TIDMAGL
RNS Number : 1504V
Angle PLC
26 January 2017
For Immediate Release 26 January 2017
ANGLE plc
("ANGLE" or "the Company")
Interim Results for the six months ended 31 October 2016
OVARIAN CANCER CLINICAL STUDIES PROGRESSING WELL
ANGLE plc (AIM: AGL and OTCQX: ANPCY), the specialist medtech
company, today announces its unaudited interim financial results
for the six months ended 31 October 2016.
Operational Highlights
-- Initiated two 200 patient clinical studies in Europe and the
US for the Company's first clinical application for detection of
ovarian cancer in women with a high risk pelvic mass
- Interim evaluations of first 50 patients in both studies are
positive (announced today, see separate release)
- Patient enrolment is over 90% complete in Europe and 70%
complete in the US
- Headline data from the full studies is expected to be
available in Q2, 2017
-- Extensive work towards FDA clearance in metastatic breast cancer
- Analytical study work under way and making good progress
- Clinical study plan, involving 200 metastatic breast cancer
patients and 200 healthy volunteers, submitted to the Scientific
Review Committees at three world-leading US cancer centres for
formal review
- Completion of analytical and clinical studies expected in 2017
to enable FDA submission
-- Increase in research use with a wide range of leading cancer
centres throughout Europe and North America evaluating and adopting
Parsortix into their research and clinical studies
- Cancer Research UK Manchester Institute selected Parsortix for
routine use in clinical trials and has processed 1,100 patient
samples in 16 clinical trials (multiple cancers)
- Medical University of Vienna incorporated Parsortix in the
Gannet53 ovarian cancer trial and have processed over 400 patient
samples
-- Growing body of published evidence, from
internationally-recognised cancer centres, validates Parsortix as a
leading liquid biopsy solution
- Fourth peer-reviewed paper on the application of Parsortix
published in Clinical Chemistry by University Medical Centre
Hamburg-Eppendorf (breast cancer and prostate cancer)
- Highlights key Parsortix advantages compared to competing
approaches
- Demonstrates potential use of Parsortix in assessing
chemotherapy resistance
- Third party research using Parsortix presented at leading
cancer conferences including EACR and AACC and, post period end,
NCRI and SABC(1)
Financial Highlights
-- Revenues of GBP0.2 million (H1 2016: GBPnil)
-- Loss from continuing operations of GBP2.7 million (H1 2016: loss GBP2.3 million)
-- Successful fundraising from major institutional investors
raising GBP10.2 million (GBP9.6 million net of expenses)
-- Cash balance at 31 October 2016 of GBP9.7 million (30 April 2016: GBP3.8 million)
Garth Selvey, Chairman, commented:
"The Parsortix system is now delivering early adoption revenues
with increasing sales for research use. Our two major ovarian
cancer studies are progressing towards completion by mid-year and
data from the initial patient cohort is positive.
We have also continued to work hard towards obtaining FDA
clearance of the system. Our sustained efforts have resulted in
detailed analytical and clinical study plans. The analytical study
is in progress and the clinical study plan has recently been
submitted to three world-leading US cancer centres for formal
scientific committee review.
There is still much to do, but the goal remains to layer
additional supportive scientific data from clinical studies
incorporating Parsortix use on top of our hard-won reputation in
the international research environment. This, we believe, is the
gateway to competing effectively in a very large and growing liquid
biopsy market."
Analyst meeting and webcast details
A meeting for analysts will be held at 10:30 am on 26 January
2017 at the offices of FTI Consulting, 200 Aldersgate, Aldersgate
Street, London EC1A 4HD. Please contact FTI Consulting on 020 3727
1000 for details.
To listen to the live webcast of the analyst meeting, please
see
http://www.angleplc.com/investor-information/investor-centre/
for details.
1. European Association for Cancer Research (EACR 2016);
American Association for Clinical Chemistry (AACC 2016); the
National Cancer Research Institute (NCRI 2016); San Antonio Breast
Cancer Symposium (SABC 2016)
For further information:
ANGLE plc 01483 685830
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Cenkos Securities
Stephen Keys (Nominated adviser),
Steve Cox
Russell Kerr (Sales) 020 7397 8900
FTI Consulting
Simon Conway, Mo Noonan 020 3727 1000
Kimberly Ha (US) 001 212 850 5612
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 including the
success of the Group's research and development and
commercialisation strategies, the uncertainties related to
regulatory clearance and the acceptance of the Group's products by
customers.
CHAIRMAN'S STATEMENT
Introduction
During the half year, ANGLE continued its progress to
commercialise its Parsortix(TM) liquid biopsy for cancer.
Following the initial sales for research use in the previous
period, sales efforts during the past period were intensified, with
many leading cancer centres in Europe and the United States
initiating evaluations of the Parsortix system.
The highlight of the half year was the Company moving into the
clinical studies phase. Following a successful 65 patient pilot
study and intensive work over a prolonged period, major clinical
studies to evaluate the risk of a malignancy in women with a pelvic
mass were initiated in Europe and the United States in support of
the Company's first clinical application, for ovarian cancer.
Continued progress was made with the design of analytical and
clinical studies which will support an FDA application for
clearance of the platform in metastatic breast cancer. Furthermore,
key opinion leaders have continued to demonstrate the significant
performance capabilities of the Parsortix system, in multiple pilot
studies, with a wide range of cancer types.
Results
Revenue of GBP0.2 million (H1 2016: GBPnil) came from sales of
the Parsortix system for research use. Planned investment in
studies to develop and validate the clinical application and
commercial use of Parsortix increased, resulting in operating costs
of GBP3.1 million (H1 2016: GBP2.4 million). Thus the resulting
loss for the period from continuing operations correspondingly
increased to GBP2.7 million (H1 2016: GBP2.3 million).
The cash balance was GBP9.7 million at 31 October 2016 (30 April
2016: GBP3.8 million). The financial position was strengthened
during the half year with a successful placing of shares with major
institutional investors, which raised GBP10.2 million gross (GBP9.6
million net of expenses).
Research use sales
Following first research use sales of the Parsortix system in
December 2015, good progress has been made during the period in
building a sales pipeline in this market, which is estimated to be
GBP250 million per annum.
It was notable that, particularly in the United States, many
customers have budget cycles based on the calendar year.
Consequently, we expect sales to increase substantially in the
second half.
Most targeted customers are large, established cancer centres
that offer the prospect of repeat sales and significant growth, as
other departments within the same entity become aware of the
research capability that Parsortix offers.
Considerable efforts are underway to further the use of
Parsortix in drug trials, the largest part of the research use
market.
Adoption of Parsortix by Cancer Research UK Manchester
Institute, for routine use in their clinical trials, is an
important step in establishing the credibility of the system. This
contract has led to ongoing revenue generation, with Parsortix
already incorporated into 16 clinical trials involving 1,100
patient samples to date. Cancer Research UK Manchester Institute's
partner hospital, the Christie, is one of the largest single-site
cancer hospitals in Europe with 620 currently active clinical
trials in process.
Likewise adoption by Medical University of Vienna in the
Gannet53 ovarian cancer trial and the processing of over 400
patient samples in that trial is another important reference
point.
The installed base, including those at ANGLE labs, key opinion
leaders, customers and prospective customers, is now over 135
Parsortix systems and around 24,000 blood samples have now been
processed with the system. Each new customer brings additional
instrument revenue and increases the installed base, driving
increased ongoing revenues from consumables and service contracts.
Furthermore, each new research use customer undertaking
investigations into new uses of the system for publication, creates
increased awareness and consequent market demand for the Parsortix
system.
We are aware of research being undertaken with the Parsortix
system funded and developed by third parties in 14 different cancer
types including:
Breast cancer Cervical cancer
Colorectal cancer Endometrial cancer
Head and neck cancer Hepatocellular cancer (liver)
Melanoma Neuroendocrine cancer
Non-small cell lung cancer Ovarian cancer
(NSCLC)
Pancreatic cancer Prostate cancer
Renal cancer (kidney) Small cell lung cancer
(SCLC)
Half of the top 10 researchers worldwide into CTCs in breast
cancer, as measured by the number of publications they have
published on CTCs, have now adopted Parsortix for CTC analysis.
In the United States, over 40% of the 27 National Comprehensive
Cancer Centres have purchased the Parsortix system or are currently
evaluating it for purchase.
