Interim Analysis of Phase 3 HONOR study of

Interim Analysis of Phase 3 HONOR study of

Tonmya (Cyclobenzaprine HCI Sublingual Tablets) in Military-Related PTSD Expected 1H18 and Topline Results Expected 2H18

2017 (GLOBE NEWSWIRE) - Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company in Phase 3 development of Tonmya*,

a U.S. Food and Drug Administration-designated Breakthrough Therapy for the treatment of posttraumatic stress disorder (PTSD),

and in various development stages for other innovative pharmaceutical and biological products to address public health challenges,

recently announced financial results for the second quarter ended June 30, 2017.

"The past quarter was a busy and exciting

time for us as we continued enrollment in the Phase 3 HONOR study of Tonmya for the treatment of military-related PTSD,"

said Seth Lederman, M.D., president and chief executive officer of Tonix. "HONOR remains on track for an unblinded interim

analysis of 50% of efficacy evaluable participants in the first half of 2018 and to report topline results from the full study

in the second half of 2018. As discussed with the U.S. Food and Drug Administration (FDA) at the Initial Cross-Disciplinary Breakthrough

Therapy meeting, statistically persuasive topline data from this interim analysis could support early filing of a New Drug Application (NDA)."

The sublingual formulation of Tonmya is designed

for transmucosal absorption of the active ingredient, cyclobenzaprine, which acts on PTSD symptoms by improving sleep quality.

It is administered once daily at bedtime. The FDA has indicated that no additional drug dependence and addiction study is needed

At June 30, 2017, Tonix had cash and cash equivalents

of $34.4 million. Net cash used in operating activities for the three months ended June 30, 2017 was $4.4 million.

Recent Program Highlights:

For a video overview of the current Tonix development pipeline,

please see http://ir.tonixpharma.com/video.

* Tonmya has been conditionally accepted

by the FDA as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD. TNX-102

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

Second Quarter Financial Results

Tonix reported a net loss of $4.8 million,

or $0.65 per share, for the second quarter of 2017, compared to a net loss of $9.8 million, or $4.97 per share, for the second

quarter of 2016. The net loss for the three months ended June 30, 2017, excluding non-cash expenditures of $0.5 million, was $4.3

million, as compared to a net loss, excluding non-cash expenditures of $0.7 million, of $9.1 million for the second quarter of

2016. The lower net loss was primarily due to decreased research and development expense for clinical studies and related research,

as well as lower general and administrative expense related to these and other corporate development activities.

Tonix reported a net loss of $9.8 million,

or $1.74 per share, for the six months ended June 30, 2017, compared to a net loss of $23.8 million, or $12.31 per share, for the

six months ended June 30, 2016. The net loss for the six months ended June 30, 2017, excluding non-cash expenditures of $1.1 million,

was $8.7 million, as compared to a net loss of $22.1 million, excluding non-cash expenditures of $1.7 million, for the six months

ended June 30, 2016. The lower net loss was primarily due to decreased research and development expense during the first six months

of 2017 for clinical studies and research, as well as lower general and administrative expense needed to support these and other

corporate development activities.

Cash used in operations was $4.4 million and

$9.2 for the three and six months ended June 30, 2017, respectively, as compared to $8.0 million and $23.5 million for the three

and six months ended June 30, 2016, respectively. At June 30, 2017, cash, cash equivalents, and marketable securities totaled $34.4

million, compared to $26.1 million at December 31, 2016. Management believes that cash, cash equivalents and marketable securities

as of June 30, 2017 are sufficient to fund operating expenses and the Phase 3 HONOR study to completion with up to 550 participants.

About Tonmya and the Phase 3 HONOR Study

Tonmya 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 the Initial 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.

About Tonix Pharmaceuticals Holding Corp.

Tonix is developing innovative pharmaceutical

and biological 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 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 vaccine.

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

TONIX PHARMACEUTICALS HOLDING CORP.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

TONIX PHARMACEUTICALS HOLDING CORP.

CONDENSED CONSOLIDATED BALANCE SHEETS

(1) The condensed consolidated balance

sheet for the year ended December 31, 2016 has been derived from the audited financial statements but does not include all of the

information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

For more information:

Tonix Pharmaceuticals