Appili Therapeutics Reports FY 2024 Financial and Operational Results

Appili Therapeutics Inc., a biopharmaceutical company specializing in drug development for infectious diseases and medical countermeasures, has released its financial and operational results for the fiscal year ending March 31, 2024. The company has also provided an overview of its strategic direction for fiscal 2025.

During this past fiscal year, Appili achieved significant milestones, including the FDA approval of its most advanced asset, LIKMEZ™ (ATI-1501). This proprietary taste-masked liquid suspension formulation of metronidazole addresses unmet needs in patients with dysphagia, helping to avoid risks associated with drug compounding and antimicrobial resistance. LIKMEZ™, the first FDA-approved ready-made suspension of metronidazole for treating anaerobic bacterial infections, was successfully launched in November 2023 in collaboration with Saptalis Pharmaceuticals LLC. The commercial sales of the product are ongoing in the United States.

The United States Patent and Trademark Office published patent claims for ATI-1501 under US Application No. 18/072,154, which protects the drug's composition and preparation methods until 2039. During the fiscal year, Appili earned US$600,000 in milestone payments from Saptalis. The company anticipates additional sales-based milestone payments and royalties from Saptalis based on the product's sales.

In addition to LIKMEZ™, Appili has made significant progress with ATI-1701, a biodefense vaccine candidate. The U.S. Air Force Academy (USAFA) has awarded Appili approximately US$14 million to advance the development of ATI-1701, a novel, live-attenuated vaccine for preventing F. Tularensis. The funding supports a comprehensive development program, including nonclinical studies, manufacturing, clinical preparatory, and regulatory activities aimed at an Investigational New Drug (IND) submission in 2025.

Appili has also been advancing ATI-1801, a novel topical formulation of paromomycin (15% w/w) for treating cutaneous leishmaniasis. This disfiguring skin infection affects hundreds of thousands worldwide annually. Following Phase 3 studies, ATI-1801 demonstrated safety and effectiveness, earning an Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis. Appili is actively engaging with the FDA to discuss linking to previously generated Phase 3 data and agreeing on the necessary registration package to support a New Drug Application submission. The company is pursuing non-dilutive funding and partnership opportunities with NGOs and government agencies focused on tropical diseases to complete the remaining development work.

In April 2024, Appili announced a definitive arrangement 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 Common Share held at the closing of the proposed arrangement. This transaction is subject to customary conditions, including court and shareholder approval and Aditxt raising a minimum of US$20 million in additional funding.

Financially, Appili reported a net loss and comprehensive loss of $3.8 million or $0.03 loss per share for FYE 2024, which was significantly lower than the $9.2 million net loss or $0.08 loss per share in the previous year. This improvement was due to an increase in government assistance, higher revenue, and reduced general and administrative expenses, offset by higher research and development expenses and increased financing costs. The company's cash balance as of March 31, 2024, was $0.1 million, down from $2.5 million the previous year. Appili's financial statements include a going concern note, emphasizing the company's dependence on successfully closing the proposed transaction with Aditxt or securing additional financing to meet its obligations.

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