may appeal the determination to a hearings panel but such appeal may not stay the suspension and delisting action.

There can be no assurance that the Merger will be completed. If the Merger is not completed, the Werewolf Board may decide to pursue a dissolution and liquidation of Werewolf. In such an event, the amount of cash available for distribution to Werewolf’s stockholders will depend heavily on the timing of such decision and, ultimately, such liquidation, since the amount of cash available for distribution continues to decrease as Werewolf funds its operations while pursuing the Merger. In addition, if the Werewolf Board were to approve and recommend, and Werewolf’s stockholders were to approve, a dissolution and liquidation of Werewolf, Werewolf would be required under Delaware law to pay its outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to stockholders. Werewolf’s commitments and contingent liabilities may include obligations under Werewolf’s employment and related agreements with certain employees that provide for severance and other payments following a termination of employment occurring for various reasons, including a change in control of Werewolf, litigation against Werewolf, various claims and legal actions arising in the ordinary course of business and other unexpected and/or contingent liabilities. As a result of this requirement, a portion of Werewolf’s assets would need to be reserved pending the resolution of such obligations.

In addition, Werewolf may be subject to litigation or other claims related to a dissolution and liquidation of Werewolf. If a dissolution and liquidation were to be pursued, the Werewolf Board, in consultation with Werewolf’s advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of Werewolf Common Stock could lose all or a significant portion of their investment in the event of liquidation, dissolution or winding up of Werewolf. A liquidation would be a lengthy and uncertain process with no assurance of any value ever being returned to Werewolf’s stockholders.

The principal purposes of the Reverse Stock Split are to (i) increase the per-share market price of Werewolf Common Stock above the minimum bid price requirement under the Nasdaq rules so that the listing of the shares of Werewolf Common Stock being issued in connection with the Merger on Nasdaq will be approved and (ii) increase the number of authorized and unissued shares available for future issuance in connection with the Merger, though such increase may not alone be sufficient to complete the Merger. It cannot be assured, however, that the Reverse Stock Split will accomplish any increase in the per-share market price of Werewolf Common Stock for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of Werewolf Common Stock will

proportionally increase the market price of Werewolf Common Stock, it cannot be assured that the Reverse Stock Split will increase the market price of Werewolf Common Stock by a multiple of the Reverse Stock Split Ratio (as defined below) or result in any permanent or sustained increase in the market price of the combined company’s common stock, which is dependent upon many factors, including the combined company’s business and financial performance, general market conditions and prospects for future success. Thus, while the stock price of Werewolf Common Stock might meet the listing requirements for Nasdaq initially after the Reverse Stock Split, it cannot be assured that it will continue to do so.

Although the Werewolf Board believes that the anticipated increase in the market price of the combined company’s common stock resulting from the proposed Reverse Stock Split could encourage interest in Werewolf Common Stock and possibly promote greater liquidity for its stockholders, such liquidity could also be adversely affected by the reduced number of shares outstanding after the Reverse Stock Split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for the combined company’s common stock. In addition, the Reverse Stock Split may not result in an increase in the combined company’s stock price necessary to satisfy Nasdaq’s listing requirements for the combined company.

Should the market price of the combined company’s common stock decline after the Reverse Stock Split, the percentage decline will be greater, due to the smaller number of shares outstanding, than it would have been prior to the Reverse Stock Split. A reverse stock split is often viewed negatively by the market and, consequently, can lead to a decrease in the combined company’s overall market capitalization. If the per share market price does not increase in proportion to the Reverse Stock Split Ratio, then the value of the combined company, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected reverse stock splits subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of the combined company’s common stock will remain the same after the Reverse Stock Split is effected, or that the Reverse Stock Split will not have an adverse effect on the combined company’s stock price due to the reduced number of shares outstanding after the Reverse Stock Split.

Throughout this “Risks Related to Werewolf” section, unless otherwise indicated or the context otherwise requires, references to the “Company,” “we,” “us,” “our” and other similar terms refer to Werewolf and its subsidiaries.

As of June 30, 2026, we had cash and cash equivalents of $22.0 million, an accumulated deficit of $485.3 million and during the six months ended June 30, 2026 we used $4.0 million in cash and cash equivalents to fund operating activities. On August 14, 2026, we entered into an asset purchase agreement (the “EMD Purchase Agreement”) with EMD Serono Research & Development Institute Inc. (“EMD”), pursuant to which, and subject to the terms and conditions thereof, the Company sold to EMD technology comprising (i) our preclinical INDUCER^TM platform, including all patents and know-how related thereto, preclinical compounds and related intangible assets and (ii) our INDUKINE platform, including certain patents, certain know-how related thereto, and preclinical compounds, excluding the clinical development programs for WTX-124 and WTX-330 (collectively, the “Transferred Assets”, and such transaction, the “EMD Asset Sale”). See the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations of Werewolf—Purchase Agreement with EMD” of this proxy statement/prospectus. Pursuant to the EMD Purchase Agreement and related ancillary agreements, in consideration for the Transferred Assets, EMD agreed to pay to us upfront consideration of $28.0 million and an additional $5.0 million upon the completion of the transfer of the Transferred Assets technology. We expect to incur substantial operating losses and negative cash flows from operations for the foreseeable future. There is substantial doubt about our ability to continue as a going concern for at least twelve months from the date of the condensed consolidated financial statements included in this proxy statement/prospectus, and we expect continuing operations beyond the near term will require additional liquidity. We have not established a source of revenue to fund operating activities and we have no dedicated

source of liquidity available to us other than our ATM Offering (as defined below). We have been in the past and are currently subject to General Instruction I.B.6 of Form S-3, which may limit our ability to sell shares of Werewolf Common Stock through the ATM Offering for the foreseeable future. We may also be required to reduce our current spending requirements where possible.

If we utilize our capital resources more quickly than anticipated or are unable to obtain additional funding or engage in strategic alternatives to support any future development activities, we may have to significantly curtail, delay, reduce or eliminate any research and development programs we may pursue, which could materially adversely affect our business, financial condition, and results of operations. If we are unable to successfully mitigate the conditions which raise substantial doubt about our ability to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that investors will lose all or part of their investment, or the Werewolf Board may conclude that it is in the best interest of Werewolf stockholders to cease normal operations and wind down the Company through bankruptcy or dissolution proceedings. In such case, we would be required to pay our obligations and set aside funds for reserves prior to making any distribution to stockholders and there would be no assurances that there would be any assets remaining available for distribution to stockholders in such event.

Based on our current operating plan, we do not expect that our existing cash resources will be sufficient to fund our operations for at least twelve months from the date of the condensed consolidated financial statements included in this proxy statement/prospectus. Accordingly, our ability to continue operations is dependent on consummating the Merger on a timely basis. We have incurred, and expect to continue to incur, significant expenses in connection with the Merger, and our cash resources will continue to decrease as we fund our operations and pursue completion of the Merger. There can be no assurance that the Merger will be completed on the anticipated timeline or at all.

If the Merger is not completed, we will need to obtain additional capital to continue our operations. Such additional capital may not be available to us on acceptable terms, or at all. In addition, we may seek to pursue another strategic transaction, which could include a sale of Werewolf, a business combination or merger, a sale or divestiture of assets or proprietary technologies, or licensing or collaboration arrangements. There can be no assurance that we would be able to raise sufficient additional capital or identify, negotiate or consummate another strategic transaction on a timely basis, on favorable terms or at all. If we are unable to do so, we may be required to significantly reduce or discontinue our operations or the Werewolf Board may determine to pursue a dissolution and liquidation of Werewolf. In any such event, our future business, prospects, financial position and operating results could be materially adversely affected, and holders of Werewolf Common Stock could lose all or a significant portion of their investment.

The February 2026 strategic review process resulted in, among other things, our entry into the Merger Agreement. As a result, our efforts are currently focused on completing the Merger rather than continuing a general process to explore strategic alternatives. If the Merger is not completed, however, the Werewolf Board may consider other strategic alternatives, subject to our then-available cash resources and other circumstances. There can be no assurance that any such alternative would be available or successfully consummated.

We are an early-stage biopharmaceutical company with a limited operating history upon which our business and prospects can be evaluated. We commenced operations in 2017. To date, we have focused primarily on organizing and staffing our Company; business planning; raising capital; developing and optimizing our platform technology; identifying potential product candidates; enhancing our intellectual property portfolio; undertaking research, preclinical studies, and clinical trials; and enabling manufacturing for our development programs. Although we have completed certain early-stage clinical trials and portions of clinical trials, we have not yet demonstrated an ability to successfully complete any pivotal clinical trials, obtain regulatory approvals, manufacture a commercial-scale product, or arrange for a third party to do so on our behalf, or conduct the sales and marketing activities necessary for successful product commercialization. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing biopharmaceutical products.

We have incurred significant operating losses since our inception and have not yet generated any product revenue. If any product candidates we may develop are not successfully developed and approved, we may never generate any product revenue. Our net loss was $9.9 million for the six months ended June 30, 2026. As of June 30, 2026, we had an accumulated deficit of $485.3 million. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially if and as any product candidates advance through preclinical studies and into and through clinical trials, and as we may need to expand our clinical, regulatory, quality and manufacturing capabilities in connection with such activities. If we obtain marketing approval for any product candidate, we will incur significant commercialization expenses for marketing, sales, manufacturing and distribution. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives. We will need to develop commercial capabilities if we obtain marketing approval for any product candidate, and we may not be successful in doing so. The net losses we incur may fluctuate significantly from quarter to quarter and year to year.

To date, we have not generated any revenue from our product candidates or product sales, we do not expect to generate any revenue from the sale of products for a number of years and we may never generate revenue from the sale of products. Our ability to generate product revenue depends on a number of factors, including, but not limited to, our ability to:

Because of the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately predict the timing or amount of expenses we may incur in connection with these activities prior to generating product revenue. In addition, we may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our Company and could impair our ability to raise capital, expand our business, undertake research and development efforts, diversify any product candidates we may develop or even continue our operations. A decline in the value of our Company could also cause Werewolf stockholders to lose all or part of their investment.

Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales.

We do not have cash and cash equivalents sufficient to complete development of any product candidate. Accordingly, we will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed, on acceptable terms or at all, would have a negative effect on our financial condition and our ability to develop and commercialize product candidates, and otherwise pursue our business strategy, and we may be forced to delay, reduce or eliminate any research and development programs we may pursue or future commercialization efforts.

In addition, our cash forecasts are based on assumptions that may prove to be wrong, and we could use our available capital resources earlier than we currently expect. Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional financing sooner than planned. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

Our future capital requirements, both short-term and long-term, will depend on many factors, including:

We do not have any committed external source of funds, and adequate additional financing may not be available to us on acceptable terms, or at all. In addition, our ability to raise additional capital may be adversely impacted by potential

worsening global economic conditions both inside and outside the U.S. Our failure to raise capital as and when needed or on acceptable terms would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate any research-stage programs or clinical trials we may pursue, future commercialization efforts or other operations.

Our revenue, if any, will be derived from sales of products that we do not expect to be commercially available for a number of years, if at all. If we obtain marketing approval for any product candidates that we develop, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. Some of these expenses may be incurred in advance of marketing approval and could be substantial.

Unless and until we can generate a substantial amount of product revenue, we expect to seek additional capital through a combination of public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources. Our issuance of additional securities, whether equity or debt, or the possibility of such issuance, may cause the market price of Werewolf Common Stock to decline, and Werewolf stockholders may not agree with our financing plans or the terms of such financings. To the extent that we raise additional capital through the sale of equity or convertible debt securities, Werewolf stockholders’ ownership interests will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect Werewolf stockholders’ rights. The incurrence of indebtedness would result in payment obligations and could require us to comply with certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to declare dividends, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through collaborations and licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates or related technologies or grant licenses on terms unfavorable to us. In addition, securing additional financing would require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee any development activities we may pursue.

Changes in tax laws or in their implementation or interpretation may adversely affect our business or financial condition. The Tax Cuts and Jobs Act (the “TCJA”), as amended by the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), significantly revised the Code. The TCJA, among other things, contains significant changes to corporate taxation, including the reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21% and, for taxable years beginning after December 31, 2020, the limitation of the deduction for net operating losses (“NOLs”) to 80% of current year taxable income for losses arising in taxable years beginning after December 31, 2017 (though any such NOLs may be carried forward indefinitely but no longer carried back). In addition, beginning in 2022, the TCJA eliminated the option to deduct research and development expenditures currently and generally required corporations to capitalize and amortize them over five years or 15 years (for expenditures attributable to foreign research).

In addition to the CARES Act, as part of Congress’s response to the COVID-19 pandemic, economic relief legislation was enacted in 2020 and 2021 containing tax provisions. The Inflation Reduction Act (the “IRA”), which was signed into law in August 2022, also introduced new tax provisions, including a one percent excise tax imposed on certain stock repurchases by publicly traded companies, which generally applies to any acquisition of stock by the publicly traded company (or certain of its affiliates) from a stockholder of the Company in exchange for money or other property (other than stock of the Company itself), subject to a de minimis exception. Thus, the excise tax could apply to certain transactions that are not traditional stock repurchases.

In July 2025, the One Big Beautiful Bill Act (the “OBBBA”), which implements certain U.S. tax law changes that may impact our business, was enacted into law. The OBBBA modified and made permanent several provisions of the TCJA, including reductions in scheduled increases for the rate of taxation of foreign income, restoration of the immediate deductibility of U.S. research and development expenses for taxable years beginning after December 31, 2024, and reinstatement of 100% bonus depreciation for qualified capital assets. The OBBBA did not modify the 80% limitation on the use of NOLs described above. The effects of the OBBBA on our business and the healthcare industry in general

are not yet known. Regulatory guidance under the OBBBA and other recent tax legislation is and continues to be forthcoming, and such guidance could ultimately increase or lessen their impact on our business and financial condition. Congress may also enact additional legislation, some of which could have an impact on us. In addition, it is uncertain if and to what extent various states will conform to the OBBBA and additional tax legislation.

We have incurred substantial losses during our history. We do not anticipate generating revenue from sales of products for the foreseeable future, if ever, and we may never achieve profitability. As of December 31, 2025, we had federal and state NOL carryforwards of $215.3 million and $153.7 million, respectively. Under Section 382 of the Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in the ownership of its equity by certain stockholders over a three-year period), the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited. As a result of our prior private placement financings or other transactions, we have experienced ownership changes on June 10, 2019, August 2, 2019 and August 31, 2022, and we may in the future experience ownership changes as a result of subsequent changes in Werewolf Common Stock ownership for purposes of Section 382. Following the approval of each of the Required Proposals, the Merger will result in an ownership change for us and, accordingly, our NOL carryforwards and certain other tax attributes will be subject to limitations (or disallowance) on their use after completion of the Merger. Furthermore, our ability to utilize NOLs of Ambros that we will acquire as a result of the Merger may be subject to limitations. As a result, if we earn net taxable income, our ability to use our pre-change NOL carryforwards and other pre-change tax attributes to offset U.S. federal taxable income is subject to limitations, which could result in increased future tax liability to us and could have an adverse effect on our future results of operations. There is also a risk that due to regulatory changes, such as suspension of the use of NOLs, or for other unforeseen reasons, our existing NOLs and other tax attributes could expire or otherwise become unavailable to offset future income tax liabilities. As described above in “—Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition,” the TCJA, as modified by subsequent legislation, including most recently the OBBBA, includes changes to U.S. federal tax rates and rules governing NOL carryforwards that may significantly impact our ability to utilize NOLs to offset taxable income in the future. In addition, state NOLs generated in one state cannot be used to offset income generated in another state. For these reasons, we may be unable to use a material portion of our NOLs and other tax attributes.

Our ability to generate product revenue, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of product candidates, which may never occur. We currently generate no revenue from sales of any product, and we may never be able to develop or commercialize a marketable product.

Any development efforts we may pursue could be limited to a small number of cancer types and we may forego or delay pursuit of opportunities in other cancer types that may prove to have greater potential. Likewise, we may forego or delay the pursuit of opportunities with other potential product candidates that may prove to have greater commercial potential.

Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Any spending on research and development programs or product candidates for specific indications may not yield any commercially viable product candidates. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other similar arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to the product candidate.

Risk of failure for preclinical product candidates is high. Before we can commence clinical trials for any preclinical product candidates we may develop, we must complete extensive preclinical testing and studies that support INDs in the United States, or similar applications in other jurisdictions. We cannot be certain of the timely completion or outcome of any preclinical testing and studies we may conduct and cannot predict if the FDA or other regulatory authorities will accept any proposed clinical programs or if the outcome of such preclinical testing and studies will ultimately support the further development of such programs. As a result, we cannot be sure that we will be able to successfully submit INDs or similar applications for any preclinical programs we may pursue on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin.

The risk of failure for any product candidates we may develop is high. It is impossible to predict when or if any such product candidates will successfully complete preclinical studies or clinical trials evaluating their safety and effectiveness in humans or will ultimately receive regulatory approval. To obtain the requisite regulatory approvals to market and sell any such product candidates, we must demonstrate through extensive preclinical studies and clinical trials that such product candidates are safe and effective in humans for use in each target indication. Preclinical and clinical testing is expensive and can take many years to complete, and the outcome is inherently uncertain. Failure can occur at any time during the preclinical or clinical trial process. The outcome of preclinical testing and early clinical trials may not be predictive of the results of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Many companies in the biopharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway, or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events. 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 products.

In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in clinical trial procedures set forth in protocols, differences in the size and type of the patient populations, adherence to the dosing regimen and other clinical trial protocols, and the rate of dropout among clinical trial participants. If we fail to produce positive results in preclinical studies or clinical trials of any of our product candidates, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business and financial prospects, would be materially and adversely affected.

Before obtaining marketing approval from regulatory authorities for the sale of any product candidates we may develop, we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidate for its intended indications. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. We may experience numerous unforeseen events during or as a result of clinical trials that could delay or prevent our ability to receive marketing approval or commercialize product candidates, including:

If we are required to conduct additional clinical trials or other testing of our product candidates beyond the clinical trials and testing that we contemplate, if we are unable to successfully complete clinical trials or other testing of our product candidates, if the results of these clinical trials or tests are unfavorable or are only modestly favorable or if there are safety concerns associated with any of our product candidates, we may:

Conducting clinical trials in foreign countries, as we may do for any product candidates we may develop, presents additional risks that may delay completion of any such clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocols as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries.

Moreover, principal investigators for any clinical trials we may conduct may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the trial. The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authorities, as the case may be, and may ultimately lead to the denial of marketing approval of one or more product candidates.

In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may be impacted.

Similarly, the regulatory landscape related to clinical trials in the European Union (“EU”) has evolved. The EU Clinical Trials Regulation (“CTR”), which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. The CTR introduces, among other changes, a centralized process that only requires the submission of a single application to all member states concerned, coordinated review procedures, expanded reporting and increased transparency obligations. In addition, several recently adopted and pending legislation will impact regulatory procedures for medicinal products. Key developments include:

Other legislative initiatives include the proposed SPC Regulation revision, the proposed Critical Medicines Act (for which a provisional political agreement was reached in May 2026), and the proposed Biotech Act.

If we are not able to adapt to these and other changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may be impacted.

In addition to the factors above, we may make formulation or manufacturing changes to our product candidates, in which case we may need to conduct additional preclinical studies to bridge our modified product candidates to earlier versions, which may be costly, time-consuming and may not be successful at all.

