Tonix Pharmaceuticals Announces Grant by Medical CBRN Defense Consortium (MCDC) for Development of TNX-801, the Company's Single-Dose Mpox and Smallpox Vaccine Candidate The World Health Organization (WHO) recently reaff

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals

Announces Grant by Medical CBRN Defense Consortium (MCDC) for Development of TNX-801, the Company's Single-Dose Mpox and Smallpox

The World Health Organization (WHO) recently

reaffirmed the spread of new clade Ib Mpox a public health emergency of international concern (PHEIC): second Mpox-related WHO PHEIC declaration

Clade Ib Mpox cases detected in several countries

in Central and Eastern Africa as well as China, Thailand, Singapore, India, England, parts of Europe and the Middle East, Canada and the

Tolerability of TNX-801 vaccination in immune-compromised

animal models supports clinical development

CHATHAM, N.J., March 10, 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 it has been awarded a grant from the Medical CBRN Defense Consortium

(MCDC) to support the development of TNX-801 (recombinant horsepox virus, live vaccine). MCDC is a consortium of industrial, academic,

and non-profit entities that supports the U.S. government in meeting military requirements for medical products to protect against chemical,

biological, radiological and nuclear (CBRN) threats.TNX-801 is in development as an mpox and smallpox vaccine with the potential to be

delivered via innovative alternative methods to improve patient compliance, ease of use and tolerability. The MCDC grant will allow for

further comprehensive market analyses, target market identification and commercialization planning, including for both private and government

"We are excited by the opportunity to

collaborate with MCDC and are thankful for their support of our vaccine candidate," said Seth Lederman, M.D., President, and Chief

Executive Officer of Tonix. "TNX-801 offers an appealing target product profile, requiring just a single dose for durable, long-term

protection, with favorable shipping and storage requirements. With a significant global unmet need, TNX-801 is in a strong position to

make a potential impact towards preventing mpox and controlling mpox epidemics."

TNX-801 is an attenuated live-virus vaccine

based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability

than 20th century vaccinia live-virus vaccines in animals. TNX-801 has previously been shown to protect animals against lethal challenge

with intratracheal clade I monkeypox virus.1 An outbreak of clade I mpox was declared a Public Health Emergency of International

Concern (PHEIC) by the World Health Organization (WHO) in August of 2024 and reaffirmed in February 2025.2,3 Starting from

an outbreak in the Democratic Republic of the Congo, clade I mpox has spread to sixteen Central African Countries and outside of Africa,

including in China, Thailand, Singapore, India, England, parts of Europe and the Middle East, Canada and the United States.4

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 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. TNX-1500

has completed a positive Phase I trial. 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

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:

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

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 provider.

This is the most important information to know about Zembrace and

Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use.

You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs