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Moleculin Biotech, Inc.

MBRX Nasdaq Healthcare · Pharmaceutical Preparations Houston, TX www.moleculin.com
$0.78
BUSINESS Business Summary We are a late-stage pharmaceutical development company currently evaluating Annamycin, also known as L-Annamycin and by its generic name naxtarubicin , which we believe is a …

BUSINESS Business Summary We are a late-stage pharmaceutical development company currently evaluating Annamycin, also known as L-Annamycin and by its generic name naxtarubicin , which we believe is a next-generation anthracycline and, with it, are conducting a pivotal Phase 3 trial in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). We call this the MIRACLE trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation). A blinded preliminary data readout has been released for the MIRACLE trial, and we expect to have an interim unblinding of data in mid-2026 and an additional unblinding in the second half of 2026, thereby concluding Part A of the two-part trial. We believe such early visibility for a pivotal registration-enabling trial is unique in that stakeholders will receive preliminary safety and efficacy data long before the conclusion of the trial. We have two additional portfolios of technologies for hard-to-treat cancers and viruses with clinical and preclinical research funded by investigators at academic institutions. One of these portfolios has an ongoing investigator-initiated trial, another one planned and additional active preclinical testing. Since our inception, drug candidates from each of the three core portfolios are in active planning for, have approval to begin, are currently in or have successfully completed eighteen clinical trials.

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