TNYA 8-K
Tenaya Therapeutics, Inc. (TNYA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 5, 2026, Tenaya Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026 (“Earnings Press Release”). The full text of the Earnings Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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Description |
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99.1 |
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Press Release of Tenaya Therapeutics, Inc., dated August 5, 2026 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
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TENAYA THERAPEUTICS, INC. |
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By: |
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/s/ Jennifer Drimmer Rokovich |
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Jennifer Drimmer Rokovich |
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General Counsel and Secretary |
Date: August 5, 2026 |
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Exhibit 99.1
Tenaya Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update
Positive Interim Data Shared in 2Q 2026 from the MyPEAK™-1 and RIDGE™-1 Clinical Trials Each Demonstrated Meaningful Improvements in Key Disease Characteristics
Additional Data Releases Plus Updates on Regulatory Discussions on Pivotal Trial Plans for TN-201 and TN-401 Anticipated in 4Q 2026
TN-301 Advancing toward Phase 2 Trial Start in 2H 2027
$10 million Upfront Payment Received from Alnylam Collaboration Extends Cash Runway Through Q3 2027
SOUTH SAN FRANCISCO, Calif., August 5, 2026 – 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 second quarter ended June 30, 2026, and provided a corporate update.
“The second quarter marked an important period of execution for Tenaya as we shared new safety and clinical benefit data for TN-201 and TN-401,” said Faraz Ali, Chief Executive Officer of Tenaya. “We remain excited by the encouraging results emerging from our TN-201 MyPEAK-1 clinical trial in patients with MYBPC3-associated disease and the most recent RIDGE-1 data add to our confidence in TN-401’s potential as a highly promising candidate to address the underlying cause of PKP2-associated ARVC. We are engaging with regulators to discuss the efficient late-stage development and approval pathways for each candidate.”
Mr. Ali continued, “We also believe that advancing TN-301 toward Phase 2 represents an opportunity to create significant value while further diversifying our pipeline. We remain focused on disciplined execution, efficient use of capital, and advancing programs with the greatest potential to deliver meaningful impact for patients and stockholders.”
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)
TN-301 – Small Molecule HDAC6 Inhibitor for the Potential Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF) and Related Cardiac, Metabolic, or Muscular Diseases
Corporate Updates
Second Quarter 2026 Financial Highlights
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); TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC); and TN-301, a highly specific small molecule HDAC6 inhibitor with broad potential clinical utility in cardiac, metabolic and muscular conditions, including heart failure with preserved ejection fraction (HFpEF) and Duchenne muscular dystrophy (DMD). Tenaya has employed a suite of integrated internal capabilities including modality agnostic target discovery and validation, to generate a portfolio of novel medicines based on genetic insights, aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. 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 “anticipated,” “potential,” “believe,” “focused,” “promising,” “plans,” “expects,” “intends,” “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, planned timing for sharing data from RIDGE-1 and MyPEAK-1 and the expected content of such data releases; the therapeutic potential for TN-201 as a treatment for MYBPC3-associated HCM and TN-401 as a treatment for PKP2-associated ARVC; the potential for TN-301 to create significant value for Tenaya; Tenaya’s focus on disciplined execution, efficient use of capital and advancing programs with the greatest potential; planned timing for sharing updates on regulatory interactions for the TN-201 and TN-401 programs; planned timing for sharing additional details regarding TN-301 development plans; the sufficiency of Tenaya’s cash resources to fund the company through Q3 of 2027; 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 by patients who received Tenaya products; 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; the potential for the FDA to conclude at any time that Tenaya’s clinical programs may not have an appropriate risk/benefit profile; Tenaya’s ability to enroll and maintain patients in clinical trials; 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; regulatory developments in the United States and foreign countries; 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 and platform technology; 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.
Tenaya Contacts
Michelle Corral |
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Investors |
Anne-Marie Fields |
Media |
TENAYA THERAPEUTICS, INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue |
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Collaboration revenue |
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$ |
1,110 |
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$ |
— |
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$ |
1,335 |
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$ |
— |
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Operating expenses: |
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Research and development |
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16,603 |
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17,370 |
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31,447 |
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38,446 |
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General and administrative |
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5,406 |
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6,712 |
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10,853 |
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13,174 |
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Impairment loss |
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21,821 |
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— |
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21,821 |
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— |
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Loss on lease termination, net |
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1,368 |
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— |
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1,368 |
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— |
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Total operating expenses |
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45,198 |
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24,082 |
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65,489 |
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51,620 |
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Loss from operations |
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(44,088 |
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(24,082 |
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(64,154 |
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(51,620 |
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Other income, net: |
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Interest income |
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697 |
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815 |
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1,491 |
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1,449 |
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Other (loss) income, net |
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(2 |
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(16 |
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(2 |
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24 |
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Total other income, net |
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695 |
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799 |
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1,489 |
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1,473 |
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Net loss before income tax expense |
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(43,393 |
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(23,283 |
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(62,665 |
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(50,147 |
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Income tax expense |
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— |
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— |
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— |
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— |
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Net loss |
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$ |
(43,393 |
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$ |
(23,283 |
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$ |
(62,665 |
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$ |
(50,147 |
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Net loss per share, basic and diluted |
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$ |
(0.20 |
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$ |
(0.14 |
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$ |
(0.29 |
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$ |
(0.37 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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217,574,637 |
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162,791,579 |
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217,230,811 |
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136,476,623 |
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Condensed Balance Sheet Data
(In thousands)
(Unaudited)
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June 30, |
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December 31, |
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2026 |
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2025 |
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Cash and cash equivalents |
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$ |
78,085 |
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$ |
100,547 |
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Total assets |
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$ |
93,540 |
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$ |
146,921 |
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Total liabilities |
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$ |
24,131 |
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$ |
23,656 |
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Total liabilities and stockholders’ equity |
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$ |
93,540 |
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$ |
146,921 |
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