Rezolute (RZLT) investor relations material

Company overview and strategy

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

• Two late-stage programs target congenital and tumor-induced HI, both with significant unmet medical needs.

• Expanded access program and clinical trials show compelling evidence of drug activity and patient benefit.

• Management team has experience from early development through commercialization.

• $120 million in cash provides runway to mid-2028.

Clinical programs and milestones

• Two Phase 3 programs: sunRIZE for congenital HI and upLIFT for tumor HI, both expecting key data in 2H 2026.

• sunRIZE pivotal study completed with ongoing open-label extension; upLIFT is a global, multi-center, single-arm study.

• Both programs address severe, persistent hypoglycemia with limited current treatment options.

• FDA and EMA have granted multiple designations to ersodetug, including Breakthrough Therapy and Orphan Drug status.

Efficacy and safety data

• sunRIZE did not meet its primary endpoint due to confounding study effects, but showed clinically meaningful reductions in hypoglycemia by CGM.

• Consistent glycemic improvements observed across multiple CGM outcomes in maintenance phase.

• Reassuring safety profile with low rates of hypersensitivity and mild hypertrichosis.

• Expanded access program for tumor HI patients demonstrated substantial hypoglycemia improvement and allowed resumption of normal activities.