Confidential Tonix Pharmaceuticals Announces Pipeline Prioritization Update for 2023 Prioritizing Clinical-Stage CNS Programs in Fibromyalgia, Depression, Migraine, and Cocaine Intoxication Deprioritizing COVID-19 Relate

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals Announces Pipeline

Prioritization Update for 2023

Prioritizing Clinical-Stage CNS Programs in

Fibromyalgia, Depression, Migraine, and Cocaine Intoxication

Deprioritizing COVID-19 Related Programs and

Pending Posttraumatic Stress Disorder (PTSD) Trial

Cash and Cash Equivalents Totaled Approximately

$120.2 Million at December 31, 2022

CHATHAM, N.J., April 4, 2023 (GLOBE NEWSWIRE)

- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a

clinical-stage biopharmaceutical company, today announced it is reallocating resources and cash to streamline its pipeline and

focus on its mid- and late-stage clinical programs within its core central nervous system (CNS) portfolio. The pipeline realignment prioritizes

key near-term value drivers, reduces investment in several longer-term programs, particularly COVID-19-related studies, and delays the

start of a posttraumatic stress disorder (PTSD) study in Kenya.

"We are excited to focus our efforts on

the confirmatory, registration-enabling Phase 3 trial in fibromyalgia and the potentially pivotal Phase 2 trials for chronic migraine

and depression," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "To increase our operational

efficiency, we intend to focus resources on our CNS portfolio - which also includes an upcoming Phase 2 study in cocaine intoxication

- and to deprioritize several other programs with longer timelines, particularly programs related to COVID-19. With our experienced

development team, Tonix is confident in its abilities to advance its diverse portfolio with multiple opportunities for achieving value

creating milestones in 2023 and beyond."

Key Anticipated 2023 Milestones

Tonix is aligning its operational and scientific

efforts on its core CNS programs and deprioritizing other programs as follows:

Central Nervous System

(CNS): The Company is prioritizing the advancement of its late- and mid-stage clinical fibromyalgia, depression,

migraine, and cocaine intoxication studies and delaying the start of the Kenya PTSD study. The Company has received regulatory

clearance in Kenya, which will allow it to rapidly restart the PTSD program at the appropriate time. The Company is discontinuing

the enrollment of new patients in a Phase 2 clinical trial in fibromyalgia-type Long COVID. The approximately 60 patients enrolled

to date in the Long COVID study will be followed to completion, with topline data expected in the third quarter of 2023. The Company

believes that the data from the study may guide future development and support grant applications.

The Company is continuing to advance development of TNX-801 (live virus vaccine to protect against smallpox and mpox) and its portfolio

of potential broad-spectrum antiviral agents, including direct antiviral engineered proteins, TNX-4000, and the host-directed antiviral

series of molecules, TNX-3900. The Company will also continue work on the recombinant pox virus (RPV) platform vector technology as a

platform for rapid response to new pathogens, rather than specifically on the TNX-1800/TNX-1850 vaccines for COVID-19. Near-term preclinical

work on other COVID-19 related programs, including anti-COVID antibodies TNX-3600, TNX-3800 and TNX-4100, will be deprioritized.

Immunology and Rare Disease:

The Company is continuing development on TNX-1500 (a third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant

rejection and treatment of autoimmune disorders), and TNX-2900 (intranasal potentiated oxytocin), a small peptide for the treatment of

hyperphagia in Prader-Willi syndrome (PWS). The FDA has granted Orphan Drug designation for TNX-2900 for PWS.

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 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. Enrollment of approximately 60

patients 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 interim 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 second 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 second quarter of 2023. Tonix's infectious disease pipeline includes TNX-801, a

vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of

2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The

infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

*All of Tonix's product candidates

are investigational new drugs (IND) or biologics and have not been approved for any indication. TNX-801, TNX-1500, TNX-2900, TNX-3900

and TNX-4000 are in pre-IND stage of development and have not been approved for any indication.

Forward Looking Statements

Certain statements in this press release are

forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the

use of forward-looking words such as "anticipate," "believe," "forecast," "estimate,"

"expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations

and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those

indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA

clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks

related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties

of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development

efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant

risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update

or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year

ended December 31, 2022, as filed with the Securities and Exchange Commission (the "SEC") on March 13, 2023, and periodic

reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such

risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Jessica Morris (corporate)

Tonix Pharmaceuticals

Olipriya Das, Ph.D. (media)

Peter Vozzo (investors)