Enliven Therapeutics (ELVN) Q4 2025 earnings summary

Executive summary

• Reported positive initial Phase 1b data for ELVN-001 in chronic myeloid leukemia (CML), showing strong efficacy in heavily pretreated patients.

• Initiation of Phase 3 ENABLE-2 pivotal trial for ELVN-001 expected in the second half of 2026, with key data readouts and regulatory milestones anticipated throughout 2026.

• Leadership transition with Rick Fair appointed CEO in December 2025 and Scott Garland joining the Board in January 2026, aligning governance for late-stage development and commercialization.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $462.6 million as of December 31, 2025, providing runway into the first half of 2029.

• R&D expenses were $21.2 million for Q4 2025 (up from $20.7 million in Q4 2024) and $85.9 million for FY 2025 (up from $80.8 million in FY 2024).

• G&A expenses rose to $13.0 million for Q4 2025 (from $6.2 million in Q4 2024), mainly due to stock-based compensation related to CEO transition; FY 2025 G&A was $33.8 million (up from $23.8 million in FY 2024).

• Net loss was $29.7 million for Q4 2025 (vs. $23.2 million in Q4 2024) and $103.7 million for FY 2025 (vs. $89.0 million in FY 2024).

Outlook and guidance

• Additional Phase 1 data from ENABLE trial to be presented mid-2026.

• Regulatory alignment with FDA on dose selection and Phase 3 trial design expected in 2026.

• ENABLE-2 Phase 3 trial initiation planned for the second half of 2026.