Building on a leading position
in the liquid biopsy market
Annual Report and Accounts
31 December 2019
Introduction / We are ANGLE plc
Who we are:
ANGLE plc
is a commercially
driven medical
diagnostic company
specialising in the
development of
pioneering products
in cancer diagnostics.
ANGLE’s Parsortix® system has the
potential to deliver profound improvements
in clinical and health economic outcomes
in the treatment and diagnosis of cancer.
Visit our website for more information at:
www.angleplc.com
@parsortix
ANGLEplc
angleplcParsortix
The Annual Report and Accounts 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 impact
of the COVID-19 pandemic, the general economic climate and market conditions, as well as specific factors
including the success of the Group’s research and development activities, commercialisation strategies, the
uncertainties related to clinical study outcomes and regulatory clearance, obtaining reimbursement and
payor coverage, getting into national guidelines and the acceptance of the Group’s products by customers.
Our purpose
To revolutionise
cancer diagnosis
and treatment
Mission
To enable personalised
cancer care by providing the
complete picture of the
patient’s cancer from a
simple blood test
Vision
To make precision
medicine a reality
At a glance
Liquid biopsy improving patient outcomes and
reducing healthcare costs
The Parsortix system captures circulating tumour cells (CTCs) which cause cancer metastasis
and harvests them for analysis.
Tissue biopsy is the current standard of care but has many shortcomings (see over) and is challenged by:
1) the frequent lack of tissue availability
2) tumour heterogeneity and
3) the dynamic nature of the cancer response to treatment.
Obtaining cancer tissue for analysis
Solid tissue biopsy
Liquid biopsy
Tumour tissue is cut out from the cancer
site through an invasive procedure
Cancer tissue is obtained from
a simple blood test
Solid biopsy
Liquid
biopsy
Tissue samples
Tissue is specially prepared so
sections can be examined – usually
formalin-fixed paraffin-embedded
(FFPE) samples
Read more about the
tissue biopsy shortcomings
overleaf
CTCs
Living cancer cells shed
from a tumour into the
bloodstream in the process
of metastasis
Read more about the
benefits of CTCs
overleaf
Circulating tumour
DNA (ctDNA)
DNA from fragments
of dead cells shed into the
bloodstream can contain
cancer-related mutations
Benefits of Parsortix CTC solution
Source
Sample type
Procedure
Solid tissue biopsy
Liquid biopsy
Primary tumour
Metastatic site
Intact cells
Invasive
Intact cells
Invasive
CTCs1
Intact cells
Non-invasive3
ctDNA2
Fragmented DNA
Non-invasive3
Sample accessibility
Not always accessible
Less accessible
Accessible using Parsortix4
Accessible
Tumour heterogeneity
Site of biopsy sampling
Site of biopsy sampling
Multi-site sampling
Multi-site sampling
Patient recovery time
Test costs
Test turnaround time
Longitudinal monitoring5
Molecular
analysis
Live cells
DNA
RNA
Protein
Cell culture
Xenograft
Varies
Varies
Varies
Difficult
Yes
Yes
Yes
Yes
Yes
Longer
Higher
Longer
Very difficult
Yes
Yes
Yes
Yes
Yes
None
Lower
Shorter
Easy
Yes
Yes
Yes
Yes
Yes
None
Lower
Shorter
Easy
Yes
Difficult
No
No
No
Standard of care
Proven
Proven
Not yet proven
Not yet proven
1 CTCs (circulating tumour cells) are live cancer cells circulating in the blood
2 ctDNA is cell-free circulating tumour fragments of DNA from dead cells, which may be found in the plasma component of the blood
3 Tissue obtained from simple peripheral blood test
4 Access to CTCs from blood is technically challenging given the low number of CTCs present and historically has been very difficult. ANGLE’s Parsortix system has been specially
designed to address this issue
5 Solid tissue biopsy information is a one-time snapshot and rapidly becomes outdated and does not reflect response to treatment and current mutational status. Liquid biopsy
information is dynamic as tests can be repeated to provide real time information to monitor changes over time
The problem:
The challenge
What is cancer?
How cancer spreads
Cancer is a disease in which abnormal cells divide
without control and can invade nearby tissues.
Cancer starts when gene changes make one cell or a few cells begin
to grow and multiply. This may cause a growth called a tumour.
The main reason that cancer is so serious is its ability to spread in the
body. Cancer cells can spread locally by moving into nearby normal tissue
or spread regionally, to nearby lymph nodes, tissues, or organs. It can also
spread to distant parts of the body via the blood circulation. When this
happens, it is called metastatic cancer.
The process by which cancer cells spread to other parts of the body
is called metastasis.
How many people are affected?
Why is metastasis so serious?
50%
Of the population will suffer from cancer1
27%
The number of new cancer
diagnoses in the UK per year is
increasing, and has risen by more
than 27% since 20013
200
There are more than 200
different types of cancer1
1 www.cancerresearchuk.org/about-cancer/what-is-cancer
2 www.ncbi.nlm.nih.gov/pmc/articles/PMC3597235/
3 www.macmillan.org.uk/_images/cancer-statistics-factsheet_tcm9-260514.pdf
What are the challenges to treatment?
90%
Metastasis causes >90% of cancer deaths2
The “stage” of cancer at diagnosis is extremely important to survival.
Cancer staging is a way of describing the size of a cancer and how far
it has spread and is important in helping determine treatment. If the
cancer is “early” stage and just in one place then a local treatment, such
as surgery or radiotherapy may be sufficient treatment. If the cancer is
“later” stage and has spread through the body to other organs (metastasis)
then treatment is needed that also circulates throughout the whole body
such as chemotherapy, hormone therapy or targeted cancer drugs: once
cancer spreads it can be hard to control. Some types of metastatic cancer
can be driven into remission with treatment but most cannot.
There is also a huge variation in survival between cancer types. Some
cancers have screening programmes or more obvious symptoms and
can be detected earlier (e.g. breast, colorectal, cervical, skin) and others
may have mostly slow growing cancers which may remain early stage
(e.g. prostate) and therefore have higher survival rates. Other cancers may
have no obvious symptoms and/or are aggressive and may be detected
late once they have already spread (e.g. brain, ovarian, pancreatic) and
therefore have lower survival rates.
During cancer treatment,
particularly of secondary
(metastatic) cancer disease, there
are many challenges which can
arise leaving both physicians
and patients with unanswered
questions such as:
1
How do we know
which drug will work
most effectively for
a patient?
2
How can we track
whether drugs are
in fact working and
having a positive
impact?
3
How do we
monitor patients
in remission
to assess any risk
of the disease
returning?
Tissue biopsy shortcomings
The standard test for cancer cells
is to undertake a solid tissue
biopsy. This approach has many
shortcomings compared to a
liquid biopsy:
Requires invasive
surgery and can
cause adverse
reactions
Expensive to
perform and
requires a lot of
hospital resources
Patients experience
a longer recovery
time which may
delay treatment
Frequent lack of
tissue availability
from difficulty
in accessing some
tumours (pancreatic,
lung, brain, liver
and bone cancers)
Difficult to repeat
so missing the
dynamic nature
of cancer response
to treatment
Only samples one
site and does not
fully reflect tumour
heterogeneity
The solution:
Parsortix system
The Parsortix system
The benefits of CTCs
The Parsortix system from ANGLE uses a
patented microfluidic technology in the form
of a one-time use cassette to capture and
then harvest circulating tumour cells (CTCs)
from blood.
The cassette captures CTCs based on their less
deformable nature and larger size compared to
other blood components.
A closer look at the cassette
CTCs are caught on a step that “folds over” in a microscope slide
sized cassette.
Inlet
Outlet
A simple peripheral blood test can be used to provide crucial medical
information regarding a patient’s disease.
CTCs enable the complete picture of the cancer to be understood
as they are viable, intact whole cells allowing DNA, RNA and protein
analysis as well as culturing.
CTCs are biologically specific – they cannot be present unless the
patient has cancer.
By analysing CTCs you can identify the characteristics of the cancer
to better determine which drugs will be more effective.
By looking at the number of CTCs and how this changes over time,
you can predict survival rates for patients and monitor how well the
treatment is progressing.
A simple blood test monitoring the levels of CTCs for patients
in remission may act as an early warning system of a relapse, well
ahead of symptoms, allowing earlier treatment with consequent
better likelihood of success.
Competitive differentiation
Unlike many other CTC systems, the Parsortix system is applicable for all
solid tumour cancers. Parsortix can be used without modification and
to date has been shown to work with 23 different cancer types.
Cross section
Patented multifold and
separation step
Critical gap
Captured CTCs
White blood cells
Red blood cells
Blood flow
Able to capture one CTC
in a billion blood cells.
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Technology
Parsortix
microfluidic
step
Antibody-
based systems
Membrane-
based systems
Field Flow
Fractionation
systems
The Parsortix system has a unique
combination of features making it
suitable for routine clinical analysis
of patient blood samples.
Ged Brady
Cancer Research UK Manchester Institute of Technology
How it works:
Capture, harvest and analysis of CTCs
ANGLE owns both a CTC harvesting technology (Parsortix®) and a downstream molecular analysis
technology (HyCEADTM Ziplex®) to interrogate the harvested CTCs.
ANGLE has well-differentiated patent-protected products. Both systems have proprietary
consumables, which provide a “razor blade” approach to commercialisation.
ANGLE's proprietary technologies can be combined to provide automated, sample-to-answer
results in both centralised laboratory and point-of-use cartridge formats.
Automated process requiring minimum user intervention
1
Blood collection
2
Cell capture
100µl-50ml of whole blood. No pre-processing required.
Blood is pumped through the one-time use cassette.
CTCs are captured in the cassette.
3a
Cell identification in cassette
3b
Cell harvest
Staining reagents can be pumped through the cassette to allow
in-cassette identification and enumeration of CTCs.
CTCs can be harvested in <200µl buffer for identification use in
multiple downstream analysis techniques.
Downstream analysis
4a
Widely available
techniques
4b
Proprietary HyCEAD
Ziplex system
HyCEAD Ziplex at a glance
The cells harvested by the Parsortix
system can be analysed using existing
techniques already established for tissue
biopsy, including:
• Cytopathology
• Immunofluorescence
• FISH
• PCR
• NGS
Benchtop laboratory platform designed
for routine and focused multiplex analysis
of DNA, RNA and protein biomarkers.
• Low cost
• Highly multiplexed
• Rapid and sensitive capture
of targets from high variety
of sample types
HyCEAD chemistry
>100
Enables simultaneous measurement of
more than 100 genes in a single reaction
>500
Rapid content creation for new
applications of more than 500 target
genes to date
The HyCEAD Ziplex system is a medium-
density microarray platform designed for
routine and focused multiplex analysis of
DNA, RNA or protein biomarkers.
Advantages
Unlike expensive, high-density microarray
systems that overwhelm researchers with
large amounts of unnecessary data, the
HyCEAD Ziplex system uses a highly
reproducible, lower density array to
provide expression information on specific
genetic or protein biomarker signatures.
It uniquely combines three separate
automated functions (hybridisation/protein
binding, washing/labelling and imaging) into
a single benchtop instrument providing
researchers with a highly flexible platform
that is fast, simple to use and cost effective.
Performance
The HyCEAD Ziplex system 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 (>100) of gene expression
analyses in a single reaction.
To watch our video visit:
www.angleplc.com/parsortix
technology/introduction/
The potential:
Seeking first ever FDA clearance for a device
to harvest cancer cells from patient blood for
subsequent analysis
ANGLE is focused on commercialising its
liquid biopsy system which has the potential
to transform cancer diagnosis and treatment.
Unique patented microfluid approach: strongly differentiated
from competition.
Two 200 patient studies in ovarian cancer
completed with best in class 95.1% accuracy
200 patient clinical verification study in process
Read more on pages 06 and 07
Positive results from 400
subject FDA clinical study
Read more on pages
08 and 09
200
400
26
Leading independent cancer
centres have delivered 26
peer-reviewed publications
Read more on page 10
Parsortix
world-leading
liquid biopsy
system
Emerging multi-
$billion market
Read more
on page 02
$100bn
93,000
>93,000 blood
samples processed
Read more on
page 10
23
200
Shown to work
with 23 different
cancer types to date
c.200 instruments
in active use
Contents
Strategic Report
Market opportunity
Strategy
Strategic aims in action
Chairman’s Statement
Business Strategy
Key Performance Indicators
Principal Risks and Uncertainties
Financial Review
Corporate Responsibility Report
Governance
Board of Directors
Scientific Advisory Board
Directors’ Report
Corporate Governance Report
Remuneration Report
Financial Statements
Independent Auditor’s Report
Consolidated Statement of Comprehensive Income
Consolidated Statement of Financial Position
Consolidated Statement of Cash Flows
Consolidated Statement of Changes in Equity
Notes to the Consolidated Financial Statements
Company Statement of Financial Position
Company Statement of Cash Flows
Company Statement of Changes in Equity
Notes to the Company Financial Statements
Notice of Annual General Meeting
Notice of Annual General Meeting
General Information for Shareholders in
respect of the Annual General Meeting
Additional Information
Explanation of Frequently Used Terms
Company Information
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01
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Market opportunity
A major opportunity in an
emerging and growing market
The liquid biopsy market is estimated
to be in excess of US$100 billion p.a.
Source: Frost & Sullivan November 2018: United States only
Market drivers
Global burden of cancer
Key drivers of cancer incidence
• Increasing average life span
• Smoking, poor diet, obesity and alcohol
• Over exposure to sun
• Lack of exercise
• Exposure to carcinogens
• Infections and HIV
• Hormones and inherited genes
Key drivers of cancer
diagnostics market
• Shift towards precision medicine
need for companion diagnostics
• Health economics – reduced costs
• Early detection (screening)
• Therapy selection, treatment monitoring
and remission monitoring
Precision medicine
With advancements in genomics and clinical
information, a paradigm shift has begun
from “one drug fits all” towards “precision
medicine” – the right drug for the right
patient at the right time.
Key drivers
• Each patient’s cancer is different
• Each patient’s cancer changes over time
• Effective treatment requires
personalised care
>1 in 3
People (1 in 2 for developed countries)
will get cancer1
27.5m p.a.
Estimated rise in cancer cases within
the next two decades1
02
New cancer incidence
(per annum)
18.1m
2018
14.1m
2012
Living with and after cancer
43.8m
2018
32.5m
2012
Deaths from cancer
(per annum)
9.6m
2018
8.2m
2012
1 Source: International Agency for Research on Cancer (Globocan 2018)
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Global burden of cancer
ANGLE’s focus
Current
Medium term
Longer term
Detection of
cancer in high
risk groups
Therapy
selection
Assessing
treatment
Remission
monitoring
Screening for
early cancer
Ovarian pelvic mass
Breast HER-2 Abbott
Prostate AR-V7 Qiagen
Assessing minimal
residual disease
Repeat testing to
ensure CTCs not
present
Need to assess
aggressiveness and
avoid false positives
FDA clearance a major validation opening up commercial pathway
Prospect of first ever FDA clearance for harvesting cancer cells
from blood for analysis. Expected to accelerate sales and deals.
£6bn p.a. estimated global market for existing Parsortix applications
in metastatic breast cancer, ovarian cancer and prostate cancer1.
• Existing research use sales to leading translational
researchers will expand with new product development
and sample-to-answer solutions.
• Expansion into research use sales for pharma services in drug trials.
• Service-led strategy in LDT (laboratory developed test) market.
• Product-led strategy for clinical sales of Parsortix instruments and
consumables direct to hospitals.
Research
Pharma
LDTs
Clinical products
Leveraged R&D model
Proof-of-concept studies
provide evidence and drive new
applications
Large-scale research
use sales for drug trials
Culturing CTCs for
drug testing
Companion diagnostics
Biomarkers
PD-L1
Laboratory developed tests
in a service laboratory
Product sales worldwide
to hospitals
Accelerator and demonstrator
Ovarian
Metastatic breast
Market accessible on multiple fronts with Parsortix product-based solution
1 Source: Company estimate
03
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report
Strategy
A clear path to success
ANGLE has a four-pronged strategy for achieving
widespread adoption of its Parsortix system in
the emerging multi-$billion liquid biopsy market.
Our Strategy
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.
Read more on pages 06 and 07
Clinical studies
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 CTCs
from blood for subsequent analysis.
Read more on pages 08 and 09
Partnerships
Regulatory approval
Establishing partnerships with large
healthcare companies for market
deployment and development of multiple
other clinical applications incorporating the
Parsortix and/or HyCEAD Ziplex systems.
Read more on pages 12 and 13
Published evidence
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.
Read more on pages 10 and 11
04
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Effective execution of the strategy has
the potential to deliver significant financial
returns for ANGLE’s shareholders,
profoundly improve the outcome for cancer
patients, and reduce healthcare costs.
Strong progress has been made
in each of these areas
Andrew D W Newland
Chief Executive
Our Strategy
What we have achieved in the period
Building on previous achievements
Clinical studies – ovarian cancer
Ovarian cancer clinical verification study established with
leading US cancer centre. Pre-study phase completed successfully.
200 patient study initiated in August 2019.
Following COVID-19 lock down delays, completion of study
patient enrolment is expected by the end of CY20.
Regulatory approval – metastatic breast cancer
FDA clinical study enrolment of 400 subjects completed with positive
result for primary and exploratory objectives announced. FDA analytical
studies making significant progress. Q-Submission process with
FDA completed.
Following COVID-19 lock down delays, final analytical studies
in progress with prospect of making FDA submission in Q3 CY20.
Published evidence – leveraged R&D model
Leading independent cancer centres have delivered a total of
26 peer-reviewed publications as at 31 December 2019.
There have been a further eight peer-reviewed publications since
the period end.
23 separate cancer centres have published uniformly positive
results on their use of the Parsortix system.
Partnerships – leveraged partnership model
Successful US and European ovarian cancer results in two 200
patient studies. Lead study delivered best in class 95.1% accuracy
in discriminating between benign and malignant pelvic masses,
significantly out-performing standard of care.
Extensive optimisation of the HyCEAD Ziplex molecular analysis
platform successfully completed, demonstrating exceptionally
high sensitivity.
FDA clinical study in metastatic breast cancer with four leading US
cancer centres enrolling 400 subjects. FDA analytical study in progress.
Ongoing dialogue with FDA.
Total of 14 peer-reviewed publications at 31 December 2018.
Discussions progressing with multiple partners which we expect
to accelerate once FDA clearance for the system is achieved.
Collaborative agreements signed with three leading global healthcare
companies: Abbott, Philips and QIAGEN.
Progress with Abbott on combining Parsortix and PathVysion
and enabling an Abbott liquid biopsy solution. Philips collaborative
research project making progress.
QIAGEN protocol work undertaken and a joint poster and joint
marketing material developed.
05
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Strategic aims in action
Clinical studies
Ovarian cancer clinical application – abnormal pelvic mass triage test
ANGLE’s Parsortix and
HyCEAD Ziplex systems
are being developed to triage
women having surgery for an
abnormal pelvic mass to identify
those with ovarian cancer.
Extensive optimisation of the HyCEAD Ziplex
system and its combination with Parsortix was
successfully completed.
A detailed market review was completed to
identify key user requirements for the test.
Testing of the modified and further optimised
platforms has been successfully completed
and the performance of the improvements
confirmed in a pre-study.
A 200 patient clinical verification study is in
progress with the University of Rochester Medical
Center Wilmot Cancer Institute. Completion of
the patient enrolment is expected by end CY20.
Once the new performance data is available,
ANGLE intends to establish this test as a
Laboratory Developed Test in-house and/or
with third-party laboratories.
The test has the potential to significantly improve
patient outcomes whilst at the same time reduce
overall healthcare costs.
06
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 ANGLE’s Pelvic Mass
Triage test achieved
higher sensitivity
and specificity than
any other test for
the same indication.
The best in class performance of
the combined Parsortix and HyCEAD
Ziplex systems used in the US study
demonstrates the capability to
out-perform current approaches
for the detection of ovarian cancer.
The next generation
ANGLE Pelvic Mass
Triage test has the
ability to out-perform
current clinical
practice in accurately
discriminating malignant
from benign pelvic
masses prior to
biopsy or surgery.
The improved accuracy
of the test results
in a high level of
sensitivity as well as
a substantial reduction
in false positives.
Dr. Richard Moore
Director of the Gynecologic
Oncology Division, University
of Rochester Medical Center
Wilmott Cancer Institute
2x200
patient studies in Europe and the US completed
and reported positively
95.1%
correct prediction of cancer with a best in
class accuracy (area under the curve) for the
predictive assay
US$1bn
p.a. estimated market potential for Parsortix
in ovarian cancer1
5-10%
of women will develop a pelvic mass requiring
surgery at some point in their lives2
c.750k
women p.a. with an abnormal pelvic mass in
US market alone
295k
women diagnosed with ovarian cancer globally
in 20183
Survival rates
90% at stage 14
3.5% at stage IV4
1 Company estimate
2 www.contemporaryobgyn.net/view/pelvic-mass-workup
3 International Agency for Research on Cancer (Globocan 2018)
4 www.cancerresearchuk.org/health-professional/cancer-statistics/
statistics-by-cancer-type/ovarian-cancer
07
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report
Strategic aims in action
Regulatory approval
FDA clearance in metastatic breast cancer
Metastasis is responsible for the
vast majority of breast cancer
related deaths.
During the period the FDA clinical study (Study)
reported positive results that the Study had
achieved its primary objective to demonstrate
the ability of the Parsortix system to capture and
harvest cancer cells from the blood of a significant
proportion of metastatic breast cancer patients.
The Study has also achieved its exploratory goals
by demonstrating that the cells harvested from
patient blood could be interrogated using different
subsequent analysis techniques.
Considerable progress has been made on the
analytical studies and the work is ongoing.
ANGLE made a substantial Q-Submission
(a "pre-submission used to request formal
comments from FDA on key questions) to
FDA, to reduce the risk that the full De Novo
submission might be rejected, and held a
meeting with FDA in January 2020.
Work is expected to be completed to allow
submission to FDA in Q3 CY20 offering the
prospect of FDA clearance in CY21. The timing
of FDA regulatory clearance is dependent on
FDA’s review and response to our submission.
For more information on our work for breast
cancer, go to our website at:
www.angleplc.com/translational-research/
womens-health/breast-cancer/
What is FDA?
Why is it important?
What are the benefits?
FDA is the United States agency responsible for the
regulatory clearance process for clinical applications
(treating patients).
FDA clearance allows a product to be sold for
diagnosis of disease in patients in the United
States. It is also seen as a de facto gold standard
for performance worldwide.
Securing FDA clearance will allow ANGLE to sell
Parsortix for treating patients in the United States.
It will also greatly facilitate sales into pharmaceutical
drug trials directly and with contract research
organisations.
08
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 As a breast cancer
surgeon, I am very
enthusiastic about
the potential of
liquid biopsy. Our
pilot data shows
that potentially the
same information
can be obtained
from a simple
blood test using
Parsortix as from
an invasive tissue
biopsy and indeed
may be advantageous
over invasive tissue
biopsies in regards to
the diverse sites of
metastatic disease.
Julie E. Lang
Director, USC Breast Cancer
Program, Associate Professor of
Surgery, Norris Comprehensive
Cancer Center, University of
Southern California
4
leading US cancer centres enrolled patients
for FDA clinical studies
400
subject study in the US completed and
reported positively
US$2.4bn
p.a. estimated market potential for Parsortix
in metastatic breast cancer1
2.1m
women diagnosed globally with breast cancer
in 20182
6.9m
women living with and after cancer2
20-30%
of people initially diagnosed at early stages
will develop metastatic breast cancer3
ANGLE is seeking to
become the first ever
company to receive
FDA Class II clearance
for a product for
harvesting intact CTCs
from patient blood for
subsequent analysis.
US regulatory clearance by FDA is considered
the global standard for approval of medical
devices and diagnostics. ANGLE believes
that such clearance would provide ANGLE’s
Parsortix system with 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 resources
commitment on its effort to progress towards
FDA clearance over several years. Four of
the leading US cancer centres enrolled 400
subjects for the clinical studies including
200 metastatic breast cancer patients
and 200 healthy volunteers: University of
Texas MD Anderson Cancer Center, University
of Rochester Medical Center Wilmot Cancer
Institute, University of Southern California
Norris Comprehensive Cancer Center, and
Robert H Lurie Comprehensive Cancer Center
Northwestern University. The global healthcare
company Abbott joined the Study, enabling us
to use its proprietary PathVysion HER-2 DNA
FISH Probe Kits. Analytical studies have and
are being undertaken in-house to deal with key
aspects such as 1) precision and reproducibility
2) limits of quantification and detection
3) accuracy and linearity and 4) interferences
and carryover.
1 Company estimate
2 International Agency for Research on Cancer (Globocan 2018)
3 www.mbcn.org/incidence-and-incidence-rates/
09
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Strategic aims in action
Published evidence
Medical devices is an evidence led industry, and in addition
to the clinical studies and regulatory studies described previously,
peer-reviewed publications are a key performance metric.
Leveraged R&D model
achieving more
New peer-reviewed
publications
ANGLE’s product based approach means that
we are able to deploy our system to leading cancer
centres, as key opinion leaders and customers.
ANGLE’s unique approach to capturing and
harvesting CTCs is enabling these translational
researchers to undertake a wide range of research
which shows the effectiveness of the system and is
leading to new uses and applications for Parsortix as
well as achieving breakthrough research in many
areas due to the special attributes of the system.
This is leading to an increasing number of posters
and more importantly peer-reviewed publications.
Further, ANGLE is not funding customer work,
and indeed the sale of instruments and cassettes
is generating revenues. We refer to this as a
“leveraged R&D model”, because significantly
more R&D work is being undertaken than if we
had to pay for this ourselves.
During the period, 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 www.angleplc.com/library/publications/.
23 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 also working
on developments in 23 different cancer types.
This deployment of Parsortix for research now
means that the system is widely presented and
discussed at leading cancer conferences around
the world and, during the period, customers have
developed ground breaking new research using
the system.
There were 26 peer-reviewed publications as
at 31 December 2019 with six new publications
announced during the eight month reporting period:
• the University Medical Center Hamburg-
Eppendorf (UKE), demonstrating the use
of Parsortix as a liquid biopsy to investigate
a key immunotherapy target in lung cancer
• the Disseminated Cancer Cell Network
(DCCNet), Duesseldorf, developing a single
cell analysis workflow for breast cancer
• the Medical University of Vienna demonstrating
the use of Parsortix for neuroendocrine
analysis (corresponding to poor overall survival)
in small cell lung cancer
• Queen Mary University of London's
Barts Cancer Institute demonstrating the
potential for Parsortix to be used to avoid
unnecessary biopsies in prostate cancer
without missing clinically significant
prostate cancer
• the University of Birmingham publishing
a review showing key benefits of Parsortix
in head and neck cancer
• the University Medical Center Hamburg-
Eppendorf (UKE), demonstrating Parsortix
use in prediction and monitoring of
therapy responses for melanoma
patients
Since the period end there have been a further
eight peer-reviewed publications.
Installed base
c.200
installed base of Parsortix systems in active use
Parsortix samples processed
Peer-reviewed publications
93,000
64,000
41,000
24,000
11,000
4,000
2
4
0
26
14
8
2014
2015
2016
2017
2018
2019
2014
2015
2016
2017
2018
2019
Cumulative samples processed at 31 December
Cumulative publications at 31 December
10
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Some leading cancer centres we work with
11
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Strategic aims in action
Partnerships
ANGLE has a strategy to partner
with large-scale healthcare companies
for market deployment and
development of multiple other
clinical applications incorporating
our systems.
The Parsortix system is compatible with multiple
existing downstream analysis techniques. In addition
to the capture and harvest of CTCs the system
can capture and harvest other rare cells such as
fetal cells.
The HyCEAD Ziplex system can be employed with
many other sample types, not just CTCs, and in
many other sectors, not just cancer. The priority has
been on optimising this to work in the ovarian cancer
pelvic mass triage test which involves a panel of
genes. HyCEAD Ziplex is being developed for other
cancer panels including breast and prostate and with
partners for the other areas.
Progressing partnerships with
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 on achieving FDA clearance for the system.
During the period, ANGLE has progressed its three
key partnerships with large healthcare companies.
Abbott’s proprietary PathVysion HER-2
DNA FISH Probe kits were utilised in ANGLE’s
FDA clinical study for FISH (fluorescence in
situ hybridization) analysis of circulating tumour
cells. The process of analysis using FISH was
successful and ANGLE is pursuing commercial
discussions with Abbott.
The collaborative research project with Philips
to develop liquid biopsy solutions as part of
a four-year European Union research grant
funded programme progressed during the period.
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.
During the period, the co-marketing agreement
with QIAGEN progressed with a focus on the
measurement of AR-V7 in prostate cancer.
A joint poster publication was released at
a leading international cancer conference and
joint marketing material has been prepared.
Next steps are currently being evaluated.
The proposed acquisition of QIAGEN by Thermo
Fisher Scientific offers some alternative opportunities.
Non-invasive prenatal testing (NIPT)
Previously, ANGLE completed a pilot study
demonstrating that the Parsortix system could
harvest fetal cells from the blood of pregnant women.
The detection of fetal abnormalities by analysis of fetal
cells as opposed to cell free fetal DNA (tiny fragments
of dead cells) could greatly extend the applicability
of the process while addressing key limitations in
existing approaches.
The NIPT market is expected to reach US$1.0 billion
in market size by 20221. ANGLE plans to progress
commercialisation of Parsortix in this market through
commercial partnerships with one or more large
healthcare companies. Discussions are in progress
with a number of such companies.
1 www.zionmarketresearch.com/report/non-invasive-prenatal-testing-market
12
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Abbott is the global market leader for FISH testing
for HER-2 in solid tissue biopsies, a market estimated
to be worth US$0.5 billion per annum in 2016
(source: Grand View Research).
There is now the potential for Abbott to offer a
Parsortix-based product for HER-2 analysis from
a routine blood test. Testing of CTCs for HER-2
could provide Abbott with a repeat test for HER-2
giving a 4x increase in use of their PathVysion test.
Combining Parsortix and PathVysion could command
much higher reimbursement, increasing margins
as well as the potential for exclusivity in the repeat
testing market.
Abbott is pleased
to collaborate with
ANGLE in this
important evaluation
of PathVysion in liquid
biopsy specimens.
The PathVysion HER-2
DNA FISH Probe kit is
reliable and accurate in
tissue biopsy samples
and the Parsortix
system may unlock
the potential for
PathVysion use in
a simple blood test.
Kathryn B Becker
Franchise Director Oncology and
Companion Diagnostics, Abbott
Parsortix harvested HER-2 stained cells.
13
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Chairman’s Statement
Progressing towards FDA clearance
Major progress was made during
the period towards the completion
of the clinical and analytical studies
to support FDA clearance of the
Company’s Parsortix system in
metastatic breast cancer.
Garth R Selvey
Chairman
During the period ANGLE
progressed clinical and analytical
studies to support a De Novo
FDA submission for its Parsortix
system for capturing and harvesting
circulating tumour cells from
metastatic breast cancer patients.
Strong progress was also made with the Company’s
ovarian cancer assay and a clinical verification study
initiated patient enrolment during the period.
Meanwhile ANGLE’s collaborators and customers
continued to demonstrate Parsortix’s versatility in
cancer translational research developing important
new applications. This work generated six new
publications during the period increasing the body
of peer-reviewed evidence supporting the platform.
Overview of Financial Results
Revenue of £0.6 million in the eight month period
(year ended 30 April 2019: £0.7 million) came mainly
from research use of the Parsortix system. ANGLE
continued its investment in studies to develop and
validate the clinical application and commercial use
of the Parsortix system, resulting in operating costs
of £8.2 million in the eight month period (year ended
30 April 2019: £11.6 million) and a loss for the eight
month period of £6.2 million (year ended 30 April
2019: £8.9 million).
The cash balance was £18.8 million at 31 December
2019 (30 April 2019: £11.0 million) with R&D Tax
Credits due at 31 December 2019 of £3.4 million
(30 April 2019: £1.9 million) of which £1.8 million
was received after the period end. The cash position
was strengthened during the period with a successful
placing of new shares with institutional investors
including significant new US investors in July 2019,
which raised gross proceeds of £18.0 million.
Proceeds net of expenses were £16.9 million.
Strategy
ANGLE has continued with its sustained focus on
its four-pronged strategy for achieving widespread
adoption of its Parsortix system in the emerging
multi-billion dollar liquid biopsy market:
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
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 the blood of patients
(initially metastatic breast cancer patients) for
subsequent analysis
Establishing a body of published evidence
from leading cancer centres showing the
utility of the system through peer-reviewed
publications, scientific data and clinical research
evidence, highlighting a wide range of potential
applications
Establishing partnerships with large healthcare
companies for market deployment and
development of multiple other clinical
applications incorporating the Parsortix system.
ANGLE is in the process of establishing an
independent accredited clinical laboratory that will
have the capability of offering validated clinical tests.
This clinical laboratory will be used as an accelerator
and demonstrator in support of the Company’s
established plan for product sales of Parsortix
instruments and cassettes.
Read more about our strategy on pages 04 to 13
14
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Subsequent to the period end, the COVID-19 lock
down in the UK beginning in March 2020 resulted in
the immediate loss of availability of healthy volunteer
blood donors required to complete the analytical
samples remaining to complete the Submission.
As announced on 22 June 2020, blood donations
have now recommenced and the analytical studies
have been re-started with the aim of making the
FDA submission in Q3 CY20.
The outcome and timing of the FDA regulatory
decision is entirely dependent on FDA’s review and
response to the Company’s submission.
Large-scale clinical studies
Ovarian cancer clinical application:
triaging abnormal pelvic mass
During the period, following further successful
optimisation of the combination of ANGLE’s
Parsortix CTC system with its proprietary HyCEAD
Ziplex downstream molecular analysis process, an
ovarian cancer clinical verification study was established
with University of Rochester Medical Center Wilmot
Cancer Institute, New York, USA (URMC) and patient
enrolment initiated.
The study has been designed to evaluate the
performance of ANGLE’s predictive ovarian cancer
detection assay developed using the results from
the previous 200 subject study, which achieved
best in class results AUC>95% accuracy, in a new
patient cohort.
Subsequent to the period end, the COVID-19 lock
down in the US beginning in March 2020 resulted in
URMC ceasing elective surgeries, patient enrolment,
and research laboratory activities. As announced
on 22 June 2020, URMC has now recommenced
patient enrolment and completion of study patient
enrolment is expected by the end of CY20.
Once the new performance data is available and,
assuming comparable results to the previous study,
ANGLE intends to establish this test as a laboratory
developed test (LDT) in an accredited clinical
laboratory setting. The test has the potential to
significantly improve patient outcomes whilst at
the same time reducing overall healthcare costs.
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 independent
third parties driving development of new clinical
applications, is working very well.
Over 93,000 samples have been processed using the
Parsortix system as at 31 December 2019, with over
20,000 samples in the eight month period (year to
30 April 2019: 24,000). There were 26 peer-reviewed
publications as at 31 December 2019 with six new
publications announced during the eight month
reporting period (see www.angleplc.com/library/
publications/) including:
• the University Medical Center Hamburg-
Eppendorf (UKE), demonstrating the use of
Parsortix as a liquid biopsy to investigate a key
immunotherapy target in lung cancer
• the Disseminated Cancer Cell Network
(DCCNet), Duesseldorf, developing a single
cell analysis workflow for breast cancer
• the Medical University of Vienna demonstrating
the use of Parsortix for neuroendocrine
analysis (corresponding to poor overall survival)
in small cell lung cancer
• Queen Mary University of London’s Barts
Cancer Institute demonstrating the potential
for Parsortix to be used to avoid unnecessary
biopsies in prostate cancer without missing
clinically significant prostate cancer
• the University of Birmingham publishing a review
showing key benefits of Parsortix in head and
neck cancer
• the University Medical Center Hamburg-
Eppendorf (UKE), demonstrating Parsortix use
in prediction and monitoring of therapy
responses for melanoma patients
To date, 23 separate cancer centres from around
the world have published uniformly positive reports
on their use of the Parsortix system. Leading
independent cancer centres throughout Europe,
North America and elsewhere using ANGLE’s
Parsortix system are working on developments
in 23 different cancer types.
Progress towards FDA clearance
ANGLE is seeking to become the first ever company
to receive FDA clearance for a medical device
that harvests intact circulating tumour cells from
the blood of metastatic breast cancer patients for
subsequent analysis. US regulatory clearance by
FDA is considered the global standard for approval
of medical devices and diagnostics.
During the period, the FDA clinical studies and a
substantial number of the FDA analytical studies
demonstrating the performance of the Parsortix
system for the capture and harvesting of circulating
tumour cells in metastatic breast cancer were
completed. These studies have been technically and
logistically extremely challenging, requiring a total of
over 10,000 samples to be processed with Parsortix.
The FDA clinical studies were undertaken by four of
the leading US cancer centres (University of Texas
MD Anderson Cancer Center, University of Rochester
Medical Center Wilmot Cancer Institute, University
of Southern California Norris Comprehensive Cancer
Center, and Robert H Lurie Comprehensive Cancer
Center Northwestern University).
The analytical studies demonstrated the performance
of the Parsortix system in key aspects including
precision and reproducibility, limits of quantification
and detection, accuracy and linearity, and interferents
and carryover. These studies have required resolution
of numerous technical challenges to meet FDA
requirements, giving ANGLE a thoroughly characterised
platform and consequent competitive advantage.
On 29 October 2019, ANGLE made a substantial
Q-Submission (a “pre-submission” used to request
formal comment from FDA on key questions) to
FDA. The Q-Submission responded to a number of
questions and suggestions previously made by FDA
on ANGLE’s study plans and set out headline data
from both the clinical and analytical studies. ANGLE
also requested FDA formally respond to a series
of questions, including whether our responses to
specific questions which FDA had previously raised,
were acceptable. ANGLE’s intention in making this
Q-Submission was to reduce the risk that the full
FDA De Novo Submission might be rejected.
FDA provided a written response to the
Q-Submission and held a formal face-to-face
meeting with ANGLE in January to discuss their
response, which identified some additional analytical
study work requested by FDA, as announced on
22 January 2020. Subsequent to this meeting, a
full De Novo Submission to FDA is in preparation,
requesting clearance for the Parsortix PC1 system
for capturing and harvesting circulating tumour
cells from metastatic breast cancer patients.
15
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Chairman’s Statement
continued
Strong progress was also made with
the Company's ovarian cancer assay
and a clinical verification study initiated
patient enrolment during the period.
Garth R Selvey
Chairman
16
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Cancer is the second leading cause of death globally
and is responsible for an estimated 9.6 million deaths
in 2018 with an estimated 18.1 million new cases
every year and some 43.8 million living with and after
cancer. The need for a simple blood test alternative to
tissue biopsies is being even further demonstrated in
the current COVID-19 situation as cancer diagnosis
and treatment for critically important metastatic
tissue biopsies are being postponed or cancelled.
Outlook
Major progress was made during the period with
the clinical and analytical studies to support FDA
clearance of the Company’s Parsortix system in
metastatic breast cancer. The full De Novo FDA
Submission is in preparation so that this can be
rapidly submitted once the remaining analytical
samples needed to meet the requirements identified
in the January 2020 meeting with FDA are available
and have been analysed. These samples were
delayed by the COVID-19 restrictions preventing
the recruitment of healthy volunteer blood donors
but work is now back in progress and the FDA
submission is expected to be made in Q3 CY20.
Patient enrolment has also recommenced and
ANGLE is again making progress with its ovarian
cancer test. It is expected that patient enrolment
will complete by the end of CY20, with the aim
of supporting the establishment of a laboratory
developed test for ovarian cancer in the new year.
During the period, we raised further growth capital,
expanding our existing UK shareholder base and
adding key new US investors. ANGLE has a robust
balance sheet with sufficient working capital and
liquidity. We remain confident about the Group’s
long-term prospects.
Garth Selvey
Chairman
24 June 2020
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 once FDA clearance for the system has
been achieved.
During the period, ANGLE has progressed its three
key partnerships with the large healthcare companies
Abbott, QIAGEN and Philips, and is continuing to
seek a corporate partner to progress the use of
Parsortix in non-invasive prenatal testing (NIPT).
COVID-19
The Company has had some short-term negative
impacts from government lock downs associated
with COVID-19. Although this has created some
uncertainty and a need to adapt the operating model
it is not expected to have any significant long-term
impact on the Company. As a mitigating step, the
decision was made not to pay executive or staff
bonuses for the eight month period to 31 December
2019 in order to preserve cash during the COVID-19
lock down uncertainty.
While the COVID-19 lock down caused some
unanticipated disruption and delays outside of
the Company’s control, the Company adopted a
proactive approach to the lock down advancing
on multiple fronts and developing some new
initiatives. The business continuity plan was enacted,
disruption was minimised and employees, suppliers
and customers were flexible and proactive in dealing
with the situation. Those employees that can work
from home have done so, whereas laboratory staff
have moved to double shift patterns with enhanced
hygiene and operating procedures in order to provide
a safe working environment and meet government
laws and guidelines. Research use revenues have
been disrupted, as the cancer centres we sell to
are mainly within hospital facilities that have been
closed except for COVID-19 related activities, but
we have taken the opportunity to work on remote
customer support measures and proactive business
development programmes.
17
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Business Strategy
Sustained focus on delivering our strategy
ANGLE’s ultimate objective is the
widespread adoption of the Parsortix
system in the diagnosis, treatment and
monitoring of cancer patients.
Andrew D W Newland
Chief Executive
ANGLE has been following a
consistent strategy for several years
to bring its Parsortix technology
to market. This strategy is set
out below.
Cancer medical applications
The treatment of cancer is highly problematic
primarily because of the heterogeneity of cancer
in multiple dimensions:
• Each cancer patient may have different
mutations from other patients with the same
type of cancer
Introduction
ANGLE is a world-leading liquid biopsy company
commercialising a platform technology that can
capture cells circulating in blood, such as cancer
cells, even when they are as rare in number as one
cell in one billion blood cells, and harvest the cells
for analysis.
ANGLE’s cell separation technology is called Parsortix
and is the subject of granted patents in the United
States, Europe, China, Australia, Canada, India, Japan
and Mexico. Three extensive families of patents are
being progressed worldwide. The system is based
on a microfluidic device that captures cells based
on a combination of their size and compressibility.
The analysis of the cells that can be harvested from
patient blood with ANGLE’s Parsortix system has the
potential to deliver profound improvements in clinical
and health economic outcomes in the treatment and
diagnosis of various forms of cancer.
As well as cancer, the Parsortix technology has
the potential for deployment with several other
important cell types in the future, including for
example fetal cells.
• Each cancer patient may have several different
types of cancer cell mutation within a particular
tumour
• Each patient’s cancer may mutate and change
over time
In order to treat patients effectively, doctors need to
deploy drugs that target the individual patient’s cancer
at that point in time. This approach is called “precision
medicine” and in recent years has become accepted
worldwide as the most likely way to improve patient
outcomes in the long run.
There is therefore a crucial need for ongoing
information as to the patient’s cancer status. Initially,
where the cancer tumour can be accessed, this is
currently achieved through a solid tissue biopsy,
for example through a breast cancer lumpectomy.
The tissue excised is analysed and the oncologist
makes a decision on therapy based on the analysis,
for example in breast cancer if the patient is HER2
positive (human epidermal growth receptor 2, a
protein which if positive promotes the growth of
cancer cells) they may receive Herceptin or a similar
drug but otherwise they will not.
The use of the solid tissue biopsy where it can be
applied is effective and the current “gold standard” in
treatment. However it is invasive, relatively costly and
not suited to repeat testing compared with a blood
test. Importantly it cannot always be used effectively
in difficult to access tumours, such as brain, pancreatic
and lung cancers where insufficient tissue may be
obtained for analysis or the patient is too ill for the
biopsy surgery.
Crucially, whether or not a solid tissue biopsy can
be taken when the patient presents, biopsy of the
primary tissue cannot be repeated at a later date
when the tissue concerned has already been excised
and is no longer there.
Primary cancers shed cancer cells into the patient’s
bloodstream. These cells circulate in the blood and
are known as circulating tumour cells or CTCs.
The CTCs can then land in another part of the
body and initiate a secondary cancer. If they can be
harvested for analysis, the CTCs have the potential to
provide, through a simple peripheral blood test as is
routinely used in medical application, crucial medical
information regarding the changing metastatic and
mutational status of the patient’s disease.
It is widely agreed that a non-invasive liquid biopsy
that could harvest CTCs for analysis on a repeat
basis would have a profound impact in understanding
the patient’s current cancer status and evolution and
ensuring the optimum treatment is deployed for that
individual patient at that particular time.
18
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Economics of cancer patient treatment
Treatment of cancer patients can be very expensive.
For example a single chemotherapy drug prescribed
may cost in excess of £50,000 for a course. Newer
immunotherapy drugs may cost up to £150,000
per annum. Such drugs are prescribed because they
are thought to be the best option available to treat
patients, whilst in reality they will be beneficial to
only a proportion, typically 20-30%, of patients.
In this situation, 70-80% of the drug cost may be
wasted on patients who have no medical benefit
from the treatment. Worse still these drugs are toxic
and, regardless of whether they receive any benefit
from the drug, patients will often experience severe
side effects.
Furthermore, it is often the case that without specific
information on the individual patient’s cancer a
cocktail of drugs is prescribed where the doctors
know that several will be ineffective for that patient
but they do not know which ones.
ANGLE’s aim is to demonstrate the Parsortix
system’s capability to harvest CTCs for an analysis
that will enable a determination of which patients
will benefit from which drug.
This will not only improve patient treatment and
reduce unnecessary side effects but dramatically
reduce overall patient treatment costs allowing
more efficient and effective deployment of medical
resources. This approach will support the efforts
of the National Institute for Health and Clinical
Excellence (NICE) in the UK, and similar organisations
elsewhere in the world, to ensure effective use of
medical resources.
Market size
ANGLE’s ultimate objective is the widespread
adoption of the Parsortix system in the diagnosis,
treatment and monitoring of cancer patients.
According to the World Health Organization, there
were an estimated 18.1 million new cancer cases
worldwide in 2018, a marked rise on the 14.1 million
cases in 2012. In 2018, there were an estimated
9.6 million deaths from cancer (2012: 8.2 million).
In 2018, there were an estimated 43.8 million people
living with and after cancer (2012: 32.5 million).
(Source: International Agency for Research on
Cancer – Globocan 2018).
The incidence of cancer continues to grow as a result
of demographic, lifestyle and environmental factors
and it is estimated that one in two people in the UK
will get cancer during their lifetime (Source: CRUK).
There is a wide range of potential applications for
harvested CTCs including diagnosis, prognosis,
mutational analysis and drug selection, drug
development, assessment of treatment effectiveness,
and remission monitoring. Frost & Sullivan have
estimated that the liquid biopsy market will be worth
in excess of $100 billion per annum in the United
States alone.
Commercialisation
ANGLE has a clear strategy to commercialise its
Parsortix technology.
Competitive differentiation
Major competitive differentiators of the system
successfully demonstrated include:
The cell capture and harvesting technology has been
developed together with an automated instrument
to run blood samples through the cell separation
cassette and extensive intellectual property
protection of the system is being prosecuted.
A great deal of work has been completed with
the aim of ensuring the system is robust, operates
reproducibly and can run patient samples efficiently.
Following this the product was released for
commercial launch with first sales registered in
December 2015. Optimisation of the system is
a continuous improvement process along with
developing Standard Operating Procedures (SOP) for
new applications and new product development to
meet customer needs to ensure it operates effectively
with existing medtech platforms for cell analysis.
The system is well established with an installed base
of c.200 instruments in active use.
Successful evaluation of the system by major cancer
research centres as key opinion leaders (KOLs)
for the market was achieved and has led to good
adoption amongst leading translational researchers.
ANGLE continues to work with a select number of
KOLs to develop 1) new uses of the system 2) new
clinical applications 3) proof that the system works
with different types of cancer. Customers have also
delivered ground breaking research and identified
new uses. This raises awareness of the Parsortix
system through peer-reviewed publications and other
published evidence as well as the cancer centres
presenting at conferences.
Regulatory authorisation for the clinical use of the
system in patient treatment in the European Union
has already been achieved and the process is ongoing
with the FDA for the USA.
Widespread adoption of the Parsortix system in the
clinical market crucially depends on ongoing work
with KOLs and customers to:
• Undertake successful pilot studies demonstrating
patient applications with clear medical utility
(patient benefit)
• Select key medical applications with clear
medical utility
• Undertake successful patient studies providing
fully documented evidence of how the system
should be used for particular patient applications
in routine treatment
• Convert cancer centre support and peer-reviewed
publications into widespread adoption of the
Parsortix system in routine patient care
Major areas of work currently in progress are
described below.
• Epitope independence with no
requirement for the use of an antibody
to capture cells. The Parsortix system has key
advantages over antibody-based systems that
rely on the expression of a cell surface protein
(such as EpCAM) including:
– the system is able to capture CTCs that
have undergone the epithelial mesenchymal
transition during the process of metastasis
(and are no longer EpCAM positive)
– the system is able to capture CTCs in cancer
types, such as ovarian cancer, which only have
weak or no EpCAM expression
– the system is versatile and may be used for
other cell types such as fetal cells
– the harvest is clean and does not contain
immuno-magnetic beads or other additives
needed for the antibody-based cell capture
systems, which may compromise analysis
of the cells
• Easy harvest of cells from the system for
molecular analysis, unlike many other systems
where cells may be captured but can get stuck
in the separation system so that they cannot
be harvested for analysis
• Low level of background white blood
cell contamination thereby allowing either
single cell analysis or direct analysis of the
harvested cells containing both the CTCs and
a low number of white blood cells. Competing
systems may have far more background white
blood cell contamination thereby making analysis
of target cells more difficult
• Simplicity and cost effectiveness so
that both the one-time use consumable,
the Parsortix cassette, and the automated
instrument that runs the blood through the
cassette are simple, easy to use, straightforward
in training and cost competitive
• The Parsortix system is easily deployed
at customer sites in stark contrast to many
competing systems which, as a result of their
size and complexity, the need for expert
operators and difficulty in securing regulatory
authorisation, may be forced to rely solely on
a CLIA (certified laboratory) approach where
the customer has to send the patient sample
for analysis at a remote laboratory and cannot
process it near the patient.
19
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Summary
ANGLE has a well-differentiated patent-protected
product addressing a large developing medical
market with a clear strategy to secure a substantial
market share.
Effective execution of the strategy has the potential
to deliver significant financial returns for ANGLE’s
shareholders, profoundly improve the outcome for
cancer patients, and reduce healthcare costs.
On behalf of the Board
Andrew D W Newland
Chief Executive
24 June 2020
Business Strategy
continued
Optimising the system and ongoing
improvements
ANGLE continues to undertake work on the
Parsortix system with the aim of ensuring that it is
robust, operates reproducibly and can run patient
samples efficiently.
Secure regulatory authorisation
In order to be able to sell the Parsortix system for
use in treating patients in the clinical market, it is
necessary to secure regulatory authorisation for
the clinical use of the system in patient treatment
in each geographic region.
ANGLE has successfully completed extensive work
in key areas of functionality including:
• developing, testing and then automating the
harvesting protocols to allow harvesting of cells
from the Parsortix system for molecular analysis
• developing and refining protocols to reduce
the level of background white blood cell
contamination of the harvested cells. This
enables the analysis of the harvested cells
directly without the need for a separate single
cell separation step, although this may still be
useful in some applications
The main areas of work that are currently taking
place include:
• developing interface protocols for the existing
molecular analysis platforms deployed by some
of the world’s largest medtech companies
• investigating how best the Parsortix system
can be used by major pharma companies for
cancer drug development and as a “companion
diagnostic” to determine the suitability and
effectiveness of drugs for individual patients
• development of an in-house proprietary
molecular analysis system HyCEAD Ziplex,
which allows multiplex gene expression for
more than 100 genes simultaneously on a
highly cost-effective basis
ANGLE has secured CE Mark authorisation for the
use of Parsortix as an in vitro diagnostic device in
the European Union in the treatment of patients.
ANGLE is working towards FDA Class II clearance
for clinical use of the Parsortix system in the United
States. The timing of FDA regulatory clearance is
dependent on the FDA’s review and responses to
our submission.
There are no FDA cleared systems for harvesting
CTCs for analysis and only one system authorised
for the capture and counting of CTCs, which is
antibody-based. Securing FDA authorisation will
be a key competitive differentiation of the
Parsortix system.
Patient studies by key opinion leaders
to identify potential clinical applications
A critical element in progressing commercialisation
of the Parsortix system is ensuring KOLs undertake
successful patient studies to demonstrate patient
applications with clear medical utility. This involves
working closely with KOLs to encourage and support,
with both human and financial resources, their
investigative work using the Parsortix system.
The first such KOL to report was the Medical
University of Vienna, whose study in ovarian cancer
demonstrated the potential to use the system to
detect ovarian cancer in women having operations
to surgically remove abnormal pelvic mass growths.
This is now being developed as the Company’s first
clinical application with the objective of a simple
blood test to determine which patients are likely to
have ovarian cancer (approximately 10%) and which
are likely to have benign growths. This application
will save healthcare costs and improve patient
outcomes by focusing resources appropriate to the
patient condition. The clinical study programmes have
been developed and are recruiting patients. This is
described in more detail in the Chairman’s Statement
on pages 14 to 17.
The FDA clearance studies in metastatic breast
cancer utilise cytological examination, RT-PCR, FISH
and RNA-seq methods for analysing cancer cells.
20
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 There are no FDA cleared systems
for harvesting CTCs for analysis and
only one system authorised for the
capture and counting of CTCs, which
is antibody-based. Securing FDA
clearance will be a key competitive
differentiation of the Parsortix system.
Andrew D W Newland
Chief Executive
21
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Key Performance Indicators
Strong progress against key milestones
The Group measures its performance according to a range
of key performance indicators (KPIs). The main KPIs and details
of performance against them are as follows:
KPI
Performance
Cash position
The cash position at 31 December 2019 was £18.8 million (30 April 2019: £11.0 million). The Group carefully plans
expenditure with rolling cash flow forecasts and tight financial control. Since the period end, the COVID-19 virus
pandemic has impacted the business and following a detailed review, certain expenditures have been reduced and/or
deferred in order to extend the cash runway. The Group has a high level of discretionary expenditure given the nature
of its activities.
The Group utilises a collaborative cost sharing leveraged R&D model approach with key opinion leaders (KOLs) and
an outsourced approach with third-party suppliers, avoiding long-term commitments as far as possible. Manufacturing
of instruments and cassettes is outsourced and product can be ordered on relatively short lead times.
Intellectual
property
Intellectual property strengthened with new patent filings, and the acquisition of the HyCEAD Ziplex intellectual
property, increasing the breadth and duration of patent coverage and the range of medical applications covered.
Patent applications are being progressed worldwide.
24 patents protecting the Parsortix system granted at the reporting date (30 April 2019: 23) in the United States,
Europe, Australia, Canada, China, Japan, India and Mexico, extending patent coverage out to 2034.
Ovarian cancer
clinical application:
triaging abnormal
pelvic mass
There have been two successful 200 patient studies for the detection of ovarian cancer in patients having surgery
for abnormal pelvic masses and the optimisation of the ovarian assay combining Parsortix and HyCEAD Ziplex has
been completed.
The optimised assay is now being tested in a new 200 patient study being run by the University of Rochester Medical
Center Wilmot Cancer Institute (URMC). Since the period end, COVID-19 has resulted in URMC temporarily ceasing
enrolment which has since been restarted.
Product
development
The Parsortix cell capture and harvesting technology has been developed and comprises an automated instrument
to run blood samples through the separation cassette.
Extensive product development and system optimisation has been successfully completed to address the operational
requirements of a wide range of KOLs and customers. Product development work has been completed to develop,
test, optimise, characterise and document key operating protocols enabling customers to undertake analysis in a
specific area of interest.
The Parsortix system has been demonstrated to be reliable, easy to use and produces robust reproducible results.
There were c.200 Parsortix instruments in active use (in-house, KOLs and customers) at the reporting date
(30 April 2019: c.200). Over 93,000 blood separations have been performed on the system at the reporting date
(30 April 2019: 73,000). This experimental data provides a broad body of evidence that demonstrates the system’s
potential to be applicable to a wide range of cancer types and forms of analysis. To date Parsortix has been used
successfully with 23 different types of cancer.
Upgrades, enhancements and optimisation of the Parsortix and HyCEAD Ziplex systems are ongoing to further
enhance operational performance and product reliability and to develop additional utility and operating protocols
based on customer and KOL feedback.
22
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 KPI
Performance
Published evidence
Successful evaluations and studies with multiple third-party cancer centres has led to a growing body of published evidence:
• 26 as at 31 December 2019 (30 April 2019: 20) publications in peer-reviewed journals
Regulatory
authorisation
Research use sales
Regulatory authorisation is a requirement before the Parsortix system can be sold for use in the clinical market
(for the treatment of patients).
ANGLE has already successfully secured CE Mark authorisation for indicated clinical use of the Parsortix system as an
in vitro diagnostic device in the European Union.
ANGLE is pursuing FDA clearance for the system for harvesting cancer cells from patient blood for analysis in the first
instance for metastatic breast cancer. Clinical studies have been completed and reported positively. Since the period end,
COVID-19 has resulted in analytical studies, which are nearly complete, being halted due to COVID-19 related restrictions
in the UK causing the loss of availability of healthy volunteer blood donors and the temporary closure of the ANGLE
Guildford laboratory. Blood donations have recently been restarted and the remaining analytical studies and documentation
are in progress so that the FDA submission can be made.
Four leading US cancer centres conducted the clinical studies:
• University of Texas MD Anderson Cancer Center
• University of Rochester Medical Center Wilmot Cancer Institute
• University of Southern California Norris Comprehensive Cancer Center
• Robert H Lurie Comprehensive Cancer Center Northwestern University
ANGLE Europe maintains its Quality Control system to ISO 13485:2016 and has a BSI certificate of registration
certifying our compliance with this standard and is subject to and continues to receive annual compliance audits by BSI.
Work is ongoing to prepare for 21CFR820 compliance in support of FDA clearance. Work also continues in ANGLE’s
Toronto facility in preparation for securing ISO 13485:2016 certification (by BSI) for ANGLE Biosciences Inc. under the
Health Canada regulations.
Sales have been made to multiple customers in Europe, North America and elsewhere including existing KOLs, new
research users, big pharma and immunotherapy companies comprising new instrument sales and repeat orders for
cassettes and warranties. The product was launched in late summer 2015 after uniformly positive results published
by five KOLs with first sales in December 2015. Sales for the eight month period were £0.6 million (year ended
30 April 2019: £0.7 million). Since the period end, sales have temporarily reduced due to the impact of COVID-19
with customer sites being closed.
23
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Principal Risks and Uncertainties
Managing risks
The nature of medical diagnostics development and
the early stage and scale of our operations means
there are a number of risks and uncertainties.
The Directors maintain a risk register and have summarised the principal
risks and uncertainties that could have a material impact on the Group.
These are set out in the table below, along with mitigation strategies.
Risk
Description
Mitigation
The Group is developing a clinical application in
the triaging of abnormal pelvic masses. This is
dependent on both successful harvesting of CTCs
by the Parsortix system and identifying a set of
RNA markers that can be detected by HyCEAD
Ziplex to discriminate between malignant ovarian
cancer and other benign conditions.
Clinical studies may be delayed due to slow
or insufficient patient enrolment or may be
temporarily ceased due to factors outside of
our control, such as the COVID-19 pandemic.
There can be no guarantee that the clinical
application will be developed into a commercially
viable product.
Regulatory approval may be delayed or may
not be obtained depending on the results of
the studies.
Data produced may not be sufficient to support
rollout of the application via a clinical service
laboratory (CLIA Laboratory).
Appropriate third-party payer reimbursement
codes may be delayed or may not be obtained
thereby limiting commercial uptake of the
application.
Vested and competing interests may impede
market acceptance for either a laboratory
developed test or a regulated device.
There are numerous competitive groups
seeking to develop alternative cancer
diagnostic products in direct competition
(other CTC technologies) and indirect
competition (other methods, for example,
ctDNA analysis). It is possible at any time that
a competing technology which out-performs
Parsortix may enter the market. Some
competitors have greater resources which
may allow them to deploy commercial tactics
which restrict the Group.
Clinical
application in
ovarian cancer
Competitive
position
24
The Group employs an experienced clinical studies director, who has
developed detailed clinical study programmes (including prior experience in
CTCs and ovarian cancer) which have had thorough internal and third-party
reviews, including by the study lead and other experts.
A significant amount of preparation, including additional R&D on the proposed
RNA markers and study processes, has been undertaken to minimise the
risks. The Group carefully selected this clinical application based on a set of key
criteria including strong pilot study data, access to leading KOLs and access
to patients.
The Group assembles multiple study sites and partners where possible to
achieve patient accrual rates in a timely fashion.
The Group has undertaken independent market research to understand end
user needs and ensure the studies produce the necessary data.
The Group is taking independent advice on reimbursement codes and
commercialisation strategy.
The Group manages its product development, IP position, accelerates
product launch and monitors customer needs and competitors internally,
with its Scientific Advisory Board (SAB), through its relationships with
key opinion leaders (KOLs), customers and prospective customers,
and through attendance at conferences.
The Directors believe that the patented Parsortix technology has the potential
to be more simple, effective and affordable than competing technologies.
The Group has developed a low-cost affordable solution, which puts it in a
strong position for pricing, and it is antibody independent allowing for a range
of cancers to be analysed that other CTC systems may not be able to handle.
CTCs are the closest solution to a tissue biopsy allowing all types of analysis
to be undertaken and is differentiated from ctDNA analysis.
The Group strengthened its competitive position through the acquisition
of the HyCEAD Ziplex technology as used in the ovarian cancer studies.
This further differentiates the Group and enhances the ability of the Group
to offer sample-to-answer solutions.
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Risk
Financial
Description
Mitigation
The Board undertakes careful planning, management of expenditure and
rolling cash flow forecasting, has a strong focus on milestone and performance
delivery and avoids long-term supplier contracts where it can.
The research use market offers the potential for earlier revenues and sales have
been initiated in this area.
The Group is pursuing development of a laboratory service-based offer for
research use sales to the Pharmaceutical sector providing CTC capture and
analysis services that would support the use of CTC derived information in
drug development studies, pre-clinical and clinical drug trials.
The Group is working with KOLs, SAB members and specialist consultants
to identify suitable clinical applications which offer significant revenue potential
either as a lab developed test or FDA cleared product. Clinical applications
need to meet key criteria and the Group is progressing its clinical application
in ovarian cancer.
The Board maintains close shareholder relations, high standards of corporate
governance and explores different sources of funding including potential
partners. The Group has successfully raised funds on several occasions in
the past.
The Group monitors its currency exposures on an ongoing basis. The Group
is building US and European sales to provide a natural hedge.
The Group holds a modest finished goods inventory, held in multiple locations
to help mitigate any COVID-19 and Brexit related supply chain problems.
The Group is investing significantly in R&D,
clinical studies, FDA/regulatory studies, product
development and product marketing for
research use sales and consequently is loss
making and utilising cash reserves to support
operational activities. The commencement
of material revenues is difficult to predict as
1) the Group is launching a new product
in an emerging market and suitable clinical
applications need to be identified, have successful
clinical studies completed, achieve regulatory
approvals and achieve market acceptance, and
2) the Group needs FDA clearance to boost
research use sales and in particular to pharma
in drug trials. Operating losses are anticipated
to continue for some time.
In the event that new funds are required there
can be no guarantee that these will be available
on acceptable terms, at the quantum required,
or at all, which could affect the ability to
commercialise the technology and may require
operations to be scaled back, delayed or even
affect the ability to continue as a going concern.
The Group incurs significant costs in US and
Canadian Dollars and is exposed to US and
Canadian Dollar exchange rates which it is
unable to control. The Group also has critical
European suppliers and incurs costs in Euros and
is exposed to Euro exchange rates which it is
unable to control.
Brexit in December 2020, or at such later
date to be agreed and the potential impact of
COVID-19, may have an effect on the Group
operations. Exchange rates may be adversely
affected. With the UK status as a “Third
Country”, the movement of goods between
ANGLE and European customers and within
ANGLE’s European supply chain may be
adversely affected.
Intellectual
property
The Group's success depends in part on its
intellectual property (IP) in order that it can
stop others from exploiting its inventions. There
is a risk that patent pending applications will not
be issued. It is possible that competitors may
infringe this IP or otherwise challenge its validity,
which may result in uncertainty, litigation costs
and/or loss of earnings.
The Group invests significantly in its IP, employs experienced patent agents and
protects its IP with confidentiality agreements, patents and patent applications
in order to reduce the risks over their validity and enforceability. The Group has
also undertaken freedom-to-operate searches.
The Group had 24 granted patents protecting the Parsortix system at the
reporting date in the USA, Europe, Australia, Canada, China, India, Japan and
Mexico, with others in progress, extending patent coverage out to 2034.
25
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Principal Risks and Uncertainties
continued
Risk
Description
Mitigation
Manufacturing
Market
acceptance
As precision equipment, it is extremely
important that manufacturing is of a consistent
and extremely high quality to ensure that
instruments and cassettes operate as specified
and produce consistent results and meet the
necessary manufacturing tolerances specified.
Product lead times need to be appropriate
for timely delivery whilst maintaining product
quality. The Group is dependent on three key
single source suppliers. Problems at outsourced
manufacturers and their suppliers could lead
to disruption in supplies, delays, product
inconsistency and product failure.
We anticipate the COVID-19 pandemic
may impact our supply chains. These events
may result in increased lead times, product
costs, duties and taxes and may require a
reconfiguration of supply chains with associated
knock-on time and cost impacts.
Success depends on both clinical and health
economic acceptance of the Group's products.
Studies are required to demonstrate the
utility of clinical applications and there is a risk
that the data may be weak, inconclusive or
negative. The medical diagnostics market is
conservative by nature, CTCs are an emerging
technology, customers may be slow to adopt
new products, vested interests may impede
market penetration and products may not
achieve commercial success. The Group may
not be able to sell its products profitably if
reimbursement by third-party payers is limited
or unavailable. The Group may be subject to
price limits on reimbursement of products
which are outside its control, negatively
impacting revenues.
The Group has outsourced manufacturing to specialist organisations that can
manufacture the cassettes at the required tolerances, can assemble instruments
and have capacity for scale-up of production. Investment has been made in
specialist moulding tools and validated processes to help achieve the highest
standards. Key suppliers are ISO 13485:2016 certified and subject to ongoing
audit by the Group. Where possible, designs use standard components and any
components on long lead times are held in inventory. Designs are subject to
continuous improvement to help eliminate issues as they arise.
To manage the risk of loss or disruption of supply (e.g. from COVID-19 and
Brexit), safety inventory levels have been established, (held at multiple locations)
of critical components and also finished product, thereby enabling the Group
to continue to supply for a finite period whilst manufacturing capability and/or
supply lines are restored. Dual sourcing of product from key suppliers is actively
being pursued but it is unlikely that this will be fully achievable in the short-term.
Product manufacture is subject to good manufacturing practice and regulatory
control and oversight. The Group also has product liability insurance.
Although relatively modest, the research use sales market to leading translational
researchers is a good market in its own right and will help generate additional data
on utility, new uses and clinical applications as well as generating peer-reviewed
publications.
The Group undertakes in-house R&D and works with partners and KOLs to
act as reference customers, to obtain data relating to clinical applications and the
efficacy, safety and quality of the product. It monitors industry developments and
customer needs through its interaction with customers and prospects, attendance
at conferences and through the Group SAB and KOLs.
The Group is pursuing a laboratory service-based offer for research use sales
to the Pharmaceutical sector providing CTC capture and analysis services that
would support the use of CTC derived information in drug development studies,
pre-clinical and clinical drug trials. This will aim to promote the wider use of the
Parsortix system and associated technology in the development of drugs and
treatment protocols, which may ultimately lead to the establishment of Parsortix
as a companion diagnostic for particular therapies in the oncology space.
Clinical studies are set up to generate clinical data and analysis for accurate and
complete submissions to secure regulatory approval. Health economic studies,
advocacy and other activities will be undertaken at the appropriate time.
The Group is working with KOLs, SAB members including specialist consultants to
identify suitable clinical applications which offer significant revenue potential either
as a lab developed test or FDA cleared product. Clinical applications need to meet
key criteria and the Group is progressing its clinical application in ovarian cancer.
26
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Risk
Description
Mitigation
Operational
In order for the Group to operate effectively
the infrastructure needs to be robust, efficient
and scalable.
Unexpected events (such as COVID-19) could
disrupt the business by affecting a key facility
or critical equipment or donor or patient
enrolment, which could lead to an inability to
undertake development work (e.g. analytical
studies for FDA clearance or clinical studies
with partners).
Cyber-crime is increasing in sophistication,
consequences and incidence, with risks including
virus and malware infection, unauthorised access
and fraud.
Pandemic/
epidemic
Exposure to a pandemic, such as COVID-19,
or an epidemic that directly or indirectly leads
to disruption of the Group’s operations in
particular to laboratory-based operations and
delays to clinical studies.
The Group has a disaster recovery and business continuity plan to ensure
a rapid response in an effective and managed way to a variety of situations.
This plan has been deployed in the current COVID-19 pandemic due to its
impact across the entire operations of the business and has allowed a rapid
and effective response, ensuring a practical level of continuity of Group
operations, despite ongoing restrictions across the world.
Business critical systems are cloud-based facilitating remote working and back
up mechanisms are also regularly tested.
Staff have laptops and ongoing IT training. Staff can work remotely if required,
although laboratory and engineering staff are limited in the amount of work
they can undertake remotely.
Critical equipment has service and maintenance contracts.
The Group uses expert IT firms to ensure it operates with appropriate cyber
defences. There is daily offsite back-up for rapid recovery from a problem.
The back-up is regularly tested.
The Group has a disaster recovery and business continuity plan that enables
the rapid establishment and deployment of a Leadership Team (LT) to assess
and manage disruptions to operations and task sub-teams with specific actions.
It is the LT’s responsibility to ensure the Group complies with all laws and
guidance issued by Governments at any time. This may result in the Group’s
offices and/or laboratories being temporarily closed or operated on a
restricted basis.
It is the LT’s responsibility to ensure management practices keep staff safe
and healthy and produce updated or new procedures as required. Staff are
transitioned where appropriate to working from home and with unnecessary
travel avoided. Staff unable to work from home are transitioned where
appropriate to split-shift working to assist social distancing and with the use
of PPE, hygiene and enhanced procedures as appropriate to manage the
work environment.
The LT will review the impact of Government Laws and Guidelines and how
they impact clinical and analytical studies. While the Group may be able to
mitigate certain aspects of any Government Laws and Guidelines by enhancing
or introducing new procedures, in certain situations studies may need to be
temporarily paused in order to meet such Government Laws and Guidelines
and can only be restarted once the Government Laws and Guidelines are
updated and relaxed. This may include restrictions on the collection of patient
samples needed for clinical studies and/or healthy volunteer blood samples
needed for analytical studies.
The LT will also review customer needs in the context of the pandemic.
Ways of working are being adapted to provide virtual support to customers.
The existing customer base is predominantly leading translational researchers
based at hospitals and universities and consequently Government Laws and
Guidelines may result in their operations temporarily being ceased, which
means evaluations and ongoing research work may also be paused and sales
reduced significantly until Government Laws and Guidelines are eased.
27
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Principal Risks and Uncertainties
continued
Risk
Description
Mitigation
The LT will review supply chain requirements. Close contact will be maintained
with key suppliers to ensure they are able to provide services and goods in
a relatively normal fashion, although noting they may have to modify their
ways of working. The Group already holds significant levels of certain critical
inventories to mitigate any potential supply chain problems and to date has not
experienced any significant supply chain issues. Other supplies may be ordered
to ensure the Group has a buffer stock and can continue operations.
The Group seeks to maintain a reasonable cash balance to mitigate against the
need to raise funding in potentially adverse market conditions. Discretionary
and/or non-mission critical expenditure can be deferred or reduced where
necessary to conserve cash until the environment is more certain. The Group
may utilise Government support schemes where appropriate.
CE Mark regulatory authorisation has been achieved in Europe for the indicated
clinical use. FDA regulatory clearance is in progress in the United States.
Authorisations will be sought in other territories in due course.
The Group conducts its operations within ISO 13485:2016 quality system and
continues to invest in its systems and people. The quality system is subject to
annual Notified Body audit (BSI). The Group uses external specialist resources
(regulatory, design, manufacturing etc) as required.
The Group employs an experienced clinical studies director to design and
develop clinical study programmes that will meet international regulatory
requirements as appropriate.
The Group is currently responding to significant changes in the European
regulatory environment driven by the release of the ISO 13485:2016 standard
to which we have already transitioned and the new In Vitro Diagnostic Device
Regulation (IVDR), which will replace the current IVD Directive in 2022.
The Group is confident that compliance with the new IVD requirements
can be successfully achieved.
The current CE Mark regime for IVD devices is based upon a European
Regulation which has been implemented in the UK. How this regulation will
evolve after Brexit and what the impact on the Group will be is not clear at this
time owing to the uncertainty of the Brexit process. The Group’s UK based
Notified Body BSI has put in place contingency measures such that European
IVDR compliance certificates and Quality System certificates can continue to
be issued from within Europe and hence CE Mark applied. The UK government
has also introduced outline UKCA marking guidance in the event of a no-deal
Brexit scenario.
The Group operates in a highly regulated
industry and needs to meet recognised quality
assurance standards that are subject to third-
party audit.
The Group must comply with a broad range
of regulations relating to the development,
approval, manufacturing and marketing of its
products and is subject to regulatory inspection.
There is a risk that a regulatory audit will find
problems that could have severe consequences
on the Group’s ability to sell products in the
relevant country, lead to a loss of marketing
authorisation, a loss of reputation, a loss of
customers, recall or remediation costs as well
as enforcement action and sanctions from
a regulator.
Major success with the cancer diagnostic
product (and other products) will require
regulatory authorisation for clinical use from
various regulatory authorities which will require
data from studies relating to the efficacy, safety
and effectiveness of the product. Regulatory
regimes are complex and dynamic and it can be
difficult to predict their exact requirements, so
authorisations may be delayed and alterations
to the regulations may also result in delays.
If it proves difficult to achieve authorisations,
major revenues may be delayed or without
authorisation may not be achievable.
Pandemic/
epidemic
continued
Regulation
and quality
assurance
28
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Risk
Description
Mitigation
Research and
development
The Group undertakes significant research
and development activity with the aim of
launching improved and new products and
services, but there remain considerable technical
risks, which may result in delays, increased costs
or ultimately failure.
The Group uses skilled staff and third-party experts in various fields from
science and product design to engineering and manufacturing. There is good
knowledge and experience within the Group and third-party experts in
place with established relationships. The nature of medical devices means
that although development can be challenging, there should generally be
a technical solution, provided sufficient resources and expertise are applied
to the problem. As developments and enhancements are generally to
existing products there is somewhat less risk than developing a completely
new product.
Staff, key
suppliers and
key partners
The Group's future success is dependent on
its management team and staff and there is
the risk of loss of key personnel. With complex
and critical development projects, alignment
of business and project objectives, good project
planning and clear staff focus are required.
The Group manages staff requirements closely, invests in skills development
and new staff and has staff incentive schemes for retention and motivation.
Using our competency framework, staff are assessed regularly to ensure
they develop and maintain the skills needed for high performance. Individual
competencies and skills are aligned with business objectives and requirements
and personal development goals.
The Group also outsources certain aspects
of product development, regulatory advice
and manufacturing and is heavily dependent
on these key suppliers.
The Group is also heavily dependent on its
clinical study partners who are responsible
for patient enrolment and on occasion core
laboratory work.
Suppliers, clinical study partners and KOLs are carefully chosen and
actively managed.
Written agreements are in place for all key suppliers in line with Quality
System requirements and compliance assured through regular auditing.
Work with collaborators is controlled using contracts and clinical study
protocols where appropriate. Clinical study protocols are generally subject
to institutional scientific and ethics approval prior to study commencement.
29
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Financial Review
The Group has a strong cash position
An over-subscribed placing during
the period increased cash resources
substantially and has allowed the
Group to progress its key studies.
Ian F Griffiths
Finance Director
Financial Highlights
£0.6 million at 76%
Research use revenues for the eight
month period of £0.6 million (year ended
30 April 2019: £0.7 million) at a gross profit
margin of 76% (2019: 77%)
£8.2 million
Planned expenditure on Parsortix system
of £8.2 million (year ended 30 April 2019:
£11.6 million)
£6.2 million
Loss from continuing operations of £6.2 million
(year ended 30 April 2019: loss £8.9 million)
£18.0 million
Fundraise of £18.0 million (£16.9 million
net of expenses) in July 2019
£18.8 million
Cash balance at 31 December 2019
£18.8 million (30 April 2019: £11.0 million)
Grant income for the eight month period of
£0.1 million (year ended 30 April 2019: £0.2 million)
was recognised in the period. This primarily relates to
a collaboration with Philips on a €6.3 million Horizon
2020 EU grant of which ANGLE will receive £0.4m
over four years.
Planned investment in studies to develop and validate
the clinical application and commercial use of the
Parsortix system resulted in operating costs for the
eight month period of £8.2 million (year ended
30 April 2019: £11.6 million). Expenditure was also
made on Intangible assets (including patents) and
Property, plant and equipment and this is discussed
in the Consolidated Statement of Financial Position
section below.
This planned expenditure includes investment of
£6.0 million (year ended 30 April 2019: £8.0 million)
in research and development, in particular the FDA
analytical and clinical studies, the ovarian cancer clinical
application, where significant work was undertaken
on the optimisation of the test, in-house work and
ongoing work with KOLs on pilot studies and other
potential uses of the system as well as new product
development, patent prosecution and new patent
grants. Fundamental aspects of the FDA analytical
and clinical studies were successfully completed in
the period with the clinical studies completing
enrolment from four leading US cancer centres
and announcement that the primary and secondary
objectives had been met. Expenditure includes
sales and marketing costs associated with product
promotion and attendance at conferences for
marketing purposes. Corporate costs including
costs associated with being a listed company
were in line with plans.
The Group has continued to make
substantial investment in the FDA
analytical and clinical studies, the
ovarian cancer pelvic mass triage
clinical application studies, new
product development and sales
and marketing for research use
sales to advance and drive the
development and adoption of the
Parsortix cell separation system.
Change in accounting reference date
and comparative numbers
In January 2020, the Group changed its accounting
reference date from 30 April to 31 December. As
a consequence, there is an eight month reporting
period from 1 May 2019 to 31 December 2019.
Consolidated Statement of
Comprehensive Income
Revenues for the eight month period were £0.6
million (year ended 30 April 2019: £0.7 million) with
a gross profit margin of 76% (year ended 30 April
2019: 77%). Research use sales have been made to
multiple customers of both Parsortix instruments
(including an annually renewable service-based
warranty) and cassettes (a one-time use consumable).
As the installed base of instruments builds we
are seeing recurring revenues from cassette sales
and service-based warranty renewals increase.
The sales pipeline is developing in the research
use market and our sales team continues to focus
on supporting customers as they evaluate Parsortix
in their laboratory procedures. However, evaluations
have taken longer to close than expected, generally
because of limitations in downstream analytical
techniques outside the Parsortix system, and
the grant funding environment for our research
customers remains very challenging.
30
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 The adoption of IFRS 16 Leases resulted in the
capitalisation of right-of-use assets represented by
our leased office and laboratory premises and has
increased the depreciation charge and reduced the
leasing cost by £0.2 million, both presented within
operating costs, and increased finance costs by
£0.1 million.
The Group made a loss before tax for the eight
month period of £7.7 million (year ended 30 April
2019: loss £10.9 million). The significant research
and development expenditure resulted in research
and development tax credits of £1.5 million for the
eight month period (year ended 30 April 2019:
£1.9 million). The Group made a loss after tax of
£6.2 million for the eight month period (year ended
30 April 2019: £8.9 million) resulting in a basic and
diluted loss per share attributable to owners of the
parent of 3.82 pence for the eight month period
(year ended 30 April 2019: 6.56 pence).
Consolidated Statement of
Financial Position
Intangible assets increased to £7.7 million (30 April
2019: £6.8 million). Parsortix intellectual property and
product development expenditure of £1.1 million
(30 April 2019: £1.7 million) was capitalised during
the period in accordance with IAS 38 Intangible
Assets, increasing the value of the intangible assets.
Amortisation and impairment costs of £0.2 million
(30 April 2019: £0.5 million) reduced the carrying
value of the intangible assets.
Property, plant and equipment increased to
£1.5 million (30 April 2019: £1.3 million) with the
expansion of premises and the addition of some key
items of laboratory equipment. The prior year saw
an increase in the bank of Parsortix instruments used
for testing and clinical and regulatory study sites.
The adoption of IFRS 16 Leases resulted in the
capitalisation of right-of-use assets represented by our
leased office and laboratory premises of £1.5 million
(net). A corresponding lease liability has been created.
The present value of the future lease payments at
31 December 2019 is £1.6 million.
Inventories of £0.8 million (30 April 2019: £1.0 million)
reflect the inventory required for studies (in-house,
KOLs and clinical study sites), in building inventory
levels for research use sales prospects where systems
are placed out for an initial evaluation period prior
to sale and as a Brexit risk mitigation strategy. As
the Group relies on a number of single-source key
suppliers then higher levels are maintained than
would otherwise be the case.
The Trade and other receivables balance is lower
than the prior period at £0.6 million (30 April 2019:
£0.9 million), a reflection of the impact of the change
in reporting date on the timing of payments including
the VAT and HST returns.
The tax receivable balance of £3.4 million (year
ended 30 April 2019: £1.9 million) reflects the fact
that research and development expenditure is eligible
for research and development tax credits. The tax
credit for the year to 30 April 2019 was received
in April 2020.
The Trade and other payables balance of £2.4 million
(30 April 2019: £3.7 million) includes £0.5 million
(30 April 2019: £0.9 million) in relation to the FDA
clinical studies. No bonus payments were awarded
for the reporting period or payable at 31 December
2019 due to the potential impact and associated
uncertainties of the COVID-19 pandemic and the
desire of the Company to conserve cash (30 April
2019: £0.9 million).
Cash
The Group ended the period with a cash balance
of £18.8 million (30 April 2019: £11.0 million).
The Company completed a fundraise of £16.9 million
net of expenses during the period. The Company was
pleased with the continued support from our major
institutional investors and existing and new investors.
Summary
The Group is carefully executing its strategy so that
business activities are in line with the available and
anticipated cash resources. Good progress has been
made against key milestones. The immediate priorities
are completing the studies to support FDA clearance
in metastatic breast cancer in the US, progressing
our optimised ovarian cancer application with clinical
studies to support the US and European launch
of our first clinical application in ovarian cancer,
building research use sales, undertaking key product
development activities and for the first time, the
establishment of a clinical laboratory as an accelerator
and demonstrator. Now that the COVID-19 lock
down has relaxed so that blood samples can again be
collected, ANGLE is progressing all of these milestones.
The Directors have a reasonable expectation that
the Group has adequate resources to continue in
business for the foreseeable future as detailed in
Note 1.4 to the Financial Statements.
Ian F Griffiths
Finance Director
24 June 2020
31
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Corporate Responsibility Report
Environmental, Social and Governance
Environment
Liquid
biopsy
Social
(community)
Governance
Liquid biopsy
Environment
Our Parsortix system captures circulating tumour
cells (CTCs), which are shed from a tumour and
cause cancer metastasis, and harvests them for
analysis. This is known as liquid biopsy and
is fundamentally about improving patient
outcomes and reducing healthcare costs.
The Group seeks to operate with high standards
of corporate responsibility in its business activities.
At ANGLE we endeavour to minimise our
impact on the environment, make a significant
positive social contribution and benefit our
wider community while operating high standards
of corporate governance.
As our business grows we are placing
increasing emphasis on Environmental, Social
and Governance (ESG) aspects and developing
and reporting on our policies and actions.
Government lock downs in response to
COVID-19 were enacted subsequent to the
period end impacting our operating procedures.
These resulted in positive environmental effects
(working from home more, less business travel
etc) but at the expense of wide ranging negative
social impacts (delayed or cancelled cancer
diagnosis and treatment), which liquid biopsy
could help mitigate. We will be reporting on
this next year.
The Group seeks to restrict business travel
to necessary business travel and promotes
the use of video conferencing. The Group
promotes home and flexible working where
feasible to reduce overall travel and travel during
rush hour. A number of our employees use
car-pooling and we also promote the use of the
cycle-to-work scheme.
Our Parsortix system uses a cassette that takes
advantage of the size and deformability of CTCs
with the instrument using pressure to harvest the
cells rather than a chemical approach with higher
level of antibody reagents and other chemicals that
many of our competitors use. Whilst our cassettes
are single use to meet medical requirements, we
aim to use as many materials as possible that can
be recycled.
Parsortix-based tests have the potential to
significantly reduce patient travel and the
consumption of healthcare resources. Blood can
be drawn locally by a phlebotomist and shipped
(with other goods) rather than an individual
having to drive to a clinic for a tissue biopsy
and all that may entail in terms of using hospital
resources – facilities, surgeon, anaesthetist, nurses,
etc. A negative liquid biopsy result, such as with
our Ovarian Cancer Pelvic Mass Triage test, may
allow local surgery with a simplified procedure
rather than having to travel to a major cancer
centre for surgery.
As a technology-based Group with most
staff in a small number of locations we believe
our environmental footprint is small.
Nevertheless we seek to minimise the Group’s
impact on the environment and to improve
our operational efficiency.
Our landlords also take their sustainability
responsibilities seriously, for example, information
can be found on our head office location at
www.surrey.ac.uk/sustainability/estates-and-
operations.
Our landlords offer waste management services
and seek to divert landfill and recycle as much as
possible. The Group undertakes some additional
recycling with specialist suppliers associated with
old electrical equipment, coffee pods etc and uses
specialist hazardous waste disposal experts for
laboratory waste.
All of our offices now use LED lights with
a programme of updates to tungsten and some
halogen lighting since 2016 and completing
this year. As well as providing a better working
environment for staff, the most recent update is
forecast to produce a 64% reduction in our
annual consumption of energy for lighting
purposes. We also use lighting sensors so that
lights are automatically turned off for areas not
in use. We have installed energy saving internet
enabled thermostats, and use programmed
heating controls seeking to optimise temperatures
dependent on whether people are present.
We aim to buy higher rated energy efficient
equipment for our labs. We use 100% renewable
energy at our two main sites with hydro-electricity
in Toronto. The Group uses plumbed water
coolers which reduces the consumption of single-
use plastic bottles, and plumbed boiling water taps
which are more energy efficient than kettles.
The Group also uses indoor plants to help clean
the air although benefits are more social in nature.
32
Strategic Report ANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Social (community)
Governance
Cancer has a major negative social impact - an
estimated one in two people born after 1960 in
the UK will be diagnosed with cancer during their
lifetime. Each patient’s cancer is different and highly
complex and their cancer changes over time.
Effective treatment requires personalised care.
The Guildford laboratory uses healthy volunteer
blood donors to enable it to test multiple aspects
of the Parsortix system and also to perform
analytical studies for its clinical applications. We
are very grateful for the blood donors who are
predominantly from the local vicinity.
The existing standard of care is a solid tissue biopsy
which is invasive, can have medical complications
and as described above uses a lot of healthcare
resources and is expensive. Further it is difficult
to repeat so missing the dynamic nature of cancer
response to treatment.
ANGLE believes its Parsortix liquid biopsy system
has the potential to significantly improve care
for cancer patients as it is non-invasive and
repeatable as well as reducing the costs and
resources involved in cancer healthcare.
The Directors are committed to ensuring high
standards of health and safety for employees
and visitors. The Group complies with all
applicable laws and regulations wherever it
operates and holds all of the licences necessary
to operate its business, including ethics approvals
for blood donors and patient enrolments.
The Group has a strong focus on complying
with relevant quality and other standards.
We also have anti-bribery, anti-corruption and
anti-money laundering policies and procedures.
The Group works with a number of charitable
research organisations, such as Cancer Research
UK, and has donated products and funded
medical research in pursuit of our mission.
We have also worked with each of the local
Universities near our facilities in Guildford,
Toronto and Philadelphia.
The Directors recognise the benefits of diversity
in the workforce. Appointments are based on
selecting the best candidates regardless of their
age, gender, sexuality, disability and marital status
etc for the role. We recognise that a diverse
workforce provides a range of perspectives that
can help innovation and business success, and in
particular refers the reader to QCA Principle 8.
The Group works with Universities to support
science and business programmes and regularly
employs students on work placements. A number
of staff are also enrolled on business related
training programmes.
The Board is committed to high standards
of corporate governance and adheres to the
Quoted Companies Alliance (QCA) Corporate
Governance Code for small and mid-size quoted
companies (the “QCA Code”).
Section 172 of the Companies Act is a new
reporting requirement, summarised in the
statement below. The Corporate Governance
Report on pages 41 to 48 sets out how the Board
has approached its duty under Section 172 in order
to meet these requirements, and in particular
refers the reader to QCA Principle 2 and
Principle 3. The Corporate Governance Report
can also be found on the Company’s website
www.angleplc.com.
Section 172 Statement
In accordance with Section 172 of the
Companies Act 2006, the Directors recognise the
importance of our wider stakeholders to
the sustainability of our business. The Directors
behave and carry out their activities to promote
the long-term success of the Group for
the benefit of the Company’s shareholders,
employees, partners, customers, suppliers and
other stakeholders such as regulatory authorities.
The Group engages with stakeholders to reflect
their insights and views when making decisions
on strategy, delivering operational effectiveness,
driving initiatives and delivering outcomes.
The culture and values promoted by the
Directors create a focus across the Group on
observing and maintaining high standards of
regulatory compliance, quality control and
business conduct whilst promoting the long-
term success of the Company. The impact of
the Group’s operations on the environment and
community and how these enhance social value
are described above.
The Strategic Report on pages 02 to 33 is approved
on behalf of the Board by:
Ian F Griffiths
Finance Director
24 June 2020
33
ANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019Strategic Report Board of Directors
Experienced team delivering performance
A
R
N
Garth R Selvey
Chairman
Appointed
September 2006
Andrew D W Newland
Chief Executive
Ian F Griffiths
Finance Director
Appointed
March 2004
Appointed
March 2004
Skills and experience
Garth Selvey has a BSc in Physics and Electronic
Engineering from the University of Manchester and
has spent over 36 years in the computer industry
with technical, product, sales and marketing roles.
He became Managing Director of TIS Applications
Ltd in 1984 and a main board Director of TIS
Ltd prior to its acquisition by Misys in 1989. He
organised the management buyout of the social
housing division of Misys and became Group Chief
Executive of Comino Group plc when it floated
on AIM in 1997. Comino moved to a full listing in
1999 where he remained until its successful public
sale to Civica plc in February 2006.
Garth joined ANGLE as a Non-executive Director
in September 2006 and became Chairman in
September 2007.
Brings to the Board
Extensive experience of the listed sector and
leading companies.
34
Skills and experience
Ian Griffiths is the Finance Director of ANGLE plc.
He has specialised in technology commercialisation
for over 30 years and is an expert on the development
and growth of new technology-based businesses.
Ian has a BSc in Mathematics with Management
Applications from Brunel University and is qualified
as a chartered accountant. For seven years he
worked for KPMG, initially in accountancy with a
special work focus, then in management consulting
within KPMG's High Technology Consulting Group
where he specialised in financial modelling, business
planning, corporate finance, market development
and strategy work.
Ian joined ANGLE in 1995. As well as leading the
finance function at ANGLE plc, he has been closely
involved with the development and delivery of the
former UK, US and Middle East Consulting and
Management services businesses and in developing
new Ventures, both third-party and ANGLE’s own.
Ian has been heavily involved in the start-up phase
and also the ongoing development of ANGLE’s own
ventures by working closely with management on
business plans, financial and operational management,
fundraising and commercial aspects, including both
medical and physical sciences companies. Ian led
the financial aspects of ANGLE plc listing on the
Alternative Investment Market. He is currently leading
the financial development of ANGLE’s major medical
diagnostic business Parsortix.
Brings to the Board
Over 30 years of experience in finance and
technology-based businesses, and over ten years
in the liquid biopsy space.
Skills and experience
Andrew Newland is Chief Executive of ANGLE
plc. He has an MA in Engineering Science from the
University of Cambridge and is a qualified Chartered
Accountant. He has 19 years of medical diagnostics
experience and has specialised in the liquid biopsy
space for the last ten years.
He has led the development of technology-based
businesses based on strong intellectual property
for over 29 years and for the last 19 years he
has been Chairman or on the Board of several
specialist medical technology companies. After
working with the engineering conglomerate TI
plc, he worked for KPMG from 1982 to 1994;
from 1985 to 1987 he was based in the US as a
manager providing corporate finance and business
advice to high technology firms in the area around
Route 128, Boston, Massachusetts. During this
time, he led KPMG’s involvement in the IPO of
the medical technology company Cardio Data Inc.
From 1987 to 1994 he worked for KPMG in the
UK with responsibility for establishing KPMG’s UK
and European High Technology Practices and High
Technology Consulting Group.
Andrew founded ANGLE in 1994. In 1999, Andrew
led the team that founded the medical diagnostic
company Acolyte Biomedica. Acolyte was the first
ever spin-out of the Defence Science and Technology
Laboratory (Dstl) Porton Down, which specialised
in rapid diagnosis of MRSA, the ‘hospital super-bug’.
Andrew chaired the company for several years and
successfully led the company through three major
rounds of venture capital investment. Andrew also
founded Provexis, the first ever spin-out of Rowett
Institute, Europe’s leading nutrition research institute.
Andrew chaired the Board of Provexis, a specialist
nutraceutical company with a heart-health product,
through to its successful flotation in 2005.
Brings to the Board
Over 29 years’ experience of setting up, leading and
building technology-based businesses, over 19 years
leading specialist medtech businesses, and over ten
years in the liquid biopsy space.
GovernanceANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 A
R
N
A
R
N
Committees key
Chair of Committee
Member of the Committee
Audit Committee
Remuneration Committee
Nomination Committee
A
R
N
Brian Howlett
Non-executive Director and
Senior Independent Director
Appointed
January 2013
Dr. Jan Groen
Non-executive Director
Appointed
November 2018
Skills and experience
Brian Howlett has a wealth of international
experience as a medtech leader which he is
currently applying in a Non-executive/Chairman
capacity for neuro-endovascular company Oxford
Endovascular Ltd, and medical device coating and
surface modification company Accentus Medical Ltd,
as well as ANGLE plc. Brian was formerly CEO of
Lombard Medical Technologies PLC, an AIM listed
company specialising in stents for abdominal aortic
aneurysms from 2005 to 2009. During his tenure
significant capital was raised to fund the development
of operations to commercialise the Aorfix stent graft
towards regulatory approvals and growing revenues
in EU, USA, Russia and Brazil.
Corporate experience includes six years as UK
Country Leader of Boston Scientific Ltd, between
1999 and 2005, during which time major medical
devices such as the TAXUS drug eluting stent were
launched driving sales and profits to the point where
the UK and Ireland subsidiary became one of the
leading revenue contributors to the corporation’s
European operations. Between 1987 and 1999,
Brian was Managing Director of the UK sales and
manufacturing subsidiary of Cobe Laboratories
Inc. In addition, Brian spent almost 20 years in the
pharmaceutical industry, gaining strong sales and
marketing experience through a number of senior
management positions in UK, Scandinavia and the
Benelux markets within Fisons plc.
Brings to the Board
Extensive commercial operations experience
of the medtech sector.
Skills and experience
Dr. Jan Groen is currently the Chief Executive Officer
of Novigenix SA, an ImmunoTranscriptomics startup
developing products for early cancer detection and
precision medicine. Jan was previously the Chief
Executive Officer of MDxHealth, a Euronext listed
genomic diagnostics company that improves the
lives of patients by reducing diagnostic ambiguity in
urological cancers. MDxHealth’s genomic tests are
setting new standards in prostate and bladder cancer
diagnosis, where they have helped over 100,000
patients avoid unnecessary diagnostic procedures.
Jan’s career spans over 25 years in clinical diagnostics
and life science global markets. Jan was previously the
President and COO of Agendia, responsible for their
United States and European diagnostic operations,
respectively. Jan is co-founder of ViroClinics and
DxOrange and has held numerous management and
scientific positions at Focus Diagnostics, a subsidiary
of Quest Diagnostics, the Erasmus Medical Center,
and Akzo-Nobel. Jan has had board mandates in
several diagnostic companies. Currently he serves
on the board of SPL Medical in the Netherlands.
Jan holds a Ph.D. degree in Medical Microbiology from
the Erasmus University Rotterdam, a BSc in Clinical
Laboratory Studies and has published more than
125 papers in international scientific journals in the
field of clinical diagnostics.
Brings to the Board
Expertise in new product development, including
development and successful commercialisation of
CE marked and FDA cleared diagnostic products
and lab-developed tests in Europe and the USA.
35
GovernanceANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Scientific Advisory Board
Wealth of experience and expertise
The Scientific Advisory Board
(SAB) is comprised of a group
of individuals that have significant
scientific technical backgrounds in
medical devices, diagnostics and
other areas related to ANGLE’s
products. SAB members provide
strategic input, insight and expertise
in the blood and cancer fields
and also advise the Company on
technical aspects in relation to
platform development, product
development and clinical studies
as well as providing broader
industry input.
Dr. Daniel Danila
Skills and experience
Dr. Daniel Danila is an assistant attending physician
at Memorial Hospital Cancer Center in New York.
Dr. Danila also serves as an assistant with the Weill
Cornell Medical College. Dr. Danila’s primary research
focuses on prostate cancer. Specifically, Dr. Danila
is exploring a hypothesis that molecular profiling of
CTCs can be used to assess biological determinants
of the growth of prostate cancer tumors.
Dr. Danila served as the principal investigator (PI) for
“Circulating Tumor Cells as Biomarkers for Patients
with Metastatic Prostate Cancer: Developing Assays
for Androgen Receptor Signaling Pathway,” which
focused on analysing CTCs from patients with
metastatic prostate cancer for molecular biomarkers
predictive of tumour sensitivity to targeted
treatments. Funding for the research was provided
by the Department of Defense Congressionally
Directed Medical Research Programs, Prostate
Cancer Research Program, Physician Research
Training Award. Dr. Danila received his MD from
Carol Davila University of Medicine and Pharmacy in
Bucharest, Romania and was a research fellow, intern
and resident at Massachusetts General Hospital prior
to joining Memorial Sloan Kettering Cancer Center
in 2005.
Brings to the SAB expertise in – development
and adoption of CTCs as predictive biomarkers to
help clinicians select appropriate treatments, prostate
cancer and wide network of contacts in the field.
36
Dr. George Hvichia
Prof. Adrian Newland
Skills and experience
Prof. Adrian Newland (who is not related to ANGLE’s
Chief Executive) is Professor of Haematology at
Barts Health NHS Trust and Queen Mary University
of London. Prof. Newland was also Director of
Pathology for the Trust and Clinical Director of the
North East London Cancer Network until 2018.
Prof. Newland was President of the Royal College
of Pathologists from 2005 to 2008 and the
International Society of Hematology from 2014
to 2016. Prof. Newland chaired the National Blood
Transfusion Committee and was pathology lead for
NHS London. Prof. Newland is National Clinical
Advisor in Pathology to NHS Improvement and
Clinical Advisor to the Transforming Cancer Service
Team in London. He chairs the National Pathology
Implementation Optimisation Delivery Group.
Prof. Newland was previously chair of the Diagnostic
Assessment Programme for the National Institute
for Health and Clinical Excellence (NICE) and of the
NICE Sifting Group for cancer drugs. Prof. Newland
has been a member of the Scientific Advisory Panel
of the Institute of Cancer Research from 1995 until
2003 and Chair of the London Cancer New Drugs
Group since 2002. Prof. Newland was a member of
the National Chemotherapy Implementation Group
until 2018 and a member of the Expert Reference
Group on Cancer Care in London, the national
Cancer Outcomes Advisory Group and the Human
Genome Strategy Group. Prof. Newland is co-chair
of the WHO Strategic Advisory Group of Experts
for In-Vitro Diagnostic Devices (SAGE-IVD) and
recently completed the five year review of the WHO
Cancer programme. He is currently a non-executive
director of the UK Accreditation Service and chairs
their Healthcare Forum.
Brings to the SAB expertise in – haematology,
pathology, cancer diagnostics, accreditation and NICE.
Skills and experience
Dr. George Hvichia is the original inventor of the
core Parsortix technology and played a lead role in
ANGLE’s Parsortix patents. Dr. Hvichia is an expert
in microfluidic technology related to cell and particle
separation and platform integration. Dr. Hvichia was
the first person to recognise the combined principle
of separation by size and deformability of rare cells in
fluids, such as blood, and that microfluidic devices could
be used to achieve this, even though manufacturing at
the necessary tolerances was not possible at the time.
This core technology yields low cost, efficient, single
use and scalable micro-devices for use in the fields
of Liquid Biopsy and Precision Medicine.
Dr. Hvichia played a lead role in advancing the
Parsortix technology by working in the laboratory
and introducing multiple solutions and innovations.
Dr. Hvichia also focused on collecting and analysing
data from the microfluidic cassette, instrument and
assay development process, resulting in ANGLE’s first
peer-reviewed publication in the International Journal
of Cancer (IJC) in January 2016. This publication
made the prestigious list of 10 most popular cancer
publications in recent years, presented at World
Cancer Congress 2018 by renowned publisher Wiley
and International Journal of Cancer.
Brings to the SAB expertise in – microfluidics
and biochips with ongoing thoughts and advice on
development of the Parsortix system.
Dr. Joseph Khoury
Skills and experience
Dr. Joseph Khoury is a recognised expert in
diagnostic pathology and has significant experience
in the cytological and morphological analysis of
cancer cells as well as molecular diagnostics and
immunophenotyping. Dr. Khoury is a tenured
Professor of Pathology and Laboratory Medicine
at The University of Texas MD Anderson Cancer
Center in Houston, Texas and is the Executive
Director of the MD Anderson Cancer Network for
the Division of Pathology and Laboratory Medicine.
Dr. Khoury is also the Director of the MD Anderson
Clinical Immunohistochemistry Laboratory.
Dr. Khoury is a leader in translational research
focused on hematolymphoid neoplasia (a class of
tumours that affect the blood, bone marrow, and
organs of the immune system). Dr. Khoury has
authored over 210 publications, many in prestigious
peer-review scientific and medical journals, two
textbooks, and several book chapters. He has trained
numerous clinical and research fellows. Dr. Khoury
is an active member of the College of American
Pathologists and has lectured extensively at various
institutions and conferences globally.
Brings to the SAB expertise in – diagnostic
pathology and cytological and morphological analysis
of cancer cells.
GovernanceANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Dr. James Reuben
Dr. Clive Stanway
Skills and experience
Dr. Reuben is a Professor in the Department
of Hematopathology, Division of Pathology/Lab
Medicine at The University of Texas MD Anderson
Cancer Center, Houston, Texas. Dr. Reuben is a
leading authority and has conducted significant
research on circulating tumour cell subsets, including
those with epithelial and mesenchymal phenotypes
and their clinical relevance to minimal residual disease
in breast cancer.
Some related publications include “Circulating tumor
cells, disease progression, and survival in metastatic
breast cancer in the New England Journal of
Medicine”; “Circulating tumor cells are associated
with increased risk of venous thromboembolism
in metastatic breast cancer patients” in the British
Journal of Cancer; and “Circulating tumor cells in
metastatic inflammatory breast cancer” published in
the Annals of Oncology. Dr. Reuben received his PhD
in immunology from McGill University in Montreal,
Canada and his MBA from University of Houston,
Houston, Texas. Dr. Reuben completed his research
fellowship in the Department of Experimental
Therapeutics at The University of Texas MD
Anderson Cancer Center with Evan M. Hersh, MD
and Emil J Freireich, MD, as mentors.
Brings to the SAB expertise in – knowledge
and understanding of CTCs, breast cancer and wide
network of contacts in the field.
Mr Greg L Shaw
Skills and experience
Mr Shaw is a Consultant Urological Surgeon at
University College Hospital in London and is a clinical
academic with a strong interest in prostate cancer
diagnostics and treatment. Having completed an
M.D. in prostate cancer at the University of London
investigating circulating tumour cells in prostate
cancer, and subsequently completed four years as a
lecturer at the University of Cambridge, Mr Shaw has
published widely on prostate cancer and is currently
an honorary Associate Professor at University College
and Senior Lecturer at Queen Mary College of the
University of London.
Mr Shaw leads several research programmes focused
on current weaknesses in the way prostate cancer
is treated and is interested in exploring the role
novel biomarkers may play in advancing practice
in these areas. Mr Shaw is currently chief investigator
for two NIHR portfolio studies investigating 1) the
effects of refinements to robotic surgery and
2) the use of drugs to prevent progression in men
on active surveillance for prostate cancer. Mr Shaw
is an expert in robotic surgery with a high case
volume. Mr Shaw is known for his innovative
approach and commitment to quality assurance.
Brings to the SAB expertise in – prostate
cancer diagnostics and treatment.
Skills and experience
Dr. Clive Stanway is currently an independent
drug discovery and development advisor to several
companies including acting as a non-executive
director for CytoSeek Ltd and Atelerix Ltd.
Dr. Stanway was until 2018 Chief Scientific Officer
of Cancer Research UK’s Commercial Partnerships
which is responsible for the development and
commercialisation of research innovations.
Dr. Stanway is an expert in cancer drug discovery
and a key part of his former role was working closely
with major pharmaceutical partners. Dr. Stanway
has extensive knowledge and experience of cancer
research, detailed understanding of the drug discovery
and development process, and worldwide contacts
with major pharma development groups.
Dr. Stanway was engaged in raising the scientific
profile of Commercial Partnerships with the
pharmaceutical industry; his efforts have led to several
significant partnerships and alliances. Dr. Stanway has
also driven internal Commercial Partnerships projects
addressing cancer immunomodulation bringing
together different technologies and expertise leading
to a compound progressing towards a Phase 1 trial.
The annual research spend of Cancer Research UK
is in the region of £375 million and Commercial
Partnerships has annual revenues of approximately
£50 million. Prior to becoming Chief Scientific Officer
of Commercial Partnerships, Dr. Stanway established
and led the drug discovery and biotherapeutic
discovery activity within Cancer Research UK, which
has been or is now partnered with AstraZeneca,
FORMA Therapeutics, BMS, Artios and Merck KGaA.
Brings to the SAB expertise in – cancer
drug discovery and development and major
pharma networks.
Dr. Harold Swerdlow
Skills and experience
Dr. Harold Swerdlow is currently Senior Director
of NGS R&D at DNA Electronics (DNAe) in
London. His role there involves managing Next-
Generation Sequencing (NGS) technology and
product development for an initial sepsis diagnostic
offering. Dr. Swerdlow is a leading expert in NGS and
recently served as a consultant for both ONI (Oxford
Nanoimaging), a super-resolution microscopy
company, and Nuclera, a DNA synthesis start-up
after being Head of NGS Technology Development
at LGC Genomics. As VP of Sequencing at the New
York Genome Center (NYGC) from 2014-2017, Dr.
Swerdlow directed the Technology Innovation group
and managed the production and clinical laboratory
facilities (with about 30 Illumina DNA sequencers).
Prior to NYGC, Dr. Swerdlow was Head of Research
and Development for the Wellcome Trust Sanger
Institute in Cambridge, UK (2008-2014). In that role,
Dr. Swerdlow directed the R&D department and
helped build the Sanger Institute’s next-generation
DNA-sequencing production facility into one of the
world’s largest.
Previously, Dr. Swerdlow was the Chief Technology
Officer of Dolomite Ltd., a leader in microfluidics and
microfabrication. Prior to Dolomite, Dr. Swerdlow
was an inventor of the core technology relating to
NGS at Solexa Ltd., a company which he joined
in 2000 when it had only three employees. From
then until 2006, as Senior Director of Research,
Dr. Swerdlow helped launch Solexa’s first product,
the Genome Analyzer DNA sequencing platform.
At Solexa, Dr. Swerdlow was responsible for
instrument engineering, integration of the next-
generation DNA sequencing system and early
applications work, along with assisting in the
development of many of the system’s biochemical
components. Dr. Swerdlow was a key member of
the Senior Management team that delivered Solexa’s
first genome sequence, an end-to-end proof-of-
principle. Following its NASDAQ listing, Solexa was
acquired by Illumina Inc. for US$600 million and
Solexa’s technology became the core of Illumina’s
world-leading NGS products.
