Abivax (NASDAQ:ABVX) today announced its full-year 2025 financial results and provided a comprehensive corporate update, underscored by a significantly strengthened capital structure and steady clinical progress.
The company ended the year with €530.4 million in cash and short-term investments, a substantial increase driven by the completion of a $700.3 million net U.S. offering.
This capital provides Abivax with a projected financial runway into the fourth quarter of 2027, covering the anticipated commercial launch preparations for its lead asset.
The company also reported a net loss of €336.1 million for the full year 2025, reflecting the heavy investment required for its global Phase 3 ABTECT program.
Despite the loss, operational milestones remained on track.
A recent Data Safety Monitoring Board (DSMB) review for the ABTECT-UC maintenance trial reported no new safety signals, reinforcing the favorable tolerability profile previously observed in induction studies.
This safety clearance is a pivotal step as the company nears the finish line for its primary ulcerative colitis (UC) program.
Management also confirmed that topline results from the Phase 3 ABTECT-UC maintenance trial are expected in late Q2 2026.
If successful, these data will form the basis of a New Drug Application (NDA) submission to the FDA planned for the second half of the year.
Beyond UC, Abivax is progressing with its ENHANCE-CD Phase 2b trial in Crohn’s disease, with induction results anticipated by late 2026.