TIDMAGL
RNS Number : 4381D
Angle PLC
29 January 2015
For Immediate Release 29 January 2015
ANGLE plc
("ANGLE" or "the Company")
Interim Results for the six months ended 31 October 2014
MOVING CLOSER TO A CLINICAL APPLICATION
ANGLE plc (AIM: AGL and OTCQX: ANPCY), the specialist medtech
company, today announces unaudited interim results for the six
months ended 31 October 2014.
Highlights
-- Collaboration agreements signed with a further five leading
international cancer research centres bringing the total number of
key opinion leaders working with the Parsortix system to eight
covering the UK, Europe and the United States collectively covering
breast, colorectal, oesophageal, ovarian, prostate and pancreatic
cancers
-- Four of the key opinion leaders publicly reported during the
period bringing a total of five key opinion leaders reporting
positively on their evaluation of the Parsortix system. The
remaining three are in progress
-- Continued progress towards FDA authorisation
-- Second US patent granted relating to improvements in
technology and specific use for foetal and cancer applications
-- Management team strengthened with US specialist medtech commercialisation experience
-- Loss for the half year of GBP1.6 million (H1 2014: loss
GBP0.5 million) reflecting planned investment in Parsortix of
GBP1.6 million (H1 2014: GBP1.1 million)
-- Cash balance at 31 October 2014 of GBP2.3 million (30 April 2014: GBP3.9 million)
Progress post the half year end
-- Commercial collaboration established with the diagnostics
division of a large pharmaceutical company to investigate the
combination of ANGLE's Parsortix circulating tumour cell (CTC)
harvesting platform as a front end to the Collaborator's single
cell analysis system
-- Commercial collaboration established with EKF Diagnostics
Holdings plc to investigate the combination of ANGLE's Parsortix
circulating tumour cell (CTC) harvesting platform with EKF's
PointMan(TM) DNA enrichment technology as a liquid biopsy to
provide a combined solution
-- Patient study provides basis for clinical application in
ovarian cancer with the Medical University of Vienna reporting the
Parsortix system delivers "unprecedented sensitivity and
specificity". Following these excellent results in ovarian cancer,
ANGLE has commenced a process, in collaboration with the Medical
University of Vienna to develop a clinical application for ovarian
cancer.
Garth Selvey, Chairman, commented:
"Following patient study results from our key opinion leader the
Medical University of Vienna showing 'unprecedented sensitivity and
specificity' of the Parsortix system in ovarian cancer, ANGLE is
now progressing its first clinical application in ovarian cancer.
There is a very strong medical need for such an application in
ovarian cancer detection and monitoring of patients and we estimate
there is a sales potential in excess of GBP300 million per annum
for this application. Our other seven key opinion leaders will
continue to pursue clinical applications in other types of cancer
including breast cancer, colorectal cancer and prostate
cancer."
Analyst meeting and webcast details
A meeting for analysts will be held at 10:00am on 29 January
2015 at the offices of Buchanan, 107 Cheapside, London EC2V 6DN.
Please contact Buchanan on 020 7466 5000 for details.
To listen to the live webcast of the analyst meeting, please log
on to the following web address approximately 5 minutes prior to
10.00am:
http://vm.buchanan.uk.com/2015/angle290115/registration.htm
For further information:
ANGLE plc 01483 685830
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Cenkos Securities
Stephen Keys, Christopher Golden (Nominated
adviser)
Andy Roberts (Sales) 020 7397 8900
Buchanan
Mark Court, Sophie Cowles 020 7466 5000
Notes for editors
About ANGLE plc
ANGLE is a specialist medtech company commercialising a platform
technology that can capture cells circulating in blood, such as
cancer cells, even when they are as rare in number as one cell in
one billion blood cells, and harvest the cells for analysis.
ANGLE's cell separation technology, known as the Parsortix
system, harvests the cells of interest through a liquid biopsy,
with the patient only subjected to a simple blood test. Parsortix
is the subject of two granted US patents and three extensive
families of patents being progressed worldwide. The system is based
on a microfluidic device that captures cells based on a combination
of their size and compressibility. The Parsortix system is
established with strong positive evaluations from leading cancer
research centres and is working with these cancer centres to
demonstrate key applications. Parsortix has a CE Mark for Europe
and FDA authorisation is in process for the US.
The analysis of the cells that can be harvested from patient
blood with ANGLE's Parsortix system has the potential to help
deliver personalised cancer care offering profound improvements in
clinical and health economic outcomes in the treatment and
diagnosis of various forms of cancer.
The Parsortix system is designed to be compatible with existing
major medtech analytical platforms and to act as a companion
diagnostic for major pharma in helping to identify patients that
will benefit from a particular drug and then monitoring the drug's
effectiveness.
ANGLE has established formal collaborations with world-class
cancer centres and is working with these cancer centres to
demonstrate key applications for its Parsortix non-invasive cancer
diagnostic system as a liquid biopsy. Details are available here
http://www.angleplc.com/the-company/collaborators/
In addition to cancer, the Parsortix technology has the
potential for deployment with several other important cell types in
the future.
For Frequently Used Terms, please see the Company's website on
http://www.angleplc.com/the-parsortix-system/glossary/
For more information visit www.angleplc.com.
Forward Looking Statements
These Interim Results may contain forward-looking statements.
These statements reflect the Board's current view, are subject to a
number of material risks and uncertainties and could change in the
future. Factors that could cause or contribute to such changes
include, but are not limited to, the general economic climate and
market conditions, as well as specific factors relating to the
financial or commercial prospects or performance of the Group's
products.
CHAIRMAN'S STATEMENT
Introduction
ANGLE was previously involved in the commercialisation of
intellectual property and has set up and developed several medtech
and technology-based companies. Having identified an outstanding
commercial opportunity in Parsortix, ANGLE has transitioned over
the past few years to become a specialist medtech operating company
whose focus is Parsortix.
The transition to medtech will be completed later this year and
it is expected that the Company will be reclassified by the London
Stock Exchange from the support services sector to the healthcare
equipment & services sector.
ANGLE's patented Parsortix system can harvest very rare
circulating tumour cells (CTCs) in cancer patient blood - even
where there is less than one CTC in a billion healthy cells. The
aim of the resulting liquid biopsy (simple blood test) is to enable
the investigation of mutations in the patient's cancer to enable
personalised cancer care.
In the first six months of the year, ANGLE successfully
completed evaluations with its key opinion leaders of the Parsortix
system's capability to harvest CTCs from patient blood for analysis
and moved into the commercialisation phase.
This has been followed by the initiation of patient studies by
key opinion leaders into potential clinical applications in breast,
ovarian and prostate cancers with further studies due to start in
colorectal, oesophageal and pancreatic cancers. The first of these
studies has reported "unprecedented sensitivity and specificity" in
ovarian cancer.
Results
The loss for the half year was GBP1.6 million (H1 2014: loss
GBP0.5 million), reflecting the planned investment in
Parsortix.
Investment, principally relating to Parsortix, increased to
GBP1.6 million (H1 2014: GBP1.1 million). This comprised operating
costs of GBP1.4 million (H1 2014: GBP0.8 million) and capitalised
expenditure of GBP0.2 million (H1 2014: GBP0.3 million).
The cash balance was GBP2.3 million at 31 October 2014 (30 April
2014: GBP3.9 million).
The Parsortix system
The Parsortix system comprises a desktop machine and consumable
cassette, protected by patents, approved to CE Mark standard,
available in volume under manufacturing agreements and already in
active use in a number of prestigious research environments. The
equipment can separate and harvest circulating tumour cells (CTCs)
from patient blood (a liquid biopsy) where the ratio is of the
order of one CTC to one billion healthy cells. In a research
environment, this can help gain further knowledge about the
progression of various cancers. In a clinical environment, the
equipment can help a clinician select the most efficacious
personalised care. Harvested CTCs may also be analysed further by a
variety of other types of commercially available analytical
equipment.
Strategy
The strategy is to collect clinical data and establish
commercially viable and effective clinical procedures for a limited
number of cancers. This is being done with key opinion leaders
(KOLs) in the UK, Europe and the USA. Much of the costs of such
studies is covered by the key opinion leader and the Company's
costs are contained. We are currently working with eight key
opinion leaders. Selective revenue opportunities from research
projects, where the use of Parsortix is already being specified in
plans, are modest in comparison to the clinical market but will
reinforce later entry into related clinical applications. Marketing
to clinical users will be indirect and collaborative such that
costs will be contained and available funds will be used to maximum
effect. The early definition of clinical applications is number one
on our critical path and we are delighted to have identified an
excellent potential clinical application in ovarian cancer.
Alongside this important accreditation work in the USA continues
with the FDA and constructive dialogue is ongoing.
Medtech focus
ANGLE has transitioned from a 'broad portfolio investment'
position to an operating medtech company with the potential to be a
market leader in an estimated GBP8 billion market. All systems
including remuneration have been simplified and adapted to the
norms of the healthcare sector in a continuing effort to keep
existing investors and attract new ones, both institutional and
private.
ANGLE has also established an American Depositary Receipt (ADR)
in the United States representing 10 ANGLE plc shares for 1 ADR,
which now trades on the OTCQX market with the ticker ANPCY. The ADR
is intended to enable US investors to invest in ANGLE shares to
increase the liquidity in ANGLE shares and increase the sources of
capital available to the Company.
The Company believes that the focus and progress of the
Parsortix product accompanied with a well-defined strategy offers a
new investment opportunity with a well defined route to
success.
Key opinion leaders
A core part of ANGLE's strategy is to work closely with world
class cancer research centres in order to access drug trials and
develop patient data in support of clinical applications. An
objective for the year was to extend the range and number of key
opinion leaders working with the Parsortix system.
At the start of the year, the Company had three established key
opinion leaders:
-- Cancer Research UK Manchester (formally known as Paterson
Institute for Cancer Research) working on colorectal, pancreatic
and lung cancer
-- University of Surrey Oncology Department working on colorectal cancer and melanoma
-- Medical Research Council Cancer Unit at the University of
Cambridge and Addenbrooke's Hospital working on oesophageal,
colorectal and pancreatic cancer
During the half year, strong progress was made with extending
the key opinion leader relationships into continental Europe and
the United States. Collaboration agreements have been signed with a
further five world class cancer research centres:
-- University Medical Center Hamburg-Eppendorf working on a
range of cancer types including non small cell lung cancer,
colorectal and breast cancers
-- Medical University of Vienna working on ovarian cancer
-- University of Southern California Norris Comprehensive Cancer
Center working on breast cancer
-- Sidney Kimmel Cancer Center at Thomas Jefferson University working on breast cancer
-- Barts Cancer Institute working on prostate cancer
There are now a total of eight world-class cancer centres
working with ANGLE's Parsortix system in the UK, continental Europe
and the United States to develop applications in the most prevalent
types of cancer.
Key opinion leader evaluations
During the half year, four of the Company's key opinion leaders
reported publicly on their use of the Parsortix system. All four
reported favourably and key aspects of the Parsortix system
identified included:
-- Cancer Research UK Manchester: The Parsortix system is
applicable to all types of CTCs including mesenchymal CTCs because
it does not rely on antibody-based capture. The Parsortix system
offers a very high level of purity of harvested CTCs enabling
molecular analysis
-- Medical University of Vienna: The Parsortix system can handle
large volumes of patient blood, up to 20ml, and continues to
capture CTCs efficiently. CTCs harvested from the Parsortix system
can be analysed using qPCR (an established form of molecular
analysis) and the Parsortix system efficiently reduces the level of
contaminating white blood cell background to below the limit of
detection of qPCR
-- University Medical Center Hamburg-Eppendorf: The Parsortix
system is an effective device for the enrichment of epithelial
and/or mesenchymal-like CTCs. The system overcomes hurdles of
label-dependent techniques since it is not based on antibody
affinity capture. Using the Parsortix system, tumour cells as well
as tumour cell clusters are easily accessible and ready for
molecular analysis
-- Barts Cancer Institute: the Parsortix system worked well with
prostate cancer patients. The Parsortix system captured a high
purity of CTCs and was 30 times purer than a leading antibody-based
system. The Parsortix CTC harvest was well suited for downstream
molecular analysis and was demonstrated with fluorescence in-situ
hybridisation analysis (an established form of molecular
analysis)
These evaluations confirm the system's capability to harvest
cancer cells from patient blood for analysis and brings to a total
of five key opinion leaders reporting uniformly positively on their
evaluation of the Parsortix system. The remaining three are in
progress.
Continued progress towards FDA authorisation
The Parsortix system is CE Mark authorised for clinical sales in
the European Union.
A submission was made to the FDA at the end of March 2014
seeking clearance for the use of the system as a platform for the
capture and harvesting of large cells from blood for the purposes
of analysis.
The FDA has engaged constructively with ANGLE and its advisors
in an ongoing dialogue in relation to this novel clinical
approach.
Research use sales to support drug trials and other research
So far, despite customer interest, ANGLE has deliberately held
back on sales in order to concentrate on key opinion leaders and
refine the system based on their feedback. Following uniformly
positive evaluations of the system by five different key opinion
leaders, ANGLE now intends to progress sales for research use
addressing this estimated GBP250 million per annum market.
The Parsortix system has already been specified in the plans for
several research projects, which are expected to lead to first
sales during 2015.
ANGLE is seeking the adoption of the Parsortix system in
pharmaceutical company drug trials using the CTC as a marker to
indicate therapy effectiveness. There are estimated to be 750 Phase
II cancer drug trials initiated each year. These typically cover
100 patients over two years with the need for three blood tests per
patient. We estimate that each such trial has the potential to
generate in excess of GBP100,000 revenue for ANGLE if the Parsortix
system is used.
There are estimated to be 120 Phase III cancer drug trials
initiated each year. These typically cover 1,000 patients over
three years with the need for five blood tests per patient. We
estimate that each such trial has the potential to generate in
excess of GBP750,000 revenue for ANGLE if the Parsortix system is
used.
Securing 5% of the Phase II and Phase III cancer drug trials as
customers would generate an estimated GBP8 million of sales per
annum.
As well as generating sales revenue, use of the Parsortix system
in successful cancer drug trials may lead to the adoption of
Parsortix as a companion diagnostic to the new drug when launched
in the market. This would result in the Parsortix system being
routinely used with that drug to assess the suitability of the drug
for each patient and then to assess its efficacy once used.
Sales for clinical use
Sales of the Parsortix system for clinical use is the primary
objective for commercialisation of the business. We estimate that
the clinical market available to ANGLE is worth in excess of GBP8
billion per annum.
Accessing this market requires both regulatory authorisation and
strong patient data proving the benefit of the clinical application
to the patient. Both of these requirements are understandably
highly challenging.
As well as the work on regulatory authorisation described above,
ANGLE has a comprehensive strategy in place to deliver the
necessary patient data. This involves working with key opinion
leaders on patient studies to identify clinical applications and
then undertaking prospective clinical studies to demonstrate the
medical benefit to the patient.
To this end, ANGLE has established multiple patient studies with
the key opinion leaders to investigate new clinical applications
for the treatment of patients using the Parsortix system. The
studies are being coordinated on a highly cost efficient basis
leveraging the resources and capabilities of the key opinion
leaders.
Patient studies are being conducted in ovarian cancer (already
reported), breast cancer and prostate cancer and studies are due to
start soon in colorectal, oesophageal and pancreatic cancers.
Ovarian cancer - Medical University of Vienna
The first such patient study has just been completed by the
Medical University of Vienna, who reported "unprecedented
sensitivity and specificity" using the Parsortix system in
combination with their own RNA markers. Vienna consider the patient
study to have been highly successful and a strong basis for a
clinical application in ovarian cancer.
Other patient studies are expected to report during 2015. These
include potential clinical applications in relation to breast
cancer, prostate cancer and colorectal cancer.
Where patient studies are successful, as in the case of ovarian
cancer, they will then be followed by clinical studies to
substantiate the medical benefit to patients from taking
therapeutic decisions based on analysis of the CTCs harvested using
the Parsortix system. The results of these studies together with
FDA authorisation will be the trigger for widespread use of the
Parsortix system in patient care.
Ovarian Cancer
Annually 239,000 women are diagnosed with ovarian cancer
worldwide. There is a high mortality rate and 152,000 die from it
each year. Ovarian cancer is commonly known as the silent killer
due to its lack of symptoms in its earlier stages. It is frequently
diagnosed late in which case the UK five year survival rate is only
3.5% for Stage IV and 18.6% for Stage III at diagnosis (Source:
Cancer Research UK Ovarian Cancer survival statistics). In contrast
where it is diagnosed at Stage I, the UK five year survival rates
are much higher at 90%. As a result there is an acute medical need
for improved ovarian cancer detection.
The Parsortix system used in combination with Vienna's RNA
markers was able to detect cancer in primary epithelial ovarian
cancer patients with a sensitivity of 90% and a specificity of
100%. Epithelial ovarian cancer (also known as ovarian carcinoma)
is the most common ovarian cancer and accounts for some 90% of
cases. If these results are repeated in the clinical study, this
offers the potential for a blood test to enable early diagnosis of
ovarian cancer.
For each ovarian cancer patient, there is the potential for the
Parsortix system to be deployed, on average, 3 times in screening,
5 times in monitoring therapy and twice in remission monitoring. We
estimate that the market size for Parsortix sales of a clinical
application in ovarian cancer, for Europe and the United States
markets only, is in excess of GBP300 million per annum.
The Vienna team has worked for many years with a wide range of
CTC systems, both those commercially available from ANGLE's
competitors and new technologies under development including
commercial and academic systems. Due to lack of suitable cell
surface markers, antibody-based systems are ineffective for ovarian
cancer. The best result that has been obtained to date with other
non-antibody based systems is a CTC detection sensitivity level of
24.5% (i.e. fails to capture CTCs from three quarters of ovarian
cancer patients).
A key priority now is for ANGLE to work with the Medical
University of Vienna, and other leading ovarian cancer centres with
whom they partner, to deliver a robust clinical study supporting
clinical application. This will be progressed as quickly as
possible and is expected to take 18 months to complete. This would
allow for initial sales for this clinical application in ANGLE
financial year ending 30 April 2017.
Other Clinical Applications
Metastatic breast cancer screening
ANGLE is working with the University of Southern California
Norris Comprehensive Cancer Center on a patient study using
Parsortix as a liquid biopsy for metastatic breast cancer
patients.
If successful, such a liquid biopsy could replace the need for
surgical biopsy of the secondary cancer site such as liver
resection. This would reduce the need for surgical intervention (no
patient wants unnecessary operations) and reduce healthcare costs
as a blood test is much cheaper than an operation and an over-night
hospital stay. Furthermore, it could easily be repeated as often as
required, which is not possible with a traditional solid
biopsy.
The patient study is using the Parsortix liquid biopsy to
harvest CTCs for RNA analysis of the cancer cells to determine the
disease status of the metastatic sites so that therapeutic
decisions can be made for the patient's ongoing treatment. The
results of the RNA analysis allow the oncologists to make key
decisions over which therapies may be most effective for the
patient at that stage of their disease. Possible therapeutic
decisions include:
-- Clinical grade therapies: The RNA analysis will allow the
determination of (i) HER2 status (ii) oestrogen receptor (ER) and
(iii) progesterone receptor (PR). Women who have breast cancer with
hormone receptors are prescribed hormonal treatments, such as
tamoxifen or anastrozole. Women with breast cancers that have high
levels of HER2 receptors are given a drug called trastuzumab
(Herceptin(R) )
-- Research grade therapies: In addition there are numerous
(dozens) breast cancer drug trials in progress, which can be
prescribed to late stage patients once the RNA analysis is
completed, that may enable an improved outcome. Examples include
trials of new drugs in relation to the P1K3CA gene and triple
negative breast cancer
The incidence of new breast cancer cases in 2012 is estimated at
1,700,000 worldwide. Of these a total of approximately 33% either
present at Stage IV (metastatic cancer) or progress to Stage IV.
The targeted clinical application has the potential to address some
300,000 metastatic patients per annum in the accessible market
geographies. If a liquid biopsy is undertaken on a six monthly
basis for these patients over a five year follow-up period and
ANGLE secures a 10% share of the resulting market, the sales
potential accessible to ANGLE is worth around GBP100 million per
annum for this clinical application.
The aim is to complete the patient study in the middle of 2015
and then follow it with a clinical study targeting the end of 2016
for completion. This would allow for initial sales for this
clinical application in ANGLE year ending 30 April 2017.
Other cancer types
Similar to the metastatic breast cancer clinical application,
ANGLE is working with Barts Cancer Institute on a patient study in
relation to a potential metastatic prostate cancer clinical
application.
Work is also being undertaken with Cancer Research UK Manchester
with patient studies due to start soon in relation to colorectal
cancer and pancreatic cancer and with the Medical Research
Council's Cancer Unit at the University of Cambridge in relation to
oesophageal cancer.
Commercialisation partnerships with diagnostic companies
The Parsortix system is "open-source" and has been designed to
work with all existing analytical systems in the same way that the
existing solid biopsy provides cancer cells for a wide variety of
analytical systems. Such systems cannot otherwise be used with
CTCs. Combination with the Parsortix system gives the analytical
system the potential for an additional source of revenue analysing
a different form of patient tissue.
ANGLE's commercialisation strategy is to establish a series of
partnerships with multiple leading diagnostic companies to offer a
complete solution to the oncologist. ANGLE believes this is the
optimal approach for unlocking the multi-billion dollar worldwide
market available to the Company and its potential strategic
partners.
Partners will be selected for their specialist technical
capabilities enabling new high medical utility applications and/or
their market strength and existing installed base of diagnostic
systems enabling accelerated market adoption of the Parsortix
system.
Commercial returns from these partnerships may include upfront
payments, milestone payments as the combined product is brought to
market and royalty income and/or sales revenues as the product is
sold in the market.
Through partnerships with established analytical platforms,
ANGLE intends to leverage their distribution channels whilst at the
same time limiting the need for its own investment in direct sales
and marketing. It is expected that the Parsortix system may be
integrated as a front end into multiple analytical platforms as
"Parsortix inside".
Earlier this month, ANGLE announced the first two such
commercial collaborations.
Diagnostics division of a large pharmaceutical company
The first was with the diagnostics division of a large
pharmaceutical company (the "Collaborator") to investigate the
combination of ANGLE's Parsortix CTC harvesting platform with the
Collaborator's single cell analysis system. The Collaborator is
evaluating the use of the Parsortix system as a standard
pre-enrichment system for their single cell analysis system.
If the collaboration is successful, the Parsortix system may be
sold by the Collaborator along side its own system as a source of
patient sample for analysis using the Collaborator's analytical
platform.