Brings to the SAB expertise in – next generation
sequencing, genomics and system integration.
Prof. Ashok Venkitaraman
Skills and experience
Prof. Ashok Venkitaraman holds the Ursula Zoellner
Professorship of Cancer Research at the University
of Cambridge, and is Director of the Medical Research
Council’s Cancer Cell Unit and Joint Director of the
Medical Research Council Hutchison Cancer Research
Centre. Prof. Venkitaraman’s research has helped to
elucidate the connections between chromosome
instability and the genesis of epithelial cancers.
Prof. Venkitaraman has been instrumental in
establishing the Cambridge Molecular Therapeutics
Programme, an initiative that links chemists, physicists,
structural biologists, cancer biologists and clinicians
at the University of Cambridge. Prof. Venkitaraman
has been a member of the Scientific Advisory Boards
of Astex Therapeutics Ltd, Cambridge Antibody
Technology (AstraZeneca affiliate), Massachusetts
General Hospital Cancer Center and currently chairs
the Scientific Advisory Board of Sentinel Oncology
Ltd. Prof. Venkitaraman has also been a John H Blaffer
Lecturer at M D Anderson Cancer Center. Prof.
Venkitaraman was elected a Fellow of the Academy
of Medical Sciences, London, in 2001, and a member
of the European Molecular Biology Organization
(EMBO) European Academy, Heidelberg, in 2004.
Brings to the SAB expertise in – cancer cell
biology and personalised cancer care.
37
GovernanceANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Directors’ Report
For the period ended 31 December 2019
The Directors present their Report and Financial Statements for the eight month period ended 31 December 2019 for ANGLE plc (the “Company”) and its
subsidiaries (the “Group” or “ANGLE”). ANGLE plc, Company registration number 04985171, is a public limited company, incorporated and domiciled in England
and quoted on the London Stock Exchange Alternative Investment Market (AIM). ANGLE plc also has a Level 1 American Depository Receipt (ADR) program that
trades on the Over-The-Counter (OTC) market in the United States. The Remuneration Report on pages 49 to 51 is a voluntarily prepared report.
The Directors who held office as at the date of approval of this Directors’ Report confirm that, so far as they are each aware, there is no relevant audit information
of which the Company’s auditors are unaware, and each Director has taken all the steps that they ought to have taken as a Director to make themselves aware
of any relevant audit information and to establish that the Company’s auditors are aware of that information.
Principal activities
The principal activity of the Company is that of a holding company. The Group’s principal trading activity is undertaken in relation to the development and
commercialisation of the Parsortix cell separation system, with deployment in liquid biopsy – non-invasive cancer diagnostics.
Review of the business and future developments
The Strategic Report (including the Chairman’s Statement and the Financial Review) on pages 02 to 33 reports on the Group’s performance during the past financial
period and its prospects.
The information that fulfils the requirements of the Business Review is contained within the Strategic Report (including the Chairman’s Statement and the Financial
Review) on pages 02 to 33 and is incorporated into this report by reference.
Key Performance Indicators (KPIs)
The Group’s main KPIs and details of performance against them are set out on pages 22 and 23.
Results and dividends
The Consolidated Statement of Comprehensive Income for the period is set out on page 55.
The Group made a loss for the eight month period of £6.2 million (year ended 30 April 2019: loss £8.9 million).
The Directors do not recommend the payment of a dividend for the period (year ended 30 April 2019: £nil). The Board periodically reviews the Company’s dividend
policy in the context of its financial position.
Research and development
Total expenditure on research and development in the period amounted to £6.0 million (year ended 30 April 2019: £8.0 million). Expenditure on research and
development expensed through the Consolidated Statement of Comprehensive Income amounted to £5.0 million in the period (year ended 30 April 2019:
£6.4 million), including both third-party research and development costs and own staff costs. Additional expenditure on product development was capitalised
on the Consolidated Statement of Financial Position, in accordance with IAS 38, and amounted to £1.0 million in the period (year ended 30 April 2019: £1.6 million).
Directors and their interests
The following Directors have held office since 1 May 2019:
I F Griffiths
J Groen
B Howlett
A D W Newland
G R Selvey
The Directors’ interests, including beneficial interests, in the Ordinary shares and share options of the Company are shown in the Directors’ Remuneration Report
on pages 50 and 51.
Directors’ and Officers’ liability insurance
As permitted by the Companies Act 2006, the Directors and Officers of the Company and its subsidiaries are indemnified under the Group’s Directors’ and
Officers’ liability insurance in respect of proceedings which might be brought by a third-party. No cover is provided in respect of any fraudulent or dishonest acts.
38
GovernanceANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Significant shareholdings
The following fund managers and shareholders had an interest in 3% or more of the Company’s ordinary share capital, according to the Link Asset Share Portal,
as at 16 June 2020:
Fund manager/shareholder
Jupiter Asset Management Limited*
Fidelity International Limited (FIL)*
Dermot Keane
Conifer Management LLC
Legal and General
Andrew D W Newland
Number of shares
Holding
27,890,838
14,241,348
12,777,088
12,032,522
10,369,092
7,054,686
16.14%
8.24%
7.39%
6.96%
6.00%
4.08%
* Fund manager does not hold all of the voting rights as some are retained and voted by the beneficial owner.
Risk management
Details of the Group’s financial risk management objectives and policies are disclosed in Note 14 to the Financial Statements, along with further information on the
Group’s use of financial instruments.
Principal Risks and Uncertainties
The Directors consider that the Group is exposed to a number of risks and uncertainties which it seeks to mitigate and the principal ones are set out on pages 24 to 29.
Directors’ responsibilities
The Directors are responsible for preparing the Strategic Report, Directors’ Report and the Financial Statements in accordance with applicable law and regulations.
Company law requires the Directors to prepare Group and Company Financial Statements for each financial period. The Directors are required by the AIM Rules of
the London Stock Exchange to prepare Group Financial Statements in accordance with International Financial Reporting Standards ("IFRS") as adopted by the European
Union (“EU”) and have elected to prepare the Company Financial Statements in accordance with IFRS as adopted by the EU.
The Group and Company Financial Statements are required by law and IFRS adopted by the EU to present fairly their financial position and performance; the
Companies Act 2006 provides in relation to such financial statements that references in the relevant part of that Act to financial statements giving a true and fair view
are references to their achieving a fair presentation.
Under company law the Directors must not approve the Financial Statements unless they are satisfied that they give a true and fair view of the state of affairs of the
Group and the Company and of the profit or loss of the Group for that period.
In preparing each of the Group and Company Financial Statements, the Directors are required to:
• select suitable accounting policies and then apply them consistently;
• make judgements and accounting estimates that are reasonable and prudent;
• state whether they have been prepared in accordance with IFRS adopted by the EU; and
• prepare the Financial Statements on the going concern basis unless it is inappropriate to presume that the Group and the Company will continue in business.
The Directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Group’s and the Company’s transactions and disclose
with reasonable accuracy at any time the financial position of the Group and Company and enable them to ensure that the Financial Statements comply with the
Companies Act 2006. They are also responsible for safeguarding the assets of the Group and the Company and hence for taking reasonable steps for the prevention
and detection of fraud and other irregularities.
The Directors are responsible for the maintenance and integrity of the corporate and financial information included on the ANGLE plc website. The Group’s website
is intended to meet the legal requirements for the UK and not to meet the different legal requirements relating to the preparation and dissemination of financial
information in other countries.
39
GovernanceANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Directors’ Report
For the period ended 31 December 2019
continued
Post reporting date event
As reported in Note 24, the Chairman’s Statement and elsewhere, the Company has had some short-term negative impacts from government lock downs associated
with COVID-19. Although this has created some uncertainty and a need to adapt the operating model it is not expected to have any significant long-term impact
on the Company.
Going concern
The Directors have considered the uncertainties, risks and potential impact on the business associated with COVID-19 and are carefully managing the discretionary
expenditure in line with available cash resources.
The Directors have prepared and reviewed the financial projections for the 12 month period from the date of signing of these Financial Statements with discretionary
expenditure carefully controlled. Based on the level of existing cash and expected R&D tax credits, 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. Notes 1.4 and 24 provide
additional information.
Auditor
The auditor RSM UK Audit LLP, Chartered Accountants, has indicated its willingness to continue in office.
Annual General Meeting
The Annual General Meeting (AGM) of the Company will be held at 2:00 pm on Thursday 27 August 2020 at ANGLE plc, 10 Nugent Road, Surrey Research Park,
Guildford, Surrey GU2 7AF. In line with the UK Government’s COVID requirements to maintain social distancing this will be a closed meeting and shareholders will not
be permitted to attend the AGM in person. Shareholders will be able to join the AGM remotely with questions invited to be submitted before the meeting. The Notice
of Annual General Meeting is enclosed within this report on pages 88 to 91.
On behalf of the Board
Andrew D W Newland
Chief Executive
24 June 2020
40
GovernanceANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Corporate Governance Report
Corporate Governance
The Company’s shares trade on the Alternative Investment Market (AIM) of the London Stock Exchange.
The Board is committed to high standards of corporate governance and adheres to the Quoted Companies Alliance (QCA) Corporate Governance Code for small
and mid-size quoted companies (the “QCA Code”).
The Board has voluntarily applied the QCA Code since 2014, with elements of the UK Corporate Governance Code prior to that. Since 28 September 2018,
AIM companies were required to comply or explain against a recognised corporate governance code. The QCA Code was revised in April 2018 (“QCA Code 2018”)
and sets out 10 broad principles of corporate governance, states what are considered to be appropriate corporate governance arrangements for growing companies
and requires companies to provide an explanation about how they are meeting the principles through certain prescribed disclosures.
The Board has considered how each principle is applied and provides below an explanation of the approach taken in relation to each and how they support the
Company’s medium to long-term success.
In accordance with Section 172 of the Companies Act 2006, the Board recognises the importance of our stakeholders to our business. The Board has thought carefully
about how to formalise its consideration of the impact of its decisions on key stakeholders and has updated the report below on how it applies the S172 duties under
the Companies Act 2006, in particular as it relates to QCA Principles 2 and 3.
Chairman’s Statement
As Chairman of the ANGLE plc (“ANGLE”) Board, it is my responsibility to ensure that the Board is performing its role effectively and has the capacity, ability, structure
and support to enable it to continue to do so.
We believe that a sound and well understood governance structure is essential to maintain the integrity of the Group in all its actions, to enhance performance and
to impact positively on our shareholders, staff, customers, suppliers and other stakeholders.
ANGLE applies the QCA Code 2018 as the benchmark for measuring our adherence to good governance principles. These principles provide us with a clear
framework for assessing our performance as a Board and as a Company, and the report below shows how we apply the Code’s ten guiding principles in practice
and also incorporate Section 172 of the Companies Act 2006.
Strategy and business model (QCA Principle 1)
The Group’s strategy and business model is explained within the Strategic Report on pages 02 to 33, and is summarised below.
ANGLE is a world-leading liquid biopsy company commercialising a platform technology that can capture cells circulating in blood, such as cancer cells, even when they
are as rare in number as one cell in one billion blood cells, and harvest the cells for analysis.
ANGLE’s cell separation technology is called Parsortix and is the subject of granted patents in multiple jurisdictions. The system is based on a microfluidic device that
captures cells based on a combination of their size and compressibility.
The analysis of the cells that can be harvested from patient blood with ANGLE’s Parsortix system has the potential to deliver profound improvements in clinical and
health economic outcomes in the treatment and diagnosis of various forms of cancer.
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 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.
ANGLE intends to establish an independent accredited clinical laboratory that will have the capability of offering validated clinical tests. This clinical laboratory will be
used as an accelerator and demonstrator in support of the Company’s established plan for product sales of Parsortix instruments and cassettes.
ANGLE’s ultimate objective is the widespread adoption of the Parsortix system in the diagnosis, treatment and monitoring of cancer patients.
41
GovernanceANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Corporate Governance Report
continued
ANGLE is seeking to become the first ever company to receive FDA Class II clearance for a product for harvesting intact circulating tumour cells 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.
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.
Meeting shareholder needs (QCA Principle 2)
The Company seeks to maintain and enhance good relations with its shareholders and analysts. The Group’s Interim and Annual Reports are supplemented by regular
published updates to investors on commercial progress. All investors have access to up-to-date information on the Group via its website, www.angleplc.com, which
has an investor relations section providing contact details for investor relations queries, details on the Company’s share price, share price graphs and share trading
activity. The Company also distributes Group announcements electronically. Shareholders and other interested parties wishing to receive announcements via email
are invited to sign up to the “Email Alert” facility in the Investor Relations, Regulatory News section on the Company’s website.
The Directors seek to build on a mutual understanding of objectives between the Company and its shareholders, especially considering the specialist and
medium-term nature of the business. Institutional shareholders, private client brokers and analysts are in contact with the Directors through a regular programme
of briefing presentations and meetings to discuss issues and give feedback, primarily following the announcement of the interim and preliminary results, but also
throughout the year as required. The Board also uses and receives formal feedback through the Company’s joint stockbrokers, financial public relations advisor
and other advisors. Investor forums and presentation seminars and shows provide other channels of communication to shareholders, analysts and potential investors.
Individual shareholders are welcome to and regularly make contact with the Company via email or telephone.
All shareholders are encouraged to make use of the Company’s Annual General Meeting (AGM) to vote on resolutions (see Principle 10) and to raise any questions
regarding the strategy, management, operations and corporate governance of the Group. The Chairmen of the Audit, Remuneration and Nomination Committees
are available to answer any questions from shareholders at the AGM.
finnCap and WG Partners act as joint brokers to the Company, to further improve the quality and quantity of investor relations activities.
Along with the usual presentations and webinars the Company held a number of non-deal roadshows in the period and a deal roadshow resulting in a successful
fundraise in July 2019 which was oversubscribed and marked a successful introduction to the US market with the addition of two significant US investors.
During the period we changed our IR website tools providers to improve the shareholder experience with easier to use investor tools, and have seen an increase
of 9% in subscribers to our email alert facility.
The addition of a Corporate Responsibility Report on pages 32 and 33 is in response to shareholder requests to better understand how the Group deals with
environmental, social and governance (ESG) issues.
Manage our responsibilities to wider stakeholders (QCA Principle 3)
The Board recognises its prime responsibility under UK corporate law is to promote the success of the Group for the benefit of its members as a whole. We conduct
business in an ethical way and take seriously our responsibilities to our employees, clinical study partners, contractors, key opinion leaders, trading partners, research and
laboratory customers, suppliers and regulatory authorities.
We recognise that our employees are a core fundamental component to our success. We hold regular all-employee meetings to discuss business progress and provide
updates on initiatives. These meetings also include opportunities for staff to present on ongoing projects. One of the goals of these meetings is to ensure that staff feel
valued and engaged with the wider Group.
ANGLE provides training and development programmes, inclusive and interactive appraisal systems, merit-based promotions, flexible and family-friendly employee
policies and a range of employee and family benefits. Woven throughout all initiatives and programmes is a philosophy which promotes an open culture for discussion
and honest feedback. Employees are encouraged to be creative and offer ideas across the Group. Group-wide competitions have been held to encourage creativity and
camaraderie. An example of this in the period was a competition for the naming and branding of our product lines.
The Company places importance on the development of internal candidates for management roles and utilises a combination of competency and development plans to
progress this. During the period we introduced a Management Charter which formalises the ANGLE culture and clarifies our expectations to and from staff, and puts
in place a structure to ensure we achieve it. This has delivered a number of new initiatives across the Group during the period including a refined structured promotions
process, a coaching programme to support managers and the development of a New Manager training course to be delivered in the new year. Local teams have
engaged staff in a number of team building events.
ANGLE operate a high standard of quality management to ensure we comply with the appropriate regulations in the various territories in which we operate.
The Group uses external specialists where needed in relation to areas such as the quality systems and health and safety.
42
GovernanceANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 The complex nature of our products and product development process means that close working relationships with a number of key suppliers are essential to ensure
we receive the highest quality products and services. An ISO 13485:2016 quality system is mandatory for key suppliers. This involves senior staff clearly communicating
requirements and working closely with suppliers to develop appropriate products and services. We ensure there are clear processes for change control to avoid issues
and clear billing arrangements and we aim to pay suppliers based on the terms agreed. As a result we receive high quality goods delivered on time and to specification.
It puts us in a position to negotiate discounts, for example, bulk discounts on cassettes with the first large-scale frame order in the period.
We work closely with key opinion leaders (KOLs) and customers who have access to patient samples, who provide feedback on their use of the system, including
problems encountered, development needs such as new processes and workflows and working with different downstream analysis systems. Our success, competitive
advantage and reputation are dependent on understanding these needs and providing solutions. The relationships are managed by key account managers. KOLs,
customers and the Group regularly present at scientific conferences. We have a leveraged R&D model driving an increased number of peer-reviewed publications
enabled by the Parsortix system in order to be at the forefront of CTC research and clinical adoption.
Six peer-reviewed publications were issued in the eight month period by KOLs and customers (year ending 30 April 2019: 10). Most notably these included
a publication from UKE Hamburg demonstrating the utility of the Parsortix system for determining PD-L1 status of circulating tumour cells, and a publication from
Barts Cancer Institute (UK) demonstrating the capability of Parsortix system to detect clinically significant prostate cancer to reduce over-diagnosis and over-treatment.
We presented at five conferences in the period. ANGLE customer, University of Basel presented their breakthrough research on CTC clusters at the ACTC
conference in Corfu.
We operate in a highly regulated area of business. National governments and regulators (Competent Authorities) implement highly structured product certification
regimes to national, supra-national and international standards. Such certifications are necessary by law to manufacture and market research and clinical devices.
Notified Bodies are designated by Competent Authorities to perform assessments to agreed standards. ANGLE is subject to those assessments where appropriate
to the products manufactured and marketed by the Company.
We employ consultants with high levels of regulatory knowledge, experience and contacts to ensure our working knowledge is comprehensive, up to date and
appropriate to our needs. Guidance documents and training are identified to enable us to keep up to date with regulatory developments across different regulatory
bodies and different standards domains.
Through engagement, we ensure that we understand the regulatory landscape so that we can identify and comply with all applicable product standards in all relevant
territories. We engage with regulatory authorities, through telephone, email and face-to-face meetings, to ensure we obtain their views, understand the regulations
and their impact on our work plans and submissions.
During the period we have maintained ISO 13485:2016 accreditation (Europe) and CE marking (IVDD) for the intended use and are working towards securing
ISO 13485:2016 accreditation (Canada) and are in the final stages of completing our submission for FDA clearance for the intended use. We have developed
a regulatory roadmap to support future product strategy.
Risk management (QCA Principle 4)
The Board is responsible for identifying the major business risks faced by the Group and for determining the appropriate course of action and systems to manage
and mitigate those risks.
The nature of medical diagnostics development and the early stage and scale of our operations means there are a number of risks and uncertainties. The Directors
maintain a risk register and have summarised the principal risks and uncertainties that could have a material impact on the Group. The Principal Risks and Uncertainties
are reported on pages 24 to 29.
The Board monitors the key areas such as clinical applications, competitive position, financial, intellectual property, manufacturing, market acceptance, operational,
regulation and quality assurance, research and development, staff, key suppliers and key partners. An ongoing assessment is made of their potential impact and
mitigation strategies and actions. New potentially material risks which arise between reviews, such as Brexit and the impact of the COVID-19 pandemic, are added
to the risk register, discussed at Board level as they arise and followed up by the Board as appropriate.
The Audit Committee has adopted formal terms of reference (see Principle 9) and considers financial reporting, corporate governance and internal controls. Its review
of financial reporting includes discussion of major accounting issues, policies and compliance with International Financial Reporting Standards (IFRS), the law (Companies
Act 2006), review of key management judgements and estimates, review and update of the risk register, risk identification and assessment and risk management and
mitigation activities and going concern assumptions.
Internal control systems are designed to meet the particular needs of the Group and the risks to which it is exposed. The system of internal control is designed to
manage the risk of failure to achieve business objectives, rather than to eliminate it, and by its nature can only provide reasonable but not absolute assurance against
material misstatement or loss.
An internal audit function is not considered necessary or practical due to the size of the Group and the close day-to-day control exercised by the Executive Directors
and senior management. The Board will continue to monitor the requirement to have an internal audit function.
43
GovernanceANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Corporate Governance Report
continued
The key procedures that the Directors have established with a view to providing an effective system of internal control are as follows:
Management structure
The Board has overall responsibility for the Group and focuses on the overall Group strategy (see Principle 1) and the interests of shareholders (see Principles 2
and 10). There is a schedule of matters specifically reserved for decision by the Board (see Principle 9). The Board has an organisational structure with clearly defined
responsibilities and lines of accountability and each Executive Director has been given responsibility for specific aspects of the Group’s affairs (see Principles 5 and 9).
Internal financial risks are controlled through authorisation procedures/levels and segregation of accounting duties.
Quality and integrity of personnel
The integrity and competence of personnel are ensured through high recruitment standards and subsequent training. We assess employee competence at all levels,
identify development requirements and provide training and development support, aligned with business and personal objectives. High-quality, motivated personnel are
seen as an essential part of the control environment.
Budgets and reporting
Each year the Board approves the annual budget which includes an assessment of key risk areas. Performance is monitored and relevant action taken throughout
the year through regular reporting to the Board of variances from the budget and preparation of updated forecasts for the year together with information on the
key risk areas.
Investment and divestment appraisal
All material investment and divestment decisions require appraisal, review and approval by the Board.
Internal controls
The Board reviews the effectiveness of the Group’s systems of internal controls and has a process for the continuous identification, evaluation and management of the
significant risks the Group faces. Assessment considers the external environment, the industry in which the Group operates, the internal environment and non-financial
risks such as operational and legal risks. The risks identified are ranked based on significance and likelihood of occurrence. The Board reviews the controls in place to
mitigate those risks and improvements are made where required. The Group conducts its operations within the ISO 13485:2016 quality management system and
continues to invest in its systems and people in light of Group strategy and risk assessment to ensure the appropriate operational controls and measures are in place
and working effectively. The quality system is subject to annual Notified Body audit (BSI). The Group uses external specialist resources (regulatory, design, manufacturing
etc) as required. Day-to-day responsibility for the implementation of effective internal control and risk monitoring rests with senior management.
Metrics and quality objectives continue to be actively implemented and monitored as part of a continual improvement programme. A number of incremental
improvements have been made in the year driven by planned internal quality system auditing and risk assessment and other larger improvements have been identified
and are being progressed. Improvements have included 1) data security (password) minimum criteria requirements and training; 2) segregation of duties review and
refinement; 3) electronics systems for supplier and equipment control within the quality system; 4) piloting of electronic forms, document signatures and signing
authorities; 5) improvements to purchasing procedures and inbound goods inspections; and 6) implemented a new dashboard reporting system across the Group.
Maintain a well-functioning Board (QCA Principle 5)
The Board of Directors is led by the Chairman, has overall responsibility for strategy (see Principle 1) and is responsible to shareholders for the governance of
ANGLE plc and for the effective operation and management of the Group. Its aim is to provide leadership and control in order to ensure the growth and development
of a successful business, while representing the interests of the Company’s shareholders (see Principles 2 and 10).
Composition
The Board comprises the Chairman, two Non-executive and two Executive Directors. The QCA Code recommends there are at least two non-executive directors.
Different Directors hold the roles of Chairman and Chief Executive and there is a clear division of responsibilities between them. The Chairman is responsible
for corporate governance, for overseeing the running of the Board, ensuring that no individual or group dominates the Board’s decision making and ensuring that the
Non-executive Directors are properly briefed on matters. The Chief Executive has responsibility for implementing the strategy of the Board and managing the day-to-
day business activities of the Group through his management of the Executive Directors and senior managers. The Finance Director also acts as the Company Secretary
as the size and nature of the business activities do not justify a dedicated person or a need to outsource the activity; in this role he supports the Chairman directly on
governance matters as well as dealing with legal and regulatory compliance.
The Board’s composition is geared toward the Group’s current stage of development and priorities and will be refreshed as appropriate. The skill set of the Board
therefore includes experience in non-executive director/chairman/CEO roles, listed companies, investor relations, fundraising, medical diagnostics, technology
development, product development and commercialisation, lab-developed tests, CE Mark and FDA cleared product approvals and reimbursement. Individual Directors
possess a wide variety of skills and experience and biographical details of the Directors are set out on pages 34 and 35.
There are currently no female or ethnic minority directors. The Board is confident both that the opportunities in the Company are not excluded or limited by any
diversity issues (including gender) and that the Board nevertheless contains the necessary mix of experience, skills and other personal qualities and capabilities necessary
to deliver its strategy. This area will continue to be monitored.
44
GovernanceANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Independence
The Chairman and Non-executive Directors are considered by the Board to be independent of management and free of any relationship which could materially
interfere with the exercise of their independent judgement. They do not have a significant shareholding (see page 39) or represent a major shareholder, they receive
no remuneration from the Company other than directors’ fees and occasional consultancy fees (see page 50), they have no day-to-day involvement in running
the business and have never been employees of the Company, they have no personal financial and/or material interest in any other matters to be decided, such as
contracts, and they have no conflicts of interests arising from cross-directorships or advisory roles. Each Board meeting starts with a declaration of Directors’ interest
to identify potential or actual conflicts of interest. The Board considers that the Non-executive Directors are of sufficient calibre to bring the strength of independence
to the Board. The Board has nominated Brian Howlett as Senior Independent Director. Issues can also be raised directly through the normal channels of the Chairman,
Chief Executive and Finance Director and where necessary the Non-executive Directors can be approached directly.
The Chairman joined the Board in September 2006. The Chairman was independent at the time of his appointment and under the previous QCA code he counted as
an independent director. The Board considers that the Chairman’s long standing knowledge and detailed experience of the business are extremely valuable and that the
length of tenure does not affect his independence of judgement.
Committees of the Board
The Board maintains Audit, Remuneration and Nomination Committees. All Committees operate with written terms of reference (see Principle 9).
Ensure Directors have necessary, up-to-date skills (QCA Principle 6)
Individual Directors possess a wide variety of skills and experience.
Detailed biographical information on the individual Directors are set out on pages 34 and 35.
The key skills they bring to the Board are:
• Garth Selvey, Chairman – extensive experience of the listed sector and leading companies.
• Andrew Newland, Chief Executive – over 29 years of experience in setting up, leading and building technology-based businesses, over 19 years leading specialist
medtech businesses, and over ten years in the liquid biopsy space.
• Ian Griffiths, Finance Director – over 30 years of experience in finance and technology-based businesses, and over ten years in the liquid biopsy space.
• Jan Groen, Non-executive Director – expertise in new product development, including development and successful commercialisation of CE marked and FDA
cleared diagnostic products and lab-developed tests in Europe and the USA.
• Brian Howlett, Non-executive Director – extensive commercial operations experience of the medtech sector.
The Non-executive Directors also serve on other boards in the medical diagnostics sector which gives a broad range of skills, capabilities and experience. All Directors
are able to take training and/or independent professional advice in the furtherance of their duties if necessary. Directors keep their skill set up to date through attending
industry events, seminars and research. The Executive Directors will typically undertake specific training during the year. All Directors also have access to the Company’s
Nominated Advisor, legal advisors, financial advisors and other independent professional advisors as required. Professional advisors provide briefings and update notes
on necessary legislation from time to time.
No individual Director or Committee of the Board received any external advice in relation to their Board duties in the year.
There is an induction process for new directors including briefing by the Nominated Advisor and the Company.
Evaluate Board performance (QCA Principle 7)
The Company supports the concept of an effective Board leading and controlling the Company. The Chairman discusses and deals with any concerns with an individual
Director, or the Board as a whole, on Board performance as they arise. Additionally, the Board undertakes a periodic formal evaluation of its performance, its Directors
and its Committees, the last one being in 2018. The review, led by the Chairman, involves each Board member providing feedback and comments on the others and
where necessary specific actions are identified to improve certain areas.
The evaluation criteria take into account the Financial Reporting Council’s guidance on board effectiveness. The criteria against which board, committee and individual
effectiveness is considered comprise the Board structure (composition, constitution, diversity and succession planning – see Principle 5), the dynamics and functioning
of the Board (annual Board meeting schedule, quality of information, interactions and communications with the Executive Directors and senior management team,
cohesiveness and the quality of participation in Board meetings), the Board’s role in strategy and the financial reporting process. Evaluation procedures are evolving
to ensure they are relevant to the Group’s stage of development and Board dynamics. Due to the experience and size of the Board and the size of the Company,
the Board does not consider it necessary to have evaluations facilitated by an external consultant but will keep this under review.
45
GovernanceANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Corporate Governance Report
continued
Promote a values-based corporate culture (QCA Principle 8)
The Board places emphasis on its values-based corporate culture and ethical behaviour which are crucial to the Group’s reputation in the highly regulated field in which
it operates. The Group’s success depends on maintaining a supportive, innovative and can-do culture when working with suppliers and customers.
The Group manages a highly regarded quality management system which has a very strong influence on culture. The Group’s competency framework sets values-based
expectations at all levels in terms of the way we communicate and behave towards each other and external stakeholders. Our competency framework links to our
performance management system and, in turn, to our rewards strategy.
The Group operates a flat structure with all staff having the ability to discuss matters with Directors and senior managers. The management teams meet regularly
to promote communications and teamwork. The majority of projects take a team based approach. Staff regularly work at different offices. Recruitment practices are
heavily focused on recruiting people with similarly strong values. We have expanded our HR team to ensure a consistently open and ethical approach to recruitment,
management and employee communication throughout our offices.
The Group has established a Management Charter which formalises and clarifies expectations that managers at all levels take responsibility for supporting and
promoting an ethical values-based culture. Senior managers are coached in the development and maintenance of an open and ethical culture. This Charter forms
the basis of our management development programme and is part of management objectives.
The Group has taken further steps to promote a supportive culture. These include improving healthcare benefits, training Mental Health First Aiders, subscription
for employees to Thrive: Mental Wellbeing app and team building events.
The highly skilled and diverse nature of the Group influences culture which, at the most recent review, is characterised by:
• Qualifications, with 87% (April 2019: 87%) of staff having higher education qualifications including Degrees, Masters and Doctorates as well as Chartered
Accountants and MBAs, with the majority of staff having multiple qualifications.
• Gender split, with 48%:52% (April 2019: 47%:53%) Male:Female.
• Different nationalities, with 31 (April 2019: 25) different countries represented.
Maintain fit for purpose governance structures (QCA Principle 9)
Roles and responsibilities
Chairman: the Chairman is responsible for the leadership of the Board and ensuring the effective running and management of the Board. He is also responsible for the
Board’s oversight of the Company’s affairs, which includes ensuring that the Directors receive accurate, timely and clear information, ensuring the effective contribution
of the Non-executive Directors and implementing effective communication with shareholders.
Chief Executive Officer: the Chief Executive Officer is responsible for the day-to-day management and the executive leadership of the business. His other
responsibilities include the progress and development of objectives for the Company, managing the Company’s risk exposure, implementing the decisions of the Board
and ensuring effective communication with shareholders and regulatory bodies.
Non-executive Directors' independence
The Board considers the Non-executive Directors to be sufficiently independent to provide appropriate oversight and scrutiny (see Principle 5).
Service contracts and letters of appointment
The two Executive Directors Andrew Newland and Ian Griffiths have service contracts with the Company dated 9 March 2004 and effective from 17 March 2004,
as amended from time to time. The contracts are not set for a specific term, but include a rolling 12 month notice period by the Company or the individual. In the
event of a change in control, the Executives have the right to terminate their employment without the requirement to work their notice period.
The Chairman Garth Selvey has a letter of appointment dated and effective from 7 September 2006. The Non-executive Director Brian Howlett has a letter of
appointment dated and effective from 7 January 2013. The Non-executive Director Dr. Jan Groen has a letter of appointment dated and effective from 1 November
2018. These letters are issued in place of service contracts. These appointments are not set for a specific term and are terminable at will without notice by either party.
Re-election and election of Directors
In accordance with the Company’s Articles of Association, Directors are subject to re-election every three years, and newly appointed Directors are subject to election
at the first Annual General Meeting (AGM) after their appointment.
All Directors were re-elected by the shareholders at the AGM held on 30 October 2019 and accordingly no Directors are seeking re-election at this AGM.
Committees of the Board
The Board maintains Audit, Remuneration and Nomination Committees. All Committees operate with written terms of reference, the details of which can be found
on the website. Their minutes are circulated for review and consideration by the full Board of Directors, supplemented by oral reports on matters of particular
significance from the Committee Chairmen at Board meetings.
46
GovernanceANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Audit Committee
The members of the Committee are the Non-executive Director Brian Howlett (Chairman of the Audit Committee), the Chairman Garth Selvey and the
Non-executive Director Jan Groen. The Audit Committee meets at least twice a year to review the interim and annual accounts before they are submitted to the
Board. The external auditors, Finance Director and Chief Executive may attend by invitation. Provision is made to meet with the auditors at least once a year without
any Executive Director present.
The Committee has adopted formal terms of reference and considers financial reporting, corporate governance and internal controls. Its review of financial reporting
includes discussion of major accounting issues, policies and compliance with International Financial Reporting Standards (IFRS), the law (Companies Act 2006), review
of key management judgements and estimates, review and update of the risk register, risk assessment and risk management activities and going concern assumptions.
It also reviews the scope and results of the external audit and the independence and objectivity of the auditors and makes recommendations to the Board on issues
surrounding their remuneration, rotation of partners/staff, appointment, resignation or removal. The Audit Committee also considers and determines relevant action
in respect of any control issues raised by the auditors. The Audit Committee is also responsible for monitoring the provision of non-audit services provided by the
Group’s auditors and assesses the likely impact on the auditor’s independence and objectivity when considering an award of any material contract for additional
services. The fees in respect of audit and non-audit services are disclosed in Note 3; the fees for non-audit services are not deemed to be significant enough to impair
their independence and objectivity. A new ethical guide for auditors came into force with effect from 15 March 2020 which tightens up on the non-audit services that
auditors can provide. The Audit Committee will be considering the potential impact of this on the services provided.
Remuneration Committee
The members of the Committee are the Chairman Garth Selvey (Chairman of the Remuneration Committee) and the Non-executive Directors Brian Howlett and
Jan Groen. The Remuneration Committee meets as required. The Chief Executive and Finance Director may attend by invitation but are not present when matters
affecting their own remuneration arrangements are considered.
The Committee has adopted formal terms of reference and the Committee reviews and sets the remuneration and terms and conditions of employment of the
Executive Directors and senior management. It also agrees a policy for the salaries of all staff and is responsible for the development of the Company’s remuneration
scheme. The decisions of the Committee are formally ratified by the Board.
The Company is not required by either the AIM Listing Rules or the Companies Act to produce a remuneration report but provides the information in the
Annual Report and Accounts because of its commitment to maintaining high standards of corporate governance. The Company’s Remuneration Policy is the
responsibility of the Remuneration Committee. The Remuneration Policy, in so far as it relates to the Directors, is subject to an advisory vote by shareholders every
three years, and was last approved at the 2018 Annual General Meeting (AGM). The Directors’ Remuneration Report is subject to an advisory vote by shareholders
at each AGM.
The Remuneration Report on pages 49 to 51 provides details of the Remuneration Policy and the Directors’ Remuneration.
Nomination Committee
The members of the Committee are the Chairman Garth Selvey (Chairman of the Nomination Committee) and the Non-executive Directors Brian Howlett
and Jan Groen. The Nomination Committee meets as required. The Chief Executive and Finance Director may attend by invitation.
The Committee has adopted formal terms of reference and is responsible for reviewing the structure, size and composition of the Board, planning for succession
and for identifying and recommending to the Board suitable candidates for both executive and non-executive Board appointments.
Information
Management supply the Board and/or Committees with appropriate and timely information, including a business update and management accounts so that trading
performance can be regularly reviewed.
Matters reserved for the Board
The Board has a schedule of matters specifically reserved to it for decision, including the review and approval of:
• Group policy and long-term plans and strategy for the profitable development of the business;
• interim and annual Financial Statements;
• major investments and divestments;
• other significant financing matters such as fundraising, material contracts including clinical studies and product development, acquisitions and capital item purchases;
• cash flow forecasts, annual budgets and amendments; and
• senior executive remuneration and appointments.
Share dealing code
The Company has adopted and operates a share dealing code governing the share dealings of the Directors and applicable employees to ensure compliance with
the AIM Rules.
