Rezolute Reports First Quarter Fiscal 2026 Financial Results and Provides Business Update

Core Insights - Rezolute, Inc. is focused on treating hypoglycemia caused by hyperinsulinism and is on track to report topline results from the Phase 3 sunRIZE trial in December 2025 [2][8] - The company has received FDA alignment for a streamlined Phase 3 trial for tumor hyperinsulinism, with enrollment currently underway and topline data expected in the second half of 2026 [2][8] Financial Results - As of September 30, 2025, the company reported cash, cash equivalents, and investments in marketable securities totaling $152.2 million, down from $167.9 million as of June 30, 2025 [5] - Research and development expenses for the first quarter of fiscal 2026 were $13.1 million, an increase from $12.8 million in the same period the previous year, primarily due to higher clinical trial activities and employee-related expenses [6] - General and administrative expenses rose to $6.7 million for the first quarter of fiscal 2026, compared to $4.2 million for the same period a year ago, driven by increased professional fees and headcount [7] - The net loss for the first quarter of fiscal 2026 was $18.2 million, compared to a net loss of $15.4 million for the same period in the previous year [9] Pipeline Progress and Milestones - The sunRIZE trial is a Phase 3 study for congenital hyperinsulinism, with topline results expected in December 2025 [8] - The company achieved FDA alignment for a streamlined clinical development path for the Phase 3 registrational program of ersodetug for tumor hyperinsulinism, with a single-arm, open-label study now underway [8] - An investor event is scheduled for November 10, 2025, where the company will discuss commercial opportunities for ersodetug and ongoing clinical development programs [8] Product Information - Ersodetug is a fully human monoclonal antibody designed to treat hypoglycemia due to hyperinsulinism by decreasing receptor over-activation [10][11]