8-K
Verastem, Inc. (VSTM)
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): December 15, 2025
Verastem,
Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-35403 | 27-3269467 |
|---|---|---|
| (State or Other Jurisdiction <br><br>of Incorporation) | (Commission<br> File Number) | (IRS Employer<br> Identification No.) |
| 117 Kendrick Street, Suite 500, Needham, MA | 02494 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code:
(781) 292-4200
(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<br>the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under<br>the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under<br>the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under<br>the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | TradingSymbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common stock, $0.0001 par value per share | VSTM | The Nasdaq Capital 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. ¨
Item 5.02. Departure of Directors or CertainOfficers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
Departure of Chief Operating Officer
As previously disclosed on December 15, 2025, as of December 19, 2025, Matthew Ros separated from Verastem, Inc. (the "Company") as its Chief Operating Officer.
In connection with his separation, on December 19, 2025, the Company entered into a Separation Agreement (the “Separation Agreement”) with Mr. Ros. Under the Separation Agreement, Mr. Ros will receive severance benefits consistent with his employment agreement with the Company, dated January 14, 2025. These benefits include (i) nine months of base salary continuation, (ii) if Mr. Ros exercises his right to continue participation in the Company’s health and dental plans under the federal law known as COBRA, a monthly cash amount equal to the full premium cost of that participation for nine months (or, if earlier, until the time when Mr. Ros becomes eligible to enroll in the health or dental plan of a new employer) and (iii) a pro-rated bonus payment for the portion of the year during which Mr. Ros was employed by the Company prior to the separation, with the actual amount of any bonus determined by actual performance of the Company.
The Separation Agreement includes customary provisions regarding release of claims, non-disparagement, cooperation and return of Company property.
The foregoing summary of the Separation Agreement is qualified in its entirety by the copy of the Separation Agreement filed as Exhibit 10.1 hereto and incorporated herein by this reference.
Item 7.01 Regulation FD Disclosure
On December 15, 2025, the Company issued a press release announcing, among other developments, Mr. Ros’s departure.
A copy of this press release is furnished hereto as Exhibit 99.1 to this Current Report on Form 8-K.
Item9.01. Financial Statements and Exhibits
| Exhibit No. | Description |
|---|---|
| 10.1 | Separation Agreement dated December 19, 2025 by and between Verastem, Inc. and Matthew Ros |
| 99.1 | Press Release, dated December 15, 2025 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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.
| VERASTEM, INC. | ||
|---|---|---|
| Dated: December 19, 2025 | By: | /s/ Daniel W. Paterson |
| Daniel W. Paterson | ||
| President and Chief Executive Officer |
Exhibit 10.1
December 19, 2025
Matthew E. Ros
| RE: | Separation from Employment |
|---|
Dear Matthew:
As we have discussed, your employment with Verastem, Inc. (the “Company”) will terminate, effective as of December 19, 2025 (the “Separation Date”). Please consider this letter as written notice under Paragraph 10 of your Employment Agreement, dated January 14, 2025 (the “Employment Agreement”), that the Employment Agreement will terminate as of the Separation Date. The purpose of this letter (the “Agreement”) is to confirm the terms concerning your separation from employment, as follows:
1. Final Salary. You acknowledge that you have received pay for all work you performed for the Company through the Separation Date, to the extent not previously paid.
2. Severance Benefits. In consideration of your acceptance (without subsequent revocation) of this Agreement and subject to your meeting in full your obligations under it, and compliance with your Continuing Obligations (as defined below) and in full consideration of any rights you may have under the Employment Agreement, dated as of January 14, 2025:
(a) The Company will pay you your base salary, at your final base rate of pay of $485,000.00 (the “Severance Payments”), in roughly equal installments, for a period of nine (9) months, totaling $363,750.00 following the Separation Date. Severance Payments will be made in the form of salary continuation and will begin on the Payment Commencement Date (as defined in the Employment Agreement). The first payment will be retroactive to the day following the Separation Date.
