Tonix Pharmaceuticals Reports Third Quarter 2022 Financial Results and Operational Highlights Five Potentially Pivotal Phase 2 or 3 Studies for CNS Programs Expected to be in the Clinic by First Quarter 2023 Data from Pl

Tonix Pharmaceuticals Holdings Corp. 8-K

Tonix Pharmaceuticals

Reports Third Quarter 2022 Financial Results and Operational Highlights

Five Potentially Pivotal Phase 2 or 3

Studies for CNS Programs Expected to be in the Clinic by First Quarter 2023

Data from Planned Interim Analyses of

TNX-102 SL in Phase 3 Fibromyalgia Study and Phase 2 Long COVID Study Expected Second Quarter 2023

Advanced Development Center in Dartmouth,

Mass. and Infectious Disease Research and Development Facility in Frederick, Md. Operational

Cash and Cash Equivalents Totaled Approximately

$140 Million at September 30, 2022

CHATHAM, N.J., November 7, 2022 (GLOBE

NEWSWIRE) - Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical

company, today announced financial results for the third quarter ended September 30, 2022, and provided an overview of recent operational

"Tonix continues to make meaningful

progress in the development of multiple programs within its robust pipeline, having already commenced a confirmatory Phase 3 study

for fibromyalgia in the second quarter of this year and a potentially pivotal Phase 2 study for Long COVID in the third quarter

of this year," said Seth Lederman, M.D., Chief Executive Officer of Tonix. "We look forward to the interim data from

both of these TNX-102 SL studies in the second quarter of 2023. Additionally, we look forward to advancing our other central nervous

system or CNS product candidates including TNX-102 SL for PTSD, TNX-1900 for chronic migraine, TNX-1300 for cocaine intoxication,

and TNX-601 ER for depression, all of which we expect to be in the clinic by first quarter 2023. Finally, we continue to make strides

in immunology with TNX-1500 for preventing organ transplant rejection expected to enter into a Phase 1 study in the first half

of 2023, as well as in infectious diseases with TNX-801, a vaccine to prevent smallpox and monkeypox, expected to enter into a

Phase 1 study also in the first half of next year."

Recent Highlights-Key Product Candidates*

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual

tablet): small molecule for the management of fibromyalgia (FM)

TNX-102 SL for the treatment of Long

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

TNX-102 SL for the treatment of Posttraumatic

Stress Disorder (PTSD)

TNX-1300 (recombinant double mutant

cocaine esterase): biologic for life-threatening cocaine intoxication

TNX-1900 (intranasal potentiated oxytocin):

small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and obesity associated binge eating disorder

TNX-601 ER (tianeptine hemioxalate extended-release

tablets): a once-daily small molecule for the treatment of major depressive disorder (MDD), PTSD, and neurocognitive dysfunction

associated with corticosteroid use.

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 monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.

Infectious Disease Pipeline

TNX-801 (live horsepox virus vaccine

for percutaneous administration): vaccine against smallpox and monkeypox designed as a single-administration vaccine to elicit

*All of Tonix's product

candidates are investigational new drugs or biologics and have not been approved for any indication.

Recent Highlights--Financial

As of September 30, 2022, Tonix had $140.0 million of cash and

cash equivalents, compared to $178.7 million as of December 31, 2021.

In October 2022, Tonix issued 1,400,000 shares of Series A convertible

redeemable preferred stock and 100,000 shares of Series B convertible redeemable preferred stock to certain institutional investors

in a private placement for gross proceeds of $15.0 million. The Company expects to use the proceeds to redeem the preferred stock.

Cash used in operations was approximately

$23.5 million for the three months ended September 30, 2022, compared to $12.9 million for the same period in 2021. The increase

in cash outlays was primarily due to an increase in research and development activities. Capital expenditures were approximately

$8.8 million for the three months ending September 30, 2022 compared to $7.8 million for the same period in 2021. The increase

was primarily due to the continued buildout of the ADC in North Dartmouth, Mass.

Third Quarter 2022 Financial Results

Research and development (R&D) expenses

for the three months ended September 30, 2022 were $22.2 million, compared to $13.1 million for the same period in 2021. The increase

is predominately due to increased clinical, manufacturing, non-clinical, employee-related and laboratory expenses. The Company

continues to expect R&D expenses to increase throughout the remainder of 2022 as it moves its clinical development programs

forward and invests in its development pipeline.

General and administrative (G&A) expenses

for the three months ended September 30, 2022 were $7.4 million, compared to $5.5 million for the same period in 2021. The increase

is primarily due to increased employee-related and financial reporting expenses.

Net loss available to common stockholders

was $29.0 million, or $0.69 per share, basic and diluted, for the three months ended September 30, 2022, compared to net loss of

$18.5 million, or $1.60 per share, basic and diluted, for the same period in 2021. The basic and diluted weighted average common

shares outstanding for the three months ended September 30, 2022 was 41,944,289 compared to 11,581,367 shares for the same period

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage

biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease

and alleviate suffering. Tonix's portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious

disease product candidates. Tonix's CNS portfolio includes both small molecules and biologics to treat pain, neurologic,

psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is

in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and

interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute-COVID-19

condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter

of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy

designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal

potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study

in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine

being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the

first quarter of 2023. Tonix's rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment

of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix's immunology portfolio includes

biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody

targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment

of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix's infectious

disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19,

and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix's vaccine in development to prevent

smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious

diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix's lead vaccine

candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix's recombinant pox live virus vector vaccine platform.

of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information

about Tonix can be found at www.tonixpharma.com.