Rezolute to initiate Phase 3 for RZ358 in congenital HI outside US in Q4 2023; FDA restrictions prevent US inclusion

Rezolute, Inc.

Phase 3 sunRIZE study of RZ358 planned in Europe/ex-US starting Q4 2023; topline results expected 1H 2025.
FDA maintained age restriction (12+ years) and re-imposed dose cap based on rat toxicology; US inclusion currently infeasible.
Company evaluating nonclinical studies to address FDA concerns in parallel with ex-US Phase 3; cash $129M sustains ops through Q3 2025.
Phase 2b RIZE study showed RZ358 generally safe, well-tolerated, and effective in improving hypoglycemia.
Estimated congenital HI prevalence >10,000 in primary markets; >50% lack adequate treatment.

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