Tonix Pharmaceuticals Reports First Quarter 2023 Financial Results and Operational Highlights Prioritizing Late-Stage Clinical CNS Programs in Fibromyalgia, Depression, Migraine, and Cocaine Intoxication Topline Results

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals

Reports First Quarter 2023 Financial Results and Operational Highlights

Prioritizing Late-Stage Clinical CNS Programs in

Fibromyalgia, Depression, Migraine, and Cocaine Intoxication

Topline Results Expected in Fourth Quarter 2023

for Potentially Confirmatory Phase 3 Trial of TNX-102 SL for Fibromyalgia

Potentially Pivotal Phase 2 Trial of TNX-601 ER

for Major Depressive Disorder (MDD) Enrolling; TNX-601 ER Represents an Innovative Approach for MDD through Restoration of Neuroplasticity

Cash and Cash Equivalents of Approximately $72.0

Million at March 31, 2023

CHATHAM, N.J., May 8, 2023 (GLOBE NEWSWIRE) -

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

financial results for the first quarter ended March 31, 2023, and provided an overview of recent operational highlights.

"With much achieved already, we expect 2023

will continue to serve as an important milestone year for Tonix," said Seth Lederman, M.D., Chief Executive Officer of Tonix. "The

prioritization of key programs in our pipeline highlights our commitment to helping bring relief and value to patients suffering from

diseases with limited or insufficient therapeutic options. We are pleased with the enrollment in our current RESILIENT Phase 3 study for

TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in fibromyalgia. We are looking forward to topline results from the trial in the fourth

quarter of this year. If successful, we believe it will be the second and final adequate and well-controlled efficacy trial required for

filing a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA). Moreover, we believe we have satisfied

all the other clinical and non-clinical requirements for an NDA submission. In addition, we are excited to have initiated enrollment in

the potentially pivotal UPLIFT Phase 2 study of TNX-601 ER (tianeptine hemioxalate extended release tablets) for major depressive disorder

(MDD). TNX-601 ER represents a novel approach to treating depression in the U.S., since the active ingredient tianeptine restores neuroplasticity

and neurogenesis rather than modulating neurotransmitter levels and activity."

Recent Highlights-Key Product Candidates*

Central Nervous System (CNS) Pipeline

TNX-102 SL: small molecule for the management

of fibromyalgia (FM)

TNX-102 SL for the treatment of Fibromyalgia-Type

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

TNX-601 ER: a once-daily orally-administered

small molecule for the treatment of MDD, Posttraumatic Stress Disorder (PTSD), neurocognitive dysfunction associated with corticosteroid

use and potentially Alzheimer's disease

TNX-1900 (intranasal potentiated oxytocin):

small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and obesity-associated 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 monoclonal antibody):

third generation anti-CD40L 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 to protect against smallpox and monkeypox (mpox) designed as a single-administration vaccine to

elicit T cell immunity.

*All of Tonix's product candidates

are investigational new drugs or biologics and none has 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.

3Noyce RS, et al. (2023).

Single Dose of Recombinant Chimeric Horsepox Virus (TNX-801) Vaccination Protects Macaques from Lethal Monkeypox Challenge. Viruses.

15(2):356. doi: 10.3390/v15020356

Recent Highlights-Corporate and Other

Recent Highlights-Financial

As of March 31, 2023, Tonix had $72.0 million of cash and cash

equivalents, compared to $120.2 million as of December 31, 2022. Net cash used by financing activities was approximately $11.5 million

for first quarter 2023, compared to net cash provided by financing activities of $13.1 million for the same period in 2022.

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

"Sales Agreement") with AGP of up to $320.0 million in at-the-market offerings ("ATM") sales. During the quarter

ended March 31, 2023, the Company sold approximately 3.2 million shares of common stock under the Sales Agreement, for net proceeds of

approximately $2.0 million. Subsequent to March 31, 2023, the Company has sold 0.9 million shares of common stock under the Sales Agreement,

for net proceeds of approximately $0.5 million.

In January 1, 2023, the Company repurchased 16,700,269 shares

of common stock under its share repurchase programs at an average price per share of $0.82 for a gross aggregate cost of approximately

Cash used in operations was approximately $32.9

million for the first quarter ended March 31, 2023, compared to $31.0 million for the first quarter ended March 31, 2022.

Cash used by investing activities for the first

quarter ended March 31, 2023, and 2022 was approximately $3.8 million and $20.2 million, respectively, related to the purchase of property

First Quarter 2023 Financial Results

R&D expenses for the first quarter 2023

were $26.5 million, compared to $18.4 million for the same period in 2022. As planned, R&D expenses will be increasing during 2023

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

G&A expenses for the first quarter 2023

were $7.4 million, compared to $8.0 million for the same period in 2022. The decrease is primarily due to decreased employee-related and

financial reporting expenses.

Net loss was $33.0 million, or $0.52 per share,

basic and diluted, for the first quarter 2023, compared to net loss of $26.4 million, or $1.61 per share, basic and diluted, for the same

period in 2022. The basic and diluted weighted average common shares outstanding for the first quarter 2023 was 63,352,898 compared to

16,445,010 shares for the same period in 2022.

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 topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat

Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected

in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling

with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation

being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth

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 third 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