Rezolute (RZLT) investor relations material

Company overview and strategy

• Focuses on late-stage development for rare diseases, specifically hyperinsulinism (HI).

• Lead asset, ersodetug (RZ358), is a fully human monoclonal antibody targeting hypoglycemia from all forms of HI.

• Two rare disease programs: congenital HI and tumor HI, both in advanced clinical stages.

• Management team has experience from early development through commercialization.

• $133 million in cash provides runway to mid-2028.

Clinical programs and trial results

• Ersodetug is in Phase 3 for both congenital and tumor HI; topline data expected in 2H 2026.

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

• Phase 3 sunRIZE study did not meet primary or key secondary endpoints but showed pharmacologic activity and favorable safety.

• All patients rolled over to open-label extension, with some discontinuing other therapies.

• FDA acknowledged behavioral confounders in trials and encouraged further data submission.

Disease background and unmet need

• Congenital HI affects 1 in 22,000 US births, with 50% of children developing neurological deficits.

• Standard of care (diazoxide) is ineffective for 60% of patients and has significant side effects.

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

• Ersodetug has shown real-world benefit in severe, refractory tumor HI cases, enabling hospital discharge and resumption of tumor therapies.