First Tracks' ANB033 hits Phase 1b celiac endpoints; Vh:Cd delta +0.49 (p=0.009), IEL density -20.03 (p<0.001)

First Tracks Biotherapeutics, Inc.

• Vh:Cd LS mean change -0.17 on ANB033 vs -0.66 on placebo (placebo-adjusted +0.49, p=0.009); IEL density -1.20 vs +18.83 (-20.03, p<0.001).
• Cohort 1 enrolled 32 patients (17 ANB033, 15 placebo) with a 14-day gluten challenge of 6g daily, about two slices of bread.
• Symptoms suppressed throughout the challenge; 6% of ANB033 patients took rescue GI meds vs 47% on placebo; CDSD benefit significant from day 1.
• Safety: no SAEs, no severe AEs, no discontinuations on ANB033; moderate AEs 16.7% vs 75.0% placebo; nausea 5.6% vs 43.8%; injection site erythema 27.8%.
• Next: Cohort 2 mucosal healing topline Q1 2027, EoE cohort of 50 patients Q3 2027, late-stage celiac trial in 2027; FDA Fast Track already granted.