TIDMAGL
RNS Number : 6487V
Angle PLC
25 July 2018
For Immediate Release 25 July 2018
ANGLE plc
("ANGLE" or "the Company")
Preliminary Results for the year ended 30 April 2018
STRENGTHENING A LEADING POSITION IN THE LIQUID BIOPSY MARKET
OVARIAN CANCER CLINICAL STUDIES SUCCESSFULLY COMPLETED AND
FDA CLINICAL STUDY IN PROGRESS
ANGLE plc (AIM: AGL OTCQX: ANPCY), a world leading liquid biopsy
company, today announces unaudited results for the year ended 30
April 2018.
Operational Highlights
-- FDA clinical study of 400 subjects set up and in progress
with four leading US cancer centres, targeted for completion this
year
-- Successful US and European ovarian cancer studies in 400
patients. Blood test delivered 95.1% accuracy in discriminating
between benign and malignant pelvic masses significantly
out-performing standard of care
-- Acquisition of the assets of Axela Inc. for GBP3.6 million.
The principal asset, the Ziplex(R) platform allows multiplex gene
expression analysis of cancer cells. This complements the
Parsortix(TM) system and, in time, will be offered to customers as
a full 'sample to answer' solution
-- Collaborative agreements signed with three leading, global
healthcare companies QIAGEN, Philips and Abbott
-- Research equipment installed base increased to 200 Parsortix systems (2017: 145)
-- Total of 10 peer-reviewed publications (30 April 2017: 4) and
21 publicly available posters (30 April 2017: 13)
Financial Highlights
-- Loss for the year GBP7.5 million (2017: loss GBP6.4 million) reflecting planned investment
-- Revenue and grant income GBP0.7 million (2017: GBP0.5 million)
-- GBP15.0 million fundraising during the year (GBP14.4 million net of expenses)
-- Cash balance at 30 April 2018 of GBP7.6 million (30 April 2017: GBP5.5 million)
-- Post year end fundraising of GBP12.7 million (GBP12.0 million net of expenses)
Garth Selvey, Non-Executive Chairman of ANGLE plc,
commented:
"With two successful ovarian cancer studies, the initiation of
our FDA clinical studies and three global healthcare companies
secured as partners, ANGLE has established world-wide recognition
and potential. The acquisition of downstream analysis technology
complements the Parsortix system and will, in time, allow us to
offer our customers a full 'sample to answer' solution.
We continue to invest heavily to pursue FDA clearance for the
Parsortix system as the first ever FDA cleared clinical device to
harvest intact circulating tumour cells for analysis from patient
blood. Commencement of clinical trials at four prestigious US
cancer centres marks a major step forward for the business."
Details of webcast
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, Max Bullen-Smith
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
Evan Smith, Anne Troy (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 Preliminary 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
ANGLE has strengthened its leading position in the liquid biopsy
market. Two successful ovarian cancer clinical studies were
followed by the successful design and commencement of clinical and
analytical studies in metastatic breast cancer specifically to
support a submission to the FDA in pursuit of FDA marketing
clearance.
ANGLE also acquired the assets of Axela Inc for GBP3.6 million.
The principal asset, the Ziplex platform, provides multiplex gene
expression analysis of cancer cells making it complementary to the
Parsortix system and ultimately allowing ANGLE to offer a full
'sample to answer' solution.
Overview of Financial Results
Revenue and grant income of GBP0.7 million (2017: GBP0.5
million) came mainly from research use of the Parsortix system.
Planned investment in studies to develop and validate the clinical
application and commercial use of the Parsortix system increased,
resulting in operating costs of GBP9.4 million (2017: GBP7.8
million). Thus, the loss for the year correspondingly increased as
expected to GBP7.5 million (2017: GBP6.4 million).
The cash balance was GBP7.6 million at 30 April 2018 (30 April
2017: GBP5.5 million) and an R&D tax credit of GBP1.1 million
was received shortly after the year end. The financial position was
strengthened during the year with a placing of shares with major
institutional investors, which raised GBP15.0 million gross
(GBP14.4 million net of expenses).
Post year end a further GBP12.7 million gross fundraising was
completed (GBP12.0 million net of expenses).
Strategy
ANGLE has made strong progress in its four pronged strategy for
achieving widespread adoption of its Parsortix system in the
emerging multi-billion dollar liquid biopsy market:
1) Completion of 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 gain FDA clearance for a
system which harvests circulating tumour cells (CTCs) from blood
for subsequent analysis
3) Establishing a body of published evidence from leading cancer
centres showing the effectiveness of the system through peer
reviewed publications, scientific data and clinical research
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.
Progress towards FDA clearance
ANGLE is seeking to become the first ever company to receive FDA
Class II clearance for a product for harvesting intact circulating
tumour cells (CTCs) from patient blood for subsequent analysis. US
regulatory clearance by the FDA is considered the global standard
for approval of medical diagnostic systems and ANGLE believes that
such clearance would provide ANGLE's Parsortix system with a
further competitive differentiation, which would accelerate all
forms of commercial adoption of the system in both research and
clinical settings.
ANGLE has sustained a high level of resource commitment on its
efforts to progress towards FDA clearance over several years.
Preparation for the analytical and clinical studies required to
make a comprehensive submission to the FDA has necessitated an
enormous amount of work to develop, test and finalise the protocols
involved. Optimisation of the techniques used to analyse cells
harvested by the Parsortix system has required the development of
know-how which, now successfully completed, adds to the overall
capability and differentiation of the Parsortix system in the
market.
We are delighted that the FDA clinical study ANG-002 is in
progress with four of the leading US cancer centres enrolling
patients: University of Texas MD Anderson Cancer Center, University
of Rochester Wilmot Cancer Center, University of Southern
California Norris Comprehensive Cancer Center, and Robert H Lurie
Comprehensive Cancer Center Northwestern University.
We are also delighted that the global healthcare company Abbott
has joined the study enabling us to use its proprietary
PathVysion(TM) HER-2 DNA FISH Probe kits.
A key aim for the Company in the new financial year is to
complete the FDA clinical and analytical studies. Whilst the
enrolment of patients and analysis of results are conducted by
independent cancer centres and outside the control of the Company,
current expectations continue to be that both the FDA studies will
complete this year.
Large scale clinical studies
Ovarian cancer clinical application: triaging abnormal pelvic
mass
During the year, the Company's first clinical application for
the Parsortix system was advanced with two clinical studies
designed as a Pelvic Mass Triage (PMT) test to detect the presence
of ovarian cancer in women with an abnormal pelvic mass requiring
surgery.
Both studies reported positively during the year and the
detailed results of the US clinical study were reported at the
Society of Gynecologic Oncology (SGO) Annual Meeting on Women's
Cancer by the Principal Investigator, Dr Richard Moore, Director of
the Gynecologic Oncology Division, University of Rochester Medical
Center Wilmot Cancer Institute on 24 March 2018. The results
demonstrated a correct prediction of cancer with an accuracy (area
under the curve) of 95.1% for the predictive assay. ANGLE's PMT
test achieved higher sensitivity and specificity than any other
test available for the same application.
The excellent performance of ANGLE's Parsortix system in this
large scale clinical study for the detection of ovarian cancer
demonstrates the capability of ANGLE's CTC system to out-perform
current approaches for the detection of ovarian cancer. ANGLE is
now working to optimise this assay by the end of the year and then
complete a further clinical study in 2019/20 to progress
commercialisation. ANGLE estimates that the total addressable
market for its PMT test is worth US$1 billion per annum.
Ziplex 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 (polymerase chain reaction) techniques to
undertake molecular analysis of the harvested cells whereas the US
study used the novel multiplex gene and protein analysis platform,
Ziplex system provided by Axela.
On comparison of the studies, the Ziplex 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 and the ability to multiplex a large number (up to
200) of gene expression analyses in a single reaction.
All the Axela assets, including worldwide intellectual property
in relation to the Ziplex platform, were acquired by ANGLE for
GBP3.6 million on 1 November 2017.
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.
Prostate cancer: blood test alternative to prostate biopsy
During the year Barts Cancer Institute reported in the
peer-reviewed journal, Clinical Cancer Research, results of their
40 patient study, which showed that combining the analysis of
mesenchymal CTCs and megakaryocytes using Parsortix enabled the
identification of patients 10 times more likely to die of their
disease in the short term.
Coupled with Barts' earlier work, this suggests that the use of
the Parsortix system may enable not only the detection of prostate
cancer but also an assessment of its aggressiveness. The latter is
a key point as currently many men have invasive treatment for
prostate cancer which would have remained indolent. It would be a
big step forward in the treatment of prostate cancer if a forward
looking assessment could identify those men who need and those who
do not need invasive treatment.
At present, ANGLE is focusing resources primarily on breast
cancer and ovarian cancer, with prostate cancer receiving smaller
scale investment while plans are being developed. However, a number
of options are being explored to expedite further development in
the prostate cancer area through partnering.
Establishing a body of published evidence
Further strong progress was made this year in establishing a
body of published evidence.
The Company's strategy to secure research use adoption of the
Parsortix system by leading cancer research centres in order to get
third parties driving development of new applications for Parsortix
independent of ANGLE is working very well.
The installed base of Parsortix instruments is continuing to
grow, standing at over 200 at 30 April 2018, up from c. 145 at 30
April 2017. Over 49,000 blood separations have now taken place
using the Parsortix system, up from c. 30,000 at 30 April 2017.
This deployment of Parsortix in research use now means that the
system is widely presented and discussed at leading cancer
conferences around the world and, during the year, paying customers
have developed ground-breaking new research using the system. An
example of this was the breakthrough research presented at the
American Association for Cancer Research (AACR) Annual Meeting 2018
by the Robert H Lurie Comprehensive Cancer Center and the Feinberg
School of Medicine, Northwestern University, Chicago (Northwestern)
providing an optimised workflow for the recovery and culturing of
CTCs from a simple blood test to produce an effective ex-vivo
culture (cells growing outside the patient) of the individual
patient's cancer cells.
The development of CTC cultures is considered one of the hottest
topics in cancer currently and the Principal Researcher, Professor
Massimo Cristofanilli described it as "opening up a new frontier in
the management of breast cancer" as it offers the prospect of
testing cancer drugs outside the patient, avoiding unnecessary
toxic side effects, to determine which will be most effective,
thereby providing the patient with truly personalised cancer
care.
During the year, 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 https://angleplc.com/library/publications/. So far 17
separate cancer centres have published uniformly positive reports
on their use of the Parsortix system.
Leading independent cancer centres throughout Europe and North
America using ANGLE's Parsortix system are working on developments
in 21 different cancer types. Developments announced during the
year are summarised following the Chairman's Statement.
Progressing 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). We expect to see our partnership programme
accelerate as the FDA clearance process progresses.
During the year, three partnerships were signed.
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.
An agreement was signed with global healthcare company Abbott in
which Abbott will supply ANGLE with its proprietary PathVysion
HER-2 DNA FISH Probe kits for ANGLE's ANG-002 FDA study for FISH
(fluorescence in situ hybridization) analysis of circulating tumor
cells (CTCs) in the form of a research grant. The objective of this
end-point is to demonstrate that harvested CTCs can be subjected to
FISH analysis to determine their HER-2 status. Assuming this is
successful, we hope to be able to work with Abbott to extend
PathVysion use into routine blood test analysis as an important
downstream application of the Parsortix system in breast cancer.
Abbott is the global market leader for FISH testing in solid tissue
biopsies, a market estimated to be worth $0.5 billion per annum in
2016 (source: Grand View Research). A positive result in this
clinical study would demonstrate the potential for Abbott to offer
a Parsortix-based product for HER-2 analysis from a routine blood
test.
Outlook
With two successful ovarian cancer studies, the initiation of
our FDA clinical studies and three global healthcare companies
secured as partners, ANGLE has established world-wide recognition
and potential. The acquisition of downstream analysis technology
complements the Parsortix system and will, in time, allow us to
offer our customers a full 'sample to answer' solution.
We continue to invest heavily to pursue FDA clearance for the
Parsortix system as the first ever FDA cleared clinical device to
harvest intact circulating tumour cells for analysis from patient
blood. Commencement of clinical trials at four prestigious US
cancer centres marks a major step forward for the business.
Garth Selvey
Chairman
24 July 2018
Summary: Published research during the year using the Parsortix
system
Leading independent cancer centres throughout Europe and North
America using ANGLE's Parsortix system are working on developments
in 21 different cancer types. Key developments achieved during the
year, which were described in Company announcements at the time,
included:
-- June 2017: MD Anderson demonstrated ability to measure meEGFR
on CTCs in colorectal cancer, which is an indicator of whether a
patient will respond to EGFR inhibitor drugs.
-- June 2017: Barts Cancer Institute's discovery of the role of
megakaryocytes in prostate cancer. ANGLE subsequently acquired a
worldwide exclusive option over the resulting intellectual
property.
-- July 2017: Western University, Canada demonstrated use of
Parsortix in mouse models of human cancer.
