Moleculin Announces Notice of Allowance for Japanese Patent Covering Annamycin

, (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that the Japan Patent Office (JPO) has issued a notice of allowance for Patent Application No. 2021-577862 titled, “METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN.” A patent from the application is expected to be issued in the coming months.

The allowed claims cover proprietary methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilizate under controlled temperature conditions to achieve precise concentrations suitable for intravenous administration. These methods are designed to ensure consistent dosing, stability, and handling during preparation and delivery, including maintaining the formulation at physiologic temperatures throughout reconstitution and dilution. Annamycin, Moleculin’s novel, lipid-based anthracycline drug candidate, is being developed for the treatment of acute myeloid leukemia (AML) and other hematologic malignancies and is positioned to potentially become the first non-cardiotoxic anthracycline approved for clinical use. Additional preclinical studies conducted at leading cancer centers suggest Annamycin may have broader applicability across multiple cancer types. This Japanese patent allowance complements Moleculin’s existing U.S. and European patent coverage, with additional Annamycin-related patent applications pending in major jurisdictions worldwide.

“Securing strong patent protection across key global markets remains a core strategic priority as we advance our non-cardiotoxic therapy for relapsed or refractory acute myeloid leukemia through pivotal Phase 3 development,” commented Walter Klemp, Chairman and CEO of Moleculin. “This newly allowed Japanese patent further strengthens our international intellectual property position by protecting critical methods supporting the preparation and clinical use of our therapy, reinforcing our confidence in its long-term value as we work toward potential regulatory approval and commercialization in key territories worldwide.”

Annamycin, also known by its non-proprietary name of naxtarubicin, 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 AML from the EMA.

Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) and, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.