Moleculin Presents ASCO 2026 Data Demonstrating No Detectable Cardiotoxicity with Annamycin Despite Exposure Levels Far Exceeding Conventional Anthracycline Limits

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Independent Cleveland Clinic Cardiac Review Supports Potential Best-in-Class Safety Profile as MIRACLE Phase 2b/3 Trial Advances HOUSTON, May 29, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced new data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting further reinforcing the differentiated cardiac safety profile of its lead drug candidate, Annamycin (also known as “L-Annamycin” or “naxtarubicin”). The poster presentation, titled “Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis,” highlighted findings from a pooled analysis across five completed clinical trials evaluating Annamycin in patients with acute myeloid leukemia (AML) and soft tissue sarcoma. The analysis demonstrated no detectable cardiotoxicity despite cumulative exposure levels that substantially exceeded traditional lifetime anthracycline dose limitations. “This poster presentation adds significant momentum to the growing clinical evidence supporting Annamycin’s differentiated profile,” said Walter Klemp, Chairman and CEO of Moleculin Biotech. “Anthracyclines remain among the most effective agents in oncology, yet their long-term use has historically been constrained by irreversible cumulative cardiotoxicity. These data continue to suggest that Annamycin may have the potential to fundamentally change that paradigm.” The pooled analysis included 90 patients treated with Annamycin across five completed clinical trials, with source-verified paired pre- and post-treatment left ventricular ejection fraction (LVEF) assessments available for 78 patients. Patients received a median cumulative Annamycin dose of 660 mg/m², with exposure ranging from 210 mg/m² to 2,970 mg/m² — levels that, in many cases, substantially exceeded conventional anthracycline lifetime dose thresholds. Key findings from the analysis included: Importantly, the data were independently reviewed by Cleveland Clinic cardiology specialists, providing additional external validation to the cardiac safety findings. “The absence of detectable cardiotoxicity at exposure levels well beyond conventional anthracycline limits is particularly encouraging,” added Mr. Klemp. “If confirmed in larger studies, we believe Annamycin could potentially enable patients to continue benefiting from anthracycline-based t...

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