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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): January 6, 2026

 

 

DAY ONE BIOPHARMACEUTICALS, INC. 

(Exact name of registrant as specified in its charter)

 

 

Delaware   001-40431   83-2415215
(State or Other Jurisdiction
of Incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)
 

 

1800 Sierra Point Parkway, Suite 200

Brisbane, California 94005

(Address of Principal Executive Offices, including Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 484-0899

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading
Symbol(s)
 
  Name of each exchange
on which registered
 
Common Stock, par value $0.0001 per share   DAWN   Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company ¨

 

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

 

 

 

 

 

Introductory Note.

 

As previously disclosed in the Current Report on Form 8-K filed with the Securities and Exchange Commission (“SEC”) by Day One Biopharmaceuticals, Inc., a Delaware corporation (“Parent”) on November 13, 2025, the Parent entered into an Agreement and Plan of Merger (the “Merger Agreement”), dated as of November 12, 2025, with Emerald Merger Sub, Inc., a Delaware corporation and a direct wholly owned subsidiary of the Parent (“Merger Sub”), and Mersana Therapeutics, Inc., a Delaware corporation (“Target”). Pursuant to the Merger Agreement, on December 5, 2025, Parent, through Merger Sub, commenced a tender offer to purchase all of the issued and outstanding shares (the “Target Shares”) of Target’s common stock, par value $0.0001 per share (the “Target Common Stock”), for (i) $25.00 per Target Share (the “Upfront Consideration”), net to the stockholder in cash, without interest and less any applicable tax withholding, plus (ii) one non-tradable contingent value right (each, a “CVR”) per Target Share, representing the right to receive certain contingent payments of up to an aggregate amount of $30.25 per CVR in cash, without interest, less any applicable tax withholding, upon the achievement of certain specified milestones on or prior to the applicable milestone outside dates in accordance with the terms and conditions set forth in the Contingent Value Rights Agreement (the “CVR Agreement”), entered into with Computershare Inc., a Delaware corporation and Computershare Trust Company, N.A., a federally chartered trust company (together, the “Rights Agent”) (the Upfront Consideration plus the CVR, collectively, the “Offer Price”), upon the terms and subject to the conditions set forth in the Offer to Purchase, dated December 5, 2025 (together with any amendments or supplements thereto, the “Offer to Purchase”) and in the related Letter of Transmittal (together with any amendments or supplements thereto, the “Letter of Transmittal” and, collectively with the Offer to Purchase, the “Offer”). The Offer to Purchase and the Letter of Transmittal were filed as Exhibits (a)(1)(A) and (a)(1)(B), respectively, to the Tender Offer Statement on Schedule TO originally filed with the SEC by Merger Sub and Parent on December 5, 2025.

 

Item 1.01Entry into a Material Definitive Agreement.

 

Contingent Value Rights Agreement

 

Pursuant to the Merger Agreement, on January 6, 2026, the Parent and the Rights Agent entered into the CVR Agreement governing the terms of the CVRs issued pursuant to the Offer and the Merger (as defined below). The Rights Agent will maintain an up-to-date register of the holders of CVRs (the “Holders”). Holders will not be permitted to transfer the CVRs (subject to certain limited exceptions as set forth in the CVR Agreement).

 

Each CVR represents the right to receive the following contingent cash payments, without interest, subject to any applicable tax withholding (each, a “Milestone Payment”), conditioned upon the achievement of the following milestones (the “Milestones”) within the following specified time periods:

 

(i)$1.00 per CVR, without interest and less any applicable tax withholding, payable upon the U.S. Food and Drug Administration (the “FDA”) granting “breakthrough therapy” designation in the United States for emiltatug ledadotin (XMT-1660) (“Emi-Le”) on or before December 31, 2027;

 

(ii)$1.25 per CVR, without interest and less any applicable tax withholding, payable upon receipt by Parent or any of its affiliates (including the surviving corporation) of the $8.0 million milestone payment payable upon achievement of a specified development milestone set forth in that certain Research Collaboration and License Agreement, dated as of February 2, 2022, by and between the Target and Janssen Biotech, Inc., on or before December 31, 2026;

 

(iii)$4.00 per CVR, without interest and less any applicable tax withholding, payable upon occurrence of the first dosing of the first participant in a Registrational Clinical Trial (as defined in the CVR Agreement) of Emi-Le for adenoid cystic carcinoma type 1 (“ACC-1”) on or before December 31, 2027;

 

(iv)$9.00 per CVR, without interest and less any applicable tax withholding, payable upon the occurrence of Regulatory Approval (as defined in the CVR Agreement) by the FDA for Emi-Le indicated for use in ACC-1 on or before December 31, 2030;

 

 

 

 

(v)$2.00 per CVR, without interest and less any applicable tax withholding, payable upon the achievement of the first time that cumulative Net Sales (as defined in the CVR Agreement) of Emi-Le in any calendar year ending on or before December 31, 2032 is equal to or exceeds $100.0 million;

 

(vi)$4.00 per CVR, without interest and less any applicable tax withholding, payable upon the achievement of the first time that cumulative Net Sales of Emi-Le in any calendar year ending on or before December 31, 2035 is equal to or exceeds $200.0 million;

 

(vii)$6.00 per CVR, without interest and less any applicable tax withholding, payable upon the achievement of the first time that cumulative Net Sales of Emi-Le in any calendar year ending on or before December 31, 2037 is equal to or exceeds $300.0 million;

 

(viii)$2.00 per CVR, without interest and less any applicable tax withholding, payable upon the occurrence of the First Commercial Sale (as defined in the CVR Agreement) of Emi-Le in the first to occur of France, Germany, Italy, Spain or the United Kingdom (the “European First Sale Milestone”) on or before December 31, 2030 (the “European First Sale Milestone End Date”); provided, however, that the European First Sale Milestone will be deemed to have occurred if, at any time on or before the European First Sale Milestone End Date, cumulative Net Sales of Emi-Le in the European Union and the United Kingdom is equal to or exceeds $10.0 million; and

 

(ix)$1.00 per CVR, without interest and less any applicable tax withholding, payable upon the First Commercial Sale of Emi-Le in Japan on or before December 31, 2030.

 

With respect to each Milestone, until the earlier of the date on which such Milestone has been achieved and the applicable milestone outside date, as applicable, Parent (directly or through its assignees or their respective affiliates or certain sublicensees of any of the foregoing) is obligated to use certain specified commercially reasonable efforts to achieve such Milestone. There can be no assurance that any Milestone will be achieved on or before the applicable milestone outside date or that any Milestone Payments will be made.

 

The foregoing description of the CVR Agreement is not complete and is qualified in its entirety by reference to the CVR Agreement, a copy of which is attached hereto as Exhibit 10.1 and incorporated herein by reference.

 

Item 2.01Completion of Acquisition or Disposition of Assets.

 

The information set forth in the Introductory Note and Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 2.01.

 

The Offer and related withdrawal rights expired as scheduled at one minute after 11:59 p.m., Eastern time, on January 5, 2026 (such date and time, the “Expiration Date”). Merger Sub was advised by Computershare Trust Company, N.A., the depositary for the Offer, that as of the Expiration Date, a total of 3,029,135 Target Shares had been validly tendered (and not validly withdrawn) pursuant to the Offer, representing approximately 60.57% of the issued and outstanding Target Common Stock as of the Expiration Date. As of the Expiration Date, the number of Target Shares validly tendered and not validly withdrawn pursuant to the Offer satisfied the Minimum Condition (as defined in the Merger Agreement), and all other conditions to the Offer were satisfied. Promptly after the Expiration Date, Merger Sub irrevocably accepted for payment all Target Shares validly tendered and not validly withdrawn pursuant to the Offer and payment of the Offer Price for such Target Shares was made promptly in accordance with the terms of the Offer and the Merger Agreement. Parent completed the acquisition of Target on January 6, 2026, by causing Merger Sub to merge with and into Target (the “Merger”) pursuant to the Merger Agreement without any action by Target stockholders in accordance with Section 251(h) of the Delaware General Corporation Law (the “DGCL”). At the effective time of the Merger (the “Effective Time”), Merger Sub was merged with and into Target, the separate existence of Merger Sub ceased and Target continued as a direct wholly owned subsidiary of Parent.

 

 

 

 

At the Effective Time, each Target Share issued and outstanding immediately prior to the Effective Time (other than Target Shares owned by Target, Parent or Merger Sub or by any of their respective subsidiaries (or held in Target’s treasury), which were cancelled and ceased to exist, and no consideration was delivered in exchange therefor) was cancelled and ceased to exist, and (other than any Target Shares held by holders who were entitled to appraisal rights under Section 262 of the DGCL and who properly exercised and perfected such holder’s respective demands for appraisal and, as of the Effective Time, had not effectively withdrawn or lost such holder’s rights to such appraisal and payment under the DGCL), was converted into the right to receive the Offer Price, without interest, subject to any applicable tax withholding.

 

In addition, pursuant to the terms of the Merger Agreement, effective as of immediately prior to the Effective Time, by virtue of the Merger, without any action on the part of Target, Parent or the holder thereof: (i) each option to purchase Target Common Stock that was outstanding and unexercised as of immediately prior to the Effective Time and that had an exercise price per Target Share that is less than the Upfront Consideration (“Cash-Out Options”), became fully vested and was canceled and converted into the right to receive (a) the Offer Price minus (b) the exercise price payable per share of Target Common Stock underlying such Cash-Out Option, without interest and less any applicable tax withholding, and (ii) each restricted stock unit, which represents the right to receive one share of Target Common Stock, that was outstanding immediately prior to the Effective Time, whether or not then vested, was canceled and converted into the right to receive the Offer Price, without interest and less any applicable tax withholding.

 

The aggregate cash paid by Parent and Merger Sub in the Offer and the Merger on January 6, 2026 was approximately $128.8 million, which was funded by Parent from its available cash on hand.

 

The foregoing summary of the Offer, the Merger, the Merger Agreement and the transactions contemplated thereby does not purport to be complete and is qualified in its entirety by reference to the Merger Agreement, a copy of which is attached hereto as Exhibit 2.1 and incorporated herein by reference.

 

Item 7.01Regulation FD Disclosure.

 

On January 6, 2026, Parent issued a press release announcing the closing of the Merger. A copy of the press release is attached hereto as Exhibit 99.1.

 

On January 6, 2026, Parent made available a corporate presentation containing an overview of the Parent’s pipeline, financial results and opportunities. A copy of the corporate presentation is attached hereto as Exhibit 99.2.

 

This information and Exhibits 99.1 and 99.2 are being furnished pursuant to Item 7.01 of this report and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by Parent under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference. This report will not be deemed an admission as to the materiality of any information in this Item 7.01 or Exhibits 99.1 and 99.2.

 

 

 

 

Cautionary Note Regarding Forward-Looking Statements

 

This report contains forward-looking statements. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “will”, “goal” and similar expressions. These forward-looking statements include, without limitation, statements related to the payment and timing of payment of the Offer to holders of Target Shares, the CVR Agreement, the expected benefits from the acquisition of Target, and other statements that are not historical facts. These forward-looking statements are based on Parent’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the outcome of legal proceedings that may be instituted against Parent and/or others relating to the transactions and the risk that such legal proceedings may result in significant costs of defense, indemnification and liability; disruption from the transactions, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; the risk that Parent will not be able to retain the employees of Target following the closing of the transaction given the at-will nature of their employment; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of clinical trials and reporting data; risks related to future opportunities and plans for Target and its product candidates, including uncertainty of the expected financial performance of Target and its product candidates and the possibility that the Milestone Payments related to the CVRs will never be achieved and that no Milestone Payment may be made; the possibility that if Target does not achieve the perceived benefits of the proposed transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price of Parent’s shares could decline; as well as other risks related to Parent’s business detailed from time-to-time under the caption “Risk Factors” and elsewhere in Parent’s SEC filings and reports, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent quarterly and current reports filed with the SEC. Parent undertakes no duty or obligation to update any forward-looking statements contained in this report as a result of new information, future events or changes in their expectations, except as required by law.

 

Item 9.01Financial Statements and Exhibits.

 

(a) Financial Statements of Business Acquired.

 

The financial statements required by this Item 9.01(a) will be filed by amendment to this Current Report on Form 8-K not later than 71 calendar days after the date on which this Current Report on Form 8-K is required to be filed.

 

(b) Pro Forma Financial Information.

 

The unaudited pro forma condensed combined financial information of Parent as of and for the nine months ended September 30, 2025 and the year ended December 31, 2024 required by this Item 9.01(b) will be filed by amendment to this Current Report on Form 8-K not later than 71 calendar days after the date on which this Current Report on Form 8-K is required to be filed.

 

(d) Exhibits.

 

Exhibit Number   Description
2.1*#   Agreement and Plan of Merger, dated November 12, 2025, by and among Mersana Therapeutics, Inc., Day One Biopharmaceuticals, Inc., and Emerald Merger Sub, Inc. (incorporated by reference to Exhibit 2.1 to the Current Report on Form 8-K (File No. 001-38129) filed by Mersana Therapeutics, Inc. with the Securities and Exchange Commission on November 13, 2025)
10.1**   Contingent Value Rights Agreement, dated as of January 6, 2026, by and between Day One Biopharmaceuticals, Inc., Computershare Inc. and Computershare Trust Company, N.A.
99.1**   Press Release, dated January 6, 2026.
99.2**   Corporate Presentation.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

*Previously filed.
**Filed herewith.
#Certain annexes, exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplemental copies of any of the omitted annexes and schedules upon request by the SEC.

 

 

 

 

SIGNATURE

 

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

 

Dated: January 6, 2026

 

DAY ONE BIOPHARMACEUTICALS, INC.  
     
By: /s/ Charles N. York II, M.B.A.  
  Charles N. York II, M.B.A.  
  Chief Operating Officer and Chief Financial Officer  

 

 

  

Exhibit 10.1

 

Contingent Value Rights Agreement

 

This Contingent Value Rights Agreement, dated as of January 6, 2026 (this “Agreement”), is entered into by and between Day One Biopharmaceuticals, Inc., a Delaware corporation (“Parent”), and Computershare Inc., a Delaware corporation (“Computershare”), and its affiliate, Computershare Trust Company, N.A., a federally chartered trust company (“Computershare Trust” and, together with Computershare, the “Rights Agent”), as Rights Agent.

 

RECITALS

 

Whereas, Parent, Emerald Merger Sub, Inc., a Delaware corporation and a wholly-owned direct subsidiary of Parent (“Merger Sub”), and Mersana Therapeutics, Inc., a Delaware corporation (the “Company”), have entered into an Agreement and Plan of Merger, dated as of November 12, 2025 (as it may be amended, amended and restated, modified or supplemented from time to time pursuant to the terms thereof, the “Merger Agreement”), pursuant to which, (a) Parent caused Merger Sub to commence a tender offer (as it may be amended, modified or extended from time to time as permitted under the Merger Agreement, the “Offer”) to acquire all of the outstanding shares of common stock, $0.0001 par value per share, of the Company (“Company Common Stock” or “Company Shares”) and (b) following the acceptance for payment for the shares of Company Common Stock pursuant to the Offer, Merger Sub will merge at the Effective Time with and into the Company (the “Merger”), with the Company surviving the Merger as a subsidiary of Parent (the “Surviving Corporation”) and as a wholly owned direct subsidiary of Parent;

 

Whereas, pursuant to the terms of the Merger Agreement, Parent has agreed to provide, in each of the Offer and the Merger, (a) the holders of Company Shares (other than Cancelled Shares and other than any Dissenting Company Shares) as of immediately prior to the Effective Time and (b) holders of Cash-Out Options and Company RSU Awards as of immediately prior to the Effective Time the right to contingent cash payments as hereinafter described upon the terms and subject to the conditions of this Agreement and the Merger Agreement without interest and subject to reduction for any applicable withholding Taxes;

 

Whereas, the Rights Agent is willing to act in connection with the issuance, transfer, exchange and payment of such contingent value rights as provided herein.

 

Now, Therefore, in consideration of the premises and mutual agreements herein and the consummation of the transactions referred to above, Parent and the Rights Agent hereby agree, for the equal and proportionate benefit of all Holders (as defined below), as follows:

 

1.             DEFINITIONS; RULES OF CONSTRUCTION

 

1.1            Definitions. Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the Merger Agreement, unless otherwise expressly set forth herein. As used in this Agreement, the following terms shall have the following meanings:

 

ACC-1” means adenoid cystic carcinoma type 1.

 

 

 

 

Acting Holders” means, at the time of determination, Holders of at least 30% of the outstanding CVRs as set forth on the CVR Register.

 

Agreement” has the meaning set forth in the Preamble.

 

Annual Net Sales Milestone I” means the first time that cumulative Net Sales of Emi-Le in any calendar year ending on or before the Annual Net Sales Milestone I End Date is equal to or exceeds $100.0 million.