Our failure to successfully initiate and complete any clinical trials we may conduct with respect to product candidates and to demonstrate the efficacy and safety necessary to obtain regulatory approval to market any such product candidates would significantly harm our business. We cannot provide assurances that any such clinical trials will begin as planned or be completed on schedule, if at all, or that we will not need to restructure such clinical trials. Significant preclinical study or clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize product candidates, which may harm our business and results of operations. In addition, many of the factors that cause, or lead to, delays of clinical trials may ultimately lead to the denial of regulatory approval of product candidates.

We may experience difficulties in patient enrollment in any clinical trials we may conduct for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. The enrollment of patients depends on many factors, including:

In addition, any clinical trials we may conduct may compete with other clinical trials for product candidates that are in the same therapeutic areas as product candidates we may develop, and this competition could reduce the number and types of patients available to us, because some patients who might have opted to enroll in a trial we conduct may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, to the extent we conduct clinical trials, we may conduct them at the same clinical trial sites that some of our competitors use, which could reduce the number of patients who are available for such trials at those clinical trial sites.

Our inability to enroll a sufficient number of patients in any clinical trials we may conduct would result in significant delays or might require us to abandon one or more clinical trials altogether. Enrollment delays in any such clinical trials

may result in increased development costs for product candidates, slow down or halt the product candidate development and approval process and jeopardize our ability to seek and obtain the marketing approval required to commence product sales and generate revenue, which would cause the value of our Company to decline and limit our ability to obtain additional financing, if needed.

Undesirable or unexpectedly severe side effects caused by our product candidates could cause us to interrupt, delay or halt preclinical studies or could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities. It is likely that, as is the case with many treatments for cancer, there may be side effects associated with the use of our product candidates. Results of our trials could reveal a high and unacceptable severity and prevalence of these or other side effects. In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications. Treatment-related side effects 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 our business, financial condition and prospects significantly.

Further, by design, clinical trials rely on a sample of the potential patient population. With a limited number of patients and limited duration of exposure, rare and severe side effects of our product candidates may only be uncovered when a significantly larger number of patients is exposed to the product candidate. If our product candidates receive marketing approval and we or others identify undesirable side effects caused by such product candidates after such approval, a number of potentially significant negative consequences could result, including:

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects.

From time to time, we may publish interim top-line or preliminary data from any clinical trials we may conduct. Interim data from clinical trials that we may conduct 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. Preliminary or “top-line”

data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

Our ability to develop and ultimately commercialize product candidates used in combination with third-party products will depend on our ability to access such products on commercially reasonable terms for clinical trials and their availability for use with our commercialized product, if approved. We cannot be certain that any commercial relationships we establish will provide us with a steady supply of such products on commercially reasonable terms or at all. Any failure to enter into and maintain successful commercial relationships, or the expense of purchasing such third-party products in the market, may delay our development timelines, increase our costs and jeopardize our ability to develop product candidates as commercially viable therapies. If any of these occur, our business, financial condition, operating results, or prospects may be materially harmed.

Moreover, the development of product candidates for use in combination with another product or product candidate may present challenges that are not faced for single agent product candidates. Checkpoint inhibitors have been shown to have adverse events, including immune-related adverse events involving the lung, liver and other organ systems, which may limit the maximum dose in any clinical trials we may conduct or otherwise negatively impact any combination clinical trials we may conduct. In addition, the FDA or comparable foreign regulatory authorities may require us to use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to any observed effects. It is possible that the results of such trials could show that any positive previous trial results are attributable to the third-party product and not our product candidate. Developments related to the third-party product may also impact any such clinical trials for the combination as well as our commercial prospects should we receive regulatory approval. Such developments may include changes to the third-party product’s safety or efficacy profile, changes to the availability of the third-party product, quality, and manufacturing and supply issues with respect to the third-party product.

If we are able to obtain marketing approval, the FDA or comparable foreign regulatory authorities may require that products used in conjunction with each other be cross-labeled for combined use. To the extent that we do not have rights to the third-party product, this may require us to work with such third party to satisfy such a requirement. We would also continue to be subject to the risks that the FDA or comparable foreign regulatory authorities could revoke approval of the third-party product used in combination with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with such product. Similarly, if any third-party products we may use in combination with product candidates are replaced as the standard of care for the indications we choose for any such product candidates, the FDA or comparable foreign regulatory authorities may require us to conduct additional clinical trials. The occurrence of any of these risks could result in our own products, if approved, being removed from the market or being less successful commercially.

Although we may in the future explore other therapeutic opportunities in addition to the product candidates that we have historically developed, we may fail to identify or discover viable new product candidates for clinical development for a number of reasons. If we fail to identify additional potential product candidates, our business could be materially harmed.

Research programs to pursue the development of product candidates and to identify new product candidates and disease targets require substantial technical, financial and human resources whether or not they are ultimately successful. Any research programs we may pursue may initially show promise in identifying potential indications and/or product candidates, yet fail to yield results for clinical development for a number of reasons, including:

Accordingly, there can be no assurance that we will ever be able to identify additional therapeutic opportunities for product candidates or to develop suitable additional product candidates through internal research programs, which could materially adversely affect our future growth and prospects.

We are exposed to potential product liability risks that are inherent in the research, development, manufacturing, marketing and use of biopharmaceutical products. The use of product candidates by us in clinical trials, and any sale of approved products in the future, may expose us to liability claims. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical trials, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts.

Although the clinical trial process is designed to identify and assess potential side effects, it is always possible that a product, even after regulatory approval, may exhibit unforeseen side effects. If any of our product candidates were to cause adverse side effects during clinical trials or after approval thereof, we may be exposed to substantial liabilities. Physicians and patients may not comply with any warnings that identify known potential adverse effects and patients who should not use our product candidates. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or cease the development or commercialization of our product candidates or any products for which we may have received marketing approval. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

Although we will seek to procure and maintain product liability insurance coverage, such insurance may not be adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage each time we commence a clinical trial and if we successfully commercialize any product candidate. As the expense of insurance coverage is increasing, we may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. If a successful product liability claim or series of claims is brought against us for uninsured liabilities or in excess of insured liabilities, our assets may not be sufficient to cover such claims and our business operations could be materially harmed.

We have never commercialized a product candidate. We currently have no sales force or marketing or distribution capabilities. To achieve commercial success of our product candidates, if any are approved, we will have to develop our own sales, marketing and supply capabilities or outsource these activities to one or more third parties. Even if we obtain approval in one jurisdiction, we may never obtain or commercialize any product in any other jurisdiction, which would limit our ability to realize their full market potential.

Factors that may affect our ability to commercialize our product candidates on our own include our ability to recruit and retain adequate numbers of effective sales and marketing personnel and obtain access to or persuade adequate numbers of physicians to prescribe our product candidates, as well as any unforeseen costs we may incur in connection with creating an independent sales and marketing organization. Developing a sales and marketing organization requires significant investment, is time-consuming and could delay the launch of our product candidates. We may not be able to build an effective sales and marketing organization in the United States, the EU or other key global markets. To the extent we need to rely upon one or more third parties, we may have little or no control over the marketing and sales efforts of those third parties and our revenue from product sales may be lower than if we had commercialized our product candidates ourselves. We will also face competition in any search for third parties to assist us with sales and marketing efforts for our product candidates. If we are unable to build our own distribution and marketing capabilities or to find suitable partners for the commercialization of our product candidates, we may have difficulties generating revenue from them.

The development and commercialization of new drug and biologic products is highly competitive. We have faced, and will face, competition with respect to any product candidates that we may seek to develop or commercialize from major pharmaceutical, specialty pharmaceutical and biotechnology companies, among others. There are other companies working to develop immunotherapies for the treatment of cancer including divisions of pharmaceutical and biotechnology companies of various sizes. Some of these competitive therapies are based on scientific approaches that are the same as or similar to approaches we may pursue, and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

If we develop product candidates for the treatment of cancer, we may not receive marketing approval for any such product candidates. There are already a variety of available therapies marketed for cancer and some of the currently approved therapies are branded and subject to patent protection, and others are available on a generic basis. Many of these approved therapies are well-established and widely accepted by physicians, patients and third-party payors. Insurers and other third-party payors may also encourage the use of generic products. If any product candidates we may develop are approved, they may be priced at a significant premium over competitive generic products. This may make it difficult to successfully commercialize such product candidates, including in combination with or as alternatives to existing therapies. Competition may further increase with advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.

We are aware of a number of companies that are developing cytokines as immunotherapies, as well as different modalities, including monoclonal antibodies, cell therapies, oncolytic viruses and vaccines.

Our competitors may succeed in developing, acquiring or licensing, on an exclusive basis, products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. We may also compete with these organizations in establishing clinical trial sites and patient registration for clinical trials, as well as in recruiting and retaining qualified scientific and management personnel, which could negatively affect our level of expertise and our ability to execute our business plan.

Many of our competitors, either alone or with their collaborators, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products than we do. Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel product candidates or to in-license novel product candidates that could make any product candidates we develop less competitive or obsolete. Smaller or early-stage companies may

also prove to be significant competitors, including through collaborative arrangements with large and established companies. In addition, any new product that competes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be commercially successful. The availability of competing products could limit the demand and the price we are able to charge for product candidates we commercialize, if any. The inability to compete with existing or subsequently introduced products would harm our business, financial condition and results of operations.

The potential market opportunities for our product candidates are difficult to estimate and, if our product candidates are approved, will ultimately depend on, among other things, the indications for which our product candidates are approved for sale, any products with which our product candidates are co-administered, the success of competing therapies and therapeutic approaches, acceptance by the medical community, patient access, product pricing and reimbursement. Our estimates of the potential market opportunities for our product candidates are predicated on many assumptions, which may include industry knowledge and publications, third-party research reports and other surveys. Although we believe that our internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are inherently uncertain, and their reasonableness has not been assessed by an independent source. If any of the assumptions proves to be inaccurate, the actual markets for our product candidates could be smaller than our estimates of the potential market opportunities.

The availability and adequacy of coverage and reimbursement by third-party payors, including governmental healthcare programs such as Medicare and Medicaid, managed care organizations, and private health insurers, are essential for most patients to be able to afford prescription medications such as our product candidates, if approved. Our ability to achieve acceptable levels of coverage and reimbursement for products by third-party payors will have an effect on our ability to successfully commercialize our product candidates. We cannot be sure that coverage and reimbursement in the United States, the EU or elsewhere will be available for our product candidates, if approved, or any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

Third-party payors increasingly are challenging prices charged for pharmaceutical products and services, and many third-party payors may refuse to provide coverage and reimbursement for particular drugs or biologics when an equivalent generic drug, biosimilar or a less expensive therapy is available. For example, the U.S. Department of Health and Human Services (“HHS”) imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. In addition, HHS has been empowered to negotiate the price of certain single-source drugs that have been on the market for at least seven years and certain single-source biological products that have been on the market for at least eleven years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year, up to 20 products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per-unit basis. It is possible that a third-party payor may consider our product candidates as substitutable and only offer to reimburse patients for the less expensive product. Even if we show improved efficacy or improved convenience of administration with our product candidates, pricing of existing third-party therapeutics may limit the amount we will be able to charge for our product candidates. These payors may deny or revoke the reimbursement status of a given product or establish prices for new or existing marketed products at levels that are too low to enable us to realize an appropriate return on our investment in our product candidates, if approved. Even if our product candidates are approved and we obtain coverage for our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. Interim reimbursement levels for new medicines, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Net prices for medicines may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of medicines from countries where they may be sold at lower prices than in the United States. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates, if approved, and may not be able to obtain a satisfactory financial return on our product candidates.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. The regulations that govern marketing approvals, pricing and reimbursement for new medicines vary widely from country to country. In the United States, third-party payors play an important role in determining the extent to which new drugs and biologics will be covered. The Medicare and Medicaid programs increasingly are used as models in the United States for how third-party payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors may require pre-approval of coverage for new or innovative devices or pharmaceutical therapies before they will reimburse healthcare providers who use such therapies. We cannot predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates, if approved.

No uniform policy for coverage and reimbursement for products exists among third-party payors in the United States. Therefore, coverage and reimbursement for products can differ significantly from payor to payor and coverage and reimbursement by one payor does not guarantee coverage and reimbursement by another payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases on short notice, and we believe that changes in these rules and regulations are likely.

If any product candidate we develop receives marketing approval, whether as a single agent or in combination with other therapies, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, hospitals, cancer treatment centers, third-party payors, and others in the medical community. For example, cancer treatments like chemotherapy, radiation therapy and certain existing immunotherapies are well established in the medical community, and doctors may continue to rely on these therapies. If the product candidates we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable.

The degree of market acceptance of any product, if approved for commercial sale, will depend on a number of factors, including:

If we obtain marketing approval for a product but such product does not achieve an adequate level of market acceptance, we may not generate or derive significant revenue from that product and our business, financial condition and results of operations may be adversely affected.

If we pursue preclinical studies or clinical trials, we expect to depend upon third parties, including independent investigators and CROs, to conduct such studies and trials. We may need to negotiate budgets and contracts with CROs and trial sites, and any such third parties may terminate their engagements with us at any time, any of which may result in delays to any development timelines and increased costs.

Our reliance on third parties for any research and development activities we may pursue would reduce our control over these activities but would not relieve us of our responsibility to ensure that each trial is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on third parties would not relieve us of our regulatory responsibilities. We and these third parties would be required to comply with Good Laboratory Practice (“GLP”) requirements for preclinical studies, current Good Clinical Practices (“GCP”) requirements for clinical trials, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these GLP and GCP requirements through periodic inspections of trial sponsors, clinical investigators and trial sites. If we or any of these third parties fail to comply with applicable GLP or GCP requirements, the clinical data generated in any clinical trials we may conduct may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to suspend or terminate such trials or perform additional preclinical studies or clinical trials before approving our marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine that any preclinical studies or clinical trials we may conduct comply with GLP and/or GCP requirements. In addition, any clinical trials we may conduct must be conducted with products produced under current Good Manufacturing Practice (“GMP”) requirements.

Any failure by us or such third parties to comply with applicable regulations may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any such third party violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Any third parties conducting clinical trials on our behalf will not be our employees and, except for remedies that may be available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to any such clinical trials. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to applicable clinical protocols or regulatory requirements or for other reasons, any clinical trials we may conduct may be extended, delayed or terminated, and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize product candidates. As a result, our financial results and the commercial prospects for product candidates could be harmed, our costs could increase and our ability to generate revenue could be delayed.

If any relationships we may establish with third-party CROs or others terminate, we may not be able to enter into arrangements with alternative CROs or other third parties or to do so on commercially reasonable terms. Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work. As a result, delays may occur, which could materially impact clinical development timelines. We would need to carefully manage any relationships with CROs, and there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

We have supplied and may continue to supply and otherwise support third party research, including investigator-initiated clinical trials. Investigator-initiated clinical trials pose similar risks as those set forth elsewhere in this section relating to our internally-sponsored clinical trials. We have less control over the protocols, administration or conduct of these trials, including follow-up with patients and ongoing collection of data after treatment. The conduct or findings of these trials may have a negative impact on our development programs notwithstanding that we have little involvement or control over these trials. As a result, we are subject to additional risks associated with the way investigator-initiated trials are conducted. In particular, we may be named in lawsuits that would lead to increased costs associated with legal

defense. Additional risks include difficulties or delays in communicating with investigators or administrators, procedural delays and other timing issues and difficulties or differences in interpreting data. Third-party investigators may design clinical trials with clinical endpoints that are more difficult to achieve, or in other ways that increase the risk of negative clinical trial results compared to clinical trials that we may design on our own. Negative results in investigator-initiated clinical trials could have a material adverse effect on our efforts to obtain regulatory approval for our product candidates and the public perception of our product candidates. As a result, our lack of control over the conduct and timing of and communications with the FDA and other regulatory authorities regarding investigator-sponsored trials may expose us to additional risks and uncertainties, many of which are outside our control, and the occurrence of which could adversely affect the commercial prospects for our product candidates.

We do not own manufacturing facilities capable of producing drug and biologic products at clinical scale. We have in the past experienced delays in receiving preclinical product supplies from third-party manufacturers and there can be no assurance that product supplies from third parties will not in the future be limited or interrupted, be of satisfactory quality or be available at acceptable prices. Additionally, the process of manufacturing drugs and biologics is complex, highly regulated, and subject to multiple risks. Manufacturing drugs and biologics are highly susceptible to product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, inconsistency in yields, variability in product characteristics and difficulties in scaling the production process. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, other supply disruptions and higher costs. If microbial, viral or other contaminations are discovered at the facilities of any contract manufacturing organizations (“CMOs”) we may engage, such facilities may need to be closed for an extended period of time to investigate and remedy the contamination, which could delay clinical trials, result in higher costs of our product and adversely affect our business.

To support the manufacture of our products, any CMOs we may engage would conduct substantial analytical testing of drug substance and vialed drug product. If such CMOs are unable to supply us with sufficient clinical grade quantities of product candidates, and we are unable to timely establish an alternate supply from one or more third-party contract manufacturers, we would experience delays in any development efforts we may pursue as we seek to locate and qualify new manufacturers. In particular, any replacement of a CMO could require significant effort and expertise because there may be a limited number of qualified replacements or capacity could be limited at each of the qualified replacements. Additionally, contract manufacturers may rely on single-source suppliers for certain raw materials for any preclinical or clinical product supplies we may require. If suppliers are delayed or unable to supply sufficient raw materials to manufacture product for any preclinical studies or clinical trials we may conduct, we may experience delays in any development efforts we may pursue as materials are obtained or we locate and qualify new raw material manufacturers. If we are unable to procure sufficient supplies of third-party products needed for any clinical trials we may conduct, we may be required to purchase such supplies on the open market, which may result in significant additional expense.

The manufacturing process for a clinical candidate is subject to FDA and foreign regulatory authority review. Suppliers and manufacturers must meet applicable manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities in order to comply with their standards, such as GMPs. In the event that any CMO we may engage fails to comply with such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if any supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves, for which we currently do not have the capabilities or resources, or enter into an agreement with another third party, which we may not be able to do on reasonable terms, if at all. The transfer of the manufacturing of drug or biologic products to a new CMO and any additional process development that may be necessary can be lengthy and involve significant additional costs. If we are required to change CMOs for any reason, we will be required to verify that the new CMO maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The delays associated with the verification of a new CMO would negatively affect our ability to develop product candidates in a timely manner or within budget.

Further, any reliance on third-party manufacturers would expose us to risks beyond our control, including the:

Some of these events could be the basis for FDA action, including injunction, recall, seizure or total or partial suspension of production, any of which could result in a failure to begin or a requirement to stop any clinical trials we may conduct. In addition, any CMOs and suppliers we may engage would be subject to FDA inspections from time to time. Failure by such CMOs and suppliers to pass such inspections and otherwise satisfactorily complete the FDA approval regimen with respect to a product candidate may result in regulatory actions such as the issuance of FDA Form 483 notices of observations, warning letters or injunctions or the loss of operating licenses. In addition, such CMOs and suppliers would be subject to numerous environmental, health and safety laws and regulations, including those governing the handling, use, storage, treatment and disposal of waste products, and failure to comply with such laws and regulations could result in significant costs associated with civil or criminal fines and penalties for such third parties. Based on the severity of the regulatory action, our supply of clinical or commercial product and packaging and other services could be interrupted or limited, which could harm our business.

In addition, any CMOs we may engage may be engaged with other companies to supply and manufacture materials or products for such companies, which would also expose such suppliers and CMOs to regulatory risks for the production of such materials and products. As a result, failure to meet the regulatory requirements for the production of those materials and products may also affect the regulatory clearance of a contract supplier’s or CMO’s facility, which could impact the contract supplier’s or CMO’s ability to manufacture product for us.

We may evaluate and, as deemed appropriate, enter into collaborations in the future on an asset-by-asset basis to maximize the value of any product candidates or technologies we may develop. For example, in April 2022, we entered into a Collaboration and License Agreement (the “Jazz Collaboration Agreement”) with Jazz Pharmaceuticals Ireland Limited (“Jazz”), pursuant to which we granted Jazz certain licenses to develop and commercialize products containing our Interferon alpha (“IFNα”), INDUKINE molecule, JZP898, as well as products containing certain isolated recombinant polypeptides comprising IFNα that meet specified criteria. In May 2026, we terminated the Jazz Collaboration Agreement and we entered into an asset purchase agreement (the “Jazz Purchase Agreement”) with Jazz, pursuant to which we sold to Jazz the JZP898 (formerly WTX-613) program (the “898 Program”). We may enter into other collaborations in connection with any platform technology or product candidates we may develop. Such collaborations may include the development and commercialization of product candidates or the commercialization of product candidates that are approved for marketing outside the United States. Potential collaborators include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies. We have limited capabilities for product development and do not yet have any capability for commercialization. Accordingly, we may enter into collaborations with other companies to provide us with important technologies and

funding for any programs or platform technology we may pursue. We will face significant competition in seeking appropriate collaborators. We may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for any 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 such product candidates as having the requisite potential to demonstrate safety and efficacy. We may also be restricted under future license agreements from entering into agreements on certain terms or at all with potential collaborators.

Future collaborations involving any product candidates we may develop may pose significant risks to us, including the following:

Any collaborations that we enter into may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. In addition, all of the risks relating to product development, regulatory approval and commercialization described in this proxy statement/prospectus will apply to the activities of any of our collaborators.

Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to WTX-124, WTX-330 and related technologies, including their respective components, formulations, combination therapies, methods used to manufacture them and methods of treatment and development that are important to our business. If we do not adequately protect our intellectual property rights, competitors may be able to erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability. To protect our proprietary position, we file or in-license patent applications in the United States and abroad related to WTX-124, WTX-330 and related technologies that are important to our business; we also license and may in the future license or purchase additional patents and patent applications filed by others. Following the EMD Asset Sale, our patent portfolio relating to WTX-124 and WTX-330 includes patents and patent applications that we own or license pursuant to the EMD License Agreement. If we are unable to secure or maintain patent protection with respect to WTX-124, WTX-330 and related technologies and any proprietary products and technology we develop, our business, financial condition, results of operations and prospects could be materially harmed.

If the scope of the patent protection we or our potential licensors obtain is not sufficiently broad, we may not be able to prevent others from developing and commercializing technology and products similar or identical to ours. The degree of patent protection we require to successfully compete in the marketplace may be unavailable or severely limited in some cases and may not adequately protect our rights or permit us to gain or keep any competitive advantage. We cannot provide any assurances that any of our patents have, or that any of our pending patent applications that mature into issued patents will include, claims with a scope sufficient to protect our product candidates or otherwise provide any competitive advantage. In addition, to the extent that we license intellectual property in the future, we cannot provide assurances that those licenses will remain in force. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Furthermore, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. 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 commercialized.

Our patents and pending patent applications, if issued, may not provide us with any meaningful protection or prevent competitors from designing around our patent claims to circumvent our patents by developing similar or alternative technologies or therapeutics in a non-infringing manner. For example, a third party may develop a competitive therapy that provides benefits similar to one or more of our product candidates but that uses a formulation and/or a device that falls outside the scope of our patent protection. If the patent protection provided by the patents and patent applications we hold or pursue with respect to our product candidates is not sufficiently broad to impede such competition, our ability to successfully commercialize our product candidates could be negatively affected, which would harm our business.

Patent positions of life sciences companies can be uncertain and involve complex factual and legal questions. No consistent policy governing the scope of claims allowable in the field of engineered therapeutic proteins has emerged in the United States. The scope of patent protection in jurisdictions outside of the United States is also uncertain.

Changes in either the patent laws or their interpretation in any jurisdiction in which we seek patent protection may diminish our ability to protect our inventions, maintain and enforce our intellectual property rights; and, more generally, may affect the value of our intellectual property, including the narrowing of the scope of our patents and any that we may license.

The patent prosecution process is complex, expensive, time-consuming and inconsistent across jurisdictions. We may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patent rights at a commercially reasonable cost or in a timely manner. In addition, we may not pursue or obtain patent protection in all relevant markets. It is possible that we will fail to identify important patentable aspects of our research and development efforts in time to obtain appropriate or any patent protection. While we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development efforts, including, for example, our employees, external academic scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose our confidential or proprietary information before a patent application is filed, thereby endangering our ability to seek patent protection. In addition, publications of discoveries in the scientific and scholarly literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Consequently, we cannot be certain that we were the first to file for patent protection on the inventions claimed in our patents or pending patent applications.

The issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Pending patent applications cannot be enforced against third parties unless, and until, patents issue from such applications, and then only to the extent the issued claims cover the technology. There can be no assurance that our patent applications or any patent applications that we may license in the future will result in patents being issued. Further, the scope of the invention claimed in a patent application can be significantly reduced before the patent is issued, and this scope can be reinterpreted after issuance. Even if patent applications we currently own or that we may license in the future issue as patents, they may not issue in a form that will provide us with adequate protection to prevent competitors or other third parties from competing with us, or otherwise provide us with a competitive advantage. Any patents that eventually issue may be challenged, narrowed or invalidated by third parties. Consequently, we do not know whether WTX-124, WTX-330 or related technologies will be protectable or remain protected by valid and enforceable patent rights. Our competitors or other third parties may be able to evade our patent rights by developing new products that are similar to our product candidates, biosimilars of our product candidates, or alternative technologies or products in a non-infringing manner.

The issuance or grant of a patent is not irrefutable as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. There may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim. There also may be prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. We may in the future become subject to a third-party pre-issuance submission of prior art or opposition, derivation, revocation, re-examination, post-grant and inter partes review (“IPR”), or interference proceeding and other similar proceedings challenging our patent rights or the patent rights of others in the U.S. Patent and Trademark Office (the “USPTO”) or other foreign patent office. An unfavorable determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or extinguish our ability to manufacture or commercialize products without infringing third-party patent rights.

In addition, 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 commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Moreover, some of our owned and in-licensed patents and patent applications may in the future be co-owned with third parties. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we or our licensors may need the cooperation of any such co-owners of our owned and in-licensed patents in order to enforce such patents against third parties, and such cooperation may not be provided to us or our licensors. Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.

Biotechnology and pharmaceutical companies generally, and we in particular, compete in a crowded competitive space characterized by rapidly evolving technologies and aggressive defense of intellectual property. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process.

We rely upon a combination of patents, confidentiality agreements, trade secret protection and license agreements to protect the intellectual property related to our technologies and our product candidates. Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements and product candidates, thus eroding our competitive position in our market. We, or any future partners, collaborators, or licensees, may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, we may miss potential opportunities to strengthen our patent position.

It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments (“PTA”). If we or our partners, collaborators, licensees or licensors fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If our partners, collaborators, licensees or licensors are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form, preparation, prosecution, or enforcement of our patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

We seek or plan to seek patent protection for WTX-124, WTX-330 and related technologies by filing and prosecuting patent applications in the United States and other countries as appropriate. However, we cannot predict:

Additionally, we cannot be certain that the claims in our pending patent applications covering WTX-124, WTX-330 and related technologies will be considered patentable by the USPTO, or by patent offices in foreign countries, or that the claims in any of our issued patents will be considered valid by courts in the United States or foreign countries.

The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates or technology or uses thereof in the United States or in other foreign countries. Even if patents do successfully issue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from designing around our claims. If the breadth or strength of protection provided by the patents and patent applications we hold with respect to our product candidates or technology is threatened, it could dissuade companies from collaborating with us to develop, and threaten our ability to commercialize, our product candidates. Further, if we encounter delays in any clinical trials we may conduct, the period of time during which we could market our product candidates under patent protection would be reduced. Since patent applications in the United States and most other countries are confidential for a period of time after filing, we cannot be certain

that we were the first to file any patent application related to our product candidates. Furthermore, for U.S. applications in which all claims are entitled to a priority date before March 16, 2013, an interference proceeding can be provoked by a third party or instituted by the USPTO to determine who was the first to invent any of the subject matter covered by the patent claims of our applications. We cannot be certain that we are the first to invent the inventions covered by pending patent applications and, if we are not, we may be subject to priority disputes. We may be required to disclaim part or all of the term of certain patents or all of the term of certain patent applications. Various post-grant review proceedings, such as IPR, post-grant review (“PGR”) and derivation proceedings, are available and may be pursued by any interested third party in the USPTO to challenge the patentability of claims issued in patents to us or our licensors. No assurance can be given as to the outcome of any such proceedings. No assurance can be given that if challenged, our patents would be declared by a court to be valid or enforceable or that even if found valid and enforceable, a competitor’s technology or product would be found by a court to infringe our patents. We may analyze patents or patent applications of our competitors that we believe are relevant to our activities, and consider that we are free to operate in relation to our product candidates, but our competitors may achieve issued claims, including in patents we consider to be unrelated, which block our efforts or may potentially result in our product candidates or our activities infringing such claims. The possibility exists that others will develop products which have the same effect as our products on an independent basis which do not infringe our patents or other intellectual property rights, or will design around the claims of patents that we have had issued that cover our products.

Recent or future patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. In March 2013, under the Leahy-Smith America Invents Act (the “America Invents Act”), the United States moved from a “first to invent” to a “first-to-file” system. Under a “first-to-file” system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to a patent on the invention regardless of whether another inventor had made the invention earlier. The America Invents Act includes a number of other significant changes to U.S. patent law, including provisions that affect the way patent applications are prosecuted, redefine prior art and establish a USPTO-administered post-grant review system that has affected patent litigation. The America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.

The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:

Composition of matter patents for biological and pharmaceutical products are generally considered to be the strongest form of intellectual property protection for those types of products, as such patents provide protection without regard to any method of making or method of use. We cannot be certain that the claims in our pending patent applications, including those claims covering the composition of matter of our product candidates, will be considered patentable by the USPTO or by patent offices in foreign countries, or that the claims in any of our patents that have issued or may issue will be considered valid and enforceable by courts in the United States or foreign countries. Furthermore, in some cases, we may not be able to obtain issued claims covering compositions of matter relating to our product candidates, and instead may need to rely on filing patent applications with claims covering a method of use and/or method of manufacture. Method of use patents protect a specified method of using a product, such as a method of use for treating a particular medical indication. This type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method. Moreover, even if competitors do not actively promote their products for our targeted indications, physicians may prescribe these products “off-label” for those uses that are covered by our method of use patents. Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent by enforcing patent rights or otherwise. There can be no assurance that any such patent applications will issue as granted patents, and even if they do issue, such patent claims may be insufficient to prevent third parties, such as our competitors, from utilizing our technology. Any failure to obtain or maintain patent protection with respect to our product candidates could have a material adverse effect on our business, financial condition, results of operations, and prospects.

In addition to the protection afforded by patents, we seek to rely on trade secret protection, confidentiality agreements, and license and other agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our product discovery and development processes that involve proprietary know-how, information, or technology that is not covered by patents. We cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.

Courts outside the United States are sometimes less willing to protect trade secrets. If we choose to go to court to stop a third party from using any of our trade secrets, we may incur substantial costs. These lawsuits may consume our time and other resources even if we are successful. For example, certain aspects of WTX-124 and WTX-330 and related technologies and know-how are based on unpatented trade secrets that are not publicly disclosed. Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees and consultants, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology.

Thus, we may not be able to meaningfully protect our trade secrets. It is our practice to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information concerning our business or financial affairs developed or made known to the individual or entity during the course of the party’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees, the agreements provide that all inventions conceived by the individual, and which are related to our business or research and development or made during normal working hours, on our premises or using our equipment or proprietary information, are our exclusive property. In addition, we take other appropriate precautions, such as physical and technological security measures, to guard against misappropriation of our proprietary technology by third parties. We have also adopted policies and conduct training that provides guidance on our expectations, and our advice for best practices, in protecting our trade secrets. However, we cannot provide assurance that these agreements and policies will not be breached by our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors and that our trade secrets and other proprietary and confidential information will not be disclosed publicly or to competitors.

These risks are heightened due to our reliance on third parties, including third-party CROs and CMOs, for certain aspects of our business. The activities conducted by our third-party vendors require us to share our trade secrets with them, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, reexamination, and other post-grant proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights alleging that any product candidates we may develop and/or proprietary technologies infringe their intellectual property rights. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in fields in which we may develop product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that product candidates we may develop may give rise to claims of infringement of the patent rights of others. Moreover, it is not always clear to industry participants, including us, which patents cover various types of drugs, products or their methods of use or manufacture. Thus, because of the large number of patents issued and patent applications filed in these fields, there may be a risk that third parties may allege they have patent rights encompassing product candidates, technologies or methods we may develop.

If a third party claims that we infringe its intellectual property rights, we may face a number of issues, including, but not limited to:

Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations or could otherwise have a material adverse effect on our business, results of operations, financial condition and prospects.

Third parties may assert that we are employing their proprietary technology without authorization. Generally, conducting preclinical and clinical trials and other development activities in the United States is not considered an act of infringement. If any product candidate we develop is approved by the FDA, a third party may then seek to enforce its patent by filing a patent infringement lawsuit against us. For example, we have received, and we may in the future receive, correspondence from third parties or their legal counsel disclosing that such third party owns patents that may encompass one or more of our product candidates. It is also possible that a third party may file a lawsuit against us alleging infringement of its patents. The outcome of any such proceeding is uncertain and would likely result in the expenditure of significant financial resources and the diversion of management’s time and resources, which could harm our business. While we do not believe that any claims that could otherwise have a materially adverse effect on the commercialization of our product candidates are valid and enforceable, we may be incorrect in this belief, or we may not be able to prove it in litigation. In this regard, patents issued in the United States by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and convincing,” a heightened standard of proof. There may be issued third-party patents of which we are currently unaware with claims to compositions, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Patent applications can take many years to issue. There may be currently pending patent applications which may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. Moreover, we may fail to identify relevant patents or incorrectly conclude that a patent is invalid, not enforceable, exhausted, or not infringed by our activities. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our product candidates, constructs or molecules used in or formed during the manufacturing process, or any final product itself, the holders of any such patents may be able to block our ability to commercialize the product candidate unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patent may be able to block our ability to develop and commercialize the product candidate unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our product candidates may be impaired or delayed, which could in turn significantly harm our business. Even if we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize product candidates.

Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates. Defense of these claims, regardless of their merit, could involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available on commercially reasonable terms or at all. Furthermore, even in the absence of litigation, we may need or may choose to obtain licenses from third parties to advance our research or allow commercialization of our product candidates. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize our product candidates, which could harm our business significantly.

Our development of product candidates may require the use of proprietary rights held by third parties and the growth of our business will likely depend in part on our ability to acquire, in-license or use these proprietary rights. Similarly, efficient production or delivery of our product candidates may also require specific compositions or methods, and the rights to these may be owned by third parties. We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as necessary or important to our business operations. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all, which would harm our business. We may need to cease use of the compositions or methods covered by such third-party intellectual property rights and may need to seek to develop alternative approaches that do not infringe on such intellectual property rights which may entail additional costs and development delays, even if we were able to develop such alternatives, which may not be feasible. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In that event, we may be required to expend significant time and resources to develop or license replacement technology. Moreover, the specific components, such as linkers and antibody fragments, that will be used with our product candidates may be covered by the intellectual property rights of others.

Additionally, we may collaborate with or sponsor research at academic institutions to accelerate our preclinical research or development under written agreements with these institutions. In certain cases, these institutions may provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration or sponsorship. Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to others, potentially blocking our ability to pursue our program. If we are unable to successfully obtain rights to required third-party intellectual property or to maintain the existing intellectual property rights we have, we may have to abandon development of such program and our business and financial condition could suffer.

The licensing and acquisition of third-party intellectual property rights is a competitive area, and companies, which may be more established, or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to commercialize our product candidates. More established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

A portion of our patent portfolio is in-licensed. As such, we are a party to license agreements and certain aspects of our business depend on patents and/or patent applications owned by other companies or institutions. We rely on a license from EMD for certain patent rights related to WTX-124 and WTX-330. Our rights with respect to in-licensed patents and patent applications may be lost if the applicable license agreement expires or is terminated or if we fail to satisfy the obligations under the license agreement. If we are unable to maintain these patent rights for any reason, our ability to develop and commercialize our product candidates could be materially harmed.

Our licensors may not successfully prosecute certain patent applications, the prosecution of which they control, under which we are licensed and on which our business depends. Even if patents issue from these applications, our licensors may fail to maintain these patents, may decide not to pursue litigation against third-party infringers, may fail to prove infringement, or may fail to defend against counterclaims of patent invalidity or unenforceability.

Risks with respect to parties from whom we have obtained intellectual property rights may also arise out of circumstances beyond our control. In spite of our best efforts, our licensors might conclude that we have materially breached our intellectual property agreements and might therefore terminate the intellectual property agreements, thereby removing our ability to market products covered by these intellectual property agreements or requiring us to enter into costly and time-consuming litigation. If any such litigation is unsuccessful, our intellectual property agreements may be terminated. In addition, if the underlying patents fail to provide the intended market exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, products similar or identical to ours. If our intellectual property agreements are terminated, our former licensors and/or assignors may be able to prevent us

from utilizing the technology covered by the licensed or assigned patents and patent applications. Such an event may require us to develop design-around approaches, which may be expensive and time-consuming, if possible at all. Any of these outcomes could have a material adverse effect on our competitive business position and our financial condition, results of operations and our business prospects.

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 commercialized. Depending upon the timing, duration and conditions of FDA marketing approval of our product candidates, one or more of our United States patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments, and similar legislation in the European Union. The Hatch-Waxman Amendments permit a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Only one patent 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. However, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that product will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced and could have a material adverse effect on our business.

Further, recent judicial decisions in the U.S. raised questions regarding the award of PTA for patents in families where related patents have issued without PTA. Thus, it cannot be said with certainty how PTA will be viewed in the future and whether patent expiration dates may be impacted.

Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file lawsuits with infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of our patents is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put our patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.

Post-grant proceedings provoked by third parties or brought by the USPTO may be necessary to determine the validity or priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could result in a loss of our current patent rights and could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms, or at all. Litigation or post-grant proceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of Werewolf Common Stock.

Some of our patent applications have been granted or may be granted or allowed in the future. We cannot be certain that an allowed patent application will become an issued patent. There may be events that can cause the allowance of a patent application to be withdrawn. For example, after a patent application has been allowed, but prior to being issued, material that could be relevant to patentability may be identified. In such circumstances, the applicant may pull the application from allowance in order for the USPTO to review the application in view of the new material. We cannot be certain that the USPTO will re-allow the application in view of the new material. Further, periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process and following the issuance of a patent. We rely on our outside counsel and other professionals or our licensing partners to pay these fees due to the USPTO and non-U.S. government patent agencies and to help us comply with other procedural, documentary and other similar requirements and we are also dependent on our licensors to take the necessary action to comply with these requirements with respect to our licensed intellectual property. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.

