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


Leadership team strengthened with the addition of Sunita Sethi as Senior Vice President of Regulatory Affairs and Naymisha Patel as Senior Vice President of Quality

SOUTH SAN FRANCISCO, Calif., March 23, 2022–(BUSINESS WIRE)–Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company whose mission is to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, provided today updates on activities and programs, and released financial results for the fourth quarter and year ended December 31, 2021.

“In 2021, we achieved significant milestones in research, preclinical studies, manufacturing and enterprise, in line with our commitment to advancing the treatment of heart disease with disease-modifying therapies. Our progress continues in 2022 with three therapeutic candidates advancing to the clinic, and with increasingly robust manufacturing and clinical development capabilities,” said Faraz Ali, President and CEO 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 to a clinical-stage company.”

Updates on activities and programs

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

  • Sunita Sethi, Pharm.D., has been named senior vice president of regulatory affairs. Dr. Sethi has over thirty years of relevant industry experience, having held leadership positions in regulatory, medical affairs, clinical research and pharmacovigilance at Astra Zeneca, Pharmacyclics, Elan Pharmaceuticals , J&J and Parke Davis. Most recently, she served as Senior Vice President, Head of Global Regulatory Affairs at ChemoCentryx, leading efforts to support the company’s first FDA approval for an orphan indication. Dr. Sethi earned his BS from Rutgers University and Pharm.D. from the University of South Carolina.

  • Naymisha (Isha) Patel, MBA, has been named senior vice president of quality. Ms. Patel has over twenty-five years of experience in the quality and compliance industry, with a focus on building quality functions from the ground up for various therapies, including some cell and gene therapies. She has held progressive leadership positions at Ocular Therapeutics, Prothena, StemCells, Geron and Nektar Therapeutics. Prior to joining Tenaya, Ms. Patel served as Vice President, Quality, for Evolus Inc., where she strengthened quality systems in support of the global commercialization of medical aesthetic products. Ms. Patel holds a BS from Maharaja Sayajirao University (MS), India, a BA from California State University and an MBA from Northcentral University.

  • Kee Hong Kim, Ph.D., has been promoted to chief technology officer. Dr. Kim has served as Senior Vice President, Manufacturing and Technical Operations at Tenaya since October 2018, and has led Tenaya’s efforts to internalize process development, analytical development, and quality control capabilities, and has oversaw the establishment of the Tenaya cGMP manufacturing facility. Prior to joining Tenaya, he held progressive leadership positions at several gene and cell therapy companies, including Agilis Biotherapeutics, Shire, Avalanche Biotechnologies (now Adverum), and Dendreon.

2021 Financial Highlights

  • Treasury : As of December 31, 2021, cash, cash equivalents and investments in marketable securities were $251.3 million, compared to $128.5 million as of December 31, 2020. Tenaya expects the cash, cash equivalents and current investments in marketable securities are sufficient to fund its current assets. operating plan until at least the second half of 2023.

  • Research and development (R&D) costs: R&D expenses for the year ended December 31, 2021 were $54.4 million, compared to $31.1 million in 2020. Non-cash stock-based compensation included in R&D expenses s amounted to $1.2 million for the year ended December 31, 2021.

  • General and Administrative Expenses (G&A): General and administrative expenses for the year ended December 31, 2021 were $18.4 million in 2021, compared to $7.8 million in 2020. Non-cash stock-based compensation included in expenses general and administrative was $1.8 million for the year ended December 31, 2021.

  • Net loss: Net loss for the year ended December 31, 2021 was $72.7 million, or $4.10 per share, compared to a net loss of $38.4 million, or $39.50 per share. share, for the year ended December 31, 2020.

About Tenaya Therapeutics
Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that attack the underlying drivers of heart disease. Founded by leading cardiovascular scientists from the Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya develops therapies for rare genetic cardiovascular disorders, as well as more prevalent heart diseases, through three distinct but interdependent products: gene therapy, cell 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 statements 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 on Tenaya’s current expectations. and involve assumptions that may never materialize or could These forward-looking statements do not constitute promises or guarantees and are subject to a variety of risks and uncertainties, including, but not limited to: risks associated with process of discovery, development and commercialization of safe and effective drugs for use as human therapeutics and to function as a start-up business; 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 other Tenaya programs; Tenaya’s ability to raise any additional financing it needs to pursue its business and product development plans; adverse 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 possibility that results of a clinical trial will differ from preclinical, interim, preliminary, primary or expected results; Tenaya’s manufacturing, sales and marketing capabilities and strategy; loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s dependence 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 can be found in the section titled “Risk Factors” in documents 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 undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except if required by law.

TENAYA THERAPEUTICS, INC.
Condensed Income Statements
(In thousands, except per share and per share data)
(Unaudited)

Quarter ended December 31

Year ended December 31

2021

2020

2021

2020

Operating costs :

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

Operating loss

(26,164)

(10,322)

(72,806)

(38,912)

Other income (expenses), net:

interest income

67

5

108

87

Change in fair value of convertible bonds
share tranche liabilities

75

Other income (expenses), net

(54)

(1)

(23)

355

Total other income (expenses), 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 the calculation of net loss per share,
basic and dilute

41,253,720

1,046,790

17,734,166

972 091

TENAYA THERAPEUTICS, INC.
Condensed balance sheets
(In thousands)
(Unaudited)

The 31st of December,

The 31st of December,

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 SHARES AND
EQUITY (DEFICIT)

Current liabilities

21,774

5,041

Deferred rent and other lease obligations, non-current

3,662

Operating lease debts, non-current

13,707

Other non-current liabilities

182

19

Convertible preferred shares

220,754

Equity (deficit)

278,526

(81,315)

Total Liabilities, Convertible Preferred Shares and Equity (Deficit)

$

314 189

$

148 161

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220323005199/en/

contacts

Investors
michelle corral
Vice President, Investor Relations and Corporate Communications
Therapeutic Tenaya
[email protected]

Media
wendy ryan
Ten-bridge communications
[email protected]

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