Item 7.01

On March 19, 2021, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced the issuance of a U.S. patent for compositions and uses of tianeptine oxalate salt, the active ingredient of the Company’s TNX-601 CR product candidate. A copy of the press release is furnished as Exhibit 99.01 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 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.

On March 19, 2021, the Company announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 10,946,027 to the Company on March 16, 2021. Tianeptine oxalate is the active pharmaceutical ingredient of Tonix’s development candidate, TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablet). The new patent, “Tianeptine Oxalate Salts and Polymorphs,” includes claims directed to pharmaceutical compositions comprising crystalline tianeptine oxalate salts, methods of using those compositions to treat various disorders, and methods of producing the oxalate salts. This patent is expected to provide the Company with U.S. market exclusivity until December 28, 2037, excluding any patent term extensions.

The crystalline tianeptine oxalate of the patented compositions is believed to provide improved stability, consistency, and manufacturability as compared to the amorphous sodium salt that is available in Europe for the treatment of depression. The mechanism of TNX-601 CR in treating depression is distinct from any other antidepressant available in the U.S. The Company believes that the physiochemical properties of the crystalline oxalate salt are superior to the amorphous sodium salt, and together with its controlled-release technology will provide a once-daily dosage product.

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 intellectual property, 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. 

99.01 Press release of the Company, dated March 19, 2021

Tonix Pharmaceuticals Holding Corp. Exhibit
EX-99.01 2 ex99-01.htm PRESS RELEASE   Tonix Pharmaceuticals Holding Corp. 8-K Exhibit 99.01       Tonix Pharmaceuticals Announces Issuance of U.S. Patent for Compositions and Uses of Tianeptine Oxalate Salt,…
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