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Initiation of Coverage
27 October 2016
Adding value to the cancer drug development process
Key Statistics
Code PYC Following the decision not to proceed with the acquisition of oncology
Listing AIM therapeutics Company BioMoti, Physiomics is now 100% focused on growing
Sector Healthcare
Market Cap 1.43m the revenues and creating a path to profitability in the core modelling and
Share in issue 5,701.66m simulation business. The Companys Virtual Technology is being used by
Current Price* 0.025p several major pharmaceutical and biotech companies, and has demonstrated
12 mnth High/Low 0.06p/0.02p
*Priced at 14:31 on 27/10/2016 its ability to predict the outcome of pre-clinical and clinical cancer studies.
Stock Performance Last years signing of the Companys first clinical contract with a major
0.07 pharmaceutical Company, Merck Serono, represents an opportunity to move
0.06 up the value chain, and deliver larger projects with limited investment in
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0.04 additional resource. There are several reasons why we believe the Company
0.03 is better placed than ever to accelerate its growth.
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Virtual Tumour has effect on the tumour of various interventions. The Physiomics team works
been shown to have closely with its clients to identify relevant input data (e.g. concentration,
strong predictive
power of tumour biomarkers, tumour growth measurements) and simulate the outcome of
size in a pre-clinical single agents and therapy combinations including radiotherapy. This is
and more recently
clinical setting important as cancers are rarely treated on a single agent basis. As we will
discuss further, Virtual Tumour is powerful in that it has been shown as
effective in closely predicting the outcome of cancer trials in blinded tests.
The softwares main output is estimated tumour size. The technology can also
be used to estimate optimal dosage and timing of administration, and assess
use across different cancer types thereby maximising the potential value of
clients development candidates.
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difficulties that even a well-resourced global company would have in
replicating Virtual Tumour.
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2. Investment case
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In order to accurately simulate a given treatment regime for a particular
Virtual Tumour can
be populated by cancer type, the model needs to be calibrated using inputs which can include
data from a wide
tumour control growth data, pharmacokinetic profiles (data on how a drug
range of sources
from Physiomics might be absorbed, distributed, metabolised and excreted by an organism),
own data bank of
and pharmacodynamic profiles (data on how drugs inhibit tumour growth).
literature through to
clients earlier pre- This can come from various sources such as in-vitro (test tube/petri dish)
clinical work
experiments, literature, preclinical studies and previous clinical studies.
Therefore rather than an off the shelf product Virtual Tumour is, at present
Virtual Tumour is
constantly evolving primarily sold as a bespoke project by project service based proposition with
with the scientific
Physiomics ultimately delivering a report predicting the outcome of
communities
understanding of preclinical animal studies or early stage clinical trials. The expertise
cancer and its
accumulated by Physiomics in this field would be challenging to replicate in-
treatments.
house. Virtual Tumour is constantly evolving with the scientific communitys
understanding of cancer and its treatments.
The ability of Virtual Whereas some models seek to simulate the internal dynamics of dozens or
Tumour to deliver hundreds of proteins within a cell, this sort of complexity makes models
results is
underpinned by the difficult to calibrate, and leads to challenges in making quantitative
Companys ability to predictions about tumour growth. Virtual Tumour adopts an agent-based
identify a small
number of key approach. Each cell in the tumour is described by a separate software agent,
inputs that make the which uses a relatively simple set of equations. The aim is to capture the
model predictive yet
manageable overall effect of the drug on a cell population, rather than the precise
processes within each cell. A number of other simplifications are also made.
The complexity of the model is thus deliberately constrained, so that it can
be parameterised with the available data.
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Physiomics has demonstrated significant evidence of helping researchers and
Case studies have
provided evidence drug developers to meet their objectives, and of the predictive efficacy of
of Virtual Tumours Virtual Tumour. In one case study aimed at blind validation of the
predictive power
technology, a customer provided 21 proposed dosing regimens for
combinations of DNA repair inhibitors, targeted agent and standards of care.
In 19 out of 21 regimens, virtual tumour correctly predicted the outcomes of
the mice experiments. Such predictive behaviour can massively reduce the
number of animal experiments required to extract the relevant pre-clinical
data. Blind tests like these can give researchers the confidence they need to
engage Physiomics on new projects. Whilst some pharmaceutical companies
might seek to replicate this activity in house, we believe Physiomics track
record, combined with its third party independence, makes Virtual Tumour a
compelling addition to any oncology companys drug development toolset.
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Clinical projects Physiomics scientists working closely with Merck Serono scientists to develop
have revenue and calibrate a model that can predict optimal combination partners for both
potential of 150k+
vs 50k+ for pre- marketed and pipeline drugs. Earlier pre-clinical projects typically generated
clinical revenues in excess of 50k, whilst the revenue potential of clinical projects is
typically 150k plus per project.
