Full Press Release Details
Tenaya Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Updates
SOUTH SAN FRANCISCO, Calif. - (BUSINESS WIRE) -November 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."
Business and Program Updates
Third Quarter 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 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)
| 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
| 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 AND STOCKHOLDERS' 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 |
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