03/04/2026 | Press release | Distributed by Public on 03/04/2026 15:04
AVMAPKI™ FAKZYNJA™ CO-PACK net product revenues of $17.5 million for the fourth quarter of 2025 and $30.9 million for the full year 2025, following accelerated U.S. FDA approval in May 2025
Based on FDA guidance, Company to develop Phase 2 registration-directed protocols to evaluate VS-7375, a highly selective, oral KRAS G12D (ON/OFF) inhibitor with best-in-class potential, in 2L PDAC, 2L/3L NSCLC and 2L+ CRC in combination with cetuximab
Cleared multiple dose levels of VS-7375 with no DLTs, continuing dose escalation to 1200 mg QD; cleared 600 mg QD dose level of VS-7375 in combination with cetuximab with no DLTs; continuing higher dose evaluations
Company cash, cash equivalents, and investments of $205 million as of December 31, 2025; pro-forma year-end cash, cash equivalents and investments of $234 million inclusive of net proceeds from exercise of expiring cash warrants; expected cash runway into first half of 2027
BOSTON--(BUSINESS WIRE)--Mar. 4, 2026-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today reported financial results for the three months and full year ended December 31, 2025, and highlighted recent progress.
"2025 was a transformative year for us, highlighted by the landmark FDA approval of AVMAPKI FAKZYNJA CO-PACK, the only medicine approved to specifically treat KRAS-mutated recurrent LGSOC. The launch is off to a strong start, and this novel-novel combination therapy is gaining positive response across the LGSOC community with gynecologic and medical oncologists in both academic and community settings increasingly turning to it when patients experience a first or subsequent recurrence. We also made considerable progress with VS-7375, our oral, KRAS G12D (ON/OFF) inhibitor with best-in-class potential for solid tumor cancers, clearing multiple dose levels across both monotherapy and cetuximab combination cohorts with no DLTs or major toxicities. Building on the insights from the China data, the tolerability profile that is emerging with VS-7375 in the U.S. has shown meaningful improvement and supports continued dose escalation," said Dan Paterson, president and chief executive officer at Verastem Oncology. "In 2026, our priorities are to continue driving a strong launch of AVMAPKI FAKZYNJA CO-PACK to fuel sustainable growth, while we continue to accelerate the clinical development of VS-7375 and breakout Phase 2 registration-directed clinical trials in pancreatic, lung, and colorectal cancers."
Fourth Quarter 2025 and Recent Highlights
AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets) U.S. Launch
Expected Key Milestones:
VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor in Advanced Solid Tumors
The Company shared multiple updates from GenFleet and its ongoing evaluation of VS-7375, known as GFH375, in China:
Expected Key Milestones:
RAMP 205: Avutometinib Plus Defactinib in Combination with Chemotherapy in 1L Metastatic Pancreatic Cancer
Expected Key Milestone:
Upcoming Presentations
Corporate Updates
Fourth Quarter 2025 Financial Results
Verastem Oncology ended the fourth quarter of 2025 with cash, cash equivalents, and investments of $205 million. On a pro forma basis, taking into account the net proceeds from the exercise of warrants in January 2026 of $29.4 million, cash, cash equivalents, and investments were $234.4 million as of December 31, 2025. These additional sources of capital along with the existing cash, cash equivalents, and investments and ongoing product revenue provide an expected cash runway into first half of 2027.
Net product revenue for the three months ended December 31, 2025 (the "2025 Quarter") was $17.5 million, compared to no revenue recognized for the three months ended December 31, 2024 (the "2024 Quarter"). The Company began commercial sales of the AVMAPKI FAKZYNJA CO-PACK within the U.S. following receipt of FDA approval in May 2025.
Total operating expenses for the 2025 Quarter were $59.0 million, compared to $31.6 million for the 2024 Quarter. Cost of sales associated with product revenue was $2.9 million for the 2025 Quarter, compared to no cost of sales recognized for the 2024 Quarter.
Research & development expenses for the 2025 Quarter were $31.7 million, compared to $20.8 million for the 2024 Quarter. The increase of $10.9 million, or 52.4%, was primarily due to higher costs incurred for drug substance and drug product manufacturing, contract research organizations, and investigator fees.