 

Annual Net Sales Milestone I Amount” means, with respect to the achievement of the Annual Net Sales Milestone I, an amount per CVR equal to $2.00.

 

Annual Net Sales Milestone I End Date” means December 31, 2032.

 

Annual Net Sales Milestone II” means the first time that cumulative Net Sales of Emi-Le in any calendar year ending on or before the Annual Net Sales Milestone II End Date is equal to or exceeds $200.0 million.

 

Annual Net Sales Milestone II Amount” means, with respect to the achievement of the Annual Net Sales Milestone II, an amount per CVR equal to $4.00.

 

Annual Net Sales Milestone II End Date” means December 31, 2035.

 

Annual Net Sales Milestone III” means the first time that cumulative Net Sales of Emi-Le in any calendar year ending on or before the Annual Net Sales Milestone III End Date is equal to or exceeds $300.0 million.

 

Annual Net Sales Milestone III Amount” means, with respect to the achievement of the Annual Net Sales Milestone III, an amount per CVR equal to $6.00.

 

Annual Net Sales Milestone III End Date” means December 31, 2037.

 

“Breakthrough Therapy Designation Milestone” means the granting of “breakthrough therapy” designation in the U.S. by the FDA for Emi-Le on or before the Breakthrough Therapy Designation Milestone End Date.

 

Breakthrough Therapy Designation Milestone Amount” means, with respect to the achievement of the Breakthrough Therapy Designation Milestone, an amount per CVR equal to $1.00.

 

Breakthrough Therapy Designation Milestone End Date” means December 31, 2027.

 

Change of Control” means (i) a sale or other disposition of all or a majority of the assets of either Parent or the Surviving Corporation on a consolidated basis (other than to any direct or indirect wholly owned subsidiary of Parent), (ii) a merger, consolidation or other similar business combination transaction involving either Parent or the Surviving Corporation in which Parent or the Surviving Corporation, respectively, is not the surviving entity and (iii) any other transaction involving either Parent or the Surviving Corporation in which Parent or the Surviving Corporation, respectively, is the surviving entity but in which the stockholders of Parent or the Surviving Corporation, respectively, as of immediately prior to such transaction own less than fifty percent (50%) of the surviving entity’s voting power immediately after the transaction.

 

2 

 

 

Commercial Milestone” means each of the Annual Net Sales Milestone I, the Annual Net Sales Milestone II and the Annual Net Sales Milestone III.

 

Commercially Reasonable Efforts” means, with respect to the development and commercialization, as applicable, of Emi-Le, the level of efforts that Parent and its Affiliates would devote to a product of similar potential (including commercial potential) at a similar stage in its development or product life, and to which they hold exclusive rights, taking into account its proprietary position, anticipated or actual market conditions and economic return potential, and the regulatory environment and other relevant commercial, technical, legal, scientific or medical factors. Parent and Rights Agent acknowledge and agree that (i) the level of efforts that constitute Commercially Reasonable Efforts may change over time and vary from country to country, reflecting changes in the status of the product, compound or therapy, (ii) the use of Commercially Reasonable Efforts may result in Parent and its Affiliates ceasing the research, development, commercialization or other exploitation of Emi-Le, (iii) the use of Commercially Reasonable Efforts does not require that Parent or its Affiliates to act in a manner which would otherwise be contrary to prudent business judgment, including business judgment as exercised in Parent’s or Affiliate’s ordinary course of business, and (iv) once research, development, commercialization or other exploitation of Emi-Le has ceased in compliance with this Agreement, the use of Commercially Reasonable Efforts does not require the continued reevaluation of whether development, commercialization or exploitation must be reinitiated for such compound. Notwithstanding the foregoing, if the development or commercialization of Emi-Le is being conducted by a Licensee under an agreement that contains a commercially reasonable and customary definition of “Commercially Reasonable Efforts” (or equivalent term) that is at least substantially equivalent, then for purposes of such Licensee’s activities under this Agreement, such definition shall replace the above definition.

 

Company” has the meaning set forth in the Recitals.

 

Company Common Stock” has the meaning set forth in the Recitals.

 

CVR” means the right of a Holder to receive contingent payments of cash with respect to the achievement of Milestones pursuant to the Merger Agreement and this Agreement.

 

CVR Register” has the meaning set forth in Section 2.3(b).

 

Development and First Sale Milestone” means each of the Breakthrough Therapy Designation Milestone, the European First Sale Milestone, the FDA Milestone, the First Patient Dosed Milestone, the Janssen Milestone and the Japan First Sale Milestone.

 

DTC” means The Depository Trust Company or any successor entity thereto.

 

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

 

Emi-Le” means emiltatug ledadotin (XMT-1660).

 

3 

 

 

Equity Award Holder” means a Holder of a CVR granted with respect to a Cash-Out Option or a Company RSU Award.

 

Event of Default” has the meaning set forth in Section 6.1(a).

 

European First Sale Milestone” means the First Commercial Sale of Emi-Le in the first to occur of France, Germany, Italy, Spain or the United Kingdom on or before the European First Sale Milestone End Date. Notwithstanding the foregoing, the European First Sale Milestone will be deemed to have occurred if, at any time on or before the European First Sale Milestone End Date, cumulative Net Sales of Emi-Le in the European Union and the United Kingdom is equal to or exceeds $10.0 million.

 

European First Sale Milestone Amount” means, with respect to the achievement of the European First Sale Milestone, an amount per CVR equal to $2.00.

 

European First Sale Milestone End Date” means December 31, 2030.

 

FDA” means the United States Food and Drug Administration, or any successor agency.

 

FDA Milestone” means Regulatory Approval by the FDA for Emi-Le indicated for use in ACC-1 on or before the FDA Milestone End Date.

 

FDA Milestone Amount” means, with respect to the achievement of the FDA Milestone, an amount per CVR equal to $9.00.

 

FDA Milestone End Date” means December 31, 2030.

 

First Commercial Sale” means, with respect to Emi-Le and a given country, the first sale for monetary value for use or consumption by the end user of such product in such country by Parent, its Affiliates (including the Surviving Corporation) or its or their Licensees to a third party, in each case after (i) receipt of all Regulatory Approvals necessary for the sale of Emi-Le in such country, and (ii) completion of any applicable pricing and reimbursement approvals necessary for the sale of Emi-Le in such country; provided, however, that (a) any sale or distribution of Emi-Le for use in clinical trials, expanded access programs, compassionate use, patient assistance programs, or other similar programs, or (b) the transfer of reasonable quantities of Emi-Le for regulatory purposes, or for development or marketing activities prior to commercial launch, in each case ((a) and (b)) at or below Emi-Le’s direct manufacturing cost, shall not be deemed a First Commercial Sale.

 

First Patient Dosed Milestone” means the first dosing of the first participant in a Registrational Clinical Trial of Emi-Le for ACC-1 on or before the First Patient Dosed Milestone End Date.

 

First Patient Dosed Milestone Amount” means, with respect to the achievement of the First Patient Dosed Milestone, an amount per CVR equal to $4.00.

 

First Patient Dosed Milestone End Date” means December 31, 2027.

 

4 

 

 

Funds” has the meaning set forth in Section 2.6.

 

GAAP” means United States generally accepted accounting principles.

 

Holder” means a Person in whose name a CVR is registered in the CVR Register at the applicable time.

 

“Independent Accountant” has the meaning set forth in Section 4.4(a).

 

Janssen Agreement” means that certain Research Collaboration and License Agreement by and between the Company and Janssen Biotech, Inc. (“Janssen”), dated as of February 2, 2022, as amended.

 

Janssen Milestone” means the receipt by Parent or any of its Affiliates (including the Surviving Corporation) of the $8.0 million milestone payment payable upon achievement of the Development Milestone Event No. 3.b set forth in Section 8.4.1 of the Janssen Agreement on or before the Janssen Milestone End Date.

 

Janssen Milestone Amount” means, with respect to the achievement of the Janssen Milestone, an amount per CVR equal to $1.25.

 

Janssen Milestone End Date” means December 31, 2026.

 

Japan First Sale Milestone” means the First Commercial Sale of Emi-Le in Japan on or before the Japan First Sale Milestone End Date.

 

Japan First Sale Milestone Amount” means, with respect to the achievement of the Japan First Sale Milestone, an amount per CVR equal to $1.00.

 

Japan First Sale Milestone End Date” means December 31, 2030.

 

Licensee” means any third party that has been granted by Parent or its Affiliates the right to develop or commercialize Emi-Le, whether by license, sublicense or assignment, but excluding any contract research organization or contractor engaged to provide services to Parent or its Affiliates, or any wholesaler, distributor, reseller, or other similar intermediary that purchases Emi-Le in arm’s-length transactions, where such third party does not have a sublicense or license to develop or commercialize Emi-Le except for the right to sell the quantities of Emi-Le purchased by such third party and, where applicable, limited sublicenses or licenses to perform packaging for Emi-Le for local distribution and other ancillary services (e.g., marketing support).

 

“Loss” has the meaning set forth in Section 3.2(h).

 

Merger” has the meaning set forth in the Recitals.

 

Merger Agreement” has the meaning set forth in the Recitals.

 

Merger Sub” has the meaning set forth in the Recitals.

 

5 

 

 

Milestone” means each of the Annual Net Sales Milestone I, the Annual Net Sales Milestone II, the Annual Net Sales Milestone III, the Breakthrough Therapy Designation Milestone, the European First Sale Milestone, the FDA Milestone, the First Patient Dosed Milestone, the Janssen Milestone and the Japan First Sale Milestone.

 

Milestone Amount” means each of the Annual Net Sales Milestone I Amount, the Annual Net Sales Milestone II Amount, the Annual Net Sales Milestone III Amount, the Breakthrough Therapy Designation Milestone Amount, the European First Sale Milestone Amount, the FDA Milestone Amount, the First Patient Dosed Milestone Amount, the Janssen Milestone Amount and the Japan First Sale Milestone Amount.

 

Milestone End Date” means each of the Annual Net Sales Milestone I End Date, the Annual Net Sales Milestone II End Date, the Annual Net Sales Milestone III End Date, the Breakthrough Therapy Designation Milestone End Date, the European First Sale Milestone End Date, the FDA Milestone End Date, the First Patient Dosed Milestone End Date, the Janssen Milestone End Date and the Japan First Sale Milestone End Date.

 

Milestone Notice” has the meaning set forth in Section 2.4(a).

 

Milestone Payment Date” has the meaning set forth in Section 2.4(a).

 

Milestone Report” has the meaning set forth in Section 4.6.

 

Net Sales” means the gross amount invoiced by or on behalf of Parent, any of its Affiliates (including the Surviving Corporation) or any Licensees (each, a “Selling Party”) to a third party for sales or distribution of Emi-Le, less the following deductions as calculated in accordance with GAAP (or IFRS, as applicable) consistently applied and as actually taken, paid, accrued, allocated, or allowed based on good faith estimates consistently applied across the books and records of the Selling Parties, as applicable:

 

(a)            rebates, credits and allowances given by reason of rejections returns, damaged or defective product or recalls;

 

(b)            government-mandated rebates, credits and adjustments paid or deducted;

 

(c)            customary price adjustments, rebates and chargeback payments granted to managed care organizations, pharmacy benefit management companies, national, state/provincial, local, and other governments, their agencies and purchasers and reimbursers, or to trade customers (including Medicare, Medicaid, managed care and similar types of rebates and chargebacks);

 

(d)            reasonable and customary freight, shipping, insurance and other transportation expenses, if borne by the applicable Selling Party without reimbursement from any third party and to the extent separately invoiced to the customer and included in gross amounts invoiced; taxes, duties or other governmental charges (including any tax such as a value added or similar tax, other than any taxes based on income), as adjusted for rebates and refunds, including excise taxes; and

 

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(e)            any other deductions actually deducted from gross invoiced sales amounts as reported by the applicable Selling Party in its financial statements in accordance with GAAP (or IFRS).

 

If Emi-Le is combined with one or more other therapeutically active ingredients (collectively, “Other Components”), whether in a single formulation finished form, co-packaged, or as separate products otherwise sold and invoiced under a single invoiced price (a “Combination Product”), the Net Sales of Emi-Le shall be determined by multiplying the gross invoice price of the Combination Product by the fraction A / (A + B), where: A is the average gross invoice price (without discounts, rebates, or similar deductions) of Emi-Le containing the same dosage of the same active ingredient(s) when sold separately in finished form in the same country, and B is the average gross invoice price (without discounts, rebates, or similar deductions) of the Other Component(s) when sold separately in finished form in the same country. If such average sale prices are not available for either Emi-Le or the Other Component(s) in such country, Net Sales for such Combination Product shall be deemed to equal the gross invoice price of the Combination Product multiplied by the percentage that reasonably reflects the relative fair market value of Emi-Le portion, as determined by the applicable Selling Party in good faith in accordance with its standard allocation methodologies consistently applied across all of its products.

 

Furthermore, Net Sales shall not include use of or sale in reasonable and customary quantities at or below the direct manufacturing cost of Emi-Le by an applicable Selling Party (a) for non-clinical or clinical studies, patient-assistance programs, expanded access programs, compassionate use programs, patient assistance programs, bona fide charitable donations or similar programs, or (b) for regulatory development, or marketing purposes, in each case ((a) and (b)) at or below Emi-Le’s direct manufacturing cost. Resales or sales of Emi-Le made in good faith between or among any Selling Party(ies) for the purpose of subsequent resale to non-Selling Parties shall not be included in the calculation of Net Sales but the subsequent resale or sale to non-Selling Party(ies) shall be included in the computation of Net Sales.

 

All Net Sales shall be computed in Dollars, and where any Net Sales are calculated in a currency other than Dollars, they shall be translated into Dollars in accordance with GAAP (or IFRS, as applicable).

 

Notwithstanding the foregoing, if Emi-Le is commercialized by a Licensee that is a pharmaceutical company with pharmaceutical sales greater than $3,000,000,000 (based on sales on the most recently available trailing twelve (12) month period for such pharmaceutical company) under an agreement that contains a commercially reasonable and customary definition of “Net Sales” (or equivalent term), calculated in accordance with GAAP (or IFRS, as applicable) and consistently applied by the Licensee, then for purposes of this Agreement such definition shall replace the above definition with respect to the sales of Emi-Le covered by such other agreement.

 

Offer” has the meaning set forth in the Recitals.

 

Officer’s Certificate” means a certificate signed by the chief executive officer, president, chief financial officer, any vice president, the controller, the treasurer or the secretary, in each case of Parent, in his or her capacity as such an officer, and delivered to the Rights Agent.

 

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Ongoing Clinical Trial” means the human clinical trial of Emi-Le ongoing as of the date of this Agreement, as such clinical trial may be amended, altered, or otherwise modified from time to time.

 

Parent” has the meaning set forth in the Preamble.

 

Permitted Transfer” means a transfer of one or more CVRs (a) upon death of a Holder by will or intestacy; (b) by instrument to an inter vivos or testamentary trust in which the CVRs are to be passed to beneficiaries of the Holder upon the death of the Holder; (c) pursuant to a court order; (d) by operation of law (including by consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity; (e) in the case of CVRs held in book-entry or other similar nominee form, from a nominee to a beneficial owner and, if applicable, through an intermediary, as allowable by DTC; or (f) as provided in Section 2.8.

 

Registrational Clinical Trial” means a human clinical trial conducted, at least in part, in the U.S. that is intended to be or is used as a registrational study to support an application for Regulatory Approval of Emi-Le in ACC-1 in the U.S. For clarity, following the earlier of (a) the first dosing of the first participant in an expansion cohort in the Ongoing Clinical Trial initiated by or on behalf of the Company, Parent, or each of their Affiliates (including the Surviving Corporation) or any of its or their licensees or sublicensees or (b) the conduct of the Ongoing Clinical Trial under an amended, modified, or otherwise altered (from the protocol in effect as of the date of this Agreement) protocol that allows the Company, Parent, or each of their Affiliates (including the Surviving Corporation) or any of its or their licensees or sublicensees to enroll additional ACC-1 patients, the Ongoing Clinical Trial shall be deemed to be a Registrational Clinical Trial of Emi-Le.

 

Regulatory Approval” means the approval by the applicable Regulatory Authority (other than pricing or reimbursement approval(s)) that is necessary to market and sell a product candidate in an applicable country.

 

Regulatory Authority” means any federal, national, multinational, state, provincial, or local regulatory agency, department, bureau, or other Governmental Authority with authority over the testing, manufacture, use, storage, import, promotion, marketing, or sale (including pricing and reimbursement approval) of any pharmaceutical or biologic product in any country or territory.

 

Rights Agent” means the Rights Agent named in the Preamble, until a successor Rights Agent becomes such pursuant to the applicable provisions of this Agreement, and thereafter “Rights Agent” shall mean such successor Rights Agent.