EKF Diagnostics Holdings plc
The second commercial collaboration was with EKF Diagnostics
Holdings plc, the AIM listed point-of-care, central laboratory and
molecular diagnostics business to investigate the combination of
ANGLE's Parsortix CTC harvesting platform with EKF's PointMan(TM)
DNA enrichment technology as a liquid biopsy. The collaboration
will initially work on colorectal cancer and then expand to cover
other cancer types. CTCs will be harvested from cancer patients'
blood using ANGLE's Parsortix system and then analysed using EKF's
PointMan(TM) DNA enrichment technology to identify genetic
variation in the cancer, which may aid therapeutic decision
making.
ANGLE believes that the combination of ANGLE's Parsortix system
with EKF's PointMan(TM) technology may be advantageous for two
reasons. Firstly the PointMan(TM) system preferentially amplifies
variant sequences of interest whilst suppressing amplification of
the wild type i.e. normal DNA. As a result it has the potential to
identify all mutations in gene sequences associated with clinical
utility of targeted cancer therapies. In contrast competing genetic
analysis systems generally amplify only those areas which may be
predicted to be mutant and therefore can miss unexpected mutations.
Secondly the system is highly sensitive with the ability to work
with very low levels of target material, potentially as low as one
CTC.
If the collaboration is successful, ANGLE and EKF will explore
ways to offer their respective systems as a combined solution.
Second US patent granted
The Company continues to strengthen its intellectual property.
During the half year, a second US patent was granted protecting the
Parsortix system. Patents are being prosecuted worldwide.
Management team strengthened
During the half year, ANGLE appointed a senior US business
development executive, Peggy Robinson as US Vice President. From
2007 to 2011, Peggy was director of marketing for Johnson &
Johnson company Veridex, and its predecessor Immunicon, responsible
for the launch and market expansion of CellSearch. Following this,
in 2011 and 2012, Peggy was Director of Strategic Alliances /
Services for Veridex. During this time she developed and
implemented strategies to form collaborations for CellSearch with
pharmaceutical and biotech companies. More recently, Peggy has been
consulting on business strategies, marketing, strategic alliances,
key opinion leaders and product development of new technologies,
with an emphasis on cancer, chronic disease and companion
diagnostics.
Outlook
Following patient study results from our key opinion leader the
Medical University of Vienna showing 'unprecedented sensitivity and
specificity' of the Parsortix system in ovarian cancer, ANGLE is
now progressing its first clinical application in ovarian cancer.
There is a very strong medical need for such an application in
ovarian cancer detection and monitoring of patients and we estimate
there is a sales potential in excess of GBP300 million per annum
for this application. Our other seven key opinion leaders will
continue to pursue clinical applications in other types of cancer
including breast cancer, colorectal cancer and prostate cancer.
Garth Selvey
Chairman
28 January 2015
ANGLE plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHS ENDED 31 OCTOBER 2014
Six months
Note ended Year ended
31 October 31 October 30 April
2014 2013 2014
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Revenue 2 288 414 801
Change in fair value 17 404 1,334
Operating costs (1,918) (1,374) (3,485)
________ ________ ________
Operating profit/(loss) (1,613) (556) (1,350)
Net finance income/(costs) _______7 _______80 112
Profit/(loss) before tax (1,606) (476) (1,238)
Tax 3 - - -
Profit/(loss) for the
period (1,606) (476) (1,238)
Other comprehensive income
Items that may be subsequently
reclassified to profit
or loss
Exchange differences on
translating foreign operations 49 (44) (96)
Other comprehensive income __ 49 __ (44) _ (96)
Total comprehensive income
for the period (1,557) (520) (1,334)
========= ========= ==========
Profit/(loss) for the period
attributable to:
Owners of the parent (1,476) (396) (1,064)
Non-controlling interests (130) (80) (174)
_________ _________ _________
Profit/(loss) for the
period (1,606) (476) (1,238)
========= ========= =========
Total comprehensive income for the period
attributable to:
Owners of the parent (1,394) (455) (1,198)
Non-controlling interests (163) (65) (136)
_________ __________ _________
Total comprehensive income
for the period (1,557) (520) (1,334)
========= ========= =========
Earnings/(loss) per share 4
Basic and Diluted (pence per
share) (3.56) (1.05) (2.74)
All activity arose from continuing operations
ANGLE plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 OCTOBER 2014
Note 31 October 31 October 30 April
2014 2013 2014
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
ASSETS
Non-current assets
Other receivables 618 - 601
Property, plant and equipment 338 198 139
Intangible assets 5 1,186 1,099 1,142
_SHY____________ _SHY_________ __________
Total non-current assets 2,142 1,297 1,882
_SHY____________ _SHY_________ _SHY________
Current assets
Non-controlled investments - 4,839 -
Inventories 106 15 52
Trade and other receivables 305 530 328
Cash and cash equivalents 2,268 358 3,898
__________ __________ __________
Total current assets 2,679 5,742 4,278
___________ __________ __________
Total assets 4,821 7,039 6,160
========= ========= =========
EQUITY AND LIABILITIES
Equity
Issued capital 6 4,524 4,524 4,524
Share premium 18,414 18,414 18,414
Share based payments reserve 473 397 432
Other reserve 2,553 2,553 2,553
Translation reserve (40) (47) (122)
Retained earnings (21,253) (19,069) (19,777)
ESOT shares (102) (102) (102)
__________ __________ __________
Equity attributable to owners
of the parent 4,569 6,670 5,922
__________ __________ __________
Non-controlling interests (570) (376) (407)
Total equity 3,999 6,294 5,515
============== ============== ==============
Liabilities
Non-current liabilities
Controlled investments -
loans - 132 -
_________ _________ _________
Total non-current liabilities - 132 -
Current liabilities
Trade and other payables 822 613 645
_________ _________ _________
Total current liabilities 822 613 645
_________ _________ _________
Total liabilities 822 745 645
_________ _________ _________
Total equity and liabilities 4,821 7,039 6,160
============= ============= =============
ANGLE plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHS ENDED 31 OCTOBER 2014
Six months ended Year ended
31 October 31 October 30 April
2014 2013 2014
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Operating activities
Profit/(loss) before tax from
continuing operations (1,606) (476) (1,238)
Adjustments for:
Depreciation of property, plant
and equipment 43 29 57
Disposal of property, plant
and equipment - - 13
Amortisation and impairment
of intangible assets 46 150 99
Exchange differences (19) (2) 9
Net finance (income)/costs (7) (80) (112)
Change in fair value (17) (404) (1,334)
Share based payments __ 41 _____27 _ 62
Operating cash flows before
movements in working capital: (1,519) (756) (2,444)
(Increase)/decrease in inventories (148) 47 22
(Increase)/decrease in trade
and other receivables 22 (99) 131
Increase/(decrease) in trade
and other payables ___200 ___61 ___56
Net cash from/(used in) operating
activities (1,445) (747) (2,235)
Investing activities
Purchase of property, plant
and equipment (153) (84) (83)
Purchase of intangible assets (42) (235) (270)
Provision of short term loans - (407) (511)
Proceeds on disposal of investment - - 5,160
Interest received ______8 _____4 _____11
Net cash from/(used in) investing
activities (187) (722) 4,307
Financing activities
Net proceeds from issue of share
capital - - -
Interest paid - - _______-
Net cash from/(used in) financing
activities - -
Net increase/(decrease) in cash
and cash equivalents (1,632) (1,469) 2,072
Cash and cash equivalents at
start of period 3,898 1,828 1,828
______
Effect of exchange rate fluctuations ________2 (1) _________(2)
Cash and cash equivalents at
end of period 2,268 358 3,898
=========== =========== ===========
ANGLE plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHS ENDED 31 OCTOBER 2014
------------------------------------------------------------
Attributable to equity holders of the parent ------------------------------------------------------------
Share Non-
based Total
Issued Share payments Other Translation Retained ESOT Shareholders' controlling Total
capital premium reserve reserve reserve earnings shares equity interests equity
(Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 May 2013 4,524 18,414 370 2,553 12 (18,673) (102) 7,098 (311) 6,787
For the period
to 31 October
2013
------------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ --------------- ------------ ------------
Consolidated
profit/(loss) (396) (396) (80) (476)
Other
comprehensive
income
Exchange
differences
in
translating
foreign
operations (59) (59) 15 (44)
------------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ --------------- ------------ ------------
Total
comprehensive
income (59) (396) (455) (65) (520)
Share based
payments 27 27 27
___
___ ______ ___ _______ ___ ______ ___ ______ ___ ______ ________ ___ ______ ___ _______ ___ _______ ___ _______
At 31 October
2013 4,524 18,414 397 2,553 (47) (19,069) (102) 6,670 (376) 6,294
For the period
to 30 April
2014
------------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ --------------- ------------ ------------
Consolidated
profit/(loss) (668) (668) (94) (762)
Other
comprehensive
income
Exchange
differences
in
translating
foreign
operations (75) (75) 23 (52)
------------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ --------------- ------------ ------------
Total
comprehensive
income (75) (668) (743) (71) (814)
Share based
payments 35 35 35
Disposal of
controlling
interest (40) (40) 40 -
At 30 April
2014 4,524 18,414 432 2,553 (122) (19,777) (102) 5,922 (407) 5,515
For the period
to 31 October
2014
Consolidated
profit/(loss) (1,476) (1,476) (130) (1,606)
Other
comprehensive
income
Exchange
differences
in
translating
foreign
operations 82 82 (33) 49
------------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ --------------- ------------ ------------
Total
comprehensive
income 82 (1,476) (1,394) (163) (1,557)
Share based
payments 41 41 41
___
___ ______ ___ _______ ___ ______ ___ ______ ___ ______ ________ ___ ______ ___ _______ ___ _______ ___ _______
At 31 October
2014 4,524 18,414 473 2,553 (40) (21,253) (102) 4,569 (570) 3,999
========== ========== ========== ========== ========= =========== ========== ========== ========== ==========
ANGLE plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (continued)
FOR THE SIX MONTHS ENDED 31 OCTOBER 2014
Share premium
Represents amounts subscribed for share capital in excess of the
nominal value, net of directly attributable share issue costs.
Other reserve
The other reserve is a "merger" reserve arising from the
acquisition of the former holding company.
Translation reserve
The translation reserve account comprises cumulative exchange
differences arising on consolidation from the translation of the
financial statements of international operations. Under IFRS this
is separated from retained earnings.
ESOT shares
This reserve relates to shares held by the ANGLE Employee Share
Ownership Trust (ESOT) and may be used to assist in meeting the
obligations under employee remuneration schemes.
Non-controlling interests
Represents amounts attributed to non-controlling (minority)
interests for profits or losses in the Statement of Comprehensive
Income and assets or liabilities in the Statement of Financial
Position.
Share based payments reserve
The share based payments reserve account is used for the
corresponding entry to the share based payments charged through a)
the Statement of Comprehensive Income for staff incentive
arrangements relating to ANGLE plc equity b) the Statement of
Comprehensive Income for staff incentive arrangements relating to
the controlled investments equity, and c) the Statement of
Financial Position for acquired intangible assets in the controlled
investments comprising intellectual property (IP). These components
are separately identified in the table below.
Transfers are made from this reserve to retained earnings as the
related share options are exercised, cancelled, lapse or expire or
as a controlled investment becomes non-controlled (a deemed
disposal).
