Moleculin Biotech to Advance Annamycin Pivotal Trials in 2026

Moleculin Biotech provided a business outlook and outlined expected upcoming milestones for its next generation non-cardiotoxic anthracycline Annamycin and its STAT3 inhibitor WP1066. "Annamycin is set for a number of milestones in 2026 including two data readouts in its pivotal Phase 2B/3 MIRACLE trial treating second line acute myeloid leukemia plus embarking in its first clinical trial for the treatment of pancreatic cancer," commented Walter Klemp, Chairman and CEO of Moleculin. "The two MIRACLE data readouts will set the course for the pivotal trial in two ways - potentially demonstrating the efficacy of the Annamycin arms versus the control arm and setting the dose for the Annamycin arm to be used in Part B of the MIRACLE trial... Importantly, we believe Annamycin has the potential to become the world's first ever non-cardiotoxic anthracycline and we are expecting more data supporting its lack of cardiotoxicity to be presented early this year. Considering that nearly half of all cancers and 60% of all childhood cancers are currently treated with cardiotoxic anthracyclines that are known to result in permanent heart damage, we think that makes the market opportunity for Annamycin potentially enormous." The company is advancing the development of Annamycin in combination with cytarabine with a Phase 3 pivotal trial for the treatment of AML subjects who are refractory to or relapsed after first line induction therapy. This Phase 3 "MIRACLE" trial is global, including sites in the US, the European Union and Eastern Europe. The trial has expanded to nine countries - the US, Spain, Italy, Poland, Czechia, Romania, Ukraine, Lithuania and Georgia with over 46 sites selected, about 20 sites contracted with more coming online weekly. The company is on track to treat the 45th subject in Part A of the MIRACLE trial in the first quarter of 2026.