 

Section 409A” has the meaning set forth in Section 2.4(d).

 

Share” means each share of Company Common Stock outstanding immediately prior to the Effective Time, except any (i) shares of Company Common Stock held by the Company or any wholly-owned Subsidiary of the Company as of immediately prior to the Effective Time (or held in the Company’s treasury), (ii) shares of Company Common Stock held by Parent, Merger Sub or any other wholly-owned Subsidiary of Parent as of immediately prior to the Effective Time or (iii) Dissenting Company Shares.

 

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Surviving Corporation” has the meaning set forth in the Recitals.

 

U.S.” means the United States of America and its territories, districts and possessions.

 

1.2            Rules of Construction. For purposes of this Agreement, the parties hereto agree that: (a) whenever the context requires, the singular form of nouns and pronouns shall include the plural, and vice versa; (b) the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine genders; (c) the word “extent” in the phrase “to the extent” means the degree to which a subject or other thing extends, and does not simply mean “if”; (d) the words “include” and “including,” and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation;” (e) where a word or phrase is defined in this Agreement, each of its other grammatical forms has a corresponding meaning unless the context otherwise requires; (f) a reference to any specific Law or to any provision of any Law includes any amendment to, and any modification, re-enactment or successor thereof, any legislative provision substituted therefor and all rules, regulations and statutory instruments issued thereunder or pursuant thereto; (g) references to any agreement or contract are to that agreement or contract as amended, modified or supplemented; (h) the Parties agree that they have been represented by legal counsel during the negotiation and execution and delivery of this Agreement and therefore waive the application of any Law, holding or rule of construction providing that ambiguities in an agreement or other document will be construed against the party drafting such agreement or document; (i) whenever this Agreement refers to a number of days, such number shall refer to calendar days unless Business Days are specified and whenever any action must be taken hereunder on or by a day that is not a Business Day, then such action may be validly taken on or by the next day that is a Business Day; (j) the word “or” shall not be exclusive, and “and/or” means A or B or both A and B; and (k) references to “$” and “dollars” are to the currency of the United States of America. The headings contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred to in connection with the construction or interpretation of this Agreement. All references to “Dollars” or “$” are to United States Dollars, unless expressly stated otherwise.

 

2.             CONTINGENT VALUE RIGHTS

 

2.1            CVRs. As provided in the Merger Agreement: (i) effective as of the Offer Acceptance Time, Merger Sub will accept for payment and promptly thereafter pay for each Company Share validly tendered and not validly withdrawn pursuant to the Offer; and (ii) effective as of the Effective Time, (A) each Company Share outstanding as of immediately prior to the Effective Time (other than Cancelled Shares and other than any Dissenting Company Shares) shall be converted into the right to receive the Merger Consideration, (B) each Cash-Out Option will become fully vested and cancelled and converted into the right to receive the Merger Consideration (minus the exercise price payable per share of Company Common Stock subject to such Cash-Out Option) and (C) each Company RSU Award outstanding as of immediately prior to the Effective Time (whether vested or unvested) will be cancelled and converted into the right to receive the Merger Consideration in respect of each share of Company Common Stock subject to such Company RSU Award immediately prior to the Effective Time. The initial Holders shall be determined pursuant to the terms of the Merger Agreement and this Agreement, and a list of the initial Holders shall be furnished to the Rights Agent by or on behalf of Parent in accordance with Section 4.1.

 

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2.2            Non-transferable. The CVRs may not be sold, assigned, transferred, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than through a Permitted Transfer, and, in the case of a Permitted Transfer, only in accordance with Section 2.3(c) and in compliance with applicable United States federal and state securities laws and the terms and conditions hereto. Any such sale, assignment, transfer, pledge, encumbrance or disposal of CVRs, in whole or in part, in violation of this Section 2.2, shall be null and void ab initio and of no effect.

 

2.3            No Certificate; Registration; Registration of Transfer; Change of Address.

 

(a)             The CVRs shall not be evidenced by a certificate or other instrument.

 

(b)             Subject to the receipt by the Rights Agent of the information and instructions described in Section 4.1, the Rights Agent shall keep a register (the “CVR Register”) for the purpose of identifying the Holders and registering CVRs and Permitted Transfers of CVRs as herein provided. The CVR Register will initially show one position for Cede & Co. representing all of the CVRs that are issued to the holders of Shares held by DTC on behalf of the street holders of the Shares. The Rights Agent will have no responsibility whatsoever directly to the street name holders or DTC participants with respect to transfers of CVRs. With respect to any payments to be made under Section 2.4, the Rights Agent will accomplish such payment to any former street name holders of the Shares by sending one payment to DTC representing the amounts due to all such holders. The Rights Agent will have no responsibilities whatsoever with regard to the distribution of payments by DTC to such street name holders. Upon request of any Holder and at such Holder’s sole cost, the Rights Agent will make available to such Holder a list of the other Holders, the number of CVRs held by such Holder and the contact information maintained by the Rights Agent with respect to each Holder. The Rights Agent hereby acknowledges the restrictions on transfer contained in Section 2.2 and agrees not to register a transfer which does not comply with Section 2.2.

 

(c)             Subject to the restrictions on transferability set forth in Section 2.2, every request made to transfer a CVR must be in writing and accompanied by a written instrument of transfer and other documentation reasonably requested by the Rights Agent, in form reasonably satisfactory to the Rights Agent pursuant to its guidelines, which may include a guaranty of signature by an “eligible guarantor institution” that is a member or participant in the Securities Transfer Agents Medallion Program, duly executed by the Holder thereof, the Holder’s attorney duly authorized in writing, the Holder’s personal representative or the Holder’s survivor, as applicable, and setting forth in reasonable detail the circumstances relating to the transfer. Upon receipt of such written notice, the Rights Agent shall, subject to its reasonable determination that the transfer instrument is in proper form and the transfer otherwise complies with the other terms and conditions of this Agreement (including the provisions of Section 2.2), register the transfer of the CVRs in the CVR Register and notify Parent of the same. Any registration, transfer or assignment of the CVRs shall be without charge to the Holder (other than payment of a sum to the extent necessary to cover any stamp or other Tax or other governmental charge that is imposed in connection with any such registration, transfer or assignment). The Rights Agent shall have no duty or obligation to take any action under any section of this Agreement that requires the payment of applicable Taxes or charges unless and until the Rights Agent is satisfied that all such Taxes or charges have been paid. All duly transferred CVRs registered in the CVR Register shall be the valid obligations of Parent and shall entitle the transferee to the same benefits and rights under this Agreement as those held immediately prior to the transfer by the transferor. No transfer of a CVR shall be valid unless and until registered in the CVR Register in accordance with this Agreement.

 

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(d)            A Holder may make a written request to the Rights Agent to change such Holder’s address of record in the CVR Register. The written request must be duly executed by the Holder. Upon receipt of such written request, the Rights Agent is hereby authorized to, and shall promptly, record the change of address in the CVR Register.

 

2.4            Payment Procedures.

 

(a)             If, (A) in the case that any of the Development and First Sale Milestones is achieved prior to the applicable Milestone End Date by or on behalf of the Company, Parent, or each of their Affiliates (including the Surviving Corporation) or any of its or their Licensees, then, on or prior to the date that is 20 Business Days following the achievement of such Development and First Sale Milestone, and (B) in the case that any of the Commercial Milestones is achieved prior to the applicable Milestone End Date, then, on or prior to the date that is 60 days following the last day of the fiscal quarter of Parent in which such Commercial Milestone is achieved (in each case, a “Milestone Payment Date”), Parent will deliver (or cause to be delivered) to the Rights Agent (1) a written notice (each, a “Milestone Notice”) indicating the achievement of such Milestone and that the Holders are entitled to receive the applicable Milestone Amount and instructing the Rights Agent to solicit from Holders other than Equity Award Holders Tax forms or other information required to make Tax deductions or withholdings, to the extent applicable, and (2) cash in the aggregate amount equal to the applicable portion of the Milestone Amount payable to all Holders (other than the applicable portion of the Milestone Amount payable to Equity Award Holders, which such aggregate amount shall be retained by Parent and paid in accordance with Section 3.6(c) of the Merger Agreement and Section 2.4(b) of this Agreement). The applicable Milestone Amount payable with respect to each corresponding Milestone that is achieved prior to the applicable Milestone End Date shall only be paid in respect of such corresponding Milestone, if at all achieved, and only one time under this Agreement and the maximum aggregate potential amount payable under this Agreement per CVR shall be $30.25. If a Milestone has not been achieved prior to the applicable Milestone End Date, then Parent will not be required to make any payment to the Rights Agent or the Holders pursuant to this Agreement in respect of such Milestone. In the event that a Milestone was achieved prior to the Closing, such Milestone shall be deemed to have been achieved as of the date of this Agreement and the Milestone Payment Date for such Milestone shall be determined in accordance with this Section 2.4(a).

 

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(b)             The Rights Agent shall as promptly as practicable, and in any event within 10 Business Days of receipt of a Milestone Notice, send each Holder at its registered address a copy of such Milestone Notice as well as any letter of instruction reasonably required by the Rights Agent. If any Milestone Amount is payable to the Holders, then at the time the Rights Agent sends a copy of such Milestone Notice to the Holders, the Rights Agent shall also pay to each Holder (other than Equity Award Holders to be paid in accordance with Section 3.6(c) of the Merger Agreement and this Section 2.4(b)), subject to any applicable withholding Tax and without interest, such Holder’s applicable portion of the Milestone Amount (the amount of which each Holder is entitled to receive shall be based on the applicable Milestone Amount payable per CVR multiplied by the number of CVRs held by such Holder as reflected in the CVR Register as of 5:00 p.m. New York City time on the date of the applicable Milestone Notice), in accordance with the corresponding letter of instruction (i) by check mailed to the address of such Holder reflected in the CVR Register as of 5:00 p.m. New York City time on the date of the applicable Milestone Notice or (ii) with respect to any such Holder that is due an amount in excess of $100,000 in the aggregate who has provided the Rights Agent wiring instructions in writing as of the close of business on the date of the Milestone Notice, by wire transfer of immediately available funds to the account specified on such instruction (less any applicable reasonable and documented wiring fees and expenses); provided that with respect to any Milestone Amount that is payable to an Equity Award Holder, instead of paying such amount to the Rights Agent, Parent shall, as soon as reasonably practicable following the Milestone Payment Date (but in any event no later than the second regular payroll date following the Milestone Payment Date, and in all events no later than the date that is 60 days following the date on which the Milestone is achieved) pay, or shall cause the Surviving Corporation or an Affiliate thereof to pay, through Parent’s, the Surviving Corporation’s or such Affiliate’s payroll system, the applicable Milestone Amount to each such Equity Award Holder (e.g., with respect to payments made to a Company employee in respect of his or her Cash-Out Options or Company RSU Awards).

 

(c)             Any portion of any aggregate Milestone Amount delivered to the Rights Agent that remains undistributed to a Holder 12 months after the date of the delivery of the applicable Milestone Notice shall be delivered by the Rights Agent to Parent, upon demand, and any Holder thereafter shall look only to Parent (subject to abandoned property, escheat, and other similar applicable Law) for payment of such Milestone Amount, without interest, but such Holder shall have no greater rights against Parent than those accorded to general unsecured creditors of Parent under applicable Law. Neither Parent, the Rights Agent nor any of their Affiliates shall be liable to any Holder for any payments delivered to a public official pursuant to any abandoned property, escheat law or other similar Laws. If, despite Parent’s and the Rights Agent’s commercially reasonable efforts to deliver a Milestone Amount to the applicable Holder, such Milestone Amount has not been paid prior to the date on which such Milestone Amount would otherwise escheat to or become the property of any Governmental Authority, any such Milestone Amount shall, to the extent permitted by applicable Law, immediately prior to such time, become the property of Parent, free and clear of all claims or interest of any Person previously entitled thereto.

 

(d)             Parent intends that each payment provided under this Agreement with respect to a CVR constitutes a separate “payment” for purposes of Section 1.409A-2(b)(2)(i) of the U.S. Treasury Regulations. For the avoidance of doubt, and to the extent applicable, Parent intends that the Milestone Amounts satisfy, to the greatest extent possible, the exemption from the application of Section 409A of the Code and the Treasury Regulations and other guidance issued thereunder and any state law of similar effect (collectively “Section 409A”) provided under Treasury Regulations Section 1.409A-1(b)(4) and, to the extent not so exempt, that the payment of any Milestone Amount comply, and this Agreement be interpreted to the greatest extent possible, as consistent with Treasury Regulations Section 1.409A-3(i)(5)(iv)(A)—that is, as “transaction-based compensation.” To the extent this Agreement (and any definitions hereunder), or any payments hereunder, are not exempt, they shall be construed in a manner that complies with Section 409A and shall incorporate by reference all required definitions and payment terms. Notwithstanding the foregoing, neither Parent, the board of directors of Parent, the Company, the Rights Agent, nor any of their respective representatives makes any representation or warranty and will have no liability to a Holder or transferee or any other Person if any payments under any provisions of this Agreement are determined to constitute deferred compensation under Section 409A but do not satisfy the requirements of that section (or any similar U.S. state tax law). The Rights Agent makes no representations or warranties with respect to tax treatment of CVRs. None of the Rights Agent, its affiliates or the services provided by the Rights Agent hereunder are intended to provide legal, tax or financial advice.

 

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2.5            Tax Matters.

 

(a)             Unless otherwise required as a result of a change of law, and except to the extent any portion of a Milestone Amount is required to be treated as imputed interest pursuant to applicable Tax Law, the parties hereto intend that, for all U.S. federal and applicable state and local income Tax purposes, (i) the CVRs received in respect of the Company Shares will be treated as additional consideration paid at the Effective Time with respect to such Shares pursuant to the Offer or the Merger Agreement, as the case may be, (ii) any Milestone Amount paid in respect of the CVRs described in clause (i) will be treated as amount realized in respect of such CVRs, and (iii) any Milestone Amount paid in respect of Cash-Out Options or Company RSU Awards will be treated as wages or other compensation for services in the year in which the applicable Milestone Amount is paid, and none of the parties hereto shall take any position contrary to the foregoing on any Tax Return or for other U.S. federal and applicable state and local income Tax purposes except as required by applicable Tax law. Parent, the Rights Agent, and the Surviving Corporation may report imputed interest on the CVRs (other than CVRs in respect of Cash-Out Options or Company RSU Awards) as required by applicable Tax law.

 

(b)             Each of Parent, the Rights Agent, the Surviving Corporation, their respective Affiliates, and any other Person who has any obligation to deduct or withhold from any consideration payable pursuant to this Agreement shall be entitled to deduct and withhold from the amounts otherwise payable pursuant to this Agreement such amounts as are required by any applicable law to be deducted and withheld, as may be reasonably determined by such Person. To the extent that amounts are so withheld and remitted to the appropriate Governmental Authority in accordance with applicable law, such withheld amounts shall be treated for all purposes of this Agreement as having been paid to the Person in respect of which such deduction and withholding was made. Prior to making any such Tax withholdings or causing any such Tax withholdings to be made with respect to any Holder (other than with respect to amounts paid through Parent’s, the Surviving Corporation’s, or an Affiliate’s payroll system pursuant to Section 2.4(b)), Parent shall instruct the Rights Agent, to the extent practicable, to provide notice to the Holder of such potential withholding and a reasonable opportunity for the Holder to provide any necessary Tax forms (including an IRS Form W-9 or an applicable IRS Form W-8) in order to avoid or reduce such withholding amounts; provided that the time period for payment of a Milestone Amount by the Rights Agent set forth in Section 2.4(b) shall be extended by a period equal to any delay caused by the Holder providing such forms; provided, further, that in no event shall such period be extended for more than 10 Business Days, unless otherwise requested by the Holder for the purpose of delivering such forms and agreed to by the Rights Agent.

 

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2.6            Holding of Funds. All funds received by the Rights Agent under this Agreement that are to be distributed or applied by the Rights Agent in the performance of services hereunder (the “Funds”) shall be held by the Rights Agent as agent for Parent and deposited in one or more separate bank accounts to be maintained by the Rights Agent in its name as agent for Parent and not to be commingled with the money, assets or property of the Rights Agent or any other Person. Until paid pursuant to the terms of this Agreement, the Rights Agent will hold or invest the Funds as directed by Parent; provided that any such investments shall be in obligations of, or guaranteed by, the United States of America, in deposit accounts of commercial banks with Tier 1 capital exceeding $1 billion or with an average rating above investment grade by S&P (LT Local Issuer Credit Rating), Moody’s (Long Term Rating) and Fitch Ratings, Inc. (LT Issuer Default Rating) (each as reported by Bloomberg Finance L.P.), in commercial paper obligations rated A-1 or P-1 or better by Moody’s Investors Service, Inc. or Standard & Poor’s Corporation, respectively, or in money market funds having a rating in the highest investment category granted by a recognized credit rating agency at the time of acquisition or a combination of the foregoing. The Rights Agent shall have no responsibility or liability for any diminution of the Funds that may result from any deposit made by the Rights Agent in accordance with this paragraph, including any losses resulting from a default by any bank, financial institution or other third party; provided that in the event the Funds are diminished below the level required for the Rights Agent to make cash payments as required under this Agreement, including any such diminishment as a result of investment losses, Parent shall promptly pay additional cash to the Rights Agent in an amount equal to the deficiency in the amount required to make such payments. The Rights Agent may from time to time receive interest, dividends or other earnings in connection with such deposits. The Funds shall not be used for any purpose other than the payment of the Milestone Amounts, if and to the extent payable; provided that any interest, dividends, income or earnings produced by investments with respect to the Funds shall be the property of Parent.

 

2.7           No Voting, Dividends or Interest; No Equity or Ownership Interest.

 

(a)             Nothing contained in this Agreement shall be construed as conferring upon any Holder, by virtue of being a Holder of a CVR, the right to receive dividends, or the right to vote or to consent or to receive notice as stockholders in respect of the meetings of stockholders or the election of directors of Parent or any or any other matter, or any other rights of any kind or nature whatsoever as a stockholder of Parent, either at law or in equity. No interest shall accrue on any amounts payable on the CVRs to any Holder.

 

(b)             The CVRs shall not represent any equity or ownership interest in Parent or in any constituent company to the Merger or any of their respective Subsidiaries or Affiliates. The rights of a Holder to receive Milestone Amounts (if and to the extent payable) in respect of the CVRs are limited to those expressed in this Agreement and the Merger Agreement.

 

2.8            Ability to Abandon CVR. A Holder may at any time, at such Holder’s option, abandon all of such Holder’s remaining rights in a CVR by transferring such CVR to Parent or any of its Subsidiaries without consideration therefor, which a Holder may effect via a delivery of a written notice of such abandonment to Parent. Nothing in this Agreement shall prohibit Parent or any of its Affiliates from offering to acquire or acquiring any CVRs for consideration from the Holders, in private transactions or otherwise, in its sole discretion. Any CVRs acquired by Parent or any of its Affiliates shall be automatically deemed extinguished and no longer outstanding for purposes of the definition of Acting Holders and Section 5. The Rights Agent shall update the CVR Register to reflect any abandonment or acquisition of CVRs described in this Section 2.8.

 

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3.             THE RIGHTS AGENT

 

3.1           Certain Duties and Responsibilities.

 

(a)            Parent hereby appoints the Rights Agent to act as rights agent for Parent in accordance with the express terms and conditions set forth in this Agreement (and no implied terms and conditions), and the Rights Agent hereby accepts such appointment. The Rights Agent shall not have any liability for any actions taken, suffered or omitted to be taken in connection with this Agreement, except to the extent of its fraud, gross negligence, bad faith or willful or intentional misconduct (each as determined by a final non-appealable order, judgment, decree or ruling of a court of competent jurisdiction).Without diminishing or abrogating the rights of the Acting Holders to take actions pursuant to this Agreement, including Article 6, the Rights Agent may upon the written request of the Acting Holders proceed to and shall be entitled and empowered to protect and enforce the rights of the Holders hereunder by such appropriate judicial proceedings as the Rights Agent shall deem most effectual to protect and enforce any such rights. The Rights Agent may only proceed to and shall be entitled and empowered to protect and enforce the rights herein for the benefit of and on behalf of all Holders to the extent directed to by the Acting Holders in writing; provided that the Rights Agent shall have the right to decline to follow any such direction if the Rights Agent, being advised by counsel in writing, shall determine that the action or proceeding so directed may not lawfully be taken or if the Rights Agent in the absence of bad faith shall determine that the action or proceedings so directed would involve the Rights Agent in personal liability or if the Rights Agent in the absence of bad faith shall so determine that the actions or forbearances specified in or pursuant to such direction would be unduly prejudicial to the interests of Holders not joint in the giving of said direction.

 

3.2           Certain Rights of the Rights Agent. The Rights Agent undertakes to perform such duties and only such duties as are specifically set forth in this Agreement, and no implied covenants or obligations shall be read into this Agreement against the Rights Agent. In addition:

 

(a)             the Rights Agent may rely upon and shall be protected and held harmless by Parent in acting or refraining from acting upon any resolution, certificate, statement, instrument, opinion, report, notice, request, direction, consent, order or other paper or document believed by it in the absence of bad faith to be genuine and to have been signed or presented by the proper party or parties;

 

(b)             whenever the Rights Agent shall deem it desirable that a matter be proved or established prior to taking, suffering or omitting any action hereunder, the Rights Agent may rely upon an Officer’s Certificate, which certificate shall be full authorization and protection to the Rights Agent, and the Rights Agent shall, in the absence of gross negligence, bad faith or willful or intentional misconduct on its part (each as determined by a final non-appealable order, judgment, decree or ruling of a court of competent jurisdiction), incur no liability and be held harmless by Parent for or in respect of any action taken, suffered or omitted to be taken by it under the provisions of this Agreement in reliance upon such certificate;

 

(c)             the Rights Agent may engage and consult with counsel of its selection and the advice of such counsel or any opinion of counsel shall be full and complete authorization and protection to the Rights Agent, and the Rights Agent shall be held harmless by Parent in respect of any action taken, suffered or omitted by it hereunder in the absence of bad faith and in reliance thereon;

 

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(d)            the permissive rights of the Rights Agent to do things enumerated in this Agreement shall not be construed as a duty;

 

(e)            the Rights Agent shall not be required to give any note or surety in respect of the execution of such powers or otherwise in respect of the premises;

 

(f)             the Rights Agent shall not be liable for or by reason of, and shall be held harmless by Parent with respect to, any of the statements of fact or recitals contained in this Agreement or be required to verify the same, but all such statements and recitals are and shall be deemed to have been made by Parent only;

 

(g)            the Rights Agent shall have no liability and shall be held harmless by Parent in respect of the validity of this Agreement or the execution and delivery hereof (except the due execution and delivery hereof by the Rights Agent and the enforceability of this Agreement against the Rights Agent assuming the due execution and delivery hereof by Parent), nor shall it be responsible for any breach by Parent of any covenant or condition contained in this Agreement;

 

(h)            Parent agrees to indemnify the Rights Agent for, and hold the Rights Agent harmless against, any loss, liability, damage, judgment, fine, penalty, claim, demand, settlement, cost or expense (including the reasonable and documented fees and expenses of legal counsel) (each, a “Loss”) which may be paid, incurred or suffered by or to which it may become subject, arising from or out of, directly or indirectly, any claims or liability resulting from any action taken, suffered or omitted by the Rights Agent in connection the execution, acceptance, administration, exercise and performance of its duties under this Agreement, including the reasonable and documented out-of-pocket costs and expenses of defending Rights Agent against any claim of liability arising therefrom, directly or indirectly, or enforcing its rights hereunder, except to the extent such Loss has been determined by a final non-appealable order, judgment, decree or ruling of a court of competent jurisdiction to have resulted from the Rights Agent’s fraud, gross negligence, bad faith or willful or intentional misconduct (each as determined by a final non-appealable order, judgment, decree or ruling of a court of competent jurisdiction);

 

(i)             notwithstanding anything to the contrary contained herein, in no event will the Rights Agent be liable for special, punitive, indirect, incidental or consequential loss or damages of any kind whatsoever (including, without limitation, lost profits), even if the Rights Agent has been advised of the likelihood of such loss or damages, and regardless of the form of action;

 

(j)             notwithstanding anything to the contrary contained herein, the aggregate liability of the Rights Agent arising in connection with this Agreement, whether in contract, or in tort, or otherwise, is limited to, and shall not exceed the amounts paid or payable hereunder by Parent to the Rights Agent as fees and charges during the twelve (12) months immediately preceding the event for which recovery from the Rights Agent is being sought;

 

(k)            Parent agrees (i) to pay the fees and expenses of the Rights Agent in connection with this Agreement as agreed upon in writing by the Rights Agent and Parent on or prior to the date hereof, and (ii) to reimburse the Rights Agent for all Taxes and governmental charges, reasonable out-of-pocket expenses and other charges of any kind and nature incurred by the Rights Agent in the execution of this Agreement (other than withholding Taxes owed by Holders and Taxes imposed on or measured by the Rights Agent’s net income and franchise or similar Taxes imposed on it (in lieu of net income Taxes)). The Rights Agent shall also be entitled to reimbursement from Parent for all reasonable and necessary documented out-of-pocket expenses paid or incurred by it in connection with the administration by the Rights Agent of its duties hereunder;

 

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(l)              no provision of this Agreement shall require the Rights Agent to expend or risk its own funds or otherwise incur any financial liability in the performance of any of its duties hereunder or in the exercise of its rights if there shall be reasonable grounds for believing that repayment of such funds or adequate indemnification against such risk or liability is not reasonably assured to it;

 

(m)            the Rights Agent shall not be subject to, nor be required to comply with, or determine if any Person has complied with, the Merger Agreement or any other agreement between or among any of the Parent, the Company or Holders, even though reference thereto may be made in this Agreement, or to comply with any notice, instruction, direction, request or other communication, paper or document other than as expressly set forth in this Agreement;

 

(n)             subject to applicable law, (i) the Rights Agent and any shareholder, affiliate, director, officer or employee of the Rights Agent may buy, sell or deal in any securities of Parent or the Company or become peculiarly interested in any transaction in which such parties may be interested, or contract with or lend money to such parties or otherwise act as fully and freely as though it were not the Rights Agent under this Agreement, and (ii) nothing herein will preclude the Rights Agent from acting in any other capacity for Parent or for any other Person;

 

(o)             the Rights Agent may execute and exercise any of the rights or powers hereby vested in it or perform any duty hereunder either itself or by or through its attorney or agents and the Rights Agent shall not be answerable or accountable for any act, default, neglect or misconduct of any such attorney or agents or for any loss to Parent resulting from any such act, default, neglect or misconduct, absent fraud, gross negligence, bad faith or willful or intentional misconduct (each as determined by a final non-appealable order, judgment, decree or ruling of a court of competent jurisdiction) in the selection and continued employment thereof;

 

(p)             the Rights Agent shall act hereunder solely as agent for Parent and shall not assume any obligations or relationship of agency or trust with any of the owners or holders of the CVRs. The Rights Agent shall not have any duty or responsibility in the case of the receipt of any written demand from any Holders with respect to any action or default by Parent or the Company, including, without limiting the generality of the foregoing, any duty or responsibility to initiate or attempt to initiate any proceedings at law or otherwise or to make any demand upon Parent or the Company;

 

(q)             the Rights Agent may rely on and be fully authorized and protected in acting or failing to act upon (a) any guaranty of signature by an “eligible guarantor institution” that is a member or participant in the Securities Transfer Agents Medallion Program or other comparable “signature guarantee program” or insurance program in addition to, or in substitution for, the foregoing; or (b) any law, act, regulation or any interpretation of the same even though such law, act, or regulation may thereafter have been altered, changed, amended or repealed;

 

(r)              the Rights Agent will not be deemed to have knowledge of any event of which it was supposed to receive notice hereunder but has not received written notice of such event, and the Rights Agent will not incur any liability for failing to take action in connection therewith, in each case, unless and until it has received such notice; and

 

(s)             the obligations of Parent and the rights of the Rights Agent under this Section 3.2, Section 3.1, and Section 2.4 shall survive the expiration of the CVRs and the termination of this Agreement and the resignation, replacement or removal of the Rights Agent.

 

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3.3            Resignation and Removal; Appointment of Successor.

 

(a)             The Rights Agent may resign at any time by giving written notice thereof to Parent specifying a date when such resignation shall take effect, which notice shall be sent at least thirty (30) days prior to the date so specified, and such resignation shall become effective on the earlier of (i) the date so specified and (ii) the appointment of a successor Rights Agent in accordance with Section 3.4. Parent has the right to remove the Rights Agent at any time by specifying a date when such removal shall take effect but no such removal shall become effective until a successor Rights Agent has been appointed and accepted such appointment in accordance with Section 3.4. Notice of such removal shall be given by Parent to the Rights Agent, which notice shall be sent at least thirty (30) days prior to the date so specified.

 

(b)             If the Rights Agent provides notice of its intent to resign, is removed pursuant to Section 3.3(a) or becomes incapable of acting, Parent shall, as soon as is reasonably practicable, appoint a qualified successor Rights Agent who shall be a stock transfer agent of national reputation or the corporate trust department of a commercial bank. Notwithstanding the foregoing, if Parent shall fail to make such appointment within a period of 60 days after giving notice of such removal or after it has been notified in writing of such resignation or incapacity by the resigning or incapacitated Rights Agent, then the incumbent Rights Agent or any Holder may apply to any court of competent jurisdiction for the appointment of a new Rights Agent. The successor Rights Agent so appointed shall, forthwith upon its acceptance of such appointment in accordance with Section 3.4, become the successor Rights Agent.

 

(c)             Parent shall give notice of each resignation and each removal of a Rights Agent and each appointment of a successor Rights Agent through the facilities of DTC in accordance with DTC’s procedures and/or by mailing written notice of such event by first-class mail to the Holders as their names and addresses appear in the CVR Register. Each notice shall include the name and address of the successor Rights Agent. If Parent fails to send such notice within 10 Business Days after acceptance of appointment by a successor Rights Agent, the successor Rights Agent shall cause the notice to be transmitted at the expense of Parent. Failure to give any notice provided for in this Section 3.3, however, shall not affect the legality or validity of the resignation or removal of the Rights Agent or the appointment of the successor Rights Agent, as the case may be.

 

(d)            Notwithstanding anything else in this Section 3.3, unless consented to in writing by the Acting Holders, Parent shall not appoint as a successor Rights Agent any Person that is not a stock transfer agent of national reputation or the corporate trust department of an international commercial bank.

 

(e)             The Rights Agent will reasonably cooperate with Parent and any successor Rights Agent in connection with the transition of the duties and responsibilities of the Rights Agent to the successor Rights Agent, including the transfer of all relevant data, including the CVR Register, to the successor Rights Agent, but such predecessor Rights Agent shall not be required to make any additional expenditure or assume any additional liability in connection with the foregoing.

 

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3.4            Acceptance of Appointment by Successor. Every successor Rights Agent appointed hereunder shall, at or prior to such appointment, execute, acknowledge and deliver to Parent and to the retiring Rights Agent an instrument accepting such appointment and a counterpart of this Agreement, and thereupon such successor Rights Agent, without any further act, deed or conveyance, shall become vested with all the rights, powers, trusts and duties of the retiring Rights Agent. On request of Parent or the successor Rights Agent, the retiring Rights Agent shall execute and deliver an instrument transferring to the successor Rights Agent all the rights, powers, trusts and duties of the retiring Rights Agent, except such rights which survive its resignation, replacement or removal under the terms hereunder.

 

4.             COVENANTS

 

4.1             List of Holders. Parent shall furnish or cause to be furnished to the Rights Agent, (a) in such form as Parent receives from the Company’s transfer agent (or other agent performing similar services for the Company with respect to the Company Shares), the names and addresses of the Holders (other than the Equity Award Holders) within 20 Business Days after the Effective Time and (b) in the case of Equity Award Holders, the names and addresses of the Holders of such securities set forth in the books and records of the Company as of immediately prior to the Effective Time and in accordance with the terms of the Merger Agreement.

 

4.2             Books and Records. Parent shall, and shall cause its Subsidiaries to, keep true, complete and accurate records in sufficient detail to enable the Holders and their consultants or professional advisors to determine the amounts payable hereunder.

 

4.3             Payment of Milestone Amounts. Parent shall duly and promptly deposit with the Rights Agent for payment to the Holders other than Equity Award Holders, the amount of any Milestone Amounts payable to such Holders hereunder when payable in accordance with the terms of this Agreement with the Rights Agent and, in the case of Equity Award Holders, Parent shall duly and promptly pay, or shall cause the Surviving Corporation or an Affiliate thereof to pay, through the applicable payroll system the amount of any Milestone Amounts payable to such Holders hereunder in each case, in the manner provided for in Section 2.4 and in accordance with the terms of this Agreement.

