Tenaya Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

Core Insights - Tenaya Therapeutics reported positive interim data from the MyPEAK-1 clinical trial for TN-201, indicating a favorable safety profile and improvements in hypertrophy and NYHA classification [1][4] - The RIDGE study highlighted a significant disease burden among adults with PKP2-associated ARVC, emphasizing the unmet need for effective treatments [1][8] - The company has extended its cash runway into the second half of 2026, supported by recent funding and cost containment measures [1][9] Clinical Programs - TN-201: - Interim data from the MyPEAK-1 trial showed TN-201 was well tolerated at a dose of 3E13 vg/kg, with robust DNA transduction and RNA expression [4] - All three patients in the initial cohort achieved NYHA Class I post-treatment, with two showing improvements in hypertrophy measures [4] - Initial data from Cohort 2 is expected in the second half of 2025 [4] - TN-401: - Enrollment for the RIDGE-1 trial is on track, with initial data anticipated in the second half of 2025 [8] - The RIDGE study revealed over 80% of participants experienced significant arrhythmias, indicating a high unmet need for TN-401 [8] Financial Highlights - For Q1 2025, Tenaya reported a net loss of $26.9 million, or $0.24 per share, an improvement from a net loss of $32.2 million, or $0.40 per share in Q1 2024 [9][14] - Research and development expenses decreased to $21.1 million from $25.1 million year-over-year [7][14] - Cash, cash equivalents, and marketable securities totaled $88.2 million as of March 31, 2025, with additional net proceeds of approximately $48.8 million from a public offering [7][16] Business Updates - The company implemented a restructuring plan to focus financial resources on clinical execution, which is expected to significantly reduce cash expenses [8][9] - Tenaya received an $8.0 million clinical grant from the California Institute for Regenerative Medicine to support the TN-401 trial [8]