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.
3. Join the
Q&A
Dr. Mike Davies
What’s 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
don’t need to be kept under a certain
temperature - ideal for vaccination
programmes in countries where
refrigeration can be a real problem).
What’s 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 world’s 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 world’s 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 I’ve 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
15. Reasons
to invest
We’ve 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 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.
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
kish.mistry@pulmorphix.com
Tel: +44 770 686 1874
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21. l
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