Appili Therapeutics Q1 FY 2025 Financial and Operational Results

Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF), a biopharmaceutical company focused on developing drugs for infectious diseases, has announced its financial and operational results for the first quarter of the fiscal year 2025, which concluded on June 30, 2024. The company's President and CEO, Don Cilla, highlighted recent regulatory engagements and the launch of their leading asset, LIKMEZ™ (ATI-1501), as significant milestones. These developments, along with funding commitments from the U.S. Air Force Academy (USAFA) for ATI-1701, are expected to advance Appili's infectious disease programs.

ATI-1701, a biodefense vaccine candidate designed to prevent F. tularensis infections, has secured US$14 million in funding from the USAFA. This funding supports a comprehensive development program, including nonclinical studies, manufacturing, and regulatory activities, with an Investigational New Drug (IND) submission anticipated in 2025. Appili has also engaged with the U.S. Food and Drug Administration (FDA) in a pre-IND meeting to confirm the development pathway for ATI-1701 and is incorporating the FDA's feedback into their plans.

ATI-1801, a topical antiparasitic product formulated with paromomycin, is under advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection. Appili has submitted a meeting request to the FDA in 2024 to discuss the registration strategy for a New Drug Application (NDA). The company is also exploring non-dilutive funding and partnerships with NGOs and government agencies to complete the remaining development work. ATI-1801 has received Orphan Drug Designation from the FDA and is being evaluated for eligibility for a priority review voucher (PRV).

LIKMEZ™ (ATI-1501), a liquid oral reformulation of the antibiotic metronidazole, was approved by the FDA in September 2023. This formulation addresses an unmet need for pediatric patients and those with dysphagia, reducing risks associated with drug compounding and antimicrobial resistance. LIKMEZ, which has patent coverage through 2039, was launched in November 2023 and is now available to patients and doctors in the United States. Appili has rights to receive sales-based milestone payments and royalties from its partner, Saptalis Pharmaceuticals LLC.

On April 2, 2024, Appili announced a definitive agreement with Aditxt Inc., through its wholly-owned subsidiary Adivir, Inc., to acquire all issued and outstanding Class A common shares of Appili. Shareholders will receive a combination of Aditxt common stock and cash for each Appili share held, pending approval at a special meeting expected in the fall of 2024.

Financially, Appili reported a net loss of $1.6 million for the three months ended June 30, 2024, compared to a net loss of $1.5 million for the same period in 2023. This increase is mainly attributed to higher research and development expenses, financing costs, and foreign exchange losses, partially offset by increased government assistance and reduced general and administrative expenses. As of June 30, 2024, the company had $0.3 million in cash, compared to $0.1 million on March 31, 2024.

Appili Therapeutics is dedicated to developing a range of anti-infective therapies, including an FDA-approved suspension of metronidazole, a vaccine candidate for a serious biological weapon threat, and a topical antiparasitic for a disfiguring disease. Led by a proven management team, Appili is at the forefront of the global fight against infectious diseases.