Item 7.01 Regulation FD Disclosure.
On September 22, 2022, Tonix Pharmaceuticals Holding Corp. (the “Company”)
announced data from a retrospective observational database study in patients
diagnosed with Long COVID at the International Association for the Study of Pain
(IASP) 2022 World Congress on Pain, being held September 20-23, 2022 (the
“Presentation”). A copy of the press release which discusses this matter is
furnished hereto as Exhibit 99.01, and incorporated herein by reference. The
Presentation, 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
Exhibit 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 September 22, 2022, the Company announced data from the Presentation
entitled, “Retrospective Observational Database Study of Patients with Long
COVID with Multi-site Pain, Fatigue, and Insomnia: A Real-World Analysis of
Symptomatology and Opioid Use.”
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 September 22, 2022 99.02 Retrospective Observational Database Study of Patients with Long COVID with Multi-site Pain, Fatigue, and Insomnia: A Real-World Analysis of Symptomatology and Opioid Use 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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