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CLEO DIAGNOSTICS LTD — Investor Relations & Filings

Ticker · COV ISIN · AU0000288045 ASX Professional, scientific and technical activities
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Filings indexed 109 across all filing types
Latest filing 2026-05-19 Regulatory Filings
Country AU Australia
Listing ASX COV

About CLEO DIAGNOSTICS LTD

https://www.cleodx.com

Cleo Diagnostics Ltd is a medical technology company focused on the development and commercialization of a novel blood-based diagnostic platform for the early detection of ovarian cancer. The company's core technology utilizes a proprietary protein biomarker, CXCL10, combined with a specialized algorithm to identify the presence of malignancy with high sensitivity and specificity. Unlike traditional screening methods such as CA-125, the CLEO platform is designed to detect ovarian cancer in its earliest stages, potentially improving patient outcomes through timely intervention. The diagnostic suite aims to provide clinicians with a reliable, non-invasive tool for triage and screening, addressing a significant unmet need in women's health. The company focuses on clinical validation and regulatory approval to integrate its testing solutions into global diagnostic workflows.

Recent filings

Filing Released Lang Actions
CLEO Establishes U.S. Reimbursement Pathway 3 pages 631.5KB
Regulatory Filings Classification · 58% confidence The document is an ASX announcement detailing the company’s U.S. reimbursement strategy and commercialization plan for its diagnostic test. It does not present financial statements, earnings figures, management discussion or an investor slide deck, nor does it announce board changes, dividends, M&A activity, share issues, or capital raising. It is an operational update/press release without substantive financial data or formal regulatory certification of a report. Therefore it does not fit specialized categories (e.g., ER, IR, 10-K, IR, RPA). It is best classified as a general Regulatory Filing (RNS) – the catch-all for miscellaneous regulatory announcements.
2026-05-19 English
Quarterly activities and cashflow report 8 pages 1.2MB
Regulatory Filings
2026-04-28 English
CLEO Commences Kit Manufacturing Ahead of FDA Submission 3 pages 539.3KB
Regulatory Filings
2026-04-27 English
Sample Collection Completion for Pivotal US Clinical Trial 3 pages 531.7KB
Regulatory Filings Classification · 95% confidence The document is an ASX announcement detailing the completion of sample collection for a pivotal U.S. clinical trial by Cleo Diagnostics Ltd. It highlights clinical trial progress, enrollment numbers, next steps toward FDA submission, and manufacturing agreements. The content is focused on clinical trial milestones and regulatory pathway updates rather than financial results, management changes, or shareholder voting. The document is approximately 8,000 characters, which is relatively short and reads as a news release or announcement rather than a full report. There is no detailed financial data, no audit information, no earnings summary, and no regulatory filing certification. It is not a report publication announcement since it does not mention the release or availability of a report but rather announces a key milestone in clinical development. Therefore, the best fitting category is Regulatory Filings (RNS), which covers general regulatory announcements and compliance updates that do not fit other specific categories.
2026-03-30 English
CLEO Optimises Biomarker Panel Ahead of FDA Submission 3 pages 522.9KB
Capital/Financing Update Classification · 90% confidence The document is an ASX announcement from Cleo Diagnostics Limited regarding the completion of biomarker panel optimization ahead of an FDA 510(k) submission. It discusses product development milestones, manufacturing agreements, and regulatory progression plans. The content is focused on a corporate update about product development and regulatory submission plans rather than financial results, management changes, or detailed financial reports. It is not a full financial report, earnings release, or regulatory filing of financial data. The document is a corporate announcement about progress and plans, fitting best into the category of Capital/Financing Update (CAP) as it relates to development and regulatory progress impacting the company's capital and commercial prospects. The document length (7672 characters) and content do not indicate it is a report publication announcement or regulatory filing. Therefore, the most appropriate classification is CAP with high confidence.
2026-03-22 English
Appendix 4D and Half Yearly Accounts 19 pages 1.1MB
Interim / Quarterly Report Classification · 100% confidence The document is titled 'Cleo Diagnostics Limited Appendix 4D Half-year report' and covers the half-year ended 31 December 2025. It includes detailed financial statements such as the statement of profit or loss, statement of financial position, statement of changes in equity, and cash flows. It also contains a directors' report, auditor's independence declaration, and an independent auditor's review report. The presence of comprehensive financial data and analysis for a half-year period, along with the auditor's review, confirms this is a substantive interim financial report. The document is approximately 15,000 characters long, indicating it is the full report rather than a brief announcement or certification. Therefore, the appropriate classification is 'Interim / Quarterly Report (IR)'.
2026-02-24 English

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