Moleculin Biotech Secures Notice of Allowance for Key Japanese Patent on Annamycin

HOUSTON, Feb. 17, 2026 — Moleculin Biotech, Inc. (Nasdaq: MBRX) (“Moleculin” or the “Company”) today announced a major intellectual property milestone as the Japan Patent Office (JPO) has issued a notice of allowance for Patent Application No. 2021-577862, titled “METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN.” This notification signals that an official Japanese patent is expected to be granted in the coming months, marking a significant step in the Company’s global IP strategy.

What the Japanese Patent Covers

The patent application that received the notice of allowance includes claims covering innovative methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilized form under precisely controlled temperature conditions. These proprietary methods are designed to ensure accurate drug concentrations suitable for safe and effective intravenous administration.

According to the announcement, the methods described ensure consistent dosing and formulation stability by maintaining specific temperatures throughout the reconstitution and dilution process. This controlled environment is critical for clinical use, handling, and delivery of the drug candidate.

Why This Patent Is Important

The notice of allowance from the JPO strengthens Moleculin’s international intellectual property portfolio, especially in Asia’s major pharmaceutical market. This allowed patent is designed to complement the Company’s existing U.S. and European patent protections and adds another layer of exclusivity for Annamycin. Moleculin also has additional related patent applications pending in other key jurisdictions worldwide.

Annamycin is a novel lipid-based anthracycline drug candidate under development for the treatment of acute myeloid leukemia (AML) and other hematologic malignancies. One of the drug’s key potential benefits is its non-cardiotoxic profile, which could differentiate it from other anthracycline therapies if approved.

CEO Commentary on Strategic Priorities

Walter Klemp, Chairman and Chief Executive Officer of Moleculin, highlighted the importance of expanding patent protection across global markets. He noted that securing IP rights for critical methods associated with Annamycin’s preparation and clinical use supports Moleculin’s confidence in the therapy’s long-term value. The strengthened patent position is aligned with the Company’s goal of pursuing potential regulatory approval and eventual commercialization in strategic territories worldwide.

Regulatory Status and Development Progress

Annamycin is currently being advanced in clinical development with Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory AML. It also holds Orphan Drug Designation for the treatment of soft tissue sarcoma (STS) lung metastases. Additionally, the European Medicines Agency (EMA) has granted Orphan Drug Designation for relapsed or refractory AML.

Moleculin has initiated the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal adaptive Phase 3 trial studying Annamycin in combination with cytarabine — a regimen referred to as AnnAraC. The trial is aimed at advancing treatment options for patients with AML who have limited therapeutic alternatives.

Broader Pipeline and Research Initiatives

In addition to Annamycin, Moleculin’s pipeline includes other therapeutic candidates targeting difficult-to-treat tumors and viruses. Among them is WP1066, an immune/transcription modulator designed to inhibit oncogenic transcription factors such as p-STAT3 while stimulating natural immune responses. The Company also has a series of antimetabolite programs, including WP1122, which are under investigation for potential antiviral and cancer applications.

Global Patent Strategy and Competitive Advantage

Securing strong patent coverage is a core component of Moleculin’s strategy to protect its innovations and enhance the commercial potential of its drug candidates. The notice of allowance in Japan builds on a foundation of previously obtained patents in the United States and Europe, with further applications underway in other major markets.

By expanding its intellectual property protections, Moleculin aims to create barriers to competition and establish a comprehensive global exclusivity framework for Annamycin. This strategy is particularly important in the biotech and pharmaceutical industries, where exclusive rights for novel therapies can drive investment, clinical partnerships, and long-term growth opportunities.

Implications for Investors and Stakeholders

The announcement of the Japanese notice of allowance has been positively received by some market observers. In related market activity, Moleculin Biotech’s stock experienced an uptick following news of the patent development, reflecting investor interest in the Company’s strengthening patent position and advancing clinical programs.

For stakeholders, this patent milestone underscores ongoing progress toward establishing Annamycin as a differentiated therapy in oncology. Continued updates on patent issuances, clinical trial milestones, and regulatory guidance are expected to remain key drivers of interest in Moleculin’s development pathway.

What’s Next for Moleculin

• Official Issuance of the Japanese Patent: The JPO notice of allowance anticipates formal patent issuance in the upcoming months.
• Clinical Development Progress: Advancing the MIRACLE Phase 3 trial with the goal of achieving pivotal data that could support regulatory submissions.
• Global IP Expansion: Pursuing additional patent protections in other major markets to further secure Annamycin exclusivity.
• Potential Partnerships: Leveraging IP assets and clinical data to explore collaborations that could help support development and commercialization efforts.

As Moleculin continues its work to bring innovative cancer therapies to patients in need, the combination of scientific innovation, regulatory progress, and intellectual property development are central to its mission.

#Moleculin #Annamycin #JapanesePatent #BiotechNews #SlimScan #GrowthStocks #CANSLIM