Tenaya Therapeutics, INC. 8-K Filing

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share TNYA Nasdaq Global Select

Filing Documents

• tnya-20251107.htm (8-K) — 51KB
• 0001193125-25-272423.txt ( ) — 160KB
• tnya-20251107.xsd (EX-101.SCH) — 25KB
• tnya-20251107_htm.xml (XML) — 5KB

01 Other Events

Item 8.01 Other Events. The U.S. Food and Drug Administration ("FDA") has placed a clinical hold on MyPEAK TM -1, Tenaya Therapeutics, Inc.'s ("Tenaya") Phase 1b/2a clinical trial evaluating TN-201 in MYBPC3 -associated hypertrophic cardiomyopathy, requesting an amendment to the protocol primarily to standardize activities related to patient monitoring and management of the immunosuppression regimen across trial sites . The request for a protocol amendment followed proactive correspondence with the FDA related to future plans for the TN-201 program and is based primarily on data previously reviewed by the trial's independent Data Safety Monitoring Board ("DSMB") during summer 2025, which concluded that TN-201 had an acceptable safety profile to allow enrollment of expansion cohorts at either the 3E13 vg/kg (Cohort 1) or 6E13 vg/kg (Cohort 2) dose levels. To date, TN-201 has been generally well tolerated and since the DSMB review, there have been no new meaningful safety events associated with TN-201. Tenaya is working swiftly and collaboratively with the FDA to resolve the clinical hold and intends to resume dosing once the protocol changes have been implemented at trial sites. Tenaya does not expect this action to impact data milestones or development timelines for TN-201.

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K 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 report that are not purely historical are forward-looking statements. Words such as "intends," "expect," and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, Tenaya's plans for the TN-201 development program, including dosing, and related expectations regarding the impact of the FDA's clinical hold on data milestones and development timelines. 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 expected timing and outcome of Tenaya's regulatory interactions related to the clinical hold on MyPEAK-1; the timing and availability of MyPEAK-1 data; the potential progress of MyPEAK-1; the potential failure of TN-201 to demonstrate safety and/or efficacy in clinical testing; the potential for any MyPEAK-1 clinical trial results to differ from preclinical, interim, preliminary or expected results; the potential for the FDA to conclude at any time that TN-201 may not have an appropriate risk/benefit profile; Tenaya's ability to enroll and maintain patients in clinical trials, including MyPEAK-1; 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 continuing compliance with applicable legal and regulatory requirements; Tenaya's ability to raise any additional funding it will need to continue to pursue its product development plans; Tenaya'

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. TENAYA THERAPEUTICS, INC. By: /s/ Jennifer Drimmer Rokovich Jennifer Drimmer Rokovich General Counsel and Secretary Date: November 7, 2025