Moleculin Biotech Reports Preliminary Phase 2/3 MIRACLE Trial Results

What Happened

• Moleculin Biotech, Inc. (MBRX) filed an 8-K (Item 7.01, Regulation FD Disclosure) on July 31, 2026 to announce updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial (MB-108) of Annamycin plus cytarabine (AnnAraC) for relapsed or refractory acute myeloid leukemia (R/R AML).
• With 62 subjects evaluable to date, the preliminary blinded complete remission (CR) rate is 24% and the composite complete remission (CRc) rate is 37%. A press release with these results was attached to the filing as Exhibit 99.1.

Key Details

• Trial: Phase 2/3 MIRACLE (MB-108) evaluating Annamycin + cytarabine (AnnAraC) for R/R AML.
• Evaluable subjects: 62 (preliminary, blinded).
• Overall rates: CR = 24%; CRc = 37%.
• Prior venetoclax subgroup: 30 subjects (48% of evaluable); subgroup CR = 23%, CRc = 37% (essentially matching overall results).

Why It Matters

• These are early, blinded efficacy signals from a pivotal trial in a difficult-to-treat population (R/R AML). The reported CR and CRc rates give investors an initial measure of how the regimen is performing across the enrolled cohort and specifically in patients previously treated with venetoclax.
• The data are preliminary and blinded; final unblinded results, additional safety and durability data, and regulatory milestones will be needed to assess clinical and commercial impact. The company publicly disclosed the update via press release (Exhibit 99.1) as part of its 8-K filing.