Rezolute Logs $16.2M Q3 Loss with $120.3M Cash, Phase 3 Study Shows >50% Hypoglycemia Reduction
Rezolute ended Q3 FY2026 with $120.3M in cash, R&D expenses down to $11.4M and net loss improved to $16.2M from $18.9M a year ago. Expanded Phase 3 sunRIZE analyses showed >50% reductions in hypoglycemic time and events, while Phase 3 tumor HI enrollment proceeds with topline H2 2026.
1. Third Quarter Financial Results
Rezolute ended Q3 FY2026 with $120.3M in cash and marketable securities, down from $167.9M at FY2025 year-end. R&D expenses fell to $11.4M from $15.3M a year ago, while G&A rose to $6.0M. Net loss narrowed to $16.2M from $18.9M.
2. Phase 3 sunRIZE Study Updates
Expanded analyses from the Phase 3 sunRIZE trial demonstrated clinically relevant, nominally significant >50% reductions in time in hypoglycemia for the Full Analysis Set and 60–80% for the Per Protocol Set. Continuous glucose monitoring showed 50–65% fewer weekly hypoglycemia events, 25–50% higher normoglycemia AUC, and 10–15 mg/dL increases in average blood glucose.
3. FDA Interaction and Next Steps
In March, Rezolute held a Type B meeting with the FDA, which recognized challenges from patient heterogeneity and limitations of self-monitored glucose metrics in congenital HI trials. The agency encouraged submission of comprehensive datasets for independent review. Rezolute expects a program update in H2 2026.
4. Tumor HI Phase 3 Progress
The upLIFT Phase 3, single-arm, open-label study for tumor-related hyperinsulinism is enrolling up to 16 hospitalized patients, with nine participants’ Expanded Access Program data already filed with the SEC. Topline results are anticipated in the second half of 2026.