Tonix Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Highlights FDA PDUFA goal date of

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

Tonix Pharmaceuticals

Reports First Quarter 2025 Financial Results and Operational Highlights

FDA PDUFA goal date of August 15, 2025, for TNX-102

SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than

Announced positive topline results from Phase 1

study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejection and treatment

of autoimmune disorders

Cash and cash equivalents of $131.7 million reported

as of March 31, 2025; Current cash sufficient to fund operations into the second quarter of 2026

CHATHAM, N.J., May12, 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 financial results for the first quarter ended March 31, 2025, and provided

an overview of recent operational highlights.

"We believe TNX-102 SL (cyclobenzaprine HCl

sublingual tablets)* is on track to become a new therapeutic option for patients suffering with fibromyalgia," said Seth Lederman,

M.D., Chief Executive Officer of Tonix. "TNX-102 SL would be the first member of a new class of FDA approved drugs for fibromyalgia.

TNX-102 SL is a non-opioid analgesic that targets fibromyalgia's characteristic disturbed sleep to improve the widespread pain of

fibromyalgia, while also being well tolerated. Our focus continues to be on the upcoming U.S. Food and Drug Administration (FDA) Prescription

Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on the market authorization on TNX-102 SL for the management of

fibromyalgia. We are building out our commercial team for the anticipated product launch in the fourth quarter of this year. Tonix believes

it has sufficient cash to fund operations beyond these key milestones."

Dr. Lederman continued, "Beyond TNX-102 SL

for fibromyalgia, we are encouraged by the continued achievements in our pipeline, including positive Phase 1 results for TNX-1500, a

next generation anti-CD40L Fc-modified humanized monoclonal antibody (mAb) in development for prevention of kidney transplant rejection

and pre-clinical results for TNX-801, a live-virus vaccine in development for preventing mpox and smallpox. We look forward to providing

additional updates to each of these promising programs in 2025."

Key Investigational Product Candidates*

-- Recent Highlights

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual

tablets): 5.6 mg, once-daily at bedtime small molecule for the management of fibromyalgia (FM) - a centrally-acting, non-opioid

TNX-102 SL in development for the treatment

of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

TNX-1300 (recombinant double mutant cocaine

esterase): under investigation for biologic for cocaine intoxication

TNX-1500 (anti-CD40L Fc-modified humanized

monoclonal antibody): third generation anti-CD40L monoclonal antibody under investigation for prophylaxis for organ transplant rejection

and treatment of autoimmune disorders.

Infectious Disease Pipeline

TNX-801 (recombinant horsepox virus, minimally

replicative live vaccine): potential vaccine to protect against mpox and smallpox.

Corporate and Partnerships - Recent

Financial - Recent Highlight

As of March 31, 2025, Tonix had $131.7 million

of cash and cash equivalents, compared to $98.8 million as of December 31, 2024. Net cash used in operations was approximately $16.6 million

for first quarter 2025, compared to net cash used in operations of $17.6 for the same period in 2024.

On July 30, 2024, the Company entered into

a Sales Agreement with AGP pursuant to which the Company may issue and sell, from time to time, shares of the Company's common stock

having an aggregate offering price of up to $250.0 million in at-the-market sales. During the three months ended March 31, 2025, the Company

sold approximately 2.7 million shares of common stock for net proceeds of approximately $59.8 million. Subsequent to March 31, 2025, the

Company sold 0.6 million shares of common stock under the Sales Agreement, for net proceeds of approximately $9.9 million.

The Company believes that its cash resources

at March 31, 2025, along with the net proceeds of $9.9 million raised from equity offerings in the second quarter of 2025, will meet its

planned operating and capital expenditure requirements into the second quarter of 2026.

Subsequent to March 31, 2025, the Company

repurchased 150,000 of its shares of common stock outstanding under a share repurchase program, for a gross aggregate cost of approximately

First Quarter 2025 Financial Results

Net product revenue for the first quarter

2025 was approximately $2.4 million compared to $2.5 million for the same period in 2024. Net product revenue consisted of combined net

sales of Zembrace SymTouch and Tosymra . Cost of Sales for the first quarter 2025 was approximately $0.9 million compared

to $1.7 million for the same period in 2024.

Research and development expenses for the

first quarter 2025 were $7.4 million, compared to $12.9 million for the same period in 2024. This decrease

is predominantly due to decreased clinical, non-clinical, manufacturing and employee-related expenses.

Selling, general and administrative expenses

for the first quarter 2025 were $10.1 million, compared to $9.3 for the same period in 2024. The increase was primarily due to an increase

in sales and marketing expenses offset by a decrease in employee-related expenses resulting from a reduction in workforce in earlier 2024.

Net loss available to common stockholders

was $16.8 million, or $2.84 per share, basic and diluted, for the first quarter 2025, compared to net loss of $14.9 million, or $535.72

per share, basic and diluted, for the same period in 2024. The basic and diluted weighted average common shares outstanding for the first

quarter 2025 was 5,927,231 compared to 27,886 shares for the same period in 2024.

About 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.

In March 2025 the FDA guided that no Advisory Committee Meeting will be required for this NDA. 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. Department of Defense'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, Tosymra and TONIX ONE are 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,"