Tenaya Therapeutics(TNYA) - 2025 Q1 - Quarterly Report

Financial Performance - Total operating expenses for Q1 2025 were $27.54 million, a decrease of 18% from $33.76 million in Q1 2024[114]. - The net loss for Q1 2025 was $26.86 million, a reduction of 17% compared to a net loss of $32.23 million in Q1 2024[114]. - Net loss for Q1 2025 was $26.9 million, compared to a net loss of $32.2 million in Q1 2024, indicating an improvement in financial performance[121]. - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $88.2 million, with an accumulated deficit of $541.3 million[122]. - Net cash used in operating activities for Q1 2025 was $23.1 million, compared to $28.7 million in Q1 2024, reflecting improved cash flow management[134][135]. - The company expects to continue incurring operating losses and plans to utilize existing cash and available funds under a loan agreement to support ongoing product development and commercialization efforts[129][130]. Research and Development - Research and development expenses decreased by 16% to $21.08 million in Q1 2025 from $25.06 million in Q1 2024[114]. - Research and development expenses for Q1 2025 were $21.1 million, a decrease of $4.0 million or 16% from $25.1 million in Q1 2024, primarily due to reduced clinical trial costs and workforce reduction[116]. - TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy, is currently in the MyPEAK-1 clinical trial, with initial data expected in the second half of 2025[100][101]. - TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, has initiated the RIDGE-1 clinical trial, with initial data expected in the second half of 2025[106][108]. - TN-301, a small molecule for heart failure with preserved ejection fraction, showed positive data in a Phase 1 clinical trial, indicating potential for once-daily dosing[110]. - The company has completed enrollment for a seroprevalence study related to AAV9 antibodies among adults with MYBPC3-associated HCM, supporting ongoing clinical trials[103]. - The FDA has granted Fast Track and Orphan Drug designations for both TN-201 and TN-401, enhancing their development prospects[104][109]. Cost Management - General and administrative expenses decreased by 26% to $6.46 million in Q1 2025 from $8.71 million in Q1 2024[114]. - General and administrative expenses decreased by $2.2 million or 26% to $6.5 million in Q1 2025 from $8.7 million in Q1 2024, mainly driven by lower employee-related costs[119]. - The company announced a workforce reduction plan in March 2025 to extend its cash runway into the second half of 2026[98]. Financing Activities - The company completed a follow-on offering of 75 million units at a price of $0.70 per unit, resulting in net proceeds of approximately $48.8 million[126]. - Net cash provided by financing activities in Q1 2025 was $50.3 million, mainly from the follow-on offering completed in March 2025[139]. - The company received an $8 million grant from CIRM in February 2025 to support the RIDGE-1 project, contingent on achieving specific clinical milestones[123]. - Net cash provided by investing activities for Q1 2025 was $22.2 million, primarily from maturities and sales of marketable securities[137]. Company Classification - The company is classified as an emerging growth company under the JOBS Act, remaining so until it exceeds $1.235 billion in annual revenue or meets other specified criteria[144]. - The market value of the company's stock held by non-affiliates is less than $700 million, qualifying it as a smaller reporting company[146]. - The company may continue to be classified as a smaller reporting company if its annual revenue remains below $100 million and the market value of its stock held by non-affiliates stays below $700 million[146]. - As a smaller reporting company, the company can present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K[147]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[148].