InvestSMART

Cleo Diagnostics Ltd (ASX:COV)

ALERT: Price-sensitive ASX Announcement for COV
Current share price for COV : $0.360 -0.405 (-52.94%)+
Announcement
Release
29 Jan 2026 8:24AM
Price at Release
$0.765
Full Release
download
Summary
Cleo Diagnostics Ltd, trading as ASX:COV, released a quarterly activities and cash flow report for the period ending December 2025. The company is advancing its blood test for early detection of ovarian cancer, focusing on the CXCL10 biomarker. During the quarter, Cleo Diagnostics successfully completed Stage 1 of the Medical Device Single Audit Program (MDSAP) and continued recruitment for its U.S. clinical trial, aiming for FDA submission. Financial activities included a $5 million capital raise and a $1.7 million refund from the Australian R&D Tax Incentive program, contributing to a closing cash balance of A$9.6 million. The funds will support market entry and commercial launch of their pre-surgical test. The company has expanded its target market in the U.S., estimating a significant number of women annually could benefit from early detection tests. They have also engaged their first U.S. Key Opinion Leader to help in clinical advocacy and market entry.
Key Points
  • Completion of Stage 1 of the MDSAP for regulatory progress
  • Continued recruitment for U.S. clinical trial with a target of 500 subjects
  • Capital raise of $5 million to support market entry and test development
  • Receipt of $1.7 million from the Australian R&D Tax Incentive program
  • Expansion of U.S. market opportunity with an estimated 2 million women annually
  • Appointment of first U.S. Key Opinion Leader for market strategy
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.