
Core Insights - Rezolute, Inc. is focused on treating hypoglycemia caused by hyperinsulinism and has received Breakthrough Therapy Designation from the FDA for its drug ersodetug [1][2][6] Pipeline Progress and Milestones - The Phase 3 sunRIZE study for congenital hyperinsulinism (HI) is on track to complete enrollment in May 2025, with topline results expected in December 2025 [6] - An independent Data Monitoring Committee recommended the continuation of the sunRIZE study after an interim analysis in April 2025 [6] - The registrational upLIFT study for tumor HI is anticipated to begin mid-2025, with topline data expected in the second half of 2026 [6] Financial Performance - As of March 31, 2025, cash, cash equivalents, and investments in marketable securities totaled $88.4 million, down from $127.1 million as of June 30, 2024 [8] - Research and development expenses increased to $15.3 million for the third quarter of fiscal 2025, compared to $12.4 million for the same period a year ago [9] - General and administrative expenses rose to $4.7 million for the third quarter of fiscal 2025, up from $3.8 million in the same period last year [10] - The net loss for the third quarter of fiscal 2025 was $18.9 million, compared to a net loss of $17.1 million for the same period a year ago [10] Corporate Updates - Erik Harris, a rare disease commercial leader, was appointed to the Board of Directors in March 2025 [6] - The company closed an underwritten offering in April 2025, raising approximately $97 million, extending its cash runway to mid-2027 [6][7]