Tenaya Therapeutics Reports $111.1 Million Net Loss for 2024, Decreases Operating Expenses

Tenaya Therapeutics, Inc., a clinical-stage biotechnology company focused on heart disease treatments, reported a net loss of $111.1 million for the year ended December 31, 2024, compared to a net loss of $124.1 million in 2023. Total operating expenses decreased by 12% to $115.9 million, primarily due to a 12% reduction in research and development expenses ($86.7 million in 2024 versus $98.0 million in 2023) and a 12% decrease in general and administrative expenses ($29.2 million versus $33.2 million). The decrease in research and development costs stemmed from lower manufacturing costs and research costs, partially offset by increased clinical trial costs for TN-201 and TN-401. The company had $61.4 million in cash, cash equivalents, and marketable securities as of December 31, 2024.

Significant developments during the year included the completion of Cohort 1 dosing in the MyPEAK-1 clinical trial for TN-201, with the DSMB recommending dose escalation to 6x10¹³ vg/kg. Early data from Cohort 1 showed TN-201 was generally well-tolerated, with detectable vector DNA and transgene RNA expression in the heart. The company also initiated patient dosing in the RIDGE-1 clinical trial for TN-401 in November 2024 and completed a follow-on offering of common stock and warrants in March 2025, raising net proceeds of approximately $48.9 million. Additionally, Tenaya received an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to fund the RIDGE-1 trial.

The company's product pipeline includes TN-201 (gene therapy for MYBPC3-associated HCM), TN-401 (gene therapy for PKP2-associated ARVC), and TN-301 (small molecule for HFpEF). TN-201 and TN-401 have received orphan drug designations from both the FDA and the European Commission, as well as Fast Track Designation from the FDA. TN-401 also received a rare pediatric disease designation from the FDA. Positive Phase 1 data for TN-301 were presented at the 2023 Heart Failure Society of America Annual Scientific Meeting. Tenaya employs 97 full-time employees as of December 31, 2024, with 79 engaged in research, development, and technical operations.

Tenaya's outlook indicates continued operating losses are expected in the foreseeable future. The company anticipates that its existing cash resources, along with funds from the March 2025 offering and the SVB loan agreement, will be sufficient to fund operations for at least the next twelve months. However, substantial additional funding will be required to complete product development and commercialization efforts. The company plans to pursue additional funding through equity or debt offerings, strategic collaborations, or other capital sources. The company's financial statements are prepared in accordance with U.S. GAAP and include several critical accounting policies and estimates, including those related to research and development expenses and stock-based compensation. The company also notes its status as an emerging growth company and smaller reporting company, which impacts certain regulatory reporting requirements.