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

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

Commencement of U.S. Regulatory Process

CLEO completed an initial pre-submission meeting with the U.S. Food and Drug Administration (FDA) where the Company outlined its submission framework and clinical plan for its ovarian cancer detection blood test. The pre- submission meeting is designed to allow CLEO to receive early guidance from FDA review teams prior to an eventual application submission.

The meeting was interactive with the FDA providing constructive and positive feedback on CLEO’s approach to obtaining regulatory approval in the U.S. for its ovarian cancer detection blood test. This outcome provides confidence that CLEO's clinical trial designs and strategic direction are appropriately aligned with FDA requirements.

Early interaction with the FDA is important as a part of CLEO’s U.S. market access strategy for a number of reasons, as the guidance outcomes allow CLEO to:

• Refine its clinical trial design to maximise resourcing and quality of data;
• Reduce the possibility of rework;
• Shorten the potential timeframe to application submission; and
• Operate with an open and transparent approach.

CLEO is pursuing expedited FDA approval for its first ovarian cancer detection product - the pre-surgical Triage test - via the 510(k) application pathway. This approach provides the quickest pathway to achieve regulatory approval for devices that achieve "substantial equivalence" to an existing predicate.

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