Enliven Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• 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 same period in 2025.
• Research and development (R&D) expenses totaled $28.0 million for the third quarter of 2026, an increase from $18.2 million in the third quarter of 2025.
• General and administrative (G&A) expenses were $8.0 million for the third quarter of 2026, up from $6.9 million in the third quarter of 2025.
• Total operating expenses for the quarter were $36.0 million in 2026 versus $25.1 million in 2025.
• Other income (expense), net, was $8.3 million for the third quarter of 2026, compared to $4.9 million in the prior year period.
• Net loss per share (basic and diluted) was $0.36 for the third quarter of 2026, compared to $0.32 in the third quarter of 2025.
• Cash, cash equivalents, and marketable securities totaled $884.4 million as of September 30, 2026, compared to $462.6 million as of December 31, 2025.
• Total assets were $897.2 million as of September 30, 2026, compared to $476.2 million as of December 31, 2025.
• Total liabilities were $20.3 million as of September 30, 2026, compared to $16.6 million as of December 31, 2025.
• Stockholders' equity was $876.9 million as of September 30, 2026, compared to $459.6 million as of December 31, 2025.

Guidance and Future Outlook:

• The company expects its current cash position to provide a cash runway into 2030.
• Management remains on track to initiate the ENABLE-2 pivotal Phase 3 trial before the end of 2026.

Business Segments and Product Lines:

• The United States Adopted Names (USAN) Council adopted "relcobatinib" as the nonproprietary name for the product candidate ELVN-001.
• The company reached alignment with the FDA on the final design of the ENABLE-2 pivotal Phase 3 trial for relcobatinib in patients with previously treated chronic myeloid leukemia (CML).
• Clinical data from the Phase 1 ENABLE trial was featured in encore oral presentations at the Society of Hematologic Oncology (SOHO), International CML Foundation (ESH-iCMLf), Japanese Society of Hematology (JSH), and German Society for Hematology and Medical Oncology (DGHO).
• Preclinical data published in the journal Leukemia demonstrated relcobatinib's unique binding mode, high selectivity for BCR::ABL1, and activity against a broad range of TKI-resistant mutations.
• ENABLE-2 is a planned randomized Phase 3 trial expected to enroll approximately 450 patients randomized 1:1 to receive relcobatinib 80 mg once daily or an investigator-selected second-generation TKI.
• The primary endpoint for ENABLE-2 is major molecular response (MMR) at Week 24, with MMR at Week 96 serving as the key secondary endpoint.

Market and Competitive Landscape:

• Relcobatinib is designed as a highly selective active-site TKI with a mechanism of action complementary to allosteric BCR::ABL1 inhibitors.
• The drug was designed to have activity against the T315I mutation, which confers resistance to nearly all approved TKIs, as well as mutations conferring resistance to allosteric BCR::ABL1 inhibitors.
• Management noted strong engagement across the medical community and enthusiasm from physicians and investigators following data presented at EHA in June.

Risks and Challenges:

• Forward-looking statements highlight risks including potential delays in completing the ongoing ENABLE trial or initiating ENABLE-2.
• Risks include the possibility that relcobatinib may fail to demonstrate sufficient safety, efficacy, or therapeutic benefit in clinical trials.
• Potential for regulatory authorities to disagree with clinical trial design, dose selection, or endpoints, or to require additional studies.
• Risks associated with the company's limited resources and the ability to attract, hire, and retain skilled employees.
• Potential for the cash runway estimate to be incorrect if capital resources are used sooner than expected.
• Risks related to the inability to obtain additional capital to fund general corporate activities and research and development.

Management Commentary and Tone:

• CEO Rick Fair stated that reaching FDA alignment on the ENABLE-2 design marked an important milestone providing a clear path to the first pivotal trial.
• Management expressed confidence in relcobatinib's potential to become a best-in-class therapy for patients with CML.
• The tone was described as confident regarding the execution of the Phase 3 development program as the company approaches year-end.

Other Key Points:

• Enliven appointed Kristine Ball, an accomplished biopharmaceutical executive, to its Board of Directors.
• Management announced participation in the Guggenheim Healthcare Innovation Conference (Nov 9-11), Stifel Healthcare Conference (Nov 10-12), and Jefferies Global Healthcare Conference (Nov 16-19).
• Fireside chats at the upcoming conferences will be webcast live and archived for 90 days.
• The company is based in Burlingame, California, and focuses on the discovery and development of small molecule therapeutics for CML and other unmet needs.