Moleculin's Annamycin Confirmed Cardiotoxicity-Free in 90 Subjects, De-risking Lead Oncology Drug

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This filing reports a critical safety confirmation for Moleculin Biotech's lead drug candidate, Annamycin. The independent assessment, covering 90 subjects across five clinical trials, validates the absence of cardiotoxicity, a severe side effect common with existing anthracycline chemotherapy drugs. This significantly de-risks Annamycin's development pathway and enhances its competitive profile, positioning it as a potentially safer and more effective 'next-generation' treatment for acute myeloid leukemia (AML) and soft tissue sarcoma (STS). For a clinical-stage biotech company, this positive safety data for its primary asset is a major catalyst.

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• Annamycin Confirmed Cardiotoxicity-Free

  An independent assessment confirmed no evidence of cardiotoxicity for Annamycin in 90 subjects across five clinical trials.

• Exceeds Lifetime Anthracycline Exposure

  Many subjects were treated with Annamycin above the recommended lifetime maximum for other cardiotoxic anthracyclines, further validating its safety profile.

• De-risks Lead Oncology Program

  This safety confirmation significantly de-risks Annamycin, the company's lead program, which is in Phase 3 development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

• Positions Annamycin as 'Next-Generation'

  The absence of cardiotoxicity, a major issue with current anthracyclines, positions Annamycin as a potentially superior treatment with a large market opportunity.

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This filing reports a critical safety confirmation for Moleculin Biotech's lead drug candidate, Annamycin. The independent assessment, covering 90 subjects across five clinical trials, validates the absence of cardiotoxicity, a severe side effect common with existing anthracycline chemotherapy drugs. This significantly de-risks Annamycin's development pathway and enhances its competitive profile, positioning it as a potentially safer and more effective 'next-generation' treatment for acute myeloid leukemia (AML) and soft tissue sarcoma (STS). For a clinical-stage biotech company, this positive safety data for its primary asset is a major catalyst.