Abivax Presents First Quarter 2026 Financial Results and Reports Three-Year Interim Data from Study 108, a Phase 2a/2b Open-Label Extension Trial of Obefazimod Following Dose De-Escalation in Patients with Ulcerative Colitis

§ 01 Executive Snapshot

• What: Abivax presents Q1 2026 financial results and three-year interim data from Study 108 on obefazimod for ulcerative colitis.
• Who: Abivax SA, a clinical-stage biotechnology company; Fabio Cataldi, MD, Chief Medical Officer.
• Why it matters: The data demonstrates the potential of obefazimod as a long-term treatment option for ulcerative colitis, highlighting its efficacy and safety profile.

§ 02 Key Developments

• Interim analysis showed 68% of patients in clinical remission at week 144 after dose de-escalation from 50 mg to 25 mg.
• 80% of the 130 patients enrolled completed the full 144-week evaluation, indicating strong retention in the study.
• Cash position of €491.6 million as of March 31, 2026, with a projected runway into Q4 2027.

§ 03 Strategic Context

• Abivax is focused on developing therapies that modulate the immune response, particularly for chronic inflammatory diseases like ulcerative colitis.
• The ongoing Phase 3 ABTECT trial is critical for validating obefazimod’s efficacy and securing regulatory approval, which could significantly impact market positioning.

§ 04 Strategic Implications

• Immediate implications include potential regulatory approval and commercialization of obefazimod, which could enhance Abivax's market presence in inflammatory disease therapeutics.
• Long-term operational implications involve sustained investment in R&D to support obefazimod's development and potential expansion into additional indications.

§ 05 Risks & Constraints

• Regulatory hurdles may affect the timeline for NDA submission and approval of obefazimod.
• Competition from other therapies in the ulcerative colitis market could impact market share and pricing strategies.

§ 06 Watchlist / Forward Signals

• Topline results of the Phase 3 maintenance trial expected in late Q2 2026, which will be critical for future commercialization efforts.
• NDA submission for obefazimod in ulcerative colitis anticipated in Q4 2026, contingent on positive trial data.