Controlled Controlled
ANGLE investments investments
employees employees IP Total
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000
At 1 May 2013 212 41 117 370
Charge for the period 27 - - 27
_________ _________ _________ _________
At 31 October 2013 239 41 117 397
Charge for the period 35 - - 35
_________ _________ _________ _________
At 30 April 2014 274 41 117 432
Charge for the period 41 - - 41
_________ _________ _________ _________
At 31 October 2014 315 41 117 473
========== ========== ========= =========
ANGLE plc
NOTES TO THE INTERIM FINANCIAL INFORMATION
FOR THE SIX MONTHS ENDED 31 OCTOBER 2014
1 Basis of preparation and accounting policies
This Condensed Interim Financial Information is the unaudited
interim consolidated financial information (the "Condensed Interim
Financial Information") of ANGLE plc, a company incorporated in
Great Britain and registered in England and Wales, and its
subsidiaries (together referred to as the "Group") for the six
month period ended 31 October 2014 (the "interim period").
The Condensed Interim Financial Information has been prepared in
accordance with International Accounting Standard 34 Interim
Financial Reporting ("IAS 34"), as adopted by the EU, and on the
basis of the accounting policies which are expected to be adopted
in the Report and Accounts for the year ending 30 April 2015. New
and revised International Financial Reporting Standards (IFRS) and
interpretations recently adopted by the EU and that became
effective in the period did not have or are not expected to have a
significant impact on the Group. Where necessary, comparative
information has been reclassified or expanded from the previously
reported Condensed Interim Financial Information to take into
account any presentational changes which may be made in the Report
and Accounts 2015.
This Condensed Interim Financial Information does not constitute
statutory financial statements as defined in section 434 of the
Companies Act 2006 and is unaudited. The comparative information
for the six months ended 31 October 2013 is also unaudited. The
comparative figures for the year ended 30 April 2014 have been
extracted from the Group financial statements as filed with the
Registrar of Companies. The report of the auditors on those
accounts was unqualified and did not contain statements under
sections 498(2) or (3) of the Companies Act 2006.
The Condensed Interim Financial Information was approved by the
Board and authorised for issue on 28 January 2015.
Going concern
The Financial Information has been prepared on a going concern
basis which assumes that the Group will be able to continue its
operations for the foreseeable future.
The Directors have prepared and reviewed the financial
projections for the 12 month period from the date of signing of
this Condensed Interim Financial Information. Based on the level of
existing cash, expected availability of funding from investors and
projected income and expenditure (the timing of some of which is at
the Group's discretion), the Directors have a reasonable
expectation that the Company and Group have adequate resources to
continue in business for the foreseeable future. Accordingly the
going concern basis has been used in preparing the Condensed
Interim Financial Information.
Critical accounting estimates and judgements
The preparation of the Condensed Interim Financial Information
requires the use of estimates and assumptions and judgements that
affect the reported amounts of assets and liabilities at the date
of the Financial Information and the reported amounts of revenues
and expenses during the reporting period. Although these estimates
and assumptions and judgements are based on management's best
knowledge of the amounts, events or actions, and are believed to be
reasonable, actual results ultimately may differ from those
estimates.
The estimates and assumptions that have a significant risk of
causing a material adjustment to the carrying amounts of assets and
liabilities relate to 1) the valuation and impairment of unlisted
investments held at fair value and 2) the valuation, amortisation
and impairment of intangible assets.
2 Operating segment and revenue analysis
The Group's principal trading activity is undertaken in relation
to Parsortix, a specialist medical diagnostics company with
pioneering products in cancer diagnostics and foetal health.
For management reporting purposes, the Group is divided into the
following operating segments:
-- Medical diagnostics
-- Legacy businesses comprising:
- non-controlled investments
- management services
The nature of these operations is significantly different.
ANGLE has redesigned its business as a specialist medtech
company. The management services business is a legacy business. The
remaining contracts complete on 31 March 2015 and no new contracts
are being sought. Once this is completed, ANGLE intends to seek
reclassification with the London Stock Exchange into the healthcare
sector.
In assessing performance and making resource allocation
decisions, the Board of Directors reviews each segment. The tables
below show the operating results by segment together with assets
and liabilities.
Medical Non-controlled Management
diagnostics investments services Total
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000
Period ended 31 October
2014
Statement of Comprehensive Income
Revenue 288 288
Change in fair value 17 17
Amortisation and impairment
of intangible assets (46) (46)
Other operating costs (1,533) (339) (1,872)
----------------------------- ------------- --------------- ------------- ------------
Operating costs ___(1,579) __________ ___ (399) _ (1,918)
Operating profit/(loss) (1,579) 17 (51) (1,613)
Finance income/(costs) _______7 __________ ____________ _______7
Profit/(loss) before
tax (1,572) 17 (51) (1,606)
======= ======= ======= =======
Statement of Financial Position
Assets
Other receivables
(non-current) 618
Property, plant and
equipment 338
Intangible assets 1,186
Inventories 106
Trade and other receivables 305
Cash and cash equivalents 2,268
________
Total assets 4,821
======
Liabilities
Trade and other payables 822
________
Total liabilities 822
======
Medical Non-controlled Management
diagnostics investments services Total
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000
Period ended 31 October
2013
Statement of Comprehensive Income
Revenue 102 312 414
Change in fair
value 404 404
--------------------------- --------------- ----------------- -------------- ----------------
Amortisation and
impairment of intangible
assets (150) (150)
Other operating
costs (903) (321) (1,224)
--------------------------- --------------- ----------------- -------------- ----------------
Operating costs ___(1,053) ________ ____(321) __(1,374)
Operating profit/(loss) (951) 404 (9) (556)
Finance income/(costs) _80 ________ ________ ______80
Profit/(loss) before
tax (871) 404 (9) (476)
====== ====== ====== ======
Statement of Financial Position
Assets
Property, plant
and equipment 198
Intangible assets - product
development 974
Intangible assets
- other 125
Investments (current) 4,839
Inventories 15
Trade and other
receivables 530
Cash and cash equivalents 358
____________
Total assets 7,039
========
Liabilities
Trade and other
payables 613
Loans and borrowings 132
____________
Total liabilities 745
========
Medical Non-controlled Management
diagnostics investments services Total
(Audited) (Audited) (Audited) (Audited)
GBP'000 GBP'000 GBP'000 GBP'000
Year ended 30 April
2014
Statement of Comprehensive Income
Revenue 156 645 801
Change in fair value 132 1,202 1,334
----------------------------- ------------- --------------- ------------- --------------
Amortisation and
impairment of intangible
assets (99) (99)
Other operating costs (2,731) (655) (3,386)
----------------------------- ------------- --------------- ------------- --------------
Operating costs (2,830) _________ (655) (3,485)
Operating profit/(loss) (2,542) 1,202 (10) (1,350)
Finance income/(costs) 12 100 ____________ 112
Profit/(loss) before
tax (2,530) 1,302 (10) (1,238)
======== ======== ======== ========
Statement of Financial Position
Assets
Other receivables
(non-current) 601
Property, plant and
equipment 139
Intangible assets 1,142
Inventories 52
Trade and other receivables 328
Cash and cash equivalents 3,898
____________
Total assets 6,160
========
Liabilities
Trade and other payables 645
____________
Total liabilities 645
========
3 Tax
The Group is eligible for the UK corporation tax substantial
shareholdings exemption. This results in the capital gain from any
disposals of UK investments where the Group has an equity stake
greater than 10%, and subject to certain other tests, being free of
corporation tax.
