Analyst Conference Summary

biotechnology

conference date: November 4, 2025 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2025 (2nd quarter, Q2 2025)

Forward-looking statements

Overview: Product revenue ramping nicely.

Basic data (GAAP):

Revenue was $11.2 million, up sequentially from $2 million and up from $0 million in the year-earlier quarter.

Net Income was negative $99 million, down sequentially from negative $26 million, and down from negative $24 million year-earlier.

EPS (Earnings per Share), diluted, were negative $1.35, down sequentially from negative $0.39, and down from negative $0.60 year-earlier. Share count greatly increased.

Guidance:

none

Conference Highlights:

CEO Dan Paterson said, "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" Revenue was above expectations. Now has 133 prescribers.

In Q3 2025 a $56 million expense for fair value of warrant liability negatively impacted net income and EPS.

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. Q3 net product revenue for the therapy was $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 initial enrollment complete in Q3 2025. But after a pre-planned interim analysis enrollment was increased (from 270 patients) by 29 patients. Expects In July 2025 the EC granted orphan drug designation. Expects enrollment completion in Q1 2026.

In Q2 the first patient was dosed in the Phase 1/2a trial of VS-7375 for KRAS G12D for advanced solid tumors. Preliminary data cleared 400mg and 600mg 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. Other cancer cohorts include NSCLC and CRC. In Q4 2025 the combination study with cetuximab was initiated. Earlier GenFleet Phase 1/2 data was positive with 600 mg ORR of 68.8%.

Cash and equivalents ended at $138 million, down sequentially from $164.3 million.

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 expects initial safety and efficacy results in Q4 2025.

Non-GAAP net income was negative $39 million, up from negative $35 million year-earlier. Non-GAAP diluted EPS was negative$0.54, up from negative $0.88 year-earlier. Share count greatly increased y/y.

Total operating costs were $52 million. Cost of sales $2 million, R&D $29 million, SG&A $21 million. Loss from operations $41 million. Other expense $0 million. Interest income net $1 million. Change in fair value of warrant liability $56 million. Change in fair value of notes $3 million.

Q&A selective summary:

Type of patients? Mix of early and later lines, and of wild-type, but most are KRAS mutant. We don't get all details on all patients.

We are blinded to the data on the Phase 3 co-pack trial.

MCCN October review, wild-type label? We have not heard, we know the committee met. We might not hear until early next year.

Refills v. starts? Not providing that year. But if they started early, they likely recieved refills.

LGSOC market patient retention? Too early to tell, but in the clinical trial average duration was about 18 months. We do see people coming in at first recurance.

VS-7375, differences with Chinese studies? Yes, Chinese patients were fasted. In the U.S. they were fed and had prophylactic medications. We saw no GI toxicities greater than Grade 1.

Phase 3 trial KRAS mutant v. wild? About half and half. The additional patients were in both groups.

Prescriptions are for a month, three weeks out of four.

In the 7375 trial there were a few 2 and 3 adverse events.

Most users so far have been KRAS mutant, not wild type.

Potential partnerships? We have had a fair amount of inbound interest. We evaluate if we could do more with more resources.

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