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

With respect to Appili’s ATI-1801 program, for the treatment of cutaneous leishmaniasis, the Company plans to request a meeting with the FDA later this year to discuss the previously generated Phase 3 data and agree on the registration package necessary to support a New Drug Application (“NDA”) submission, which the Company expects will include available nonclinical, manufacturing, and clinical data generated to date. Appili expects to pursue non-dilutive funding and partnership opportunities with NGOs and government agencies which share the Company’s focus on tropical diseases to help complete remaining development work.

Upcoming Milestones

• Appili anticipates receiving royalty and milestone payments from its partner Saptalis, based on LIKMEZ NDA approval and commercialization.
• Appili plans to hold a pre-IND meeting with the FDA to discuss ATI-1701’s regulatory, CMC, toxicology, and Phase 1 strategies.
• Appili expects the ATI-1701 CMO to successfully produce engineering batches.
• Appili plans to request a meeting with the FDA later this year to discuss the previously generated ATI-1801 Phase 3 data and agree on the necessary registration package to support an NDA submission.

Corporate Update

Today the company announced that it has appointed Prakash Gowd, MBA, BSc. Pharm, C.Dir., to its Board of Directors. Mr. Gowd’s career covers a broad range of commercial successes involving corporate development, fundraising, and marketing across multiple business models and therapeutic areas.

“We are very pleased to welcome Prakash to Appili’s Board. His background in corporate finance, product development and strategic planning will be very valuable as we advance our programs through multiple milestones, from ATI-1701’s IND submission, to the FDA interactions for our ATI-1801 asset,” said Dr. Armand Balboni, Chair of the Appili Board. “We are thrilled to have Prakash as a Board member and look forward to his leadership experience as we progress our candidates through these next crucial stages.”

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 $1.0 million or $0.01 loss per share for the three months ended September 30, 2023, was $0.6 million lower than the net loss and comprehensive loss of $1.6 million or $0.02 loss per share during the three months ended September 30, 2022. This relates mainly to an increase in milestone revenue of $0.3 million, an increase in government assistance of $1.0 million, a decrease in foreign exchange losses of $0.2 million and a decrease in general and administrative expenses of $0.1 million. These decreases were offset by an increase in research and development expenses of $0.8 million and an increase in financing costs of $0.2 million.