• Peer-reviewed publication highlights ATI-1701’s robust protection against aerosolized Francisella tularensis exposure in multiple animal models

HALIFAX, Nova Scotia, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced a new publication in the journal Vaccine, supporting the efficacy of its biodefense 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 biodefense institutions in the U.S., 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% survival in rats challenged with aerosolized SCHU S4 up to one-year post-vaccination, even at challenge doses >10,000x the median lethal dose (LD₅₀).
• In cynomolgus macaques, ATI-1701 demonstrated up to 100% 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 biodefense 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 biodefense 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 

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 epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.   

Forward looking statements 

This news release contains “forward-looking statements”, including with respect to further anticipated milestones and the timing thereof and the Company’s development plans with respect to ATI-1701. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that ATI-1701 may never become an approved vaccine for the prevention or treatment of tularemia, and the other risks listed in the annual information form of the Company dated June 25, 2025, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Media Contact: 
Jenna McNeil, Communications Manager 
Appili Therapeutics  
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Investor Relations Contact: 
Don Cilla, President and CEO 
Appili Therapeutics 
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