Tenaya Therapeutics Announces Restructuring and Promising Gene Therapy Results

Tenaya Therapeutics, a gene therapy specialist, has unveiled a significant restructuring plan alongside encouraging early-stage clinical trial results for its lead candidate in hypertrophic cardiomyopathy. The dual announcement marks a pivotal moment for the company as it navigates financial challenges while advancing its innovative therapeutic pipeline.

Workforce Reduction and Financial Strategy

Tenaya Therapeutics has initiated a restructuring program that will result in the termination of 30% to 40% of its staff. The layoffs, set to occur throughout 2025, will primarily impact the company's research and manufacturing operations, as well as some administrative positions. Faraz Ali, Tenaya's CEO, confirmed that the restructuring is expected to be completed by the end of the year.

The company, which reported 97 full-time employees in its 2024 annual report, aims to extend its financial runway into the second half of 2026 through these cost-cutting measures. The restructuring is projected to cost between $1.6 million and $2.7 million, mainly due to severance payments and continued health benefits for affected employees.

As part of the restructuring, a Tenaya manufacturing facility in California will become dormant later this year. While the company will retain ownership of the site, it will not be actively used in the immediate future.

Promising Results for TN-201 Gene Therapy

Concurrent with the restructuring announcement, Tenaya released data from the Phase Ib/II MyPEAK-1 trial of TN-201, its investigational gene therapy for hypertrophic cardiomyopathy associated with insufficient levels of myosin-binding protein C (myBP-C).

The initial results from the first three treated patients show that TN-201 DNA successfully reached the heart, with a 13-fold increase in RNA of the gene over the course of the trial. Importantly, concentrations of myBP-C protein levels rose following TN-201 treatment, suggesting successful transcription and expression of the gene therapy in target cells.

All three patients demonstrated marked improvements in daily activities. The treatment was generally well-tolerated, with most treatment-emergent toxicities being mild in severity and either manageable or reversible.

Strategic Focus and Future Outlook

Tenaya emphasizes that the restructuring will not impact its ability to execute on projected enrollment milestones or data readouts. The company has produced sufficient quantities of its drug products to support ongoing trials, and manufacturing efforts continue as planned. Key capabilities to support early research have also been retained.

While William Blair analysts noted that the MyPEAK-1 readout provided clarity on TN-201's functional benefits, they highlighted that protein expression data remains challenging to interpret. Tenaya will continue to assess the trial to better understand the relationship between myBP-C expression and functional outcomes.

As Tenaya Therapeutics navigates this period of transition, the company remains focused on advancing its gene therapy pipeline, particularly TN-201 for hypertrophic cardiomyopathy. The coming months will be crucial as the biotech balances financial constraints with the promising potential of its therapeutic candidates.