If we or one of our licensors initiate legal proceedings against a third party to enforce a patent covering one of our product candidates or our technology, the defendant could counterclaim that the patent covering our product candidate or technology, as applicable, is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, IPR, PGR and equivalent proceedings in foreign jurisdictions (such as opposition proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates or technology. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, or if we are otherwise unable to adequately protect our rights, we would lose at least part, and perhaps all, of the patent protection on our product candidates or technology. Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize or license our technology and product candidates.

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity and is therefore costly, time-consuming and inherently uncertain. In addition, the United States continues to adapt to wide-ranging patent reform legislation that became effective starting in 2012. Moreover, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. For example, in the case Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held that certain claims to DNA molecules are not patentable. While we do not believe that any of the patents owned or licensed by us will be found invalid based on

this decision, we cannot predict how future decisions by the courts, Congress or the USPTO may impact the value of our patents. Similarly, changes in the patent laws of other jurisdictions could adversely affect our ability to obtain and effectively enforce our patent rights, which would have a material adverse effect on our business and financial condition.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. 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 United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Most of our patent portfolio is at the very early stage. We will need to decide whether and in which jurisdictions to pursue protection for the various inventions in our portfolio prior to applicable deadlines.

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 biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

In addition, many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. Many countries also limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business and financial condition may be adversely affected.

We generally enter into confidentiality and intellectual property assignment agreements with our employees, consultants, and contractors. These agreements generally provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property. However, those agreements may not be honored and may not effectively assign intellectual property rights to us. Moreover, there may be some circumstances where we are unable to negotiate for such ownership rights. Disputes regarding ownership or inventorship of intellectual property can also arise in other contexts, such as collaborations and sponsored research. If we are subject to a dispute challenging our rights in or to patents or other intellectual property, such a dispute could be expensive and time-consuming. If we were unsuccessful, we could lose valuable rights in intellectual property that we regard as our own.

Many of our employees were previously employed at other pharmaceutical companies, including our competitors or potential competitors, in some cases until recently. We may be subject to claims that we or our employees have inadvertently or otherwise used or disclosed trade secrets or other confidential information of these former employers

or competitors. In addition, we have been and may in the future be subject to claims that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and could be a distraction to management. If our defense to those claims fails, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Any litigation or the threat thereof may adversely affect our ability to hire employees. A loss of key personnel or their work product could hamper or prevent our ability to commercialize product candidates, which could have an adverse effect on our business, results of operations and financial condition.

Our trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. We rely on both registration and common law protection for our trademarks. We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for name recognition by potential partners or customers in our markets of interest. During the trademark registration process, we may receive Office Actions from the USPTO objecting to the registration of our trademark. Although we would be given an opportunity to respond to those objections, we may be unable to overcome such rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and/or to seek the cancellation of registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected.

The degree of future protection afforded by our intellectual property rights, whether owned or in-licensed, is uncertain because intellectual property rights have limitations, and may not adequately protect our business, provide a barrier to entry against our competitors or potential competitors, or permit us to maintain our competitive advantage. Moreover, if a third party has intellectual property rights that cover the practice of our technology, we may not be able to fully exercise or extract value from our intellectual property rights. The factors that may limit any potential competitive advantage provided by our intellectual property rights include:

Should any of these events occur, they could significantly harm our business and results of operation.

The research, testing, manufacturing, labeling, approval, selling, marketing, promotion and distribution of products are subject to extensive regulation by the FDA and comparable foreign regulatory authorities. We are not permitted to market any product candidates we may develop in the United States or in other countries until we receive approval of a new drug application (“NDA”) or biologics license application (“BLA”) from the FDA or marketing approval from applicable regulatory authorities outside the United States. Any such product candidates would be subject to the risks of failure inherent in development. We have not submitted an application for or received marketing approval for any product candidate in the United States or in any other jurisdiction. Our Company has no experience in filing and supporting the applications necessary to gain marketing approvals and expects to rely on third-party CROs to assist us in this process if we pursue such applications.

The process of obtaining marketing approvals, both in the United States and abroad, is lengthy, expensive and uncertain. It may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information, including manufacturing information, to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. The FDA or other regulatory authorities may determine that our product candidates are not safe and effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use.

In addition, changes in marketing approval policies during the development period, changes in or the enactment or promulgation of additional statutes, regulations or guidance or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. Regulatory authorities have substantial discretion in the approval process and varying interpretations of the data obtained from preclinical and clinical testing, including based on trial design, quality of trial conduct, analysis of trial results, and the overall persuasiveness of the results, could delay, limit or prevent marketing approval of a product candidate. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other data. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

Further, under the Pediatric Research Equity Act, NDAs and BLAs must contain data to assess the safety and effectiveness of the product for the claimed indication in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless the sponsor receives a deferral or waiver from the FDA. A deferral may be granted for several reasons, including a finding that the product or therapeutic candidate is ready for approval for use in adults before pediatric trials are complete or that additional safety or effectiveness data needs to be collected before the pediatric trials begin. The applicable legislation in the EU also requires sponsors to either conduct clinical trials in a pediatric population in accordance with a Pediatric Investigation Plan approved by the Pediatric Committee of the European Medicines Agency (“EMA”) or to obtain a waiver or deferral from the conduct of these studies by this Committee. For any of our product candidates for which we are seeking regulatory approval in the U.S. or the EU, we cannot guarantee that we will be able to obtain a waiver or alternatively complete any required studies and other requirements in a timely manner, or at all, which could result in associated reputational harm and subject us to enforcement action.

Under the current presidential administration, there have been significant and wide-ranging reforms to federal policy and the federal government. In particular, as in recent preceding presidential administrations, pricing and reimbursement reform is a focus of reform efforts. Other healthcare reform efforts or other actions under the current presidential administration may adversely affect the development of new therapies, access to healthcare coverage or the funding of healthcare benefits, although the full impact of such efforts or actions cannot be predicted. For example, the Congressional Budget Office has estimated that Medicaid provisions in the OBBBA, including restrictions in eligibility and funding for Medicaid, as well as changes to the healthcare marketplace, will increase the number of uninsured by 16 million by 2034.

Any delay in obtaining or failure to obtain required approvals could negatively affect our ability or that of any future collaborators to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact Werewolf Common Stock price.

In order to market and sell our products in the US, EU and other foreign jurisdictions, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The marketing approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. We may file for marketing approvals but not receive necessary approvals to commercialize our products in any market.

In many countries outside the United States, a product candidate must also be approved for reimbursement before it can be sold in that country. In some cases, the price that we intend to charge for our products, if approved, is also subject to approval. Obtaining non-U.S. regulatory approvals and compliance with non-U.S. regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our product candidates in certain countries. In addition, if we fail to obtain the non-U.S. approvals required to market our product candidates outside the United States or if we fail to comply with applicable non-U.S. regulatory requirements, our target markets will be reduced and our ability to realize the full market potential of our product candidates will be harmed and our business, financial condition, results of operations and prospects may be adversely affected.

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 overhaul, 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 (the Pharma Package) was published on April 26, 2023. This package—comprised of a new directive and regulation to replace existing legislation—aims to modernize the EU regulatory framework. On December 11, 2025, the European Commission, the Parliament and the European Council reached a political agreement. Following endorsement of the compromise texts by the Council's Committee of Permanent Representatives (COREPER) and approval by the European Parliament's Committee on Public Health (SANT) in March 2026, the proposed revisions must now be formally adopted by the Council of the EU and the European Parliament in plenary, currently anticipated by fall 2026. The reform encompasses a broad range of measures, including changes to regulatory exclusivity, incentives to combat antimicrobial resistance, intellectual property exemptions for generic medicines, orphan products, and marketing authorization procedures. The new framework is expected to enter into force in late 2026 and to be subject to transitional arrangements, with full application not anticipated before 2028. The revisions may, however, have a significant impact on the pharmaceutical industry and our business in the long term.

We expect that we will be subject to additional risks in commercializing any of our product candidates that receive marketing approval outside the United States, including tariffs, trade barriers and regulatory requirements; economic weakness, including inflation, or political instability in particular foreign economies and markets; compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; and workforce uncertainty in countries where labor unrest is more common than in the United States.

Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug or biologic 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 United States, or for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biologic for such disease or condition will be recovered from sales in the United States of such product. Generally, a product with orphan drug designation only becomes entitled to orphan drug exclusivity if it receives the first marketing approval for the indication for which it has such designation, in which case the FDA will be precluded from approving another marketing application for the same product for that indication for the applicable exclusivity period. The applicable exclusivity period is seven years in the United States.

We may seek orphan drug designations for our product candidates and may be unable to obtain such designations. Even if we do secure such designations and orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different products can be approved for the same condition. Further, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later product is clinically superior in that it is shown to be safer, to be more effective or, in unusual cases, to make a major contribution to patient care. Finally, orphan drug exclusivity may be lost and this may occur if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or condition or for other reasons.

It is also possible that current or future litigation or action by Congress could change the scope of available orphan exclusivity. Any changes to the orphan drug provisions could change our opportunities for, or likelihood of success in obtaining, orphan drug exclusivity and could materially adversely affect our business, financial condition, results of operations, cash flows and prospects.

We do 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 our business. Depending on what changes the FDA may make to its orphan drug regulations and policies, our business could be adversely impacted.

In addition, to obtain orphan drug designation in the EU, we would need to demonstrate that (1) the product is intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions; (2) either (a) such conditions affect not more than five in 10,000 persons in the EU when the application is made, or (b) the product without the benefits derived from orphan status, would not generate sufficient return in the EU to justify the necessary investment in developing the medicinal product; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the EU or, if such method exists, the medicinal product will be of significant benefit to those affected by that condition. The period of market exclusivity is ten years during which the EMA cannot accept another marketing authorization application or accept an application to extend for a similar product and the European Commission cannot grant a marketing authorization for the same indication for a period of ten years. The period of market exclusivity may be extended by two years for orphan medicinal products that have also complied with an agreed Pediatric Investigation Plan. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications. The period of market exclusivity may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria on the basis of which it received orphan medicinal product designation, including where it can be demonstrated on the basis of available evidence that the original orphan medicinal product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold. Additionally, a marketing authorization may be granted to a similar medicinal product with the same orphan indication during the 10-year period if: (i) the applicant consents to a second original orphan medicinal product application, (ii) the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities; or (iii) the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior to the original orphan medicinal product. There is no assurance that we would be able to meet that standard for any of our product candidates. Further, if we do obtain orphan drug designation for a candidate product in the EU, we will not be able to maintain that designation if we are not able to show, to the satisfaction of the EU regulatory authorities, that the candidate product is of significant benefit to patients over available commercial products for the indication in the EU and any additional products that are ahead of our product candidate in clinical development for the indication. In addition, the Pharma Package discussed above includes proposed changes to the EU orphan medicinal product framework that may modify the length of orphan market exclusivity and change the way in which market exclusivity is awarded to drugs with more than one approved orphan indication. The Pharma Package is subject to formal adoption by the European Parliament and Council and, if adopted, could alter the exclusivity protections currently available for orphan designated products in the EU.

Any product candidate for which we obtain marketing approval will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, GMP requirements relating to quality control and manufacturing, quality assurance and corresponding maintenance of records and documents, and requirements regarding the distribution of samples to physicians and recordkeeping. In addition, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product, including the requirement to implement a risk evaluation and mitigation strategy.

In addition, later discovery of previously unknown adverse events or other problems with any product for which we may obtain marketing approval and its manufacturers or manufacturing processes or failure to comply with regulatory requirements, may yield various results, including:

Further requirements, including post-approval requirements, apply to the approval of products in the EU. The holder of a marketing authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products. These include: compliance with the EU’s stringent pharmacovigilance or safety reporting rules, which can impose post-authorization studies and additional monitoring obligations; the manufacturing of authorized medicinal products, for which a separate manufacturer’s license is mandatory; and the marketing and promotion of medicinal products, which are strictly regulated in the EU and are also subject to EU member state laws. Moreover, much like the Anti-Kickback Statute prohibition in the United States, the provision of benefits or advantages to physicians and other health care professionals to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the EU. Interactions between pharmaceutical companies and health care professionals are governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment. The failure to comply with these and other EU requirements can also lead to significant penalties and sanctions.

Accordingly, if we receive marketing approval for one or more of our product candidates, we will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance

and quality control. If we fail to comply with these requirements, we could have the marketing approvals for our products withdrawn by regulatory authorities and our ability to market any products could be limited, which could adversely affect our ability to achieve or sustain profitability.

The regulations relating to the promotion of products for unapproved uses are complex and subject to substantial interpretation by the FDA, national competent authorities of EU Member States and other government agencies. In September 2021, the FDA published final regulations which describe the types of evidence that the agency will consider in determining the intended use of a pharmaceutical product. Physicians may nevertheless prescribe our products off-label to their patients in a manner that is inconsistent with the approved label. We intend to implement compliance and training programs designed to ensure that our sales and marketing practices comply with applicable regulations. Notwithstanding these programs, the FDA or other government agencies may allege or find that our practices constitute prohibited promotion of our products for unapproved uses. We also cannot be sure that our employees will comply with our Company policies and applicable regulations regarding the promotion of products for unapproved uses.

Notwithstanding the regulatory restrictions on off-label promotion, the FDA and other regulatory authorities allow companies to engage in truthful, non-misleading, and non-promotional scientific communications concerning their products in certain circumstances. For example, in January 2025, the FDA published final guidance outlining its policies governing the distribution of scientific information to healthcare providers about unapproved uses of approved products. The final guidance calls for such communications to be truthful, non-misleading and to include all information necessary for healthcare providers to interpret the strengths and weaknesses and validity and utility of the information about the unapproved use of the approved product. If a company engages in such communications consistent with the guidance’s recommendations, the FDA indicated that it will not treat such communications as evidence of unlawful promotion of a new intended use for the approved product. We will need to carefully navigate the FDA’s various regulations, guidance and policies, along with recently enacted legislation, to ensure compliance with restrictions governing promotion of our products.

In addition, under some relatively recent guidance from the FDA and the Pre-Approval Information Exchange Act signed into law as part of the Consolidated Appropriations Act of 2023, companies may also promote information that is consistent with the prescribing information and proactively speak to formulary committee members of payors regarding data for an unapproved product or unapproved uses of an approved product. We may engage in these discussions and communicate with healthcare providers, payors and other constituencies in compliance with all applicable laws, regulatory guidance and industry best practices. We will need to carefully navigate the FDA’s various regulations, guidance and policies, along with recently enacted legislation, to ensure compliance with restrictions governing promotion of our products.

In recent years, a significant number of pharmaceutical and biotechnology companies have been the target of inquiries and investigations by various federal and state regulatory, investigative, prosecutorial and administrative entities in connection with the promotion of products for unapproved uses and other sales practices, including the DOJ and various U.S. Attorneys’ Offices, the Office of Inspector General of the Department of HHS, the FDA, the Federal Trade Commission (the “FTC”) and various state Attorneys General offices. These investigations have alleged violations of various federal and state laws and regulations, including claims asserting antitrust violations, violations of the Federal Food, Drug, and Cosmetic Act, the False Claims Act, the Prescription Drug Marketing Act and anti-kickback laws and other alleged violations in connection with the promotion of products for unapproved uses, pricing and Medicare and/or Medicaid reimbursement. Many of these investigations originate as qui tam actions under the False Claims Act. Under the False Claims Act, any individual can bring a claim on behalf of the government alleging that a person or entity has presented a false claim or caused a false claim to be submitted to the government for payment. The person bringing a qui tam suit is entitled to a share of any recovery or settlement. Qui tam suits, also commonly referred to as whistleblower suits, are often brought by current or former employees. In a qui tam suit, the government must decide whether to intervene and prosecute the case. If it declines, the individual may pursue the case alone.

In the EU, the advertising and promotion of medicinal products are subject to both EU and EU Member States’ laws governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices. General requirements for advertising and promotion of medicinal products, such as direct-to-consumer advertising of prescription medicinal products, are established in EU law. However, the details are governed by regulations in individual EU Member States and can differ

from one country to another. For example, applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product’s Summary of Product Characteristics (SmPC), which may require approval by the competent national authorities in connection with an MA. The SmPC is the document that provides information to physicians and other healthcare professionals concerning the safe and effective use of the product. Promotional activity that does not comply with the SmPC is considered off-label and is prohibited in the EU.

If the FDA or any other governmental agency initiates an enforcement action against us or if we are the subject of a qui tam suit and it is determined that we violated prohibitions relating to the promotion of products for unapproved uses, we could be subject to substantial civil or criminal fines or damage awards and other sanctions such as consent decrees and corporate integrity agreements pursuant to which our activities would be subject to ongoing scrutiny and monitoring to ensure compliance with applicable laws and regulations. Any such fines, awards or other sanctions would have an adverse effect on our revenue, business, financial prospects and reputation.

We may seek certain designations for one or more of our product candidates that could expedite review and approval by the FDA. 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, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens.

The FDA may also 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. For Fast Track products, sponsors may have greater interactions with the FDA and the FDA may initiate review of sections of a Fast Track product’s application before the application is complete. This rolling review may be available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a Fast Track product may be effective.

We may also seek a priority review designation for one or more of our product candidates. If the FDA determines that a product candidate is 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. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting product adverse reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation. A priority review designation means that the goal for the FDA to review an application is six months, rather than the standard review period of ten months.

Products may qualify for more than one designation and these designations are within the discretion of the FDA. Accordingly, even if we believe that one of our product candidates meets the criteria for these designations, the FDA may disagree and instead determine not to make such designation. Further, even if we receive a designation, 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 one or more of our product candidates qualifies 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, we may seek PRIME designation for our product candidates in the future. PRIME is a voluntary program aimed at enhancing the EMA’s role to reinforce scientific and regulatory support in order to optimize development and enable accelerated assessment of new medicines that are of major public health interest with the potential to address unmet medical needs. The program focuses on medicines that target conditions for which there exists no satisfactory

method of treatment in the EU or even if such a method exists, it may offer a major therapeutic advantage over existing treatments. PRIME is limited to medicines under development and not authorized in the EU and the applicant intends to apply for an initial marketing authorization application through the centralized procedure. To be accepted for PRIME, a product candidate must meet the eligibility criteria in respect of its major public health interest and therapeutic innovation based on information that is capable of substantiating the claims.

The benefits of a PRIME designation include the appointment of a rapporteur from the Committee for Medicinal Products for Human Use 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 designation enables an applicant to request parallel EMA scientific advice and health technology assessment advice to facilitate timely market access. Even if we receive PRIME designation for any of our 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.

We may seek approval of any of our product candidates using the FDA’s accelerated approval pathway. A product may be eligible for accelerated approval if it treats a serious or life-threatening condition, generally provides a meaningful advantage over available therapies, and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (“IMM”) that is reasonably likely to predict an effect on IMM or other clinical benefit (i.e., an intermediate clinical endpoint). The FDA or other applicable regulatory agency makes the determination regarding whether a surrogate endpoint is reasonably likely to predict long-term clinical benefit.

Prior to seeking such accelerated approval, we will seek feedback from the FDA and otherwise evaluate our ability to seek and receive such accelerated approval. As a condition of approval, the FDA requires that a sponsor of a product receiving accelerated approval perform a post-marketing confirmatory clinical trial or trials. These confirmatory trials must be completed with due diligence, and we may be required to evaluate different or additional endpoints in these post-marketing confirmatory trials. These confirmatory trials may require enrollment of more patients than we currently anticipate and will result in additional costs, which may be greater than the estimated costs we currently anticipate. In addition, the FDA currently requires, as a condition for accelerated approval preapproval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

There can be no assurance that the FDA will agree with any proposed surrogate endpoints or that we will decide to pursue or submit a BLA or NDA for accelerated approval or any other form of expedited development, review or approval for any product candidates. Similarly, there can be no assurance that, after feedback from FDA, we will continue to pursue or apply for accelerated approval or any other form of expedited development, review or approval, even if we initially decide to do so. Furthermore, if we decide to submit an application for accelerated approval or under another expedited regulatory designation, there can be no assurance that such submission or application will be accepted or that any expedited review or approval will be granted on a timely basis, or at all.

The FDA may withdraw approval of a product candidate approved under the accelerated approval pathway if, for example, the trial required to verify the predicted clinical benefit of our product candidate fails to verify such benefit or does not demonstrate sufficient clinical benefit to justify the risks associated with the product candidate. The FDA may also withdraw approval if other evidence demonstrates that our product candidate is not shown to be safe or effective under the conditions of use, we fail to conduct any required post-approval trial of our product candidate with due diligence or we disseminate false or misleading promotional materials relating to our product candidate. A failure to obtain accelerated approval or any other form of expedited development, review or approval for our product candidates, or withdrawal of a product candidate, would result in a longer time period for commercialization of such product candidate, could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.

Further, there can be no assurance that we will satisfy all FDA requirements, including new provisions, that govern accelerated approval. For example, with passage of the 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 and to submit progress reports on its post-approval studies to FDA every six months until the study is completed. Moreover, FDORA established expedited procedures authorizing FDA to withdraw an accelerated approval if certain conditions are met, including where a required confirmatory study fails to verify clinical benefit or evidence demonstrates that the product is not shown to be safe or effective under its conditions of use. The FDA may also use such procedures to withdraw an accelerated approval if a sponsor fails to conduct any required post-approval study of the product with due diligence. The new procedures include the provision of due notice and an explanation for a proposed withdrawal, and opportunities for hearing. We will need to fully comply with these and other requirements in connection with the development and approval of any product candidate that qualifies for 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 conditions are fulfilled, a conditional marketing authorization can become a “standard” marketing authorization. However, if the conditions are not fulfilled within the timeframe set by the European Commission, the marketing authorization will cease to be renewed.

All entities involved in the preparation of product candidates for clinical trials or commercial sale, including any contract manufacturers, are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with GMP. These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants or to inadvertent changes in the properties or stability of any product candidates we may develop that may not be detectable in final product testing.

If we pursue a BLA or an NDA, we or any contract manufacturer we engage must supply all necessary documentation in support of the application on a timely basis and must adhere to the FDA’s GLP and GMP regulations enforced through its facilities inspection program and other requirements. The facilities and quality systems of any third-party contractors we may engage must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of any product candidate. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of any product candidates we may develop or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If these facilities do not pass a pre-approval plant inspection, FDA approval of the products will not be granted. Comparable requirements and related risks apply abroad.

The regulatory authorities also may, at any time following approval of a product for sale, audit manufacturing facilities used by us or those of third-party contractors we may engage. If any such inspection or audit identifies failure to comply with applicable regulations or if a violation of applicable product specifications or regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for us or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with which we may contract could materially harm our business.

Despite our efforts to audit and verify regulatory compliance, one or more of our third-party contractors may be found on regulatory inspection by the FDA, or other comparable foreign regulatory authorities to be noncompliant with cGMP regulations. If we or any third-party manufacturers we may engage fail to maintain regulatory compliance, the FDA and comparable foreign regulatory authorities can impose regulatory sanctions including, among other things, shutdown of the third-party vendor or invalidation of product lots or processes, fines, injunctions, civil penalties, delays, suspension, variation or withdrawal of approvals, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, refusal to approve a pending application for a new product, or revocation of a pre-existing approval. Any such consequence could significantly and adversely affect supplies of our products, if approved, and would severely harm our business, financial condition and results of operations.

We may in the future conduct one or more clinical trials with trial sites that are located outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of these data is subject to certain conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with GCPs. The FDA must be able to validate the data from the trial through an onsite inspection if necessary and the data must be applicable to the U.S. population and U.S. medical practice. In addition, while these clinical trials are subject to the applicable local laws, the FDA acceptance of the data will be dependent upon its determination that the trials also complied with all applicable U.S. laws and regulations. There can be no assurance that the FDA will accept data from clinical trials conducted outside of the United States. If the FDA does not accept the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and delay or permanently halt our development of product candidates.

In addition, the conduct of clinical trials outside the United States could have a significant adverse impact on us or the trial results. Risks inherent in conducting international clinical trials include:

In the United States and foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval. We expect 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 we may receive for any approved products. If reimbursement of our products is unavailable or limited in scope, our business could be materially harmed.

The 2010 Patient Protection and Affordable Care Act (“ACA”) substantially changed the way healthcare is financed by both governmental and private insurers and continues to significantly impact the U.S. pharmaceutical industry.

The ACA has been subject to litigation challenging its provisions, and such litigation is likely to continue with uncertain results. In addition, other legislative changes have been proposed and adopted since the ACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect until fiscal year 2032 unless additional congressional action is taken.

Since enactment of the ACA, there have been, and continue to be, numerous legal challenges and Congressional actions to repeal and replace provisions of the law. For example, on July 4, 2025, the One Big Beautiful Bill Act, or OBBBA, was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance. The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.

In the EU, on 12 January 2025, Regulation No 2021/2282 on Health Technology Assessment (“HTA Regulation”) entered into application. The HTA Regulation initially applies to new active substances for oncology products and advanced therapy medicinal products, and will expand to orphan medicinal products in January 2028 and to all centrally authorized medicinal products by 2030. The Regulation intends to boost cooperation among EU member states in

assessing health technologies, including new medicinal products as well as certain high-risk medical devices, and provide the basis for cooperation at the EU level for joint clinical assessments in these areas. It permits EU member states to use common HTA Regulation tools, methodologies, and procedures across the EU, and requires them to rely on EU-level joint clinical assessment reports for the clinical components of their national HTA evaluations. Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement. As implementation of the HTA Regulation is phased in and key methodological and procedural guidance continues to evolve, there remains uncertainty regarding the evidence requirements, timing, and impact of joint clinical assessments on national reimbursement processes. The new framework may result in additional or differently structured evidentiary expectations, misalignment between assessment and regulatory timelines, or delays in national decisions.

The prices of prescription pharmaceuticals have also been the subject of considerable discussion in the United States. There have been several recent U.S. congressional inquiries, as well as proposed and enacted state and federal legislation designed to, among other things, bring more transparency to pharmaceutical pricing, review the relationship between pricing and manufacturer patient programs, and reduce the costs of pharmaceuticals under Medicare and Medicaid.

In addition, in October 2020, HHS and the FDA published a final rule allowing states and other entities to develop a Section 804 Importation Program to import certain prescription products from Canada into the U.S. That regulation was challenged in a lawsuit by the Pharmaceutical Research and Manufacturers of America (“PhRMA”), but the case was dismissed by a federal district court in February 2023 after the court found that PhRMA did not have standing to sue HHS. Several states have passed laws allowing for the importation of products from Canada. For example, on June 15, 2026, the FDA approved Colorado’s Section 804 Importation Program proposal to import certain products from Canada for specific state healthcare programs. It is unclear how this and Florida’s similar program, approved by the FDA in 2024, will be implemented and whether they will overcome potential legal, regulatory, or industry challenges in the United States and/or Canada.

On April 15, 2025, President Trump issued an Executive Order that directs HHS to take steps to reduce the prices of pharmaceutical products. The executive order repeats many of the proposals advanced during the first Trump administration, including directing the FDA to streamline and improve its existing importation program so as to make it easier for states to obtain approval without sacrificing the safety or quality of pharmaceutical products. With respect to the IRA’s Medicare drug pricing program, the executive order, among other things, calls for alignment in “the treatment of small molecule prescription drugs with that of biological products, ending the distortion that undermines relative investment in small molecule prescription drugs, coupled with other reforms to prevent any increase in overall costs to Medicare and its beneficiaries.”

Subsequently, on May 12, 2025, President Trump issued an additional executive order (the “Additional Order”) calling on pharmaceutical manufacturers to voluntarily reduce the prices of medicines in the U.S. The Additional Order directs the Secretary of HHS to communicate most-favored-nation (“MFN”) price targets to pharmaceutical manufacturers to bring prices in line with comparably developed nations. Since the Additional Order, the Trump administration has continued to exert pressure on pharmaceutical manufacturers to implement MFN pricing. For example, the current administration has announced agreements with certain pharmaceutical companies that require the manufacturers to offer, through a direct-to-consumer platform (“TrumpRx”), U.S. patients and Medicaid programs prescription MFN pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues. Additionally, on December 21, 2025, Centers for Medicare & Medicaid Services (“CMS”) issued two proposed rules that, if implemented, would introduce two mandatory payment models, the Global Benchmark for Efficient Drug Pricing and Guarding U.S. Medicare Against Rising Drug Costs models, where manufacturers of certain Medicare Part B and Medicare Part D products would be assessed rebates if the prices for such products exceed those paid in economically comparable countries. The GLOBE and GUARD pilot programs are proposed to go into effect beginning October 1, 2026 and January 1, 2027, respectively. More recently, on April 2, 2026, President Trump issued an executive order establishing a tariff framework for imported patented pharmaceuticals and related inputs, with more favorable rates and/or exceptions tied to MFN pricing and domestic manufacturing commitments. Additionally, the current administration recently called on Congress to enact “The Great Healthcare Plan,” to codify and expand MFN pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical products available for over-the-counter purchase, and enact

restrictions on pharmacy benefit manager payment methodologies, among other things. It remains to be seen how these pricing initiatives will affect the broader pharmaceutical industry.

At the U.S. state level, legislatures are increasingly 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. Another emerging trend at the state level is the establishment of prescription product affordability boards, some of which will prospectively permit certain states to establish upper payment limits for products that the state has determined to be “high-cost.” Prescription product affordability boards in several states have begun identifying products for affordability reviews and issuing information requests to manufacturers to determine whether upper payment limits may be justified. 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 our products, once approved, or put pressure on our product pricing. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures. This may be increasingly true with respect to products approved pursuant to the accelerated approval pathway. State Medicaid programs and other payers are developing strategies and implementing significant coverage barriers, or refusing to cover these products outright, arguing that accelerated approval products have insufficient or limited evidence despite meeting the FDA’s standards for accelerated approval.

Finally, outside the United States, in some nations, including those of the EU, the pricing of prescription pharmaceuticals is subject to governmental control and access, and reimbursement schemes vary widely from country to country. For example, some EU Member States may restrict the range of products for which their national health insurance systems provide reimbursement. Other countries may control the prices of medicinal products for human use or allow companies to fix their own prices for products but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we or our collaborators may be required to conduct a clinical trial that compares the cost-effectiveness of our product to other available therapies. This Health Technology Assessment (HTA) process is the procedure according to which the assessment of the public health impact, therapeutic impact and the economic and societal impact of use of a given medicinal product in the national healthcare systems of the individual country is conducted. The outcome of HTA regarding specific medicinal products will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU Member States. The HTA Regulation discussed above introduces key changes to this process, which are intended to boost cooperation among Member States in assessing health technologies, including new medicinal products. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be materially harmed.

Healthcare providers, physicians, and third-party payors will play a primary role in the recommendation and prescription of any products for which we obtain marketing approval. Any future arrangements we may have with healthcare providers, third-party payors, and customers will subject us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we may conduct clinical research or market, sell and distribute any products for which we obtain marketing approval. These include, but are not limited to, the following:

Anti-Kickback Statute. The federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid.

False Claims Laws. The federal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, impose criminal and civil penalties, including those from civil whistleblower or qui tam actions against individuals or entities for, among other things, knowingly presenting, or causing to be presented to the federal

government, claims for payment that are false or fraudulent or making a false statement or record material payment of a false claim or avoiding decreasing or concealing an obligation to pay money to the federal government.

HIPAA. The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal and civil liability for, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program.

HIPAA and HITECH Act. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”), also imposes obligations on certain types of individuals and entities, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.

False Statements Statute. The federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services.

Transparency Requirements. 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 and other transfers of value made to U.S.-licensed physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and certain other U.S.-licensed healthcare providers and U.S. teaching hospitals, as well as information regarding ownership and investment interests by physicians and their immediate family members. Applicable manufacturers are also required to report such information regarding its payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year.

Analogous State and Foreign Laws. Analogous state and foreign fraud and abuse laws and regulations, such as state and foreign anti-kickback and false claims laws, and transparency laws, may apply to sales or marketing arrangements, and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and some state and local laws require certain regulatory licenses to manufacture or distribute products commercially and/or the registration of pharmaceutical sales representatives in the jurisdiction. Additionally, some state and foreign laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the government, in addition to requiring manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures. Many state and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

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 prohibited in the EU. 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. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

Efforts to ensure that our business arrangements with third parties, and our business generally, will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products from federal healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, and reputational harm, any of which could substantially disrupt our operations. If any of the physicians or other providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from federal healthcare programs.

We, and the third parties with whom we work, are and may become subject to data privacy and protection laws and regulations, which among other things, impose certain requirements relating to the privacy, security and transmission of personal information, including comprehensive regulatory systems in the U.S., EU and United Kingdom. The regulatory framework for the collection, use, safeguarding, sharing, transfer and other processing of information worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future. Failure to comply with any of these laws and regulations could result in enforcement action against us (including fines and other penalties), claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.

In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, “process”) personal information and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, data we collect about trial participants in connection with clinical trials, sensitive third-party data, and other sensitive data the Company may process (e.g., business plans, transactions, financial information, etc.).

In the United States, there are numerous federal and state laws and regulations related to the privacy and security of personal information that may be applicable to our current and future activities. For instance, a wide range of enforcement agencies at both the state and federal levels can review companies for privacy and data security concerns based on general consumer protection laws. The FTC and state Attorneys General are aggressive in reviewing privacy and data security protections for consumers. For example, the FTC has focused on the unpermitted processing of health and genetic data, including through enforcement actions, and has expanded the types of privacy violations that it interprets to be “unfair” under Section 5 of the Federal Trade Commission Act, as well as the types of activities it views to trigger the Health Breach Notification Rule (which the FTC also has the authority to enforce). We will need to account for the FTC’s evolving rules and guidance for proper privacy and data security practices in order to mitigate our risk for a potential enforcement action, which may be costly. If we are subject to a potential FTC enforcement action, we may be subject to a settlement order that requires us to adhere to very specific privacy and data security practices, which may impact our business. We may also be required to pay fines as part of a settlement (depending on the nature of the alleged violations). If we violate any consent order that we reach with the FTC, we may be subject to additional fines and compliance requirements.

In addition to consumer protection laws, a broad range of privacy-related legislation has been introduced at both the federal and, especially, state levels. For example, the California Consumer Privacy Act (the “CCPA”), which went into effect on January 1, 2020, imposes many requirements on businesses that process the personal information of California residents, including requiring businesses to provide notice to data subjects regarding the information collected about them and how such information is used and shared, and providing data subjects the right to request access to such personal information and, in certain cases, request the deletion of such personal information.

In addition to California, many other states have passed comprehensive privacy laws that are currently in effect or will go into effect in the coming years. Like the CCPA, these laws create obligations related to the processing of personal information, as well as special obligations for the processing of “sensitive” data (which includes health data in some cases). Although these and similar laws often have exemptions for personal information collected in the context of clinical trials, some provisions of these laws may apply to our business activities. Other states are and will be considering these laws in the future, and Congress has also continued to consider passing a federal privacy law. These laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.

Plaintiffs’ lawyers are also increasingly using privacy-related statutes at both the state and federal level to bring lawsuits against companies for their data-related practices. For example, there have been a significant number of cases filed against companies for their use of pixels and other web trackers. These cases often allege violations of the California Invasion of Privacy Act and other state laws regulating wiretapping, as well as federal laws, such as the Video Privacy Protection Act. The rise in these types of lawsuits creates potential risk for our business.

In addition to the risks associated with enforcement activities by government authorities, there also is the threat of consumer class actions related to these laws and the overall protection of personal information. Even if we are not determined to have violated the law, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our reputation and our business.

In addition to the United States, there are significant privacy and data security laws that apply in Europe and other countries. For example, the European Union’s General Data Protection Regulation (“EU GDPR”) and the United Kingdom’s (“UK”) GDPR (“UK GDPR”) (collectively, “GDPR”) impose strict requirements for processing personal data. For example, the collection, use, disclosure, transfer, or other processing of personal information, including personal health data, regarding individuals who are located in the European Economic Area (“EEA”) is subject to the GDPR. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal information, including strict rules on the transfer of personal information to countries outside the EU, including the United States. The GDPR also permits data protection authorities to require destruction of improperly gathered or used personal information and/or impose substantial fines for violations of the GDPR, which can be up to four percent of annual global revenues or 20 million Euros, whichever is greater, and it also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. In addition, the GDPR provides that EU member states may make their own further laws and regulations limiting the processing of personal information, including genetic, biometric or health data. As a result, there is increased scrutiny on the extent to which clinical trial sites located in the EEA should apply the GDPR to transfers of personal information from such sites to countries that are considered to lack an adequate level of data protection, such as the United States. Similar obligations and risks are associated with the United Kingdom’s version of the GDPR. The requirements and uncertainty around this and other data protection and data transfer regimes have the potential to impact our business.

These evolving compliance and operational requirements related to privacy and data protection impose significant costs that are likely to increase over time. Preparing for and complying with such requirements is rigorous and time-intensive. It requires significant resources and a review of our technologies, systems and practices, as well as those of any third-party collaborators, service providers, contractors or consultants that process or transfer personal information, and may require us to modify our data processing practices and policies, divert resources from other initiatives and projects, and restrict the way products and services involving data are offered. Further, current and future laws or regulations associated with the enhanced protection of certain types of sensitive data, such as healthcare data or other personal information from any clinical trials we may conduct, could require us to change our business practices and put in place additional compliance mechanisms, interrupt or delay our development, regulatory and commercialization activities and increase our cost of doing business, and could lead to government enforcement actions, private litigation and significant fines and penalties against us. Any of these events could have a material adverse effect on our business, financial condition, results of operations and prospects.

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control, the U.S. Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, third-party intermediaries, joint venture partners and collaborators from authorizing, promising, offering or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector. We may have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. In addition, we may engage third-party intermediaries to promote any clinical research activities we may pursue abroad and/or to obtain necessary permits, licenses, and other regulatory approvals. We can be held liable for the corrupt or other illegal activities of these third-party intermediaries, our employees, representatives, contractors, partners and agents, even if we do not explicitly authorize or have actual knowledge of such activities.

Noncompliance with the laws and regulations described above could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, suspension and/or debarment from contracting with

certain persons, the loss of export privileges, reputational harm, adverse media coverage and other collateral consequences. If any subpoenas, investigations or other enforcement actions are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, results of operations and financial condition could be materially harmed. In addition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense and compliance costs and other professional fees. In certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor which can result in added costs and administrative burdens.

As a result of numerous changes in tariffs and trade restrictions that have been announced and/or implemented by the Trump administration since taking office, and other countries in response to Trump administration actions, and the underlying uncertainty currently surrounding international trade, we could experience a negative impact on our costs of materials or supply chain disruptions and delays. If, in connection with any development activities we may pursue, we are unable to obtain necessary raw materials or product components in sufficient quantity and in a timely manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, the development, testing and clinical trials of any product candidates we may develop may be delayed or rendered infeasible, and regulatory approval or commercial launch of any resulting product may be delayed, which could significantly harm our business. We cannot yet predict the effect of recently imposed U.S. tariffs, or of possible future U.S. tariffs, including, but not limited to, tariffs on pharmaceuticals, pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients and key starting materials, and derivative products of those items, on imports, or the extent to which other countries will impose quotas, duties, tariffs, taxes or other similar restrictions upon imports or exports in the future, nor can we predict future trade policy or the terms of any renegotiated trade agreements and their impact on our business.

Trade tensions and conflicts between the United States and China have been escalating in recent years and, as such, we could be exposed to the possibility of product supply disruption and increased costs and expenses in the event of changes to the laws, rules, regulations and policies of the governments of the United States or China, or as a result of geopolitical unrest or unstable economic conditions. Certain Chinese biotechnology companies may become subject to trade restrictions, sanctions, other regulatory requirements or proposed legislation by the U.S. government, which could restrict or even prohibit our ability to work with such entities, thereby potentially disrupting the supply of material to us. For example, in February 2024, U.S. lawmakers called for investigations into and the imposition of possible trade sanctions against certain Chinese biotechnology companies, including WuXi AppTec and WuXi Biologics over alleged ties to the Chinese military. Sustained uncertainty about or further escalating trade and political tensions between the United States and China may prevent or hinder the export of materials or technical information between us and third parties, such as pharmaceutical partners, or could result in trade or retaliatory restrictions that may hinder or potentially inhibit our ability to rely on any contract development and manufacturing organizations or other service providers that operate in China. These third parties may voluntarily require compliance or supply chain requirements that go above and beyond potential legislation to address perceived risk of “pass through,” which would make it difficult for us to operate our business.

In December 2025, Congress enacted a law that, subject to certain grandfather provisions, will prohibit U.S. federal agencies from procuring or obtaining “biotechnology equipment or services” from certain Chinese companies designated as “biotechnology companies of concern.” It will also prohibit U.S. federal agencies from entering into, extending or renewing contracts with any entity that either uses biotechnology equipment or services provided by a designated biotechnology company of concern in performance of the contract or enters into any contract with a third party that requires either party to use biotechnology equipment or services produced or provided by a biotechnology company of concern. It also prohibits an executive agency from obligating or expending a loan or grant to procure biotechnology equipment or services produced or provided by a designated biotechnology company of concern. Regulatory or legislative action taken by the U.S. government to impose restrictions on transactions with China, like the restrictions described above, could have the potential to severely restrict the ability of companies like ours to contract with Chinese biotechnology companies of concern, which could have adverse effects on any development of product candidates we may pursue and our business operations.

Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may increase the cost of manufacturing any product candidates we may develop, affect the demand for any products we may commercialize if approved, the competitive position of any product candidates we may develop, and the import or export of raw materials and finished product candidate used in any preclinical studies or clinical trials we or our collaborators may conduct, particularly with respect to any product candidates and materials that we may import from China. If any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated or, in particular, if either the U.S. or Chinese government takes retaliatory trade actions due to the recent trade tension, such changes could have an adverse effect on our business, financial condition and results of operations.

We are 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. From time to time and in the future, our operations may involve the use of hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste products. Even if we contract with third parties for the disposal of these materials and waste products, we cannot completely eliminate the risk of contamination or injury resulting from these materials. In the event of contamination or injury resulting from the use or disposal of our hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

We maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials; however, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Current or future environmental laws and regulations may impair any research, development or production efforts we may pursue. In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions.

We are exposed to the risk of fraud or other misconduct by our employees, independent contractors, consultants and vendors and, to the extent we engage them, CROs, commercial partners and principal investigators. Misconduct by these parties could include intentional failures to comply with FDA regulations or the regulations applicable in the EU and other jurisdictions, provide accurate information to the FDA, the European Commission and other regulatory authorities, comply with healthcare fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately, or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

Such misconduct also could involve the improper use of information obtained in the course of clinical trials or interactions with the FDA or other regulatory authorities, which could result in regulatory sanctions and cause serious harm to our reputation. Even with appropriate policies and procedures, it is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent such activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition, results of operations and prospects, including the imposition of significant fines or other sanctions.

In June 2024, the U.S. Supreme Court issued an opinion in Loper Bright Enterprises v. Raimondo holding that courts reviewing agency action pursuant to the Administrative Procedure Act “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision has impacted how lower courts evaluate challenges to agency interpretations of law, including those by the FDA, HHS, CMS and other agencies with significant oversight of the biopharmaceutical industry. This is likely to increase both the frequency of such challenges and their odds of success by eliminating one way in which the government previously prevailed in such cases. As a result, significant regulatory policies will be subject to increased litigation and judicial scrutiny.

In addition, federal agency activities, priorities, leadership, policies, rulemaking, communications, spending and staffing may be significantly impacted by election cycles and legislative developments. For example, the current presidential administration aims to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agencies, such as the FDA, HHS and CMS. Efforts by the current administration to limit federal agency budgets or personnel may result in reductions to agency budgets, employees and operations. The administration and agencies have also made abrupt announcements about new or changed regulatory policies, such as policies related to use of artificial intelligence (“AI”) to review product applications. Additionally, any federal government shutdowns may prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, and may significantly impact the ability of the FDA to timely review and process any regulatory submissions we may make. These developments may lead to slower response times and longer review periods, potentially affecting any development of product candidates we may pursue or our ability to obtain regulatory approval for any such product candidates. Any resulting changes in regulation may result in unexpected delays, increased costs, or other negative impacts on our business that are difficult to predict.

We are highly dependent on the management, research and development, clinical, financial and business development expertise of our executive officers, as well as the other members of our scientific and clinical teams. Although we have employment offer letters which outline the terms of employment with each of our executive officers, each of them may terminate their employment with us at any time. As such, these employment offer letters do not guarantee our retention of our executive officers for any period of time. We do not maintain “key person” insurance for any of our employees.

Recruiting and retaining qualified scientific and clinical personnel and, if we are successful in obtaining marketing approval for any product candidates, sales and marketing personnel, would be critical to our success. The loss of the services of our executive officers or other key employees could impede the achievement of any research, development and commercialization objectives we may pursue and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and other key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval for and commercialize product candidates. We are based in the Boston area, a region that is home to many other biopharmaceutical companies as well as many academic and research institutions, resulting in fierce competition for qualified personnel. Furthermore, to the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output. We may also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we may rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating any research and development strategy we may pursue. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to attract and retain high-quality personnel as needed, our ability to pursue our growth strategy will be limited, and could harm our business, prospects, financial condition and results of operations.

A cyberattack or similar incident could occur and result in information theft, data corruption, operational disruption, damage to our reputation, or financial loss. We are increasingly dependent on information technology systems and infrastructure, including mobile technologies and third-party service providers, to operate our business. Our technologies, systems, networks, or other proprietary information, and those of our vendors, suppliers and other business partners, may become the target of cyberattacks or information security breaches that could result in the unauthorized release, gathering, monitoring, misuse, loss, or destruction of proprietary and other information, or could otherwise lead to the disruption of our business operations. The risk of a security breach or disruption, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. Moreover, certain cyber incidents, such as advanced persistent threats, may remain undetected for an extended period and could lead to disruptions in critical systems or the unauthorized release of confidential or otherwise protected information. These events could lead to financial loss and other adverse consequences, for instance due to remedial actions, loss of business, disruption of operations, damage to our reputation, or potential liability. Our systems and insurance coverage for protecting against cybersecurity risks may not be sufficient. Furthermore, as cyberattacks continue to evolve, we may be required to expend significant additional resources to continue to modify or enhance our protective measures or to investigate and remediate any vulnerability to cyberattacks.

Despite the implementation of security measures, our internal computer systems and those of any third parties with whom we work, such as CROs and other contractors, vendors and consultants, may be vulnerable to damage from cybersecurity threats, including attempts to gain unauthorized access to and to harm sensitive or confidential information and networks, insider threats, and ransomware. These vulnerabilities may be heightened as a result of flexible work arrangements.

Investigations into and remedial efforts in connection with any security incidents, even those with immaterial impact, can be costly and time-consuming and could be material, or cause significant disruption, to our business. For example, the loss of clinical trial data from any clinical trials we may conduct could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we may rely on third parties for research and development, the manufacture and supply of drug product and drug substance and to conduct clinical trials. We depend on these third parties to implement adequate controls and safeguards to protect against, detect, report and remediate cybersecurity incidents. If they fail to do so or are otherwise impacted by security incidents, we may suffer financial and other harm, including to our information, operations, performance, and reputation. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or systems, or inappropriate disclosure of confidential or proprietary information, we could incur liability and any further development and commercialization of product candidates could be delayed.

Cybersecurity threats, both on premises and in the cloud, are evolving and include, but are not limited to: malicious software, destructive malware, ransomware, attempts to gain unauthorized access to systems or data, disruption to operations, critical systems or denial of service attacks; unauthorized release of confidential, personal or otherwise protected information; corruption of data, networks or systems; harm to individuals; and loss of assets. In addition, we could be impacted by cybersecurity threats or other disruptions or vulnerabilities found in products or services we use that are provided to us by third parties, for instance via supply chain attacks. The techniques used by criminal elements and state-sponsored actors to attack computer systems are sophisticated, change frequently and may originate from less regulated and remote areas of the world. As a result, we may not be able to address these techniques proactively or implement adequate preventative measures. These events, if not prevented or effectively mitigated, could damage our reputation, require remedial actions and lead to loss of business, regulatory actions, potential liability and other financial losses.

Certain data breaches may also be required to be reported to affected individuals and various government and/or regulatory agencies, under provisions of HIPAA, as amended by the HITECH Act, other U.S. federal and state laws, and requirements of non-U.S. jurisdictions, including the EU Data Protection Directive, and financial penalties may also apply.

Our insurance policies may not be adequate to compensate us for the potential losses arising from security breaches, failures or disruptions of our infrastructure, catastrophic events and disasters or otherwise. In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, our insurance may not cover all claims made against us and defending a suit, regardless of its merit, could be costly and divert management’s attention.

We depend on our employees, consultants and other service providers, including any contract manufacturers and CROs we may engage, for the continued operation of our business. Our or their operations could be significantly disrupted by earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, ice and snowstorms, extreme weather conditions, medical epidemics or pandemics, wars or other armed conflicts, geopolitical tensions or trade wars, terrorist attacks, and other natural or man-made disasters or business interruptions, for which we are, and they may be, predominantly self-insured. To the extent we develop product candidates and rely on third-party contract manufacturers to produce them, our ability to obtain clinical supplies for such product candidates could be disrupted if the operations of these suppliers were affected by a man-made or natural disaster or other business interruption. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

In addition, unfavorable economic conditions both inside and outside the U.S., including, without limitation, heightened inflation, capital market volatility, interest rate and currency rate fluctuations, any potential economic slowdown or recession, banking disruptions, public health crises and geopolitical events, including trade wars or civil or political unrest (such as the ongoing war between Ukraine and Russia and conflict in the Middle East), have resulted in a significant disruption of global financial markets. If the disruption persists or deepens, we could experience an increase in our costs and expenses, including an increase in financing costs, and restrictions on our access to potential sources of future capital. If we are unable to raise additional capital when needed or on attractive terms, our business, financial condition, stock price and results of operations could be adversely affected, and we could be forced to delay, reduce or altogether terminate one or more future research and development programs. Further, we hold our cash and cash equivalents that we use to meet our working capital and operating expense needs in deposit accounts at multiple financial institutions, and if a financial institution in which we hold such funds fails or is subject to significant adverse conditions in the financial or credit markets, we could be subject to a risk of loss of all or a portion of any uninsured funds or be subject to a delay in accessing all or a portion of such uninsured funds. Any such loss or lack of access to these funds could adversely impact our short-term liquidity and ability to meet our operating expense obligations. In addition, there is a risk that one or more service providers, manufacturers and other partners on which we may rely may not survive such difficult economic times, which could directly affect our ability to attain our operating goals. Any of the foregoing could harm our business, future revenue and financial condition.

We may seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:

Any of these factors could harm our future international expansion and operations and, consequently, our results of operations.

From time to time, we may engage in other strategic transactions, such as acquisitions of companies, asset purchases and out-licensing or in-licensing of intellectual property, products or technologies. Additional potential transactions that we may consider in the future include a variety of business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments. Any future transactions could increase our near and long-term expenditures, result in potentially dilutive issuances of our equity securities, including Werewolf Common Stock, or the incurrence of debt, contingent liabilities, amortization expenses or acquired in-process research and development expenses, any of which could affect our financial condition, liquidity and results of operations. Future acquisitions may also require us to obtain additional financing, which may not be available on favorable terms or at all. These transactions may never be successful and may require significant time and attention of management. In addition, the integration of any business that we may acquire in the future may disrupt our existing business and may be a complex, risky and costly endeavor for which we may never realize the full benefits of the acquisition. Accordingly, although there can be no assurance that we will undertake or successfully complete any additional transactions of the nature described above, any additional transactions that we do complete could have a material adverse effect on our business, results of operations, financial condition and prospects.

We are required to comply with the continued listing requirements of Nasdaq including, among other things, maintaining a minimum closing bid price of $1.00 per share, referred to as the minimum bid price requirement. On February 4, 2026, we received a deficiency letter (the “Notice”) from the Nasdaq Listing Qualifications Department (the “Staff”) notifying us that we had failed to meet the minimum bid price requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were provided an initial period of 180 calendar days, which expired on August 3, 2026, to regain compliance with the minimum bid price requirement. We did not regain compliance during this initial compliance period.

Following the expiration of the initial compliance period, Nasdaq granted us an additional 180-calendar-day period, expiring on January 30, 2027, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of Werewolf Common Stock must be at least $1.00 per share for a minimum of 10 consecutive business days during this additional compliance period, at which time the Staff will provide written notification to us that we have regained compliance with the minimum bid price requirement, unless the Staff exercises its discretion to extend this ten-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H).

As of the date of this proxy statement/prospectus, we have not regained compliance with the minimum bid price requirement. There can be no assurance that we will regain compliance during the additional compliance period. If we do not regain compliance by the expiration of the additional compliance period, the Staff will notify us that Werewolf Common Stock is subject to delisting, which determination we may appeal to a Nasdaq Hearings Panel. Werewolf Common Stock would remain listed pending the panel's decision, although there can be no assurance that any such appeal would be successful.

Any delisting of Werewolf Common Stock from Nasdaq would have a material adverse effect on the market for, and liquidity and price of, Werewolf Common Stock and would adversely affect our ability to raise capital on terms

acceptable to us, or at all. Delisting from Nasdaq could also have other negative consequences, including, without limitation, the potential loss of confidence by investors, customers and employees and fewer business development opportunities. Delisting would also make it more difficult for Werewolf stockholders to sell their shares of Werewolf Common Stock in the public market.

Werewolf’s Common Stock price is likely to be volatile. For example, from January 1, 2025, until July 27, 2026, Werewolf’s Common Stock price has ranged from $0.27 to $2.38. The stock market in general and the market for biotechnology and pharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell their common stock at an attractive price or at all. The market price for Werewolf Common Stock may be influenced by many factors, including:

In addition, in the past, stockholders have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market prices of these companies’ stock. This risk is especially relevant for us because biopharmaceutical companies have experienced significant stock price volatility in recent years. Such litigation, if instituted against us, could cause us to incur substantial costs and divert management’s attention and resources from our business.

The trading market for Werewolf Common Stock relies, in part, on the research and reports that securities or industry analysts publish about us or our business. We do not have research control over these analysts. There can be no assurance that existing analysts will continue to cover us or that new analysts will begin to cover us. There is also no assurance that any covering analysts will provide favorable coverage. Although we have obtained coverage, if one or more of the analysts covering us downgrade Werewolf Common Stock or publish unfavorable or inaccurate research about our business, Werewolf Common Stock price may decline. If one or more of these analysts cease coverage of our Company or fail to publish reports on us regularly, demand for Werewolf Common Stock could decrease, which might cause Werewolf Common Stock price and trading volume to decline.

Our management has broad discretion in the application of our cash and cash equivalents. We could utilize our cash and cash equivalents in ways Werewolf stockholders may not agree with or that do not yield a favorable return, if any, and our management might not apply our cash and cash equivalents in ways that ultimately increase the value of Werewolf stockholders’ investments. If we do not utilize our cash and cash equivalents in ways that enhance stockholder value, we may fail to achieve expected financial results, which could cause Werewolf Common Stock price to decline.

We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future.

As a public company, we incur significant legal, accounting and other expenses that we did not previously incur as a private company. The Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), the Dodd-Frank Wall Street Reform and Consumer Protection Act, Nasdaq listing requirements, and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel have and will need to continue to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs, particularly as we hire additional financial and accounting employees to meet public company internal control and financial reporting requirements and will make some activities more time-consuming and costly compared to when we were a private company.

We are continually evaluating these rules and regulations and cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities. If, notwithstanding our efforts to comply with new laws, regulations and standards, we fail to comply, regulatory authorities may initiate legal proceedings against us and our business may be harmed.

Pursuant to Section 404 of the Sarbanes-Oxley Act (“Section 404”), we are required to furnish a report by our management on our internal control over financial reporting. However, while we remain an emerging growth company or a smaller reporting company with less than $100.0 million in annual revenue, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we are engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, including through hiring additional financial and accounting personnel, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404. If we identify one or more material weaknesses in our internal control over financial reporting, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

In the past, we have identified material weaknesses in our internal control over financial reporting. All material weaknesses previously identified have been fully remediated.

If, in the future we have a material weakness in our internal controls over financial reporting, we may not detect errors on a timely basis and our consolidated financial statements may be materially misstated. We or our independent registered public accounting firm may not be able to conclude on an ongoing basis that we have effective internal control over financial reporting, which could harm our operating results, cause investors to lose confidence in our reported financial information and cause the trading price of Werewolf Common Stock to fall. In addition, as a public company, we are required to file accurate and timely quarterly and annual reports with the SEC under the Exchange Act. Any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from the Nasdaq Global Select Market or other adverse consequences that would materially harm our business. In addition, we could become subject to investigations by the stock exchange on which our securities are listed, the SEC, and other regulatory authorities, and become subject to litigation from investors and stockholders, which could harm our reputation and our financial condition, or divert financial and management resources from our core business.

Effective internal control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, is designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. As discussed above, we have identified material

weaknesses in the past which have since been remediated. However, our remediation of previous material weaknesses may not prevent any future deficiency in our internal control over financial reporting. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could harm our business and have a negative effect on the trading price of Werewolf Common Stock.

We are required to disclose changes made in our internal controls and procedures on a quarterly basis, and our management is required to assess the effectiveness of these controls annually. However, for as long as we are an emerging growth company under the Jumpstart Our Business Startups Act (the “JOBS Act”), enacted in April 2012 or a smaller reporting company with less than $100.0 million in annual revenue, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404. We could be an emerging growth company for up to five years. An independent assessment of the effectiveness of our internal control over financial reporting could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation, which could have a negative effect on the trading price of Werewolf Common Stock.

