Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection and Treatment of Autoimmune Diseases Resu

Tonix Pharmaceuticals Holding Corp 8-K

Tonix Pharmaceuticals Announces Positive

Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection

and Treatment of Autoimmune Diseases

Results from the Phase 1 single ascending

dose study support proceeding to develop a Phase 2 trial for the prevention of kidney transplant rejection

TNX-1500 blocked the primary and secondary

antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses

TNX-1500 showed mean half-life of 34-38

days for the 10 mg/kg and 30 mg/kg doses supporting monthly dosing for future efficacy trials

TNX-1500 was generally well-tolerated with

a favorable safety profile

Anti-CD40L has multiple potential indications

in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product

CHATHAM, N.J., February 6, 2025 (GLOBE

NEWSWIRE) - 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 positive topline results from its Phase 1, single ascending

dose trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy participants. The objectives of the

Phase 1 trial were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500, as well as to support

dosing in a planned Phase 2 trial in kidney transplant recipients.

"There remains a significant need

for new agents with improved activity and safety to prevent transplant rejection and treat autoimmune diseases," said Seth Lederman,

M.D., Chief Executive Officer of Tonix Pharmaceuticals. "First generation anti-CD40L mAb therapy, particularly ruplizumab (a.k.a.,

humanized 5c8 or BG9588) showed activity in modulating autoimmunity and rejection in allo- and xeno-transplantation but was limited by

an increased risk of thrombosis.1-3 Tonix created TNX-1500, a next generation anti-CD40L mAb, by reengineering the Fc region

of ruplizumab, to preserve activity with improved safety. The results of the Phase 1 study indicate that TNX-1500 has met these design

objectives. We believe the results of this study and our prior animal studies4,5 indicate that TNX-1500 is potentially best-in-class

among next-generation anti-CD40L mAbs in development."

Gregory Sullivan, M.D., Chief Medical Officer

of Tonix Pharmaceuticals said, "Topline results from the TNX-1500 Phase 1 study showed TNX-1500 at the 10 mg/kg and 30 mg/kg doses

blocked both the primary and secondary antibody responses to a test antigen. The pharmacokinetic data support monthly dosing at doses

of 10 mg/kg or above. Based on these findings, we are eager to advance this promising candidate into a Phase 2 efficacy study. We believe

TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden relative

to current immunosuppressive regimens."

Methods and Topline Results

Tonix plans to discuss these results with

the U.S. Food and Drug Administration (FDA) in an End-of-Phase 1 meeting. Pending alignment with the FDA, a Phase 2 study of TNX-1500

in kidney transplant recipients will be pursued.

TNX-1500 (Fc-modified humanized anti-CD40L

mAb) is a humanized monoclonal antibody that binds and functionally inhibits the CD40-ligand (CD40L), also known as CD154. TNX-1500 is

being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after

hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. Two published articles in the American

Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent

or in combination with other drugs in non-human primate renal and heart allografts. 4,5

*TNX-1500 is an investigational new biologic and

is not approved for any indication

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical

company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio

is focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management

of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia

and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization.

The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to

treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS

study funded by the U.S. Department of Defense (DoD). Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in

Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported

by a grant from the U.S. National Institute on Drug Abuse. Tonix's immunology development portfolio consists of biologics to address

organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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 infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract

with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule

broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military

personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick,

Md. 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; their efficacy and safety have not been established and have not been approved for any indication.

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

Indication and Usage

Zembrace SymTouch (sumatriptan

succinate) injection (Zembrace) and Tosymra (sumatriptan) nasal spray are prescription medicines used to treat acute

migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It

is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including

heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: