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TENAYA THERAPEUTICS Tenaya Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Updates November 10 , 2021 - Initiated global natural history study for pediatric patients with MYBPC3 mutation to support clinical development of TN - 201 gene therapy - Presented preclinical data supporting both TN - 201 and PKP2 gene therapy programs at the European Society of Gene and Cell Therapy conference demonstrating significant and durable disease reversal and survival in severe murine models of disease - Initiated cGMP manufacturing to support the IND filing for TYA - 11631 small molecule for HFPEF SOUTH SAN FRANCISCO , Calif .-- ( BUSINESS WIRE ) -- Nov . 10 , 2021-- Tenaya Therapeutics , Inc. ( NASDAQ : TNYA ) , a biotechnology company with a mission to discover , develop and deliver curative therapies that address the underlying causes of heart disease , today reported business and program updates and third quarter 2021 financial results . " The third quarter of 2021 was a significant marker in Tenaya's history with the successful completion of our IPO , and it also represented a period of growth for the company as we continued to make progress on our key pipeline programs and operations , " said Faraz Ali , CEO of Tenaya . " We are pleased to announce the initiation of our global natural history study for pediatric patients with MYBPC3 mutations , as this supports our TN - 201 gene therapy program as well as our evolution towards becoming a clinical - stage company . The initiation of cGMP manufacturing for TYA - 11631 is an important operational milestone and another step in the direction of our vision for modality - agnostic drug discovery . The first - ever presentation of data supporting our PKP2 gene therapy program at an important scientific conference provides new hope for individuals and families fighting the leading genetic cause of Arrhythmogenic Right Ventricular Cardiomyopathy , a severe disease with high unmet need . " Business and Program Updates • TN - 201 – MYBPC3 Gene Therapy Program for Genetic HCM ( gHCM ) : • Pre - clinical data on the treatment in a severe MYBPC3 mutant mouse model of gHCM with TN - 201 demonstrating extended survival to 18 months after a single dose and continued improvement in functional measures was presented at the annual meeting of the European Society of Gene and Cell Therapy ( ESGCT ) in October 2021 . o Tenaya has initiated a global natural history study to improve our understanding of disease progression and unmet need in individuals carrying mutations in the MYBPC3 gene , with an initial focus on pediatric patients under the age of 18. For additional information about the natural history study , please visit www.clinicaltrials.gov using Identifier NCT05112237 . These efforts may support the evaluation of Tenaya's TN - 201 gene therapy product candidate in this patient population during clinical development . • Tenaya has initiated IND - enabling activities and intends to submit an investigational new drug ( IND ) application or clinical trial application ( CTA ) to the U.S. Food and Drug Administration ( FDA ) or European Medicine Agency ( EMA ) , respectively , in 2022 . • TYA - 11631 - HDAC6 Inhibitor ( HDAC6i ) Small Molecule for Heart Failure with Preserved Ejection Fraction ( HFPEF ) • Tenaya has initiated cGMP manufacturing activities to support the production of TYA - 11631 at larger scales . Tenaya had previously announced initiation of IND - enabling activities and intends to submit an IND to the FDA in 2022 . • PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy ( ARVC ) • Pre - clinical data on the treatment of a severe mouse model of ARVC due to PKP2 gene mutations with Tenaya's gene therapy product construct demonstrated prevention of symptoms and continued , significant improvement in functional measures and survival benefit at 15 weeks after a single dose as presented in a poster at ESGCT . Mutations due to the PKP2 gene are the leading genetic cause of ARVC , a severe disease estimated to effect more than 70,000 patients in the US alone and with no approved disease - specific therapies . • Strong balance sheet with net proceeds of $ 188.5 million from the sale of 13.8 million shares of its common stock in the Company's initial public offering ( IPO ) , bringing cash , cash equivalents and investments in marketable securities to $ 280.5 million as of September 30 , 2021 . Third Quarter 2021 Financial Highlights • Cash Position : As of September 30 , 2021 , Tenaya had cash , cash equivalents and investments in marketable securities of $ 280.5 million which included net proceeds from the Company's IPO in August 2021. Tenaya expects its current cash , cash equivalents and investments in marketable securities will be sufficient to fund its current operating plan at least into the second half of 2023 . • Research & Development ( R & D ) Expenses : R & D expenses were $ 12.9 million for the third quarter of 2021. Non - cash stock - based compensation included in R & D expense was $ 0.3 million for the third quarter of 2021 .