Tonix Pharmaceuticals Announces First Patient Dosed in Phase 2 OASIS Study of TNX-102 SL for Reduction of Acute Stress Reaction Investigator-initiated Phase 2 trial to evaluate TNX-102 SL's potential to reduce severity o

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals Announces First Patient

Dosed in Phase 2 OASIS Study of TNX-102 SL for Reduction of Acute Stress Reaction

Investigator-initiated Phase 2 trial to evaluate

TNX-102 SL's potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD)

Trial is sponsored by the University of North

Carolina (UNC) and supported by a grant from the U.S. Department of Defense

Topline results from the trial are expected

in the second half of 2026

CHATHAM, N.J., May 21, 2025 (GLOBE NEWSWIRE)

- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a

fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the first

patient has been dosed in the Phase 2, investigator-initiated OASIS trial to evaluate TNX-102 SL in reducing the severity of acute stress

reaction (ASR) and the frequency of acute stress disorder (ASD). The trial is sponsored by the University of North Carolina (UNC) Institute

for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (DoD).

"TNX-102 SL has been shown to improve

sleep quality in PTSD, and previous trials of TNX-102 SL suggested activity on sleep and stress-related symptoms in the first several

weeks of treatment," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Addressing sleep disturbances

is crucial in managing ASR, as poor sleep can exacerbate other symptoms and hinder recovery. There is a significant unmet need for treating

ASR after traumatic events, such as civilian motor vehicle collisions or warfighter experiences in forward bases or in theater. We are

encouraged by the support of TNX-102 SL's prior data improving PTSD symptomatology in the first several weeks of treatment, which

may be crucial to reducing ASR symptoms and their sequalae. We look forward to topline results in the second half of 2026."

The Optimizing Acute Stress Reaction Interventions

with TNX-102 SL (OASIS) trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae

among patients presenting to the emergency department (ED) after a motor vehicle collision (MVC). The trial plans to enroll approximately

180 MVC-trauma survivors at ED study sites around the U.S. Participants will be randomized in the ED to receive a two-week course of either

TNX-102 SL 5.6 mg or placebo.

The OASIS trial will build upon a foundation

of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. AURORA is a major national research initiative

to improve the understanding, prevention and recovery of individuals who experience a traumatic event. AURORA is supported by funding

from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading

tech companies, such as Mindstrong Health and Verily Life Sciences, the healthcare arm of Alphabet, the parent company of Google.

Acute and chronic stress disorders can affect

both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience

at least one trauma in their lives In the U.S. alone, one-third of ED visits (40-50 million patients per year) involve evaluation after

trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event

during their service. Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD. Currently,

no medication is available in the immediate aftermath of traumatic events to treat the initial reaction and support long term health

via a post-trauma clinical trajectory that prevents development or worsening of ASD, thereby also preventing PTSD.

For more information, see ClinicalTrials.gov

Identifier: NCT06636786

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.

Tonix Pharmaceuticals Holding Corp.*

Tonix 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 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 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 statements. The information set forth herein speaks only as of the date thereof.

Tonix Pharmaceuticals