- TN-201 MYBPC3 gene therapy product candidate for the leading
genetic cause of hypertrophic cardiomyopathy granted Orphan Drug
Designation (ODD) by the U.S. Food and Drug Administration
(FDA)
- Expanded leadership team appointing Leone Patterson as Chief
Financial and Business Officer and Matt Pollman, MD, as SVP,
Clinical Development
- Completed Initial Public Offering of common stock on August 3,
2021, raising $207 million in gross proceeds
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 second quarter 2021
financial results.
“Tenaya has made significant financial and operational progress
in the first half of 2021 that supports our efforts to improve and
extend the lives of patients who are fighting both rare and
prevalent forms of heart disease,” said Faraz Ali, CEO of Tenaya
Therapeutics. “With the completion of our successful IPO,
significant preclinical updates, and a strengthened leadership
team, we are very well positioned to advance TN-201 and TYA-11631,
the two most advanced programs from our Gene Therapy and Precision
Medicine platforms respectively, towards INDs in 2022.”
Business and Program Updates
- Initial Public Offering (IPO) Successfully Completed: In
August 2021, Tenaya announced the closing of its underwritten,
upsized initial public offering of 13,800,000 shares of its common
stock, including the full exercise of the underwriters’ option to
purchase 1,800,000 additional shares of its common stock. The
aggregate gross proceeds from the offering were $207.0 million,
before deducting underwriting discounts and commissions and
offering expenses payable by Tenaya.
- TN-201 – MYBPC3 Gene Therapy Program for Genetic HCM
(gHCM): TN-201 was granted Orphan Drug Designation (ODD) by the
FDA in May 2021. Preclinical data supporting TN-201 was presented
at the annual meeting of the American Society of Gene and Cell
Therapy (ASGCT) in May 2021 that demonstrate significant and
durable disease reversal and survival benefit in a severe murine
model of disease. Tenaya is expected to initiate a global natural
history study for patients with MYBPC3 mutations in the second half
of 2021. Tenaya has initiated IND-enabling activities and intends
to submit an investigational new drug (IND) application or clinical
trial application (CTA) to the FDA or European Medicine Agency
(EMA), respectively, in 2022.
- TYA-11631 – HDAC6 Inhibitor (HDAC6i) for Heart Failure with
Preserved Ejection Fraction (HFpEF) and Genetic DCM (gDCM):
Preclinical data supporting Tenaya’s highly-specific small molecule
HDAC6 inhibitors was presented at the annual meeting of the
European Society of Cardiology Heart Failure (ESC-HF) in July 2021
that demonstrate improved cardiac function in mouse models of HFpEF
and gDCM, and that also provide proof of concept for the utility of
Tenaya’s Precision Medicine platform to support modality agnostic
drug discovery. Tenaya has initiated IND-enabling activities and
intends to submit an IND to the FDA in 2022.
- Strengthened Leadership Team: In June, gene therapy
industry veteran Leone Patterson joined Tenaya as Chief Financial
and Business Officer. In addition, cardiologist Matthew Pollman,
MD, was appointed as Senior Vice President, Clinical Development
and will lead efforts to develop novel delivery methods that
support future product candidates from Tenaya’s Gene Therapy and
Cellular Regeneration platforms.
Second Quarter 2021 Financial Highlights
- Cash Position: As of June 30, 2021, Tenaya had cash,
cash equivalents and restricted cash of $112.4 million which
excludes the $188.8 million of net proceeds from the Company’s IPO
in August 2021. Tenaya expects its current cash and cash
equivalents, including the net proceeds from the IPO, will be
sufficient to fund its current operating plan at least into the 2nd
half of 2023.
- R&D Expenses: Research and development expenses were
$10.9 million for the second quarter of 2021. Non-cash stock-based
compensation included in R&D expense was $0.2 million for the
second quarter of 2021.
- G&A Expenses: General and administrative expenses
were $4.3 million for the second quarter of 2021. Non-cash
stock-based compensation included in G&A expense was $0.3
million for the second quarter of 2021.
- Net Loss: Net loss was $15.2 million, or $13.26 per
basic and diluted share, for the second 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 and utility of, and expectations regarding,
Tenaya’s drug discovery platforms; statements regarding Tenaya’s
pipeline of product candidates, including TN-201 and TYA-11631, to
demonstrate improved outcomes for heart failure; statements
regarding the expected timing of studies, IND-enabling activities
and IND and CTA submissions to the FDA or EMA, respectively, for
Tenaya’s product candidates; statements regarding the sufficiency
of Tenaya’s cash to finance its operations; 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 in its pipeline; 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 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
June 30,
Six Months Ended
June 30,
2021
2020
2021
2020
Operating expenses:
Research and development
$
10,906
$
6,958
$
20,496
$
14,255
General and administrative
4,331
1,914
7,846
3,883
Total operating expenses
15,237
8,872
28,342
18,138
Loss from operations
(15,237
)
(8,872
)
(28,342
)
(18,138
)
Other income (expense), net:
Interest income
9
18
18
75
Change in fair value of convertible
preferred stock tranche liability
—
(57
)
—
(76
)
Other income (expense), net
18
180
16
357
Total other income (expense), net
27
141
34
356
Net loss before income tax expense
(15,210
)
(8,731
)
(28,308
)
(17,782
)
Income tax expense
—
—
—
—
Net loss and comprehensive loss
$
(15,210
)
$
(8,731
)
$
(28,308
)
$
(17,782
)
Net loss per share, basic and diluted
$
(13.26
)
$
(9.21
)
$
(25.21
)
$
(19.32
)
Weighted-average shares used in computing
net loss per share, basic and diluted
1,147,471
948,403
1,122,775
920,196
TENAYA THERAPEUTICS,
INC.
Condensed Balance
Sheets
(In thousands)
June 30,
December 31,
2021
2020
ASSETS
(Unaudited)
Current assets:
Cash and cash equivalents
$
111,886
$
128,535
Prepaid expenses and other current
assets
1,336
1,429
Total current assets
113,222
129,964
Property and equipment, net
24,910
17,185
Operating lease right-of-use assets
12,315
—
Restricted cash, non-current
547
547
Other non-current assets
5,901
465
Total assets
$
156,895
$
148,161
LIABILITIES, CONVERTIBLE PREFERRED
STOCK AND
STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable
$
5,020
$
1,017
Accrued expenses and other current
liabilities
3,143
3,161
Deferred rent and other lease liabilities,
current
—
863
Operating lease liabilities, current
1,637
—
Total current liabilities
9,800
5,041
Deferred rent and other lease liabilities,
non-current
—
3,662
Operating lease liabilities,
non-current
14,893
—
Other non-current liabilities
3
19
Total liabilities
24,696
8,722
Commitments and contingencies
Convertible preferred stock
240,735
220,754
Stockholders’ deficit:
Common stock
—
—
Additional paid-in capital
2,596
1,584
Notes receivable from stockholders
(12
)
(87
)
Accumulated deficit
(111,120
)
(82,812
)
Total stockholders’ deficit
(108,536
)
(81,315
)
Total liabilities, convertible preferred
stock and stockholders’ deficit
$
156,895
$
148,161
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210908006012/en/
Investor Contact Leone Patterson Tenaya Therapeutics
IR@tenayathera.com Media Contact Wendy Ryan Ten Bridge
Communications wendy@tenbridgecommunications.com
Tenaya Therapeutics (NASDAQ:TNYA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Tenaya Therapeutics (NASDAQ:TNYA)
Historical Stock Chart
From Jul 2023 to Jul 2024