On May 14, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported financial results for the first quarter ended March 31, 2025, and provided a business update, including highlights of pipeline progress (Press release, Enliven Therapeutics, MAY 14, 2025, View Source [SID1234653091]).
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"We are very pleased with the continued progress of ELVN-001 and the data that was just released in the EHA (Free EHA Whitepaper) abstract. We continue to gain confidence and momentum in the program as the efficacy, safety and tolerability data consistently compare favorably to the approved BCR::ABL inhibitors. We are excited to share further updated data at EHA (Free EHA Whitepaper) next month," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "Looking towards the rest of the year, we remain focused on clinical execution as we prepare for the potential start of a pivotal trial for ELVN-001 in 2026."
Recent Research and Development Highlights and Upcoming Milestones
ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion
Today, the Company announced positive updated data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML) (NCT05304377) in an abstract that was accepted for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress.
As of the cutoff date for the abstract (January 21, 2025), 74 patients were enrolled in the trial across dose levels from 10-160 mg daily, and the vast majority of patients (82%) remain on study with a median treatment duration of ~26 weeks.
16 of 36 (44%) evaluable patients were in major molecular response (MMR) by 24 weeks, with 7 of 27 (26%) achieving and 9 of 9 (100%) maintaining MMR.
ELVN-001 continues to demonstrate a favorable safety and tolerability profile, consistent with its selective kinase profile.
These data continue to compare favorably to precedent Phase 1 trials of the approved BCR::ABL1 tyrosine kinase inhibitors (TKIs), particularly given the more heavily pre-treated patient population in the ELVN-001 clinical trial.
An oral presentation will be delivered at the EHA (Free EHA Whitepaper) 2025 Congress, taking place June 12–15 in Milan, Italy, and virtually, and will highlight updated results, including data from additional patients and longer treatment duration.
Enliven will also host a webcast and conference call at 1:30 p.m. ET on Friday, June 13, 2025, to discuss the updated data. Details of the webcast are posted on the Upcoming Events page of the Company’s website.
ELVN-002 is a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations
The Company dosed the first patient in its Phase 1 exploratory cohort evaluating ELVN-002 in combination with trastuzumab deruxtecan (NCT05650879) and progressed its Phase 1 trial evaluating ELVN-002 in combination with trastuzumab in HER2+ colorectal cancer (NCT06328738).
To prioritize the advancement of ELVN-001 and its upcoming pivotal trial, the Company plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025, which is expected to extend cash runway into late 2027.
First Quarter 2025 Financial Results
Cash Position: As of March 31, 2025, the Company had cash, cash equivalents and marketable securities totaling $289.6 million, which is expected to provide cash runway into late 2027.
Research and development (R&D) expenses: R&D expenses were $24.9 million for the first quarter of 2025, compared to $20.0 million for the first quarter of 2024.
General and administrative (G&A) expenses: G&A expenses were $6.8 million for the first quarter of 2025, compared to $6.0 million for the first quarter of 2024.
Net Loss: Enliven reported a net loss of $28.5 million for the first quarter of 2025, compared to a net loss of $22.7 million for the first quarter of 2024.