Tonix Pharmaceuticals Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for TNX-102 SL for the Management of Fibromyalgia On track for

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals Announces that FDA Will Not

Require an Advisory Committee Meeting to Discuss New Drug Application for TNX-102 SL for the Management of Fibromyalgia

On track for August 15, 2025 FDA PDUFA goal date

TNX-102 SL is a non-opioid analgesic; if approved,

TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years

Commercial planning for TNX-102 SL underway for launch

in the fourth quarter of 2025

CHATHAM, N.J., March 24, 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 that the U.S. Food and Drug Administration (FDA) will not require an Advisory

Committee meeting to discuss the Company's New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia. If approved,

TNX-102 SL (cyclobenzaprine HCl sublingual tablets) would be the first new treatment option for fibromyalgia patients in 15 years.

"We are pleased that FDA will not require an advisory

committee meeting as part of the regulatory review process for TNX-102 SL," said Seth Lederman, M.D., President, and Chief Executive

Officer of Tonix Pharmaceuticals. "We believe that TNX-102 SL has the potential to be the first member of a new class of medicines

for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. We believe we are well positioned

to launch TNX-102 SL for the management of fibromyalgia in the fourth quarter of 2025 if approved by the FDA."

The FDA previously granted Fast Track designation to

TNX-102 SL for the management of fibromyalgia in 2024, a designation intended to expedite FDA review of important new drugs to treat serious

conditions and fill an unmet medical need.

Fibromyalgia is a common chronic pain disorder that

is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain

imaging studies have localized the functional disorder to the brain's insula and anterior cingulate cortex. Fibromyalgia afflicts

more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative

sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety,

headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired

quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

Fibromyalgia is now recognized as the prototypic nociplastic syndrome and as a chronic overlapping pain condition (COPC) 1-3.

Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain

syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization.

Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating

event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness;

a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious

illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other

conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable

condition that can occur after recovery from COVID-19 in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping

Pain Condition, which is a group of related conditions that include chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable

bowel syndrome, endometriosis, low back pain, post-concussive syndrome (also known as mild traumatic brain injury), chronic Lyme Disease,

chronic diabetic neuropathy and chronic post-herpetic neuralgia.

TNX-102 SL is a centrally acting, non-opioid investigational

drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime

dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor

subtypes: serotonergic-5-HT2A, adrenergic- 1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions

are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine

is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl

and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently

into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation

and required for efficient transmucosal absorption. Patents based on TNX-102 SL's eutectic composition and its properties have issued

in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent

Office's Opposition Division maintained Tonix's European Patent EP 2 968 992 in unamended form after an Opposition was filed

against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically

for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime

somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure

during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose

and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL,

the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing

oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.

1Fitzcharles MA, et al. Lancet. 2021;397:2098-110

2Clauw DJ. Ann Rheum Dis. Published Online

3Kaplan CM, et al. Nat Rev Neurol. 2024;20,

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

* 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, 2024, as filed with

the Securities and Exchange Commission (the "SEC") on March 18, 2025, and periodic reports filed with the SEC on or after