Business
Tenaya Therapeutics Reports Fourth Quarter and Year-End 2021 Financial Results and Provides Business Updates
Strengthened Leadership Team with the Additions of Sunita Sethi as Senior Vice President of Regulatory Affairs and Naymisha Patel as Senior Vice President of
About this update from Tenaya Therapeutics, Inc.
[{"type":"text","content":"\nStrengthened Leadership Team with the Additions of Sunita Sethi as Senior Vice President of Regulatory Affairs and Naymisha Patel as Senior Vice President of Quality\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nTenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today provided business and program updates, and reported financial results for the fourth quarter and full year ended December 31, 2021.\n\n“In 2021, we achieved important milestones across research, preclinical, manufacturing and corporate operations, in line with our commitment to advance the treatment of heart disease with disease-modifying therapeutics. Our progress continues in 2022 with three therapeutic candidates advancing towards the clinic, and with increasingly robust manufacturing and clinical development capabilities,” said Faraz Ali, Chief Executive Officer of Tenaya. “With the appointments of Dr. Sethi and Ms. Patel, we continue to add depth, breadth, and diversity to our leadership team to support our transition into a clinical-stage company.”\n\nBusiness and Program Updates\n\n\nTN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy\n\n\nTenaya expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second half of 2022.\n\n\nSite activation and enrollment in the MyClimb Natural History Study of pediatric patients with MYBPC3 mutations is ongoing.\n\n\n\n\n\nTN-301 – HDAC6 Small Molecule Inhibitor for Heart Failure with Preserved Ejection Fraction\n\n\nTenaya expects to submit an IND application to the FDA in the second half of 2022.\n\n\n\n\n\nTN-401 – PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy\n\n\nTenaya expects to submit an IND application to the FDA in 2023.\n\n\n\n\n\ncGMP Manufacturing Facility\n\n\nTenaya expects its state-of-the-art, modular cGMP manufacturing facility in Union City, California, will become operational in the first half of 2022.\n\n\n\n\n\nLeadership Team\n\n\nTenaya continues to strengthen its leadership team with the following appointments and promotions.\n\n\nSunita Sethi, Pharm.D., has been appointed Senior Vice President of Regulatory Affairs. Dr....