-- September 2017: Heinrich Heine University Duesseldorf
published in the International Journal of Molecular Science work
showing the Parsortix system captures clinically relevant CTCs in
the waste of antibody-based CTC systems (i.e. cells missed by
competing systems).
-- October 2017: Heinrich Heine University Duesseldorf
demonstrated the ability to culture CTCs (grow the cells) harvested
from DLA blood product.
-- October 2017: University of Maryland demonstrated the use of
live CTCs harvested from patient blood to test the efficacy of
drugs outside the patient by observing the response of the
micro-tentacles on the living cancer cell surface.
-- October 2017: University Hospital Muenster published results
evaluating four CTC systems in clear cell renal carcinoma (kidney
cancer) showing that Parsortix out-performed all the other
systems.
-- October 2017: The Center for Women's Health Tuebingen,
Germany demonstrated a protocol for harvesting disseminated tumour
cells (DTCs) from cancer patient bone marrow samples.
-- November 2017: Medical University of Vienna published
peer-reviewed research in the journal Oncotarget showing molecular
characterisation of CTCs with positive results in 95% primary and
100% recurrent gynaecological cancers and 92% in metastatic breast
cancer.
-- December 2017: University of Southern California Norris
Comprehensive Cancer Center demonstrated comparable gene expression
of CTCs obtained from a simple blood test when compared to the
invasive tissue biopsy of the metastatic site. This will be an
important potential use of the Parsortix system post FDA
clearance.
-- January 2018: University of Hamburg, Medical University of
Graz and Stockholm University demonstrated measurement of the
expression of ARV7 (androgen receptor splice variant 7) in CTCs,
which is correlated with prostate cancer patient response to novel
hormone therapy (NHT) drugs such as Enzalutamide and
Abiraterone.
-- April 2018: Robert H Lurie Comprehensive Cancer Center and
the Feinberg School of Medicine, Northwestern University presented
an optimised work flow for culturing CTCs from blood of metastatic
breast cancer patients at AACR 2018. This is now an area of focus
for use of Parsortix post FDA clearance.
-- May 2018: ANGLE and QIAGEN jointly presented protocols for
the measurement of ARV7 in prostate cancer blood.
ANGLE PLC
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEARED 30 APRIL 2018
2018 2017
(Unaudited) (Audited)
Note GBP'000 GBP'000
Revenue 628 498
Cost of sales (169) (123)
------------ ----------
Gross profit 459 375
Other operating income 52 -
Operating costs (9,444) (7,810)
------------ ----------
Operating profit/(loss) (8,933) (7,435)
Net finance income/(costs) 8 25
------------ ----------
Profit/(loss) before tax (8,925) (7,410)
Tax (charge)/credit 5 1,387 1,018
------------ ----------
Profit/(loss) for the year (7,538) (6,392)
Other comprehensive income/(loss)
Items that may be subsequently reclassified to profit
or loss:
Exchange differences on translating
foreign operations (99) 139
------------ ----------
Other comprehensive income/(loss) (99) 139
Total comprehensive income/(loss)
for the year (7,637) (6,253)
============ ==========
Profit/(loss) for the year attributable
to:
Owners of the parent (7,556) (6,567)
Non-controlling interests 18 175
Profit/(loss) for the year (7,538) (6,392)
============ ==========
Total comprehensive income/(loss)
for the year attributable to:
Owners of the parent (7,702) (6,414)
Non-controlling interests 65 161
Total comprehensive income/(loss)
for the year (7,637) (6,253)
============ ==========
Earnings/(loss) per share attributable
to owners of the parent
Basic and Diluted (pence per share) 6 (10.09) (8.95)
All activity arose from continuing
operations.