Regulatory authorisation
The Parsortix system must gain regulatory authorisation before
it can be sold for use in clinical markets (for use in the
management of patients). ANGLE already has a CE Mark for the
indicated clinical use of the Parsortix system in Europe as a
platform for harvesting cancer cells for analysis. Significant
efforts are being made to secure a United States FDA clearance for
use of the platform in the enrichment and harvesting of cancer
cells from metastatic breast cancer patients. FDA clearance would
not only allow sale of the product for clinical use in the United
States but would also validate the performance of the system,
thereby influencing system adoption worldwide.
During the half year, significant progress was made in the
design of the analytical and clinical validation studies required
for FDA clearance. The analytical studies address key technical
issues, such as establishing the reproducibility and sensitivity of
the system and the identification of any potential interferents.
Extensive work has already been completed including the
establishment of new functionality tests for the Parsortix
instrument, together with procedures to enable analytical studies
of the instrument that will take place at different sites. The
clinical version of the Parsortix instrument has been subjected to
intensive testing in advance of the formal start of the clinical
study and has performed well.
During the half year, extensive work was completed, both
in-house and in conjunction with three world-leading US cancer
centres, which will be responsible for conducting ANGLE's FDA
clinical study. This work led to the development and finalisation
of the processes and procedures to be used for the clinical study
and a detailed FDA clinical study plan for metastatic breast
cancer. Post period end, the study plan was finalised, and it has
been submitted to Scientific Review Committees at the three cancer
centres for formal review.
The clinical study comprises the harvesting of circulating tumor
cells (CTCs) using the Parsortix system from blood samples
collected from 200 metastatic breast cancer patients and 200
matching healthy volunteers. The harvested cells will be evaluated
using several different analysis techniques, with the results
designed to support the following "Intended Use Statement" for the
Parsortix(TM) PC1 system:
"The Parsortix(TM) PC1 instrument is an in vitro diagnostic
device intended to harvest circulating tumor cells (CTCs) from the
peripheral blood of patients diagnosed with metastatic breast
cancer. The CTCs can be harvested from the instrument for
subsequent analysis."
The clinical study will be initiated once the participating
centres have obtained Scientific Committee and ethics approvals and
contractual arrangements are completed. Samples will be blinded and
all aspects of the clinical study, including the downstream
analyses, will be undertaken by the independent cancer centres.
The aim is to complete the necessary analytical and clinical
studies in the 2017 calendar year. The timing of eventual FDA
clearance is dependent on the Agency's assessment of the study
results, both analytical and clinical and consequently their
acceptance of our proposed intended use.
Once the breast cancer FDA clearance has been obtained, it is
intended to extend it to other cancer types, progressively,
including ovarian and prostate cancer.
Ovarian cancer clinical application: triaging abnormal pelvic
mass
Following a period of extensive planning and preparation, during
the half year major clinical studies were initiated in both Europe
and the United States in support of the Company's ovarian cancer
clinical application.
The studies are progressing well with patient enrolment over 90%
complete in Europe and due to complete in February 2017, and 70%
complete in the US and currently on target for completion by the
end of April 2017. Headline data from the full studies are expected
to be available in Q2, 2017.
A planned interim evaluation of the first 50 patients from both
studies has been undertaken to evaluate the optimum combination of
RNA markers to detect malignancy. The early evaluation of data from
both studies suggest that an assay using the Parsortix system may
be able to identify women with a malignant pelvic mass more
effectively than the assays currently available in clinical
practice, in particular with much higher specificity (avoiding
classifying benign conditions as malignant 'false positives').
Furthermore, it now appears likely that the gene expression
information available using Parsortix, which is not accessible
using existing techniques, may be valuable guiding treatment,
including neo-adjuvant chemotherapy, prior to surgery.
Both studies are designed and controlled to provide medical
evidence in support of using the Parsortix system to help assess
the likelihood of whether a woman who is having surgery for an
abnormal pelvic mass has a malignancy. This is a major unmet
medical need, as women with cancer require a specialist cancer
surgeon to undertake their operation followed by intensive care if
they are to have a favourable outcome, whereas women with a benign
pelvic mass fare well with a general surgeon at their local
hospital, which is more cost effective. At present, there is no
test providing both high sensitivity and high specificity for this
discrimination, which leads to many women receiving inappropriate
care, either insufficient surgeon expertise or unnecessary use of
expensive specialist healthcare resources.
In the United States alone there are over 200,000 women every
year having surgery for abnormal pelvic masses, and we estimate
that the market value available to ANGLE if this test was fully
implemented would be in excess of GBP300 million revenue per
annum.
Both of the current studies require the enrolment of 200
patients, and are being conducted by independent cancer centres
such that the researchers undertaking the analysis are blinded to
the patient condition until after the sample evaluations have been
completed.
The cancer centres involved are:
-- Europe: Medical University of Vienna, Charité Medical
University Berlin and three clinics from Vivantes Network for
Health GmbH
-- United States: University of Rochester Medical Center Wilmot Cancer Institute
A blood sample taken prior to surgery is separated on the
Parsortix system to harvest any circulating tumour cells that may
be present. The expression of several different cancer related RNA
markers is then determined and compared with the actual status of
the tissue removed by surgery, which is analysed by a pathologist
as part of standard care. The comparison of the RNA marker results
from the Parsortix harvests with the histopathological diagnoses
will enable an evaluation of the sensitivity (ability to detect
malignant conditions) and specificity (ability to detect benign
conditions) of the assay. Existing blood tests for ovarian cancer
have poor specificity, with nearly half of the benign patients
being incorrectly diagnosed as malignant. In contrast, in the pilot
study, the Parsortix based RNA assay had a high specificity.
Once the European study is complete, European hospitals with
accredited laboratories will be able to design a laboratory
developed test (LDT) based on the RNA markers identified, thus
enabling ANGLE to start generating revenue from clinical sales of
the instrument and cassettes. ANGLE will then seek to undertake a
European "validation study" to validate the clinical utility of a
Parsortix RNA assay. The successful validation of such an assay
would allow ANGLE to sell instruments and ovarian specific assay
kits to all European hospitals without the requirement for an
LDT.
The United States study is intended to provide additional
patient data in the United States market, which will be important
for subsequent FDA clearance of an ovarian-specific assay as
described above. The US study will similarly support the
development of LDTs. A further multi-site United States "validation
study" will be needed to secure FDA clearance for the ovarian
application, which will then enable the sale of the application
throughout hospitals in the United States.
Other potential clinical applications
Following successful pilot studies, ANGLE is assessing the
potential to develop additional clinical applications in metastatic
breast cancer and prostate cancer.
Breast cancer: blood test alternative to invasive metastatic
biopsy
Post period end, the University of Southern California (USC)
Norris Comprehensive Cancer Center presented further work with
Parsortix as a poster at the San Antonio Breast Cancer Conference
(SABC 2016). Their findings continue to support the potential for
the use of Parsortix as a liquid biopsy for metastatic breast
cancer. Having assessed how best to progress this potential
clinical application from the perspective of cost and speed to
market, ANGLE now intends to include this form of gene expression
analysis as an element of the FDA clinical study. Consequently we
hope to have clinical data within calendar year 2017.
Prostate cancer: blood test alternative to prostate biopsy
Post period end, Barts Cancer Institute has presented further
work with the Parsortix system as a poster at the National Cancer
Research Institute (NCRI 2016). In a study of around 80 samples
from men with prostate cancer, Barts reported that the mesenchymal
CTCs captured by Parsortix, which are missed by antibody-based CTC
systems and cannot be addressed by ctDNA-based assays, may have
particular relevance in assessing the status of the disease.
ANGLE is now working on plans to further develop the commercial
diagnostic potential in this approach leading to a possible
clinical study of the use of Parsortix as an alternative, or
pre-cursor, to solid prostate biopsy. If successful, this would
mean that men without cancer or with low level (indolent) disease
could avoid unnecessary and potentially harmful solid biopsy and
surgical intervention, instead having "active surveillance",
whereas men with an aggressive form of disease could be
fast-tracked for further investigation and treatment.
A simple blood test to assess whether a solid prostate biopsy is
warranted would improve patient care as well as reduce healthcare
costs.
Growing body of published evidence
The Parsortix system is now being adopted amongst leading
researchers in the field, and as a result there is a growing body
of published evidence from third party cancer centres in support of
the Parsortix system.