Selling, general & administrative expenses for the 2025 Quarter were $24.4 million, compared to $10.8 million for the 2024 Quarter. The increase of $13.6 million, or 125.9%, was primarily due to commercialization costs, including consulting, personnel costs, and professional fees, incurred in connection with the launch of AVMAPKI FAKZYNJA CO-PACK in KRAS-mutated recurrent LGSOC.
Net loss (GAAP basis) for the 2025 Quarter was $32.9 million, or $0.39 per share (basic), compared to $64.6 million, or $1.33 per share (basic and diluted) for the 2024 Quarter.
For the 2025 Quarter, non-GAAP adjusted net loss was $39.8 million, or $0.48 per share (basic) compared to non-GAAP adjusted net loss of $29.3 million, or $0.60 per share (basic), for the 2024 Quarter. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.
Full-Year 2025 Financial Results
Net product revenue for the year ended December 31, 2025 (the "2025 Period") was $30.9 million, compared to no product revenue recognized for the year ended December 31, 2024 (the "2024 Period"). Sale of COPIKTRA license and related assets revenue was $0.0 million for the 2025 Period, compared to $10.0 million for the 2024 Period. Revenue for the 2024 Period was comprised of one sales milestone payment of $10.0 million due upon Secura Bio achieving cumulative worldwide net sales of COPIKTRA exceeding $100.0 million.
Total operating expenses for the 2025 Period were $201.0 million, compared to $125.0 million for the 2024 Period. Cost of sales associated with product revenue was $5.3 million for the 2025 period, compared to no cost of sales recognized for the 2024 Period.
Research & development expenses for the 2025 Period were $114.6 million, compared to $81.3 million for the 2024 Period. The increase of $33.3 million, or 41.0%, was primarily due to higher costs incurred for contract research organizations, investigator fees, and drug substance and drug product manufacturing.
Selling, general & administrative expenses for the 2025 Period were $81.1 million, compared to $43.6 million for the 2024 Period. The increase of $37.5 million, or 86.0%, was primarily due to commercialization costs, including consulting, personnel costs, and professional fees, incurred in connection with the launch of AVMAPKI FAKZYNJA CO-PACK in KRAS-mutated recurrent LGSOC.
Net loss for the 2025 Period was $209.5 million, or $3.02 per share (basic and diluted), compared to $130.6 million, or $3.66 per share (basic and diluted) for the 2024 period.
For the 2025 Period, non-GAAP adjusted net loss was $163.1 million, or $2.35 per share (basic) compared to non-GAAP adjusted net loss of $107.4 million, or $3.01 per share (basic), for the 2024 Period. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.
Conference Call and Webcast
Verastem will host a conference call and webcast today at 4:30 p.m. ET to review the fourth quarter and full year 2025 financial results and recent business updates. To access the conference call, please dial (888) 596-4144 (U.S.) or (646) 968-2525 (international) and enter the passcode 7321921 at least 10 minutes prior to the event start time. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company's website, https://investor.verastem.com/events. A replay of the webcast will be archived and available following the event.
Use of Non-GAAP Financial Measures
To supplement Verastem Oncology's condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), the Company uses the following non-GAAP financial measures in this press release: non-GAAP adjusted net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP.
Management believes this non-GAAP information is useful for investors, taken in conjunction with the Company's GAAP financial statements, because it provides greater transparency and period-over- period comparability with respect to the Company's operating performance and can enhance investors' ability to identify operating trends in the Company's business. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company's operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three months and year ended December 31, 2025, and 2024 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.
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). 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
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
Use in Specific Populations
Click here for full Prescribing Information.
About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor
VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem initiated VS-7375-101, an international Phase 1/2 clinical trial, in June of 2025 in the U.S., that is evaluating the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy.
About the GenFleet Therapeutics Collaboration
The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. Verastem selected VS-7375 (also known as GFH375), an oral KRAS G12D (ON/OFF) inhibitor, as its lead program in December 2023 and the license for VS-7375 that was exercised in January 2025 is the first one from this collaboration. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan.
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 https://www.verastem.com and follow us on LinkedIn.
