AU/NZ
Dr Bill Ketelbey CEO & MD of Actinogen Medical Limited

Dr Bill Ketelbey

CEO & MD

Dr Bill Ketelbey

CEO & MD

Actinogen Medical Limited (ASX:ACW)

Market Cap (AUD)
35.87M
Last Trade (AUD)
Sector
Health Care
Market
ASX
  • 1. About

    Actinogen Medical is an ASX-listed biotechnology company developing innovative treatments for Alzheimer’s disease and the cognitive decline associated with neurodegenerative diseases and metabolic diseases, like Type 2 diabetes.

     

    Our management team, clinical and scientific advisory boards include world-renowned Alzheimer’s disease and dementia researchers, and industry specialists in drug design and clinical trial management.

     

    Actinogen Medical’s drug candidate XanamemTM has been specifically designed to block the production of cortisol in the brain. Drugs that reduce cortisol in the brain offer a promising new approach to slowing, or even preventing, the cognitive decline associated with Alzheimer’s disease. Additionally, the underlying mechanism of action through the inhibition of cortisol, offers Xanamem a broad platform of significant additional disease applications for which it can be developed, including diabetes cognitive impairment, PTSD and post-myocardial infarction.

     

    Actinogen Medical is currently conducting XanADu, a Phase II double-blind, 12-week, randomised, placebo-controlled study to assess the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer’s disease. XanADu, will enrol 174 patients at 20 research sites across Australia, the UK and the USA.

     

    Recruitment and treatment of patients started in 2017, with results expected in early 2019.

     

    For more information visit www.actinogen.com.au

    For more information on the XanADu trial visit www.clinicaltrials.gov with identifier: NCT02727699

    2. Business model

    The company is registered as Actinogen Limited, and trades as Actinogen Medical as a single entity. The company is in the clinical research phase of developing its lead research compound as a promising new treatment for Alzheimer’s disease:[1]

     

    Business

    Revenue ($)

    % of Revenue

    % of Loss

    (before Tax)

    Profit drivers

    Actinogen Medical

    $155,768

    100%

    100%

    The Company has not commercialised its operation. It is in clinical research, phase II

    3. Strategy

    Key strategies include:

     

    • Completing the clinical development of Xanamem, the company's very promising research compound for Alzheimer’s disease. XanADu, the definitive proof-of-concept Phase II study of Xanamem in mild Alzheimer’s disease, is currently enrolling patients. It is being conducted at 20 research sites in the USA, the UK and Australia, with regulatory approval under and IND received from the FDA in the US, and with similar regulatory approvals from the authorities in the UK and Australia.

     

    • The last patient is expected to be enrolled in Q4 2018, with top-line results available in Q1 2019.

     

    • The nature of Xanamems mechanism of action, through inhibiting the production of cortisol, opens up a broad platform of potential additional indications over and above Alzheimer’s. Additional potential uses for the product under evaluation include, diabetes cognitive impairement, PTSD, Parkinson’s associated dementia, cognitive decline associated with schizophrenia and depression and post-myocardial infarction. While Alzheimer’s disease remains the primary focus for the development of Xanamem, these other indications are being evaluated for concurrent development.

    4. Markets

     

    Indications

    Pharma Industry annual revenue (global)

    Growth rate – Alzheimer’s population

    Alzheimer’s disease

    US$14bn+

    Doubling every 20 years

     

    Industry (Australia)

    Industry Revenue (2015)

    Growth Rate (annual 10-15)

    Biotechnology

    $7 billion

    3.5%

     

    [2]

    5. Competition

    Many major Big Pharma companies are currently undertaking Alzheimer’s research, as are numerous smaller biotechs. Importantly, none of this ongoing research is directly competitive to Xanamem. None is as advanced as Actinogen in actively researching cortisol inhibition as a potential therapy for Alzheimer’s disease. Additionally, Alzheimer’s treatment will likely be combination therapy for the foreseeable future, targeting the disease from a number of directions. Consequently, Actinogen does not consider any of the current Alzheimer’s research to be in direct competition to Xanamem.

    6. History

    2007   
    Actinogen’s lead treatment candidate Xanamem™ was discovered by professors Brian Walker and Scott Webster at the University of Edinburgh. Seven major patent families registered protecting the IP.

     

    Nov. 2014   
    Actinogen acquires the global licence for Xanamem from the University of Edinburgh University.

     

    Dec. 2014   
    Dr Bill Ketelbey employed as CEO and Managing Director.

     

    2015/2016   
    Actinogen successfully completes all the clinical stages of the pre-clinical and Phase I studies necessary for the definitive Phase II trial in mild Alzheimer’s disease.

     

    2016/2017

    Actinogen completes the design for XanADu, their Phase II proof-of-concept study of Xanamem in mild Alzheimers disease, and applies for regulatory approval from the authorities in the USA, UK and Australia. All approvals are received in late 2016 and early 2017.

     

    2017

    ICON, the CRO selected to conduct the study, initiates XanADu, with the first patient recruited in May 2017. As at end September, 34 patients had been enrolled into XanADu. 