(b) If you are enrolled in the Company’s group medical, dental and/or vision plans on the Separation Date, you may elect to continue your participation and that of your eligible dependents in those plans for a period of time pursuant to the federal law known as “COBRA” or similar applicable state law (together, “COBRA”). You may make such an election whether or not you accept this Agreement. However, if you accept (without subsequently revoking) this Agreement and you timely elect to continue your participation and that of your eligible dependents in such plans, the Company will pay you a monthly amount equal to the full premium cost of your COBRA participation (the “Monthly Premium Payment”), until the earlier of (i) nine (9) months following the Separation Date or (ii) the date you become eligible to enroll in the health (or, if applicable, dental) plan of a new employer. Monthly Premiums Payments will begin on the Payment Commencement Date. The first payment will be retroactive to the day following the Separation Date. Notwithstanding the foregoing, in the event that the Company’s payment of the Monthly Premium Payments, as described in this Section would subject the Company to any tax or penalty under Section 105(h) of the Internal Revenue Code of 1986, as amended, the Patient Protection and Affordable Care Act, as amended, any regulations or guidance issued thereunder, or any other applicable law, in each case, as determined by the Company, then you and the Company agree to work together in good faith to restructure such benefit. You agree to provide the Company with prompt notice of your eligibility to participate in the health (and, if applicable, dental) plan of any employer. You further agree to repay any overpayment of the Monthly Premium Payments made by the Company hereunder.
| 117 Kendrick Street | Suite 500 | Needham, MA | 02494 | P: (781) 292-4200 | F: (617) 812-0059 | www.verastem.com |
|---|
(c) The Company will pay you an annual bonus in respect of 2025, pro-rated for the portion of the year during which you were employed by the Company prior to the Separation Date, with the actual amount of any bonus determined by actual performance totaling $196,425.00 (the “Pro-Rated Bonus”). The Pro-Rated Bonus will be paid by the Company as a lump sum on the Payment Commencement Date.
3. Acknowledgement of Full Payment and Withholding; Unemployment.
(a) You acknowledge and agree that, except as provided under Section 4 of this Agreement, the payments provided under Section 2 of this Agreement are in complete satisfaction of any and all compensation or benefits due to you from the Company, whether for services provided to the Company or otherwise, through the Separation Date and that, except as expressly provided under this Agreement, no further compensation or benefits are owed or will be paid to you.
(b) All payments made by the Company under this Agreement shall be reduced by any tax or other amounts required to be withheld by the Company under applicable law and all other lawful deductions authorized by you.
(c) The Company agrees that it shall not contest any application you make for unemployment benefits.
4. Status of Employee Benefits, Expenses and Equity Awards.
(a) Except for any right you may have to continue your participation and that of your eligible dependents in the Company’s medical, dental, and vision plans under COBRA, your participation in all employee benefit plans of the Company will end as of the Separation Date (or, as applicable, as of the end of the month in which the Separation Date occurred), in accordance with the terms of those plans. You will receive information about your COBRA continuation rights under separate cover.
(b) Within two (2) weeks following the Separation Date, you must submit your final expense reimbursement statement reflecting all business expenses you incurred through the Separation Date, if any, for which you seek reimbursement, and, in accordance with Company policy, reasonable substantiation and documentation for the same. The Company will reimburse you for your authorized and documented expenses within thirty (30) days of receiving such statement pursuant to its regular business practice.
(c) Your rights and obligations with respect to any stock options granted to you by the Company that are vested as of the Separation Date shall be governed by the applicable equity plan and the award agreements applicable to those options. All stock options and other equity awards that are unvested as of the Separation Date will terminate and be forfeited for no consideration as of the Separation Date, in accordance with their terms.
| 117 Kendrick Street | Suite 500 | Needham, MA | 02494 | P: (781) 292-4200 | F: (617) 812-0059 | www.verastem.com |
|---|
5. Continuing Obligations and Non-Disparagement.
(a) You acknowledge that you continue to be bound by your obligations under any employment or other agreement concerning confidentiality and/or assignment of rights to intellectual property by and between you and the Company or any of its Affiliates, including but not limited to the Employee Non-Solicitation, Non-Competition, Confidential Information and Inventions Assignment Agreement, which you signed on January 14, 2025 (the “Restrictive Covenant Agreement”), that survive the termination of your employment by necessary implication or the terms thereof (the “Continuing Obligations”). Notwithstanding anything else to the contrary and for purposes of clarity, the Company agrees that you are not bound by any post-employment noncompetition obligation, including Section 4.1 of the Restrictive Covenant Agreement, and affirms that a noncompetition obligation is not part of your Continuing Obligations.
(b) Subject to Section 8(b) of this Agreement, you agree that you will not disclose this Agreement or any of its terms or provisions, directly or by implication, except to members of your immediate family and to your legal and tax advisors, and then only on condition that they agree not to further disclose this Agreement or any of its terms or provisions to others.
(c) Subject to Section 8(b) of this Agreement, you agree that you will never disparage the Company or its Affiliates (as defined below), or any of their business, management or products or services in a manner that could reasonably cause financial harm to the Company or its Affiliates and that you will not otherwise do or say anything that could reasonably cause disruption to the good morale of employees of the Company or any of its Affiliates or reasonably cause financial harm to the interests or reputation of the Company or any of its Affiliates. The Company agrees to instruct its executive officers, board members, and other employees with any other knowledge of the circumstances concerning the end of your employment with the Company and/or the negotiation of this Agreement as of the Separation Date that they are not to make any statements (written or oral, including through the use of social media) that are professionally or personally disparaging about, or adverse to, your interests. Notwithstanding the foregoing, nothing herein shall prevent you or the Company’s authorized corporate representatives from testifying truthfully in any legal or administrative proceeding where such testimony is compelled or requested, or from otherwise complying with applicable legal requirements. You agree that you will direct any inquiries by potential future employers to the Company’s Human Resources department, which shall provide only your last position and dates of employment.
(d) For the purposes of this Agreement, “Affiliates” means all persons and entities directly or indirectly controlling, controlled by or under common control with the Company, where control may be by management authority, equity interest or otherwise.
6. Return of Company Documents and Other Property. In signing this Agreement, you agree that you will return to the Company any and all documents, materials and information (whether in hardcopy, on electronic media or otherwise) related to the business of the Company and its Affiliates (whether present or otherwise), and all keys, access cards, credit cards, computer hardware and software, telephones and telephone-related equipment and all other property of the Company or any of its Affiliates in your possession or control. Further, you agree that you will not retain any copy or derivation of any documents, materials or information (whether in hardcopy, on electronic media or otherwise) of the Company or any of its Affiliates. Recognizing that your employment with the Company will terminate as of the Separation Date, you agree that you will not, following the Separation Date, for any purpose, attempt to access or use any computer or computer network or system of the Company or any of its Affiliates, including without limitation the electronic mail system. Further, you agree to disclose to the Company, on or before the Separation Date, all passwords necessary or desirable to obtain access to, or that would assist in obtaining access to, all information which you have password-protected on any computer equipment, network or system of the Company or any of its Affiliates.
| 117 Kendrick Street | Suite 500 | Needham, MA | 02494 | P: (781) 292-4200 | F: (617) 812-0059 | www.verastem.com |
|---|
7. EmployeeCooperation. You agree to reasonably cooperate with the Company and its Affiliates hereafter with respect to all matters arising during or related to your employment, including but not limited to all matters in connection with any governmental investigation, litigation or regulatory or other proceeding which may have arisen or which may arise following the signing of this Agreement. The Company will reimburse your out-of-pocket expenses incurred in complying with Company requests hereunder, provided such expenses are authorized by the Company in advance.
