UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
On April 20, 2022, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced the results of a retrospective observational database study in over 50,000 patients diagnosed with Long COVID. A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein by reference.
On April 21, 2022, the Company will present certain information regarding the Company and its product candidates at the NobleCon18 Investor Conference (the “Presentation”). 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 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 April 20, 2022, the Company issued a press release announcing the results of a retrospective observational database study in over 50,000 patients diagnosed with Long COVID. The goal of the retrospective database study, which was commissioned by the Company, was to assess the proportion of Long COVID patients who experience fibromyalgia-like multi-site pain and to measure their use of opiates. In the study, over 40% of patients with symptoms of Long COVID had fibromyalgia-like multi-site pain. The retrospective analysis was undertaken in part to determine the feasibility and representative nature of the Company’s upcoming Phase 2 study of the Company’s TNX-102 SL product candidate in patients with Long COVID who present with fibromyalgia-like multi-site pain. The Company believes that these findings suggest that the Company may be able to recruit a robust cohort of participants to test the effects of TNX-102 SL in treating this condition. Further, these findings suggest that the group of Long COVID patients with fibromyalgia-like multi-site pain represents a significant portion of this patient population. The primary efficacy endpoint of the upcoming Phase 2 study will be change from baseline in the weekly average of daily self-reported worst pain intensity scores.
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. | ||
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104 |
Press release of the Company, dated April 20, 2022 Presentation by the Company Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| TONIX PHARMACEUTICALS HOLDING CORP. | |||
| Date: April 20, 2022 | By: | /s/ Bradley Saenger | |
| Bradley Saenger | |||
| Chief Financial Officer | |||