ABIVAX (ABVX) investor relations material

Maintenance data and treatment goals

• UEG maintenance results showed endoscopic remission in 50% of patients in the high-dose arm, a result positioned as a leading cross-trial outcome.

• A priori analyses found strong efficacy in both advanced-therapy-naïve and experienced patients; efficacy was maintained through four or more prior failures, with ~one-third reaching remission in that subgroup despite small Ns.

• Updated STRIDE-III guidance identifies symptom improvement as a short-term target and endoscopic remission as the long-term target for treatment choices in UC and Crohn’s disease.

• Clinicians are encouraged to pursue endoscopic remission early, as delayed achievement after multiple therapy failures may reduce the chance of success and allow further disease damage.

• Obefazimod’s described value proposition includes oral dosing, rapid symptom response from week one, and no currently anticipated testing or monitoring; malignancy rates were described as consistent with background UC rates.

Regulatory and commercial preparation

• NDA filing is targeted by year-end 2026; one batch’s additional 30-day stability data is to follow submission, with FDA agreement that the PDUFA clock will not change.

• Commercial leadership and experienced IBD hires are building launch infrastructure; expected launch use is weighted toward second line and later, with first-line access expected to grow as clinical experience develops.

• Planned U.S. field-team size is within the 120–150-rep range; targeting will prioritize an estimated 8,000 GIs meaningfully treating IBD, supported by multichannel outreach.

• The oral therapy’s safety and simplicity may lower barriers to advanced treatment for moderate-to-severe patients not currently using one; the commercial view is that efficacy and endoscopic remission can support payer access.

Crohn’s disease program

• Crohn’s enrollment has picked up in newly opened countries; topline data are expected mid-2027, and blinded review showed no red flags or reason to stop.

• The phase IIb study tests 12.5 mg, 25 mg and 50 mg against placebo; based on UC phase III results, substantial efficacy is not expected at 12.5 mg.

• FDA-preferred Crohn’s endpoints are co-primary CDAI remission (score below 150) and endoscopic response (50% SES-CD improvement).

• A potential phase III path is one dose in a placebo-controlled induction study feeding responder maintenance, potentially with an open-label induction arm; design remains subject to regulatory discussion.