Cleo Diagnostics Boosts Cash by $1.7M Ahead of US FDA Milestone
Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.
- Received $1.7 million Australian Government R&D tax incentive refund
- Cash balance now approximately $5.75 million
- Funding supports completion of US pivotal clinical trial
- FDA submission for Pre-Surgical Ovarian Cancer Test planned next year
- Focus on early and accurate ovarian cancer detection using CXCL10 biomarker
Strengthening Financial Position
Melbourne-based Cleo Diagnostics Limited (ASX, COV) has announced a significant boost to its financial resources with the receipt of a $1.7 million Research and Development (R&D) tax incentive refund from the Australian Government for the fiscal year 2025. This refund lifts the company's cash holdings to approximately $5.75 million as of late November 2025, providing a solid runway to advance its clinical and regulatory milestones.
Advancing Clinical Trials and Regulatory Goals
The timing of this refund is particularly critical as Cleo prepares to complete its pivotal clinical trial in the United States, a key step before submitting its Pre-Surgical Ovarian Cancer Test for FDA approval next year. This test aims to accurately distinguish between benign and malignant ovarian disease prior to surgery, addressing a major unmet need in women's health diagnostics.
Innovative Technology with Global Potential
Cleo’s diagnostic technology leverages the CXCL10 biomarker, which is elevated early in ovarian cancer but absent in benign conditions. This biomarker-based approach is supported by over 15 years of scientific research and positions Cleo to potentially transform ovarian cancer detection worldwide. The company’s staged development strategy starts with this pre-surgical test, with plans to expand into recurrence monitoring and ultimately global screening.
Strategic Focus on Commercialisation
CEO Dr Richard Allman emphasized that the R&D refund strengthens Cleo’s financial footing as it enters a critical phase of development and commercialisation. The company is focused on its initial entry into the US market, which could pave the way for broader international adoption. Success in this pivotal trial and regulatory approval would mark a major milestone in redefining ovarian cancer care.
Looking Ahead
While the refund bolsters Cleo’s near-term prospects, the company’s journey remains contingent on clinical trial outcomes and regulatory review. The next 12 months will be pivotal in determining whether Cleo’s innovative test can meet the stringent standards required for FDA approval and commercial launch.
Bottom Line?
Cleo’s strengthened cash position sets the stage for a critical US regulatory push that could reshape ovarian cancer diagnostics.
Questions in the middle?
- What are the expected timelines for completion of the US pivotal clinical trial?
- How will FDA feedback influence the final design or deployment of the Pre-Surgical Ovarian Cancer Test?
- What are Cleo’s plans for scaling production and distribution post-FDA approval?