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Annual report for the year ended 2025-12-31. These are reported annual figures, not trailing twelve-month estimates.
In July 2024, we announced the completion of our EOP2 meeting with the FDA for our Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). We believe that this meeting, based upon the FDA minutes, was a positive discussion and resulted in the design and implementation of a Phase 2B/3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). The MIRACLE trial is a global trial, including sites in the US, Europe or the European Union (EU), and Eastern Europe.
Excerpt from Item 1 — Business; filed 2026-03-18. May be shortened.
Source: SEC Company Facts. Checked 2026-10-05. Data is refreshed in the background. Missing or ambiguous figures are left unavailable.
