Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2024

FDA approved LIKMEZ (ATI-1501) for Metronidazole Oral Suspension 500mg/5mL

Additional USAFA funding commitment from the U.S. Air Force Academy, intended to advance the ATI-1701 program toward an IND submission to the FDA

Engaging regulatory authorities to align on ATI-1801 development plans

HALIFAX, Nova Scotia, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the third quarter of its fiscal year 2024, which ended on December 31, 2023. All figures are stated in Canadian dollars unless otherwise stated.

In recent months, we've achieved significant milestones by solidifying ATI-1701 government partnerships, engaging regulatory authorities for ATI-1801, and bringing our most advanced innovative asset, LIKMEZ (ATI-1501) to market through our partner. Beginning 2024, Appili’s skilled team stands with a clear vision, and committed funding enabling us to execute on our infectious disease program priorities, said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. “Additionally, the issuance of the patent claims for ATI-1701, shortly after receiving an additional funding commitment from USAFA, strengthens the programs position in biodefense and the new methods are expected to allow Appili to further develop a valuable vaccine that is urgently needed on the market”.

Operational Highlights

LIKMEZ ATI-1501: FDA Approved Product,

In September 2023, Appili announced the FDA approval of LIKMEZ (ATI-1501), our proprietary taste-masked liquid suspension reformulation of metronidazole, through our U.S. partner, Saptalis Pharmaceuticals LLC.

LIKMEZ is the first and only FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections that addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding, and discontinuation related anti-microbial resistance. Saptalis launched LIKMEZ in November 2023 and commercial sales in the United States are ongoing.

The FDA approval of LIKMEZ, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili’s ability to identify promising opportunities and develop and monetize them for the benefit of both patients and shareholders. Collaborating with Saptalis, Appili earned US$600,000 in milestone payments in fiscal 2024. Appili expects to receive sales-based milestone payments and royalties from Saptalis based on sale of the product.