Moleculin Biotech Reports 78% Enrollment Toward First Interim Data Unblinding In Pivotal Phase 2B/3 MIRACLE Study Of Annamycin + Cytarabine In r/r AML

Continues to drive enrollment with increase to 78% now consented

Blinded response activity tracking within expected range

Consented subjects now across seven countries supporting the expansion of the MIRACLE trial

HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today provided an update on enrollment from its November report with an increase to 78% of the target number of subjects for the first planned interim unblinding of data having consented to its pivotal Phase 2B/3 "MIRACLE" study of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML). This is up from 60% in its report in November. The targeted number for the first unblinding of data is 45 subjects. Additional subjects beyond the 78% mark continue to be identified by site investigators. This update is as of December 3, 2025, as identification and recruitment are ongoing. The Company expects to complete treatment of the first 45 subjects in the first quarter of 2026.