Mr. Don Cilla reports

APPILI THERAPEUTICS AND COLLEAGUES PUBLISH MANUSCRIPT DEMONSTRATING EFFICACY OF ATI-1701 TULAREMIA VACCINE

Appili Therapeutics Inc. has published in the journal Vaccine, supporting the efficacy of its biodefence vaccine candidate, ATI-1701. The manuscript, titled, "Vaccination with a novel live attenuated strain of Francisella tularensis subsp. tularensis protects cynomolgus macaques against aerosol F. tularensis infection," details studies showing robust and durable protection from lethal tularemia exposure in both rat and non-human primate models.

ATI-1701, a live attenuated strain of F. tularensis, is being developed as a first-in-class vaccine to protect against tularemia, a highly contagious and potentially fatal bacterial disease. The publication, co-authored by Dr. Carl Gelhaus, director of non-clinical research at Appili, and researchers from leading biodefence institutions in the United States, Canada and Sweden, highlights key findings from multiple preclinical studies.

"This publication marks a significant milestone in the development of ATI-1701 and adds to the growing body of evidence supporting its protective potential," said Dr. Carl Gelhaus. "In both rats and cynomolgus macaques, ATI-1701 showed strong immunity against aerosolized F. tularensis SCHU S4 -- one of the most virulent strains and most concerning routes of exposure. Protection was dose-dependent, long lasting and associated with robust immune responses, including strong antigen-specific antibody titers."

Key results from the study include:

• 100-per-cent survival in rats challenged with aerosolized SCHU S4 up to one-year postvaccination, even at challenge doses greater than 10,000 times the median lethal dose (LD50);
• In cynomolgus macaques, ATI-1701 demonstrated up to 100-per-cent protection, reduced disease severity and improved histopathological outcomes;
• Immunized animals exhibited robust antibody responses, correlating with survival and supporting the vaccine's immunogenic potential.

This study reinforces ATI-1701's potential as a leading candidate for tularemia prevention and supports continued development in partnership with the U.S. Department of Defense.

ATI-1701 is the company's first-in-class vaccine candidate for the prevention of infection with F. tularensis. Since it is a highly infectious pathogen capable of causing severe illness, medical countermeasures for F. tularensis are a top biodefence priority for governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets, strengthening ATI-1701's position as a potentially valuable vaccine urgently needed on the market.

About ATI-1701

ATI-1701 is a novel, live-attenuated vaccine for F. tularensis, which causes tularemia, a Category A pathogen which can be aerosolized and is over 1,000 times more infectious than anthrax. Since it is a highly infectious pathogen capable of causing severe illness, medical counter measures for F. tularensis are a top biodefence priority for the United States and governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets.

About Appili Therapeutics Inc.

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio driven and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili's goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease and a novel easy-to-use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicentre of the global fight against infection.

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