SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (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 for the second quarter ended June 30, 2024, and provided a corporate update.
“We remain laser focused on advancing our lead gene therapy candidates, as we prepare to report initial data from our first-in-human study of TN-201 in the second half and to dose the first patient in our Phase 1b trial of TN-401 in the fourth quarter of 2024. Our focus on clinical execution now and in the future is evident with more than forty sites in seven countries across our interventional and natural history studies for both programs, and with the recent receipt of rare pediatric disease designation for MYBPC3-associated HCM in infants, children and adolescents,” said Faraz Ali, Chief Executive Officer of Tenaya. “Consistent with that focus, we have taken important steps to increase our financial flexibility in anticipation of additional clinical data readouts in 2025.”
Business and Program Updates
TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Research and Manufacturing
Corporate Updates
Second Quarter 2024 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 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 “focused,” “anticipates,” “plans,” “expects,” “estimates”, "may,” “will” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, Tenaya’s plans and expectations regarding its clinical development efforts and activities, including site activation, enrolling and dosing patients and generating data for MyPEAK-1 and RIDGE-1 and the RIDGE natural history study; the timing of executive departures and appointments; Tenaya’s potential to receive a priority review voucher; planned timing of sharing initial data from MyPEAK-1 and additional clinical data readouts; the clinical, therapeutic and commercial potential of, and expectations regarding, Tenaya’s product candidates; the sufficiency of Tenaya’s cash resources to fund the company into the second half 2025 and the availability of the credit facility to extend that runway; and statements made 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 and progress of Tenaya’s clinical trials; availability of data at the referenced times; unexpected concerns that may arise as a result of the occurrence of adverse safety events in Tenaya’s clinical trials; the potential failure of Tenaya’s product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; 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 develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to comply with specified operating covenants and restrictions in its loan agreement; 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.
Contact
Michelle Corral
VP, Corporate Communications and Investor Relations
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Investors
Anne-Marie Fields
Precision AQ (formerly Stern Investor Relations)
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Media
Wendy Ryan
Ten Bridge Communications
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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, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 22,649 | $ | 26,477 | $ | 47,704 | $ | 52,082 | |||||||
General and administrative | 8,174 | 8,627 | 16,881 | 16,745 | |||||||||||
Total operating expenses | 30,823 | 35,104 | 64,585 | 68,827 | |||||||||||
Loss from operations | (30,823 | ) | (35,104 | ) | (64,585 | ) | (68,827 | ) | |||||||
Other income, net: | |||||||||||||||
Interest income | 1,393 | 1,837 | 2,845 | 3,810 | |||||||||||
Other income (loss), net | (1 | ) | (2 | ) | 81 | 11 | |||||||||
Total other income, net | 1,392 | 1,835 | 2,926 | 3,821 | |||||||||||
Net loss before income tax expense | (29,431 | ) | (33,269 | ) | (61,659 | ) | (65,006 | ) | |||||||
Income tax expense | — | — | — | — | |||||||||||
Net loss | $ | (29,431 | ) | $ | (33,269 | ) | $ | (61,659 | ) | $ | (65,006 | ) | |||
Net loss per share, basic and diluted | $ | (0.34 | ) | $ | (0.45 | ) | $ | (0.74 | ) | $ | (0.89 | ) | |||
Weighted-average shares used in computing net loss per share, basic and diluted | 85,706,501 | 73,399,847 | 83,344,414 | 73,249,702 | |||||||||||
Condensed Balance Sheet Data (In thousands) (Unaudited) | |||||||
June 30, | December 31, | ||||||
2024 | 2023 | ||||||
Cash, cash equivalents and marketable securities | $ | 99,303 | $ | 104,642 | |||
Total assets | $ | 163,185 | $ | 170,515 | |||
Total liabilities | $ | 29,188 | $ | 31,091 | |||
Total liabilities and stockholders’ equity | $ | 163,185 | $ | 170,515 | |||
Last Trade: | US$2.30 |
Daily Change: | 0.14 6.44 |
Daily Volume: | 2,088,159 |
Market Cap: | US$181.370M |
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