Analyst Conference Summary

biotechnology

conference date: August 8, 2025
for quarter ending: July 30, 2025 (2nd quarter, Q2 2025)

Forward-looking statements

Overview: First quarter with product revenue.

Basic data (GAAP):

Revenue was $2 million, down from $10 million in the year-earlier quarter.

Net Income was negative $26 million, down from negative $8 million year-earlier.

EPS (Earnings per Share), diluted, was negative $0.39, down from negative $0.31 year-earlier. Share count greatly increased.

Guidance:

Cash runway to 2H 2026.

Conference Highlights:

The combination of Avmapki and Fakzynja was approved by the FDA on May 8, 2025 for adults with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC). In quarter net product revenue for the therapy was $2.1 million. Distribution and group purchasing agreements have now been put into place, plus a patient support system, Verastem Cares. In May recommended by NCCN. A confirmatory Phase 3 trial is underway with enrollment nearly complete. In July 2025 the EC granted orphan drug designation.

CEO Dan Paterson said, "In the second quarter of 2025, Avmapki Fakzynja Co-Pack became the first-ever treatment approved by the FDA specifically for use in patients with KRAS-mutated recurrent low-grade serous ovarian cancer, and we are off to a strong start with the launch of this innovative combination therapy. In the quarter, we also made significant progress across our pipeline programs with the first patient dosed in the U.S. Phase 1/2a trial for VS-7375, our potential best-in-class KRAS G12D (ON/OFF) inhibitor, and with positive updated data from our RAMP 205 trial in the front-line setting of metastatic pancreatic cancer. Our focus for the second half of the year is to continue to build on the positive launch momentum, continue to advance RAMP 205 and RAMP 301 clinical trials, and enroll patients in both the VS-7375 monotherapy and combination cohorts to unlock new opportunities with our RAS/MAPK-pathway focused portfolio." Verastem is already seeing repeat prescriptions from physicians, and refills, with both commercial and Medicare payers.

In Q2 the first patient was dosed in the Phase 1 trial of VS-7375 for KRAS G12D for advanced solid tumors. 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.

Cash and equivalents eneded at $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%. Expansion cohort is now enrolling.

In Q2 2025 Avutometinib plus Defactinib in combination with a KRAS G12C inhibitor trial in NSCLC continues to enroll cohorts.

Cost of sales in Q2 was low because drugs in inventory had been expensed before approval.

Total operating costs were $45.9 million. Cost of sales $0.4 million, R&D $24.8 million, SG&A $20.7 million. Loss from operations $43.8 million. Other expense $0.1 million. Interest income net $0.6 million. Change in fair value of warrant liability $20.3 million. Change in fair value of notes $3.0 million.

Q&A selective summary:

Reimbursement trends? We do not promote off-label use, but we have seen use in the wild-type population.

KRAS Q4 update? Magnitude roughly similar to the ASCO Chinese data, with safety this year and efficacy next year.

Launch expectations? Too early to project. We are just starting to track data. Over time we will report in more detail.

Launch exceeds our expectations. We had some prescriptions from physicians whom the sales team had not called on yet. But best thing for patients is to stay on current therapy until the cancer advances, then our therapy would be next. Seeing business from top one and two tier sites.

Payers? We have the data to support the reimbursment. But it does require prior authorization. We are giving away very little free drug. IRA helps patients cap out-of-pocket costs.

Because we got the approval early, we were not fully ready for sales. There is not a big bolus of patients. But should accrue over time and be on therapy for a long time. We are looking at a potential KOL trial as a front-line therapy.

There was minimal stocking in Q2. Each of the SPs has been restocked several times now. No specifics on gross-to-net yet.

VS-7375 specific indications? We started at a relatively high dose because we already had the GenFleet Chinese data. We intend to move quickly.

We believe for commercial patients the copay will typically be zero. The Medicare copay would kick in the first month.

Japan timeline? Doing a small bridging study there, wrapping up approval now. Will seek conditional approval.

In EU, question is whether we will need a confirmatory study for approval.

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