Item 7.01    Regulation FD Disclosure.

On September 13, 2021, Tonix Pharmaceuticals Holding Corp. (the "Company") issued a press release announcing the results of a pre-Investigational New Drug Application ("pre-IND") meeting with the U. S. Food and Drug Administration ("FDA") for TNX-1800 (recombinant horsepox virus, live vaccine) as a potential SARS-CoV-2 vaccine to protect against COVID-19. A copy of the press release is furnished as Exhibit 99.01 hereto and incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.01 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.




 Item 8.01. Other Events.

On September 13, 2021, the Company announced that it received the official written response from a pre-IND meeting with the FDA to develop TNX-1800 (as a potential SARS-CoV-2 vaccine to protect against COVID-19. The Company believes written response provides a path to agreements on the design of the Phase 1 study and the overall clinical development plan to qualify TNX-1800 as a vaccine to prevent COVID-19. Based on the response, the Company expects to begin a Phase 1 study of TNX-1800 for the prevention of COVID-19 in the first half of 2022. This pre-IND meeting demonstrates concurrence and clear guidance on the proposed manufacturing, nonclinical pharmacology and toxicology studies, and Phase 1 clinical design for TNX-1800.





Forward- Looking Statements

This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the development of TNX-601 CR, the Company's product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Item 9.01 Financial Statements and Exhibits.






(d)    Exhibit
         No.                           Description.
        99.01     Press Release of the Company, dated September 13, 2021

© Edgar Online, source Glimpses