Rezolute, Inc.

Rezolute, Inc. (Nasdaq Capital Market: RZLT) is a late-stage rare disease company focused on developing therapeutics for hypoglycemia caused by hyperinsulinism. The company's website is www.rezolutebio.com.

The company's lead clinical asset is ersodetug, an intravenously administered human monoclonal antibody that binds to an allosteric site on the insulin receptor in target tissues including the liver, fat, and muscle. By down-modulating insulin's binding, signaling, and action, ersodetug counteracts the effects of elevated insulin and helps restore glucose to normalized ranges. The drug demonstrates dose-dependent pharmacokinetics with a half-life exceeding two weeks, enabling potential monthly dosing. Ersodetug is being developed to treat multiple forms of hyperinsulinism, including congenital hyperinsulinism and tumor hyperinsulinism, with the mechanism of action potentially providing universal effectiveness regardless of whether the condition is genetic or acquired.

Rezolute completed enrollment in May 2025 of the sunRIZE Phase 3 clinical study evaluating ersodetug for congenital hyperinsulinism, an ultra-rare pediatric genetic disorder characterized by excessive pancreatic insulin production. The company also initiated the upLIFT Phase 3 registrational study in mid-2025 for tumor hyperinsulinism. Ersodetug has received Orphan Drug Designation and Rare Pediatric Disease Designation in the United States, as well as PRIME designation from the European Medicines Agency and Breakthrough Therapy Designation from the FDA for both indications. The company maintains an Expanded Access Program providing compassionate use of ersodetug for various hyperinsulinism indications.

As of June 30, 2025, Rezolute employed 71 full-time employees, with 52 engaged in research and development and 19 in general and administrative functions, all located in the United States. The company holds a worldwide exclusive license from XOMA to patents covering the ersodetug molecule, including 38 issued patents worldwide with expiration dates between 2030 and 2036. Rezolute incurred approximately $61.5 million in research and development expenses during fiscal year 2025 and maintains cash and marketable securities totaling approximately $167.9 million as of June 30, 2025.