Slide 1: Pioneering the Transformation of Ovarian Cancer Detection
PIONEERING THE TRANSFORMATION OF OVARIAN CANCER DETECTION Corporate Presentation ASX: COV JUNE 2025
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer This investor presentation has been prepared by Cleo Diagnostics Limited (“Cleo Diagnostics” or the “Company”). This presentation is not a financial product or investment advice or recommendation, offer or invitation by any person or to any person to sell or purchase
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS Capital Structure Addresses a critical unmet need on a ASX Ticker COV global scale Share Price (10 June 2025) $0.375 Shares on Issue 128.5M CLEO DIAGNOSTICS • cleodx.com Options 15.25M Disruptive patented technology for the Performance Options 1.5M early detection of Ovarian Ca
Slide 4: By 2050, Over Half a Million Women
By 2050, over half a CLEO DIAGNOSTICS • cleodx.com million women each year will be diagnosed with Ovarian Cancer Critically, no effective screening test exists 4 4
Slide 5: The Silent Killer – Why Early Detection Is Key
THE SILENT KILLER – WHY EARLY DETECTION IS KEY Currently, the only way to diagnose Ovarian Cancer is after surgery The clinical unmet need for a screening solution is urgent. Ovarian Cancer 51% of women continue to die within 5 years of an Ovarian CLEO DIAGNOSTICS • cleodx.com is one of the Cancer d
Slide 6: Limitations of CA125 as a Screening Tool
LIMITATIONS OF CA125 AS A SCREENING TOOL A biomarker with clinical value, but insufficient for early detection or population screening How CLEO’s test overcomes the CLEO’s Test vs CA125 Key limitations of CA125 shortfalls of CA125 Test for Early Detection1 Low sensitivity Misses up to 50% of early-s
Slide 7: Cleo's Disruptive Patented Technology Offers Superior Performance
CLEO’s disruptive patented CLEO DIAGNOSTICS • cleodx.com technology offers superior performance to current clinical tests 7 7
Slide 8: Cleo's Patented Novel Biomarker: CXCL10
CLEO’s PATENTED NOVEL BIOMARKER: CXCL10 CXCL10 is a biological marker that is highly expressed in Ovarian Cancer from an early stage CLEO DIAGNOSTICS • cleodx.com Over 15 years of funded research confirm it to be a robust indicator across all stages of Ovarian Cancer Dr Andrew Stephens Superior perf
Slide 9: Role of CXCL10 in Ovarian Cancer Development
ROLE OF CXCL10 IN OVARIAN CANCER DEVELOPMENT CLEO’s biomarker, CXCL10, plays a pivotal role in the immune system’s ability to recognise and attack Ovarian Cancer in its early stages 1. Tumour 2. Immune 3. Immune Why CXCL10 Matters Initiation Disruption Suppression CLEO DIAGNOSTICS • cleodx.com • Ear
Slide 10: Disruptive Patented Technology
DISRUPTIVE PATENTED TECHNOLOGY CLEO has developed a proprietary algorithm underpinned by its novel biomarker, CXCL10, which can be used to detect the presence of Ovarian Cancer from a patient’s blood sample CLEO DIAGNOSTICS • cleodx.com BLOOD SAMPLE PATHOLOGY LAB CLEO’s RESULT TECHNOLOGY Multi-bioma
Slide 11: Materially Outperforms Existing Pre-Surgical Tests
MATERIALLY OUTPERFORMS EXISTING PRE-SURGICAL TESTS CLEO’s test outperforms all other clinical tools currently in-use, regardless of menopausal status Sensitivity of CLEO’s Pre-Surgical Test vs Other Tests1 CLEO’s Competitive CLEO DIAGNOSTICS • cleodx.com 100.0% 98.5% Advantage 84.4% 81.7% 79.0% 79.0
Slide 12: UKCTOCS: The Largest Ovarian Cancer Screening Trial
UKCTOCS: THE LARGEST OVARIAN CANCER SCREENING TRIAL Collaboration Agreement a Major Step Forward for CLEO’s Screening Test Development Program The performance data and • UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) was conducted at University College London (UCL) with the aim to eval
Slide 13: Ovarian Cancer Is Known as the Silent Killer
Ovarian Cancer is known as CLEO DIAGNOSTICS • cleodx.com "the silent killer" due to its non-specific symptoms which often go untreated 13 13
Slide 14: Significant Total Addressable Market
SIGNIFICANT TOTAL ADDRESSABLE MARKET CLEO is strategically targeting three key markets in phased execution, with the goal to establishing a transformative mass screening market where none currently exists today PRE-SURGICAL MARKET RECURRENCE MARKET SCREENING MARKET CLEO DIAGNOSTICS • cleodx.com 1M 1
Slide 15: Pathway to Market
PATHWAY TO MARKET CLEO has advanced-stage Ovarian Cancer detection technology with line of sight to first revenue Technology Design Commence AUS Alpha Testing Commercial FDA Transfer Transfer Clinical Trial Completion Scale-up Submission Biomarker Clinical Validation FDA Pre-Submission Commence U.S.
