Tenaya Therapeutics to Present Preclinical Data on TN-301 HDAC6 Inhibitor at European Society of Cardiology Heart Failure 2022 Conference

Rhea-AI Summary

Tenaya Therapeutics (NASDAQ: TNYA) announced the presentation of preclinical data for its TN-301 program at the European Society of Cardiology Heart Failure conference scheduled for May 21-24, 2022. TN-301, an HDAC6 inhibitor, is in development for heart failure with preserved ejection fraction (HFpEF), a condition affecting over three million patients in the U.S. The data reveals TN-301's ability to reduce cardiac fibrosis and enhance mitochondrial function, showing comparable efficacy to empagliflozin. An IND application to the FDA is anticipated in the second half of 2022.

Positive

• Preclinical data for TN-301 demonstrates efficacy in reducing cardiac fibrosis and enhancing mitochondrial function.
• TN-301 shows comparable efficacy to empagliflozin in a mouse model of HFpEF.
• Company expects to submit IND application for TN-301 to the FDA in the second half of 2022.

Negative

• No significant negative aspects identified.

Heart Failure 2022 Presentation Includes Preclinical Data Supporting TN-301 Effect in HFpEF Models

TN-301 IND Submission on Track for Second Half of 2022

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- 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 that it will present preclinical data for its TN-301 program at the upcoming European Society of Cardiology (ESC) Heart Failure 2022 conference taking place May 21-24, 2022, in Madrid, Spain and virtually.

TN-301 (previously named TYA-11631) is a small molecule HDAC6 inhibitor initially being developed by Tenaya for the potential treatment of heart failure with preserved ejection fraction (HFpEF). HFpEF is one of the greatest areas of unmet need in heart disease with more than three million patients in the United States. Data accepted for presentation at Heart Failure 2022 further elucidates the multi-modal mechanism of action by which HDAC6 inhibition has a direct impact on heart function and structure in several relevant models and compares the effect of HDAC6 inhibition to that of empagliflozin in a mouse model of HFpEF. Tenaya expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second half of 2022.

Details of the presentations are as follows:

Sunday, May 22, 2022
Session: Focus on Chronic Heart Failure
ePoster Presentation: HDAC6 inhibition reduces cardiac fibrosis, enhances mitochondrial function and demonstrates comparable efficacy as empagliflozin in a mouse model of heart failure with preserved ejection fraction (Abstract 60507)
Lead Author: Jin Yang, Ph.D., Associate Director, Pharmacology, Tenaya Therapeutics

To view full event programming, please visit the ESC Heart Failure 2022 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 cardiovascular 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 “will”, “potential,” and “expects” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, Tenaya’s plans to present preclinical data on its TN-301 programs at Heart Failure 2022; the therapeutic potential of TN-301 as a treatment for HFpEF; and expectations regarding the timing of the IND filing for TN-301. 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: the availability of data at the referenced times; 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-301 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220520005224/en/

Investors

Michelle Corral

Tenaya Therapeutics

IR@tenayathera.com

Media

Wendy Ryan

Ten Bridge Communications

wendy@tenbridgecommunications.com

Source: Tenaya Therapeutics, Inc.

FAQ

What is the purpose of the TN-301 program by Tenaya Therapeutics?

The TN-301 program aims to develop a treatment for heart failure with preserved ejection fraction (HFpEF) using an HDAC6 inhibitor.

When will Tenaya present data for TN-301?

Tenaya will present preclinical data for TN-301 at the European Society of Cardiology Heart Failure conference from May 21-24, 2022.

What were the results of the TN-301 preclinical studies?

Preclinical results indicate that TN-301 can reduce cardiac fibrosis, enhance mitochondrial function, and has comparable efficacy to empagliflozin in HFpEF models.

What is the expected timeline for the TN-301 IND submission?

Tenaya expects to submit the Investigational New Drug (IND) application for TN-301 to the FDA in the second half of 2022.

How many patients in the U.S. are affected by HFpEF?

More than three million patients in the United States are affected by heart failure with preserved ejection fraction (HFpEF).