Rezolute Adds Seventh upLIFT Responder
Cash, cash equivalents and investments in marketable securities were $107.8 million as of June 30, 2026, as the company awaited FDA feedback on sunRIZE.
Rezolute, Inc. (RZLT), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism, reported that a seventh participant in its Phase 3 upLIFT study had met the responder criterion for the primary endpoint since the company’s June interim update.
The antibody maker said enrollment in upLIFT, a single-arm, open-label trial in up to 16 hospitalized participants with tumor hyperinsulinism, is in progress and that topline results are expected before the end of 2026. In June, the company shared that, of eight enrolled participants, six had already met the responder criterion within the 8-week pivotal treatment phase, and each of those six had also completely discontinued intravenous glucose with ersodetug. Since that announcement, the seventh participant met the criterion.
One of the eight enrolled participants withdrew study consent and discontinued ersodetug and other non-palliative therapies before completing the pivotal phase. The participant had Stage 4 metastatic colon cancer and an ECOG performance status of 4, elected hospice care at home, and died one week later of cancer progression. The participant was counted as a non-responder for the primary endpoint.
At the Endocrine Society annual meeting in June, Rezolute presented a case series of nine patients with refractory hypoglycemia from malignant insulinoma and non-islet cell tumors, reporting that 75% of those receiving IV dextrose or total parenteral nutrition in the expanded access program achieved complete discontinuation of that support. Those outcomes were published in The Journal of Clinical Endocrinology & Metabolism.
Congenital hyperinsulinism remained the other clinical thread. In September, Rezolute said data from the Phase 3 sunRIZE study, which did not meet its primary endpoint, remained under review with the U.S. Food and Drug Administration. In June, the company provided additional datasets, including source and analysis files and summary results from pre-specified, post-hoc and sensitivity analyses focused on continuous glucose monitoring outcomes from the pivotal portion of the study. The open-label extension is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in background standard-of-care therapies. Rezolute will continue to await FDA feedback and reserves the ability to request a formal meeting.
The FDA could determine that the only path forward for congenital HI is a new randomized controlled trial similar to sunRIZE, which would adversely affect the company’s ability to pursue that indication and the commercial potential for ersodetug.
Cash, cash equivalents and investments in marketable securities were $107.8 million as of June 30, 2026, down from $120.3 million as of March 31, 2026. Net loss was $20.5 million for the fourth quarter of fiscal 2026, compared with a net loss of $24.4 million a year earlier, or $0.20 a share versus $0.26 a share. Research and development expenses were $14.9 million in the fourth quarter. General and administrative expenses were $6.7 million.
For the full fiscal year ended June 30, 2026, net loss was $77.6 million, compared with $74.4 million in fiscal 2025. Full-year R&D expenses were $53.8 million, primarily due to decreased manufacturing costs for ersodetug, partially offset by increased employee-related stock-based compensation. Full-year G&A expenses were $29.2 million, primarily due to increased employee-related stock-based compensation and higher professional fees in preparation for future ersodetug commercial activities. Shares used to compute basic and diluted net loss were 104,488 thousand for the three months ended June 30, 2026.
Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor. The drug is investigational for hyperinsulinism, and statements about safety and efficacy have not been approved by any health authority.