Verastem(US:VSTM)2025-11-04 21:11FDA Approvals and Clinical Trials - The FDA approved AVMAPKI FAKZYNJA CO-PACK for treating adult patients with KRAS mutant recurrent LGSOC on May 8, 2025, under the accelerated approval pathway [170]. - The RAMP 301 trial, a confirmatory Phase 3 study for the combination of avutometinib and defactinib, completed enrollment of 270 patients a quarter early in September 2025, with an additional 29 patients recommended for enrollment [174]. - In the RAMP 205 trial, 83% of patients (10 out of 12) achieved partial responses at dose level 1, leading to an expansion of enrollment from 12 to 29 patients [180]. - The RAMP 203 study is evaluating the combination of avutometinib and Amgen's LUMAKRAS in patients with KRAS G12C NSCLC, with the trial progressing to the recommended Phase 2 dose [177]. - The RAMP 201J trial in Japan began dosing patients in October 2024, with preliminary results showing no dose-limiting toxicities observed [176]. - GenFleet initiated a Phase 1b/2 study of GFH375 combined with cetuximab or chemotherapy for advanced solid tumors on October 22, 2025 [189]. Financial Performance - As of September 30, 2025, the company reported a net loss of $98.5 million, a significant increase of 311% compared to the same period in 2024 [193]. - The company recorded approximately $11.2 million in net product revenue for the three months ended September 30, 2025, following the commercial launch of AVMAPKI FAKZYNJA CO-PACK [199]. - Total revenue for the nine months ended September 30, 2025, was $13.38 million, a 34% increase compared to $10 million in the 2024 Period [216]. - The company reported a net loss of $176.56 million for the nine months ended September 30, 2025, compared to a net loss of $66.09 million in the 2024 Period, representing a 167% increase [216]. - The total operating expenses for the nine months ended September 30, 2025, were $142.03 million, a 52% increase from $93.37 million in the 2024 Period [216]. Research and Development - Research and development expenses increased by 17% to $28.9 million in the 2025 Quarter, driven by higher manufacturing and contract research organization costs [204]. - Research and development expenses for the nine months ended September 30, 2025, were $82.93 million, a 37% increase from $60.52 million in the 2024 Period [220]. - The increase in R&D expenses was primarily driven by a $1.61 million rise in costs for the Avutometinib + Defactinib - LGSOC project due to advancing trial costs [208]. - The combination of avutometinib and defactinib is being investigated in various solid tumors, including colorectal cancer and breast cancer, through investigator-sponsored trials [182]. Collaborations and Partnerships - The collaboration with GenFleet Therapeutics includes options for three oncology programs targeting RAS pathway-driven cancers, with the lead program being the oral KRAS G12D inhibitor VS-7375 [183]. - The FDA cleared the IND application for VS-7375 in the U.S. in April 2025, with the first patient dosed in the Phase 1/2a clinical trial in June 2025 [185]. - GenFleet reported an objective response rate (ORR) of 52% and a disease control rate (DCR) of 100% for pancreatic ductal adenocarcinoma (PDAC) patients at a dosage of 400 or 600 mg QD [186]. - At the recommended phase 2 dose of 600 mg QD, the ORR was 68.8% and the DCR was 93.8% for patients in the study [187]. - In the dose expansion phase, GFH375 achieved a 41% ORR and a 96.7% DCR for heavily pre-treated PDAC patients [188]. Cash Flow and Financing - Cash used in operating activities was $107.6 million for 2025, compared to $79.7 million for 2024, reflecting net losses adjusted for non-cash charges [236]. - Cash provided by financing activities for 2025 was $164.7 million, significantly higher than $54.0 million in 2024, driven by proceeds from common stock issuance and the Note Purchase Agreement [237]. - The company expects to finance operations through future potential milestones and royalties from collaboration agreements [232]. - As of September 30, 2025, the company had $137.7 million in cash, cash equivalents, and investments [233]. Expenses and Liabilities - Selling, general and administrative expenses for the 2025 Quarter were $21.0 million, up $8.7 million (70.7%) from $12.3 million in the 2024 Quarter [209]. - Selling, general and administrative expenses increased to $56.7 million in 2025 from $32.8 million in 2024, primarily due to a $19.9 million rise in consulting and professional fees [224]. - Interest income increased to $1.2 million in the 2025 Quarter, compared to $0.8 million in the 2024 Quarter, driven by higher cash equivalents [211]. - Interest income decreased to $3.0 million in 2025 from $3.2 million in 2024, attributed to lower investment balances and interest rates [226]. - Interest expense significantly dropped to $0.7 million in 2025 from $3.4 million in 2024, mainly due to the termination of the Loan Agreement with Oxford [227]. - The change in fair value of warrant liability resulted in a $55.9 million expense for the 2025 Quarter, compared to a $13.5 million income in the 2024 Quarter [213]. - The change in fair value of warrant liability resulted in a $38.0 million expense for 2025, compared to a $13.5 million income in 2024, driven by an increase in stock price [230]. - The loss on debt extinguishment for 2025 was $1.8 million, resulting from the early repayment of a Loan Agreement totaling $42.7 million [228]. Market Risks - The company is exposed to market risks related to interest rates, with a potential immaterial effect on the fair market value of its investment portfolio from a 100 basis point change in interest rates [239].