Tonix Pharmaceuticals Holding

TNXP

Tonix Pharmaceuticals (Tonix Pharmaceuticals Holding Corp.) is a pharmaceutical company based in New York City that focuses on repurposed drugs for central nervous system conditions and as of 2020 was also pursuing a vaccine for COVID-19 and a biodefense project.The company's predecessors were Tamandare Explorations Inc. which had been formed in 2007 as a mining wildcat vehicle focused on land in Nevada and the shares of which were traded over the counter, and L & L Technologies, LLC, which had been formed in 1996 by Seth Lederman and Donald Landry to repurpose drugs for CNS development. L&L had formed Janus Pharmaceuticals, Inc., which later became Vela Pharmaceuticals, Inc. to develop some of its inventions, and Vela returned those assets to L&L in 2006. L&L placed them in a subsidiary called Krele Pharmaceuticals, Inc., and that subsidiary and Tamandare Explorations Inc. performed a reverse merger in October 2011; the new entity was renamed Tonix Pharmaceuticals Holding Corp. and Lederman was named CEO. It was listed on the NASDAQ exchange in 2013 under the symbol TNXP.The current lead candidates in the pipeline are the Phase 3 study of TNX-102 SL for the bedtime treatment of fibromyalgia, the Phase 2 study of TNX-1300 for cocaine intoxication and overdose and the preclinical study of TNX-1800, a potential coronavirus vaccine.In February 2020 Tonix began development of a potential vaccine to protect against COVID-19 with collaboration with Southern Research based on its live horsepox vaccine platform. In May 2020 it announced an additional collaboration with the University of Alberta to develop more horsepox-based vaccines, TNX-1810, TNX-1820 and TNX-1830, partnering with FUJIFILM Diosynth Biotechnologies in College Station, TX, to manufacture the TNX-1800 vaccine candidate.In November 2019 Tonix announced the initiation of the Phase 3 study of TNX-102 SL for the management of fibromyalgia with interim analysis expected in September 2020 and topline data in the first quarter of 2021. In January 2020, Tonix reported it has finished the essential fed-fasting and dose proportionality tests in support of a NDA. Tonix continued work on TNX-102 SL in PTSD; the IND for that use had been accepted in 2014 and in December 2016 after the Phase IIa trial was done, TNX-102 was granted Breakthrough Therapy designation by the FDA in December 2017 which was rescinded in January 2019, but then restored in March 2019. A Phase 3 trial of military-related PTSD began in February 2017, but was stopped in July 2018 after an interim analysis of 50% of target participants were evaluated, for "inadequate separation on primary efficacy endpoint".

Tonix Pharmaceuticals Holding has been a target of short sellers for a while. The current short interest of 18.09% is slightly above the average of the last 12 months (14.76%).