Lexeo Therapeutics Reports $98.3 Million Net Loss for Fiscal Year 2024

Lexeo Therapeutics, Inc. reported a net loss of $98.3 million for the fiscal year ended December 31, 2024, compared to a net loss of $66.4 million in 2023. Total operating expenses increased from $68.5 million in 2023 to $105.8 million in 2024, driven primarily by increases in research and development expenses ($20.9 million increase) and general and administrative expenses ($16.3 million increase). The company attributed the increase in research and development expenses to higher clinical trial costs, employee compensation, CMC expenses, and milestone payments, partially offset by decreases in preclinical expenses and an adjustment to estimated accrued clinical trial expenses. The increase in general and administrative expenses was mainly due to higher employee compensation, legal fees, and professional service provider fees related to becoming a publicly traded company. The company had $128.5 million in cash, cash equivalents, and investments as of December 31, 2024.

Significant developments during the year included interim clinical updates for LX2006 (for Friedreich ataxia cardiomyopathy) and LX2020 (for PKP2-arrhythmogenic cardiomyopathy). LX2006 showed improvements in key cardiac biomarkers and an increase in frataxin protein expression in cardiac biopsies. The FDA has been consulted on a registrational development plan for LX2006, including an accelerated approval pathway. LX2020 showed an increase in PKP2 protein expression and a reduction in PVCs in treated patients. As of December 31, 2024, Lexeo had 72 full-time employees, 50 of whom were engaged in research and development. The company also announced alignment with the FDA on key elements of a registrational development plan for LX2006, specifying left ventricular mass index and frataxin protein expression as co-primary endpoints.

The company's pipeline includes several gene therapy candidates targeting various cardiovascular diseases. LX2006 and LX2020 are the most advanced, currently in Phase 1/2 clinical trials. LX2021 targets DSP cardiomyopathy, and LX2022 targets TNNI3-associated hypertrophic cardiomyopathy, both in preclinical development. The company also has programs for APOE4-associated Alzheimer's disease, with LX1001 having completed a Phase 1/2 trial and the company seeking partnering opportunities for its continued development. Lexeo's strategy focuses on capital-efficient development, leveraging early clinical data to advance its pipeline. The company utilizes a baculovirus/Sf9 expression system for manufacturing its gene therapy candidates.

Lexeo's financial performance is heavily reliant on the success of its clinical trials and subsequent regulatory approvals. The company acknowledges significant risks associated with clinical development, regulatory hurdles, manufacturing challenges, competition, and securing adequate funding. The company's outlook anticipates continued net losses for the foreseeable future, with expenses expected to increase as clinical trials progress and commercialization efforts begin. The company's cash reserves are projected to fund operations into 2027, but this is contingent upon various factors and assumptions. The company is currently involved in litigation with Rocket Pharmaceuticals, Inc. regarding alleged misappropriation of confidential information and trade secrets.

Lexeo Therapeutics, Inc. is an emerging growth company and a smaller reporting company, allowing it to utilize certain exemptions from reporting requirements. The company has elected not to use the extended transition period for complying with any new or revised financial accounting standards. As of March 21, 2025, the company had 33,196,997 shares of common stock outstanding, and the aggregate market value of common equity held by non-affiliates was approximately $527.9 million as of June 30, 2024. The company does not anticipate paying cash dividends in the foreseeable future.