During the half year, a fourth peer-reviewed paper on the
application of Parsortix was published in Clinical Chemistry by
University Medical Centre Hamburg-Eppendorf, Germany. This
highlighted key Parsortix advantages compared to competing
approaches in analysing breast cancer and prostate cancer liquid
biopsies and demonstrated the potential use of Parsortix in
assessing chemotherapy resistance.
Multiple other leading cancer centres presented research using
Parsortix at leading cancer conferences including:
European Association for Cancer Research (EACR 2016)
-- Fraunhofer ITEM Regensburg, Germany: lymph node analysis (melanoma)
-- CRUK Manchester Institute, UK: combined CTC and ctDNA analysis (pancreatic cancer)
American Association for Clinical Chemistry (AACC 2016)
-- MD Anderson, US: gene expression analysis (breast cancer)
The National Cancer Research Institute (NCRI 2016)
-- Barts Cancer Institute, UK: detection and assessment of aggressiveness (prostate cancer)
San Antonio Breast Cancer Symposium (SABC 2016)
-- University Hospital Dusseldorf, Germany: single cell analysis (breast cancer)
-- University of Southern California, US: gene expression analysis (breast cancer)
Publications that have been released publicly are available
at
http://www.angleplc.com/the-parsortix-system/download-files/
The rate of third party publications is accelerating as research
use customers are beginning to publish their results. Peer reviewed
publications, scientific data and Level 1 clinical evidence are
fundamental to the Company's overall strategy aimed at Parsortix
being routinely adopted as the system of choice for the harvesting
of cancer cells from patient blood for analysis.
Intellectual property further strengthened
Intellectual property protecting the Parsortix system was
further strengthened, post the period end, with grants of patents
in Japan and United States; the latter being the third patent
granted in the United States.
The Parsortix system is now covered by granted patents in the
United States, Europe, Australia, Canada, China and Japan, which
extend out to 2034. Additional patents are being pursued
worldwide.
Outlook
The Parsortix system is now delivering early adoption revenues
with increasing sales for research use. Our two major ovarian
cancer studies are progressing towards completion by mid-year and
data from the initial patient cohort is positive.
We have also continued to work hard towards obtaining FDA
clearance of the system. Our sustained efforts have resulted in
detailed analytical and clinical study plans. The analytical study
is in progress and the clinical study plan has recently been
submitted to three world-leading US cancer centres for formal
scientific committee review.
There is still much to do, but the goal remains to layer
additional supportive scientific data from clinical studies
incorporating Parsortix use on top of our hard-won reputation in
the international research environment. This, we believe, is the
gateway to competing effectively in a very large and growing liquid
biopsy market.
Garth Selvey
Chairman
25 January 2017
ANGLE plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHSED 31 OCTOBER 2016
Note Six months ended Six months ended Year ended
31 October 31 October 30 April
2016 2015 2016
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Revenue 219 - 361
Cost of sales (43) - (107)
Gross profit 176 - 254
Operating costs (3,088) (2,399) (5,703)
________ ________ ________
Operating profit/(loss) from continuing operations (2,912) (2,399) (5,449)
Net finance income/(costs) ______20 _______12 22
Profit/(loss) before tax from continuing operations (2,892) (2,387) (5,427)
Tax (charge)/credit 3 202 104 309
Profit/(loss) for the period from continuing
operations (2,690) (2,283) (5,118)
Profit/(loss) from discontinued operations - 10 32
Profit/(loss) for the period (2,690) (2,273) (5,086)
Other comprehensive income/(loss)
Items that may be subsequently reclassified to
profit or loss
Exchange differences on translating foreign
operations 188 _ (35) __ (7)
Other comprehensive income/(loss) 188 __ _ (35) ____ _ (7)
Total comprehensive income/(loss) for the period (2,502) (2,308) (5,093)
========= ========= ==========
Profit/(loss) for the period attributable to:
Owners of the parent
From continuing operations (2,598) (2,189) (4,924)
From discontinued operations - 10 31
Non-controlling interests
From continuing operations (92) (94) (194)
From discontinued operations - - 1
_________ _________ _________
Profit/(loss) for the period (2,690) (2,273) (5,086)
========= ========= =========
Total comprehensive income/(loss) for the period attributable to:
Owners of the parent
From continuing operations (2,633) (2,231) (4,978)
From discontinued operations - 10 31
Non-controlling interests
From continuing operations 131 (87) (147)
From discontinued operations - - 1
_________ __________ _________
Total comprehensive income/(loss) for the period (2,502) (2,308) (5,093)
========= ========= =========
Earnings/(loss) per share 4
Basic and Diluted (pence per share)
From continuing operations (3.74) (3.88) (8.69)
From discontinued operations - 0.02 0.05
From continuing and discontinued operations (3.74) (3.86) (8.64)
ANGLE plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 OCTOBER 2016
Note 31 October 31 October 30 April
2016 2015 2016
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
ASSETS
Non-current assets
Property, plant and equipment 558 476 455
Intangible assets 5 1,634 1,168 1,346
__________ __________ __________
Total non-current assets 2,192 1,644 1,801
__________ __________ __________
Current assets
Inventories 631 271 376
Trade and other receivables 646 786 489
Taxation 511 104 309
Cash and cash equivalents 9,651 5,828 3,764
__________ __________ __________
Total current assets 11,439 6,989 4,938
__________ __________ __________
Total assets 13,631 8,633 6,739
========= ========= =========
EQUITY AND LIABILITIES
Equity
Share capital 6 7,482 5,898 5,898
Share premium 33,285 25,299 25,299
Share-based payments reserve 700 493 629
Other reserve 2,553 2,553 2,553
Translation reserve (56) (9) (21)
Retained earnings (30,738) (25,398) (28,141)
ESOT shares (102) (102) (102)
__________ __________ __________
Equity attributable to owners of the parent 13,124 8,734 6,115
__________ __________ __________
Non-controlling interests (749) (850) (880)
Total equity 12,375 7,884 5,235
============== ============== ==============
Liabilities
Current liabilities
Trade and other payables 1,256 749 1,504
_________ _________ _________
Total current liabilities 1,256 749 1,504
_________ _________ _________
Total liabilities 1,256 749 1,504
_________ _________ _________
Total equity and liabilities 13,631 8,633 6,739
============= ============= =============
ANGLE plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHSED 31 OCTOBER 2016
Six months ended Six months ended Year ended
31 October 31 October 30 April
2016 2015 2016
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Operating activities
Profit/(loss) before tax from continuing operations (2,892) (2,387) (5,427)
Adjustments for:
Depreciation of property, plant and equipment 116 92 198
Amortisation and impairment of intangible assets 74 61 187
Exchange differences 73 (10) (65)
Net finance (income)/costs (20) (12) (22)
Share-based payments _ 72 __ 102 _238
Operating cash flows before movements in working capital: (2,577) (2,154) (4,891)
(Increase)/decrease in inventories (275) (165) (238)
(Increase)/decrease in trade and other receivables (215) 93 (107)
Increase/(decrease) in trade and other payables _ __(342) ___(170) ___474
Net cash from/(used in) operating activities (3,409) (2,396) (4,762)
Investing activities
Purchase of property, plant and equipment (50) (56) (186)
Purchase of intangible assets (158) (89) (332)
Interest received ______17 ______12 _ ____21
Net cash from/(used in) investing activities (191) (133) (497)
Financing activities
Net proceeds from issue of share capital 9,570 1 ____1
Net cash from/(used in) financing activities 9,570 1 1
Net increase/(decrease) in cash and cash equivalents from
continuing operations 5,970 (2,528) (5,258)
Discontinued operations
Net cash from/(used in) operating activities - (87) (34)
Net cash from/(used in) investing activities _ - - _ __611
Net increase/(decrease) in cash and cash equivalents from
discontinued operations - (87) 577
Net increase/(decrease) in cash and cash equivalents 5,970 (2,615) (4,681)
Cash and cash equivalents at start of period 3,764 8,443 8,443
Effect of exchange rate fluctuations __ ___(83) __ ______- _______2
Cash and cash equivalents at end of period 9,651 5,828 3,764
========= ========= =========
ANGLE plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHSED 31 OCTOBER 2016
-----------------------------
Equity attributable to owners
of the parent ---------------------------------------------
Share-based
Share Share payments Other Translation
capital premium reserve reserve reserve
(Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 May
2015 5,897 25,299 432 2,553 33
For the period
to 31 October
2015
-------------------------- ------------- ------------ ------------ ------------ ------------
Consolidated
profit/(loss)
Other comprehensive
income/(loss)
Exchange
differences
in translating
foreign operations (42)
