Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical-stage pharmaceutical company headquartered in Houston, Texas, focused on developing therapeutic candidates for hard-to-treat cancers and viruses. Founded in 2015, the company's core mission is to translate innovative science into life-saving medicines by developing drug candidates designed to bypass multidrug resistance mechanisms common in various cancers.

The company's lead drug candidate is Annamycin, also known as L-Annamycin or naxtarubicin, a next-generation anthracycline engineered to avoid multidrug resistance and cardiotoxicity. Annamycin is currently in clinical development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, holding Fast Track Status and Orphan Drug Designation from the FDA for both indications. Moleculin also maintains a portfolio of other drug candidates, including WP1066, an immune/transcription modulator targeting brain tumors, pancreatic, and other cancers, and WP1122, an antimetabolite portfolio aimed at tumors and viruses, including COVID-19.

Under the leadership of Co-Founder, Chairman, President & CEO Walter V. Klemp, Moleculin is actively advancing its pivotal Phase 2B/3 MIRACLE trial for AML, with key data readouts anticipated in 2026. Recent preliminary blinded results from the MIRACLE trial indicated a 40% complete remission/complete remission with incomplete hematologic recovery (CRc) rate in the first 30 patients. The company has also announced positive preclinical data for Annamycin in pancreatic cancer and secured initial country approval in Europe to commence recruitment for the Phase 3 MIRACLE trial.