ANGLE PLC
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 APRIL 2018
Note 2018 2017
(Unaudited) (Audited)
GBP'000 GBP'000
Non-current assets
Intangible assets 7 5,588 1,918
Property, plant and equipment 1,475 824
------------ -----------
Total non-current assets 7,063 2,742
------------ -----------
Current assets
Inventories 599 665
Trade and other receivables 828 714
Taxation 2,147 1,261
Cash and cash equivalents 7,645 5,536
------------ -----------
Total current assets 11,219 8,176
------------ -----------
Total assets 18,282 10,918
------------ -----------
Current liabilities
Trade and other payables (2,398) (2,112)
------------ -----------
Total current liabilities (2,398) (2,112)
------------ -----------
Total liabilities (2,398) (2,112)
------------ -----------
Net assets 15,884 8,806
============ ===========
Equity
Share capital 9 11,709 7,482
Share premium 43,449 33,285
Share-based payments reserve 1,072 822
Other reserve 2,553 2,553
Translation reserve (14) 132
Retained earnings (42,129) (34,647)
ESOT shares (102) (102)
------------ -----------
Equity attributable to owners of the parent 16,538 9,525
------------ -----------
Non-controlling interests (654) (719)
Total equity 15,884 8,806
------------ -----------
ANGLE PLC
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEARED 30 APRIL 2018
2018 2017
(Unaudited) (Audited)
GBP'000 GBP'000
Operating activities
Profit/(loss) before tax from continuing
operations (8,925) (7,410)
Adjustments for:
Depreciation of property, plant and equipment 446 267
(Profit)/loss on disposal of property,
plant and equipment 1 5
Amortisation and impairment of intangible
assets 344 245
Share-based payments 324 254
Exchange differences (33) (50)
Net finance (income)/costs (8) (25)
------------ ----------
Operating cash flows before movements in
working capital (7,851) (6,714)
(Increase)/decrease in inventories (83) (575)
(Increase)/decrease in trade and other
receivables (106) (290)
Increase/(decrease) in trade and other
payables 727 131
------------ ----------
Operating cash flows (7,313) (7,448)
Research and development tax credits received 501 65
Net cash from/(used in) operating activities (6,812) (7,383)
Investing activities
Purchase of property, plant and equipment (1,031) (70)
Purchase of intangible assets (830) (374)
Acquisition of assets and business (Note
8) (3,613) -
Interest received 8 26
------------ ----------
Net cash from/(used in) investing activities (5,466) (418)
Financing activities
Net proceeds from issue of share capital 14,391 9,570
------------ ----------
Net cash from/(used in) financing activities 14,391 9,570
Net increase/(decrease) in cash and cash
equivalents from continuing operations 2,113 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 2,113 1,764
Cash and cash equivalents at start of year 5,536 3,764
Effect of exchange rate fluctuations (4) 8
------------ ----------
Cash and cash equivalents at end of year 7,645 5,536
============ ==========
ANGLE PLC
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEARED 30 APRIL 2018
------------ Equity attributable
to owners of the parent -----------------
Share-based
Share Share payments Other Translation
capital premium reserve reserve reserve
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 year to 30 April 2017
-------------------------------------------------- ----------- ------------ ------------ ----------- ------------
Consolidated profit/(loss)
Other comprehensive income/(loss):
Exchange differences on translating foreign
operations 153
-------------------------------------------------- ----------- ------------ ------------ ----------- ------------
Total comprehensive income/(loss) 153
Issue of shares (net of costs) 1,584 7,986
Share-based payments 254
Released on exercise (1)
Released on forfeiture (60)
___ ___
___ ______ ___ _______ ___ ______ ______ ______
At 30 April 2017 (Audited) 7,482 33,285 822 2,553 132
For the year to 30 April 2018
-------------------------------------------------- ----------- ------------ ------------ ----------- ------------
Consolidated profit/(loss)
Other comprehensive income/(loss):
Exchange differences on translating foreign
operations (146)
-------------------------------------------------- ----------- ------------ ------------ ----------- ------------
Total comprehensive income/(loss) (146)
Issue of shares (net of costs) 4,227 10,164
Share-based payments 324
Released on forfeiture (74)
___ ___
___ ______ ___ _______ ___ ______ ______ ______
At 30 April 2018 (Unaudited) 11,709 43,449 1,072 2,553 (14)
========== ========== ========== ========== =========
---------- Equity attributable to owners of the parent -----
Total Non-
Retained ESOT Shareholders' controlling Total
earnings shares equity interests equity
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 year to 30
April 2017
----------------------- --------------------- ------------------ ---------------------- ------------ ------------
Consolidated
profit/(loss) (6,567) (6,567) 175 (6,392)
Other comprehensive
income/(loss):
Exchange
differences on
translating
foreign
operations 153 (14) 139
----------------------- --------------------- ------------------ ---------------------- ------------ ------------
Total comprehensive
income/(loss) (6,567) (6,414) 161 (6,253)
Issue of shares (net
of costs) 9,570 9,570
Share-based payments 254 254
Released on exercise 1 - -
Released on
forfeiture 60 - -
___ ________ ___ ______ ___ _______ __ _______ ___ _______
At 30 April 2017
(Audited) (34,647) (102) 9,525 (719) 8,806
For the year to 30
April 2018
----------------------- --------------------- ------------------ ---------------------- ------------ ------------
Consolidated
profit/(loss) (7,556) (7,556) 18 (7,538)
Other comprehensive
income/(loss):
Exchange
differences on
translating
foreign
operations (146) 47 (99)
----------------------- --------------------- ------------------ ---------------------- ------------ ------------
Total comprehensive
income/(loss) (7,556) (7,702) 65 (7,637)
Issue of shares (net
of costs) 14,391 14,391
Share-based payments 324 324
Released on
forfeiture 74 - -
___ ________ ___ ______ ___ _______ ___ ______ ___ _______
At 30 April 2018
(Unaudited) (42,129) (102) 16,538 (654) 15,884
=========== ========== ========== ========== ==========
ANGLE PLC
NOTES TO THE PRELIMINARY ANNOUNCEMENT
FOR THE YEARED 30 APRIL 2018
1 Preliminary announcement
The preliminary announcement set out above does not constitute
ANGLE plc's statutory Financial Statements for the years ended 30
April 2018 or 2017 within the meaning of section 434 of the
Companies Act 2006.
