Moleculin Reports First Quarter 2026 Financial Results and Provides Clinical Update on Pivotal MIRACLE Trial

About this update from Moleculin Biotech, Inc.

Early blinded results show 40% composite complete remission rate across difficult-to-treat AML patient population in MIRACLE Trial First interim unblinding expected in June 2026 following 45 subject enrollment milestone achieved in MIRACLE trial Enrollment in MIRACLE trial continues to advance on pace with 90th subject expected in Q3 2026 HOUSTON, May 15, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update. “With enrollment now surpassing the first interim analysis threshold in the MIRACLE trial, we are just weeks away from beginning what we believe will be the most transformative period in the Company’s history. The impressive preliminary blinded remission data trend we reported earlier this year continues with the 45 subject blinded data. This trend supports our belief in Annamycin’s potential to meaningfully improve outcomes for patients with relapsed or refractory AML,” said Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “We also believe Annamycin has the potential to redefine the anthracycline class by addressing one of the most significant limitations of these foundational therapies, cardiotoxicity, while potentially expanding access to treatment options for patients who otherwise may not be eligible for standard anthracycline-based therapy due to current life-time dose limits,” Mr. Klemp added.Recent Highlights Clinical Development Update Annamycin – MIRACLE TrialMoleculin continues to advance the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) trial, a pivotal adaptive-design Phase 3 study evaluating AnnAraC in adult patients with relapsed or refractory AML. Expected Milestones for Annamycin Development Program Additional Pipeline Programs Moleculin continues to support externally funded and investigator-sponsored studies involving WP1066 and other pipeline candidates targeting difficult-to-treat cancers and viral diseases. First Quarter 2026 Financial Results Research and development expenses for the three months ended March 31, 2026 and 2025 were $5.4 million and $3.4 million, respectively. The increase of $2.0 million is mainly related to the MIRACLE clinical trials in Europe of $1.4 million, additional nonclinical studies of $0.3 million and other research costs durin...

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