We are subject to certain reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal control over financial reporting, 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 realities 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 our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected.

Provisions in the Werewolf Charter and the Third Amended and Restated Bylaws of Werewolf (the “Werewolf Bylaws”) may discourage, delay or prevent a merger, acquisition or other change in control of our Company that stockholders may consider favorable, including transactions in which Werewolf stockholders might otherwise receive a premium for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of Werewolf Common Stock, thereby depressing the market price of Werewolf Common Stock. In addition, because the Werewolf Board is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by Werewolf stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of the Werewolf Board. Among other things, these provisions:

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the DGCL which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

The Werewolf Charter provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, if the Court of Chancery of the State of Delaware does not have jurisdiction, the federal district court for the District of Delaware) will be the sole and exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

These choice of forum provisions will not apply to suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions, and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Accordingly, both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, the Werewolf Charter provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any claims arising under the Securities Act. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of the Werewolf Charter. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

These exclusive forum provisions may limit the ability of Werewolf stockholders to bring a claim in a judicial forum that such stockholders find favorable for disputes with us or our directors, officers or employees, and increase the costs to such stockholders of bringing such a claim, either of which may discourage such lawsuits against us and our directors, officers and employees. If a court were to find either exclusive forum provision contained in the Werewolf Charter to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving such action in other jurisdictions, all of which could materially adversely affect our business, financial condition and operating results.

Throughout this “Risks Related to Ambros” section, unless otherwise indicated or the context otherwise requires, references to the “Company,” “we,” “us,” “our” and other similar terms refer to Ambros.

We are a clinical-stage biopharmaceutical company with a limited operating history. Since our inception in September 2024, we have focused primarily on organizing, staffing, and financing our company, conducting research and development activities, conducting clinical development of, and manufacturing development for, our only product

candidate, neridronate, and establishing and protecting our intellectual property portfolio. Biopharmaceutical product development is a highly speculative undertaking, involving substantial upfront capital expenditure and significant risk. Neridronate or any future product candidates we develop may fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval or become commercially viable, despite substantial investment in development or commercialization. To date, we have not demonstrated our ability to successfully complete a clinical trial, obtain regulatory approvals, manufacture a product on a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing biopharmaceutical products. We continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred losses in each year since our inception. For the years ended December 31, 2025 and 2024, we had net losses of $24.2 million and $16.6 million, respectively. For the six months ended June 30, 2026, we had a net loss of $19.9 million. As of June 30, 2026, we had an accumulated deficit of $60.8 million. We expect to continue to incur significant losses for the foreseeable future and expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our only product candidate, neridronate, along with any future product candidates we may develop.

We anticipate that our expenses will increase substantially if, and as, we:

To become and remain profitable, we and any current and potential future collaborators must develop and eventually commercialize products with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies, if applicable, and clinical trials, manufacturing neridronate and any future product candidates, either on our own or with Abiogen Pharma S.p.A. (“Abiogen”), other potential future partners and CMOs, obtaining marketing approval for neridronate or any future product candidates, marketing and selling any products for which we may obtain marketing approval and satisfying any post-marketing requirements. We may never succeed in any or all of these activities and, even if we do, we may never generate revenue that is significant or large enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability. Our failure to become and remain profitable would decrease the value of the company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.

Even if we succeed in commercializing one or more of neridronate or any future product candidates, we will continue to incur substantial research and development and other expenditures to develop and market additional product candidates. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. Our future results of operations will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.

The development of biopharmaceutical product candidates, including conducting preclinical studies and clinical trials, is a time-consuming, capital-intensive and uncertain process. Our operations have consumed substantial amounts of cash since inception. To date, we have funded our operations primarily with proceeds from the sale of convertible promissory notes and preferred stock. We expect our expenses to increase in connection with our ongoing activities, particularly as we advance our CRPS-RISE Phase 3 trial of neridronate in participants with complex regional pain syndrome (“CRPS”) type 1 (“CRPS-1”) and to the extent that we research, develop and initiate clinical trials of any future product candidates. In addition, if we successfully develop and obtain regulatory approval for neridronate or any future product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or any future commercialization efforts.

As of June 30, 2026, we had cash, cash equivalents and short-term investments of approximately $103.2 million. Based on current operating assumptions, we expect that our existing cash, cash equivalents and short-term investments as of the date of this proxy statement/prospectus, together with the expected net proceeds from the Concurrent PIPE Financing, will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2029. In addition, our cash forecasts, including the Ambros Cash Forecast, are based on assumptions that may prove to be wrong, and we could use our available capital resources earlier than we currently expect. Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional financing sooner than planned. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

Future capital requirements for neridronate or any of our other product development programs will depend on many factors, including:

We cannot be certain that additional funding will be available on acceptable terms or at all. Until we can generate sufficient product or other revenue to finance our cash requirements, which we may never achieve, we expect to finance our future cash requirements through a combination of equity offerings, debt financings or other capital sources, including potential collaborations, out-licenses or dispositions and other similar arrangements.

Our ability to raise additional funds will depend on financial, economic and market conditions and other factors, over which we may have no or limited control. Market volatility resulting from geopolitical and economic instability, including as a result of trade policy, inflation and international disputes, such as the wars between Russia and Ukraine and in the Middle East, or other factors could also adversely impact our ability to access capital as and when needed. If adequate funds are not available on commercially acceptable terms when needed, we may be forced to delay, reduce or terminate the development or commercialization of all or part of our research programs or product candidates or we may be unable to take advantage of future business opportunities.

We have not received approval from any regulatory authority for any product candidate, and we do not have any product approved for commercial sale. We currently only have one product candidate, neridronate, and our business and future success depend entirely on our ability to develop, obtain regulatory approval for, and then successfully commercialize neridronate, which is currently in Phase 3 clinical development for patients with CRPS-1. Neridronate is currently marketed in Italy by Abiogen under the trade name NERIXIA® for the treatment of osteogenesis imperfecta, Paget’s disease of bone and CRPS-1 pursuant to an Italian marketing authorization held by Abiogen; however, this Italian approval was obtained by and belongs to Abiogen, not to us. We have no rights to commercialize neridronate in Italy, and the existence of Abiogen’s Italian marketing authorization does not provide any assurance that we will obtain regulatory approval for neridronate in any other jurisdiction or that any such approval, if obtained, will be on terms consistent with the Italian authorization. We have not sought regulatory advice outside of the U.S. and, while our focus and valuation are based on the U.S., any expansion outside of the U.S. may require new clinical studies and/or other costly elements. This may make an investment in our company riskier than similar companies that have multiple product candidates in active development that may be able to better sustain failure of a lead product candidate.

The success of neridronate will depend on several factors, including the following:

If we do not achieve one or more of these factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays or an inability to develop, obtain regulatory approvals or commercialize neridronate.

Even if regulatory approvals are obtained, we may never be able to successfully commercialize neridronate. In addition, we will need to transition at some point from a company with a development focus to a company capable of supporting commercial activities. We may not be successful in such a transition. Accordingly, even if we receive marketing approval, we may not be able to generate sufficient revenue through the sale of neridronate to continue our business.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, out-licenses or dispositions and other similar arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that may adversely affect the rights of our stockholders. Debt and equity financings, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as redeeming shares, making investments, incurring additional debt, making capital expenditures, declaring dividends or placing limitations on our ability to acquire, sell or license intellectual property rights.

If we raise additional capital through future collaborations, strategic alliances or third-party licensing arrangements, we may have to relinquish certain valuable rights to our intellectual property, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional capital when needed, we may be required to delay, limit, reduce or terminate our clinical development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Successful development of pharmaceutical products involves a lengthy and expensive process, is highly uncertain and is dependent on numerous factors, many of which are beyond our control. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including:

Furthermore, the length of time necessary to complete clinical trials and submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product candidate to the next and from one country or jurisdiction to another and may be difficult to predict. We may face significant setbacks as we conduct our CRPS-RISE Phase 3 trial in CRPS-1, such as difficulty finding and enrolling qualified patients (given CRPS-1 is a rare disease), challenges related to delays in diagnosis and delays in referral putting potential participants outside of the allowed timeframe, delays related to identifying and activating suitable clinical trial sites, the potential need to add additional trial sites, and difficulty in retaining participants throughout the 12-week study and open-label extension, which may delay or prevent regulatory approval of neridronate. For example, neridronate was the subject of prior clinical development by Grünenthal. During that prior development program, neridronate received Breakthrough Therapy and Orphan Drug designation (for CRPS) and Fast Track designation (for CRPS-1) in the U.S. The FDA required two adequate and well-controlled trials of at least 12 weeks’ duration to support a chronic pain indication, and the FDA also outlined the NDA safety database requirements applicable to neridronate. Grünenthal completed the required toxicology and clinical pharmacology work and generated a large safety database in support of its development program. However, Grünenthal’s two Phase 3 trials were terminated early following a pooled, pre-specified interim futility analysis. We have since received and maintained these designations, including Breakthrough Therapy and Orphan Drug designation for the treatment of CRPS and Fast Track designation for the treatment of CRPS-1 in the U.S. Although we believe we have benefited from the regulatory groundwork established during the prior development program, there can be no assurance that the FDA or a comparable foreign regulatory authority will view the prior data as sufficient to support our potential application for marketing approval or that we will not encounter similar or additional delay.

Even if we are successful in obtaining marketing approval, commercial success of any approved products will also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations in the United States or country-specific governmental organizations in foreign countries where we have commercialization rights for neridronate and any future product candidates, which may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare. Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost-effectiveness of a product, to qualify for reimbursement, which could be costly and divert our resources. There may be additional complexities around reimbursement procedures for an intravenous (“IV”) treatment that we anticipate will be delivered, if approved, to patients outside of a hospital setting. If government and other healthcare payors were not to provide coverage and adequate reimbursement for our products once approved, market acceptance and commercial success would be reduced. Even if we are able to obtain coverage and adequate reimbursement for our products once approved, there may be features or characteristics of our products, such as dose preparation requirements, that prevent our products from achieving market acceptance by the healthcare or patient communities.

In addition, if neridronate or any future product candidates receive marketing approval in jurisdictions where we have commercialization rights, the product may be approved for a more limited indication or patient population than we originally request, and the FDA or comparable foreign regulatory authorities may not approve or authorize the labeling

that we believe is necessary or desirable for the successful commercialization of a product candidate. In addition, the FDA or comparable foreign regulatory authorities may change their policies, issue additional regulations or revise existing regulations, or take other actions, including as a result of judicial challenges to regulatory policy, which may prevent or delay approval of our future products under development on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations we may have obtained.

Even if we obtain regulatory approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports and registration and will need to continue to comply (or ensure that our third-party providers comply) with GMPs and GCPs for any clinical trials that we conduct post-approval. In addition, there is the risk that we, a regulatory authority or a third party might identify previously unknown problems with a product post-approval, such as adverse events of unanticipated severity or frequency. Compliance with these requirements is costly, and any failure to comply or other issues with neridronate or any future product candidates post-approval could adversely affect our business, financial condition and results of operations.

To obtain the requisite regulatory approvals to market and sell neridronate or any future product candidates, we or our current and future collaborators must demonstrate through extensive preclinical studies and clinical trials that our product candidates are safe and effective for use in each targeted indication. 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 clinical development process. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization. We may be unable to establish clinical endpoints that applicable regulatory authorities would consider clinically meaningful, and a clinical trial can fail at any stage of testing. Further, the process of obtaining regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved, as well as the target indications, patient population and regulatory agency. Prior to obtaining approval to commercialize neridronate and any future product candidates in the United States or in jurisdictions where we have commercialization rights, we or our current and future collaborators must demonstrate with substantial evidence from adequate and well-controlled clinical trials and post-approval safety data provided from jurisdictions in which neridronate or any future product candidates have received marketing approval, if applicable, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product candidates are safe and effective for their intended uses.

Our clinical trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of, or deny approval of, neridronate or any future product candidates for any or all targeted indications. Even if this does not occur, reports of serious reactions could affect patient recruitment or the ability of enrolled patients to complete the trial. Moreover, if we elect, or are required, to not initiate, delay, suspend or terminate any future clinical trial of any of our product candidates, the commercial prospects of such product candidates may be harmed and our ability to generate product revenues from any of these product candidates may be delayed or eliminated. Any of these occurrences may harm our ability to develop other product candidates, and may harm our business, financial condition and prospects significantly.

Further, if our product candidates are associated with side effects in clinical trials or have characteristics that are unexpected, we may need to abandon their development or limit development to more narrow uses in which the side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. The FDA, an institutional review board, data monitoring committee or comparable foreign regulatory authorities may also require that we suspend, discontinue, or limit our clinical trials based on safety information, or that we conduct additional animal or human studies regarding the safety and efficacy of our product candidates which we have not planned or anticipated. Such findings could further result in regulatory authorities failing to provide marketing authorization for our product candidates or limiting the scope of the approved indication, if approved. Many product candidates that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of the product candidate.

Clinical trials that we conduct may not demonstrate the efficacy and safety necessary to obtain regulatory approval to market neridronate or any future product candidates. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in

and adherence to the clinical trial protocols, placebo-response rates, and the rate of dropout among clinical trial participants. If the results of our ongoing or potential future clinical trials are inconclusive with respect to the efficacy of neridronate or any future product candidates, if we do not meet the clinical endpoints with statistical and clinically meaningful significance, or if there are unanticipated safety concerns associated with neridronate or any future product candidates, we may need to conduct additional clinical trials or be delayed in obtaining marketing approval, if approval is received at all. Additionally, any unexpected safety concerns observed in any one of our current or potential future clinical trials in our current or potential future targeted indications could limit the prospects for regulatory approval of neridronate or any future product candidates in those and other indications.

Even if the trials are completed to our satisfaction, clinical and post-approval data are often susceptible to varying interpretations and analyses or may not provide a sufficient risk-benefit ratio, and we cannot guarantee that the FDA or comparable foreign regulatory authorities in countries where we have commercialization rights will interpret the results as we do or find a risk-benefit ratio for a proposed indication acceptable, and more trials could be required before we submit neridronate or any future product candidates for approval. We cannot guarantee that the FDA or comparable foreign regulatory authorities in countries where we have commercialization rights will view neridronate or any future product candidates as having efficacy even if we believe results observed in clinical trials are positive. Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that other jurisdiction. To the extent that the results of the trials or data from post-approval treatment populations are not satisfactory to the FDA or comparable foreign regulatory authorities in countries where we have commercialization rights for support of a marketing application, approval of neridronate and any future product candidates may be significantly delayed, may not occur, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of neridronate or any future product candidates. Even if regulatory approval is secured for neridronate or any future product candidate, the terms of such approval may limit the scope and use of the specific product candidate, which may also limit our commercial potential.

The results of preclinical studies and early-stage clinical trials may not be predictive of the results of later-stage clinical trials, and results in one indication may not predict results for the same product candidate in another indication. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Furthermore, there can be no assurance that any clinical trials, whether conducted by us or our current and future collaborators, will ultimately be successful or support further clinical development of neridronate or any future product candidates. There is a high failure rate for product candidates proceeding through clinical trials. Many companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development and any such setbacks in our clinical development could have a material adverse effect on our business and operating results. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in preclinical studies and clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain regulatory approval. Further, negative clinical trial results or post-approval data from other markets for a product candidate with respect to one indication may impact the potential or perceived potential of other indications. If neridronate or any future product candidates fail to demonstrate satisfactory characteristics in late-stage clinical trials, it could have a material adverse effect on our business, financial condition and results of operations.

In addition, the trial design for CRPS-RISE incorporates the precision medicine eligibility criteria validated in the Abiogen Phase 3 program and is supported by the results of the late-stage and registrational clinical trials conducted by Abiogen, specifically, the NERIAS Phase 3 trial and, to a lesser extent, the NAIMES Phase 3 trial. Differences in patient demographics, disease duration at enrollment, standard of care, clinical practice patterns, and healthcare delivery systems and regulatory approval requirements may mean that the results of Abiogen’s Phase 3 trials are not predictive of the outcome of CRPS-RISE or of our ability to obtain FDA approval. For example, in 2013, rights to neridronate for global development were licensed to Grünenthal, which conducted several clinical trials of neridronate, including two

global Phase 3 clinical trials. The Grünenthal trials differed substantially from the Abiogen Phase 3 trials in their patient eligibility criteria, and when approximately 80 participants across both Grünenthal Phase 3 trials had completed the week 12 primary endpoint visit, a pre-specified futility analysis was conducted, resulting in early termination of both Phase 3 trials, and the rights were returned.

Similarly, post-approval data from the Italian commercial use of neridronate may not be predictive of outcomes in other contexts, given the differences described above. The FDA may disagree with our interpretation of Abiogen’s Phase 3 or post-approval data, may require additional clinical data beyond what we currently anticipate, or may not accept foreign clinical data as sufficient support for U.S. approval, any of which could require us to conduct additional clinical trials, delay our NDA submission to the FDA, or result in denial of approval. There can be no assurance that the FDA will view the Abiogen Phase 3 NERIAS data as sufficient to support assessment of the safety of neridronate in CRPS and sufficient to support approval of neridronate in the United States for the treatment of CRPS-1, even in combination with positive results from CRPS-RISE.

Undesirable side effects that may be caused by neridronate or any future product candidates could cause us, institutional review boards, data monitoring committees or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities in countries where we have commercialization rights. While our product candidate, neridronate, has generally been observed to be well tolerated in its preclinical studies and clinical trials to date, and in post-marketing safety data from Italy, the results from our ongoing CRPS-RISE Phase 3 trial of neridronate, and preclinical studies and clinical trials of any future product candidates, may identify safety concerns or other undesirable properties of neridronate or any future product candidates.

The results of our ongoing CRPS-RISE Phase 3 trial of neridronate and future clinical trials of other future product candidates may show that neridronate or any future product candidates cause undesirable or unacceptable side effects or even death. For example, while neridronate is expected to have a safety profile similar to other IV bisphosphonates given at a high dose over a short time frame, new or unanticipated safety findings or findings occurring at a much higher rate than has been seen with other IV bisphosphonates may occur. For example, CRPS-RISE participants may experience osteonecrosis of the jaw, a rare side effect seen in the post-marketing data from Italy. In such an event, our clinical trials could be suspended, varied or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of neridronate or any future product candidates for any or all targeted indications. These potential drug-related side effects could affect participant recruitment or the ability of enrolled participants to complete the trials or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. Furthermore, we may be required to expend time and incur costs to train medical personnel using neridronate or any future product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of neridronate or any future product candidates. Finally, the independent data monitoring committee that reviews CRPS-RISE safety data may recommend changes to trial procedures that halt the trial or delay the timing of, or adversely affect the likelihood of success of, a regulatory filing. Such recommendations may halt the trial, make the trial enrollment more difficult or impact the final labeling (if approved). Any of these occurrences may harm our business, financial condition and results of operations significantly.

Moreover, if neridronate or any future product candidates are associated with undesirable side effects in preclinical studies, clinical trials, post-approval treatments or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for the product candidate, if approved. Although approximately 600,000 patients across all approved indications have been treated with neridronate in Italy, the safety profile in patients in the United States with CRPS-1 is unknown and may be different than observed in other populations. Furthermore,

post-approval data is inherently subject to underreporting and does not capture all adverse effects with the same rigor of a controlled clinical trial. As such, results from our clinical trials or post-approval treatment populations in other markets could reveal a high and unacceptable severity and prevalence of side effects.

