Tonix Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operational Highlights Topline Results from Four CNS Clinical Trials Expected in the Third and Fourth Quarters of 2023 Fibromyalgia Topline Results

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

Tonix Pharmaceuticals

Reports Second Quarter 2023 Financial Results and Operational Highlights

Topline Results from Four CNS Clinical Trials Expected

in the Third and Fourth Quarters of 2023

Fibromyalgia Topline Results Expected in the Fourth

Quarter of 2023 for Phase 3 Potentially NDA-Enabling Study of the Centrally-Acting Non-Opioid Analgesic TNX-102 SL

Completed Strategic Acquisition of Two Marketed

Acute Migraine Products: Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray)

CHATHAM, N.J., August 10, 2023 (GLOBE NEWSWIRE) -

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced financial results

for the second quarter ended June 30, 2023, and provided an overview of recent operational highlights.

"We have recently completed enrollment in four

clinical trials for central nervous system (CNS) indications, representing our continuing progress towards bringing forth new treatments

for serious CNS conditions that affect large patient populations," said Seth Lederman, M.D., Chief Executive Officer of Tonix. "We

look forward to data readouts before year-end 2023 for fibromyalgia, fibromyalgia-type Long COVID, chronic migraine, and depression. The

topline results from the Phase 3 fibromyalgia trial are of particular importance because we believe the RESILIENT trial, if successful,

will be the final efficacy trial required for submitting a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration

On June 30, 2023, Tonix completed the acquisition

of two marketed products from Upsher-Smith Laboratories, LLC (Upsher-Smith): Zembrace SymTouch (sumatriptan injection) 3 mg

and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both non-oral proprietary products indicated for the

treatment of acute migraine with or without aura in adults. Zembrace SymTouch is the only branded sumatriptan autoinjector professionally

promoted in the United States and is designed for ease of use and favorable tolerability with a low 3 mg dose. Tosymra is a novel intranasal

sumatriptan product formulated with a permeation enhancer that provides rapid and efficient absorption of sumatriptan. Collectively, these

products generated gross factory sales of approximately $30 million for the twelve months ended March 31, 2023. Zembrace SymTouch and

Tosymra each may provide onset of migraine pain relief in as few as 10 minutes for some patients and currently have patent protection

to 2036 and 2031, respectively.

Seth Lederman continued, "The acquisition

of these two marketed products is transformative for Tonix as we believe that we are on track to become a fully integrated pharmaceutical

company and to expand our expertise in CNS disorders by interacting with health care providers and payers. The build out of our commercial

capabilities is timely, given the potential 2025 launch of TNX-102 SL(cyclobenzaprine HCl sublingual tablets) for fibromyalgia, if results

from the RESILIENT trial are positive. The two marketed acute migraine products also align strongly with our clinical product candidate

TNX-1900 (intranasal potentiated oxytocin), in development as a preventive medication in chronic migraineurs."

"We plan to submit an IND to study TNX-2900

(intranasal potentiated oxytocin) in Prader-Willi syndrome, for which Orphan Drug Designation has already been granted by the FDA,"

said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. "Academic collaborators have initiated enrollment in

three Phase 2 investigator-initiated trials studying TNX-1900 (intranasal potentiated oxytocin). The trials in adolescent obesity and

binge eating disorder at Massachusetts General Hospital (MGH) have the potential to expand the use of TNX-1900 to the treatment of disorders

of appetite, eating behaviors and weight. The trial in social anxiety at University of Washington has the potential to expand the use

of TNX-1900 to the treatment of disorders of social functioning."

Dr. Lederman continued, "During the second

quarter of 2023, we also announced the prioritization of our clinical stage CNS programs and de-prioritization of our COVID-19 vaccine

and related therapeutic programs, as well as certain other preclinical programs in order to reallocate cash and resources. We also streamlined

several CNS studies by eliminating interim analyses and reducing enrollment targets to ensure data readouts this year. We incurred a one-time

cash outlay related to our acquisition of Zembrace SymTouch and Tosymra in the second quarter."

Recent Highlights-Marketed Products

On June 30, 2023, Tonix completed the acquisition

of two currently marketed products from Upsher-Smith Laboratories, LLC (Upsher-Smith): Zembrace SymTouch (sumatriptan injection) 3 mg

and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both indicated for the treatment of acute migraine with

or without aura in adults.

Recent Highlights-Key Product Candidates*

Upcoming Data Readouts in Central Nervous

System (CNS) Pipeline During 2023

Fibromyalgia (4Q): Phase 3 Potentially NDA-Enabling

Fibromyalgia-Type Long COVID (3Q): Phase 2

Proof-of-Concept Study of TNX-102 SL

Chronic Migraine (4Q): Phase 2 Proof-of-Concept

Depression (4Q): Phase 2 Proof-of-Concept

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual

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

TNX-102 SL for the treatment of Fibromyalgia-Type

Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)

TNX-1900 (intranasal potentiated oxytocin):

small peptide for migraine, craniofacial pain, social anxiety disorder, insulin resistance and related disorders, and adolescent obesity

and binge eating disorder

TNX-601 ER (tianeptine hemioxalate extended-release

tablets): a once-daily orally administered small molecule for the treatment of major depressive disorder (MDD), posttraumatic stress disorder

(PTSD), neurocognitive dysfunction associated with corticosteroid use, and potentially Alzheimer's disease

TNX-4300 (estianeptine): small molecule

oral therapeutic for MDD, bipolar disorder, Alzheimer's disease and Parkinson's disease

TNX-1300 (recombinant double mutant cocaine

esterase): biologic for life-threatening cocaine intoxication

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin):

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

TNX-1500 (anti-CD40L monoclonal antibody):

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

*All of Tonix's product candidates

are investigational new drugs or biologics and none have been approved for any indication.

1Lassiter, G., et al. (2023). TNX-1500, a crystallizable

fragment-modified anti-CD154 antibody, prolongs non-human primate renal allograft survival. American Journal of Transplantation.

2Miura, S., et al. (2023). TNX-1500, a crystallizable

fragment-modified anti-CD154 antibody, prolongs non-human primate cardiac allograft survival. American Journal of Transplantation.

Recent Highlights-Financial

As of June 30, 2023, Tonix had approximately

$25.6 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Subsequent to the end of the second quarter

of 2023, Tonix raised $7.0 million in gross proceeds through a public offering of its common stock. Cash used in operations was approximately

$56.3 million for the six months ended June 30, 2023, compared to $52.2 million for the same period in 2022. Cash used by investing activities

for the six months ended June 30, 2023 was approximately $27.8 million, primarily driven by the purchase of certain assets from Upsher-Smith

The acquisition cost of Zembrace SymTouch and

Tosymra was $15 million, consisting of $12 million up front and an additional deferred payment of $3.0 million. We also purchased inventory

for $10.0 million and expect to pay an additional $1.3 million related to an inventory adjustment.

On April 8, 2020, the Company entered into a sales agreement with

AGP of up to $320.0 million in at-the-market offerings sales. During the quarter ended June 30, 2023, the Company sold approximately 0.4

million shares of common stock under the sales agreement, for net proceeds of approximately $1.0 million.

On August 1, 2023, the Company sold in a public offering securities

consisting of 2,530,000 shares of common stock, pre-funded warrants to purchase up to 4,470,000 shares of common stock, and accompanying