Tenaya Therapeutics Announces New Clinical Data for TN-201 Gene Therapy will be Featured in Late-Breaking Presentation at the American Heart Association Scientific Sessions 2025

Rhea-AI Summary

Tenaya Therapeutics (NASDAQ: TNYA) announced two late-breaking oral presentations at the American Heart Association Scientific Sessions 2025 on November 8–9, 2025 highlighting new clinical and preclinical data.

Key items: interim safety and efficacy results from dose cohorts 1 and 2 of the MyPEAK-1 Phase 1b/2a study of TN-201 for MYBPC3-associated hypertrophic cardiomyopathy will be presented on Nov 8, 2025, 10:25–10:35 am CT by Milind Y Desai, M.D., MBA. A separate late-breaking oral presentation of a cellular reprogramming gene therapy showing significant and durable improvement in cardiac function in a pig ischemic heart failure model will be presented on Nov 9, 2025, 8:00–8:10 am CT by Kathy Ivey.

Tenaya will host a webcast and conference call on Nov 10, 2025 at 8:00 am ET to discuss MyPEAK-1 data; presentations will be posted on the company website after each session.

Positive

• Interim safety and efficacy reported from MyPEAK-1 dose cohorts 1 and 2
• Preclinical pig study showed significant, durable cardiac function improvement

Negative

• Clinical results are described as interim and incomplete for final assessment
• Preclinical pig-model results do not establish efficacy in humans

Insights

Clinical Development Expert

Early human safety and efficacy signals from TN-201 are being shared as interim data at AHA; details and metrics are not provided here.

Tenaya will present interim safety and efficacy results from dose cohorts 1 and 2 of the MyPEAK-1 Phase 1b/2a study of TN-201 on November 8, 2025. The presentation is an oral late-breaking session led by a Cleveland Clinic investigator, which signals academic engagement and clinical interest.

Without numerical safety or efficacy figures, the disclosed fact of an interim presentation conveys progress but not outcome quality. Key dependencies are the explicit safety profile, objective efficacy measures, and cohort sizes disclosed in the slides or webcast on November 10, 2025. Watch for exact adverse event rates, functional or biomarker endpoints, and durability across cohorts in the company presentation within one to two weeks.

Translational/Preclinical Expert

Preclinical pig data on direct reprogramming will be presented as late-breaking work; the release does not supply quantitative results.

Tenaya will present a preclinical study reporting "significant and durable improvement" in cardiac function in a pig ischemic heart failure model at AHA on November 9, 2025. The abstract notes precise delivery via guided intramyocardial injection catheter and names a senior Tenaya researcher as presenter, indicating internal ownership of the data.

Because the announcement contains no effect sizes, statistical significance values, or histological/mechanistic detail, the result should be treated as a progress signal rather than definitive proof of translational readiness. Monitor the slide deck and the webcast for numeric cardiac function changes, sample sizes, timing of follow-up, and any safety or off-target findings reported within days after the session.

Oral Presentation on Saturday to Highlight Interim Safety and Efficacy Results from the MyPEAK™-1 Phase 1b/2a Clinical Trial in Adults with MYBPC3-Associated Hypertrophic Cardiomyopathy

Second Late-Breaking Presentation on Sunday to Showcase Results of Cellular Reprogramming Gene Therapy Treatment in Pig Model of Ischemic Heart Failure

Tenaya Management to Host Webcast Conference Call on Monday, November 10, 2025, to Review MyPEAK-1 Data

SOUTH SAN FRANCISCO, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced two late-breaking oral presentations at the American Heart Association (AHA) 2025 Scientific Sessions taking place November 7-10, 2025, in New Orleans, Louisiana.

The AHA presentation of new TN-201 clinical data will include interim safety and efficacy results from dose cohorts 1 and 2 in the MyPEAK-1 Phase 1b/2a clinical trial of TN-201. TN-201 is being developed for the potential treatment of myosin-binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM), a condition caused by insufficient levels of myosin-binding protein C (MyBP-C).

Details of the TN-201 clinical data presentation are as follows:

Abstract Title: TN-201, an Investigational MYBPC3 Gene Replacement Therapy: Interim Clinical Data from MyPEAK-1, a Phase Ib/2a Study Evaluating Safety and Early Efficacy of TN-201 in Adult Patients with MYBPC3-Associated Hypertrophic Cardiomyopathy
Session Type: Late-Breaking Science: Main Event (Oral Presentation)
Session Title: Forgotten No More: The Current Belle of the Ball? Breakthrough Evolutions in Hypertrophic Cardiomyopathy
Presenting Author: Milind Y Desai, M.D., MBA, director of the Hypertrophic Cardiomyopathy Center at Cleveland Clinic and vice chair of Cleveland Clinic’s Heart, Vascular & Thoracic Institute
Presentation Date & Time: Saturday, November 8, 2025, from 10:25 am – 10:35 am CT

Tenaya will also present results from a preclinical study of its cellular reprogramming treatment in a pig model of ischemic heart failure. The goal of reprogramming gene therapy is to improve heart function following ischemic injury through cardiac cell regeneration. Details for this late-breaking presentation are below:

Abstract Title: First Demonstration of Significant and Durable Improvement of Cardiac Function in Pig Model of Ischemic Heart Failure with Direct Reprogramming Delivered Precisely to Infarct Border via Guided Intramyocardial Injection Catheter
Session Type: Late-Breaking Basic Science (Oral Presentation)
Session Title: Next-Generation Therapies for Ischemic Heart Repair: From Cells to Imaging
Presenting Author: Kathy Ivey, Senior Vice President of Research, Tenaya Therapeutics
Presentation Date & Time: Sunday, November 9, 2025, from 8:00 am – 8:10 am CT

Copies of the presentations at AHA Scientific Sessions 2025 will be available in the “Our Science” and “Investors” sections of the company’s website following each late-breaking session.

Conference Call and Webcast
Tenaya management will host a conference call on Monday, November 10, 2025, at 8:00 a.m. ET/5:00 a.m. PT to discuss the TN-201 data being presented at the upcoming American Heart Association Scientific Sessions 2025.  Investors and analysts are invited to participate by joining the webcast. The webcast can be accessed from the investor section of the Tenaya website at www.tenayathera.com.

About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). Tenaya has employed a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of novel medicines based on genetic insights, including TN-301, a clinical-stage small molecule HDAC6 inhibitor for the potential treatment of heart failure and related cardio/muscular disease, and multiple early-stage programs in preclinical development aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. For more information, visit www.tenayatherapeutics.com.

Tenaya Contacts
Michelle Corral
VP, Corporate Communications and Investor Relations
IR@tenayathera.com

Investors
Anne-Marie Fields
Precision AQ
annemarie.fields@precisionaq.com

Media
Wendy Ryan
Ten Bridge Communications
wendy@tenbridgecommunications.com

FAQ

What TN-201 MyPEAK-1 data will Tenaya (TNYA) present at AHA 2025?

Tenaya will present interim safety and efficacy results from dose cohorts 1 and 2 of the MyPEAK-1 Phase 1b/2a study.

When and who will present Tenaya's TN-201 MyPEAK-1 results at AHA 2025?

The TN-201 oral presentation is on Nov 8, 2025, 10:25–10:35 am CT, presented by Milind Y Desai, M.D., MBA.

What preclinical data will Tenaya (TNYA) share at AHA 2025 and when?

On Nov 9, 2025, 8:00–8:10 am CT Tenaya will present pig-model results showing significant and durable improvement in cardiac function after direct reprogramming therapy.

How can investors access Tenaya's AHA presentations and webcast for TNYA?

Presentations will be posted in the company's Our Science and Investors pages; the webcast is scheduled for Nov 10, 2025 at 8:00 am ET via Tenaya's investor website.

Do the MyPEAK-1 TN-201 results represent final clinical outcomes for TNYA?

No; the company describes the data as interim from early dose cohorts, not final trial outcomes.

Does the pig-model reprogramming result prove TN-201 effectiveness in humans?

No; the presentation reports preclinical animal results, which do not establish human efficacy.