Blog: TONIX PHARMACEUTICALS HOLDING CORP. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) –

Item 7.01    Regulation FD Disclosure.

On January 24, 2023, Tonix Pharmaceuticals Holding Corp. (the “Company”)
announced the publication of a paper entitled, “Development of a rapid
image-based high-content imaging screening assay to evaluate therapeutic
antibodies against the monkeypox virus,” in the journal Antiviral Research (the
“Paper”). A copy of the press release which discusses this matter is furnished
hereto as Exhibit 99.01, and incorporated herein by reference. The Paper, which
may contain nonpublic information, 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.

Item 8.01    Other Events.

On January 24, 2023, the Company announced the publication of the Paper, which
describes the development and optimization of two high-content image-based
assays that were employed to screen for potential therapeutic antibodies against
the monkeypox virus using surrogate poxviruses such as vaccinia virus, and
highlights the Company’s TNX-3400 product candidate, which includes antibodies
to potentially prevent or treat monkeypox and smallpox. One assay detected viral
proteins of vaccinia virus and was used to screen a large library of antibodies
made against pox viruses. This assay identified several antibodies with the
capacity to protect against vaccinia virus infection. The second assay
specifically detected phenotype changes in cells, called syncytia, after
infection and protection by therapeutics. The Company believes this technology
may allow it to identify combination therapies for monkey pox and smallpox
viruses. Data suggest that applying this technology has the potential to
increase the throughput of screening novel antivirals to shorten the discovery
time for antivirals..

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
or otherwise.

Item 9.01    Financial Statements and Exhibits.

(d)    Exhibit
         No.                                  Description.
        99.01     Press release of the Company, dated January 24, 2023
        99.02     Development of a rapid image-based high-content imaging screening
         104      assay to evaluate therapeutic antibodies against the monkeypox virus
                  Cover Page Interactive Data File (embedded within the Inline XBRL

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