Forward-Looking Statements
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "may," "believe," "estimate," "forecast," "goal," "project," and other words of similar meaning. Such forward-looking statements address various matters about, among other things, Verastem Oncology's programs and product candidates, strategy, future plans and prospects, including statements related to the potential for and timing of commercialization of product candidates, the anticipated timing for the IND application for VS-7375/GFH375, the expected outcome and benefits of the Company's collaboration with GenFleet Therapeutics (Shanghai), Inc., 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 clinical trials. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the uncertainties inherent in research and development, such as the possibility of negative or unexpected results of clinical trials; that we may not see a return on investment on the payments we have and may continue to make pursuant to the collaboration and option agreement with GenFleet, or that GenFleet may fail to fully perform under the agreement; that we may not be successful in our continued commercialization of AVMAPKI FAKZYNJA CO-PACK; 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; risks associated with preliminary and interim data, which may not be representative of more mature data; risks associated with the recent changes in administration policy or actions that may create regulatory uncertainty 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; that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients; and the risks identified under the heading "Risk Factors" as detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission (SEC) on March 4, 2026, as well as the other information we file with the SEC, are possibly 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 https://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.
|
Verastem Oncology Condensed Consolidated Balance Sheets (in thousands) |
|||||
|
December 31, 2025 |
December 31, 2024 |
||||
|
Cash, cash equivalents, & investments |
$ |
204,990 |
$ |
88,818 |
|
|
Accounts receivable, net |
8,813 |
- |
|||
|
Inventory |
1,833 |
- |
|||
|
Grants receivable |
200 |
200 |
|||
|
Prepaid expenses and other current assets |
7,577 |
5,943 |
|||
|
Property and equipment, net |
- |
32 |
|||
|
Right-of-use asset, net |
491 |
1,405 |
|||
|
Intangible assets, net |
16,426 |
- |
|||
|
Restricted cash and other assets |
6,112 |
5,140 |
|||
|
Total assets |
$ |
246,442 |
$ |
101,538 |
|
|
Current Liabilities |
72,268 |
30,973 |
|||
|
Long term debt |
76,330 |
40,724 |
|||
|
Vendor financing arrangement, long-term |
5,000 |
- |
|||
|
Lease liability, long-term |
- |
535 |
|||
|
Warrant Liability |
35,647 |
58,199 |
|||
|
Stockholders' equity |
57,197 |
(28,893) |
|||
|
Total liabilities, convertible preferred stock and stockholders' equity |
$ |
246,442 |
$ |
101,538 |
|
|
Verastem Oncology Condensed Consolidated Statements of Operations (in thousands, except per share amounts) (unaudited) |
|||||||||||
|
Three months ended December 31, |
Year ended December 31, |
||||||||||
|
2025 |
2024 |
2025 |
2024 |
||||||||
|
Revenue: |
|||||||||||
|
Product Revenue, net |
$ |
17,535 |
$ |
- |
$ |
30,914 |
$ |
- |
|||
|
Sale of COPIKTRA license and related assets |
- |
- |
- |
10,000 |
|||||||
|
Total revenue |
17,535 |
- |
30,914 |
10,000 |
|||||||
|
Operating expenses: |
|||||||||||
|
Cost of sales - product |
2,611 |
- |
4,600 |
- |
|||||||
|
Cost of sales - intangible amortization |
280 |
- |
698 |
- |
|||||||
|
Research and development |
31,675 |
20,811 |
114,599 |
81,334 |
|||||||
|