47
GovernanceANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Corporate Governance Report
continued
Commitment
Directors are required to allocate sufficient time to the Company to discharge their responsibilities effectively. The Chairman is required to commit approximately
3-5 days per month. Non-executive Directors are required to commit approximately 2-4 days per month. Executive Directors work full-time.
Directors’ attendance
The Board has at least eight main Board meetings per year with additional special meetings as required, the special meetings typically being telephone meetings to cover
specific items. Certain Directors may be appointed as a Committee of the Board of Directors. Directors’ attendance at Board and Committee meetings during the
eight month period ended 31 December 2019 is set out below:
Board
Committee of the Board*
Audit
Remuneration
Nomination
Garth
Selvey
Brian
Howlett
Jan
Groen
Andrew
Newland
Ian
Griffiths
6/6
1/1
1/1
3/3
0/0
6/6
N/A
1/1
3/3
0/0
6/6
N/A
1/1
3/3
0/0
6/6
2/2
N/A
N/A
N/A
6/6
3/3
N/A
N/A
N/A
* The Board appointed Garth Selvey or Andrew Newland together with Ian Griffiths as a Committee of the Board of Directors in relation to the fundraise during the period.
Scoring represents individual Directors’ attendance for those meetings when they were members of the Board or Committee.
In addition, the Board has other non-Board meetings to discuss strategy and key business areas with the senior management team.
Communicate governance and performance with shareholders (QCA Principle 10)
The Board communicates regularly with shareholders providing updates on Group performance to shareholders via interim and annual financial reports, trading
updates, investor presentations and a regular news flow of significant developments for the Group (see Principle 2). The website includes historical financial reports
and governance related material.
The Annual General Meeting (AGM) presents an opportunity for shareholders to vote on the various resolutions proposed.
48
GovernanceANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Remuneration Report
The Company is not required by either the AIM Listing Rules or the Companies Act to produce a remuneration report but has voluntarily provided the information
below because of its commitment to maintaining high standards of corporate governance. The Company’s Remuneration Policy is the responsibility of the
Remuneration Committee.
Remuneration Policy
The Company’s aim is to attract, retain and incentivise the Executive Directors, senior management and staff in a manner consistent with the goals of good
corporate governance. In setting the Company’s Remuneration Policy, the Remuneration Committee considers a number of factors including the basic salary, benefits
and incentives available to Executive Directors, senior management and staff of comparable companies and for new senior recruits based on executive search specialist
advice. The Company’s remuneration packages awarded to Executive Directors and senior management are intended to be competitive, include a significant proportion
of performance related remuneration and align employees’ with shareholders’ interests.
The Remuneration Policy was approved as an advisory vote by shareholders at the 2018 Annual General Meeting (AGM) and remains effective for three years.
Basic salary and benefits
Salary levels are reviewed annually. The Committee believes that basic salary and benefits should be competitive in the relevant employment market and reflect
individual responsibilities and performance. Medical health insurance, life cover, income replacement and pension benefits are also provided to employees once they
have met eligibility criteria. Executive Directors and senior management are eligible for employer pension contributions on the same basis as eligible staff in the relevant
jurisdiction. Basic salary may be taken in part as a pension payment. Basic salary and pension are considered together as a “Combined Figure”.
Annual Bonus Plan
The Annual Bonus Plan allows a bonus payment of up to 50% of the Combined Figure upon the achievement of defined targets relating to business progress and up to
a further 50% in the case of exceptional achievement. The Remuneration Committee has the discretion to settle an element of any bonus in the form of share options,
“Bonus Options”, exercisable at par value and not subject to performance conditions.
Share options
The Company has an Enterprise Management Incentive (EMI) Scheme and Unapproved Share Option Schemes as a means of encouraging ownership and aligning
the interests of staff and external shareholders. Reflecting the need to attract, incentivise, reward and retain high calibre staff to deliver the business strategy, the
Remuneration Committee has established a limit for the Company’s share option schemes of up to 16% of the issued and to be issued share capital from time to time.
Long-Term Incentive Plan
The Company has a Long-Term Incentive Plan (LTIP) as a means of further encouraging ownership and aligning the interests of senior management and shareholders
to achieve key strategic goals and build long-term value. The Company’s Non-executive Directors are not eligible to participate in the LTIP. The LTIP provides for awards
of options to acquire shares for nil consideration subject to performance conditions, “LTIP Options”. Performance conditions, targets and weightings will be set by the
Remuneration Committee at the time of an award to ensure they are stretching and aligned with the Company’s strategy to build shareholder value. Details in respect
of each award will be disclosed at the time of award and also in the subsequent Annual Report and Accounts. LTIP Options have a performance and holding period
of not less than five years, with a minimum performance period of three years and an additional holding period. Awards vest only to the extent that the performance
conditions and targets have been met at the end of the relevant performance period and will be capable of sale once the holding period is completed. The LTIP
contains normal “good leaver”, “bad leaver” and change of control provisions. Malus and clawback provisions will apply under certain circumstances. Awards will be
made from within the overall 16% limit described in share options above.
Discretionary incentives
The Group may operate with discretionary incentives either in addition to or instead of the incentives described above in any particular year, dependent on the needs
of the business.
Non-pensionable
None of the awards under the Annual Bonus Plan, Share Option Schemes, Long-Term Incentive Plan or discretionary incentives are pensionable.
Non-executive Directors
Non-executive Directors receive a fixed fee for their services. The remuneration of the Non-executive Directors is determined by the Board as a whole within the
overall limits stipulated in the Articles of Association. Non-executive Directors are not eligible to participate in any of the Company’s incentive schemes.
49
GovernanceANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Remuneration Report
continued
Directors’ Remuneration Report
Directors’ interests – shares
The Directors’ interests, including beneficial interests, in the Ordinary shares of the Company were as stated below:
I F Griffiths
J Groen
B Howlett
A D W Newland
G R Selvey
Directors’ emoluments
The aggregate remuneration received by Directors who served during the period was as follows:
Ordinary shares of £0.10 each
31 December 2019
1 May 2019
673,832
–
10,000
7,054,686
20,000
673,832
–
10,000
7,054,686
20,000
Chairman
G R Selvey
Executive
I F Griffiths
A D W Newland
Non-executive
J Groen*
B Howlett
Total
Salary/Fees
£’000
Benefits
£’000
Pension
£’000
8 months ended
31 December 2019
Total
£’000
Bonus
£’000
Year ended
30 April 2019
Total
£’000
17
94
160
17
17
305
–
2
4
–
–
6
–
10
–
–
–
10
–
–
–
–
–
–
17
106
164
17
17
321
23
258
403
12
23
719
*
J Groen’s prior period fees cover the period from his appointment as a Director on 1 November 2018.
Benefits include amounts in respect of private medical insurance and taxation advice.
Performance bonuses were not awarded in the current financial period under the terms of the Annual Bonus Plan due to the potential impact and associated
uncertainties of the COVID-19 pandemic and the desire of the Company to conserve cash, notwithstanding the fact that the Executives were deemed to have met the
performance criteria in relation to a proportion of the performance bonus.
Performance bonuses were awarded in the prior financial year under the terms of the Annual Bonus Plan. The Executives were deemed to have met the performance
criteria in relation to a 70% performance bonus, major factors of which were: progressing the FDA clearance studies with positive results from the clinical study,
completing the optimisation and progressing the ovarian clinical application, progressing the corporate partnerships and a successful fundraise.
I F Griffiths sacrificed salary during the current period and in the prior year. The Company elected to make contributions to his personal pension.
Directors’ interests – options
The Directors’ interests in options over the Ordinary shares of the Company were as stated below.
LTIP Options
A Long-Term Incentive Plan (LTIP) was established during the prior year and approved by the shareholders at the Annual General Meeting on 30 October 2018.
The Remuneration Committee approved a grant of nil-cost options to Executive Directors on 20 December 2018 over a maximum of 6,000,000 Ordinary shares
of £0.10. The LTIP Options have performance conditions as set out below, a performance period of three years and an additional holding period of two years.
Subject to the rules of the LTIP, awards will vest only to the extent that the performance conditions have been met at the end of the performance period and the
underlying shares may only be traded once the holding period is completed.
50
GovernanceANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Share price CAGR
< 40%
> 40%
> 55%
> 75%
Share options
Name
I F Griffiths
A D W Newland
The intention of the LTIP is to reward tangible increases in shareholder value. The performance conditions for the LTIP Options relate to the compound annual
growth rate (CAGR) of the share price over the three-year performance period. The mid-market share price on 20 December 2018 was £0.385 per Ordinary share.
As different levels of performance are achieved the number of shares that vest increases up to a maximum, as set out below:
Multiple of
share price
(at 3 years)
< 2.7
> 2.7
> 3.7
> 5.4
Proportion
vesting
0%
20%
50%
100%
Andrew
Newland
0
720,000
1,800,000
3,600,000
Ian
Griffiths
0
480,000
1,200,000
2,400,000
Date of
grant
30/08/2011
18/11/2011
05/11/2012
05/11/2012
10/11/2014
12/11/2015
25/11/2016
466,019
187,315
33,981
312,685
500,000
46,980
500,000
2,046,980
30/08/2011
603,334
18/11/2011 1,000,000
05/11/2012
346,666
10/11/2014 1,000,000
73,826
12/11/2015
25/11/2016 1,000,000
4,023,826
At
1 May
2019 Granted
Lapsed Cancelled Exercised
At 31 Vested –
December capable of
exercise
2019
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
466,019
187,315
33,981
312,685
500,000
46,980
500,000
466,019
–
33,981
–
–
46,980
–
– 2,046,980
546,980
–
603,334
– 1,000,000
–
346,666
– 1,000,000
73,826
–
– 1,000,000
603,334
–
346,666
–
73,826
–
– 4,023,826 1,023,826
Total
0
1,200,000
3,000,000
6,000,000
Expiry
date
29/08/2021
17/11/2021
29/08/2021
17/11/2021
09/11/2024
11/11/2025
24/11/2026
Exercise
price (£)
Earliest
exercise
date
0.2575 Note (1)
0.7550 Note (2)
0.2575 Note (1)
0.7550 Note (2)
0.8625 Note (3)
0.1000 Note (4)
0.6450 Note (5)
0.2575 Note (1)
0.7550 Note (2)
0.2575 Note (1)
0.8625 Note (3)
0.1000 Note (4)
0.6450 Note (5)
29/08/2021
17/11/2021
29/08/2021
09/11/2024
11/11/2025
24/11/2026
(1) Vesting is subject to a) a performance condition that the Company’s share price together with any dividend payments has risen by at least 50% at some point from the market price on 30 August 2011, and b) a service
condition with options vesting over a three-year period. These conditions have been met and the options are fully vested and capable of exercise.
(2) Vesting is subject to a) the performance conditions that (i) the Company’s share price must have increased to £2.00 at some point since the date of grant and (ii) the Parsortix separation device must have been
demonstrated to successfully capture circulating tumour cells from cancer patient blood (this condition has been met), and b) a service condition with options vesting over a three-year period (this condition has been met).
(3) Vesting is subject to the performance conditions that a) the Company’s share price must have increased to £2.00, £2.25, £2.50 and £2.75 at some point since the date of grant for each quarter of the allocation
and b) a time/event condition with options vesting after five years or on the sale of the Parsortix business, whichever is earliest.
(4) Options were granted as Bonus Options in accordance with the Remuneration Committee’s discretion to settle an element of the Annual Bonus in the form of share options. The Bonus Options vested immediately
and are exercisable at par value.
(5) Vesting is subject to a) a performance condition that the Company’s share price has risen by at least 100% at some point from the market price on 25 November 2016, and b) a service condition with options vesting
over a three-year period.
No share options were issued to Directors in the current or prior periods. No Directors’ share options were forfeited, lapsed, cancelled or exercised in the current
or prior periods.
Note 19 provides additional information on share options and LTIP Options.
Shareholder return
The market price of the Company’s shares on 31 December 2019 was £0.627 and the range of market price during the period from 1 May 2019 until 31 December
2019 was between £0.556 (low) and £0.835 (high).
By order of the Board
Garth Selvey
Remuneration Committee Chairman
24 June 2020
51
GovernanceANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Independent Auditor’s Report
To the Members of ANGLE plc
Opinion
We have audited the Financial Statements of ANGLE plc (the ‘Parent Company’) and its subsidiaries (the ‘Group’) for the period ended 31 December 2019 which
comprise the Consolidated Statement of Comprehensive Income, Consolidated and Company Statements of Financial Position, Consolidated and Company Statements
of Cash Flows, Consolidated and Company Statements of Changes in Equity and Notes to the Financial Statements, including a summary of significant accounting
policies. The financial reporting framework that has been applied in their preparation is applicable law and International Financial Reporting Standards (IFRSs) as adopted
by the European Union and, as regards the Parent Company Financial Statements, as applied in accordance with the provisions of the Companies Act 2006.
In our opinion:
• the Financial Statements give a true and fair view of the state of the Group’s and of the Parent Company’s affairs as at 31 December 2019 and of the Group’s loss
for the period then ended;
• the Group Financial Statements have been properly prepared in accordance with IFRSs as adopted by the European Union;
• the Parent Company Financial Statements have been properly prepared in accordance with IFRSs as adopted by the European Union and as applied in accordance
with the Companies Act 2006; and
• the Financial Statements have been prepared in accordance with the requirements of the Companies Act 2006.
Basis for opinion
We conducted our audit in accordance with International Standards on Auditing (UK) (ISAs (UK)) and applicable law. Our responsibilities under those standards
are further described in the Auditor’s responsibilities for the audit of the Financial Statements section of our report. We are independent of the Group and Parent
Company in accordance with the ethical requirements that are relevant to our audit of the Financial Statements in the UK, including the FRC’s Ethical Standard as
applied to SME listed entities and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit evidence we have
obtained is sufficient and appropriate to provide a basis for our opinion.
Conclusions relating to going concern
We have nothing to report in respect of the following matters in relation to which the ISAs (UK) require us to report to you where:
• the Directors’ use of the going concern basis of accounting in the preparation of the Financial Statements is not appropriate; or
• the Directors have not disclosed in the Financial Statements any identified material uncertainties that may cast significant doubt about the Group’s or the Parent
Company’s ability to continue to adopt the going concern basis of accounting for a period of at least twelve months from the date when the Financial Statements
are authorised for issue.
Summary of our audit approach
Key audit matters
Materiality
Group
• None
Parent Company
• None
Group
• Overall materiality: £422,000
• Performance materiality: £316,000
Parent Company
• Overall materiality: £422,000
• Performance materiality: £316,000
Scope
Our audit procedures covered 100% of revenue, 100% of net assets and 100% of loss before tax.
Key audit matters
We have determined that there are no key audit matters to communicate in our report.
52
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Our application of materiality
When establishing our overall audit strategy, we set certain thresholds which help us to determine the nature, timing and extent of our audit procedures. When
evaluating whether the effects of misstatements, both individually and on the Financial Statements as a whole, could reasonably influence the economic decisions of the
users we take into account the qualitative nature and the size of the misstatements. Based on our professional judgement, we determined materiality as follows:
Overall materiality
Overall materiality: £422,000
Overall materiality: £422,000
Group
Parent Company
Basis for determining
overall materiality
Rationale for
benchmark applied
5% of loss before tax
0.7% of net assets. The percentage applied to the
benchmark has been restricted to Group overall materiality.
Loss before tax is an appropriate measure as it is a
key performance indicator and reflects the scale of
activities of the Group.
As this is the Parent Company of the Group,
it does not carry out trading operations.
Net assets are of most relevance to users of the
Financial Statements in respect of the Parent Company.
Performance materiality
Performance materiality: £316,000
Performance materiality: £316,000
Basis for determining
performance materiality
Reporting of misstatements
to the Audit Committee
75% of overall materiality
75% of overall materiality
Misstatements in excess of £21,100 and
misstatements below that threshold that, in our view,
warranted reporting on qualitative grounds.
Misstatements in excess of £21,100 and misstatements
below that threshold that, in our view, warranted
reporting on qualitative grounds.
An overview of the scope of our audit
The Group consists of ten legal entities but operates as a single business. Our audit work was therefore carried out on the basis that the Group was a single
component and was subject to full scope audit by RSM UK Audit LLP covering 100% of revenue, 100% of net assets and 100% of the loss before tax.
Other information
The Directors are responsible for the other information. The other information comprises the information included in the Annual Report, other than the Financial
Statements and our Auditor’s Report thereon. Our opinion on the Financial Statements does not cover the other information and, except to the extent otherwise
explicitly stated in our report, we do not express any form of assurance conclusion thereon.
In connection with our audit of the Financial Statements, our responsibility is to read the other information and, in doing so, consider whether the other information
is materially inconsistent with the Financial Statements or our knowledge obtained in the audit or otherwise appears to be materially misstated. If we identify such
material inconsistencies or apparent material misstatements, we are required to determine whether there is a material misstatement in the Financial Statements or
a material misstatement of the other information. If, based on the work we have performed, we conclude that there is a material misstatement of this other
information, we are required to report that fact.
We have nothing to report in this regard.
Opinions on other matters prescribed by the Companies Act 2006
In our opinion, based on the work undertaken in the course of the audit:
• the information given in the Strategic Report and the Directors’ Report for the financial period for which the Financial Statements are prepared is consistent with
the Financial Statements; and
• the Strategic Report and the Directors’ Report have been prepared in accordance with applicable legal requirements.
Matters on which we are required to report by exception
In the light of the knowledge and understanding of the Group and the Parent Company and their environment obtained in the course of the audit, we have not
identified material misstatements in the Strategic Report or the Directors’ Report.
We have nothing to report in respect of the following matters in relation to which the Companies Act 2006 requires us to report to you if, in our opinion:
• adequate accounting records have not been kept by the Parent Company, or returns adequate for our audit have not been received from branches not visited
by us; or
• the Parent Company Financial Statements are not in agreement with the accounting records and returns; or
• certain disclosures of Directors’ remuneration specified by law are not made; or
• we have not received all the information and explanations we require for our audit.
53
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Independent Auditor’s Report
To the Members of ANGLE plc
continued
Responsibilities of Directors
As explained more fully in the Directors’ responsibilities statement, set out on page 39, the Directors are responsible for the preparation of the Financial Statements
and for being satisfied that they give a true and fair view, and for such internal control as the Directors determine is necessary to enable the preparation of Financial
Statements that are free from material misstatement, whether due to fraud or error.
In preparing the Financial Statements, the Directors are responsible for assessing the Group’s and the Parent Company’s ability to continue as a going concern, disclosing,
as applicable, matters related to going concern and using the going concern basis of accounting unless the Directors either intend to liquidate the Group or the Parent
Company or to cease operations, or have no realistic alternative but to do so.
Auditor’s responsibilities for the audit of the Financial Statements
Our objectives are to obtain reasonable assurance about whether the Financial Statements as a whole are free from material misstatement, whether due to fraud
or error, and to issue an Auditor’s Report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted
in accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if,
individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these Financial Statements.
A further description of our responsibilities for the audit of the Financial Statements is located on the Financial Reporting Council’s website at:
http://www.frc.org.uk/auditorsresponsibilities. This description forms part of our Auditor’s Report.
Use of our report
This report is made solely to the Company’s members, as a body, in accordance with Chapter 3 of Part 16 of the Companies Act 2006. Our audit work has been
undertaken so that we might state to the Company’s members those matters we are required to state to them in an Auditor’s Report and for no other purpose.
To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company and the Company’s members as a body,
for our audit work, for this report, or for the opinions we have formed.
Colin Roberts (Senior Statutory Auditor)
For and on behalf of RSM UK Audit LLP,
Statutory Auditor
Chartered Accountants
Third Floor
One London Square
Cross Lanes
Guildford
Surrey
GU1 1UN
24 June 2020
54
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Consolidated Statement of Comprehensive Income
For the period ended 31 December 2019
Revenue
Cost of sales
Gross profit
Other operating income
Operating costs
Operating profit/(loss)
Net finance income/(costs)
Profit/(loss) before tax
Tax (charge)/credit
Profit/(loss) for the period
Other comprehensive income/(loss):
Items that may be subsequently reclassified to profit or loss:
Exchange differences on translating foreign operations
Other comprehensive income/(loss)
Total comprehensive income/(loss) for the period
Profit/(loss) for the period attributable to:
Owners of the parent
Non-controlling interests
Profit/(loss) for the period
Total comprehensive income/(loss) for the period attributable to:
Owners of the parent
Non-controlling interests
Total comprehensive income/(loss) for the period
8 months ended
31 December 2019
£’000
Note
Year ended
30 April 2019
£’000
2
3
3
7
8
581
(142)
439
61
(8,204)
(7,704)
(26)
(7,730)
1,482
(6,248)
(24)
(24)
(6,272)
(6,248)
–
(6,248)
(6,272)
–
(6,272)
678
(155)
523
175
(11,597)
(10,899)
28
(10,871)
1,939
(8,932)
72
72
(8,860)
(8,942)
10
(8,932)
(8,822)
(38)
(8,860)
Earnings/(loss) per share attributable to owners of the parent
Basic and Diluted (pence per share)
9
(3.82)
(6.56)
All activity arose from continuing operations.
55
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Consolidated Statement of Financial Position
As at 31 December 2019
Assets
Intangible assets
Property, plant and equipment
Right-of-use assets
Inventories
Trade and other receivables
Taxation
Cash and cash equivalents
Total assets
Liabilities
Lease liabilities
Trade and other payables
Total liabilities
Net assets
Equity
Share capital
Share premium
Share-based payments reserve
Other reserve
Translation reserve
Retained earnings
ESOT shares
Total equity
31 December 2019
£’000
Note
30 April 2019
£’000
11
12
13
15
16
13
17
18
20
7,701
1,508
1,514
788
627
3,398
18,766
34,302
(1,553)
(2,425)
(3,978)
6,833
1,347
–
988
942
1,900
11,010
23,020
–
(3,684)
(3,684)
30,324
19,336
17,277
67,272
1,518
2,553
82
(58,276)
(102)
30,324
14,349
53,273
1,266
2,553
106
(52,109)
(102)
19,336
The Consolidated Financial Statements on pages 55 to 83 were approved by the Board and authorised for issue on 24 June 2020 and signed on its behalf by:
Ian F Griffiths
Director
Andrew D W Newland
Director
56
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Consolidated Statement of Cash Flows
For the period ended 31 December 2019
Operating activities
Profit/(loss) before tax from continuing operations
Adjustments for:
Depreciation of property, plant and equipment
Depreciation of right-of-use assets
(Profit)/loss on disposal of property, plant and equipment
Amortisation and impairment of intangible assets
Share-based payments
Exchange differences
Net finance (income)/costs
Operating cash flows before movements in working capital
(Increase)/decrease in inventories
(Increase)/decrease in trade and other receivables
Increase/(decrease) in trade and other payables
Operating cash flows
Research and development tax credits received
Overseas tax payments
Net cash from/(used in) operating activities
Investing activities
Purchase of property, plant and equipment
Purchase of intangible assets
Interest received
Net cash from/(used in) investing activities
Financing activities
Net proceeds from issue of share capital
Interest paid
Principal elements of lease payments
Interest elements of lease payments
Net cash from/(used in) financing activities
Net increase/(decrease) in cash and cash equivalents
Cash and cash equivalents at start of period
Effect of exchange rate fluctuations
Cash and cash equivalents at end of period
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
(7,730)
(10,871)
432
219
13
240
333
(27)
26
(6,494)
90
303
(841)
(6,942)
–
(59)
(7,001)
(529)
(1,431)
40
(1,920)
16,921
(2)
(231)
(13)
16,675
7,754
11,010
2
18,766
622
–
8
452
332
(14)
(28)
(9,499)
(583)
(91)
608
(9,565)
2,251
–
(7,314)
(219)
(1,133)
28
(1,324)
11,996
–
–
–
11,996
3,358
7,645
7
11,010
57
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Consolidated Statement of Changes in Equity
For the period ended 31 December 2019
Equity attributable to owners of the parent
Share-
based
Share payments
reserve
£’000
Share
capital premium
£’000
£’000
Other Translation Retained
earnings
reserve
reserve
£’000
£’000
£’000
ESOT
shares
£’000
Total
share
Non-
holders’ controlling
interests
£’000
equity
£’000
Total
equity
£’000
At 1 May 2018
For the year to 30 April 2019
11,709
43,449
1,072
2,553
(14)
(42,129)
(102)
16,538
(654)
15,884
Consolidated profit/(loss)
Other comprehensive income/(loss):
Exchange differences on translating foreign operations
Total comprehensive income/(loss)
Issue of shares (net of costs)
Share-based payments
Released on forfeiture
Acquisition of non-controlling interest
At 1 May 2019
For the 8 months to 31 December 2019
2,540
9,456
100
368
332
(138)
(8,942)
(8,942)
10
(8,932)
120
120
(48)
72
120
(8,942)
138
(1,176)
(8,822)
11,996
332
–
(708)
(38)
692
(8,860)
11,996
332
–
(16)
14,349
53,273
1,266
2,553
106
(52,109)
(102)
19,336
–
19,336
Consolidated profit/(loss)
Other comprehensive income/(loss):
Exchange differences on translating foreign operations
Total comprehensive income/(loss)
Issue of shares (net of costs)
Share-based payments
Released on forfeiture
Released on exercise
2,928
13,999
333
(78)
(3)
(6,248)
(24)
(24)
(6,248)
78
3
(6,248)
(24)
(6,272)
16,927
333
–
–
–
–
–
(6,248)
(24)
(6,272)
16,927
333
–
–
At 31 December 2019
17,277
67,272
1,518
2,553
82
(58,276)
(102)
30,324
–
30,324
Share premium
Represents amounts subscribed for share capital in excess of nominal value, net of directly attributable share issue costs.
Other reserve
The other reserve is a “merger” reserve arising from the acquisition of the former holding company.
Translation reserve
The translation reserve comprises cumulative exchange differences arising on consolidation from the translation of the Financial Statements of international operations.
Under IFRS this is separated from retained earnings.
ESOT shares
This reserve relates to shares held by the ANGLE Employee Share Ownership Trust (ESOT) and may be used to assist in meeting the obligations under employee
remuneration schemes.
Non-controlling interests
Represents amounts attributed to non-controlling (minority) interests for profits or losses in the Consolidated Statement of Comprehensive Income and assets or
liabilities in the Consolidated Statement of Financial Position. During the year ended 30 April 2019 the Company acquired the remainder of the original inventor’s shares.
Share-based payments reserve
The share-based payments reserve is used for the corresponding entry to the share-based payments charged through a) the Consolidated Statement
of Comprehensive Income for employee incentive arrangements relating to ANGLE plc equity and b) the Consolidated Statement of Financial Position for acquired
intangible assets in investments comprising intellectual property (IP). Transfers are made from this reserve to retained earnings as the related share options are
exercised, forfeited, lapse or expire.
58
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Notes to the Consolidated Financial Statements
For the period ended 31 December 2019
1 Accounting policies
1.1 Basis of preparation
The Financial Statements of the Group have been prepared in accordance with International Financial Reporting Standards (IFRS) in issue that have been endorsed by
the EU for the eight month period ended 31 December 2019 (including comparatives for the year ended 30 April 2019). They have also been prepared in accordance
with those parts of the Companies Act 2006 that apply to companies reporting under IFRS.
The Financial Statements of the Parent Company have been prepared in accordance with IFRS and are presented on pages 84 to 87.
As announced by RNS on 30 January 2020, ANGLE changed its accounting reference date to 31 December and therefore these accounts are for an eight month
period to 31 December 2019 with comparatives for the year ended 30 April 2019.
Accounting standards adopted in the period
The following standards relevant to the Group have been amended or implemented during the period:
IFRS 9
IFRS 16
IAS 19
IFRIC 23
Various
Amendment on Prepayment Features with Negative Compensation
Leases
Plan Amendments, Curtailment or Settlement
Uncertainty over Income Tax Treatments
Annual Improvements of IFRS standards 2015-2017 Cycle (IFRS 3, IFRS 11, IAS 12, IAS 23)
The Consolidated Financial Statements have been prepared in accordance with these changes where relevant. Their adoption has not had a material impact on the
Consolidated Financial Statements, with the exception of IFRS 16 Leases. Apart from these changes, the accounting policies set out in the Notes have been applied
consistently to both reporting periods presented in these Consolidated Financial Statements.
IFRS 16 Leases, which has been issued by the IASB to replace IAS 17 Leases, came into effect for accounting periods commencing on or after 1 January 2019.
The Group has adopted the standard and included relevant disclosure for the first time in these Financial Statements. The Group has not restated comparatives
for the previous reporting period as permitted under the specific transitional provisions in the standard.
The Group has recognised right-of-use assets representing its leased property rights, and the corresponding lease liabilities representing its obligations to make
lease payments over the remaining lease terms. Previously under IAS 17, a liability was not recorded for future operating lease payments, which were disclosed
as commitments.
The effect of IFRS 16 was to recognise right-of-use assets and corresponding lease liabilities of £1.7 million at 1 May 2019 (the date of initial application). The right-of-use
assets and the corresponding lease liabilities are shown separately on the Statement of Financial Position. There is no impact on reserves as at 1 May 2019.
Lease costs are recognised in the form of depreciation of the right-of-use assets and interest on the lease liability which will be discounted at either the interest rate
implicit in the lease or, when this is not determinable, the expected incremental borrowing rate for the Group for the item under lease. Under IAS 17, operating lease
rentals were expensed on a straight-line basis over the lease term within operating costs.
The Group’s incremental borrowing rate was estimated at 5.75% at the date of adoption of IFRS 16.
The following is a reconciliation of the Financial Statement line items from IAS 17 to IFRS 16 at 1 May 2019.
Description
Reason for change
I May 2019
under IAS 17
£’000
IFRS 16
1 May 2019
adjustments under IFRS 16
£’000
£’000
Right-of-use assets
Current assets
Current liabilities
Current liabilities
Non-current liabilities
Profit/(loss) before tax
Recognition of right to use assets for rented items previously classed as operating leases
Adjustment for previously recognised prepayment relating to property lease
Adjustment for previously recognised accruals relating to property lease
Recognition of current portion of lease liability for rented items
Recognition of lease liability due greater than one year for rented items
Adjustment for previously recognised prepayment and accruals relating to property lease
–
(3)
9
–
–
(12)
1,718
3
(9)
348
1,370
12
1,718
–
–
348
1,370
–
The following is a reconciliation of total operating lease commitments at 30 April 2019 (as disclosed in the prior year accounts) to lease liabilities recognised at 1 May 2019.
Total operating lease commitments disclosed at 30 April 2019
Lease payments relating to renewal periods not included in operating lease commitments(1)
Effect of discounting using the weighted average incremental borrowing rate of 5.75%
Exempt low-value or short-term leases
Total lease liability recognised under IFRS 16 at 1 May 2019
£’000
784
1,362
(420)
(8)
1,718
(1) The Group has two lease contracts that include extension/termination options. It has been determined that the extension options are reasonably certain to be exercised taking the leases beyond the termination option/
notice period. As these extensions were not contractual, they were not disclosed as commitments in the prior year accounts. See Note 1.22.
59
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notes to the Consolidated Financial Statements
continued
1 Accounting policies continued
1.1 Basis of preparation continued
Accounting standards adopted in the period continued
Note 13 provides additional information on the impact of IFRS 16 for the reporting period.
The Group has elected to account for short-term leases and leases of low-value assets using the practical expedients. Instead of recognising a right-of-use asset and
lease liability, the payments in relation to these are recognised as an expense in profit or loss on a straight-line basis over the lease term.
No other new accounting standards that have become effective and adopted in the period have had a significant effect on the Group’s Financial Statements.
Accounting standards issued but not yet effective
The following pronouncements which have been issued by the IASB are effective for annual periods beginning on or after 1 January 2020. The Directors have not yet
assessed the impact of the adoption of these Standards and Interpretations for future periods.
Amendments to IFRS 3
Amendments to IAS 39 and IFRS 7
Amendments to IAS 1 and IAS 8
Amendments to IFRS 10 and IAS 28
Amendments to References to the Conceptual Framework in IFRS Standards
Definition of a Business
Interest Rate Benchmark Reform
Definition of Material
Sale or Contribution of Assets between an Investor and its Associate or Joint Venture
1.2 Accounting convention
These Financial Statements have been prepared under the historical cost convention. The basis of consolidation is set out in Note 1.5.
1.3 Presentation of Financial Statements
The financial information, in the form of the primary statements contained in this report, is presented in accordance with International Accounting Standard
(IAS) 1 Presentation of Financial Statements. The Group has reviewed the items disclosed separately on the face of the statement of comprehensive income
and the components of financial performance considered by management to be significant, or for which separate disclosure would assist, both in a better understanding
of financial performance and in making projections of future results. This has been done taking into account the materiality, nature and function of components of
income and expense.
1.4 Going concern
The Financial Statements have been prepared on a going concern basis which assumes that the Group will be able to continue its operations for the foreseeable future.
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 and elsewhere in the Strategic Report on pages 02 to 33. The principal risks and uncertainties are stated on pages 24 to 29. In addition Note 14 to
the Financial Statements includes details of the Group’s exposure to liquidity risk, capital risk, credit risk, interest rate risk and foreign currency risk. The Chairman’s
Statement and Note 24 to the Financial Statements provides information on the impact of COVID-19 on the business.
The Directors have considered the uncertainties, risks and potential impact on the business associated with COVID-19 and are carefully managing the discretionary
expenditure in line with available cash resources.
The Directors have prepared and reviewed the financial projections for the 12 month period from the date of signing of these Financial Statements with discretionary
expenditure carefully controlled. Based on the level of existing cash and expected R&D tax credits, 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.
1.5 Basis of consolidation
The Consolidated Financial Statements incorporate the Financial Statements of the Company and its subsidiaries.
Subsidiary undertakings
Subsidiary undertakings are entities controlled by the Group, generally as a result of owning a shareholding of more than half of the voting rights. The Group controls an
entity when it is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity.
Subsidiary undertakings are consolidated on the basis of the acquisition method of accounting. Under this method of accounting the results of subsidiaries sold
or acquired are included in the consolidated statement of comprehensive income up to, or from the date control passes. Subsidiary undertakings’ accounting policies
are amended where necessary to ensure consistency with the policies adopted by the Group.
Non-controlling interests in the net assets of consolidated subsidiaries are identified separately from the Group’s equity therein. The interests of non-controlling
shareholders may be initially measured at fair value or at the non-controlling interests’ proportionate share of the fair value of the acquired entity’s identifiable net assets.
The choice of measurement is made on an acquisition by acquisition basis. Subsequent to acquisition, the carrying amount of non-controlling interests is the amount
of those interests on initial recognition plus the non-controlling interests’ share of subsequent changes in equity. Total comprehensive income is attributed to non-
controlling interests even if this results in the non-controlling interest having a deficit balance.
Intra-group transactions and balances are eliminated fully on consolidation and the consolidated accounts reflect external transactions only.
60
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 1 Accounting policies continued
1.6 Business combinations
Acquisitions of businesses are accounted for using the acquisition method. The consideration for each acquisition is measured at the aggregate of the fair values
(at the date of exchange) of identifiable assets, liabilities incurred or assumed, and equity instruments issued by the Group in exchange for control of the acquired entity.
Identifiable assets are recognised if the asset is separable or arise from contractual or other legal rights and its fair value can be measured reliably. The excess of the cost
of acquisition over the fair value of the Group’s share of the identifiable net assets, including intangible assets, is recorded as goodwill. If the cost of acquisition is less than
the fair value of the net assets acquired the difference is recognised directly in the income statement as a “bargain purchase”. Acquisition-related costs are charged to the
statement of comprehensive income as incurred.
Where a business combination is achieved in stages, the Group’s previously held interests in the acquired entity are re-measured to fair value at the acquisition date
(i.e. the date at which the Group attains control) and the resulting gain or loss, if any, is taken through the statement of comprehensive income.
1.7 Revenue
Revenue for the sale of instruments, cassettes and reagents “products” and instrument hire, fee-for-service, support and maintenance “services” is measured at the fair
value of the consideration received or receivable for the sale of products and services net of sales taxes, rebates and discounts and excludes intercompany sales.
Sale of products
Revenue from the sale of products is recognised when the significant risks and rewards of ownership of the products are transferred to the customer. This is usually
when a Group company has delivered products to the customer, the customer has accepted delivery of the products and collection of the related receivables
is reasonably assured.
