Clinical TrialMay 15, 2026, 08:31 AM
Moleculin's MIRACLE Trial Shows 40% Remission Rate in AML Patients
AI Summary
Moleculin Biotech reported encouraging early blinded results from its pivotal MIRACLE Phase 2B/3 trial for Annamycin in relapsed/refractory AML, showing a 40% composite complete remission rate. The first interim unblinding of data for 45 subjects is expected in June 2026, with enrollment continuing towards 90 subjects in Q3 2026. For Q1 2026, the company reported a net loss of $12.8 million, R&D expenses of $5.4 million, and cash and equivalents of $10.3 million, stating current resources will support operations into Q3 2026.
Key Highlights
- MIRACLE trial showed 40% composite complete remission rate in difficult-to-treat AML patients.
- First interim unblinding of 45 subjects in MIRACLE trial expected in June 2026.
- Q1 2026 R&D expenses increased to $5.4 million from $3.4 million YoY.
- Q1 2026 net loss was $12.8 million, compared to $5.9 million in Q1 2025.
- Cash and cash equivalents were $10.3 million as of March 31, 2026.
- Completed financing transactions in Q1 2026 generated $8.3 million in gross proceeds.
- Management believes current cash supports operations into Q3 2026, but needs additional financing.
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