Additionally, adverse developments in clinical trials of pharmaceutical and biopharmaceutical products conducted by others may cause the FDA or other regulatory oversight bodies to suspend or terminate our clinical trials or to change the requirements for approval of neridronate or any future product candidates. For example, adverse events such as meaningful adverse renal events, osteonecrosis of the jaw, eye inflammation and femoral fractures may occur. Such adverse events in participants in our trials may lead to additional review by the independent data monitoring committee or regulatory authorities, which in turn may lead to protocol amendments, clinical holds or other actions that delay or significantly diminish the approval prospects for neridronate or any future product candidates. Furthermore, we have study stopping rules that, if triggered by the appearance of certain adverse events, would cause CRPS-RISE to cease.

Additionally, if neridronate or any future product candidates receive marketing approval in a country where we have commercialization rights and we or others later identify undesirable or unacceptable side effects caused by such product, a number of potentially significant negative consequences could result, including:

Any of these events could prevent us or our current and potential future partners from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of neridronate or any future product candidates, if approved.

From time to time, we or our current and future collaborators may publish interim, topline or preliminary data from our current or future clinical trials. Preliminary and interim data from our current or future clinical trials may change as more patient data become available. Preliminary or interim data from our clinical trials are not necessarily predictive of final results. Preliminary and interim data are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, more patient data become available and we issue our final clinical trial report. Interim, topline and preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, preliminary, topline and interim data should be viewed with caution until the final data are available. Moreover, in connection with any data that may be presented, caution should be exercised in drawing any conclusions from a comparison of data that does not come from head-to-head analysis. Material differences in the final data compared to the interim data could significantly harm our business prospects. Additionally, data from a clinical trial as of any measurement date are only reflective of observations in such clinical trial at such date and should not be unduly used to predict any effect at a later measurement date.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could delay or prevent regulatory approval of, or limit commercial prospects for, the particular product candidate and harm our business prospects. In addition, the information we or our current and future collaborators choose to publicly disclose regarding a particular preclinical study, clinical trial or post-approval analysis is based on what is typically extensive information, and you or others may not agree with what we determine to include in our public disclosure. If the preliminary and interim data that are reported differ from actual results or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, neridronate or any future product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

Patient enrollment and retention in clinical trials is a significant factor in the timing of clinical trials and depends on many factors, including the size and nature of the patient population, the eligibility criteria for the clinical trial, the nature of the trial protocol, the existing body of safety and efficacy data with respect to the study drug from other clinical trials, the number, nature and duration of competing treatments and ongoing clinical trials of competing drugs for the same indication and the proximity of patients to clinical trial sites. As we or our current and future collaborators progress our programs, we or our current and future collaborators may not be able to initiate or continue clinical trials for any product candidates we identify or develop if we or our current and future collaborators are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or other comparable foreign regulatory authorities in countries where we have commercialization rights or as needed to provide appropriate statistical power for a given trial. Potential patients for any planned clinical trials may not be adequately or timely diagnosed or identified with the diseases which we are targeting or may not meet the entry criteria for such trials. We or our current and future collaborators also may encounter difficulties in identifying and enrolling patients with a stage of disease appropriate for our planned clinical trials and monitoring such patients adequately during and after treatment. Other pharmaceutical companies targeting these same diseases are recruiting clinical trial patients from these patient populations, which may make it more difficult to fully enroll our clinical trials.

In addition, we and our current and future collaborators may, in the future, compete for trial participants with other clinical trials for product candidates that are in the same areas as neridronate or any future product candidates, which could reduce the number and types of participants available to us and our current and future collaborators and could affect the timing and cost of our clinical trials. For example, some participants who might have opted to enroll in our or our current and future collaborators’ clinical trials may instead opt to enroll in a clinical trial being conducted by one of our competitors or to use marketed therapies that may then be available. Delay in recruiting clinical trial participants could adversely affect our ability to bring a product to market prior to our competitors and increase trial costs. Further, research and discoveries by others may result in breakthroughs that render neridronate or any future product candidates obsolete even before they begin to generate any revenue.

The eligibility criteria of our clinical trials, once established, may further limit the pool of available trial participants. For example, our CRPS-RISE Phase 3 trial requires that enrolled participants have a symptom duration of six months or less, exhibit warm phase clinical features, and have a positive triple-phase bone scan (“TPBS”). If the actual number of patients that meet such criteria is smaller than we anticipate or patients are not diagnosed quickly enough to meet the symptom duration requirements, we may encounter difficulties in enrolling patients in our clinical trials, thereby delaying or preventing development and approval of neridronate or any future product candidates. Even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our trials.

Furthermore, our or our current and future collaborators’ efforts to build relationships with patient communities may not succeed, which could result in delays in patient enrollment in our clinical trials. In addition, any negative results that have been or may be reported in clinical trials of a product candidate may make it difficult or impossible to recruit and retain patients in other clinical trials of that same product candidate or other product candidates. Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our or our current and future collaborators’ ability to develop neridronate or any future product candidates or could render further development impossible. Further, if patients drop out of our clinical trials, miss scheduled doses or follow-up visits or otherwise fail to follow clinical trial protocols, the integrity of data from our clinical trials may be compromised or not accepted by the FDA or other comparable foreign regulatory authorities in countries where we have commercialization rights, which would represent a significant setback for the applicable

program. Prior clinical trials of neridronate have in the past experienced and we may in the future experience participant withdrawals and discontinuations. Withdrawal of participants from our clinical trials may compromise the quality of our data. In addition, we and our current and future collaborators may rely on CROs and clinical trial sites to ensure proper and timely conduct of our future clinical trials and, while we intend to enter into agreements governing their services, we will be limited in our ability to compel their actual performance. Such delays or failures could adversely affect our business, operating results and prospects.

From time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include our expectations regarding the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings. From time to time, we may publicly announce the expected timing of some of these milestones, such as the completion of an ongoing clinical trial or the initiation of other clinical programs. All of these milestones are and will be based on numerous assumptions, including:

The actual timing of these milestones can vary dramatically compared to our estimates, in some cases for reasons beyond our control. If we do not meet these milestones as publicly announced, or at all, the commercialization of neridronate or any future product candidates may be delayed or never achieved and, as a result, the value of Ambros Common Stock may decline.

Obtaining and maintaining marketing approval of neridronate or any future product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain marketing approval in any other jurisdiction. For example, although neridronate is approved in Italy for treatment of CRPS-1, it does not mean that the FDA or comparable regulatory authorities in foreign jurisdictions where we have commercialization rights will also approve the manufacturing, marketing and promotion and reimbursement of neridronate in those countries. In addition, a failure or delay in obtaining marketing approval in one jurisdiction may negatively impact the marketing approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, 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 United States where we have commercialization rights, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for neridronate or any future product candidates is also subject to approval. The price set in one jurisdiction may also have an impact on the price of neridronate in the U.S., which could adversely affect our financial condition and results of operations.

The research, development, testing, quality control, safety, effectiveness, manufacturing, labeling, packaging, storage, record-keeping, advertising, promotion, marketing, import, export, distribution, post-approval monitoring and post-approval reporting of our neridronate or any future product candidates are subject to extensive regulation by the FDA in the United States and by comparable foreign regulatory authorities in foreign markets. In the United States, neither we nor any current or future collaborators are permitted to market neridronate or any future product candidates until we receive regulatory approval from the FDA. The process of obtaining regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved, as well as the target indications and patient population. Approval policies or regulations may change, new relevant statutes or regulations may be enacted, and the FDA and other comparable foreign regulatory authorities have substantial discretion in the drug approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Regulatory authorities may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other data. Despite the time and expense invested in clinical development of product candidates, regulatory approval is never guaranteed.

The FDA generally expects sponsors entering Phase 3 to have quality systems and procedures in a mature, well-documented state; these systems are typically developed and refined over the course of earlier clinical phases. Because Ambros did not build its own quality infrastructure through Phase 1 and Phase 2 development of neridronate, FDA inspections and audits of our operations, including pre-approval inspections in connection with our NDA, may be more complex, more intensive, and subject to heightened scrutiny than inspections of sponsors that have progressively developed their quality systems over time. Despite our best efforts to implement robust quality management systems, any deficiencies identified in the course of such inspections could adversely affect the approvability of our NDA, require remediation that delays potential approval, or result in additional pre-approval requirements. Furthermore, we rely substantially on Abiogen, our contracted CROs, and other third-party partners to maintain quality standards commensurate with FDA and applicable foreign regulatory authority requirements across the supply chain and in the conduct of CRPS-RISE. We have limited ability to control the quality systems and day-to-day compliance activities of these third parties, and any failure by Abiogen, our CROs, or other partners to maintain adequate quality procedures could trigger regulatory findings that are attributed to our overall program and could have a material adverse effect on our ability to obtain or maintain regulatory approval for neridronate.

Prior to obtaining approval to commercialize a product candidate in the United States or abroad, we or our potential future collaborators must demonstrate with substantial evidence from adequate and well-controlled clinical trials, and to the satisfaction of the FDA or other comparable foreign regulatory authorities in countries where we have commercialization rights, that such product candidates are safe and effective for their intended uses. Results from preclinical studies and clinical trials can be interpreted in different ways. Even if we believe the data for neridronate or any future product candidates are promising, such data may not be sufficient to support approval by the FDA and other comparable foreign regulatory authorities in countries where we have commercialization rights, which could require us to delay or abandon clinical development plans.

In addition, regulatory authorities may require further preclinical studies before evaluating neridronate or any future product candidates in a clinical trial. Once we initiate clinical trials, the FDA or other comparable foreign regulatory authorities may require additional clinical trials, place our trials on clinical hold or suggest changes to our planned clinical trials, prior to and in support of the approval of a marketing application. Changes to data requirements by the FDA or other comparable foreign regulatory authorities during the development of our current and future product candidates may cause the applicable regulatory authorities to require us to conduct additional preclinical studies or clinical trials for neridronate or any future product candidates either prior to or post-approval, or regulatory authorities may object to elements of our clinical development program.

The FDA or other comparable foreign regulatory authorities in countries where we have commercialization rights can delay, limit or deny approval of a product candidate for many reasons, including:

With respect to foreign markets, events raising questions about the safety of certain marketed pharmaceuticals may result in increased cautiousness by the FDA and other comparable foreign regulatory authorities in countries where we have commercialization rights in reviewing new drugs based on safety, efficacy or other regulatory considerations and may result in significant delays in obtaining regulatory approvals. Any delay in obtaining, or inability to obtain, applicable regulatory approvals would prevent us or any of our potential future collaborators from commercializing neridronate or any future product candidates.

Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market neridronate or any future product candidates, which would significantly harm our business, financial condition, results of operations and prospects.

CRPS-1 has been the subject of numerous clinical drug development programs by prior sponsors, including large, well-resourced pharmaceutical companies, many of which have not demonstrated efficacy in adequately powered, well-controlled randomized clinical trials. With respect to bisphosphonates specifically, a large Phase 3 program in CRPS-1 was conducted by Grünenthal, which initiated two global, randomized, double-blind, placebo-controlled Phase 3 trials of IV neridronate in CRPS patients. Following a pre-specified futility analysis conducted when approximately 80 participants across both Grünenthal Phase 3 trials had completed the week 12 primary endpoint visit, both trials were terminated early and the rights were returned. In addition to the Grünenthal program, clinical programs sponsored by Axsome Therapeutics, Celgene Corporation, and Takeda/Millennium Pharmaceuticals evaluating distinct investigational agents in CRPS have also not demonstrated efficacy in broad CRPS populations.

This history of development failures may adversely affect our prospects from a regulatory development perspective. CRPS-RISE incorporates several design features that we believe distinguish it from the Grünenthal Phase 3 program, including: enrollment of participants with CRPS-1 only (not CRPS type 2 (“CRPS-2”)), a requirement for a positive TPBS as an enrollment criterion, restriction of symptom duration to six months or less from CRPS-1 onset, and a requirement that enrolled participants exhibit warm phase clinical features. The FDA may not agree with our scientific rationale for these design differences, may view CRPS-RISE as insufficiently distinguished from prior failed programs, or may determine that the primary endpoint, patient population size, or analytical approach are not adequate to support approval. If the FDA raises concerns about the trial design at any stage, we may be required to amend the protocol, conduct additional studies, or provide additional data, any of which could delay our development timeline and increase our costs.

Moreover, there is a risk that the design differences between CRPS-RISE and the Grünenthal trials are not sufficient to produce a statistically significant and clinically meaningful treatment effect distinguishable from the outcomes seen in those prior programs. Our eligibility criteria may not fully eliminate the sources of heterogeneity that contributed to the Grünenthal results, and CRPS-RISE may produce results that are mixed, inconclusive, or indicative of futility, as occurred in one of the two Grünenthal trials. If CRPS-RISE fails to achieve its primary endpoint or produces results that are ambiguous or insufficient, that would have a material adverse effect on our clinical program, our regulatory prospects, and our business, financial condition, and results of operations.

The FDA has provided guidance regarding the design of our ongoing Phase 3 clinical trial and indicated that a single, very persuasive, adequately controlled Phase 3 study may be reasonable to support NDA submission for neridronate in CRPS-1. The acceptability of the approach would be predicated on study design, robustness of the results and strength of confirmatory evidence. We have designed our CRPS-RISE clinical trial in reliance on FDA guidance. The FDA also provided guidance regarding the size of our safety database and indicated that it may be reasonable, unless there are novel safety concerns that arise during clinical development. However, FDA guidance provided in the context of development meetings is not legally binding and does not guarantee approval or any particular regulatory outcome. The FDA retains the authority to change its position at any time. For example, if the data from CRPS-RISE are ambiguous, the observed treatment effect size is smaller than anticipated, the safety profile requires further characterization, or the FDA determines that the patient population enrolled in CRPS-RISE is not sufficiently representative of the broader CRPS-1 population for which approval is sought, the FDA may determine that additional clinical trials are necessary before it will approve neridronate. The FDA may also apply heightened scrutiny to our NDA given the history of clinical development failures in CRPS-1, including the early termination of the Grünenthal Phase 3 program, and may require a more robust data package than its prior guidance suggested. In addition, the FDA’s guidance was provided based on the information available at the time of our meeting, and changes in the regulatory environment, the emergence of new safety information, or developments in the broader CRPS-1 clinical landscape could cause the FDA to revise its position.

If the FDA determines that a single Phase 3 trial is not sufficient, requires us to conduct one or more additional pivotal trials or requires us to modify CRPS-RISE, we would face substantial additional time and cost to comply with the FDA’s requests. Conducting an additional Phase 3 trial in CRPS-1 (or implementing substantial changes to CRPS-RISE) would likely require several years and significant capital expenditure, could delay potential approval and commercialization by several years, and might require us to raise additional capital on terms that may not be favorable to us or our stockholders. There can be no assurance that we would be able to raise such capital when needed or on acceptable terms. Any such delay or additional capital requirement could have a material adverse effect on our business, financial condition, results of operations, and prospects.

The ability of the FDA and applicable foreign authorities in countries where we have commercialization rights to review and approve new product candidates 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. Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of other government agencies 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 may also slow the time necessary for new drugs to be reviewed and approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government shut down several times and certain regulatory agencies, such as the FDA, furloughed or laid off critical employees and ceased critical activities. If a prolonged government shutdown or disruption occurs, it could significantly impact the ability of the FDA and applicable foreign authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. In addition, such issues could also prevent the FDA or applicable foreign authorities from conducting their regular inspections, reviews or other regulatory activities, which in turn could significantly impact the ability of such authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

On June 28, 2024, the U.S. Supreme Court issued an opinion holding that courts reviewing agency action pursuant to the Administrative Procedure Act “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision will have a significant impact on how lower courts evaluate challenges to agency interpretations of law, including those by the FDA and other agencies with significant oversight of the biopharmaceutical industry. The new framework is likely to increase both the frequency of such challenges and their odds of success by eliminating one way in which the government previously prevailed in such cases. As a result, significant regulatory policies will be subject to increased litigation and judicial scrutiny. Any resulting changes in regulation may result in unexpected delays, increased costs, or other negative impacts on our business that are difficult to predict.

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. In order to obtain orphan drug designation, the request must be made before submitting an NDA. In the United States, 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. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. Comparable foreign regulatory authorities may have similar orphan drug designation regimes with varying eligibility criteria and benefits.

If a product that has orphan drug designation subsequently receives the first FDA approval of that particular product for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. As a result, even if one of our product candidates receives orphan exclusivity, the FDA can still approve

other drugs for use in treating the same indication or disease or the same drug for a different indication or disease during the exclusivity period. Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture sufficient supply of our product or if a subsequent applicant demonstrates clinical superiority over our product.

We have received orphan drug designation for neridronate in the United States for the treatment of CRPS. Additionally, we may seek orphan drug designation for some or all of any future product candidates in specific orphan indications. Even if we obtain orphan drug designation, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if we are unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition, or if a subsequent applicant demonstrates clinical superiority over our products, if approved. Similar considerations may apply in other jurisdictions where we may seek orphan drug designation. In addition, although we may seek orphan drug designation for other product candidates, we may never receive such designations. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.

We have obtained Breakthrough Therapy Designation from the FDA for neridronate for the treatment of CRPS, and we may seek additional Breakthrough Therapy Designations for our current and future product candidates where we believe the clinical data support such designation. A “Breakthrough Therapy” is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition, where preliminary clinical evidence indicates that the drug or biologic 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 product candidates that have been designated as Breakthrough Therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Products designated as Breakthrough Therapies are also eligible for priority review if supported by clinical data at the time of NDA or efficacy supplement submission.

Designation as a Breakthrough Therapy is within the discretion of the FDA. Accordingly, even if we believe additional product candidates meet the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a Breakthrough Therapy Designation for a product candidate may not result in a faster development process or review and does not assure ultimate approval by the FDA. In addition, even if one or more of our product candidates qualify as Breakthrough Therapies, the FDA may later decide that the product candidate no longer meets the conditions for qualification and rescind the designation.

We have obtained Fast Track designation for neridronate for the treatment of CRPS-1, and we may seek additional Fast Track designations for other product candidates we may develop. If a drug or biologic is intended for the treatment of a serious or life-threatening condition and the drug or biologic demonstrates the potential to address unmet medical needs for this condition, the sponsor may apply for Fast Track designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even if we do receive Fast Track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from the clinical development program. Fast Track designation alone does not guarantee qualification for the FDA’s priority review procedures.

We do not currently plan to conduct clinical trials of neridronate outside of the United States, but we may need to do so should we encounter difficulties recruiting participants in CRPS-RISE. Prior clinical trials for neridronate have been conducted in Italy, including the NERIAS and NAIMES Phase 3 trials. The acceptance of data by the FDA or any comparable foreign regulatory authority in countries where we have commercialization rights from clinical trials conducted outside, or post-treatment populations located outside, their respective jurisdictions may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials or post-treatment populations are intended to serve as the basis for marketing approval in the United States, 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 are performed by clinical investigators of recognized competence and pursuant to compliance with current GCP requirements and (iii) the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA’s clinical trial requirements, including the adequacy of the patient population studied and statistical powering, must be met. In addition, such foreign trials are subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA will accept data from trials conducted outside of the U.S., including data from prior clinical trials of neridronate in other jurisdictions. If the FDA 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 our business plan, and which may result in neridronate or any future product candidates not receiving approval for commercialization in the applicable jurisdiction.

Conducting trials outside the United States also exposes us to additional risks, including risks associated with: