TIDMAGL
RNS Number : 4020D
Angle PLC
31 January 2018
For Immediate Release 31 January 2018
ANGLE plc
("ANGLE" or "the Company")
Interim Results for the six months ended 31 October 2017
OVARIAN CANCER CLINICAL STUDIES SUCCESSFULLY COMPLETED
ACQUISITION ADDS DOWNSTREAM ANALYSIS TO PARSORTIX CTC HARVESTING
PROVIDING COMPLETE 'SAMPLE TO ANSWER' CAPABILITY
INSTITUTIONAL REVIEW BOARD APPROVALS RECEIVED FOR FDA STUDY
ANGLE plc (AIM: AGL and OTCQX: ANPCY), a world-leading liquid
biopsy company, today announces its unaudited interim financial
results for the six months ended 31 October 2017.
Operational Highlights
-- Clinical evidence from successful US and European ovarian
cancer studies in 400 patients, demonstrating potential for a
Parsortix(TM) -based blood test to significantly out-perform
current standard of care in discriminating between benign and
malignant pelvic masses
-- Acquisition of Axela Inc. downstream analysis platform assets
(known as the Ziplex(R) platform) for GBP3.6 million, expands the
Company's liquid biopsy capabilities to enable unique 'sample to
answer' solution with multiplex gene and protein expression
-- Extensive work towards FDA Class II clearance in metastatic
breast cancer completed with analytical studies in progress and
clinical study commencing patient enrolment shortly
- Number 1 cancer centre in the United States, MD Anderson
leading the clinical study primary endpoint analysis
- Detailed protocols fully developed and agreed
- Institutional Review Board (IRB) approvals received from MD
Anderson and the University of Rochester Wilmot Cancer Center
-- The Company's ISO13485 quality management system, which
supports regulatory clearance for CE Mark and FDA, successfully
completed BSI audit in January 2018 and has been approved for
transition to the new ISO13485:2016 standard ahead of schedule
-- Signed collaborations with leading, global healthcare companies
- Co-marketing partnership with QIAGEN, a world-leading
molecular testing company
- Collaboration with Philips in breast and rectal cancer, post
period end
-- Growing body of published evidence, from
internationally-recognised cancer centres during and post period
end, validating the potential of the Parsortix system as a leading
liquid biopsy platform for, amongst others, ovarian, breast and
prostate cancers
- Installed base of over 145 Parsortix instruments deployed
worldwide (H1 2017: 120) with over 39,000 blood separations
completed (H1 2017: 22,000)
- Extensive research usage is expected to drive increasing
revenues as new protocols are developed and adopted
Financial Highlights
-- Revenues of GBP0.2 million (H1 2017: GBP0.2 million)
-- Loss from continuing operations of GBP3.4 million (H1 2017: loss GBP2.7 million)
-- Successful fundraising from institutional and other investors
raising gross proceeds of GBP15.0 million. Proceeds net of expenses
were GBP14.4 million.
-- Cash balance at 31 October 2017 of GBP4.3 million (30 April
2017: GBP5.5 million); before receipt of majority of placing
proceeds
Garth Selvey, Chairman, commented:
"ANGLE has continued to make excellent progress in executing its
strategy for commercialisation of the Parsortix system, and its
adoption as a gold standard in liquid biopsy, during the first half
of the year. We have successfully completed two large scale ovarian
cancer clinical studies, progressed our FDA studies, broadened our
liquid biopsy capabilities to include a downstream analysis
platform with the acquisition of assets of Axela, and secured
corporate partnerships with two leading, global healthcare
companies.
"Our pivotal US FDA analytical and clinical studies in
metastatic breast cancer are expected to complete in H2 CY 2018.
ANGLE is seeking to become the first company to receive FDA
clearance for a product for harvesting intact circulating cancer
cells from patient blood for subsequent analysis. We believe this
will differentiate ANGLE in the liquid biopsy market and will have
a major positive impact, driving the business forward on numerous
fronts.
"With our leading and differentiated technology platforms, a
growing body of clinical evidence and robust partnerships with
leading cancer centres and global healthcare companies, we believe
ANGLE is well placed to secure a leading position within the
emerging multi-billion dollar liquid biopsy market."
Analyst meeting and webcast details
A meeting for analysts will be held at 10:30am on 31 January
2018 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.
For further information ANGLE:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
finnCap Ltd (NOMAD and Joint
Broker)
Corporate Finance - Adrian
Hargrave, Simon Hicks, Kate
Bannatyne
Corporate Broking - Alice Lane,
Nikita Jain +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks,
Andrew Craig, Chris Lee +44 (0) 203 705 9330
FTI Consulting
Simon Conway, Mo Noonan, Stephanie
Cuthbert +44 (0) 203 727 1000
Kimberly Ha (US) +1 212 850 5612
For Frequently Used Terms, please see the Company's website on
http://www.angleplc.com/the-parsortix-system/glossary/
This announcement contains inside information.
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 first half, ANGLE completed its first two large scale
clinical studies, both focused on ovarian cancer. Each of these 200
patient studies reported successfully, with results indicating the
potential of a Parsortix(TM) system based test to significantly
out-perform standard of care in the detection of ovarian cancer
ahead of surgery for women with an abnormal pelvic mass.
Also during the period, ANGLE broadened its liquid biopsy
capabilities with the acquisition of the assets of Axela Inc., the
downstream analysis platform used to analyse the cells harvested by
the Parsortix system in its US ovarian study. This acquisition is
transforming ANGLE's offering to enable the provision of full
'sample to answer' liquid biopsy solutions. The Company now owns
leading proprietary technology covering the whole process of
capturing and harvesting circulating tumour cells (CTCs) from a
blood sample through to highly multiplexed gene and protein
expression results. This combination further differentiates ANGLE
from its competitors and provides the solution required by
customers for a simple blood test that has the potential to enable
precision medicine and transform cancer care.
Continued progress was made with the design and delivery of the
analytical and clinical studies which will support an FDA
application for clearance of the platform in metastatic breast
cancer.
ANGLE has also made strong progress with its corporate
partnership programme.
Results
Revenue of GBP0.2 million (H1 2017: GBP0.2 million) came from
sales of the Parsortix instrument and cassettes for research use.
Leading international research centres continue to increase their
usage of the Parsortix system as a means of furthering their
interest in developing new clinical applications. Establishment
revenues as a result help drive adoption of the system by other
leading cancer centres while building the body of evidence in
preparation for more widespread use in clinical applications and
drug trials. Extensive research usage is expected to drive
increasing revenues as new protocols are developed and adopted. As
experienced in the prior year, revenues are expected to increase
substantially in the second half.
Planned investment to develop and validate the clinical
application and commercial use of the Parsortix system increased,
resulting in operating costs of GBP4.2 million (H1 2017: GBP3.1
million). Thus the resulting loss for the period from continuing
operations correspondingly increased to GBP3.4 million (H1 2017:
GBP2.7 million).
The cash balance was GBP4.3 million at 31 October 2017 (30 April
2017: GBP5.5 million). The financial position was strengthened
during the half year with a successful placing of shares with
institutional and other investors, which raised gross proceeds of
GBP15.0 million. Proceeds net of expenses were GBP14.4 million,
with GBP3.1 million received in the period and GBP11.3 million
received post period end.
Strategy
ANGLE has a four pronged strategy for achieving widespread
adoption of its Parsortix system in the emerging multi-billion
dollar liquid biopsy market:
1) Completing rigorous large scale clinical studies run by
leading cancer centres, demonstrating the effectiveness of
different applications of the system in cancer patient care
2) Securing regulatory approval of the system with the emphasis
on FDA clearance as the de facto global gold standard. ANGLE is
seeking to be the first company ever to have FDA clearance for a
system to harvest circulating tumour cells (CTCs) from blood for
subsequent analysis
3) Establishment of a body of published evidence from leading
cancer centres showing the effectiveness of the system through peer
reviewed publications, scientific data and clinical evidence,
highlighting a wide range of potential applications
4) Establishing partnerships with large healthcare companies for
market deployment and development of multiple other clinical
applications incorporating the Parsortix system.
Strong progress was made in each of these areas during the first
half. All four elements are necessary to achieve major success.
Large scale clinical studies
Ovarian cancer clinical application: triaging abnormal pelvic
mass
During the half year, two major clinical studies of 200 patients
each were successfully completed in Europe and the United States
generating clinical data in support of the Company's ovarian cancer
clinical application.
The studies demonstrated that an assay (test) using the
Parsortix system may be able to significantly out-perform currently
available clinical assays for identification of women with a
malignant pelvic mass, in particular with much higher specificity
(avoiding classifying benign conditions as malignant 'false
positives').
Furthermore, the gene expression information available using the
Parsortix system and the Axela platform, but not accessible using
existing techniques, may provide valuable insights to help guide
treatment decisions prior to surgery, such as the use of
neo-adjuvant chemotherapy.
Both studies were designed and controlled to provide clinical
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 specialist cancer
surgeons 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 (and may have less invasive, lower risk laparoscopic "key
hole" surgery), 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
non-optimal 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 global market value available to ANGLE if this test was
fully implemented would be in excess of GBP300 million revenue per
annum.
Following the success of these studies and the acquisition of
the Axela downstream analysis technology (see below), ANGLE is
currently optimising the cancer gene panel that will be used for
the ovarian assay. Once this is complete, a further study will be
designed and executed to support necessary regulatory clearances so
that the test can be used clinically in triaging patients with an
abnormal pelvic mass between suspected benign and malignant
conditions.
Axela downstream analysis technology
Whilst both the 200 patient European and US ovarian studies
outlined above utilised the Parsortix system to harvest cancer
cells from the blood of patients where present, the European study
used traditional PCR to undertake molecular analysis of the
harvested cells whereas the US study used the novel multiplex gene
and protein analysis platform, Axela.
On comparison of the studies, the Axela platform was shown to
offer key advantages over other technologies available on the
market including:
-- High sensitivity enabling successful use on only a small
number of cancer cells amongst a larger background population of
blood cells
-- Ability to multiplex a large number of gene expression
analyses in a single reaction. This contrasts with PCR where each
gene requires a separate reaction resulting in a practical
limitation for the number of genes that can be evaluated by PCR
from a single sample ( eight genes maximum)
-- Comparable to targeted next generation sequencing (NGS) in
terms of its ability to analyse over one hundred genes
simultaneously but at a much lower cost with a much faster and less
complex process.
All the assets including worldwide intellectual property in
relation to the Axela platform were acquired for GBP3.6 million.
The Axela platform has had investment in excess of GBP25 million to
develop the technology to date.
The acquisition represents a major strengthening of ANGLE's
position within the liquid biopsy market providing a key
competitive differentiation of owning both a CTC harvesting
technology and a downstream molecular analysis technology to
interrogate the harvested CTCs.
ANGLE will be able to offer a complete 'sample to answer'
solution allowing customers to load whole blood from a simple blood
test onto the instrument and obtain gene expression information
from a large number of genes as an output.
ANGLE believes that the market is moving towards a requirement
for cancer gene panel analysis of 30 to 100+ genes at a time.
Reliably analysing such a large number of gene targets is not
possible with traditional PCR systems and currently requires next
generation sequencing at a price of over $1,000 per sample. Some
existing assays for analysis of tissue biopsies are priced at up to
$5,000 per patient sample. Combining Parsortix and Axela, now known
as the Ziplex platform, gives ANGLE the potential to offer a
repeatable solution based on a non-invasive blood test with a cost
of goods far below the competition. This provides the potential for
ANGLE to lead the market in both technical and economic
performance.
Regulatory clearance
The Parsortix system must gain regulatory clearance / approval
before it can be sold for use in clinical markets (for use in the
management of patients). ANGLE already holds 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 FDA Class II clearance for use
of the Parsortix system in the capture and harvesting of cancer
cells from metastatic breast cancer patients for use in subsequent
downstream analyses.
FDA clearance is the de facto global gold standard for in vitro
diagnostic tests and will enable the sale of the product for the
intended clinical use in the United States, and will also validate
the performance of the system, thereby positively influencing
system adoption worldwide.
Extensive work towards a submission to the FDA for a de novo
clearance in metastatic breast cancer was completed during the
period.
The clinical study will involve recruitment of 200 metastatic
breast cancer patients and 200 healthy volunteers enrolled at up to
six leading US cancer centres. The study is designed to prove the
following intended use:
"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. Harvested CTCs can be used in subsequent analyses."
The primary endpoint of the Study, being led by MD Anderson, is
the cytological evaluation conducted by a qualified pathologist of
harvested cells confirming that CTCs are harvested from metastatic
breast cancer patients but not from healthy volunteers.
The exploratory endpoints are to demonstrate that, in addition
to the cytological evaluation, the Parsortix harvested cells can be
analysed using quantitative PCR (qPCR, MD Anderson), fluorescence
in situ hybridisation (FISH, University of Southern California) and
whole transcriptome sequencing (RNA-Seq, University of Southern
California).
Institutional Review Board (IRB) approvals for the study, which
cover scientific, ethical and regulatory matters have already been
received from MD Anderson and the University of Rochester Wilmot
Cancer Center and approval processes are well advanced within the
University of Southern California Norris Comprehensive Cancer
Center. Discussions are progressing with three other cancer centres
in relation to their participation in patient enrolment.
Whilst the enrolment of patients and analysis of results are
conducted by independent cancer centres and outside the control of
the Company, both the clinical study and the associated analytical
studies are expected to complete in H2 CY 2018. This is intended to
allow a full FDA submission promptly after the completion of the
studies, once all the analysis and necessary submission
documentation have been completed.
Following the submission, the timing of FDA clearance will be
driven by the de novo submission evaluation process within the FDA.
The aim is for the Parsortix system to be the first ever FDA
cleared system for harvesting cancer cells from blood for
subsequent analyses.
Once the breast cancer FDA clearance has been obtained, it is
intended to extend it to other cancer types and applications,
progressively, including ovarian and prostate cancer applications.
Subsequent clearances will be less onerous to obtain as they will
be based on an already cleared platform.
The Company's ISO13485 quality management system, which supports
regulatory clearance for CE Mark and FDA, successfully completed
BSI audit in January 2018 and has been approved for transition to
the new ISO13485:2016 standard ahead of schedule.
Establishment of a body of published evidence
Further strong progress was made in establishing a body of
published evidence.
During the half year and post period end, there were a further
six peer-reviewed publications and numerous posters and
presentations at leading conferences. Publications that have been
released publicly are available at
http://www.angleplc.com/the-parsortix-system/download-files/.
Leading independent cancer centres throughout Europe and North
America using ANGLE's Parsortix system are working on developments
in 20 different cancer types. Breakthrough developments achieved
during the period included:
-- Barts Cancer Institute's discovery of the role of
megakaryocytes in prostate cancer as positive indicators of overall
survival. The Parsortix system is the only system to thus far show
capability of harvesting megakaryocytes. Barts Cancer Institute
combined the analysis of megakaryocytes with mesenchymal-type CTCs,
also harvested by the Parsortix system, as a prognostic risk
profile and determined that patients identified as high risk (based
on Barts own classification) were ten times more likely to die than
those classified as low risk (in the same way). This approach may
allow patients to receive stratified treatment thereby improving
overall outcomes. Following these findings, ANGLE acquired a
worldwide exclusive option over the resulting intellectual
property.
-- University of Maryland presented highly novel work
demonstrating the use of live CTCs harvested from patient blood
using the Parsortix system to test the efficacy of drugs outside
the patient. They capitalised on a key attribute of the Parsortix
system that it harvests intact, undamaged and thus viable cells and
showed that these cells could be held in place in the Parsortix
separation cassette. By using a proprietary biological "tether",
drugs were passed through the Parsortix cassette and thus over the
cancer cells. By examination under a high powered microscope, the
researchers were able to directly observe the impact of the drugs
by observing the response of the micro-tentacles on the living
cancer cell surface.
-- University of Southern California Norris Comprehensive Cancer
Center presented the first direct comparative evaluation of whole
genome analysis of matched samples of tissue from invasive solid
biopsy in metastatic breast cancer together with whole genome
analysis of circulating cancer cells harvested from a simple blood
test using Parsortix. The evaluation demonstrated comparable gene
expression of CTCs obtained from a simple blood test when compared
to the invasive tissue biopsy of the metastatic site. The results
open the potential for a Parsortix blood test to replace an
invasive tissue biopsy in metastatic breast cancer. This will be an
important potential use of the Parsortix system post FDA
clearance.
-- Heinrich Heine University Duesseldorf demonstrated the
ability to culture CTCs (grow the cells) harvested from blood using
the Parsortix system. The CTCs were isolated from diagnostic
leukapheresis (DLA) blood product. This was only possible because
the Parsortix system's patented size and deformability technology
enables the harvesting of intact, undamaged, living cancer cells
from blood. The cultured cells continued to proliferate several
months after they were originally harvested from blood product by
the Parsortix system, providing a sustainable population of cells
for ongoing research and investigation outside the patient.
-- The Center for Women's Health Tuebingen, Germany demonstrated
a protocol for harvesting disseminated tumour cells (DTCs) from
cancer patient bone marrow samples using the Parsortix system. The
reactivation of dormant DTCs and their release into the bloodstream
as circulating tumour cells (CTCs), is the process by which a
patient may, sometimes after many years of remission, suffer a
relapse through metastasis. There is intense interest in the
existence and status of such DTCs "hibernating" in the bone
marrow.
-- University of Hamburg, Medical University of Graz and
Stockholm University have published results of work demonstrating
that the expression of ARV7 (androgen receptor splice variant 7)
transcripts can be measured from CTCs harvested from later stage
prostate cancer patients using the Parsortix system. Measurement of
the expression of ARV7 on circulating tumour cells (CTCs) obtained
from a blood test has been correlated with patient response to
novel hormone therapy (NHT) drugs such as Enzalutamide and
Abiraterone. Where ARV7 is positively expressed, patients are
unlikely to respond to NHT and benefit from moving directly to
taxane-based chemotherapies. When ARV7 is not expressed, patients
benefit more by receiving NHT first before moving to taxane-based
chemotherapy.
-- Western University, Canada presented their work on the use of
the Parsortix system with small volumes of blood using an ANGLE
proprietary low volume adaptor in mouse models of human cancer.
Their success highlights the potential for the Parsortix system to
be utilised in pharma-based early stage cancer drug research, where
mouse models are routinely used prior to human trials.
Establishing partnerships with large healthcare companies
Large scale deployment of the Parsortix system across numerous
cancer types and application areas requires ANGLE to partner with
large, global healthcare companies to take advantage of their
distribution and sales channels and economic resources.
Discussions are ongoing with companies in relevant fields:
medtech companies, pharma companies, contract research
organisations and reference laboratories (laboratories offering
clinical tests).
During the half year and post period end, two partnerships were
signed with such healthcare companies.
A co-marketing agreement was signed with world-leading molecular
testing company QIAGEN. QIAGEN employs 4,600 people in over 35
countries and has more than 500,000 customers with annual revenues
exceeding US $1.3 billion. The first area of focus is to couple the
Parsortix system with QIAGEN's downstream technologies for use in
prostate and breast cancer research. Protocols are currently being
developed and optimised to allow sales into QIAGEN's established
customer base.
A collaborative research project was signed with Philips, a
global leader in health technology, to develop liquid biopsy
solutions as part of a four year European Union research grant
funded programme worth EUR6.3 million, of which GBP0.4 million will
flow to ANGLE. Philips has selected the Parsortix system as the
only system to be used for harvesting CTCs within the programme.
Breast and rectal cancers are being targeted.
Outlook
ANGLE has continued to make excellent progress in executing its
strategy for commercialisation of the Parsortix system, and its
adoption as a gold standard in liquid biopsy, during the first half
of the year. We have successfully completed two large scale ovarian
cancer clinical studies, progressed our FDA studies, broadened our
liquid biopsy capabilities to include a downstream analysis
platform with the acquisition of assets of Axela, and secured
corporate partnerships with two global healthcare companies.
Our pivotal US FDA analytical and clinical studies in metastatic
breast cancer are expected to complete in H2 CY 2018. ANGLE is
seeking to become the first company to receive FDA clearance for a
product for harvesting intact circulating cancer cells from patient
blood for subsequent analysis. We believe this will differentiate
ANGLE in the liquid biopsy market and will have a major positive
impact, driving the business forward on numerous fronts.
With our leading and differentiated technology platforms, a
growing body of clinical evidence and robust partnerships with
leading cancer centres and global healthcare companies, we believe
ANGLE is well placed to secure a leading position within the
emerging multi-billion dollar liquid biopsy market.
Garth Selvey
Chairman
30 January 2018
ANGLE plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHSED 31 OCTOBER 2017
Year
Note Six months ended Six months ended ended
31 October 31 October 30 April
2017 2016 2017
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Revenue 188 219 498
Cost of sales ____(54) ____(43) ____(123)
Gross profit 134 176 375
Operating costs (4,245) (3,088) (7,810)
________ ________ ________
Operating profit/(loss) (4,111) (2,912) (7,435)
Net finance income/(costs) ______1 ______20 ______25
Profit/(loss) before tax (4,110) (2,892) (7,410)
Tax (charge)/credit 3 ____680 ____202 ___1,018
Profit/(loss) for the period (3,430) (2,690) (6,392)
Other comprehensive income/(loss)
Items that may be subsequently reclassified to profit or
loss
Exchange differences on translating foreign operations ____(36) ____188 ____139
Other comprehensive income/(loss) ____(36) ____188 ____139
Total comprehensive income/(loss) for the period (3,466) (2,502) (6,253)
========= ========= ==========
Profit/(loss) for the period attributable to:
Owners of the parent (3,438) (2,598) (6,567)
Non-controlling interests 8 (92) 175
_________ _________ _________
Profit/(loss) for the period (3,430) (2,690) (6,392)
========= ========= =========
Total comprehensive income/(loss) for the period attributable to:
Owners of the parent (3,467) (2,633) (6,414)
Non-controlling interests 1 131 161
_________ __________ _________
Total comprehensive income/(loss) for the period (3,466) (2,502) (6,253)
========= ========= =========
Earnings/(loss) per share 4
Basic and Diluted (pence per share) (4.58) (3.74) (8.71)
All activity arose from continuing operations
ANGLE plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 OCTOBER 2017
Note 31 October 31 October 30 April
2017 2016 2017
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
ASSETS
Non-current assets
Property, plant and equipment 849 558 824
Intangible assets 5 2,160 1,634 1,918
__________ __________ __________
Total non-current assets 3,009 2,192 2,742
__________ __________ __________
Current assets
Inventories 854 631 665
Trade and other receivables 1,478 646 714
Taxation 1,440 511 1,261
Cash and cash equivalents 4,281 9,651 5,536
__________ __________ __________
Total current assets 8,053 11,439 8,176
__________ __________ __________
Total assets 11,062 13,631 10,918
========= ========= =========
EQUITY AND LIABILITIES
Equity
Share capital 6 8,605 7,482 7,482
Share premium 36,081 33,285 33,285
Share-based payments reserve 997 700 822
Other reserve 2,553 2,553 2,553
Translation reserve 103 (56) 132
Retained earnings (38,078) (30,738) (34,647)
ESOT shares (102) (102) (102)
__________ __________ __________
Equity attributable to owners of the parent 10,159 13,124 9,525
__________ __________ __________
Non-controlling interests (718) (749) (719)
Total equity 9,441 12,375 8,806
============== ============== ==============
Liabilities
Current liabilities
Trade and other payables 1,621 1,256 2,112
_________ _________ _________
Total current liabilities 1,621 1,256 2,112
_________ _________ _________
Total liabilities 1,621 1,256 2,112
_________ _________ _________
Total equity and liabilities 11,062 13,631 10,918
============= ============= =============
ANGLE plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHSED 31 OCTOBER 2017
Six months Six months Year
ended ended ended
31 October 31 October 30 April
2017 2016 2017
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Operating activities
Profit/(loss) before tax from
continuing operations (4,110) (2,892) (7,410)
Adjustments for:
Depreciation of property, plant
and equipment 191 116 267
(Profit)/loss on disposal of
property, plant and equipment - - 5
Amortisation and impairment
of intangible assets 84 74 245
Exchange differences (4) 73 (50)
Net finance (income)/costs (1) (20) (25)
Share-based payments _____182 ______72 _____254
Operating cash flows before
movements in working capital: (3,658) (2,577) (6,714)
(Increase)/decrease in inventories (309) (275) (575)
(Increase)/decrease in trade
and other receivables 280 (215) (290)
Increase/(decrease) in trade
and other payables ____(457) ____(342) ____131
Operating cash flows (4,144) (3,409) (7,448)
Research and development tax
credits received ____501 _______- _____65
Net cash from/(used in) operating
activities (3,643) (3,409) (7,383)
Investing activities
Purchase of property, plant
and equipment (344) (50) (70)
Purchase of intangible assets (353) (158) (374)
Interest received ______1 ______17 ______26
Net cash from/(used in) investing
activities (696) (191) (418)
Financing activities
Net proceeds from issue of share
capital ___3,086 ____9,570 ___9,570
Net cash from/(used in) financing
activities 3,086 9,570 9,570
Net increase/(decrease) in cash
and cash equivalents from continuing
operations (1,253) 5,970 1,769
Discontinued operations
Net cash from/(used in) operating
activities - - (5)
Net increase/(decrease) in cash
and cash equivalents from discontinued
operations - - (5)
Net increase/(decrease) in cash
and cash equivalents (1,253) 5,970 1,764
Cash and cash equivalents at
start of period 5,536 3,764 3,764
Effect of exchange rate fluctuations _____(2) _____(83) ______8
Cash and cash equivalents at
end of period 4,281 9,651 5,536
======= ======= =======
ANGLE plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHSED 31 OCTOBER 2017
--------------------------------- 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 2016
(Audited) 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
(net of costs) 1,584 7,986
Share-based
payments 72
Released on
exercise (1)
_________ __________ _________ _________ _________
At 31 October
2016 7,482 33,285 700 2,553 (56)
For the period to
30 April 2017
------------------ ---------------- ----------------- ----------------- ----------------- -----------------------
Consolidated
profit/(loss)
Other
comprehensive
income/(loss):
Exchange
differences
in
translating
foreign
operations 188
------------------ ---------------- ----------------- ----------------- ----------------- -----------------------
Total
comprehensive
income/(loss) 188
Share-based
payments 182
Released on
forfeiture (60)
At 30 April 2017
(Audited) 7,482 33,285 822 2,553 132
For the period to
31 October 2017
-----------------------
Consolidated
profit/(loss)
Other
comprehensive
income/(loss):
Exchange
differences
in
translating
foreign
operations (29)
------------------ ---------------- ----------------- ----------------- ----------------- -----------------------
Total
comprehensive
income/(loss) (29)
Issue of shares
(net of costs) 1,123 2,796
Share-based
payments 182
Released on
forfeiture (7)
_________ __________ _________ _________ _________
At 31 October
2017 8,605 36,081 997 2,553 103
========== ========== ========== ========== =========
----- 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 2016 (Audited) (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 (net of costs) 9,570 9,570
Share-based payments 72 72
Released on exercise 1 - -
___________ _________ __________ __________ __________
At 31 October 2016 (30,738) (102) 13,124 (749) 12,375
For the period to 30 April 2017
---------------------------------------------- ------------ ------------ -------------- ------------ ------------
Consolidated profit/(loss) (3,969) (3,969) 267 (3,702)
Other comprehensive income/(loss):
Exchange differences in translating
foreign operations 188 (237) (49)
---------------------------------------------- ------------ ------------ -------------- ------------ ------------
Total comprehensive income/(loss) (3,969) (3,781) 30 (3,751)
Share-based payments 182 182
Released on forfeiture 60 - -
At 30 April 2017 (Audited) (34,647) (102) 9,525 (719) 8,806
For the period to 31 October 2017
Consolidated profit/(loss) (3,438) (3,438) 8 (3,430)
Other comprehensive income/(loss):
Exchange differences in translating
foreign operations (29) (7) (36)
---------------------------------------------- ------------ ------------ -------------- ------------ ------------
Total comprehensive income/(loss) (3,438) (3,467) 1 (3,466)
Issue of shares (net of costs) 3,919 3,919
Share-based payments 182 182
Released on forfeiture 7 - -
___________ _________ __________ __________ __________
At 31 October 2017 (38,078) (102) 10.159 (718) 9,441
=========== ========== ========== ========== ==========
ANGLE plc
NOTES TO THE INTERIM FINANCIAL INFORMATION
FOR THE SIX MONTHSED 31 OCTOBER 2017
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 2017 (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 2018. 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 2017 and which may be made in the Report and Accounts
2018.
