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Dec 31, 2023
Enliven Therapeutics Q4 2023 Earnings Report
Reported financial results for the fourth quarter and full year ended December 31, 2023, and provided updated guidance on parallel lead product candidates and highlighted pipeline progress.
Key Takeaways
Enliven Therapeutics reported a net loss of $19.4 million for the fourth quarter of 2023, with R&D expenses at $17.9 million and G&A expenses at $4.8 million. The company closed the year with $253.1 million in cash, cash equivalents, and marketable securities, expected to provide cash runway into early 2026. Initial proof of concept data from Phase 1a trial evaluating ELVN-001 in adults with chronic myeloid leukemia (CML) is expected in the second quarter of 2024.
Phase 1 trial of ELVN-001 is on track, with initial proof of concept data expected in Q2 2024.
FDA accepted IND application for ELVN-002 to evaluate combination therapy in HER2+ cancers, with first patient dosing expected by mid-2024.
R&D expenses were $17.9 million for Q4 2023, compared to $8.2 million for Q4 2022.
Cash, cash equivalents, and marketable securities totaled $253.1 million as of December 31, 2023.
Forward Guidance
Enliven Therapeutics is focused on advancing its clinical pipeline, with key milestones expected in 2024 for both ELVN-001 and ELVN-002, and has sufficient cash runway into early 2026.
Positive Outlook
- ELVN-001 Phase 1 trial is on track.
- Initial proof of concept data for ELVN-001 expected in Q2 2024.
- FDA acceptance of ELVN-002 IND application.
- First patient dosing for ELVN-002 combination trial expected by mid-2024.
- Cash runway into early 2026.
Challenges Ahead
- Significant net losses incurred since inception.
- Limited operating history.
- Risk of failing to demonstrate safety and efficacy of product candidates.
- Potential delays or difficulties in the enrollment or maintenance of patients in clinical trials.
Historical Earnings Impact
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