Rezolute, Inc. (Nasdaq: RZLT) released its financial results for the fourth quarter and full fiscal year ended June 30, 2026, alongside a business update regarding its clinical trials for ersodetug. The company reported a net loss of $77.6 million for fiscal year 2026, a slight increase from the $74.4 million loss recorded in fiscal 2025. Research and development expenses for the full year were $53.8 million, down from $61.5 million in the prior year, primarily due to decreased manufacturing costs for ersodetug, which was partially offset by higher stock-based compensation. General and administrative expenses rose to $29.2 million in fiscal 2026 from $18.4 million in 2025, driven by increased compensation and professional fees related to future commercial activities.
As of June 30, 2026, the company held $107.8 million in cash, cash equivalents, and investments in marketable securities, a decrease from $167.9 million at the same point in the previous year. Rezolute is currently advancing its Phase 3 upLIFT study, a single-arm trial for tumor hyperinsulinism. Enrollment is ongoing, and topline results are expected before the end of 2026. In June 2026, the company shared interim data showing that 7 of the 8 enrolled participants had met the responder criterion for the study's primary endpoint, achieving a complete discontinuation of intravenous glucose requirements with ersodetug. The eighth participant, who had Stage 4 metastatic colon cancer and poor performance status, withdrew consent to receive hospice care and is counted as a non-responder.
Regarding the congenital hyperinsulinism indication, Rezolute reported that the Phase 3 sunRIZE study did not meet its primary endpoint. The company stated that data from the study remains under review with the U.S. Food and Drug Administration (FDA). Rezolute provided additional datasets and analysis results to the FDA, including data focused on continuous glucose monitoring outcomes. The open-label extension phase of the sunRIZE study is ongoing, with data presentations delivered at the Endocrine Society Annual Meeting in June 2026. The company noted that it will await FDA feedback and reserves the ability to request a formal meeting under a regulatory timeline.
