Adrulipase (FW-EPI) for Exocrine Pancreatic Insufficiency (EPI) - First Wave BioPharma is developing targeted, non-systemic therapies for gastrointestinal diseases, focusing on billion-dollar markets[3] - Adrulipase is a recombinant lipase biologic for EPI treatment, targeting Cystic Fibrosis (CF) and Chronic Pancreatitis (CP) patients[8, 29] - The U S market for EPI treatment is approximately $1.7 billion[13] - The global PERT market exceeds $2.2 billion[22] - A Phase 2 bridging study for Adrulipase was initiated in January 2023, with topline data expected in the second half of 2023[8, 26] - Current projections show a potential 70% to 87% reduction in patient cost per month compared to 2020 GMP batch projections due to manufacturing optimization and reformulation[38] Niclosamide for Inflammatory Bowel Disease (IBD) - Niclosamide, a repurposed small molecule drug, is being developed for IBD, specifically Ulcerative Colitis-Ulcerative Proctitis and Immune Checkpoint Inhibitor-Associated Colitis[8] - Approximately 54% to 59% of patients fail to achieve remission with current 5-ASA treatments for ulcerative colitis[43] - The US market size for Ulcerative Colitis is approximately $5 billion, with $4.6 billion attributed to mild-moderate cases[49] - The US market size for Crohn's Disease is approximately $7.4 billion, with $4.3 billion attributed to mild-moderate cases[49]
First Wave BioPharma (FWBI) Investor Presentation - Slideshow