Moleculin Biotech, Inc. 8K

Moleculin Biotech announced positive blinded interim efficacy and safety data, particularly in venetoclax-failed R/R AML patients, from Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine, with full Part A unblinded results expected in late 2026 to early 2027.

On July 31, 2026, Moleculin Biotech, Inc. reported updated preliminary blinded interim results from Part A of its pivotal Phase 2/3 MIRACLE (MB-108) trial of Annamycin in combination with cytarabine (AnnAraC) for relapsed or refractory acute myeloid leukemia, showing a 24% complete remission rate and a 37% composite complete remission rate among 62 evaluable patients, including identical 23% CR and 37% CRc rates in the 30 patients who had previously failed first-line venetoclax-based therapy, a population for which published salvage remission rates are about 13%. The company highlighted that these blinded results include control-arm patients and are therefore expected to be lower than the unblinded Annamycin-arm data from a June 2026 interim analysis, which showed CRc rates of 50% and 57% in the two Annamycin dosing cohorts versus 29% for control, while also emphasizing the continued absence of cardiotoxicity signals. Enrollment has reached 74 of 90 Part A subjects, with final Part A treatment expected in September 2026 and comprehensive unblinded Part A data anticipated between December 2026 and February 2027, which management characterized as a potential value-inflection period for advancing Annamycin’s regulatory pathway and partnering opportunities.

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