A small number of customers may request “bill and hold” arrangements, where the Group holds the goods sold to the customer on their behalf until the customer
is ready to receive them. Revenue is only recognised on a bill and hold basis when a formal contract is in place, the goods are on hand and are separately identified
as belonging to the customer and are unable to be redirected to an alternative customer, are ready for delivery, and the customer has acknowledged formal acceptance
of the bill and hold transaction.
Sale of services
Revenue from services provided is recognised over the period during which the service has been performed.
Income from support and maintenance is recognised in the period in which the related chargeable costs are incurred and when the service is completed or where
applicable on a straight-line basis over the period of the contract to match the benefits to the customer.
Research and development fees
Revenue from third-party-funded contract research and development agreements is recognised as research and development services are delivered. Where services
are in-progress at the reporting date, the Group recognises revenues proportionately, in line with the percentage of completion of the service.
Licence fee income
Revenue in respect of licence fee income is recognised when the agreement is signed, where the Group is entitled to receive the income, all obligations have been
fulfilled and the agreement is non-cancellable.
Contract liabilities
Advance payments received from customers are credited to contract liabilities and the related revenue is released to the consolidated statement of comprehensive
income in accordance with the recognition criteria described above.
1.8 Cost of sales
Cost of sales for products (Note 1.7) includes the direct costs incurred in manufacturing and bringing products to sale in the market (shipping, installation, training
and evaluation). Cost of sales for services (Note 1.7) includes the direct costs incurred in providing the service (time, travel and parts) and are reflected in costs
of sales as they are incurred.
1.9 Other operating income – grants
Grant income is disclosed as “Other operating income” on the face of the consolidated statement of comprehensive income.
Grant income receivable or received in respect of revenue expenditure is released to the statement of comprehensive income as the related expenditure is incurred
when there is a reasonable assurance that the grant money will be received and any conditions attached to it have been fulfilled. Grant income receivable is held on the
statement of financial position as contract assets and grant income received in advance of expenditure is held on the statement of financial position as contract liabilities.
Grant income receivable or received in respect of capital expenditure is recognised as contract liabilities in the statement of financial position and is released to the
statement of comprehensive income on a straight-line basis over the expected useful life of the related assets.
61
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Notes to the Consolidated Financial Statements
continued
1 Accounting policies continued
1.10 Employee benefits
Share-based payments
IFRS 2 Share-based Payment has been applied to all share-based payments.
Share-based incentive arrangements which allow Group employees to acquire shares of the Company may be provided to employees, subject to certain criteria.
The fair value of options granted is recognised as a cost of employment within operating costs with a corresponding increase in equity. Share options granted are
valued at the date of grant using an appropriate option pricing model and taking into account the terms and conditions upon which they were granted. Market related
performance conditions are taken into account in calculating the fair value, while service conditions and non-market related performance conditions are excluded from
the fair value calculation, although the latter are included in initial estimates about the number of instruments that are expected to vest. The fair value is charged to
operating costs over the vesting period of the award, which is the period over which all the specified vesting conditions are to be satisfied. Options are fully vested and
capable of exercise when the employee becomes unconditionally entitled to the options. The annual charge is modified to take account of revised estimates about the
number of instruments that are expected to vest, for example, options granted to employees who leave the Group during the performance or service condition vesting
period and forfeit their rights to the share options and in the case of non-market related performance conditions, where it becomes unlikely they will vest.
For options granted to employees under unapproved share-based payment compensation schemes, including the Long-Term Incentive Plan, to the extent that the share
price at the reporting date is greater than the exercise price then a provision is made for any employer’s National Insurance Contributions, or equivalent. Share option
agreements in the UK and Canada include a tax indemnity that allows employer’s National Insurance Contributions, or equivalent, to be recovered from the Option
holder and where this is likely to be applied a receivable for such taxes is also recorded, otherwise a charge is made to the statement of comprehensive income.
Pension obligations
Pension costs are charged against profits as they fall due and represent the amount of contributions payable to the Group’s defined contribution pension scheme
or employee personal pension schemes on an individual basis. The Group has no further payment obligations once the contributions have been paid.
Compensated absences
A liability for short-term compensated absences, such as holiday, is recognised for the amount the Group may be required to pay as a result of the unused entitlement
that has accumulated at the reporting date.
1.11 Taxes
Tax on the profit or loss for the period comprises current and deferred tax.
Current tax is the expected tax payable on the taxable income for the period, using tax rates (and laws) that have been enacted or substantively enacted at the
reporting date, and any adjustment to tax payable in respect of previous years.
The Group undertakes research and development activities. In the UK these activities qualify for tax relief and result in tax credits.
Deferred tax is provided for in full on all temporary differences resulting from the carrying value of an asset or liability and its tax base, except where they arise from
the initial recognition of goodwill or from the initial recognition of an asset or liability that at the date of initial recognition does not affect accounting or taxable profit
or loss on a transaction that is not a business combination. Deferred tax is determined using tax rates (and laws) that have been enacted or substantively enacted at
the reporting date and are expected to apply when the related deferred tax liability is settled or deferred tax asset realised.
Deferred tax liabilities are recognised on any increase in the fair value of investments to the extent that substantial shareholdings relief or unutilised losses may be
unavailable. Deferred tax assets are only recognised to the extent that it is probable that future taxable profit will be available against which the temporary differences
can be utilised.
IAS 12 Income Taxes requires the separate disclosure of deferred tax assets and liabilities on the Group’s statement of financial position. If there is a legally enforceable
right to offset current tax assets and liabilities, and they relate to taxes levied by the same tax authority, and the Group intends to settle current tax liabilities and assets
on a net basis, or their tax assets and liabilities will be realised simultaneously, then deferred tax assets and liabilities are offset.
Deferred tax is provided on temporary differences arising on investments in subsidiaries, except where the timing of the reversal of the temporary difference can be
controlled and it is probable that the temporary difference will not reverse in the foreseeable future.
62
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 1 Accounting policies continued
1.12 Intangible assets
Intellectual property (IP)
IP assets (comprising patents, know-how, copyright and licences) are recognised as a purchase at cost or where acquired by the Group as a result of a business
combination are initially recognised at fair value (Note 1.6 – in accordance with IFRS 3 Business Combinations), and are capitalised.
Internally generated IP costs are written off as incurred except where IAS 38 criteria, as described in research and development below, would require such costs
to be capitalised.
The Group’s view is that capitalised IP assets have a finite useful life and to that extent they should be amortised over their respective unexpired periods with provision
made for impairment when required. Capitalised IP assets are not amortised until the Group is generating an economic return from the underlying asset. Amortisation
is calculated using the straight-line method to allocate the costs of IP over their estimated useful economic lives. Estimated useful economic life is based on remaining
patent life or specific terms of licences or agreements, or in the absence of any observable date, ten years. The amortisation period applied to these assets ranges from
8.5 to 19 years. Amortisation is included within operating costs.
Computer software
Under IAS 38 Intangible Assets, acquired computer software should be capitalised as an intangible asset unless it is an integral part of the related hardware (such as the
operating system) where it remains as an item of property, plant and equipment.
Internally developed computer software will be capitalised in accordance with the research and development accounting policy. If the software is developed for in-house
use the capitalised amount is reclassified from research and development to computer software.
Amortisation is calculated using the straight-line method to allocate the cost of the software over its estimated useful economic life and is included within operating
costs. The useful economic life is estimated at three years, unless there are specific circumstances that dictate this should be for a shorter or longer period.
Research and development
Research expenditure is written off as incurred.
Development expenditure is written off as incurred, except where the Directors are satisfied that a new or significantly improved product or process results and other
relevant IAS 38 criteria are met as to the technical, commercial and financial viability of individual projects that would require such costs to be capitalised. In such cases,
the identifiable directly attributable expenditure is capitalised and amortised.
The Group’s view is that capitalised assets have a finite useful life and to that extent they should be amortised over their respective unexpired periods with provision
made for impairment when required. Assets capitalised are not amortised until the associated product is available for use or sale. Amortisation is calculated using the
straight-line method to allocate the costs of development over the estimated useful economic lives. Estimated useful economic life is assessed by reference to the
remaining patent life and may be adjusted after taking into consideration product and market characteristics such as fundamental building blocks and product life cycle
specific to the category of expenditure. The amortisation period applied to these different categories ranges from 5.0 to 13.5 years. Amortisation is included within
operating costs.
Other acquired intangible assets
Other intangible assets acquired by the Group as a result of a business combination that are separable or arise from contractual or other legal rights and can be reliably
measured are initially recognised at fair value (Note 1.6 – in accordance with IFRS 3 Business Combinations) and are capitalised.
The Group’s view is that these acquired intangible assets have a finite useful life and to that extent they should be amortised over their respective unexpired periods
with provision made for impairment when required. Acquired intangible assets are not amortised until the Group is generating an economic return from the underlying
intangible asset. Amortisation is calculated using the straight-line method to allocate the costs over their estimated useful economic lives. Estimated useful economic life
is based on specific terms of contracts and agreements. Amortisation is included within operating costs. The acquired intangible assets that may be recognised and the
amortisation period applied is:
Brands and trademarks
Over the expected useful life of an actively used and/or marketed brand or trademark
Critical supplier contracts and relationships,
including exclusive agreements
Over the term of the agreement or the expected useful life of the relationship
Customer contracts and relationships
Over the term of the contract or the expected useful life of the relationship
Technology*
Over the remaining life of the key patents or the expected useful life (3 to 10 years)
*
Technology includes patents, licensed IP, copyright on software and designs, developed and in-process products, completed and in-process research and development, documented trade secrets such as technical know-how,
manufacturing and operating procedures, methods and processes.
63
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Notes to the Consolidated Financial Statements
continued
1 Accounting policies continued
1.12 Intangible assets continued
Impairment of intangible assets excluding goodwill
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.
An impairment loss is recognised within operating costs for the amount by which the carrying amount in the cash-generating units (CGUs) exceeds its recoverable
amount. The impairment loss is allocated to reduce the assets of the CGUs on a pro-rata basis. The recoverable amount is the higher of the asset’s fair value less
costs to sell and the value-in-use. In the event that an intangible asset will no longer be used, for example, when a patent is abandoned, the balance of unamortised
expenditure is written off. Where intangible assets have suffered an impairment, they are reviewed for possible reversal of the impairment at each reporting date.
Impairment reviews require the estimation of the recoverable amount based on value-in-use calculations. Intangible assets relate typically to in-process development
and patents and require broader assumptions than for developed technology. Key assumptions taken into consideration relate to technological, market and financial
risks and include the chance of product launch taking into account the stage of development of the asset, the scale of milestone and royalty payments, overall market
opportunities, market size and competitor activity, revenue projections, estimated useful lives of assets (such as patents), contractual relationships and discount and
terminal value rates to determine present values of cash flows.
Goodwill
Goodwill arising in a business combination is recognised as an intangible asset at the date of acquisition and represents the excess of the cost of a business combination
over the Group’s interest in the fair value of the identifiable assets, liabilities and contingent liabilities including those intangible assets identified under IFRS 3 Business
Combinations. After initial recognition, goodwill is stated at cost less any accumulated impairment losses.
Goodwill is deemed to have an indefinite useful life and is not amortised, but is reviewed for impairment annually or more frequently if events or changes in
circumstances indicate a potential impairment. Goodwill arising on a business combination is allocated to the associated cash-generating units (CGUs) expected to
benefit from the acquisition and any synergies of the combination. This is then assessed against the estimation of the recoverable amount based on fair value less costs
to sell calculations of the CGUs for impairment. Where the recoverable amount of the CGUs is less than the carrying amount, including goodwill, an impairment loss
is recognised in operating costs. The impairment loss is allocated first to reduce the carrying amount of any goodwill allocated to the CGUs and then to assets of the
CGUs on a pro-rata basis. An impairment loss recognised for goodwill is not reversed in a subsequent period.
1.13 Property, plant and equipment
Property, plant and equipment is stated at historical cost less accumulated depreciation or impairment value. Cost includes the original purchase price and expenditure
that is directly attributable to the acquisition of the items to bring the asset to its working condition. Assets acquired through a business combination are initially
recognised at their fair value. Depreciation is provided at rates calculated to write off the cost less estimated residual value of each asset over its expected useful
economic life. Assets held under finance leases, if any, are depreciated over their expected useful economic life on the same basis as owned assets, or where shorter,
the lease term. Assets are reviewed for impairment when events or changes in circumstances indicate that the carrying amount may not be recoverable.
The following rates are used:
Computer equipment
Fixtures, fittings and equipment
Laboratory equipment
Moulds and tooling
Leasehold improvements
33.33%
20.00% – 33.33%
20.00% – 50.00%
Utilisation basis
Term of the lease
Straight-line
Straight-line
Straight-line
Volume
Straight-line
1.14 Leases
At the inception of a contract the Group assesses whether the contract is, or contains, a lease. A lease is defined as a contract that conveys the right to use an
underlying asset for a period of time in exchange for consideration. The Group applies a single recognition and measurement approach for all leases, except for
short-term leases and leases of low-value assets. The lease liability represents the Group’s obligation to make lease payments and the right-of-use asset representing
the right to use the underlying asset.
In respect of short-term leases and leases of low-value assets, the Group has elected to recognise the payments as an expense in the statement of comprehensive
income on a straight-line basis over the lease term.
64
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
1 Accounting policies continued
1.14 Leases continued
Right-of-use assets
The Group recognises right-of-use assets at the commencement date of the lease (the date the underlying asset is available for use). The right-of-use asset is measured
as cost, which is made up of the initial lease liability, any direct costs incurred, and lease payments made at or before the commencement date net of any lease
incentives received.
The Group depreciates right-of-use assets on a straight-line basis over the shorter of the lease term and the estimated useful lives of the assets over the term
of the lease.
The right-of-use assets are also subject to impairment and are adjusted for any re-measurement of lease liabilities.
Lease liabilities
At the commencement date of the lease, the Group recognises lease liabilities measured at the present value of lease payments, unpaid at the date, to be made over
the lease term.
In calculating the present value of lease payments, the Group uses its incremental borrowing rate at the lease commencement date because the interest rate implicit
in the lease is not readily determinable. After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for
the lease payments made. In addition, the carrying amount of lease liabilities is re-measured if there is a modification, a change in the lease term, a change in the lease
payments (e.g. changes to future payments resulting from a change in an index or rate used to determine such lease payments) or a change in the assessment of an
option to purchase the underlying asset.
Right-of-use assets and lease liabilities are separately identified as line items on the statement of financial position.
Short-term leases and leases of low-value assets
The Group applies the short-term lease recognition exemption to its short-term leases of property and equipment (i.e. leases that have a 12 month or less lease term
from date of commencement and do not contain a purchase option). The Group also applies the lease of low-value assets recognition exemption to leases of office
and laboratory equipment that are considered low value. Lease payments relating to short-term leases and leases of low-value assets are recognised as expense on
a straight-line basis over the lease term.
1.15 Instruments loaned to customers
In order to support the development of the sales platform and use of the Parsortix system in the clinical market, the Parsortix instruments may be placed on long-term
loan with leading cancer research centres (key opinion leaders) so that they can provide valuable feedback on the operation of the instruments and suggest new
uses and protocols, act as reference customers, identify clinical applications and provide clinical data. Where these instruments are expected to be placed for a period
longer than six months, the instruments are transferred at book value to property, plant and equipment and depreciated over three years. Where instruments are
placed on a short-term loan for a customer evaluation and it is expected that the instrument will be sold at the end of the loan period, the instruments are included
within inventories.
1.16 Inventories
Inventories comprises finished goods (instruments, cassettes and production parts) that are available for sale and use internally or with partners, raw materials and
work in progress. Inventories are initially recognised at cost and subsequently held at the lower of cost and net realisable value. Cost is calculated using the weighted
average cost method. Cost includes materials and direct labour. Inventory acquired through business combinations are initially recognised at their fair value. Net realisable
value is the estimated selling price, less all estimated costs of completion and costs to be incurred in marketing, selling and distribution. Provision is made, if necessary,
for any costs of modifications required to bring the asset to a working condition due to new standards and/or regulations, or for slow-moving or obsolete inventory.
If net realisable value is lower than the carrying amount, a write down provision is recognised within operating costs for the amount by which the carrying amount
exceeds its net realisable value.
Inventories of finished goods used for research and development projects are initially recognised at cost, as all inventories are held together and available for sale, and
subsequently charged to research and development expenditure as they are used.
1.17 Employee Share Ownership Trust
The Group has an Employee Share Ownership Trust (ESOT) to assist with meeting the obligations under share option and other employee remuneration schemes.
The ESOT is consolidated as if it is a subsidiary and accounted for as Treasury (own) shares. Shares in ANGLE plc held by the ESOT are stated at weighted average
purchase cost and presented in the statement of financial position as a deduction from equity under the heading of “ESOT shares”. Gain or loss is not recognised
on the purchase or sale of ESOT shares and consideration paid or received is recognised directly in equity. Finance and administration costs relating to the ESOT
are charged to operating costs as incurred.
65
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Notes to the Consolidated Financial Statements
continued
1 Accounting policies continued
1.18 Foreign currency
The Consolidated Financial Statements are presented in Pounds Sterling, which is the Company’s functional and presentational currency. The Group determines the
functional currency of each entity and items included in the Financial Statements of each entity are measured using that functional currency. The functional currencies
of the Group’s operations are Pounds Sterling, US Dollars and Canadian Dollars.
Transactions denominated in foreign currencies are recorded at the rate ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign
currencies are translated at the rates of exchange ruling at the reporting date.
Non-monetary assets and liabilities denominated in foreign currencies and held at cost use the exchange rate at the date of the initial transactions. Non-monetary
assets and liabilities denominated in foreign currencies and held at fair value use the exchange rate at the date that the fair value was determined.
Profits and losses on both the individual transactions during the period and monetary assets and liabilities are dealt with in the statement of comprehensive income.
On consolidation, the statements of comprehensive income of the foreign subsidiaries are translated at the average exchange rates for the period and the statement
of financial position at the exchange rates at the reporting date. The exchange differences arising as a result of translating statements of comprehensive income
at average rates and restating opening net assets at closing rates are taken to the translation reserve. On disposal of a foreign operation, the cumulative amount
recognised in the translation reserve relating to that particular foreign operation is recognised in the statement of comprehensive income.
1.19 Financial instruments
Financial assets and liabilities are recognised in the statement of financial position when the Group becomes a party to the contractual provisions of the instrument.
Cash and cash equivalents
Cash and short-term deposits in the statement of financial position comprise cash at bank and in hand and short-term deposits with an original maturity of three
months or less.
For the purposes of the statement of cash flows, cash and cash equivalents comprise cash and short-term deposits as defined previously and other short-term highly
liquid investments that are readily convertible into cash and are subject to an insignificant risk of changes in value, net of outstanding short-term borrowings.
Deposits
Deposits in the statement of financial position comprise longer-term deposits with an original maturity of greater than three months.
Bank loans, loan notes and borrowings
All loans and borrowings are initially recognised at the fair value of the consideration received net of issue costs associated with the borrowings. After initial recognition,
these are subsequently measured at amortised cost.
Other assets
Assets, other than those specifically accounted for under a separate policy, include trade and other receivables and are recognised at amortised cost. Receivables may be
impaired by means of a provision, to take into account any difficulties in recovering the outstanding amounts. Provisions for impairment are determined by comparing
the carrying value and the likely realisable value, which is defined as the present value of the estimated recoverable amounts.
For trade receivables, expected credit losses are measured by applying an expected loss rate to the gross carrying amount. The expected loss rate comprises the risk
of a default occurring and the expected cash flows on default based on the ageing of the receivable. The risk of a default occurring always takes into consideration
all possible default events over the expected life of those receivables (“the lifetime expected credit losses”). Different provision rates and periods are used based on
groupings of historic credit loss experience by product type, customer type and location.
Other liabilities
Liabilities, other than those specifically accounted for under a separate policy, include trade and other payables and are stated based on their amortised cost at the
amounts which are considered to be payable in respect of goods or services received up to the reporting date.
1.20 Provisions
Provisions are recognised when the Group has a present obligation of uncertain timing or amount as a result of past events, and it is probable that the Group will be
required to settle that obligation and a reliable estimate of the obligation can be made. The provisions are measured at the Directors’ best estimate of the amount to
settle the obligation at the reporting date, and are discounted back to present value if the effect is material. Changes in provisions are recognised in the statement of
comprehensive income for the reporting period.
66
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 1 Accounting policies continued
1.21 Operating segments
The Group determines and presents operating segments based on the reporting information that is provided to the Board of Directors to allow it to make operating
decisions. The Board of Directors is responsible for all significant decisions and collectively is the Chief Operating Decision-Making (CODM) body as defined by IFRS 8
Operating Segments.
An operating segment is a component of the Group that engages in business activities from which it may earn income and incur expenses, including income and
expenses that relate to transactions with any of the Group’s other components. An operating segment’s results are reviewed regularly by the Board of Directors
to make decisions about resources to be allocated to the segment and assess its performance.
1.22 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 (Notes 1.12 and 11)
IAS 38 Intangible Assets contains specific criteria that if met mean development expenditure must be capitalised as an internally generated intangible asset. The carrying
value of the capitalised product development at the reporting date is £3.9 million (30 April 2019: £3.0 million). 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.
Impairment of intangible assets (Notes 1.12 and 11)
The Group is required to review, at least annually, whether goodwill has suffered any impairment and whether the carrying amount may exceed the recoverable amount.
The Group is required to review, at least annually, whether there are indications (events or changes in circumstances) that intangible assets excluding goodwill 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 for the cash-generating unit giving rise to the intangible assets.
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 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 (Notes 1.10 and 19)
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 8)
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.
Leases – calculating the incremental borrowing rate (Notes 1.14 and 13)
As the Group cannot readily determine the interest rate implicit in the lease, it uses its incremental borrowing rate (IBR) to measure lease liabilities. The IBR
is the rate of interest that the Group would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of
a similar value to the right-of-use asset in a similar economic environment. The rate was determined following discussions with our main commercial bank with regard
to our particular circumstances. The rate therefore reflects what the Group ‘would have to pay’, which requires estimation when no observable rates are available
(such as for subsidiaries that do not enter into financing transactions) or when they need to be adjusted to reflect the terms and conditions of the lease (for example,
when leases are not in the subsidiary’s functional currency). The Group estimates the IBR using observable inputs (such as market interest rates) when available and is
required to make certain entity-specific estimates (such as the subsidiary’s stand-alone credit rating).
Leases – extension and/or termination options (Notes 1.1, 1.14 and 13)
The Group has two lease contracts that include extension and/or termination options. The Directors exercise significant judgement in determining whether these
extension and/or termination options are reasonably certain to be exercised, and agreed that it was reasonable to assume that both of these lease contracts would
be extended beyond the termination option/notice period due to significant fit-out and renovations to create specialist laboratories and the prohibitive cost of finding
equivalent alternative accommodation. The impact of including the extension and/or termination options is to increase both the carrying value of the right-of-use assets
and the non-current lease liability at the reporting date by £0.9 million.
67
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Notes to the Consolidated Financial Statements
continued
2 Operating segment and revenue analysis
Operating segment
The Group’s principal trading activity is undertaken in relation to the commercialisation of its Parsortix cell separation system and its HyCEAD Ziplex multiplex analysis
system. There are separate work streams on the Parsortix and HyCEAD Ziplex systems however the HyCEAD Ziplex system is used as the downstream analysis tool
primarily in combination with Parsortix in the ovarian cancer clinical application. There is significant overlap of work between the teams involved in R&D and commercial
activities and as a result the Directors believe that these activities are best shown as one operating segment. All significant decisions are made by the Board of Directors
with implementation of those decisions on a Group-wide basis. The Group manages all overseas R&D and commercial activities from the UK.
Segmental analysis is not considered necessary for one operating segment, as the segment information is substantially in the form of and on the same basis as the
Group’s IFRS information.
Segmental reporting will continue to be reviewed and considered in light of the ongoing development and growth of the Group's businesses.
Revenue analysis
The Group revenues are to the research use market and involve a mix of customers located in various territories. These are early-stage revenues with a modest
customer base.
Significant customers
The Group had one significant customer (revenues in excess of 10% of total revenues) which contributed 10% of Group revenues in the reporting period (year ended
30 April 2019: two significant customers contributing 13% and 12%).
Analysis of revenue from contracts with customers
The Group derives revenues from the sale of products and services in the following geographical regions:
8 months ended
31 December 2019
Year ended
30 April 2019
Product-
related
£’000
288
180
468
Service-
related
£’000
67
46
113
Total
£’000
355
226
581
Product-
related
£’000
499
49
548
Service-
related
£’000
110
20
130
Total
£’000
609
69
678
Europe
North America / RoW
Total
All of the revenues are recognised in line with the Group’s accounting policy (Note 1.7) and have been generated from contracts with customers.
Assets and liabilities related to contracts with customers
Services in-progress but not yet invoiced result in a contract asset and services paid for in advance but not yet delivered result in a contract liability and are recognised
in line with the Group’s accounting policy (Note 1.7). At the point where completed work is invoiced the contract asset is derecognised and a corresponding receivable
is recognised.
Contract assets at the reporting date of £3,000 (30 April 2019: £nil) were subsequently invoiced.
Sales of instruments include a service-based warranty which is renewable annually. Revenue associated with the unexpired warranty period and service is deferred
at the reporting date.
Contract liabilities
At 1 May
Recognised in period, relating to amounts invoiced in prior periods
Deferred at period end relating to amounts invoiced in the current period
At period end
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
47
(39)
46
54
57
(47)
37
47
The Group has applied the practical expedient to disclosure of performance obligations at the reporting date because all contracts with customers have an original
expected duration of one year or less.
The standard credit period allowed for trade receivables is 30 days, although this may be extended such that invoices become payable after completion
of a key milestone.
68
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
3 Costs
Operating costs
Employment costs (Note 5)
Depreciation of property, plant and equipment (Note 12)
Depreciation of right-of-use assets (Note 13)
(Profit)/loss on disposal of property, plant and equipment
Amortisation of intangible assets (Note 11)
Impairment of intangible assets (Note 11)
Operating lease costs (Note 1.1)
Operating lease costs – short-term (Note 13)
Auditor’s remuneration (see below)
Third-party research, development and clinical study costs
Patent and legal costs
Inventories used in research and development
Listed company costs
Foreign exchange
Other operating costs
Total operating costs
Cost of sales
Inventories
Other
Total cost of sales
Total costs
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
3,303
432
219
13
240
–
–
27
93
1,949
74
445
281
35
1,093
8,204
106
36
142
4,737
622
–
8
405
47
372
40
65
2,445
171
325
463
42
1,855
11,597
122
33
155
8,346
11,752
Operating costs are shown net of product development and patent costs capitalised in accordance with IAS 38 (Note 11).
Third-party research and development costs include the cost of clinical studies (patient enrolment, core lab work etc), key opinion leader research agreements,
instrument design, scientific advisory board fees and laboratory supplies.
Auditor’s remuneration
Audit services
Statutory audit of parent and consolidated accounts
Statutory audit of subsidiaries
Non-audit services
Tax compliance services
Total
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
65
10
18
93
57
8
–
65
The Group has taken advantage of the exemption from audit for certain subsidiary undertakings. Audit work is still required on the exempt subsidiaries to support the
Group audit opinion and these costs are included with the “Statutory audit of parent and consolidated accounts”.
69
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notes to the Consolidated Financial Statements
continued
4 Directors’ emoluments
Aggregate emoluments for qualifying services
Employer pension contributions (Note 6)
Sub-total per Directors’ Remuneration Report (page 50)
Employer’s National Insurance contributions
Total
The above includes the following amounts paid in respect of the highest paid Director:
Emoluments for qualifying services
Employer’s National Insurance contributions
Total
Disclosures relating to individual Directors’ emoluments are given in the Directors’ Remuneration Report on page 50.
5
Employment
Employment costs
The aggregate of employment costs of employees (including Directors) for the period was:
Wages and salaries
Social security costs
Pension contribution costs (Note 6)
Share-based payment charge (Note 19)
Total staff costs
Staff costs capitalised as product development
Total staff costs in operating costs (Note 3)
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
311
10
321
36
357
164
21
185
709
10
719
91
810
403
54
457
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
2,830
309
65
3,204
333
3,537
(234)
3,303
4,264
467
101
4,832
332
5,164
(427)
4,737
The key management personnel are the Directors and their remuneration is disclosed in Note 4 and within the Directors’ Remuneration Report on pages 50 and 51.
Number of employees
The average monthly number of employees (including Directors) during the period was:
8 months ended
31 December 2019
Number
Year ended
30 April 2019
Number
67
20
87
50
12
62
Research and development, engineering, manufacturing, quality control and regulatory
Commercial and administrative
Total
70
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Pension costs
6
The Group incurred UK pension contribution charges for the period of £44,832 (year ended 30 April 2019: £86,889) for payment directly to personal pension plan
schemes and £19,686 to the ANGLE auto-enrolment pension scheme (year ended 30 April 2019: £13,923).
Contributions to personal pension plan schemes for the period of £5,858 (30 April 2019: £5,048) and to the ANGLE auto-enrolment pension scheme of £17,518
(30 April 2019: £17,714) were payable at the reporting date and are included in trade and other payables (Note 17).
One Director has received contributions under a defined contribution pension scheme (year ended 30 April 2019: one) – see Directors’ Remuneration Report
on page 50.
7 Net finance income/(costs)
Finance income
Bank interest
Finance costs
Lease liabilities finance charges (Note 1.1)
Other interest charges
Net finance income/(costs)
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
40
(64)
(2)
(26)
28
–
–
28
8 Tax
The Group undertakes research and development activities. In the UK these activities qualify for tax relief resulting in research and development tax credits.
Current tax:
Research and development tax credit receivable for the current period
Prior year adjustment in respect of research and development tax credit
Deferred tax:
Origination and reversal of timing differences
Tax charge/(credit)
Profit/(loss) before tax
Corporation tax:
Tax on profit/(loss) at 19.0% (year ended 30 April 2019: 19.0%)
Factors affecting charge:
Permanent differences
Excess of depreciation (over)/under capital allowances
Enhanced research and development relief
Share-based payments
Unutilised losses carried forward
Other tax adjustments
Prior year adjustment
Tax charge/(credit)
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
(1,553)
71
–
(1,482)
(1,869)
(70)
–
(1,939)
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
(7,730)
(10,871)
(1,469)
(2,065)
–
(40)
(873)
63
749
17
71
11
3
(821)
63
909
31
(70)
(1,482)
(1,939)
71
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notes to the Consolidated Financial Statements
continued
8 Tax continued
The rate of tax used in the above reconciliation is the weighted average rate of tax applicable to the profit/losses of the consolidated entities in their respective countries.
The Group has accumulated losses available to carry forward against future trading profits of £41.5 million (30 April 2019: £36.5 million). No deferred tax asset has
been recognised in respect of tax losses since it is uncertain at the reporting date as to when future profits will be available against which the unused tax losses can be
utilised. The estimated value of the deferred tax asset not recognised, measured at a weighted average rate of 18.9% (30 April 2019: 20.0%) is £7.5 million (30 April
2019: £7.4 million).
The Finance (No 2) Act 2016, which provides for reductions in the main rate of corporation tax from 20% to 19% effective from 1 April 2017 and to 17% effective
from 1 April 2020, was substantively enacted on 26 October 2016. However, on 17 March 2020, the rate reduction to 17% was repealed and the rate remains at 19%
with effect from 1 April 2020.
Earnings/(loss) per share
9
The basic and diluted earnings/(loss) per share is calculated by dividing the after tax loss for the eight month period attributable to the owners of the parent
of £6.2 million (year ended 30 April 2019: £8.9 million) by the weighted average number of shares in the period.
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 both the 2019 reporting periods, share options are non-dilutive for those 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.
Profit/(loss) for the period attributable to owners of the parent
Weighted average number of Ordinary shares
Weighted average number of ESOT shares
Weighted average number of Ordinary shares – basic
Effect of potential dilutive share options
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
(6,248)
(8,942)
Number
of shares
163,795,270
(113,259)
163,682,011
–
Number
of shares
136,511,727
(113,259)
136,398,468
–
Adjusted weighted average number of Ordinary shares – diluted
163,682,011
136,398,468
(3.82)
(6.56)
Class of
share held
Holding
%
Common
Ordinary
Common and Preferred
Ordinary
Ordinary
Ordinary
Ordinary
Membership units
Membership units
100
100
100
100
100
100
100
100
100
Principal activity
Medical diagnostics
Medical diagnostics
Medical diagnostics
Medical diagnostics
Medical diagnostics
Dormant
Dormant
Dormant
Dormant
Earnings/(loss) per share attributable to owners of the parent
Basic and Diluted (pence per share)
Investments
10
The Company has investments in the following subsidiaries:
Company name
ANGLE Biosciences Incorporated(1)
ANGLE Europe Limited(1)
ANGLE North America Incorporated
ANGLE Technology Limited(1)
ANGLE Technology Ventures Limited
ANGLE Partnerships Limited(1)
ANGLE Technology Licensing Limited
ANGLE Technology LLC
ANGLE Technology Ventures LLC
(1) Subsidiary held directly
72
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Investments continued
10
The Group structure is in the process of being further rationalised.
The Group has taken advantage of the exemption from audit in accordance with section 479A of the Companies Act 2006 for ANGLE Technology Limited and
ANGLE Technology Ventures Limited.
ANGLE Biosciences Incorporated is incorporated and registered in British Columbia, Canada. Its registered address is 725 Granville Street, Suite 400, Vancouver, British
Columbia, V7Y 1G5, Canada.
ANGLE Europe Limited, ANGLE Technology Limited, ANGLE Technology Ventures Limited, ANGLE Partnerships Limited and ANGLE Technology Licensing Limited
are incorporated and registered in England and Wales. Their registered address is 10 Nugent Road, Surrey Research Park, Guildford, Surrey, GU2 7AF, UK.
ANGLE North America Incorporated, ANGLE Technology LLC and ANGLE Technology Ventures LLC are registered in the US. ANGLE North America’s registered
address is 1150 1st Avenue, Suite 1010, King of Prussia, PA 19406, USA. ANGLE Technology LLC and ANGLE Technology Ventures LLC registered address is Rees
Broome, PC, 1900 Gallows Road STE 700, Tysons Corner, VA 22182.
11
Intangible assets
Cost
At 1 May 2018
Additions
Disposals
Exchange movements
At 30 April 2019
Additions
Exchange movements
At 31 December 2019
Amortisation and impairment
At 1 May 2018
Charge for the year
Disposals
Impairment
Exchange movements
At 30 April 2019
Charge for the period
Exchange movements
At 31 December 2019
Net book value
At 31 December 2019
At 30 April 2019
Acquired
intangible
assets
£’000
Goodwill
£’000
2,207
–
–
–
2,207
–
–
1,213
–
–
1
1,214
–
2
Intellectual
Product
property development
£’000
£’000
809
95
–
12
916
57
(3)
2,385
1,558
(3)
79
4,019
1,053
(23)
2,207
1,216
970
5,049
–
–
–
–
–
–
–
–
–
2,207
2,207
87
143
–
–
–
230
96
1
327
889
984
181
42
–
47
6
276
25
(2)
758
220
(3)
–
42
1,017
119
(21)
299
1,115
1,741
671
640
3,934
3,002
7,701
6,833
Total
£’000
6,614
1,653
(3)
92
8,356
1,110
(24)
9,442
1,026
405
(3)
47
48
1,523
240
(22)
The goodwill arose on the acquisition of the assets of Axela Inc. on 1 November 2017. It 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, the advantages of the
combination of Parsortix and HyCEAD Ziplex technologies enabling sample-to-answer tests, capturing more of the value chain and competitive differentiation.
73
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notes to the Consolidated Financial Statements
continued
Intangible assets continued
11
Goodwill is deemed to have an indefinite useful life, is carried at fair value and is reviewed for impairment annually or more frequently if events or changes in
circumstances indicate a potential impairment.
Goodwill acquired in a business combination is allocated at acquisition to the cash-generating units (CGUs) that are expected to benefit from that business combination.
The goodwill has been allocated to the combined Group as a single CGU for the purposes of the impairment review, since this is the lowest level within the entity
at which management monitors goodwill and the related cash flows are primarily generated from a combined existing and acquired technology product offering.
The whole Group is expected to benefit from the business combination.
The carrying amount of goodwill has been assessed by reference to the fair value less costs to sell of the single CGU, which comprises the combined Group. The fair
value of the Group can be estimated by reference to the market capitalisation of ANGLE plc, which at 31 December 2019 stood at £108.3 million, and which after
taking into account any possible costs of disposal exceeds the carrying amount of the CGU by a considerable margin.
