pulmorphix slidedeck
DESCRIPTION
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
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PHARMACEUTICAL DRUGSSAVELIVES
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Join the Q&AWhat’s the problem?
Dr. Mike Davies - The pharmaceutical industry needs an accuratereplication of the in-vivo pulmonary environment (i.e. the deep lung) inorder to develop new and betterinhaled drugs. To date, there is no specific, industry-wide acceptedtechnology for testing inhaledformulations. 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 ofdelivering drugs via the lungs?
Inhaled drugs have many advantages. They bypass the liver, leading to fewer side effects;
They require lower dosages, withimproved patient outcomes;No need for needles -avoiding e.g. daily injection of insulinfor diabetes sufferers.No requirement for cold chainmanagement (drugs in powder formdon’t need to be kept under a certaintemperature - ideal for vaccinationprogrammes in countries whererefrigeration can be a real problem).
What kinds of conditions can be treated by inhaled drugs?
Kish Mistry - The pharmaceuticalindustry is developing inhalationdevices and formulations to deliver drugs to the lungs for a wide range of conditions; including for examplediabetes and pain management.
Great emphasis is also placed onoptimising current products forimproved patient outcomes andrevenue generation.
What’s the solution?
Dr. Mike Davies - Pulmorphix has the solution - via the world’s first lungbiosimulator. Our device replicates the conditions in the deep lung andprovides a reliable method for drug developers to test how their drugs will behave when inhaled into the lungs.
How was the technology developed?
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 andexperiments.
Early conception and research within a University is useful, as it brings anacademic rigour to the earlydevelopment phase, and we haveaccess to world-leading expertise inPharmacy, Chemistry and relatedsectors.
Dr. Mike Davies Kish Mistry
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Although some progress has beenmade in terms of technologies toimprove the effect of inhaled drugs...
This market need is backed up by our discussions with large and speciality pharmaceutical companies.
“...this alone is nolonger sufficient for therapeutic success of inhalation drugs;a paradigm shift isneeded, with anincreased focus onpulmonary barriers to drug delivery.”Lancet
RespiRatoRy
Medicine
2013
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We have built the world’s first prototype lung biosimulator which can accurately replicate the deep lung environment.Our technology has been specificallydesigned to test orally inhaled products.
• temperature• humidity• breathing• fluid hydrodynamics• lung fluid composition• light
We can controlspecific parameters such as:
.. so we can mimic the conditions in the deep lung where inhaled drugs startworking
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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.
In order to achieve this, the patient must inject insulin throughout the day and thus experience theassociated 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.
As such, alternative methods ofinsulin delivery are currently being researched and inhaled insulin has been the topic of speculation within industry for a number of years. Pharmaceutical companies arecontinuing with their research in this field in order to produce an insulin inhaler similar to an asthma inhaler. The availability of a unit to sprayinsulin into the body would satisfy a market need and help numerouspeople manage their condition throughout the world.
iMAGine if it were possible to treAt diAbetes with An inhAler
insteAd of Aneedle.
Transport of insulin through the lungs allows delivery across a surface area the size of a singles tennis court.
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“I got involved in this project over a year ago, and immediatelyrecognised that there was an unmet market need.
have a background in the pharma-ceutical industry and a good track record with start-upcompanies.
So far I’ve given my time to this pro-ject at a significantlyreduced rate, since I genuinelybelieve we have a unique marketopportunity, with really disruptive technology.”
dr. Mike dAvies
kish
Mistry
“I first had a light bulb moment about 6 years ago, when I wasattending 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 wouldreplicate the conditions in the lung where inhaled drugs get to work.
Six years later, with help from theUniversity, I have developed asecond generation prototype which works really well.
With further investment and grant funding we believe we can take thisto market and help pharmaceuticalcompanies develop betterinhaled drugs.”
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Emma Nolan is an experienced IP Manager, with over 20 yearsexperience in technologytransfer - primarily managinginventions and patents in the Univer-sity 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.
Kish Mistry is an experiencedbusiness executive with extensive hands-on commercial responsibilities whilst at GSK and Serono. As CEO, he will be responsible for commercialis-ing the technology platform. He will lead the development and growth strategy whilst directing resources within Pulmorphix to meet priorities and timelines
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 andabilities relevant to this role withinPulmorphix include:. Significant Business Developmentexperience in biopharmaceutical sector· Non-executive Directorships of several start-up organisations during Business Development role atGlaxoWellcome managing asoft-venture fund.· Good track record of attractinginvestment funding from VC· Experienced Managing Director / CEO
Kish has excellent interpersonal skills and analytical ability. He is aninnovative thinker, articulate, creative with a consultative approach.
Dr. Michael Davies is a UK registered Pharmacist and holds a PhD inPharmaceutical 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 methodsroutinely employed to assessformulation characteristics. This background has led to the vision and
development of the Pulmorphixtechnology platform. Michael iscurrently employed at Liverpool John Moores University as a SeniorLecturer 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 assessformulation suitability * Doctoral study focussed on drug delivery to the lung* Author of peer-reviewed articlesrelevant to pulmonary drug delivery* Project management within the laboratory setting* Translating research findings topotential applications to real-lifescenariosMichael is a commercially orientated academic. He is proactive, a problem-solver and has the capability to drive ideas forward to completion.
The Tea
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Within 5 years of trading PulmorPhix aims to become the market leader in testing inhaled drugs
OUR VIsION
Within 5 years of trading Pulmorphix aims to become the market leader in the testing of inhaled drugs
§
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breAkinG down MArket need
who Areour clients?We are already talking to several of the major pharmaceutical companies who are interested in our services and technology.
System/Attribute
Body temperature
Pulmanory relativehumidity
Pulmonary surfactant
hydrodynamics
Particle dispersion
Control over light conditions
Reflective of the Invivostate
Acceptable to industry
1* ✓ X X ✓ X X X
2** ✓ X X ✓ X X X
3*** ✓ ✓ X ✓ Potentially X X
The ParaytecSD1300
Optional X X X ✓ X X
The PulmorphixLungBiosimulator
✓ ✓ ✓ ✓ ✓ ✓ ✓
* 1. Impaction insert in NGI cup usingstandard USP Apparatus II
** 2. Total trap fibre filter in ACI throat using modified USP Apparatus IV (Flow Cell)
*** 3. Impaction collection on PDF mem-brane filter in CI stage using a Transwell system
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Pharmaceutical companies will need our services at most stages of theinhaled drugdevelopment &manufacturingprocess:When testing inhaleddrug formulations.
Developing more sophisticateddosage forms.
On the production line testingbatch to batch variations.
Quality control checkswhen manufacturing.
Stability monitoring.
Testing generics versusbranded drugs.
Formulation and Material scientists in the Pharmaceutical and Biotechnology sectors.
Clinical Research Organisations (CROs).
University Research Departments.
Environmental Agencies.
We will initially develop and offer a range ofservices for our endusers using our patent pending technology.
WHAT Is THE BUsINEssMODEL?
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 generaterevenues via research fees for the dissolution testing and other services.
B2B sERVICEs
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PULMORPHIX 13
Revenue £310,000£40,000 £1,000,000
£0£17,027Grants £58,833
£754,401
£251,950
£489,543
£218,046
£135,690
£74,465
£39,368GrossProfitsOperationalCosts
EBITDA
£76,650
-£42,507Y1 Y2 Y3
A FINANCIALsNAPsHOT
the next 24 Months
Over the first two years, we will targetadditional grant funding opportunities.
We will also explore end user requirements regarding a product sales model forcompanies 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 3YEAR 2YEAR 1
WE NEED £100,000INVEsTMENT
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REASOnSTO INVEsT WE’VE DE-RIsKED THIs OPPORTUNITY BY...
INVEsTORs BY:
1securinggrantfunding of £82,000 from TsB
Lining up a number of privateinvestors
Filing forpatentprotection(GB1310502.8)
Engaging anexperienced commercial lead
2Engaging with endusers and potential blue chip clients.
3 4 5seeking/obtainingadvanced assurances on sEIsstatus
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Our mission is to enable developers of orally inhaled products to optimise their formulations which will ultimately improve patient outcomes to treatment.
We will achieve this by providing access to our unique technology to the leadingbiopharmaceutical companies involved in drug delivery treatment via the lungs.
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We want to build a company which is at theforefront of good science and leads the way inproviding cutting edge services to industry. We want to build strong relationships with our end users and clients, and to listen to the needs ofindustry. We want to engage a technical board which will include key opinion leaders in the field of inhaled drug testing. We want to use your investment wisely and keep you regularly updated via communications, tweets and mailers. We want to generate a healthy return on investment for our shareholders and stakeholders. We don’t 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, we’d like to hear from you.
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