Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Pharmaceuticals Reports Second Quarter 2019 Financial Results and Operational Highlights
Continues for Phase 3 RECOVERY Trial of Tonmya for the Treatment of PTSD; Topline Data Expected First Half of
Expanded in Addiction Medicine with Cocaine Antidote TNX-1300 and Potential New Alcohol Use Disorder Indication for TNX-102 SL
Sheet Strengthened with July Equity Offering
YORK, August 12, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage
biopharmaceutical company, today announced financial results for the quarter ended June 30, 2019, and an overview of recent operational
highlights. Tonix's lead program is the development of TNX-102 SL, or Tonmya* (cyclobenzaprine HCl sublingual tablets),
for the treatment of posttraumatic stress disorder (PTSD), which is currently being studied in a Phase 3 efficacy trial.
continues in our Phase 3 RECOVERY study of Tonmya for the treatment of PTSD, and we anticipate topline results in the first half
of 2020, as previously guided," said Seth Lederman, M.D., President and Chief Executive Officer. "Since the end of
the first quarter, we have re-started Phase 3 development of TNX-102 SL for fibromyalgia. We are also expanding TNX-102 SL development
to include alcohol use disorder (AUD), which is in the pre-investigational new drug (IND) application stage. We also added to
our pipeline with the in-licensing of TNX-1300**, a Phase 2 biologic for the treatment of cocaine intoxication, and with the internal
development of TNX-1500 for the prevention and treatment of organ transplant rejection. Finally, we successfully raised equity
proceeds to reinforce our balance sheet and further fund our programs. The first half of 2019 has been an exciting time for Tonix
and provides great momentum for the rest of the year."
Quarter 2019 Financial Results
June 30, 2019, Tonix had $12.2 million of cash and cash equivalents, compared to $25.0 million as of December 31, 2018. Cash used
in operations was $4.7 million for the second quarter of 2019, compared to $5.5 million for the same period last year and $8.6
million for the first quarter of 2019.
and development expenses for the second quarter of 2019 totaled $3.6 million, compared to $4.1 million for the same period in
2018. This decrease is primarily due to timing of development milestones related to the PTSD HONOR study which was completed in
and administrative expenses for the second quarter of 2019 totaled $2.4 million, compared to $2.1 million for the same period
in 2018. The modest increase is primarily due to an increase in patent prosecution costs and higher insurance premiums in 2019.
loss was $5.8 million, or $0.95 per share, for the second quarter of 2019, compared to net loss of $6.1 million, or $7.23 per
share, for the second quarter of 2018. The weighted average common shares outstanding for the second quarter of 2019 was 6,167,012
shares. The weighted average common shares outstanding for the second quarter of 2018, which gives effect to the 1-for-10 reverse
stock split in November 2018, was 842,041 shares.
Tonix Pharmaceuticals Holding Corp.
is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat psychiatric,
pain and addiction conditions, to improve biodefense through potential medical counter-measures and to prevent and treat organ
transplant rejection. Tonix's lead program is for the development of Tonmya* (TNX-102 SL), 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, agitation in Alzheimer's
disease and alcohol use disorder, to be developed under separate Investigational New Drug applications (INDs) to support potential
pivotal efficacy studies. The fibromyalgia program is in Phase 3 development, the agitation in Alzheimer's program is Phase
2 ready and the alcohol use disorder program is in the pre-IND application stage. TNX-1300** (double-mutant cocaine esterase)
is being developed under an IND and is in Phase 2 development for the treatment of cocaine intoxication. TNX-601 (tianeptine oxalate)
is in the pre-IND application stage, also for the treatment of PTSD but by 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. Data is expected in the second half of 2019 for a Phase 1 clinical formulation selection pharmacokinetic study of TNX-601
that is being conducted outside of the U.S. TNX-801 (live virus vaccine for percutaneous (scarification) administration) is a
potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus, currently in the pre-IND application
stage. Finally, TNX-1500 is being developed to prevent and treat organ transplant rejection, as well as to treat autoimmune conditions,
and is 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 for the
treatment of PTSD. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved
(T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is an investigational new biologic and has not been approved
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 on Form 10-Q filed with the SEC on or after the date thereof.
Tonix does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by law.
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Costs and expenses | ||||||||||||||||
| Research and development | $ | 3,554 | $ | 4,067 | $ | 7,450 | $ | 9,237 | ||||||||
| General and administrative | 2,352 | 2,076 | 4,753 | 3,894 | ||||||||||||
| Total costs and expenses | 5,906 | 6,143 | 12,203 | 13,131 | ||||||||||||
| Operating loss | (5,906 | ) | (6,143 | ) | (12,203 | ) | (13,131 | ) | ||||||||
| Interest income, net | 66 | 56 | 130 | 109 | ||||||||||||
| Net loss | $ | (5,840 | ) | $ | (6,087 | ) | $ | (12,073 | ) | $ | (13,022 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.95 | ) | $ | (7.23 | ) | $ | (2.19 | ) | $ | (15.98 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 6,167,012 | 842,041 | 5,511,249 | 815,120 |
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2019 | December 31, 2018(1) | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 12,150 | $ | 25,034 | ||||
| Prepaid expenses and other current assets | 2,009 | 1,022 | ||||||
| Total current assets | 14,159 | 26,056 | ||||||
| Other non-current assets | 849 | 263 | ||||||
| Total assets | $ | 15,008 | $ | 26,319 | ||||
| Liabilities and stockholders' equity | ||||||||
| Total liabilities | $ | 2,186 | $ | 2,655 | ||||
| Stockholders' equity | 12,822 | 23,664 | ||||||
| Total liabilities and stockholders' equity | $ | 15,008 | $ | 26,319 |
condensed consolidated balance sheet for the year ended December 31, 2018 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.