Tenaya Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update
09 Août 2023 - 10:05PM
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 and
provided a corporate update for the second quarter ended June 30,
2023.
“We are looking ahead to important near-term milestones across
all our programs. Dosing the first patient in our first clinical
trial for TN-201 will be a significant moment for our company and
bring us one step closer to bringing much-needed solutions to those
impacted by genetic HCM,” said Faraz Ali, Chief Executive Officer
of Tenaya. “We are also looking forward to presenting healthy
participant data from our TN-301 small molecule program and filing
the IND for our TN-401 gene therapy candidate later this year. Our
continued progress is supported by our unwavering commitment to
fight heart disease on behalf of individuals and families.”
Business and Program UpdatesTN-201 – Gene
Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
- In April 2023, the U.S. Food and Drug
Administration (FDA) granted Fast Track designation for Tenaya’s
lead gene therapy program, TN-201. Companies with therapies that
receive the Fast Track designation are eligible for more frequent
communication with the agency and may qualify for Accelerated
Approval and Priority Review if relevant criteria are met.
- Tenaya anticipates dosing its first
patient in the “MyPeak-1” Phase 1b multi-center, open-label,
dose-escalation clinical trial of TN-201 during the third quarter
of 2023 (ClinicalTrials.gov #NCT05836259).
- The Phase 1b trial is designed to
assess the safety, tolerability and pharmacodynamics of a one-time
intravenous infusion of TN-201 in symptomatic adults with
MYBPC3-associated HCM. Initial data from the MyPeak-1 clinical
trial are anticipated in 2024.
- In July 2023, Tenaya received
notification from the U.S. Patent and Trademarks Office (USPTO)
that a notice of allowance has been issued for patent application
No. 17/581,576. The allowed patent application includes claims
covering a method of treating HCM or cardiomyopathy caused by a
MYBPC3 mutation and expands upon Tenaya’s existing composition of
matter protections by extending coverage to methods of use as the
company continues to enhance its protection around different
aspects of the TN-201 gene therapy program. The new patent issuing
from the allowed patent application is expected to expire no
earlier than February 2041.
TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with
Preserved Ejection Fraction (HFpEF)
- Data from Tenaya’s Phase 1 clinical
trial of TN-301 in healthy volunteers have been accepted for
presentation at the Heart Failure Society of America’s (HFSA)
Annual Scientific Meeting, taking place October 6-9, 2023.
- Tenaya has completed the Phase 1
clinical trial of TN-301 in healthy participants. No dose-limiting
toxicities were reported across a wide range of doses and initial
target engagement, measured by the biomarker tubulin acetylation,
was achieved.
- The randomized, double-blind,
placebo-controlled clinical trial was designed to evaluate the
safety, tolerability, pharmacokinetics and pharmacodynamics of
escalating oral doses of TN-301 to help guide dosing in future
studies.
- Results from preclinical studies
testing the combination of HDAC6 inhibition with SGLT2 inhibition
in a validated model of HFpEF have also been accepted for
presentation at the upcoming HFSA meeting.
- Preclinical data from the TN-301
program presented on August 1, 2023, at the American Heart
Association’s Basic Cardiovascular Sciences (BCVS) Scientific
Session suggest HDAC6 inhibition may improve undesirable HFpEF
phenotype characteristics such as dysregulated metabolism, fibrosis
and hypertrophy.
TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right
Ventricular Cardiomyopathy (ARVC)
- Tenaya plans to submit an
Investigational New Drug application (IND) to the FDA for TN-401
for the potential treatment of ARVC caused by PKP2 genetic
mutations in the second half of 2023. A single dose of TN-401 is
designed to deliver a fully functional PKP2 gene to cardiomyocytes
in the heart and restore production of the plakophilin 2 protein in
order to prevent arrhythmia and reverse disease following a single
dose.
- Tenaya presented data from a new
preclinical mouse model at BCVS on August 1, 2023, showing that a
single dose of gene therapy prevented ARVC development and
significantly prolonged survival.
- In June 2023,
Tenaya received notification from the USPTO that a notice of
allowance has been issued for patent application No. 17/390,395.
The new patent issuing from the allowed patent application will be
the first patent issued by the USPTO to cover an AAV gene therapy
for PKP2 and is expected to expire no earlier than July 2041.
