Tonix Pharmaceuticals Announces Proposed Public Offering
28 Setembro 2023 - 5:01PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the
“Company”), a biopharmaceutical company, today announced that
it intends to offer and sell shares of its common stock (or common
stock equivalents in lieu thereof) and warrants to purchase shares
of common stock in a public offering. All of the securities to be
sold in the offering are to be offered by Tonix. The offering is
subject to market conditions, and there can be no assurance as to
whether or when the offering may be completed, or as to the actual
size or terms of the offering.
The Company intends to use the net proceeds from
the offering for working capital and general corporate purposes,
the build out of the Company’s manufacturing and research and
development facilities, and the acquisition or licensing of
approved products and products in development.
A.G.P./Alliance Global Partners is acting as
lead placement agent for the offering. Brookline Capital Markets, a
division of Arcadia Securities, LLC is acting as co-placement agent
for the offering.
This offering is being made pursuant to an
effective shelf registration statement on Form S-3 (File No.
333-254975) previously filed with the U.S. Securities and Exchange
Commission (the “SEC”). The offering will be made only by means of
a prospectus supplement and accompanying prospectus. The
preliminary prospectus supplement and accompanying prospectus
describing the terms of the proposed offering will be filed with
the SEC and will be available on the SEC’s website located at
http://www.sec.gov. Electronic copies of the preliminary prospectus
supplement may be obtained, when available, from A.G.P./Alliance
Global Partners, 590 Madison Avenue, 28th Floor, New York, NY
10022, or by telephone at (212) 624-2060, or by email at
prospectus@allianceg.com. Before investing in this offering,
interested parties should read in their entirety the prospectus
supplement and the accompanying prospectus and the other documents
that Tonix has filed with the SEC that are incorporated by
reference in such prospectus supplement and the accompanying
prospectus, which provide more information about Tonix and such
offering.
This press release shall not constitute an offer
to sell or the solicitation of an offer to buy nor shall there be
any sale of these securities in any state or 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 jurisdiction.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix
Medicines, our commercial subsidiary markets
Zembrace® SymTouch® (sumatriptan injection) 3 mg and
Tosymra® (sumatriptan nasal spray) 10 mg under a transition
services agreement with Upsher-Smith Laboratories from whom the
products were acquired on June 30, 2023. Zembrace SymTouch and
Tosymra are each indicated for the treatment of acute migraine with
or without aura in adults. Tonix’s development portfolio is
composed of central nervous system (CNS), rare disease, immunology
and infectious disease product candidates. Tonix’s CNS development
portfolio includes both small molecules and biologics to treat
pain, neurologic, psychiatric and addiction conditions. Tonix’s
lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl
sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia, having completed enrollment of a
potentially confirmatory Phase 3 study in the third quarter of
2023, with topline data expected in the fourth quarter of 2023.
TNX-102 SL is also being developed to treat fibromyalgia-type Long
COVID, a chronic post-acute COVID-19 condition. Enrollment in a
Phase 2 proof-of-concept study has been completed, and topline
results were reported in the third quarter of 2023. TNX-601 ER
(tianeptine hemioxalate extended-release tablets) is a once-daily
oral formulation being developed as a treatment for major
depressive disorder (MDD), that completed enrollment in a Phase 2
proof-of-concept study in the third quarter of 2023, with topline
results expected in the fourth quarter of 2023. TNX-4300
(estianeptine) is a single isomer version of TNX-601, small
molecule oral therapeutic in preclinical development to treat MDD,
Alzheimer’s disease and Parkinson’s disease. Relative to
tianeptine, estianeptine lacks activity on the µ-opioid receptor
while maintaining activity in the rat Novel Object Recognition
test in vivo and the ability to activate PPAR-β/δ and
neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated
oxytocin), is in development for preventing headaches in chronic
migraine, and has completed enrollment in a Phase 2
proof-of-concept study with topline data expected in the fourth
quarter of 2023. TNX-1900 is also being studied in binge eating
disorder, pediatric obesity and social anxiety disorder by academic
collaborators under investigator-initiated INDs. TNX-1300 (cocaine
esterase) is a biologic designed to treat cocaine intoxication and
has been granted Breakthrough Therapy designation by the FDA. A
Phase 2 study of TNX-1300 is expected to be initiated in the fourth
quarter of 2023. Tonix’s rare disease development portfolio
includes TNX-2900 (intranasal potentiated oxytocin) for the
treatment of Prader-Willi syndrome. TNX-2900 has been granted
Orphan Drug designation by the FDA. Tonix’s immunology development
portfolio includes biologics to address organ transplant rejection,
autoimmunity and cancer, including TNX-1500, which is a humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being
developed for the prevention of allograft rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was
initiated in the third quarter of 2023. Tonix’s infectious disease
pipeline includes TNX-801, a vaccine in development to prevent
smallpox and mpox. TNX-801 also serves as the live virus vaccine
platform or recombinant pox vaccine platform for other infectious
diseases. The infectious disease development portfolio also
includes TNX-3900 and TNX-4000, which are classes of broad-spectrum
small molecule oral antivirals.*Tonix’s product development
candidates are investigational new drugs or biologics and have not
been approved for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. Intravail is a registered trademark
of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis,
Inc. All other marks are property of their respective owners.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995 including those relating to
the completion of the public offering, the timing and size of
the public offering, the intended use of proceeds from the public
offering and other statement that are predictive in nature.
These statements may be identified by the use of forward-looking
words such as “anticipate,” “believe,” “forecast,” “estimate,”
“expect,” and “intend,” among others. These forward-looking
statements are based on Tonix's current expectations and actual
results could differ materially. There are a number of factors that
could cause actual events to differ materially from those indicated
by such forward-looking statements. These factors include, but are
not limited to, risks related to the failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations;
risks related to the failure to successfully market any of our
products; risks related to the timing and progress of clinical
development of our product candidates; our need for additional
financing; uncertainties of patent protection and litigation;
uncertainties of government or third party payor reimbursement;
limited research and development efforts and dependence upon third
parties; and substantial competition. As with any pharmaceutical
under development, there are significant risks in the development,
regulatory approval and commercialization of new products. Tonix
does not undertake an obligation to update or revise any
forward-looking statement. Investors should read the risk factors
set forth in the Annual Report on Form 10-K for the year ended
December 31, 2022, as filed with the Securities and Exchange
Commission (the “SEC”) on March 13, 2023, and periodic reports
filed with the SEC on or after the date thereof. All of Tonix's
forward-looking statements are expressly qualified by all such risk
factors and other cautionary statements. The information set forth
herein speaks only as of the date thereof.
Investor ContactJessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Peter VozzoICR
Westwickepeter.vozzo@westwicke.com(443) 213-0505
Media ContactBen ShannonICR
Westwickeben.shannon@westwicke.com(919) 360-3039
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