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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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:
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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 March 8, 2023, Tenaya Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2022. 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 March 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: March 8, 2023 |
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Exhibit 99.1
Tenaya Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
TN-201 IND Cleared in January; Plan to Begin Phase 1b Dosing in MYBPC3-associated HCM Patients
in Third Quarter 2023
Dosing Commenced in Multiple-Ascending Dose Stage of First-In-Human Clinical Trial of TN-301; Data Anticipated in Second Half 2023
2022 Year End Cash and Investments of $204 Million; Runway to Fund Operations into First Half 2025
South San Francisco, Calif. – March 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 for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.
“Tenaya enters 2023 well capitalized and with meaningful milestones ahead,” said Faraz Ali, Chief Executive Officer of Tenaya. “This year, we look forward to beginning clinical testing of our lead gene therapy candidate, TN-201, sharing data from our first-in-human clinical trial of TN-301, and submitting an IND for our TN-401 gene therapy candidate, as well as presenting additional data detailing insights on current pipeline candidates and emerging platform innovations.”
Business and Program Updates
TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy (HCM)
TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction (HFpEF)
TN-401 – PKP2 Gene Therapy Program for Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Financing:
Fourth Quarter and Full Year 2022 Financial Highlights
Cash Position: As of December 31, 2022, cash, cash equivalents and investments in marketable securities (current and noncurrent) were $204.2 million. Tenaya expects current cash, cash equivalents and investments in marketable securities (current and noncurrent) will be sufficient to fund the company into the first half of 2025.
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 “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 key milestones, including the initiation of clinical testing of TN-201, data from the first-in-human clinical trial of TN-301, submission of the TN-401 IND and the presentation
of data from pipeline candidates and platform innovations; 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 of, and expectations regarding, Tenaya’s product candidates; 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; negative impacts of the COVID-19 pandemic on Tenaya’s operations, including preclinical studies, planned clinical trials and manufacturing activities; 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)
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Three Months Ended |
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Year Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
25,748 |
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$ |
20,953 |
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$ |
94,537 |
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$ |
54,393 |
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General and administrative |
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8,802 |
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5,211 |
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31,084 |
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18,413 |
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Total operating expenses |
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34,550 |
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26,164 |
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125,621 |
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72,806 |
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Loss from operations |
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(34,550 |
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(26,164 |
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(125,621 |
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(72,806 |
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Other income (expense), net: |
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Interest income |
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1,037 |
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67 |
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1,954 |
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108 |
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Other income (expense), net |
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(3 |
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(54 |
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2 |
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(23 |
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Total other income (expense), net |
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1,034 |
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13 |
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1,956 |
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85 |
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Net loss before income tax expense |
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(33,516 |
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(26,151 |
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(123,665 |
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(72,721 |
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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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(33,516 |
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(26,151 |
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(123,665 |
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(72,721 |
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Net loss per share, basic and diluted |
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$ |
(0.61 |
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$ |
(0.63 |
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$ |
(2.76 |
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$ |
(4.10 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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55,250,372 |
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41,253,720 |
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44,823,597 |
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17,734,166 |
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TENAYA THERAPEUTICS, INC.
Condensed Balance Sheet Data
(In thousands)
(Unaudited)
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and marketable securities |
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$ |
204,230 |
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$ |
251,300 |
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Total assets |
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$ |
278,945 |
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$ |
314,189 |
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Total liabilities |
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$ |
35,569 |
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$ |
35,663 |
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Total liabilities and stockholders’ equity |
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$ |
278,945 |
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$ |
314,189 |
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