8. General Release of Claims.
(a) In exchange for the continued employment and the special severance pay and benefits provided to you under this Agreement, to which you would not otherwise be entitled, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, on your own behalf and that of your heirs, executors, administrators, beneficiaries, personal representatives and assigns, you agree that this Agreement shall be in complete and final settlement of any and all causes of action, rights and claims, whether known or unknown, that you have had in the past, now have, or might now have, against the Company or any of its Affiliates of any nature whatsoever, including but not limited to those in any way related to, connected with or arising out of your employment or your other association with the Company or any of its Affiliates or the termination of the same or the Employment Agreement or pursuant to Title VII of the Civil Rights Act, the Americans with Disabilities Act, the Age Discrimination in Employment Act, as amended by the Older Workers Benefit Protection Act, the Employee Retirement Income Security Act, the Massachusetts Wage Act, the wage and hour, wage payment and/or fair employment practices laws and statutes of the state or states in which you have provided services to the Company or any of its Affiliates (each as amended from time to time), and/or any other federal, state or local law, regulation or other requirement, and you hereby release and forever discharge the Company, its Affiliates and all of their respective past, present and future directors, shareholders, officers, members, managers, general and limited partners, employees, employee benefit plans, administrators, trustees, agents, representatives, predecessors, successors and assigns, and all others connected with any of them, both individually and in their official capacities (collectively, the “Released Parties”), from any and all such causes of action, rights and claims.
(b) Nothing contained in this Agreement shall be construed to prohibit you from filing a charge with or participating in any investigation or proceeding conducted by the federal Equal Employment Opportunity Commission, the National Labor Relations Board or a comparable state or local agency; provided however, that you hereby waive your right to recover monetary damages or other individual relief in any such charge, investigation or proceeding or any related complaint or lawsuit filed by you or by anyone else on your behalf; provided, further, that you are not waiving any right to seek and receive a financial incentive award for any information you provide to a governmental agency or entity. Nothing in this Agreement or in the Continuing Obligations limits, restricts or in any other way affects your communicating with any governmental agency or entity, or communicating with any official or staff person of a governmental agency or entity, concerning matters relevant to the governmental agency or entity.
| 117 Kendrick Street | Suite 500 | Needham, MA | 02494 | P: (781) 292-4200 | F: (617) 812-0059 | www.verastem.com |
|---|
(c) This Agreement, including the general release of claims set forth in Section 8(a), creates legally binding obligations and the Company and its Affiliates therefore advise you to consult an attorney before signing this Agreement. In signing this Agreement, you give the Company and its Affiliates assurance that you have signed it voluntarily and with a full understanding of its terms; that you have had sufficient opportunity of not less than twenty-one (21) days, before signing this Agreement, to consider its terms and to consult with an attorney, if you wished to do so, or to consult with any other of those persons to whom reference is made in Section 5(b); and that, in signing this Agreement, you have not relied on any promises or representations, express or implied, that are not set forth expressly in this Agreement. You acknowledge and agree that you may not sign this Agreement prior to the Separation Date.
9. Miscellaneous.
(a) This Agreement constitutes the entire agreement between you and the Company, and supersedes all prior and contemporaneous communications, agreements and understandings, whether written or oral, with respect to your employment, its termination and all related matters, excluding only the Continuing Obligations, and your rights and obligations with respect to the securities of the Company, all of which shall remain in full force and effect in accordance with their terms.
(b) If any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of this Agreement shall be valid and enforceable to the fullest extent permitted by law; provided, however, and for the avoidance of doubt, in no event shall the Company be required to provide payments or benefits to you pursuant to Section 2 of this Agreement if all or part of the general release in Section 8 of this Agreement or the Release is held to be invalid or unenforceable.
(c) This Agreement may not be modified or amended, and no breach shall be deemed to be waived, unless agreed to in writing by you and the Chief Executive Officer of the Company or his expressly authorized designee. The captions and headings in this Agreement are for convenience only, and in no way define or describe the scope or content of any provision of this Agreement.
| 117 Kendrick Street | Suite 500 | Needham, MA | 02494 | P: (781) 292-4200 | F: (617) 812-0059 | www.verastem.com |
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(d) The obligation of the Company to make payments to you or on your behalf under this Agreement, and your right to retain the same, is expressly conditioned upon your continued full performance of your obligations under this Agreement and the Continuing Obligations.
