Appili Therapeutics Announces Notice of Allowance from the U.S. Patent and Trademark Office for ATI-1501 Liquid Oral Reformulation of Metronidazole

HALIFAX, Nova Scotia--(BUSINESS WIRE)-- Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced that the United States Patent and Trademark Office (“USPTO”) has issued a Notice of Allowance of new patent claims for ATI-1501, Appili’s liquid oral reformulation of the antibiotic metronidazole. A notice of allowance is issued by the USPTO to indicate that the application has passed the examination.

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 are pleased with this notice of allowance for a new patent that will further strengthen ATI-1501’s potential as a more convenient antibiotic treatment option,” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics. “For far too long, the bitter taste of the current form of metronidazole has made it challenging for patients to take, increasing rates of treatment failure, infection recurrence and antibiotic resistance. This patent protects our investment in making metronidazole more accessible and easier to take for all patients, especially for the elderly and children who often have difficulty taking solid oral medicines.”

Appili and their partner Saptalis Pharmaceuticals LLC (“Saptalis”), a New York-based specialty pharmaceuticals company, expect ATI-1501 to be approved by the FDA by the end of 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.

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, NY, USA, Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility designed to meet FDA cGMP requirements. For more information, visit www.Saptalis.com.

Forward looking statements
This news release contains “forward-looking statements”, including with respect to the proposed development and commercialization plans for ATI-1501. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to the FDA application and approval process for ATI-1501. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.

Forward looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that the New Drug Application for ATI-1501 may ultimately not be approved by the FDA, and the other risk factors listed in the annual information form of the Company dated June 23, 2022 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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