“Acquired intangible assets“ also relates to the acquisition of the assets of Axela Inc. and comprises the fair value of the identifiable intangible assets arising at the date
of acquisition. This comprises mainly the technology but also some modest amounts for customer contracts and relationships and critical supplier contracts and
relationships. Identifiable intangible assets are amortised over their expected useful economic life.
“Product development” relates to internally generated intangible assets that were capitalised in accordance with IAS 38 Intangible Assets (Note 1.12). A negligible
amount relating to other computer software has been combined in the total. 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 £2.6 million (30 April 2019: £2.3 million) in relation to the
FDA development work.
The carrying value of intangible assets excluding goodwill 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 and terminal value rate to determine the net
present value of these cash flows. Where fair value less costs to sell exceeds the carrying value then no impairment is made. Where fair value less costs to sell 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.
74
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
12 Property, plant and equipment
Cost
At 1 May 2018
Additions
Disposals
Transfers (to)/from inventories
Exchange movements
At 30 April 2019
Additions
Disposals
Transfers (to)/from inventories
Exchange movements
At 31 December 2019
Depreciation
At 1 May 2018
Charge for the year
Disposals
Transfers (to)/from inventories
Exchange movements
At 30 April 2019
Charge for the period
Transfers (to)/from inventories
Exchange movements
At 31 December 2019
Net book value
At 31 December 2019
At 30 April 2019
Leasehold
improvements
£’000
Computer
equipment
£’000
Laboratory
equipment
and tooling
£’000
Fixtures,
fittings and
equipment
£’000
250
69
–
–
–
319
1
–
–
–
65
35
(8)
–
–
92
20
–
–
–
2,060
198
(19)
(18)
30
2,251
451
(13)
66
5
86
67
–
–
1
154
3
–
–
(1)
Total
£’000
2,461
369
(27)
(18)
31
2,816
475
(13)
66
4
320
112
2,760
156
3,348
50
51
–
–
–
101
42
–
–
143
177
218
26
26
(8)
–
–
44
22
–
–
66
46
48
842
521
(11)
(131)
10
1,231
350
(54)
(6)
68
24
–
–
1
93
18
–
(1)
986
622
(19)
(131)
11
1,469
432
(54)
(7)
1,521
110
1,840
1,239
1,020
46
61
1,508
1,347
Laboratory equipment includes a carrying value of £308,207 (30 April 2019: £350,531) in relation to Parsortix instruments being used in-house and on long-term loan
to key opinion leaders, including instruments for the FDA and ovarian cancer clinical studies. Tooling includes amounts in relation to moulds for the productionisation of
cassettes, enabling higher volume production, lower pricing and compliance with medical device manufacturing quality requirements.
Depreciation charges are charged to operating costs in the consolidated statement of comprehensive income.
75
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notes to the Consolidated Financial Statements
continued
13 Leases
The Group has lease contracts for office accommodation and specialist laboratories. These lease contracts generally have lease terms between 4 and 10 years,
with earlier break clauses in some cases. The Group’s obligations under its leases are secured by the lessor’s title.
As set out in Note 1.1, the Group has used the “modified retrospective approach” to the implementation of IFRS 16 under which a lessee does not have to restate
comparative information. Accordingly, no comparatives are stated in the notes below.
The carrying amounts of right-of-use assets recognised and the movements during the period are shown below:
Right-of-use assets
Laboratory and office premises
At I May 2019
Depreciation
Exchange movements
Total
The carrying amounts of lease liabilities and the movements during the period are shown below:
Lease liabilities
At I May 2019
Payments in the period
Accretion of interest
Exchange movements
Total
Non-current
Current
Total
31 December 2019
£’000
1,718
(219)
15
1,514
31 December 2019
£’000
1,718
(244)
64
15
1,553
1,201
352
1,553
The Group had total cash outflows for leases of £243,798 for the period.
The Group has two lease contracts that include extension and/or termination options. The Directors exercise significant judgement in determining whether these
extension and termination options are reasonably certain to be exercised (see Note 1.22) and agreed that it was reasonable to assume that both of these lease
contracts would be extended beyond the termination option/notice period due to significant fit-out and renovations to create specialist laboratories and the prohibitive
cost of finding equivalent alternative accommodation.
The Group also holds certain leases with lease terms of 12 months or less and leases of low-value office equipment. The Group applies the ‘short-term lease’ and ‘lease
of low-value assets’ recognition exemptions for these leases. Payments made under such leases are expensed on a straight-line basis and the expense recorded in the
period relating to such leases was £27,351.
Maturity analysis of the undiscounted lease payments:
Undiscounted lease payments at 31 December 2019
Within 1
year
£’000
375
1 to 2
years
£’000
432
2 to 5
years
£’000
742
More than
5 years
£’000
274
76
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
14 Financial risk management
Overview
The Group is exposed, through its normal operations, to a number of financial risks, the most significant of which are credit, liquidity and investment (market) risks.
The Group’s financial instruments comprise cash, trade and other receivables and trade and other payables which arise directly from its operations, and from time
to time treasury deposits, overdrafts and finance leases.
It is the Group’s policy that no trading in financial derivatives shall be undertaken.
Financial assets
Financial assets of the Group comprise cash at bank and in hand as well as treasury deposits, trade and other receivables (Note 16). It is the Group’s policy to place
surplus cash resources on deposit at both floating and fixed term deposit rates of interest with the objective of maintaining a balance between accessibility of funds and
competitive rates of return. Fixed term deposits are for varying periods ranging from one to six months, to the extent that cash flow can be reasonably predicted.
Financial liabilities
Financial liabilities of the Group in the normal course of business comprise trade and other payables (Note 17), overdraft facilities and finance leases. It is the Group’s
policy to use various financial instruments with floating and fixed rates of interest with the objective of maintaining a balance between continuity of funding, matching
the liability with the use of the asset and finding flexible funding options for a reasonable charge.
The Group currently does not utilise overdraft facilities or finance leases. The Group has no long-term borrowings or undrawn committed borrowing facilities.
The Group is currently not exposed to any interest rate risk on its financial liabilities.
Liquidity risk
The principal risk to which the Group is exposed is liquidity risk, which is that the Group will not be able to meet its financial obligations as they fall due. The Group
seeks to manage liquidity through planning, forecasting, careful cash management and managing the operational risk.
The nature of the Group’s activities means it finances its operations through earnings and the issue of new shares to investors. The principal cash requirements are
in relation to funding operations and meeting working capital requirements.
The Company may also find it difficult to raise additional capital to develop its business depending on progress with meeting milestones and/or market conditions.
Sensitivity analysis examining a small percentage increase and decrease in liquidity is of limited use and accordingly no analysis has been shown.
Capital risk management
The Group defines the capital that it manages as the Group’s total equity. The Group’s objectives when managing capital are to:
• safeguard the Group’s ability to continue as a going concern;
• have available the necessary financial resources to allow the Group to meet milestones and deliver benefits from its operational activities; and
• optimise the return to investors based on the level of risk undertaken.
In order to maintain or adjust the capital structure, the Group may issue new shares or pay dividends or return capital to shareholders through share buybacks.
The Group’s capital and equity ratios are shown in the table below:
Total equity attributable to owners of the parent
Total assets
Equity ratio
31 December 2019
£’000
30 April 2019
£’000
30,324
34,302
88.4%
19,336
23,020
84.0%
Credit risk
The Group’s credit risk is attributable to its cash and cash equivalents and trade receivables and other receivables. The Group’s risk on cash and cash equivalents
is limited as funds are held in banks with the highest credit ratings. The risk for trade receivables is that a customer fails to pay for goods or services received and
the Group suffers a financial loss. The Group’s objective with respect to credit risk is to minimise the risk of default by customers. For private and overseas clients
Group policy is to assess the credit quality of each customer and where appropriate seek full or part-payment in advance.
The maximum exposure to credit risk at the reporting date is represented by the carrying amount of the assets described above.
77
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notes to the Consolidated Financial Statements
continued
14 Financial risk management continued
Interest rate risk
There is currently no interest rate risk on financial assets and liabilities.
Cash held on deposit of £18.1 million earns interest at fixed rates of between 0.03% and 0.95% (30 April 2019: £10.2 million 0.03% and 1.40%). Fixed rate deposits
of £10.2 million at 30 April 2019 were mis-classified as floating rate deposits.
There is currently no interest rate risk on financial liabilities as the Group has no interest bearing loans and borrowings.
All amounts, excluding lease liabilities, have maturity dates of less than 12 months (30 April 2019: £nil was greater than 12 months). Contractual maturities in respect
of lease obligations are disclosed in Note 13 on page 76.
Foreign currency risk
The Group has overseas subsidiaries whose income and expenses are primarily denominated in US Dollars (USD) and Canadian Dollars (CAD). As a result the
Consolidated Financial Statements will be affected by movements in the USD:Sterling and CAD:Sterling exchange rates.
The majority of the Group’s operating revenues and expenses are in Sterling, Euros, USD and CAD. Sales are priced in Sterling, Euros and USD although the Group
may have a limited amount of revenues denominated in other currencies. The Group monitors its currency exposures on an ongoing basis and is building US and
European sales which provide a natural hedge. Excess exposure, if any, may be managed for all significant foreign currencies using forward currency contracts or
currency swaps.
Sensitivity analysis
The impact of a 5% variation in currency exchange rates on the profit/(loss) for the period is as follows:
8 months ended
8 months ended
31 December 2019 31 December 2019
CAD
£’000
USD
£’000
Profit/(loss) – 5% strengthening
Profit/(loss) – 5% weakening
(100)
111
(86)
95
Hedging
The Group did not hedge its financial transactions in the periods ending 31 December 2019 or 30 April 2019.
Currency profile
The Group’s financial assets and financial liabilities which are stated at amortised cost have the following currency profile:
Year ended
30 April 2019
USD
£’000
(167)
184
Year ended
30 April 2019
CAD
£’000
(109)
120
Sterling
£’000
USD
£’000
Euro
£’000
CAD
£’000
31 December 2019
Total
£’000
Sterling
£’000
USD
£’000
Euro CAD
£’000
£’000
30 April 2019
Total
£’000
Financial assets:
Trade and other receivables
–
Cash and cash equivalents 18,288
Total
18,288
Financial liabilities:
Lease liabilities – non-current 692
139
Lease liabilities – current
836
Trade and other payables
Total
1,667
40
192
232
122
44
801
967
188
110
298
–
–
188
188
–
176
176
387
169
117
673
228
18,766
18,994
28
10,421
10,449
1,201
352
1,942
3,495
–
–
1,398
1,398
22
178
200
–
–
294
294
73
315
388
–
–
1,311
1,311
–
96
96
–
–
215
215
123
11,010
11,133
–
–
3,218
3,218
Fair values of financial assets and liabilities
The Directors believe that the fair value and the book value of financial assets and financial liabilities are not materially different. Trade payables and receivables have
a remaining life of less than one year so their value on the consolidated statement of financial position is considered to be a fair approximation of fair value.
78
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
15
Inventories
Raw materials and work in progress
Finished goods
Total
16 Trade and other receivables
Current assets:
Trade receivables
Other receivables
Prepayments and contract assets
Total
31 December 2019
£’000
30 April 2019
£’000
–
788
788
18
970
988
31 December 2019
£’000
30 April 2019
£’000
139
167
321
627
123
358
461
942
Other receivables principally comprise recoverable taxes (VAT and HST).
All trade and other receivable accounts are short-term. The Directors consider the carrying amount of trade and other receivables to approximate their fair value and
that all the above financial assets are of good credit quality and no changes have been experienced since initial recognition. Receivables are unsecured and interest free,
unless past their due date when interest may be charged.
The Group has applied the IFRS 9 simplified approach to measuring expected credit losses, and the expected credit loss rates are based on historical experience that
the risk of loss is low. On this basis any credit loss provision would be negligible and no provision has been made.
Age profile of trade receivables:
Not past due
0 – 30 days past due
30 – 60 days past due
> 60 days past due
Total
31 December 2019
£’000
30 April 2019
£’000
114
24
1
–
139
41
25
14
43
123
The standard credit period allowed for trade receivables is 30 days, although this may be extended such that invoices become payable after completion of a key milestone.
17 Trade and other payables
Current liabilities:
Trade payables
Other taxes and social security costs
Other payables
Accruals and contract liabilities
Total
31 December 2019
£’000
30 April 2019
£’000
914
294
23
1,194
2,425
1,540
246
22
1,876
3,684
Accruals include amounts for professional fees, vacation, salary and bonuses (Note 23). Contract liabilities include amounts for pre-billed revenues (Note 2).
All trade and other payables are short-term. The Directors consider that the carrying value of trade and other payables are a reasonable approximation of fair value.
The contractual maturity of all the amounts above are within one year of the reporting date.
79
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notes to the Consolidated Financial Statements
continued
18 Share capital
The share capital of the Company is shown below:
Allotted, called up and fully paid
172,771,483 (30 April 2019: 143,486,522) Ordinary shares of £0.10 each
The Company has one class of Ordinary shares which carry no right to fixed income.
31 December 2019
£’000
30 April 2019
£’000
17,277
14,349
The Company issued 29,268,294 new Ordinary shares with a nominal value of £0.10 at an issue price of £0.615 per share in a subscription of shares realising gross
proceeds of £18.0 million. Shares were admitted to trading on AIM in July 2019.
The Company issued 16,667 new Ordinary shares with a nominal value of £0.10 at an exercise price of £0.385 per share as a result of the exercise of share options
by an employee. Shares were admitted to trading on AIM in December 2019.
19 Share-based payments
The key disclosures that enable the user of the Financial Statements to understand the nature and extent of share-based payment charges through the statement
of comprehensive income in relation to ANGLE plc shares are detailed below.
The share-based payment charge for the Company Employee Share Option Schemes and Long-Term Incentive Plan (LTIP) was £332,817 (year ended 30 April 2019:
£331,553).
Company – Share Option Schemes
The Company operates Share Option Schemes as a means of encouraging ownership and aligning interests of staff and external shareholders. The Company also
operates an LTIP for Executive Directors. These are a key part of the remuneration package and granted at the discretion of the Remuneration Committee taking
into account the need to motivate, retain and recruit high calibre executives and staff.
Each scheme is governed by a specific set of rules and administered by the Directors of the Company. Options are generally granted at the market price of the shares
on the date of grant, except for “Bonus Options” and “LTIP Options”. Options granted may have a service condition and/or a non-market performance condition
and/or a market performance condition (such as a target share price). If the performance conditions are not met, the options do not vest and will lapse at the date
specified at the time of grant. Options are forfeited if the employee leaves the Group before the awards vest unless the conditions under which they leave are such
that they are considered to be a “good leaver”; in this case some or all of their options may remain exercisable for a limited period of time, subject to any performance
condition having been met. Options lapse if they are not exercised by the date they cease to be exercisable. LTIP Options also have an additional holding period
of up to two years such that the minimum performance and holding period is five years.
EMI Share Option Scheme and Unapproved Share Option Schemes
The Company has an Enterprise Management Incentive (EMI) Share Option Scheme and Unapproved Share Option Schemes for the United Kingdom, Canada and the
United States. Share options are granted under a service condition and/or a non-market performance condition and/or a market performance condition. Options cease
to be exercisable after ten years from the date of grant or on an earlier specified date.
The movement in the number of employee share options is set out below:
Outstanding at 1 May
During the period:
Granted
Exercised
Forfeited/lapsed
Outstanding at period end
31 December 2019 31 December 2019
Weighted
average
exercise
price (£)
Number
of share
options
#
13,795,806
–
(16,667)
(883,333)
12,895,806
0.5432
–
0.3850
0.4221
0.5517
30 April 2019
Number
of share
options
#
10,325,806
4,345,000
–
(875,000)
13,795,806
Capable of being exercised at period end
4,715,805
0.4640
3,497,475
30 April 2019
Weighted
average
exercise
price (£)
0.6235
0.3935
–
0.7477
0.5432
0.4699
The options outstanding at 31 December 2019 had a weighted average remaining contractual life of five years and ten months (30 April 2019: six years and
nine months).
80
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
19 Share-based payments continued
The Company uses a Trinomial option pricing model as the basis to determine the fair value of the Company’s share options.
The following assumptions are used in the model to determine the fair value of share options at the respective date of grant that are still outstanding at
31 December 2019:
Date of grant
30 August 2011
18 November 2011
5 November 2012
5 November 2012
11 December 2013
18 July 2014
10 November 2014
10 November 2014
31 March 2015
12 November 2015
1 March 2016
25 November 2016
25 November 2016
1 November 2017
1 November 2017
16 November 2017
20 August 2018
20 December 2018
20 December 2018
Total
Exercise
price (£)
Share price
at date
of grant (£)
Expected
volatility
Risk free
interest rate
Expected
life of
option
(years)
Expected
dividends
Vesting
conditions
Outstanding
share
options
0.2575
0.7550
0.2575
0.7550
0.7300
0.7500
0.8625
0.8625
0.8625
0.1000
0.5650
0.6450
0.6450
0.4000
0.4000
0.4025
0.4900
0.3850
0.3850
0.2575
0.7550
0.3750
0.3750
0.7300
0.7500
0.8625
0.8625
0.7850
0.7550
0.5650
0.6450
0.6450
0.4000
0.4000
0.4025
0.4900
0.3850
0.3850
45.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
40.00%
1.06%
0.62%
0.35%
0.23%
0.97%
1.40%
1.53%
1.03%
0.67%
0.68%
0.42%
0.30%
0.30%
0.57%
0.57%
0.55%
0.77%
0.75%
0.75%
3.5
2.5
3.0
2.0
3.0
3.0
5.0
3.0
3.0
2.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
(1)
(2)
(1)
(2)
(3)
(4)
(5)
(4)
(4)
(6)
(4)
(4)
(7)
(8)
(4)
(4)
(4)
(4)
(9)
1,189,353
1,197,315
380,647
312,685
490,000
40,000
1,500,000
20,000
390,000
120,806
150,000
1,100,000
1,500,000
500,000
450,000
100,000
100,000
1,355,000
2,000,000
12,895,806
Expected volatility was derived from observation of the volatility of quoted shares in similar sectors to the Company and observation of the historic volatility of the
Company’s shares, adjusted for any unusual historic events and expected changes to future volatility. The expected life used in the model is based on management’s
best estimate taking into account the effects of non-transferability, exercise restrictions, behavioural conditions and expected future events.
The share options issued were subject to both performance and service (employment) conditions:
(1) Vesting is subject to a) a performance condition that the Company’s share price together with any dividend payments has risen by at least 50% at some point
from the market price on 30 August 2011, and b) a service condition with options vesting over a three-year period. These conditions have been met and the
options are fully vested and capable of exercise.
(2) Vesting is subject to a) the performance conditions that (i) the Company’s share price must have increased to £2.00 at some point since the date of grant and
(ii) the Parsortix separation device must have been demonstrated to successfully capture circulating tumour cells from cancer patient blood (this condition has
been met), and b) a service condition with options vesting over a three-year period (this condition has been met).
(3) Vesting is subject to a) specific performance conditions for senior management and b) a service condition with options vesting over a three-year period.
(4) Vesting is subject to a service condition with options vesting over a period up to three years.
(5) Vesting is subject to the performance conditions that a) the Company’s share price must have increased to £2.00, £2.25, £2.50 and £2.75 at some point since
the date of grant for each quarter of the allocation and b) a time/event condition with options vesting after five years or on the sale of the Parsortix business,
whichever is earliest.
(6) Options were granted as Bonus Options in accordance with the Remuneration Committee’s discretion to settle an element of the Annual Bonus in the form
of share options. The Bonus Options vest immediately and are exercisable at par value.
(7) Vesting is subject to a) a performance condition that the Company’s share price has risen by at least 100% at some point from the market price on 25 November
2016, and b) a service condition with options vesting over a three-year period.
(8) Vesting is subject to a) a performance condition that the Company’s share price has risen by at least 100% at some point from the market price on 1 November
2017 (this condition has been met), and b) a service condition with options vesting over a three-year period.
(9) Vesting is subject to a performance condition that the Company’s share price has risen to at least £1.056 on 21 December 2021.
Once all performance and/or service conditions have been met the employee becomes unconditionally entitled to the options and they are capable of exercise.
Based on these performance and/or service conditions a number of options have vested and become capable of exercise. 16,667 options were exercised in the period
(year ended 30 April 2019: nil).
81
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notes to the Consolidated Financial Statements
continued
19 Share-based payments continued
Long-Term Incentive Plan
The Company has a Long-Term Incentive Plan (LTIP) for Executive Directors. Disclosures for an award made during the prior year are set out in the Directors’
Remuneration Report on pages 50 and 51.
The Company uses a Trinomial option pricing model as the basis to determine the fair value of the Company’s LTIP Options.
The following assumptions are used in the model to determine the fair value of LTIP Options at the respective date of grant that are still outstanding at
31 December 2019:
Date of grant
20 December 2018
20 December 2018
20 December 2018
Total
20 ESOT shares
At period end
Exercise
price (£)
0.0000
0.0000
0.0000
Share price
at date
of grant (£)
Expected
volatility
Risk free
interest rate
0.3850
0.3850
0.3850
40.00%
40.00%
40.00%
0.88%
0.88%
0.88%
Expected
life of
option
(years)
5.0
5.0
5.0
Barrier
Expected
dividends
(Performance Outstanding
LTIP
Options
condition)
(£)
Nil
Nil
Nil
1.056
1.434
2.063
1,200,000
1,800,000
3,000,000
6,000,000
31 December 2019
£’000
30 April 2019
£’000
102
102
Employee Share Ownership Trust (ESOT) shares are ANGLE plc shares held by the ANGLE Employee Trust. At 31 December 2019 the Trust held 113,259 shares
(30 April 2019: 113,259 shares). The market value of these shares at 31 December 2019 was £71,013 (30 April 2019: £86,077). Shares purchased by the ANGLE
ESOT are used to assist in meeting the obligations under employee remuneration schemes.
21 Contingent liabilities
Geomerics Limited was sold to ARM Holdings plc in December 2013. As is normal for this type of transaction, the Sale and Purchase Agreement contained
various warranties given by the sellers to the buyer and the warrantors have indemnified the buyer in respect of any claims against Geomerics Limited in connection
with the business prior to acquisition. The warranties comprise a general warranty claim period of two years (now expired), an IP warranty claim period of four years
(now expired) and a fundamental/tax warranty claim period of seven years (expires December 2020). In the unlikely event a claim is made and determined as valid then
any amounts would be recoverable from the warrantors up to a capped amount.
22 Guarantees and other financial commitments
The Group has a number of retainers with professional advisors which can be terminated on short notice periods.
During the period, the Group entered into certain commitments in relation to the development of the Parsortix cancer diagnostic product. In aggregate these gave rise
to financial commitments of up to £1.0 million over one year (30 April 2019: £1.7 million).
The Group has taken advantage of the exemption from audit in accordance with section 479A of the Companies Act 2006 for ANGLE Technology Limited and
ANGLE Technology Ventures Limited. ANGLE plc has provided a statutory guarantee over these subsidiaries’ liabilities in accordance with section 479C of the
Companies Act 2006.
Other than these, the Group has no contractual commitments to provide financial support to its investments.
82
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
23 Related party transactions
Transactions between subsidiaries within the Group are not disclosed as they are eliminated on consolidation.
Directors’ interests – related party interests and transactions
Apart from the interests disclosed in the Directors’ Remuneration Report on pages 50 and 51 and below, none of the Directors had any interest at any time during
the period ended 31 December 2019 in the share capital of the Company or its subsidiaries.
At the reporting date, £nil of remuneration (30 April 2019: £164,227) was due to Andrew Newland and £nil of remuneration (30 April 2019: £104,508) was due
to Ian Griffiths.
Brian Howlett entered into a consultancy contract with effect from 7 January 2013 to provide specialist commercial advice outside of his normal Board responsibilities.
Consultancy fees of £nil were paid in the period to Brian Howlett under this contract (year ended 30 April 2019: £nil).
SoBold Limited provides digital marketing services and website management to ANGLE with fees in the period of £25,450 (year ended 30 April 2019: £37,850)
and a balance of £7,440 (30 April 2019: £3,720) due at the reporting date. Andrew Newland’s son is the managing director and a main shareholder of SoBold Limited.
The relationship is managed by Business Development Director, Michael O’Brien.
No other Director had a material interest in a contract, other than a service contract, with the Company or its subsidiaries, or investments during the period.
24 Post reporting date event
As reported in the Chairman’s Statement and elsewhere, the Company has had some short-term negative impacts from government lock downs associated
with COVID-19. Although this has created some uncertainty and a need to adapt the operating model it is not expected to have any significant long-term impact
on the Company.
83
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Company Statement of Financial Position
As at 31 December 2019
Assets
Investment in subsidiaries
Other receivables
Cash and cash equivalents
Total assets
Equity
Share capital
Share premium
Share-based payments reserve
Retained earnings
Equity attributable to owners
31 December 2019
£’000
Note
30 April 2019
£’000
C3
C4
C5
4,476
34,560
17,695
56,731
17,277
67,272
1,495
(29,313)
56,731
4,143
32,635
9,438
46,216
14,349
53,273
1,243
(22,649)
46,216
The Company’s loss and total comprehensive loss for the eight month period to 31 December 2019 were £6,745,487 (year ended 30 April 2019: £978,700).
The Financial Statements on pages 84 to 87 were approved by the Board and authorised for issue on 24 June 2020 and signed on its behalf by:
Ian F Griffiths
Director
Andrew D W Newland
Director
Registered No. 04985171
84
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Company Statement of Cash Flows
For the period ended 31 December 2019
Operating activities
Profit/(loss) before tax
Adjustments for:
Impairment of loans
Net cash from/(used in) operations
Investing activities
Loans to subsidiaries
Net cash from/(used in) investing activities
Financing activities
Net proceeds from issue of share capital
Net cash from/(used in) financing activities
Net increase/(decrease) in cash and cash equivalents
Cash and cash equivalents at start of period
Cash and cash equivalents at end of period
8 months ended
31 December 2019
£’000
Year ended
30 April 2019
£’000
(6,745)
6,745
–
(8,664)
(8,664)
16,921
16,921
8,257
9,438
17,695
(979)
979
–
(8,988)
(8,988)
11,996
11,996
3,008
6,430
9,438
Company Statement of Changes in Equity
For the period ended 31 December 2019
At 1 May 2018
For the year to 30 April 2019
Profit/(loss) for the year
Issue of shares (net of costs)
Share-based payments
Released on forfeiture
At 30 April 2019
For the 8 month period to 31 December 2019
Profit/(loss) for the period
Issue of shares (net of costs)
Share-based payments
Released on forfeiture
Released on exercise
Equity attributable to owners
Share
capital
£’000
Share
premium
£’000
Share-based
payments
reserve
£’000
Retained
earnings
£’000
Total
equity
£’000
11,709
43,449
1,049
(21,808)
34,399
2,640
9,824
(979)
138
(979)
12,464
332
–
332
(138)
14,349
53,273
1,243
(22,649)
46,216
2,928
13,999
(6,745)
78
3
(6,745)
16,927
333
–
–
333
(78)
(3)
At 31 December 2019
17,277
67,272
1,495
(29,313)
56,731
85
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notes to the Company Financial Statements
For the period ended 31 December 2019
C1 Accounting policies
C1.1 Basis of preparation
The Parent Company Financial Statements have been prepared in accordance with International Financial Reporting Standards (IFRS) in issue that have been endorsed
by the EU for the eight month period ended 31 December 2019. They have also been prepared in accordance with those parts of the Companies Act 2006 that apply
to companies reporting under IFRS.
The accounting policies of the Company which have been applied consistently throughout the period are the same as those of the Group and are presented on pages
59 to 67.
C1.2 Presentation of Financial Statements
The financial information, in the form of the primary statements contained in this report, is presented in accordance with International Accounting Standard
(IAS) 1 Presentation of Financial Statements.
C1.3 Judgements and key sources of estimation uncertainty
Accounting for intercompany loans
In accordance with IFRS 9, the Company is required to make an assessment of expected credit losses. Having considered the quantum and probability of credit
losses expected to arise across a number of scenarios, an additional adjustment for expected credit loss of £6.7 million (year ended 30 April 2019: £1.0 million) was
recognised in the reporting period.
The calculation of the allowance for lifetime expected credit losses requires a significant degree of estimation and judgement, in particular in determining the probability
weighted likely outcome for each scenario considered to determine the expected credit loss in each scenario. Should the assumptions in the business plan vary, this
could have a significant impact on the carrying value of the intercompany loans in following periods.
C1.4 Investments
Investments in subsidiaries are stated at cost plus capital contribution to the subsidiary in respect of share-based payments, less any provision for impairment.
The Company considers the recoverability of loans and investments on an annual basis. Where there is an indication that the carrying value exceeds the recoverable
amount an impairment review will be undertaken and a provision for impairment made when considered necessary. An impairment loss is recognised in the profit and
loss in the statement of comprehensive income.
C2 Total comprehensive income
As permitted by Section 408 of the Companies Act 2006, the Parent Company’s Statement of Comprehensive Income has not been included in these Financial
Statements. The total comprehensive loss for the period was £6,745,487 (year ended 30 April 2019: £978,700).
The only employees of the Company are the Directors; the remuneration of the Directors is borne by Group subsidiary undertakings. Full details of their remuneration
can be found in the Directors’ Remuneration Report on pages 50 and 51.
Administrative expenses, including auditor’s remuneration, are borne by other Group companies.
C3
Investment in subsidiary undertakings
Cost
At 1 May
Share-based payments charge
At period end
31 December 2019
£’000
30 April 2019
£’000
4,143
333
4,476
3,811
332
4,143
Details of the Company’s subsidiary undertakings at 31 December 2019 are shown in Note 10 to the Consolidated Financial Statements along with other interests held
indirectly through subsidiary undertakings.
86
Financial StatementsANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
C4 Other receivables
Non-current assets: Amounts due from Group undertakings
Current assets: Issued share capital receivable
Total
Non-current assets
Amounts due from Group undertakings
Cost
At 1 May
Additions/(repayments)
At period end
Provision
At 1 May
Impairment charge
At period end
Net book value
At period end
At 1 May
31 December 2019
£’000
30 April 2019
£’000
34,554
6
34,560
32,635
–
32,635
31 December 2019
£’000
30 April 2019
£’000
57,309
8,664
65,973
24,674
6,745
31,419
34,554
32,635
47,853
9,456
57,309
23,695
979
24,674
32,635
24,158
The Company provides a centralised treasury function to trading subsidiaries through ANGLE Technology Limited. The amounts due from Group undertakings are
interest free, unsecured and have no fixed date of repayment. Amounts due from Group undertakings are due on demand but are not expected to be recovered
within 12 months.
C5 Share capital
The share capital of the Company is shown below:
Allotted, called up and fully paid
172,771,483 (30 April 2019: 143,486,522) Ordinary shares of £0.10 each
31 December 2019
£’000
30 April 2019
£’000
17,277
14,349
Details of the Company’s share capital and changes in its issued share capital can be found in Note 18 to the Consolidated Financial Statements on page 80.
Details of the Company’s share options schemes can be found in Note 19 to the Consolidated Financial Statements on pages 80 to 82.
C6 Related party transactions
Group transactions and balances
Details of balances owed by ANGLE Technology Limited are given in Note C4 above.
Directors’ interests – related party interests and transactions
Details are given in Note 23 to the Consolidated Financial Statements on page 83.
C7 Post reporting date event
Details are given in Note 24 to the Consolidated Financial Statements on page 83.
87
Financial StatementsANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notice of Annual General Meeting
Directors:
I F Griffiths (Finance Director)
J Groen (Non-executive Director)
B Howlett (Non-executive Director)
A D W Newland (Chief Executive)
G R Selvey (Chairman)
24 June 2020
Dear Shareholder
Registered Office
10 Nugent Road
Surrey Research Park
Guildford
GU2 7AF
Annual General Meeting
You will find included with this document a Notice convening the Annual General Meeting (the “Meeting”) of the Company for 2:00 pm on Thursday 27 August 2020
at which the following resolutions will be proposed:
1. Resolution 1 to receive the Annual Report and Accounts of the Company for the eight month period ended 31 December 2019.
2. Resolution 2 to approve the Directors’ Remuneration Report for the eight month period ended 31 December 2019 set out on pages 50 and 51 of the Annual Report.
Note: this is an advisory vote only.
3. Resolution 3 to re-appoint the auditors of the Company, RSM UK Audit LLP, and authorise the Directors to determine their level of remuneration.
4. Resolution 4 to grant the Directors authority to allot unissued shares in the capital of the Company up to an aggregate nominal amount of £5,759,883.
Note: the Directors wish to renew their authorisations with respect to the allotment of new shares.
5. Resolution 5 to disapply statutory pre-emption rights.
Note: the Directors wish to renew their authorisations for the disapplication of the statutory pre-emption rights in respect of the allotment of new shares
pursuant to rights issues or otherwise for cash, as detailed in the Notice of Annual General Meeting, to enable the Directors to take advantage of opportunities
as they arise without the need for further shareholder approval.
6. Resolution 6 to grant the Directors authority to purchase issued shares in the capital of the Company up to an aggregate nominal amount of £1,727,965.
Note: whilst the Directors have no present intention of purchasing the Company’s shares, the Directors are seeking authorisation as they wish to have the flexibility
to do so if this was generally in the best interests of the shareholders and (except in the case of purchases intended to satisfy obligations under share schemes) the
expected effect of the purchase would be to increase earnings per share of the remaining shares.
The authorities requested in items 4, 5 and 6 will expire at the 2021 Annual General Meeting or, if earlier, 31 August 2021.
Coronavirus (COVID-19)
Due to the unprecedented situation with COVID-19 and in line with the UK Government’s measures to maintain social distancing, the Board has taken the decision
to hold this year’s Meeting as a “closed meeting” with the Chief Executive and Finance Director attending in person and the rest of the Board attending remotely.
Shareholders will not be permitted to attend the Meeting in person. It will not be possible for shareholders to vote during the Meeting and shareholders are therefore
strongly encouraged to submit their Proxy Votes online via www.signalshares.com or CREST where applicable. The Meeting will be streamed online and shareholders
will be able to watch the AGM remotely via an electronic platform, details of which are provided in the Notice.
Business Update Presentation
The Board remains keen to encourage engagement with shareholders. The Company will provide a business update presentation after the formalities of the AGM are
concluded. Shareholders are invited to submit questions in advance of the AGM, which the Board will aim to answer during the business update presentation. While
it may not be possible to answer individual questions, questions will be grouped into key themes and we will endeavour to answer these during the presentation or as
part of concluding matters. Questions should be submitted to investor@angleplc.com before 5:00pm on Wednesday 26 August 2020.
Details of how to join the Meeting and the business update presentation via an electronic platform are provided on page 92.
Action to be taken
Shareholders should register their Proxy Vote either online at www.signalshares.com or through CREST as outlined in the Notes to the Notice of Annual General
Meeting as soon as possible, but in any event no later than 48 hours before the time fixed for the Meeting. Shares held in uncertificated form (i.e. in CREST) may be
voted through the CREST Proxy Voting Service in accordance with the procedures set out in the CREST manual.
Recommendation
Your Directors consider the resolutions to be proposed at the Annual General Meeting to be in the best interests of the Company and its shareholders. Accordingly,
the Directors unanimously recommend shareholders to vote in favour of all the resolutions to be proposed at the Annual General Meeting.
Yours faithfully
Garth Selvey
Chairman
88
Notice of Annual General MeetingANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
(Company number 04985171)
NOTICE IS HEREBY GIVEN that the seventeenth ANNUAL GENERAL MEETING of ANGLE plc ("the Company") will be held at 2:00 pm on Thursday
27 August 2020 at ANGLE plc, 10 Nugent Road, Surrey Research Park, Guildford GU2 7AF for the purpose of considering and, if thought fit, passing the following
resolutions of which the resolutions numbered 1 through 4 will be proposed as ordinary resolutions and resolutions numbered 5 and 6 will be proposed as special
resolutions. The meeting will be held as a "closed meeting" and shareholders will not be permitted to attend in person. Please refer to the notes to this Notice for
details of how to watch the meeting online.
Ordinary Business
1. TO receive the Accounts of the Company for the eight month period ended 31 December 2019, and the reports of the Directors and auditors thereon.
