MBRX

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, Aug. 14, 2026 (GLOBE NEWSWIRE) -- 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.

Prior venetoclax failure — a setting in which published salvage remission rates are approximately 13% and median survival approximately 2.4 months — shows no adverse impact on blinded composite remission rates as MIRACLE approaches the end of Part A

HOUSTON, July 06, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin, participated in a Virtual Investor “What This Means” segment.

Both Annamycin dose arms outperformed control on the primary endpoint of complete remission (CR): 43% and 36% versus 12% — reported on a full intent-to-treat (ITT) basis with no patient exclusions Composite complete remission (CRc) reached 50% and 57% in the respective Annamycin arms versus 29% for control Enrollment in the MIRACLE trial continues with more than two-thirds (67 of 90 subjects) of Part A target as Company advances toward optimal dose selection HOUSTON, June 30, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the Company's pivotal Phase 2/3 MIRACLE trial, analyzed on a full intent-to-treat basis with no patient exclusions. Both Annamycin treatment arms demonstrated favorable efficacy trends compared with the control arm in patients with relapsed or refractory acute myeloid leukemia (R/R AML).

Surveyed oncologists reported high likelihood to prescribe (6 of 7), citing deep remissions, transplant-bridging potential, biomarker-agnostic use and reduced cardiotoxicity as key drivers

- Access the segment here

Independent Cleveland Clinic Cardiac Review Supports Potential Best-in-Class Safety Profile as MIRACLE Phase 2b/3 Trial Advances

Early blinded results show 40% composite complete remission rate across difficult-to-treat AML patient population in MIRACLE Trial

Moleculin Biotech Inc. (NASDAQ:MBRX) said it remains on track to unblind the first set of data from its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML), before June 30, 2026.

Preliminary blinded CR rate for the first 45 subjects in the trial approximates 30% and represents ~67% improvement vs. standard of care First 45-subject data unblinding expected before June 30, 2026 Program targets high-unmet-need AML population, including R/R Venetoclax subjects Recruitment of Part A continues to the target 90 subjects in Q3 2026 with 56 or 62% subjects recruited and randomized Continued absence of cardiotoxicity and high efficacy expected to position Annamycin as a “significant advancement” in AML treatment HOUSTON, May 13, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that it is approaching the first unblinding of data from its pivotal Phase 2B/3 “MIRACLE” trial evaluating Annamycin in combination with cytarabine for the treatment of subjects that have been relapsed or refractory to their primary line of treatment for acute myeloid leukemia (R/R AML).