Tonix Pharmaceuticals Reports Third Quarter 2016 Financial Results

NEW YORK, Nov. 10, 2016 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), which is developing a next-generation treatment for PTSD, announced financial results for the third quarter ended September 30, 2016.

"Tonix undertook significant changes in the third quarter," said Seth Lederman, M.D., president and chief executive officer of Tonix.  "We shifted our clinical development strategy to focus resources on our promising PTSD program following a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).  Positive data from AtEase - a 12-week randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating TNX-102 SL*, 5.6 mg, in military-related PTSD - bolstered our enthusiasm for moving forward with this therapy. We plan to initiate the HONOR study, a 12-week Phase 3 trial evaluating TNX-102 SL, 5.6 mg, in military-related PTSD, in the first quarter of the coming year."

At September 30, 2016, Tonix had $26.7 million in cash and cash equivalents and marketable securities, as compared to $31.2 million as of June 30, 2016.  During the quarter ended September 30, 2016, Tonix raised approximately $1.4 million in net proceeds from the fully exercised over-allotment from a June 2016 underwritten offering, and $2.5 million in net proceeds through an at-the-market offering. Subsequent to the quarter end, Tonix raised approximately $4.6 million in net proceeds from an underwritten offering.

Upcoming Milestones and Recent Program Highlights: TNX-102 SL, 5.6 mg, for PTSD
  • FDA acceptance of the Phase 3 HONOR study design and interim analysis plan expected in the fourth quarter of 2016.
  • Phase 3 HONOR study, a 12-week randomized, double-blind, placebo-controlled trial, is planned to begin in the first quarter of 2017.  The primary efficacy endpoint is mean change from baseline in total CAPS-5 at week 12 compared between TNX-102 SL, 5.6 mg, and placebo.  This is the same primary endpoint used in the Phase 2 AtEase study.
  • Topline data from the first interim analysis of the Phase 3 HONOR study in approximately 180 military-related PTSD patients expected to be released in the second half of 2017.
  • New results will be presented today at the International Society for Traumatic Stress Studies 32 nd Annual Meeting, from a retrospective analysis of AtEase study data regarding the effects of TNX-102 SL on reckless and self-destructive behaviors in patients with military-related PTSD.
  • Tonix hosted a PTSD Awareness Day with key opinion leaders in PTSD research, highlighting the challenges in combating this growing mental health concern, especially in veterans. The webcast of the event can be accessed here:

PTSD affects approximately 8.6 million Americans and is a chronic and debilitating condition, in which patients experience nightmares and disturbed sleep, and which is associated with depression and suicide.  Individuals who suffer from PTSD experience impaired social functioning, occupational disability, intense anxiety and avoidance, emotional numbness, intense guilt or worry, agitation and an overall poor quality of life.  PTSD is sometimes associated with substance abuse and unpredictable or violent behaviors; additional reasons that make it a critical public health concern.  PTSD can result from witnessing or experiencing a traumatic event or ordeal in which there was the threat or actual occurrence of grave physical harm.

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