The financial information for the year ended 30 April 2018 is
unaudited and an auditor's report has not yet been issued.
Statutory audited financial statements for the year will be
finalised on the basis of the financial information presented by
the directors in this preliminary announcement.
The financial information for the year ended 30 April 2017 is
derived from the audited financial statements for that year, which
have been delivered to the registrar of companies, and the
auditor's report on the consolidated Financial Statements for the
year ended 30 April 2017 is unqualified and does not contain
statements under s498(2) or (3) of the Companies Act 2006.
The format of the financial information has been amended to
incorporate "Other operating income" (being grant income), the
acquisition completed in the year, and a re-ordering of the
Consolidated Statement of Financial Position. The accounting
policies used for the year ended 30 April 2018 are unchanged from
those used for the statutory Financial Statements for the year
ended 30 April 2017, except as referred to in Note 2. The 2018
statutory accounts will be delivered to the Registrar of Companies
following the Company's Annual General Meeting.
2 Compliance with accounting standards
While the financial information included in this preliminary
announcement has been computed in accordance with the measurement
principles of IFRS, this announcement does not itself contain
sufficient information to comply with IFRS.
Accounting standards adopted in the year
No new accounting standards that have become effective and
adopted in the year have had a significant effect on the Group's
Financial Statements.
Accounting standards issued but not yet effective
At the date of authorisation of the Financial Statements, there
were a number of other Standards and Interpretations (International
Financial Reporting Interpretation Committee - IFRIC) which were in
issue but not yet effective, and therefore have not been applied in
these Financial Statements. Other than for IFRS 15, the Directors
have not yet assessed the impact of the adoption of these standards
and interpretations for future periods.
IFRS 15 Revenue from Contracts with Customers (effective for
accounting periods commencing on or after 1 January 2018) will be
adopted by ANGLE in the next financial year. During the year, ANGLE
have reviewed all income streams against the requirements of IFRS
15. The review concluded that there were no material contracts
which would require different treatment under IFRS 15 versus
current standards. Consequently, the introduction of IFRS 15 is not
expected to materially impact the financial statements in future
periods other than additional disclosure requirements.
Accounting policies have been added and/or updated to address
acquisition accounting in relation to business combinations,
acquired intangible assets and goodwill. A number of other
accounting policies have been slightly amended and updated for
readability.
3 Going concern
The Group's business activities, together with the factors
likely to affect its future development, performance and financial
position are set out in the Chairman's Statement.
The Directors have prepared and reviewed the financial
projections for the 12 month period from the date of signing of
these Financial Statements. Based on the level of existing cash,
agreed funding, the projected income and expenditure (the timing of
some of which is at the Group's discretion) and other potential
sources of funding, 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 Financial Statements.
4 Critical accounting estimates and judgements
The preparation of the Financial Statements requires the use of
estimates, assumptions and judgements that affect the reported
amounts of assets and liabilities at the date of the Financial
Statements and the reported amounts of revenues and expenses during
the reporting period. Although these estimates, assumptions and
judgements are based on the Directors' 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 are described below.
Valuation and amortisation of internally-generated intangible
assets (Note 7)
IAS 38 Intangible Assets contains specific criteria that if met
mean development expenditure must be capitalised as an internally
generated intangible asset. Judgements are required in both
assessing whether the criteria are met (for example,
differentiating between enhancements and maintenance) and then in
applying the rules (for example, determining an estimated useful
life). Intangible assets are amortised over their useful lives.
