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 August 9, 2023, Tenaya Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 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 August 9, 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: August 9, 2023 |
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Exhibit 99.1
Tenaya Therapeutics Reports Second Quarter 2023 Financial Results and
Provides Business Update
Dosing of First Patient in Phase 1b Trial of TN-201 On Track to Occur in Q3 2023
Data from Phase 1 Clinical Trial of TN-301 Accepted for Presentation at HFSA 2023
IND Application for TN-401 Anticipated in Second Half 2023
Second Quarter Cash and Investments of $152 Million;
Runway to Fund Operations into First Half 2025
SOUTH SAN FRANCISCO, Calif., August 9, 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 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
Tenaya researchers also presented new data at BCVS on August 1, 2023, detailing the company’s drug discovery capabilities for identifying human genetic targets in models of human heart conditions.
Tenaya’s novel high throughput screening methods in human induced pluripotent stem cells derived cardiomyocytes were applied to identifying genes of interest in heart muscle cells.
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 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 June 30, |
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Six Months Ended June 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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$ |
26,477 |
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$ |
20,876 |
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$ |
52,082 |
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$ |
45,031 |
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General and administrative |
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8,627 |
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7,743 |
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16,745 |
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14,742 |
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Total operating expenses |
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35,104 |
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28,619 |
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68,827 |
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59,773 |
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Loss from operations |
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(35,104 |
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(28,619 |
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(68,827 |
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(59,773 |
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Other income (expense), net: |
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Interest income |
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1,837 |
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222 |
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3,810 |
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321 |
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Other income (expense), net |
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(2 |
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— |
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11 |
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(1 |
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Total other income (expense), net |
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1,835 |
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222 |
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3,821 |
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320 |
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Net loss before income tax expense |
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(33,269 |
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(28,397 |
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(65,006 |
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(59,453 |
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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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$ |
(33,269 |
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$ |
(28,397 |
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$ |
(65,006 |
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$ |
(59,453 |
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Net loss per share, basic and diluted |
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$ |
(0.45 |
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$ |
(0.69 |
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$ |
(0.89 |
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$ |
(1.44 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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73,399,847 |
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41,302,157 |
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73,249,702 |
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41,285,168 |
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TENAYA THERAPEUTICS, INC.
Condensed Balance Sheet Data
(In thousands)
(Unaudited)
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June 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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$ |
151,641 |
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$ |
204,230 |
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Total assets |
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$ |
220,754 |
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$ |
278,945 |
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Total liabilities |
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$ |
30,814 |
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$ |
35,569 |
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Total liabilities and stockholders’ equity |
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$ |
220,754 |
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$ |
278,945 |
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