AU/NZ
Bill Ketelbey CEO of Actinogen Medical Limited

Bill Ketelbey

CEO

Bill Ketelbey

CEO

Actinogen Medical Limited (ASX:ACW)

Market Cap (AUD)
39.07M
Last Trade (AUD)
Sector
Health Care
Market
ASX
  • 1. About

    Actinogen Medical is focused on the treatment of Alzheimer's disease and mild cognitive impairment, a transitional stage of cognitive impairment between normal aging and the more serious conditions of Alzheimer's and dementia. Actinogen Medical is developing a novel drug to treat the condition and other age-related neurodegenerative diseases. Chronically elevated cortisol in the brain is associated with cognitive impairment, amyloid plaquing and neural death – the hallmarks of Alzheimer's disease. Actinogen Medical’s lead candidate drug, XanamemTM, blocks the production of cortisol in the brain. In 2015, the company completed a second placebo-controlled double-blind Phase I trial in 40 healthy volunteers (36 blinded). Previously, an additional 48 healthy volunteers participated in a placebo-controlled double-blind Phase I study in the United Kingdom. These studies confirm that Xanamem™ is appropriately safe and well tolerated across the dosage range. Actinogen Medical is now well advanced with plans to initiate a Phase II study in mild Alzheimer's disease patients in 2016. This study will be run in Australia, the United Kingdom, and the United States, under an FDA approved IND.[1]

    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:[2]

     

    Business

    Revenue ($)

    % of Revenue

    % of Loss (before Tax)

    Sales and distribution model

    Profit drivers

    Actinogen Medical

    $49,927

    100%

    100%

    Compound in research phase II

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

    3. Strategy

    Key strategies include:

     

    • The clinical development of Xanamem, the companies very promising lead compound for Alzheimer’s disease. The definitive proof-of-concept Phase II study in mild Alzheimer’s disease is expected to start recruiting patients in Q2 2016, and will be run under an FDA approved IND in the US, and similar regulatory approval, to run the study in Australia and the UK as well.

     

    • A very successful capital raising in May 2015 raised nearly $11m, which, along with the Commonwealth Government R&D rebate, will provide adequate funds to run the Phase II study to completion. The study results are expected to read out around the end of 2017.

     

    • 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, PTSD, Parkinson’s associated dementia, cognitive decline associated with schizophrenia and depression, post-myocardial infarction and diabetic foot ulceration. 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%

     

    [3]

    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 professor Brian Walker and Dr. Scott Webster at the University of Edinburgh. Seven major patent families registered protecting the IP.

     

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

     

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

     

    Sep. 2015   
    Actinogen successfully completed all the clinical stages of the pre-clinical and Phase I studies necessary for the definitive Phase II trial in mild Alzheimer’s disease, expect to start in Q2 2016.

     

    [4]  [5]

    7. Team

    Board of Directors [6]

     

    Martin Rogers - Chairman

    A well-recognised Australian Biotechnology entrepreneur and executive, Mr. Roger has a depth of experience in incubating companies and publicly listed organisations, with degree in Chemical Engineering and Science.

     

    Experienced in all aspects of financials, strategic and operational management, he has helped raise over $100m cash equity. Both an investor and senior executive in a private funded advisory business, he was instrumental in significantly increasing the value of investments in the science and biotechnology sectors.

     

    Mr. Roger is currently Non-Executive Director of Oncosil (ASX: OSL), Chairman of Rhinomed Ltd (ASx: RNO), and holds a number of not-for-profit roles.

     

    Dr. Bill Ketelbey - CEO & Managing Director

    Dr Bill Ketelbey is a highly experienced and successful healthcare and pharmaceutical sector professional, with 30 years’ experience in the industry, including most recently in senior medical and management roles with global pharmaceutical giant, Pfizer’s Primary Care Business Unit for Australia and New Zealand, Japan, Canada, Korea and Country Medical Director for Pfizer Australia and New Zealand.

     

    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. At Pfizer, Dr. Ketelbey lead the Australian/New Zealand clinical development, and was involved in the launch and commercialisation of AriceptTM  (Denepezil), an acetylcholinesterase inhibitor, the market leading Alzheimer’s disease therapy locally and globally. More recently he was involved in developing monoclonal antibodies directed at amyloid plaques, a hallmark of Alzheimer’s.

     

    Dr. Ketelbey is a medical graduate from the University of the Witwatersrand, South Africa, a fellow of the Faculty of Pharmaceutical Physicians from the Royal College of Physicians in the UK, 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 biotechnologies companies. As a venture investor with JAFCO Nomura, Dr. Loveridge participated and invested in the start-up of over 24 companies in Europe, the US and Israel. Since leaving the investment arena in 2005, he has been directly involved in the management of a number of a small innovative companies in the medical field, specifically in restructuring, refinancing and in product commercialisation.

     

    Dr. Loveridge is currently a Non-Executive Director of Resonance Health (ASX: RHT), an Australian healthcare company specialising in the development and commercialisation of magnetic resonance imaging (MRI) related technology.

     

    Dr. Anton Uvarov - Non-Executive Director

    Dr. Uvarov has significant experience as an equity analyst in healthcare sector, both domestically and internationally. Prior to moving to Australia he was with Citigroup Global Markets where he spent two years as a member of a New York based biotechnology team. Dr Uvarov has significant experience working with leading US institutional clients and a deep knowledge of healthcare industry including intellectual property, FDA and EMA regulations, reimbursement coverage, and clinical science.

     

    Dr. Uvarov holds a PhD in Biochemistry and Medical Genetics from the University of Manitoba and an MBA from the University of Calgary. He obtained his undergraduate degree from Moscow State University. Dr. Uvarov has also co-authored several peer-reviewed publications and abstracts on the mechanisms of intracellular protein degradation and its role in cancer and cardiovascular diseases.

     

    Dr. Uvarov is currently an Executive Director of Sun Biomedical Ltd.

     

    Vincent Ruffles - Vice President of Clinical Research

    Mr. Ruffles has nearly 20 years of experience in the pharmaceutical and biotechnology industries, and has worked across all phases of the drug development cycle. Mr. Ruffles began his career in the UK at Hoechst-Roussel (now Sanofi) and relocated to Geneva, Switzerland to work for Serono (now Merck Serono). After returning to the UK to work at Procter & Gamble and then Amgen, Vincent moved to Sydney, Australia in 2008.

     

    He has worked on several drugs taking them 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 has given him great exposure to the Asia Pacific region and a variety of companies and their needs including local start-up pharmaceutical companies with limited resources but significant potential and multinational clients.

     

    Mr. Ruffles will be responsible for providing the overall strategy, scientific and regulatory oversight and direction of clinical programs of Xanamem™.

     

    Peter Webse - Company Secretary

    Peter has over 23 years’ 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 is a non-executive director of Cynata Therapeutics Limited and Sun Biomedical Limited.

    8. Financials

    Financial Year 2014/2015 (ended 30 June): [7]

     

    Business

    Revenue ($)

    % Change

     

    Loss (before Tax) ($)

    % Change

    Actinogen Medical

    $49,927

    46%

    ($5,431,009)

    (1134%)

    9. Risk

    Major risks include: [8]

     

    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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