Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Kidney and Heart Allograft Transplantation in Animal Models at the 2022 American Trans

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

Tonix Pharmaceuticals Announces Data Presentations

Involving TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Kidney and Heart Allograft Transplantation in Animal

Models at the 2022 American Transplant Congress

Research Directed by Faculty of the Center

for Transplantation Sciences, Massachusetts General Hospital

CHATHAM, N.J., June 9, 2022 (GLOBE NEWSWIRE)

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

data from three oral presentations at the 2022 American Transplant Congress (ATC) by faculty at the Center for Transplantation Sciences,

Massachusetts General Hospital. The data involve studies of Tonix's TNX-1500 (Fc-modified anti-CD40L monoclonal antibody) product

candidate in development for the prevention of organ transplant rejection. The molecular target of TNX-1500 is CD40-ligand (CD40L), which

is also known as CD154. Copies of the presentations are available under Scientific Presentations on the Tonix Pharmaceuticals corporate

website at www.tonixpharma.com.

The presentations titled, "Long-Term

Rejection Free Renal Allograft Survival with Fc-Modified Anti-CD154 Antibody Monotherapy in Nonhuman Primates," "TNX-1500,

an Fc-modified Anti-CD154 Antibody, Prolongs Nonhuman Primate Cardiac Allograft Survival," and "Novel Targetable Pathways

in Costimulation Pathway Blockade" include data demonstrating that TNX-1500 showed activity in preventing organ rejection and

was well tolerated in non-human primates. Blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity

in a non-human primate cardiac allograft model without clinical thrombosis.

"There remains a significant need for

new treatments with improved activity and tolerability to prevent organ transplant rejection," said Seth Lederman, M.D., Chief Executive

Officer of Tonix Pharmaceuticals. "To date, there has not been a humanized anti-CD40L antibody that can effectively prevent transplant

rejections with acceptable level of tolerability. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering

to decrease Fc RII binding and to reduce the potential for thrombosis. The animal studies found that TNX-1500 retains activity to

prevent rejection and preserve graft function. We believe TNX-1500 has the potential for treating and preventing organ transplant rejection."

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

of Tonix's 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)