Enliven Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update

Core Insights - Enliven Therapeutics reported positive initial Phase 1b data for ELVN-001 in chronic myeloid leukemia (CML) and plans to initiate the Phase 3 ENABLE-2 trial in the second half of 2026 [1][2] - The company has a strong financial position with $463 million in cash, expected to fund operations into the first half of 2029 [1][2] ELVN-001 Program Highlights - ELVN-001 is a selective small molecule kinase inhibitor targeting the BCR::ABL gene fusion in CML patients [1] - Initial Phase 1b data showed that among 60 heavily pretreated patients, 47% achieved a cumulative Major Molecular Response (MMR) with a dose of 80 mg QD and 69% with 60/120 mg QD [1] - The company plans to present additional Phase 1 data mid-year and align with the FDA on trial design and dose selection [1][2] Financial Results - Enliven reported a net loss of $29.7 million for Q4 2025, compared to a net loss of $23.2 million in Q4 2024, with a total net loss of $103.7 million for the full year 2025, up from $89.0 million in 2024 [1][2] - General and administrative expenses increased to $13.0 million in Q4 2025 from $6.2 million in Q4 2024, primarily due to stock-based compensation related to leadership changes [1] - Research and development expenses were $21.2 million for Q4 2025, slightly up from $20.7 million in Q4 2024, totaling $85.9 million for the full year 2025 compared to $80.8 million in 2024 [1][2] Upcoming Milestones - The initiation of the ENABLE-2 Phase 3 trial is expected in the second half of 2026 [1] - Key regulatory interactions and operational catalysts are anticipated throughout 2026 [1][2]