Appili Therapeutics Reports Financial and Operational Results for First Quarter of Fiscal Year 2024

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 first quarter of its fiscal year 2024, which ended on June 30, 2023. All figures are stated in Canadian dollars unless otherwise stated.

"During this quarter, we executed an agreement with United States Air Force Academy (“USAFA”) for an initial amount of US$7.3million in funding from the Defense Threat Reduction Agency and USAFA for our ATI-1701 vaccine, a crucial defense against Tularemia, which is a top-priority biothreat. Our partnership with USAFA and the recent agreement execution will enable us to advance this program towards an Investigational New Drug (“IND”),” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics. "Additionally, securing US patent coverage through at least 2039 for ATI-1501, our Metronidazole formulation, is a significant milestone leading up to the anticipated FDA Prescription Drug User Fee (“PDUFA”) date on September 23, 2023. We look forward to receiving milestone payments and royalties from our partner, Saptalis Pharmaceuticals LLC ("Saptalis”), in the coming quarters based on their submission and commercialization plans. These achievements are expected to position us with the required resources to continue to make progress in advancing our infectious disease assets."

Operational Highlights

On May 5, 2023, Appili executed an initial cooperative agreement with USAFA the previously announced funding of the ATI-1701 program. This agreement provides the first stage of funding from the previously announced US$14 million 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 submit proposals to USAFA for additional tranches of funding to continue development through IND submission. 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.