• Completed pivotal U.S. clinical trial with over 800 women enrolled
• Expanded biomarker panel from five to eight for enhanced accuracy
• Selected Bio-Techne's platform for manufacturing at scale
• Positive feedback from FDA pre-submission meeting
• Engaged market experts for U.S. commercial strategy

Cleo Diagnostics Ltd reported financial results for the year ended 30 June 2026, showing a decline in revenues from ordinary activities by 31.6% to $232,352 and a significant increase in loss from ordinary activities after tax attributable to owners by 48.4% to $(5,936,480). Despite the financial loss, the company made substantial progress in its clinical and commercial development, including the completion of sample collection for its pivotal U.S. clinical trial with over 800 women enrolled, the expansion of its Pre-Surgical Ovarian Cancer Test biomarker panel from five to eight biomarkers, and the selection of Bio-Techne's next-generation Ella platform for manufacturing at scale. Additionally, the company received positive feedback from its second FDA pre-submission meeting and completed Stage One of the Medical Device Single Audit Program (MDSAP). Cleo Diagnostics Ltd also engaged market experts to assist with its U.S. commercial strategy, highlighting its commitment to addressing the unmet clinical need for accurate, non-invasive ovarian cancer detection.

Cleo Diagnostics Ltd plans to submit its FDA 510(k) application in the first half of CY2027 and aims for a U.S. commercial launch through a capital-light, business-to-business laboratory model.