Enliven’s Third-Quarter 2026 Net Loss Widens to $27.7 Million

The Tip Desk · November 7, 2026 · 3 min read

Third-quarter 2026 R&D expenses rose to $28.0 million and net loss widened to $27.7 million. Cash, cash equivalents and marketable securities stood at $884.4 million as of September 30, 2026, with runway the company said would extend into 2030.

Enliven Therapeutics (ELVN), a clinical-stage biopharmaceutical company developing small-molecule therapeutics, reported a net loss of $27.7 million for the third quarter ended September 30, 2026, compared with $20.1 million a year earlier, as research and development expenses rose to $28.0 million from $18.2 million. The company also said it reached alignment with the U.S. Food and Drug Administration on the final design of ENABLE-2, the planned pivotal Phase 3 trial of relcobatinib in previously treated chronic myeloid leukemia, and remains on track to start the study before year-end 2026.

The alignment on the final trial design provided a path to initiate the planned trial. In the second-quarter update it had said it had aligned with the FDA on key Phase 3 design components and expected to initiate ENABLE-2 later in 2026. The third-quarter update moved that language to final design and a before-year-end start.

Chief Executive Officer Rick Fair said the alignment provided a clear path to initiate the company’s first pivotal trial. He said ENABLE data presented at the European Hematology Association meeting in June generated engagement across the medical community and that the company remained confident in relcobatinib’s potential as a best-in-class therapy for CML as it prepared to start Phase 3.

ENABLE-2 is planned as a randomized trial of about 450 adults with CML previously treated with one or more tyrosine kinase inhibitors, randomized 1:1 to relcobatinib 80 mg once daily or an investigator-selected second-generation TKI (dasatinib, nilotinib, or bosutinib). The primary endpoint is major molecular response at Week 24, which the company said could support accelerated approval, with MMR at Week 96 as the key secondary endpoint that could support full approval.

The United States Adopted Names Council adopted relcobatinib as the nonproprietary name for ELVN-001. Clinical data from the Phase 1 ENABLE trial were featured in encore oral presentations at meetings of the Society of Hematologic Oncology, the International CML Foundation, the Japanese Society of Hematology and the German Society for Hematology and Medical Oncology. Preclinical data published in Leukemia, the company said, demonstrated relcobatinib’s binding mode, selectivity for BCR::ABL1 and activity against a range of TKI-resistant mutations. Enliven also appointed Kristine Ball to its board.

Research and development expenses were $28.0 million for the three months ended September 30, 2026, compared with $18.2 million a year earlier. General and administrative expenses were $8.0 million. The company reported a net loss of $27.7 million, or $0.36 a share, versus a net loss of $20.1 million, or $0.32 a share, in the year-ago quarter. Weighted-average shares outstanding were 77.98 million.

Those quarterly results followed a widening of the loss in the second quarter. Net loss was $32.5 million in the three months ended June 30, 2026, after $23.6 million in the first quarter. R&D was $29.0 million in the second quarter and $20.7 million in the first. G&A was $8.2 million in the second quarter and $7.1 million in the first.

Cash, cash equivalents and marketable securities were $884.4 million as of September 30, 2026, down from $895.2 million as of June 30, 2026. The company said that cash position is expected to provide runway into 2030, matching the June 30 statement. At March 31, 2026, cash, cash equivalents and marketable securities totaled $452.4 million and the company had described runway into the first half of 2029. Stockholders’ equity was $876.9 million at September 30.

Management is scheduled to appear at the Guggenheim Healthcare Innovation Conference, Stifel Healthcare Conference and Jefferies Global Healthcare Conference in November.