Appili Therapeutics Reports Financial and Operational Results for Second 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 second quarter of its fiscal year 2024, which ended on September 30, 2023. All figures are stated in Canadian dollars unless otherwise stated.

"Notably, the Company’s most advanced asset ATI-1501, received U.S. Food and Drug Administration (“FDA”) approval on September 22, 2023, along with its brand name LIKMEZ. The approval of LIKMEZ, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili’s ability to identify promising opportunities, accelerate their development, and unlock value for the benefit of both patients and shareholders, ” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics, "Importantly, ATI-1701 recently received an additional funding commitment from USAFA, bringing the total program funding awarded to US$14 million. At Appili, we are proud of our strong government partnerships which enable us to advance this biodefense program towards an Investigational New Drug (“IND”).”

Operational Highlights

The Company has made significant operational progress during this quarter. The Company received FDA approval for LIKMEZ (ATI-1501) for the treatment of anaerobic bacterial infections on September 22, 2023. Appili expects to receive additional milestone payments and royalties from its partner, Saptalis Pharmaceuticals (“Saptalis”) based on this FDA approval and Saptalis’ commercialization. Saptalis is preparing for commercial launch in late 2023. On October 13, 2023, the Company’s recently issued U.S. patent related to LIKMEZ with coverage through 2039, U.S. Application No. 18/072,154 was listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the “Orange Book”.

Appili’s development program ATI-1701, for the prevention of F. Tularensis, has received awards totalling US$14 million from the U.S. Air Force Academy (“USAFA”). Under the terms of the recently modified agreement with USAFA governing such awards, Appili will be reimbursed for subcontractor and vendor costs necessary to carry out the technical tasks. Additionally, Appili will be reimbursed for direct labour costs associated with budgeted program activities, including a portion of its overhead costs. During our second fiscal quarter, Appili progressed early-stage development activities and regulatory activities. In addition, Appili successfully completed a knowledge transfer and executed a technology transfer for the ATI-1701 drug substance manufacturing process to the Phase 1 Contract Manufacturing Organization (“CMO”).