Rezolute (RZLT) investor relations material

Company overview and strategy

• Focuses on treating severe hypoglycemia caused by all forms of hyperinsulinism (HI) with the antibody ersodetug (RZ358).

• Two rare disease programs target congenital HI and tumor HI, both with significant unmet needs.

• Management team has experience from early development through commercialization.

• Well-capitalized with $152 million in cash, providing runway to mid-2027.

• Total addressable global market opportunity exceeds $1 billion.

Clinical development and results

• Ersodetug is a fully human monoclonal antibody that allosterically modulates the insulin receptor, counteracting excess insulin or IGF signaling.

• Phase 2b RIZE study showed up to 90% improvement in hypoglycemia time and events at top doses, with a strong safety profile.

• Phase 3 sunRIZE study did not meet primary or key secondary endpoints, but showed pharmacologically mediated reductions in hypoglycemia and high patient retention.

• No limiting safety findings; most common adverse event was hypertrichosis.

• Phase 3 upLIFT study for tumor HI is ongoing, with topline results expected in the second half of 2026.

Market opportunity and patient populations

• Approximately 1,500 initially addressable pediatric congenital HI patients and 1,500 each for malignant insulinoma and NICTH in the U.S.

• Tumor HI patients require higher dosing, representing a larger revenue opportunity per patient.

• Combined initial U.S. market opportunity is about 4,500 patients, with potential for expansion.

• High prescriber overlap between indications among adult endocrinologists.