Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, announced today that it will present new preclinical data at the virtual 28th Annual Congress of the European Society of Gene and Cell Therapy (ESGCT), October 19 - 22, 2021.

In an oral presentation, Tenaya will present key data on TN-201, its AAV-based gene therapy product candidate for patients carrying mutations of the MYBPC3 gene, the most common genetic cause of hypertrophic cardiomyopathy (HCM) that affects more than 115,000 patients in the United States alone. TN-201 is in IND-enabling studies, and Tenaya expects to file an IND in 2022.

Additionally, a late-breaker poster will be published on the event website including the first preclinical data related to Tenaya’s AAV-based gene therapy program for patients carrying mutations of the PKP2 gene, the most common genetic cause of arrhythmogenic right ventricular cardiomyopathy (ARVC) that affects more than 70,000 patients in the United States alone. This program is in the candidate selection stage.

Oral Presentation

“Prevention of Premature Lethality and Reversal of Cardiac Hypertrophy with an Optimized MYBPC3 Gene Therapy”
Wednesday, October 20, 2021, 10:45 a.m. – 11:00 a.m. ET (16:45 – 17:00 CEST) (Session 3c)
Laura Lombardi, Associate Director, Gene Therapy Biology, Tenaya Therapeutics

Poster:

“Cardiac AAV:PKP2 Gene Transfer Prevents Development of Arrhythmogenic Cardiomyopathy in a PKP2-deficient Mouse Model”
This poster will only be available on the ESGCT website on October 19, 2021.

To view full event programming, please visit the ESGCT website.

About Tenaya Therapeutics

Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. For more information, visit www.tenayatherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “expects” and “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, Tenaya’s expectations regarding the timing of the IND filing for TN-201. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; the timing, progress and results of preclinical studies for TN-201 and Tenaya’s other programs; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Tenaya’s manufacturing and operations, including preclinical studies and planned clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s reliance on third parties; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.