Cleo Diagnostics (ASX:COV) Investor Overview

Overview

A medical know-how firm based mostly in Australia, Cleo Diagnostics (ASX:COV) is revolutionising ladies’s healthcare with its disruptive most cancers detection platform know-how, by a easy blood take a look at that may precisely detect ovarian most cancers early – the main reason for cancer-related deaths amongst ladies.

Roughly 50 p.c of girls will die inside 5 years of an ovarian most cancers prognosis. The possibilities of survival past 5 years, nonetheless, enhance with early detection. In accordance with the American Most cancers Society, solely about 20 p.c of ovarian cancers are identified at an early stage, and greater than 90 p.c of girls dwell past 5 years when the most cancers is detected early.

With early prognosis being key to the next survival charge, ovarian most cancers has develop into a goal for biomarker analysis. And one specific biomarker holds promise.

Cleo’s know-how is underpinned by the CXCL10 novel and patented biomarker, which was first recognized as a small inflammatory molecule in ovarian most cancers tissue sections. Subsequent analysis demonstrated that CXCL10 was overexpressed in ovarian cancers, however importantly not expressed in benign illness, and stays all through the lifetime of the most cancers. The biomarker successfully supplies a sturdy indicator in any respect levels of most cancers. Recognizing that early detection is a considerably unmet want within the medical diagnostics market, Cleo Diagnostics is targeted on bringing to market a easy blood take a look at to precisely detect ovarian most cancers early.

Cleo’s first medical validation research for its ovarian most cancers triage take a look at has been revealed within the peer-reviewed worldwide journal Cancers. The article concluded that Cleo’s ovarian most cancers take a look at was extremely correct with 95 p.c sensitivity and 95 p.c specificity, appropriately discriminated malignant from benign samples, and has outperformed and was superior to present medical strategies. The second peer-reviewed dataset has additionally been revealed within the medical journal Diagnostics, which concluded that CLEO’s take a look at has appropriately recognized most most cancers circumstances that have been missed by the usual marker CA125. It additionally eradicated nearly all of “false optimistic” outcomes brought on by CA125 use, and it appropriately recognized nearly all of sufferers with early-stage ovarian cancers.

CLEO has appointed New York-based healthcare trade consultancy, HcFocus, to assist the graduation of its US market entry program. HcFocus will present specialised and strategic experience to help CLEO in navigating the complexities of the US well being system and regulatory setting.

The addressable marketplace for a know-how like that is compelling, and with a administration crew that brings to the desk many years of management expertise within the medical know-how area, Cleo is well-positioned to leverage this market alternative.

Cleo chief government and government director Dr. Richard Allman has over 30 years of expertise in commercially targeted scientific analysis and innovation. All through his profession, Allman has overseen and expedited a product growth pipeline protecting at least six main cancers, heart problems, type-2 diabetes and a commercially accessible COVID-19 take a look at.

Chief scientific officer Dr. Andrew Stephens boasts an equally spectacular resume. A profession analysis scientist with 20 years of expertise in molecular and mobile biology, Stephens is called in over 60 educational publications and holds quite a few patents within the most cancers remedy and diagnostic area. Cleo’s blood take a look at appears to be like for a novel and patented biomarker within the blood known as CXCL10, which was found by Stephens, the product of over ten years of scientific work at Monash Medical Centre’s Hudson Institute of Medical Analysis.

There’s additionally Professor Tom Jobling, Cleo’s non-executive director and lead medical advisor. As the pinnacle of gynaecological oncology at Monash Well being and visiting medical officer on the Peter MacCallum Most cancers Centre, Jobling has been treating ovarian most cancers for over thirty years. He was additionally the founding chairman of the Ovarian Most cancers Analysis Basis (OCRF)

Non-executive director Lucinda Nolan, in the meantime, brings important enterprise and strategic experience to the desk. Most lately, she served because the CEO of the Ovarian Most cancers Analysis Basis.

These skilled professionals, along with the opposite members of Cleo’s administration and board, have developed a staged execution technique targeted on de-risking the pathway to the worldwide screening market — guaranteeing that, though Cleo continues to be in its superior R&D stage, its prospects for commercialisation stay extremely promising.

