Moleculin to Highlight its Ongoing Phase 3 Acute Myeloid Leukemia “MIRACLE” Clinical Trial at the 14th Annual Acute Leukemia Meeting

On October 30, 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 cancers and viral infections, reported it will present at the 14th Annual Acute Leukemia Meeting being held October 30-31, 2025 at the MD Anderson Cancer Center Spain Foundation in Madrid, Spain.

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Details of the presentation are as follows:

Title: L-Annamycin – Non-Cardiotoxic Anthracycline; MIRACLE Pivotal AML Study
Session: Lunch Session: Moleculin
Presenter: Dr. Paul Waymack, Senior Chief Medical Officer of Moleculin
Date and Time: Thursday, October 30th at 2:35 PM CEST

As part of the presentation, Dr. Waymack will discuss the Company’s ongoing pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study of 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 adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global approval trial, including sites in the US, Europe and the Middle East (clinicaltrials.gov NCT06788756; euclinicaltrials.eu 2024-518359-47-00).

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.

For more information about the 14th Annual Acute Leukemia Meeting, please visit the meeting website.

(Press release, Moleculin, OCT 30, 2025, View Source [SID1234657159])