Tenaya Therapeutics, Inc. Stock Price, News & Analysis

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.

Tenaya Therapeutics (NASDAQ: TNYA) has reported promising early data from the first cohort of the MyPEAK-1 Phase 1b/2 clinical trial of TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM). The trial's preliminary results from three patients at the 3E13 vg/kg dose showed that TN-201 was generally well-tolerated with:

- Detectable vector DNA in the heart
- Evidence of transgene RNA expression
- Increasing TN-201 mRNA and MyBP-C protein levels over time
- Stable or improved circulating biomarkers of cardiac muscle strain and injury

The first patient reached 52 weeks, the second 40 weeks, and the third 12 weeks of follow-up. Additional data readouts from Cohort 1 and the higher dose Cohort 2 are expected in 2025.

Tenaya Therapeutics (NASDAQ: TNYA) announced it will present initial data from Cohort 1 of the MyPEAK-1 Phase 1b/2 clinical trial of TN-201 gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) on December 17, 2024. The company will host a conference call and webcast at 8:00 a.m. ET to discuss the results. The presentation will be accessible through the company's website, with a replay available afterward in the Investor Relations section.

Tenaya Therapeutics (NASDAQ: TNYA) has dosed the first patient in its RIDGE-1 Phase 1b clinical trial of TN-401, a gene therapy treatment for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC). The trial, currently enrolling at six U.S. centers, will assess safety and efficacy of a one-time intravenous infusion in up to fifteen adults with PKP2-associated ARVC. TN-401 uses AAV9 capsid to deliver functional PKP2 genes to heart cells, aiming to address the underlying cause of the disease. Initial clinical data is expected in 2025. The first dose being tested is 3E13 vg/kg, which showed near maximal efficacy in preclinical studies.

Tenaya Therapeutics (NASDAQ: TNYA) has granted stock options to two new non-executive employees as employment inducements. The options allow purchase of 12,000 total shares at $1.97 per share, matching the November 15, 2024 closing price. These ten-year options vest over four years, with 25% vesting after one year and the remainder vesting monthly at 1/48th of the original shares. The grants were made under the company's 2024 Inducement Equity Incentive Plan in accordance with NASDAQ Rule 5635(c)(4).

Tenaya Therapeutics (NASDAQ: TNYA) reported Q3 2024 financial results and provided updates on its gene therapy programs. The company completed dosing of the first three patients in Cohort 1 of the MyPEAK-1 trial for TN-201, with the Data Safety Monitoring Board endorsing dose escalation to Cohort 2. Initial data from Cohort 1 will be reported in December 2024. The company reported a net loss of $25.6 million ($0.30 per share) and had cash and investments of $79.5 million as of September 30, 2024, sufficient to fund operations into second half of 2025. R&D expenses were $20.4 million, down from $23.1 million in Q3 2023.

Tenaya Therapeutics has provided updates on its TN-201 gene therapy program for MYBPC3-associated hypertrophic cardiomyopathy (HCM). The company has completed dosing of the first three patients in Cohort 1 of the MyPEAK-1 clinical trial at the 3E13 vg/kg dose, with no unexpected events or toxicities observed. An independent Data and Safety Monitoring Board (DSMB) has recommended proceeding with dose escalation to 6E13 vg/kg for Cohort 2, which is now enrolling.

Tenaya has implemented protocol changes, including adding a baseline biopsy, expanding eligibility criteria, and increasing the potential number of patients in the dose expansion portion. The company plans to report initial data from Cohort 1 in December 2024, focusing on safety, tolerability, and biomarker analyses.

Additionally, Tenaya presented data on the disease burden for children and adolescents with MYBPC3-associated HCM, highlighting the high cumulative lifetime risk of severe events and the need for new genetic medicines.

Tenaya Therapeutics (NASDAQ: TNYA), a clinical-stage biotech company focused on heart disease therapies, has announced its participation in three upcoming investment conferences. CEO Faraz Ali will represent the company at:

• Morgan Stanley 22nd Annual Global Healthcare Conference (Sept. 5, 2024)
• 10th Annual World Medical Innovation Forum (Sept. 23, 2024)
• Chardan's 8th Annual Genetic Medicines Conference (Oct. 1, 2024)

The events will feature fireside chats and panel discussions. Live and archived webcasts of the fireside chats will be available on Tenaya's website for approximately 30 days after each conference.