TNXP Tonix Pharmaceuticals Holding Corporation

On November 16, 2022, the Company announced data describing the impact of oxytocin on isolated human sensory neurons from the Poster entitled, “In Vitro Impact of Oxytocin on Human Sensory Neurons.” This study supports the belief that oxytocin plays a key role in pain modulation and is the first to demonstrate that oxytocin receptors are present on human sensory neurons, that inflammation drives expression of oxytocin receptors on these neurons, and that oxytocin inhibits these neurons, suggesting a mechanism by which oxytocin can produce analgesia. The study also demonstrates the contribution of magnesium to this analgesia, as the impact of oxytocin on the sensory neurons was dramatically enhanced in the presence of supraphysiologic levels of this ion, and are consistent with prior work which demonstrated that magnesium ions (Mg2+) bind to a pocket in the oxytocin receptor, enhancing the activity of oxytocin at its receptor. The results of this study are consistent with data from animal models and provide support for the use of oxytocin agonists for the treatment of pain.

The Company expects to begin enrollment in a Phase 2 study of its TNX-1900 (intranasal potentiated oxytocin) product candidate for the prevention of migraine headache in chronic migraineurs during the fourth 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 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.