June 2024 Quarterly Activities Report

Highlights

  • U.S. regulatory process commenced with FDA following initial pre-submission meeting held
    where CLEO outlined its submission framework and clinical plan

  • A benchmarking study published in scientific journal “Cancers” demonstrated that CLEO’s
    ovarian cancer blood test outperforms current clinical benchmark

  • FDA-enabling U.S. clinical trials commencing this quarter, targeting recruitment of 500 patients to verify CLEO’s pre-surgical ovarian cancer test

  • CLEO’s U.S. market access and reimbursement program bolstered by appointment of New York-based healthcare industry consultancy HcFocus

  • A$9.373M cash at bank at 30 June 2024



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CLEO Selects U.S. Clinical Trial Sites

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Cleo Commences U.S. Regulatory Process with FDA