Tonix Pharmaceuticals Completes Acquisition of Two FDA-Approved, Marketed Migraine Products Strategic Acquisition Helps Build Tonix's Commercial Capabilities and Infrastructure Ahead of Potential Launch of TNX-102 SL for

Tonix Pharmaceuticals Holding Corp, Inc. 8-K

Tonix Pharmaceuticals

Completes Acquisition of Two FDA-Approved, Marketed Migraine Products

Strategic Acquisition Helps Build Tonix's

Commercial Capabilities and Infrastructure Ahead of Potential Launch of TNX-102 SL for the Management of Fibromyalgia

Acquisition of Zembrace SymTouch (sumatriptan

injection) and Tosymra (sumatriptan nasal spray), Indicated for the Treatment of Acute Migraine in Adults, Complements Tonix's

Current Intranasal Clinical Development Program of TNX-1900 for Migraine Prevention

CHATHAM, N.J., July 3, 2023 - Tonix Pharmaceuticals

Holding Corp. (Nasdaq: TNXP) (Tonix Pharmaceuticals or Tonix), a biopharmaceutical company, and its wholly-owned commercialization subsidiary

Tonix Medicines, Inc. (Tonix Medicines), today announced it has completed the acquisition of two currently-marketed products from Upsher-Smith

Laboratories, LLC (Upsher-Smith): Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray)

10 mg. Zembrace SymTouch and Tosymra are both indicated for the treatment of acute migraine with or without aura in adults. As previously

announced, these products collectively generated product sales of approximately $23 million for the full year 2022.1

of these two products represents an important step in the evolution of Tonix into a fully integrated biopharmaceutical company and builds

on our expertise in central nervous systems disorders," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.

"In addition to the potential growth that these two on-market products represent over time, the acquisition helps build Tonix's

commercial capabilities ahead of the potential launch of our TNX-102 SL product candidate for the treatment of fibromyalgia, and aligns

strongly with our TNX-1900 (intranasal potentiated oxytocin) product candidate in clinical development for the prevention of headaches

in chronic migraine."

and breakthrough migraine headaches remain a significant burden, and we believe both Zembrace SymTouch and Tosymra are well-suited to

address the unmet needs of patients currently using traditional or emerging oral acute migraine medications, particularly for rapid-onset

treatment," said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix

Zembrace SymTouch is the only actively promoted brand

of sumatriptan autoinjector in the United States (other sumatriptan autoinjector products on the market are Imitrex and generics

to Imitrex ). It has a unique low dose and has demonstrated onset of migraine pain relief in as few as 10 minutes (17% of patients

vs. 5% for placebo).2 Zembrace SymTouch also demonstrated migraine pain freedom for 46% of patients (vs 27% for placebo) at

2 hours in a single-attack, double-blind study (N=230).3 Zembrace SymTouch currently has patent protection to 2036. Tosymra

employs Intravail permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan.4,5

Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for

placebo).2,5, 6 Tosymra currently has patent protection to 2031.

Nearly 40 million people in the United States

suffer from migraine7 and it has been recognized as the second leading cause of disability in the world.7

Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of

moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and

sensitivity to light (photophobia).8

Tonix Pharmaceuticals Holding Corp.*

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

disease and alleviate suffering. Tonix markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra

(sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or

without aura in adults. Tonix's development portfolio is composed of central nervous system (CNS), rare disease, immunology

and infectious disease product candidates. Tonix's CNS development 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 topline data expected in the first quarter

of 2024. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2

study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate

extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also

currently enrolling with topline results expected in the first quarter of 2024. TNX-4300 (estianeptine) is a small molecule oral

therapeutic in preclinical development to treat MDD, Alzheimer's disease and Parkinson's disease. TNX-1900 (intranasal

potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth 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 third quarter of 2023. Tonix's rare

disease development 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 development 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 rejection and for the treatment of autoimmune diseases.

A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix's infectious disease pipeline

includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or

recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900

and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

product development candidates are investigational new drugs or biologics and have not been approved for any indication.

Zembrace SymTouch and Tosymra

are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary

of Neurelis, Inc. All other marks are the 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, 2022, as filed with the Securities and Exchange Commission (the "SEC") on March 13, 2023, 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

Zembrace SymTouch (sumatriptan

Injection): IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) 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

Zembrace is 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 if you have:

Tell your provider about all of your medical conditions and medicines

you take, including vitamins and supplements.

Zembrace 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 may cause serious side effects including:

The most common side effects of Zembrace include: pain

and redness at injection site; 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.