TN-201 Received Orphan Medicinal Product
Designation from the European Commission
Preclinical TN-401 Data Presented at Heart
Rhythm 2022
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 first quarter ended March 31, 2022.
“Tenaya continues to advance a broad pipeline of potentially
first-in-class programs for both rare and prevalent forms of heart
disease,” said Faraz Ali, Chief Executive Officer of Tenaya. “Our
progress is measurable across all aspects of our business. We
recently presented encouraging preclinical data for our emerging
gene therapy program, TN-401, being developed for the treatment of
genetic arrhythmogenic right ventricular cardiomyopathy. Our
IND-enabling efforts for TN-201 and TN-301 are on track, as are
efforts for our cGMP manufacturing facility to become operational.
We are also pleased to announce that TN-201 has been granted orphan
drug designation in Europe.”
Recent Business and Program Updates
TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic
Cardiomyopathy (HCM)
- TN-201 received Orphan Medicinal Product designation from the
European Commission for the treatment of HCM due to mutations in
the MYBPC3 gene. TN-201 has also received Orphan Drug Designation
from the U.S. Food and Drug Administration (FDA).
- Tenaya expects to submit an Investigational New Drug (IND)
application for TN-201 to the FDA in the second half of 2022.
TN-401 – PKP2 Gene Therapy Program for Genetic Arrhythmogenic
Right Ventricular Cardiomyopathy (ARVC)
- Tenaya presented preclinical data at the Heart Rhythm Society’s
annual Heart Rhythm 2022 meeting for its investigational PKP2 gene
therapy, TN-401. In a preclinical study using a Pkp2 knockout mouse
model to assess prevention of disease onset and progression, a
single dose of PKP2 gene therapy restored heart function, reduced
the occurrence of severe arrythmia, prevented adverse remodeling
and fibrosis, and significantly increased survival.
- Tenaya expects to submit an IND application for TN-401 to the
FDA in 2023.
TN-301 – HDAC6 Small Molecule Inhibitor for Heart Failure with
Preserved Ejection Fraction (HFpEF)
- Tenaya expects to submit an IND application for TN-301 to the
FDA in the second half of 2022.
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.
First Quarter 2022 Financial Highlights
- Cash Position: As of March 31, 2022, cash, cash
equivalents and investments in marketable securities (current and
noncurrent) were $213.5 million. Tenaya expects current cash, cash
equivalents and investments in marketable securities (current and
noncurrent) 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 first quarter ended March 31, 2022, were $24.2
million. Non-cash stock-based compensation included in R&D
expense was $1.0 million for the first quarter ended March 31,
2022.
- General & Administrative (G&A) Expenses: G&A
expenses for the first quarter ended March 31, 2022, were $7.0
million. Non-cash stock-based compensation included in G&A
expense was $1.1 million for the first quarter ended March 31,
2022.
- Net Loss: Net loss for the first quarter ended March 31,
2022, was $31.1 million, or $0.75 per share.
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 “potentially,” “on
track”, “expects”, “will,” and similar expressions are intended to
identify forward-looking statements. Such forward-looking
statements include, among other things, statements regarding the
breadth, timing and therapeutic potential of Tenaya’s pipeline;
statements regarding IND enabling activities for TN-201 and TN-301
and the cGMP manufacturing facility; the expected timing for
submission of IND applications for TN-201, TN-401 and TN-301; 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 March
31,
2022
2021
Operating expenses:
Research and development
$
24,155
$
9,590
General and administrative
6,999
3,515
Total operating expenses
31,154
13,105
Loss from operations
(31,154
)
(13,105
)
Other income (expense), net:
Interest income
99
9
Other income (expense), net
(1
)
(2
)
Total other income (expense), net
98
7
Net loss before income tax expense
(31,056
)
(13,098
)
Income tax expense
—
—
Net loss
(31,056
)
(13,098
)
Net loss per share, basic and diluted
$
(0.75
)
$
(11.93
)
Weighted-average shares used in computing
net loss per share, basic and diluted
41,267,990
1,097,805
TENAYA THERAPEUTICS,
INC.
Condensed Balance
Sheets
(In thousands)
(Unaudited)
March 31,
December 31,
2022
2021
ASSETS
(Unaudited)
Current assets:
Cash and cash equivalents
$
25,970
$
38,129
Investments in marketable securities
184,484
213,171
Prepaid expenses and other current
assets
3,328
4,058
Total current assets
213,782
255,358
Property and equipment, net
49,384
43,020
Operating lease right-of-use assets
11,353
11,685
Restricted cash, noncurrent
399
547
Other noncurrent assets
6,579
3,579
Total assets
$
281,497
$
314,189
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities
19,095
21,774
Operating lease liabilities,
noncurrent
13,093
13,707
Other noncurrent liabilities
212
182
Stockholders’ equity
249,097
278,526
Total liabilities and stockholders’
equity
$
281,497
$
314,189
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220511005393/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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