Firm Highlights

• Backed by medical professionals and most cancers specialists with many years of expertise, Cleo Diagnostics has developed a disruptive, correct and early-stage ovarian most cancers detection blood take a look at.
• Cleo targets the CXCL10 novel biomarker, which is now recognized to be overexpressed in all levels of ovarian most cancers.
• Cleo is the results of greater than a decade of analysis on the Hudson Institute of Medical Analysis, the place chief scientist Dr. Andrew Stephens acquired greater than $5 million OCRF & NHMRC funding for growth and medical research.
• The take a look at can be supported by Professor Tom Jobling, founding father of the Ovarian Most cancers Basis and Lucinda Nolan, the muse’s former CEO.
• Cleo has developed a staged execution technique targeted on an achievable path to market. This ensures the mission, which is at the moment in its superior R&D stage, can maximise business worth for all stakeholders.

Developed over a decade by Dr. Andrew Stephens, Cleo’s blood take a look at is underpinned by the CXCL10 novel and patented protein biomarker recognized to be current in all levels of ovarian most cancers. By combining CXCL10 with a number of different biomarkers in a customized algorithm, Cleo cannot solely be utilized in triage, but additionally for screening and recurrence testing. The mission is at the moment within the superior R&D stage and has to date carried out two medical research, analysing greater than 700 affected person samples within the course of.

Highlights:

• Readily Accessible: Cleo requires no further or specialised gear and could be carried out in any normal pathology lab both by itself or as a part of an ordinary panel of exams ordered by a doctor.
• AI-based Threat Evaluation: As soon as the pattern has been collected and examined, Cleo leverages a proprietary algorithm to carry out a threat analysis on the affected person, figuring out the probability of a most cancers prognosis.
• Intuitive Outcomes: Cleo generates an easy-to-understand post-assessment report which might then be despatched to the affected person’s major care supplier or surgeon for triage.
• Excessive Efficiency: The Cleo prototype outperforms FDA-cleared predicates and medical guideline exams by way of accuracy and specificity.
• Present Roadmap: Cleo plans for the take a look at to be prepared for medical use in a surgical triage setting by 2025, the place will probably be accessible initially to 1 million sufferers. Goal launch dates for recurrence, high-risk screening and mass screening are nonetheless to be decided. Moreover, the corporate has quite a few inflection factors deliberate over the following two years:
  • Package Improvement:
    • Inner trial antibody optimisation
    • Finalisation of antibody choice for the Cleo test-kit
    • Full re-agent growth
    • Pre-IDE strategic growth
  • Manufacturing:
    • Institution and accreditation of ISO13485 high quality system
    • Manufacturing institution of Cleo key biomarker
    • Manufacturing institution of Cleo Ovarian Most cancers Package
  • Scientific Research:
    • Signal key opinion leaders and trial websites
    • Carry out and finalise verification of the Cleo package by medical research
  • Regulatory Approval:
    • FDA Pre-IDE submission
    • CE regulatory submissions and approval
    • TGA regulatory submission and approval
    • FDA submission and approval

Constructive Peer Evaluations: Cleo’s first medical validation research for its ovarian most cancers triage concluded that the ovarian most cancers take a look at was extremely correct with 95 p.c sensitivity and 95 p.c specificity. It has appropriately discriminated malignant from benign samples, and out-performed and was superior to present medical strategies. The second peer-reviewed dataset concluded that CLEO’s take a look at has appropriately recognized most most cancers circumstances that have been missed by the usual marker CA125. It additionally eradicated nearly all of “false optimistic” outcomes brought on by CA125 use, and it appropriately recognized nearly all of sufferers with early-stage ovarian cancers.

Cleo is bringing to market three examsfor ovarian most cancers prognosis, monitoring and screening.

Administration Crew

Dr. Richard Allman — Chief Govt Officer and Govt Director

Dr. Richard Allman has over 30 years of scientific analysis management and innovation with a transparent give attention to commercialisation. He has huge expertise in analysis management, innovation administration, and mental property technique, protecting oncology, diagnostics, and product growth.

