Analyst Conference Summary

biotechnology

conference date: March 4, 2026 @ 1:30 PM Pacific Time
for quarter ending: December 31, 2025 (fourth quarter, Q4 2025)

Forward-looking statements

Overview: Product revenue ramping nicely, on a small base.

Basic data (GAAP):

Revenue was $17.5 million, up 56% sequentially from $11.2 million and up from $0 million in the year-earlier quarter.

Net Income was negative $33 million, up sequentially from negative $99 million, and up from negative $65 million year-earlier.

EPS (Earnings per Share), diluted, were negative $0.50, up sequentially from negative $1.35, and up from negative $1.33 year-earlier.

Guidance:

Cash runway into first half of 2027. Believes Copack revenue will become self sustaining in second half of 2026.

Conference Highlights:

CEO Dan Paterson said, "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." Given limited resouces will prioritize most likely and valuable indications.

In February 2026 the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Ovarian Cancer did not expand the recomendation for the Avmapki and Fakzynja (co-pack) to LGSOC patients without a KRAS mutation. Verastem will continue generating data to show the benefits for these patients.

In February 2026 a small Japaneses study of Avmapki and Fakzynja (co-pack) for LGSOC patients reported updated positive results.

The combination of Avmapki and Fakzynja (co-pack) was approved by the FDA on May 8, 2025 for adults with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC), who have received a prior therapy. Q4 net product revenue for the therapy was $17.5 million, up sequentially from $11.2 million. Distribution and group purchasing agreements have now been put into place, plus a patient support system, Verastem Cares. A confirmatory Phase 3 trial is underway with enrollment completed in Q1 2026. A topline readout of the confirmatory RAMP 301 trial is expected in mid-2027.

Genfleet continued to evaluate VS-7375 (GFH375) in China. In December a Phase 3 study in pretreated KRAS mutated metastatic pancreatic cancer was initiated. Additional data for PDAC announced in Q4 2025 was positive.

In Q1 2026, the Phase 1/2 VS-7375 study, after clearing the 900 mg daily dose level with no dose-limiting toxicities, the dose escalation phase will continue to 1200 mg. Preliminary data cleared 400mg through 900mg doses with no dose-limiting toxicities. Next is 900 mg. Of five patients evaluated four had tumor reduction and remain on treatment. The FDA granted Fast Track for 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. Also in Q1 2026, with FDA feedback, Phase 2 trials will run separately for KRAS G12D mutated 2L pancreatic ductal adenocarcinoma (PDAC) and 2L/3L non-small cell lung cancer (NSCLC) (monotherapy) and 2L+ colorectal cancer (CRC) in combination with cetuximab.

Cash and equivalents ended at $205 million, up sequentially from $138 million. In Q4 borrowed $75 million of a $150 million available notes.

In Q2 2025 Avutometinib plus Defactinib in combination with chemotherapy in first-line metastatic PDAC, in the Phase 1/2 trial, reported a dose level 1 ORR of 83%. Enrollment was completed in Q3 2025, with a data update expected in 1H 2026..

For Avutometinib plus Defactinib in combination with a KRAS G12C inhibirot in NSCLC

Non-GAAP net income was negative $40 million, down sequentially from negative $39 million, down from negative $29 million year-earlier. Non-GAAP diluted EPS was negative$0.48, up sequentially from negative$0.54 , and up from negative $0.60 year-earlier. Share count greatly increased y/y.

Total operating costs were $59 million. Cost of sales $3 million, R&D $32 million, SG&A $24 million. Loss from operations $41 million. Other expense $0 million. Interest income net $0.7 million. Change in fair value of warrant liability $10 million. Change in fair value of notes $2.6 million.

Full year 2025 revenue was $30.9 million. Net income negative $210 million. GAAP EPS negative $2.35

Q&A selective summary:

NCCN, wild-type reimbursements? It was disappointing. Might have something to do with coming Phase 3 readout. It would be nice to have NCCN, but we can get reimbursement without it.

VS-7375, any discontinuations? Dose selection for Phase 2 studies? Dose modifications have been low and slow, showing good tolerability. Dropout rate is very low. For chronic cancer we are looking for longer-term tolerability. Our drug works quickly, so we can see a lot in several months, but it takes at least 2 CT scans to confirm a response. We also want to see prolonged disease control, at least 6 months.

Combination strategy? Goal is to move into second and third line settings. Then first line. Then combo trials, probably investigator-sponsored.

Plan to revisit with NCCN? Yes, as we develop more evidence in wild-type in particular.

Prescribing dynamics? No specific guidance. Growing prescriber numbers, both community and academic. Cares program is performing well.

Extending cash runway? Any additional capital raise would be based on good data. We would like to raise cash without dilution. We have had a lot of strategic interest. Growing concensus this is a best-in-class molecule.

Currently we do not believe we will need to start with a high dose and then lower it.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: