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Tonix Pharmaceuticals Reports Second Quarter 2018 Financial Results and Operational Highlights | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
By: Nasdaq / GlobeNewswire - 13 Aug 2018 | Back to overview list |
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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, Aug. 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 any indication. Second Quarter 2018 Financial Results 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 fewer personnel. 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 Holding Corp. 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 stage. 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.
TONIX PHARMACEUTICALS HOLDING CORP.
(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 statements. Contacts Jessica Morris (corporate) Scott Stachowiak (media) Peter Vozzo (investors) |
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Copyright 2018 Nasdaq / GlobeNewswire | Back to overview list |