Verastem(US:VSTM)2025-11-04 12:30Financial Performance - Achieved net product revenue of $11.2 million for AVMAPKI™ FAKZYNJA™ CO-PACK in Q3 2025, marking the first full quarter since its launch[1][4][15] - Total revenue for the three months ended September 30, 2025, was $11,242,000, compared to $0 for the same period in 2024[39] - Net loss for Q3 2025 was $98.5 million, or $1.35 per share, compared to a net loss of $24.0 million, or $0.60 per share, in Q3 2024[1][19] - The net loss for the three months ended September 30, 2025, was $98,518,000, compared to a net loss of $23,967,000 for the same period in 2024[39] - Adjusted net loss (non-GAAP) for Q3 2025 was $39.354 million, compared to $35.278 million in Q3 2024, indicating a slight increase in adjusted losses[43] - Net loss per share (diluted, GAAP) for Q3 2025 was $(1.35), compared to $(0.60) in Q3 2024, reflecting a worsening loss per share[43] - For the nine months ended September 30, 2025, the net loss was $176.555 million, compared to $66.086 million for the same period in 2024[43] - The total adjusted net loss for the nine months ended September 30, 2025, was $123.765 million, compared to $78.002 million for the same period in 2024[43] Cash and Expenses - Ended Q3 2025 with cash and cash equivalents of $137.7 million, with an expected cash runway extending into the second half of 2026[1][20] - Research and development expenses increased by $4.2 million, or 16.9%, to $29.0 million in Q3 2025, primarily due to higher drug substance and trial costs[1][17] - Selling, general, and administrative expenses rose by $8.7 million, or 70.7%, to $21.0 million in Q3 2025, driven by commercialization costs for AVMAPKI FAKZYNJA[1][18] - Total operating expenses for the nine months ended September 30, 2025, were $142,033,000, compared to $93,366,000 for the same period in 2024[39] - Stock-based compensation expense for Q3 2025 was $2.178 million, up from $1.935 million in Q3 2024[43] Clinical Trials and Research - Preliminary safety and efficacy data for VS-7375 showed no dose-limiting toxicities in the ongoing Phase 1/2a trial, with four out of five patients experiencing tumor reduction[1][8] - Enrollment for the combination cohort of VS-7375 with cetuximab in advanced solid tumors has been initiated[1][8] - The company expects to report updates on the safety and efficacy of the RAMP 205 expansion cohort in 1H 2026[1][11] - The ongoing Phase 3 RAMP 301 trial completed enrollment of 270 patients a quarter early, with an additional 29 patients to be added based on IDMC recommendations[1][8] - The company is conducting RAMP 301, an international Phase 3 confirmatory trial for the combination of avutometinib and defactinib[24] - Verastem initiated a Phase 1/2a clinical trial for VS-7375, a KRAS G12D dual ON/OFF inhibitor, in June 2025[32] Regulatory and Collaborations - AVMAPKI™ FAKZYNJA™ CO-PACK received FDA approval for treating adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) on May 8, 2025[24] - The company plans to engage with the FDA regarding potential registration-directed clinical trials in PDAC and NSCLC in 1H 2026[1][12] - The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers[33]