Tonix Pharmaceuticals Announces Publication of Paper in Antiviral Research Highlighting the Company's Development of Monoclonal Antibody Therapeutics for Monkeypox and Smallpox Data Represent Research and Development Wor

TONIX PHARMACEUTICALS HOLDING CORP. FORM 8-K

Tonix Pharmaceuticals Announces Publication of Paper

in Antiviral Research Highlighting the Company's Development of Monoclonal Antibody Therapeutics for Monkeypox and Smallpox

Data Represent Research and Development Work Being

Conducted at Tonix's Infectious Disease R&D Center (RDC) in Frederick, Md.

CHATHAM, N.J., January 24, 2023 - Tonix

Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the

publication of a paper entitled, "Development of a rapid image-based high-content imaging screening assay to evaluate therapeutic

antibodies against the monkeypox virus," in the journal Antiviral Research. The publication describes the development

and optimization of two high-content image-based assays that were employed to screen for potential therapeutic antibodies against the

monkeypox virus using surrogate poxviruses such as vaccinia virus. The article highlights Tonix's TNX-3400 platform, which includes

antibodies to potentially prevent or treat monkeypox and smallpox. The article can be accessed online at https://pubmed.ncbi.nlm.nih.gov/36592670/.

"These data represent the first wave of

research and development conducted at our Infectious Disease R&D Center (RDC) in Frederick, Md," said Seth Lederman, M.D., Chief

Executive Officer of Tonix Pharmaceuticals. "The RDC greatly enhances our ability to advance development of our pipeline of vaccines

and therapeutics for infectious diseases. The TNX-3400 platform has promise for preventative and therapeutic monoclonal antibodies to

treat monkeypox and smallpox."

"The article describes how we optimized

and standardized two high-content high-throughput image-based assays. The first assay was a neutralizing assay which detected viral proteins

of vaccinia virus and used the assay to screen a large library of antibodies made against pox viruses. The second assay specifically detected

phenotype changes in cells, called syncytia, after infection and protection by therapeutics." said Sina Bavari, Ph.D., Executive

Vice President of Tonix Pharmaceuticals and site director of the RDC. A critical component in assessing antibodies during pandemics requires

the development of rapid but detailed methods to detect and quantitate the neutralization activity. "The neutralizing assay identified

several antibodies with the capacity to protect against vaccinia virus infection. We believe this technology will allow us to identify

combination therapies for monkeypox and smallpox viruses which was difficult to achieve before. Furthermore, our data suggest that applying

this technology has the potential to increase the throughput of screening novel antivirals to shorten the discovery time for antivirals."

TNX-3400 is the term for series of

monoclonal antibodies which bind to key components of pox viruses such as monkeypox and smallpox and protect cells and tissues from infection

with these pandemic causing viruses. These antibodies are being developed as broad-spectrum antipox virus and to potentially prevent or

treat monkeypox and smallpox infection.

Tonix Pharmaceuticals Holding Corp.*

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 second

quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase

2 study in Long COVID in the third quarter of 2022 and expects interim data 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. A Phase 2 study

of TNX-1300 is expected to be initiated in the first quarter of 2023. 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 first quarter of 2023. TNX-601 ER (tianeptine

hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive

disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. 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 (CD40L or CD154) 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 first

half of 2023. Tonix's infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801,

a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600,

and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix's vaccine in development

to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other

infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023.

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)