Tonix Pharmaceuticals Announces Expansion of Leadership Team with Two Strategic Hires Tonix appoints two executives with decades of experience successfully launching and commercializing new CNS products Bradley Raudabaug

TONIX PHARMACEUTICALS HOLDING CORP 8-K

Tonix Pharmaceuticals Announces Expansion

of Leadership Team with Two Strategic Hires

Tonix appoints two executives with decades

of experience successfully launching and commercializing new CNS products

Bradley Raudabaugh, MBA, joins as Vice President,

Marketing, bringing over 25 years of marketing, sales and product planning experience to Tonix

Errol Gould, Ph.D., joins Tonix as Vice

President, Medical Affairs, with over 25 years of experience in R&D and medical affairs across a wide range of therapeutic areas,

including fibromyalgia

New Drug Application (NDA) for TNX-102 SL

for the management of fibromyalgia submitted to FDA in October 2024; NDA acceptance expected December 2024; Fast Track designation previously

granted by FDA; FDA decision on approval expected 2025

If approved by FDA, TNX-102 SL would be the

first member of a new class of analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years

CHATHAM, N.J., December 3, 2024 (GLOBE NEWSWIRE)

- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products

and a pipeline of development candidates, today announced the expansion of its leadership team to support the launch of TNX-102 SL for

the management of fibromyalgia. Bradley Raudabaugh, MBA, has been appointed Vice President, Marketing, and Errol Gould, Ph.D., has been

appointed Vice President, Medical Affairs.

"We have further strengthened our leadership

team with these two strategic hires as we continue to develop our commercial strategies and enhance the potential of our pipeline products.

We look forward to leveraging their leadership capabilities and commercial experience as Tonix prepares for the launch of TNX-102 SL for

the management of fibromyalgia," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Bradley's

experience in spearheading successful product launches and his deep commercial insights provide us a crucial asset as we prepare to receive

a decision from the U.S. Food and Drug Administration (FDA) for our TNX-102 SL NDA in 2025. Similarly, we believe Errol's experience

from working with Tonix since March 2024 as a medical affairs consultant and his vast and well-rounded experience in the development of

products in a variety of therapeutic areas will help us continue to build our reputation within the medical community."

Mr. Raudabaugh offers significant leadership

experience in building and launching major brands. Most recently, he was the Vice President of Product Strategy at Axsome Therapeutics,

where he led the strategic go-to-market planning across five products/indications in psychiatry and neurology. Earlier at Axsome, he led

their first commercial launch with Auvelity for the treatment of major depressive disorder, and the integration of Sunosi upon acquisition

for the treatment of excessive daytime sleepiness in patients with narcolepsy and sleep apnea. Prior to Axsome, Bradley has held roles

of increasing responsibility across marketing, sales, and market access at Insmed, Amgen, Teva, and AstraZeneca. Mr. Raudabaugh holds

a Master of Business Administration from the Olin Business School at Washington University in St. Louis and a Bachelor of Arts from Louisiana

"This is an exciting time to be joining Tonix as it prepares

to receive an FDA decision on its NDA for TNX-102 SL for the management of fibromyalgia," said Mr. Raudabaugh. "I am ecstatic

to work with the Tonix team. We have an opportunity to bring to patients and clinicians the first newly approved drug for fibromyalgia

in more than 15 years."

Dr. Gould has over 25 years of experience in

research and development and medical affairs across multiple therapeutic areas, including neurology, pain, and sleep, and worked with

Tonix as a medical affairs consultant since March 2024. Since 2022, Dr. Gould has served as Head of Medical Affairs in a consultant role

at Enalare Therapeutics, developing medical strategy, external messaging and publication plans for its novel respiratory stimulant candidate,

ENA-001. Previously, he spent over eight years at Currax Pharmaceuticals, where he ultimately served as Head of Medical and Scientific

Affairs. In this role, he led clinical and non-clinical research, developed U.S. and global medical affairs strategies and oversaw medical

information for all marketed products. Earlier in his career, Dr. Gould had various medical affairs roles at Synchrony Healthcare Communications,

Nuvo Research and Endo Pharmaceuticals. Dr. Gould began his career at GlaxoSmithKline as the Assistant Director in the Metabolism Therapeutic

Area and later served on secondment as an Associate Product Manager for the Diabetes Franchise. Dr. Gould holds a Ph.D. in pharmacology

from West Virginia University and a Bachelor of Science in biochemistry from the University of Massachusetts-Amherst. He also served as

a Research Associate at Hahnemann University and as a Post-Doctoral Fellow/Research Associate at the University of Virginia.

"I look forward to partnering with the

Tonix team and building upon the Company's successes to support TNX-102 SL as well as provide medical and strategic insight across

the entire Tonix portfolio," said Dr. Gould.

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.

The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. We expect an FDA decision on the acceptance

of the NDA for review and a PDUFA date in December 2024 and if accepted, a decision on NDA approval in August 2025 for standard review.

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 of Drug Abuse and Addiction. 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 the areas of rare disease, including TNX-2900

for Prader-Willi syndrome, and 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

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