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:
Title of each class |
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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 Conditions.
On November 10, 2022, Tenaya Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 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 November 10, 2022 |
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 10, 2022 |
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Exhibit 99.1
Tenaya Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update
Extends Cash Runway to Mid-2024
Commenced Dosing in Phase 1 Clinical Trial of TN-301; Data Expected in 2023
Plans to Submit TN-201 IND by Year End
South San Francisco, Calif. – November 10, 2022—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, 2022.
Tenaya announced the extension of its cash runway to mid-2024. Management believes that existing cash, cash equivalents and investments will be sufficient to support the continued advancement of the company’s product candidates, TN-201, TN-301 and TN-401. This meaningful conservation of resources will be accomplished through prioritization of certain research and development (R&D) and manufacturing expenditures, as well as stringent management of future headcount growth. Tenaya ended the third quarter with $149.5 million in cash, cash equivalents and investments in marketable securities.
“The initiation of our first clinical trial for TN-301 during the third quarter was a major milestone marking our transition to a clinical-stage company. Our unwavering commitment to improve the lives of those affected by heart disease also requires careful management of finite resources and prioritization of portfolio opportunities,” said Faraz Ali, Chief Executive Officer of Tenaya. “With the extension of our cash runway to mid-2024, we believe we can reach meaningful milestones for our more advanced product candidates, TN-201, TN-301 and TN-401, and still continue to selectively invest in research efforts to advance our deep pipeline of earlier-stage programs.”
Program Updates
TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy (HCM)
TN-301 – HDAC6 Small Molecule Inhibitor for Heart Failure with Preserved Ejection Fraction (HFpEF)
TN-401 – PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Research Updates
Third Quarter 2022 Financial Highlights
About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic cardiovascular disorders, as well as for more prevalent heart
conditions, through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. 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 “expected,” “plans,” “believes,” “will,” “can,” “continue,” “potential,” “intends,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, Tenaya’s product candidates and novel capsids; expected timing of data from Tenaya’s TN-301 Phase 1 clinical trial; expected timing for submission of an IND application for TN-201 and expected timing of an update on the status of the IND; Tenaya’s plan to prioritize certain expenditures and manage headcount growth; the sufficiency of the company’s cash resources to support business operations and plans and reach meaningful milestones for the company’s more advanced product candidates; expiration date of a patent covering TN-301; expected timing for submission of an IND application for TN-401 and plans to initiate a global non-interventional study of patients with ARVC; the potential efficacy and safety profile for Tenaya’s novel AAV capsids; 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: the timing, scope and likelihood of regulatory filings and approvals; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials for its product candidates; 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; negative impacts of the COVID-19 pandemic on Tenaya’s manufacturing and operations, including preclinical studies and planned clinical trials; 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 |
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Nine Months 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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$ |
23,758 |
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$ |
12,944 |
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$ |
68,789 |
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$ |
33,440 |
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General and administrative |
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7,540 |
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5,356 |
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22,282 |
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13,202 |
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Total operating expenses |
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31,298 |
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18,300 |
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91,071 |
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46,642 |
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Loss from operations |
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(31,298 |
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(18,300 |
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(91,071 |
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(46,642 |
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Other income (expense), net: |
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Interest income |
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596 |
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23 |
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917 |
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41 |
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Other income (expense), net |
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6 |
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15 |
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5 |
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31 |
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Total other income (expense), net |
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602 |
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38 |
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922 |
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72 |
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Net loss before income tax expense |
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(30,696 |
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(18,262 |
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(90,149 |
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(46,570 |
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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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(30,696 |
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(18,262 |
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(90,149 |
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(46,570 |
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Net loss per share, basic and diluted |
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$ |
(0.74 |
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$ |
(0.68 |
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$ |
(2.18 |
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$ |
(4.75 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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41,358,296 |
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26,895,716 |
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41,309,812 |
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9,808,162 |
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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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2022 |
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2021 |
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Cash, cash equivalents and marketable securities |
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$ |
149,450 |
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$ |
251,300 |
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Total assets |
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$ |
226,310 |
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$ |
314,189 |
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Total liabilities |
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$ |
29,982 |
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$ |
35,663 |
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Total liabilities and stockholders’ equity |
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$ |
226,310 |
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$ |
314,189 |
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