ABIVAX (ABVX) Corporate Presentation summary

Company overview and strategy

• Focuses on developing oral small molecule therapies that modulate the immune response, targeting inflammatory bowel disease (IBD) with obefazimod as the lead candidate.

• Aims to establish obefazimod as a first-line advanced therapy for IBD, leveraging its novel mechanism of action and robust Phase 2 data.

• Pipeline includes ongoing Phase 3 trials in ulcerative colitis (UC), planned Phase 2b in Crohn's disease, and R&D for miR-124 enhancer follow-on compounds.

• Strategy includes expanding intellectual property protection for obefazimod, with potential US patent coverage extended to 2039.

• Strengthened leadership and board with experienced executives and international expertise.

Market opportunity

• IBD represents a large and growing market, with global sales projected to reach $26.8B by 2028, and the US accounting for ~70% of sales.

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

• Most UC patients in the US are covered by commercial insurance, supporting a strong commercial opportunity.

Obefazimod clinical development and data

• Obefazimod enhances miR-124 expression, stabilizing dysregulated inflammation in UC, with a mechanism confirmed in both preclinical and clinical studies.

• Phase 2b trial in moderate-to-severe UC showed statistically significant improvements in the primary endpoint (Modified Mayo Score) across all doses versus placebo.

• Secondary endpoints, including clinical remission, response, and endoscopic improvement, showed positive trends.

• Efficacy was observed in both biologic/JAKi-naïve and experienced patients, with a high proportion of refractory patients included.

• Long-term open-label extension data demonstrated sustained clinical remission rates at 48 and 96 weeks, with over 50% of patients maintaining remission.

• Safety profile was consistent with previous studies, with no new safety signals, low rates of serious infections, and no deaths or malignancies.