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DESCRIPTIONPulmorphix 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.
- 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 light conditions 1* X X X X X 2** X X X X X 3*** X Potentially X X Optional X X X X X The Paraytec SD1300 The Pulmorphix Lung Biosimulator * 1. Impaction insert in NGI cup using standard USP Apparatus II ** 2. Total trap fibre filter in ACI throat using modified USP Apparatus IV (Flow Cell) *** 3. Impaction collection on PDF membrane filter in CI stage using a Transwell system 10 PULMORPHIX Reflective of the Acceptable Invivostate to industry Who are our clients? We are already talking to several of the ma jor pharmaceutical companies who are interested in our services and technology.
- 11. Pharmaceutical companies will need our services at most stages of the inhaled drug development & manufacturing process: When testing inhaled drug formulations. Developing more sophisticated dosage forms. We will initially develop and offer a range of services for our end users using our patent pending technology. Formulation and Material Scientists in the Pharmaceutical and Biotechnology sectors. On the production line testing batch to batch variations. Clinical Research Organisations (CROs). Quality control checks when manufacturing. University Research Departments. Stability monitoring. Environmental Agencies. Testing generics versus branded drugs.
- 12. What is the business model? B2B SERVICES We will use your investment to translate our technology platform into a commercial business to business service. With established standardised testing protocols, we aim to start offering a commercial service within Year 1. Your investment will be used to market our services and generate revenues via research fees for the dissolution testing and other services. 12 PULMORPHIX
- 13. A Financial Snapshot The next 24 months Over the first two years, we will target additional grant funding opportunities. We will also explore end user requirements regarding a product sales model for companies that prefer to undertake their own testing in-house. We aim to have at least one service contract in place with a customer before the end of year one. YEAR 1 Y2 Y3 YEAR 3 Revenue Y1 YEAR 2 40,000 310,000 1,000,000 Grants Gross Profits Operational Costs EBITDA 58,833 17,027 0 39,368 218,046 754,401 76,650 135,690 251,950 74,465 489,543 -42,507 PULMORPHIX 13
- 14. We need 100,000 Investment 14 PULMORPHIX
- 15. Reasons to invest Weve de-risked this opportunity by... investors by: 1 2 3 4 5 6 Engaging an Filing for experienced patent commercial protection (GB1310502.8) lead Securing grant funding of 82,000 from TSB Engaging with end users and potential blue chip clients. Lining up a number of private investors Seeking/ obtaining advanced assurances on SEIS status PULMORPHIX 15
- 16. Our Mission Our mission is to enable developers of orally inhaled products to optimise their formulations which will ultimately improve patient outcomes to treatment. Investor Charter We want to build a company which is at the forefront of good science and leads the way in providing cutting edge services to industry. We want to build strong relationships with our end users and clients, and to listen to the needs of industry. We want to engage a technical board which will include key opinion leaders in the field of inhaled drug testing. We will achieve this by providing access to our unique technology to the leading We want to use your investment wisely and keep biopharmaceutical companies involved in you regularly updated via communications, tweets drug delivery treatment via the lungs. and mailers. We want to generate a healthy return on investment for our shareholders and stakeholders. We dont expect anything in return... however if you are active in the pharmaceutical field and you think you can help to open doors and assist in growing the business, wed like to hear from you. 16 PULMORPHIX
- 17. Sign up to Crowdcube Pre-register your deposit Transfer funds to Crowdcube 2 3 w w w. c r o w d c u b e . c o m 1 Invest in Pulmorphix 4 Receive confirmation 5 PULMORPHIX 17
- 18. Click Invest Now Join us on our journey www.pulmorphix.com [email protected] Tel: +44 770 686 1874
- 19. IMPORTANT INFORMATION The content of this pitch by [PULMORPHIX] (the Company) and the documents, comments and information contained within it (together the Pitch) have not been approved by an authorised person within the meaning of the Financial Services and Markets Acts 2000 (the Act). Reliance on the Pitch for the purpose of engaging in any investment activity may expose the individual concerned to a significant risk of losing all of the money or other assets invested. IMPORTANT - PLEASE READ CAREFULLY The Pitch is exempt from the general restriction (in section 21 of the Act) on the communication of invitations or inducements to engage in investment activity on the grounds that it is made to persons who are exempt from the general restriction, by virtue of Article 43 of the Financial Services and Markets Act 2000 (Financial Promotion Order) 2005, as a member of a body corporate in the same group as the Company making the communication. Any recipient of the Pitch who does not qualify under the terms of the above exemption must not view the Pitch, return the Pitch documents to the Company immediately and should not read or act upon any of the information contained within it. The Pitch does not constitute an offer or an invitation for securities to the public that would otherwise be required to comply with the Prospectus Regulations 2005. No public offer in any jurisdiction is being made by the Pitch. The Pitch is primarily intended for release in the United Kingdom and does not constitute an offer, or the solicitation of an offer, in relation to shares in any jurisdiction in which such offer or solicitation is unlawful. CONFIDENTIALITY The Pitch has been prepared by the Company. It is being provided to a limited number of persons, each of whom is considered to be a legitimate recipient, solely as a guide for the purpose of giving background information to enable recipients to assess whether they wish to express an interest in subscribing for shares in the Company. The information and opinions contained within the Pitch are strictly confidential and are being made available only to parties who agree to keep them confidential. Neither the Pitch nor any part of it may be copied, published, disclosed, reproduced or distributed to any person at any time without the prior written consent of the Company, and shall not be used for any purpose other than in connection with the proposed investment in the Company. By accepting the Pitch you are deemed to undertake and warrant to the Company that you will keep it confidential. You agree to indemnify the Company against any losses incurred by the Company as a result of any unauthorised disclosure, and to return on demand, the Pitch and any related documents or information to the Company. GENERAL Although the Company has used publicly available information in compiling the Pitch and has used reasonable efforts to check the accuracy of the information in the Pitch, its accuracy cannot be guaranteed. The Company has not independently verified any of the information in the Pitch and the Pitch does not purport to be all-inclusive or necessarily to contain all the information that a prospective investor may desire in investigating the Company, and may be subject to updating, revision or amendment. No representation or warranty, express or implied, is or will be given by the Company, its advisers or any of their respective directors, shareholders, partners or employees as to the accuracy or completeness of the Pitch or the information or opinions contained therein.
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- 21. l A Kiss The Light Slidedeck [email protected] t n