Rezolute, Inc.

Rezolute, Inc. is a late-stage rare disease company that develops treatments for persistent and severe low blood sugar (hypoglycemia) linked to various forms of hyperinsulinism (HI). The company's primary clinical asset is ersodetug, an intravenously administered human monoclonal antibody. Ersodetug is designed to treat refractory hypoglycemia caused by multiple forms of hyperinsulinism. It works by binding to a specific site on the insulin receptor in insulin-sensitive tissues like the liver, fat, and muscle. This action reduces insulin receptor activity, which helps to normalize glucose levels in conditions where insulin or insulin-like substances (such as IGF-2 variants) are elevated. Ersodetug exhibits dose-dependent pharmacokinetics with a half-life exceeding 2 weeks, suggesting the potential for monthly dosing. The company is developing ersodetug to treat any form of HI, as its mechanism of action, downstream from the source of HI (insulin or IGF-2 production), could make it broadly effective for HI-related hypoglycemia, whether genetic or acquired. In the sunRIZE Phase 3 study for congenital HI, announced on December 11, 2025, ersodetug did not meet its primary endpoint (hypoglycemia events by finger stick self-monitored blood glucose) or its key secondary endpoint (time in hypoglycemia by continuous glucose monitoring) at the Week 24 evaluable window. However, the study consistently showed larger and often nominally statistically significant reductions in hypoglycemia compared to placebo throughout the maintenance dosing phase across various pre-specified and post-hoc CGM-based endpoints.