Tonix Pharmaceuticals Announces Registered Direct Offering of up to $144 Million
20 Dezembro 2023 - 12:35PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
biopharmaceutical company with marketed products and a pipeline of
development candidates, today announced that the Company has signed
securities purchase agreements with certain healthcare-focused
institutional investors that have agreed to provide up to $144
million in gross proceeds to Tonix through a registered
direct offering that includes initial upfront funding of $30
million.
About the Registered Direct Offering
Pursuant to the securities purchase agreements, the Company has
agreed to issue an aggregate of 54,054,054 shares of common stock
(or prepaid warrants) and two series of registered warrants to
purchase an aggregate of 162,162,162 shares of common stock for a
purchase price of $0.555 per share and associated warrants (less
$0.0001 in the case of prepaid warrants). The Series C warrants are
exercisable at $0.555 per share and the Series D warrants are
exercisable at $0.85 per share as follows:
- Series C warrants for an aggregate
cash exercise price of approximately $45
million, exercisable until the earlier of two years from
the initial exercisable date and 10 trading days following notice
by the Company to the warrant holder of the Company’s public
announcement of the U.S. Food and Drug Administration’s
acknowledgement and acceptance of the Company’s new drug
application relating to TNX-102 SL in patients with
Fibromyalgia;
- Series D warrants for an aggregate
cash exercise price of approximately $69
million exercisable for five years from the initial
exercisable date.
Neither the Series C nor the Series D warrants shall be
exercisable until the Company receives shareholder approval
authorizing the exercise of such warrants.
A.G.P./Alliance Global Partners is acting as the sole placement
agent for the offering.
The closing of the offering is expected to occur on December 22,
2023, subject to customary closing conditions.
Tonix currently intends to use the net proceeds from the
offering for the preparation of their new drug application relating
to TNX-102 SL in patients with fibromyalgia, as well as working
capital and general corporate purposes. For further information,
please see the Company's current report on Form 8-K to be filed
with the SEC.
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, LLC 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), has completed two positive
Phase 3 studies for the management of fibromyalgia. Tonix intends
to meet with the FDA and submit an NDA for the approval of TNX-102
SL for the management of fibromyalgia in the second half of 2024.
TNX-102 SL is also being developed to treat fibromyalgia-type Long
COVID, a chronic post-acute COVID-19 condition, and topline results
were reported in the third quarter of 2023. TNX-1900 (intranasal
potentiated oxytocin) is being studied in binge eating disorder,
pediatric obesity, bone health in autism 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 first quarter of 2024 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, including TNX-1800, in development
as a vaccine to protect against COVID-19. During the fourth quarter
of 2023, TNX-1800 was selected by the U.S. National Institutes of
Health (NIH), National Institute of Allergy and Infectious Diseases
(NIAID) Project NextGen for inclusion in Phase 1 clinical trials.
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. 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 offering, the satisfaction of customary
closing conditions, the intended use of proceeds from the 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, statements about the expected closing of the offering;
anticipated gross proceeds from the offering; 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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