Appendix 4D and Half Yearly Accounts

Cleo Diagnostics Limited (ASX:COV) (Cleo, or the Company) is bringing to market a simple blood test for the accurate and early diagnosis of ovarian cancer, using its novel patented CXCL10 biomarker. Cleo's first test - AdnexaSure^TM is designed to distinguish benign from malignant growths and will be compatible with standard diagnostic laboratory workflows worldwide.

The Company successfully completed its listing of shares on the Australian Securities Exchange (ASX) on 22 August 2023, after an Initial Public Offering (IPO) raising a total of A$12 million (before costs) in capital by issuing 60,000,000 shares at $0.20 per share.

During the half-year ending 31 December 2023, and up to the date of this report, Cleo has already delivered and made material progress against its strategy to make accurate and earlier detection of ovarian cancer a reality, including:

Development

• Early progress delivered against development program with the selection of biomarkers panel for Cleo’s ovarian cancer test-kit finalised and completion of a prototype scoring algorithm to accompany the test;
• In-house performance verification of CXCL antibodies completed, increasing confidence for commercial assay development and upscaled manufacturing;
• In-house production of Hybridomas to generate the supporting biomarker antibodies are well progressed

Manufacturing

• Evaluation of four commercial antibody manufacturing partners in late stage as part of a robust tender process;
• Design transfer completed, establishing Cleo’s capability to deliver reproducible and reliable results for its ovarian cancer detection test.

Commercial

• U.S. patent granted for key novel ovarian cancer biomarker supporting CLEO's commercialisation pathway into the world’s largest diagnostics market;
• Initial documentation for first FDA meeting under review by regulatory consultant;
• First clinical validation study of the Cleo Triage Test, AdnexaSure^TM published in the peer-reviewed journal “Cancers”, detailing excellent performance for Cleo’s ovarian cancer diagnostic:
  • Highly accurate with 95% sensitivity / 95% specificity;
  • Correctly discriminated malignant from benign samples; and
  • Out-performed and was superior to current clinical methods.

Business Development

• European and U.S. clinical validation partners discussions progressed;
• Discussions ongoing with respect to securing U.S. reimbursement and market access partners.

Intellectual Property

• Grant of U.S. Patent No: US 11,725,048, "CXCL10 Binding Proteins and Compositions Thereof" by the U.S. Patents and Trademarks Office (USPTO
• The granted Patent covers CLEO proprietary biomarkers and antibody formulations, which comprise the core technology of the Company’s ovarian cancer diagnostic blood test.

Financial

• The Company ended the half year period with $10.1M cash at bank; and
• Cleo is operating in line with its budgeted plan as outlined in the Company’s prospectus, and continues to be appropriately funded to execute on its strategic plan to deliver AdnexaSure^TM in CY’25

Corporate

• Board capacity enhanced with Chief Scientific Officer and Executive Director, Dr Andrew Stephens, expanding responsibilities to full-time.

Click here for the full ASX Release

This article includes content from CLEO Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.