Tenaya 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 reported financial results and provided a corporate update for the second quarter ended June 30, 2022.
“Tenaya continues to make strides forward in our transition to becoming a fully integrated clinical-stage company and continues to invest in research that will keep us at the forefront of discovering promising new treatments to address both rare and prevalent forms of heart disease,” said Faraz Ali, Chief Executive Officer of Tenaya. “We remain on track with our IND submission plans for TN-201 and TN-301 in the second half of 2022. The operational launch and state licensing of our Genetic Medicines Manufacturing Center in the second quarter were important milestones that will enable us to produce clinical drug product in the near term for TN-201 and allow us to readily scale production of AAV gene therapies as our pipeline matures and evolves.”
Business and Program Updates
TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy (HCM)
TN-301 – HDAC6 Small Molecule Inhibitor for Heart Failure with Preserved Ejection Fraction (HFpEF)
TN-401 – PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Genetic Medicines Manufacturing Facility
Research Updates
Second Quarter 2022 Financial Highlights
About Tenaya Therapeutics
Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic cardiovascular disorders, as well as for more prevalent heart conditions, through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. For more information, visit www.tenayatherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “potentially,” “on track”, “will,” “plans,” “intends,” “expects”, and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements regarding the status of IND submission plans for TN-201 and TN-301; expected timing for submission of an IND application for TN-401 and plans to establish a global natural history study of ARVC; statements regarding Tenaya’s AAV gene therapy manufacturing capabilities; the sufficiency of projected cash flows to support business operations and plans; and statements by Tenaya’s chief executive officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: the timing, scope and likelihood of regulatory filings and approvals; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials for its product candidates; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Tenaya’s manufacturing and operations, including preclinical studies and planned clinical trials; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Tenaya’s ability to successfully operate a manufacturing facility for clinical or commercial supply; Tenaya’s commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s reliance on third parties; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contacts | |
Investors | Media |
Michelle Corral Vice President, Investor Relationship and Corporate Communications Tenaya Therapeutics This email address is being protected from spambots. You need JavaScript enabled to view it. | Wendy Ryan Ten Bridge Communications This email address is being protected from spambots. You need JavaScript enabled to view it. |
TENAYA THERAPEUTICS INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 20,876 | $ | 10,906 | $ | 45,031 | $ | 20,496 | ||||||||
General and administrative | 7,743 | 4,331 | 14,742 | 7,846 | ||||||||||||
Total operating expenses | 28,619 | 15,237 | 59,773 | 28,342 | ||||||||||||
Loss from operations | (28,619 | ) | (15,237 | ) | (59,773 | ) | (28,342 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Interest income | 222 | 9 | 321 | 18 | ||||||||||||
Other income (expense), net | — | 18 | (1 | ) | 16 | |||||||||||
Total other income (expense), net | 222 | 27 | 320 | 34 | ||||||||||||
Net loss before income tax expense | (28,397 | ) | (15,210 | ) | (59,453 | ) | (28,308 | ) | ||||||||
Income tax expense | — | — | — | — | ||||||||||||
Net loss | (28,397 | ) | (15,210 | ) | (59,453 | ) | (28,308 | ) | ||||||||
Net loss per share, basic and diluted | $ | (0.69 | ) | $ | (13.26 | ) | $ | (1.44 | ) | $ | (25.21 | ) | ||||
Weighted-average shares used in computing net loss per share, basic and diluted | 41,302,157 | 1,147,471 | 41,285,168 | 1,122,775 | ||||||||||||
Condensed Balance Sheet Data
(In thousands)
(Unaudited)
June 30, | December 31, | |||||||
2022 | 2021 | |||||||
Cash, cash equivalents and marketable securities | $ | 180,916 | $ | 251,300 | ||||
Total assets | $ | 255,929 | $ | 314,189 | ||||
Total liabilities | $ | 32,062 | $ | 35,663 | ||||
Total liabilities and stockholders’ equity | $ | 255,929 | $ | 314,189 |
Last Trade: | US$1.70 |
Daily Change: | 0.29 20.57 |
Daily Volume: | 9,258,204 |
Market Cap: | US$134.670M |
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