Tenaya Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
08 November 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 third quarter ended September
30, 2023.
“The successful execution across all of our program milestones
slated for 2023, including two gene therapy INDs cleared and the
dosing of the first patient in our TN-201 clinical trial,
represents the strong commitment and capabilities of our team,”
said Faraz Ali, Chief Executive Officer of Tenaya. “We have
momentum as we head into 2024, with three clinical-stage programs
for the treatment of rare and prevalent heart conditions and
unmatched capabilities focused on the discovery of precision heart
disease medications.”
Business and Program UpdatesTN-201 – Gene
Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
- In October 2023, Tenaya dosed the first
patient in the MyPeak-1 Phase 1b clinical trial of TN-201 for the
treatment of myosin binding protein C3 (MYBPC3)-associated
hypertrophic cardiomyopathy (HCM). MyPeak-1 (NCT05836259) is a
multi-center, open-label, dose-escalation trial designed to assess
safety, tolerability and clinical efficacy of a one-time
intravenous infusion of TN-201.
- Tenaya anticipates sharing initial data
from the MyPeak-1 trial in 2024.
- In October 2023, Tenaya shared interim
results from its ongoing seroprevalence study indicating that
patients with MYBPC3-associated HCM have low levels of preexisting
neutralizing antibodies to adeno-associated virus serotype 9 (AAV9)
and the majority of patients could be eligible for TN-201 treatment
in clinical trials.
- The seroprevalence study is being
conducted across 10 clinic sites. As of the data cut off in August
2023, 76 patients with MYBPC3-associated HCM were enrolled. These
data were presented at the HCM Society (HCMS) Scientific
Sessions.
TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right
Ventricular Cardiomyopathy (ARVC)
- In October 2023, the U.S. Food and Drug
Administration (FDA) notified Tenaya that clinical testing of
TN-401 may proceed based on review of the company’s Investigational
New Drug (IND) application.
- Tenaya is advancing TN-401 into the
clinic for the treatment of plakophilin-2 (PKP2)-associated
arrhythmogenic right ventricular cardiomyopathy (ARVC), a dangerous
condition estimated to effect 70,000 people in the U.S.
- The company plans to initiate the
RIDGE-1™ Phase 1b clinical trial of TN-401 at leading U.S. centers
for ARVC treatment and is currently conducting a non-interventional
seroprevalence and natural history study among PKP2-associated ARV
patients.
- cGMP grade clinical trial material for
TN-401 was produced at the 1000L scale at Tenaya’s Genetic Medicine
Manufacturing Center.
- In November, TN-401 received Fast Track
Designation from the FDA. The FDA Fast Track program is designed to
facilitate the development and expedite the review of drug
candidates intended to treat serious conditions and for which
nonclinical data demonstrates the potential to address unmet
medical need.
- In September 2023, Tenaya received
Orphan Medicinal Product designation from the European Medicines
Agency (EMA) for TN-401 for the potential treatment of ARVC caused
by PKP2 genetic mutations. TN-401 has also Orphan Drug Designation
from the U.S. FDA.
TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with
Preserved Ejection Fraction (HFpEF)
- In October 2023, Tenaya shared positive
Phase 1 data for TN-301 at the 2023 Heart Failure Society of
America (HFSA) Annual Scientific Meeting.
- The Phase 1 trial enrolled 72
participants in two stages, single ascending doses (SAD) and
multiple ascending doses (MAD).
- TN-301 was generally well tolerated
across the broad range of doses studied. Pharmacokinetic (PK)
results showed overall dose proportionality in the SAD and MAD
stages of the study with a half-life supportive of once-daily
dosing.
- Robust HDAC6 inhibition was observed
and increasing doses and exposures with TN-301 correlated with
increased pharmacodynamic (PD) effects. Plasma exposure and target
engagement observed in this healthy participant study met or
exceeded those required for maximal efficacy in preclinical
studies.
- At HFSA Tenaya also presented new
preclinical results demonstrating additive benefit of combining
TYA-018 (an HDAC6 inhibitor structurally and functionally similar
to TN-301) with empagliflozin (a sodium-glucose cotransporter-2
inhibitor), which is approved for the treatment of HFpEF. This
builds on the growing body of evidence supporting the multi-modal
mechanism of action that is orthogonal from SGLT2 inhibitors.
