Tenaya Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update
November 10 2022 - 4:05PM
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 third quarter ended September
30, 2022.
Tenaya announced the extension of its cash runway to mid-2024.
Management believes that existing cash, cash equivalents and
investments will be sufficient to support the continued advancement
of the company’s product candidates, TN-201, TN-301 and TN-401.
This meaningful conservation of resources will be accomplished
through prioritization of certain research and development
(R&D) and manufacturing expenditures, as well as stringent
management of future headcount growth. Tenaya ended the third
quarter with $149.5 million in cash, cash equivalents and
investments in marketable securities.
“The initiation of our first clinical trial for TN-301 during
the third quarter was a major milestone marking our transition to a
clinical-stage company. Our unwavering commitment to improve the
lives of those affected by heart disease also requires careful
management of finite resources and prioritization of portfolio
opportunities,” said Faraz Ali, Chief Executive Officer of Tenaya.
“With the extension of our cash runway to mid-2024, we believe we
can reach meaningful milestones for our more advanced product
candidates, TN-201, TN-301 and TN-401, and still continue to
selectively invest in research efforts to advance our deep pipeline
of earlier-stage programs.”
Program Updates
TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic
Cardiomyopathy (HCM)
- Tenaya plans to submit an
Investigational New Drug (IND) application for TN-201 to the U.S.
Food and Drug Administration (FDA) by year end 2022. The company
expects to provide an update on the status of the TN-201 IND in
early 2023.
- In September, Tenaya received
notification from the U.S. Patent and Trademarks Office (USPTO) of
the issuance of patent No. 11,446,397. This patent provides
composition of matter protections for TN-201, covering a
recombinant adeno-associated viral (AAV)-based therapy containing
MYBPC3. This is the second patent granted by the USPTO related
to the TN-201 product candidate. This new patent is expected to
expire no earlier than 2041.
TN-301 – HDAC6 Small Molecule Inhibitor for Heart Failure with
Preserved Ejection Fraction (HFpEF)
- Tenaya received IND clearance for
TN-301 and commenced dosing in the single-ascending dose (SAD)
portion of its Phase 1 clinical trial in healthy participants.
TN-301 is the company’s small molecule histone deacetylase (HDAC) 6
inhibitor being developed for the potential treatment of HFpEF.
- Tenaya expects to report data from both
the SAD and multiple-ascending dose (MAD) portions of the Phase 1
clinical trial in 2023.
- The Phase 1 clinical trial is designed
to assess the safety, tolerability, pharmacokinetics and
pharmacodynamics, including target engagement, of TN-301 in healthy
adult participants.
- At the American Heart Association’s
2022 Scientific Sessions, Tenaya researchers presented preclinical
data showing that HDAC6 inhibition demonstrated comparable in vivo
activity to empagliflozin, an SGLT2 inhibitor that was approved for
the treatment of HFpEF earlier this year.
- In a murine model of HFpEF, TYA-018 (an
HDAC6 inhibitor structurally and functionally similar to TN-301)
showed improvements in metabolism, hypertrophy and diastolic
dysfunction at rates similar to empagliflozin, and demonstrated
superior reductions in inflammatory, fibrotic and N-terminal pro
B-type natriuretic peptide (NT-proBNP) gene expression.
- In October 2022, Tenaya received
notification from the USPTO of the allowance of U.S. Application
No. 17/731,949. This patent covers small molecule HDAC6 inhibitors,
including lead compound TN-301. The new patent is expected to
expire no earlier than 2040.
TN-401 – PKP2 Gene Therapy Program for Genetic
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
- Tenaya plans to submit an IND
application for TN-401 to the FDA in 2023.
- Tenaya intends to initiate a global
non-interventional study in 2022 to collect treatment history and
seroprevalence to AAV antibodies data among ARVC PKP2 gene mutation
carriers.
Research Updates
- New preclinical data from Tenaya’s capsid engineering efforts
were presented at the annual meeting of the European Society for
Gene and Cell Therapy held in Edinburgh, Scotland.
- Tenaya researchers identified several
novel AAV capsids capable of delivering cardiac gene therapy with
enhanced specificity and expression for the heart and detargeting
of the liver compared to AAV9. The superior heart-to-liver
transduction ratio of these novel capsids was confirmed in multiple
animal models and is expected to result in improved efficacy and
safety profiles for next-generation cardiac gene therapy
candidates.
Third Quarter 2022 Financial Highlights
- Cash Position and updated cash
guidance: As of September 30, 2022, cash, cash equivalents
and investments in marketable securities were $149.5 million.
