Moleculin Reports Second Quarter 2025 Financial Results and Highlights

Core Insights - Moleculin Biotech, Inc. is making significant progress in its Phase 2B/3 MIRACLE trial for Annamycin, targeting relapsed or refractory acute myeloid leukemia (AML) with an expected data readout before the end of 2025 [1][2][21] Clinical Development Updates - The MIRACLE trial is expanding with over 20 additional clinical sites expected to begin recruitment by the end of Q3 2025, including locations in the US, Europe, and the Middle East [1][7] - The trial utilizes an adaptive design, with the first 75 to 90 subjects randomized to receive different doses of Annamycin combined with high-dose cytarabine [6][10] - Preliminary efficacy data is expected to be unblinded for the first 45 subjects treated before the end of 2025, with a second unblinding anticipated in the first half of 2026 [8] Financial Results - For Q2 2025, the company reported a research and development expense of $3.6 million, down from $4.1 million in Q2 2024, primarily due to reduced clinical trial activity [18] - General and administrative expenses remained stable at $2.1 million for both Q2 2025 and Q2 2024 [18] - As of June 30, 2025, the company had cash and cash equivalents of $7.6 million, which is expected to fund operations into Q4 2025 [19] Annamycin Development Milestones - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML and soft tissue sarcoma [15] - Positive topline results from the U.S. Phase 1B/2 trial for Annamycin in treating soft tissue sarcoma lung metastases showed a median overall survival of 13.5 months, compared to 8-12 months for standard treatments [13] Intellectual Property and Strategic Partnerships - The company has bolstered its intellectual property portfolio with a notice of intent to grant a new European patent for Annamycin [7] - An industry veteran has been engaged to explore strategic partnerships related to Annamycin [7]