On November 12, 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 third quarter ended September 30, 2025, and provided a business update, including highlights of pipeline progress.

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"We continue to make great progress advancing the ENABLE Phase 1 trial of ELVN-001 in people living with CML. I’m pleased to report that during the quarter, we completed enrollment of the randomized Phase 1b portion of the ENABLE trial and achieved key readiness milestones across multiple geographies, positioning us to rapidly launch our Phase 3 trial globally next year," said Sam Kintz, Co-Founder and Chief Executive Officer of Enliven. "Since we announced our positive, updated ENABLE data in June, we have had oral presentations at multiple medical meetings, which is a testament to the strength of the data and the potential for ELVN-001 as a selective active-site inhibitor. Additionally, we are pleased that the CML community continues to validate our work and enthusiastically supports ELVN-001 as we move through clinical trials. We remain focused on clinical execution as we look to initiate our Phase 3 pivotal trial in 2026."

Pipeline Updates

ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).

Completed enrollment of the randomized Phase 1b cohorts of the ongoing ENABLE trial of ELVN-001 in CML (NCT05304377).
Presented encore data from the ENABLE Phase 1a/1b clinical trial of ELVN-001 at several medical meetings, including:
An oral and poster presentation at the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting in Houston, Texas, on September 3, 2025.
An oral presentation at the European Society of Hematology International Chronic Myeloid Leukemia Foundation (ESH-iCMLf) 27th Annual John Goldman Conference on Chronic Myeloid Leukemia: Biology and Therapy in Estoril, Portugal, on October 10, 2025.
An oral presentation at the German, Austrian, and Swiss Societies for Hematology and Medical Oncology (DGHO) in Cologne, Germany, on October 25, 2025.
Featured in an oral presentation titled, ELVN-001 for the treatment of CML with and without T315I mutation: a Phase 1 trial in Japan, at the 87th Annual Meeting of the Japanese Society of Hematology (JSH) in Kobe, Japan, on October 10, 2025.
Remains on track to initiate a Phase 3 pivotal trial of ELVN-001 in 2026.
Upcoming Medical Meeting Presentations

The Company recently announced that data from the ENABLE Phase 1a/1b clinical trial of ELVN-001 in a subset of CML patients with atypical fusion transcripts will be presented at the 67th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida. Andreas Hochhaus, M.D., will present the data in a poster presentation on December 7, 2025.

Upcoming Investor Conference Participation

Management will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Tuesday, November 18, 2025, at 2:00 p.m. GMT. The fireside chat will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at View Source The webcast will be archived for a period of 90 days following the conclusion of the live event.

Third Quarter 2025 Financial Results

Cash Position: As of September 30, 2025, the Company had cash, cash equivalents and marketable securities totaling $477.6 million, which is expected to provide cash runway into the first half of 2029.
Research and development (R&D) expenses: R&D expenses were $18.2 million for the third quarter of 2025, compared to $21.3 million for the third quarter of 2024.
General and administrative (G&A) expenses: G&A expenses were $6.9 million for the third quarter of 2025, compared to $5.8 million for the third quarter of 2024.
Net Loss: Enliven reported a net loss of $20.1 million for the third quarter of 2025, compared to a net loss of $23.2 million for the third quarter of 2024.
About ELVN-001

ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active site inhibitor, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

About the ENABLE Trial

The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. The trial is currently in Phase 1a/1b development and is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response. Enliven is preparing for the potential start of a pivotal trial for ELVN-001 in 2026.

(Press release, Enliven Therapeutics, NOV 12, 2025, View Source [SID1234659846])