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Press release content from Business Wire. The AP news staff was not involved in its creation.
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Press release content from Business Wire. The AP news staff was not involved in its creation.

Tenaya Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Updates

November 10, 2021 GMT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov 10, 2021--

Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today reported business and program updates and third quarter 2021 financial results.

“The third quarter of 2021 was a significant marker in Tenaya’s history with the successful completion of our IPO, and it also represented a period of growth for the company as we continued to make progress on our key pipeline programs and operations,” said Faraz Ali, CEO of Tenaya. “We are pleased to announce the initiation of our global natural history study for pediatric patients with MYBPC3 mutations, as this supports our TN-201 gene therapy program as well as our evolution towards becoming a clinical-stage company. The initiation of cGMP manufacturing for TYA-11631 is an important operational milestone and another step in the direction of our vision for modality-agnostic drug discovery. The first-ever presentation of data supporting our PKP2 gene therapy program at an important scientific conference provides new hope for individuals and families fighting the leading genetic cause of Arrhythmogenic Right Ventricular Cardiomyopathy, a severe disease with high unmet need.”

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Business and Program Updates

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  • TN-201 – MYBPC3 Gene Therapy Program for Genetic HCM (gHCM):
    • Pre-clinical data on the treatment in a severe MYBPC3 mutant mouse model of gHCM with TN-201 demonstrating extended survival to 18 months after a single dose and continued improvement in functional measures was presented at the annual meeting of the European Society of Gene and Cell Therapy (ESGCT) in October 2021.
    • Tenaya has initiated a global natural history study to improve our understanding of disease progression and unmet need in individuals carrying mutations in the MYBPC3 gene, with an initial focus on pediatric patients under the age of 18. For additional information about the natural history study, please visit www.clinicaltrials.gov using Identifier NCT05112237. These efforts may support the evaluation of Tenaya’s TN-201 gene therapy product candidate in this patient population during clinical development.
    • Tenaya has initiated IND-enabling activities and intends to submit an investigational new drug (IND) application or clinical trial application (CTA) to the U.S. Food and Drug Administration (FDA) or European Medicine Agency (EMA), respectively, in 2022.
  • TYA-11631 – HDAC6 Inhibitor (HDAC6i) Small Molecule for Heart Failure with Preserved Ejection Fraction (HFpEF)
    • Tenaya has initiated cGMP manufacturing activities to support the production of TYA-11631 at larger scales. Tenaya had previously announced initiation of IND-enabling activities and intends to submit an IND to the FDA in 2022.
  • PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
    • Pre-clinical data on the treatment of a severe mouse model of ARVC due to PKP2 gene mutations with Tenaya’s gene therapy product construct demonstrated prevention of symptoms and continued, significant improvement in functional measures and survival benefit at 15 weeks after a single dose as presented in a poster at ESGCT. Mutations due to the PKP2 gene are the leading genetic cause of ARVC, a severe disease estimated to effect more than 70,000 patients in the US alone and with no approved disease-specific therapies.
  • Strong balance sheet with net proceeds of $188.5 million from the sale of 13.8 million shares of its common stock in the Company’s initial public offering (IPO), bringing cash, cash equivalents and investments in marketable securities to $280.5 million as of September 30, 2021.

Third Quarter 2021 Financial Highlights

  • Cash Position: As of September 30, 2021, Tenaya had cash, cash equivalents and investments in marketable securities of $280.5 million which included net proceeds from the Company’s IPO in August 2021. Tenaya expects its current cash, cash equivalents and investments in marketable securities will be sufficient to fund its current operating plan at least into the second half of 2023.
  • Research & Development (R&D) Expenses: R&D expenses were $12.9 million for the third quarter of 2021. Non-cash stock-based compensation included in R&D expense was $0.3 million for the third quarter of 2021.
  • General & Administrative (G&A) Expenses: G&A expenses were $5.4 million for the third quarter of 2021. Non-cash stock-based compensation included in G&A expense was $0.6 million for the third quarter of 2021.
  • Net Loss: Net loss was $18.3 million, or $0.68 on a per share basis, for the third quarter of 2021.

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 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. Such forward-looking statements include, among other things, statements regarding the potential of and expectations regarding Tenaya’s product candidates and programs, including TN-201 and TYA-11631; statements regarding the expected timing of IND and CTA submissions to the FDA or EMA, respectively, for Tenaya’s product candidates; statements regarding the sufficiency of Tenaya’s cash, cash equivalents and investments in marketable securities to fund its operating plan; and statements by Tenaya’s chief executive officer. Words such as “expects,” “intends,” “potential,” “utility,” and “will,” and similar expressions are intended to identify forward-looking statements. 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. Actual results could differ materially from those projected in any forward-looking statements due to numerous 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 clinical stage company including the potential for Tenaya’s product candidates to cause serious adverse events; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates for heart failure patients or other patient populations; the timing, progress and results of preclinical studies and clinical trials for TN-201 and TYA-11631 and Tenaya’s other product candidates and 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 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 ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; 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 the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

TENAYA THERAPEUTICS, INC.

Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

12,944

 

 

$

8,480

 

 

$

33,440

 

 

$

22,735

 

General and administrative

 

 

5,356

 

 

 

1,972

 

 

 

13,202

 

 

 

5,855

 

Total operating expenses

 

 

18,300

 

 

 

10,452

 

 

 

46,642

 

 

 

28,590

 

Loss from operations

 

 

(18,300

)

 

 

(10,452

)

 

 

(46,642

)

 

 

(28,590

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

23

 

 

 

7

 

 

 

41

 

 

 

82

 

Change in fair value of convertible preferred stock tranche liability

 

 

 

 

 

151

 

 

 

 

 

 

75

 

Other income (expense), net

 

 

15

 

 

 

(1

)

 

 

31

 

 

 

356

 

Total other income (expense), net

 

 

38

 

 

 

157

 

 

 

72

 

 

 

513

 

Net loss before income tax expense

 

 

(18,262

)

 

 

(10,295

)

 

 

(46,570

)

 

 

(28,077

)

Income tax expense

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

(18,262

)

 

 

(10,295

)

 

 

(46,570

)

 

 

(28,077

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on marketable securities

 

 

(23

)

 

 

 

 

 

(23

)

 

 

 

Comprehensive loss

 

$

(18,285

)

 

$

(10,295

)

 

$

(46,593

)

 

$

(28,077

)

Net loss per share, basic and diluted

 

$

(0.68

)

 

$

(10.29

)

 

$

(4.75

)

 

$

(29.65

)

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

 

 

26,895,716

 

 

 

1,000,052

 

 

 

9,808,162

 

 

 

947,009

 

TENAYA THERAPEUTICS, INC.

Condensed Balance Sheets
(In thousands)

 

 

September 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

ASSETS

 

(Unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

117,077

 

 

$

128,535

 

Investments in marketable securities

 

 

163,388

 

 

 

 

Prepaid expenses and other current assets

 

 

4,357

 

 

 

1,429

 

Total current assets

 

 

284,822

 

 

 

129,964

 

Property and equipment, net

 

 

30,891

 

 

 

17,185

 

Operating lease right-of-use assets

 

 

12,006

 

 

 

 

Restricted cash, non-current

 

 

547

 

 

 

547

 

Other non-current assets

 

 

3,528

 

 

 

465

 

Total assets

 

$

331,794

 

 

$

148,161

 

LIABILITIES, CONVERTIBLE PREFERRED STOCK ANDSTOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

6,171

 

 

$

1,017

 

Accrued expenses and other current liabilities

 

 

5,607

 

 

 

3,161

 

Deferred rent and other lease liabilities, current

 

 

 

 

 

863

 

Operating lease liabilities, current

 

 

1,914

 

 

 

 

Total current liabilities

 

 

13,692

 

 

 

5,041

 

Deferred rent and other lease liabilities, non-current

 

 

 

 

 

3,662

 

Operating lease liabilities, non-current

 

 

14,307

 

 

 

 

Other non-current liabilities

 

 

96

 

 

 

19

 

Total liabilities

 

 

28,095

 

 

 

8,722

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Convertible preferred stock

 

 

 

 

 

220,754

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

 

 

Common stock

 

 

4

 

 

 

 

Additional paid-in capital

 

 

433,112

 

 

 

1,584

 

Notes receivable from stockholders

 

 

(12

)

 

 

(87

)

Accumulated other comprehensive loss

 

 

(23

)

 

 

 

Accumulated deficit

 

 

(129,382

)

 

 

(82,812

)

Total stockholders’ equity (deficit)

 

 

303,699

 

 

 

(81,315

)

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

 

$

331,794

 

 

$

148,161

 

 

View source version on businesswire.com:https://www.businesswire.com/news/home/20211110006154/en/

CONTACT: Investors

Leone Patterson

Tenaya Therapeutics

IR@tenayathera.comMedia

Kit Rodophele

Ten Bridge Communications

krodophele@tenbridgecommunications.com

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH SCIENCE RESEARCH CARDIOLOGY

SOURCE: Tenaya Therapeutics, Inc.

Copyright Business Wire 2021.

PUB: 11/10/2021 04:05 PM/DISC: 11/10/2021 04:06 PM

http://www.businesswire.com/news/home/20211110006154/en