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
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
- TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic
Cardiomyopathy
- Tenaya expects to submit an Investigational New Drug (IND)
application to the U.S. Food and Drug Administration (FDA) in the
second half of 2022.
- Site activation and enrollment in the MyClimb Natural History
Study of pediatric patients with MYBPC3 mutations is ongoing.
- TN-301 – HDAC6 Small Molecule Inhibitor for Heart Failure with
Preserved Ejection Fraction
- Tenaya expects to submit an IND application to the FDA in the
second half of 2022.
- TN-401 – PKP2 Gene Therapy Program for Genetic Arrhythmogenic
Right Ventricular Cardiomyopathy
- Tenaya expects to submit an IND application to the FDA in
2023.
- cGMP Manufacturing Facility
- Tenaya expects its state-of-the-art, modular cGMP manufacturing
facility in Union City, California, will become operational in the
first half of 2022.
Tenaya continues to strengthen its leadership team with the
following appointments and promotions.
- Sunita Sethi, Pharm.D., has been appointed Senior Vice
President of Regulatory Affairs. Dr. Sethi has over thirty years of
relevant industry experience, having held leadership roles 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 her B.S. from
Rutgers University and Pharm.D. from the University of South
Carolina.
- Naymisha (Isha) Patel, M.B.A., has been appointed Senior Vice
President of Quality. Ms. Patel has over twenty-five years industry
experience in Quality and Compliance, with a focus on building
Quality functions from the ground up for diverse therapeutics,
including some cell and gene therapies. She has held positions of
increasing leadership 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 global commercialization
of medical aesthetic products. Ms. Patel earned her B.S. from
Maharaja Sayajirao (MS) University, India, B.A. from California
State University, and M.B.A. 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 effort to internalize Process Development, Analytical
Development, and Quality Control capabilities, and overseen the
establishment of Tenaya’s cGMP manufacturing facility. Prior to
joining Tenaya, he served in roles of increasing leadership at
several gene and cell therapies companies, including Agilis
Biotherapeutics, Shire, Avalanche Biotechnologies (now Adverum),
and Dendreon.
Full Year 2021 Financial Highlights
- Cash Position: 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 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 for the full 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 expense was $1.2 million for the
full year ended December 31, 2021.
- General & Administrative (G&A) Expenses: G&A
expenses for the full 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 G&A expense was $1.8
million for the full year ended December 31, 2021.
- Net Loss: Net loss for the full 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, for the full 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 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
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version on businesswire.com: https://www.businesswire.com/news/home/20220323005199/en/
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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