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 2016 is also unaudited. The
comparative figures for the year ended 30 April 2017 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 30 January 2018.
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. The Directors will
assess the impact of the acquisition of the Axela Inc assets,
completed shortly after the reporting date, with the full year
results.
3 Tax
The Group undertakes 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 on continuing operations of GBP3.4 million (six
months to 31 October 2016: loss GBP2.7 million, year to 30 April
2017: loss GBP6.4 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 considers 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 as adding them would have the effect of reducing
the loss per share 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
74,920,311 weighted average ordinary 10p shares (six months to 31
October 2016: 72,020,501; year to 30 April 2017: 73,350,486).
5 Intangible assets
Intellectual Computer Product
property software development Total
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000
Cost
At 1 May 2016 (Audited) 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
Additions 153 1 356 510
Disposals - (5) - (5)
Exchange movements 3 (1) (88) (86)
_________ _________ _________ _________
At 30 April 2017 (Audited) 677 2 1,969 2,648
Additions 92 2 258 352
Exchange movements (7) - (38) (45)
_________ _________ _________ _________
At 31 October 2017 762 4 2,189 2,955
======= ======= ======= =======
Amortisation and impairment
At 1 May 2016 (Audited) 62 4 375 441
Charge for the period 4 1 69 74
Exchange movements - - 80 80
_________ _________ _________ _________
At 31 October 2016 66 5 524 595
Charge for the period 9 - 73 82
Disposals - (5) - (5)
Impairment 89 - - 89
Exchange movements - - (31) (31)
_________ _________ _________ _________
At 30 April 2017 (Audited) 164 - 566 730
Charge for the period 12 1 71 84
Exchange movements (3) - (16) (19)
_________ _________ _________ _________
At 31 October 2017 173 1 621 795
======= ======= ======= =======
Net book value
At 31 October 2017 589 3 1,568 2,160
At 30 April 2017 (Audited) 513 2 1,403 1,918
At 31 October 2016 455 2 1,177 1,634
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 GBP498,455 (31
October 2016: GBP650,205; 30 April 2017: GBP555,827) in relation to
the Parsortix instrument. Costs in relation to the FDA development
work of GBP258,341 were capitalised in the period (31 October 2016:
GBP106,696; 30 April 2017: GBP461,799)
6 Share capital
The Company has one class of ordinary shares which carry no
right to fixed income and at 31 October 2017 had 86,054,490
Ordinary shares of GBP0.10 each allotted and called up and these
were fully paid with the exception of 3,757,146 new ordinary shares
which became fully paid shortly after the reporting date when funds
were settled. A receivable in respect of these new ordinary shares
was included in Trade and other receivables at the reporting
date.
During the period the Company issued 1) 7,481,570 new ordinary
shares with a nominal value of GBP0.10 at an issue price of
GBP0.375 per share in a subscription of shares realising gross
proceeds of GBP2.8 million and 2) 3,757,146 new ordinary shares
with a nominal value of GBP0.10 at an issue price of GBP0.35 per
share in a placing of shares realising gross proceeds of GBP1.3
million. Shares were admitted to trading on AIM in October
2017.
Post the reporting date, the placing was completed in November
2017 with a further 31,032,032 new ordinary shares with a nominal
value of GBP0.10 at an issue price of GBP0.35 per share realising
gross proceeds of GBP10.9 million with the shares admitted to AIM
in November 2017. Total gross proceeds of the fundraise were
GBP15.0 million.
7 Post reporting date events
As explained in the Chairman's Statement, subsequent to the
reporting date the Company has made continued strong progress with
Parsortix and made further announcements in relation to 1)
completion of the GBP15 million fundraise realising further gross
proceeds of GBP10.9 million and 2) purchase of certain assets of
Axela Inc providing the Company with a downstream analysis
capability.
Shareholder communications
The announcement is being sent to all shareholders on the
register at 30 January 2018. Copies of this announcement are posted
on the Company's website www.ANGLEplc.com and are available from
the Company's registered office: 10 Nugent Road, Surrey Research
Park, Guildford, Surrey, GU2 7AF.
This information is provided by RNS
The company news service from the London Stock Exchange
END
IR LFFLILAIIVIT
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