 

4.4            Audit Rights.

 

(a)             Until December 31, 2038, upon reasonable advance written notice from the Acting Holders, Parent shall permit an independent certified public accounting firm of nationally recognized standing selected by such Acting Holders and reasonably acceptable to Parent (the “Independent Accountant”) to have access at reasonable times during normal business hours to the books and records of Parent and its Affiliates as may be reasonably necessary to evaluate and verify Parent’s calculation of Net Sales hereunder; provided that (i) such Acting Holders (and the Independent Accountant) enter into customary confidentiality agreements reasonably satisfactory to Parent with respect to the confidential information of Parent or its Affiliates to be furnished pursuant to this Section 4.4 and (ii) such access does not unreasonably interfere with the conduct of the business of Parent or any of its Affiliates. The fees charged by such accounting firm shall be borne by such Acting Holders; provided that Parent will pay such fees if such review shall indicate that a Milestone Payment was payable hereunder, and not paid by Parent. The Independent Accountant shall provide Parent with a copy of all disclosures made to the Acting Holders. The decision of such accounting firm shall be final, conclusive and binding on Parent and the Holders, shall be nonappealable and shall not be subject to further review, absent manifest error. Parent shall not enter into any transaction with a Licensee granting such Licensee the right to develop or commercialize Emi-Le or constituting a Change of Control unless such agreement contains provisions that would permit such accounting firm with such access to the records of the other party in such transaction or Change of Control if and to the extent as are reasonably necessary to ensure compliance with this Section 4.4. The audit rights set forth in this Section 4.4(a) may not be exercised by the Acting Holders more than once in any given twelve (12) month period.

 

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(b)             If, in accordance with the procedures set forth in Section 4.4(a), the Independent Accountant concludes that any Milestone Amount should have been paid but was not paid when due, Parent shall promptly, and in any event within 30 days of the date the Independent Accountant delivers to Parent the Independent Accountant’s written report, pay each Holder such Milestone Amount (to the extent such amount remains unpaid), plus interest at the 30-day U.S. dollar “prime rate” effective for the date such payment was due, as reported by Bloomberg, from when such Milestone Amount should have been paid, as applicable, to the date of actual payment, pursuant to Section 2.4(a) and Section 2.4(b), as applicable.

 

4.5            Commercially Reasonable Efforts. Commencing upon the Effective Time and continuing until the earlier of the applicable Milestone End Date and the achievement of such Milestone, Parent shall, directly, or through its Affiliates or its or their Licensees, use Commercially Reasonable Efforts to achieve such Milestone.

 

4.6            Net Sales Reports. Within ninety (90) days of each June 30 and December 31 occurring after the first Net Sales of Emi-Le and prior to the earlier of the achievement of all Commercial Milestones or the Annual Net Sales Milestone III End Date, Parent shall provide the Rights Agent for distribution to the Holders with a written report setting forth the cumulative Net Sales of Emi-Le in the previous six (6) month period (each, a “Milestone Report”); provided that Parent may satisfy the obligation to deliver a Milestone Report to the Rights Agent if Parent’s Annual Reports on Form 10-K or Quarterly Reports on Form 10-Q, in each case, filed with the SEC for such applicable period contain the information regarding cumulative Net Sales of Emi-Le required by the first sentence of this Section 4.6. Promptly after the Rights Agent’s receipt of a given Milestone Report, the Rights Agent shall promptly, and in any event within 10 Business Days of receipt of a Milestone Report, send each Holder at its registered address a copy of such Milestone Report.

 

5.             AMENDMENTS

 

5.1            Amendments without Consent of Holders.

 

(a)            Without the consent of any Holders, Parent, at any time and from time to time, may enter into one or more amendments hereto, for any of the following purposes:

 

(i)              to evidence the succession of another person to Parent and the assumption by any such successor of the covenants of Parent herein as provided in Section 7.3;

 

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(ii)             to evidence the succession of another Person as a successor Rights Agent and the assumption by any such successor of the covenants and obligations of the Rights Agent herein as provided in Section 3.3 and Section 3.4;

 

(iii)            to add to the covenants of Parent such further covenants, restrictions, conditions or provisions as Parent shall consider to be for the protection of the Holders; provided that, in each case, such provisions do not adversely affect the interests of the Holders;

 

(iv)            to cure any ambiguity, to correct or supplement any provision herein that may be defective or inconsistent with any other provision herein or in the Merger Agreement, or to make any other provisions with respect to matters or questions arising under this Agreement; provided that, in each case, such provisions do not adversely affect the interests of the Holders;

 

(v)            as may be necessary or appropriate to ensure that the CVRs are not subject to registration under the Securities Act, the Exchange Act or any applicable state securities or “blue sky” laws; provided that, such provisions shall not adversely affect the interests of the Holders;

 

(vi)            to evidence the assignment of this Agreement by Parent as provided in Section 7.3;

 

(vii)          as may otherwise be necessary for the purpose of adding, eliminating or changing any provisions of this Agreement, unless such addition, elimination or change is adverse to the interests of the Holders; or

 

(viii)         as may be necessary or appropriate to ensure that the Surviving Corporation complies with applicable law.

 

In addition to the foregoing, upon the request of Parent, the Rights Agent hereby agrees to enter into one or more amendments hereto to evidence the succession of another person as a successor Rights Agent in accordance with the terms of this Agreement and the assumption by any successor of the covenants and obligations of such Rights Agent herein, without modification of such covenants or obligations other than as permitted by this Section 5.1.

 

(b)            Without the consent of any Holders, Parent and the Rights Agent, at any time and from time to time, may enter into one or more amendments hereto to reduce the number of CVRs, in the event any Holder agrees to renounce such Holder’s rights under this Agreement in accordance with Section 7.4 or to transfer CVRs to Parent pursuant to Section 2.10.

 

(c)             Promptly after the execution by Parent and the Rights Agent of any amendment pursuant to the provisions of this Section 5.1, Parent shall mail (or cause the Rights Agent to mail) a notice thereof through the facilities of DTC in accordance with DTC’s procedures and/or by first class mail to the Holders at their addresses as they appear on the CVR Register, setting forth such amendment.

 

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5.2            Amendments with Consent of Holders.

 

(a)             Subject to Section 5.1 (which amendments pursuant to Section 5.1 may be made without the consent of any Holder), with the written consent of the Acting Holders, whether evidenced in writing or taken a meeting of the Holders, Parent and the Rights Agent may enter into one or more amendments hereto for the purpose of adding, eliminating or changing any provisions of this Agreement, even if such addition, elimination or change is materially adverse to the interest of the Holders.

 

(b)             Promptly after the execution by Parent and the Rights Agent of any amendment pursuant to the provisions of this Section 5.2, Parent shall mail (or cause the Rights Agent to mail) a notice thereof through the facilities of DTC in accordance with DTC’s procedures and/or by first class mail to the Holders at their addresses as they appear on the CVR Register, setting forth such amendment.

 

5.3            Execution of Amendments. Prior to executing any amendment permitted by this Section 5, the Rights Agent shall be entitled to receive, and shall be fully protected in relying upon, an opinion of counsel selected by Parent and reasonably acceptable to Rights Agent stating that the execution of such amendment is authorized or permitted by this Agreement. Each amendment to this Agreement shall be evidenced by a writing signed by the Rights Agent and Parent. No supplement or amendment to this Agreement shall be effective unless duly executed by the Rights Agent. The Rights Agent may, but is not obligated to, enter into any such amendment that affects the Rights Agent’s own rights, obligations, privileges, immunities, protections, covenants or duties under this Agreement or otherwise.

 

5.4             Effect of Amendments. Upon the execution of any amendment under this Section 5, this Agreement shall be modified in accordance therewith, such amendment shall form a part of this Agreement for all purposes and every Holder shall be bound thereby.

 

6.             REMEDIES OF THE HOLDERS

 

6.1             Event of Default.

 

(a)            Event of Default” with respect to the CVRs, means each one of the following events which shall have occurred and be continuing (whatever the reason for such Event of Default and whether it shall be voluntary or involuntary or be effected by operation of Law, pursuant to any judgment, decree or order of any court or any order, rule or regulation of any Governmental Authority or otherwise): (i) default in the payment by Parent pursuant to the terms of this Agreement of all or any part of a Milestone Amount after a period of 10 Business Days after the Milestone Amount shall become due and payable and (ii) material default in the performance, or breach in any material respect, of any other covenant or warranty of Parent hereunder, and continuance of such default or breach for a period of 60 days after a written notice specifying such default or breach and requiring it to be remedied is given, which written notice states that it is a “Notice of Default” hereunder and is sent by registered or certified mail to Parent and the Rights Agent by the Acting Holders.

 

(b)            If an Event of Default described above occurs and is continuing (and has not been cured or waived), then, and in each and every such case, the Acting Holders by notice in writing to Parent and the Rights Agent, may, in their discretion, commence a Legal Proceeding to protect the rights of the Holders, including to obtain payment for any Milestone Amounts then due and payable in accordance with this Agreement.

 

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6.2            Suits by Holders. In addition to the rights of the Rights Agent set forth herein, the Acting Holders will have the sole right (other than the rights of the Rights Agent as set forth herein), on behalf of all Holders, by virtue of or under any provision of this Agreement, to institute any Legal Proceeding with respect to this Agreement, and no individual Holder or other group of Holders will be entitled to exercise such rights. Notwithstanding the foregoing, the right of any Holder of any CVR to receive payment of the amounts that a Milestone Notice indicates are payable in respect of such CVR on or after the applicable due date shall not be impaired or affected without the consent of such Holder and, in the event of an insolvency proceeding of Parent, individual Holders shall be entitled to assert claims in such insolvency proceeding and take related actions in pursuit of such claims with respect to any payment that may be claimed by or on behalf of Parent or by any creditor of Parent. The Acting Holders shall have the right to direct the time, method and place of conducting any Legal Proceeding for any remedy available to the Rights Agent, or exercising any power conferred on the Rights Agent by this Agreement. Notwithstanding anything to the contrary contained herein, neither the Rights Agent or the Holders shall have any right of specific performance with respect to the obligations of Parent set forth in Section 4.5.

 

7.             OTHER PROVISIONS OF GENERAL APPLICATION

 

7.1            Notices to the Rights Agent and Parent. All notices and other communications hereunder shall be in writing and shall be deemed to have been duly delivered and received hereunder (a) two Business Days after being sent by registered or certified mail, return receipt requested, postage prepaid, (b) one Business Day after being sent for next Business Day delivery, fees prepaid, via a reputable nationwide overnight courier service, (c) immediately upon delivery by hand, or (d) on the date of receipt, if delivered by email (to the extent that no “bounce back” or similar message indicating non-delivery is received with respect thereto), in each case, to the intended recipient as set forth below (or to such other recipient or address as designated in a written notice to the other parties hereto in accordance with this Section 7.1):

 

If to the Rights Agent, to it at:

 

Computershare Inc. 

Computershare Trust Company, N.A. 

150 Royall Street 

Canton, MA 02021 

Attention: Client Services

 

If to Parent, to it at:

 

Day One Biopharmaceuticals, Inc.
1800 Sierra Point Parkway, Suite 200
Brisbane, California 94005 

Attention: Adam Dubow and Sishir Mokkapati 

Email: [***]; [***]

 

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with a copy to:

 

Fenwick & West LLP
801 California Street
Mountain View, CA 94041
Attention: Robert Freedman, Stefano Quintini; David K. Michaels
Email: [email protected]; [email protected]; [email protected]

 

The Rights Agent or Parent may specify a different address or email address by giving notice in accordance with this Section 7.1.

 

7.2            Notice to Holders. Where this Agreement provides for notice to Holders, such notice shall be sufficiently given (unless otherwise herein expressly provided) if in writing and transmitted through the facilities of DTC in accordance with DTC’s procedures or mailed, first-class postage prepaid, to each Holder affected by such event, at the Holder’s address as it appears in the CVR Register, not later than the latest date, and not earlier than the earliest date, if any, prescribed for the giving of such notice. In any case where notice to Holders is given by mail, neither the failure to mail such notice, nor any defect in any notice so mailed, to any particular Holder shall affect the sufficiency of such notice with respect to other Holders.

 

7.3            Successors and Assigns. Parent may assign, in its sole discretion and without the consent of any other Person, any or all of its rights, interests and obligations hereunder to (i) any Affiliate controlled by, or under common control with, Parent for so long as they remain controlled by, or under common control with, Parent and any such Affiliate may assign any or all of its rights, interests and obligations hereunder to one or more other Affiliates controlled by, or under common control with, Parent for so long as they remain controlled by, or under common control with, Parent; provided that each such assignee agrees to assume and be bound by all of the terms and conditions of this Agreement; provided, further, that Parent shall remain liable for the performance by each such assignee of all covenants, agreements and obligations of Parent hereunder. This Agreement will be binding upon, inure to the benefit of and be enforceable by Parent’s successors and each assignee. Other than in a Change of Control, each of Parent’s successors and each assignee shall, by a supplemental contingent consideration payment agreement or other acknowledgement executed and delivered to the Rights Agent, expressly agree to assume and be bound by all of the terms and conditions of this Agreement. This Agreement shall not restrict Parent’s or any successor’s ability to merge or consolidate or enter into or consummate any Change of Control; provided that in the event of a Change of Control, Parent or the Company, as applicable, shall cause the acquirer to assume Parent’s or the Company’s obligations, duties and covenants under this Agreement. Except as otherwise permitted herein, Parent may not assign this Agreement without the prior written consent of the Acting Holders. Any attempted assignment of this Agreement or any such rights in violation of this Section 7.3 shall be void and of no effect.

 

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7.4            No Third Party Beneficiaries. Nothing in this Agreement, express or implied, shall give to any Person (other than the Rights Agent and its permitted successors and assigns, Parent, Parent’s permitted successors and assignees, and the Holders and the Holders’ successors and assigns pursuant to Permitted Transfers, each of whom is intended to be, and is, a third party beneficiary hereunder) any benefit or any legal or equitable right, remedy or claim under this Agreement or under any covenant or provision herein contained, all such covenants and provisions being for the sole benefit of the Rights Agent and its permitted successors and assigns, Parent, Parent’s permitted successors and assignees, and the Holders and the Holders’ successors and assigns pursuant to Permitted Transfers. The rights hereunder of Holders and their successors and assigns pursuant to Permitted Transfers are limited to those expressly provided in this Agreement. Notwithstanding anything to the contrary contained herein, any Holder or Holder’s successor or assign pursuant to a Permitted Transfer may at any time agree to renounce, in whole or in part, whether or not for consideration, its rights under this Agreement by written notice to the Rights Agent and Parent, which notice, if given, shall be irrevocable, and Parent may, in its sole discretion, at any time offer consideration to Holders in exchange for their agreement to irrevocably renounce their rights, in whole or in part, hereunder.

 

7.5            Governing Law; Jurisdiction; WAIVER OF JURY TRIAL.

 

(a)             This Agreement, the CVRs and all actions arising under or in connection herewith and therewith (whether sounding in contract, tort or otherwise) shall be governed by and construed in accordance with the he laws of the State of Delaware, without giving effect to any laws, rules or provisions that would cause the application of the laws of any jurisdiction other than the State of Delaware.

 

(b)             In any action between any of the parties arising out of or relating to this Agreement or the CVRs, each of the parties irrevocably and unconditionally: (i) consents to submit itself to the exclusive personal jurisdiction of the Court of Chancery of the State of Delaware, New Castle County, or, if that court does not have jurisdiction, a federal court sitting in the State of Delaware; (ii) agrees that all claims in respect of such action or proceeding shall be heard and determined in any such court, (iii) agrees that it shall not attempt to deny or defeat such personal jurisdiction by motion or other request for leave from any such court, (iv) agrees not to bring any action or proceeding arising out of or relating to this Agreement or the CVRs in any other court, and (v) waives any defense of inconvenient forum to the maintenance of any action or proceeding so brought and waives any bond, surety or other security that might be required of any other Person with respect thereto. All rights and remedies existing under this Agreement are cumulative to, and not exclusive of, any rights or remedies otherwise available.

 

(c)             EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE TRANSACTIONS CONTEMPLATED HEREBY OR THE ACTIONS OF ANY OF THE PARTIES HERETO IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF. EACH PARTY HERETO CERTIFIES AND ACKNOWLEDGES THAT (A) NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER, (B) EACH PARTY HERETO UNDERSTANDS AND HAS CONSIDERED THE IMPLICATION OF THIS WAIVER, (C) EACH PARTY HERETO MAKES THIS WAIVER VOLUNTARILY, AND (D) EACH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 7.5(C).

 

25 

 

 

7.6            Severability. In the event that any provision of this Agreement, or the application thereof, becomes or is declared by a court of competent jurisdiction to be illegal, void or unenforceable, the remainder of this Agreement shall continue in full force and effect and the application of such provision to other Persons or circumstances shall be interpreted so as reasonably to effect the intent of the parties. The parties further agree to negotiate in the absence of bad faith to replace such void or unenforceable provision of this Agreement with a valid and enforceable provision that will achieve, to the extent possible, the economic, business and other purposes of such void or unenforceable provision.

 

7.7            Termination. This Agreement shall be terminated and of no force or effect, the parties hereto shall have no liability hereunder (other than with respect to monies due and owing by Parent to Rights Agent), and no payments shall be required to be made following the earlier to occur of (a) the payment in full of each of the Milestone Amounts, including the mailing by the Rights Agent to the address of each Holder as reflected in the CVR Register the full amount of each Milestone Amount, as required to be paid under the terms of this Agreement and (b) the termination of the Merger Agreement prior to the Offer Acceptance Time and the Effective Time in accordance with its terms. Notwithstanding the foregoing, no such termination shall affect this Section 7, which shall survive the termination of this Agreement, or the resignation, replacement or removal of the Rights Agent.

 

7.8            Entire Agreement; Counterparts. This Agreement and the Merger Agreement constitutes the entire agreement of the parties hereto with respect to the subject matter of this Agreement and supersedes all contemporaneous and prior agreements and understandings, both written and oral, among or between any of the parties hereto, with respect to the subject matter hereof. If and to the extent that any provision of this Agreement is inconsistent or conflicts with the Merger Agreement, (a) this Agreement shall govern and be controlling with respect to CVR matters only and (b) the Merger Agreement shall govern and control with respect to all matters unrelated to the CVR. This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by PDF shall be sufficient to bind the parties hereto to the terms and conditions of this Agreement.

 

7.9            Payments on Next Business Day. In the event that a Milestone Payment Date or any other date by which any payment in respect of the CVRs shall be required to be made hereunder shall not be a Business Day, then, notwithstanding any provision of this Agreement to the contrary, any payment required to be made in respect of the CVRs on such date need not be made on such date, but may be made on the next Business Day thereafter with the same force and effect as if made on the applicable required date.

 

7.10          No Fiduciary Obligations. Each of Parent and the Rights Agent acknowledges and agrees that the other party, its Affiliates and their respective officers, directors and controlling Persons do not owe any fiduciary duties to the first party or any of its respective Affiliates, officers, directors or controlling Persons, or to the Holders. The only obligations of Parent and the Rights Agent to each other and their Affiliates and their respective officers, directors and controlling Persons arising out of this Agreement are the contractual obligations expressly set forth in this Agreement.

 

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7.11            Confidentiality. The Rights Agent agrees that all books, records, information and data pertaining to the business of Parent or its Affiliates, including inter alia, personal, non-public Holder information, which are exchanged or received pursuant to the negotiation or the carrying out of this Agreement including the fees for services set forth in the attached schedule shall remain confidential, and shall not be voluntarily disclosed to any other person, except as may be required by a valid order of a court or governmental body of competent jurisdiction or is otherwise required by law or regulation, including SEC or any stock exchange on which the securities of the Rights Agent are listed, or pursuant to subpoenas from state or federal government authorities (subject to (x) the Rights Agent notifying, to the extent practicable, Parent of such potential disclosure reasonably in advance of such disclosure, (y) cooperating with Parent, at Parent’s expense, in any effort to restrict disclosure of such book, records, information or data and (z) the Rights Agent only disclosing such books, records, information or data that is required to be so disclosed by such valid order, such applicable Law, rule or regulation of the SEC or any stock exchange on which the securities of the Rights Agent are listed or such subpoena). This Section 7.11 shall survive the termination of this Agreement and shall remain in full force and effect in accordance with its terms.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 

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IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed on its behalf by its duly authorized officers as of the day and year first above written.

 

  Day One Biopharmaceuticals, Inc.
   
  By: /s/ Jeremy Bender
  Name: Jeremy Bender
  Title: CEO
   
  Computershare Trust Company, N.A. and Computershare Inc.,
  on behalf of both parties
   
  By: /s/ Thomas Borbely
  Name: Thomas Borbely
  Title: Senior Manager, Corporate Actions

 

28 

 

Exhibit 99.1

 

 

 

Day One Completes Acquisition of Mersana Therapeutics

 

Acquisition expands Day One’s pipeline with clinical-stage antibody drug conjugate (ADC)
emiltatug ledadotin (Emi-Le) targeting rare cancer adenoid cystic carcinoma (ACC)

 

BRISBANE, Calif., JANUARY 6, 2026 – Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the successful close of its acquisition of Mersana Therapeutics, Inc., (NASDAQ: MRSN) (“Mersana”) following completion of all conditions of the tender offer to acquire all outstanding shares of Mersana at a price of $25 per share in cash, plus one non-tradable contingent value right (“CVR”) per share to receive certain potential milestone payments of up to an aggregate of $30.25 per CVR in cash.

 

“This acquisition of Mersana is a strategic fit with Day One’s mission and ambitions, allowing us to continue to expand into adult oncology while maintaining a focus on rare cancers. With promising early clinical data, Emi-Le represents a potentially transformative advancement in the treatment of ACC, and we will leverage our distinct capabilities to rapidly develop the asset and pursue registration to reach patient communities who have no approved therapies today,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Building on the strong momentum of OJEMDA in the market and our continually progressing pipeline, this acquisition strengthens our overall position to expand our impact on patient communities while delivering sustainable business growth.”

 

Through this acquisition, Day One has added a second novel ADC to the company’s clinical pipeline. Emi-Le (emiltatug ledadotin) represents an innovative and differentiated ADC directed against B7-H4, a well-characterized target in certain cancers including adenoid cystic carcinoma (ACC), a challenging rare cancer usually arising within the salivary gland with a clear unmet medical need. For additional background on Emi-Le and the acquisition, please read the announcement press release and view Day One’s investor presentation.

 

Terms of the Acquisition

 

Day One has acquired all outstanding shares of Mersana common stock at a price of $25 per share in cash, plus one non-tradable CVR per share to receive certain potential milestone payments of up to an aggregate of $30.25 per CVR in cash, for total consideration of up to $55.25 per share in cash. The CVR is payable subject to certain terms and conditions of achievement of specified milestones.

 

The tender offer expired as scheduled at one minute following 11:59 p.m., Eastern Time, on January 5, 2026 (the “Expiration Date”). The depositary for the tender offer, Computershare Trust Company, N.A., advised Day One that, as of the Expiration Date, a total of 3,029,135 shares of Mersana common stock were validly tendered and not validly withdrawn pursuant to the tender offer, representing 60.57% of the outstanding shares of Mersana common stock and satisfying the minimum condition to consummate the tender offer. All of the conditions of the tender offer having been satisfied, Day One accepted for payment all such tendered shares, and following a statutory merger under Section 251(h) of the Delaware General Corporation Law on January 6, 2026, Mersana became a direct wholly owned subsidiary of Day One. All remaining shares of Mersana common stock that were not tendered in the tender offer were converted into the right to receive the same per share consideration as shares that were tendered in the tender offer, as described above. With the completion of the acquisition, Mersana’s common stock will cease to trade on the Nasdaq stock exchange prior to market open on January 6, 2026 and Mersana’s common stock will be delisted from Nasdaq.

 

 

 

 

Advisors

 

Gordon Dyal & Co., LLC acted as the exclusive financial advisor to Day One, with Fenwick & West LLP serving as legal counsel. TD Cowen acted as financial advisor to Mersana, with Wilmer Cutler Pickering Hale and Dorr LLP serving as legal counsel.

 

About Day One Biopharmaceuticals

 

Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company that believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.

 

Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. Day One’s pipeline includes tovorafenib (OJEMDA™), DAY301, and following the January 2026 acquisition of Mersana Therapeutics, Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate (ADC) targeting the B7-H4 protein in clinical development to treat the rare cancer adenoid cystic carcinoma (ACC).

 

Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find Day One on LinkedIn or X.

 

Day One uses its Investor Relations website (ir.dayonebio.com), its X handle (x.com/DayOneBio), and LinkedIn Home Page (linkedin.com/company/dayonebio) as a means of disseminating or providing notification of, among other things, news or announcements regarding its business or financial performance, investor events, press releases, and earnings releases, and as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

 

Cautionary Note Regarding Forward-Looking Statements

 

This press release contains “forward-looking” statements, including, but not limited to: Day One’s plans to develop and commercialize cancer therapies and its pipeline, including the ability of Emi-Le to treat ACC or other cancers, statements regarding the payment and timing of payment of the offer to former Mersana common stockholders, the ability and timing of delisting of Mersana common stock, and the ability to achieve any milestones under the CVR within the milestone payment period under the CVR. Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

 

 

 

 

Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of the consummation of the acquisition on the market price of Day One’s common stock and/or operating results; significant transaction costs; unknown liabilities; Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate; Day One’s ability to protect intellectual property; the potential impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

 

DAY ONE MEDIA

[email protected]

 

DAY ONE INVESTORS

LifeSci Advisors, PJ Kelleher

[email protected]

 

# # #

 

 

 

 

 

Exhibit 99.2

 

Targeted therapies for people of all ages January 2026 Day One Biopharmaceuticals

 

 

2 Disclaimer This presentation and the accompanying oral commentary contain forward - looking statements that are based on our management’s bel iefs and assumptions and on information currently available to our management. Forward - looking statements are inherently subject to risks and uncertainties, some of whi ch cannot be predicted or quantified. In some cases, you can identify forward - looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “plan,” anticipate,” “believe,” “estimate,” “predict,” “intend,” “potential,” “would,” “continue,” “ongoing” or the negative of these terms or other comparab le terminology. Forward - looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our fut ure financial performance, including the sufficiency of our cash, cash equivalents and short - term investments to fund our operations, business plans and objectives, timi ng and success of our commercialization and marketing efforts, timing and success of our planned nonclinical and clinical development activities, the success of our acquisition of Mersana Therapeutics and its Emi - Le program, the results of any of our strategic collaborations, including the potential achievement of milestones and provision of royalty payments thereunder, efficacy and safety profiles of our products and product candidates, the ability of OJEMDA ( tovorafenib ) to treat pediatric low - grade glioma (pLGG) or related indications, the potential therapeutic benefits and economic value of our products and product candidates, potential growth opportunities, competitive position, ind ust ry environment and potential market opportunities, our ability to protect intellectual property and the impact of global business or macroeconomic conditions, in clu ding as a result of inflation, changing interest rates, government shutdowns, cybersecurity incidents, significant political, trade or regulatory developments, including tari ffs , shifting priorities within the U.S. Food and Drug Administration and reduced funding of federal healthcare programs, and global regional conflicts, on our business and operati ons . Forward - looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors. It is not possi ble for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may ca use actual results to differ materially from those contained in any forward - looking statements we may make. These factors, together with those that are described under the heading “Risk Factors” contained in our most recent Quarterly Report on Form 10 - Q filed with the Securities and Exchange Commission (SEC) and other documents we file from time to t ime with the SEC, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward - looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. Th ese statements are based upon information available to us as of the date of this presentation, and although we believe such information forms a reasonable basis for su ch statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, a ll potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Furthermore, if our fo rward - looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward - looking statements, you s hould not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time fram e, or at all. We undertake no obligation to publicly update any forward - looking statements, whether as a result of new information, future events or otherwise, except as required by law. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market si ze and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such est imates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.

 

 

3 Inspired by the urgent needs of children, Day One creatively and intentionally develops new medicines for people of all ages with life - threatening diseases

 

 

Bringing life - changing medicines to patients sooner 4 • Commercial - stage biopharmaceutical company • Our goal is to develop and provide access to targeted new medicines to patients of all ages as rapidly as possible • Focused on advancing first - or best - in - class medicines for childhood and adult diseases Who we are OJEMDA received approval in April 2024 and is indicated for the treatment of pediatric patients 6 months of age and older wit h r elapsed or refractory pediatric low - grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. 2021 IPO 2018 FOUNDED 2024 OJEMDA TM APPROVAL Nasdaq: DAWN

 

 

5 Day One’s Future Potential Value creation • Continued revenue growth from OJEMDA globally • Indication expansion in front - line pLGG with FIREFLY - 2 • Generate clinical POC data in DAY301 program • Advance Emi - Le toward registrational development in ACC • Fund pipeline expansion • Maintaining a strong financial foundation through thoughtful capital allocation Proven Track Record Intentional in our approach • Expertise developing and commercializing products • Demonstrated ability to find and acquire first - or best - in - class medicines Pillars to Support Growth Accomplishments x Launched OJEMDA in the U.S., delivering double - digit revenue growth, for the 5 consecutive quarters since launch x Ex - U.S. commercial partnership with Ipsen for OJEMDA, EMA regulatory decision expected in 2026 x Acquisition of DAY301 (PTK7 - targeted ADC) meaningfully expands our pipeline x Acquisition of Mersana Therapeutics, including Emi - Le (B7 - H4 - Targeted ADC) Compelling near - term opportunities to help patients are the foundation for long - term growth and sustainability pLGG, pediatric low - grade glioma; POC, proof of concept; ADC, antibody - drug conjugate; PTK7, protein tyrosine kinase 7. 5

 

 

Recent & Anticipated Milestones Approved Phase 3/ Registrational Phase 2 Phase 1 Dose Expansion Phase 1 Dose Escalation Therapeutic Area Product Candidate FDA accelerated approval April 2024 EMA regulatory decision expected 2026 3 - year follow - up data presented SNO Conference, November 2025 BRAF - altered relapsed pLGG Tovorafenib Type II RAF Inhibitor OJEMDA brand name in U.S. 1 Ex - U.S. Rights: 3 Enrollment completion expected 1H 2026 Front - line RAF - altered pLGG Development timelines & data presentation to be outlined for 2026 Adenoid Cystic Carcinoma (ACC) Emiltatug Ledadotin (Emi - Le) B7 - H4 - Targeted ADC First dose cohort cleared January 2025 Adult and pediatric solid tumors DAY301 4 PTK7 - Targeted ADC 6 Our goal is to take aim at the gaps that have left patients and their families behind. FIREFLY - 1 (pivotal Phase 2) 2 FIREFLY - 2 (pivotal Phase 3) 1 OJEMDA has received accelerated approval by the U.S. Food and Drug Administration. 2 FIREFLY - 1 is an open - label, pivotal Phase 2 trial. 3 Ex - U.S. license agreement with Ipsen to commercialize OJEMDA ( tovorafenib ) outside the U.S. 4 DAY301 is a license agreement with MabCare Therapeutics for exclusive worldwide rights, excluding Greater China, for MTX - 13/CB - 002, a novel ADC targeting PTK7. The safet y and efficacy of investigational agents and/or investigational uses of approved products have not been established. Our pipeline

 

 

Relapsed or refractory BRAF - altered pLGG OJEMDA 7 Nora Living with pLGG

 

 

8 A serious and life - threatening disease *Incidence of BRAF alterations varies across pLGG subtypes. 1 Sievert AJ, Fisher MJ. Pediatric low - grade gliomas. J Child Neurol. 2009;24(11): 1397 - 1408 . doi:10.1177/0883073809342005 . 2 Penman CL et al. Front Oncol . 2015;5:54. 3 Cohen AR ., N Engl J Med. 2020;386(20):1922 - 1931. 4 Lassaletta A, et al. J Clin Oncol . 2017;35(25):2934 - 2941. 5 Faulkner C, et al. J Neuropathol Exp Neurol. 2015;74(9):867 - 872. 6 Packer RJ, et al. Neuro Oncol. 2017;19(6):750 - 761. 7 Ostrum QT et al., Neuro Oncol. 2015; 16( Suppl 10):x1 - x36; 8 De Blank P. et al., Curr Opin Pediatr . 2019 Feb; 31(1):21 - 27. Pediatric low - grade glioma: The most common type of brain tumor in children • For the majority of patients with pLGG in the relapsed setting, there is no standard of care, and until recently, no approved therapies • Up to 75% of pLGGs have a BRAF alteration*, of those ~80% are BRAF fusions and ~20% are BRAF V600 mutations 2 - 6 • Despite surgery playing a significant role in treatment, the vast majority of patients still require systemic therapy 7,8 • Due to high rate of disease recurrence, most patients will undergo multiple lines of systemic therapy over the course of their disease pLGGs are chronic and relentless , with patients suffering profound tumor and treatment - associated morbidity that can impact their life trajectory over the long term 1

 

 

9 Available in tablet formulation and pediatric - friendly powder for oral suspension Overview U.S. prescribing information for OJEMDA 9 Indication OJEMDA is indicated for the treatment of pediatric patients 6 months of age and older with relapsed or refractory pediatric low - grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation Recommended Dose 380 mg/m 2 administered orally once weekly (not to exceed a dose of 600mg once weekly); OJEMDA can be taken with or without food For full prescribing information, visit dayonebio.com * This indication is approved under accelerated approval based on response rate and duration of response. Continued approval fo r t his indication may be contingent upon verification of clinical benefit in a confirmatory trial.

 

 

10 Data from Pivotal Phase 2 FIREFLY - 1 trial. • Meaningful tumor stabilization or shrinkage may be possible with OJEMDA, in the clinical trial: • 51% of children experienced tumor shrinkage by at least 25% • 82% of children saw their tumors shrink or remain stable Efficacy Safety • Generally well - tolerated therapy, with 9 out of 10 patients staying on treatment in the clinical trial • Most common grade 3 / 4 adverse events include: anemia, elevated CPK, maculo - papular rash, fatigue & vomiting Dosing • Once - weekly, taken with or without food conveniently from home can mean fewer daily interruptions OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low - grade glio ma (pLGG) harboring a BRAF fusion, rearrangement, or BRAF V600 mutation. Product profile aligns with what physicians are looking for in a therapy

 

 

11 1 US Census. 2 CBTRUS, Qaddoumi et al 2009, Schreck et al 2019, ClearView Analysis. 3 Penman CL et al. Front Oncol. 2015;5:54. 4 Cohen AR., N Engl J Med. 2020;386(20):1922 - 1931. 5 Lassaletta A, et al. J Clin Oncol. 2017;35(25):2934 - 2941. 6 Faulkner C, et al. J Neuropathol Exp Neurol. 2015;74(9):867 - 872. 7 Packer RJ, et al. Neuro Oncol. 2017;19(6):750 - 761. * Incidence of BRAF alterations varies across pLGG subtypes. † Predominantly seen in pilocytic astrocytomas . †† May vary across pLGG subtypes. BRAF, V - Raf murine sarcoma viral oncogene homolog B; MAPK, mitogen - activated protein kinase; pLGG , pediatric low - grade glioma. § Estimated annual incidence, estimated prevalence, estimated progression rates, and estimated recurrent/progressive total addressable opportunity are Day On e calculations based on publicly available data. The estimated recurrent/progressive total addressable opportunity is based on progression free survival curves modeled from published literature and internal market re sea rch conducted by EpidStrategies , A Division of ToxStrategies , Inc. on behalf of Day One. r/r, relapsed or refractory. Incident Therapeutic Build for New pLGG Patients to be Treated in Frontline Setting U.S. Incident Patients <25 years old with CNS Tumors (0.00521%) 1,2 ~5,500 Rate of Low Grade Gliomas (Gliomas rate 63%, Low - Grade 77%) 2 ~2,600 ~1,500 Patients Ineligible for Surgery or Post Surgery (58%) 2 ~1,100 % BRAF Fusion (80%) † % BRAF V600 (20%) † † ~880 ~220 Frontline (1L) Annual Incident Patients ~1,100 1L BRAF - Altered pLGG Patients Eligible for Systemic Therapy Illustrative pLGG Patient Flow § Prevalence of Systemically - Treated Patients Under 25 Years ~26,000 5 Year Prevalence ~5,500 Progressed After 5 Years ~55 - 60% Relapsed / Refractory (2L+) ~55 - 60% Majority of patients with pLGG will progress within 5 years Opportunity for OJEMDA in Annual U.S. Treated r/r pLGG Population in the U.S. Rate of BRAF - Altered (70% - 75%) 3 - 7* Treatment Eligible Population ~2,000 - 3,000 Recurrences Trigger Entry to Treatment Eligible Population Foundational U.S. opportunity for OJEMDA in both relapsed and frontline pLGG 11

 

 

Delivering double - digit Q3 2025 growth across core metrics 12 1 Prescriptions are approximations based on data available as of September 30, 2025. Quarterly growth in net product revenue, pre scriptions and new patient starts versus Q2 2025. 15% Growth in Net Product Revenue 18% $38.5M in Q3 2025 19% Growth in New Patient Starts Growth in Total Prescriptions 1 1,256 TRx in Q3 2025

 

 

13 1 2024 net revenue included approximately $3.0M of revenue associated with Ex - U.S. sales which has been removed for the purposes o f calculating compounded annual revenue growth rate. 2 Compounded annual growth represents the comparison of 2024 to Q3 2025 YTD U.S. net product revenue. Commercial execution driving strong top - line growth and performance $30.5 $33.6 $38.5 Net Product Revenue Q3 2025 Q1 2025 Q2 2025 +$4.9M +15% ~89% Compounded Annual Growth 1,2 Achieved $38.5M in Q3 2025 OJEMDA net product revenue Net Revenue Highlights • Achieved $102.6M in net product revenue for 2025 year - to - date • Year - to - date net product revenue already exceeds full - year 2024 by ~89% 1,2

 

 

923 1,062 1,256 14 19% growth in new patient starts driven by 2 - year follow up data 3 Prescription Highlights • Gaining share in the 2L setting as prescriber confidence grows • High percentage of on - label patients staying on therapy month - to - month • ~90% of on - label patients receiving approval on first request Accelerating uptake driving TRx growth and demonstrating durable demand Prescriptions OJEMDA Prescriptions ( TRx ) 1 Q3 2025 Q1 2025 Q2 2025 ¹ Prescriptions are approximations based on data available as of September 30, 2025. 2 Compounded annual growth represents the comparison of 2024 to Q3 2025 YTD. 3 2 - year follow - up data is from the FIREFLY - 1 clinical trial and quarterly growth represents the comparison of Q2 2025 to Q3 2025. ~97% Compounded Annual Growth 2 +18%

 

 

Positive physician experience continues to build across treatment settings 15 1 Day One Biopharmaceuticals market research, self - reported data fielded September 2025 versus October 2024. Strong Persistency 2L Adoption Increasing 20 months median duration of treatment for EAP patients 75% of EAP patients who reached 24 months on OJEMDA continued on treatment ~90% of active patients are commercial new patient starts (non - EAP) 2L adoption grew >60% in past 12 months 1 Increasing number of HCPs stating OJEMDA is their 2L treatment of choice “My default right now for second line is OJEMDA” “I’ve changed my practice recently and now offer OJEMDA after a patient fails chemotherapy” - pLGG Treating Physicians

 

 

16 1 Sequential growth refers to Q3 2025 versus Q2 2025. • >60% of prescribing accounts have treated multiple patients with OJEMDA • 28% sequential growth in number of accounts with 4 or more patients 1 • >80% Priority 1 accounts have initiated 4 or more patients Launch Dec 2024 Sept 2025 1 Patient 2 - 3 Patients 4 - 5 Patients 6 - 8 Patients 9+ Patients Breadth & Depth of Prescribing by Account Breadth & Depth Highlights Prescriber confidence driving repeat use with significant opportunity remaining

 

 

Focused execution and meaningful progress driving continued adoption and treatment durability through 2025 17 * On label patients only. Raising 2025 guidance to $145 - $150 million net product revenue OPTIMIZE PERSISTENCE Support physicians and patients to optimize their experience on OJEMDA including effective AE management and reimbursement support Increase depth of prescribing by expanding physicians' belief in which patients will benefit from OJEMDA and using it in 2L* Continue to expand prescriber base by converting non - users into first - time adopters of OJEMDA DRIVE NEW PATIENT STARTS

 

 

We continue to strengthen the OJEMDA story through enhancing the target product profile and data generation 18 FIREFLY - 1 3 - Year Data Highlighting clinical stability following treatment with OJEMDA and opportunity for retreatment Potential to further expand physician confidence and adoption while reinforcing target product profile Presentation at SNO conference in November 2025; publication efforts underway Establishing OJEMDA as the Standard of Care in 2L r/r BRAF - altered pLGG

 

 

19 OJEMDA IP summary and regulatory designations • Composition of matter patent of tovorafenib provides protection in the U.S. out to mid - 2036 (with patent term extension) 1 • Patent portfolio covers formulations, manufacturing methods, and uses of tovorafenib, with issued and pending applications potentially extending into the 2040s 2 1 Composition of matter and pharmaceutical compositions of tovorafenib are co - owned; patent term extension is estimated at 5 years . 2 Future patent term coverage assumes pending applications are granted. Intellectual Property U.S. • Orphan Drug Exclusivity (granted 7 years exclusivity) • New Chemical Entity (granted 5 years exclusivity) • Breakthrough Therapy Designation • Rare Pediatric Disease Designation Europe • Orphan Drug Designation (eligible for 10 years exclusivity) Regulatory Designations

 

 

Phase 2 FIREFLY - 1 Trial 20 3 - year follow - up data from the FIREFLY - 1 trial studying OJEMDA

 

 

After 26 OJEMDA cycles, patients could enter an observation period* 21 June 6, 2025 data cutoff. *A cycle was counted if a patient had at least 1 dose in a cycle; patients were treated for a planned period of 26 cycles, after which they could continue tovorafenib or opt to enter an observation period. † 1 patient of 77 patients in Arm 1 had a target lesion not meeting the minimum size at baseline per IRC; the remaining 76 were included in the time to next treatment analysis. ‡ Among the 44 patients with ≥26 cycles, 5 did not enter post - treatment observation: 4 remain on primary treatment, 1 died, 2 discontinued due to PD, and 2 discontinued due to other reasons but op ted out of post - treatment observation; among the 39 post - treatment observation patients, 4 received <26 cycles of treatment because of prolonged dose hold due to growth suppression. ¥ Hereafter referred to as RAPNO. ¶ Defined as the lowest tumor size (measured by SPPD per RAPNO) at any timepoint. CBR, clinical benefit rate; DOR, duration of response; HGG, high - grade glioma; IRC, independent radiology review committee; LGG, low - grade glioma; ORR, overall r esponse rate; PFS, progression - free survival; RANO, Response Assessment in Neuro - Oncology ; RAPNO, Response Assessment in Pediatric Neuro - Oncology; PD, progressive disease; SPPD, sum of product of perpendicular diameters; TTR, time to response . Updated 3 - year analysis Endpoints (Arm 1): • Primary • ORR per RANO - HGG • Secondary • Safety, ORR per RAPNO - LGG ¥ , CBR, TTR, DOR, PFS based on RAPNO - LGG ¥ • Exploratory • ORR and CBR per RANO - LGG • Time to next treatment: composite endpoint of the time from the date of the first OJEMDA dose to the start date of the first subsequent anticancer therapy (including retreatment with OJEMDA), or date of death, whichever was earlier • Treatment - free interval: composite endpoint of time from the last dose of OJEMDA to the start of subsequent treatment or date of death, whichever was earlier • Post hoc • Clinical progression: composite endpoint of first visual PD, deteriorating clinical status, or death, whichever was earliest • Radiographic progression: composite endpoint of first PD (>25% increase compared to nadir ¶ ) in target lesion and/or non - target lesion, any new lesions, or death, whichever was earliest Subsequent anticancer therapy or death OJEMDA Arm 1, n=77 26 cycles* (~24 months) Received 26 cycles, n=44* Observation period ( no anticancer therapy) Time to next treatment, n=76 † Treatment - free inter val , n=39 ‡ Day 1 PD or death PFS: RAPNO - LGG ¥ , n=76

 

 

Deep, durable responses with OJEMDA evaluated by IRC - assessed RAPNO 22 June 6, 2025 data cutoff. * 1 patient of 77 had a target lesion not meeting the minimum size at baseline per IRC. † ORR for RAPNO included MRs (i.e., ORR=CR+PR+MR). For CR, PR, and MR, confirmation of response by a subsequent scan approximately 3 months after the initial response was required. ‡ Of any duration. ¥ As measured by SPPD per RAPNO at last scan prior to last dose. ¶ Medians and 95% CIs were calculated using the Kaplan - Meier method; responders who had not progressed at the time of data cutoff were censored at the date of their last adequate imaging examina tio n. CI, confidence interval; CR, complete response; DOR, duration of response; IRC, independent radiology review committee ; MR, minor response; NE, not evaluable; ORR, overall response rate; PD, progressive disease; PR, partial response; RAPNO, Response Assessment in Pediatric Neuro - Oncology ; SD, stable disease; SPPD, sum of the products of the perpendicular diameters; TTR, time to response. Updated 3 - year analysis 3 - year Arm 1 ( n=76) * Exposure 44/76 (58) Completed ≥26 cycles of treatment, n (%) Response (IRC) 40 (53) ORR, † n (%) 0 30 (39) 10 (13) 22 (29) 13 (17) 1 (1) Best Overall Response, n (%) CR PR MR SD ‡ PD NE - 47.3 ( - 97.3 – 162.0) Median change in tumor size, ¥ % (range) 19.4 (13.8 – 27.2) Median DOR, months (95% CI) ¶ 5.4 (1.6 – 17.5) Median TTR, months (range)

 

 

Many patients continued OJEMDA beyond RAPNO - defined radiographic progression by IRC 23 June 6, 2025 data cutoff. * 1 patient of 77 had a target lesion not meeting the minimum size at baseline per IRC. † 58 patients had RAPNO - defined PD events reported by the data cutoff. Of patients who had RAPNO - defined PD on tovorafenib , t here are 37/38 patients with a scan at PD. One patient was assessed as having PD per RAPNO by IRC because of visual acuity. ‡ A s measured by SPPD per RAPNO at EOT. EOT, end of treatment; IRC, independent radiology review committee ; PD, progressive disease; RAPNO, Response Assessment in Pediatric Neuro - Oncology ; SPPD, sum of product of perpendicular diameters. Updated 3 - year analysis OJEMDA beyond PD: 100% ( 38 /38) ≥26 cycles of OJEMDA: 66% ( 25 /38) Reduced tumor size ‡ at last scan prior to last dose, relative to baseline: 76% ( 29 /38) Further tumor reduction ‡ beyond PD: 45% ( 17 /38) 0% 25% 50% 75% 100% Proportion of patients with PD while on tovorafenib (%) In the 3 - year follow - up analysis, 38 † patients had RAPNO - defined PD while on OJEMDA

 

 

RAPNO PFS demonstrates efficacy with OJEMDA; time to next treatment more accurately reflects the full clinical benefit 24 June 6, 2025 data cutoff. *1 patient of 77 had a target lesion not meeting the minimum size at baseline per IRC. † T ime to next treatment : an exploratory composite endpoint of time from the date of the first tovorafenib dose to the start date of the first subsequent anticancer therapy (including retreatment with tovorafenib ), or date of death, whichever was earlier . ‡ Clinical PFS = clinical deterioration per RAPNO, defined as neurologic or functional decline that is unequivocally attributable to tumor progression and not explained by treatment - related effects. ¥ RAPNO PFS event can occur due to either radiographic PD or clinical deterioration (clinical PD). ¶ rPFS =radiographic progression per RAPNO, defined as a ≥25% increase in the tumor size (as measured by SPPD per RAPNO) of measurab le lesions relative to the nadir, or the appearance of new lesions. § Based on Kaplan - Meier estimate. ₸ Defined as the lowest tumor size (as measured by SPPD per RAPNO) at any timepoint. CI, confidence interval; IRC, independent radiology review committee ; NE, not evaluable; NR, not reached; PD, progressive disease; PFS, progression - free survival; RAPNO, Response Assessment in Pediatric Neuro - Oncology ; rPFS , radiographic progression - free survival; SPPD, sum of product of perpendicular diameters . Updated 3 - year analysis 1.0 0.0 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 Time from the first dose (months) 0.8 0.6 0.4 0.2 Probability Clinical PFS rPFS PFS T ime to next treatment † Median time to next treatment § was 42.6 months (95% CI 36.7 – NE) • RAPNO defines radiographic PD as a ≥25% increase in tumor size from nadir ₸ — not baseline – Deep responses induced by OJEMDA lower the PD threshold — modest measurement variability on scans can score as PD • Time to next treatment is a better assessment of clinical benefit than RAPNO PFS – More closely aligned with clinician - driven intervention than RAPNO PFS

 

 

Tumor rebound was minimal in the first 6 months off therapy 25 June 6, 2025 data cutoff. Time 0 is the date of the last tumor assessment before the final dose of primary tovorafenib treatment; plot lines extend to the last follow - up assessment (prior to tovorafenib retreatment if applicable). *Tumor rebound was defined as a ≥25% increase in tumor size within 6 months of the last dose of tovorafenib as determined by the change in tumor size (as measured by SPPD per RAPNO) from the last scan before the final dose of tovoraf en ib. 1 † “3 months ” is the first scan after the last dose, and “6 months” is any scan after EOT within 6 months. ‡ As measured by SPPD per RAPNO. C1D1, cycle 1, day 1; EOT, end of treatment (last dose) ; Q, quartile; RAPNO, Response Assessment in Pediatric Neuro - Oncology; SPPD, sum of product of perpendicular diameters. Post - treatment observation period: Tumor kinetics aft er last scan prior to last dose (n=39). 1. O'Hare P, et al. Neuro Oncol . 2024;26(8):1357 – 1366. Updated 3 - year analysis 0 3 6 9 12 15 18 21 24 -100 -80 -60 -40 -20 0 20 40 60 80 C h a n g e i n t u m o r s i z e ( p e r R A P N O ) c o m p a r e d w i t h b a s e l i n e ( C 1 D 1 ) d u r i n g t h e o b s e r v a t i o n p e r i o d ( % ) No tumor rebound (n=27) Tumor rebound (n=12)* Last scan prior to last dose Months Post - treatment observation patients, n=39 6 months post - EOT † 3 months post - EOT † 1.8 (0 – 4.2) Median time between prior scan and last dose, months (range) - 55 ( - 67, - 35) - 51 ( - 64, - 33) Median tumor size ‡ change from baseline (C1D1) after the last dose, % (Q1, Q3) 12 (31%) ≥25% increase in tumor size ‡ from last scan prior to last dose, n (%) V600 mutation (n=6): 4 of 12 total patients with rebound 2 of 27 total patients without rebound

