On November 5, 2026 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, 2026, and provided a business update.
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"This quarter marked an important milestone for Enliven as we reached alignment with the FDA on the final design of ENABLE-2, providing a clear path to initiate our first pivotal trial," said Rick Fair, Chief Executive Officer of Enliven. "The compelling ENABLE data presented at EHA (Free EHA Whitepaper) in June generated strong engagement across the medical community, and we are encouraged by the enthusiasm from physicians and investigators as we prepare to initiate ENABLE-2. As we approach year-end, we remain confident in relcobatinib’s potential to become a best-in-class therapy for patients with CML and are focused on executing our Phase 3 development program."
Relcobatinib Updates
The United States Adopted Names (USAN) Council adopted relcobatinib as the nonproprietary name for ELVN-001.
The Company announced that it reached alignment with the U.S. Food and Drug Administration (FDA) on the final design of the ENABLE-2 pivotal trial of relcobatinib in patients with previously treated chronic myeloid leukemia (CML).
Clinical data for relcobatinib from the Phase 1 ENABLE trial were featured in encore oral presentations at the meetings of the Society of Hematologic Oncology (SOHO), the International CML Foundation (ESH-iCMLf), the Japanese Society of Hematology (JSH) and the German Society for Hematology and Medical Oncology (DGHO), reflecting continued enthusiasm for its clinical profile.
Preclinical data published in the peer-reviewed journal Leukemia demonstrated relcobatinib’s unique binding mode, high selectivity for BCR::ABL1 and activity against a broad range of clinically relevant tyrosine kinase inhibitor (TKI)-resistant mutations, supporting its potential as a best-in-class TKI for CML.
The Company remains on track to initiate ENABLE-2 before year-end 2026.
Additional Company Updates
Enliven appointed Kristine Ball, an accomplished biopharmaceutical executive, to its Board of Directors.
Management will participate at the following investor conferences:
Guggenheim Healthcare Innovation Conference, November 9-11, Boston, MA (Fireside Chat and 1×1 Meetings)
Stifel Healthcare Conference, November 10-12, New York, NY (1×1 Meetings)
Jefferies Global Healthcare Conference, November 16-19, London, UK (Fireside Chat and 1×1 Meetings)
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 2026 Financial Results
Cash position: As of September 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $884.4 million, which is expected to provide cash runway into 2030.
Research and development (R&D) expenses: R&D expenses were $28.0 million for the third quarter of 2026, compared to $18.2 million for the third quarter of 2025.
General and administrative (G&A) expenses: G&A expenses were $8.0 million for the third quarter of 2026, compared to $6.9 million for the third quarter of 2025.
Net loss: Enliven reported a net loss of $27.7 million for the third quarter of 2026, compared to a net loss of $20.1 million for the third quarter of 2025.
About Relcobatinib (ELVN-001)
Relcobatinib (ELVN-001) is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with CML. As a highly selective active-site TKI, relcobatinib 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. Relcobatinib 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-2 Trial
ENABLE-2 is a planned randomized Phase 3 trial of relcobatinib in adults with CML previously treated with one or more TKIs. The trial is expected to enroll approximately 450 patients, who will be randomized 1:1 to receive relcobatinib 80 mg once daily or an investigator-selected second-generation TKI (dasatinib, nilotinib, or bosutinib). The primary endpoint is major molecular response (MMR) at Week 24, which could support accelerated approval, with MMR at Week 96 serving as the key secondary endpoint that could support full approval.
(Press release, Enliven Therapeutics, NOV 5, 2026, View Source [SID1234674351])