Appili Therapeutics Reports Fiscal Year 2026 Financial and Operational Results

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LIKMEZ® (ATI-1501) commercial momentum building in U.S. market

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US$40 million NIAID award supporting VXV-01 advancement through Phase 1

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HALIFAX, Nova Scotia, June 26, 2026 (GLOBE NEWSWIRE) — Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and operational results for the fiscal year ended March 31, 2026 (“FYE 2026”), and provided an update on fiscal 2027. All figures are stated in Canadian dollars unless otherwise stated.

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“Fiscal year 2026 marked a significant transition for Appili as we advanced commercial-stage programs and continued to build our non-dilutive funding base,” said Don Cilla, Pharm.D., M.B.A., President and CEO of Appili Therapeutics. “With LIKMEZ gaining traction in the U.S., our pipeline progressing with government backing, and US$40 million in new awards, we are executing on the strategy we set out to build.”

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“With a clear roadmap in place, the Company is focused on growing LIKMEZ, advancing our funded pipeline programs, and securing additional non-dilutive and equity capital as we move into fiscal 2027” adds Dr. Don Cilla.

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ATI-1801, Topical Antiparasitic with Aligned Regulatory Path
ATI-1801 is a novel topical formulation of paromomycin (15% w/w) under advanced clinical development for the treatment of cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people annually and remains a priority for governments and non-governmental organizations globally.

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Appili licensed the exclusive worldwide rights to ATI-1801 from the U.S. Army Medical Materiel Development Activity and holds a complete clinical dossier, including a randomized, vehicle-controlled Phase 3 study conducted in Tunisia that met its primary endpoint, with ATI-1801 demonstrating a significant improvement in the rate of clinical cure of the index lesion compared to vehicle at 6 months.

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Following Appili’s Type B meeting with the U.S. Food and Drug Administration (“FDA”), the agency agreed with the Company’s proposed scientific bridging strategy between previously used clinical trial material and new drug product batches. This approach centers on developing a validated in vitro release test and manufacturing a new reference standard to support an NDA submission without the need for additional clinical efficacy studies, potentially accelerating time to registration.

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ATI-1801 has received Orphan Drug Designation from the FDA for the treatment of certain forms of cutaneous leishmaniasis, and Appili believes the program may be eligible to receive a Priority Review Voucher (“PRV”) upon approval. Appili is actively pursuing non-dilutive funding and partnership opportunities with NGOs and government agencies to implement the agreed-upon regulatory strategy and complete remaining development work.

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LIKMEZ^®
(ATI-1501), Seeing Commercial Momentum in the U.S. Market
LIKMEZ® (metronidazole oral suspension, 500 mg/5 mL), Appili’s licensed, taste-masked oral liquid formulation of metronidazole, is being commercialized in the U.S. by Saptalis Pharmaceuticals, LLC (“Saptalis”). LIKMEZ is the first and only FDA-approved, ready-to-use liquid oral suspension of metronidazole, designed for patients who have difficulty swallowing tablets or who are sensitive to taste.