Item 7.01 Regulation FD Disclosure.
On July 28, 2022, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced
a collaboration with the Kenya Medical Research Institute (“KEMRI”) to plan,
seek regulatory approval for and conduct a Phase 1 clinical study in Kenya to
develop the Company’s TNX-801 product candidate as a vaccine to protect against
monkeypox and smallpox. A copy of the press release which discusses this matter
is furnished hereto as Exhibit 99.01, 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 July 28, 2022, the Company announced a collaboration with KEMRI to plan, seek
regulatory approval for and conduct a Phase 1 clinical study in Kenya to develop
TNX-801 as a vaccine to protect against monkeypox and smallpox. The study is
expected to start in the first half of 2023.
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 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
Item 9.01 Financial Statements and Exhibits.
(d) Exhibit No. Description. 99.01 Press release of the Company, dated July 28, 2022 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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