Slide 16: Commercial Model
COMMERCIAL MODEL CLEO will operate out of the U.S. through a B2B sales model to maximise patient accessibility, increase market adoption and maximise margins B2B sales model CLEO DIAGNOSTICS • cleodx.com Cost efficient Higher Mass PATHOLOGY MANUFACTURER market PATIENT distribution LAB & DISTRIBUTOR
Slide 17: Investment Summary
INVESTMENT SUMMARY Disruptive patented technology for the early detection of Ovarian Cancer CLEO DIAGNOSTICS • cleodx.com Significant opportunity to deliver a much-needed solution to women globally Superior performance to existing tests supported by published clinical studies Staged execution strate
Slide 18: Management Team
MANAGEMENT TEAM Highly experienced team focused on execution Board of Directors Core Team ADRIEN DR RICHARD DR ANDREW LUCINDA PROFESSOR DAYNA NATHAN EMMA WING ALLMAN STEPHENS NOLAN TOM JOBLING LOUCA HODGSON LESTER Non-Executive Executive Director Executive Director Non-Executive Executive Director H
Slide 19: Cleo Diagnostics Limited
cleodx.com Cleo Diagnostics Limited ASX:COV ACN 655 717 169 office@cleodx.com +61 3 9614 0600 Level 2, 480 Collins Street, Melbourne, VIC, 3000 Richard Allman Chief Executive Officer richard.allman@cleodx.com Andrew Stephens Chief Scientific Officer andrew.stephens@cleodx.com Dayna Louca Head of Cor
Slide 20: Appendix One: Evidence Base
APPENDIX ONE: Evidence Base RESEARCH PAPERS 1. Stephens AN, Hobbs SJ, Kang S-W, Oehler MK, Jobling TW, Allman R (2024). Utility of a Multi-Marker Panel with Ultrasound for Enhanced Classification of Adnexal Mass. Cancers doi: 10.3390/cancers16112048 2. Stephens AN, Hobbs SJ, Kang S-W, Bilandzic M, R
Slide 21: Appendix Two: Clinical Trials for Pre-Surgical Test
APPENDIX TWO: Clinical Trials for Pre-Surgical Test ONGOING TRIALS TRIAL OBJECTIVES & END POINTS 1. 2. 3. 4. CLEO DIAGNOSTICS • cleodx.com U.S. Clinical Trial AUS Clinical Trial Determine the Correlate post- Demonstrate Collect robust CLEO adnexal mass surgical pathology superiority of the clinical
Slide 22: Appendix Three: Current Standard of Care
APPENDIX THREE: Current Standard of Care Currently, no diagnostic or screening test exists for Ovarian Cancer Research shows most women with Ovarian Cancer were seeing their doctor about symptoms for more than six months before they received a diagnosis CLEO DIAGNOSTICS • cleodx.com CA125 Unexplaine