(e) This is a Massachusetts contract and shall be governed and construed in accordance with the laws of the Commonwealth of Massachusetts, without regard to any conflict of laws principles that would result in the application of the laws of another jurisdiction. You agree that any dispute shall be brought only in, and you agree to submit to the exclusive jurisdiction of, the courts of and in the Commonwealth of Massachusetts in connection with any dispute arising out of, connected with, or relating to this Agreement or your employment or other association with the Company or the termination of the same.
(f) This Agreement may be executed in any number of counterparts, any of which may be executed and transmitted by DocuSign, facsimile, electronic mail (including “pdf”), and any other means of electronic transmission complying with the U.S. federal ESIGN Act of 2000, and each of which shall be deemed to be an original, but all of which together shall be deemed to be one and the same instrument.
***
| 117 Kendrick Street | Suite 500 | Needham, MA | 02494 | P: (781) 292-4200 | F: (617) 812-0059 | www.verastem.com |
|---|
If the terms of this Agreement are acceptable to you, please sign, date and return it to me within twenty-one (21) days of the date you receive it. You may revoke this Agreement at any time during the seven-day period immediately following the date of your signing by notifying me in writing of your revocation within that period. If you do not revoke this Agreement, then, on the eighth (8^th^) day following the date that you signed it, this Agreement shall take effect as a legally binding agreement between you and the Company on the basis set forth above. You agree that if there have been any changes to a prior version of this Agreement (material or immaterial), the twenty-one (21)-day consideration period will not be reset. The enclosed copy of this letter, which you should also sign and date, is for your records.
| Sincerely, | ||||||
|---|---|---|---|---|---|---|
| VERASTEM, INC. | ||||||
| By: | /s/ Daniel W. Paterson | |||||
| Daniel Paterson | ||||||
| Chief Executive Officer | ||||||
| Accepted and agreed: | ||||||
| --- | --- | |||||
| Signature: | /s/ Matthew E. Ros | |||||
| Matthew E. Ros | ||||||
| Date: | December 19, 2025 | |||||
| 117 Kendrick Street | Suite 500 | Needham, MA | 02494 | P: (781) 292-4200 | F: (617) 812-0059 | www.verastem.com |
| --- |
Exhibit 99.1
Verastem Oncology Announces Strategic TransitionPlan to Accelerate Next Phase of Growth
John Johnson, current board member, appointedto chairman of the board
Michael Kauffman, MD, PhD, lead director since2016, appointed to president of development
Commercial launch progresses as RAMP 301 Phase3 confirmatory trial in recurrent LGSOC completes additional patient enrollment; topline data anticipated in mid-2027
BOSTON--(BUSINESS WIRE)—Dec. 15, 2025-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced strategic leadership changes to accelerate its next phase of growth. Michael Kauffman, M.D., Ph.D., currently lead director of the Board, has been appointed as the president of development and will join the Company’s executive leadership team, while John Johnson, a board member since 2020, has been appointed as chairman of the board of directors succeeding Dr. Kauffman. Dr. Kauffman will remain on the Board but will no longer serve as lead director, or on the audit committee, or compensation committee of the Board upon transition to his new role. As part of these changes, Matthew Ros, chief operating officer, will be departing from the organization as the Company streamlines its operational structure and transitions his responsibilities across the executive team.
“2025 has been a year of significant accomplishments where we advanced key clinical trials and launched an important new treatment for people living with a specific type of LGSOC, a rare ovarian cancer that is persistent and highly recurrent. We expect to enter 2026 from a position of strength and in that regard, I’m pleased to announce that John will assume the position of Chairman of the Board and bring his decades of corporate strategy and oncology commercialization to the role,” said Dan Paterson, president and chief executive officer of Verastem Oncology. “The appointment of Michael as President of Development not only brings in a depth of experience in advancing novel agents from early development all the way through successful commercial launch, but also underscores our commitment to our R&D program and specifically the importance of VS-7375, and the anticipated positive impact we believe this potential best-in-class treatment may have on patients around the world.”
