Rezolute (RZLT) investor relations material

Company overview and strategy

• Focuses on treating severe hypoglycemia caused by hyperinsulinism (HI) with the antibody ersodetug (RZ358), targeting both congenital and tumor-related HI.

• Two rare disease programs in late-stage development, addressing significant unmet needs in pediatric and adult populations.

• Management team has experience from early development through commercialization, supported by $133 million in cash with runway to mid-2028.

• Combined U.S. market opportunity estimated at 4,500 patients, with a $1B+ global market potential.

Clinical development and trial results

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

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

• Phase 3 sunRIZE study did not meet primary or key secondary endpoints, but showed pharmacologic activity and consistent reductions in hypoglycemia time at some time points.

• 100% of eligible patients rolled over to open-label extension, with some discontinuing other therapies and remaining on ersodetug monotherapy.

• Ongoing FDA discussions, with a program update expected in the second half of 2026.

Disease background and unmet need

• Congenital HI affects about 1 in 22,000 live births in the U.S., with no approved chronic therapy and high risk of neurological complications.

• Standard of care (diazoxide) is ineffective in 60% of patients and associated with significant side effects; other options are suboptimal or invasive.

• Tumor HI includes islet cell and non-islet cell tumors, both causing severe, refractory hypoglycemia with limited treatment options and high morbidity.