• Appointment of first U.S. Key Opinion Leader to support early adoption
• Total addressable market significantly expanded to ~2.0m women per year in the U.S.
• U.S. pivotal clinical trial on track for completion in Q1 CY2026

Cleo Diagnostics Limited (ASX:COV) has provided an update on its activities in the December 2025 quarter as it develops its blood test for the detection of ovarian cancer. Key highlights include the appointment of its first U.S. Key Opinion Leader, Dr. Nicholas Lambrou, to support clinical advocacy, data interpretation, and presentation of CLEO's research. The company's total addressable market in the U.S. has been significantly expanded to approximately 2.0 million women per year, based on analysis of insurance data. CLEO's pivotal U.S. clinical trial continues to progress, with the company on track to meet its initial 500-subject recruitment target in Q1 2026. The company has also successfully completed Stage 1 of the Medical Device Single Audit Program (MDSAP), a key milestone toward ISO13485 certification and FDA submission. CLEO raised $5 million via a placement and received a $1.7 million R&D tax incentive refund, further strengthening its cash position to execute on its commercial launch plans.

CLEO is well-funded with a cash balance of A$9.6 million as of 31 December 2025 to execute on its commercial launch plans for the Pre-Surgical Ovarian Cancer Test in 2026.

CLEO is focused on completing its U.S. pivotal clinical trial, advancing regulatory activities, and preparing for FDA submission and commercial launch of its Pre-Surgical Ovarian Cancer Test in 2026. The company is also accelerating the development of its screening test.