Exhibit 99.1
Tenaya Therapeutics Reports First Quarter 2023 Financial Results and
Provides Business Update
TN-201 Received Fast Track Designation from the FDA
Dosing Complete in Phase 1 Clinical Trial of TN-301; Data Expected in Second Half 2023
Renowned Researchers Drs. Christine Seidman and Alex Marson Join Scientific Advisory Board
Announces Formation of Technical Advisory Board with Deep Expertise in Gene Therapy Manufacturing
SOUTH SAN FRANCISCO, Calif., May 10, 2023 -- 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 first quarter ended March 31, 2023.
“Tenaya is making meaningful progress across multiple fronts of our business while maintaining a solid cash position. We are pleased to have recently received Fast Track designation for TN-201 and completed dosing in our Phase 1 trial of TN-301. We remain on track to achieve our 2023 development and regulatory milestones for TN-201, TN-301 and TN-401, including the release of clinical data for TN-301 in the second half of 2023,” said Faraz Ali, Chief Executive Officer of Tenaya. “In addition to our focus on achieving near-term catalysts, we continue to invest in our future. We look forward to highlighting the depth and breadth of our core capabilities at the upcoming ASGCT conference. We have also added leading industry and academic experts to our Scientific Advisory Board and to our newly created Technical Advisory Board. These efforts will collectively help Tenaya lay the foundation for commercial-ready manufacturing for our existing product candidates and support the expansion of Tenaya’s pipeline into new modalities, including gene editing, so that we can bring the promise of genetic medicines to individuals and families fighting heart disease.”
Business and Program Updates
TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
Tenaya received notification that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to TN-201. The FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates intended to treat serious conditions and for which nonclinical data demonstrates the potential to address unmet medical need.
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 Updates
Leadership
First 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 “expected,” “look forward,” “plans,” “anticipated,” “expects,” “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 abstracts covering manufacturing, capsid engineering and gene editing at the upcoming ASGCT conference; expected timing for, commencement of dosing in the Phase 1b clinical trial evaluating TN-201 and availability of initial data from the trial, data from the SAD and MAD stages of the Phase 1 clinical trial evaluating TN-301 and the submission of the TN-401 IND; 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 Vice President, Investor Relationship and Corporate Communications |
Wendy Ryan |
TENAYA THERAPEUTICS, INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
$ |
25,605 |
|
|
$ |
24,155 |
|
General and administrative |
|
|
8,118 |
|
|
|
6,999 |
|
Total operating expenses |
|
|
33,723 |
|
|
|
31,154 |
|
Loss from operations |
|
|
(33,723 |
) |
|
|
(31,154 |
) |
Other income (expense), net: |
|
|
|
|
|
|
||
Interest income |
|
|
1,973 |
|
|
|
99 |
|
Other income (expense), net |
|
|
13 |
|
|
|
(1 |
) |
Total other income (expense), net |
|
|
1,986 |
|
|
|
98 |
|
Net loss before income tax expense |
|
|
(31,737 |
) |
|
|
(31,056 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(31,737 |
) |
|
$ |
(31,056 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.75 |
) |
Weighted-average shares used in computing net loss per share, basic and diluted |
|
|
73,097,889 |
|
|
|
41,267,990 |
|
TENAYA THERAPEUTICS, INC.
Condensed Balance Sheet Data
(In thousands)
(Unaudited)
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
Cash, cash equivalents and marketable securities |
|
$ |
173,635 |
|
|
$ |
204,230 |
|
Total assets |
|
$ |
245,341 |
|
|
$ |
278,945 |
|
Total liabilities |
|
$ |
29,929 |
|
|
$ |
35,569 |
|
Total liabilities and stockholders’ equity |
|
$ |
245,341 |
|
|
$ |
278,945 |
|