Core Insights - Moleculin Biotech, Inc. announced the release of a webcast discussing final data from its U.S. Phase 1B/2 clinical trial evaluating Annamycin for treating soft tissue sarcoma lung metastases [2] - The company is advancing a pipeline of therapeutic candidates targeting hard-to-treat tumors and viruses, with Annamycin being a key program [5] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on drug candidates for difficult-to-treat cancers and viruses [2][5] - Annamycin is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity associated with current treatments [5] - The company has initiated the MIRACLE Trial (MB-108), a Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia [6] Clinical Development - The Phase 1B/2 study (MB-106) of Annamycin has received positive input from the FDA, which the company believes has de-risked its development pathway for potential approval [6] - Moleculin is also developing WP1066, an immune/transcription modulator targeting various cancers, and WP1122 for treating pathogenic viruses [7]

Core Insights - The company is advancing its Phase 3 clinical trial, known as the "MIRACLE" trial, evaluating Annamycin (naxtarubicin) for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) with interim data readout expected in the second half of 2025 [1][11] - The European Medicines Agency (EMA) has granted approval for the trial in nine additional countries, enhancing the company's operational scope [1][6] - The company reported a decrease in research and development expenses for Q1 2025 compared to the same period in 2024, indicating a focus on clinical trial activities [18] Clinical Development Update - The MIRACLE trial is a pivotal, adaptive Phase 3 study evaluating Annamycin in combination with Cytarabine for R/R AML patients, with 38 sites selected globally, including 5 in the US as of April 2025 [4][23] - The trial design allows for unblinding of preliminary efficacy data at 45 subjects, with the first unblinding expected in the second half of 2025 [8][11] - The company is also seeing advancements in its pipeline, including the MB-107 trial for soft tissue sarcoma lung metastases, with final data readouts expected by the end of June 2025 [3][13] Financial Results - For Q1 2025, the company reported research and development expenses of $3.4 million, down from $4.3 million in Q1 2024, reflecting reduced clinical trial activity levels [18] - General and administrative expenses increased slightly to $2.5 million in Q1 2025 from $2.4 million in Q1 2024, primarily due to higher regulatory and legal fees [19] - As of March 31, 2025, the company had cash and cash equivalents of $7.7 million, which is expected to fund operations into Q3 2025 [19] Regulatory and Intellectual Property Developments - The company received EMA approval for its Clinical Trial Application to conduct the MIRACLE trial in all nine EU countries submitted [6] - Two new U.S. patents were granted, enhancing the intellectual property portfolio for Annamycin [6] - Annamycin has received Fast Track Status and Orphan Drug Designation from both the FDA and EMA for the treatment of R/R AML and soft tissue sarcoma [14]