---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-028528"
form_type: "8-K"
ticker: "MBRX"
cik: "0001659617"
company_name: "Moleculin Biotech, Inc."
filed_at: "2025-09-08T23:59:59+00:00"
generated_at: "2026-05-17T07:37:15.411028+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Moleculin enrolls first EU patients in pivotal Phase 3 MIRACLE trial for R/R AML

## Summary
- First two subjects enrolled, one treated in Spain; active sites in US, Spain, Ukraine, Georgia, Romania.
- Goal to recruit 45 subjects for Part A unblinding by end of 2025; initial data readout in 2H 2025.
- Phase 2B/3 adaptive design with Annamycin+cytarabine vs placebo; FDA Fast Track and Orphan Drug designations.
- Part A randomizes 1:1:1 to HiDAC+placebo, 190 or 230 mg/m² Annamycin; Part B adds ~220 subjects.
- EMA approval conditional on nonclinical GLP results before Part B.

## SEC filing metadata
- accession: 0001437749-25-028528
- form_type: 8-K
- ticker: MBRX
- cik: 0001659617
- company_name: Moleculin Biotech, Inc.
- filed_at: 2025-09-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1659617/000143774925028528/0001437749-25-028528-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1659617/000143774925028528/mbrx20250905_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-028528
- JSON: https://secwatch.observer/filing/0001437749-25-028528.json
- Plain text: https://secwatch.observer/filing/0001437749-25-028528.txt

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