Moleculin Receives Japanese Patent Allowance for Annamycin Preparation Methods

Moleculin Biotech, Inc. (Nasdaq: MBRX) 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, also known by its non-proprietary name of naxtarubicin, is Moleculin's novel, lipid-based anthracycline drug candidate 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.

The company's Chairman and CEO stated that securing strong patent protection across key global markets remains a core strategic priority as the company advances its non-cardiotoxic therapy for relapsed or refractory acute myeloid leukemia through pivotal Phase 3 development. The newly allowed Japanese patent further strengthens the company's international intellectual property position by protecting critical methods supporting the preparation and clinical use of the therapy.

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.

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 metastases. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.

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") 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.

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, 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.