 

 

Early evidence of retreatment activity observed in the OJEMDA - retreated cohort 26 June 6, 2025 data cutoff. *Based on maximum % change from last scan before retreatment. † A s measured by SPPD per RAPNO. Post - treatment observation patients: OJEMDA retreatment (n=8). RAPNO, Response Assessment in Pediatric Neuro - Oncology; SPPD, sum of product of perpendicular diameters. Updated 3 - year analysis n=8 Patients retreated with OJEMDA - 38.3 ( - 80.9 – 0) Median change, % (range)* 9.0 (2.6 – 18.0) Median duration of retreatment, months (range) 10.5 Median number of tovorafenib cycles administered during retreatment At time of data cutoff: • All 8 patients receiving OJEMDA retreatment were still on therapy • Median tumor size † was smaller than the median tumor size recorded prior to retreatment initiation

 

 

77% of 39 patients were treatment free for at least 12 months; median treatment - free interval not yet reached 27 June 6, 2025 data cutoff. * Treatment - free interval: an exploratory endpoint of time from the last dose of tovorafenib to the start of subsequent treatment or date of death, whichever was earlier. † Among the 44 patients with ≥26 cycles, 5 did not enter post - treatment observation: 4 remain in primary treatment, 1 died, 2 discontinued due to PD and 2 di scontinued due to other reasons but opted out of post - treatment observation; among the 39 post - treatment observation patients, 4 received <26 cycles of treatment because of prolonged dose hold due to growth suppression . Post - treatment observation period: Treatment - free interval (n=39). CI, confidence interval; NE, not evaluable; NR, not reached; PD, progressive disease. Updated 3 - year analysis Post - treatment observation patients n=39 † 24.6 (16.0 – 38.7) Median duration of treatment, months (range) 16.0 (1.4 – 24.5) Median follow - up from last dose to subsequent anticancer therapy, months (range) NR (NE – NE) Treatment - free interval, months Median (95% CI) Treatment free ≥12 months: 77 % (30/39) 0 10 20 30 40 50 60 70 80 90 100 Proportion of patients (%) Post - treatment observation period

 

 

No new safety signals were observed in the 3 - year update 28 June 6, 2025 data cutoff. Adverse events were cumulative events from day 1 to the earliest of (last dose + 30 days, start dat e o f subsequent anticancer treatment , data cut, end of study ). *TRAEs reported at grade ≥3 in ≥5% of patients. AESI, adverse event of special interest; ALT, alanine aminotransferase; CPK, creatine phosphokinase; TEAEs, treatm ent - emergent adverse events; TRAEs, treatment - related adverse events. Safety analysis set (arms 1 & 2, n=137). 1. Kilburn LB, et al. Nat Med. 2024;30(1):207 – 217. Updated 3 - year analysis Safety analysis set (n=137), n (%) 137 (100) All TEAEs 136 (99) All TRAEs 113 (82) Grade ≥3 TEAEs 91 (66) Grade ≥3 TRAEs 19 (14) TEAEs leading to discontinuation 18 (13) TRAEs leading to discontinuation Safety analysis set (n=137) Grade ≥3 TRAEs, n (%) Preferred term* 91 (66) Any 46 (34) Decreased growth velocity 19 (14) Anemia 15 (11) CPK increased 11 (8) Maculopapular rash 7 (5) ALT increased

 

 

29 Pivotal Phase 3 trial of tovorafenib in front - line pLGG FIREFLY - 2 Bradon Living with pLGG since age 11

 

 

30 Trial design Endpoints • Randomized, global, registrational Phase 3 trial of monotherapy tovorafenib vs SoC chemotherapy • Eligibility: Patients aged up to <25 years with LGG harboring a RAF alteration and requiring first - line systemic therapy • Tovorafenib available as tablets and pediatric - friendly liquid suspension • Patients who progress after stopping tovorafenib may be re - challenged • Patients who progress in the SoC arm during or post - treatment may cross - over to receive tovorafenib • Primary endpoint: ORR based on RAPNO - LGG criteria, assessed by blinded independent central review ‒ The ORR primary analysis is expected to occur ~12 months after the last patient randomized • Key secondary endpoints: PFS and DoR by RAPNO - LGG criteria • Other secondary endpoints: changes in neurological and visual function, safety, and tolerability • Key exploratory objectives: QoL and health utilization measures Non - resectable or sub - total resected LGG AND Requiring first - line systemic therapy N ≈ 400 Stratified by • Location of tumor • Genomic alteration • CDKN2A status • Infant CHG diagnosis Tovorafenib , 380mg/m 2 QW (not to exceed 600 mg) Investigator's choice of vincristine/carboplatin* or vinblastine or monthly carboplatin Long - term follow - up (48 months) 1:1 Randomization * COG or SIOPe - LGG regimen. Abbreviations: CHG, chiasmatic, hypothalamic glioma; DoR , duration of response; LGG, low - grade glioma; ORR, objective response rate; QoL, quality of life; QW, once weekly; SoC, standar d of care. Expansion into front - line treatment represents a meaningful expansion opportunity for tovorafenib in pLGG

 

 

B7 - H4 - targeted antibody - drug conjugate (ADC) 31 Emi - Le

 

 

32 Emi - Le represents a transformational opportunity to address the unmet need for patients with adenoid cystic carcinoma (ACC) • ACC is a rare cancer, with an annual US incidence of ~1,300 patients 2 • Recurrent/metastatic ACC often presents with aggressive features; no approved therapeutic options exist 2 • B7 - H4 is highly and uniformly overexpressed in patients with recurrent/metastatic ACC 3 • B7 - H4 is also expressed in other adult and pediatric tumor types with high unmet need 4 • Emi - Le is an investigational B7 - H4 - directed ADC, utilizing a target - optimized molecular design and a proprietary linker - payload ( Dolasynthen ) 5 • Measurable anti - tumor activity observed in patients living with ACC - 1 and a well - defined safety profile support accelerated clinical development 1,6 Emi - Le ( Emiltatug Ledadotin ) 1 Potential First - in - Class B7 - H4 - targeted ADC opportunity in ACC 1 Hamilton EP et al. 2025 ASCO Annual Meeting; 2 Adenoid Cystic Carcinoma Research Foundation; 3 Mota Siquera J et al 2024 Modern Pathology; 4 Dawidowicz M et al 2024 Cancers; 5 Fessler et al 2023 Mol Cancer Ther ; 6 Hamilton E et al 2025 ESMO Breast Cancer.

 

 

PTK7 - targeted antibody - drug conjugate (ADC) 33 DAY301

 

 

Substantial development and commercial potential for DAY301 Novel ADC active in preclinical models, designed to maximize therapeutic window 34 PTK7: clinically - validated ADC target Anti - tumor activity of anti - PTK7 ADC demonstrated in Phase 1b trial of cofetuzumab pelidotin 1 DAY301: potential first - in - class asset High PTK7 expression in multiple adult and pediatric tumor indications First dose cohort cleared January 2025 1 Cho BC, et al. Ann Oncol. (34; Suppl 2): S460 - S461, 2023. DAY301: Next generation ADC targeting PTK7

 

 

35 Potential opportunity for a next - generation PTK7 ADC with improved therapeutic index • Clinical results for cofetuzumab pelidotin 1 demonstrated proof of concept for PTK7 - targeted ADCs • Cofetuzumab pelidotin activity seen in multiple tumor types: • Ovarian (Pt - resistant): ORR 27% (n=63) • TNBC: ORR 21% (n=29) • NSCLC: ORR 19% (n=31) • mDOR : 4.2 - 5.7m for Ovarian (Pt - resistant)/TNBC/NSCLC • mPFS : 1.5 - 2.9m for Ovarian (Pt - resistant)/TNBC/NSCLC • Aur0101 program limited by toxicity, resulting in reduced dose intensity and duration • A next generation product with optimized properties and a better therapeutic index may achieve greater clinical efficacy 1 Phase 1b study of PF - 06647020/ABBV - 647. PTK7: A clinically - validated ADC target

 

 

36 DAY301 has been designed to maximize therapeutic index and overcome limitations of prior programs • Tumor regression at tolerable doses seen in multiple preclinical models • Higher HNSTD in cyno toxicology studies; payload with known safety profile • High cell permeability / bystander effect; low efflux (not a P - gp substrate) • Novel, highly hydrophilic, cleavable linker • Moderate - to - high affinity antibody with favorable stability and developability profile • Drug - antibody - ratio (DAR) of 8, shown to be effective for other ADCs in solid tumors • IP: Composition of Matter patent term expected 2044, once issued 1) Damelin M, et al. A PTK7 - targeted antibody - drug conjugate reduces tumor - initiating cells and induces sustained tumor regressions. Sci Transl Med. 2017. HNSTD, Highest Non - Severely Toxic Dose; P - gp , P - glycoprotein. DAY301: Potential first - in - class asset

 

 

37 37 Improved tumor regression activity demonstrated for DAY301 vs. benchmarks in multiple preclinical models DAY301: First - in - class potential PDX LD1 - 200615 HNSCC H - score 120 Vehicle Control antibody + DAY301 payload Control antibody + auristatin payload Cofetuzumab pelidotin , 5 mg/kg DAY301, 10 mg/kg * P=0.0316 Days post administration * 0 7 14 21 28 35 Tumor volume (mm 3 ) (mean “ SEM) 2,400 0 2,000 1,600 1,200 800 400 Control antibody + auristatin payload, 5 mg/kg Cofetuzumab pelidotin , 5 mg/kg Control antibody + DAY301 payload, 10 mg/kg Cofetuzumab antibody + DAY301 payload, 10 mg/kg DAY301, 5 mg/kg DAY301, 10 mg/kg * P=0.0435 0 PDX 362310 TNBC H - score 255 4,000 3,000 2,000 1,000 0 7 14 21 28 * Days post administration Tumor volume (mm 3 ) (mean “ SEM) 0 Vehicle Cofetuzumab pelidotin , 10 mg/kg Anti - DLL3 mAb + DAY301 payload, 10 mg/kg B7 - H3 DXd ADC, 10 mg/kg Chemotherapy control Cofetuzumab mAb + DAY301 payload Control antibody + DAY301 payload DAY301, 10 mg/kg 20 40 60 80 0 3,000 2,000 1,000 Days post administration PDX 362797 SCLC H - score 210 Tumor volume (mm 3 ) (mean “ SEM) Adapted from Kong C, et al. Mol Cancer Ther. 2023;22:1128 – 1143. Indicates drug administration 4,000 5,000

 

 

38 Median OS at Relapse ORR at Relapse U.S. Patient Population Cases/Deaths PTK7 Expression ( > 1+) Indication 9 months 7 39% 7 67,880/13,250 3 100% 2 Endometrial 3 months 4 5% 4 22,370/16,130 3 76% 1 Esophageal SCC ​ 6 - 14 months 15 12% 14 26,890/10,880 3 35% 2 Gastric 7.8 months 5 32% 5 54,540/11,580 3 75% 1 Head & Neck SCC 7 - 12 months 9 45 - 60% 8 199,393/106,310 3 50% 2 NSCLC 17.2 months 6 20 - 35% 3 19,710/13,270 3 30% 2 (95%)* Ovarian (platinum resistant) 9 - 12 months 11 10 - 40% 10 35,187/18,760 3 50% 2 Small Cell Lung 28 months 13 5 - 35% 12 46,608/12,675 3,16 70% 2 TNBC Potential pediatric indications include: neuroblastoma, rhabdomyosarcoma and osteosarcoma 1 Kong et al, 2023; 2 Protein Atlas; 3 PDQ; 4 Parry et al, 2015; 5 Vermorken et al, 2010; 6 Sehouli et al, 2008; 7 Rutten et al, 2021; 8 Park et al, 2017; 9 Assi et al, 2023; 10 Abughanimeh et al, 2020; 11 Asai et al, 2014; 12 Bardia et al, 2021; 13 Cai et al, 2023; 14 Sym et al, 2008; 15 Ji et al, 2023; 16 Saraivaet al, 2017. * MabCare data DAY301: Encouraging development and commercial opportunities

 

 

39 Phase 1a: Monotherapy Dose Escalation FDA - cleared starting dose DL5 RD1 RD2 Identify two recommended dose levels for further evaluation, based on safety and anti - tumor activity • BOIN design for efficiency of dose escalation • Backfill active dose levels to generate additional safety data • Enroll tumor types with known high PTK7 expression • Advance two recommended dose levels to Phase 1b • Final dose optimization scheme and possible registrational path(s) pending discussions with FDA at end of dose escalation/expansion RD1 Simon 2 - stage design Expand to a potential single - arm registrational trial for accelerated approval or randomized trial at optimized dose RD1 cohort RD2 cohort Go to dose optimization Phase 1b: Monotherapy Dose Expansion and Optimization Phase 1: Pediatric Monotherapy Dose Confirmation RD - 1 RD2 Lower of the two adult RDs • Potential adult indications include platinum resistant ovarian cancer, squamous NSCLC, esophageal SCC, HNSCC, endometrial, and/or SCLC • Patients to be selected based on PTK7 expression clinical trial assay • Pediatric dose confirmation and efficacy assessment to begin near/at the end of adult dose escalation • Initial target indications include neuroblastoma, osteosarcoma, rhabdomyosarcoma Key design elements Adult & pediatric development DL4 DL3 DL2 DL1 RD1 DL, Dose Level; RD, Recommended Dose; BOIN, Bayesian Optimal Interval; HNSCC, Head and Neck Squamous Cell Carcinoma; SCLC, Sm all Cell Lung Cancer; SCC, Squamous - Cell Carcinoma; NSCLC, Non - Small Cell Lung Cancer DAY301: Initial Phase1a/b clinical trial design

 

 

40 Summary

 

 

41 Third quarter 2025 financial results All financial information as of 9/30/25 is unaudited. 1 Includes stock - based compensation expense of $3.0 million and $10.8 million for the three and nine months ended 9/30/25, and $3. 8 million and $13.2 million for the three and nine months ended 9/30/24. 2 Includes stock - based compensation expense of $6.6 million and $22.5 million for the three and nine months ended 9/30/25, and $7 .7 million and $24.1 million for the three and nine months ended 9/30/24. 3 Includes sale of Priority Review Voucher of $108.0 million for the nine months ended 9/30/24. Nine Months Ended 9/30/24 Nine Months Ended 9/30/25 Three Months Ended 9/30/24 Three Months Ended 9/30/25 Financial Summary ($ in millions) 28.3 102.6 20.1 38.5 OJEMDA Net Revenue 73.7 1.9 73.7 1.3 License Revenue $102.0 $104.5 $93.8 $39.8 Total Revenue 2.3 11.1 1.6 4.5 Cost of Product and License Revenue 165.9 107.2 33.6 31.4 Research and Development Expense 1 85.7 86.4 29.0 28.1 Selling, General and Administrative Expense 2 $253.9 $204.7 $64.2 $64.0 Total Cost and Operating Expenses 122.8 14.2 6.5 4.5 Non - operating Income 3 (0.7) -- 0.9 -- Income Tax Benefit (Expense) ($29.8) ($86.0) $37.0 ($19.7) Net Income (Loss) 6/30/25 9/30/25 $453.1 $451.6 Cash, cash equivalents and short - term investments

 

 

42 Day One is well positioned for sustainable growth and long - term success 42 Drive OJEMDA revenue growth Execute on clinical development pipeline for FIREFLY - 2 and DAY301 Leverage our development and commercialization expertise to further expand our multiple asset portfolio Maintain strong capital position while investing in our pipeline

 

 

Appendix 43

 

 

44 Tovorafenib is an investigational, oral, selective, CNS - penetrant, type II RAF inhibitor that was designed to inhibit both monomeric and dimeric RAF kinase • Activity in tumors driven by both RAF fusions and BRAF V600E mutations • Tablet and pediatric - friendly liquid suspension • Once weekly dosing Currently approved type I BRAF inhibitors are indicated for use in patients with tumors bearing BRAF V600 mutations • Type I BRAF inhibitors cause paradoxical MAPK activation in the setting of wild - type RAF, increasing the risk of tumor growth in BRAF fusion - driven RAS RAF MEK ERK Proliferation and survival RAF mutation RAF fusion Proliferation and survival Proliferation and survival Tovorafenib RAS - independent activation of the MAPK pathway MAPK pathway Source: 1. Sun Y et al., Neuro Oncol. 2017; 19: 774 – 85; 2. Sievart AJ et al., PNAS. 2013; 110:5957 - 62; 3. Karajannis MA et al., Neuro Oncol 2014;16(10):1408 - 16. Tovorafenib inhibits both BRAF fusions and BRAF V600 mutations