ABIVAX (ABVX) Q1 2026 earnings summary

Executive summary

• Interim analysis from Study 108 shows durable clinical remission in moderately to severely active ulcerative colitis patients treated with obefazimod, with 68% in remission at week 144 after dose de-escalation and no new safety signals observed.

• Patients treated for up to seven years maintained favorable tolerability, supporting obefazimod's potential as a long-term treatment.

• Key upcoming milestones include Phase 3 maintenance trial results in late Q2 2026 and NDA submission for obefazimod in UC in Q4 2026, pending positive data.

Financial highlights

• Cash, cash equivalents, and short-term investments totaled €491.6M as of March 31, 2026, providing a projected cash runway into Q4 2027.

• R&D expenses rose to €49.5M (86.0% of operating expenses) in Q1 2026, mainly due to new indications and clinical trial progression.

• G&A expenses decreased to €6.3M (10.9% of operating expenses), primarily due to lower personnel costs.

• Sales and marketing expenses increased to €1.7M (3.0% of operating expenses), reflecting preparation for commercialization.

• Net loss for Q1 2026 was €48.5M, an improvement from €52.4M in Q1 2025.

Outlook and guidance

• Topline results for the UC ABTECT Phase 3 maintenance trial are expected in late Q2 2026.

• NDA submission for obefazimod in UC is planned for Q4 2026, subject to positive trial data.

• Cash runway is projected to extend into Q4 2027 based on current operating assumptions.

• Topline results of Phase 2b induction trial for Crohn's disease anticipated in Q4 2026.

• Half-year financial results scheduled for September 21, 2026.