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Appili Therapeutics Reports Fiscal Year 2025 Financial and Operational Results
Globenewswire· 2025-06-25 22:04
Core Viewpoint - Appili Therapeutics has successfully re-launched LIKMEZ™ (ATI-1501), a metronidazole oral suspension, and is actively pursuing funding opportunities to support its development programs and enhance its market position [2][3][14]. Group 1: Product Development and Market Position - LIKMEZ™ (ATI-1501) is the first FDA-approved, ready-to-use liquid oral suspension of metronidazole, specifically designed for patients who have difficulty swallowing tablets or are sensitive to taste [3][4]. - The re-launch of LIKMEZ follows new patent coverage extending to 2039, marking a significant milestone for the company and its partner, Saptalis Pharmaceuticals [2]. - Appili is focused on driving continued sales of LIKMEZ while advancing other product candidates, including ATI-1701 and ATI-1801 [3]. Group 2: Funding and Financial Performance - The company has submitted five non-dilutive funding proposals to the U.S. government, with a total potential value of up to US$125 million, aimed at supporting the development of critical infectious disease products [3][14]. - For the fiscal year ended March 31, 2025, Appili reported a net loss of CAD 2.6 million, which is an improvement from a net loss of CAD 3.8 million in the previous year, primarily due to increased government assistance and other income [19][20]. - As of March 31, 2025, the company had cash reserves of CAD 1.2 million, a significant increase from CAD 0.1 million a year earlier, indicating improved liquidity [21]. Group 3: Research and Development Progress - ATI-1701, a biodefense vaccine candidate for tularemia, has received approximately US$11.6 million in funding from the U.S. Air Force Academy and has shown promising results in providing protection against lethal tularemia [5][6]. - The company is actively pursuing additional funding and partnership opportunities for ATI-1801, a topical antiparasitic product that has received Orphan Drug Designation from the FDA [10][13]. - Appili has successfully completed technology transfer for the ATI-1701 manufacturing process, supporting future development activities [8].
Appili Therapeutics Announces New Patents Granted for Commercial Stage Asset LIKMEZ®™
Globenewswire· 2025-04-28 11:41
Core Viewpoint - Appili Therapeutics has secured new patents for its oral formulation of metronidazole, LIKMEZ, enhancing its market protection and supporting its commercialization efforts [1][2][3] Patent Protection - The newly granted patents will expire in 2039 and provide comprehensive protection for LIKMEZ, covering its unique taste-masked composition and therapeutic applications [2] - The U.S. patent has been listed in the FDA's Orange Book, which is crucial for ensuring additional protection for the formulation [2][3] Product Overview - LIKMEZ is the first FDA-approved ready-made suspension of metronidazole, specifically designed for treating antimicrobial-resistant infections, particularly beneficial for patients with dysphagia [4] - The formulation aims to improve stability and palatability, which are essential for patient adherence to medication and better treatment outcomes [3] Commercialization Efforts - Saptalis Pharmaceuticals, the partner of Appili, is planning to re-launch LIKMEZ under its own label in May 2025, leveraging the newly granted patent for commercialization activities [3][4] - The collaboration with Saptalis emphasizes the commitment to bringing innovative pharmaceutical solutions to market [5][6] Company Background - Appili Therapeutics focuses on developing therapies for infectious diseases and aims to address urgent medical needs through a diverse pipeline of anti-infectives [7][9] - The company is strategically positioned to tackle life-threatening infections, with a proven management team leading its initiatives [9]