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

Executive Summary

• Appili Therapeutics announced a U.S. $40 million non‑dilutive award from NIAID for the VXV‑01 vaccine program and disclosed ≈US $90 million in pending government proposals across its pipeline.
• The company reported a net loss of C$1.0 M ($0.01/share) for Q2 FY 2026, with cash on hand falling to C$0.3 M, but highlighted significant non‑dilutive funding secured to date (over US $66 M).
• Key pipeline milestones were achieved: GMP manufacture of ATI‑1701 vaccine, FDA‑aligned progress on ATI‑1801 topical antiparasitic, and successful U.S. re‑launch of LIKMEZ® generating milestone payments and royalties.

Key Details

• NIAID Award (VXV‑01): Up to US $40 M over five years for IND‑enabling work, IND filing, and Phase 1 trials; exclusive option granted to Appili to acquire worldwide rights.
• Pending Proposals: Combined potential value of ≈US $90 M submitted to U.S. government and other agencies; awards expected in Q1 2026.
• Historical Non‑Dilutive Funding: Over US $66 M already secured via contracts and grants, underscoring the company’s non‑dilutive financing model.
• ATI‑1701 (Tularemia Vaccine): Completed GMP manufacture of drug substance & product; data presented at NATO CBRN Conference; peer‑reviewed publication confirms durable protection in primates; new funding request filed to advance to IND.
• ATI‑1801 (Topical Paromomycin for Cutaneous Leishmaniasis): Received positive FDA feedback on scientific bridging strategy; progressing toward NDA submission; pursuing non‑dilutive financing and potential PRV eligibility (>US $150 M valuation).
• LIKMEZ® (Metronidazole Oral Suspension, ATI‑1501): Re‑launched in U.S. May 2025 via Saptalis partnership; generating increasing sales; Appili entitled to milestone payments and ongoing royalties.
• Financial Results (Q2 FY 2026):
• Net & comprehensive loss: C$1.0 M ($0.01/share), up from C$0.7 M YoY.
• Drivers: $2.1 M reduction in government assistance, $0.2 M FX loss; partially offset by lower R&D (‑C$1.2 M), financing costs (‑C$0.7 M) and G&A expenses (‑C$0.1 M).
• Cash balance: C$0.3 M (down from C$1.2 M at March 31 2025).
• Capital structure: 121,266,120 common shares outstanding; 11,910,281 stock options; 34,930,000 warrants.

Notable Quotes

• “The recent award of up to US$40 million for VXV‑01… highlights the confidence the NIAID placed in our execution…” – Dr. Don Cilla, President & CEO
• “We are progressing ATI‑1801 toward NDA submission, leveraging non‑dilutive funding and a potential PRV that could unlock significant value.” – Dr. Don Cilla

All figures are presented in Canadian dollars unless otherwise noted.