Through prioritization of certain R&D and manufacturing
expenditures, plus management of future headcount growth, Tenaya
expects existing funds to extend the company’s cash runway to
mid-2024.
- R&D Expenses:
R&D expenses for the quarter ended September 30, 2022, were
$23.8 million. Non-cash stock-based compensation included in
R&D expense was $1.3 million for the quarter ended September
30, 2022.
- General & Administrative
(G&A) Expenses: G&A expenses for the quarter ended
September 30, 2022, were $7.5 million. Non-cash stock-based
compensation included in G&A expense was $1.8 million for the
quarter ended September 30, 2022.
- Net Loss: Net loss for
the second quarter ended September 30, 2022, was $30.7 million, or
$0.74 per share.
About Tenaya TherapeuticsTenaya Therapeutics is
a clinical-stage 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 StatementsThis 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 “expected,” “plans,” “believes,” “will,” “can,”
“continue,” “potential,” “intends,” and similar expressions are
intended to identify forward-looking statements. Such
forward-looking statements include, among other things, statements
regarding the potential of, and expectations regarding, Tenaya’s
product candidates and novel capsids; expected timing of data from
Tenaya’s TN-301 Phase 1 clinical trial; expected timing for
submission of an IND application for TN-201 and expected timing of
an update on the status of the IND; Tenaya’s plan to prioritize
certain expenditures and manage headcount growth; the sufficiency
of the company’s cash resources to support business operations and
plans and reach meaningful milestones for the company’s more
advanced product candidates; expiration date of a patent covering
TN-301; expected timing for submission of an IND application for
TN-401 and plans to initiate a global non-interventional study of
patients with ARVC; the potential efficacy and safety profile for
Tenaya’s novel AAV capsids; 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: the timing, scope and
likelihood of regulatory filings and approvals; Tenaya’s ability to
develop, initiate or complete preclinical studies and clinical
trials for its product candidates; 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; negative impacts of the COVID-19 pandemic on Tenaya’s
manufacturing and operations, including preclinical studies and
planned clinical trials; 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
InvestorsMichelle CorralVice President,
Investor Relations and Corporate CommunicationsTenaya
TherapeuticsIR@tenayathera.com
MediaWendy RyanTen Bridge
Communicationswendy@tenbridgecommunications.com
TENAYA THERAPEUTICS, INC.
Condensed Statements of
Operations (In thousands, except share and per
share data) (Unaudited)
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
23,758 |
|
|
$ |
12,944 |
|
|
$ |
68,789 |
|
|
$ |
33,440 |
|
General and administrative |
|
|
7,540 |
|
|
|
5,356 |
|
|
|
22,282 |
|
|
|
13,202 |
|
Total operating expenses |
|
|
31,298 |
|
|
|
18,300 |
|
|
|
91,071 |
|
|
|
46,642 |
|
Loss from operations |
|
|
(31,298 |
) |
|
|
(18,300 |
) |
|
|
(91,071 |
) |
|
|
(46,642 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
596 |
|
|
|
23 |
|
|
|
917 |
|
|
|
41 |
|
Other income (expense), net |
|
|
6 |
|
|
|
15 |
|
|
|
5 |
|
|
|
31 |
|
Total other income (expense), net |
|
|
602 |
|
|
|
38 |
|
|
|
922 |
|
|
|
72 |
|
Net loss before income tax
expense |
|
|
(30,696 |
) |
|
|
(18,262 |
) |
|
|
(90,149 |
) |
|
|
(46,570 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
|
(30,696 |
) |
|
|
(18,262 |
) |
|
|
(90,149 |
) |
|
|
(46,570 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.74 |
) |
|
$ |
(0.68 |
) |
|
$ |
(2.18 |
) |
|
$ |
(4.75 |
) |
Weighted-average shares used in
computing net loss per share, basic and diluted |
|
|
41,358,296 |
|
|
|
26,895,716 |
|
|
|
41,309,812 |
|
|
|
9,808,162 |
|
TENAYA THERAPEUTICS, INC.
Condensed Balance Sheet Data(In
thousands)(Unaudited)
|
|
September 30, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Cash, cash equivalents and marketable securities |
|
$ |
149,450 |
|
|
$ |
251,300 |
|
Total assets |
|
$ |
226,310 |
|
|
$ |
314,189 |
|
Total liabilities |
|
$ |
29,982 |
|
|
$ |
35,663 |
|
Total liabilities and
stockholders’ equity |
|
$ |
226,310 |
|
|
$ |
314,189 |
|
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