Moleculin's MIRACLE Trial Shows 43% and 36% Complete Remission vs. 12% Control in Relapsed AML — 90-Patient Enrollment Targeted September 2026

Moleculin Biotech (MBRX) has interim data worth reading carefully: complete remission rates of 43% and 36% in its two Annamycin arms versus 12% in the control arm of the pivotal MIRACLE trial in relapsed or refractory acute myeloid leukemia.

Those numbers came from an interim unblinding reported in June 2026 and were highlighted again in the company's August 14, 2026 news release on GlobeNewswire covering second-quarter 2026 financial results. The trial — a Phase 2B/3 study evaluating Annamycin in combination with cytarabine (branded AnnAraC) in adult patients with R/R AML — is still running, but the interim efficacy signal runs in one direction.

The two Annamycin arms tested are 190 mg/m² plus HiDAC and 230 mg/m² plus HiDAC; both cleared the control arm's 12% CR rate by a wide margin, per the interim analysis reported via StockTitan. The trial design requires Part A to reach 90 enrolled subjects before the next major gate.

As of July 31, 2026, enrollment stood at 74 of 90 planned subjects, per Investing.com's coverage of the company's blinded remission data update. The company is targeting completion of that 90-patient cohort in September 2026, with a full unblinded efficacy readout expected in the December 2026 to February 2027 window. That readout — not the interim — is the event that will determine whether the trial advances to Phase 3 and what the regulatory path looks like.

The financial picture is tighter than the efficacy data. Moleculin reported a Q2 2026 net loss of $7.6 million, or $1.40 per share, per the company's 8-K filed with the SEC. R&D expenses were $5.5 million for the quarter, up from $3.6 million in the same period a year earlier, with the increase driven primarily by MIRACLE trial costs. Cash on hand as of June 30, 2026 was $7.3 million. A post-quarter financing added $9.3 million. Per the August 14, 2026 GlobeNewswire release, the combined cash position — $7.3 million at quarter-end plus $9.3 million raised after quarter-end — is expected to fund operations into the first quarter of 2027.

That timeline is worth noting: the unblinded efficacy readout lands in December 2026 to February 2027, and the runway runs to Q1 2027. The margin between data and cash depletion is narrow. If the full readout comes in at the later end of the February 2027 range, the company will likely need additional capital before or concurrent with the data — a financing risk that sits alongside the clinical one.

On the market side, MBRX closed at $0.593 on August 21, 2026, up from $0.591 the prior session, per StockInvest.us. The stock moved in a range of $0.560 to $0.630 that day on volume of 292 thousand shares. CNN Markets places MBRX in the micro-capitalization category, defined as up to $300 million market cap.

No named executive quote is available from the sourced documents.

The next concrete milestone is enrollment completion, targeted September 2026. After that, the trial moves toward the unblinded December 2026–February 2027 readout — the number that will either validate or complicate what the interim has suggested.