Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the U.S. Patent and Trademark Office (USPTO) has granted two additional U.S. patents with claims covering Annamycin. U.S. patent number 12,257,261 titled, “Preparation of Preliposomal Annamycin Lyophilizate”, has claims covering methods of making liposomal Annamycin and U.S. patent 12,257,262 titled “Method of Reconstituting Liposomal Annamycin“, has claims covering methods of making liposomal Annamycin suspension. Both patents have a base patent term currently extending until June 2040, subject to adjustment for delays in prosecution and extension to account for time required to fulfill requirements for regulatory approval. Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

Annamycin, Moleculin’s novel drug candidate, is being positioned to become the first anthracycline demonstrating a lack of cardiotoxicity to be approved and is currently being developed for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Additional preclinical studies performed at a world-renowned cancer center indicate Annamycin may be a potential treatment for many other types of cancers. The new chemical entity uses a unique lipid-based delivery technology and has shown the potential to be used in a wide range of cancers.

Wally Klemp, Chairman and CEO of Moleculin, said, “We remain focused on expanding our intellectual property portfolio for Annamycin. Following the issuance of two U.S. patents in 2024, these new patents enhance the exclusivity of Annamycin, bringing to four the total number of U.S. patents related to Annamycin, in addition to the European patents granted. Based on the data seen to date and feedback we continue to receive from clinicians and patients, we are dedicated to advancing this important and much needed treatment option forward. We continue to make solid progress in our ongoing pivotal, adaptive Phase 3 MIRACLE trial and remain on track to report initial data in the second half of 2025.”

Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).