Full Press Release Details
Pharmaceuticals Reports Second Quarter 2018 Financial Results and Operational Highlights
HONOR Study Results to be
Included in Poster Presentation at a Scientific Conference in August 2018
FDA Meeting in October 2018
Confirmed to Discuss New Phase 3 Study for Tonmya in PTSD
New Phase 3 Study for Tonmya
May Initiate as Early as 2019
NEW YORK, August 13, 2018 (GLOBE NEWSWIRE) -- Tonix
Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix), 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 second quarter ended June 30, 2018, and an overview of recent operational highlights.
"In developing Tonmya for
PTSD we have learned a tremendous amount about the condition and how to design and conduct trials for PTSD patients, especially
those with military-related PTSD. PTSD is serious psychiatric disorder and we remain committed to developing a treatment option
that may help alleviate symptoms of the condition," said Seth Lederman, M.D., President and Chief Executive Officer. "We
look forward to presenting results from the HONOR study at a scientific conference in August and meeting with the FDA in October
to discuss the new Phase 3 study of Tonmya for the treatment of PTSD."
Recent Program Highlights
*Tonmya has been conditionally
accepted by the FDA as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for PTSD which has been
designated as a Breakthrough Therapy in December 2016. TNX-102 SL is an investigational new drug and has not been approved for
# AMRIX (cyclobenzaprine HCl extended-release capsules)
is indicated for 2-3 weeks use as an adjunct to rest and physical therapy for relief of muscle spasm
associated with acute, painful musculoskeletal conditions. The recommended adult dose for most patients is one AMRIX 15 mg
capsule taken once daily. Some patients may require up to 30 mg/day, given as one AMRIX 30 mg capsule taken once daily or as two
(2) AMRIX 15 mg capsules taken once daily.
Second Quarter 2018 Financial
Research and development expenses
for the second quarter of 2018 totaled $4.1 million, compared to $2.8 million for the same period in 2017. The increase is primarily
due to clinical development work associated with the PTSD program.
General and administrative expenses
for the second quarter of 2018 were $2.1 million, compared to $2.0 million for the same period in 2017. The increase is primarily
due to an increase in professional services fees, partially offset by a decrease in compensation-related expenses as a result of
Net loss was $6.1 million, or
$0.73 per share, for the second quarter of 2018, compared to net loss of $4.8 million, or $0.65 per share, for the second quarter
of 2017. The greater net loss was primarily due to higher research and development expenses.
At June 30, 2018, Tonix had $16.7
million of cash and cash equivalents, compared to $25.5 million as of December 31, 2017. Cash used in operations was $5.5 million
for the three months ended June 30, 2018, compared to $4.4 million for the three months ended June 30, 2017. Research and development
expenses are expected to decrease following the orderly closing of the HONOR study, in the near term.
About Tonix Pharmaceuticals
Tonix 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 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 granted
Fast Track designation 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
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, 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.
TONIX 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, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Costs and expenses | ||||||||||||||||
| Research and development | $ | 4,067 | $ | 2,806 | $ | 9,237 | $ | 5,800 | ||||||||
| General and administrative | 2,076 | 2,016 | 3,894 | 4,113 | ||||||||||||
| Total costs and expenses | 6,143 | 4,822 | 13,131 | 9,913 |
| Operating loss | (6,143) | (4,822) | (13,131) | (9,913) |
| Interest income, net | 56 | 42 | 109 | 69 |
| Net loss | $(6,087) | $ (4,780) | $ (13,022) | $ (9,844) |
| Net loss per common share, basic and diluted | $ (0.73) | $ (0.65) | $ (1.60) | $ (1.74) |
| Weighted average common shares outstanding, basic and diluted | 8,391,709 | 7,327,890 | 8,122,499 | 5,666,457 |
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2018 | December 31, 2017(1) | |
| Assets | ||
| Cash, cash equivalents and marketable securities | $16,679 | $25,496 |
| Prepaid expenses and other current assets | 1,480 | 947 |
| Total current assets | 18,159 | 26,443 |
| Other non-current assets | 196 | 311 |
| Total assets | $18,355 | $26,754 |
| Liabilities and stockholders' equity | ||
| Total liabilities | $ 2,513 | $ 2,138 |
| Stockholders' equity | 15,842 | 24,616 |
| Total liabilities and stockholders' equity | $18,355 | $26,754 |
(1) The 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
Jessica Morris (corporate)
Tonix Pharmaceuticals
Scott Stachowiak (media)
Peter Vozzo (investors)