Tonix Pharmaceuticals Reports Third Quarter 2023 Financial Results and Operational Highlights Topline Results from Phase 3 Potentially NDA-Enabling Study of TNX-102 SL in Fibromyalgia Expected Late December 2023: Central

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

Tonix Pharmaceuticals

Reports Third Quarter 2023 Financial Results and Operational Highlights

Topline Results from Phase 3 Potentially NDA-Enabling

Study of TNX-102 SL in Fibromyalgia Expected Late December 2023: Centrally-Acting Non-Opioid Analgesic

Topline Results from Phase 2 Proof-of-Concept Study

of TNX-1900 in Chronic Migraine Expected Early December 2023: Intranasal Potentiated Oxytocin

Meaningful Progress Made in Obtaining External

Support for Clinical Trials from U.S. Government Agencies and Other Institutions

Revenue from Marketed Acute Migraine Products:

Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) Included in Third Quarter Financial Statements

CHATHAM, N.J., November 9, 2023 (GLOBE NEWSWIRE)

- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products

and a pipeline of development candidates, today announced financial results for the third quarter ended September 30, 2023, and provided

an overview of recent operational highlights.

"Tonix expects topline results from its Phase

3 fibromyalgia study and Phase 2 chronic migraine study before year end," said Seth Lederman, M.D., Chief Executive Officer of Tonix.

"The Phase 3 RESILIENT trial in fibromyalgia, if successful, is expected to be the final efficacy trial required for submitting

a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual

tablets). In the Phase 2 proof-of-concept PREVENTION study in chronic migraine of TNX-1900 (intranasal potentiated oxytocin), all patients

have completed their final visit and topline results are expected in early December 2023."

Dr. Lederman continued, "We are continuing

to shift the expense of clinical trials from our operating budget to U.S. government agencies and other institutions through partnerships.

The U.S. Department of Defense (DoD) is supporting the upcoming Phase 2 study of TNX-102 SL in acute stress disorder, being conducted

and sponsored by University of North Carolina (UNC). The U.S. National Institutes of Health (NIH) and National Institute of Allergy and

Infectious Diseases (NIAID), through its Project NextGen, will conduct the Phase 1 study of our vaccine candidate TNX-1800 (modified recombinant

horsepox virus, live vaccine). The National Institute of Drug Abuse (NIDA) is supporting our Phase 2 study of TNX-1300 (recombinant double

mutant cocaine esterase) for cocaine intoxication. Massachusetts General Hospital (MGH) is conducting Phase 2 studies of TNX-1900 in binge

eating disorder and pediatric obesity, and the University of Washington is conducting a Phase 2 study of TNX-1900 in social anxiety disorder.

Finally, we continue to collaborate with MGH on several preclinical non-human primate studies for TNX-1500 (anti-CD40L Fc-modified humanized

monoclonal antibody), currently in a Phase 1 study being conducted by Tonix. These outside collaborations leverage our internal resources

and allow us to progress our clinical programs in a capital efficient manner."

Partnerships with External Funding -

Marketed Products - Recent Highlights

Key Product Candidates* -- Recent Highlights

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual

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

TNX-102 SL for the treatment of acute

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

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 (SAD), insulin resistance and related disorders, and adolescent

obesity and binge eating disorder

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 Fc-modified humanized

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

Infectious Disease Pipeline

TNX-1800 (modified recombinant horsepox

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

TNX-801 (recombinant horsepox virus, live

vaccine): potential vaccine to protect against mpox disease and smallpox.

*All of Tonix's product candidates

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

1Tzabazis A, et al. Cephalalgia. 2016.

2Anand R.P., et al. Nature. 2023. 622,

3Lassiter, G., et al. (2023). TNX-1500, a crystallizable

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

4Miura, 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 September 30, 2023, Tonix had approximately

$6.9 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Additionally, Tonix had inventory totaling

approximately $13.3 million as of September 30, 2023. In August 2023, Tonix received net proceeds of approximately $6.3 million through

a public offering of common stock, after deducting underwriting discount and other offering expenses. Cash used in operations was approximately

$79.7 million for the nine months ended September 30, 2023, compared to $75.8 million for the same period in 2022. Cash used by investing

activities for the nine months ended September 30, 2023 was approximately $28.6 million.

On September 28, 2023, the Company sold 4,050,000

shares of common stock, pre-funded warrants to purchase up to 4,950,000 shares of common stock, and accompanying common A warrants to

purchase 9,000,000 shares of common stock and common B warrants to purchase up to 9,000,000 shares of common stock in a public offering

for net proceeds of approximately $4.0 million, after deducting underwriting discount and other offering expenses. This public offering

closed on October 3, 2023.

Third Quarter 2023 Financial Results

Net product revenue for the third quarter

2023 was approximately $4.0 million. As a reminder, Tonix completed the acquisition of two currently marketed products from Upsher-Smith

Laboratories, LLC on June 30, 2023.

During the three months ended September 30,

2023, Tonix received $0.4 million from NIDA for the TNX-1300 study to treat cocaine intoxication.

R&D expenses for the third quarter 2023

were approximately $21.1 million, compared to $22.2 million for the same period in 2022. This decrease is predominantly due to decreased

non-clinical and manufacturing expenses, offset by an increase in clinical, employee-related and professional expenses.

SG&A expenses for the third quarter 2023

were $8.7 million, compared to $7.4 million for the same period in 2022. The increase was primarily due to sales and marketing associated

with the Company's recently acquired marketed products.

Net loss available to common stockholders

was $28.0 million, or $1.83 per share, basic and diluted, for the third quarter 2023, compared to net loss available to common stockholders

of $29.0 million, or $4.24 per share, basic and diluted, for the same period in 2022. The basic and diluted weighted average common shares

outstanding for the third quarter 2023 was 15,327,558 compared to 6,843,099 shares for the same period in 2022.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing,

developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial

subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg under a

transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch