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TENAYA THERAPEUTICS Tenaya Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Updates September 8 , 2021 -TN - 201 MYBPC3 gene therapy product candidate for the leading genetic cause of hypertrophic cardiomyopathy granted Orphan Drug Designation ( ODD ) by the U.S. Food and Drug Administration ( FDA ) - Expanded leadership team appointing Leone Patterson as Chief Financial and Business Officer and Matt Pollman , MD , as SVP , Clinical Development - Completed Initial Public Offering of common stock on August 3 , 2021 , raising $ 207 million in gross proceeds SOUTH SAN FRANCISCO , Calif .-- ( BUSINESS WIRE ) -- Sep . 8 , 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 second quarter 2021 financial results . " Tenaya has made significant financial and operational progress in the first half of 2021 that supports our efforts to improve and extend the lives of patients who are fighting both rare and prevalent forms of heart disease , " said Faraz Ali , CEO of Tenaya Therapeutics . " With the completion of our successful IPO , significant preclinical updates , and a strengthened leadership team , we are very well positioned to advance TN - 201 and TYA - 11631 , the two most advanced programs from our Gene Therapy and Precision Medicine platforms respectively , towards INDs in 2022. " Business and Program Updates • Initial Public Offering ( IPO ) Successfully Completed : In August 2021 , Tenaya announced the closing of its underwritten , upsized initial public offering of 13,800,000 shares of its common stock , including the full exercise of the underwriters ' option to purchase 1,800,000 additional shares of its common stock . The aggregate gross proceeds from the offering were $ 207.0 million , before deducting underwriting discounts and commissions and offering expenses payable by Tenaya . • TN - 201 – MYBPC3 Gene Therapy Program for Genetic HCM ( gHCM ) : TN - 201 was granted Orphan Drug Designation ( ODD ) by the FDA in May 2021. Preclinical data supporting TN - 201 was presented at the annual meeting of the American Society of Gene and Cell Therapy ( ASGCT ) in May 2021 that demonstrate significant and durable disease reversal and survival benefit in a severe murine model of disease . Tenaya is expected to initiate a global natural history study for patients with MYBPC3 mutations in the second half of 2021. Tenaya has initiated IND - enabling activities and intends to submit an investigational new drug ( IND ) application or clinical trial application ( CTA ) to the FDA or European Medicine Agency ( EMA ) , respectively , in 2022 . • TYA - 11631 - HDAC6 Inhibitor ( HDAC6i ) for Heart Failure with Preserved Ejection Fraction ( HFPEF ) and Genetic DCM ( gDCM ) : Preclinical data supporting Tenaya's highly - specific small molecule HDAC6 inhibitors was presented at the annual meeting of the European Society of Cardiology Heart Failure ( ESC - HF ) in July 2021 that demonstrate improved cardiac function in mouse models of HFPEF and gDCM , and that also provide proof of concept for the utility of Tenaya's Precision Medicine platform to support modality agnostic drug discovery . Tenaya has initiated IND - enabling activities and intends to submit an IND to the FDA in 2022 . • Strengthened Leadership Team : In June , gene therapy industry veteran Leone Patterson joined Tenaya as Chief Financial and Business Officer . In addition , cardiologist Matthew Pollman , MD , was appointed as Senior Vice President , Clinical Development and will lead efforts to develop novel delivery methods that support future product candidates from Tenaya's Gene Therapy and Cellular Regeneration platforms . Second Quarter 2021 Financial Highlights • Cash Position : As of June 30 , 2021 , Tenaya had cash , cash equivalents and restricted cash of $ 112.4 million which excludes the $ 188.8 million of net proceeds from the Company's IPO in August 2021. Tenaya expects its current cash and cash equivalents , including the net proceeds from the IPO , will be sufficient to fund its current operating plan at least into the 2nd half of 2023 . • R & D Expenses : Research and development expenses were $ 10.9 million for the second quarter of 2021. Non - cash stock - based compensation included in R & D expense was $ 0.2 million for the second quarter of 2021 . • G & A Expenses : General and administrative expenses were $ 4.3 million for the second quarter of 2021. Non - cash stock - based compensation included in G & A expense was $ 0.3 million for the second quarter of 2021 . • Net Loss : Net loss was $ 15.2 million , or $ 13.26 per basic and diluted share , for the second quarter of 2021 .