Selling, general and administrative |
24,443 |
10,779 |
81,146 |
43,622 |
|||||||
|
Total operating expenses |
59,009 |
31,590 |
201,043 |
124,956 |
|||||||
|
Loss from operations |
(41,474) |
(31,590) |
(170,129) |
(114,956) |
|||||||
|
Other income (expense) |
(18) |
9 |
(203) |
(123) |
|||||||
|
Interest income |
1,103 |
968 |
4,068 |
4,149 |
|||||||
|
Interest expense |
(415) |
(1,146) |
(1,138) |
(4,562) |
|||||||
|
Loss on debt extinguishment |
- |
- |
(1,826) |
- |
|||||||
|
Change in fair value of preferred stock tranche liability |
- |
- |
- |
4,189 |
|||||||
|
Change in fair value of warrant liability |
10,485 |
(32,606) |
(27,492) |
(19,149) |
|||||||
|
Change in fair value of Notes |
(2,597) |
- |
(12,751) |
- |
|||||||
|
Net loss before taxes |
(32,916) |
(64,365) |
(209,471) |
(130,452) |
|||||||
|
Income tax expense |
- |
(185) |
- |
(185) |
|||||||
|
Net Loss |
$ |
(32,916) |
$ |
(64,550) |
$ |
(209,471) |
$ |
(130,637) |
|||
|
Net loss per share-basic |
$ |
(0.39) |
$ |
(1.33) |
$ |
(3.02) |
$ |
(3.66) |
|||
|
Net loss per share-diluted |
$ |
(0.50) |
$ |
(1.33) |
$ |
(3.02) |
$ |
(3.66) |
|||
|
Weighted average common shares outstanding used in computing: |
|||||||||||
|
Net loss per share - basic |
83,400 |
48,709 |
69,309 |
35,713 |
|||||||
|
Net loss per share - diluted |
86,710 |
48,709 |
69,309 |
35,713 |
|||||||
|
Verastem Oncology Reconciliation of GAAP to Non-GAAP Financial Information (in thousands, except per share amounts) (unaudited) |
|||||||||||
|
Three months ended December 31, |
Year ended December 31, |
||||||||||
|
2025 |
2024 |
2025 |
2024 |
||||||||
|
Net loss reconciliation: |
|||||||||||
|
Net loss (GAAP basis) |
$ |
(32,916) |
$ |
(64,550) |
$ |
(209,471) |
$ |
(130,637) |
|||
|
Adjust: |
|||||||||||
|
Stock-based compensation expense |
2,025 |
2,019 |
9,404 |
7,342 |
|||||||
|
Amortization of acquired intangible assets |
280 |
- |
698 |
- |
|||||||
|
Non-cash interest, net |
- |
207 |
29 |
(5) |
|||||||
|
Change in fair value of preferred stock tranche liability |
- |
- |
- |
(4,189) |
|||||||
|
Change in fair value of warrant liability |
(10,485) |
32,606 |
27,492 |
19,149 |
|||||||
|
Non-cash change in fair value of Notes |
890 |
- |
6,560 |
- |
|||||||
|
Loss on debt extinguishment |
- |
- |
1,826 |
- |
|||||||
|
Severance and other |
392 |
371 |
392 |
990 |
|||||||
|
Adjusted net loss (non-GAAP basis) |
$ |
(39,814) |
$ |
(29,347) |
$ |
(163,070) |
$ |
(107,350) |
|||
|
Reconciliation of net loss per share |
|||||||||||
|
Net loss per share - basic (GAAP basis) |
(0.39) |
$ |
(1.33) |
$ |
(3.02) |
$ |
(3.66) |
||||
|
Adjust per basic share |
|||||||||||
|
Stock-based compensation expense |
0.02 |
0.04 |
0.14 |
0.21 |
|||||||
|
Amortization of acquired intangible assets |
- |
- |
0.01 |
- |
|||||||
|
Non-cash interest, net |
- |
0.01 |
- |
- |
|||||||
|
Change in fair value of preferred stock tranche liability |
- |
- |
- |
(0.12) |
|||||||
|
Change in fair value of warrant liability |
(0.12) |
0.67 |
0.39 |
0.53 |
|||||||
|
Non-cash change in fair value of Notes |
0.01 |
- |
0.09 |
- |
|||||||
|
Loss on debt extinguishment |
- |
- |
0.03 |
- |
|||||||
|
Severance and other |
- |
0.01 |
0.01 |
0.03 |
|||||||
|
Adjusted net loss per share - basic (non-GAAP basis) |
$ |
(0.48) |
$ |
(0.60) |
$ |
(2.35) |
$ |
(3.01) |
|||
|
Weighted average common shares outstanding used in computing net loss per share-basic |
83,400 |
48,709 |
69,309 |
35,713 |
|||||||
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Vice President, Corporate Communications,
Investor Relations & Patient Advocacy
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Source: Verastem Oncology