Moleculin Biotech Reports $21.8 Million Net Loss for 2024, Focuses on Annamycin Trials

Moleculin Biotech, Inc. reported a net loss of $21.8 million for the year ended December 31, 2024, a decrease from a net loss of $29.8 million in the previous year. The company did not generate any revenue during this period. Operating expenses totaled $26.6 million, down from $29.6 million in 2023, primarily due to reduced research and development costs, which fell to $17.7 million from $19.5 million. This decrease was attributed to the termination of a sublicense agreement that allowed the company to reacquire certain intellectual property rights. General and administrative expenses also decreased to $8.8 million from $10.0 million, reflecting lower regulatory and legal service costs.

Moleculin is currently focused on advancing its lead drug candidate, Annamycin, which is undergoing a pivotal Phase 3 trial for the treatment of relapsed/refractory acute myeloid leukemia (AML). The trial, known as the MIRACLE trial, is expected to provide interim unblinded data by the end of 2025, with a second unblinding anticipated in the first half of 2026. The company has also initiated a Phase 2B/3 trial for Annamycin in combination with Cytarabine, which is designed to evaluate its efficacy and safety in a global setting, including sites in the U.S., Europe, and the Middle East.

As of December 31, 2024, Moleculin had cash and cash equivalents of $4.3 million, which, along with $9.3 million raised in early 2025, is projected to fund operations into the third quarter of 2025. The company has indicated that it will require additional funding to support ongoing clinical trials and operations. The continuation of its business is contingent upon securing necessary financing, as it has not yet achieved profitability and has no products approved for commercial sale.

Moleculin's workforce consisted of 17 employees as of year-end 2024, and the company operates in a highly competitive pharmaceutical market. It faces challenges from larger pharmaceutical companies with more resources and established products. The company has received orphan drug designations for Annamycin and WP1066, which may provide certain regulatory advantages, but it remains uncertain whether these designations will significantly impact its market position.

Looking ahead, Moleculin's management remains focused on the development of Annamycin and other drug candidates, with plans to pursue additional funding through equity offerings and collaborations. However, the company acknowledges the inherent risks associated with drug development, including regulatory approval processes and the potential for adverse clinical trial outcomes, which could affect its ability to commercialize its products and achieve profitability.