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:
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 8, 2024, Tenaya Therapeutics, Inc. (“Tenaya or the “Company”) issued a press release announcing Tenaya’s financial results for the quarter ended June 30, 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 (“Exchange Act”), 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Interim Principal Financial Officer
Effective August 14, 2024, upon Ms. Leone Patterson ceasing to be the Chief Financial and Business Officer, Principal Financial Officer (PFO) and Principal Accounting Officer (PAO) for Tenaya, Faraz Ali, Chief Executive Officer of Tenaya, will become Interim PFO in addition to his role as Chief Executive Officer.
For Mr. Ali’s biographical information, see the disclosure included under the heading “Management and Corporate Governance - Director Biographies” included in Tenaya’s definitive proxy statement for the 2024 annual meeting of stockholders filed with the Securities and Exchange Commission (“SEC”) on April 14, 2024, which disclosure is incorporated by reference herein.
There are no arrangements or understandings between Mr. Ali and any other persons in connection with Mr. Ali’s appointment as Interim PFO. Mr. Ali has no family relationships with any of Tenaya’s directors or executive officers, and he has no direct or indirect material interest in any transaction or proposed transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K, promulgated under the Exchange Act. Mr. Ali is continuing under the terms of his existing compensation arrangement with the Company.
Appointment of Interim Principal Accounting Officer
Effective August 14, 2024, upon Ms. Patterson ceasing to be PAO, Ms. Chihiro Saito, Tenaya’s Senior Vice President, Accounting and Financial Operations, will assume the role of Interim PAO for the Company in addition to her role as Senior Vice President, Accounting and Financial Operations.
Ms. Saito, age 58, has served as Tenaya’s Senior Vice President, Accounting and Financial Operations since August 2024 and previously as Vice President, Corporate Controller, from September 2021 until July 2024. Prior to joining Tenaya, Ms. Saito was Head of Financial Reporting at Gilead Sciences, Inc., a publicly traded biopharmaceutical company, from June 2020 to September 2021. From 2002 to June 2020, she held various roles of increasing responsibility in the finance department at McKesson Corporation, culminating in Vice President, Accounting and Financial Reporting. Prior to McKesson, she served as Assistant Controller at Viador, Inc. and as an Assurance Manager at Aurthur Anderson LLP. Ms. Saito is a Certified Public Accountant and holds a B.A. in Political, Legal and Economic Analysis from Mills College and an M.S. in Business Administration, Accounting from San Francisco State University.
There are no arrangements or understandings between Ms. Saito and any other persons in connection with Ms. Saito’s appointment as Interim PAO. Ms. Saito has no family relationships with any of Tenaya’s directors or executive officers, and she has no direct or indirect material interest in any transaction or proposed transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K promulgated under the Exchange Act. Ms. Saito is continuing under the terms of her existing compensation arrangement with the Company.
In connection with Ms. Saito’s appointment, the Company plans to enter into its standard form of director and officer indemnification agreement with Ms. Saito. The foregoing description of the indemnification agreement is qualified in its entirety by reference to the full text of such agreement, the form of which was filed as Exhibit 10.1 to the Company’s registration statement on Form S-1/A, filed with the SEC on June 26, 2021, and incorporated in this Item 5.02 by reference.
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 8, 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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Date: |
August 8, 2024 |
By: |
/s/ Leone D. Patterson, M.B.A. |
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Chief Financial and Business Officer |
Exhibit 99.1
Tenaya Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
Received Rare Pediatric Disease Designation from U.S. Food and Drug Administration for
TN-201 for MYBPC3-associated Hypertrophic Cardiomyopathy
Received UK Clearance to Initiate Clinical Testing of TN-401 for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy
Established $45 Million Credit Facility with Silicon Valley Bank to Provide Financial Flexibility Ahead of Multiple Potential Milestones
SOUTH SAN FRANCISCO, Calif., August 8, 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 second quarter ended June 30, 2024, and provided a corporate update.
“We remain laser focused on advancing our lead gene therapy candidates, as we prepare to report initial data from our first-in-human study of TN-201 in the second half and to dose the first patient in our Phase 1b trial of TN-401 in the fourth quarter of 2024. Our focus on clinical execution now and in the future is evident with more than forty sites in seven countries across our interventional and natural history studies for both programs, and with the recent receipt of rare pediatric disease designation for MYBPC3-associated HCM in infants, children and adolescents,” said Faraz Ali, Chief Executive Officer of Tenaya. “Consistent with that focus, we have taken important steps to increase our financial flexibility in anticipation of additional clinical data readouts in 2025.”
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)
Research and Manufacturing
Corporate Updates
Second 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,” “estimates”, "may,” “will” 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 site activation, enrolling and dosing patients and generating data for MyPEAK-1 and RIDGE-1 and the RIDGE natural history study; the timing of executive departures and appointments; Tenaya’s potential to receive a priority review voucher; planned timing of sharing initial data from MyPEAK-1 and additional clinical data readouts; 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 the availability of the credit facility to extend that runway; 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 comply with specified operating covenants and restrictions in its loan agreement; 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 June 30, |
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Six Months Ended June 30, |
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2024 |
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2023 |
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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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$ |
22,649 |
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$ |
26,477 |
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$ |
47,704 |
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$ |
52,082 |
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General and administrative |
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8,174 |
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8,627 |
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16,881 |
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16,745 |
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Total operating expenses |
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30,823 |
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35,104 |
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64,585 |
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68,827 |
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Loss from operations |
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(30,823 |
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(35,104 |
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(64,585 |
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(68,827 |
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Other income, net: |
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Interest income |
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1,393 |
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1,837 |
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2,845 |
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3,810 |
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Other income (loss), net |
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(1 |
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(2 |
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81 |
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11 |
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Total other income, net |
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1,392 |
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1,835 |
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2,926 |
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3,821 |
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Net loss before income tax expense |
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(29,431 |
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(33,269 |
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(61,659 |
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(65,006 |
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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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$ |
(29,431 |
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$ |
(33,269 |
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$ |
(61,659 |
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$ |
(65,006 |
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Net loss per share, basic and diluted |
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$ |
(0.34 |
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$ |
(0.45 |
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$ |
(0.74 |
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$ |
(0.89 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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85,706,501 |
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73,399,847 |
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83,344,414 |
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73,249,702 |
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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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2024 |
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2023 |
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Cash, cash equivalents and marketable securities |
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$ |
99,303 |
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$ |
104,642 |
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Total assets |
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$ |
163,185 |
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$ |
170,515 |
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Total liabilities |
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$ |
29,188 |
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$ |
31,091 |
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Total liabilities and stockholders’ equity |
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$ |
163,185 |
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$ |
170,515 |
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