Moleculin Expands Phase 2B/3 MIRACLE Trial in AML

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Cancer therapeutics company extends MIRACLE trial footprint with $7.6M cash runway through Q4 2025

Moleculin Biotech reported $7.6 million in cash on hand, expected to fund operations through Q4 2025, while announcing expansion of its MIRACLE Phase 2B/3 trial for relapsed/refractory acute myeloid leukemia (AML) into new U.S. and European sites.

The MIRACLE trial evaluates WP1066, Moleculin’s novel STAT3 inhibitor, in combination with standard-of-care treatments for AML patients who have failed previous therapies. This represents one of the most challenging patient populations in oncology, with significant unmet medical need.

Trial Expansion Strategy: The addition of new clinical sites across the U.S. and Europe is designed to accelerate patient enrollment and ensure adequate diversity in the study population. AML affects patients globally, and international site activation should improve recruitment timelines.

Data from the expanded MIRACLE trial are expected in late 2025, providing crucial information about WP1066’s efficacy and safety profile in this difficult-to-treat cancer type.

STAT3 Pathway Targeting: WP1066’s mechanism of action focuses on the STAT3 signaling pathway, which plays critical roles in cancer cell survival, proliferation, and immune evasion. By inhibiting STAT3, the compound may sensitize resistant AML cells to conventional treatments while enhancing immune system recognition.

Financial Runway: While the company’s cash position provides operational funding through Q4 2025, successful interim data from the MIRACLE trial could support additional financing or partnership opportunities to advance WP1066 development.

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