Appili Therapeutics Reports Fiscal Year 2023 Financial and Operational Results

Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the fiscal year ended March 31, 2023, and provided an update on the Company’s strategy for fiscal 2024. All figures are stated in Canadian dollars unless otherwise stated.

“During this fiscal year, the Defense Threat Reduction Agency (“DTRA”) in partnership with the U.S. Air Force Academy (“USAFA”) approved approximately US$14 million in funding over two years for the advancement of ATI-1701, our vaccine against Tularemia, a top-priority biothreat. Recently, we executed an agreement with USAFA for an initial amount of this funding. With this funding and the additional strength added to our senior leadership team, we have the resources in place to continue the advancement of this program and to execute our strategy in advancing our infectious disease assets forward,” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics. “In addition, we recently received patent coverage providing exclusivity through at least 2039 for ATI-1501, our taste-masked liquid oral suspension formulation of Metronidazole. This is a key achievement prior to the upcoming FDA PDUFA date of September 23, 2023.”

ATI-1701, Biodefense Vaccine Candidate with Secured Funding from U.S. Air Force Academy

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.

In May 2023, Appili executed the initial contract with USAFA (the “USAFA Cooperative Agreement”) for the previously announced funding of the ATI-1701 program. This contract represents the first stage of funding from the previously announced award from the U.S. Department of Defense (“DOD”). This initial funding, in the amount of US$7.3 million, will be used to kick-off ATI-1701 early-stage development and regulatory activities. As the initial activities progress, Appili will be engaging USAFA for additional tranches of funding to continue development through IND. Under the terms of its agreement with USAFA, Appili will be reimbursed for direct costs and labour associated with budgeted program activities, plus will recover a portion of its overhead costs. Appili has submitted its first invoice for such costs and anticipates receiving payment by the end of June 2023.