Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2026

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New NIAID Non-Dilutive Funding Award of up to US $40Million with US$90 Million in Pending Proposals Across Multiple Infectious Disease Programs

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LIKMEZ® (ATI-1501): Building Commercial Momentum in the U.S. Through Re-Launch and Increasing Sales Growth

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HALIFAX, Nova Scotia, Nov. 13, 2025 (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 second quarter of its fiscal year 2026, which ended on September 30, 2025. All figures are in Canadian dollars unless otherwise stated.

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“Strategic government partnerships are foundational to Appili’s impact in infectious disease and biodefense,” said Dr. Don Cilla, President and CEO of Appili. “The recent award of up to US$40 million for VXV-01, developed in collaboration with Vitalex Biosciences, highlights the confidence the NIAID placed in our execution, and empowers us to accelerate the development of much-needed solutions for urgent public health threats as we pursue additional high-value opportunities”.

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Non-Dilutive Government Funding Strategy

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Appili has submitted multiple funding proposals to U.S. government and other agencies, representing a combined potential award value of approximately US$90 million. If awarded, the awards would support critical development activities, including manufacturing optimization, preclinical and non-clinical studies, regulatory activities, IND submissions, and Phase 1 clinical trials. The Company anticipates that awards from multiple proposals may be announced in the first quarter of calendar 2026.

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To date, Appili and its partners have secured over US$66 million in government contracts and grants, demonstrating the strength of its non-dilutive funding model. This strategic approach leverages public sector support for high-priority anti-infective and biodefense programs, providing sustainable capital to accelerate pipeline development without diluting shareholder value. By combining these historic achievements with current proposal submissions, Appili is well-positioned to advance infectious disease and biodefense products while maintaining financial flexibility.

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ATI-1801 – Topical Antiparasitic Program with an Aligned Regulatory Path

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ATI-1801 is a novel topical formulation of paromomycin (15% w/w), currently in development for the treatment of cutaneous leishmaniasis, a serious and disfiguring skin disease that affects hundreds of thousands of individuals worldwide each year.

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Encouraged by recent positive FDA feedback on its scientific bridging strategy, Appili is progressing ATI-1801 toward NDA submission. The Company is pursuing non-dilutive funding from global health organizations and strategic partners to accelerate the FDA-aligned development pathway, expedite regulatory filing, and provide patient access in neglected tropical disease markets.

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Additionally, Appili believes that ATI-1801 may be eligible for a Priority Review Voucher (“PRV”), when approved by the FDA. PRVs have recently been monetized for amounts in excess of US$150 million.

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LIKMEZ™ (ATI-1501), Commercial Momentum Building in U.S. Market

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Saptalis Pharmaceuticals, Appili’s manufacturing and commercialization partner, successfully re-launched LIKMEZ^® (metronidazole oral suspension, 500 mg/5 mL) in the U.S. market, the first and only FDA-approved liquid oral formulation of metronidazole. Since the re-launch in May 2025, LIKMEZ has seen a steady increase in sales, reflecting strong demand among clinicians and patients seeking improved anti-infective therapy options.