Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Tonix Pharmaceuticals Announces Two Oral
Presentations Involving TNX-1500 (Fc-modified anti-CD40L mAb) on Prevention of Rejection in Kidney and Heart Allograft Transplantation
at the 2022 American Transplant Congress
Research Directed by Faculty of the
Center for Transplantation Sciences, Massachusetts General Hospital
NEW YORK, May 31, 2022 (GLOBE NEWSWIRE) - Tonix Pharmaceuticals
Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced two upcoming oral presentations
by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital at the 2022
American Transplant Congress (ATC), being held June 4-8, 2022, in Boston, Mass. The research groups are led by Professor Tatsuo Kawai
and Professor Richard Pierson. The research involves studies of Tonix's TNX-1500 (Fc-modified anti-CD40L monoclonal antibody) in
development for the prevention of rejection of organ transplants. The molecular target of TNX-1500 is CD40-ligand (CD40L), which is also
known as CD154. Copies of the presentations will be made available on the Tonix Pharmaceuticals corporate website following the presentations
Oral Presentation Details
About Tonix Pharmaceuticals Holding Corp.1
Tonix is a clinical-stage biopharmaceutical company
focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's
portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix's
CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's
lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia
with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is
also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID
in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is expected
to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. Finally,
TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with
a Phase 2 study in the second half of 2022. Tonix's rare disease 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 portfolio
includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500 which is a humanized
monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment
of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix's infectious disease
pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19,
and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix's lead vaccine candidates for COVID-19 are TNX-1840
and TNX-1850, which are live virus vaccines based on Tonix's recombinant pox live virus vector vaccine platform.
product candidates are investigational new drugs or biologics and have not been approved for any indication.
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; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and Exchange Commission
(the "SEC") on March 14, 2022, 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.
Jessica Morris (corporate)
Tonix Pharmaceuticals
Olipriya Das, Ph.D. (media)
Peter Vozzo (investors)