secwatch.observer — SEC 8-K summary
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Issuer:     Moleculin Biotech, Inc. (MBRX)
CIK:        0001659617
Form:       8-K
Filed at:   2026-09-28T11:00:14+00:00
Accession:  0001437749-26-031280
Event type: other_material
Sentiment:  positive
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Moleculin publishes peer-reviewed Annamycin cardiac safety analysis: no cardiotoxicity in 90 patients across 5 trials
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- Pooled analysis of 5 trials (3 AML, 2 metastatic STS): 90 patients treated, paired echocardiographic data for 78; mean LVEF 60.6% at baseline vs 60.0% post-treatment (p=0.84).
- No association between cumulative Annamycin dose or patient age and LVEF change; serial ECGs, troponin I/T and global longitudinal strain showed no treatment-related cardiotoxicity.
- Median cumulative Annamycin dose was 660 mg/m2, exceeding conventional anthracycline lifetime limits; analysis independently reviewed by a Cleveland Clinic cardio-oncology laboratory.
- CEO Walter Klemp said the absence of detectable cardiac toxicity beyond traditional dose thresholds supports continued development of Annamycin as a potentially safer anthracycline.
- Annamycin is currently being evaluated in Moleculin's MIRACLE clinical development program for relapsed or refractory AML.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1659617/000143774926031280/0001437749-26-031280-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1659617/000143774926031280/mbrx20260925_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-031280

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