Verastem(VSTM) - 2025 Q4 - Annual Results

Financial Projections - Verastem expects AVMAPKI™ FAKZYNJA™ CO-PACK net product revenues of approximately $17.5 million for Q4 2025 and approximately $30.9 million for the full year 2025[1][4]. - As of December 31, 2025, Verastem reported cash, cash equivalents, and investments of $205 million, which increases to $234 million when including net proceeds from exercised cash warrants[1][4]. - The company anticipates that the LGSOC commercial launch and development program will be self-sustaining by the second half of 2026[1][4]. Clinical Trials and Development - The ongoing RAMP 301 Phase 3 trial for AVMAPKI FAKZYNJA CO-PACK is fully enrolled and aims to confirm the initial indication for KRAS-mutated recurrent LGSOC[1][5]. - In the RAMP 201J Phase 2 trial in Japan, a confirmed overall response rate (ORR) of 38% was achieved among 16 efficacy evaluable patients, with a 57% ORR in KRAS-mutated patients[1][5]. - Verastem plans to report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027[1][8]. - The company is advancing VS-7375, a selective oral KRAS G12D inhibitor, in an international Phase 1/2 trial for advanced KRAS G12D solid tumors[1][8]. - Verastem expects to provide an update on the safety and efficacy of the RAMP 205 expansion cohort in Q2 2026[1][9]. Regulatory Approvals and Collaborations - The FDA approved AVMAPKI™ FAKZYNJA™ CO-PACK for KRAS-mutated recurrent LGSOC on May 8, 2025, with continued approval contingent on confirmatory trial results[1][13]. - The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers, with VS-7375 being the lead program[1][19]. - Verastem Oncology is focused on developing and commercializing new medicines for patients with RAS/MAPK pathway-driven cancers, with a pipeline that includes novel small molecule drugs targeting critical signaling pathways[21]. Product Information and Safety - The company markets AVMAPKI™ FAKZYNJA™ CO-PACK in the U.S., which is designed to inhibit cancer cell survival and tumor growth[21]. - The company advises against the concomitant use of AVMAPKI FAKZYNJA CO-PACK with strong and moderate CYP3A4 inhibitors and inducers, as well as warfarin and certain gastric acid reducing agents[20]. - The use of AVMAPKI FAKZYNJA CO-PACK may impair fertility in both males and females[20]. Risks and Forward-Looking Statements - Forward-looking statements indicate potential risks and uncertainties related to the commercialization of product candidates and the conduct of clinical trials, which may affect actual results[22]. - There are risks associated with the FDA's review process, including potential delays and regulatory uncertainties that could impact product approval and commercialization[22]. - Investors are cautioned not to place considerable reliance on forward-looking statements due to inherent risks in research and development[22]. - The company’s Annual Report on Form 10-K for the year ended December 31, 2024, details additional risks and uncertainties[22]. Contact Information - For inquiries, the Vice President of Corporate Communications can be contacted via provided email addresses[23].