Financial Performance - The company reported a net loss of $20.148 million for the three months ended September 30, 2025, compared to a net loss of $23.156 million for the same period in 2024, reflecting a decrease in losses of approximately 13.1%[145] - Total operating expenses for the three months ended September 30, 2025, were $25.096 million, down from $27.068 million in 2024, indicating a reduction of about 7.3%[145] - The company reported a net loss of $74.0 million for the nine months ended September 30, 2025, compared to a net loss of $65.8 million in the same period of 2024[167][168] Research and Development - Research and development expenses decreased to $18.225 million in Q3 2025 from $21.258 million in Q3 2024, a decline of approximately 14.3%[145] - Research and development expenses for Q3 2025 were $18.2 million, a decrease of $3.1 million from $21.3 million in Q3 2024, primarily due to a $6.1 million decrease in ELVN-002 costs[147] - Research and development expenses for the nine months ended September 30, 2025, were $64.6 million, an increase of $4.5 million from $60.1 million in 2024, driven by higher internal costs[151] Cash and Liquidity - The company had cash, cash equivalents, and marketable securities totaling $477.6 million as of September 30, 2025, which is expected to fund operations for at least the next 12 months[128] - The company expects to require substantial additional capital to fund ongoing operations and product development, with existing resources projected to last at least 12 months[163] - Cash, cash equivalents, and marketable securities as of September 30, 2025, primarily consisted of U.S. Treasury securities and U.S. Treasury-backed money market funds[178] Operating Expenses - General and administrative expenses for Q3 2025 increased to $6.9 million from $5.8 million in Q3 2024, an increase of $1.1 million attributed to higher stock-based compensation[148] - General and administrative expenses for the nine months ended September 30, 2025, rose to $20.8 million from $17.6 million in 2024, reflecting a $3.2 million increase in stock-based compensation[152] - Total operating expenses for the nine months ended September 30, 2025, were $85.4 million, compared to $77.7 million for the same period in 2024, resulting in a net loss of $74.0 million[150] Financing Activities - 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[127] - The company has raised a total of $230.0 million from public offerings and private placements since February 2023, with $40.0 million received through the Sales Agreement by September 30, 2025[154][158] - Net cash provided by financing activities rose to $218.2 million in 2025, up from $93.2 million in 2024, driven mainly by net proceeds from the sale of common stock and pre-funded warrants[171][172] Other Income and Expenses - Other income for Q3 2025 was $4.9 million, up from $3.9 million in Q3 2024, mainly due to a $1.1 million increase in interest income[149] - Other income for the nine months ended September 30, 2025, was $11.3 million, a decrease of $0.5 million from $11.8 million in 2024, primarily due to a lower gain related to the CVR liability[153] Debt and Lease Obligations - As of September 30, 2025, the company had no debt outstanding, eliminating exposure to interest rate risk related to debt[179] - The company entered into a non-cancellable operating lease for approximately 20,011 rentable square feet of office and laboratory space from January 1, 2025, through December 31, 2026[174] Strategic Initiatives - The company is advancing its ELVN-001 program into Phase 3 initiation expected in 2026, focusing on a highly selective active site inhibitor for CML[124] - The company plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025[123] Cash Flow Activities - Net cash used in operating activities for the nine months ended September 30, 2025 was $54.5 million, compared to $56.0 million for the same period in 2024, reflecting a decrease of 2.7%[167][168] - Net cash used in investing activities increased significantly to $186.2 million in 2025 from $36.7 million in 2024, primarily due to cash used to purchase marketable securities of $371.3 million[169][170] - The company experienced net cash outflows from changes in operating assets and liabilities of $2.3 million in 2025, compared to $4.0 million in 2024[167][168] Risk Management - The company has not engaged in any hedging activities to mitigate foreign currency exchange risk, although it may consider this in the future[180] - The company has entered into agreements with vendors for goods and services, which may include purchase obligations and termination obligations[174]
Enliven Therapeutics(ELVN) - 2025 Q3 - Quarterly Report