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

Executive Summary

• Appili Therapeutics reported Q3 FY2026 financial results, posting a net loss of $1.0M ($0.01/share) and a cash balance of $0.2M as of December 31, 2025.
• The company secured a US$40 million NIAID contract to advance VXV-01 through Phase 1, with an additional US$82 million in pending government funding proposals across multiple programs.
• Operational highlights include LIKMEZ commercial momentum, ATI-1801 FDA feedback, ATI-1701 GMP manufacturing milestone, and extensions on existing lender loans.

Key Details

• Financial Results (Q3 FY2026 ended Dec 31, 2025): Net and comprehensive loss of $1.0M ($0.01/share), an increase of $0.5M from $0.5M ($0.004/share) in Q3 FY2025. Loss increase driven by a $2.6M reduction in government assistance, partially offset by a $1.2M decrease in R&D expenses, $0.2M decrease in G&A expenses, and $0.7M increase in foreign exchange gains.
• Cash Position: $0.2M as of Dec 31, 2025, down from $1.2M as of March 31, 2025.
• Share Count (Dec 31, 2025): 128,366,120 common shares, 11,910,281 stock options, and 39,048,000 warrants outstanding.
• NIAID Funding Award: US$40 million contract awarded to advance VXV-01 (Vitalex Biosciences’ first-in-class dual-antigen vaccine targeting multidrug-resistant Candida species) through Phase 1. Appili acts as prime contractor with Vitalex as subcontractor. Appili retains an exclusive option to acquire worldwide rights to VXV-01.
• Pending Government Proposals: US$82 million in active review across multiple infectious disease and biodefense programs.
• ATI-1801 (Topical Antiparasitic): Received positive FDA feedback on scientific bridging strategy for cutaneous leishmaniasis. Clear NDA submission pathway established. Potentially eligible for a Priority Review Voucher (PRV) upon FDA approval (anticipated Q4 2029), with recent PRV transactions reaching up to US$200 million.
• LIKMEZ® (ATI-1501): Metronidazole oral suspension showing steady sales growth since May 2025 re-launch. Appili eligible for sales-based milestone payments and royalties. Additional patents published in U.S. and Mexico in April 2025, extending protection through 2039.
• ATI-1701 (Biodefense Vaccine): Live-attenuated tularemia vaccine candidate successfully completed GMP manufacture of drug substance and drug product. Product may be dispositioned for Phase 1 clinical trials. Potentially eligible for a PRV upon FDA approval.
• Lender Extensions: Bloom Burton Loan and Long Zone Holdings Loan extended. All principal and accrued interest due March 31, 2026. Long Zone Holdings extension remains in full force if Appili completes an equity financing with minimum gross proceeds of at least CAD$450,000 by February 28, 2026.
• Accounting Standards: Financials prepared under IFRS; all figures in Canadian dollars unless otherwise stated.

Notable Quotes

• “During the past quarter, we made important progress in advancing multiple U.S. federal funding proposals that, if awarded, could meaningfully support our key pipeline and collaborator programs.” – Dr. Don Cilla, President and CEO
• “With the recent award up to US $40 million for VXV-01 and continued access to non-dilutive capital, Appili is steadily strengthening its funding base to drive infectious disease assets forward.” – Dr. Don Cilla, President and CEO