2. TO approve the Directors’ Remuneration Report as set out on pages 50 and 51 of the Annual Report for the eight month period ended 31 December 2019.
Note: this is an advisory vote only.
3. TO re-appoint RSM UK Audit LLP as auditors of the Company to hold office from the conclusion of this Meeting until the conclusion of the next annual general
meeting of the Company at which accounts are laid and to authorise the Directors to determine their remuneration.
Special Business
4. THAT, for the purposes of section 551 of the Companies Act 2006 ("the Act"), the Directors be and they are hereby generally and unconditionally authorised
to exercise all powers of the Company to allot shares in the Company, or grant rights to subscribe for or convert any security into shares in the Company, up to
an aggregate nominal amount of £5,759,883 PROVIDED that this authority shall expire (unless previously renewed, varied or revoked by the Company in general
meeting) at the earlier of the conclusion of the next Annual General Meeting of the Company or on 31 August 2021 EXCEPT that the Company may, before
such expiry, make an offer or agreement which would or might require shares to be allotted or the granting of rights to subscribe for, or convert any security into,
shares in the Company after such expiry and the Directors may allot shares and grant rights to subscribe for, or convert any security into, shares in the Company
in pursuance of any such offer or agreement as if the authority conferred hereby had not expired. This authority shall replace any existing like authority which is
hereby revoked with immediate effect.
5. THAT, subject to and conditional upon the passing of Resolution 4, the Directors be and they are hereby generally empowered, in addition to all existing
authorities, pursuant to section 570 of the Act to allot equity securities (within the meaning of section 560 of the Act) for cash pursuant to the authority conferred
by Resolution 4 above as if section 561 of the Act did not apply to any such allotment, provided that this power shall be limited to:
(a) the allotment of equity securities in connection with an offer of equity securities open for acceptance for a period fixed by the Directors to holders of equity
securities on the register of members of the Company on a date fixed by the Directors in proportion (as nearly as may be) to their respective holdings of
such securities or in accordance with the rights attached thereto but SUBJECT to such exclusions, variations or other arrangements as the Directors may
deem necessary or expedient to deal with:
fractional entitlements;
directions from any holders of shares to deal in some other manner with their respective entitlements;
legal or practical problems arising in any overseas territory;
the requirements of any regulatory body or stock exchange; or
i.
ii.
iii.
iv.
v. otherwise howsoever;
(b) the allotment of equity securities (otherwise than pursuant to sub-paragraph (a) above) up to an aggregate nominal amount of £1,727,965,
and the power hereby conferred shall expire (unless previously renewed, varied or revoked by the Company in general meeting) on 31 August 2021 or at the
conclusion of the next Annual General Meeting of the Company (whichever first occurs) EXCEPT that the Company may, before such expiry, make an offer or
agreement which would or might require equity securities to be allotted after such expiry and the Directors may allot equity securities in pursuance of such offer
or agreement as if the power conferred hereby had not expired.
89
Notice of Annual General MeetingANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
Notice of Annual General Meeting
continued
6. THAT, the Company be and is hereby generally and unconditionally authorised for the purposes of section 701 of the Act to make market purchases (within the
meaning of section 693(4) of the Act) of Ordinary shares of £0.10 each in the capital of the Company provided that:
(a) the maximum number of Ordinary shares that may be purchased is 17,279,648 (representing approximately 10% of the Company’s issued share capital at the
date of this notice);
(b) the minimum price (exclusive of expenses) which may be paid for each Ordinary share is £0.10;
(c)
the maximum price (exclusive of expenses) which may be paid for each Ordinary share is an amount equal to 105% of the average of the middle market
quotations of an Ordinary share of the Company taken from the London Stock Exchange Daily Official List for the five business days immediately preceding
the day on which the Ordinary share is contracted to be purchased,
and the power hereby conferred shall expire (unless previously renewed, varied or revoked by the Company in general meeting) on 31 August 2021 or at the
conclusion of the next Annual General Meeting of the Company (whichever first occurs) EXCEPT that the Company may, before such expiry, enter into one or
more contracts to purchase Ordinary shares under which such purchases may be completed or executed wholly or partly after the expiry of this authority and
may make a purchase of Ordinary shares in pursuance of any such contract or contracts.
Registered Office
10 Nugent Road
Surrey Research Park
Guildford
GU2 7AF
Dated 24 June 2020
By Order of the Board
Ian F Griffiths
Company Secretary
Notes:
1. Under the Articles of Association of the Company, a member of the Company entitled to attend and vote at the Annual General Meeting may appoint one or
more proxies to vote instead of him. For the reasons given in the Chairman’s letter that accompanies this Notice, under the current UK Government measures in
relation to the Coronavirus (COVID-19) pandemic, shareholders and proxies will not be allowed to attend the Annual General Meeting and shareholders are not
able to appoint a proxy other than the Chairman of the Meeting.
2. To be valid, an appointment of proxy must be registered with or returned to the Company’s Registrars at least 48 hours before the time of the Meeting
or any adjourned meeting by one of the following methods:
• by logging on to www.signalshares.com and following the instructions;
• you may request a hard copy Form of Proxy directly from the registrars, Link Asset Services, on Tel: 0371 664 0300. Calls are charged at the standard geographic
rate and will vary by provider. Calls outside the United Kingdom will be charged at the applicable international rate. Link Asset Services are open between 09:00
- 17:30, Monday to Friday excluding public holidays in England and Wales. The Form of Proxy in hard copy duly executed, together with the power of attorney
or other authority (if any) under which it is signed (or a notarially certified copy of such power or authority) must be deposited at the Company's registrars, Link
Asset Services, PXS, 34 Beckenham Road, Beckenham, Kent BR3 4TU. If a hard copy Form of Proxy is used to appoint more than one proxy, the Form of Proxy
should be photocopied and completed for each proxy holder and the proxy holder's name should be written on the Form of Proxy together with the number
of shares in relation to which the proxy is authorised to act. The box on the Form of Proxy must also be ticked to indicate that the proxy instruction is one of
multiple instructions being given; or
• in the case of CREST members, by utilising the CREST electronic proxy appointment service in accordance with the procedures set out in Note 5
of this document.
3. While appointment of a proxy electronically or completing and returning a Form of Proxy would generally not stop you from attending the Annual General
Meeting and voting in person should you so wish, under the current UK Government measures in relation to the Coronavirus (COVID-19) pandemic, shareholders
will not be allowed to attend the Annual General Meeting, vote in person or appoint a proxy other than the Chairman of the Meeting.
4. Pursuant to regulation 41 of the Uncertificated Securities Regulations 2001, the Company has specified that, to be entitled to vote at the Meeting (and for the
purpose of determining the number of votes they may cast), members must be entered on the Company's register of members at close of business on 25 August
2020. Changes to entries on the relevant register of securities after that time shall be disregarded in determining the rights of any person to vote at the Meeting.
5. To appoint a proxy or to give or amend an instruction to a previously appointed proxy via the CREST system, the CREST message must be received by the issuer’s
agent RA10 by at least 48 hours before the time of the Meeting or any adjourned meeting. For this purpose, the time of receipt will be taken to be the time (as
determined by the timestamp applied to the message by the CREST Applications Host) from which the issuer’s agent is able to retrieve the message. After this
time any change of instructions to a proxy appointed through CREST should be communicated to the proxy by other means. EUI does not make available special
procedures in CREST for any particular messages, therefore normal system timings and limitations will apply in relation to the input of CREST proxy instructions.
CREST Personal Members or other CREST sponsored members, and those CREST Members who have appointed voting service provider(s) should contact their
CREST sponsor or voting service provider(s) for assistance with appointing proxies via CREST. For further information on CREST procedures, limitations and
system timings please refer to the CREST Manual. We may treat as invalid a proxy appointment sent by CREST in the circumstances set out in Regulations 35(5)
(a) of the Uncertificated Securities Regulations 2001. In any case your Proxy Vote must be received by the Company’s registrars no later than at least 48 hours
before the time of the Meeting or any adjourned meeting.
90
Notice of Annual General MeetingANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Explanatory Notes:
Resolution 1: Report and Accounts
The Directors are required to present to the Meeting the audited accounts and the reports of the Directors and the auditors for the eight month period ended
31 December 2019.
Resolution 2: Directors’ Remuneration Report
This resolution seeks approval of the Directors’ Remuneration Report for the eight month period ended 31 December 2019. The full text of the Directors’
Remuneration Report is contained on pages 50 and 51 of the Company’s Annual Report.
This is an advisory vote and no entitlement to remuneration for the eight month period ended 31 December 2019 is conditional on the resolution being passed.
Resolution 3: Re-appointment of auditors
The Company is required to appoint auditors at each general meeting at which accounts are laid before the Company, to hold office until the end of the next such
meeting. This resolution proposes the appointment and, in accordance with standard practice, gives authority to the Directors to determine the remuneration to be
paid to the auditors.
Resolution 4: Directors' authority to allot shares
Section 551 of the Act provides that the directors of a company may not allot shares (or grant rights to subscribe for shares or to convert any security into shares)
in a company unless they have been given prior authorisation for the proposed allotment by ordinary resolution of the Company's shareholders or by the Articles of
Association of a company.
Accordingly, this resolution seeks to grant a new authority under section 551 of the Act to authorise the Directors to allot shares in the Company or grant rights
to subscribe for, or convert any securities into, shares of the Company and will expire on 31 August 2021 or at the conclusion of the next Annual General Meeting
of the Company following the passing of this resolution, whichever occurs first.
If passed, Resolution 4 would give the Directors authority to allot shares or grant rights to subscribe for, or convert any security into, shares in the Company up to a
maximum nominal value of £5,759,883 representing approximately one-third of the Company's nominal value of the issued share capital at the date of this notice.
Resolution 5: Disapplication of pre-emption rights
Under section 561(1) of the Act, if the Directors wish to allot any of the unissued shares or grant rights over shares for cash (other than pursuant to an employee
share scheme) they must in the first instance offer them to existing shareholders in proportion to their holdings. There may be occasions, however, when the Directors
will need the flexibility to finance business opportunities by the issue of shares without a pre-emptive offer to existing shareholders. This cannot be done under the Act
unless the shareholders have first waived their pre-emption rights.
Resolution 5 empowers the Directors to allot equity securities for cash other than in accordance with the statutory pre-emption rights in respect of (i) rights issues and
similar offerings, where difficulties arise in offering shares to certain overseas shareholders, and in relation to fractional entitlements and certain other technical matters
and (ii) generally in respect of Ordinary shares up to a maximum nominal value of £1,727,965, representing approximately 10% of the Company’s nominal value of the
issued share capital at the date of this notice. This is proposed as a special resolution.
Resolution 6: Authority for market purchase
Resolution 6 will permit the Company to purchase up to 17,279,648 Ordinary shares of £0.10 each (approximately 10% of the shares in issue as at the date of
this notice) through the market subject to the pricing limits set out in the resolution and shall expire (unless previously renewed, varied or revoked by the Company
in general meeting) on 31 August 2021 or at the conclusion of the next Annual General Meeting of the Company (whichever first occurs). This is proposed as a
special resolution.
91
Notice of Annual General MeetingANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019
General Information for Shareholders
In respect of the Annual General Meeting
Time of the Meeting
The AGM will start promptly at 2:00 pm on Thursday 27 August 2020.
The venue
The Meeting will be held at ANGLE plc, 10 Nugent Road, Surrey Research Park, Guildford, Surrey, GU2 7AF.
Attendance
Due to the unprecedented situation with COVID-19 and in line with Government’s measures to maintain social distancing, the AGM will be held as a “closed meeting”
and shareholders will not be permitted to join the AGM in person. Shareholders attempting to attend the AGM will be refused admission.
Shareholders are asked to exercise their votes by submitting their proxy as set out in the Notice of AGM above. All shareholders are strongly recommended to vote
electronically at www.signalshares.com as your vote will automatically be counted.
Viewing the Meeting
Shareholders can join and view the AGM remotely and the Company will provide a business update presentation after the formalities of the AGM are concluded.
A live webcast of the AGM may be accessed via https://arkadin-event.webex.com/arkadin-event/onstage/g.php?MTID=e5ec2c5b7c9e4e639fa876ca436eb2e56
Please register in advance and log on to the webcast approximately 5 minutes before 2:00pm on Thursday 27 August 2020.
Alternatively, the webcast can be accessed by telephone and listened to by calling:
United Kingdom Toll-Free: 08003589473
United Kingdom Toll: +44 3333000804
PIN: 58174213#
URL for international dial in numbers:
https://events-ftp.arkadin.com/ev/docs/NE_W2_TF_Events_International_Access_List.pdf
The Board remains keen to encourage engagement with our shareholders. Shareholders are invited to submit questions in advance of the AGM, which the Board will
aim to answer during the business update presentation. While it may not be possible to answer individual questions, questions will be grouped into key themes and we
will endeavour to answer these during the presentation or as part of concluding matters. Questions should be submitted to investor@angleplc.com before 5:00pm on
Wednesday 26 August 2020.
92
Notice of Annual General MeetingANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Explanation of Frequently Used Terms
Term
Antibody
Antigen
AR-V7
AUC-ROC
Benign
Biomarker
Biopsy
Cancer
Capture
Capture efficiency
Carcinogen
CD45
Cell(s)
Cell culture
Cell-free DNA
Cell labelling
Cell lines
CE Mark
Chemotherapy
Explanation
A protein made by white blood cells in response to an antigen (a toxin or foreign substance). Each antibody can bind
to only one specific antigen. The purpose of this binding is to help destroy the antigen
Proteins that can be used as markers in laboratory tests to identify cancerous and normal tissues or cells
The androgen receptor (AR) has been proposed as a mechanism of therapeutic resistance to AR signalling (ARS)
inhibitors. Androgen receptor variant 7 (AR-V7) participates in regulating prostate cancer cell proliferation and gene
expression and is correlated with drug resistance. Patients with low-risk disease should receive taxanes if they are AR-V7+
or ARS inhibitors if they are AR-V7-
The area under the curve (AUC) for a receiver operating characteristic (ROC) plot, a plot of 1-specificity on the x-axis
vs. the sensitivity on the y-axis at each possible threshold for a test’s results, is a measure of a diagnostic test’s accuracy.
The accuracy of the test depends on how well the test separates the two groups being compared into those with the
outcome (sensitivity) and those without the outcome (specificity) in question. An AUC of 1 (100%) represents a perfect
test while an AUC of 0.5 (50%) represents a worthless test. The traditional academic classification system for AUC-ROCs
is 90% to 100% = excellent; 80% to 90% = good; 70% to 80% = fair; 60% to 70% = poor; 50% to 60% = fail. Source:
University of Cambridge MRC Unit http://imaging.mrc-cbu.cam.ac.uk/statswiki/FAQ/roc
Not cancerous. Benign tumours may grow larger but do not spread to other parts of the body. Also called non-malignant
A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process,
or of a condition or disease. A biomarker may be used to see how a disease is developing or how well the body
responds to a treatment for a disease or condition. Also called molecular marker and signature molecule
Process by which cancer cells are removed from the tumour for molecular analysis
A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also
spread to other parts of the body through the blood and lymph systems
Process for capturing target cells from sample
Proportion of target cells captured
Any substance that is directly involved in causing cancer
The CD45 antibody recognises the human CD45 antigen, also known as the leukocyte common antigen. WBC are
CD45+ whereas CTCs are CD45-. Staining with CD45 often used as a negative confirmation that CTCs are not WBC
In biology, the smallest unit that can live on its own and that makes up all living organisms and the tissues of the body.
The human body has more than 30 trillion cells
See cultured cells
Genomic DNA found in the plasma
Technique involving the staining of target cells with fluorescent and/or chromogenic markers for cell identification
Cultured cells
Regulatory authorisation for the marketing and sale of products for clinical use in the European Union. The CE marking
is the manufacturer's declaration, following appropriate assessment by a CE Notified Body, that the product meets the
requirements of the applicable EC directives
The treatment of cancer by chemicals (drugs). In cancer care the term usually means treatment with drugs that destroy
cancer cells or stop them from growing
Circulating tumor cell
Cancer cell that is circulating in the patient’s blood
CTC
CTC labelling
CLIA Laboratory
Clinical application
Clinical samples
Clinical study
Clinical use
Companion diagnostic
Circulating tumor cell
CTCs are often labelled with three markers and are formally identified as CTCs if they are CK+, CD45-, DAPI+
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are federal regulatory standards that apply to
all clinical laboratory testing performed on humans in the United States (with the exception of clinical trials and basic
research). A clinical laboratory is defined by CLIA as any facility which performs laboratory testing on specimens obtained
from humans for the purpose of providing information for health assessment and for the diagnosis, prevention, or
treatment of disease
Use in treating patients
Patient samples usually blood
A type of research study that tests how well new medical approaches work in people. These studies test new methods
of screening, prevention, diagnosis, or treatment of a disease
Use in treating patients
A medical device which provides information that is essential for the safe and effective use of a corresponding drug
or biological product
93
Additional InformationANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Explanation of Frequently Used Terms
continued
Term
Explanation
Contract Research Organisation (CRO)
A company hired by another company or research centre to take over certain parts of running a clinical trial.
The company may design, manage, and monitor the trial, and analyse the results
ctDNA
Cultured cells
Cytokeratin (CK)
CK+
Cytopathological
DAPI
DEPArray™
Diagnosis
ctDNA is cell-free circulating tumour fragments of DNA from dead cells, which may be found in the plasma component
of the blood
Cultured cells grown in the laboratory from human-derived cells used for experimental work
Cytokeratins are a family of intracytoplasmic cytoskeleton proteins with members showing tissue specific expression
A cell positive for the presence of cytokeratin protein or mRNA with the presence of distinct cytokeratins often used
to identify epithelial cells
A branch of pathology that studies and diagnoses diseases at the cellular level, generally used on samples of free cells
or tissue fragments
A nuclear stain that is often used to identify the nucleus in a cell
A commercial single cell isolation system
The process of identifying a disease, condition, or injury from its signs and symptoms. A health history, physical examination
and tests, such as blood tests, imaging tests, and biopsies, may be used to help make a diagnosis
Diagnostic LeukApheresis (DLA)
Removal of the blood to collect specific blood cells such as leukocytes. The remaining blood is then returned to the body
Diagnostic test
DNA
A type of test used to help diagnose a disease or condition
Deoxyribonucleic acid (DNA) is the molecule that encodes the genetic instructions used in the development and
functioning of all known living organisms and many viruses
Downstream technologies
Technologies used to undertake molecular analysis of harvested cells after the separation has taken place
EGFR
Enrichment
EpCAM
EpCAM+ cells
Epithelial cells
The epidermal growth factor receptor – a signalling molecule which is typically present on the cell surface and can control
cell activity including cell proliferation. Mutations in EGFR or deregulation have been associated with a number of cancers
including ~30% of all epithelial cancers
Generic term for concentrating target cells or molecules in a starting heterogeneous mixture
The Epithelial Cell Adhesion Molecule (EpCAM) protein is found spanning the membrane that surrounds epithelial cells,
where it is involved in cell adhesion
Cells that express EpCAM. CTCs can be either EpCAM+ or EpCAM-
Cells that line the surfaces and cavities of the body
Epithelial-mesenchymal transition
Process by which epithelial cells lose their cell polarity and cell-cell adhesion, and gain migratory and invasive properties
to become mesenchymal cells. EMT is thought to occur as part of the initiation of metastasis and is often responsible for
cancer progression
Epithelial-mesenchymal transition
A part of a molecule to which an antibody will bind
U.S. Food and Drug Administration responsible for authorised medical products in the United States
Medical devices with an intended use that is considered medium or moderate risk. For non-exempt devices the FDA
require a pre-market clearance or approval to be issued before a company can legally market their device. The company
will be required to have general medical device quality system controls in place as well as device specific special controls
(which may include device labelling and design control processes and documentation)
A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and
effective, that is, substantially equivalent, to a legally marketed device that is not subject to Premarket Approval. Submitters
must compare their device to one or more similar legally marketed devices and make and support their substantial
equivalency claims
The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general
and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there
is no legally marketed predicate device (therefore the FDA 510(k) route does not apply). Devices that are classified into
class I or class II through a De Novo classification request may be marketed and used as predicates for future premarket
(510(k)) submissions
A disposable consumable containing a highly uniform porous substrate on which up to 576 individual zones are printed
with reagents that specifically bind to molecules of interest in the sample. Sample flowing through the 10 micron pores is
forced into contact with the coated surface, providing very rapid and efficient capture of any targets present in solution
that each assay is designed to measure
EMT
Epitope
FDA
FDA Class II Device
FDA 510(k)
FDA De Novo
Flow-Thru Chip®
94
Additional InformationANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Term
Explanation
Fluorescence In-Situ Hybridization
(FISH)
Gene expression
Genome
Genotyping
Gleason Score
A laboratory technique for detecting and locating a specific DNA sequence on genes or chromosome in tissue and cells.
The technique relies on exposing genes or chromosomes to a small DNA sequence called a probe that has a fluorescent
molecule attached to it. The probe sequence binds to its corresponding sequence on the genes or chromosome and they
light up when viewed under a microscope with a special light
The process by which a gene gets turned on in a cell to make RNA and proteins. Gene expression may be measured by
looking at the RNA or the protein made from the RNA
Genetic material of an organism. The genome includes both protein coding and non-coding sequences
Process of determining differences in the genetic make-up (genotype) by examining the DNA sequence
A system of assessing how aggressive prostate cancer tissue is based on how it looks under a microscope. Gleason scores
range from 2 to 10 and indicate how aggressive and fast-growing the cancer is. A low Gleason score means the cancer
tissue is similar to normal prostate tissue and the tumour is less likely to spread; a high Gleason score means the cancer
tissue is very different from normal prostate tissue and the tumour is more likely to spread
Gynaecological cancer
Cancer of the female reproductive tract, including the cervix, endometrium, fallopian tubes, ovaries, uterus, and vagina
Harvest
Harvest efficiency
Harvest purity
HER2
Heterogeneity
Histopathology
HNV
HT29
HyCEAD™
Immunohistochemistry
Immunostain
Immunotherapy
Process for recovering captured cells from the separation system to allow molecular analysis
Proportion of target cells harvested
The number of target cells (such as CTCs) in the harvest as a proportion of the WBC. The minimum purity from
which downstream analysis is possible is 0.5%. Analysis of one target cell therefore requires no more than 200 WBC
be in the harvest
A member of the epidermal growth factor receptor (EGFR/ERBB) family. Amplification or overexpression of HER2 has
been shown to play an important role in the development and progression of certain aggressive types of breast cancer.
In recent years the protein has become an important biomarker and target of therapy for ~ 30% of breast cancer patients
A word that signifies diversity
The study of diseased cells and tissues using a microscope
Healthy normal volunteer
Cultured colorectal cancer cell line
Hybrid Capture, Enrichment, Amplification and Detection
A sample preparation method for capturing targeted nucleic acid sequences (RNA or DNA) directly from biological
samples without the need for extraction, introducing universal priming sequences into copies of those specific sequence
regions, and permitting amplification of all targets simultaneously in a single PCR reaction for direct detection on Ziplex
A lab test that uses antibodies to test for certain antigens (markers) in a sample of tissue. Immunohistochemistry is used
to help diagnose diseases, such as cancer. It may also be used to help tell the difference between different types of cancer
A general term that applies to any use of an antibody-based method to detect a specific protein or antigen in a sample
Treatment that stimulates the body's immune system to fight cancer
In-cassette labelling or in-situ labelling
CTC labelling for cell identification undertaken inside the separation system
Indolent cancer
In vitro diagnostic (IVD)
A type of low risk cancer that grows slowly
An in vitro diagnostic is a method of performing a diagnostic test outside of a living body in an artificial environment,
usually a laboratory
Key opinion leader
Key opinion leaders (KOLs) are research centres and/or physicians who influence their peers’ medical practice
KRAS
Leukocytes
Liquid biopsy
Localised
Lymphocyte
Lysis
Malignant
A signalling molecule frequently mutated in the development of many cancers
White blood cells
Term used for the process of obtaining cancer cells (or cell-free DNA) from a blood sample. Unlike solid biopsy, liquid
biopsy is non-invasive and repeatable
Describes disease that is limited to a certain part of the body. For example, localised cancer is usually found only in the
tissue or organ where it began, and has not spread to nearby lymph nodes or to other parts of the body. Some localised
cancers can be completely removed by surgery
A type of immune cell that is made in the bone marrow and is found in the blood and in lymph tissue. A lymphocyte
is a type of white blood cell
The breaking down of a cell, often by viral, enzymatic, or osmotic mechanisms that compromise its integrity
Cancerous. Malignant cells form part of the tumour, and can invade and destroy nearby tissue and spread to other parts
of the body
95
Additional InformationANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Explanation of Frequently Used Terms
continued
Term
Marker
meEGFR
Megakaryocyte
Mesenchymal CTCs
Metastasis
Microfluidic device
Microtentacles
Molecular analysis
Morphology
Mouse model
mRNA
Mutation
Explanation
A diagnostic indication that disease may develop or is already present. A chemical substance produced by a cancer and
used to monitor the progress of the disease. These chemicals are usually measured by a blood test
Arginine methylation of the epidermal growth factor receptor
A large bone marrow cell with a lobulated nucleus responsible for the production of blood thrombocytes (platelets),
which are necessary for normal blood clotting
CTCs generally lacking epithelial markers with mesenchymal features
Spread of a cancer from one site to another
An instrument that uses very small amounts of fluid on a microchip to do certain laboratory tests. A microfluidic device
may use body fluids or solutions containing cells or cell parts to diagnose diseases
Microtubule-based membrane protusions in detached cancer cells
Analysis of DNA, RNA and protein often used to determine the mutational status of a patient
The study of the form and structure of cells
The use of special strains of mice to study a human disease or condition, and how to prevent and treat it
Messenger RNA used to direct the synthesis of proteins
A gene mutation is a permanent change in the DNA sequence that makes up a gene. Gene mutations can be inherited
from a parent or can happen during a person’s lifetime. Mutations passed from parent to child are called hereditary
or germline mutations. Mutations that happen during a person’s life, known as somatic mutations, can be caused by
environmental factors such as ultraviolet radiation from the sun. Or they can occur if a mistake is made as DNA copies
itself during cell division
Mutational analysis
Testing for the presence of a specific mutation or set of mutations
Next Generation Sequencing (NGS)
NICE
Non-invasive
NSCLC
Off-chip labelling
Oncologist
Oncology
Paired samples
Parsortix® system
Pathologist
PathVysion
Patient study
PCR
PD-L1
Pelvic mass
96
Also known as high-throughput sequencing, is the catch-all term used to describe a number of different modern
sequencing technologies including: Illumina (Solexa) sequencing. Roche 454 sequencing. Thermo Fisher Ion torrent:
Proton/PGM sequencing. It is a method by which the bases of DNA and RNA can be determined, which is used in
biological research and to obtain clinically relevant information
Abbreviation for the National Institute for Health and Care Excellence
In medicine, it describes a procedure that does not require inserting an instrument through the skin or into a body
opening. Although a needle is inserted to draw blood, liquid biopsies are referred to as non-invasive as they do not
require surgery
Non Small Cell Lung Cancer
CTC labelling for cell identification of harvested cells undertaken outside the separation system
A doctor who has special training in diagnosing and treating cancer and may also specialise in certain cancers or techniques
A branch of medicine that specialises in the diagnosis and treatment of cancer. It includes medical oncology (the use of
chemotherapy, hormone therapy and other drugs to treat cancer), radiation oncology (the use of radiation therapy to treat
cancer) and surgical oncology (the use of surgery and other procedures to treat cancer)
Two related samples often used to compare different systems
The name of the core technologies developed and used by ANGLE to capture and harvest CTCs comprising the
automated instrument to run blood samples through the microfluidic cassette and all the associated operating procedures
and protocols
A doctor who has special training in identifying diseases by studying cells and tissues under a microscope
The name of the Abbott Molecular test kit. The PathVysion HER-2 DNA Probe Kit II (PathVysion Kit II) is designed to
detect amplification of the HER-2/neu gene via FISH in formalin-fixed, paraffin-embedded human breast and gastric
cancer tissue specimens. The PathVysion HER-2 DNA Probe Kit II is one of the first examples of what is recognised as
genomic disease management, or personalised medicine. This means that the test helps enable the accurate assessment
of a patient's HER-2 status at the DNA level with a high degree of accuracy and helps guide doctors to make the most
appropriate therapy decisions based on the patient's own genetic profile
A type of research study, on a smaller scale than a clinical study, that tests how well new medical approaches work
in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease
See Polymerase Chain Reaction
Programmed death ligand 1 (PD-L1) is the principal ligand of programmed death 1 (PD-1), a coinhibitory receptor that
can be constitutively expressed or induced in myeloid, lymphoid, normal epithelial cells and in cancer
A general term for any growth or tumour on the ovary or in the pelvis. A pelvic mass can be cystic (cystadenoma), solid
(fibroma) or both (dermoid). A pelvic mass can be benign or malignant
Additional InformationANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019 Term
Peripheral blood
Explanation
Blood circulating throughout the body
Personalised cancer care
Treating a patient individually based on their personal data often including mutational and disease status
Phenotype
Pilot study
Plasma
A phenotype is the composite of an organism’s observable characteristics or traits, such as its morphology, development,
biochemical or physiological properties, behaviour and products of behaviour. A phenotype results from the expression of
an organism's genes as well as the influence of environmental factors and the interactions between the two
The initial study examining a new method or treatment
Pale-yellow liquid component of blood obtained following removal of cells
Polymerase Chain Reaction (PCR)
Precision medicine
A laboratory technique used to amplify DNA sequences. The method involves using short DNA sequences called primers
to select the portion of the genome to be amplified. The temperature of the sample is repeatedly raised and lowered to
help a DNA replication enzyme copy the target DNA sequence. The technique can produce a billion copies of the target
sequence in just a few hours
The customisation of healthcare – with medical decisions, practices, and/or products being tailored to the individual patient.
In this model, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of
a patient’s genetic content or other molecular or cellular analysis
Pre-labelled cell lines
Cells which are labelled often with a fluorescent label to facilitate identification during analysis or enrichment
Prognosis
The likely outcome or course of a disease; the chance of recovery or recurrence
Prostate-Specific Antigen (PSA)
A protein made by the prostate gland and found in the blood. PSA blood levels may be higher than normal in men who
have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland
Protocol
PSA
Purity
Q-Submission
A detailed plan of a scientific or medical experiment, treatment, or procedure. In clinical studies, it states what the study
will do, how it will be done, and why it is being done. It explains how many people will be in the study, who is eligible to
take part in it, what study drugs or other interventions will be given, what tests will be done and how often, and what
information will be collected
See Prostate-Specific Antigen
The relative absence of extraneous matter in a sample
The FDA’s Pre-Submission Program which allows medical device and IVD manufacturers to discuss specific aspects
of the regulatory process and requirements with FDA experts
Regulatory authorisation
The authorisation by the appropriate regulatory body for a specific territory that allows an in vitro diagnostic product
to be sold for clinical use in that territory
Relapse
Remission
Research use
RNA
When an illness that has seemed to be getting better, or to have been cured, comes back or gets worse again
If a cancer is in remission, there is no sign of it in examinations or tests. Generally, the longer the remission, the less likely
it is that the patient will relapse
Sales can be made to certain organisations of in vitro diagnostic products without the need for regulatory authorisation
provided they are labelled as Research Use Only (RUO) or Investigational Use Only (IUO)
Ribonucleic acid performs multiple vital roles in the coding, decoding, regulation, and expression of genes. Together with
DNA, RNA comprises the nucleic acids, which, along with proteins, constitute the three major macromolecules essential
for all known forms of life
RNA-Sequencing (RNA-seq)
Also called whole transcriptome shotgun sequencing (WTSS), uses next-generation sequencing (NGS) to reveal the
presence and quantity of RNA in a biological sample at a given moment in time
Screening
Sensitivity
Separation
Single cell analysis
Solid biopsy
Specificity
Checking for disease when there are no symptoms. Since screening may find diseases at an early stage, there may be
a better chance of curing the disease
Refers to the percentage of people who test positive for a specific disease or condition among people who actually have
the disease or condition
Term used for processing of a sample through the Parsortix system
Extraction of a single target cell from the harvest for analysis
Standard process for surgically excising (cutting out) cells from a solid tumour when that tumour is accessible
Refers to the percentage of people who test negative for a specific disease or condition among a group of people who
do not have the disease or condition
Spiked cell experiments
Experiments where cultured cells are added (spiked) to HNV blood to assess the capture and harvest efficiency of the system
Stage
The extent of a cancer in the body. Staging is usually based on the size of the tumour, whether lymph nodes contain
cancer and whether the cancer has spread from the original site to other parts of the body
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Additional InformationANGLE plc Annual Report and Accounts For the eight months ended 31 December 2019 Explanation of Frequently Used Terms
continued
Term
Explanation
Standard Operating Procedure
(SOP)
Written instructions for doing a specific task in a certain way. In clinical trials, Standard Operating Procedures are set up to
store records, collect data, screen and enrol subjects and submit Institutional Review Board (IRB) applications and renewals
Transcriptome (whole)
Translational research
Triage
Tumor/Tumour
Tumour heterogeneity
Tumour marker
The transcriptome is the set of all messenger RNA molecules in one cell or a population of cells
A term used to describe the process by which the results of research done in the laboratory are used to develop new
ways to diagnose and treat disease
The process of determining the priority of patients' treatments based on the severity of their condition
An abnormal mass of tissue that results when cells divide more than they should or do not die when they should.
Tumours may be benign (not cancer), or malignant (cancer)
Tumor is the American English spelling and Tumour is the standard English spelling
Describes the observation that different tumour cells can show distinct morphological and phenotypic profiles, including
cellular morphology, gene expression, metabolism, motility, proliferation, and metastatic potential. This phenomenon occurs
both between tumours (inter-tumour heterogeneity) and within tumours (intra-tumour heterogeneity)
The heterogeneity of cancer cells introduces significant challenges in designing effective treatment strategies
A substance found in tissue, blood, or other body fluids that may be a sign of cancer or certain benign (non-cancerous)
conditions. Most tumour markers are made by both normal cells and cancer cells, but they are made in larger amounts by
cancer cells. A tumour marker may help to diagnose cancer, plan treatment, or determine how well treatment is working
or if the patient has relapsed
Examples of tumour markers include CA-125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in colon cancer),
and PSA (in prostate cancer)
WBC
WGA
White blood cells
Whole genome amplification
Whole genome amplification
Method for amplification of an entire genome necessary for the picogram amounts of genomic DNA present in
a single cell
Ziplex®
An automated hybridization array platform that combines chemiluminescence and Flow-Thru Chips for the detection
of minute amounts of up to 500 nucleic acid or protein targets simultaneously
Primary source: www.cancer.gov/publications/dictionaries/cancer-terms
98
Additional InformationANGLE plc Annual Report and Accounts For the eight month period ended 31 December 2019
Additional Information
Company Information
Directors
Ian F Griffiths, Finance Director
Jan Groen, Non-executive DirectorANR
Brian Howlett, Non-executive DirectorANR
Andrew D W Newland, Chief Executive
Garth R Selvey, ChairmanANR
A – Audit Committee
N – Nomination Committee
R – Remuneration Committee
Secretary
Ian F Griffiths
Company number
04985171
Registered office and
Business address
Auditor
10 Nugent Road
Surrey Research Park
Guildford
Surrey
GU2 7AF
+44 (0)1483 343434
www.angleplc.com
RSM UK Audit LLP
Third Floor
One London Square
Cross Lanes
Guildford
Surrey
GU1 1UN
Nominated Advisor
and Joint Broker
finnCap Ltd
One Bartholomew Close
London
EC1A 7BL
Joint Broker
Registrar
Bank
Solicitor
Financial Public
Relations
WG Partners
85 Gresham Street
London
EC2V 7NQ
Link Asset Services Ltd
34 Beckenham Road
Beckenham
Kent
BR3 4TU
National Westminster Bank
PO Box 1
2 Cathedral Hill
Guildford
Surrey
GU1 3ZR
Pinsent Masons LLP
30 Crown Place
Earl Street
London
EC2A 4ES
FTI Consulting
200 Aldersgate
Aldersgate Street
London
EC1A 4HD
ANGLE plc Annual Report and Accounts
For the eight months ended 31 December 2019
99
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ANGLE plc
10 Nugent Road
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Surrey
GU2 7AF
United Kingdom
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