Tax is therefore based on the profits in the Management services
business as relieved by losses incurred in the Group's other UK
trading activities. Loss relief may not absorb the tax in relation
to all of the profits and where this occurs tax is provided on the
basis of the estimated effective tax rate for the full year.
Controlled investments undertake research and development
activities. In the UK these activities qualify for tax relief and
result in tax credits.
4 Earnings/(loss) per share
The basic and diluted earnings/(loss) per share is calculated on
an after tax loss of GBP1.6 million (six months to 31 October 2013:
loss GBP0.5 million, year to 30 April 2014: loss GBP1.2 million).
In accordance with IAS 33 Earnings per share 1) the "basic"
weighted average number of ordinary shares calculation excludes
shares held by the Employee Share Ownership Trust (ESOT) as these
are treated as treasury shares and 2) the "diluted" weighted
average number of ordinary shares calculation excludes potentially
dilutive ordinary shares from instruments that could be converted.
Share options are potentially dilutive where the exercise price is
less than the average market price during the period. Due to the
losses in the periods, share options are non-dilutive for the
respective periods and therefore the diluted loss per share is
equal to the basic loss per share.
The basic and diluted earnings/(loss) per share are based on
45,129,800 weighted average ordinary 10p shares (six months to 31
October 2013: 45,129,800; year to 30 April 2014: 45,129,800).
5 Intangible assets
Intellectual Computer Product
Property software Goodwill development Total
(Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Cost or deemed
cost
At 1 May 2013 524 12 98 973 1,607
Additions - - - 201 201
Exchange movements (1) - - (36) (37)
_________ _________ _________ _________ _________
At 31 October
2013 523 12 98 1,138 1,771
Additions 30 1 - 16 47
Reclassification 62 - (62) -
Disposals (400) (2) (98) - (500)
Exchange movements (9) - - (47) (56)
_________ _________ _________ _________ _________
At 30 April 2014 206 11 - 1,045 1,262
Additions 22 1 - 10 33
Exchange movements 7 1 - 57 65
_________ _________ _________ _________ _________
At 31 October
2014 235 13 - 1,112 1,360
======= ======= ======= ======= =======
Amortisation and impairment
At 1 May 2013 400 10 98 19 527
Charge for the
period - - - 150 150
Exchange movements - - - (5) (5)
_________ _________ _________ _________ _________
At 31 October
2013 400 10 98 164 672
Charge for the
period - 1 - (52) (51)
Disposals (400) (2) (98) - (500)
Exchange movements - - - (1) (1)
_________ _________ _________ _________ _________
At 30 April 2014 - 9 - 111 120
Charge for the
period - 1 - 45 46
Exchange movements - - - 8 8
________ _________ _________ _________ _________
At 31 October
2014 - 10 - 164 174
======= ======= ======= ======= =======
Net book value
At 31 October
2014 235 3 - 948 1,186
At 30 April 2014 206 2 - 934 1,142
At 31 October
2013 123 2 - 974 1,099
The carrying value of intangible assets is reviewed for
impairment annually or whenever events or changes in circumstances
indicate that the carrying value may not be recoverable. The
recoverable amount is assessed on the basis of "value in use". The
key assumptions to assess value in use are the estimated useful
economic life, future revenues, cash flows and the discount rate to
determine the net present value of these cash flows. Where value in
use exceeds the carrying value then no impairment is made. Where
value in use is less than the carrying value then an impairment
charge is made.
Amortisation and impairment charges are included in operating
costs in the Consolidated Statement of Comprehensive Income.
"Product development" relates to internally generated assets
that were capitalised in accordance with IAS 38 Intangible Assets.
Capitalised product development costs are directly attributable
costs comprising cost of materials, specialist contractor costs,
labour and overheads. Product development costs are amortised over
their estimated useful lives commencing when a new product is in
commercial production. Development costs not meeting the IAS 38
criteria for capitalisation continue to be expensed through the
Statement of Comprehensive Income as incurred.
6 Share capital
The Company has one class of ordinary shares which carry no
right to fixed income and at 31 October 2014 had 45,243,059
Ordinary shares of GBP0.10 each allotted, called up and fully paid.
During the period the Company issued 60,000 and subsequent to the
period end a further 2,500,000 new share options with performance
and/or vesting conditions.
7 Post reporting date events
As explained in the Chairman's Statement, the Company has made
strong progress with Parsortix.
Shareholder communications
The announcement is being sent to all shareholders on the
register at 28 January 2014. Copies of this announcement are posted
on the Company's website www.ANGLEplc.com and are available from
the Company's registered office: 3 Frederick Sanger Road, Surrey
Research Park, Guildford, Surrey, GU2 7YD.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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