ABIVAX (ABVX) Corporate Presentation summary

Pipeline and clinical development

• Obefazimod is in pivotal Phase 3 trials (ABTECT) for moderately to severely active ulcerative colitis, with enrollment completed in April 2025 and topline induction data expected in Q3 2025; maintenance data is anticipated in Q2 2026, and NDA submission is planned for 2H 2026.

• Phase 2b trial in Crohn's disease began in October 2024, with topline induction results expected in 2H 2026.

• Preclinical combination therapy data are encouraging, with a decision on a combination agent and selection of a follow-on compound expected in 2025.

• No new safety signals have been observed in the latest DSMB review for the maintenance trial as of April 2025.

Market opportunity and unmet need

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

• The US ulcerative colitis market reached $5.3B in sales, with 776,000 patients treated in the 12 months ending May 2023; 27% (210,000) are candidates for new advanced therapies.

• The global IBD market is projected to reach $30.8B by 2030, with the US accounting for 70% of sales.

Mechanism of action and scientific rationale

• Obefazimod is an oral small molecule that selectively enhances miR-124 expression, stabilizing dysregulated inflammatory responses in UC by reducing pro-inflammatory cytokines and chemokines.

• Preclinical and clinical data show sustained upregulation of miR-124 in blood and rectal tissue, with normalization of IL-17 and IL-23 levels in UC patients.

• Preclinical combination studies with etrasimod demonstrated synergistic effects in IBD mouse models, including improved weight protection and reduced cytokines.