ELVN

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Enliven Therapeutics Reports Third Quarter 2026 Financial Results and Provides a Business Update

Reached alignment with the FDA on the final design of the ENABLE-2 pivotal Phase 3 trial

On track to initiate ENABLE-2 before year-end 2026

Strong balance sheet with $884 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into 2030

BURLINGAME, Calif., Nov. 5, 2026 /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, 2026, and provided a business update.

“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 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 1x1 Meetings)

• Stifel Healthcare Conference, November 10-12, New York, NY (1x1 Meetings)

• Jefferies Global Healthcare Conference, November 16-19, London, UK (Fireside Chat and 1x1 Meetings)

• The fireside chat will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at https://ir.enliventherapeutics.com/. 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

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

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

Announced positive Phase 1 clinical data for ELVN-001 in CML, demonstrating encouraging ELVN-001 efficacy data and a favorable safety and tolerability profile

Reached alignment with the FDA on key Phase 3 trial design components

Strong balance sheet with $895 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into 2030

BURLINGAME, Calif., Aug. 5, 2026 /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 second quarter ended June 30, 2026, and provided a business update.

“The second quarter was an important period for Enliven as we announced compelling updated clinical data for ELVN-001, reached alignment with the FDA on key components of the ENABLE-2 Phase 3 2L+ trial design, and significantly strengthened our balance sheet,” said Rick Fair, Chief Executive Officer of Enliven. “The updated Phase 1 data support ELVN-001’s potential to become a best-in-class treatment for patients living with CML. Combined with our recent regulatory and financial progress, we are well positioned to initiate ENABLE-2 later this year and rapidly advance ELVN-001 across all lines of CML therapy.”

ELVN-001 Program Highlights

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 chronic myeloid leukemia (CML).

• In June 2026, the Company announced positive data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377). The data were presented in an oral presentation at the European Hematology Association (EHA) Congress by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. Highlights include:

o 61% overall major molecular response (MMR) and 48% MMR achievement by 24 weeks in the 80 mg once daily (QD) Phase 1b cohort.

o Response rates were higher in earlier-line patients, with 67% overall MMR and 55% achieving MMR by 24 weeks among patients with only one or two prior unique tyrosine kinase inhibitors (TKIs).

o Patients previously treated with asciminib achieved response rates comparable to the overall efficacy-evaluable population.

o Favorable safety and tolerability profile with 161 patients enrolled and a median treatment duration of 35 weeks, as of the March 10, 2026 cutoff.

• Key outcomes from the End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA):

o 80 mg QD selected as the recommended dose for Phase 3 ENABLE-2 trial.

o ENABLE-2 is expected to enroll patients with CML previously treated with one or more TKIs, and to be randomized to receive either ELVN-001 or physician's choice of an ATP-competitive TKI.

o Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026.

• FDA granted Fast Track Designation to ELVN-001.

• Collectively, these data and regulatory milestones continue to support advancement of ELVN-001 into the planned ENABLE-2 Phase 3 trial, which the Company expects to initiate in the second half of 2026.

Second Quarter 2026 Financial Results

• Cash position: As of June 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $895.2 million, which is expected to provide cash runway into 2030.

• Research and development (R&D) expenses: R&D expenses were $29.0 million for the second quarter of 2026, compared to $21.5 million for the second quarter of 2025.

• General and administrative (G&A) expenses: G&A expenses were $8.2 million for the second quarter of 2026, compared to $7.1 million for the second quarter of 2025.

• Net loss: Enliven reported a net loss of $32.5 million for the second quarter of 2026, compared to a net loss of $25.3 million for the second quarter of 2025.

About Enliven Therapeutics

Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Burlingame, California. To learn more, visit www.enliventherapeutics.com and connect with us on Link

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