Mr. Don Cilla reports

RESEARCHERS PUBLISH MANUSCRIPT ON THE PREVENTION AND EMERGENCY RESPONSE TO TULAREMIA OUTBREAKS

Appili Therapeutics Inc. has published publication a manuscript in the journal Frontiers in Bacteriology on the prevention of tularemia. Dr. Carl Gelhaus, PhD, Appili's director of non-clinical research, together with medical doctors from the United States Uniformed Services University of the Health Sciences and Ukrainian researchers, published a perspective manuscript entitled "Considerations for prevention of and emergency response to tularemia outbreaks in Ukraine: vaccine involvement."

"Appili has been developing ATI-1701, a biodefence vaccine, to protect war fighters from tularemia," said Dr. Gelhaus, PhD, director of non-clinical research of Appili Therapeutics. "With the help of our Ukrainian colleagues and U.S. Army physicians, we have assessed the potential risk for tularemia outbreaks in Ukraine, by reviewing the literature of previous wartime outbreaks in Eastern Europe. Many of the conditions for tularemia outbreaks now exist in Ukraine, and their war fighters need protection. We suspected that rodent populations would explode and carry tularemia into war-affected areas. Even as we were preparing the manuscript, "Mouse fever," an infection of unknown etiology was reported in news outlets, underscoring the urgency of making sure Ukrainians are protected from the risk of many infectious diseases, including tularemia. The acceptance and publication of this perspective article recognizes that the epidemiological, medical, military and scientific tularemia experts should prepare to prevent and respond to tularemia outbreaks in wartime Ukraine."

The perspective manuscript explores the current war in Ukraine and the increased risk for outbreaks of tularemia. Several wartime tularemia outbreaks have been documented, as far back as the siege of Stalingrad in the second world war. Furthermore, F. tularensis was weaponized and stockpiled as an offensive agent, and experts consider tularemia to have a high potential use in a biological weapons attack. Russia administers its own tularemia vaccine, but that vaccine is not available in Ukraine. Furthermore, the legacy Russian vaccine is unlikely to meet the rigorous FDA (Food and Drug Administration) and EMEA (Europe, the Middle East and Africa) standards for safety and efficacy.

ATI-1701 is the company's potential 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 that is urgently needed on the market.

Appili is working hard to develop its ATI-1701 vaccine that could potentially help protect the Ukrainian people living in what United Nations Secretary-general Antionio Guterres described as "an epicentre of unbearable heartache and pain." Don Cilla, PharmD, MBA, president and chief executive officer of Appili, adds, "At Appili, we hope that our products can alleviate that kind of human suffering."

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 countermeasures 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.

Appili secured a $14-million (U.S.) funding commitment for ATI-1701 from the United States Air Force Academy (USAFA), which is working in partnership with the Defense Threat Reduction Agency. These funds, along with other potential financing sources, are anticipated to continue to advance the ATI-1701 program toward an IND (investigational new drug) submission to the FDA in 2025.

About Appili Therapeutics Inc.

Appili Therapeutics is a biopharmaceutical company that is purposefully built, portfolio-driven and people-focused to fulfill its mission of solving life-threatening infectious diseases. 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 an FDA-approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicentre of the global fight against infection.

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