Dr. Don Cilla reports

NEW PATENTS PROVIDE ADDITIONAL COMPOSITION OF MATTER AND METHODS OF USE CLAIMS, STRENGTHENING THE PROTECTION FOR LIQUID ORAL TASTE-MASKED REFORMULATION, LIKMEZ

Appili Therapeutics Inc. has been granted new patent claims protecting the company's oral formulation of metronidazole, Likmez, from the United States Patent and Trademark Office and the Mexican Patent Office.

The newly granted patents include:

• U.S. patent No. 20230086660A1 -- Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same;

• Mexican patent No. 2020007494 -- Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same.

The two new patents, set to expire in 2039, provide comprehensive protection for Likmez, covering its unique taste masked composition and accessible therapeutic applications. The company's partner, Saptalis Pharmaceuticals, LLC, has successfully undertaken the necessary steps to have the U.S. patent listed in the Food and Drug Administration Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

"Our proprietary formulation of metronidazole offers improved stability and palatability -- key factors in helping patients adhere to their medications and improve treatment outcomes," said Dr. Don Cilla, president and chief executive officer at Appili Therapeutics. "Securing additional patents, shortly after launching Likmez in the U.S., is a significant achievement that demonstrates the creativity of Appili's R&D team, and reinforces our commitment to developing products for the benefit of patients and shareholders."

"We are pleased with the issuance of the new patent for Likmez," said Polireddy Dondeti, PhD, president and chief executive officer at Saptalis. "The listing of the patent in the Orange Book will ensure additional protection of the unique taste masking technology used in Likmez formulation and support Saptalis's team product commercialization activities. The timing of the listing is especially beneficial, as Saptalis is planning to relaunch Likmez in May of this year under its own label."

About Likmez

Likmez is the first and only FDA-approved ready-made suspension of metronidazole for the treatment of anti-microbial-resistant infections that addresses the unmet need in patients with dysphagia and avoids risks associated with drug compounding, and discontinuation related anti-microbial resistance.

About Saptalis Pharmaceuticals, LLC

Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing and commercialization of generic and innovative products in liquid and semi-solid dosage forms.

Located in the Hauppauge Industrial Park on Long Island, N.Y., Saptalis has fully equipped research and development laboratories and state-of-the-art commercial scale manufacturing facility designed to meet FDA cGMP requirements.

About Appili Therapeutics Inc.

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 an FDA-approved ready-made suspension of metronidazole for the treatment of anti-microbial infections, a vaccine candidate to eliminate a serious biological weapon threat and a topical antiparasitic for the treatment of a disfiguring disease.

We seek Safe Harbor.