ABIVAX (ABVX) Corporate Presentation summary

Pipeline and clinical development

• Obefazimod is in pivotal Phase 3 trials (ABTECT) for moderately to severely active ulcerative colitis (UC), with topline induction data expected in Q3 2025 and maintenance data in Q2 2026.

• Phase 2b trial in Crohn's disease (CD) began in October 2024, with topline results anticipated in 2H 2026.

• Preclinical combination therapy programs are ongoing, with initial data showing synergy between obefazimod and etrasimod in IBD models.

• Selection of a follow-on compound from the miR-124 library is expected in 2025.

Market opportunity and unmet need

• Significant unmet need exists for a simple, safe, and durable oral therapy in UC, as many patients remain uncontrolled on conventional therapies and hesitate to step up to advanced options.

• The global IBD market is projected to reach $30B by 2030, with the US accounting for 70% of sales.

• 77% of US UC patients are treated with conventional therapy, and 27% (210K) are candidates for new advanced therapies.

Mechanism of action and scientific foundation

• Obefazimod is an oral small molecule that selectively enhances miR-124 expression, stabilizing dysregulated inflammation in UC.

• The mechanism is supported by Nobel Prize-winning research on microRNAs, with obefazimod shown to reduce key inflammatory cytokines (IL-17, IL-23) in both preclinical and clinical settings.

• Sustained upregulation of miR-124 was observed in rectal tissue and blood out to 96 weeks in Phase 2b OLE.