- Interim analysis from approximately 275 randomized participants in the Phase 3 HONOR study is anticipated in the first half of 2018.
- Topline results from the Phase 3 HONOR study of 550 participants (if needed) are anticipated in the second half of 2018.
- Enrolled the first participant in the 12-week, double-blinded, placebo-controlled Phase 3 HONOR study of TNX-102 SL 5.6 mg for the treatment of military-related PTSD in March 2017.
- Held the Initial Cross-Disciplinary Breakthrough meeting with the FDA in March 2017. Minutes from the meeting indicated that registration of TNX-102 SL could be solely supported by the Phase 3 HONOR study if topline data are statistically persuasive.
- Eutectic proprietary Protectic™ formulation patent (U.S. Patent No. 9,636,408), issued in May 2017, provides for TNX-102 SL market exclusivity until 2034.
- In the first quarter of 2017, announced synthesis of a potential smallpox-preventing vaccine candidate, TNX-801, a live form of horsepox virus, which has demonstrated protective vaccine activity in mice. TNX-801 is the first-ever synthesized chimeric horsepox virus.
- In the first quarter of 2017, announced addition to pipeline of tianeptine oxalate, TNX-601, a novel oral formulation for development as a potential daytime treatment for PTSD.
Cash used in operations was $4.8 million for the three months ended March 31, 2017, compared to $15.5 million for the three months ended March 31, 2016. At March 31, 2017, cash, cash equivalents, and marketable securities totaled $22.4 million, compared to $26.1 million at December 31, 2016. Management believes that cash, cash equivalents and marketable securities as of March 31, 2017, in addition to the approximately $16.3 million net proceeds raised from the recent public offerings, are sufficient to fund operating expenses and the Phase 3 HONOR study to completion with up to 550 participants.About Tonix Pharmaceuticals Holding Corp. Tonix is developing innovative pharmaceutical products to address public health challenges. TNX-102 SL is in Phase 3 development and has been granted Breakthrough Therapy designation by the FDA for the treatment of PTSD. 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. Tonix was issued U.S. patent 9,636,408 "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride", which includes compositions of cyclobenzaprine HCl and methods of manufacturing the eutectic. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix's proprietary TNX-102 SL composition. The patent provides Tonix with U.S. market exclusivity until 2034. Other development efforts include TNX-801, a potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus, and TNX-601 (tianeptine oxalate), a clinical candidate at pre-IND (Investigational New Drug) application stage, designed for daytime use for the treatment of PTSD. 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 the date hereof.
|TONIX PHARMACEUTICALS HOLDING CORP.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share amounts)|
|Three Months Ended March 31,|
|Costs and expenses|
|Research and development||$ 2,994||$ 10,671|
|General and administrative||2,097||3,343|
|Total costs and expenses||5,091||14,014|
|Interest income, net||27||38|
|Net loss per common share, basic and diluted||$ (1.27||)||$ (7.41||)|
|Weighted average common shares outstanding, basic and diluted||3,985,529||1,886,043|
|TONIX PHARMACEUTICALS HOLDING CORP.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31, 2017||December 31, 2016 (1)|
|Cash, cash equivalents and marketable securities||$22,423||$26,121|
|Prepaid expenses and other current assets||1,009||1,019|
|Total current assets||23,432||27,140|
|Other non-current assets||352||370|
|Liabilities and stockholders' equity|
|Total liabilities||$ 1,809||$ 2,149|
|Total liabilities and stockholders' equity||$23,784||$27,510|
ContactsJessica SmileyInvestor RelationsInvestor.firstname.lastname@example.org(212) 980-9155 x185Edison Advisors (investors) Tirth Pateltpatel@edisongroup.com(646) 653-7035Russo Partners (media)Rich AllanRich.email@example.com(646) 942-5588