secwatch.observer — SEC 8-K summary
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Issuer:     Moleculin Biotech, Inc. (MBRX)
CIK:        0001659617
Form:       8-K
Filed at:   2026-05-13T12:00:58+00:00
Accession:  0001437749-26-016535
Event type: other_material
Sentiment:  positive
Materiality: 0.78
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Moleculin reports preliminary blinded CR rate ~30% in MIRACLE trial; first unblinding before June 30
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- Preliminary blinded CRc >40%, CR ~30% vs. historical ~17-18% for cytarabine alone.
- First unblinding of 45-subject data expected before June 30, 2026; ~30 Annamycin + cytarabine vs 15 control.
- 56 of 90 subjects recruited in Part A as of May 1, 2026; on track for Q3 2026 completion.
- Over 30% of subjects are R/R to prior venetoclax regimen, a challenging population.
- Annamycin has FDA Fast Track and Orphan Drug Designations for R/R AML.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1659617/000143774926016535/0001437749-26-016535-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1659617/000143774926016535/mbrx20260511_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-016535

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