Corbus Pharmaceuticals Holdings (CRBP) investor relations material

Study design and participant details

• Phase 1a SAD-MAD study included 112 participants, both healthy and obese, with oral dosing up to 600 mg/day and a 14-day in-clinic period for MAD.

• The study was double-blind, placebo-controlled, and included a dedicated obese cohort receiving 150 mg daily.

• Primary endpoints were safety and pharmacokinetics, with additional focus on weight loss and adverse event profiles.

• A 12-week, double-blind, placebo-controlled Phase 1b study (CANYON-1) in 240 obese, non-diabetic participants is underway, testing 20 mg, 40 mg, and 60 mg daily doses with titration.

Safety and tolerability findings

• CRB-913 demonstrated a highly favorable safety profile, with no serious treatment-emergent adverse events and minimal GI issues (one mild diarrhea case).

• No neuropsychiatric adverse events such as suicidality, depression, or insomnia; only mild, transient anxiety and irritability in the obese cohort at the highest dose, resolving quickly.

• No significant changes in laboratory values or vital signs; minor, non-concerning findings included transient arthralgia and mild hypertension in some obese participants.

• Daily neuropsychiatric assessments remained stable and negative for all participants.

Efficacy and weight loss outcomes

• All obese participants on CRB-913 lost weight, with a placebo-adjusted mean reduction of 2.9% by Day 14; individual losses ranged from 1.3% to 4.3%.

• Weight loss began early and deepened over the dosing period, with similar efficacy at 75 mg and 150 mg doses.

• Weight loss was not driven by GI side effects, indicating a differentiated mechanism.

• Some participants reported reduced food-related thoughts and cravings.

• The pharmacokinetic profile supports once-daily oral dosing.