---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-126021"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2023-12-14T23:59:59+00:00"
generated_at: "2026-06-07T12:47:02.258122+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Rezolute completes Phase 2 DME enrollment, initiates Phase 3 for congenital hyperinsulinism

## Summary
- Phase 2 study of oral RZ402 for diabetic macular edema enrolled ~95 participants; topline data expected mid-Q2 2024.
- Phase 3 sunRIZE study of RZ358 for congenital hyperinsulinism initiated; first clinical site activated outside US.
- Phase 3 to enroll up to 56 patients at ~20 centers in >12 countries; topline results anticipated mid-2025.
- RZ358 previously received EMA PRIME designation in October 2023 for congenital hyperinsulinism.

## SEC filing metadata
- accession: 0001104659-23-126021
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2023-12-14T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1509261/000110465923126021/0001104659-23-126021-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465923126021/tm2332663d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-126021
- JSON: https://secwatch.observer/filing/0001104659-23-126021.json
- Plain text: https://secwatch.observer/filing/0001104659-23-126021.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.