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Pulmorphix Limited is a start-up company from Liverpool John Moores University (LJMU). We’ve developed what we believe is the world’s first ‘lung biosimulator’ – a device that replicates the conditions deep in the human lung. We’ve already secured a £82,000 grant from the Technology Strategy Board, the UK Government’s innovation agency. As well as de-risking the project for investors, we think this is a big vote of confidence both for our technology and our ability to bring it successfully to market. The Board described the lung biosimulator as “highly innovative and potentially disruptive”, and agreed with us that there is a significant “unmet need” within the pharmaceutical industry. Using this technology, Pulmorphix intends to offer a commercial testing service to give drug developers a reliable way of understanding how their drugs will behave when inhaled.

TRANSCRIPT

  • 1. Supported By An Investment Opportunity
  • 2. PHARMACEUTICAL DRUGS SAVE LIVES Invest in Pulmorphix and make a difference 2 PULMORPHIX
  • 3. Join the Q&A Dr. Mike Davies Whats the problem? Dr. Mike Davies - The pharmaceutical industry needs an accurate replication of the in-vivo pulmonary environment (i.e. the deep lung) in order to develop new and better inhaled drugs. To date, there is no specific, industry-wide accepted technology for testing inhaled formulations. Such preparations are referred to as orally inhaled products (OIPs) and scientists have a drive to understand how these formulations behave in the body. To this end, crude methodologies are frequently employed that do not reflect the lung. The Pulmorphix lung biosimulator aims to address this issue. What are the advantages of delivering drugs via the lungs? Kish Mistry They require lower dosages, with improved patient outcomes; No need for needles avoiding e.g. daily injection of insulin for diabetes sufferers. No requirement for cold chain management (drugs in powder form dont need to be kept under a certain temperature - ideal for vaccination programmes in countries where refrigeration can be a real problem). Whats the solution? What kinds of conditions can be treated by inhaled drugs? Dr. Mike Davies - The technology was developed over the course of 6 years at Liverpool John Moores University, which supported the initial idea, prototype device development and experiments. Kish Mistry - The pharmaceutical industry is developing inhalation devices and formulations to deliver drugs to the lungs for a wide range of conditions; including for example diabetes and pain management. Great emphasis is also placed on Inhaled drugs have many advantages. optimising current products for They bypass the liver, leading to fewer improved patient outcomes and side effects; revenue generation. Dr. Mike Davies - Pulmorphix has the solution - via the worlds first lung biosimulator. Our device replicates the conditions in the deep lung and provides a reliable method for drug developers to test how their drugs will behave when inhaled into the lungs. How was the technology developed? Early conception and research within a University is useful, as it brings an academic rigour to the early development phase, and we have access to world-leading expertise in Pharmacy, Chemistry and related sectors. PULMORPHIX 3 PULMORPHIX 3
  • 4. Although some progress has been made in terms of technologies to improve the effect of inhaled drugs... This market need is backed up by our discussions with large and speciality pharmaceutical companies. 4 PULMORPHIX ...this alone is no longer sufficient for therapeutic success of inhalation drugs; a paradigm shift is needed, with an increased focus on pulmonary barriers to drug delivery. Lancet Respiratory Medicine 2013
  • 5. We have built the worlds first prototype lung biosimulator which can accurately replicate the deep lung environment. Our technology has been specifically designed to test orally inhaled products. We can control specific parameters such as: temperature humidity breathing fluid hydrodynamics lung fluid composition light .. so we can mimic the conditions in the deep lung where inhaled drugs start working PULMORPHIX 5
