UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ Commission File Number: 001-40656 TENAYA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 81-3789973 (St ...

Exhibit 99.1 Interim Data from Low Dose Cohort in MyPEAKTM-1 Clinical Trial of TN-201 Showed Encouraging Safety Profile, Transduction and Expression, Plus Improvements in Hypertrophy and NYHA Classification RIDGE Natural History and Seroprevalence Study Highlights Significant Disease Burden and Unmet Need Among Adults with PKP2-associated ARVC Data Readouts for TN-201 and TN-401 Clinical Programs On Track for the Second Half of 2025 Cash Runway Extended into Second Half of 2026 SOUTH SAN FRANCISCO, Calif., ...

RIDGE is Largest Natural History Study Conducted with More Than 175 Participants Enrolled to Date with Arrhythmogenic Right Ventricular Cardiomyopathy Due to Mutations in the PKP2 Gene Patients Experience High Burden of Arrhythmias and Severe Disease Progression Despite Standard-of-Care Treatments Large Majority of PKP2-associated ARVC Patients Appear Eligible for TN-401 Gene Therapy Based on Low Rates of Preexisting Immunity to AAV9 Antibodies SAN DIEGO, April 24, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeuti ...

Core Insights - Tenaya Therapeutics announced promising interim data from the MyPEAK-1 Phase 1b/2 clinical trial of TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), presented at the 2025 American College of Cardiology Scientific Sessions [1][2][3] Group 1: Clinical Trial Data - TN-201 was well tolerated at a dose of 3E13 vg/kg, with treatment-emergent adverse events primarily mild and manageable [2][3] - All three patients in Cohort 1, who had severe disease at baseline, achieved NYHA Class I, indicating no limitations on physical activity [3] - Serial biopsies showed sustained presence of TN-201 DNA in the heart and robust RNA expression, increasing up to 13-fold from Week 8 to Week 52 post-dose [2][3] - MyBP-C protein levels increased from 56% to 59% and from 62% to 64% of normal between Week 8 and Week 52 for Patients 1 and 2, respectively [2][3] - Cardiac troponin levels decreased by more than 60% in two patients, returning to normal or near normal [2][3] Group 2: Future Expectations - Enrollment for Cohort 2 is expected to be completed in the first half of 2025, with initial data to be reported in the second half of 2025 [1][2][7] - The company anticipates sharing additional data from Cohort 1 and initial safety and biopsy data from Cohort 2 later this year [3][7] - Tenaya has updated its cash guidance into the second half of 2026, positioning itself to achieve important clinical data milestones for both TN-201 and TN-401 gene therapy programs [3] Group 3: Disease Context - MYBPC3-associated HCM is a severe condition affecting approximately 120,000 patients in the U.S., with no approved therapeutics addressing its underlying genetic cause [11][12] - Patients with MYBPC3 mutations are at higher risk for serious complications, including heart failure and sudden cardiac death, particularly if diagnosed before age 40 [10][11]

Core Insights - Tenaya Therapeutics announced promising interim data from the MyPEAK-1 Phase 1b/2 clinical trial of TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), presented at the 2025 American College of Cardiology Scientific Sessions [1][2][3] Group 1: Clinical Trial Data - TN-201 was well tolerated at a dose of 3E13 vg/kg, with treatment-emergent adverse events primarily mild and manageable [2][3] - All three patients in Cohort 1, who had severe disease at baseline, achieved NYHA Class I, indicating no limitations on physical activity [3][4] - Serial biopsies showed sustained presence of TN-201 DNA in the heart and robust RNA expression, increasing up to 13-fold from Week 8 to Week 52 post-dose [2][3] - MyBP-C protein levels increased from 56% to 59% and from 62% to 64% of normal between Week 8 and Week 52 for Patients 1 and 2, respectively [2][3] - Cardiac troponin levels decreased by more than 60% in two patients, returning to normal or near normal [2][3] Group 2: Future Expectations - Enrollment for Cohort 2 is expected to be completed in the first half of 2025, with initial data to be reported in the second half of 2025 [1][2][8] - The company anticipates sharing additional data from Cohort 1 and initial safety and biopsy data from Cohort 2 later this year [3][8] - Tenaya has updated its cash guidance into the second half of 2026, positioning itself to achieve important clinical data milestones for both TN-201 and TN-401 gene therapy programs [3][4] Group 3: Background on MYBPC3-Associated HCM - MYBPC3 mutations are the most common genetic cause of HCM, affecting approximately 120,000 patients in the U.S. alone [12][13] - Patients with MYBPC3-associated HCM are at higher risk for serious outcomes, including heart failure and sudden cardiac death, with younger patients experiencing more rapid disease progression [11][12]

Core Insights - Tenaya Therapeutics has published positive preclinical data for its gene therapy candidate TN-201, aimed at treating MYBPC3-associated hypertrophic cardiomyopathy (HCM) [1][2][3] Company Overview - Tenaya Therapeutics is a clinical-stage biotechnology company focused on developing potentially curative therapies for heart disease [1][13] - The company is currently evaluating TN-201 in the MyPEAK-1 Phase 1b/2 clinical trial, which is designed to assess the safety and efficacy of the therapy [11] Preclinical Findings - TN-201, an AAV9-based gene therapy, has shown dose-dependent increases in MyBP-C protein levels, improving cardiac function in preclinical models [2][5] - Treatment with TN-201 reversed left ventricular hypertrophy, a key feature of HCM, demonstrating significant improvements in cardiac parameters [2][8] - The therapy achieved near-maximal efficacy at doses of 3x10 vg/kg, with durable effects lasting up to 20 months post-treatment [9][15] Clinical Development - The MyPEAK-1 trial is enrolling symptomatic adults diagnosed with MYBPC3-associated HCM, testing doses of 3E13 vg/kg and 6E13 vg/kg [11] - Initial findings from the first cohort of patients in the MyPEAK-1 trial are expected to be presented at the upcoming American College of Cardiology Scientific Sessions [4] Disease Context - MYBPC3 mutations are the most common genetic cause of HCM, affecting approximately 120,000 patients in the U.S. [10] - The condition leads to severe symptoms and high rates of serious outcomes, with no approved therapies targeting the underlying genetic cause [10]

Core Insights - Tenaya Therapeutics is set to present new clinical and disease burden data related to its MYBPC3-associated hypertrophic cardiomyopathy (HCM) program at the American College of Cardiology's Annual Scientific Session from March 29-31, 2025 [1][2] Company Overview - Tenaya Therapeutics is a clinical-stage biotechnology company focused on discovering, developing, and delivering potentially curative therapies for heart disease [5] - The company is advancing a pipeline that includes TN-201, a gene therapy for MYBPC3-associated HCM, TN-401 for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor for heart failure with preserved ejection fraction (HFpEF) [5] Clinical Trials and Presentations - Data from the MyPEAK-1 Phase 1b/2 clinical trial will be presented, featuring one-year assessments of the first two patients who received TN-201 gene therapy, along with baseline biopsy and six-month assessments from a third patient [2] - A poster presentation will discuss findings from the Sarcomeric Human Cardiomyopathy Registry (SHaRe), highlighting differences in disease burden among adults with HCM caused by MYBPC3 mutations [3] Event Details - The presentations will take place on March 30 and March 31, 2025, at the ACC conference, with specific sessions dedicated to heart failure and cardiomyopathies [6]

Core Insights - Tenaya Therapeutics is set to present new clinical and disease burden data related to its MYBPC3-associated hypertrophic cardiomyopathy (HCM) program at the American College of Cardiology's Annual Scientific Session from March 29-31, 2025 [1][2] Group 1: Clinical Developments - The company is advancing TN-201, an AAV9-based gene therapy targeting MYBPC3-associated HCM, which is caused by insufficient levels of myosin-binding protein C (MyBP-C) [2][5] - Data from the MyPEAK-1 Phase 1b/2 clinical trial will be presented, including one-year assessments of the first two patients and six-month assessments from a third patient in the 3E13 vg/kg cohort [2][3] Group 2: Research Findings - A poster presentation will discuss findings from the Sarcomeric Human Cardiomyopathy Registry (SHaRe), highlighting differences in disease burden among adults with HCM due to MYBPC3 mutations [3][6] - The presentations will be made by notable experts, including Dr. Milind Desai from the Cleveland Clinic [2][6] Group 3: Company Overview - Tenaya Therapeutics is a clinical-stage biotechnology company focused on developing potentially curative therapies for heart disease, with a pipeline that includes TN-201, TN-401 for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, and TN-301, a small molecule HDAC6 inhibitor for heart failure with preserved ejection fraction [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM___________TO___________ Commission File Number 001-40656 TENAYA THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) (State or other jurisdict ...

Exhibit 99.1 Tenaya Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update Dosing Initiated in Cohort 2 of the MyPEAK™-1 Phase 1b/2 Clinical Trial of TN-201 for Treatment of MYBPC3-Associated Hypertrophic Cardiomyopathy TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy • In December 2024, Tenaya reported promising early data from the first cohort of patients in the MyPEAK-1 Phase 1b/2 clinical trial of TN-201 gene therapy. o Preliminary da ...