Tenaya Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
March 08 2023 - 4:01PM
Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage
biotechnology company with a mission to discover, develop and
deliver potentially curative therapies that address the underlying
causes of heart disease, today reported financial results for the
fourth quarter and full year ended December 31, 2022, and provided
a corporate update.
“Tenaya enters 2023 well capitalized and with
meaningful milestones ahead,” said Faraz Ali, Chief Executive
Officer of Tenaya. “This year, we look forward to beginning
clinical testing of our lead gene therapy candidate, TN-201,
sharing data from our first-in-human clinical trial of TN-301, and
submitting an IND for our TN-401 gene therapy candidate, as well as
presenting additional data detailing insights on current pipeline
candidates and emerging platform innovations.”
Business and Program Updates
TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic
Cardiomyopathy (HCM)
- In January 2023, Tenaya received notification from the U.S.
Food and Drug Administration (FDA) that clinical testing of TN-201
may proceed based on the agency’s review of the company’s
Investigational New Drug (IND) application. TN-201 is designed to
deliver a fully functional MYBPC3 gene to restore normal levels of
MyBP-C protein and thereby potentially halt disease progression and
reverse the course of genetic HCM after a single dose.
- Tenaya plans to commence a Phase 1b multi-center, open-label,
dose-escalation study to assess the safety, tolerability and
pharmacodynamics of a one-time intravenous infusion of TN-201 in
symptomatic adults with MYBPC3-associated HCM in the third quarter
of 2023. Initial data from the Phase 1b trial are anticipated in
2024.
TN-301 – Small Molecule HDAC6 Inhibitor for Heart
Failure with Preserved Ejection Fraction (HFpEF)
- Tenaya commenced dosing of healthy participants in the
multiple-ascending dose (MAD) stage of its ongoing Phase 1 trial
evaluating the safety, tolerability, pharmacokinetics, and
pharmacodynamics of escalating oral doses of TN-301, a highly
selective small molecule inhibitor of HDAC6 being developed for the
potential treatment of HFpEF.
- TN-301 was generally well tolerated during the single ascending
(SAD) stage of Tenaya’s randomized, double-blind,
placebo-controlled Phase 1 trial.
- Initial target engagement, measured by the biomarker of tubulin
acetylation, was achieved at dose levels thought to be in
therapeutic ranges based on preclinical experiments.
- Tenaya expects to report data from both the SAD and MAD stages
of the Phase 1 clinical trial in the second half of 2023.
TN-401 – PKP2 Gene Therapy Program for
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
- Tenaya plans to submit an IND application for TN-401 to the FDA
in the second half of 2023. IND-enabling studies and manufacturing
of clinical supply are currently underway. TN-401 is designed to
deliver a fully functional PKP2 gene to reverse disease and prevent
arrhythmia after a single dose.
Financing:
- In November 2022, Tenaya completed a follow-on public offering
of approximately 25.4 million shares of its common stock and, to
certain investors in lieu of common stock, pre-funded warrants to
purchase up to an aggregate of approximately 6.2 million shares at
a public offering price of $2.60 per share and $2.599 per
pre-funded warrant. The net proceeds to Tenaya were $76.9 million
after discounts, commissions, and other offering expenses.
Fourth Quarter and Full Year 2022
Financial Highlights
Cash Position: As of December 31,
2022, cash, cash equivalents and investments in marketable
securities (current and noncurrent) were $204.2 million. Tenaya
expects current cash, cash equivalents and investments in
marketable securities (current and noncurrent) will be sufficient
to fund the company into the first half of 2025.
- Research & Development (R&D) Expenses:
R&D expenses were $25.7 million for the fourth quarter and
$94.5 million for the full year ended December 31, 2022. Non-cash
stock-based compensation included in R&D expense was $1.1
million for the fourth quarter and $4.9 million for the full year
ended December 31, 2022.
- General & Administrative (G&A)
Expenses: G&A expenses were $8.8 million for the
fourth quarter and $31.1 million for the full year ended December
31, 2022. Non-cash stock-based compensation included in G&A
expense was $2.1 million for the fourth quarter and $6.6 million
for the full year ended December 31, 2022.
- Net Loss: Net loss was $33.5 million, or $0.61
loss per share for the fourth quarter ended December 31, 2022. For
the full year 2022, net loss was $123.7 million, or $2.76 per
share. The number of Tenaya’s common stock outstanding as of
December 31, 2022, was 66.9 million shares.