Useful lives are assessed by reference to observable data (for
example, remaining patent life) and taking into consideration
specific product characteristics (for example, product life cycle)
and market characteristics (for example, estimates of the period
that the assets will generate revenue). Each of these factors is
periodically reviewed for appropriateness. Changes to estimates in
useful lives may result in significant variations in the
amortisation charge.
Business combinations - identification, valuation and
amortisation of acquisition-related assets (Notes 7 and 8)
In accounting for business combinations, the Group is required
to determine the fair value of the identifiable assets acquired and
allocate the purchase price accordingly. In determining the fair
value of the intangible assets acquired, judgement is required in
determining and valuing the identifiable intangible assets through
the use of appropriate valuation techniques and discount rates.
Assumptions on future cash flows, length of life of the assets,
reproduction and replacement cost are, where possible, based on
information available to management at the time of acquisition.
Future cash flows include significant subjective assumptions in
relation to market demand, success in obtaining regulatory
clearance, pricing, levels of reimbursement and gross margins and
getting in national guidelines. The Group considers that for each
of these variables there is a range of reasonably possible
alternative values, which results in a range of fair value
estimates, and determining values requires considerable judgement
and there remain inherent uncertainties in forecasting. Changes to
key assumptions may result in significant variations to fair values
of the identifiable assets. The amount of goodwill initially
recognised is dependent on the allocation of the fair value of the
identifiable assets acquired.
Impairment (Note 7)
The Group is required to review, at least annually, whether
there are indications (events or changes in circumstances) that
intangible assets have suffered impairment and that the carrying
amount may exceed the recoverable amount. If there are indications
of impairment then an impairment review is undertaken. The
recoverable amount is the higher of the asset's fair value less
costs to sell and its value-in-use. The value-in-use method
requires the estimation of future cash flows and the selection of a
suitable discount rate in order to calculate the present value of
these cash flows. When reviewing intangible assets for impairment
the Group has had to make various assumptions and estimates of
individual components and their potential value and potential
impairment impact. The Group considers that for each of these
variables there is a range of reasonably possible alternative
values, which results in a range of fair value estimates. None of
these estimates of fair value is considered more appropriate or
relevant than any other and therefore determining a fair value
requires considerable judgement.
Share-based payments
In calculating the fair value of equity-settled share-based
payments the Group uses an options pricing model. The Directors are
required to exercise their judgement in choosing an appropriate
options pricing model and determining input parameters that may
have a material effect on the fair value calculated. These input
parameters include, among others, expected volatility, expected
life of the options taking into account exercise restrictions and
behavioural considerations of employees, the number of options
expected to vest and liquidity discounts.
Research and development tax credit (Note 5)
The Directors make their best estimate of qualifying R&D
expenditure to calculate the R&D tax credit. The interpretation
of qualifying expenditure requires judgement.
5 Tax
The Group undertakes research and development activities. In the
UK these activities qualify for tax relief and result in research
and development tax credits.
6 Earnings/(loss) per share
The basic and diluted earnings/(loss) per share is calculated by
dividing the after tax loss for the year attributable to the owners
of the parent of GBP7.6 million (2017: GBP6.6 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 2018 and 2017, share options are non-dilutive for those
years 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
95,500,762 weighted average ordinary 10p shares (2017:
73,350,486).
7 Intangible assets
Total
GBP'000
Cost
At 1 May 2016 1,787
Additions 672
Disposals (5)
Exchange movements 194
At 30 April 2017 2,648
Additions 651
Acquisition of assets (Note
8) 3,421
Disposals (1)
Exchange movements (105)
At 30 April 2018 6,614
=========
Amortisation and impairment
At 1 May 2016 441
Charge for the year 156
Disposals (5)
Impairment 89
Exchange movements 49
At 30 April 2017 730
Charge for the year 341
Disposals (1)
Impairment 3
Exchange movements (47)
At 30 April 2018 1,026
=========
Net book value
At 30 April 2018 5,588
=========
At 30 April 2017 1,918
=========
Intangible assets arising as a result of the business
combination are described in Note 8 and comprise the fair value of
the identifiable intangible assets and the goodwill arising at the
date of acquisition. Identifiable intangible assets are amortised
over their estimated useful economic life. Goodwill is deemed to
have an indefinite useful life and is not amortised.