-------------------------- ------------- ------------ ------------ ------------ ------------
Total comprehensive
income/(loss) (42)
Issue of
shares 1 -
Share-based
payments 102
Released
on deemed
disposal (41)
___ ___ ___
______ ___ _______ ___ ______ ______ ______
At 31 October
2015 5,898 25,299 493 2,553 (9)
For the period
to 30 April
2016
-------------------------- ------------- ------------ ------------ ------------ ------------
Consolidated
profit/(loss)
Other comprehensive
income/(loss)
Exchange
differences
in translating
foreign operations (12)
-------------------------- ------------- ------------ ------------ ------------ ------------
Total comprehensive
income/(loss) (12)
Issue of
shares
Share-based
payments 136
Deemed disposal
of controlling
interest
in investment
At 30 April
2016 5,898 25,299 629 2,553 (21)
For the period
to 31 October
2016
------------
Consolidated
profit/(loss)
Other comprehensive
income/(loss)
Exchange
differences
in translating
foreign operations (35)
-------------------------- ------------- ------------ ------------ ------------ ------------
Total comprehensive
income/(loss) (35)
Issue of
shares 1,584 7,986
Share-based
payments 72
Released
on exercise (1)
___ ___ ___
______ ___ _______ ___ ______ ______ ______
At 31 October
2016 7,482 33,285 700 2,553 (56)
========== ========== ========== ========== =========
--- Equity attributable
to owners of the
parent --
Total Non-
Retained ESOT Shareholders' controlling Total
earnings shares equity interests equity
(Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 May
2015 (23,260) (102) 10,852 (763) 10,089
For the period
to 31 October
2015
-------------------------- ------------- ------------ -------------- ------------ ------------
Consolidated
profit/(loss) (2,179) (2,179) (94) (2,273)
Other comprehensive
income/(loss)
Exchange
differences
in translating
foreign operations (42) 7 (35)
-------------------------- ------------- ------------ -------------- ------------ ------------
Total comprehensive
income/(loss) (2,179) (2,221) (87) (2,308)
Issue of
shares 1 1
Share-based
payments 102 102
Released
on deemed
disposal 41 - -
___ ___
___ ________ ___ ______ ___ _______ _______ _______
At 31 October
2015 (25,398) (102) 8,734 (850) 7,884
For the period
to 30 April
2016
-------------------------- ------------- ------------ -------------- ------------ ------------
Consolidated
profit/(loss) (2,714) (2,714) (99) (2,813)
Other comprehensive
income/(loss)
Exchange
differences
in translating
foreign operations (12) 40 28
-------------------------- ------------- ------------ -------------- ------------ ------------
Total comprehensive
income/(loss) (2,714) (2,726) (59) (2,785)
Issue of
shares
Share-based
payments 136 136
Deemed disposal
of controlling
interest
in investment (29) (29) 29 -
At 30 April
2016 (28,141) (102) 6,115 (880) 5,235
For the period
to 31 October
2016
Consolidated
profit/(loss) (2,598) (2,598) (92) (2,690)
Other comprehensive
income/(loss)
Exchange
differences
in translating
foreign operations (35) 223 188
-------------------------- ------------- ------------ -------------- ------------ ------------
Total comprehensive
income/(loss) (2,598) (2,633) 131 (2,502)
Issue of
shares 9,570 9,570
Share-based
payments 72 72
Released 1
on exercise - -
___ ___
___ ________ ___ ______ ___ _______ _______ _______
At 31 October
2016 (30,738) (102) 13,124 (749) 12,375
=========== ========== ========== ========== ==========
ANGLE plc
NOTES TO THE INTERIM FINANCIAL INFORMATION
FOR THE SIX MONTHSED 31 OCTOBER 2016
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 2016 (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 2017. 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 were made in the Report
and Accounts 2016 and which may be made in the Report and Accounts
2017.
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 2015 is also unaudited. The
comparative figures for the year ended 30 April 2016 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 25 January 2017.
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 approval of
this Condensed Interim Financial Information. Based on the level of
existing cash and the 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, 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,
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, assumptions and judgements that have a
significant risk of causing a material adjustment to the carrying
amounts of assets and liabilities relate to 1) the valuation,
amortisation and impairment of intangible assets 2) share-based
payments 3) research and development tax credit and 4) deferred tax
assets.
