MBRX: MBRX: ASCO pooled data show no detectable cardiotoxicity with Annamycin despite very high cumulative doses

AI Summary

Moleculin (MBRX) presented a pooled ASCO 2026 analysis of 90 patients (78 with paired LVEF) showing no detectable cardiotoxicity with Annamycin despite median cumulative exposure of 660 mg/m2 and individual exposures up to 2,970 mg/m2; an independent Cleveland Clinic review found no LVEF decline, ECG/biomarker or strain signals. The company highlighted prior Phase 1b/2 AML efficacy (CR 50%, CRc 60%, median OS 12.39 months) and said the safety data support its ongoing pivotal Phase 2b/3 MIRACLE trial, with unblinding of the first 45 patients on track for June 2026.

Positives

Independent Cleveland Clinic review reported no evidence of drug-induced cardiotoxicity across LVEF, ECGs, biomarkers and available GLS
No statistically significant change in LVEF from baseline to final assessment (mean difference -0.12%; p=0.84) and no correlation between dose and LVEF change
Patients experienced cumulative Annamycin exposures well above conventional anthracycline lifetime limits (median 660 mg/m²; range 210–2,970 mg/m²) without detected cardiotoxicity

Negatives

Small pooled dataset: 90 patients total with 78 having paired pre/post LVEF measurements, so evidence remains preliminary
Analysis is pooled and non-randomized with limited long-term follow-up; confirmation in larger, controlled trials is required
Company states it will require significant additional financing (no commitments) to complete planned trials