Rezolute Shares sunRIZE Study Results, Discusses ersodetug Treatment Efficacy

Rezolute shared observations from the Phase 3 sunRIZE study in patients with congenital HI and provided details on the treatment of tumor HI patients with ersodetug under the Company's EAP. While sunRIZE did not meet its primary or key secondary endpoints, the Company believes that the totality of the data further supports previous clinical evidence that ersodetug is active against hypoglycemia in patients. Specifically, there was evidence of pharmacologic activity as target therapeutic drug concentrations were achieved in both treatment groups with highly sensitive biomarker responses in the active treatment groups that are indicative of reduced insulin activity at its receptor. Notably, these responses were consistent with those of the Company's Phase 2 RIZE study. The study also demonstrated reductions from baseline in events and time in hypoglycemia in both treatment groups, but not enough to be statistically significant compared to the pronounced study effect in the placebo arm. While in the early stages of evaluating study data and understanding the results, learnings in the field of glycemic control and initial observations from sunRIZE inform the Company's belief that the pharmacologic response can translate to clinical efficacy. The magnitude of the placebo response observed for hypoglycemia events reveals a significant challenge in studying glucose in an ambulatory setting, where factors such as intensive monitoring where caregivers receive alerts regarding hypoglycemic events and frequent clinical interactions can independently influence outcomes. The Company believes that the extent of reduction from baseline in hypoglycemia events and time in hypoglycemia relative to placebo may have been impacted by the prolonged treatment duration of six months and the fact that glucose monitoring is necessary for safe patient management while also serving as the key endpoint in the study. This sentiment has been shared with the Company by investigator physicians as well as study participants. The Company is currently exploring how to characterize the overall study dynamic including evaluating patient-reported quality of life outcomes. In light of these limitations, assessing the potential benefit in the ongoing open-label extension portion of the study will be important. All 59 participants who completed the study elected to continue to receive ersodetug in the OLE. To date, 57 participants remain in the OLE, with an exposure duration ranging from ~6 weeks for the most recently entered patients, to ~18 months. The Company believes that a potential indicator of ersodetug's underlying efficacy is that several children in the OLE have been able to stop taking all other therapies and are now receiving ersodetug as monotherapy. The Company looks forward to interacting with FDA in Q1 2026 under its Breakthrough Therapy Designation to further characterize these and other clinical outcomes to inform a review of the full sunRIZE dataset with the intent of exploring options for this indication.