Tenax Therapeutics Reports First Quarter 2024 Financial Results and Provides a Corporate Update
14 Maggio 2024 - 2:00PM
Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3,
development-stage pharmaceutical company focused on identifying,
developing and commercializing products that address cardiovascular
and pulmonary diseases with high unmet medical need, announced
financial results for the first quarter of 2024 and provided a
corporate update.
“The first quarter of 2024 was a productive and historically
important period for Tenax Therapeutics, highlighted by the
initiation of our Phase 3 LEVEL study evaluating TNX-1o3 (oral
levosimendan) for the treatment of PH-HFpEF,” said Chris Giordano,
President and Chief Executive Officer of Tenax Therapeutics. “We
were also able to expand our patent estate and secure global
commercial rights for levosimendan for the treatment of PH-HFpEF.
In April, we hosted a KOL event entitled “LEVEL Setting,” featuring
four prominent experts in the field of heart failure discussing the
pathophysiology of PH-HFpEF and the potential for levosimendan to
address one of the largest unmet needs in cardiovascular
medicine.”
“As we approach the midpoint of 2024, we continue initiating
trial sites and enrolling patients in LEVEL. We are excited to see
the cardiology community enthusiastically embracing this Phase 3
study. We plan to provide updates on the TNX-103 program later this
year.”
Recent Corporate and Clinical Highlights
- In April 2024, the
Company announced that the United States Patent and Trademark
Office (USPTO) granted the Company a patent, U.S. Patent No.
11,969,424, covering the use of TNX-103 (oral levosimendan),
TNX-102 (subcutaneous levosimendan), TNX-101 (IV levosimendan), the
active metabolites of levosimendan (OR1896 and OR18955) and various
combinations of cardiovascular drugs with levosimendan when used to
improve exercise performance in patients with pulmonary
hypertension from heart failure with preserved ejection fraction
(PH-HFpEF). The ‘424 patient also expressly provides IP protection
for levosimendan at all therapeutic doses, and for levosimendan in
combination with various cardiovascular drugs, for use in
PH-HFpEF.
- In April 2024, the
Company hosted “LEVEL Setting” – a scientific roundtable exploring
the rationale for TNX-103 (oral levosimendan) in the treatment of
PH-HFpEF. Presentations were made by four globally recognized
experts in the field who then answered questions from attendees
(LINK TO EVENT):
- Understanding the
setting of PH-HFpEF – Sanjiv Shah, M.D. (Northwestern
University)
- Mechanism of Action
of Levosimendan – Daniel Burkhoff, M.D., Ph.D.
(Columbia)
- Review of data from
the Phase 2 HELP Study – Barry Borlaug, M.D. (Mayo
Clinic)
- Current treatment
landscape in PH-HFpEF – Javed Butler, M.D., M.P.H.,
M.B.A. (Baylor Scott & White)
- In February 2024, Dr. Sanjiv Shah,
Stone Professor of Medicine, Director of Research for the Bluhm
Cardiovascular Institute, and Director of the HFpEF Program at
Northwestern University Feinberg School of Medicine, presented data
and reviewed the scientific basis for the use of levosimendan in
PH-HFpEF. Dr Shah’s presentation capped off a scientific session
focused on the treatment of PH in patients with heart failure at
Cardiovascular Research Foundation’s Technology and Heart Failure
Therapeutics (THT) 2024 Conference in Boston.
- In February 2024, the Company
announced that it secured global IP, development, and commercial
rights to oral and subcutaneous levosimendan for the treatment of
PH-HFpEF. The agreement expands the rights of Tenax Therapeutics to
engage potential global strategic pharmaceutical partners and
improves net sales royalty rate structure, now ranging from high
single-digit to low-teen percentages, and lowers maximum cost of
goods.
- In February 2024, the Company closed
a registered public offering of its common stock, pre-funded
warrants and warrants. The Company intends to use the net proceeds
to advance the initiation of sites and the enrollment and treatment
of patients in its LEVEL study, as well as for working capital and
other general corporate purposes.
- In February 2024, Tenax Therapeutics
announced that the first patient had enrolled in the Phase 3
LEVEL Study (LEVosimendan to Improve
Exercise Limitation in PH-HFpEF
Patients) (NCT05983250).
Over 50 sites (U.S. and Canada) have agreed to participate in the
LEVEL study, a randomized, controlled Phase 3 trial of 152
patients. The Company is thrilled to have the support of leading
research centers with large PH-HFpEF populations. The Company
forecasts topline LEVEL data will be available second half
2025.
