Tonix Pharmaceuticals Reports Second Quarter 2022 Financial Results and Operational Highlights Phase 1 Study of TNX-801, a Vaccine in Development for the Prevention of Monkeypox and Smallpox, Expected to Initiate in Firs

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals

Reports Second Quarter 2022 Financial Results and Operational Highlights

Phase 1 Study of TNX-801, a Vaccine in Development

for the Prevention of Monkeypox and Smallpox, Expected to Initiate in First Half 2023 in Kenya; the U.S. has Declared Monkeypox a Public

US National Institute of Drug Abuse (NIDA) Grant

Awarded for the Development of TNX-1300 for Cocaine Intoxication; Phase 2 Study of TNX-1300 Expected to Initiate in Fourth Quarter 2022

Advanced Development Center in Dartmouth, Mass.

is Open and Expected to Imminently Conduct Process Development and Clinical Trial Manufacturing of Live-Virus Vaccines

Cash and Cash Equivalents Totaled Approximately

$145 Million at June 30, 2022

CHATHAM, N.J., August 8, 2022 (GLOBE NEWSWIRE) -

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

financial results for the second quarter ended June 30, 2022, and provided an overview of recent operational highlights.

"The rapidly expanding outbreaks of monkeypox

in the U.S. and approximately 80 other countries outside of Africa have brought attention to our work on a novel monkeypox vaccine, TNX-801,

which has already been shown to protect non-human primates against a challenge with lethal doses of monkeypox. The U.S. has declared monkeypox

a public health emergency. In addition, we are excited by the many opportunities ahead for our pipeline of CNS, rare disease, immunology

and infectious disease product candidates," said Seth Lederman, M.D., Chief Executive Officer of Tonix. "We are on track to

have four CNS programs in the clinic by the end of 2022, including our most advanced program, TNX-102 SL (cyclobenzaprine HCl sublingual

tablets) for fibromyalgia, which is in mid-Phase 3 development, Phase 2 studies of TNX-102 SL for Long COVID and PTSD and a Phase 2 study

of TNX-1300 for cocaine intoxication."

Recent Highlights-Key Product Candidates*

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 T cell immunity

Chimeric Horsepox Virus (scHPXV) Vaccination

Protects Macaques from Monkeypox," describes data from animals vaccinated with TNX-801 to protect against monkeypox. The poster

presentation reports that all animals (n=8) vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with

intra-tracheal monkeypox. The vaccinations with TNX-801 were well tolerated. Synthetic horsepox virus is the basis for the Company's

TNX-801 vaccine in development to protect against monkeypox and smallpox and for the Company's Recombinant Pox Virus (RPV) platform

to protect against other pathogens, including SARS-CoV-2.

TNX-1850 (live virus vaccine based on Tonix's

recombinant pox virus vector): COVID-19 vaccine designed as single-administration vaccine to elicit T cell immunity

TNX-2300: Live virus vaccine based on a

bovine parainfluenza virus vector to protect against COVID-19

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): small molecule for the treatment of major depressive disorder (MDD), PTSD, and neurocognitive dysfunction associated with corticosteroid

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.

*All of Tonix's product candidates

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

Recent Highlights-Facilities and Corporate

Recent Highlights--Financial

As of June 30, 2022, Tonix had $145.5 million of cash and cash

equivalents, compared to $178.7 million as of December 31, 2021. In June 2022, Tonix issued 2,500,000 shares of Series A convertible redeemable

preferred stock and 500,000 shares of Series B convertible redeemable preferred stock to certain institutional investors in a private

placement for gross proceeds of $28.5 million. The Company expects to use the proceeds to redeem the preferred stock.

Cash used in operations was approximately

$21.2 million for the three months ended June 30, 2022, compared to $19.1 million for the same period in 2021. Capital expenditures were

approximately $14.4 million for the three months ending June 30, 2022 compared to $1.4 million for the same period in 2021. The increase

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

Second Quarter 2022 Financial Results

Research and development (R&D) expenses

for the three months ended June 30, 2022 were $16.6 million, compared to $18.1 million for the same period in 2021. The decrease is predominately

due to decreased non-clinical expenses, offset by an increase in employee-related expenses. We continue to expect R&D expenses to

increase during 2022 as we move our clinical development programs forward and invest in our development pipeline.

General and administrative (G&A) expenses

for the three months ended June 30, 2022 were $6.8 million, compared to $5.4 million for the same period in 2021. The increase is primarily

due to employee-related expenses.

Net loss available to common stockholders

was $27.4 million, or $1.22 per share, basic and diluted, for the three months ended June 30, 2022, compared to net loss of $23.6 million,

or $2.25 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 June 30, 2022 was 22,404,371, compared to 10,483,112 shares for the same period in 2021.

About Tonix Pharmaceuticals Holding

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 first

quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate

a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication

that is Phase 2 ready and has been granted Breakthrough Therapy designation by the FDA. 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 first half 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. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

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