September 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 September 2023 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.

Highlights

• U.S.patent granted for key novel ovarian cancer biomarker supporting CLEO's commercialisation pathway into its primary U.S. target market
• Early progress delivered against development program with the selection of biomarkers panel for Cleo’s ovarian cancer test-kit finalised
• Antibody development advanced increasing confidence for commercial assay development and upscaling for commercial manufacturing
• Evaluation of four commercial antibody manufacturing partners progressed in late stage as part of a robust tender process
• Board capacity enhanced with Chief Scientific Officer and Executive Director, Dr Andrew Stephens, expanding responsibilities to full-time
• A$10.73M cash at bank at 30 September 2023

The granted Patent (U.S. Patent No: US 11,725,048, "CXCL10 Binding Proteins and Compositions Thereof”) covers CLEO proprietary biomarkers and antibody formulations, which comprise the core technology of the Company’s ovarian cancer diagnostic blood test. This Patent family is directed towards C-X-C motif chemokine ligand 10 (CXCL10) binding proteins and methods of diagnosing a condition, such as a malignancy, comprising determining a level of CXCL10 in a subject. Determination of the level of CXCL10 may also be utilised to monitor tumour burden, malignancy progression or likelihood of tumour recurrence in a subject.

The U.S. Patent expands the Company’s Intellectual Property (IP) portfolio, adding to the patent granted in Australia earlier this year (patent number 2020404453). Additional patent applications are currently pending in Europe, China, India, Japan, Korea, Israel, New Zealand and Singapore.

U.S. MARKET OPPORTUNITY

The U.S. is the largest diagnostic market in the world, and represents the Company’s primary target market for its potentially lifesaving simple diagnostic blood test. Ovarian cancer survival rates are much lower than other cancers that affect women, largely due to the fact that existing testing is insufficient to identify early stage cancers or differentiate from benign disease. Diagnosis is only made following radical surgery to remove the ovaries. The 5 year survival rate for ovarian cancer is 49%, compared to 92% for breast cancer¹ where early detection screening exists.

A significant unmet clinical need exists and CLEO plans to bring to market a suite of ovarian cancer diagnostic blood tests based on the novel patented CXCL10 biomarker, which is expressed early and at high levels by ovarian cancers, but not in non-malignant disease. The tests aim to distinguish benign from malignant growths in a standard format that will be readily compatible with existing equipment used by pathology laboratories worldwide.

The U.S. Patent complements CLEO’s regulatory approval strategy designed to access target markets and secure a path to reimbursement approvals in the future. The Company is also currently preparing for the submission of a 510(k) U.S. Food and Drug Administration (FDA) application.

CLEO is initially targeting the delivery of its blood test for the surgical triage market, however has a staged execution strategy that de-risks a pathway to all ovarian cancer diagnostic markets:

• Surgical Triage Distinguishes benign from malignant disease to allow appropriate design of treatment before surgical intervention is considered;
• Recurrence Identifies relapse for earlier intervention to control/manage disease progression
• High Risk Screening Testing women with known BRCA status or extensive family history; and
• Early Stage Screening Systematic national screening to identify early stage ovarian cancers in patients without symptoms, to allow medical intervention before cancer spreads.

Early detection is vital. When ovarian cancers are diagnosed at stage 1, patients have over a 90% 5 year survival rate. However, this rate reduces rapidly to <40% if diagnosed once the cancer has spread beyond the ovaries.

TEST-KIT BIOMARKERS PANEL FINALISED

Cleo has finalised the selection of biomarkers to be used in its ovarian cancer test-kit, along with completing the development for a prototype of the proprietary scoring algorithm. The performance metrics of the test were evaluated in a clinical study of 334 patients, the results of which are being prepared for publication in a peer-reviewed medical journal. The Company expects the publication outcome to be reported to the market by the end of CY2023. The data cannot be released prior to publication due to the nature of the peer-review process. Concurrently, Cleo is also preparing a further patent application based on the findings.

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