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
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
|
|||
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
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 |
|
Trading Symbol(s) |
|
Name of exchange on which registered |
|
|
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 18, 2024, Tenaya Therapeutics, Inc. (the “Company”) issued a press release announcing the Company's financial results for the quarter ended December 31, 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 |
|
Description |
|
|
|
99.1 |
|
Press Release of Tenaya Therapeutics, Inc., dated March 18, 2024 |
104 |
|
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.
|
|
TENAYA THERAPEUTICS, INC. |
||
|
|
By: |
|
/s/ Leone D. Patterson, M.B.A. |
|
|
|
|
Leone D. Patterson, M.B.A. |
|
|
|
|
Chief Financial and Business Officer |
|
|
|
|
|
Date: March 18, 2024 |
|
|
|
|
Exhibit 99.1
Tenaya Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
Initial Data from Ongoing MyPeak™-1 Phase 1b of TN-201 for MYBPC3-associated HCM Expected in Second Half of 2024
On Track to Dose First Patient in RIDGE™-1Phase 1b Clinical Trial of TN-401 for
PKP2-associated ARVC in Second Half 2024
$47 Million Net Proceeds from Recent Financing Extends Cash Runway into
Second Half of 2025
SOUTH SAN FRANCISCO, Calif., March 18, 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 fourth quarter and full year ended December 31, 2023, and provided a corporate update.
“Tenaya had a successful year of sustained execution in 2023 that meaningfully advanced our portfolio of genetic medicines for heart disease. We announced IND clearance for the TN-201 and TN-401 gene therapy programs; activated clinical trial sites in the USA, Canada, and Europe; dosed the first patient with TN-201; manufactured sufficient clinical trial material for both gene therapy programs at our own cGMP facility; and presented compelling preclinical data from our gene editing and capsid engineering efforts,” said Faraz Ali, Chief Executive Officer of Tenaya. “We look forward to focusing efforts in 2024 on generating early clinical data with TN-201 from the MyPeak-1 study and on initiating patient dosing with TN-401 in the RIDGE-1 study.”
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)
Follow-on Financing
In February 2024, Tenaya completed a follow-on offering with net proceeds of $46.5 million after discounts, commissions, and other offering expenses. The offering consisted of approximately 8.89 million shares of common stock priced at $4.50 per share and, in lieu of common stock for one investor, pre-funded warrants to purchase up to an aggregate of approximately 2.2 million shares at a price of $4.499 per pre-funded warrant. The offering included participation from new and existing investors, The Column Group, RA Capital Management, Venrock Healthcare Capital Partners, Octagon Capital, funds and accounts managed by BlackRock, Armistice Capital, Integral Health Asset Management, PFM Health Sciences, LP and Soleus Capital.
Fourth Quarter and Full Year 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 integrated proprietary core capabilities enabling target identification and validation, design of AAV-based genetic medicines and in-house manufacturing 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 “expected,” “on track,” “look forward,” “anticipates,” “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 the planned timing of sharing initial data from MyPeak-1 and planned initiation of patient dosing in RIDGE-1; 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 |
|
Investors |
Anne-Marie Fields |
Media |
TENAYA THERAPEUTICS, INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
22,865 |
|
|
$ |
25,748 |
|
|
$ |
98,038 |
|
|
$ |
94,537 |
|
General and administrative |
|
|
8,581 |
|
|
|
8,802 |
|
|
|
33,155 |
|
|
|
31,084 |
|
Total operating expenses |
|
|
31,446 |
|
|
|
34,550 |
|
|
|
131,193 |
|
|
|
125,621 |
|
Loss from operations |
|
|
(31,446 |
) |
|
|
(34,550 |
) |
|
|
(131,193 |
) |
|
|
(125,621 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
1,470 |
|
|
|
1,037 |
|
|
|
7,056 |
|
|
|
1,954 |
|
Other income (expense), net |
|
|
41 |
|
|
|
(3 |
) |
|
|
53 |
|
|
|
2 |
|
Total other income, net |
|
|
1,511 |
|
|
|
1,034 |
|
|
|
7,109 |
|
|
|
1,956 |
|
Net loss before income tax expense |
|
|
(29,935 |
) |
|
|
(33,516 |
) |
|
|
(124,084 |
) |
|
|
(123,665 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(29,935 |
) |
|
$ |
(33,516 |
) |
|
$ |
(124,084 |
) |
|
$ |
(123,665 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.61 |
) |
|
$ |
(1.68 |
) |
|
$ |
(2.76 |
) |
Weighted-average shares used in computing net loss per share, basic and diluted |
|
|
74,097,642 |
|
|
|
55,250,372 |
|
|
|
73,786,126 |
|
|
|
44,823,597 |
|
TENAYA THERAPEUTICS, INC.
Condensed Balance Sheet Data
(In thousands)
(Unaudited)
|
|
December 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Cash, cash equivalents and marketable securities |
|
$ |
104,642 |
|
|
$ |
204,230 |
|
Total assets |
|
$ |
170,515 |
|
|
$ |
278,945 |
|
Total liabilities |
|
$ |
31,091 |
|
|
$ |
35,569 |
|
Total liabilities and stockholders’ equity |
|
$ |
170,515 |
|
|
$ |
278,945 |
|