Cleo Diagnostics Ltd · ASX:COV
Cleo Diagnostics — Investor Presentation (February 2024)
21 slides from Cleo Diagnostics's investor presentation, Feb 20, 2024
Slide 1: Making earlier detection of ovarian cancer a reality
ASX : COV For personal use only Making earlier detection of ovarian cancer a reality CORPORATE PRESENTATION FEBRUARY 2024
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: Corporate Overview and Capital Structure
Corporate Overview Capital Structure ASX Ticker COV Cleo Diagnostics is making accurate Share Price (12 February 2024) $0.18 Shares on Issue 128.5M and early detection of ovarian Options 14M cancer a reality. For personal use only Market Capitalisation (fully diluted) $23M Cash (as at 31 December 20
Slide 4: Cleo Diagnostics
For personal use only Cleo Diagnostics Is bringing to market a simple blood test to accurately detect Ovarian Cancer early. Cleo Diagnostics Ltd | Corporate Presentation February 2024 | 4 ASX : COV
Slide 5: Why Cleo Diagnostics
Why Cleo Diagnostics : A simple blood test for accurate and early detection of Ovarian Cancer For personal use only Significant global total addressable cancer diagnostics market opportunity Technology supported by gold-standard clinical evidence Strong intellectual property position with core found
Slide 6: Ovarian cancer: the deadliest of all female reproductive cancers
Ovarian cancer: the deadliest of all female reproductive cancers Accurate and early detection of ovarian cancers will significantly increase survival ● DIFFICULT to detect and diagnose For personal use only ● POOR SPECIFICITY of existing tests ● NO SCREENING for early disease detection New cases 300
Slide 7: Current Standard Of Care is Inadequate
Current Standard Of Care is Inadequate ● CA125 biomarker has only ~50% accuracy for detection of early stage cancer ● ULTRASOUND + CA125 (gold standard clinical care) is incorrect >20% of the time ● NO SCREENING TEST exists for early disease detection For personal use only Diagnosis only occurs foll
Slide 8: Cleo Technology: How it works
Cleo Technology: How it works ASX: COV BLOOD TEST Blood collected via a simple blood draw. Part of a standard panel of tests ordered by RESULT a doctor. An easy to understand Report is prepared and sent to the patient’s doctor for surgical For personal use only triage CleoDX Technology Test-Kit Algo
Slide 9: Cleo Diagnostics: World-class Technology
Cleo Diagnostics : World-class Technology CleoDX technology is underpinned by the CXCL10 novel biomarker PROTOTYPE TRIAGE TEST CXCL10 novel biomarker discovered in Ovarian cancers For personal use only 5-biomarker panel for cancer detection: Over-expressed in ovarian cancers Specificity = 95% Sensit
Slide 10: Cleo AdnexaSure: Outperforms existing clinical tests
Cleo AdnexaSure : Outperforms existing clinical tests Exceptional performance in both Pre- and Post-Menopausal women Sensitivity @ 90% Specificity Pre-Menopausal Sensitivity @ 90% Specificity Post-Menopausal 100 100 90 90 For personal use only 80 80 70 70 60 60 50 50 40 40 30 30 20 20 10 10 0 0 Cleo
Slide 11: Generating Gold-standard Clinical Evidence
Cleo Diagnostics : Generating Gold-standard Clinical Evidence Building a portfolio of peer-reviewed scientific evidence backed by over 10 years of scientific Research & Development at the Hudson Institute of Medical Research, with two clinical studies For personal use only conducted in over 500 pati
Slide 12: Significant global total addressable market opportunity
Significant global total addressable market opportunity Staged execution strategy with initial focus on triage test de-risks pathway to national screening market. Initial Market 1 Market 2 Market 3 2025 TBC TBC Surgical Triage Test Recurrence Test High Risk Screening Screening Program Priority Count
Slide 13: Understanding the Medical Guidelines and Triage Market
Understanding the Medical Guidelines and Triage Market Diagnostic Workflow ASX: COV • Symptoms review Initial assessment • Physical examination • Family & medical history For personal use only UK Australia, USA (NICE NZ (ACOG • CA125 is used off label for surgical triage guidelines) (RCOG guidelines
Slide 14: Designing Tests That Make a Difference
Cleo Diagnostics : Designing Tests That Make a Difference Cleo is bringing to market three tests, to address the clinical unmet worldwide need for ovarian cancer diagnosis, monitoring and screening. Cleo’s technology exploits the novel blood marker “CXCL10” that is found at high levels in ovarian ca
Slide 15: Cleo Diagnostics: Path to Market
Cleo Diagnostics : Path to Market Staged execution strategy with initial focus on triage test de-risks pathway to national screening market For personal use only Note: The timeline is indicative and subject to change. Cleo Diagnostics Ltd | Corporate Presentation February 2024 | 15 ASX : COV
Slide 16: Developing the Clinical Implementation Pathway
Cleo Diagnostics : Developing the Clinical Implementation Pathway Clinical Studies Cleo is developing a multi- For personal use only Clinical Guidelines International Collaborations faceted strategy to facilitate clinical Early Adopters implementation & early revenue generation Regulatory KOL Approv
Slide 17: A clear focus on delivery and execution
A clear focus on delivery and execution Post IPO Milestones Achieved ● Foundational CXCL10 Patent Granted in USA For personal use only ● Triage Test biomarker panel finalized ● In-house performance verification of CXCL antibodies complete ● Proprietary provisional patent filed covering the Triage Te
Slide 18: Catalyst rich path to first test product - AdnexaSure
Catalyst rich path to first test product - AdnexaSure Numerous inflection points planned over next 24 months 2023/24 2024/25 For personal use only • Sign clinical trial sites • Establish & accreditation of ISO13485 quality system • Commence Australian Trials • Perform & finalise validation of the Cl
Slide 19: The Team to Execute
The Team to Execute Experienced team with deep domain experience For personal use only ADRIEN DR RICHARD ALLMAN DR ANDREW STEPHENS LUCINDA PROFESSOR WING NOLAN TOM JOBLING Non-Executive Executive Director Executive Director Non-Executive Executive Director Chairman and CEO and CSO Director and Medic
Slide 20: Summary
Summary ● Owner of world-class technology ● Building a team to deliver For personal use only ● Designing tests that make a difference ● Generating Gold-Standard clinical evidence ● De-risking the path to market with a staged execution strategy ● Experienced leadership team with credentials to execut
Slide 21: Contact
Richard Allman CEO richard.allman@cleodx.com Adrien Wing Chairman office@cleodx.com For personal use only Elvis Jurcevic Investor Relations ej@cleodx.com 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 2
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