Enliven Therapeutics Reports Third Quarter Financial Results and Provides a Business Update

In This Article:

Announced positive data from the Phase 1 clinical trial of ELVN-001 in CML, reporting a cumulative MMR rate of 44% (8/18) by 24 weeks and showing that ELVN-001 remains well-tolerated with no dose reductions

Continued to progress ELVN-002 with a focus on recently initiated combination clinical trials evaluating patients with HER2+ MBC and CRC

Strong balance sheet with $292 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into late 2026

BOULDER, Colo., Nov. 13, 2024 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the third quarter ended September 30, 2024, and provided a business update, including highlights of pipeline progress.

"We are thrilled by the progress that we made in the third quarter of 2024. We reported updated clinical data for ELVN-001, which continues to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs despite a more heavily pre-treated patient population. Since our data release, we have seen strong enrollment and momentum for the program," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "Additionally, we are encouraged by the recent accelerated approval of Scemblix in 1L CML, which we believe will pave the way for earlier line use of this new treatment option, thereby creating a potentially large, 2L+ opportunity for ELVN-001. It has been an exciting year for Enliven, and I look forward to sharing additional updates in 2025."

Pipeline Updates

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 (CML).

  • The Company announced positive updated data from the Phase 1 clinical trial evaluating ELVN-001 in patients with CML that have failed, or are intolerant to or not a candidate for, available therapies known to be active for treatment of their CML (NCT05304377).

    • As of the cutoff date, June 25, 2024, ELVN-001 achieved a cumulative major molecular response (MMR) rate of 44.4% (8/18) by 24 weeks with stable or deepening responses between weeks 12 and 24.

    • ELVN-001 remains well-tolerated, consistent with its selective kinase profile, and there have been no dose reductions or discontinuations at ≥ 40 mg due to treatment-related adverse events (TRAE).

    • These data continued to compare favorably to precedent Phase 1 cumulative MMRs for approved BCR::ABL1 TKIs, particularly given the more heavily pre-treated patient population in the ELVN-001 clinical trial. Further details can be found on the Enliven website.

  • The Company plans to report additional Phase 1 data in 2025 and is expected to include between approximately 60-100 patients across various lines of therapy with significant follow-up.

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