Tenaya Therapeutics Q2 2024 Financial Results and Business Update

Tenaya Therapeutics, Inc., a clinical-stage biotech company focused on developing treatments for heart disease, announced its financial results for Q2 2024, alongside several corporate updates.

Tenaya is progressing with its lead gene therapies, with initial human trial data for TN-201 expected later this year and the first patient to be dosed in their TN-401 trial in Q4 2024. Currently, they are conducting studies in over 40 sites across seven countries. TN-201 recently received rare pediatric disease designation from the FDA for treating MYBPC3-associated Hypertrophic Cardiomyopathy (HCM) in young patients. This designation could grant Tenaya a priority review voucher if TN-201 proves effective and is approved.

The MyPEAK™-1 trial for TN-201, aiming to assess its safety and efficacy, is ongoing with active patient screening and enrollment. Interim results are expected in the latter half of 2024. An accompanying natural history study, MyClimb, is also in progress, providing crucial data on MYBPC3-associated HCM in younger populations across more than 20 sites in the US, Canada, and Europe.

For TN-401, aimed at treating PKP2-associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), Tenaya has initiated the RIDGE™-1 trial, which will begin patient dosing by the end of 2024. The trial will evaluate the safety and efficacy of TN-401 administered through a one-time intravenous infusion. Recent data from an ongoing natural history study showed that a significant majority of individuals with PKP2-associated ARVC have low preexisting antibodies to the viral vector used in TN-401, making them eligible for the trial. Enrollments are ongoing at 18 sites across the US and Europe.

In terms of research and manufacturing, Tenaya’s teams presented several innovations at the American Society for Gene and Cell Therapy meeting. They also received a notice of allowance for a patent covering an optimized vector for the DWORF gene therapy program, aimed at treating dilated cardiomyopathy and heart failure, with patent protection expected until at least 2042.

On the corporate front, Tenaya announced the departure of Leone Patterson, their Chief Financial and Business Officer, effective August 14, 2024, with a search for her successor underway. Additionally, Chihiro Saito, CPA, will step in as interim principal accounting officer, and CEO Faraz Ali will serve as interim principal financial officer. The company also promoted Kathy Ivey, Ph.D., to Senior Vice President, Research, while former Chief Scientific Officer Timothy Hoey, Ph.D., will continue in an advisory role. Barry J. Byrne, M.D., Ph.D., was appointed to Tenaya’s Scientific Advisory Board.

Tenaya has implemented cost containment measures to align with their clinical goals and entered into a $45 million credit facility with Silicon Valley Bank. This facility provides financial flexibility, with $15 million available immediately and up to $30 million accessible upon achieving certain milestones or at the bank’s discretion.

Financially, Tenaya reported a cash position of $99.3 million as of June 30, 2024, sufficient to fund operations into the second half of 2025. The credit facility could potentially extend this runway. R&D expenses were $22.6 million for Q2 2024, down from $26.5 million in the same period last year. General and administrative expenses also saw a slight decrease to $8.2 million. The net loss for the quarter was $29.4 million, or $0.34 per share, compared to a net loss of $33.3 million, or $0.45 per share, in Q2 2023.

Tenaya Therapeutics is committed to developing innovative therapies for heart disease through their gene therapy, cellular regeneration, and precision medicine platforms. Their pipeline includes advanced candidates like TN-201, TN-401, and TN-301, with multiple early-stage programs in preclinical development. The company remains focused on delivering potentially curative treatments for both rare and common cardiovascular conditions.