Item 8.01 Other Events.

On October 25, 2022, the United States Patent and Trademark Office (the "USPTO") issued U.S. Patent No. 11478534 B1 (the "534 Patent") and made publicly available provisional patent application (U.S. Application No. 17/374.317) (the "Provisional Patent Applications") to which the 534 Patent claims priority.

The 534 Patent and the Provisional Patent Application for Formulation and Method of Preparing Zinc-Charged Insulin for Oral Administration described an invention that is directed to a zinc-charged insulin composition that is effective in treating diabetes and lowering and stabilizing blood glucose levels when administered orally. The zinc-charged insulin is acid and enzyme resistant, such that the zin-charged insulin is capable of surviving the acidic conditions of the stomach. The zinc-charged insulin is capable of being absorbed through the gastrointestinal tract and stored in the liver, such that the zinc-charged insulin is long lasting and similar to the insulin normally generated by the body.

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