SOUTH SAN FRANCISCO, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage 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, 2023.
“We are looking ahead to important near-term milestones across all our programs. Dosing the first patient in our first clinical trial for TN-201 will be a significant moment for our company and bring us one step closer to bringing much-needed solutions to those impacted by genetic HCM,” said Faraz Ali, Chief Executive Officer of Tenaya. “We are also looking forward to presenting healthy participant data from our TN-301 small molecule program and filing the IND for our TN-401 gene therapy candidate later this year. Our continued progress is supported by our unwavering commitment to fight heart disease on behalf of individuals and families.”
Business and Program Updates
TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction (HFpEF)
TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Research
Second Quarter 2023 Financial Highlights
About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Leveraging its integrated and interrelated Gene Therapy, Cellular Regeneration and Precision Medicine platforms and proprietary core capabilities, the company is advancing a pipeline of novel therapies with diverse treatment modalities for rare genetic cardiovascular disorders and more prevalent heart conditions. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development. For more information, visit www.tenayatherapeutics.com.
Forward-looking Statement
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 “anticipated,” “looking ahead,” “looking forward,” “may,” “expected,” “plans,” “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements regarding 2023 development and regulatory milestones; Tenaya’s plan to present data from the Phase 1 clinical trial evaluating TN-301, as well as results from preclinical studies, at the upcoming HFSA conference; expected timing of the submission of the TN-401 IND; eligibility for increased communication with the FDA and potential qualification for accelerated approval and priority review for TN-201; expected timing for, commencement of dosing in the Phase 1b clinical trial evaluating TN-201 and availability of initial data from the trial; the expected expiration dates of new patents; the potential for Tenaya’s future programs; the sufficiency of Tenaya’s cash resources to fund the company into the first half 2025; 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: Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials for its product candidates; the timing, scope and likelihood of regulatory filings and approvals; the availability of data at the referenced times; 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; 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 | Wendy Ryan |
Vice President, Investor Relationship and | Ten Bridge Communications |
Corporate Communications | This email address is being protected from spambots. You need JavaScript enabled to view it. |
Tenaya Therapeutics | |
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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, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 26,477 | $ | 20,876 | $ | 52,082 | $ | 45,031 | ||||||||
General and administrative | 8,627 | 7,743 | 16,745 | 14,742 | ||||||||||||
Total operating expenses | 35,104 | 28,619 | 68,827 | 59,773 | ||||||||||||
Loss from operations | (35,104 | ) | (28,619 | ) | (68,827 | ) | (59,773 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Interest income | 1,837 | 222 | 3,810 | 321 | ||||||||||||
Other income (expense), net | (2 | ) | — | 11 | (1 | ) | ||||||||||
Total other income (expense), net | 1,835 | 222 | 3,821 | 320 | ||||||||||||
Net loss before income tax expense | (33,269 | ) | (28,397 | ) | (65,006 | ) | (59,453 | ) | ||||||||
Income tax expense | — | — | — | — | ||||||||||||
Net loss | $ | (33,269 | ) | $ | (28,397 | ) | $ | (65,006 | ) | $ | (59,453 | ) | ||||
Net loss per share, basic and diluted | $ | (0.45 | ) | $ | (0.69 | ) | $ | (0.89 | ) | $ | (1.44 | ) | ||||
Weighted-average shares used in computing net loss per share, basic and diluted | 73,399,847 | 41,302,157 | 73,249,702 | 41,285,168 |
Condensed Balance Sheet Data (In thousands) (Unaudited) | ||||||||
June 30, | December 31, | |||||||
2023 | 2022 | |||||||
Cash, cash equivalents and marketable securities | $ | 151,641 | $ | 204,230 | ||||
Total assets | $ | 220,754 | $ | 278,945 | ||||
Total liabilities | $ | 30,814 | $ | 35,569 | ||||
Total liabilities and stockholders’ equity | $ | 220,754 | $ | 278,945 |
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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