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Rezolute Updates on Phase 3 Study Progress of ersodetug

Rezolute provided an interim update on its ongoing open-label Phase 3 study of ersodetug in tumor HI. With eight participants enrolled in upLIFT to date, comprising both insulinoma and non-islet cell tumor hypoglycemia, the company is midway through enrollment of the planned study sample size of 16 participants. Of the 8 participants enrolled, 6 have already met the responder criterion for the study's primary endpoint, which is the number of participants achieving at least a 50% reduction from baseline in intravenous glucose requirements within the 8-week pivotal treatment phase. Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug. One of the 8 enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status. The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint. The 8th participant was recently enrolled and is still dosing in the pivotal phase of the study. All participants that have completed the 8-week pivotal treatment period have elected to continue into the open-label extension, with a cumulative treatment duration of up to 6 months. Ersodetug has been well-tolerated in the pivotal and extension phases of the study, with no drug-related adverse events or other safety findings reported to date.

Cash and Investments Decrease to $120.3M

Cash, cash equivalents and investments in marketable securities were $120.3M as of March 31, compared with $167.9M as of June 30, 2025.

Rezolute Presents ersodetug Study Results at Pediatric Endocrine Society Annual Meeting

Rezolute announced that expanded analyses from the Phase 3 sunRIZE study of ersodetug in patients with congenital HI were presented at the Pediatric Endocrine Society 2026 Annual Meeting. The oral presentation was made by Diva De Leon-Crutchlow, Chief of the Division of Endocrinology and Diabetes, Director of the Congenital Hyperinsulinism Center at Children's Hospital of Philadelphia, and Principal Investigator of the sunRIZE study. In addition to the previously reported topline results, the presentation included additional results from pre-specified and post-hoc sunRIZE analyses, which the Company believes reiterates evidence of target engagement and highlights the potential therapeutic benefit of ersodetug. As discussed in today's presentation, although statistical significance for the secondary endpoint was not achieved at the Week 24/End of Treatment evaluation window, larger and often nominally statistically significant glycemic improvements were consistently observed throughout the maintenance dosing phase of the study, across time and numerous pre-specified and post-hoc CGM-based endpoints. Average daily percent time in hypoglycemia by CGM: clinically relevant and nominally statistically significant reductions of greater than50% and ~60-80%, compared to placebo across multiple timepoints. Average weekly hypoglycemia events by CGM: clinically relevant and nominally statistically significant reductions of ~50-65% and ~50-80%, compared to placebo across multiple timepoints. Average daily AUC 70 to 180 mg/dL by CGM: clinically relevant and nominally statistically significant increases of ~25-50%, compared to placebo across multiple timepoints. Average blood glucose by CGM: clinically relevant and nominally statistically significant increases of ~10-15% in both the FAS and PPS, compared to placebo across multiple timepoints. The Company is also assessing the longer-term efficacy and safety of ersodetug in a real-world setting in an ongoing OLE phase of the study, including the roll-over of placebo participants. Following the conclusion of the randomized and placebo-controlled phase of sunRIZE, all 59 study completers elected to enter the OLE, as previously reported by the Company. Reflecting no change since last reported, 57 participants continue to attend regular study visits at sunRIZE study centers to receive ersodetug in the OLE, now representing a cumulative ersodetug exposure duration in the study ranging from approximately 6 to 24 months. Preliminary OLE observations demonstrate continued glycemic benefit, including a clinically significant change in glycemic control in the rolled-over placebo participants compared to the controlled period of the study. These glycemic benefits have enabled a concurrent significant overall reduction in background SOC therapies, with a significant number of patients now receiving ersodetug as monotherapy. Notably, a summary of these same CGM-based study outcomes and preliminary observations from the OLE phase of the study were recently discussed with the U.S. Food and Drug Administration as part of the Company's Type B meeting held on March 17, 2026. The meeting resulted in the agency acknowledging challenges associated with the study primary endpoint and concluded with the agency requesting that the Company submit the broader study data for the agency's comprehensive evaluation to inform next steps for the program.