Verastem(US:VSTM)2025-05-13 20:04Regulatory Approvals - 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 [153]. Financial Performance - The company reported a net loss of $52.1 million for the three months ended March 31, 2025, compared to a net loss of $33.9 million for the same period in 2024 [170]. - As of March 31, 2025, the company had an accumulated deficit of $1,007.6 million and cash, cash equivalents, and investments totaling $117.6 million [170]. - Total operating expenses for Q1 2025 were $44.2 million, a 57% increase from $28.1 million in Q1 2024 [178]. - Research and development expenses rose to $29.2 million in Q1 2025, up 65% from $17.7 million in Q1 2024, primarily due to a $6.0 million GenFleet Option payment [178][185]. - Selling, general and administrative expenses increased to $15.0 million in Q1 2025, a 45% rise from $10.4 million in Q1 2024, driven by commercialization costs and personnel expenses [185]. - Net loss for Q1 2025 was $52.1 million, compared to a net loss of $33.9 million in Q1 2024, reflecting a 54% increase in losses [178]. - Interest income decreased to $1.0 million in Q1 2025, down 30% from $1.4 million in Q1 2024, due to lower investment balances and interest rates [187]. - Interest expense significantly decreased to $0.2 million in Q1 2025 from $1.1 million in Q1 2024, primarily due to the termination of the Loan Agreement with Oxford [188]. - Cash used in operating activities was $38.7 million in Q1 2025, compared to $28.3 million in Q1 2024, reflecting increased net losses [198]. - The loss on debt extinguishment for Q1 2025 was $1.8 million, resulting from the early repayment of the Loan Agreement [190]. - The change in fair value of warrant liability resulted in a $2.4 million expense for Q1 2025, with no such liability in Q1 2024 [192]. - Cash used in operating activities for the 2025 Quarter was $38.7 million, compared to $28.3 million for the 2024 Quarter, representing a 36% increase [199]. - Cash provided by financing activities for the 2025 Quarter totaled $75.0 million from the Note Purchase Agreement, along with additional proceeds from various agreements, partially offset by a $42.6 million repayment of the Loan Agreement [200]. - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $117.6 million, primarily in cash and U.S. Government money market funds [202]. Research and Development - The RAMP 301 trial, a confirmatory Phase 3 study for the combination of avutometinib and defactinib, is expected to achieve full enrollment by the end of 2025 [156]. - The company initiated a Phase 1/2 trial for VS-7375 in China, with initial data expected to be shared at the 2025 ASCO Annual Meeting [168]. - The RAMP 205 trial is evaluating the combination of avutometinib and defactinib with GEMZAR and ABRAXANE in patients with metastatic pancreatic adenocarcinoma, supported by a grant of up to $3.8 million from PanCAN [162]. - The RAMP 203 study is evaluating the combination of avutometinib with Amgen's KRAS G12C inhibitor LUMAKRAS in patients with KRAS G12C non-small cell lung cancer [160]. Financial Outlook and Risks - The company anticipates continued operating losses and has raised substantial doubt about its ability to continue as a going concern within 12 months after the issuance of its financial statements [172]. - The company plans to finance operations through existing cash, potential future milestones, and strategic financing opportunities, but risks associated with these opportunities are deemed not probable for going concern assessment [173]. - The company has borrowed $75.0 million under the Note Purchase Agreement, with interest rates subject to fluctuations based on the Term SOFR and a minimum rate of 4.29% [204]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of the company's investment portfolio due to its short-term duration and low risk profile [202]. - The company is exposed to market risk related to changes in interest rates, particularly affecting its interest-bearing investments [202]. - As of March 31, 2025, an immaterial amount of total liabilities was denominated in foreign currencies, indicating limited exposure to foreign currency fluctuations [203]. - A 10% increase in current interest rates would have resulted in an immaterial increase in cash interest expense for the three months ended March 31, 2025, due to the overall interest rate floor and cap [205].