Verastem Oncology — Second Quarter 2026 Earnings Summary

Financial Performance

• Total revenue for the three months ended June 30, 2026, was $40.1 million, compared to $2.1 million in the same period of 2025.
• Net product revenue from AVMAPKI FAKZYNJA CO-PACK was $25.1 million for the quarter, up from $2.1 million in the prior year period.
• Sale of COPIKTRA license and related assets revenue was $15.0 million for the quarter, triggered by Secura Bio achieving $200 million in cumulative worldwide net sales.
• Total operating expenses were $72.8 million for the quarter, compared to $45.9 million in the prior year period.
• Research and development expenses increased to $41.3 million from $24.8 million in the prior year period, driven by investigator fees, CRO costs, manufacturing, and personnel costs.
• Selling, general, and administrative expenses increased to $27.4 million from $20.7 million in the prior year period, driven by personnel and commercial operations costs.
• Net loss on a GAAP basis was $34.7 million ($0.35 per share), compared to a net loss of $25.9 million ($0.39 per share) in the prior year period.
• Non-GAAP adjusted net loss was $30.6 million ($0.31 per share), compared to a non-GAAP adjusted net loss of $41.3 million ($0.62 per share) in the prior year period.
• Cash, cash equivalents, and investments ended the quarter at $136.4 million.
• Pro forma cash position, including the $50 million Oberland Capital closing and $15 million COPIKTRA milestone, was $201.4 million as of June 30, 2026.
• Long-term debt was $73.8 million as of June 30, 2026, down from $76.3 million as of December 31, 2025.
• Accounts receivable increased to $28.9 million as of June 30, 2026, from $8.8 million as of December 31, 2025.

Guidance and Future Outlook

• The company expects to extend its cash runway into the second half of 2027 based on pro forma cash, expected product revenues, and future tranches from the Oberland facility.
• Enrollment across all three TARGET-D Phase 2 trials is expected to be completed by the end of 2026.
• Updated clinical data for VS-7375 across pancreatic, lung, and colorectal cancers is expected in October 2026.
• A top-line readout of the primary endpoint in the RAMP 301 trial is expected in mid-2027.
• The company plans to meet with the FDA before the end of 2026 to review Phase 3 pivotal trial designs for 1L mPDAC, 1L mCRC, and 1L advanced NSCLC.
• Enrollment of the first patient in each of the Phase 3 pivotal trials is targeted for the first half of 2027.
• The company intends to pursue regulatory paths for potential expansion of AVMAPKI FAKZYNJA CO-PACK into Europe and Japan.

Business Segments and Product Lines

• AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) is the primary commercial product, approved for KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC).
• Updated data from the RAMP 201 Japan study showed a 44% overall response rate and 94% disease control rate in patients with recurrent LGSOC.
• Updated results from the RAMP 205 Phase 1b/2a trial in first-line metastatic pancreatic ductal carcinoma (PDAC) showed a 52% confirmed objective response rate, 86% overall survival rate, and 68% progression-free survival rate at six months.
• VS-7375, an oral KRAS G12D inhibitor, has initiated patient dosing in three registration-directed Phase 2 trials: TARGET-D 201 (2L PDAC), TARGET-D 202 (2L/3L NSCLC), and TARGET-D 203 (2L+ CRC).
• The FDA granted Fast Track Designation to VS-7375 for the treatment of KRAS G12D-mutated unresectable locally advanced or metastatic NSCLC in June 2026.
• The company entered an agreement with Erasca, Inc. to evaluate VS-7375 in combination with ERAS-0015 across KRAS G12D mutant solid tumor models.
• The company launched a new LGSOC Resource Guide in May 2026 and a new marketing campaign, "Reimagine Recurrent Low-Grade Serous Ovarian Cancer," in April 2026.

Market and Competitive Landscape

• The company focuses on RAS/MAPK pathway-driven cancers, targeting differentiated KRAS G12D inhibition with VS-7375.
• VS-7375 is designed to bind both active (ON) and inactive (OFF) states of KRAS G12D, aiming to inhibit signaling more completely than compounds targeting only one state.
• The company is conducting the RAMP 301 Phase 3 confirmatory trial for AVMAPKI FAKZYNJA CO-PACK versus standard chemotherapy or hormonal therapy for recurrent LGSOC.

Risks and Challenges

• Clinical trial results may be negative or unexpected, and data may not be available when expected.
• The company may not satisfy closing conditions to receive the $50 million from the Oberland Capital financing arrangement.
• Commercialization of AVMAPKI FAKZYNJA CO-PACK may not be successful.
• Development and commercialization timelines may be longer or cost more than planned.
• Regulatory actions, including potential FDA workforce reductions, could disrupt review and oversight.
• Product candidates may not receive regulatory approval or become commercially successful.
• Specific safety warnings include ocular toxicities, serious skin toxicities, hepatotoxicity, rhabdomyolysis, and embryo-fetal toxicity.

Management Commentary and Tone

• CEO Dan Paterson described the quarter as marking "meaningful progress" with strong quarter-over-quarter growth for AVMAPKI FAKZYNJA CO-PACK driven by new patient starts and increased refills.
• Management highlighted encouraging activity for VS-7375 across multiple KRAS G12D-driven tumors, noting dose-dependent anti-tumor activity and a manageable safety profile.
• The CEO stated that the incremental $90 million in non-dilutive funding strengthens the balance sheet and preserves strategic flexibility for future financing and partnerships.
• Management expressed confidence in advancing a differentiated KRAS G12D inhibitor with the potential to change outcomes for patients.

Other Key Points

• The company signed a non-dilutive royalty financing agreement with Oberland Capital providing up to $75 million in cash, with $50 million at closing on August 28, 2026.
• An additional $25 million tranche from the Oberland facility is available at the company's option if calendar quarterly worldwide net sales of AVMAPKI FAKZYNJA CO-PACK reach at least $40 million prior to May 15, 2027.
• Verastem received a $15 million milestone payment in July 2026 from Secura Bio upon Secura achieving $200 million in cumulative worldwide net sales of COPIKTRA.
• Michael P. Bailey was appointed to the Board of Directors on May 26, 2026.
• The company has cleared the 1200 mg daily dose of VS-7375 with no dose-limiting toxicities observed in the TARGET-D 101 study.
• More than 200 patients have been treated with VS-7375 in the TARGET-D 101 dose escalation and expansion study.