Tonix Pharmaceuticals Recently Announced Preliminary Full Year 2024 Operating Results and Year-End Cash Company had $98.8 million in cash as of

Tonix Pharmaceuticals Holding Corp 8-K

Tonix Pharmaceuticals Recently Announced

Preliminary Full Year 2024

Operating Results and Year-End Cash

Company had $98.8 million in cash as of

December 31, 2024; existing cash expected

to fund planned operations into the first quarter of 2026

Company is debt-free after repaying mortgage

TNX-102 SL fibromyalgia FDA PDUFA goal date

$10.1 million in net sales from migraine

CHATHAM, N.J., February 7, 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, recently announced selected preliminary operating results for the year ended December

31, 2024, and certain preliminary financial condition information as of December 31, 2024.

Preliminary Full Year 2024 Financial Results1

The Company expects that its cash resources

at December 31, 2024, and the gross proceeds of approximately $30.4 million raised from sales under its at-the-market facility in the

first quarter of 2025, will be sufficient to fund its planned operations into the first quarter of 2026.

The cash runway is expected to fund the company

beyond the August 15, 2025 Prescription Drug User Fee Act (PDUFA) goal date assigned by the U.S. Food and

Drug Administration (FDA) for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for

the management of fibromyalgia.

1 The above information is preliminary

financial information for the year ended December 31, 2024 and subject to completion. The unaudited, estimated results for the year ended

December 31, 2024 are preliminary and were prepared by the Company's management, based upon its estimates, a number of assumptions

and currently available information, and are subject to revision based upon, among other things, quarter and year-end closing procedures

and/or adjustments, the completion of the Company's consolidated financial statements and other operational procedures. This preliminary

financial information is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods.

However, the Company has not completed its financial closing procedures for the year ended December 31, 2024, and its actual results could

be materially different from this preliminary financial information, which preliminary information should not be regarded as a representation

by the Company or its management as to its actual results for the year ended December 31, 2024. In addition, EisnerAmper LLP, the Company's

independent registered public accounting firm, has not audited, reviewed, compiled, or performed any procedures with respect to this preliminary

financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information.

During the course of the preparation of the Company's financial statements and related notes as of and for the year ended December

31, 2024, the Company may identify items that would require it to make material adjustments to this preliminary financial information.

As a result, prospective investors should exercise caution in relying on this information and should not draw any inferences from this

information. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance

with United States generally accepted accounting principles and reviewed by the Company's auditors.

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. 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:

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: