Rezolute(US:RZLT) Globenewswire·2025-09-17 20:05Core Insights - Rezolute, Inc. has made significant advancements in its treatment for hypoglycemia caused by hyperinsulinism, particularly with its drug ersodetug, and is preparing for potential commercialization [2][12] Financial Results - As of June 30, 2025, the company reported cash, cash equivalents, and investments in marketable securities totaling $167.9 million, an increase from $127.1 million as of June 30, 2024 [6] - Research and development (R&D) expenses for Q4 2025 were $20.9 million, up from $19.1 million in Q4 2024, with total R&D expenses for the fiscal year 2025 reaching $61.5 million compared to $55.7 million in 2024 [7] - General and administrative (G&A) expenses for Q4 2025 were $5.0 million, compared to $4.0 million in Q4 2024, with total G&A expenses for the fiscal year 2025 at $18.4 million, up from $14.7 million in 2024 [9] - The net loss for Q4 2025 was $24.4 million, compared to a net loss of $23.0 million in Q4 2024, with a full-year net loss of $74.4 million versus $68.5 million in 2024 [10][15] Pipeline Progress and Milestones - The company completed enrollment in the sunRIZE trial, a Phase 3 study for congenital hyperinsulinism, with 62 participants, and topline results are expected in December 2025 [8] - FDA alignment was achieved for a streamlined Phase 3 study (upLIFT) for tumor hyperinsulinism, which will include as few as 16 participants, with topline results anticipated in the second half of 2026 [8] - Dr. Sunil Karnawat was appointed as Chief Commercial Officer to lead the launch strategy for ersodetug, bringing over 25 years of experience in biopharmaceutical commercialization [8] About Ersodetug - Ersodetug is a fully human monoclonal antibody designed to treat hypoglycemia due to hyperinsulinism by decreasing receptor over-activation, showing potential effectiveness across various forms of hyperinsulinism [11][12]