Tonix Pharmaceuticals Reports Third Quarter 2021 Financial Results and Operational Highlights Expansion of Internal Research and Development Capabilities Underway to Accelerate Infectious Disease Programs and Prepare for

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals

Reports Third Quarter 2021 Financial Results and Operational Highlights

Expansion of Internal Research and Development

Capabilities Underway to Accelerate Infectious Disease Programs and Prepare for Future Pandemic Responses

COVID-19 Pipeline Progressing with First-in-Human

Trial of TNX-2100 Novel Skin Test for SARS-CoV-2 Functional T cell Immunity Expected to Start this Quarter

Phase 2 Trial of TNX-1300 in Cocaine Intoxication

Expected to Start this Quarter

At September 30, 2021, Cash and Cash Equivalents

Totaled Approximately $183 Million

CHATHAM, NJ, November 8, 2021 (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, 2021 and provided an overview of recent operational highlights.

"Our new infectious disease Research and Development

Center (RDC) in Frederick, Md. is operational, and we have begun the build-out of our Advanced Development Center (ADC) in the New Bedford,

Mass. Business Park -- two important milestones in our goal to becoming a leading innovator and manufacturer of vaccines, therapeutics

and diagnostics for infectious diseases," said Seth Lederman, MD, President and CEO of Tonix.

"The facilities are designed to accelerate

our current COVID-19 programs and provide us with the internal resources and capabilities to develop a broad-based infectious disease

portfolio, including live virus vaccines and skin test diagnostics that specifically target new pathogens within the rapid response timeframe

set forth in the American Pandemic Preparedness Plan, or AP3," he added.

AP3, which was recently released by the White

House's U.S. Office of Science and Technology Policy calls for strengthening the nation's pandemic and biowarfare defenses,

including the capability to develop vaccines against new pathogens within 100 days of the pathogen's sequence becoming available.

This 100-day goal is a key component of preparedness for future pandemics. Tonix believes its new RDC and ADC will provide the capabilities

to help address this need. The Company is also planning a Commercial Manufacturing Center (CMC) in Hamilton, Mont. to produce clinical-scale

live virus vaccines and potentially other products for pandemic responses.

Dr. Lederman said, "Our portfolio of

COVID-19 programs continues to advance. The COVID-19 portfolio currently includes a live virus vaccine candidate based on our recombinant

pox virus (RPV) platform, a diagnostic skin test to measure functional T cell immunity, and therapeutic candidates for acute COVID-19

and Long COVID. We expect first-in-human testing of our SARS-CoV-2 diagnostic to measure T cell immunity to begin before year end, followed

by the anticipated start of a Phase 2 trial in Long COVID and a Phase 1 trial for our T cell inducing vaccine in 2022."

As part of its infectious disease research

and development programs, in the third quarter of 2021 Tonix expanded its research collaboration with Columbia University to better understand

immune responses to SARS-CoV-2 in healthy individuals who have recovered from COVID-19. This work is expected to provide a foundation

for tailoring vaccines and therapeutics to appropriate individuals with precision medicine.

Dr. Lederman added, "The Company's

clinical calendar for our pipeline of central nervous system candidates includes the anticipated start this quarter of a Phase 2 trial

of TNX-1300, an emergency antidote for cocaine intoxication, and the anticipated start of three additional Phase 2 studies in 2022, including

TNX-601 CR in major depressive disorder, TNX-102 SL in posttraumatic stress disorder, and TNX-1900 in the prophylactic treatment of chronic

Recent Highlights-Facilities and Corporate

Highlights-Key Product Candidates*

TNX-1800 (live virus vaccine based on

Tonix's recombinant pox virus vector): COVID-19 vaccine designed as a single-administration vaccine to elicit T cell immunity

TNX-2100 (diagnostic skin test): SARS-CoV-2

epitope peptide mixtures for intradermal administration to measure the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2

TNX-102 SL (cyclobenzaprine HCl sublingual

tablets): small molecule for the treatment of Long COVID Syndrome or Post-Acute Sequelae of COVID-19 (PASC)

TNX-3500 (sangivamycin): antiviral inhibitor

of SARS-CoV-2 for the treatment of COVID-19 and potential other viral disorders

TNX-1500 (anti-CD154 monoclonal antibody):

third generation monoclonal antibody as first line monotherapy for preventing or treating organ transplant rejection and treating autoimmune

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual

tablets): small molecule for the management of fibromyalgia

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-601 CR (tianeptine oxalate and naloxone

controlled-release tablets): small molecule for the treatment of major depressive disorder, PTSD and neurocognitive dysfunction associated

with corticosteroid use.

TNX-1900 (intranasal potentiated oxytocin):

small peptide for migraine, craniofacial pain, insulin resistance and related disorders

*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, 2021, Tonix had $183.0

million of cash and cash equivalents, compared to $77.1 million as of December 31, 2020. Cash used in operations was approximately $12.9

million for the three months ended September 30, 2021, compared to $15.3 million for the three months ended September 30, 2020.

Third Quarter 2021 Financial Results

R&D expenses for the third quarter of

2021 were $13.1 million, compared to $8.8 million for the same period in 2020. This increase is predominately due to increased manufacturing

expenses of $1.8 million, non-clinical expenses of $1.6 million, employee-related expenses of $1.0 million and regulatory/legal expenses

of $0.6 million offset by a decrease in clinical expenses of $0.7 million.

G&A expenses for the third quarter of

2021 were $5.5 million, compared to $3.2 million for the same period in 2020. The increase is primarily due to an increase in employee-related

expenses of $1.3 million.

Net loss available to common stockholders

was $18.5 million, or $0.05 per share, basic and diluted, for the third quarter of 2021, compared to net loss of $12.0 million, or $0.09

per share, basic and diluted, for the third quarter of 2020. The basic and diluted weighted average common shares outstanding for the

third quarter of 2021 was 366,425,157, compared to 127,199,834 shares for the third quarter of 2020.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company

focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate

suffering. Tonix's portfolio is primarily composed of immunology and central nervous system (CNS) product candidates. Tonix's

immunology portfolio includes COVID-19-related product candidates to prevent and treat COVID-19, to treat Long COVID as well as to detect

functional T cell immunity to SARS-CoV-2. The Company's CNS portfolio includes both small molecules and biologics to treat pain,

neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1 (cyclobenzaprine HCl sublingual

tablets), is in mid-Phase 3 development for the management of fibromyalgia. TNX-13002 is a biologic designed to treat cocaine

intoxication that is expected to start a Phase 2 trial before year end. Tonix's lead vaccine candidate for COVID-19, TNX-18003,

is a live replicating vaccine based on Tonix's recombinant pox vaccine (RPV) platform to protect against COVID-19, primarily by

eliciting a T cell response. Tonix expects to start a Phase 1 study in humans in the second half of 2022. Tonix is developing TNX-21004,

an in vivo diagnostic to measure the presence of functional T cell immunity to SARS-CoV-2 and intends to initiate a

first-in-human clinical study in the fourth quarter of 2021, pending IND clearance. TNX-35005 (sangivamycin) is a small

molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. Finally, TNX-102 SL is a small molecule

drug being developed to treat Long COVID, a chronic post-COVID condition, and is also in the pre-IND stage. Tonix expects to conduct

a Phase 2 study in Long COVID in the first half of 2022. Tonix's immunology portfolio also includes biologics to address immunosuppression,

cancer, and autoimmune diseases.