Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya as Proposed Brand Name for TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for the Treatment of

Tonix Pharmaceuticals

Announces Conditional Acceptance of Tonmya as Proposed Brand Name for TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets)

for the Treatment of PTSD

6, 2017 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix) a company that is developing innovative pharmaceutical

products to address public health challenges today reported that the U.S. Food and Drug Administration (FDA) has conditionally

accepted the proposed trade name Tonmya (ton-MY-ah) for TNX-102 SL* (cyclobenzaprine HCl sublingual tablets) for the management

of posttraumatic stress disorder (PTSD). Tonix recently launched the Phase 3 HONOR study of Tonmya in military-related PTSD, from

which topline results are expected to be reported in the second half of 2018. Tonmya was designated a Breakthrough Therapy by the

FDA for the treatment of PTSD.

proprietary name review for Tonmya will be submitted once the PTSD New Drug Application (NDA) is submitted. FDA's final approval

of Tonmya is subject to NDA approval. A request for review of Tonmya as the proposed name for TNX-102 SL for the management of

fibromyalgia has been withdrawn at the FDA. The U.S. Patent and Trademark Office has granted the federal registration of the Tonmya

*TNX-102 SL (cyclobenzaprine HCl sublingual

tablets)/Tonmya is an investigational new drug and has not been approved for any indication.

About Tonmya and the Phase 3 HONOR Study

Tonmya (cyclobenzaprine HCl sublingual

tablets) is a patented sublingual transmucosal formulation of cyclobenzaprine that is in Phase 3 development. PTSD is a serious

condition 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. In a Phase 2 study, Tonmya 5.6 mg (2

x 2.8 mg tablets), was found to be effective in treating military-related PTSD, which formed the basis of the Breakthrough Therapy

designation granted by the FDA. Tonix is currently conducting a Phase 3 trial of Tonmya in military-related PTSD in the United

States, the HONOR study, which is a 12-week randomized, double-blind, placebo-controlled trial evaluating the efficacy of Tonmya

5.6 mg in participants with military-related PTSD. This two-arm, adaptive-design trial is targeting enrollment of up to approximately

550 participants across approximately 35 clinical sites. An unblinded interim analysis will be conducted once the study has accumulated

efficacy results from approximately 275 randomized participants. In a recent Cross-Disciplinary Breakthrough Therapy meeting,

the FDA confirmed that a single-study NDA approval could be possible if the topline data from the HONOR study are statistically

very persuasive. Additional details of the HONOR study are available at www.thehonorstudy.com or https://clinicaltrials.gov/ct2/show/NCT03062540.

The U.S. Patent and Trademark Office has issued a patent (U.S. Patent No. 9,636,408) protecting the composition and manufacture

of the unique Tonmya formulation. The Protectic protective eutectic and Angstro-Technology formulation claimed in

the patent are important elements of Tonix's proprietary Tonmya composition. This patent is expected to provide Tonmya,

upon NDA approval, with U.S. market exclusivity until 2034.

About Tonix Pharmaceuticals Holding

Tonix is developing innovative pharmaceutical

products to address major public health challenges. In addition to Tonmya for PTSD, Tonix is developing TNX-601 (tianeptine oxalate),

a clinical candidate at pre-IND (Investigational New Drug) application stage, designed as a daytime treatment for PTSD and TNX-801,

a live synthetic version of horsepox virus, at the pre-IND application stage, to be developed as a potential smallpox-preventing

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, substantial competition; 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 risks related to failure to obtain

FDA clearances or approvals and noncompliance with FDA regulations. 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, 2016, as filed with the Securities and Exchange Commission (the "SEC") on April 13,

2017, and future periodic reports filed with the SEC on or after the date hereof. 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

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