March 2024 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 March 2024 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.

Highlights

• Design transfer activities completed, with reliable and reproducible data supporting progression to prototype manufacture
• Publication of second peer-reviewed dataset confirms substantial performance advantage over current standard of care testing using CA125
• CLEO’s strategic U.S. market access and reimbursement program underway with appointment of New York-based industry partner HcFocus
• U.S. clinical trial established, with U.S.-based Lindus Health managing site logistics and patient recruitment
• Physician engagement commenced in Australia
• A$9.973M cash at bank at 31 March 2024.

2nd PEER REVIEWED PUBLICATION

The article, entitled ‘Reclassification of patients with ambiguous CA125 for optimised pre-surgical triage’ was published in the peer reviewed medical journal, Diagnostics.

A copy of the publication is available here: https://www.mdpi.com/2075-4418/14/7/671 The article concluded:

a) CLEO’s test correctly identified most cancer cases missed by CA125, including a majority of patients with early stage cancers;

b) The test provided superior identification of benign disease to eliminate the majority of "false positive" results obtained using CA125; and

c) The test efficiently discriminated malignant from benign samples.

Background

Further data for CLEO’s ovarian cancer triage test has been published in the peer-reviewed international journal ‘Diagnostics’.

Whilst these clinical studies are complex documents to interpret for the lay-reader, they form an integral part of Cleo’s commercialisation strategy. They are crucial for providing documentary evidence of Cleo’s test performance and will be used:

• To support Cleo’s case to be included in national and international medical guidelines;
• To support Cleo’s applications for private insurance coverage in the USA; and
• To inform clinicians of Cleo’s test performance to drive uptake.

The latest study assessed the use of CLEO’s triage test to rescue those cases where CA125 provided an incorrect indication. Accurately identifying cancer patients early is critical to provide immediate referral to a gynaecological oncology specialist for surgery; whilst allowing better management of patients with non-malignant disease.

The study compared the potential clinical benefit to patients if CLEO’s Test was used for initial diagnostic work-up instead of CA125, the current gold standard ovarian cancer biomarker.

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