December 2023 Quarterly Activities Report

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to provide the market with an update on activities in the December 2023 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.

Highlights

• First clinical validation study of the CleoDX Triage Test, performed in a 334 patient cohort, was published in peer-reviewed journal “Cancers” which detailed the high performance of Cleo’s ovarian cancer diagnostics test:
  • Highly accurate with 95% sensitivity1 / 95% specificity2;
  • Correctly discriminated malignant from benign samples; and
  • Out-performed and was superior to current clinical methods.
• Important commercial foundation progress delivered with biomarkers panel for Cleo’s ovarian cancer test-kit finalised and antibody development advanced that will underpin the consistent and reliable manufacture of test-kits
• Board capacity enhanced with Chief Scientific Officer and Executive Director, Dr Andrew Stephens, commencing in a full-time capacity
• A$10.1M cash at bank at 31 December 2023

Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer- reviewed international journal ‘Cancers’. The results confirm the high accuracy of the CleoDX Triage Test, which was independent of menopausal status, and showed that it out-performed the two most widely used clinical scoring systems (the “Risk of Malignancy Index” and “Risk of Malignancy Algorithm”) for discriminating benign from malignant ovarian disease.

A copy of the publication is available here: https://www.mdpi.com/2072-6694/15/21/5267

Moreover, the CleoDX surgical triage test correctly identified 81% of early-stage cancer patients in the cohort.

The next step in development will confirm functionality of the commercially available kits in an independent clinical trial, the results of which will be submitted to the FDA for regulatory approval. Cleo anticipates commencement of this trial early in CY2024.

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