Rezolute(US:RZLT) Globenewswire·2026-02-12 21:05Core Insights - Rezolute, Inc. reported financial results and business updates for the three months ended December 31, 2025, focusing on its late-stage rare disease treatment for hypoglycemia caused by hyperinsulinism [1] Financial Performance - Cash, cash equivalents, and investments in marketable securities were $132.9 million as of December 31, 2025, down from $167.9 million as of June 30, 2025 [7] - Research and development (R&D) expenses increased to $14.3 million for the second quarter of fiscal 2026, compared to $12.6 million for the same period a year ago, primarily due to increased clinical trial activities and higher employee-related expenses [8] - General and administrative (G&A) expenses rose to $9.9 million for the second quarter of fiscal 2026, up from $4.5 million for the same period a year ago, attributed to increased professional fees and employee-related expenses [9] - The net loss for the second quarter of fiscal 2026 was $22.8 million, compared to a net loss of $15.7 million for the same period a year ago [9] Clinical Development - The Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism did not meet its primary or key secondary endpoints, although reductions in hypoglycemia events were observed [6] - The ongoing upLIFT study for tumor hyperinsulinism is currently enrolling participants, with topline results expected in the second half of 2026 [6] - In January 2026, data from the Expanded Access Program indicated that 75% of tumor HI patients achieved complete discontinuation of IV dextrose/TPN, supporting the efficacy of ersodetug [6] Corporate Updates - Rezolute plans to meet with the FDA under Breakthrough Therapy Designation to discuss next steps for the ersodetug program following the sunRIZE study results [6] - A virtual Investor Event in November 2025 highlighted the commercial opportunities for ersodetug, featuring insights from leading physician experts on the unmet clinical need in hyperinsulinism [6]