2 Operating segment and revenue analysis
The Group's principal trading activity is undertaken in relation
to the commercialisation of its Parsortix cell separation system
and it operates as one business segment, being the development and
commercialisation of the Parsortix system. All significant
decisions are made by the Board of Directors with implementation of
those decisions on a Group-wide basis. The Group manages any
overseas R&D and sales and marketing from the UK. The Directors
believe that these activities comprise only one operating segment
and, consequently, segmental analysis is not considered necessary
as the segment information is substantially in the form of and on
the same basis as the Group's IFRS information.
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.
The Group undertakes research and development activities. In the
UK these activities qualify for tax relief and result in tax
credits.
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.
4 Earnings/(loss) per share
The basic and diluted earnings/(loss) per share is calculated on
an after tax loss on continuing operations of GBP2.7 million
(continuing and discontinued: six months to 31 October 2015: loss
GBP2.3 million, year to 30 April 2016: loss GBP5.1 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
72,020,501 weighted average ordinary 10p shares (six months to 31
October 2015: 58,862,362; year to 30 April 2016: 58,863,713).
5 Intangible assets
Intellectual Computer Product development
property software Total
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000
Cost
At 1 May 2015 286 12 1,191 1,489
Additions 33 - 56 89
Exchange movements (1) - (9) (10)
_________ _________ _________ _________
At 31 October 2015 318 12 1,238 1,568
Additions 208 1 34 243
Disposals (94) (7) - (101)
Exchange movements 10 - 67 77
_________ _________ _________ _________
At 30 April 2016 442 6 1,339 1,787
Additions 56 - 106 162
Exchange movements 23 1 256 280
_________ _________ _________ _________
At 31 October 2016 521 7 1,701 2,229
======= ======= ======= =======
Amortisation and impairment
At 1 May 2015 94 10 236 340
Charge for the period - 1 60 61
Exchange movements - - (1) (1)
_________ _________ _________ _________
At 31 October 2015 94 11 295 400
Charge for the period 2 - 64 66
Disposals (94) (7) - (101)
Impairment 60 - - 60
Exchange movements - - 16 16
_________ _________ _________ _________
At 30 April 2016 62 4 375 441
Charge for the period 4 1 69 74
Exchange movements - - 80 80
_________ _________ _________ _________
At 31 October 2016 66 5 524 595
======= ======= ======= =======
Net book value
At 31 October 2016 455 2 1,177 1,634
At 30 April 2016 380 2 964 1,346
At 31 October 2015 224 1 943 1,168
The carrying value of intangible assets is reviewed for
indications of impairment whenever events or changes in
circumstances indicate that the carrying value may exceed the
recoverable amount. The recoverable amount is the higher of the
asset's fair value less costs to sell and its "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 charged to operating
costs in the 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 the related 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.
Product development includes a carrying value of GBP650,205 (31
October 2015: GBP614,126; 30 April 2016: GBP595,743) in relation to
the Parsortix instrument.
6 Share capital
The Company has one class of ordinary shares which carry no
right to fixed income and at 31 October 2016 had 74,815,774
Ordinary shares of GBP0.10 each allotted, called up and fully
paid.
During the period the Company issued 15,815,436 new ordinary
shares with a nominal value of GBP0.10 at an issue price of
GBP0.645 per share in a placing of shares realising proceeds of
GBP9.6 million net of costs. Shares were admitted to trading on AIM
in May 2016.
During the period the Company issued 22,000 new ordinary shares
with a nominal value of GBP0.10 at an exercise price of GBP0.2575
per share as a result of the exercise of share options by an
employee. Shares were admitted to trading on AIM in September
2016.
7 Post reporting date events
As explained in the Chairman's Statement, subsequent to the
period end the Company has made continued strong progress with
Parsortix and made further announcements in relation to positive
interim evaluations of the Company's two ovarian cancer studies and
further research presented by Barts Cancer Institute into prostate
cancer.
Shareholder communications
The announcement is being sent to all shareholders on the
register at 25 January 2017. 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
IR LFFVFLVIEFID
(END) Dow Jones Newswires
January 26, 2017 02:01 ET (07:01 GMT)
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