Tonix Pharmaceuticals to Participate in the 2024 BIO CEO & Investor Conference
21 February 2024 - 12:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced that Seth
Lederman, M.D., President and Chief Executive Officer of Tonix
Pharmaceuticals, will present at the BIO CEO & Investor
Conference on February 26, 2024 at 1:30 p.m. ET in New York City.
Investors interested in arranging a meeting with
the Company’s management during the conference can register on the
BIO CEO & Investor Conference website here.
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’s
development portfolio is focused on central nervous system
disorders. Tonix’s priority is to submit a New Drug Application
(NDA) to the FDA for Tonmya, which has completed two positive Phase
3 studies for the management of fibromyalgia. Tonix intends to meet
with the FDA in the first half of 2024 and submit an NDA for the
approval of Tonmya for the management of fibromyalgia in the second
half of 2024. TNX-102 SL is being developed to reduce the severity
of acute stress reaction and the frequency of acute stress disorder
and posttraumatic stress disorder. This trial is being sponsored by
the University of North Carolina and received funding support from
the U.S. Department of Defense. TNX-102 SL is also being developed
to treat fibromyalgia-type Long COVID, a chronic post-acute
COVID-19 condition, and topline results from a proof-of-concept
study were reported in the third quarter of 2023. TNX-1300 (cocaine
esterase) is a biologic designed to treat cocaine intoxication and
has been granted Breakthrough Therapy designation by the FDA and
received funding from the National Institute on Drug Abuse (NIDA).
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 (PWS). TNX-2900 has been granted
Orphan Drug designation by the FDA and an investigational new drug
(IND) application has been cleared to support a Phase 2 study in
PWS patients. 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
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 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.
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, 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 Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Ben ShannonICR
Westwickeben.shannon@westwicke.com443-213-0495
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Apr 2024 to May 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From May 2023 to May 2024