Cleo’s Revenue Plunge Raises Questions as FDA Trial and Market Entry Loom
Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.
- Revenues down 53.3% to $89,119 for half-year ended December 2025
- Net loss after tax increased slightly to $1.98 million
- FDA pivotal clinical trial ongoing with 18 active sites and 500-patient recruitment target
- Raised $5 million via placement, cash balance at $9.4 million
- Achieved ISO 13485:2016 certification and positive FDA regulatory feedback
Financial Performance Highlights
Cleo Diagnostics Limited (ASX: COV) has released its half-year results for the period ending 31 December 2025, revealing a challenging revenue environment alongside continued investment in its flagship ovarian cancer diagnostic technology. Revenues from ordinary activities fell sharply by 53.3% to just $89,119, reflecting the early-stage commercialisation phase of the company’s biomarker blood test.
Despite the revenue decline, the company’s net loss after tax edged up only marginally by 1.7% to $1.98 million, underpinned by a $1.7 million government research and development tax incentive. This loss is consistent with ongoing clinical trial and development expenditure as Cleo pushes towards regulatory approval and market entry.
Progress in Clinical Trials and Regulatory Milestones
The company is nearing completion of its pivotal FDA enabling clinical trial in the United States, with 18 active trial sites spanning regional and metropolitan areas to ensure patient diversity. Recruitment is on track to meet the target of 500 patients by the first quarter of 2026, a critical milestone for FDA submission.
Complementing the clinical work, Cleo has made significant strides in manufacturing readiness and regulatory compliance. Notably, it achieved ISO 13485:2016 certification, a key quality management standard for medical devices, and received positive feedback from the FDA during its global regulatory roadmap pre-submission meetings. These developments position Cleo well for the next phases of product approval and commercialisation.
Strategic Partnerships and Technology Enhancements
Cleo has secured approximately 1,600 biobank samples from prestigious sources including the UK Cancer Collaborative Biobank Consortium and the Hudson Institute of Medical Research. These samples will support internal testing and expedite the FDA submission process.
The company also selected Bio-Techne’s EllaTM platform for its immunoassay, which promises improved assay sensitivity, precision, and automation compared to traditional methods. This technological upgrade is expected to enhance the reliability and scalability of Cleo’s ovarian cancer test.
Capital Position and Market Outlook
Financially, Cleo strengthened its balance sheet through a well-supported $5 million placement during the period, boosting cash reserves to $9.4 million at December 31, 2025. This capital injection provides a runway to support ongoing clinical trials, regulatory activities, and early commercial initiatives.
The company’s expanded total addressable market analysis indicates over 2 million women annually in the US alone could benefit from its pre-surgical ovarian cancer test, highlighting significant commercial potential. Cleo has also commenced a health economic study to underpin future reimbursement discussions with payers and healthcare providers.
Looking Ahead
While no dividends were declared, the company’s focus remains firmly on advancing its clinical program and regulatory approvals. The appointment of key opinion leaders and the establishment of strategic partnerships further support Cleo’s ambition to become a global leader in ovarian cancer diagnostics.
Bottom Line?
Cleo’s next critical phase will be hitting its clinical trial recruitment targets and navigating FDA approval, with its cash position providing a solid buffer for these high-stakes milestones.
Questions in the middle?
- Will Cleo meet its 500-patient recruitment target on schedule in Q1 2026?
- How will the FDA respond to the pivotal trial data and regulatory submissions?
- What are the timelines and prospects for commercial launch and reimbursement agreements?
