Moleculin Biotech, Inc. — Form 8-K

Moleculin reported interim blinded data from its MIRACLE Phase 2/3 trial (n=62 evaluable subjects): preliminary composite complete remission (CRc) rate of 37% overall and 37% in the 30 patients who had failed prior venetoclax therapy—approximately 3× the published salvage remission rate of ~13% in that population. Enrollment stands at 74 of 90 subjects; final Part A treatment expected September 2026 with comprehensive unblinded results December 2026–February 2027. No cardiotoxicity observed. Data remain blinded and include control-arm subjects, so absolute efficacy vs. prior unblinded June data (50–57% Annamycin arms, 29% control) cannot be directly compared.