Enliven Therapeutics Announces Q2 Financial Results and Business Update

Enliven Therapeutics, Inc., a clinical-stage precision oncology company, has announced its financial results for the second quarter ending June 30, 2024, alongside pivotal updates regarding its developmental pipeline. Specializing in next-generation small molecule kinase inhibitors, Enliven Therapeutics is committed to discovering and developing treatments that address significant unmet medical needs in oncology.

In the second quarter of 2024, Enliven made noteworthy advancements in its two leading programs, ELVN-001 and ELVN-002. The company began dosing patients in the Phase 1b arm for ELVN-001 and in two combination trials for ELVN-002. Additionally, data from the ongoing Phase 1a trial for ELVN-001 has been accepted for presentation at the European Society of Hematology International CML Foundation Conference in September.

ELVN-001 is a highly selective small molecule kinase inhibitor designed to target the BCR-ABL gene fusion, a critical driver in chronic myeloid leukemia (CML). The first patient was dosed in the Phase 1b clinical trial for ELVN-001, targeting patients with CML that is relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs). Positive data from the Phase 1a clinical trial was announced in April, with additional Phase 1 data expected in 2025 to include around 60-100 patients across various lines of therapy.

ELVN-002 is a potent and selective HER2 inhibitor with central nervous system penetration and activity against wild type HER2 and various HER2 mutations. The Phase 1a trial for ELVN-002 began dosing patients in combination with trastuzumab and chemotherapeutic agents in HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC). Additionally, the first patient with HER2+ MBC was dosed in an exploratory Phase 1a arm evaluating ELVN-002 in combination with ado-trastuzumab emtansine (Kadcyla®). Initial data from these trials is anticipated in 2025.

Financially, Enliven Therapeutics maintains a robust balance sheet. As of June 30, 2024, the company held cash, cash equivalents, and marketable securities totaling $312.4 million. This financial reserve is projected to sustain the company’s operations into late 2026. The cash position includes a $10 million milestone payment received from Cardurion, related to an asset purchase agreement established prior to the merger between Imara Inc. and Enliven Inc.

Research and development (R&D) expenses increased to $18.8 million for the second quarter of 2024, compared to $15.2 million for the same period in 2023. General and administrative (G&A) expenses were $5.8 million for the second quarter of 2024, up from $5.0 million in the second quarter of the previous year. Consequently, the net loss for the second quarter of 2024 amounted to $20.0 million, compared to $16.7 million in the second quarter of 2023.

Enliven Therapeutics is a biopharmaceutical company dedicated to advancing small molecule inhibitors to enhance the lives and survival of cancer patients. Based in Boulder, Colorado, Enliven leverages deep insights in biological targets and innovative chemistry to create therapies that could potentially be first-in-class or best-in-class. The company’s precision oncology approach is designed to address both existing and emerging unmet needs in cancer treatment.

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