---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-034635"
form_type: "8-K"
ticker: "MBRX"
cik: "0001659617"
company_name: "Moleculin Biotech, Inc."
filed_at: "2025-11-13T23:59:59+00:00"
generated_at: "2026-05-16T20:26:12.183241+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Moleculin reports 60% enrollment for first interim unblinding of Phase 3 AML trial

## Summary
- 60% of target 45 subjects for first interim unblinding of MIRACLE (R/R AML) trial have consented (as of Nov 4, 2025).
- Completion of treatment for first 45 subjects expected Q1 2026; unblinding thereafter.
- Blinded response activity tracking within expected range based on historical trial arm responses.
- CEO notes strong recruitment momentum despite EU bed shortages.
- Annamycin has FDA Fast Track and Orphan Drug designations for R/R AML; patent protection through 2040-2045.

## SEC filing metadata
- accession: 0001437749-25-034635
- form_type: 8-K
- ticker: MBRX
- cik: 0001659617
- company_name: Moleculin Biotech, Inc.
- filed_at: 2025-11-13T23:59:59+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/1659617/000143774925034635/0001437749-25-034635-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1659617/000143774925034635/mbrx20251112_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-034635
- JSON: https://secwatch.observer/filing/0001437749-25-034635.json
- Plain text: https://secwatch.observer/filing/0001437749-25-034635.txt

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