Shares in Tonix Pharmaceuticals (NASDAQ:TNXP) nearly doubled in the pre-market Friday on the heels of a preliminary prospectus for a public offering as the clinical-stage biotech prepares for a new Phase 3 clinical trial, RECOVERY, evaluating Tonmya for the treatment of posttraumatic stress disorder (PTSD).
In the company’s filing on Thursday it indicated that 2,132,701 Class A units and 9,000 Class B units would be part of its public offering. Each Class A unit would consist of one share of common stock and one warrant to purchase one common share at 125% of the Class A unit price.
Each Class B unit consists of one Series A preferred share valued at $1,000 and one warrant to purchase 237 common shares.
READ: Tonix Pharmaceuticals shares rocket after FDA green-lights design of new late-stage study of Tonmya for PTSD
“Our lead product candidate, Tonmya, or TNX-102 SL, a proprietary low-dose cyclobenzaprine, or CBP, sublingual tablet, designed for bedtime administration, is in Phase 3 development as a potential treatment for PTSD and designated by the US Food and Drug Administration, or FDA, as a Breakthrough Therapy,” the company said in its filing.
Most significantly, the company reiterated in the filing that it planned to “start the Phase 3 RECOVERY trial of Tonmya 5.6 mg for the treatment of PTSD in the first quarter of 2019.”
The new trial will incorporate several new design features including restricting enrollment of study participants to individuals with PTSD who experienced an index trauma within nine years of screening, instead of 2001 or later as in the earlier Phase 3 HONOR study.
The RECOVERY study will also include participants who have experienced civilian traumas in addition to those with military-related traumas.
The primary endpoint will be the mean change from baseline in the severity of PTSD symptoms as measured by a scale called CAPS-5.
Tonix Pharmaceuticals CEO Seth Lederman earlier said the compnay was moving forward "expeditiously" to initiate the RECOVERY study and expected "to have topline data in the first half of 2020.”
The New York-based company said Tonmya has been conditionally accepted by the FDA as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD.
Contact Uttara Choudhury at [email protected]
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