Moleculin reports positive interim MIRACLE data, keeps trial timeline on track

Moleculin Biotech reported second quarter 2026 financial results on August 14, 2026, and highlighted progress in its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (AML).

The company said preliminary unblinded efficacy results from the first 45 patients enrolled in Part A showed complete remission rates at least three times greater than the control arm.¹ Specifically, the interim analysis showed a clear efficacy advantage for both Annamycin treatment arms, 190 mg/m² plus cytarabine and 230 mg/m² plus cytarabine, over the cytarabine control arm, with CR reaching 43% and 36% in the respective Annamycin cohorts compared with 12% for control, while composite complete remission (CRc) reached 50% and 57%, respectively, versus 29% for the control arm.¹

Enrollment remains on track, with the company stating enrollment remains on track to reach the 90-patient milestone in September with the data readout in the December 2026 to February 2027 timeframe.¹ As of the interim analysis, more than 80% of the planned 90 patients had been enrolled in Part A.¹ The company said these data are expected to support selection of the optimal Annamycin dose and the planned initiation of Part B in the first half of 2027.¹

Moleculin also reported that activity in the MIRACLE trial continues to demonstrate no evidence of cardiotoxicity.¹

On financials, the company had cash and cash equivalents of approximately $7.3 million as of June 30, 2026.¹ Management said cash on hand, together with $9.3 million in financing proceeds raised subsequent to the quarter, will support planned operations into the first quarter of 2027.¹ Research and development expenses were $5.5 million for the three months ended June 30, 2026, compared with $3.6 million for the same period in 2025.¹