Mr. Don Cilla reports

APPILI THERAPEUTICS ANNOUNCES ISSUANCE OF PATENT FOR ATI-1501 LIQUID ORAL REFORMULATION OF METRONIDAZOLE

The U.S. Patent and Trademark Office (USPTO) has published patent claims for ATI-1501 under the U.S. Application No. 18/072,154 filed on Nov. 30, 2022, and titled "Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same." The patent covers the composition and preparation methods for the drug through 2039.

Metronidazole is a widely used frontline oral treatment with over 10 million prescriptions written in the United States every year to help treat parasitic and anaerobic bacterial infections. The current tablet form of metronidazole is the only approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges.

"We believe our liquid oral reformulation solves a significant and growing issue for patients who cannot tolerate the current tablet formulation of metronidazole, especially for the elderly and children who often have difficulty taking solid oral medicines" said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics. "This patent recognizes innovative research by Appili Therapeutics to fill this significant gap in the treatment paradigm, and further strengthens ATI-1501's position as a more convenient antibiotic treatment option on the market. The market potential is significant and receiving this patent coverage prior to the upcoming FDA PDUFA date of September 23, 2023, should provide our oral reformulation metronidazole drug market exclusivity through at least 2039."

The FDA established ATI-1501 a Prescription Drug User Fee ("PDUFA") action date of September 23, 2023.

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili's goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

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