Internally-generated intangible assets comprises intellectual
property (patents) and product development costs 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.
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 Consolidated Statement of Comprehensive Income.
8 Acquisition
On 1 November 2017, the Group acquired the assets and business
of Axela Inc, a private corporation based in Toronto, Canada, with
a novel multiplex gene and protein analysis platform. The assets
and business were acquired as the Axela technology had been used
over a two year period in ANGLE's US ovarian cancer studies and had
shown key advantages over other established downstream analysis
technologies on the market. The acquisition also represented 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 thereby enabling a "sample-to-answer" solution, and also
allowing ANGLE to capture more of the value chain. The Chairman's
Statement provides more details.
The deal was structured as an asset purchase whereby specific
assets were purchased, liabilities were excluded and key people
transferred such that the business could continue. The transaction
is treated as a business combination within the scope of IFRS 3
Business Combinations.
The amounts recognised in respect of the identifiable assets
acquired on 1 November 2017 are as set out in the table below:
Fair value
GBP'000
Intangible assets 3,421
Property, plant and equipment 89
Inventories 86
Other tangible assets 17
-----------
Total consideration 3,613
===========
The total consideration was paid entirely in cash in full and
final settlement in the amount of CAD$6.2 million (GBP3.6
million).
The acquired intangible assets comprise separately identifiable
assets and goodwill.
The acquired identifiable intangible assets primarily relate to
technology assets, comprising patents, developed and in-process
products, documented trade secrets such as technical know-how and
manufacturing and operating procedures, methods and processes.
The goodwill arising represents the highly knowledgeable,
skilled and specialised workforce, cost savings and operating
synergies expected to result from having a larger R&D base in
North America, the ability to access new markets and the advantages
of the combination of Parsortix and Ziplex technologies enabling
"sample-to-answer".
The fair value of acquired property, plant and equipment
primarily relates to the residual values of the assets
acquired.
The fair value of acquired inventories represents inventories
valued at the sales price less provision to take account of the
condition of the inventory and any costs needed to bring the
product up to current regulations and standards.
Acquisition-related expenses of GBP0.1 million (2017: GBP0.3
million) are included in operating costs in the Consolidated
Statement of Comprehensive Income, which includes internal costs as
well as expenditure on market research, IP advice, legal and
accounting services.
Included in the Consolidated Statement of Comprehensive Income
in the period 1 November 2017 to 30 April 2018 for the newly
acquired business was revenue of GBP0.1 million and a loss before
tax of GBP0.6 million.
9 Share capital
The Company has one class of ordinary shares which carry no
right to fixed income and at 30 April 2018 had 117,086,522 ordinary
shares of GBP0.10 each allotted, called up and fully paid (2017:
74,815,774).
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 for shares realising gross proceeds of GBP2.8
million and 2) 34,789,178 new ordinary shares with a nominal value
of GBP0.10 at an issue price of GBP0.35 per share in a placing and
subscription for shares realising gross proceeds of GBP12.2
million. Total gross proceeds of the fundraise were GBP15.0
million. The shares were admitted to trading on AIM in October and
November 2017 respectively.
Post the reporting date the Company completed a Fundraise. The
General Meeting of 18 July 2018 approved the transaction. HMRC
Advance Assurance has now been received and the transaction is in
the process of closing. The proposed Placing and Subscription will
result in the issue of 25,400,000 new ordinary shares with a
nominal value of GBP0.10 at an issue price of GBP0.50 per share in
a placing and subscription for shares realising gross proceeds of
GBP12.7 million. Shares are expected to be admitted to trading on
AIM in late July and/or early August.
10 Shareholder communications
Copies of this announcement are posted on the Company's website
www.ANGLEplc.com.
The Annual General Meeting of the Company will be held at 2:00pm
on Tuesday 30 October 2018 at ANGLE plc, 10 Nugent Road, the Surrey
Research Park, Guildford, GU2 7AF. Notice of the meeting will be
enclosed with the audited Statutory Financial Statements.
The audited Statutory Financial Statements for the year ended 30
April 2018 are expected to be distributed to shareholders by 5
October 2018 and will subsequently be available on the Company's
website or from the registered office, 10 Nugent Road, Surrey
Research Park, Guildford, GU2 7AF.
This preliminary announcement was approved by the Board on 24
July 2018.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
FR FMGZNNDGGRZM
(END) Dow Jones Newswires
July 25, 2018 02:00 ET (06:00 GMT)
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