UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01 | Entry into a Material Definitive Agreement. |
On June 28, 2024, Tonix Pharmaceuticals Holding Corp. (the “Company”) entered into an Other Transaction Agreement (“OTA”) with the Defense Threat Reduction Agency (“DTRA”), an agency within the U.S. Department of Defense, through Advanced Technology International, an entity acting on behalf of the Medical CBRN Defense Consortium, under the authority of the U.S. Department of Defense. The OTA incorporates the terms and conditions of a Base Agreement (the “Base Agreement”, and together with the OTA, the “Agreement”) between the Company and DTRA. The objective of the Agreement is to develop a small molecule broad-spectrum antiviral for the prevention or treatment of viral infections to improve the medical readiness of military personnel in biological threat environments. The OTA will fund the development of the Company’s TNX-4200 program to develop an orally available small molecule that reduces CD45 enzymatic activity, with broad-spectrum efficacy against a range of viral families through the completion of Phase 1 clinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug submission with the U.S. Food and Drug Administration, and to fund a first-in-human Phase 1 clinical study.
The OTA provides for payments totaling up to $34 million over five years upon the achievement of specified development milestones relating to the Company’s TNX-4200 program.
The Agreement contains terms and conditions that are customary for U.S. Government agreements of this nature, including provisions giving the U.S. Government the right to terminate the Agreement based on a reasonable determination that the project funded under the OTA will not produce beneficial results commensurate with the expenditure of resources and that termination would be in the U.S. Government’s interest.
The foregoing description of the material terms of the OTA and Base Agreement does not purport to be complete and is qualified in its entirety by reference to the OTA and Base Agreement, which will be filed with the Securities and Exchange Commission as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.
SIGNATURE
Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| TONIX PHARMACEUTICALS HOLDING CORP. | |||
| Date: July 1, 2024 | By: | /s/ Bradley Saenger | |
| Bradley Saenger | |||
| Chief Financial Officer | |||