LIKMEZ™ (ATI-1501) for Metronidazole Oral Suspension 500mg/5mL re-launched and commercial sales ongoing
Five U.S. government proposals submitted, totalling up to US$125 million
HALIFAX, Nova Scotia, June 25, 2025 (GLOBE NEWSWIRE) — Appili Therapeutics Inc. (TSX:APLI, OTC: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, 2025 (“FYE 2025”), and provided an update on fiscal 2026. All figures are stated in Canadian dollars unless otherwise stated.
“The recent commercial re-launch of LIKMEZ® (ATI-1501), following new patent coverage through to 2039, marked a major milestone for Appili and our partner, Saptalis Pharmaceuticals, LLC (“Saptalis”). Appili was founded to develop ATI-1501, and it’s rewarding to see our lead development program in the market,” said Don Cilla, Pharm.D., M.B.A., President and CEO of Appili Therapeutics.
“As we look to fiscal 2026, we remain focused on driving continued sales of LIKMEZ, advancing ATI-1701 funded activities, and finalizing development plans for ATI-1801. In addition, Appili has submitted five non-dilutive funding proposals to the U.S. government, totaling up to US$125 million.”
LIKMEZ™ (ATI-1501), re-launched in the U.S.
In May 2025, the Company’s manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC (“Saptalis”) re-launched LIKMEZ® metronidazole oral suspension, (500 mg/5 mL) in the U.S. LIKMEZ is the first and only FDA-approved, ready-to-use liquid oral suspension of metronidazole, developed specifically for patients who have difficulty swallowing tablets or who are sensitive to taste.
Metronidazole is widely used as a frontline oral treatment with millions of prescriptions written in the U.S. every year. The current tablet form of metronidazole is the only other approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges. LIKMEZ is designed to fill this significant gap in the treatment paradigm with a taste-masked metronidazole oral suspension.
ATI-1701, Biodefense Vaccine Candidate with Funding Awarded from the U.S. Air Force Academy
ATI-1701, Appili’s live-attenuated vaccine candidate for the prevention of tularemia, continues to progress under a Cooperative Agreement with the U.S. Air Force Academy (“USAFA Cooperative Agreement”), with total program funding allotted of approximately US$11.6 million.
During FYE 2025, Appili presented positive findings at the Military Health System Research Symposium and IDWeek 2024™ demonstrating that a single dose of ATI-1701 provided full protection against lethal tularemia one year after vaccination. These results, combined with research highlighting the elevated risk of tularemia outbreaks in conflict zones, underscore ATI-1701’s potential as a critical tool in protecting military personnel and addressing global biodefense needs.
In May 2025, Appili Director of Non-Clinical Research, Dr. Carl Gelhaus, Ph.D., together with researchers from the USAFA, and other U.S. based researchers published the manuscript, “The Immune Response to Francisella tularensis”. The review consolidates recent findings on the immune system response to F. tularensis infections and suggests various means by which infections can be controlled. By examining diverse F. tularensis strains and animal models, the authors outline promising pathways for effective tularemia vaccine development.
Appili successfully completed a knowledge and technology transfer for the ATI-1701 drug substance manufacturing process to its selected Phase 1 contract manufacturing organization. Engineering batches were successfully produced in 2024 to support future development activities.
There is currently no approved vaccine for the prevention of tularemia in the U.S., or other major global markets, strengthening ATI-1701’s position as a potentially valuable vaccine urgently needed on the market. The …