Rezolute Reports Second Quarter Fiscal 2025 Financial Results and Provides Business Update

Core Insights - Rezolute, Inc. has received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for its novel monoclonal antibody, ersodetug, aimed at treating hyperinsulinism (HI) [1][3] - The company reported a net loss of $15.7 million for the second quarter of fiscal 2025, compared to a net loss of $13.9 million for the same period in the previous year [5][10] - The ongoing Phase 3 sunRIZE study is designed to evaluate the safety and efficacy of ersodetug in patients with congenital HI, with topline results expected in the fourth quarter of 2025 [3][7] Regulatory Progress - The FDA granted Breakthrough Therapy Designation to ersodetug for treating hypoglycemia due to congenital HI [3] - The company anticipates starting a Phase 3 registrational study for ersodetug in patients with tumor HI in the first half of 2025, with topline results expected in the second half of 2026 [3][6] Financial Performance - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $105.3 million, down from $127.1 million as of June 30, 2024 [3][10] - Research and development expenses increased to $12.6 million for the second quarter of fiscal 2025, compared to $12.0 million for the same period a year ago [3][4] - General and administrative expenses rose to $4.5 million for the second quarter of fiscal 2025, up from $3.2 million in the same period last year [4][10] Clinical Trial Updates - The Data Monitoring Committee (DMC) reviewed the open-label arm of the sunRIZE study, confirming that target drug concentrations were safely reached in infant participants [1][3] - An interim analysis of the primary study endpoint is planned for the current quarter, with three possible outcomes regarding the continuation of the study [3][4] Company Overview - Rezolute, Inc. focuses on developing therapies for rare diseases, particularly those related to hypoglycemia caused by hyperinsulinism [8] - Ersodetug is designed to treat all forms of HI and has shown substantial benefits in clinical trials [6][8]