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

Executive Summary

• Appili Therapeutics reported its financial and operational results for the first quarter of fiscal year 2026 (ended June 30, 2025), posting a net loss of $1.2 million CAD ($0.01 per share), a decrease from the $1.6 million loss in the same period of 2024.
• The company submitted two additional U.S. government funding proposals during the quarter, bringing the total value of seven submitted proposals to up to US$137 million, aimed at advancing infectious disease and biodefense products.
• Key operational milestones include acceptance into the U.S. Medical CBRN Defense Consortium (MCDC), positive Phase 3 data and FDA endorsement for the ATI-1801 leishmaniasis program, and the re-launch of LIKMEZ® in the U.S. by partner Saptalis Pharmaceuticals.

Key Details

• Financial Performance (Q1 FY2026):
  • Net loss and comprehensive loss: $1.2 million CAD ($0.01 loss per share).
  • Comparison: Decrease of $0.4 million from $1.6 million loss in Q1 FY2025.
  • Drivers of decrease: $0.8 million decrease in financing costs, $0.4 million increase in foreign exchange gain, $1.1 million decrease in R&D expenses, and $0.1 million decrease in G&A expenses.
  • Offsetting factor: $1.9 million decrease in government assistance.
  • Cash position: $1.1 million as of June 30, 2025 (down from $1.2 million on March 31, 2025).
• Capitalization:
  • Common Shares: 121,266,120 issued and outstanding.
  • Stock Options: 11,910,281 outstanding.
  • Warrants: 37,139,874 outstanding.
• U.S. Government Funding Proposals:
  • Total proposals submitted: 7.
  • Total potential award value: Up to US$137 million.
  • Breakdown:
    • 2 proposals to the Congressionally Directed Medical Research Program’s Peer Reviewed Medical Research Program (PRMRP).
    • 2 proposals to the U.S. Medical CBRN Defense Consortium (MCDC).
    • 2 proposals to the National Institute of Allergy and Infectious Diseases (NIAID).
  • Use of funds: Manufacturing, non-clinical development, regulatory activities for IND submissions, and Phase 1 clinical trials.
• ATI-1701 (Tularemia Vaccine):
  • Current funding: Cooperative Agreement with U.S. Air Force Academy totaling approximately US$11.6 million.
  • Recent development: Publication of data in July 2025 demonstrating robust and durable protection against lethal tularemia in non-human primates.
  • Funding update: Submitted a new PRMRP application valued at over US$3.3 million to replace reduced USAFA funding and advance the program to IND submission.
• LIKMEZ® (ATI-1501):
  • Partner: Saptalis Pharmaceuticals, LLC.
  • Status: Re-launched in the U.S. in May 2025.
  • Product: First and only FDA-approved, ready-to-use liquid oral suspension of metronidazole (500 mg/5 mL).
  • Revenue model: Eligible for milestone and royalty payments on development and sales.
• ATI-1801 (Cutaneous Leishmaniasis):
  • Product: Topical formulation of paromomycin (15% w/w).
  • Regulatory status: FDA endorsed proposed strategy to bridge existing clinical data with new product batches, allowing a faster path to New Drug Application (NDA) without additional trials.
  • Funding: Pursuing non-dilutive funding from global health organizations and NGOs.
  • Incentives: Assessing eligibility for a Priority Review Voucher (PRV), which could make it the second PRV-eligible program at Appili.
• MCDC Membership:
  • Appili accepted as a new member of the U.S. Medical CBRN Defense Consortium.
  • Event: Dr. Gary Nabors (CDO) participated in the MCDC Consortium event in July 2025 to align biodefense priorities.

Notable Quotes

• “Appili continues to strengthen our position within government and biodefense industries, highlighted by our recent participation in the U.S. Medical CBRN Defense Consortium (“MCDC”) Membership Meeting and the publication of new ATI-1701 data,” said Don Cilla, Pharm.D., M.B.A., President and CEO of Appili Therapeutics.
• “In the first quarter of fiscal 2026, we focused on building commercial momentum for LIKMEZ®, advancing ATI-1701 through ongoing funded activities, and securing a partner for ATI-1801. With seven non-dilutive funding proposals submitted to U.S. government agencies—representing up to US$137 million— Appili is positioned to advance infectious disease and biodefense products.”