Mr. Paterson added, “We thank Matt for his contributions to the initial success of the commercial launch of AVMAPKI FAKZYNJA CO-PACK and establishing a strong organizational foundation this year.”
“I am honored to continue the leadership Michael has established over the past decade as Lead Director. Verastem is at a pivotal moment with the initial successful launch of AVMAPKI FAKZYNJA CO-PACK, which has provided a benefit to women where previously there were no FDA-approved treatments specifically for their disease. I look forward to working closely with Dan, Michael, and the rest of the Board to support the Company’s commercial and clinical development plans,” said John Johnson, chairman of the board.
“After more than a decade on the Board, I am thrilled to join the executive team and dedicate myself full time to what I believe is a once-in-a-lifetime opportunity with VS-7375,” said Michael Kauffman, M.D., Ph.D. “This potential best-in-class KRAS G12D dual ON/OFF inhibitor could transform outcomes for patients with currently limited options, and I am excited to bring my scientific expertise and proven track record of successful drug development and commercialization to the organization at this critical time.”
RAMP 301
The Company also announced today that it has completed the additional patient enrollment for RAMP 301, its international Phase 3 confirmatory trial in recurrent LGSOC. Following a pre-planned interim analysis (IA), the Independent Data Monitoring Committee recommended a modest one-time increase of 29 patients across KRAS mutation status, based on the total enrollment achieved in October. The Company remains blinded to the IA results.
RAMP 301 is evaluating the combination of avutometinib plus defactinib versus standard chemotherapy for patients with recurrent LGSOC with and without a KRAS mutation. The trial will serve as a confirmatory study for the initial indication and has the potential to expand the indication regardless of KRAS mutation status. The Company expects to report a topline read-out of the primary endpoint in mid-2027.
Biographies for John Johnson and Michael Kauffman, M.D., Ph.D.
John Johnson
John Johnson is a recognized biopharma executive leader in the industry with more than three decades of experience across corporate strategy, operations, investing, clinical development, and oncology drug commercialization. He most recently served as Executive Chairman at Applied Therapeutics, a company focused on developing transformative treatments for rare disease. Mr. Johnson also previously was the Chief Executive Officer of Reaction Biology, a global Contract Research Organization. Prior to that he was the Chief Executive Officer of Stonebridge Biopharma prior to its merger with Xeris Biopharma. Mr. Johnson has held executive management roles at leading global corporations, including Johnson & Johnson, where he spent the majority of his career and served as the Company Group Chairman of Biopharmaceuticals within Johnson & Johnson. He was responsible for Johnson & Johnson Biotechnology, Immunology, and Oncology commercial businesses. Mr. Johnson also served as President of Eli Lilly & Company’s Worldwide Oncology unit, following the company’s 2008 acquisition of Imclone Systems, Inc., where he served as Chief Executive Officer and a member of Imclone’s Board of Directors.
Mr. Johnson has served on 19 boards and presently serves on the boards of Reaction Biology, Axogen (AXGN), Xeris Pharmaceuticals (XERS), and Verastem Oncology (VSTM). He served on two private equity backed company boards through successful exits. He has also served as a member of the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA) and as a member of the Health Section Governing Board of Biotechnology Industry Organization (BIO).
Michael Kauffman, M.D., Ph.D.
