Tenaya Therapeutics, Inc. - TNYA STOCK NEWS

Tenaya Therapeutics (NASDAQ: TNYA) presented interim data from its MyPEAK-1 Phase 1b/2 clinical trial of TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), at ACC.25. The trial's first cohort showed promising results with the 3E13 vg/kg dose:

• All three patients achieved NYHA Class I status, improving from their baseline severe condition
• Two patients showed improvements in hypertrophy measures
• Biopsy data confirmed robust TN-201 DNA presence and RNA expression
• MyBP-C protein levels increased in two patients
• Treatment was generally well-tolerated with mostly mild adverse events

The company is currently enrolling Cohort 2 patients at a higher dose of 6E13 vg/kg, with completion expected in 1H25 and initial data reporting in 2H25.

Tenaya Therapeutics (TNYA) has published positive preclinical data in Nature Communications for TN-201, its gene therapy candidate targeting MYBPC3-associated hypertrophic cardiomyopathy (HCM). The therapy demonstrated significant disease reversal in severe knock-out mice models.

Key findings show that TN-201 achieved:

• Dose-dependent increases in MyBP-C protein with improvements in cardiac function at doses as low as 1x10¹³ vg/kg
• Reversal of left ventricular hypertrophy
• Sustained increases in gene expression
• Decreased cardiac biomarkers associated with fibrosis and heart failure
• Extended survival in treated mice

The therapy is currently being evaluated in the MyPEAK™-1 Phase 1b/2 clinical trial at doses of 3x10¹³ vg/kg and 6x10¹³ vg/kg. Initial data from the first cohort will be presented at the upcoming American College of Cardiology Scientific Sessions, with high-dose cohort data expected in the second half of the year.

Tenaya Therapeutics (NASDAQ: TNYA) announced upcoming presentations of new clinical data for its MYBPC3-associated hypertrophic cardiomyopathy (HCM) program at the American College of Cardiology's Annual Scientific Session (March 29-31, 2025).

The key highlight will be a late-breaker presentation featuring one-year assessment data from the first two patients and six-month data from a third patient in Cohort 1 (3E13 vg/kg dose) of the MyPEAK-1 Phase 1b/2 trial of TN-201, their AAV9-based gene therapy. This follows encouraging early data shared in December 2024.

Additionally, a poster presentation will showcase findings from the SHaRe registry about disease burden differences in adults with MYBPC3-associated HCM. Dr. Milind Desai from Cleveland Clinic will present the clinical trial data, while Dr. Whit Tingley will present the registry findings.

Tenaya Therapeutics (NASDAQ: TNYA) has reported its Q4 and full year 2024 financial results, highlighting significant progress in its cardiovascular gene therapy programs. The company has initiated dosing in Cohort 2 of the MyPEAK-1 Phase 1b/2 trial for TN-201, with promising early data from Cohort 1 showing general tolerability and detectable vector DNA in the heart.

Key financial metrics include a net loss of $23.8 million ($0.28 per share) for Q4 2024 and $111.1 million ($1.31 per share) for full year 2024. R&D expenses were $86.7 million for 2024, down from $98.0 million in 2023. The company recently secured $48.9 million through a public offering, extending its cash runway into mid-2026.

Notable developments include the RIDGE-1 Phase 1b trial of TN-401 for PKP2-Associated ARVC, with initial data expected in 2H25. The company received an $8 million CIRM grant for the RIDGE-1 trial and was issued a new patent for HDAC6 inhibitors in treating heart failure.

Tenaya Therapeutics (Nasdaq: TNYA) has announced the pricing of a public offering of 75,000,000 units at $0.70 per unit, aiming to raise gross proceeds of approximately $52.5 million before deducting underwriting costs and expenses.

Each unit consists of one common stock share, a Series A Warrant (exercise price $0.80, 5-year expiration), and a Series B Warrant (exercise price $0.70, expires June 30, 2026) to purchase half a share. The offering is expected to close around March 5, 2025.

The clinical-stage biotech company plans to use the net proceeds to fund ongoing and planned development of clinical and early-stage product candidates, particularly TN-201 and TN-401, along with working capital and general corporate purposes. Leerink Partners and Piper Sandler are serving as joint book-running managers for the offering.

Tenaya Therapeutics (Nasdaq: TNYA), a clinical-stage biotechnology company focused on heart disease therapies, has announced plans for a proposed public offering. The offering will consist of units comprising common stock and two series of warrants (Series A and Series B) to purchase common stock.

The company will also offer pre-funded units to certain investors, which include pre-funded warrants priced at $0.001 per share, along with Series A and Series B warrants. The pre-funded warrants will be immediately exercisable with no expiration date.

Leerink Partners and Piper Sandler are serving as joint bookrunning managers for the offering. The securities will be offered through a previously filed and SEC-approved Registration Statement on Form S-3. The completion, size, and terms of the offering remain subject to market conditions.

Tenaya Therapeutics (NASDAQ: TNYA), a clinical-stage biotechnology company focused on developing curative therapies for heart disease, has announced its participation in two major investor conferences in March 2025.

The company will be featured at:

• TD Cowen's 45th Annual Health Care Conference on Tuesday, March 4, with a company presentation from 1:10 PM ET to 1:40 PM ET
• Leerink Partners Global Healthcare Conference 2025 on Wednesday, March 12, participating in a fireside chat from 8:40 AM ET to 9:10 AM ET

CEO Faraz Ali will represent the company at both events. Live and archived webcasts will be available through Tenaya's website Investors section, with replays accessible for approximately 30 days after each conference.

Tenaya Therapeutics (NASDAQ: TNYA) has received an $8 million CLIN2 grant from the California Institute for Regenerative Medicine (CIRM) to support its ongoing RIDGE-1 Phase 1b clinical trial of TN-401 gene therapy. The therapy is being developed to treat PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), a severe progressive disease affecting approximately 70,000 people in the U.S.

TN-401 is designed as a one-time intravenous gene replacement therapy using AAV9 capsid to deliver functional PKP2 genes into heart muscle cells, addressing the underlying cause of the disease. The RIDGE-1 trial is currently enrolling symptomatic adults with PKP2-associated ARVC, with initial data from the low-dose cohort expected in the second half of 2025.

Tenaya Therapeutics (NASDAQ: TNYA) has outlined its strategic priorities for 2025, focusing on advancing its gene therapy programs. The company has initiated dosing in Cohort 2 of the MyPEAK-1 Phase 1b/2 clinical trial of TN-201 for MYBPC3-Associated Hypertrophic Cardiomyopathy, with additional Cohort 1 data expected in 1H25.

Initial data from Cohort 1 showed TN-201 was generally well-tolerated at 3E13 vg/kg dose, with detectable vector DNA and transgene RNA expression in the first two patients. The company plans to complete Cohort 2 enrollment in 1H25 and provide initial data in 2H25.

For the TN-401 program targeting PKP2-Associated ARVC, Tenaya expects to complete Cohort 1 enrollment in 1H25 and report initial clinical data in 2H25. The company also plans to activate its first ex-U.S. RIDGE-1 clinical site in 1H25.