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

Item 7.01 Regulation FD Disclosure.

On June 3, 2021, Tonix Pharmaceuticals Holding Corp. (the “Company”) issued a
press release announcing the poster presentation (the “Poster”) of positive
results from the Phase 3 RELIEF study of TNX-102 SL for the management of
fibromyalgia at the 2021 American Society of Clinical Psychopharmacology
(“ASCP”) Annual Meeting. Copies of the Poster and press release which discusses
this matter are furnished hereto as Exhibits 99.01 and 99.02, respectively, 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 June 3, 2021, the Company announced the Poster presentation of positive
results from the Phase 3 RELIEF study of TNX-102 SL for the management of
fibromyalgia at the 2021 ASCP Annual Meeting. The Poster, titled, “Efficacy and
Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of
Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized,
Double-Blind, Placebo-Controlled Multicenter Trial”shows that TNX-102 SL met its
pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly
reducing daily pain compared to placebo (p=0.01) and was associated with a
higher rate than placebo of ?30% pain responders in participants with
fibromyalgia (p=0.006). TNX-102 SL at the 5.6 mg dose also showed activity in
key secondary endpoints measuring improvements in sleep quality, mitigation of
fatigue, and fibromyalgia-specific functional recovery. TNX-102 SL was well
tolerated and not associated with side-effects seen with other approved oral
fibromyalgia treatments, including weight gain, insomnia, nausea, or sexual
dysfunction.

The Company believes that the results of the Phase 3 RELIEF trial validate the
mechanism that improved sleep quality can lead to syndromal effects on
fibromyalgia, improving pain, sleep and fatigue. The Company believes that the
results of the RELIEF study provide evidence that 5.6 mg is the right dose for
the targeted patient population. Interim analysis results for the confirmatory
Phase 3 study, RALLY, are expected in the third quarter of 2021, followed by
topline data in the first quarter of 2022.



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 results of the Phase 3 RELIEF
study, 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       Poster Presentation
        99.02       Press release of the Company, dated June 3, 2021

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