Moleculin Accelerates Recruitment in Phase 3 Acute Myeloid Leukemia “MIRACLE” Clinical Trial

European expansion in September across Georgia, Italy, Lithuania, Poland, Romania, Spain, and US

13 subjects recruited (treated, enrolled, or screened)

Forecasts total recruitment of 20 or more subjects by end of September

On track to recruit to 45 patients in Q4 25 for initial data unblinding

HOUSTON, Sept. 09, 2025 (GLOBE NEWSWIRE) -- 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, today announced updates to its active site status and recruitment for its 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.

To advance this trial to recruiting the 45^th subject in Q4 2025 for its first unblinding for early data insights into the trial’s efficacy and safety endpoints, the Company has the following expectations for September:

• Global Expansion: Expanding recruiting beyond Ukraine to include Spain, Georgia, Poland, Romania, Italy, Lithuania, and the US;
• Site Expansion: Adding 8 new active sites by the end of September, increasing the total to 20 sites recruiting;
• Recruitment Goals: Treating, enrolling, or screening a total of 20 subjects by the end of September; and
• Data Insights: Setting a solid footprint to recruit the 45^th subject in Q4 2025, allowing for unblinded preliminary data assessment regarding efficacy and safety upon data lock.

Walter Klemp, Chairman and CEO of Moleculin, commented, “Our team is diligently expanding our active site footprint across the US, EU, and neighboring regions. We are confident in our target to recruit the 45^th subject by Q4 2025 and achieve our first data unblinding shortly thereafter, especially since the consistent message we are receiving from investigators is that they are very eager to enroll patients in the MIRACLE trial. Moving from our end of Phase 2 meeting with the FDA to screening 13 subjects in just over a year exemplifies our operational efficiency. Of these 13, 10 have been dosed, further supporting our confidence in the speed of recruitment for MIRACLE.”

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