Full Press Release Details
Verastem Oncology Reports Third Quarter 2025
Financial Results and Highlights Recent Business Updates
Achieved AVMAPKI FAKZYNJA CO-PACK
net product revenue of $11.2 million
VS-7375 cleared first two monotherapy dose levels
with no dose-limiting toxicities reported; no nausea, vomiting or diarrhea greater than Grade 1 were observed
Enrollment initiated for VS-7375 in combination
with cetuximab in patients with advanced KRAS G12D mutant solid tumors, including colorectal cancer
Ended Q3 2025 with $137.7 million
in cash and cash equivalents; with expected product revenue and exercise of cash warrants, Company cash runway would extend into the second
Company to host a conference call and webcast
today at 8:00 a.m. ET
BOSTON--(BUSINESS WIRE)-Nov. 4, 2025--Verastem Oncology
(Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today
announced business updates and reported financial results for the third quarter ended September 30, 2025.
"Our performance in Q3, which was the first full quarter since
our accelerated approval and launch of AVMAPKI FAKZYNJA CO-PACK, exceeded expectations with net revenue of over $11 million and demonstrated
the strength of our growing commercial business and consistent adoption by both academic and community oncologists for the first treatment
approved by the FDA specifically for patients with KRAS- mutated recurrent LGSOC," said Dan Paterson, president and chief executive
officer of Verastem Oncology. "As we continue to build on this momentum and the fundamentals we have put into place to guide our
commercial business, we're simultaneously advancing our broader strategic priorities, and are very pleased with the progress of
our clinical pipeline programs. Particularly for our KRAS G12D (ON/OFF) inhibitor, VS-7375,
preliminary safety, tolerability, and anti-tumor activity are promising, and we believe in line as a potential best-in-class option for
patients with pancreatic, lung, and other KRAS G12D-mutated solid tumor cancers. As we move ahead with opening the combination cohort
with VS-7375 and cetuximab, we look forward to several important data readouts in the first half of 2026 that we believe will further
demonstrate the breadth of our RAS/MAPK pathway-driven approach."
Third Quarter 2025 and Recent Updates
AVMAPKI FAKZYNJA CO-PACK (avutometinib in combination
with defactinib) U.S. Launch
and Defactinib Combination in LGSOC
VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Advanced Solid
RAMP 205: Avutometinib Plus Defactinib in Combination with Chemotherapy
in First-Line Metastatic PDAC
RAMP 203: Avutometinib Plus Defactinib in Combination with a KRAS
G12C Inhibitor in NSCLC
Third Quarter 2025 Financial Results
Net product revenue for the three months ended September 30, 2025
(the "2025 Quarter") was $11.2 million, compared to $0.0 million for the three months ended September 30, 2024 (the "2024
Quarter"). The Company began commercial sales of the AVMAPKI FAKZYNJA CO-PACK within the United States following receipt of FDA
approval in May 2025.
Total operating expenses for the 2025 Quarter were $52.0 million, compared
to $37.0 million for the 2024 Quarter. Cost of sales associated with product revenue was $1.7 million for the 2025 Quarter, compared to
$0.0 for the 2024 Quarter.
Research & development expenses for the 2025 Quarter were
$29.0 million, compared to $24.8 million for the 2024 Quarter. The increase of $4.2 million, or 16.9%, was primarily related to increased
drug substance and drug product costs, increased contract research organization costs, and increased investigator trial costs.
Selling, general & administrative expenses for the 2025 Quarter
were $21.0 million, compared to $12.3 million for the 2024 Quarter. The increase of $8.7 million, or 70.7%, was primarily related to commercialization
costs required as part of the launch of AVMAPKI FAKZYNJA CO-PACK in KRAS-mutated recurrent LGSOC. This was comprised of increased consulting,
personnel costs, and professional fees.
Net loss (GAAP basis) for the 2025 Quarter was $98.5 million, or $1.35
per share (basic and diluted), compared to $24.0 million, or $0.60 per share (basic and diluted) for the 2024 Quarter.
For the 2025 Quarter, non-GAAP adjusted net loss was $39.4 million,
or $0.54 per share (diluted) compared to non-GAAP adjusted net loss of $35.3 million, or $0.88 per share (diluted), for the 2024 Quarter.
Please refer to the GAAP to non-GAAP Reconciliation attached to this press release.
Verastem Oncology ended the third quarter of 2025 with cash, cash equivalents
and investments of $137.7 million. With existing cash, product revenue, and exercise of cash warrants, Company has expected cash runway
into the second half of 2026.
Conference Call and Webcast
Verastem will host a conference call and webcast today at 8:00 a.m. ET
to review the third quarter 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 8194537 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 and nine months ended September 30,
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 in combination with defactinib and other agents as a potential treatment 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
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.