Net revenue for Q1 2025 was approximately $2.2 million, a decrease of 6% versus Q1 2024 and 37% versus Q4 2024, primarily due to higher inventory levels in the prior quarter.
Mytesi prescription volume increased by about 1.8% year-over-year in Q1 2025, indicating rising demand, but decreased by 13.5% sequentially from Q4 2024.
Initial proof-of-concept results for crofelemer in rare pediatric diseases (MVID and SBS) showed significant reductions in TPN dependence (up to 27% for MVID and 12.5% for SBS), with potential for expedited regulatory approval pathways in the US and EU.
Loss from operations increased to $9.4 million in Q1 2025 from $8.2 million in Q1 2024; non-GAAP recurring EBITDA net loss was $9.7 million versus $8.8 million year-over-year; net loss attributable to common shareholders rose to $10.4 million from $9.2 million.
Multiple near-term catalysts are expected throughout 2025 and into early 2026, including ongoing and upcoming clinical trial results, potential business development/licensing deals, and regulatory meetings aimed at advancing crofelemer for both rare diseases and cancer therapy-related diarrhea.