Full Press Release Details
Presentation of MyPEAK-1 Data and the American Heart Association Scientific Sessions Showed Consistent, Deeper, and Durable Improvement in Measures of Hypertrophy for Cohort 1 Patients
Initial TN-201 Cohort 2 Data Demonstrated Early Dose Responsive Increases in TN-201 Transduction and MyBP-C Protein Expression
Completed Dosing in Cohort 2 of RIDGE™-1 Trial of TN-401 for PKP2-associated ARVC; Cohort 1 Data On Track for Fourth Quarter Company Presentation
Tenaya Management to Review New MyPEAK-1 Data on Webcast Call for Analysts and Investors Today at 8:00 a.m. EST
SOUTH SAN FRANCISCO, Calif., Nov. 10, 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, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update.
“Throughout the third quarter, we made important steps advancing our two lead gene therapy programs to provide transformative treatments to patients with serious genetic cardiomyopathies,” said Faraz Ali, Chief Executive Officer of Tenaya. “TN-201 and TN-401 each received positive recommendations from their respective Data Safety Monitoring Boards to advance into the dose expansion cohorts reflecting confidence in each product’s emerging safety profile. We were particularly pleased with the positive safety and promising clinical data presented on TN-201 as a potential treatment forMYBPC3-associated HCM at the recent AHA Scientific Sessions. We also look forward to sharing meaningful safety and interim biopsy and efficacy data from the RIDGE-1 trial of TN-401 for patients withPKP2-associated ARVC in the coming weeks.”
Business and Program Updates
TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Research and Business Updates
Third Quarter 2025 Financial Highlights
Conference Call and WebcastTenaya management will host a conference call today, Monday, November 10, 2025, at 8:00 a.m. ET/5:00 a.m. PT to discuss the TN-201 data presented and published on Saturday, November 8, 2025 at the AHA Scientific Sessions and the status of the MyPEAK-1 clinical trial. The webcast conference call, including an accompanying slide presentation, can be accessed from the investor section on the “Events and Presentations” page of the Tenaya website atwww.tenayatherapeutics.com.
About Tenaya TherapeuticsTenaya 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 forMYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy forPKP2-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, visitwww.tenayatherapeutics.com.
Forward Looking StatementsThis 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 “look forward,” “potentially,” “anticipates,” “may,” “plans,” “will,” “expects,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, planned timing for sharing data from MyPEAK-1 and RIDGE-1 and the expected content of such data releases; the clinical, therapeutic and commercial potential of TN-201 and TN-401; enrollment plans for MyPEAK-1 and RIDGE-1; planned timing for sharing data from My Climb; Tenaya’s plans to host a Key Opinion Leader event; the sufficiency of Tenaya’s cash resources to fund the company into the second half of 2026; and statements made by Tenaya’s chief executive officer. 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: availability of data at the referenced times; the timing and progress of Tenaya’s clinical trials; unexpected concerns that may arise as a result of the occurrence of adverse safety events in Tenaya’s clinical trials; the potential failure of Tenaya’s product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; 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; Tenaya’s continuing compliance with applicable legal and regulatory requirements; risks related to the impact of the restructuring plan on Tenaya’s business; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Tenaya’s reliance on third parties; 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 ability to comply with specified operating covenants and restrictions in its loan agreement; 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 lawTenaya ContactsMichelle CorralVP, Corporate Communications and Investor RelationsIR@tenayathera.com
InvestorsAnne-Marie FieldsPrecision AQannemarie.fields@precisionaq.com
MediaWendy RyanTen Bridge Communicationswendy@tenbridgecommunications.com
| TENAYA THERAPEUTICS, INC.Condensed Statements of Operations(In thousands, except share and per share data)(Unaudited) | ||||||||||||||||
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 15,363 | $ | 20,350 | $ | 53,809 | $ | 68,054 | ||||||||
| General and administrative | 5,573 | 6,361 | 18,747 | 23,242 | ||||||||||||
| Total operating expenses | 20,936 | 26,711 | 72,556 | 91,296 | ||||||||||||
| Loss from operations | (20,936 | ) | (26,711 | ) | (72,556 | ) | (91,296 | ) | ||||||||
| Other income, net: | ||||||||||||||||
| Interest income | 658 | 1,080 | 2,107 | 3,925 | ||||||||||||
| Other income (loss), net | 3 | (3 | ) | 27 | 78 | |||||||||||
| Total other income, net | 661 | 1,077 | 2,134 | 4,003 | ||||||||||||
| Net loss before income tax expense | (20,275 | ) | (25,634 | ) | (70,422 | ) | (87,293 | ) | ||||||||
| Income tax expense | — | — | — | — | ||||||||||||
| Net loss | $ | (20,275 | ) | $ | (25,634 | ) | $ | (70,422 | ) | $ | (87,293 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.30 | ) | $ | (0.48 | ) | $ | (1.04 | ) | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 163,345,972 | 86,162,841 | 145,531,495 | 84,290,747 |
| Condensed Balance Sheet Data(In thousands)(Unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, cash equivalents and marketable securities | $ | 56,312 | $ | 61,446 | ||||
| Total assets | $ | 104,980 | $ | 119,940 | ||||
| Total liabilities | $ | 22,112 | $ | 27,086 | ||||
| Total liabilities and stockholders’ equity | $ | 104,980 | $ | 119,940 |