ANGLE is now working to establish and complete a large scale
patient study to prove the efficacy of the Parsortix system for
this application. The patient study will be carefully controlled
and undertaken both in Europe and the United States. Timescales are
not yet fully determined but the aim is to complete the study in
Europe by the end of calendar 2016. This study has the potential to
unlock an ovarian cancer market estimated to be worth GBP300
million per annum.
Establishment of corporate collaborations to drive adoption of
Parsortix
ANGLE's strategy to drive market adoption is to leverage the
sales and marketing resource of existing downstream molecular
analysis companies through corporate collaborations.
The cancer cells obtained from patient blood using the Parsortix
system can be analysed using existing molecular analysis platforms
already installed worldwide in hospital pathology laboratories for
analysis of solid biopsy material. It is therefore in the interests
of the companies that own these systems to promote the use of the
Parsortix system as a front end for their own platforms as this
will generate additional sales for them from their existing
installed platform.
This process is underway with the first two corporate
collaborations initiated during the year.
Commercial strategy on track with research use sales commencing
this financial year
Our strategy to commercialise Parsortix falls into two phases.
Now that strong third party evaluations have been received for the
system and its operation robustly investigated internally, we will
initially target first sales for research use purposes.
Our main approach to achieving this is to:
-- Leverage Key Opinion Leaders to participate in cancer drug trials in which they are involved
-- Migrate existing Key Opinion Leaders to paying customers
We estimate that the research use sales market is worth
approximately GBP250 million per annum and aim to commence sales
into this market in the current financial year.
For the second phase, access to the clinical sales market
(treating patients) is dependent on successful patient studies and
regulatory authorisation. The first clinical application is
targeted to be the ovarian cancer triaging application described
above. Our aim is that the patient study to support sales in this
market will be completed in Europe by the end of calendar year
2016.
We estimate that the overall market size for clinical
applications of the Parsortix system across all cancer types is in
excess of GBP8 billion per annum.
Intellectual property further strengthened
Protecting the Company's intellectual property is crucial to
ensure a dominant position in using our Parsortix system is
established and maintained for as long as possible.
Strong progress was made with this during the year and a second
US patent and patents in China and Australia have been granted.
Progress is being made with multiple other patents worldwide and we
hope to have a granted European patent later this financial
year.
Continued momentum post year end
Prostate cancer 52-patient study published by Barts Cancer
Institute indicating capture of cancer cells from Parsortix liquid
biopsy in 100% of patients
Post the year-end, very positive results for the Parsortix
system were published by Barts Cancer Institute (BCI) in relation
to prostate cancer. These showed the capture of cancer cells from
the Parsortix liquid biopsy in 100% of patients, both those with
metastatic cancer and early stage cancer.
BCI demonstrated the ability of the Parsortix system to harvest
mesenchymal cells involved in cancer metastasis and then showed a
direct correlation between the number of these cells and the stage
of development of the patient's cancer. This was important because
traditional antibody-based systems fail to capture these cells and
the BCI study suggests that these cells may be crucially important
in the process of metastasis.
The results of this study are very encouraging and further
validate our belief that the Parsortix technology significantly
advances the field of liquid biopsy. BCI are now working towards
the development of a clinical application for a second indication
for the Parsortix platform in prostate cancer.
Scientific Advisory Board further strengthened in the United
States
The Company has established a Scientific Advisory Board of
leading researchers and oncologists to help direct the Company's
efforts towards clinical adoption of the Parsortix system.
The Scientific Advisory Board was strengthened with the
appointment of two prominent specialists from top cancer centres in
the United States; leading translational researcher Jim Reuben from
MD Anderson and leading medical oncologist Daniel Danila from
Memorial Sloan Kettering.
Regulatory authorisation
ANGLE is committed to driving acceptance and approval of its
technology worldwide.
Regulatory authorisation is a requirement before the Parsortix
system can be sold for use in the clinical market (treatment of
patients), although as discussed above, earlier sales will be made
into the research market.
ANGLE already has a CE Mark for clinical use of the Parsortix
system in the European Union. Dialogue has been in progress with
the FDA for over a year to obtain similar approval in the United
States.
ANGLE is seeking to become the first company authorised in the
United States to harvest cancer cells from patient blood. Securing
FDA approval requires extensive, detailed work to meet the
requirements of the FDA's necessarily thorough and comprehensive
review.
Dialogue continues to be positive and ANGLE is committing
substantial management resource to the process. To support this,
ANGLE has taken on additional external support from a number of
leading experts with a track record of successful FDA
authorisations for similar diagnostic systems.
Whilst some additional studies are still required, we remain
positive about the prospect of achieving FDA authorisation and
believe that once achieved, this will give the Company a further
major advantage in the market.
Outlook
We have made strong progress advancing our strategy this year
through the validation of the Parsortix cell separation system by
world class cancer centres. We have identified ovarian cancer for
the first clinical application for the Parsortix system following a
successful patient study with the Medical University of Vienna
which demonstrated Parsortix's potential to identify ovarian cancer
with high sensitivity and specificity where traditional techniques
fail. In the coming year, we are well-funded to focus on the
development of research use sales and advance a large scale study
in ovarian cancer to establish Parsortix as a diagnostic tool to
enable clinicians to choose the most appropriate treatment thereby
improving patient outcomes.
We are confident that we have the foundations in place to take a
significant share of the cancer diagnostic / liquid biopsy market
and look forward to reporting further progress in the year
ahead.
Garth Selvey
Chairman
22 July 2015
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 30 APRIL 2015
2014
(Restated(*)
2015 )
Note GBP'000 GBP'000
Operating costs (3,878) (2,211)
-------- --------------
Operating profit/(loss) from
continuing operations (3,878) (2,211)
Net finance income/(costs) 9 13
-------- --------------
Profit/(loss) before tax from
continuing operations (3,869) (2,198)
Tax - -
-------- --------------
Profit/(loss) for the year from
continuing operations (3,869) (2,198)
Profit/(loss) from discontinued
operations 5 (18) 960
-------- --------------
Profit/(loss) for the year (3,887) (1,238)
Other comprehensive income
Items that may be subsequently reclassified to profit
or loss
Exchange differences on translating
foreign operations 92 (96)
-------- --------------
Other comprehensive income/(loss) 92 (96)
Total comprehensive income/(loss)
for the year (3,795) (1,334)
======== ==============
Profit/(loss) for the year attributable
to:
Owners of the parent
From continuing operations (3,576) (2,024)
From discontinued operations (18) 960
Non-controlling interests
From continuing operations (293) (173)
From discontinued operations - (1)
Profit/(loss) for the year (3,887) (1,238)
======== ==============
Total comprehensive income/(loss)
for the year attributable to:
Owners of the parent
From continuing operations (3,421) (2,158)
From discontinued operations (18) 960
Non-controlling interests
From continuing operations (356) (135)
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