Tonix Pharmaceuticals Announces Data from an in vitro Study of the Impact of Oxytocin on Human Neurons at Neuroscience 2022 , the Annual Meeting of the Society for Neuroscience CHATHAM, N.J.

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals Announces

Data from an in vitro Study of the Impact of Oxytocin on Human Neurons at Neuroscience 2022, the Annual Meeting of the Society

CHATHAM, N.J., November 16, 2022 - Tonix

Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced data describing the impact of

oxytocin on isolated human sensory neurons, presented at Neuroscience 2022, the annual meeting of the Society for Neuroscience.

A copy of the poster is available under the Scientific Presentations

tab of the Tonix website at www.tonixpharma.com.

"This study of the effects of oxytocin

on isolated human sensory neurons adds to the growing evidence that oxytocin plays a key role in pain modulation. The potential for intranasal

oxytocin to be used as a non-opioid analgesic warrants further investigation," said Seth Lederman, M.D., Chief Executive Officer

of Tonix Pharmaceuticals. "To that end, we look forward to initiating our Phase 2 study of intranasal oxytocin in chronic migraine

by the end of 2022."

Professor David Yeomans, Director of Pain Research

at Stanford said, "The poster, titled In Vitro Impact of Oxytocin on Human Sensory Neurons, is the first to show that oxytocin

receptors are present on human sensory neurons and that inflammation drives expression of oxytocin receptors on these neurons. The study

also showed that oxytocin inhibits these neurons, suggesting a mechanism by which oxytocin can produce analgesia. The study also showed

the critical contribution of magnesium to this analgesia, as the impact of oxytocin on the sensory neurons was dramatically enhanced in

the presence of supraphysiologic levels of this ion, and are consistent with prior work which demonstrated that magnesium ions (Mg2+)

bind to a pocket in the oxytocin receptor, enhancing the activity of oxytocin at its receptor. The results of this study are consistent

with data from animal models and provide support for the use of oxytocin agonists for the treatment of pain."

In late 2021, Tonix received Investigational New Drug

(IND) clearance from the U.S. Food and Drug Administration (FDA) to support the initiation of a Phase 2 study of TNX-1900 (intranasal

potentiated oxytocin) for the prevention of migraine headache in chronic migraineurs. The Company expects to begin enrollment in the Phase

2 study during the fourth quarter of 2022.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage

biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease

and alleviate suffering. Tonix's portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious

disease product candidates. Tonix's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric

and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development

for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second

quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase

2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 (cocaine esterase)

is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study

of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in

development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine

hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive

disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix's rare disease portfolio includes

TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation

by the FDA. Tonix's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including

TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft

and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first

half of 2023. Tonix's infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation

vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix's vaccine

in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform

for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix's

lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix's recombinant pox live virus vector vaccine

of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication.

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; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and Exchange Commission

(the "SEC") on March 14, 2022, 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.

Jessica Morris (corporate)

Tonix Pharmaceuticals

Olipriya Das, Ph.D. (media)

Peter Vozzo (investors)