Clinical TrialMay 12, 2026, 04:27 PM
Rezolute sunRIZE Phase 3 Trial Fails Endpoints; Net Loss $57.1M
AI Summary
Rezolute announced that its Phase 3 sunRIZE clinical trial for congenital hyperinsulinism did not meet its primary or key secondary endpoints, with an FDA update anticipated in the second half of 2026. For the nine months ended March 31, 2026, the company reported a net loss of $57.1 million, an increase from $50.0 million in the prior year. Cash and cash equivalents significantly decreased to $11.2 million, though management projects current resources will be adequate for at least 12 months.
Key Highlights
- Phase 3 sunRIZE trial for congenital HI failed primary and key secondary endpoints.
- Net loss for nine months ended March 31, 2026, was $57.1 million, up from $50.0 million.
- Cash and cash equivalents decreased to $11.2 million from $94.1 million since June 30, 2025.
- Total operating expenses increased to $61.4 million for the nine-month period.
- Net cash used in operating activities was $51.5 million for the nine months.
- Issued 8.2 million common shares from cashless exercise of pre-funded warrants.
- Terminated $50.0 million "at the market" sales agreement in October 2025.