Rezolute (RZLT) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Company overview and therapeutic focus

• Focused on treating hyperinsulinism, including congenital and tumor-associated forms, with an antibody therapy administered via 30-minute infusion.

• Congenital program is in phase 3 with global patient enrollment; tumor-associated program to start phase 3 next year.

• Therapy is designed as a universal treatment for hyperinsulinism, operating downstream of insulin production.

Market opportunity and patient population

• In the U.S., over 3,000 people live with congenital hyperinsulinism; about half are immediately addressable.

• Tumor-associated hyperinsulinism market may be larger, with at least 500 islet cell tumor patients and 1,000 hepatocellular carcinoma patients annually as candidates.

• Additional 12 tumor types may expand the addressable market.

Clinical data and real-world evidence

• Compassionate use cases show rapid eradication of hypoglycemia, enabling patients to resume normal life and cancer therapies.

• Registrational study for tumor-associated indication will enroll about 48 patients, with top-line data expected by end of 2026.

• Phase 2 congenital study showed over 75% reduction in hypoglycemia at higher doses; phase 3 uses a loading and maintenance dosing schedule.