  • 6. People who suffer from diabetes have several problems to deal with on a daily basis, the most important of which is maintaining a healthy level of blood sugar in their bodies. IMAGINE if it were possible to treat diabetes In order to achieve this, the patient must inject insulin throughout the day and thus experience the associated discomfort with needle use. The repeated discomfort is not ideal and may be coupled with a fear of needles, which is particularly true in the case of young children. needle. As such, alternative methods of insulin delivery are currently being researched and inhaled insulin has been the topic of speculation within industry for a number of years. Pharmaceutical companies are continuing with their research in this field in order to produce an insulin inhaler similar to an asthma inhaler. The availability of a unit to spray insulin into the body would satisfy a market need and help numerous people manage their condition throughout the world. Transport of insulin through the lungs allows delivery across a surface area the size of a singles tennis court. 6 PULMORPHIX with an inhaler instead of a
  • 7. Dr. Mike Davies I first had a light bulb moment about 6 years ago, when I was attending a conference. One of the speakers mentioned that there was no established test for inhaled drugs. Given the interest in developing drugs in this area I decided to see if I could develop a device which would replicate the conditions in the lung where inhaled drugs get to work. Six years later, with help from the University, I have developed a second generation prototype which works really well. With further investment and grant funding we believe we can take this to market and help pharmaceutical companies develop better inhaled drugs. Kish Mistry I got involved in this project over a year ago, and immediately recognised that there was an unmet market need. have a background in the pharmaceutical industry and a good track record with start-up companies. So far Ive given my time to this project at a significantly reduced rate, since I genuinely believe we have a unique market opportunity, with really disruptive technology.
  • 8. The Tea Kish Mistry is an experienced business executive with extensive hands-on commercial responsibilities whilst at GSK and Serono. As CEO, he will be responsible for commercialising the technology platform. He will lead the development and growth strategy whilst directing resources within Pulmorphix to meet priorities and timelines Emma Nolan is an experienced IP Manager, with over 20 years experience in technology transfer - primarily managing inventions and patents in the University sector - working for Russell Group universities such as The University of Manchester and The University of Leeds. Emma is IP & Commercialisation Manager at LJMU and has supported this project since her move to LJMU in 2011. 8 PULMORPHIX Dr. Michael Davies is a UK registered Pharmacist and holds a PhD in Pharmaceutical Nanotechnology. He has experience of both academic (i.e. The University of Nottingham) and industrial (i.e. Bristol-Myers Squibb & AstraZeneca) sectors and has an in-depth understanding of prevalent human disease states, principles of disease management, routes of drug delivery to the body and methods routinely employed to assess formulation characteristics. This background has led to the vision and development of the Pulmorphix technology platform. Michael is currently employed at Liverpool John Moores University as a Senior Lecturer in Pharmacy Practice and Pharmaceutics, being in post for 7 years. Notable attributes of relevance to this business are: * Knowledge of pharmaceutics / industrial approaches to assess formulation suitability * Doctoral study focussed on drug delivery to the lung * Author of peer-reviewed articles relevant to pulmonary drug delivery * Project management within the laboratory setting * Translating research findings to potential applications to real-life scenarios Michael is a commercially orientated academic. He is proactive, a problemsolver and has the capability to drive ideas forward to completion. Kish has worked at Director and Board Levels in the UK and Europe, with implementation responsibilities in the USA and Asia. He has been involved with the pharmaceutical and biotechnology sectors for more than 25 years. Key experiences and abilities relevant to this role within Pulmorphix include: . Significant Business Development experience in biopharmaceutical sector Non-executive Directorships of several start-up organisations during Business Development role at GlaxoWellcome managing a soft-venture fund. Good track record of attracting investment funding from VC Experienced Managing Director / CEO Kish has excellent interpersonal skills and analytical ability. He is an innovative thinker, articulate, creative with a consultative approach.
  • 9. Our Vision Within 5 years of trading Pulmorphix aims to become the market leader in testing inhaled drugs Within 5 years of trading Pulmorphix aims to become the market leader in the testing of inhaled drugs PULMORPHIX 9
  • 10. Breaking Down Market Need System/ Attribute Body temperature Pulmanory relative humidity Pulmonary surfactant hydrodynamics Particle dispersion Control over l