Full Press Release Details
Pharmaceuticals Reports Third Quarter 2018 Financial Results and Operational Highlights
Phase 3 Trial of Tonmya for the Treatment of PTSD to Commence First Quarter 2019
YORK, November 9, 2018 (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 third quarter ended September 30, 2018, and an overview
of recent operational highlights.
are pleased to be initiating a new Phase 3 study of Tonmya* for the treatment of PTSD in the first quarter of 2019," said
Seth Lederman, M.D., President and Chief Executive Officer. "This new Phase 3 study has several innovative design features
that are based on retrospective analyses of data from the Phase 3 HONOR and Phase 2 AtEase studies, in addition to feedback received
from the FDA during a Breakthrough Therapy Clinical Guidance meeting in October. It has been preliminarily accepted by the FDA
as a potential pivotal efficacy study to support the registration of Tonmya for the treatment of PTSD."
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
Quarter 2018 Financial Results
and development expenses for the third quarter of 2018 totaled $3.3 million, compared to $3.9 million for the same period in 2017.
This decrease is predominately due to the termination of the Phase 3 HONOR study at the end of July 2018.
and administrative expenses for the third quarter of 2018 were $2.3 million, compared to $1.9 million for the same period in
2017. This increase is primarily due to an increase in legal fees related to patent prosecution, as well as investor and
loss was $5.5 million, or $0.57 per share, for the third quarter of 2018, compared to net loss of $5.8 million, or $0.77 per share,
for the third quarter of 2017.
September 30, 2018, Tonix had $14.7 million of cash and cash equivalents, compared to $25.5 million as of December 31, 2017. Cash
used in operations was $4.9 million for the three months ended September 30, 2018, compared to $5.0 million for the three months
ended September 30, 2017.
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 is developing Tonmya,
which is in Phase 3 development and 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 designated a Fast Track development program 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.
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, 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.
Pharmaceuticals Reports Third Quarter 2018 Financial Results
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Costs and expenses | ||||||||||||||||
| Research and development | $ | 3,264 | $ | 3,908 | $ | 12,501 | $ | 9,708 | ||||||||
| General and administrative | 2,277 | 1,927 | 6,171 | 6,040 | ||||||||||||
| Total costs and expenses | 5,541 | 5,835 | 18,672 | 15,748 | ||||||||||||
| Operating loss | (5,541 | ) | (5,835 | ) | (18,672 | ) | (15,748 | ) | ||||||||
| Interest income, net | 62 | 49 | 171 | 118 | ||||||||||||
| Net loss | $ | (5,479 | ) | $ | (5,786 | ) | $ | (18,501 | ) | $ | (15,630 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.57 | ) | $ | (0.77 | ) | $ | (2.15 | ) | $ | (2.49 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 9,587,025 | 7,508,036 | 8,616,039 | 6,287,062 |
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2018 | December 31, 2017(1) | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 14,674 | $ | 25,496 | ||||
| Prepaid expenses and other current assets | 1,206 | 947 | ||||||
| Total current assets | 15,880 | 26,443 | ||||||
| Other non-current assets | 175 | 311 | ||||||
| Total assets | $ | 16,055 | $ | 26,754 | ||||
| Liabilities and stockholders' equity | ||||||||
| Total liabilities | $ | 2,346 | $ | 2,138 | ||||
| Stockholders' equity | 13,709 | 24,616 | ||||||
| Total liabilities and stockholders' equity | $ | 16,055 | $ | 26,754 |
condensed consolidated balance sheet for the year ended December 31, 2017 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.