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 ...

Core Insights - Tenaya Therapeutics has initiated dosing in Cohort 2 of the MyPEAK-1 Phase 1b/2 clinical trial for TN-201, targeting MYBPC3-associated hypertrophic cardiomyopathy (HCM) [1][4] - The company reported promising early data from Cohort 1 of the MyPEAK-1 trial, with TN-201 showing good tolerability and evidence of transgene expression [4][3] - Financial results for Q4 and full year 2024 indicate a net loss of $111.1 million, with cash reserves expected to support operations into mid-2026 following a recent financing round [10][11][8] Clinical Development Updates - The MyPEAK-1 trial is designed to assess the safety and efficacy of TN-201 in patients with HCM due to MYBPC3 mutations, with data from Cohort 1 accepted for presentation at the American College of Cardiology meeting [4][3] - Initial data from the RIDGE-1 Phase 1b trial for TN-401, targeting PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), is expected in the second half of 2025 [1][9] - The company plans to release data from its pediatric study, MyClimb, in the second half of 2025, which aims to characterize disease burden in MYBPC3 patients diagnosed before age 18 [4] Financial Performance - For Q4 2024, Tenaya reported R&D expenses of $18.7 million, down from $22.9 million in Q4 2023, while G&A expenses decreased to $6.0 million from $8.6 million [10][11] - The company’s cash position as of December 31, 2024, was $61.4 million, a decrease from $104.6 million in 2023, but bolstered by a recent public offering that raised approximately $48.9 million [10][18] - The net loss for Q4 2024 was $23.8 million, or $0.28 per share, compared to a net loss of $29.9 million, or $0.40 per share, in Q4 2023 [11][16]

Core Viewpoint - Tenaya Therapeutics, Inc. has announced a public offering of 75,000,000 units, aiming to raise approximately $52.5 million to support its clinical development and general corporate purposes [1][2]. Group 1: Offering Details - The offering consists of 75,000,000 units priced at $0.70 per unit, each unit includes one share of common stock and two types of warrants [3]. - The warrants include a Series A Warrant for one share at an exercise price of $0.80, and a Series B Warrant for half a share at an exercise price of $0.70, both immediately exercisable [3]. - The offering is expected to close around March 5, 2025, pending customary closing conditions [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the ongoing and planned development of clinical and early-stage product candidates, particularly TN-201 and TN-401, along with working capital and other general corporate purposes [2]. Group 3: Company Overview - Tenaya Therapeutics is a clinical-stage biotechnology company focused on developing potentially curative therapies for heart disease, employing integrated capabilities for genetic medicine development [8]. - The company's pipeline includes TN-201 for MYBPC3-associated hypertrophic cardiomyopathy, TN-401 for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, and TN-301, a small molecule HDAC6 inhibitor for heart failure with preserved ejection fraction [8].

Company Overview - Tenaya Therapeutics, Inc. is a clinical-stage biotechnology company focused on discovering, developing, and delivering potentially curative therapies for heart disease [5] - The company employs integrated capabilities such as target validation, capsid engineering, and manufacturing to create genetic medicines for both rare genetic disorders and common heart conditions [5] Proposed Offering - Tenaya intends to offer and sell units consisting of common stock and Series A and Series B warrants, which allow the purchase of common stock [1] - The offering may also include pre-funded units with pre-funded warrants at a purchase price of $0.001 per share, which will be immediately exercisable and will not expire [1] - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1] Management and Regulatory Aspects - Leerink Partners and Piper Sandler are acting as joint bookrunning managers for the proposed offering [2] - The offering is being conducted under a Registration Statement on Form S-3, previously filed and declared effective by the SEC [2] Pipeline and Product Development - Tenaya's pipeline includes several gene therapies: TN-201 for MYBPC3-associated hypertrophic cardiomyopathy, 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] - The company also has multiple early-stage programs in preclinical development [5]

Core Insights - Tenaya Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing potentially curative therapies for heart disease [1][3] - The company will participate in two upcoming healthcare conferences, showcasing its commitment to advancing its innovative therapies [1][2] Company Overview - Tenaya Therapeutics aims to discover, develop, and deliver therapies targeting the underlying causes of heart disease [3] - The company utilizes integrated capabilities such as target validation, capsid engineering, and manufacturing to create genetic medicines [3] - Tenaya's pipeline includes: - TN-201: Gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) - TN-401: Gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC) - TN-301: Small molecule HDAC6 inhibitor for heart failure with preserved ejection fraction (HFpEF) - Multiple early-stage programs in preclinical development [3]

Core Insights - Tenaya Therapeutics has received an $8.0 million CLIN2 grant from the California Institute for Regenerative Medicine (CIRM) to support the ongoing Phase 1b RIDGE-1 clinical trial of TN-401 gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC) [2][4] - The RIDGE-1 trial aims to evaluate the safety, tolerability, and preliminary clinical efficacy of TN-401, which is designed to deliver a functional PKP2 gene to heart muscle cells [3][4] - Initial data from the RIDGE-1 trial is expected in the second half of 2025 [1][4] Company Overview - Tenaya Therapeutics is a clinical-stage biotechnology company focused on developing potentially curative therapies for heart disease [12] - The company is advancing a portfolio of genetic medicines, including TN-401 for PKP2-associated ARVC and TN-201 for MYBPC3-associated hypertrophic cardiomyopathy [12] Clinical Trial Details - The RIDGE-1 clinical trial is an open-label, dose-escalation study enrolling symptomatic adults diagnosed with PKP2-associated ARVC [3][4] - TN-401 utilizes an adeno-associated virus serotype 9 (AAV9) vector for gene delivery, which has a strong safety record and targets heart muscle cells effectively [7][9] Disease Background - PKP2 mutations are the most common genetic cause of ARVC, affecting approximately 70,000 people in the U.S. [5][6] - Current treatments for ARVC do not address the underlying genetic cause, highlighting the potential significance of TN-401 as a novel therapeutic approach [6][9] Funding and Support - CIRM has been instrumental in funding regenerative medicine research, having provided billions since its establishment in 2004 [10][11] - The grant awarded to Tenaya Therapeutics is part of CIRM's efforts to accelerate the development of transformative treatments for serious medical conditions [4][10]