Enliven Therapeutics(ELVN) - 2025 Q2 - Quarterly Report

Financial Performance - The company reported total operating expenses of $28.584 million for the three months ended June 30, 2025, compared to $24.603 million for the same period in 2024, representing an increase of approximately 16.1%[142] - The net loss for the three months ended June 30, 2025, was $25.335 million, compared to a net loss of $19.950 million for the same period in 2024, reflecting an increase in losses of approximately 27%[142] - Total operating expenses for the six months ended June 30, 2025, were $60.3 million, compared to $50.6 million for the same period in 2024, reflecting a 19.5% increase[147] - The net loss for the six months ended June 30, 2025, was $53.9 million, compared to a net loss of $42.7 million in the same period of 2024, indicating a 26.2% increase in losses[147] - Other income decreased to $3.2 million for the three months ended June 30, 2025, down from $4.7 million in the same period of 2024, a decline of 31.9%[146] Research and Development - Research and development expenses were $21.491 million for the three months ended June 30, 2025, up from $18.826 million in 2024, indicating a year-over-year increase of about 8.9%[142] - The company is advancing its ELVN-001 program into Phase 3 initiation expected in 2026, while exploring strategic alternatives for the ELVN-002 program, which will not be developed beyond 2025[121] - The company plans to expand its pipeline of product candidates and continue to incur significant expenses associated with being a public company[140] - Research and development expenses increased to $21.5 million for the three months ended June 30, 2025, up from $18.8 million in the same period of 2024, representing a 14.3% increase[144] Cash and Capital - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $490.5 million, which is expected to fund operations for at least the next 12 months[125] - The company raised aggregate gross proceeds of $90.0 million from a private placement in March 2024 and $230.0 million from a public offering in June 2025[124] - The company plans to seek additional capital through equity or debt financings to support ongoing operations and product development[156] - Future capital requirements will depend on various factors, including the costs of research and development, regulatory review, and commercialization efforts[160] - Net cash provided by financing activities rose to $218.6 million in the first half of 2025, up from $92.1 million in 2024, driven by proceeds from the sale of common stock and pre-funded warrants[167][168] Expenses - General and administrative expenses increased to $7.093 million for the three months ended June 30, 2025, from $5.777 million in 2024, marking a rise of approximately 22.8%[142] - General and administrative expenses rose to $7.1 million for the three months ended June 30, 2025, compared to $5.8 million in the same period of 2024, marking a 22.4% increase[145] - Net cash used in operating activities for the six months ended June 30, 2025 was $41.2 million, compared to $43.8 million for the same period in 2024, reflecting a decrease of 6%[163][164] - Net cash used in investing activities increased significantly to $182.2 million in the first half of 2025 from $51.6 million in 2024, primarily due to cash used for purchasing marketable securities[165][166] Debt and Financial Risks - As of June 30, 2025, the company had no debt outstanding, mitigating exposure to interest rate risk[174] - The company does not currently hedge against foreign currency risks, although it has contracts denominated in foreign currencies[175] - A hypothetical 100 basis point change in interest rates would not have a material impact on the company's financial results due to the short-term nature of its investments[173] Accounting and Compliance - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[132] - The company has not generated any revenue from product sales to date and does not expect to do so until regulatory approval is obtained[155] - The company has made no material changes to its critical accounting policies and estimates as of June 30, 2025[171] - The company has not engaged in any off-balance sheet arrangements during the reported periods[170] - The company entered into a non-cancellable operating lease for approximately 20,011 rentable square feet of office and laboratory space, with total lease obligations of $614,000 due by the end of 2026[169] - The company has an accumulated deficit of $297.4 million as of June 30, 2025, with significant losses incurred since inception, including net losses of $89.0 million and $71.6 million for the years ended December 31, 2024 and 2023, respectively[126]