As a Lead Director of Verastem’s Board of Directors since June 2016, Dr. Kauffman has a deep understanding of the Company’s strategy, clinical development plans, and operations. Previously, Dr. Kauffman served as the Chief Executive Officer of Nereid Therapeutics. He was co-founder and Chief Executive Officer of Karyopharm, where he guided that company’s transition from a discovery stage biotechnology company to a commercial stage organization and the global approvals of XPOVIO^®^. Prior to joining Karyopharm, Dr. Kauffman was Chief Medical Officer of Onyx Pharma, where he led the development of Kyprolis^®^ following the Onyx acquisition of Proteolix , where he served as board member and then Chief Medical Officer. Previously, Dr. Kauffman was President and Chief Executive Officer of EPIX Pharmaceuticals (previously Predix Pharmaceuticals.). Before that, he was the leader of the Velcade^®^ development program at Millennium Pharmaceuticals. He also held a number of senior positions at Millennium Predictive Medicine and Biogen.
Dr. Kauffman received his M.D. and Ph.D. from Johns Hopkins Medical School, trained in Internal Medicine at Beth Israel (Deaconess) Medical Center and in Rheumatology at Massachusetts General Hospital, and is board certified in Internal Medicine.
About AVMAPKI and FAKZYNJA Combination Therapy
AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.
The U.S. Food and Drug Administration (FDA) approved AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. Verastem is also evaluating avutometinib plus defactinib with standard-of-care chemotherapy as a potential treatment in the first line for patients with advanced pancreatic cancer (RAMP 205; NCT05669482) and advanced KRAS G12C mutant non-small cell lung cancer (RAMP 203; NCT05074810). Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use.
AVMAPKI FAKZYNJA CO-PACK U.S. Indication
Indication
AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
This indication is approved under accelerated approval based on tumor response rate and duration of response*.* Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Important Safety Information
Warnings and Precautions
| · | OcularToxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic<br>evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK<br>for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4<br>toxicity. |
|---|---|
| · | SeriousSkin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere<br>to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based<br>on severity, tolerability and duration. |
| --- | --- |
| · | Hepatotoxicity: Monitor<br>liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue<br>AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality. |
| --- | --- |
| · | Rhabdomyolysis: Monitor<br>creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased<br>CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK<br>based on severity and duration of the adverse reaction. |
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| · | Embryo-FetalToxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective<br>contraception. |
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Adverse Reactions
The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.
Drug Interactions
| · | Strongand moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK. |
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| · | Strongand moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK. |
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| · | Warfarin: Avoid<br>concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin. |
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| · | Gastricacid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists.<br>If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally<br>acting antacid. |
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Use in Specific Populations
| · | Lactation: Advise not to breastfeed. |
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| · | Fertility: May impair fertility in males and females. |
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Click here for full Prescribing Information.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI™ FAKZYNJA™ CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn.
Forward-Looking Statements Notice
Certain of the statements made in this press release, including those relating to Verastem Oncology’s programs and product candidates, strategy, future plans and prospects, including statements related to the adoption of AVMAPKI FAKZYNJA CO-PACK, the conduct of the Phase 3 confirmatory trial for RAMP 301, the timing of commencing and completing trials and compiling data, the expected timing of the presentation of data by the Company and the potential clinical value of various of the Company’s product candidates, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “would,” “could,” “should,” “continue,” “can,” “promising” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include, without limitation: that there may not be broad adoption of AVMAPKI FAKZYNJA CO-PACK; the uncertainties inherent in research and development, such as the possibility of negative or unexpected results of clinical trials; that the development and commercialization of our product candidates may take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that data may not be available when expected; the risk that our preliminary and interim data may not be representative of more mature data; uncertainties related to the recent change in the U.S. presidential administration, including regulatory and policy changes that may adversely affect our business; risks associated with the current administration’s reductions to the FDA’s workforce and any subsequent reductions that may lead to disruptions and delays in the FDA’s review and oversight of our product candidates and impact the FDA’s ability to provide timely feedback on our development programs; and that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients. . As a result of these and other factors, we may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. Other risks and uncertainties, including those identified under the heading “Risk Factors” as detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (SEC) on March 20, 2025, as well as the other information we file with the SEC, may possibly be realized. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
For Investor and Media Inquiries:
Julissa Viana
Vice President, Corporate Communications,
Investor Relations & Patient Advocacy
investors@verastem.com or
media@verastem.com