Aardvark Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates

Core Insights - Aardvark Therapeutics has voluntarily paused the Phase 3 HERO and OLE trials for ARD-101, aimed at treating hyperphagia in Prader-Willi Syndrome (PWS), due to unexpected cardiac observations in a separate trial [1][3] - The company has $110 million in cash and short-term investments as of December 31, 2025, which is expected to support operations into Q2 2027 [1][8] - Further guidance on the ARD-101 and ARD-201 programs is anticipated in Q2 2026 [1][4] Pipeline Updates - The voluntary pause in the ARD-101 trials follows the observation of reversible cardiac issues in a healthy volunteer trial, where two out of eight participants showed significant increases in QRS duration [3][4] - Aardvark is conducting a comprehensive review of the data and is in active discussions with the FDA regarding the next steps for the ARD-101 program [4][8] - The ARD-201 obesity program, which includes the POWER and STRENGTH trials, is also on voluntary pause pending further developments with ARD-101 [1][8] Clinical Data - Recent publications in Molecular Metabolism highlight that ARD-101 significantly reduced self-reported hunger in a Phase 2 obesity study, with a decrease of 1.63 points on the Control of Eating Questionnaire compared to 0.65 points for placebo [8] - The study also indicated that ARD-101 increased levels of gut hormones such as peptide YY (PYY) and glucagon-like peptide-1 (GLP-1), which are relevant to hunger regulation [8] Financial Highlights - Aardvark reported a net loss of $17.6 million for Q4 2025, compared to a net loss of $8.8 million in Q4 2024, and a total net loss of $57.6 million for the year ended December 31, 2025, compared to $20.6 million in 2024 [9][14] - Research and Development (R&D) expenses for Q4 2025 were $14.3 million, up from $8.1 million in Q4 2024, with total R&D expenses for the year reaching $48.9 million [8][14]