Moleculin: MIRACLE Part A 90-patient unblinded readout Dec 2026–Feb 2027

Positive interim data from the first 45 patients in Part A showed CR rates at least three times higher than control. The trial is on track to complete 90-patient enrollment in September 2026, with the unblinded efficacy readout scheduled for December 2026 to February 2027 to support optimal-dose selection and Part B initiation in 1H 2027.

Key facts

Filed: Aug 14, 2026, 12:30 PM
Event: Topline results
Direction: Positive
Company: MBRXMoleculin Biotech, Inc.
Asset: naxtarubicin
Source: SEC 8-K
Confidence: Sourced
enrollment: 89 + 1 in screening
part a split: ~50/50 fit/unfit

Source excerpt

EX-99.1 2 ex_1004839.htm EXHIBIT 99.1 ex_1004839.htm Exhibit 99.1 Moleculin Biotech Reports Second Quarter 2026 Financial Results and Highlights Continued Advancement of Pivotal MIRACLE Trial - Positive interim MIRACLE data showed complete remission rates three times higher than control in relapsed/refractory AML - MIRACLE trial advancing toward planned 90-patient enrollment milestone in September 2026 with the unblinded efficacy readout in December 2026 to February 2027 timeframe - MIRACLE trial Part B initiation expected in the first half of 2027 following optimal dose selection - Cash position, including $9.3 million raised after quarter-end, expected to fund operations into the first quarter of 2027 - Absence of cardiotoxicity continues in the MIRACLE trial HOUSTON, August 14, 2026 — Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), today reported financial results for the second quarter ended June 30, 2026, and highlighted continued progress in its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (AML). Moleculin continues to advance the pivotal Phase 2/3 MIRACLE trial following positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A, which showed complete remission rates at least three times greater than the control arm. Enrollment remains on track to reach the 90-patient milestone in September with the data readout in the December 2026 to February

SEC 8-K