Research
- Tenaya researchers also presented new
data at BCVS on August 1, 2023, detailing the company’s drug
discovery capabilities for identifying human genetic targets in
models of human heart conditions. Tenaya’s novel high throughput
screening methods in human induced pluripotent stem cells derived
cardiomyocytes were applied to identifying genes of interest in
heart muscle cells.
Second Quarter 2023 Financial Highlights
- Cash Position and
guidance: As of June 30, 2023, cash, cash equivalents and
investments in marketable securities were $151.6 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 for the quarter ended
June 30, 2023, were $26.5 million. Non-cash stock-based
compensation included in R&D expense was $1.8 million for the
quarter ended June 30, 2023.
- General & Administrative
(G&A) Expenses: G&A expenses for the quarter ended
June 30, 2023, were $8.6 million. Non-cash stock-based compensation
included in G&A expense was $2.1 million for the quarter ended
June 30, 2023.
- Net Loss: Net loss for
the quarter ended June 30, 2023, was $33.3 million, or $0.45 per
share.
About Tenaya TherapeuticsTenaya 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 StatementThis 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 “anticipated,” “looking ahead,” “looking forward,”
“may,” “expected,” “plans,” “will,” and similar expressions are
intended to identify forward-looking statements. Such
forward-looking statements include, among other things, statements
regarding 2023 development and regulatory milestones; Tenaya’s plan
to present data from the Phase 1 clinical trial evaluating TN-301,
as well as results from preclinical studies, at the upcoming HFSA
conference; expected timing of the submission of the TN-401 IND;
eligibility for increased communication with the FDA and potential
qualification for accelerated approval and priority review for
TN-201; expected timing for, commencement of dosing in the Phase 1b
clinical trial evaluating TN-201 and availability of initial data
from the trial; the expected expiration dates of new patents; the
potential for Tenaya’s future programs; 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; 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 |
Wendy Ryan |
Vice President, Investor
Relationship and |
Ten Bridge Communications |
Corporate Communications |
Wendy@tenbridgecommunications.com |
Tenaya Therapeutics |
|
IR@tenayathera.com |
|
TENAYA THERAPEUTICS, INC. |
|
|
|
Condensed Statements of Operations(In thousands,
except share and per share data)(Unaudited) |
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
26,477 |
|
|
$ |
20,876 |
|
|
$ |
52,082 |
|
|
$ |
45,031 |
|
General and administrative |
|
|
8,627 |
|
|
|
7,743 |
|
|
|
16,745 |
|
|
|
14,742 |
|
Total operating expenses |
|
|
35,104 |
|
|
|
28,619 |
|
|
|
68,827 |
|
|
|
59,773 |
|
Loss from operations |
|
|
(35,104 |
) |
|
|
(28,619 |
) |
|
|
(68,827 |
) |
|
|
(59,773 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,837 |
|
|
|
222 |
|
|
|
3,810 |
|
|
|
321 |
|
Other income (expense), net |
|
|
(2 |
) |
|
|
— |
|
|
|
11 |
|
|
|
(1 |
) |
Total other income (expense), net |
|
|
1,835 |
|
|
|
222 |
|
|
|
3,821 |
|
|
|
320 |
|
Net loss before income tax
expense |
|
|
(33,269 |
) |
|
|
(28,397 |
) |
|
|
(65,006 |
) |
|
|
(59,453 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(33,269 |
) |
|
$ |
(28,397 |
) |
|
$ |
(65,006 |
) |
|
$ |
(59,453 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.45 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.89 |
) |
|
$ |
(1.44 |
) |
Weighted-average shares used in
computing net loss per share, basic and diluted |
|
|
73,399,847 |
|
|
|
41,302,157 |
|
|
|
73,249,702 |
|
|
|
41,285,168 |
|
Condensed Balance Sheet Data(In
thousands)(Unaudited) |
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash, cash equivalents and marketable securities |
|
$ |
151,641 |
|
|
$ |
204,230 |
|
Total assets |
|
$ |
220,754 |
|
|
$ |
278,945 |
|
Total liabilities |
|
$ |
30,814 |
|
|
$ |
35,569 |
|
Total liabilities and
stockholders’ equity |
|
$ |
220,754 |
|
|
$ |
278,945 |
|
Tenaya Therapeutics (NASDAQ:TNYA)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Tenaya Therapeutics (NASDAQ:TNYA)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024