Financial Performance - The company reported a net loss of $28.5 million for the three months ended March 31, 2025, compared to a net loss of $22.7 million for the same period in 2024, reflecting an increase in losses of approximately 25.5%[132] - Total operating expenses for the three months ended March 31, 2025, were $31.7 million, up from $26.0 million in the same period of 2024, representing an increase of about 22.5%[132] - General and administrative expenses rose to $6.8 million for the three months ended March 31, 2025, compared to $6.0 million in the same period of 2024, an increase of 13.3%[135] - Net cash used in operating activities was $24.1 million for the three months ended March 31, 2025, compared to $23.4 million for the same period in 2024, reflecting a 3.0% increase[148][149] - The accumulated deficit as of March 31, 2025, was $272.0 million, indicating significant losses since inception[116] - The company has not generated any revenue to date and does not expect to do so in the foreseeable future[122] Research and Development - Research and development expenses increased to $24.9 million for the three months ended March 31, 2025, compared to $20.0 million for the same period in 2024, marking a rise of approximately 24.5%[132] - The company plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025[110] - The company is advancing the ELVN-001 program, which is currently in Phase 1 safety and efficacy trials, with a pivotal trial expected in mid-2025[111] Capital and Funding - The company has raised a total of $140.5 million from private placements and $164.5 million from common stock sales, with an additional $90.0 million raised in a recent private placement[114][115] - The company expects to require substantial additional capital to fund operations and product development, as it has not generated any revenue from product sales[140][141] - The company has a shelf registration statement allowing for equity and debt offerings up to $400.0 million, with $200.0 million available for use under this statement as of March 31, 2025[138] Cash and Liquidity - The company had cash, cash equivalents, and marketable securities of $289.6 million as of March 31, 2025, which is expected to fund operations for at least the next 12 months[115] - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $289.6 million[139] - The company's cash, cash equivalents, and marketable securities primarily consist of U.S. Treasury securities and U.S. Treasury-backed money market funds[159] Lease and Obligations - 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 $714,000 due in 2025[154] Risk Management - As of March 31, 2025, the company had no debt outstanding, eliminating exposure to interest rate risk related to debt[160] - A hypothetical 100 basis point increase or decrease in interest rates would not have had a material impact on the company's financial results due to the short-term maturities of investments[159] - The company does not currently engage in hedging activities to mitigate foreign currency transaction risks but may consider it in the future[161] - A hypothetical 100 basis point increase or decrease in foreign exchange rates would not have had a material impact on the company's financial condition or results of operations[161] Accounting Policies - There have been no material changes to the company's critical accounting policies and estimates since the last annual report[157] - The company evaluates its estimates and assumptions on a periodic basis, which may differ from actual results[157] - Recently issued accounting pronouncements that may impact the company's financial condition are disclosed in the quarterly report[158]
Enliven Therapeutics(ELVN) - 2025 Q1 - Quarterly Report