UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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(Commission File Number) |
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(Address of principal executive offices, including zip code)
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(Registrant’s telephone number, including area code)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Name of exchange on which registered |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On November 8, 2023, Tenaya Therapeutics, Inc. (the “Company”) issued a press release announcing the Company's financial results for the quarter ended September 30, 2023. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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Description |
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99.1 |
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Press Release of Tenaya Therapeutics, Inc., dated November 8, 2023 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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TENAYA THERAPEUTICS, INC. |
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By: |
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/s/ Leone D. Patterson, M.B.A. |
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Leone D. Patterson, M.B.A. |
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Chief Financial and Business Officer |
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Date: November 8, 2023 |
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Exhibit 99.1
Tenaya Therapeutics Reports Third Quarter 2023 Financial Results and
Provides Business Update
Commenced Patient Dosing in MyPeak-1TM Phase 1b Trial of TN-201 in MYBPC3-Associated Hypertrophic Cardiomyopathy
Presented Positive Phase 1 Data for TN-301 for the Potential Treatment of Heart Failure with Preserved Ejection Fraction at HFSA 2023
TN-401 for PKP2-Associated ARVC Received FDA Clearance to Begin First-in-Human
Clinical Testing and Fast Track Designation
SOUTH SAN FRANCISCO, Calif., November 8, 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 third quarter ended September 30, 2023.
“The successful execution across all of our program milestones slated for 2023, including two gene therapy INDs cleared and the dosing of the first patient in our TN-201 clinical trial, represents the strong commitment and capabilities of our team,” said Faraz Ali, Chief Executive Officer of Tenaya. “We have momentum as we head into 2024, with three clinical-stage programs for the treatment of rare and prevalent heart conditions and unmatched capabilities focused on the discovery of precision heart disease medications.”
Business and Program Updates
TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
TN-201 for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). MyPeak-1 (NCT05836259) is a multi-center, open-label, dose-escalation trial designed to assess safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-201.
TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction (HFpEF)
Research
Third 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 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 “potential,” “anticipates,” “plans,” “expects,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, the clinical, therapeutic and commercial potential of, and expectations regarding, Tenaya’s product candidates; Tenaya’s plans and expectations regarding its clinical development efforts and activities, including the planned timing of sharing initial data from the Phase 1b clinical trial of TN-201 and planned initiation of a Phase 1b clinical trial of TN-401; the sufficiency of Tenaya’s cash resources to fund the company into the first half 2025; 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: 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; the availability of data at the referenced times; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; 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 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
Michelle Corral |
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Investors |
Julie Seidel |
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Media |
Wendy Ryan |
TENAYA THERAPEUTICS, INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
23,091 |
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$ |
23,758 |
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$ |
75,173 |
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$ |
68,789 |
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General and administrative |
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7,829 |
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7,540 |
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24,574 |
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22,282 |
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Total operating expenses |
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30,920 |
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31,298 |
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99,747 |
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91,071 |
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Loss from operations |
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(30,920 |
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(31,298 |
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(99,747 |
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(91,071 |
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Other income, net: |
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Interest income |
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1,776 |
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596 |
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5,586 |
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917 |
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Other income, net |
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1 |
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6 |
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12 |
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5 |
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Total other income, net |
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1,777 |
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602 |
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5,598 |
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922 |
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Net loss before income tax expense |
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(29,143 |
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(30,696 |
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(94,149 |
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(90,149 |
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Income tax expense |
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— |
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— |
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— |
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— |
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Net loss |
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$ |
(29,143 |
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$ |
(30,696 |
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$ |
(94,149 |
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$ |
(90,149 |
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Net loss per share, basic and diluted |
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$ |
(0.39 |
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$ |
(0.74 |
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$ |
(1.28 |
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$ |
(2.18 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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73,924,937 |
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41,358,296 |
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73,579,200 |
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41,309,812 |
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TENAYA THERAPEUTICS, INC.
Condensed Balance Sheet Data
(In thousands)
(Unaudited)
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September 30, |
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December 31, |
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2023 |
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2022 |
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Cash, cash equivalents and marketable securities |
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$ |
128,120 |
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$ |
204,230 |
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Total assets |
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$ |
193,397 |
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$ |
278,945 |
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Total liabilities |
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$ |
28,513 |
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$ |
35,569 |
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Total liabilities and stockholders’ equity |
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$ |
193,397 |
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$ |
278,945 |
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