Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a late-stage pharmaceutical development company focused on evaluating Annamycin, also known as L-Annamycin and naxtarubicin. The company is conducting a pivotal Phase 3 trial, named "MIRACLE" (Moleculin R/R AML AnnAraC Clinical Evaluation), which combines Annamycin with cytarabine for treating subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). A blinded preliminary data readout for the MIRACLE trial has been released. The company anticipates an interim unblinding of data in mid-2026 and an additional unblinding in the second half of 2026, which will conclude Part A of the two-part trial. Moleculin Biotech, Inc. also maintains two additional technology portfolios targeting hard-to-treat cancers and viruses. These portfolios are supported by clinical and preclinical research funded by investigators at academic institutions. One of these portfolios currently has an ongoing investigator-initiated trial, with another planned, and additional active preclinical testing. Since its 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. All three core technologies are substantially based on discoveries made at, made in conjunction with, and/or licensed from the University of Texas MD Anderson Cancer Center in Houston, Texas. For each core technology, at least one drug candidate has successfully completed a Phase 1 or greater clinical trial. Three of the company's drug candidates have demonstrated human activity in clinical trials and are currently or have been in Phase 1B/2, Phase 2, or Phase 2B/3 clinical trials. Annamycin is one of these drug candidates and is currently in the MIRACLE trial. The company believes Annamycin is a unique DNA binding agent and a "next-generation" anthracycline.