Appili Therapeutics Announces that FDA accepts the ATI-1501 NDA

HALIFAX, Nova Scotia , February 08 /Businesswire/ - Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today, with its partner Saptalis Pharmaceuticals LLC (“Saptalis”), announced that the Food and Drug Administration (“FDA”) accepted the ATI-1501 New Drug Application (“NDA”). ATI-1501 is Appili’s liquid oral reformulation of the antibiotic metronidazole, which has been licensed to Saptalis. The FDA established a Prescription Drug User Fee (“PDUFA”) action date of September 23, 2023.

“Obtaining FDA acceptance of the NDA is an important step towards bringing ATI-1501 to market,” said Dr. Don Cilla, Pharm.D., M.B.A., Appili’s President and CEO. “With the acceptance of the application, the FDA is actively reviewing the application with the target of completing their review by the PDUFA action date. Appili is working with Saptalis on supporting the review process and responding to questions posed by the FDA. Approval of ATI-1501 will provide a convenient treatment option for those suffering devastating infections that are unable to take the current metronidazole tablet treatment.”

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 and its bitter taste and lack of appropriate dosage forms prove highly difficult for patients with trouble swallowing, presenting frequent treatment compliance challenges. Approval of ATI-1501 will unlock the potential to achieve relief and recovery for the millions facing these devastating infections by offering a convenient treatment option.

“We are pleased that the FDA has accepted the ATI-1501 NDA for review,” said Polireddy Dondeti, PhD, President and Chief Executive Officer at Saptalis Pharmaceuticals, LLC. “This is a major step in the product development process which brings us closer to FDA approval and subsequent commercialization. Our liquid formulation when approved, will address a clear market need in a more convenient dosage form of metronidazole.”

About ATI-1501

ATI-1501 is a proprietary taste-masked liquid suspension reformulation of metronidazole. Metronidazole is a widely used front-line oral treatment with over 10 million prescriptions written in the United States every year and is used to treat parasitic and anaerobic bacterial infections, which heavily burden elderly patients. The bitter taste of metronidazole and lack of appropriate dosage forms for patients with difficulty swallowing presents treatment compliance challenges, which ultimately can lead to detrimental effects on patient outcomes, healthcare costs, infection control, and antibiotic resistance. ATI-1501 is designed to enable broader use of metronidazole and provide a solution with the same safety and efficacy profile provided by metronidazole for 50 years, that is both easy to swallow and good tasting, thereby helping patients to adhere with their medication and improve their prognoses.

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 and regulatory approval process. 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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