Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Operational Highlights Phase 3 RECOVERY Trial of Tonmya for the Treatment of PTSD Initiated and Enrolling Topline Data Expected First

Tonix Pharmaceuticals Holding Corp. 8-K

Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial

and Operational Highlights

3 RECOVERY Trial of Tonmya for the Treatment of PTSD Initiated and Enrolling

Data Expected First Half 2020

YORK, March 18, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix, or the Company), a clinical-stage

biopharmaceutical company focused on developing pharmaceutical products to treat serious neuropsychiatric conditions and biological

products to improve biodefense, today announced financial results for the fourth quarter and full year ended December 31, 2018,

and an overview of recent operational highlights.

forward into 2019, we are excited about the recent initiation of our new Phase 3 study of Tonmya for PTSD. The RECOVERY study

incorporates learnings and analyses from our Phase 2 and Phase 3 studies in over 500 military-related PTSD participants and is

intended to support the registration of Tonmya for PTSD. We look forward to topline data in the first half of 2020," said

Seth Lederman, M.D., President and Chief Executive Officer. "In addition to Tonmya for PTSD, we maintain a strong and growing

pipeline of product candidates, including TNX-102 SL as a bedtime treatment of fibromyalgia and agitation in Alzheimer's

disease, and TNX-601 as a daytime treatment for PTSD and neurocognitive dysfunction associated with corticosteroid use, a potential

Clinical and Regulatory Highlights

Corporate Highlights

Quarter 2018 Financial Results

and development expenses for the fourth quarter of 2018 totaled $5.1 million, compared to $3.6 million for the same period in

2017. This increase is due primarily to costs related to the close-out of the Phase 3 HONOR study as well as other activities

related to the PTSD program.

and administrative expenses for the fourth quarter of 2018 were $2.6 million, compared to $1.9 million for the same period in

2017. This increase is due primarily to an increase in legal fees related to patent prosecution, as well as an increase in investor

and public relations expenses due to increased investor meetings.

loss available to common stockholders was $10.9 million, or $6.10 per share, for the fourth quarter of 2018, compared to net loss

of $5.5 million, or $7.07 per share, for the fourth quarter of 2017. In addition to the factors above, fourth quarter 2018 net

loss available to common stockholders was impacted by a one-time, non-cash preferred stock deemed dividend in the fourth quarter

of 2018. The weighted average common shares outstanding, basic and diluted for the fourth quarter of 2018 was 1,778,524 shares.

The weighted average common shares outstanding, basic and diluted for the fourth quarter of 2017 was 750,804 shares.

of March 13, 2019, all Series A convertible preferred stock had been converted into common stock. Total common stock outstanding

as of March 13, 2019 was 6,089,728.

Year 2018 Financial Results

and development expenses for full year 2018 totaled $17.6 million, compared to $13.3 million for full year 2017. This increase

is due primarily to the continued development work related to the PTSD program, including the completion of the NDA-required pivotal

bridging pharmacokinetic study of TNX-102 SL in 2018.

and administrative expenses for full year 2018 were $8.8 million, compared to $8.0 million for full year 2017. This increase is

due primarily to increased patent prosecution costs and an increase in investor and public relations expenses due to increased

loss available to common stockholders was $29.4 million, or $26.81 per share, for full year 2018, compared to net loss of $21.1

million, or $31.69 per share, for full year 2017. The weighted average common shares outstanding, basic and diluted for 2018 was

1,094,867 shares. The weighted average common shares outstanding, basic and diluted for 2017 was 666,509 shares.

December 31, 2018, Tonix had $25.0 million of cash and cash equivalents, compared to $25.5 million as of December 31, 2017. Cash

and cash equivalents at December 31, 2018 includes net proceeds of $14.4 million from the Company's public offering of common

stock in December 2018. Cash used in operations was $24.0 million for full year 2018, compared to $19.1 million for full year

Tonix Pharmaceuticals Holding Corp.

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's lead program

is for the development of Tonmya, which is in Phase 3 development as a bedtime treatment for PTSD. Tonix is also developing TNX-102

SL as a bedtime treatment for fibromyalgia and agitation in Alzheimer's disease under separate INDs to support potential

pivotal efficacy studies. The agitation in Alzheimer's disease IND has been designated a Fast Track development program

by the FDA. TNX-601 (tianeptine oxalate) is in the pre-IND application stage, also for the treatment of PTSD but using a different

mechanism from TNX-102 SL and designed for daytime dosing. TNX-601 is also in development for a potential indication -neurocognitive

dysfunction associated with corticosteroid use. A Phase 1 pharmacokinetic study of proprietary tianeptine oxalate formulations

will be conducted outside of the U.S. in 2019. 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.

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 the treatment of PTSD. TNX-102 SL is an investigational new drug and has not been approved for any

press release and further information about Tonix can be found at www.tonixpharma.com.

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, 2018, as filed with the Securities

and Exchange Commission (the "SEC") on March 18, 2019, 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.

Pharmaceuticals Reports Fourth Quarter 2018 Financial Results

PHARMACEUTICALS HOLDING CORP.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)(1)

PHARMACEUTICALS HOLDING CORP.

CONDENSED CONSOLIDATED BALANCE SHEETS