Research
- In October 2023, Tenaya published
preclinical research in the American Heart Association’s (AHA)
journal, Circulation, detailing its initial success in cardiac
cellular regeneration utilizing a single AAV vector to deliver
specific combinations of genes to reprogram cells in the heart
following ischemic injury.
Third Quarter 2023 Financial Highlights
- Cash Position and
guidance: As of September 30, 2023, cash, cash equivalents
and investments in marketable securities were $128.1 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
September 30, 2023, were $23.1 million. Non-cash stock-based
compensation included in R&D expense was $1.9 million for the
quarter ended September 30, 2023.
- General & Administrative
(G&A) Expenses: G&A expenses for the quarter ended
September 30, 2023, were $7.8 million. Non-cash stock-based
compensation included in G&A expense was $2.2 million for the
quarter ended September 30, 2023.
- Net Loss: Net loss for
the quarter ended September 30, 2023, was $29.1 million, or $0.39
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 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 “potential,” “anticipates,” “plans,” “expects,” and
similar expressions are intended to identify forward-looking
statements. Such forward-looking statements include, among other
things, the clinical, therapeutic and commercial potential of, and
expectations regarding, Tenaya’s product candidates; Tenaya’s plans
and expectations regarding its clinical development efforts and
activities, including the planned timing of sharing initial data
from the Phase 1b clinical trial of TN-201 and planned initiation
of a Phase 1b clinical trial of TN-401; the sufficiency of Tenaya’s
cash resources to fund the company into the first half 2025; and
statements made 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; Tenaya’s continuing compliance with applicable legal
and regulatory requirements; the availability of data at the
referenced times; the potential for any clinical trial
results to differ from preclinical, interim, preliminary, topline
or expected results; Tenaya’s ability to raise any additional
funding it will need to continue to pursue its business and product
development plans; Tenaya’s reliance on third parties; 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
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.
ContactMichelle CorralVP, Corporate
Communications and Investor RelationsIR@tenayathera.com
InvestorsJulie SeidelStern Investor
RelationsJulie.seidel@SternIR.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 Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
23,091 |
|
|
$ |
23,758 |
|
|
$ |
75,173 |
|
|
$ |
68,789 |
|
General and administrative |
|
|
7,829 |
|
|
|
7,540 |
|
|
|
24,574 |
|
|
|
22,282 |
|
Total operating expenses |
|
|
30,920 |
|
|
|
31,298 |
|
|
|
99,747 |
|
|
|
91,071 |
|
Loss from operations |
|
|
(30,920 |
) |
|
|
(31,298 |
) |
|
|
(99,747 |
) |
|
|
(91,071 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,776 |
|
|
|
596 |
|
|
|
5,586 |
|
|
|
917 |
|
Other income, net |
|
|
1 |
|
|
|
6 |
|
|
|
12 |
|
|
|
5 |
|
Total other income, net |
|
|
1,777 |
|
|
|
602 |
|
|
|
5,598 |
|
|
|
922 |
|
Net loss before income tax
expense |
|
|
(29,143 |
) |
|
|
(30,696 |
) |
|
|
(94,149 |
) |
|
|
(90,149 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(29,143 |
) |
|
$ |
(30,696 |
) |
|
$ |
(94,149 |
) |
|
$ |
(90,149 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.74 |
) |
|
$ |
(1.28 |
) |
|
$ |
(2.18 |
) |
Weighted-average shares used in
computing net loss per share, basic and diluted |
|
|
73,924,937 |
|
|
|
41,358,296 |
|
|
|
73,579,200 |
|
|
|
41,309,812 |
|
Condensed Balance Sheet Data
(In thousands)(Unaudited)
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash, cash equivalents and
marketable securities |
|
$ |
128,120 |
|
|
$ |
204,230 |
|
Total assets |
|
$ |
193,397 |
|
|
$ |
278,945 |
|
Total liabilities |
|
$ |
28,513 |
|
|
$ |
35,569 |
|
Total liabilities and
stockholders’ equity |
|
$ |
193,397 |
|
|
$ |
278,945 |
|
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