Beforehand, Allman was chief scientific officer at Genetic Applied sciences (ASX:GTG). Current successes embody the strategic design and administration of a second-generation breast most cancers threat evaluation take a look at from idea to business launch and an analogous take a look at for colorectal most cancers. These exams have now been NATA-accredited and comprise the primary commercially accessible polygenic threat exams in Australia.

Extra lately, Allman supervised the underlying R&D, translation, regulatory approval, patent submitting and business launch of a COVID-19 illness severity take a look at inside 12 months. This technique has been utilised to expedite a product growth pipeline protecting six main cancers, heart problems and type-2 diabetes which have been commercially launched in March 2022.

Dr. Andrew Stephens — Chief Scientific Officer and Govt Director

Dr. Andrew Stephens is a profession analysis scientist with 20 years of expertise in molecular and mobile biology analysis. He has broad expertise in educational and pre-clinical analysis and a powerful give attention to translation and the commercialisation of analysis findings. He established and leads an unbiased educational analysis group on the Hudson Institute of Medical Analysis, investigating mechanisms that contribute to the formation, development and dissemination of high-grade, serous epithelial ovarian cancers. Since 2010, his analysis has targeted on biomarker identification and growth in ovarian most cancers and the event of therapeutic methods to enhance affected person outcomes. He’s additionally actively concerned throughout the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.

Stephens has greater than 60 educational publications and quite a few patents (pending and provisional) within the most cancers therapeutic and diagnostic area.

Professor Tom Jobling — Lead Medical Advisor and Non-executive Director

Professor Thomas Jobling is director of gynaecologic oncology at Monash Medical Centre. He graduated from Monash College in 1980 and did his postgraduate sub-specialist coaching in gynaecologic oncology in London on the Royal Marsden and St Bartholomew’s hospitals. Jobling has subsequently been elected as a member of the Society of Pelvic Surgeons and can be founding father of the Ovarian Most cancers Analysis Basis (1999). He was the chairman of the Ovarian Most cancers Analysis Basis Board. His main pursuits are in radical surgical procedure for ovarian most cancers and the appliance of robotic surgical procedure for gynaecological malignancy.

Jobling is an energetic member of a analysis crew in biomarker detection and proteomics in ovarian most cancers. He’s concerned as a collaborative investigator on quite a few worldwide medical trials and is a member of the Australia and New Zealand Gynaecologic Oncology Group, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Group and the Worldwide Society of Gynaecological Most cancers.

Lucinda Nolan — Non-executive Director

Lucinda Nolan is a non-executive director and was most lately the CEO of the Ovarian Most cancers Analysis Basis. She has a wealth of information and expertise throughout the general public sector and not-for-profit environments. Earlier than becoming a member of the Ovarian Most cancers Analysis Basis, she was chosen as the primary feminine CEO of the Nation Hearth Authority, one of many world’s largest volunteer-based emergency companies organisations. She additionally spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.

Nolan can be the chair of BankVic and a director on the boards of Alkira Field Hill and the Melbourne Archdiocese of Catholic Faculties. She has a Grasp of Arts and a Bachelor of Arts (Honours) from Melbourne College and is an alum of the Superior Administration Programme at Harvard College.

Adrien Wing — Non-executive Chair

Adrien Wing started his skilled profession practising within the audit and company advisory divisions of a chartered accounting agency. He has over 25 years of expertise within the company sector with a big portion of this expertise in ASX small caps, lead in IPO transactions and publish itemizing reverse takeovers and acquisitions throughout a spread of trade sectors and jurisdictions. He additionally has a powerful pedigree within the life sciences trade being the founding father of Rhythm Biosciences and bringing that entity to the ASX in 2017.

Wing at the moment serves as an officer/director on the next firm boards: New Age Exploration (ASX: NAE), director and joint firm secretary; Purple Sky Vitality (ASX:ROG), director and joint firm secretary; Sparc Applied sciences (ASX:SPN), firm secretary; and Osmond Sources (ASX:OSM), firm secretary.