The emergence of Virtual Tumour has been the subject of several poster and oral presentations
drug resistance has including several at the Annual Meeting for American Association for Cancer
recently been added
as an output of the Research. This year Physiomics presented on new developments of the
model. Drug Virtual Tumour platform in drug resistance, concentrating on a case study
resistance is a major
cause of treatment that demonstrated that Virtual Tumour can be applied to model the
failure in cancer, emergence of resistance in patient-derived xenografts. Furthermore, it
and understanding
and overcoming showed that the model can be used to identify and optimise therapeutic
mechanisms of strategies for delaying the emergence of drug resistance. These findings were
resistance is a key
challenge in the subject of a presentation delivered this month, at the Seventh American
advancing cancer Conference on Pharmacometrics, the main US conference for PK/PD
therapy.
modelling.
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with another major global pharmaceutical company with whom Physiomics
has been working for over four years.
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ii. Personalised medicine software
Physiomics experience of using Virtual Tumour to evaluate drug
The predictive combinations and dosing schedules has led it to assess the feasibility of
power of the developing a software tool to determine which cancer treatment to provide
Companys models
may in time be able to which groups of patients based on individual patient data. The software
to optimise the would use as its inputs pharmacological information about the drugs coupled
treatment regimes
of individual cancer with physiological, genomic, and metabolic information about the patient.
patients The focus on forecasting would be on which treatment and schedule are likely
to lead to an increase in survival. The Company is in talks with leading
clinicians and collaborators regarding the required data and is seeking grant
funding to develop a prototype software tool.
Whilst Virtual Tumour is the core focus of the Physiomics teams sales effort
the Company has a number of complementary services that generate smaller
revenue streams. We detail some of these below.
Physiomics Cardiac
Toxicity model has
EasyAP / Cardiac Toxicity Service
been shown to have
50% greater
Cardiac toxicity is a leading cause of attrition in clinical studies and post-
predictive power
than its closest marketing withdrawal. Under FDA requirements, all candidate drugs must be
competitor
screened against the hERG potassium channel. Physiomics' technology takes
into account activity against hERG and two additional ion channels to deliver
50% greater predictive power than the best published model currently
available according to a review by Physiomics of available published
literature.
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helping to drive Virtual Tumour simulations, the database is available to
researchers and clinicians on a standalone basis on an annual subscription.
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We believe that Physiomics edge is its specific therapeutic focus on oncology
and the bespoke approach with validated predictive power. For drug
The closest listed
comparator trades developers, cancer is a high risk and high return field and any software that
at 7.4x trailing
revenues can lessen that risk and improve potential returns is something that has the
potential to become an important high value tool to the industry. There are
few listed comparators. Simulations Plus (NASDAQ:SLP) offers an arguably
more commoditised off the shelf product range than Physiomics and is not
involved in the simulation anti-cancer trials. With a market capitalisation of
$147.8m, it is trading on 7.4x trailing revenues and a 32x trailing PE ratio.
vi. Valuation
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Given the revenue multiples above, investors who get in now, at a time when
little upside is priced into the valuation, stand the chance of making a return
a multiple of the current share price.
3. Final Results
The Companys recently published results for the year ending June 2016
showed a 26% increase in revenues to 297k and a 6% decrease in operating
underlying losses (pre-share based payments and exceptional items) to
371k. Working capital was broadly neutral with operating cash out flows of
347k. The company ended the period with cash of 139k which will have
been strengthened by the 555k placing completed in September 2016.
4. Board of Directors
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Dr Christophe Chassagnole, Chief Operating Officer
Dr Christophe Chassagnole has been involved in systems biology and bio-
computing projects since the mid-nineties, with experience in both academic
and industrial environments. His Doctorate was achieved at the Victor
Segalen-Bordeaux II University, and then he held a post doctorate position
with IBVT at Stuttgart University. Before Joining Physiomics, Dr Chassagnole
worked in France as a senior researcher for CRITT Bio-Industries (Toulouse)
for 3 years. He joined Physiomics in May 2004 as project leader to develop
the model portfolio of the Company. He was appointed Chief Operating
Officer of Physiomics in May 2007.
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5. Significant Shareholders as at 10 October 2016
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6. Financial Statements
Profit & Loss
Year ended Year ended Year ended Year ended
30-Jun-13 30-Jun-14 30-Jun-15 30-Jun-16
Loss for the year attributable to equity shareholders -500,571 -425,621 -357,656 -378,697
Loss per share (pence)
Basic and diluted -0.033 -0.026 -0.017 -0.0130
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Cash Flow Statement
Net cash generated from operating activities -524,487 -351,507 -392,651 -346,869
Net increase / (decrease) cash and cash equivalents -511,788 -46,804 134,388 -127,836
Cash and cash equivalents at beginning of year 690,950 179,162 132,358 266,746
Cash and cash equivalents at end of year 179,162 132,358 266,746 138,910
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Balance Sheet
Year ended Year ended Year ended Year ended
30-Jun-13 30-Jun-14 30-Jun-15 30-Jun-16
Non-current assets
Intangible assets 16,336 11,669 7,025 2,381
Property, plant and equipment 4,250 3,589 2,242 1,557
Investments 1 1 1 1
20,587 15,259 9,268 3,939
Current assets
Trade and other receivables 180,717 96,576 47,851 107,856
Taxation recoverable 55,000 52,606
Cash and cash equivalents 179,162 132,358 266,746 138,910
359,879 228,934 369,597 299,372
Current liabilities
Trade and other payables -124,645 -107,706 -53,248 -99,158
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