Full Press Release Details
Tonix Pharmaceuticals Holding Corp - 8-K
Tonix Pharmaceuticals to Deliver an Oral Presentation
and Present Two Posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting
Oral Presentation of Tonmya (TNX-102 SL) for
Fibromyalgia; NDA preparation in progress
Posters Highlighting Other TNX-102 SL Programs
In Clinical Development; Long COVID and Acute Stress Disorder
CHATHAM, N.J., May 22, 2024 - Tonix Pharmaceuticals
Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline
of development candidates, today announced that the Company will deliver an oral presentation and present two posters at the American
Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024 at the Loews Miami Beach Hotel in Miami Beach,
The oral presentation will detail findings of studies
of Tonmya (TNX-102 SL, sublingual cyclobenzaprine HCl) in fibromyalgia. One poster will describe the Phase 2 proof of concept study of
TNX-102 SL in fibromyalgia-type Long COVID. The second poster will describe the upcoming investigator-initiated Phase 2 trial of TNX-102
SL in treating acute stress disorder and preventing posttraumatic stress disorder after motor vehicle collision, which will be conducted
by the University of North Carolina, the sponsor of the study.
TNX-102 SL is a centrally acting, non-opioid medication, which
is trade named Tonmya for the management of fibromyalgia. As previously announced, the second statistically significant Phase 3
study of Tonmya, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo in participants
with fibromyalgia (p=0.00005). Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key
secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.
Tonix plans to submit a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type
B pre-NDA meeting with FDA for the second quarter of 2024.
Copies of the Company's presentation and posters
will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com
following the conference. Additional meeting information can be found on the ASCP website here.
Oral Presentation Details
Poster Presentation Details
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused
on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's development
portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to submit a New Drug Application (NDA) to the
FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have
been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type
Long COVID. Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has
Breakthrough Therapy designation. Tonix's immunology development portfolio consists of 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. Tonix also has product candidates in development
in the areas of rare disease and infectious disease. 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 and have not been approved for any indication.
1Tonmya is conditionally accepted by the
U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved
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.
Tonix Pharmaceuticals