Moleculin Receives First Country Approval in Europe to Begin Recruiting for the MIRACLE Phase 3 R/R Acute Myeloid Leukemia (AML) Pivotal Trial

First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) in the first quarter of 2025 Recently amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects, expected in the second half of 2025 HOUSTON, Feb. 11, 2025 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has received first country regulatory approval in Europe to begin recruiting for its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine (also known as “Ara-C” and for which the combination of Annamycin and Ara-C is referred to as “AnnAraC”) for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108). In Ukraine the final necessary regulatory approvals from the Ministry of Health were received last week. This Phase 3 “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US, Europe and the Middle East.

The release as fetched from its publisher. moleculin.com ↗