About Tenaya Therapeutics Tenaya
Therapeutics is a clinical-stage biotechnology company committed to
a bold mission: to discover, develop and deliver potentially
curative therapies that address the underlying drivers of heart
disease. Leveraging its integrated and interrelated Gene Therapy,
Cellular Regeneration and Precision Medicine platforms and
proprietary core capabilities, the company is advancing a pipeline
of novel therapies with diverse treatment modalities for rare
genetic cardiovascular disorders and more prevalent heart
conditions. Tenaya’s most advanced candidates include TN-201, a
gene therapy for MYBPC3-associated hypertrophic cardiomyopathy
(HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic
right ventricular cardiomyopathy (ARVC), and TN-301, a small
molecule HDAC6 inhibitor being initially developed for heart
failure with preserved ejection fraction (HFpEF). Tenaya also has
multiple early-stage programs progressing through preclinical
development. For more information, visit
www.tenayatherapeutics.com.
Forward-looking Statement 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 “look forward,” “plans,” “anticipated,”
“expects,” “will,” and similar expressions are intended to identify
forward-looking statements. Such forward-looking statements
include, among other things, statements regarding 2023 key
milestones, including the initiation of clinical testing of TN-201,
data from the first-in-human clinical trial of TN-301, submission
of the TN-401 IND and the presentation of data from pipeline
candidates and platform innovations; expected timing for,
commencement of dosing in the Phase 1b clinical trial evaluating
TN-201 and availability of initial data from the trial, data from
the SAD and MAD stages of the Phase 1 clinical trial evaluating
TN-301 and the submission of the TN-401 IND; the potential of, and
expectations regarding, Tenaya’s product candidates; the
sufficiency of Tenaya’s cash resources to fund the company into the
first half 2025; 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: Tenaya’s ability to develop, initiate or complete
preclinical studies and clinical trials for its product candidates;
the timing, scope and likelihood of regulatory filings and
approvals; the availability of data at the referenced times; 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 raise any additional funding it will need to continue to
pursue its business and product development plans; the potential
for any clinical trial results to differ from preclinical, interim,
preliminary, topline or expected results; Tenaya’s ability to
successfully operate a manufacturing facility for clinical or
commercial supply; Tenaya’s 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; negative impacts of the COVID-19 pandemic on Tenaya’s
operations, including preclinical studies, planned clinical trials
and manufacturing activities; 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.
Contacts
Investors |
Media |
Michelle Corral Vice President, Investor Relationship and Corporate
Communications Tenaya Therapeutics IR@tenayathera.com |
Wendy Ryan Ten Bridge Communications
Wendy@tenbridgecommunications.com |
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, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
25,748 |
|
|
$ |
20,953 |
|
|
$ |
94,537 |
|
|
$ |
54,393 |
|
General and administrative |
|
|
8,802 |
|
|
|
5,211 |
|
|
|
31,084 |
|
|
|
18,413 |
|
Total operating expenses |
|
|
34,550 |
|
|
|
26,164 |
|
|
|
125,621 |
|
|
|
72,806 |
|
Loss from operations |
|
|
(34,550 |
) |
|
|
(26,164 |
) |
|
|
(125,621 |
) |
|
|
(72,806 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,037 |
|
|
|
67 |
|
|
|
1,954 |
|
|
|
108 |
|
Other income (expense), net |
|
|
(3 |
) |
|
|
(54 |
) |
|
|
2 |
|
|
|
(23 |
) |
Total other income (expense), net |
|
|
1,034 |
|
|
|
13 |
|
|
|
1,956 |
|
|
|
85 |
|
Net loss before income tax expense |
|
|
(33,516 |
) |
|
|
(26,151 |
) |
|
|
(123,665 |
) |
|
|
(72,721 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
|
(33,516 |
) |
|
|
(26,151 |
) |
|
|
(123,665 |
) |
|
|
(72,721 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.61 |
) |
|
$ |
(0.63 |
) |
|
$ |
(2.76 |
) |
|
$ |
(4.10 |
) |
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
|
55,250,372 |
|
|
|
41,253,720 |
|
|
|
44,823,597 |
|
|
|
17,734,166 |
|
TENAYA THERAPEUTICS, INC.
Condensed Balance Sheet Data
(In thousands) (Unaudited)
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Cash, cash equivalents and marketable securities |
|
$ |
204,230 |
|
|
$ |
251,300 |
|
Total assets |
|
$ |
278,945 |
|
|
$ |
314,189 |
|
Total liabilities |
|
$ |
35,569 |
|
|
$ |
35,663 |
|
Total liabilities and stockholders’ equity |
|
$ |
278,945 |
|
|
$ |
314,189 |
|
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