- In February 2024, the United States
Patent and Trademark Office (USPTO) informed Tenax Therapeutics it
has allowed claims within the Company’s patent application covering
the use of TNX-103 (oral levosimendan), TNX-102 (subcutaneous
levosimendan), TNX-101 (IV levosimendan), the active metabolites of
levosimendan (OR1896 and OR18955) and various combinations of
cardiovascular drugs with levosimendan when used to improve
exercise performance in PH-HFpEF patients
titled: “LEVOSIMENDAN FOR TREATING PULMONARY
HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION
(PH-HFpEF).”
First Quarter 2024 Financial Results
Tenax Therapeutics reported cash and cash equivalents
of $12.5 million as of March 31, 2024. In February 2024, the
Company raised approximately $8.0 million of net proceeds in a
registered public offering.
Research and Development expenses for the first quarter of 2024
were $2.7 million, compared to $265 thousand for the
first quarter of 2023. The $2.4 million increase year-over-year is
primarily attributable to increased costs for the ongoing Phase 3
LEVEL study.
General and administrative expenses for the first quarter of
2024 were $1.2 million which were comparable to the first
quarter of 2023.
Tenax Therapeutics reported a net loss for the first
quarter of 2024 of $3.8 million, compared to a net loss
of $1.4 million the first quarter of 2023.
About the Phase 3 LEVEL Study
(NCT05983250)
The LEVEL Study is a Phase 3, double-blind, randomized,
placebo-controlled study of levosimendan in patients with PH-HFpEF.
Approximately 152 subjects will be randomized in a 1:1 ratio to
receive an oral dose of levosimendan (2 mg/day) or placebo for
Weeks 1 to 4 and 3 mg/day or placebo for Weeks 5 to 12. The primary
outcome measure for the study is change in six-minute walk distance
from Baseline to Week 12. All randomized subjects will have the
option to enter the 92-week OLE following the completion of all
study events at Week 12.
About Levosimendan (TNX-101, TNX-102,
TNX-103)
Levosimendan is a unique, potassium ATP channel activator and
calcium sensitizer that affects the heart and vascular system
through multiple mechanisms of action. Initially discovered and
developed by Orion Corporation in Finland, intravenous levosimendan
has been granted marketing authorization in over 60 countries
outside the United States for use in hospitalized patients with
acutely decompensated heart failure. Results of Tenax Therapeutics’
Phase 2 HELP study of levosimendan in patients with pulmonary
hypertension (PH) with heart failure with preserved ejection
fraction (HFpEF) demonstrated that I.V. levosimendan produces
potent dilation of the central and pulmonary venous circulations
which translates into an improvement in exercise capacity, a
discovery that is the basis of LEVEL, the Phase 3 investigation of
Tenax Therapeutics’ potential groundbreaking therapy. To date, no
other drug therapy has improved exercise tolerance in patients with
PH associated with HFpEF, “a growing epidemic with high morbidity
and mortality and no treatment. The clear unmet need and lethal
nature of PH-HFpEF must be met with novel solutions at all levels
of therapeutic development” (AHA Scientific Advisory, “A Call to
Action,” 2022).
About Tenax Therapeutics
Tenax Therapeutics, Inc. is a Phase 3, development-stage
pharmaceutical company focused on identifying, developing, and
commercializing products that address cardiovascular and pulmonary
diseases with high unmet medical need. The Company owns global
rights to develop and commercialize levosimendan, which it has
prioritized in the near term. Tenax Therapeutics also may resume
developing its unique oral formulation of imatinib. For more
information, visit www.tenaxthera.com. Tenax Therapeutics’ common
stock is listed on The Nasdaq Stock Market LLC under the symbol
“TENX”.
Caution Regarding Forward-Looking
Statements
Except for historical information, all of the statements,
expectations and assumptions contained in this press release are
forward-looking statements. These forward-looking statements may
include information concerning possible or projected future
business operations. Actual results might differ materially from
those explicit or implicit in the forward-looking statements.
Important factors that could cause actual results to differ
materially include: our ability to raise additional money to fund
our operations for at least the next 12 months as a going concern;
risks related to our business strategy, including the
prioritization and development of product candidates; risks of our
clinical trials, including, but not limited to, the timing, delays,
costs, design, initiation, enrollment, and results of such trials;
any delays in regulatory review and approval of product candidates
in development; reliance on third parties, including Orion
Corporation, our manufacturers and CROs; risks regarding the
formulation, production, marketing, customer acceptance and
clinical utility of our product candidates; our estimates regarding
the potential market opportunity for our product candidates; the
potential advantages of our product candidates; our competitive
position; intellectual property risks; risks related to our
continued listing on Nasdaq; our ability to maintain our culture
and recruit, integrate and retain qualified personnel and advisors,
including on our Board of Directors; volatility and uncertainty in
the global economy and financial markets in light of the
possibility of pandemics, global financial and geopolitical
uncertainties, including in the Middle East and the Russian
invasion of and war against the country of Ukraine; changes in
legal, regulatory and legislative environments in the markets in
which we operate and the impact of these changes on our ability to
obtain regulatory approval for our products; and other risks and
uncertainties set forth from time to time in our SEC filings. Tenax
Therapeutics assumes no obligation and does not intend to update
these forward-looking statements except as required by law.
Contacts
Investor Contact:John FrauncesManaging DirectorLifeSci Advisors,
LLCC: 917-355-2395, or
Brian MullenLifeSci Advisors, LLCC: 203-461-1175
Tenax Therapeutics, Inc. - Consolidated Balance
Sheet |
for the Periods Ended March 31, 2024 and December 31,
2023 |
|
|
March 31, 2024 |
|
December 31, 2023 |
|
|
|
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
12,549,475 |
|
|
$ |
9,792,130 |
|
Prepaid expenses |
|
1,843,047 |
|
|
|
1,639,797 |
|
Other current assets |
|
66,625 |
|
|
|
251,583 |
|
Total current assets |
|
14,459,147 |
|
|
|
11,683,510 |
|
Other assets |
|
1,117 |
|
|
|
1,117 |
|
Total assets |
$ |
14,460,264 |
|
|
$ |
11,684,627 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
1,080,962 |
|
|
$ |
2,073,149 |
|
Accrued liabilities |
|
536,443 |
|
|
|
1,012,468 |
|
Note Payable |
|
413,174 |
|
|
|
500,903 |
|
Total current liabilities |
|
2,030,579 |
|
|
|
3,586,520 |
|
Total liabilities |
|
2,030,579 |
|
|
|
3,586,520 |
|
|
|
|
|
|
|
|
|
Commitments and
contingencies; |
|
|
|
Stockholders' equity |
|
|
|
Preferred stock, undesignated,
authorized 4,818,654 shares; |
|
|
|
Series A Preferred stock, par
value $.0001, authorized 5,181,346 shares; issued and outstanding
210, as of March 31, 2024 and December 31, 2023, respectively |
|
- |
|
|
|
- |
|
Common stock, par value $.0001
per share; authorized 400,000,000 shares; issued and outstanding
1,958,245 as of March 31, 2024 and 298,281 as of December 31, 2023,
respectively |
|
196 |
|
|
|
30 |
|
Additional paid-in
capital |
|
313,481,082 |
|
|
|
305,350,830 |
|
Accumulated deficit |
|
(301,051,593 |
) |
|
|
(297,252,753 |
) |
Total stockholders’
equity |
|
12,429,685 |
|
|
|
8,098,107 |
|
Total liabilities and
stockholders' equity |
$ |
14,460,264 |
|
|
$ |
11,684,627 |
|
Tenax Therapeutics, Inc. - Consolidated Income
Statement |
for the Periods Ended March 31, 2024 and March 31,
2023 |
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
General and administrative |
|
$ |
1,232,674 |
|
|
$ |
1,273,730 |
|
Research and development |
|
|
2,675,652 |
|
|
|
265,735 |
|
Total operating expenses |
|
|
3,908,326 |
|
|
|
1,539,465 |
|
|
|
|
|
|
Net operating loss |
|
|
3,908,326 |
|
|
|
1,539,465 |
|
|
|
|
|
|
Interest expense |
|
|
7,963 |
|
|
|
7,350 |
|
Interest income |
|
|
|
|
- |
|
Other expense (income),
net |
|
|
(117,449 |
) |
|
|
(140,055 |
) |
Net loss |
|
$ |
(3,798,840 |
) |
|
$ |
(1,406,760 |
) |
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(3.12 |
) |
|
$ |
(12.10 |
) |
Weighted average number of
common shares outstanding, basic and diluted |
|
|
1,219,139 |
|
|
|
116,259 |
|
Grafico Azioni Tenax Therapeutics (NASDAQ:TENX)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni Tenax Therapeutics (NASDAQ:TENX)
Storico
Da Dic 2023 a Dic 2024