First Participant Enrolled in Phase 3 HONOR Study of TNX-102 SL in Military-Related PTSD in 1Q2017

TNX-102 SL Designated a Breakthrough Therapy for PTSD by the U.S. FDA in 4Q2016

NEW YORK, April 17, 2017 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, announced financial results for the fourth quarter and full year ended December 31, 2016.

Seth Lederman, M.D., president and chief executive officer of Tonix, stated, "Tonix achieved significant momentum in the last quarter of 2016, which has carried over into 2017.  Tonix is focused on pioneering a differentiated approach for the treatment of posttraumatic stress disorder (PTSD), through improving sleep quality.  TNX-102 SL*, having shown potential advantages over existing treatments for this disorder, received Breakthrough Therapy designation from the United States Food and Drug Administration (FDA) in December 2016."

"In the first quarter of 2017, the FDA accepted the protocol design for our Phase 3 HONOR study to support the registration of TNX-102 SL for PTSD."  Dr. Lederman continued, "As we planned, the study was initiated in March and is on track to have an unblinded interim analysis (IA) by an independent data monitoring committee in the first half of 2018. If the IA results require continued enrollment, topline results from the full 550-participant trial are expected to be available in the second half of 2018.   With successful capital raising activities completed in 2017, Tonix is fully funded through the completion of, and announcement of the topline results, from the HONOR study."

At December 31, 2016, Tonix had cash, cash equivalents, and marketable securities of $26.1 million. Since January 1, 2017, Tonix has raised approximately $9.1 million in net proceeds through an at-the-market offering and approximately $8.3 million of net proceeds from the sale of common stock in an underwritten public offering.   Approximately 7.5 million shares were outstanding as of April 13, 2017.

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