TONIX PHARMACEUTICALS HOLDING CORP. (NASDAQ:TNXP) Files An 8-K Regulation FD Disclosure
Tonix Pharmaceuticals Holding Corp (the “Company”) presented (the “Presentation”) at the 3rd Annual Neuropsychiatric Drug Development Summit on November 12, 2020. The Presentation, which may contain nonpublic information, is filed as Exhibit 99.01 hereto and incorporated herein by reference. A copy of the press release that discusses this matter is filed as Exhibit 99.02 hereto and incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.01 and 99.02 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the United States Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
On November 12, 2020, the Company outlined a new statistical method to analyze future Posttraumatic Stress Disorder (“PTSD”) drug studies and presented a retrospective analysis using the new method of the Phase 3 HONOR study (P301) of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of military-related PTSD. The proposed new statistical method, called Randomization Honoring Non-Parametric Combination of Tests, was applied to a retrospective analysis of the Phase 3 HONOR study and showed a nominal p-value of 0.03 compared to the p-value of the prospective primary analysis of 0.6 in TNX-102 SL’s treatment benefit at Week 12 as measured by change from baseline in the using the Clinician Administered PTSD Scale for DSM-5.
The Company is planning a Phase 3 PTSD study of TNX-102 SL in Kenya, expected to initiate in the third quarter of 2021, and will focus on studying police.
Tonix Pharmaceuticals Holding Corp. Exhibit
EX-99.01 2 ex99-01.htm PRESENTATION TONIX PHARMACEUTICALS HOLDING CORP. 8-K Exhibit 99.01 © 2020 Tonix Pharmaceuticals Holding Corp. November 12,…
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