secwatch.observer — SEC 8-K summary
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Issuer:     Moleculin Biotech, Inc. (MBRX)
CIK:        0001659617
Form:       8-K
Filed at:   2025-09-08T23:59:59+00:00
Accession:  0001437749-25-028528
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1659617/000143774925028528/0001437749-25-028528-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1659617/000143774925028528/mbrx20250905_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-028528

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer