Abivax: Strong Clinical Data for Obefazimod, but Increased Operational Loss
Abivax confirms the sustained efficacy of its candidate obefazimod in ulcerative colitis with three-year data, showing 68% of patients in clinical remission at a reduced dose and no new safety signals observed over seven years. Concurrently, the operational loss widened in Q1 2026 (€56.2M vs. €47.2M a year earlier), driven by a €10.2M increase in research and development expenses. Although the company has €491.6M in cash, providing visibility until Q4 2027, cash burn is accelerating.
Confirmed Long-Term Efficacy Data with No New Safety Signals
The three-year interim analysis of study 108 supports Abivax's therapeutic approach. Of the 130 patients included in this open-label maintenance protocol, 80% (104 patients) had completed the full evaluation at 144 weeks as of the data closure on January 5, 2026. At week 144 of treatment at a reduced dose (25 mg after two to four years at 50 mg), 68% of the evaluated patients remained in clinical remission, compared to 73% at 48 weeks and 69% at 96 weeks, demonstrating therapeutic stability. The total duration of exposure to the treatment reached up to seven years for some patients in this cohort. The absence of new safety signals reported over this extended period reinforces the drug's tolerance profile. Abivax's Medical Director, Fabio Cataldi, stated, 'The durability of the clinical remission observed for nearly seven years, coupled with the favorable tolerance profile observed to date, confirms the potential of obefazimod as a major therapeutic breakthrough for people with ulcerative colitis.'
Accelerated R&D Spending, Operational Loss Widened by 19%
The first quarter of 2026 revealed an intensification of clinical expenses. Research and development costs increased by €10.2M to reach €49.5M (86.0% of operating expenses), compared to €39.3M (81.5% of expenses) in Q1 2025. This increase is explained by three factors: an €8.0M increase related to new indications of obefazimod in combination therapy, a €2.0M increase in cross-functional activities (chemistry, manufacturing, controls, and supply chain) in anticipation of a future commercial launch, and a €2.0M increase in the phase 2b Crohn's program. In partial offset, clinical expenses for the ulcerative colitis program decreased by €4.0M due to the approach of the end of phase 3 trials. The operational loss deepened to €56.2M in Q1 2026, compared to €47.2M a year earlier (an increase of 19%). The pre-tax net loss was €48.2M, benefiting from a financial gain of €8.0M (revaluations of exchange rates and financial instruments), compared to a financial loss of €5.2M in Q1 2025.
Financial Visibility Until Q4 2027, Key Results Expected by End of Q2 2026
As of March 31, 2026, Abivax had €491.6M in cash, cash equivalents, and short-term investments, ensuring a financing horizon until the fourth quarter of 2027 based on current operational assumptions. The regulatory and clinical timeline is expected to accelerate in the coming months: main results from the phase 3 maintenance trial ABTECT in ulcerative colitis are expected by the end of the second quarter of 2026, followed by phase 2b induction results in Crohn's disease by the end of the year. Subject to positive results, the submission of the New Drug Application (NDA) is planned for the fourth quarter of 2026.
