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Tenaya Therapeutics Reports Fourth Quarter and Year-End 2021 Financial Results and Provides Business Updates

Strengthened Leadership Team with the Additions of Sunita Sethi as Senior Vice President of Regulatory Affairs and Naymisha Patel as Senior Vice President of Quality

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today provided business and program updates, and reported financial results for the fourth quarter and full year ended December 31, 2021.

“In 2021, we achieved important milestones across research, preclinical, manufacturing and corporate operations, in line with our commitment to advance the treatment of heart disease with disease-modifying therapeutics. Our progress continues in 2022 with three therapeutic candidates advancing towards the clinic, and with increasingly robust manufacturing and clinical development capabilities,” said Faraz Ali, Chief Executive Officer of Tenaya. “With the appointments of Dr. Sethi and Ms. Patel, we continue to add depth, breadth, and diversity to our leadership team to support our transition into a clinical-stage company.”

Business and Program Updates

Tenaya continues to strengthen its leadership team with the following appointments and promotions.

Full Year 2021 Financial Highlights

About Tenaya Therapeutics

Tenaya Therapeutics is a 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 “expects” “and “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements regarding the expected timing of IND applications for TN-201, TN-301 and TN-401, statements regarding the cGMP manufacturing facility, the sufficiency of projected cash flows, 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: 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; the timing, progress and results of preclinical studies for TN-201, TN-301, TN-401 and Tenaya’s other programs; 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 timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; 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 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.

 

 

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,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

20,953

 

 

$

8,364

 

 

$

54,393

 

 

$

31,099

 

General and administrative

 

 

5,211

 

 

 

1,958

 

 

 

18,413

 

 

 

7,813

 

Total operating expenses

 

 

26,164

 

 

 

10,322

 

 

 

72,806

 

 

 

38,912

 

Loss from operations

 

 

(26,164)

 

 

(10,322)

 

 

(72,806)

 

 

(38,912)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

67

 

 

 

5

 

 

 

108

 

 

 

87

 

Change in fair value of convertible preferred

stock tranche liability

 

 

 

 

 

 

 

 

 

 

 

75

 

Other income (expense), net

 

 

(54)

 

 

(1)

 

 

(23)

 

 

355

 

Total other income (expense), net

 

 

13

 

 

 

4

 

 

 

85

 

 

 

517

 

Net loss

 

$

(26,151)

 

$

(10,318)

 

$

(72,721)

 

$

(38,395)

Net loss per share, basic and diluted

 

$

(0.63)

 

$

(9.86)

 

$

(4.10)

 

$

(39.50)

Weighted-average shares used in computing net loss per share,

basic and diluted

 

 

41,253,720

 

 

 

1,046,790

 

 

 

17,734,166

 

 

 

972,091

 

 
 

TENAYA THERAPEUTICS, INC.

Condensed Balance Sheets

(In thousands)

(Unaudited)

 

 

 

December 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

38,129

 

 

$

128,535

 

Investments in marketable securities

 

 

213,171

 

 

 

 

Prepaid expenses and other current assets

 

 

4,058

 

 

 

1,429

 

Total current assets

 

 

255,358

 

 

 

129,964

 

Property and equipment, net

 

 

43,020

 

 

 

17,185

 

Operating lease right-of-use assets

 

 

11,685

 

 

 

 

Restricted cash, non-current

 

 

547

 

 

 

547

 

Other non-current assets

 

 

3,579

 

 

 

465

 

Total assets

 

$

314,189

 

 

$

148,161

 

LIABILITIES, CONVERTIBLE PREFERRED STOCK AND

STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

Current liabilities

 

 

21,774

 

 

 

5,041

 

Deferred rent and other lease liabilities, non-current

 

 

 

 

 

3,662

 

Operating lease liabilities, non-current

 

 

13,707

 

 

 

 

Other non-current liabilities

 

 

182

 

 

 

19

 

Convertible preferred stock

 

 

 

 

 

220,754

 

Stockholders’ equity (deficit)

 

 

278,526

 

 

 

(81,315)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

 

$

314,189

 

 

$

148,161

 

 

 

Contacts

Investors

Michelle Corral

Vice President, Investor Relationship and Corporate Communications

Tenaya Therapeutics

IR@tenayathera.com

Media

Wendy Ryan

Ten Bridge Communications

Wendy@tenbridgecommunications.com

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