Core Insights - Moleculin Biotech, Inc. is making significant progress in its pivotal Phase 3 clinical trial, the "MIRACLE" trial, with the first subject expected to be treated in Q1 2025 and initial data readout anticipated in the second half of 2025 [1][2] Clinical Development Update - The company is evaluating Annamycin in combination with Cytarabine for the treatment of relapsed or refractory Acute Myeloid Leukemia (AML) in a global Phase 3 trial [4] - The MIRACLE trial will utilize an adaptive design, with the first 75 to 90 subjects randomized to receive different doses of Annamycin combined with HiDAC [5] - The first unblinding of preliminary efficacy data is expected in the second half of 2025, with a second unblinding anticipated in the first half of 2026 [5][6] Recent Highlights - The company received positive FDA guidance for the MIRACLE trial, leading to a smaller number of subjects required for the study [6] - Regulatory approvals have been obtained in Europe and the US for the trial, with multiple sites being activated for patient recruitment [7][8] Financial Results Summary - For the fiscal year ended December 31, 2024, research and development expenses were $17.7 million, a decrease from $19.5 million in 2023, primarily due to a sublicense termination [12] - General and administrative expenses also decreased to $8.8 million from $10.0 million, attributed to reduced regulatory and legal services [13] - The company reported a net loss of $21.8 million for 2024, compared to a net loss of $29.8 million in 2023, with a net loss per share of $6.32 [12][13][25] Expected Milestones - Key upcoming milestones include the first subject enrollment in the MIRACLE trial in Q1 2025, data readout in the second half of 2025, and interim efficacy data in the first half of 2026 [14][15]
Moleculin Reports Full Year 2024 Financial Results and Provides Corporate Update