Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2024 - Seite 2

ATI-1701, our Biodefense Vaccine Candidate with Strong Government Support

ATI-1701 is a novel, live-attenuated vaccine for the prevention of F. Tularensis, has received awards totaling US$14 million from the U.S. Air Force Academy (“USAFA”). Under the terms of the USAFA Cooperative Agreement, Appili oversees a comprehensive development program for ATI-1701, which includes nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities to support an IND submission in 2025.

Appili was granted a pre-IND meeting with the FDA to discuss ATI-1701’s regulatory, CMC, toxicology, and Phase 1 strategies and expects to receive feedback in early 2024. 

ATI-1801, our Licensed Topical Antiparasitic Product

ATI-1801 is a novel topical formulation of paromomycin (15% w/w) under advanced clinical development for the treatment of cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually.

In January 2024, Appili requested a meeting with the FDA to discuss the previously generated Phase 3 data and agree on the necessary registration package to support a New Drug Application submission, which the Company expects will include available nonclinical, manufacturing, and clinical data generated to date.

Annual Financial Results

The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are stated in Canadian dollars unless otherwise stated.

The net loss and comprehensive loss of $0.2 million or $0.00 loss per share for the three months ended December 31, 2023, was $2.4 million lower than the net loss and comprehensive loss of $2.6 million or $0.02 loss per share during the three months ended December 31, 2022. This relates mainly to an increase in milestone revenue of $0.5 million, an increase in government assistance of $2.0 million and a decrease in general and administrative expenses of $0.9 million. These decreases were offset by an increase in research and development expenses of $0.9 million and an increase in financing costs of $0.2 million.