UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 8.01. | Other Events. |
On January 19, 2024, Tonix Pharmaceuticals Holding Corp. (the “Company”) reduced its workforce by 19 full-time employees to align the Company’s capital and human resources with its previously announced strategic prioritization of its TNX-102 SL (cyclobenzaprine HCl sublingual tablet) product candidate for the management of fibromyalgia. The Company intends to submit a new drug application to the U.S. Federal and Drug Administration in the second half of 2024 under the 505(b)(2) regulatory pathway for the management of fibromyalgia, having completed two positive Phase 3 studies of TNX-102 SL in this indication.
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.
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: January 19, 2024 | By: | /s/ Bradley Saenger | |
| Bradley Saenger | |||
| Chief Financial Officer | |||
Cover |
Jan. 19, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Jan. 19, 2024 |
| Entity File Number | 001-36019 |
| Entity Registrant Name | TONIX PHARMACEUTICALS HOLDING CORP. |
| Entity Central Index Key | 0001430306 |
| Entity Tax Identification Number | 26-1434750 |
| Entity Incorporation, State or Country Code | NV |
| Entity Address, Address Line One | 26 Main Street |
| Entity Address, City or Town | Chatham |
| Entity Address, State or Province | NJ |
| Entity Address, Postal Zip Code | 07928 |
| City Area Code | (862) |
| Local Phone Number | 904-8182 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock |
| Trading Symbol | TNXP |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |