Tonix Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operational Highlights On track to submit NDA in second half 2024 for TNX-102 SL for fibromyalgia; completed successful pre-NDA meetings with FDA in

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals Reports

Second Quarter 2024 Financial Results and Operational Highlights

On track to submit NDA in second half 2024 for TNX-102

SL for fibromyalgia;

completed successful pre-NDA meetings with FDA in second quarter 2024

FDA granted Fast Track designation for TNX-102 SL

Commercial planning continues for U.S. launch of

TNX-102 SL, a potential new first-line,

centrally-acting, non-opioid analgesic for the management of fibromyalgia

U.S. Department of Defense contract awarded for

up to $34 million over 5 years to develop a broad-spectrum antiviral drug

World Health Organization (WHO) recently declared

spread of mpox in multiple African countries a public health emergency of international concern - Tonix's TNX-801 is an mpox

vaccine in development which protects animals against lethal challenge of monkeypox virus

CHATHAM, N.J., August 19, 2024 (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 second quarter ended June 30, 2024, and provided

an overview of recent operational highlights.

"In the second quarter of 2024, we made significant

progress advancing our New Drug Application (NDA) and market access strategy for TNX-102 SL (cyclobenzaprine HCl sublingual tablets),"

said Seth Lederman, M.D., Chief Executive Officer of Tonix. "We are working diligently on the regulatory submission and are pleased

to have been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and to be in alignment with the agency regarding

the content of our proposed NDA package. Fast Track is designed to facilitate the development and expedite FDA review of important new

drugs to treat serious conditions and fill an unmet medical need. We are hopeful that TNX-102 SL can be the first new drug to treat fibromyalgia

in more than 15 years."

Dr. Lederman continued, "Additionally, we continue

to advance other key pipeline candidates through a capital efficient strategy, including TNX-4200, our broad-spectrum antiviral program

for which we were awarded up to $34 million over five years from the U.S. Department of Defense (DoD) to advance its development."

Recent Highlights - Key Product Candidates*

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablets):

a centrally-acting, non-opioid, analgesic taken once-daily at bedtime for the management of fibromyalgia.

TNX-102 SL for the treatment of acute stress reaction

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

In May 2024, Tonix announced a plan for a Phase 2, investigator-initiated

OASIS trial, designed to examine the safety and efficacy of TNX-102 SL in treating Acute Stress Disorder (ASD) after motor vehicle collision.

The trial is sponsored by the University of North Carolina Institute for Trauma Recovery and supported by a $3 million contract from the

DoD, which was awarded in September 2023. TNX-102 SL will be evaluated for the reduction in severity of acute stress reaction (ASR) and

the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in civilians after a motor vehicle collision. Previous

trials of TNX-102 SL showed that it reduced military PTSD symptoms within two weeks while evidencing similar favorable tolerability as

in fibromyalgia patients.

Tonix expects to enroll the first patient in the Phase

2 OASIS trial in the third quarter of 2024.

TNX-1300 (recombinant double mutant cocaine esterase):

biologic for life-threatening cocaine intoxication

TNX-1900 (intranasal potentiated oxytocin): small

peptide in development through investigator-initiated studies for adolescent obesity, binge eating disorder (BED), bone health in autism

and social anxiety disorder (SAD).

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): small

peptide for the treatment of Prader-Willi syndrome (PWS)

TNX-1500 (anti-CD40L Fc-modified humanized monoclonal

antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.

Infectious Disease Pipeline

TNX-4200 (orally available CD45 antagonist), TNX-3900

(cathepsin inhibitor), TNX-4000 (glycan-targeted biologic)

TNX-801 (recombinant horsepox virus, live vaccine):

potential vaccine to protect against mpox disease and smallpox.

TNX-1800 (modified recombinant horsepox virus,

live vaccine): potential vaccine to protect against COVID-19 designed to express the SARS-CoV-2 spike protein

Marketed Products - Recent Highlights

TNX-102 SL has not been approved for any indication.

Recent Highlights - Financial

As of June 30, 2024, Tonix had $4.2 million of cash and cash equivalents,

compared to $24.9 million as of December 31, 2023. Net cash used in operations was approximately $30.5 million for the six months ended

June 30, 2024, compared to $56.3 million for the same period in 2023.

Subsequent to the quarter ending June 30, 2024, Tonix received net proceeds

of approximately $3.5 million in a securities purchase agreement with certain institutional and retail investors, and sold 0.8 million

shares of common stock under the ATM Sales Agreement, for net proceeds of approximately $0.4 million.

Second Quarter 2024 Financial Results

Net product revenue for the second quarter 2024 was

approximately $2.2 million. Net product revenue consisted of combined net sales of Zembrace SymTouch and

Tosymra , which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of Sales for the second quarter

2024 was approximately $3.4 million, which included a write-down related to Tosymra and Zembrace finished goods inventory of approximately

$1.7 million based on an assessment of inventory on hand and projected sales prior to the respective expiration dates.

Research and development expenses for the second quarter

2024 were $9.7 million, compared to $22.0 million for the same period in 2023. This decrease is predominantly due to decreased clinical,

non-clinical and manufacturing expenses aligned with the Company's capital efficient strategy.

Selling, general and administrative expenses for the

second quarter 2024 were $7.5 million, compared to $7.0 million for the same period in 2023. The increase was primarily due to sales and

marketing and the transition services expenses associated with the Company's recently acquired marketed products offset by a decrease

in financial reporting expenses.

Net loss available to common stockholders was $78.8

million, or $19.28 per share, basic and diluted, for the second quarter 2024, compared to net loss of $28.4 million, or $49.23 per share,

basic and diluted, for the same period in 2023. Included in the net loss for the three months ended June 30, 2024, are non-cash asset

impairment charges totaling $58.9 million. The basic and diluted weighted average common shares outstanding for the second quarter 2024

was 4,085,132 compared to 576,047 shares for the same period in 2023.

The impairment of the Tosymra and Zembrace inventory,

intangibles and goodwill was driven by our delayed investment in the sales personnel required to drive growth in the business as we are

focusing our cash resources to further our efforts to bring TNX-102 SL through the FDA approval process and to market. However, we believe

that the benefits and long-term value proposition of the 2023 acquisition of Tosymra and Zembrace remain, in that we now have the infrastructure

to be ready to manufacture and sell TNX-102 SL under an expedited timeline pending FDA approval for which we expect an FDA decision in

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company

focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix's development

portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA

in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed

for the management of fibromyalgia. The FDA has 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. Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic