Tonix Pharmaceuticals Announces Innovative Design in Next Phase 3 Study of Tonmya for PTSD, Following FDA Meeting New Phase 3 Trial of Tonmya for the treatment of PTSD to Commence First Quarter 2019 Primary Endpoint of N

Tonix Pharmaceuticals Announces Innovative

Design in Next Phase 3 Study of Tonmya for PTSD, Following FDA Meeting

New Phase 3 Trial of Tonmya

for the treatment of PTSD to Commence First Quarter 2019

Primary Endpoint of New Study will be

Week 4 Change from Baseline in CAPS-5

NEW YORK, October 31, 2018 (GLOBE NEWSWIRE) - Tonix Pharmaceuticals

Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced that it plans to start a new Phase 3 trial of Tonmya *

for the treatment of posttraumatic stress disorder (PTSD) in the first quarter of 2019, based on guidance from its recent Breakthrough

Therapy Type B Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA).

Tonix submitted interim analysis results from the original Phase

3 HONOR study of Tonmya in military-related PTSD to support a new Phase 3 study design discussion with the FDA. The Company plans

to incorporate several new design features into the new Phase 3 study, including restricting enrollment of study participants to

individuals with PTSD who experienced an index trauma within nine years of screening. Retrospective analysis of the Phase 3 HONOR

study revealed a treatment effect in this subgroup over the 12-week study. Another new feature of the planned Phase 3 study is

the inclusion of study participants who have experienced civilian traumas, in addition to inclusion of those with military-related

traumas. Two previous studies by the Company restricted enrollment to participants who experienced traumas during military service

since 2001. The primary endpoint, mean change from baseline in the severity of PTSD symptoms as measured by the Clinician Administered

PTSD Scale for DSM-5 (CAPS-5), is the same as that used in the Phase 3 HONOR study and the Phase 2 AtEase study, but the CAPS-5

primary endpoint will be assessed at Week 4 instead of at Week 12. The Week 4 assessment of CAPS-5 in the Phase 3 HONOR study showed

clinically meaningful improvement at this timepoint in the entire modified Intent-to-Treat sample (difference from placebo of -3.6

CAPS-5 points, p = 0.019).

Seth Lederman, M.D., President and Chief Executive Officer of

Tonix commented, "Results from our Phase 3 HONOR study strengthened the design of the new Phase 3 study, which has been accepted

by the FDA as a potential pivotal efficacy study to support NDA approval. We believe the innovative design features of this new

Phase 3 study will expedite the development of Tonmya for PTSD."

The new Phase 3 trial will be a double-blind, randomized, placebo-controlled

study of Tonmya 5.6 mg over 12 weeks of treatment for civilian and military-related PTSD. The primary efficacy endpoint will be

the Week 4 mean change from baseline in the severity of PTSD symptoms as measured by CAPS-5 between those treated with Tonmya and

those receiving placebo. A key secondary endpoint will be the Week 12 mean change from baseline in CAPS-5. The CAPS-5 is a standardized

structured clinical interview and serves as the standard in research for measuring the symptom severity of PTSD. Earlier versions

of the CAPS were used to support the approval of the two currently marketed PTSD treatments.

*Tonmya has been conditionally accepted by the U.S. Food

and Drug Administration (FDA) as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for PTSD. TNX-102

SL is an investigational new drug and has not been approved for any indication.

About the Phase 3 HONOR Study

The HONOR study was a double-blind, randomized, placebo-controlled

study of up to 550 participants with PTSD at 40 U.S. clinical sites. A formal unblinded interim analysis was completed when approximately

50 percent (n=274) of participants were randomized and completed the 12-week course of treatment with bedtime sublingual Tonmya

5.6 mg (2 x 2.8 mg tablets) or placebo sublingual tablets. The primary efficacy endpoint was the Week 12 mean change from baseline

in the severity of PTSD symptoms as measured by CAPS-5 between those treated with Tonmya and those receiving placebo. The HONOR

study was stopped at the interim analysis when the primary endpoint did not cross a predefined study continuation threshold; however,

a clinically meaningful improvement in CAPS-5 was observed at Week 4 (p = 0.019)

About Tonmya and PTSD

Tonmya or TNX-102 SL is a sublingual transmucosal tablet formulation

of cyclobenzaprine. PTSD is a serious condition that affects approximately 11 million U.S. adults, and is characterized by chronic

disability, inadequate treatment options, especially for military-related PTSD, and an overall high utilization of healthcare services

that contributes to significant economic burdens.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused

on discovering and developing pharmaceutical products to treat serious neuropsychiatric conditions and biological products to improve

biodefense through potential medical counter-measures. Tonix is developing Tonmya, which has been granted Breakthrough Therapy

designation, as a bedtime treatment for PTSD. Tonix is also developing TNX-102 SL as a bedtime treatment for agitation in Alzheimer's

disease under a separate IND to support a Phase 2, potential pivotal, efficacy study and has been granted Fast Track designation

by the FDA for this indication. TNX-601 (tianeptine oxalate) is in the pre-IND application stage, also for the treatment of PTSD

but by a unique mechanism and designed for daytime dosing. Tonix's lead biologic candidate, TNX-801, is a potential smallpox-preventing

vaccine based on a live synthetic version of horsepox virus, currently in the pre-IND application stage.

This press release and further information about Tonix can

be found at www.tonixpharma.com.

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 failure to obtain FDA clearances

or approvals and noncompliance with FDA regulations; 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, 2017, as filed with the Securities and Exchange Commission (the "SEC") on March 9, 2018, 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

Scott Stachowiak (media)

Peter Vozzo (investors)