Tonix Pharmaceuticals to Present FDA Breakthrough Therapy-Designated PTSD Program at the MicroCap Conference in New York
First 50 Percent of Participants Enrolled in Phase 3 HONOR Study of Tonmya® (Cyclobenzaprine HCl Sublingual Tablets) for the Treatment of Military-Related PTSD
Interim Results of HONOR Study Expected in Third Quarter 2018
NEW YORK, April 04, 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, announced today that it will present at the MicroCap Conference being held April 9-10, 2018, in New York City.
Tonix is in Phase 3 development of Tonmya®*, or TNX-102 SL, a U.S. Food and Drug Administration-designated Breakthrough Therapy for the treatment of posttraumatic stress disorder (PTSD).
Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will provide an update of the Tonix pipeline of development programs. Details of the presentation are as follows:
|Event:||The MicroCap Conference|
|Date:||Monday, April 9, 2018|
|Time:||8:30 a.m. EDT|
|Location:||JW Marriott Essex House, New York City|
The presentation will be webcast live and remain available for 90 days following the presentation. To access the webcast, please visit the IR Events tab of the Investor Relations section of Tonix’s website at www.tonixpharma.com.
*Tonmya 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 PTSD. TNX-102 SL is an investigational new drug and has not been approved for any indication.
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’s lead product candidate, Tonmya, or TNX-102 SL, is in Phase 3 development as a bedtime treatment for PTSD. Tonix is also developing TNX-102 SL as a bedtime treatment for agitation in Alzheimer’s disease. A Phase 2 IND (Investigational New Drug) application was submitted in March 2018 after completion of a successful pre-IND meeting with the FDA. TNX-601 (tianeptine oxalate) is in the pre-IND application stage, also for the treatment of PTSD but 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.
Jessica Morris (investors)
Rich Allan (media)
Released April 4, 2018