EPRX · Eupraxia Pharmaceuticals Inc.

This 6-K filing discloses the first endoscopic efficacy data from Eupraxia’s RESOLVE trial — specifically EREFS scores — a validated, objective measure of esophageal disease severity in eosinophilic esophagitis (EoE). The results show a clinically meaningful 65% mean reduction in EREFS (3.6-point decrease) at week-12 among the seven patients who received the full 20-injection protocol, all of whom had baseline EREFS >2. Critically, this cohort also demonstrated consistent improvement across both inflammatory and fibrotic sub-scores — a key differentiator not seen with lower injection counts — reinforcing the biological plausibility of EP-104GI’s local, sustained action via Diffusphere™ technology. These findings directly informed the dose selection for the pivotal Phase 2b trial, which is now enrolling patients at the 20-injection regimens (120mg and 160mg) and is fully aligned with regulatory endpoints used in prior EoE trials. With top-line Phase 2b data expected in Q4 2026, this disclosure materially de-risks the near-term clinical pathway and strengthens the therapeutic rationale for EP-104GI as a potential first-in-class locally delivered, extended-release therapy for EoE — a disease affecting over 450,000 people in the U.S. and lacking FDA-approved pharmacotherapies targeting esophageal fibrosis. The DDW presentation and concordance with prior EoEHSS symptom data further bolster confidence in the treatment effect, though definitive validation awaits the randomized, placebo-controlled Phase 2b results.