Tenax Therapeutics Announces Pricing of Approximately $9 Million Public Offering
08 Février 2024 - 2:16PM
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty
pharmaceutical company focused on identifying, developing and
commercializing products that address cardiovascular and pulmonary
diseases with high unmet medical need, announced today the pricing
of a public offering of (i) 1,600,000 shares of its common stock
(or pre-funded warrants in lieu thereof) and (ii) warrants to
purchase up to 3,200,000 shares of its common stock (the “Common
Warrants”) at a purchase price of $5.65 per share and
associated Common Warrant. The Common Warrants will have an
exercise price of $5.65 per share, are immediately
exercisable, and will expire five years after their initial
exercise date. The offering is expected to close on or
about February 12, 2024, subject to customary closing
conditions.
Roth Capital Partners is acting as the exclusive
placement agent in the offering.
Gross proceeds, before deducting placement agent
fees and commissions and offering expenses are expected to be
approximately $9,040,000 million. The Company intends to use
the net proceeds from the offering to advance the initiation of
sites and the enrollment and treatment of patients in its LEVEL
trial, a Phase 3 trial of oral levosimendan, as well as for working
capital, capital expenditures, and other general corporate
purposes.
The securities described above are being offered
pursuant to a registration statement on Form S-1/A (File No.
333-275856), as amended, that was declared effective by
the U.S. Securities and Exchange Commission (“SEC”),
on February 7, 2024. Copies of the accompanying prospectus
relating to and describing the terms of the offering may be
obtained, when available, at the SEC’s website
at www.sec.gov or by contacting Roth Capital
Partners, LLC, 888 San Clemente Drive, Suite 400, Newport
Beach, CA 92660 or by email at rothecm@roth.com.
This press release does not and shall not
constitute an offer to sell or the solicitation of an offer to buy
any securities, nor shall there be any sale of these securities in
any state or other jurisdiction in which such offer, solicitation
or sale would be unlawful prior to registration or qualification
under the securities laws of any such state or other jurisdiction.
Any offer, if at all, will be made only by means of a prospectus,
including a prospectus supplement, forming a part of the effective
registration statement.
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 or placebo 2
mg/day for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12. The primary
outcome measure for the study is 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 is approved in 58 countries outside the
United States for use in hospitalized patients with acutely
decompensated heart failure. Tenax Therapeutics has North American
rights to develop and commercialize IV (TNX-101), subcutaneous
(TNX-102), and oral (TNX-103) formulations of levosimendan. Results
of Tenax Therapeutics’ Phase 2 HELP trial of levosimendan in
patients with pulmonary hypertension (PH) and heart failure with
preserved ejection fraction (HFpEF) demonstrated that IV
levosimendan produces potent dilation of the central and pulmonary
venous circulations which translates into an improvement in
exercise capacity, a discovery that forms the basis for 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 TherapeuticsTenax
Therapeutics, Inc. is a specialty pharmaceutical company focused on
identifying, developing, and commercializing products that address
cardiovascular and pulmonary diseases with high unmet medical need.
The Company owns North American rights to develop and commercialize
IV, subcutaneous, and oral formulations of levosimendan. Tenax
Therapeutics also is developing a unique oral formulation of
imatinib. For more information, visit www.tenaxthera.com. Tenax’s
common stock is listed on The Nasdaq Stock Market
LLC under the symbol “TENX”.
Caution Regarding Forward-Looking
StatementsExcept 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: risks related to closing the public offering;
our anticipated use of net proceeds from the public offering; our
ability to raise additional money to fund our operations for at
least the next 12 months as a going concern and develop our product
candidates as anticipated; risks related to our business strategy,
including the prioritization and development of product candidates;
intellectual property risks; 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, 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; 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 COVID-19
pandemic or similar health epidemics and geopolitical uncertainties
such as in Ukraine and the Middle East; 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 (NASDAQ:TENX)
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