    [3]  [4]

    7. Team

    Board of Directors [5]

     

    Dr Geoff Brooke - Chairman

    Dr Brooke is a clinically trained physician turned venture capitalist with over 30 years’ experience in the healthcare investment industry. He was the founder and managing director of two venture capital firms, Medvest Inc and GBS Venture Partners, which is viewed as one of the Asia Pacific region’s premier healthcare venture investors.

    Dr Brooke has been a major investor, chairman or director of companies in the healthcare sector with a combined realised value of $1.5 billion. Dr Brooke’s expertise includes assisting high growth technology-based companies in areas such as development strategy, clinical trial design, fund raising, management structuring and investment exits.

    Dr Brooke is a medical graduate of the University of Melbourne and has an MBA from IMEDE (now IMD), Lausanne Switzerland.

     

    Dr. Bill Ketelbey - CEO & Managing Director

    Dr Ketelbey has more than 30 years’ experience in the healthcare, biotech and pharmaceutical industries, including senior medical and management roles in the Asia Pacific Region with global pharmaceutical company Pfizer.

    Dr Ketelbey has a solid track record of product development over his years in the industry leading to the successful registration, launch and commercialisation of numerous market leading medicines in a broad range of therapeutic areas, including in Alzheimer’s Disease. Dr Ketelbey led the local clinical development, and was involved in the commercialisation, of Aricept™ (donepezil), the market-leading Alzheimer’s disease therapy

    Dr Ketelbey is a medical graduate from the University of the Witwatersrand, South Africa and a Fellow of the Faculty of Pharmaceutical Physicians from the Royal College of Physicians in the United Kingdom. He also has an MBA from Macquarie Graduate School of Management, Australia, and is a Graduate of the Australian Institute of Company Directors.

     

    Dr. Jason Loveridge - Non-Executive Director

    Dr Loveridge has been working in the biomedical technology industry for over 20 years and has extensive experience in developing clinical stage biotechnology companies. As a venture investor with JAFCO Nomura, Dr Loveridge participated and invested in the start-up of over 24 companies in Europe, the United States and Israel. Since 2005, he has been directly involved in senior management of a number of small innovative companies in the biomedical field, specifically in refinancing and product commercialisation.

    In addition to Actinogen Medical, Dr Loveridge is also a Non-Executive Director of Resonance Health (ASX: RHT) and CEO of German based biopharmaceutical company 4SC AG.

    Dr Loveridge holds a PhD in Biochemistry and is a fellow of the Royal Society of Medicine.

     

    Vincent Ruffles - Vice President of Drug Development

    Mr Ruffles has 22 years of experience in the pharmaceutical and biotechnology industries, and has worked in the UK, Switzerland and Australia across all phases of the drug development cycle. He has taken several drugs through clinical development and has extensive experience in Alzheimer’s disease and related therapeutic areas. Mr Ruffles’ recent role in a global contract research organisation (CRO) has given him great exposure to the Asia-Pacific region and a variety of companies, including start-up pharmaceutical companies with limited resources but significant acquisition potential.

    Mr Ruffles is responsible for providing overall operational oversight of the manufacture, non-clinical and clinical research and regulatory strategy of Xanamem.

     

    Peter Webse - Company Secretary

    Mr Webse has over 25 years of company secretarial experience and is the managing director of Platinum Corporate Secretariat Pty Ltd, a company specialising in providing company secretarial, corporate governance, and corporate advisory services. Mr Webse also is a non-executive director of Cynata Therapeutics Limited.

    8. Financials

    Financial Year 2014/2015 (ended 30 June): [6]

     

    Business

    Revenue ($)

    % Change

     

    Loss (before Tax) ($)

    % Change

    Actinogen Medical

    $155,768

    -24%

    ($3,190,338)

    12%

    9. Risk

    Major risks include: [7]

     

    Market Risk

     

    Foreign Exchange Risk

    Foreign exchange risk arises from future commercial transactions and recognised assets and liabilities denominated in a currency that is not the entity’s functional currency and net investments in foreign operations. During the financial year, the Company acquired Corticrine Limited, a company located in the United Kingdom. The subsidiary’s cash and cash equivalents are denominated in Great British Pounds.

     

    Price Risk

    Equity price risk represents the risk that the value of a financial instrument will fluctuate as a result of changes in market prices, whether those changes are caused by factors specific to the individual instrument or its issuer or factors affecting all instruments in the market.

     

    Interest Rate Risk

    The Company’s main interest rate risk exposure relates primarily to the Company’s cash at bank and funds held on deposit that are both held with variable interest rates.

     

    Credit Risk

    Credit risk is the risk of financial loss to the Company if a counterparty to a financial instrument fails to meet its contractual obligations. The Company’s main credit risk exposure relates to the financial assets of the Company, which comprise cash and cash equivalents and trade and other receivables. The Company’s exposure to credit risk arises from potential default of the counterparty, with the maximum exposure equal to the carrying amount of these instruments.

     

    Liquidity Risk

    Liquidity risk is the risk that the Company will not be able to meet its financial liabilities as and when they fall due.

     

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