TNYA

EX-99.1

2 tnya-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Tenaya Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

One-Year Cohort 1 Data and Initial Cohort 2 Data from RIDGE™-1 Phase 1b/2 Trial of TN-401 for PKP2-Associated ARVC to be Presented at ASGCT 2026

New Data from Both Cohorts of the MyPEAK™-1 Phase 1b/2 Trial of TN-201 for Adults with MYBPC3-Associated HCM Expected in the Second Quarter 2026

Preclinical Data at MDA 2026 Highlighted TN-301’s Activity in Duchenne Muscular Dystrophy Disease Models; Distinct Mechanism of HDAC6 Inhibition Supportive of TN-301’s Potential in Multiple Indications

Entered Research Collaboration with Alnylam to Identify and Validate Genetic Targets for Cardiovascular Conditions

SOUTH SAN FRANCISCO, Calif., May 6, 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 first quarter ended March 31, 2026, and provided a corporate update.

“We are entering a catalyst-rich period for Tenaya, with multiple clinical milestones expected across our lead gene therapy programs throughout 2026. Building on the encouraging initial readouts we reported in 2025, we believe the additional data expected this year from both TN-201 and TN-401 may support alignment on registrational pathways for these novel gene therapies,” said Faraz Ali, Chief Executive Officer of Tenaya.

Mr. Ali continued, “While our focus remains on the advancement of TN-201 and TN-401 for patients suffering from these genetic cardiomyopathies, we also announced meaningful steps in the direction of our next horizon of opportunities to address unmet patient needs and to create value for stockholders. We presented new preclinical data for TN‑301, our clinical-stage small molecule candidate, in Duchenne muscular dystrophy adding to the body of compelling preclinical evidence for the broad clinical utility of this molecule in multiple prevalent and rare cardiac and cardiac-adjacent indications. Advancing TN‑301 toward a trial in patients reflects our commitment to building a diversified portfolio grounded in mechanistic insight and translational rigor. The recently announced collaboration with Alnylam also reinforces the strength of Tenaya's innovation engine and expands the reach and impact of our modality-agnostic research capabilities.”

Business and Program Updates

TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)

• On May 9, 2026, at the upcoming European Society of Cardiology (ESC) Heart Failure Conference, in Barcelona, Spain, Milind Desai, M.D., Director of the Hypertrophic Cardiomyopathy Center, Vice Chair of the Heart, Vascular & Thoracic Institute at Cleveland Clinic, and principal investigator for the MyPEAK-1 clinical trial, will present insights that

emerged early in the trial that enabled reductions in the cumulative dose and duration of immune suppressive medications, even when TN-201 is administered at the higher dose.

o Per the MyPEAK-1 protocol, sirolimus and prednisone are administered prophylactically in patients receiving TN-201 gene therapy, accompanied by post dose tapering in conjunction with monitoring of liver enzyme levels – an early indicator of potential complement system activation. Investigators found that minor adjustments, including administering sirolimus earlier, reducing the starting dose of prednisone and monitoring patients weekly, led to faster tapering and an overall decrease in the burden of immunosuppression.

o The ESC-HF presentation offers more detail on the immunosuppressive regimen results previously reported in November 2025 and includes safety data for the first seven patients enrolled in MyPEAK-1. The optimized regimen and monitoring protocols that were successfully deployed in MyPEAK-1 are also being utilized in the RIDGE-1 clinical trial of TN-401.

o Tenaya expects to report interim MyPEAK-1 data for Cohort 2 (6E13 vg/kg) and updates from Cohort 1 (3E13 vg/kg) in the second quarter of 2026.

• In January, Tenaya resumed enrollment and screening in MyPEAK-1 following implementation of modest protocol amendments in alignment with U.S. Food and Drug Administration (FDA) input.

• At the American Society of Gene and Cell Therapies (ASGCT) Annual Meeting, taking place May 11-15, 2026, in Boston, MA, Tenaya will present results from a survey exploring parental perceptions of gene therapy treatment for children with cardiomyopathies. This work was conducted by Tenaya in partnership with DDC Clinic and Children’s Cardiomyopathy Foundation. The poster presentation is scheduled for May 12, 2026.

TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

• Data from the ongoing RIDGE-1 Phase 1b/2 clinical trial of TN-401 in adults with ARVC due to variants in the PKP2

8-K

0001858848false00018588482026-03-112026-03-11

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

Date of Report (Date of earliest event reported): March 11, 2026

Tenaya Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-40656

81-3789973

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

171 Oyster Point Boulevard Suite 500

South San Francisco, California

94080

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 825-6990

(Former Name or Former Address, if Changed Since Last Report)

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: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

TNYA

Nasdaq Global Select Market

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 March 11, 2026, Tenaya Therapeutics, Inc. issued a press release announcing its financial results for the quarter and full year ended December 31, 2025 (“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 No.

Description

99.1

Press Release of Tenaya Therapeutics, Inc., dated March 11, 2026

104

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.

TENAYA THERAPEUTICS, INC.

By:

/s/ Jennifer Drimmer Rokovich

Jennifer Drimmer Rokovich

General Counsel and Secretary

Date: March 11, 2026

8-K

0001858848false00018588482025-11-102025-11-10

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

Date of Report (Date of earliest event reported): November 10, 2025

Tenaya Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-40656

81-3789973

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

171 Oyster Point Boulevard Suite 500

South San Francisco, California

94080

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 825-6990

(Former Name or Former Address, if Changed Since Last Report)

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: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

TNYA

Nasdaq Global Select Market

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 November 10, 2025, Tenaya Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2025 (“Earnings Press Release”). The full text of the Earnings Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. All of 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 No.

Description

99.1

Press Release of Tenaya Therapeutics, Inc., dated November 10, 2025

104

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.

TENAYA THERAPEUTICS, INC.

By:

/s/ Jennifer Drimmer Rokovich

Jennifer Drimmer Rokovich

General Counsel and Secretary

Date: November 10, 2025