Tonix Pharmaceuticals Announces On-line Publication of Phase 3 RESILIENT Trial Results of TNX-102 SL for Fibromyalgia in the Peer Reviewed Journal, Pain Medicine The previously disclosed and now published RESILIENT data

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals Announces On-line Publication

of Phase 3 RESILIENT Trial Results of TNX-102 SL for Fibromyalgia in the Peer Reviewed Journal, Pain Medicine

The previously disclosed and

now published RESILIENT data show that once-nightly TNX-102 SL achieved statistically significant improvement in the primary endpoint

of reducing fibromyalgia pain versus placebo, and was generally well tolerated

These results confirm findings

from the previously published RELIEF phase 3 trial, which also demonstrated a statistically significant reduction in fibromyalgia pain

FDA target PDUFA date for TNX-102

SL is August 15, 2025 and, if approved, would be the first new drug for treating fibromyalgia in more than 15 years

CHATHAM, N.J., July 9, 2025

(GLOBE NEWSWIRE) - Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced

that full results from its confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management

of fibromyalgia have been published online in the peer reviewed Pain Medicine, the official journal of the American Academy of

Pain Medicine. The publication is titled, "Pain Relief by Targeting Nonrestorative Sleep in Fibromyalgia: A Phase 3 Randomized Trial

of Bedtime Sublingual Cyclobenzaprine" and is available here.

"The RESILIENT data that

are now published on-line in Pain Medicine underscores the therapeutic promise of TNX-102 SL, our non-opioid, centrally-acting

analgesic in development for reducing fibromyalgia pain," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.

"RESILIENT confirms the pain improvement data previously reported from our RELIEF study. Based on these two statistically significant

Phase 3 studies, we submitted a New Drug Application (NDA) which has been granted a Prescription Drug User Fee Act (PDUFA) target date

of August 15 for a decision on marketing authorization."

RESILIENT was a randomized, double-blind,

placebo-controlled trial that enrolled 457 adults with fibromyalgia across 33 United States sites. Participants received TNX-102 SL 2.8

mg for two weeks followed by 5.6 mg for twelve weeks, or matching placebo, with efficacy assessed over fourteen weeks. Treatment with

TNX-102 SL produced a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale compared with a 1.2-point

reduction for placebo, achieving the primary endpoint with high statistical significance. Statistically significant improvements were

also observed across all six prespecified key secondary endpoints, including Patient Global Impression of Change responder analysis, Fibromyalgia

Impact Questionnaire - Revised (FIQR) Symptoms and Function domains, and the PROMIS Sleep Disturbance and Fatigue instruments.

TNX-102 SL was generally well

tolerated. The most common treatment-emergent adverse events were oral tingling/numbness and bitter or noticeable aftertaste, which were

typically mild, transient lasting less than an hour, and self-limiting. No drug-related serious adverse events or deaths were reported.

These safety and efficacy findings underscore TNX-102 SL's favorable risk-benefit profile and its potential to address the unmet

needs of people living with fibromyalgia

a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia

afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread

pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances,

including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality

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

TNX-102 SL is a patented sublingual tablet

formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life

active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent

binding and antagonist activities at the 5-HT2Aserotonergic, 1-adrenergic, H1-histaminergic, and M1-muscarinic receptors,

TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, acute stress reaction (ASR)/acute stress disorder (ASD),

Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder (AUD) and agitation in Alzheimer's

disease (AAD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No.

9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No.10736859 in August

2020. The Protectic protective eutectic and Angstro-Technology formulation claimed in the patent are important

elements of Tonix's proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval,

with U.S. market exclusivity until 2034/2035.

About the Phase 3 RESILIENT Study

The RESILIENT study is a double-blind, randomized,

placebo-controlled trial designed to

evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine

HCl sublingual tablets) in

the management of fibromyalgia. The two-arm trial

enrolled 457 adults with fibromyalgia across 33 United States sites. The first two weeks of treatment consist of a run-in period in

which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL

5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity

score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale

scores), analyzed by mixed model repeated measures with multiple imputation. For more information, see ClinicalTrials.gov

Identifier: NCT05273749.

Tonix Pharmaceuticals Holding Corp.*

is a fully-integrated biotech 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 ASR and ASR, Long COVID, AUD and AAD. A

phase 2 study of ASR/ASD is ongoing 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 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'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 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, 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 the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary