Tonix Pharmaceuticals to Present at the Winter 2024 Investor Summit Virtual
November 18 2024 - 4:05PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates,
announced today that Jessica Morris, Chief Operating Officer of
Tonix Pharmaceuticals, will present at the Winter 2024 Investor
Summit Virtual on Thursday, November 21, 2024, at 10:00 a.m. ET.
Investors interested in arranging a meeting with
the Company’s management virtually during the conference should
contact the Investor Summit conference coordinator. A live webcast
of the presentation can be found here or under the IR Events tab of
the Tonix website at www.tonixpharma.com.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a fully-integrated biopharmaceutical
company focused on transforming therapies for pain management and
vaccines for public health challenges. Tonix’s development
portfolio is focused on central nervous system (CNS) disorders.
Tonix’s priority is to advance TNX-102 SL, a product candidate for
the management of fibromyalgia, for which an NDA was submitted
based on two statistically significant Phase 3 studies for the
management of fibromyalgia. The FDA has granted Fast Track
designation to TNX-102 SL for the management of fibromyalgia. We
expect an FDA decision on the acceptance of the NDA for review and
a PDUFA date in December and if accepted, a decision on NDA
approval in 2025. TNX-102 SL is also being developed to treat acute
stress reaction and acute stress disorder under a
Physician-Initiated IND at the University of North Carolina in the
OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s
CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in
Phase 2 development designed to treat cocaine intoxication that has
FDA Breakthrough Therapy designation and its development is
supported by a grant from the U.S. National Institute of Drug Abuse
and Addiction. Tonix’s immunology development portfolio consists of
biologics to address organ transplant rejection, autoimmunity and
cancer, including TNX-1500, which is an Fc-modified humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being
developed for the prevention of allograft rejection and for the
treatment of autoimmune diseases. Tonix also has product candidates
in development in the areas of rare disease, including TNX-2900 for
Prader-Willi syndrome, and infectious disease, including a vaccine
for mpox, TNX-801. Tonix recently announced a contract with the
U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34
million over five years to develop TNX-4200, small molecule
broad-spectrum antiviral agents targeting CD45 for the prevention
or treatment of infections to improve the medical readiness of
military personnel in biological threat environments. Tonix owns
and operates a state-of-the art infectious disease research
facility in Frederick, MD. Tonix Medicines, our commercial
subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3
mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment
of acute migraine with or without aura in adults.
* Tonix’s product development candidates are
investigational new drugs or biologics; their efficacy and safety
have not been established 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.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. 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, 2023, as filed
with the Securities and Exchange Commission (the “SEC”) on April 1,
2024, 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 Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Healthcarepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Ray JordanPutnam Insightsray@putnaminsights.com(949)
245-5432
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