---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-009180"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2025-02-04T23:59:59+00:00"
generated_at: "2026-05-27T03:25:28.847755+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Rezolute DMC clears ersodetug open-label arm in infants; interim analysis expected Q1 2025

## Summary
- DMC reviewed 8 infants (3mo-1yr) on 5/10 mg/kg bi-weekly/monthly: safe, target concentrations reached.
- Infants may now enroll in double-blind placebo-controlled portion of sunRIZE Phase 3 study.
- Enrollment completion expected Q2 2025 pending interim analysis; topline results Q4 2025 if no change.
- Interim analysis end of Q1 2025; three outcomes: futility, continue as is, or increase sample size by 33% (18 pts).
- If sample size increased, enrollment shifts to Q4 2025, topline results to mid-2026.

## SEC filing metadata
- accession: 0001104659-25-009180
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2025-02-04T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- 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/1509261/000110465925009180/0001104659-25-009180-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465925009180/tm255467d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-009180
- JSON: https://secwatch.observer/filing/0001104659-25-009180.json
- Plain text: https://secwatch.observer/filing/0001104659-25-009180.txt

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