Rezolute Reports Fourth Quarter and Full Year Fiscal 2025 Financial Results and Provides Business Update

REDWOOD CITY, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2025.

“We have made substantial progress this year across our two indications for ersodetug in both congenital and tumor hyperinsulinism,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “We believe that FDA alignment on a streamlined Phase 3 trial in tumor hyperinsulinism is further recognition of ersodetug’s broad applicability across multiple forms of hyperinsulinism and highlights both the urgent need and the transformative potential of our therapy for patients and families living with this condition. We remain on track to report topline results from the sunRIZE trial in December and look forward to progressing towards potential commercialization.”

Recent Pipeline Progress and Anticipated Milestones

Congenital Hyperinsulinism (HI)

• Completed enrollment in sunRIZE, a Phase 3, multicenter, double-blind, randomized, controlled safety and efficacy registrational study of ersodetug for the treatment of congenital HI.
  • Exceeded enrollment with 62 participants enrolled, including approximately 15 percent from U.S. sites.
  • Topline results expected in December 2025.
• Presented “Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress” at the Annual Meeting of the Endocrine Society (ENDO 2025). The enrolled population is comparable to the Phase 2 RIZE study and include:
  • 3.4y average age: 35%