Appili Therapeutics Advances Pipeline with FDA-Approved Drug Launch and Vaccine Progress
核心洞察
Appili Therapeutics (搜索) reported a net loss of $0.8 million in Q2 FY2025, an improvement from the previous year, and anticipates closing a take-private transaction with Aditxt in December 2024.
ATI-1701, Appili's biodefense vaccine, demonstrated full protection against tularemia (搜索) for one year in animal models, supported by significant funding from the U.S. Air Force Academy.
ATI-1801 is progressing towards NDA submission for cutaneous leishmaniasis (搜索) treatment, with FDA alignment on development strategy, potentially leading to priority review voucher eligibility.
Appili Therapeutics (搜索) Inc. (TSX:APLI; OTCPink: APLIF) announced its financial and operational results for the second quarter of fiscal year 2025, highlighting advancements in its infectious disease and medical countermeasure pipeline. The company reported a net loss of $0.8 million ($0.01 per share), a $0.2 million improvement compared to Q2 FY2024. Key developments include progress with its tularemia (搜索) vaccine candidate, leishmaniasis (搜索) treatment, and the launch of its FDA-approved liquid metronidazole formulation, LIKMEZ™.
ATI-1701: Tularemia Vaccine Candidate Shows Promise
ATI-1701, a novel live-attenuated vaccine for preventing F. tularensis, has demonstrated strong efficacy in animal models. Studies presented at the Military Health System Research Symposium and IDWeek 2024™ showed that a single dose provided full protection against lethal tularemia (搜索) for one year post-vaccination. The program is supported by US$14 million in awards from the United States Air Force Academy (USAFA), facilitating nonclinical studies, manufacturing, and clinical preparatory activities. Appili anticipates an IND submission in 2025, with recent interactions with the FDA confirming the development pathway.
ATI-1801: Advancing Towards NDA Submission for Leishmaniasis
ATI-1801, a topical formulation of paromomycin (15% w/w), is under development for cutaneous leishmaniasis (搜索), a disfiguring skin infection. The FDA has agreed with Appili's strategy to bridge previous clinical trial material with new drug product batches, potentially accelerating the New Drug Application (NDA) process. ATI-1801 has received Orphan Drug Designation from the FDA and is being evaluated for a priority review voucher (PRV), similar to ATI-1701.
LIKMEZ™ (ATI-1501): FDA-Approved Liquid Metronidazole Launched in the U.S.
LIKMEZ™ (ATI-1501), the first FDA-approved liquid formulation of metronidazole, was launched in the U.S. in November 2023 by Appili's partner, Saptalis Pharmaceuticals LLC. This formulation addresses an unmet need for patients with difficulty swallowing or taste-related issues. Appili is entitled to receive additional sales-based milestone payments and royalties from Saptalis based on sales of the product.
Aditxt Acquisition
Appili's shareholders overwhelmingly approved a plan of arrangement for Aditxt Inc. (NASDAQ:ADTX) to acquire all outstanding Class A common shares of the Company. The transaction is expected to close in December 2024, subject to final court approval and Aditxt securing sufficient financing. Approximately 99.79% of the votes cast were in favor of the transaction.
Financial Overview
Appili Therapeutics (搜索) reported a net loss of $0.8 million, or $0.01 loss per share, for the three months ended September 30, 2024, compared to a net loss of $1 million for the same period in 2023. As of September 30, 2024, the Company had cash of $0.7 million, compared to $0.1 million on March 31, 2024.