TNYA 8-K
Tenaya Therapeutics, Inc. (TNYA)
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):
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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 May 14, 2024, Tenaya Therapeutics, Inc. (“Tenaya”) issued a press release announcing Tenaya’s financial results for the quarter ended March 31, 2024 (“the Earnings Press Release”). The full text of the Earnings 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 2.05 Costs Associated with Exit or Disposal Activities.
On May 14, 2024, Tenaya announced cost containment measures, including a committed plan to reduce its workforce (the “Workforce Reduction”). The cost containment measures align with Tenaya’s focus on generating data from its clinical-stage gene therapy programs.
Employees impacted by the Workforce Reduction were notified on May 13, 2024, and represent approximately 22% of the workforce. In connection with the Workforce Reduction, Tenaya estimates that it will incur approximately $1.3 million to $1.5 million, of aggregate charges, primarily related to employee cash severance and continuing health benefits, which costs are expected to be substantially recognized during the second quarter of 2024.
The foregoing estimates that Tenaya expects to incur in connection with the Workforce Reduction are contingent upon various assumptions and actual results may differ. Tenaya may also incur additional costs not currently contemplated due to events related to or resulting from the Workforce Reduction.
A copy of the press release announcing the cost containment measures is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including statements regarding the continued development of Tenaya’s clinical-stage gene therapy programs and the implementation of the Workforce Reduction, including expected charges relating thereto and the objectives and anticipated timing thereof. Actual results may differ from those set forth in or implied by this Current Report on Form 8-K due to the risks and uncertainties associated with Tenaya’s ability to conduct clinical trials of TN-201 and TN-401 sufficient to achieve a positive completion; risks related to the potential failure of TN-201 and TN-401 to demonstrate safety and efficacy in clinical trials; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; the uncertain timing and level of expenses associated with the development of TN-201 and TN-401; risks related to Tenaya’s ability to implement the Workforce Reduction and its impact on Tenaya’s business; the level of charges resulting from the Workforce Reduction; market competition; changes in economic and business conditions, and other factors described in Tenaya’s other filings with the Securities Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this Current Report on Form 8-K speak only as of the date hereof, and Tenaya specifically disclaims any obligation to update any forward-looking statement, except as required by law.
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 May 14, 2024 |
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: May 14, 2024 |
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Exhibit 99.1
Tenaya Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update
Initial Data from Ongoing MyPEAKTM-1 Phase 1b of TN-201 Expected in Second Half of 2024
Clinical Sites Activated for RIDGETM-1 Phase 1b Clinical Trial of TN-401
Announced Cost Containment Measures in Alignment with Focus on Generating Data from
Clinical-Stage Gene Therapy Programs
Raised $47 Million Net Proceeds in First Quarter Financing; Current Cash
Runway into Second Half of 2025
SOUTH SAN FRANCISCO, Calif., May 14, 2024 -- 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 first quarter ended March 31, 2024, and provided a corporate update.
“The year is off to a strong start for Tenaya,” said Faraz Ali, Chief Executive Officer of Tenaya. “We remain laser focused on dosing patients and generating clinical data for our TN-201 and TN-401 programs to reach value-creative milestones and on managing our overall resources to ensure we maintain sufficient runway to achieve those milestones.”
Business and Program Updates
TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
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 and Manufacturing
Corporate Updates
First Quarter 2024 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 “focused,” “anticipates,” “plans,” “expects,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, Tenaya’s plans and expectations regarding its clinical development efforts and activities, including dosing patients and generating data for MyPEAK-1 and RIDGE-1; Tenaya’s focus on managing overall resources; planned timing of sharing initial data from MyPEAK-1 and planned timing for initiation of patient dosing in RIDGE-1; timing for implementation of Tenaya’s cost containment measures including a committed plan to reduce its workforce; the clinical, therapeutic and commercial potential of, and expectations regarding, Tenaya’s product candidates; the sufficiency of Tenaya’s cash resources to fund the company into the second 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: the timing and progress of Tenaya’s clinical trials; availability of data at the referenced times; unexpected concerns that may arise as a result of the occurrence of adverse safety events in Tenaya’s clinical trials; the potential failure of Tenaya’s product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; 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; 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 |
Anne-Marie Fields |
Media |
TENAYA THERAPEUTICS, INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
25,055 |
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$ |
25,605 |
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General and administrative |
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8,707 |
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8,118 |
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Total operating expenses |
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33,762 |
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33,723 |
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Loss from operations |
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(33,762 |
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(33,723 |
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Other income, net: |
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Interest income |
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1,452 |
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1,973 |
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Other income, net |
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82 |
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13 |
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Total other income, net |
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1,534 |
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1,986 |
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Net loss before income tax expense |
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(32,228 |
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(31,737 |
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Income tax expense |
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— |
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— |
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Net loss |
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$ |
(32,228 |
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$ |
(31,737 |
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Net loss per share, basic and diluted |
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$ |
(0.40 |
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$ |
(0.43 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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80,982,326 |
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73,097,889 |
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TENAYA THERAPEUTICS, INC.
Condensed Balance Sheet Data
(In thousands)
(Unaudited)
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March 31, |
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2024 |
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2023 |
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Cash, cash equivalents and marketable securities |
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$ |
122,249 |
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$ |
104,642 |
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Total assets |
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$ |
184,899 |
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$ |
170,515 |
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Total liabilities |
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$ |
26,719 |
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$ |
31,091 |
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Total liabilities and stockholders’ equity |
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$ |
184,899 |
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$ |
170,515 |
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