Tonix Pharmaceuticals Announces Research Agreement with University of Maryland, Baltimore, to Study TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Heart Xenograft Transplantation in Animals Rese

TONIX PHARMACEUTICALS HOLDING CORP. FORM 8-K

Tonix Pharmaceuticals Announces Research Agreement

with University of Maryland, Baltimore, to Study TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Heart Xenograft

Transplantation in Animals

Research Study to Assess the Role of TNX-1500 in

the Prevention of Heart Xenograft Rejection

Preclinical Xenotransplantation

Studies are Expected to Support Regulatory Filings for TNX-1500

CHATHAM, N.J., February 1, 2023 - Tonix

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

it has entered into a sponsored research agreement with the University of Maryland, Baltimore (UMB), for the prevention of rejection in

heart xenograft transplantation in animals utilizing TNX-15001, an Fc-modified humanized monoclonal antibody directed against

CD40-ligand. UMB's preclinical studies will utilize genetically-modified porcine hearts supplied by

Revivicor, Inc., a subsidiary of United Therapeutics Corporation. The principal investigator is Muhammad M. Mohiuddin, M.D., MBBS,

Professor of Surgery, and Director, Cardiac Xenotransplantation Program, University of Maryland School of Medicine.

"We are excited to collaborate with the

University of Maryland and Dr. Mohiuddin on the development of TNX-1500 for the prevention of rejection in xenograft transplantation,"

said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "TNX-1500 is a third generation anti-CD40L monoclonal

antibody that has been designed by protein engineering to decrease Fc RII binding and to reduce the potential for thrombosis. Previous

preclinical studies in non-human primates demonstrated that TNX-1500 showed activity in preventing allograft and xenograft organ rejection

and was well tolerated. A positive result from this study would potentially help support an Investigational New Drug (IND) application

and human clinical studies."

"Despite exciting advancements in the

field of xenotransplantation, better therapeutics are needed to prevent xenograft organ rejection," said Dr. Mohiuddin. "Several

lines of research indicate that anti-CD40L is required for long term xenograft acceptance. We are excited to collaborate in support of

developing an effective immunosuppression regimen for patients requiring xenograft transplantation."

The primary objective of the preclinical research

study is to study the activity of TNX-1500 in preventing cardiac xenograft rejection in animals to support an IND application for human

TNX-1500 (Fc-modified anti-CD40L mAb) is a

humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), which is also known as CD154. TNX-1500 is being developed

for the prevention of allograft and xenograft rejection, for the treatment of autoimmune diseases and for the prevention of graft-versus-host

disease (GvHD) after hematopoietic stem cell transplantation (HCT). A Phase 1 study of TNX-1500 is expected to be initiated in the second

quarter of 2023. 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. In June 2022, Tonix announced data from three oral presentations at the 2022 American

Transplant Congress of animal studies found that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human

primates. In those studies, blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in

non-human primate models of cardiac and kidney allograft transplantation without clinical thrombosis. Copies of the presentations are

available under Scientific Presentations on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com.

is a biologic at the pre-IND stage of development and has not been approved for any indication

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. 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 second 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 second quarter 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

Jessica Morris (corporate)

Tonix Pharmaceuticals

Olipriya Das, Ph.D. (media)

Peter Vozzo (investors)