Tenaya Therapeutics, Inc. announced that the first patient has been dosed with TN-201 gene therapy for the treatment of Myosin Binding Protein C3 (MYBPC3)-associated HCM in the MyPeak-1 Phase 1b clinical trial at the Cleveland Clinic, Cleveland, Ohio. Tenaya anticipates sharing initial data from the MyPeak-1 trial in 2024. In preclinical studies, TN-201 halted disease progression and demonstrated significant and durable disease reversal and survival benefit following a single dose.

The MyPeak-1 phase 1b clinical trial is a multi-center, open-label, dose-escalating study designed to assess the safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-201. The trial will initially seek to enroll at least six symptomatic (New York Heart Association Class II or III) adults who have been diagnosed with MYBPC3-associated nonobstructive HCM and have an implantable cardioverter defibrillator, and potentially treat up to 15 subjects in total from the U.S. and outside the U.S. The first dose of TN-201 being assessed in the MyPeak- 1 clinical trial is 3E13 vg/kg, a dose associated with near-maximal efficacy in preclinical studies. The MyPeak- 1 clinical trials will be conducted at up to twelve leading U.S. centers specializing in HCM care.

The U.S. Food and Drug Administration has granted TN-201 Fast Track and Orphan Drug Designation. Tenaya is conducting the Phase 1b MyPeak-1 clinical trial in symptomatic adults diagnosed with MYBPC3 - nonobstructive HCM. Such forward-looking statements include, among other things, the expected timing for sharing initial clinical data from MyPeak-1; the clinical and therapeutic potential of TN-201 as a one-time treatment to correct the underlying genetic cause of MYBPC3-associated HCM and improve patient outcomes; enrollment targets for MyPeak-1; and clinical development plans for TN-201.

These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: the timing and progress of MyPeak-1; unexpected concerns that may arise as a result of the occurrence of adverse safety events in MyPeak-1; The potential failure of TN-201 to demonstrate safety and/or efficacy in clinical testing; the potential for MyPeak-1 Phase 2b clinical trial is a multi, open-label, dose, dose-escalating study aimed to assess the safety, tolerable intravenous infusion of TN- 201. The MyPeak-2 clinical trial will be conducted at up to 12 leading U.S. centers specializes in HCM care. The US.

Food and Drug Administration has awarded TN-201 Fast Track and Orphan Drug Designation. Tenay is conducting the Phase 1bMyPeak-1 clinical trial In symptomatic adults diagnosed with MY BPC3-associated nonob structural HCM. Such forward- looking statements include, among other things., the expected timing for sharing initial patients with MYBPC3- associated nonobstructive HCM, and the potential for My Peak-1 clinical trial is 3E13vg/kg, a dose related to the safety and/or efficacy in preclinical studies.

Once three patients have been dosed at the 3E13 vg/kg level, a data safety and monitoring board (DSMB) of external advisors will review safety data and advise Tenaya on plans to enroll patients at the dose level of 6E13vg/kg and enroll additional patients in the initial dose cohort. The MyPeak-1 clinical trial will be conducted at up to twelve leading U.S. centers specializing in HCM care. The first site that is actively recruiting patients is the Hypertrophic Cardiomyopathy Center at the Cleveland Clinic, Cleveland, Ohio.