• Positive engagement with U.S. FDA, with encouraging feedback
• Secured ~1,600 biobank samples to support algorithm refinement and regulatory readiness
• Commenced Health Economic Study to quantify economic benefit of CLEO's test

Cleo Diagnostics Limited (ASX:COV) has provided an update on its activities in the September 2025 quarter as it develops its simple and accurate blood test for the detection of ovarian cancer. The company has continued its positive engagement with the U.S. FDA, completing its second pre-submission meeting with encouraging feedback. The discussion focused on key technical aspects, including clinical trial design, sample stability, use of biobank samples, clinical specificity, and intended use. The FDA's guidance reinforces confidence that CLEO's clinical trial and broader strategic direction remain well aligned with regulatory expectations. CLEO has now secured approximately 1,600 biobank samples, establishing a significant and stable internal resource to accelerate its research and regulatory programs. The samples and clinical information encompass a broad range of ovarian cancer types, grades, and stages, including rare high-grade Stage I cancers. This critical resource will facilitate refinement of the Pre-Surgical Ovarian Cancer test and enable CLEO to fast-track the development of its screening and recurrence tests. CLEO has also commenced a Health Economic Study to quantify the economic benefits of its Pre-Surgical Test for Ovarian Cancer, which will support payor engagement, reimbursement strategy, and the company's U.S. market access strategy. The study is expected to be complete by the end of the year.

CLEO expects to complete recruitment for its pivotal U.S. clinical trial by Q1 CY2026, with sample analysis scheduled within the same quarter.

CLEO is advancing towards entry into the U.S. market in 2026, with momentum building as it progresses its regulatory activities and product development.