Enliven Therapeutics Reports $89M Net Loss for 2024, Increases R&D Spending

Enliven Therapeutics, Inc. reported a net loss of $89.0 million for the year ended December 31, 2024, compared to a net loss of $71.6 million in 2023. Research and development expenses increased by $16.2 million to $80.8 million, primarily due to increased costs associated with the ELVN-001 and ELVN-002 clinical trials. General and administrative expenses rose by $4.8 million to $23.8 million, mainly driven by increases in stock-based compensation and salaries. The company's other income increased by $3.6 million to $15.5 million, primarily due to higher interest income and a gain related to the change in fair value of the CVR liability.

As of December 31, 2024, Enliven had $313.4 million in cash, cash equivalents, and marketable securities. The company expects its existing cash resources to fund operations into mid-2027. The company's accumulated deficit stood at $243.5 million as of December 31, 2024. Enliven anticipates continued operating losses for the foreseeable future, as it advances its two lead product candidates, ELVN-001 and ELVN-002, through clinical development. The company's strategy includes efficiently advancing these candidates through clinical development and regulatory approval, expanding its pipeline of small molecule therapeutics, and selectively evaluating strategic collaborations.

ELVN-001, a BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML), showed anti-tumor activity in a Phase 1 clinical trial, including in patients resistant to previous TKIs. Updated Phase 1a data, presented in September 2024, included data from 39 patients with a median treatment duration of 20 weeks. ELVN-002, a HER2 TKI, demonstrated investigator-reported responses in HER2+ and HER2 mutant tumors in a Phase 1 trial, including in patients who progressed on Enhertu and those with brain metastases. The company plans to present updated Phase 1a/b data for ELVN-001 in mid-2025 and Phase 1 monotherapy and combination data for ELVN-002 in the second half of 2025.

Enliven's operations rely heavily on third-party manufacturers for the production of its product candidates. The company does not own or operate any manufacturing facilities. As of December 31, 2024, Enliven had 62 full-time employees, 47 of whom were engaged in research, product development, and clinical activities. The company's patent portfolio includes issued and pending patent applications related to its HER2 and BCR-ABL programs, with expected expiration dates ranging from 2041 to 2045, excluding any potential patent term extensions. The company acknowledges significant risks associated with its early stage of development, including the uncertainties of clinical trials, regulatory approvals, and market competition.

Enliven's forward-looking statements highlight the uncertainties inherent in drug development, including the potential for delays in clinical trials and regulatory approvals, as well as the challenges of securing additional funding and achieving market acceptance for its product candidates. The company's financial performance is subject to various factors, including the success of its clinical trials, regulatory approvals, and market conditions. The company also notes the potential impact of changes in healthcare legislation and regulations on its future operations and financial results.