Tonix Pharmaceuticals Announces Presentation of New Data on Mpox and Smallpox Vaccine Candidate TNX-801 at the Vaccine Congress 2025 TNX-801 is up to 100,000-fold less virulent than live smallpox vaccine strains and a si

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

Tonix Pharmaceuticals Announces Presentation

of New Data on Mpox and Smallpox Vaccine Candidate TNX-801 at the Vaccine Congress 2025

TNX-801 is up to 100,000-fold less virulent than

live smallpox vaccine strains and a single dose provides robust immunogenicity and protection against mpox and rabbitpox (more than one

Subcutaneous administration of TNX-801 yielded

equivalent protection to the traditional percutaneous administration

CHATHAM, N.J., July 10, 2025 (GLOBE NEWSWIRE)

- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated biopharmaceutical company with marketed products and a

pipeline of development candidates, today announced the presentation of new findings on TNX-801 (recombinant horsepox, live virus vaccine)

at the Vaccine Congress 2025 in Vienna on July 10, 2025, by Sina Bavari, PhD, Executive Vice President, Infectious Disease Research and

"The data show that TNX-801 can deliver

durable immunity while remaining highly attenuated, a balance that sets it apart from earlier orthopox vaccines," said Seth Lederman,

MD, Chief Executive Officer of Tonix Pharmaceuticals. "The novel finding that subcutaneous (s.c.) administration of TNX-801

provides equivalent protection to percutaneous administration, is leading us to develop the s.c. product first. Most live-virus

vaccines are delivered s.c. and this route of administration has further potential benefits of decreased administration-site bacterial

superinfection, scarring, or inadvertent transfer to other body sites by itching. We believe TNX-801 has the potential to become a critical

tool for containing mpox and preparedness against the malicious reintroduction of smallpox.We look forward to advancing TNX-801 into the

clinic by s.c. delivery."

TNX-801 is a recombinant horsepox-derived vaccine

candidate designed to prevent orthopox viruses and provide durable humoral and cellular immunity from a single dose. In primary human

dermal cells, the virus replicates twenty-seven to one-hundred-nineteen-fold less than licensed vaccinia strains, and in interferon receptor

knockout mice it is up to one-hundred-thousand-fold less virulent than those legacy vaccines. Preclinical studies further showed that

a single dose of TNX-801 produced strong binding and neutralizing antibody responses across mice, rabbits, hamsters, and cynomolgus macaques,

including immunocompromised animals. All vaccinated macaques survived lethal Clade I mpox challenge without lesions, and rabbit models

remained fully protected for fourteen months.

"Our data show that TNX-801 delivers durable

immunity without safety concerns of live virus vaccines," said Dr Bavari. "TNX-801 dissociates immune protection from some

of the side-effects associated with traditional vaccinia-based vaccines and potentially offers a unique risk-benefit profile for mpox

and smallpox prevention. We are excited to advance this program toward clinical evaluation in collaboration with public-health partners

The World Health Organization and the Centers

for Disease Control and Prevention continue to classify mpox as an ongoing public-health concern. A single-dose vaccine with the attenuation

and immunogenicity profile demonstrated by TNX-801 could streamline outbreak response by reducing the need for approved multi-visit immunization

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biotech 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 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's

infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has

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

molecule broad-spectrum antiviral agent 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, 2024, as filed with

the Securities and Exchange Commission (the "SEC") on March 18, 2025, 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:

Zembrace and Tosymra are not for people with risk

factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless

a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

Tell your provider about all of your medical conditions and medicines

you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness.

If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

The most common side effects of Zembrace and Tosymra

include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning

feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions

(Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect

that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your