Transforming cancer care with a liquid
biopsy based on a simple blood test
Annual Report and Financial Statements
31 December 2020
Introduction / We are ANGLE plc
Who we are
ANGLE plc
is a commercially
driven medical
diagnostics company
that has developed
pioneering products
and services in
cancer.
ANGLE’s Parsortix® system has
the potential to deliver profound
improvements in clinical and health
economic outcomes in the diagnosis
and treatment of cancer.
Visit our website for more information at:
www.angleplc.com
@parsortix
ANGLEplc
angleplcParsortix
The Annual Report and Financial Statements 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 (too ill for surgery, tumour inaccessible, insufficient tissue)
2) tumour heterogeneity as only samples one site, and
3) the dynamic nature of the cancer response to treatment meaning the original biopsy information is out-of-date
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
Non-invasive, repeatable, real time, cost effective
Solid biopsy
Liquid
biopsy
Tissue samples
Tissue is specially prepared so
sections can be examined – usually
formalin-fixed paraffin-embedded
(FFPE) samples
CTCs
Living cancer cells shed
from a tumour into the
bloodstream in the process
of metastasis
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 challenge
Cancer: a significant and growing problem
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 rapidly 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?
40-50%
Of the population will be diagnosed with cancer in their lifetime1,2
32%
The number of new cancer
diagnoses in the US per year
is increasing, and has risen by
more than 32% since 19993,4
1.8m
In 2020, an estimated 1,806,590
new cases of cancer will be
diagnosed in the US and
606,520 people will die from
the disease1
1 www.cancer.gov/about-cancer/understanding/statistics – USA (40%)
2 www.cancerresearchuk.org/about-cancer/what-is-cancer – UK (50%)
3 www.ncbi.nlm.nih.gov/pmc/articles/PMC3597235/
4 https://gis.cdc.gov/Cancer/USCS/DataViz.html
What are the challenges to treatment?
90%
Metastasis causes ~90% of cancer deaths3
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. 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 and whilst some types of metastatic
cancer can be driven into remission with treatment, 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 therefore 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
procedure and
can cause adverse
events
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 may not
fully reflect tumour
heterogeneity
Which sample type?
CTCs provide the complete picture
Solid biopsy
CTCs Complete DNA, RNA and proteins
ctDNA DNA fragments only
CTCs are living cells, often resistant to drug therapy and the cause
of metastasis. Targeting these cells will improve patient outcomes.
ctDNA is derived from dead cells and may not be indicative
of how cancer is developing.
Multiple DNA abnormalities
Multiple DNA abnormalities
RNA expression
Protein expression
Circulating
Tumour
Cell
(CTC)
In vitro and in vivo culture
Circulating
Tumour
DNA
(ctDNA)
Blood sample
Liquid
biopsy
Circulating tumour cells (CTCs) and circulating tumour DNA (ctDNA)
can be measured concurrently from a single blood draw to provide
complementary information for clinical decision making.
This includes early diagnosis, accurate prognosis, therapeutic target selection,
spatiotemporal monitoring of metastasis, as well as monitoring response
and resistance to treatment and potentially an early warning for relapse.
Genome
Between
20k-25k
Genes
Genes (units of DNA) code for proteins. Abnormalities in certain genes
can result in cancer development and growth.
Transcriptome
Approximately
100,000
Transcripts
RNA
DNA is copied to
RNA in the nucleus
and exported to
the cytoplasm
DNA
Cell Nucleus
Protein
Cell Cytoplasm
RNA is translated into
protein at ribosomes
To make proteins, genes must first be transcribed into messenger RNA
(mRNA). Different sections of a gene can either be included or excluded
from the mRNA transcript, producing multiple different transcripts from
a single gene that result in related but different proteins.
The cancer genome atlas has transformed the development of targeted
treatment, however many patients who are matched to therapy based
on their DNA fail to respond to targeted treatment or do not have a
sustained response.
Proteome
Estimated more than
1,000,000
Proteins
After mRNA transcripts are translated into proteins, proteins undergo
modifications that affect their activity and how long they are present in
a cell. Protein abundance, diversity and function could hold the key to
understanding why genomic-based therapies may not work as expected.
Key information about the biology of the tumour is missing from
looking at the genome alone. The effect of mutations on the cell can
only be understood fully by looking at protein expression, the proteome.
Understanding proteins is critically important when developing
drugs, selecting treatments, and predicting treatment response.
Integration of proteomic information is the next step in
precision oncology.
National Cancer Institute, August 2020
Source: Molecular Diagnostics for Cancer Treatment: Expanding beyond the Genome published by the National Cancer Institute, August 2020
Social and environmental impact
Liquid biopsy – helping healthcare systems
meet the challenges of COVID-19
COVID-19 has caused an unprecedented
crisis which will likely continue to have an
impact on cancer diagnosis and care for
a considerable time.
70%
fall in urgent cancer referrals1
2,000
cancer cases undiagnosed each week1
90%
decrease in elective procedures1
Diagnosis
With healthcare staff and resources diverted to care for patients
directly affected by COVID-19, cancer screening programmes for
asymptomatic patients were suspended in many countries. In the UK
urgent cancer referrals fell by 70% in April 2020 with an estimated
2,000 cancer cases undiagnosed each week. Endoscopy services in the
US, Europe, and Asia all stopped elective procedures due to the risk
of COVID-19 transmission. As a result, services reported a 90%
decrease in procedures in April 2020.
Cancer treatment
Surgical resection with the goal of complete removal of disease is, for
many cancer patients, the first line of treatment. However, requisition
of theatre space, ventilators and beds for COVID-19 patients meant
that only urgent surgery, such as for perforated, obstructed or actively
bleeding cancers, continued.
Recurrence monitoring
Postponing or cancelling visits to hospitals that did not involve
delivering treatments was one of the first and most widely
implemented measures taken by European healthcare systems.
Many planned follow-up visits were replaced by remote consultations
over the phone or internet. What was lost, in many cases, were
opportunities for follow-up tests and imaging that provide early signals
of local recurrence or metastatic spread. This reprioritisation may
have long-term implications for cancer patient outcomes.
1 In the UK in April 2020.
How can liquid biopsy support cancer
care in a post-COVID-19 world?
Cancer is the leading cause of death in most developed nations,
responsible for an estimated 9.6 million deaths per year globally.
As such, cancer diagnosis and care remain a priority and services
will need to rapidly evolve to counter the substantial challenge
of COVID-19. Ending delays and addressing backlogs – particularly
cancer surgeries and diagnostic tests – will need to be an urgent
priority moving forward.
The information provided by liquid biopsy could help clinicians
diagnose, monitor, and treat cancer more efficiently. Liquid biopsy is
minimally invasive and can be undertaken safely in community clinics
or in the home to provide patients with a rapid diagnosis and timely
treatment with targeted therapies. Liquid biopsy may also help to
safely monitor cancer patients in remission to provide early warning
of recurrence. In a future pandemic, the benefit of these features
cannot be overstated. The adverse impact of COVID-19 on
cancer care has shown that it is essential to have a diagnostic
tool which is quick, easy and alleviates the burden of
conducting hospital-based surgical tissue biopsies.
ANGLE adapted its working procedures due to COVID-19 and re-located
its phlebotomy unit first to a separate building and then to a van in order
to facilitate social distancing measures.
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.
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.
Inlet
Competitive differentiation
Outlet
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 24 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) to interrogate the
harvested CTCs.
ANGLE's proprietary technologies can be
combined to provide automated, sample-to-
answer solutions in both centralised laboratory
and point-of-use cartridge formats.
ANGLE has well-differentiated patent-protected
products. Both systems have proprietary
consumables, which provide a “razor blade”
approach to commercialisation.
ANGLE has optimised the entire process,
from blood collection and transportation
to molecular diagnostic techniques, thereby
minimising the risk of variability and allowing
reliable, repeatable and scalable CTC analysis.
Automated process requiring minimum user intervention
1
Blood collection
2
Automated blood processing
Designed for a single 10 ml tube of blood. No pre-processing required.
Blood is pumped through the cassette with minimal user input.
3
Cell capture in cassette
4
Cell harvest
Proprietary single use cassette captures intact living cancer cells.
CTCs can be harvested in <200µl buffer for multiple downstream
analysis techniques.
Downstream analysis
5a
Widely available
techniques
5b
Proprietary HyCEAD
system
HyCEAD at a glance
The cells harvested by the Parsortix
system can be analysed using existing
techniques already established for tissue
biopsy, including:
• Cytopathology
• Immunofluorescence (IF)
• Fluorescent In Situ Hybridisation
(FISH)
• Polymerase Chain Reaction (PCR)
• Next Generation Sequencing (NGS)
• RNA sequencing (RNA-seq)
• Whole Genome Amplification (WGA)
• Whole Exome Sequencing (WES)
The HyCEAD 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 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.
• Benchtop laboratory platform
• DNA, RNA and protein biomarkers
• Low cost
• Highly multiplexed
• Rapid and sensitive capture of targets
• 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
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 microfluidic 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
Emerging multi-US$
billion market
Read more
on page 02
$100bn
Parsortix
world-leading
liquid biopsy
system
41
26 leading independent cancer
centres have published 41
peer-reviewed publications
Read more on
pages 10 and 11
24
200
115,000
>115,000 blood
samples processed
Read more on
page 10
Shown to work
with 24 different
cancer types to date
>200 instruments
in active use
Contents
Strategic Report
Market opportunity
Strategy
Strategic aims in action
Chairman’s Statement
Business Strategy
Key Performance Indicators
Principal Risks and Uncertainties
Corporate Responsibility Report
Financial Review
Governance
Board of Directors
Scientific Advisory Board
Directors’ Report
Corporate Governance Report
Remuneration Report
Financial Statements
Independent Auditors’ Report
Consolidated Statement of Comprehensive Income
Consolidated Statement of Financial Position
Consolidated Statement of Cash Flows
Consolidated Statement of Changes in Equity
Notes to the Consolidated Financial Statements
Company Statement of Financial Position
Company Statement of Cash Flows
Company Statement of Changes in Equity
Notes to the Company Financial Statements
Notice of Annual General Meeting
Notice of Annual General Meeting
General Information for Shareholders in
respect of the Annual General Meeting
Additional Information
Explanation of Frequently Used Terms
Company Information
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01
ANGLE plc Annual Report and Financial Statements 2020 Market opportunity
A major opportunity in an
emerging and growing global market
Market drivers
Growing market
Key drivers of cancer incidence
Liquid biopsy: Emerging multi-US$ billion market
• Increasing average life span
• Smoking, poor diet, obesity and alcohol
• Over exposure to sun
• Lack of exercise
• Exposure to carcinogens
• Infections and HIV
• Hormones
• Inherited gene mutations
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
40-50%
People will get cancer in their lifetime2, 3
47%
Estimated rise in global cancer cases within
the next two decades4
02
Cowen – up to $130 billion per annum (US only)
Frost & Sullivan – $100 billion per annum (US only)
Global burden of cancer1
New cancer incidence
(per annum)
19.2m
2020
14.1m
2012
Living with and after cancer
50.5m
2020
32.5m
2012
Deaths from cancer
(per annum)
9.9m
2020
8.2m
2012
1 Source: International Agency for Research on Cancer (Globocan 2020)
2 www.cancer.gov/about-cancer/understanding/statistics – USA (40%)
3 www.cancerresearchuk.org/about-cancer/what-is-cancer – UK (50%)
4 Global cancer statistics, (Globocan 2020)
Estimates of incidence and mortality worldwide for 36 cancers in 185 countries
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 Growing market
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
Active surveillance
(watchful waiting)
Prostate AR-V7 Qiagen
Immunotherapy
PD-L1/PD-1 inhibitors
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
Laboratory developed tests
in a service laboratory
Biomarker discovery
Accelerator and demonstrator
Companion diagnostics
Ovarian
Culturing CTCs for
drug testing
Metastatic breast
Prostate
Product sales worldwide
to hospitals and corporate
partners
Metastatic breast cancer
Abbott PathVysion
Market accessible on multiple fronts with Parsortix product-based solution
Allows ANGLE to be both an equipment supplier and a diagnostic test provider
1 Source: Company estimate
03
ANGLE plc Annual Report and Financial Statements 2020Strategic 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-US$ 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 to support regulatory
approval of Laboratory Developed Tests
and product.
Read more on pages 06 and 07
Clinical studies
Securing regulatory approval of the Parsortix
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
Services and
partnerships
Regulatory approval
Published evidence
Building 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
Research use only services to
pharmaceutical and biotechnology
customers for drug research and use
in clinical trials.
Providing Laboratory Developed Tests
for specific clinical decision making.
Establishing partnerships with large
healthcare companies for market
deployment and development of multiple
clinical applications incorporating the
Parsortix and/or HyCEAD systems.
Read more on pages 12 to 15
04
Strategic Report ANGLE plc Annual Report and Financial Statements 2020
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 year
Building on previous achievements
and since the year end
Clinical studies – ovarian cancer
Despite COVID-19 lock down delays, the study regained momentum
and patient enrolment progressed well.
Post year end, patient enrolment was completed in April 2021.
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 molecular analysis platform
successfully completed, demonstrating exceptionally high sensitivity.
Ovarian cancer clinical verification study established with leading US
cancer centre. Pre-study phase completed successfully. 200 patient
study initiated in August 2019.
Regulatory approval – metastatic breast cancer
Following COVID-19 lock down delays, analytical and clinical studies
were completed and a full De Novo Submission made to FDA in
September 2020.
FDA clinical study enrolling 400 subjects with four leading US cancer
centres completed with positive result for primary and exploratory
objectives announced. FDA analytical studies undertaken.
FDA Administrative Review successfully completed and Substantive
Review in progress. Additional Information Request received
and response planned for submission in May 2021.
Ongoing dialogue with FDA. Q-Submission process with FDA completed.
Published evidence – leveraged R&D model
Leading independent cancer centres have delivered a total of
37 peer-reviewed publications as at 31 December 2020.
Since the year end there have been a further four peer-reviewed
publications.
26 independent cancer centres have published uniformly positive
results on their use of the Parsortix system.
Services and partnerships
New clinical services laboratories in process in the UK and US, and
opened after year end, to provide services to pharmaceutical and
biotechnology customers, and in due course for the development
and sale of Laboratory Developed Tests.
Post year end, first large scale pharma services contract signed.
Discussions progressing with multiple partners which we expect
to accelerate once FDA clearance for the system is achieved.
Total of 26 peer-reviewed publications at 31 December 2019.
Collaborative agreements signed with three leading global healthcare
companies: Abbott, Philips and QIAGEN.
Abbott development work completed 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 Financial Statements 2020Strategic Report
Strategic aims in action
Clinical studies
Ovarian cancer clinical application – abnormal pelvic mass triage test
ANGLE’s Parsortix and
HyCEAD 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 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. Patient enrolment
was completed in April 2021.
Once the new performance data is available,
and assuming positive results, 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 Financial Statements 2020 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
systems used in the US study demonstrates
the capability to out-perform current
approaches for the detection of ovarian
cancer.
With the establishment of its own
clinical laboratories (see pages 12 and
13), ANGLE will be in a position to
commercialise its ovarian cancer assay
as a Laboratory Developed Test, opening
up a significant market opportunity.
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$1.8bn
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
>200,000
women p.a. have pelvic mass surgery
in the US market alone1
314,000
women diagnosed with ovarian cancer
globally in 20203
93% at stage I4
30% at stage IV4
5-year survival rates at time of diagnosis
1 Company estimate – United States only
2 www.contemporaryobgyn.net/view/pelvic-mass-workup
3 International Agency for Research on Cancer (Globocan 2020)
4 https://seer.cancer.gov/statfacts/html/ovary.html
07
ANGLE plc Annual Report and Financial Statements 2020Strategic Report Strategic aims in action
Regulatory approval
Seeking FDA clearance in metastatic breast cancer
Metastasis is responsible for the
vast majority of breast cancer
related deaths.
The FDA clinical study (Study) previously
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
and that it had achieved secondary endpoints
demonstrating that the cells harvested from patient
blood could be interrogated using subsequent
molecular analysis techniques.
Considerable progress has also been made on the
analytical studies.
The Company has had ongoing dialogue with
the FDA and has made use of the Q-submission
process (a pre-submission used to request formal
comments from FDA on key questions) to reduce
the risk that the full De Novo Submission might
be rejected.
Despite COVID-19 related disruption, full De
Novo FDA Submission was made during the
year, comprising over 400 technical reports and
documents based on over 15,000 samples run on
the Parsortix system in the UK and at clinical sites
in the US. ANGLE received an Acceptance Review
Notification from FDA that the Submission was
accepted and contains all of the necessary elements
and information needed by FDA to proceed with
substantive review.
Following substantive review, FDA has provided
a written response in the form of an Additional
Information Request (AIR). Receipt of an AIR
was expected and is in line with typical De
Novo clearance processes. Some of the technical
information requested necessitates some
targeted additional analytical studies. However,
these additional analytical studies do not require
patient samples and ANGLE anticipates that the
necessary studies, which are already underway,
can be completed and the response submitted in
May 2021. FDA regulatory decision is anticipated
during H2 2021.
ANGLE is following a De Novo FDA process for
the Parsortix system as there is no predicate device.
Consequently, there is inherent uncertainty over
the timing of the process and its ultimate success.
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 US 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
the Parsortix system 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 Financial Statements 2020 4
leading US cancer centres enrolled patients
for FDA clinical studies
400
subject study in the US completed and
reported positively
US$3.9bn
p.a. estimated market potential for Parsortix
in metastatic breast cancer1
2.6m
women diagnosed globally with breast cancer
in 20202
7.8m
women living with and after breast cancer2
20-30%
of people initially diagnosed at early stages
will develop metastatic breast cancer3
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 the Parsortix
system 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
Chief of Breast Surgery,
Cleveland Clinic. Formerly,
Director, USC Breast Cancer
Program, Associate Professor of
Surgery, Norris Comprehensive
Cancer Center, University of
Southern California
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 – United States only
2 International Agency for Research on Cancer (Globocan 2020)
3 www.mbcn.org/incidence-and-incidence-rates/
09
ANGLE plc Annual Report and Financial Statements 2020Strategic Report Strategic aims in action
Published evidence
The medical devices industry is evidence led, 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
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 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.
26 separate cancer centres have published
uniformly positive reports on their use of the
Parsortix system. Using ANGLE’s Parsortix
system leading independent cancer centres
throughout Europe, North America and RoW
are also undertaking research in 24 different
cancer types.
This deployment of the Parsortix system for
research now means that the system is widely
presented and discussed at leading cancer
conferences around the world.
New peer-reviewed publications
There were 37 peer-reviewed publications as at 31 December 2020 with 11 new publications
announced during the year (see https://angleplc.com/library/publications/):
Edith Cowan University, Perth, Australia demonstrating prognostication and treatment response in
melanoma with the Parsortix system out-performing competing systems in head-to-head comparisons
University Medical Center Hamburg-Eppendorf, Germany with validated standardised Parsortix system
protocols for use in future clinical trials in metastatic breast cancer including single cell analysis
Istituto Nazionale Tumori di Milano, Milano, Italy showing the Parsortix system out-performing other
CTC systems in renal cell carcinoma
University Medical Center Hamburg-Eppendorf, Germany with breakthrough research into brain
metastasis and the potential for a Parsortix system blood test to replace a highly invasive tissue biopsy
of the patient’s brain
University of Athens, Greece demonstrating molecular analysis in head and neck squamous cell
carcinoma and key advantages of the Parsortix system over other CTC systems
University of Southern California, USA developing a workflow for gene expression in prostate cancer
with key advantages compared to alternative approaches
Liquid Biopsy Analysis Unit at the Health Research Institute of Santiago, Spain on MET mutations expressed
by CTCs as a target for MET inhibitor drugs in head and neck cancer and non small cell lung cancer
University of Southern California, USA comparing the Parsortix system liquid biopsy to tissue biopsy in
metastatic breast cancer. Potential actionable therapeutic targets were found using CTCs harvested by
Parsortix that were missed by tissue biopsy
Laboratory of Translational Oncology, School of Medicine, University of Crete, Greece published
breakthrough research using the Parsortix system to assess whether non-small cell lung cancer patients
will respond to immunotherapy drugs. This potentially opens a new market for ANGLE for use in PD-L1
cancer drug trials worth an estimated US$1 billion per annum globally
University of Basel, Switzerland using the Parsortix system to research the role of hypoxia (reduced oxygen
levels) in promoting breast cancer metastasis
University of Texas MD Anderson Cancer Center, USA showing that CTCs harvested by the Parsortix system
can be analysed using multiple downstream molecular techniques
Since the year end there have been a further four peer-reviewed publications.
Installed base
>200
installed base of Parsortix systems in active use
Parsortix samples processed
Peer-reviewed publications
115,000
93,000
37
26
64,000
41,000
24,000
11,000
14
8
2
4
2015
2016
2017
2018
2019
2020
2015
2016
2017
2018
2019
2020
Cumulative samples processed at 31 December
Cumulative publications at 31 December
10
Strategic Report ANGLE plc Annual Report and Financial Statements 2020
The Parsortix system
Growing body of peer-reviewed publications
CTC clusters
CTC culturing
Metastatic
brain cancer
Biomarkers for
immunotherapy
# of publications by
cancer type: top 5
Breast 20
Lung 10
Prostate 9
Melanoma 7
Head and Neck
3
35
published in
high impact
journals
26
independent
study centres in
10 countries
7
studies enabling
breakthrough
research
At least
1,526
patient samples
processed
41
peer-reviewed
journal
publications
Complete
Picture
DNA, RNA
& proteins
24
cancer types
representing
88% of solid
tumours
2nd
most published
CTC system in
last 5 years
10
studies
demonstrating
superiority to
market leader
Variety of downstream
analysis techniques:
RT-qPCR
dd-PCR
RNAseq
Immunofluorescence
NGS
WGA, WES & WTA
Mass Spectrometry
Some leading cancer centres we work with
11
ANGLE plc Annual Report and Financial Statements 2020Strategic Report
Strategic aims in action
Clinical laboratories and pharma services
What is CLIA accreditation?
The Clinical Laboratory Improvement
Amendments (CLIA) regulate laboratory
testing and require all US clinical laboratories
to be certified by the Center for Medicare
and Medicaid Services (CMS) before they can
accept human samples for diagnostic testing.
Clinical laboratories – initial focus
on PD-L1 and ovarian cancer
Both the UK and US laboratories will seek ISO
15189 accreditation and the US laboratory will also
seek Clinical Laboratory Improvement Amendments
(CLIA) accreditation, which will allow ANGLE to
market LDTs for clinical use. Given the extensive
clinical work already completed with the Ovarian
cancer pelvic mass triage assay, it is anticipated that
this will be ANGLE’s first LDT to market.
ANGLE is developing a pipeline of further assays,
for development in-house or with partners, including
PD-L1 (see more below), prostate cancer and
lung cancer. ANGLE intends the labs will act as an
“accelerator” for Parsortix LDT clinical applications
as the LDT will enable early progress with payers
and receipt of reimbursement codes ahead of a
FDA cleared product.
US$1.1bn
PD-L1 Pharma Services Market Value1
US$22bn
& growing
at >40% p.a.
Spend on PD-L1 immunotherapy drugs1
ANGLE has established
clinical laboratories in
the UK and the US with
a view to accelerating
commercialisation of
the Parsortix system.
The laboratories, which
will act as accelerators
and demonstrators,
will offer CTC analysis
services to pharmaceutical
customers and Laboratory
Developed Tests (LDTs)
in the clinical market.
PD-L1 as immunotherapy
biomarker
There are now several published studies
demonstrating the use of the Parsortix system
for enabling the molecular analysis of circulating
tumour cells (CTCs) in solid tumours, including
the investigation of PD-L1 (programmed death-
ligand 1) expression, a key target for leading
immunotherapy drugs.
ANGLE has made significant progress in developing
an immunofluorescence (IF) imaging assay for
determination of PD-L1 expression levels in CTCs
harvested by the Parsortix system. This work has
been completed and ANGLE has a method for
assessing the presence and number of PD-L1 positive
and PD-L1 negative CTCs in patient blood samples.
The newly developed in-house cell-based approach
will enable use of the Parsortix system to assess
PD-L1 status using two complementary techniques,
molecular analysis and cell imaging. We believe this
is a powerful combination, which, together with the
key advantages of the Parsortix system to capture
both epithelial and mesenchymal CTCs (traditional
antibody-based systems fail to capture the clinically
relevant mesenchymal CTCs) and to capture CTC
clusters, may provide significant benefits to the
pharma services market (see next page).
1 Company estimate
12
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 Strategic aims in action
Pharma services
Liquid biopsies are moving
towards routine clinical use, but
in the meantime, they are already
informing clinical trial outcomes
and supporting drug discovery.
A number of trials are already using CTC analysis as
an endpoint. CTC count is being used predominantly
as a measure of response to treatment and may
provide a much earlier measure of treatment
resistance, when compared to radiological measures
(e.g. CT and MRI).
A key advantage of CTCs when compared to tissue
biopsy is the ability to provide access to tumour cells
throughout the study duration (i.e. at baseline, during
and after drug intervention and remission monitoring
and short-term follow-up) which is not possible with
tissue biopsy.
Harvesting intact CTCs and CTC clusters with the
Parsortix system for downstream analysis in a robust
and scalable sample-to-answer solution should prove
highly attractive to pharmaceutical and biotech
industry partners.
As an example, there are over 2,000 PD-L1
interventional trials, recruiting over 300,000 patients
which are currently enrolling or in progress. In these
studies, assessment of PD-L1 status on CTCs from
patient blood samples may have a major bearing
on whether the trial is successful.
Future clinical studies will be targets for adoption
of the Parsortix system and ANGLE is developing
a service capability to process samples on a
commercial scale as part of these trials. ANGLE has
established a dialogue with prospective customers
and collaborators for the deployment of CTC PD-L1
analysis capabilities in pharma services cancer
drug trials.
Clinical Trial Phases
Parsortix harvested CTC cluster.
Phase
I
II
III
IV
Safety
20-80
Participants
Safety and Dosing
Safety and Efficacy
100-300
300-3000
Participants
Participants
Post approval
surveillance
1000+
Participants
Drug approved for
testing in humans
Drug submitted for
FDA approval
FDA review
Drug approved
Why does industry need a companion diagnostic
(CDx) for PD-L1 inhibitors?
Failing in late-stage clinical development
is costly and time-consuming for the
pharmaceutical and biotech industry.
As such, a robust CDx is urgently
required in this space.
A number of PD-L1 inhibitors have been
withdrawn from the market following a failure to
demonstrate statistically significant improvement
in patient outcomes. This includes Merck’s
withdrawal of Keytruda in small-cell lung cancer,
BMS’ withdrawal of Opdivo also in small-cell lung
cancer and AstraZeneca’s withdrawal of Imfinzi in
bladder cancer. Similarly, several PD-L1 inhibitors
have failed in phase 2/3 trials. These include
Novartis’ spartalizumab in skin cancer, Roche’s
Tecentriq in ovarian cancer, Pfizer’s Bavencio
in head and neck and ovarian cancer, Merck’s
Keytruda in ovarian cancer and GSK’s bintrafusp
alfa in biliary tract cancer.
13
ANGLE plc Annual Report and Financial Statements 2020Strategic Report Strategic aims in action
Services and 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
foetal cells.
The HyCEAD 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 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.
ANGLE has established 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.
A co-marketing agreement with QIAGEN has
been established 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.
Non-invasive prenatal testing (NIPT)
Previously, ANGLE completed a pilot study
demonstrating that the Parsortix system could
harvest foetal cells from the blood of pregnant
women. The detection of foetal abnormalities
by analysis of foetal cells as opposed to cell free
foetal 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.
1 www.zionmarketresearch.com/report/non-invasive-prenatal-testing-market
14
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 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.
15
ANGLE plc Annual Report and Financial Statements 2020Strategic Report Chairman’s Statement
FDA clearance in substantive review
The Company adapted to COVID-19 related
disruption and successfully completed the
work required to make the full De Novo FDA
Submission for the Parsortix system. This
marked a watershed moment for ANGLE
in its goal to achieve the first ever FDA
clearance for a system to harvest cancer cells
from patient blood for subsequent analysis,
initially in metastatic breast cancer.
Garth R Selvey
Chairman
Operational Highlights
• Full De Novo Submission made in September
2020 for US Food and Drug Administration
(FDA) clearance of the Parsortix® system for
capturing and harvesting circulating tumour
cells from metastatic breast cancer patients
• FDA Administrative Review complete and
Substantive Review in progress
• FDA Additional Information Request (AIR)
received and response planned for submission
in May 2021
• Ovarian cancer clinical verification study
in progress with leading US cancer centre
• patient enrolment completed after the year end
• surgical procedures in progress and sample
analysis in preparation
• study expected to report headline results
in Q4 2021
• targeting launch as an LDT (laboratory
developed test) around the end of the year
• Planning, recruitment and the development
of facilities progressed during the year and,
post year end, ANGLE launched clinical
laboratories in the UK and United States
and initiated a global pharma services business
• Post year end, first large-scale pharma services
contract signed with an oncology focused pharma
customer utilising the Parsortix system for
longitudinal monitoring of patients in a Phase
III drug trial with revenue potential of up to
US$1.2 million over 18 months
• Over 22,000 samples processed during the
year and a further 11 peer-reviewed publications
from internationally recognised cancer centres
with key developments in breast, head and neck,
melanoma, non-small cell lung, prostate and
renal cancers
As previously reported,
restrictions enforced as a result
of COVID-19 disrupted the
Company’s progress with both
its key development programmes
during the year, most notably
through preventing the collection
of blood samples for key studies,
including healthy volunteer
samples for our De Novo FDA
Submission and patient samples
for our ovarian cancer clinical
verification study.
The Company responded by changing working
patterns and introducing new protocols to enable
blood collection for the remaining FDA analytical
studies. Similarly, University of Rochester Medical
Center Wilmot Cancer Institute resumed patient
blood collection for the Company’s ovarian cancer
verification study, once protocols had been put in
place, albeit with slower patient enrolment while
hospital resources and facilities have been allocated
to COVID-19 patients and urgent treatments.
During the year, 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 and successfully completed
the FDA Submission in September 2020. FDA review
progress has been encouraging and an Additional
Information Request, as had been expected, has
been received and is the focus of current work.
Patient enrolment for the Company’s ovarian
cancer assay clinical verification study resumed
in June 2020 and has now completed. The study
is expected to report headline results in Q4 2021.
A laboratory developed test is scheduled for launch
around the end of 2021, pending the results of
the study and once the clinical laboratories have
received accreditation.
Following a successful fundraise in November 2020,
ANGLE has made excellent progress in establishing
clinical laboratories in the US and UK, which were
launched ahead of schedule. These laboratories
are already offering pharma services and, once
accredited, will be able to offer validated clinical tests.
These will be used as accelerators and demonstrators
in support of the Company’s established plan for
product sales of Parsortix instruments and cassettes
and to provide services to pharmaceutical and
biotech customers running drug trials. ANGLE has
already signed a large-scale pharma services contract
for the use of the Parsortix system in three separate
global clinical trials.
ANGLE’s collaborators and customers continue
to demonstrate the Parsortix system’s versatility in
cancer translational research developing important
new applications. This work generated 11 new
publications during the year increasing the body
of peer-reviewed evidence supporting the platform
from independent cancer centres.
16
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 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-US$ billion 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
Building 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 has also made excellent progress in
establishing clinical laboratories in the United
States and the UK that will have the capability of
offering validated clinical tests. These will be used
as accelerators and demonstrators in support of
the Company’s established plan for product sales of
Parsortix instruments and cassettes and to provide
services to pharmaceutical and biotech customers
running drug trials.
Read more about our strategy on pages 04 to 15
Overview of Financial Results
Following a detailed review, a number of areas were
identified for restatement or reclassification and the
prior year numbers have been amended accordingly.
These have no cash impact and are explained in
Note 21. The restatement amendments relate
to 1) a judgement that certain of the capitalised
product development costs do not meet the
IAS 38 criteria and should be expensed rather than
capitalised and 2) exchange differences on certain
overseas Group loans being recognised in the
income statement rather than other comprehensive
income resulting in a movement in reserves.
The reclassification amendment relates to certain
short-term deposits now shown separately from
cash and cash equivalents.
Revenue of £0.8 million in the year (eight months
ended 31 December 2019: £0.6 million) came mainly
from research use of the Parsortix system, with sales
impacted due to COVID-19 closures at customer
sites. ANGLE continued its investment in studies
to develop and validate the clinical application and
commercial use of the Parsortix system and began
the investment required in its new clinical laboratories
and pharma services business, resulting in operating
costs of £14.4 million (eight months ended
31 December 2019 restated: £9.5 million) and a loss
for the year of £11.6 million (eight months ended
31 December 2019 restated: loss £7.6 million).
The cash and cash equivalents and short-term
deposits combined balance was £28.6 million at
31 December 2020 (2019: £18.8 million) with
R&D Tax Credits due at 31 December 2020 of
£2.1 million (2019: £3.4 million). The cash position
was strengthened in November 2020 with a
successful placing of new shares with demand from
new and existing US and UK institutional investors,
which raised gross proceeds of £19.6 million.
Proceeds net of expenses were £18.5 million.
FDA De Novo application submitted
and in substantive review
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.
On 28 September 2020, ANGLE announced it had
submitted a full De Novo FDA Submission for its
Parsortix PC1 system seeking FDA clearance for use
with metastatic breast cancer (MBC) patients. The
Submission comprised over 400 technical reports and
documents characterising the system. This included
the assessment, inter alia, of performance with
clinical samples, recovery, linearity, limit of detection,
reproducibility, repeatability, blood volume, blood
stability and interfering substances both exogenous
and endogenous, requiring over 15,000 samples to be
run on the Parsortix system in the UK and at clinical
sites in the United States. This process, combined
with the manufacture of the Parsortix system and
associated consumables, has been completed and
fully documented under ANGLE’s ISO 13485 quality
system and in compliance with numerous other
technical and quality standards active in the United
States and Europe. The Submission was also designed
to meet the requirements for European CE Mark
and, if granted clearance by FDA in the United States,
ANGLE intends to register for European CE Mark
clearance allowing clinical sales in both the United
States and Europe for the intended use.
As announced on 20 October 2020, ANGLE
received an Acceptance Review Notification
from FDA that the Submission was accepted.
The administrative acceptance review is a formal
process undertaken by FDA to determine that the
Submission contains all of the necessary elements
and information needed by FDA to proceed with
substantive review.
Following substantive review, FDA has provided
a written response in the form of an Additional
Information Request (AIR). Receipt of an AIR
was expected and is in line with typical De
Novo clearance processes. Some of the technical
information requested necessitates some targeted
additional analytical studies. These additional analytical
studies do not require patient samples and ANGLE
anticipates that the necessary studies, which are
currently in progress, can be completed and the
response submitted in May 2021. FDA regulatory
decision is anticipated during H2 2021.
As previously communicated, ANGLE is following a
De Novo FDA process for the Parsortix system as
there is no identified predicate device. Consequently,
there is inherent uncertainty over the timing of the
process and its ultimate success. The outcome and
timing of any FDA regulatory decision is entirely
dependent on FDA’s review and response to the
Company’s Submission. Whilst there has not been
a delay to date, in its communication with FDA,
ANGLE has been advised that, due to unprecedented
allocation of resources to COVID-19 priorities, it is
currently unclear how quickly FDA will be able to
review ANGLE’s response to the AIR once it has
been submitted.
17
ANGLE plc Annual Report and Financial Statements 2020Strategic Report Chairman’s Statement
continued
Ovarian cancer clinical application
ANGLE’s ovarian cancer clinical verification study
is in progress and is being undertaken by the
University of Rochester Medical Center (URMC)
Wilmot Cancer Institute, New York, USA to evaluate
the use of ANGLE’s combined Parsortix® and
HyCEAD™ platforms as a simple blood test to
detect the presence of ovarian cancer in women
with an abnormal pelvic mass.
A positive outcome from the study will support
ANGLE’s plans to launch a clinical assay for the
detection of ovarian cancer in women with an
abnormal pelvic mass, with both high sensitivity
(correctly detecting cancer) and high specificity
(correctly detecting no cancer with a low false
positive rate).
Post year end, patient enrolment for this pivotal study
has completed and, following surgical procedures and
analysis of the patient samples, headline results of the
study are expected in Q4 2021.
Once the new performance data is available and
assuming positive results, 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 also reducing overall healthcare costs and is
scheduled for launch around the end of 2021.
PD-L1 assessment capability
There are now several published studies
demonstrating the use of the Parsortix system
for enabling the molecular analysis of CTCs in
solid tumours, including the investigation of PD-L1
(programmed death-ligand 1) expression, a key
target for leading immunotherapy drugs.
During the year, ANGLE made significant progress in
developing an immunofluorescence (IF) imaging assay
for determination of PD-L1 expression levels in CTCs
harvested by the Parsortix system. This work has
been completed and we have a method for assessing
the presence and number of PD-L1 positive and
PD-L1 negative CTCs in patient blood samples.
This approach examines actual cells (cytological
analysis) as opposed to molecular analysis approaches,
which work with cell lysates (nucleic contents of cells
that have been broken open, analysed as a mixture).
Currently the PD-L1 expression assay is Research
Use Only, however we are examining options for
clinical development.
The newly developed in-house cell-based approach
will enable use of the Parsortix system to assess
PD-L1 status using two complementary techniques,
molecular analysis and cell imaging with IF. We believe
this is a powerful combination, which, together with
the key advantages of the Parsortix system to capture
both epithelial and mesenchymal CTCs (traditional
antibody-based systems fail to capture the clinically
relevant mesenchymal CTCs) and to capture CTC
clusters, may provide significant benefits to the
pharma services market.
18
Launch of clinical laboratories
and pharma services
ANGLE has made excellent progress in establishing
clinical laboratories in the United States and the UK
that will have the capability of offering validated clinical
tests. The laboratories, in Guildford, UK and Plymouth
Meeting, Pennsylvania, United States, were completed
ahead of schedule in Q1 2021 and are now processing
clinical samples for global clinical trials. The laboratories
will be used as accelerators and demonstrators
in support of the Company’s established plan for
product sales of Parsortix instruments and cassettes
and to provide services to pharmaceutical and biotech
customers running clinical trials.
In April 2021, ANGLE announced that it has secured
its first large-scale pharma services contract. The
customer, a pharma company with numerous cancer
drugs under development and forecast revenues
exceeding US$1 billion per annum, selected ANGLE’s
Parsortix system to undertake longitudinal monitoring
of patients in a Phase III global clinical trial in prostate
cancer and two other smaller Phase I clinical trials.
Longitudinal monitoring relates to assessing a patient’s
condition at multiple time points (i.e. before, during
and after drug intervention), which cannot be
achieved with tissue biopsy.
The contract is expected to be worth up to
US$1.2 million over 18 months. The Phase I studies,
if successful, could progress to larger Phase II studies
and, if successful, much larger Phase III studies.
The services cover the capture, harvest and analysis
of CTCs and CTC clusters. Samples are being
shipped from multiple study centres to ANGLE’s
clinical laboratories in the United States and the
UK for analysis using the Parsortix system.
The contract represents the first large-scale
adoption of the Parsortix system for processing
patient blood samples to help inform decision
making in cancer drug trials. Importantly, the
customer recognises the advantage in capturing
mesenchymal as well as epithelial cancer cells and
the importance that CTC clusters as well as single
CTCs may have in the progression of disease,
metastasis, and drug resistance.
The Parsortix liquid biopsy has particular advantages
in capturing intact cancer cells including mesenchymal
cells and clusters and provides the opportunity for
longitudinal testing in a clinical setting, which is not
possible with tissue biopsy. ANGLE believes that
longitudinal monitoring of CTCs will prove highly
attractive to the pharma industry looking for new
insights in cancer drug trials.
In a further initiative, ANGLE has identified numerous
immunotherapy cancer drug trials in progress or
planned where assessment of PD-L1 status on CTCs
from patient blood samples may have a major bearing
on whether the trial is successful. The new trials being
planned are targets for adoption of the Parsortix
system and ANGLE is developing a service capability
to be able to process samples on a commercial
basis as part of these trials. ANGLE has established
a dialogue with prospective customers and
collaborators for the deployment of PD-L1 analysis
capabilities in pharma services cancer drug trials.
Building 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, continues to build momentum.
Over 115,000 samples have been processed using
the Parsortix system as at 31 December 2020, with
over 22,000 samples in the year. There were 37
peer-reviewed publications as at 31 December 2020
with 11 new publications announced during the year
(see https://angleplc.com/library/publications/):
• Edith Cowan University, Perth, Australia
demonstrating prognostication and treatment
response in melanoma with the Parsortix system
out-performing competing systems in head-to-
head comparisons
• University Medical Center Hamburg-Eppendorf,
Germany with validated standardised Parsortix
system protocols for use in future clinical trials in
metastatic breast cancer including single cell analysis
• Istituto Nazionale Tumori di Milano, Milano, Italy
showing the Parsortix system out-performing
other CTC systems in renal cell carcinoma
• University Medical Center Hamburg-Eppendorf,
Germany with breakthrough research showing
the investigation of brain metastasis in non-small
cell lung cancer and the potential for a Parsortix
system blood test to replace a highly invasive
tissue biopsy of the patient’s brain
• University of Athens, Greece demonstrating
molecular analysis in head and neck squamous
cell carcinoma and key advantages of the Parsortix
system over other CTC systems
• University of Southern California, USA developing
a workflow for RNA gene expression in prostate
cancer with key advantages compared to
alternative approaches
• Liquid Biopsy Analysis Unit at the Health
Research Institute of Santiago, Spain on the
assessment of MET alterations on CTCs as a
target for MET inhibitor drugs in head and neck
cancer and non-small cell lung cancer opening
an important new revenue opportunity for
ANGLE with pharma services
• University of Southern California, USA compared
the Parsortix system liquid biopsy to tissue
biopsy of a metastatic site in metastatic breast
cancer. Potential actionable therapeutic targets
were found in the Parsortix system liquid biopsy
that were missed in the tissue biopsy of a single
metastatic site
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 ANGLE continues to gather
momentum and, through
its new services business,
has begun to accelerate
commercialisation.
Garth R Selvey
Chairman
• Laboratory of Translational Oncology, School of
Medicine, University of Crete, Greece published
breakthrough research using the Parsortix system
to assess whether non-small cell lung cancer
patients will respond to immunotherapy drugs.
This potentially opens a new market for ANGLE
for use in PD-L1 cancer drug trials worth an
estimated US$1 billion per annum globally
• University of Basel, Switzerland using the Parsortix
system to research the role of hypoxia (reduced
oxygen levels) in promoting breast cancer metastasis
• University of Texas MD Anderson Cancer
Center, United States showing CTCs harvesting
by the Parsortix system can be analysed using
multiple downstream molecular techniques.
Following the year end, there were four further
publications of note:
• Western University and Lawson Health Research
Institute, Ontario, Canada demonstrating the
performance of the Parsortix system in a
head-to-head comparison with the leading
antibody-based CTC system
• CANCER-ID Consortium, the Europe-wide
Public-Private-Partnership aimed at standardising
protocols and driving wide adoption of liquid
biopsy in clinical practice, establishing the
performance and technical capabilities of five
CTC isolation platforms, in which key advantages
of the Parsortix system were identified
• National and Kapodistrian University of Athens,
Greece demonstrating the utility of the Parsortix
system for minimally invasive, longitudinal
monitoring of changes in CTC gene expression
in non-small cell lung cancer patients with
an EGFR mutation being treated with the
tyrosine kinase inhibitor (TKI), Osimertinib
(AstraZeneca’s Tagrisso®)
• University Medical Center Hamburg-Eppendorf,
Germany demonstrating the ability of the
Parsortix system to harvest CTCs with a
mesenchymal phenotype, which can be used
to detect the metastatic biomarker cysteine-rich
angiogenetic inducer 61 (Cyr61) in breast
cancer patients.
To date, 26 separate cancer centres from around the
world have published positive reports on their use
of the Parsortix system. Leading independent cancer
centres throughout Europe, North America and
elsewhere using the Parsortix system are working
on developments in 24 different cancer types.
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 continue 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 Parsortix
system has been achieved.
COVID-19
The Company has had some short-term negative
impacts from government lock downs associated with
COVID-19. While this created an initial need to adapt
the operating model, it has not had any significant
long-term impact on the Company.
During lock downs, ‘non-essential’ screening, surgical
and other procedures for cancer treatment have
been postponed, delayed or cancelled by clinical
institutions across the world. This extends to
procedures such as tissue biopsies both of primary
cancer sites for diagnosis and secondary cancer
sites for treatment selection. The delay of these
procedures may have significant adverse impacts
on patients. This highlights the need for the regulatory
approval of a CTC based liquid biopsy alternative
to such invasive tissue biopsy procedures. Harvested
cancer cells from a simple blood test that could be
used to progress a patient’s diagnosis and treatment
while reducing the time to answer delays associated
with the processing and pathological evaluation
of tissue biopsies would be extremely valuable.
The blood draw could be undertaken at the patient’s
home avoiding the need for the patient to visit the
clinical institution for a surgical procedure.
Outlook
The Company adapted to COVID-19 related
disruption and successfully completed the work
required to make the full De Novo FDA Submission
for the Parsortix system. This marked a watershed
moment for ANGLE in its goal to achieve the first
ever FDA clearance for a system to harvest cancer
cells from patient blood for subsequent analysis,
initially in metastatic breast cancer. It was encouraging
that the Additional Information Request was received
without undue delay despite the ongoing pressure
on FDA resources as a result of COVID-19. Whilst
recent communication with FDA indicates a potential
delay to their review processes, we anticipate a
regulatory decision during H2 2021. Approval for
use of the Parsortix system with MBC patients
would open up a market that ANGLE estimates
is worth a potential US$3.9 billion per annum in
the United States alone.
Towards the end of the year, we successfully
raised further capital in a fundraising that was
well supported by new and existing shareholders,
particularly in the United States. As planned, the
funds raised supported the launch of our commercial
laboratory and pharma services business. Post year
end, ANGLE has announced its first large-scale
contract with an oncology focused pharma customer.
The signing of a commercial contract with its first
pharma customer validates this strategy and ANGLE
looks forward to announcing the further expansion
of this business and additional customer agreements
in due course.
ANGLE is making progress with the development
of its ovarian cancer test, which in clinical studies to
date has shown the potential to out-perform current
standard of care by greatly reducing the level of false
positives. Patient enrolment has been completed in the
pivotal clinical verification study, and headline results
are expected to be reported in Q4 2021, with the
aim of supporting the establishment of a laboratory
developed test for ovarian cancer around the end
of the year, addressing a large unmet medical need.
In 2020, ANGLE made significant progress towards
its strategic objectives and has set a solid foundation
for the future. The start of 2021 has seen ANGLE
continue to gather momentum and, through its
new services business, has begun to accelerate
commercialisation of its unique liquid biopsy platform
to support personalised cancer care. The planned roll-
out of its sample-to-answer solutions and expansion
of pharma services business will further strengthen
the ANGLE offering as we move through the year.
Garth Selvey
Chairman
29 April 2021
19
ANGLE plc Annual Report and Financial Statements 2020Strategic Report Business Strategy
Sustained focus on delivering our strategy
ANGLE’s ultimate objective
is to transform cancer diagnosis,
treatment and monitoring
enabling personalised medicine
for all 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 foetal 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.
20
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 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 19.2 million new cancer cases
worldwide in 2020, a marked rise on the 14.1 million
cases in 2012. In 2020, there were an estimated
9.9 million deaths from cancer (2012: 8.2 million).
In 2020, there were an estimated 50.5 million people
living with and after cancer (2012: 32.5 million).
(Source: International Agency for Research on
Cancer – Globocan 2020).
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 and
Cowen have estimated that the liquid biopsy market
will be worth $100 billion and up to $130 billion
per annum respectively 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 more than 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 foetal 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.
21
ANGLE plc Annual Report and Financial Statements 2020Strategic Report 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, which
allows multiplex gene expression for more
than 100 genes simultaneously on a highly
cost-effective basis
• enhancing automation and throughput in
a next generation of the Parsortix system
• optimising the full process from blood collection
and stability to cytological and molecular analyses
in sample-to-answer solutions.
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.
Offer services through clinical
laboratories
ANGLE has established clinical laboratories in the
UK and United States to provide a global service
capability. These laboratories are intended to act as
accelerators and demonstrators to support ANGLE’s
product-led strategy.
They will be used to offer CTC analysis services to
pharma and biotech customers for drug trials and,
once accreditation is secured, to offer validated clinical
tests known as Laboratory Developed Tests (LDTs)
to support cancer patient management.
A growing number of drug trials are using CTC
evaluation as a key biomarker to assess patient
response as a proxy trial endpoint. CTC evaluation
may provide a measure of response to treatment and
may provide a much earlier measure of treatment
resistance, when compared to radiological measures
(e.g. CT and MRI). A key advantage of CTCs when
compared to tissue biopsy is the ability to undertake
longitudinal monitoring of the patient response
and condition during the trial through repeat
measurements, for example before, during and after
treatment. There is also the potential for remission
monitoring and long-term follow up.
Pharma services utilising the clinical laboratories
presents a large-scale commercial opportunity that
can be accessed ahead of FDA product approval.
With CLIA accreditation, ANGLE can offer LDTs
from its own laboratories for patient management
again ahead of FDA product clearance. The clinical
laboratory service approach is an established
business model for many diagnostic companies.
In addition it enables early progress with payers
and reimbursement codes ahead of FDA cleared
product. The adoption of clinical laboratories
alongside ANGLE’s core product-based strategy
is intended to accelerate commercialisation and
revenue generation.
22
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 16 to 19.
The FDA clearance studies in metastatic breast
cancer utilise cytological examination, RT-PCR, FISH
and RNA-seq methods for analysing cancer cells.
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.
This report was approved by the Board of Directors
on 29 April 2021 and is signed on its behalf by:
Andrew D W Newland
Chief Executive
29 April 2021
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 ANGLE’s new pharma services business
offers longitudinal monitoring of patients
using the Parsortix system providing
new insights for pharmaceutical cancer
drug trials.
Andrew D W Newland
Chief Executive
23
ANGLE plc Annual Report and Financial Statements 2020Strategic 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
Manage cash and
expenditure to deliver the
strategy
The cash position (cash and cash equivalents and short-term deposits) at 31 December 2020 was £28.6 million
(2019: £18.8 million). The Group carefully plans expenditure with rolling cash flow forecasts and tight financial
control. During the year the COVID-19 virus pandemic impacted the business and following a detailed review,
certain expenditures were reduced and/or deferred in order to extend the cash runway; new plans were put in
place following the fundraise. 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.
Clinical laboratories
The most recent fundraise included funds to establish clinical laboratories in the UK and US for delivering pharma
services and Laboratory Developed Tests (LDTs).
Establish clinical
laboratories
Intellectual property
Increase the depth
and breadth of IP
Ovarian cancer
clinical application:
triaging abnormal
pelvic mass
Progress patient enrolment
Product
development
Deliver ongoing upgrades,
enhancements and
optimisation of our
systems
24
The focus in the year has been on planning for these activities and recruitment of a new head of clinical laboratories
and subsequent to the fundraise developing these activities further and securing facilities for fit-out and recruiting staff
to develop the necessary procedures and systems.
Intellectual property strengthened with new patent filings increasing the breadth and duration of patent coverage
and the range of medical applications covered. Patent applications are being progressed worldwide associated with
the core Parsortix system, the HyCEAD system and new product development.
26 patents protecting the Parsortix system granted at the reporting date (2019: 24) in the United States, Europe,
Australia, Canada, China, Japan, India and Mexico, extending patent coverage out to 2034.
11 patents protecting HyCEAD and Ziplex systems granted at the reporting date (2019: 9) in the United States,
Europe, Canada, China and Japan, with an additional 15 in progress, extending patent coverage out to 2035.
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 the Parsortix system and HyCEAD 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). During the year, COVID-19 resulted in URMC temporarily ceasing
enrolment which has since been restarted.
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 more than 200 Parsortix instruments in active use (in-house, KOLs, and customers) at the reporting date
(2019: c.200). Over 115,000 blood separations have been performed on the system at the reporting date (2019: 93,000).
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 the Parsortix system has been used successfully with
24 different types of cancer.
Upgrades, enhancements and optimisation of the Parsortix and HyCEAD 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 and in order to meet pharma services needs, for example, in blood stability.
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 KPI
Performance
Published evidence
Successful evaluations and studies with multiple third-party cancer centres has led to a growing body
of published evidence:
Build the body of
independent data
Regulatory
authorisation
Make FDA Submission
and maintain quality
control systems
• 37 as at 31 December 2020 (2019: 26) publications in peer-reviewed journals
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. During the
year COVID-19 resulted in analytical studies 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 subsequently restarted and the remaining analytical studies and documentation was completed
with FDA Submission made in September 2020 and accepted by the FDA in October 2020 for substantive review.
The Company subsequently received an Additional Information Request and work is in progress to respond to the
points raised.
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. In addition, ANGLE Biosciences Inc.,
ANGLE’s Toronto facility, has secured ISO 13485:2016 certification (assessed by BSI North America) under the Health
Canada regulations in March 2021.
Research use sales
Build sales to leading
translational researchers
and develop pharma
services offering
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 year were £0.8 million (eight months ended 31 December 2019:
£0.6 million). During the year, sales temporarily reduced due to the impact of COVID-19 with customer sites being
closed. The Group is also developing leads with pharma companies for its new clinical laboratories with the aim of building
sales in 2021, the first large-scale contract being announced in April 2021.
25
ANGLE plc Annual Report and Financial Statements 2020Strategic 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 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,
which did cause patient enrolment to stop for
a period and subsequently resulted in slower
patient enrolment. 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
roll-out 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
26
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 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 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 Financial Statements 2020 Risk
Description
Mitigation
Financial
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 with leading translational researchers.
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 established a Dutch subsidiary to facilitate EU sales and mitigate
post-Brexit trading issues.
Details of the Group’s financial risk objectives and policies are disclosed
in Note 14 to the Financial Statements.
The Group is investing significantly in R&D,
clinical studies, FDA/regulatory studies, product
development, clinical laboratories and product
marketing 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.
Post-Brexit EU trading and human resource
issues and the potential impact of further
COVID-19 restrictions 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 26 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.
27
ANGLE plc Annual Report and Financial Statements 2020Strategic 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 ongoing 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, CTC systems 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 Scientific
Advisory Board 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 the Parsortix system 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 and 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.
28
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 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 have and 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.
29
ANGLE plc Annual Report and Financial Statements 2020Strategic 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. In March 2021, ANGLE Biosciences Inc. achieved
ISO 13485:2016 quality system certification under the Health Canada
regulations, which complements the ISO 13485:2016 quality system
certification held since 2015 by ANGLE Europe Ltd.
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. 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. We continue to monitor the development of, and transition to the
relevant UKCA conformity assessment procedures being put in place by UK
Government post-Brexit.
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
30
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 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.
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 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.
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.
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.
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.
31
ANGLE plc Annual Report and Financial Statements 2020Strategic Report Corporate Responsibility Report
Sustainability and ESG strategy overview
Liquid biopsy
Access to healthcare and the role
of liquid biopsy
As one of its 17 Sustainable Development Goals,
the United Nations describes “ensuring healthy lives
and well-being at all ages as essential to sustainable
development”. The UN goes on to set a number
of targets to achieve this goal, including a one third
reduction in non-communicable diseases by 2030,
including cancer. In addition, the UN places diagnosis,
early warning, and risk reduction at the heart of its
ambition to make healthcare more accessible and
affordable for all countries.
This target is similarly reflected in the UK’s NHS
Long-Term Plan which sets out new ambitions in
cancer care. These include that:
• by 2028, the proportion of cancers diagnosed
at stages 1 and 2 will rise from 50% to 75%
of cancer patients.
• genomic testing will be offered to all cancer
patients.
• all cancer patients will have access to
personalised care and targeted treatment.
• after treatment, patients will have rapid access
to clinical support where they are worried that
their cancer may have recurred.
ANGLE’s stated mission is to change the way that
cancer is diagnosed and treated. Our Parsortix system
captures circulating tumour cells (CTCs), which
are shed from a tumour, and harvests them from
peripheral blood for analysis. This is known as liquid
biopsy and its use has enormous potential throughout
the patient care continuum to improve outcomes
and reduce healthcare costs.
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 existing standard of care is a solid tissue biopsy,
which is invasive, can have medical complications and
uses a lot of healthcare resources – facilities, surgeon,
anaesthetist, nurses etc with the associated high costs.
Further, it is difficult to repeat, so risks missing the
dynamic nature of cancer response, or development
of resistance, 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.
COVID-19 impact and response
COVID-19 and cancer – the big picture
Whilst the Government enforced lock downs resulted
in positive environmental effects (working from home
more, less business travel etc), there has been a notable
negative impact on cancer diagnosis and treatment.
ANGLE believes that liquid biopsy could be a valuable
tool in addressing what is likely to become a secondary
healthcare crisis due to the global pandemic. Cancer is
the leading cause of death in most developed nations,
responsible for an estimated 9.9 million deaths per
year globally. As such, cancer diagnosis and care remain
a priority and services will need to rapidly evolve to
counter the substantial challenge of COVID-19. Ending
delays and addressing backlogs – particularly cancer
surgeries and diagnostic tests – will need to be an
urgent priority moving forward.
The information provided by liquid biopsy could
help clinicians diagnose, monitor, and treat cancer
more efficiently. Liquid biopsy is minimally invasive,
can be undertaken safely in community clinics or in
the home to provide patients with a rapid diagnosis
and timely treatment with targeted therapies. Liquid
biopsy may also help to safely monitor cancer patients
in remission to provide early warning of potential
recurrence. In a future pandemic, the benefit of these
features cannot be overstated. The adverse impact
of COVID-19 on cancer care has shown that it is
essential to have a diagnostic tool which is quick, easy
and alleviates the burden of conducting hospital-based
surgical tissue biopsies.
COVID-19 and ANGLE’s response
From an internal perspective, ANGLE sought to
follow Government guidance closely throughout the
pandemic. Management developed and supported
a viable Work-From-Home strategy wherever
possible and supported employees with the necessary
resources and flexibility in working hours to allow
for an effective and sustainable Work-From-Home
experience. ANGLE was able to maintain regular
communications using a variety of electronic media,
notably management, project and team web
conferencing supplemented by CEO video updates
and Company-wide web conferences shared
with the entire workforce. Early in the pandemic,
ANGLE deployed its Business Continuity Plan and
created a dedicated COVID-19 response team that
continuously reviewed its COVID-19 risk assessment
and implemented any changes needed to respond
to changing government guidelines and employee
feedback. This included individual risk assessments
to support vulnerable employees.
Lessons for the future
ANGLE has learned from the challenges imposed by
the COVID-19 pandemic and management believes
that there have been some positive aspects that can
be maintained in the future, in particular the greater
collaborative mentality and cross-group endeavour
that has been necessarily created. Employee Assistance
Programmes, added to benefits to offer confidential
support, counselling and advice, are likely to be
sustained. The impact on mental health has not gone
unnoticed and ANGLE will continue to recognise
and support Global Mental Health Awareness Day
as well as providing staff access to Company-funded
counselling and advice where required.
Environment
Liquid
biopsy
Social
(community)
Governance
ANGLE is committed to
adopting best practice with
respect to its impact on
society and the environment.
ANGLE believes that investing in culture and
community and in making a positive impact
on the environment will help the Group meet
its business, financial and commercial objectives.
ANGLE encourages diversity and inclusion, and
aims to support all employees to reach their
full potential. ANGLE also aims to minimise
its impact on the planet through its energy
use, resource and material requirements,
waste recovery and transportation. ANGLE
views these efforts not as additional costs
but as investments towards a sustainable
future. Further, ANGLE is committed to
good corporate governance and operational
excellence, going above and beyond the
requirements of the regulatory environment
in which it operates.
32
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 Social (community)
Human capital
ANGLE understands that long-term growth and
business performance depends on the talent, skills
and passion of its employees. The Directors therefore
aim to create a work environment that appeals to,
empowers and involves all employees at every level
of the organisation.
Finding and keeping the best people
In order to attract and retain the best talent, ANGLE
offers competitive and comprehensive salary and
benefits packages. Salaries are reviewed annually
and key roles are benchmarked externally. Benefits
plans are also reviewed annually to determine
comprehensiveness and external competitiveness.
ANGLE offers flexible working hours and part-time
working to employees to accommodate individuals’
needs and commitments outside the workplace.
This is reflected in the fact that some 10% of staff
are employed on a part-time basis and a significant
proportion of staff who are able to balance working
with caring for young children.
The Group works with universities to support
science and operates an effective placement
programme in both the UK and North America. In
the UK, ANGLE offers placements to up to three
undergraduate students each year, typically within the
R&D and Engineering teams. In North America, two
placements are offered annually within either
the R&D or Administrative functions.
Training and development
The Group places a high priority on training and
development throughout the organisation and
from the start of a career at ANGLE. There is a
comprehensive induction process in place to ensure
that new employees are quickly integrated and
operating with the Group’s quality standards. This
includes scheduled catch-up sessions between the
new joiner and their supervisor and the new joiner
and Human Resource management.
Thereafter, employees and managers are encouraged
to identify and discuss individual training needs during
regular one to one review meetings. A training
needs analysis is embedded into the performance
management process with various forms of training
available to meet the differing needs of employees.
In addition, ANGLE always seeks to promote
staff internally, maximising the potential for career
progression and development.
Performance management
Employees and managers are encouraged to meet
regularly, usually monthly, to discuss performance
feedback. Formal annual reviews are undertaken
following the Company’s financial year end. As a
key tool in that process, ANGLE uses a performance
management software system (“Clear Review”) to
enable meaningful, regular performance management.
This system is used to set, track and evaluate
employee performance and development objectives.
ANGLE operates a Development and Promotions
Committee which meets twice yearly to consider
promotions across the organisation as well as to
determine development plans for those individuals
who may in the future be considered for promotion.
Diversity and equal opportunity
The Group recognises the diversity and potential
that different people can bring to their work and is
committed to equal opportunities in the provision
of services and in employment. ANGLE strives to
allow all its people to develop as fully as possible
in accordance with their individual aspirations and
abilities. In all aspects of employment, including
recruitment, pay, training and promotion, ANGLE
avoids discrimination or harassment of any kind and
specifically on the grounds of race, colour, nationality,
ethnic or national origin, religion, gender, marital
status, sexual orientation, medical condition including
progressive illness, age and disability.
The Directors believe that, in addition to the
over-arching responsibility of the Group and its
management, all employees must take individual
responsibility for promoting an environment that
provides equality of opportunity for all. ANGLE
asks all its people to embrace its policy of equal
opportunities as their own and to take personal
responsibility for making the workplace one that is
free of discrimination. Where discrimination is found
to have taken place, ANGLE will take strong action
to address this. Discrimination of any nature, direct
or indirect, will be regarded as misconduct, will be
treated as a disciplinary matter and may lead to
dismissal. Similarly, victimisation of anyone who has
made a complaint will not be tolerated.
Communication and feedback
ANGLE ensures that appropriate emphasis is given
to the practice of good communications and that time
is allocated to it. Communications are encouraged on
a two-way basis both through a consultative process
and by encouraging feedback through all levels of
the management chain. Managers are aware of their
obligation to communicate to those with whom they
work and staff managing activities have responsibilities
to communicate relevant information to other staff
involved with these activities.
Every available means, including the appropriate
use of information technology, is used for the
dissemination of relevant, accurate and prompt
organisational and operational information.
In addition, the Clear Review platform provides a tool
for bidirectional communication and feedback relating
to professional (tied back to the organisational goals)
and personal development goals and objectives of
each employee.
Product quality
ANGLE is committed to providing quality in vitro
diagnostic devices and accessories for the capture,
harvest and analysis of cells present in blood based
on their size and deformability, fulfilling the market
and regulatory requirements to meet the needs
of the customer and for the benefit of the patient.
The quality of medical devices as a minimum will
conform to the In Vitro Diagnostic Directive 98/79/
EC (transitioning to In Vitro Diagnostic Regulation
EU 2017/746), FDA GMP 21 CFR 820 and other
requirements as applicable to the countries in
which the device or service is intended to be
offered for sale.
The Group will commit to encouraging staff
to identify non-conformities and inefficiencies with
the intent of creating and operating systems which
cause zero harm to the patient. It is the policy of
the Group to have a commitment to quality, with
all quality procedures being maintained to EN ISO
13485:2016 reflecting the current state of the art
and Post Market Surveillance findings. This policy
is regularly reviewed and notified to all employees
to ensure that it is understood, implemented
and maintained.
ANGLE’s Quality Management System falls within
the scope of EN ISO 13485:2016 and covers the
design, manufacture, testing, storage, distribution,
service of and the sale of in vitro diagnostic devices,
associated equipment and consumables for the
capture and harvest of cells present in blood. There
are no exclusions within the Quality Management
System. Customer requirements, national standards,
directives, external documents and regulatory and
statutory requirements are all considered as inputs
to the Quality Management System.
Certain activities are outsourced or subcontracted
to third-party manufacturers, including the design,
development and manufacture of mechanical,
electrical and software components. In this instance
the third-party’s procedures are used if compliant
with EN ISO 13485:2016 and certified by a suitable
Notified Body with appropriate scope.
ANGLE’s Quality Management System is subject
to inspection audits by an external notified body
(BSI). A complete annual programme of internal
audits is also established. ANGLE’s Quality Manager
is responsible for addressing any corrective or
preventative actions required.
Key Performance Indicators (KPIs) are established
and performance data is analysed to ensure that the
quality system remains effective. Issues arising are
investigated in accordance with ISO 13485 CAPA and
Defect Reporting Procedures. CAPA process requires
evidence of effective completion and all information is
captured in our quality system records and confirmed
through internal and external audits.
33
ANGLE plc Annual Report and Financial Statements 2020Strategic Report Corporate Responsibility Report
continued
Social (community) continued
Health and safety
The Directors are committed to ensuring
high standards of health and safety for employees,
visitors and the general public. The Group complies
with all applicable laws and regulations wherever
it operates and holds all the licences necessary
to operate its business.
Health and safety a shared responsibility
As the employer, ANGLE is ultimately responsible
for employee health and safety and takes every
reasonable precaution for the protection of workers
in the workplace but believes all employees share a
responsibility, and should work together, to reduce
the risk of injury and occupational disease. ANGLE
makes every effort to provide a safe, healthy work
environment. The employer and all supervisors and
employees are dedicated to reducing the risk of injury.
Supervisors are held accountable for the health and
safety of workers under their supervision. Supervisors
are subject to various duties in the workplace,
including the duty to ensure that machinery and
equipment are safe and that employees work in
compliance with established safe work practices
and procedures.
ANGLE ask that every employee must protect his or
her own health and safety by working in compliance
with the law and with safe work practices and
procedures established by the employer. Employees
will receive information, training, and competent
supervision in their specific work tasks to protect
their health and safety. It is in the best interest of all
parties to consider health and safety in every activity.
Commitment to health and safety must form an
integral part of this organisation from the executives
to the employees.
Zero tolerance of workplace violence
and harassment
ANGLE is committed to the prevention of workplace
violence and harassment and to protecting the
health and safety of our employees in the workplace.
We will take whatever steps are reasonable to
protect employees from workplace violence and
harassment. At ANGLE there is zero tolerance
for workplace violence or harassment of any kind,
including towards or from customers, clients,
supervisors, employees, or members of the public.
ANGLE has a process to report and investigate
complaints of workplace violence or harassment.
All complaints and investigations will be dealt with
in a fair, respectful, and timely manner. We will take
all reasonable precautions to protect workers from
all sources of work‐related harassment. Supervisors
are responsible to support a respectful workplace
by reinforcing a zero‐tolerance violence and
harassment policy and providing information
and training to employees.
All ANGLE employees are encouraged to
work together to support a safe, healthy and
respectful workplace.
Community, charity and outreach
The Guildford laboratory uses healthy volunteer
blood donors to enable it to test multiple aspects
of the Parsortix system and also to perform the
analytical studies for its clinical applications.
We are very grateful for the blood donors who
are predominantly from the local vicinity.
The Group works with a number of charitable
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.
Our values
Our culture
Reputation, integrity and good governance
Hard-working and adaptable
Building long-term partnerships and trust
Driven by a passion to improve the quality
of cancer diagnosis and treatment
Focus on R&D and innovation
Progressive and pragmatic
Openness and transparency
‘Open door’ and inclusive
Sustainability and responsibility
Collaborative and supportive
Governance
Governance and business ethics
Leadership from the Board of Directors
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 statement
The Corporate Governance Report on pages
45 to 52 and this Corporate Responsibility Report
set out how the Board has approached its duty
under Section 172 of the Companies Act, which
is summarised below, in order to meet these
requirements. Specifically it refers the reader to QCA
Principle 1 (Strategy and business model), Principle 2
(Meeting shareholder needs), Principle 3 (Manage our
responsibilities to wider stakeholders) and in particular
within this report the sections headed Human capital
and Health and safety for employees and the section
headed Environmental stewardship for the impact
of the Group’s operations on the community and
environment. The Corporate Governance Report
can also be found on the Company’s website
www.angleplc.com.
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 Group.
Management Charter
ANGLE recognises that it needs to support its
employees as they take on additional responsibility,
and nowhere is this truer than in their roles as
managers. Managers not only help to deliver success
through the organisation and support of their teams,
but also shape the culture of the Group through
their behaviour and leadership style. As ANGLE
grows it is striving to ensure that its values are
upheld and its collaborative, supportive and inclusive
culture continues to develop. ANGLE has, therefore,
produced a Management Charter, which sets out the
expectations of all employees in managerial roles.
34
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 Governance
Responsible marketing
ANGLE is required to have systems in place to ensure
it meets medical device regulatory standards for the
accurate marketing of function and performance of In
Vitro Diagnostic (IVD) and Research Use Only (RUO)
products in territories in which ANGLE operates.
At the moment, this is primarily the requirements
of the IVDD and IVDR in Europe and 21CF801, 809,
820, 830 and 1010 in the USA. In addition, ANGLE
retains membership of the BIVDA in the UK.
Clinical trials programmes and standards
ANGLE engages in clinical studies designed
to evaluate a new medical device or an existing
medical device for a new use and is responsible for
complying with applicable national and international
medical device and IVD regulations and requirements
(e.g. the Food and Drug Administration (FDA), Code
of Federal Regulations (CRF), European Union Medical
Device and IVD Regulations, Institutional Review
Boards (IRB) / Ethics Committees (EC), etc.) and for
ensuring that all responsibilities are properly assigned.
Project Teams are responsible for developing a
regulatory strategy, developing and implementing
an Investigational Plan (IP), monitoring the progress
of ongoing studies, and fulfilling all reporting
requirements required by applicable national and
international regulations. The Project Team may
outsource one or more of these activities to external
organisations (e.g., independent contractors, Contract
Research Organisations (CROs) or other vendors).
ANGLE must ensure these external entities are
properly selected and have the proper training,
experience and resources to adequately conduct the
outsourced activities. ANGLE remains the ultimate
authority and is responsible for all aspects in the
conduct of regulated activities and ensures clinical
studies are carried out in accordance with the IP
and applicable regulations.
Standard Operating Procedures (SOPs) are in place
for all clinical trial activities and all sites are trained in
those SOPs prior to study initiation via Study Initiation
Visits and maintenance of training records.
ANGLE’s clinical study procedures require each
site Principal Investigator and all sub-investigators
to provide a current CV and a copy of the Medical
Licence of the site, Financial Disclosure Forms
signed by the site Principal Investigator and all
sub-investigators and Duly completed Duties and
Signature Log (a.k.a. Delegation of Authority Log).
Any ANGLE sponsored study investigator is
responsible for ensuring that the study is performed
in accordance with the protocol, current International
Conference on Harmonization (ICH) guidelines E6
on Good Clinical Practice (GCP), and applicable
regulatory and institution-specific requirements.
GCP is an international ethical and scientific quality
standard for designing, conducting, recording, and
reporting studies that involve the participation of
human subjects. Compliance with this standard
provides public assurance that the rights, safety, and
well-being of study subjects are protected, consistent
with the principles that originated in the Declaration
of Helsinki, and that the study data are credible.
The site’s responsible investigator must obtain local
IRB/EC approval for the Protocol and Consent Form
prior to enrolling subjects in the study, and must
obtain IRB/EC approval for any amendments to the
protocol as necessary.
The site’s responsible investigator must ensure that
written Informed Consent is obtained from all
subjects participating in the study prior to any study
procedures being done.
The site’s responsible investigator must ensure
that subjects are enrolled according to the Inclusion/
Exclusion criteria and that all information on Informed
Consent Forms, Sample Logs, and data captured
on appropriate CRFs and/or in an eDCS is complete
and accurate.
It is the responsibility of the site’s investigators
and study coordinators to ensure that, to the best
of their knowledge, all subject information is
complete and accurate.
Informed consent
As part of the requirement to perform studies
in line with ICH GCP guidelines, all subjects enrolled
in any ANGLE sponsored study must have provided
informed consent to participate.
Each subject must give written informed consent
according to local requirements after the nature
of the study has been fully explained. The consent
form must be signed before performance of any
study-related activity. The consent form that is
used must be approved by both the Sponsor and
by the reviewing IRB and be in a language that the
patients can read and understand. The informed
consent should be in accordance with principles
that originated in the Declaration of Helsinki,
current ICH and GCP guidelines, applicable
regulatory and/or country specific requirements,
and institutional policies.
Furthermore, our pharma services agreements
include the requirement for clients to provide
assurances that samples have been ethically provided
in line with ICH and other applicable regulations
prior to the commencement of sample processing.
Environmental
Environmental stewardship
As a technology-based Group with most staff in
a small number of locations, ANGLE believes its
environmental footprint is small and climate related
risks are low. Nevertheless, ANGLE views protection
of the environment as a core priority. 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
Waste management
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. The Group uses plumbed water coolers
which reduces the consumption of plastic bottles.
Our Parsortix system uses a microfluidic 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 the higher levels of antibody reagents and other
chemicals used by many of our competitors.
Energy management
All of our offices now use LED lights with a
programme of updates to tungsten and some
halogen lighting since 2016. As well as providing a
better working environment for staff, the most recent
update is forecast to produce a 64% reduction in our
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 laboratories. We use 100%
renewable energy at our two main sites with hydro-
electricity in Toronto. The Group uses plumbed
boiling water taps which are more energy efficient
than kettles.
Travel
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. Several of our
employees are carpooling and we also promote
the use of the cycle-to-work scheme.
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. 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.
35
ANGLE plc Annual Report and Financial Statements 2020Strategic Report Financial Review
The Group has a strong cash position
Substantial investment has continued
in multiple areas of the business with
FDA analytical studies completed
and submission made to FDA and
in Substantive Review.
The fundraise was well supported
by new and existing shareholders,
particularly in the United States.
Ian F Griffiths
Finance Director
Financial Highlights
£0.8 million at 78%
Research use revenues for the year of
£0.8 million (eight months ended 31 December
2019: £0.6 million) at a gross profit margin
of 78% (2019: 76%)
£14.4 million
Planned expenditure on Parsortix system
of £14.4 million (eight months ended
31 December 2019 restated: £9.5 million)
£11.6 million
Loss of £11.6 million (eight months ended
31 December 2019 restated: loss £7.6 million)
£19.6 million
Fundraise of £19.6 million (£18.5 million
net of expenses) in November 2020
£28.6 million
Cash and cash equivalents and
short-term deposits combined balance
at 31 December 2020 £28.6 million
(2019: £18.8 million)
Introduction
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. Following a successful
fundraise in October 2020, ANGLE has made
excellent progress in establishing clinical laboratories
in the US and UK that will be able to offer pharma
services and also have the capability of offering
validated clinical tests. These laboratories will be used
as “accelerators and demonstrators” in support of
the Group’s established plan for product sales of
Parsortix instruments and cassettes and to provide
services to pharmaceutical and biotech customers
running clinical trials.
Restatement and reclassification
Following a detailed review, a number of areas
were identified for restatement or reclassification
and the prior year numbers have been amended
accordingly. This is explained in detail in Note 21.
The restatement amendments relate to 1)
a judgement that certain capitalised product
development costs do not meet the IAS 38 criteria
and should be expensed rather than capitalised and
2) that Group loans with US subsidiaries should not
be treated as part of the Group’s net investment in
those foreign operations and exchange differences
previously recognised in other comprehensive income
on consolidation be reclassified to the income
statement. In addition, there is a reclassification
amendment that certain short-term deposits should
be shown separately from cash and cash equivalents.
Consolidated Statement
of Comprehensive Income
Revenues for the year were £0.8 million (eight
months ended 31 December 2019: £0.6 million)
with a gross profit margin of 78% (eight months
ended 31 December 2019: 76%). 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 the Parsortix
system 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,
COVID-19 related issues and the grant funding
environment for our research customers remains
very challenging.
Grant income for the year of £0.1 million (eight
months ended 31 December 2019: £0.1 million)
was recognised in the year. 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 year of £14.4 million (eight months
ended 31 December 2019 restated: £9.5 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.
36
Strategic Report ANGLE plc Annual Report and Financial Statements 2020 Property, plant and equipment reduced to
£1.2 million (2019: £1.5 million) with the expansion
of premises and the addition of some key items of
laboratory equipment offset by depreciation charges.
The right-of-use assets represented by our
leased office and laboratory premises reduced to
£1.2 million (2019: £1.5 million) with the addition
of a new lease of £0.3 million offset by depreciation
and a transfer to net investment in sublease.
Inventories of £0.7 million (2019: £0.8 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 increased
to £1.4 million (2019: £0.6 million). The current year
balance includes £0.5 million in respect of a Canadian
COVID-19 relief subsidy (Canada Emergency Wage
Subsidy) receivable of £0.5 million and an increase in
prepayments of £0.2 million reflecting an increase in
purchases towards the end of the reporting period
associated with the new clinical laboratories.
The tax receivable balance of £2.1 million
(2019: £3.4 million) reflects the fact that research
and development expenditure is eligible for research
and development tax credits.
The trade and other payables balance of £3.3 million
(2019: £2.4 million) includes bonus payments of £0.9
million. No bonus payments were awarded for the
prior 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.
Cash and short-term deposits
The Group ended the year with a cash and cash
equivalents and short-term deposits combined
balance of £28.6 million (2019: £18.8 million).
The Company completed a fundraise of £19.6 million
(£18.5 million net of expenses) during the year.
The Company was pleased with the continued
support from our major institutional investors
and existing and new investors, particularly in the
United States.
This planned expenditure includes investment
of £7.8 million (eight months ended 31 December
2019: £6.0 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 year leading to the De Novo
Submission to the FDA in September 2020.
Expenditure includes sales and marketing costs
associated with product promotion and “virtual”
attendance at conferences for marketing purposes.
Corporate costs including costs associated with
being a listed company were in line with plans.
The Group made a loss before tax for the year
of £13.7 million (eight months ended 31 December
2019 restated: loss £9.0 million). The significant
research and development expenditure resulted in
research and development tax credits of £2.1 million
for the year (eight months ended 31 December
2019: £1.5 million). The Group made a loss after tax
of £11.6 million for the year (eight months ended
31 December 2019 restated: £7.6 million) resulting
in a basic and diluted loss per share attributable
to owners of the parent of 6.52 pence for the
year (eight months ended 31 December 2019
restated: 4.62 pence).
Consolidated Statement
of Financial Position
Intangible assets decreased in the year to £3.7 million
(2019 restated: £4.0 million). Intellectual property
of £0.1 million (2019 restated: £0.1 million) was
capitalised during the year in accordance with IAS 38
Intangible Assets. Amortisation and impairment costs
of £0.3 million (eight months ended 31 December
2019: £0.2 million) reduced the carrying value
of the intangible assets.
The Group has restated its intangible assets at
31 December 2019 and 30 April 2019 following
a detailed review of its policy for the capitalisation
of product development costs. “Product
development” relates to internally generated
intangible assets that are capitalised in accordance
with IAS 38 Intangible Assets (Note 1.12). IAS 38
criteria are reviewed at the end of each accounting
period. The Group assessed the cumulative capitalised
product development expenditure and determined
that some of these costs did not meet the required
IAS 38 criteria as it is now considered that the
technical feasibility of a product in development
is not proven until regulatory clearance is achieved.
This approach is consistent with other companies in
the sector. A prior year adjustment has been made
to restate the previously capitalised costs not meeting
IAS 38’s recognition criteria on technical feasibility.
Restated intangible assets had a carrying value of
£4.0 million at 31 December 2019 and £4.1 million
at 30 April 2019. Note 21 has further detail.
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 Additional Information
Request analytical 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 clinical laboratories as accelerators
and demonstrators to deliver pharma services and
laboratory developed tests.
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
29 April 2021
The Strategic Report on pages 02 to 37 was
approved by the Board of Directors on 29 April 2021
and is signed on its behalf by:
Ian F Griffiths
Director
29 April 2021
37
ANGLE plc Annual Report and Financial Statements 2020Strategic 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
in 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.
38
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.
Brings to the Board
Over 30 years of experience in finance and
technology-based businesses, and over 11 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 over 20 years of medical
diagnostics experience and has specialised in the
liquid biopsy space for the last 11 years.
He has led the development of technology-based
businesses based on strong intellectual property
for over 30 years and for the last 20 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 30 years’ experience of setting up, leading and
building technology-based businesses, over 20 years
leading specialist medtech businesses, and over 11
years in the liquid biopsy space.
GovernanceANGLE plc Annual Report and Financial Statements 2020 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 the 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.
39
GovernanceANGLE plc Annual Report and Financial Statements 2020
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.
40
Dr. George Hvichia
Prof. Adrian Newland
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 230 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.
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.
Dr. James M. Reuben
Skills and experience
Dr. Reuben is 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 and non-small cell lung 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
GovernanceANGLE plc Annual Report and Financial Statements 2020 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 lead
surgeon for the largest robotic surgery team in the
UK at UCLH. Mr Shaw is known for his innovative
approach and commitment to quality assurance.
Brings to the SAB expertise in – prostate cancer
diagnostics and treatment.
Dr. Clive Stanway
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. Also,
he was recently appointed as a non-executive
director of Babraham Bioscience Technologies 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, Ono
Pharmaceutical 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 and a future oncology test. 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 is Director, Cancer Science
Institute of Singapore, and Distinguished Professor
of Medicine at Yong Loo Lin School of Medicine.
He has also taken up appointments as Senior Principal
Investigator and Senior Adviser at the Agency for
Science, Technology and Research (A*STAR).
Prof. Venkitaraman’s research has contributed
fundamentally to our understanding of how cancer
is suppressed by genes that maintain the integrity
of DNA in the human genome. His laboratory first
discovered that mutations in the breast and ovarian
cancer gene, BRCA2, provoke genome instability
leading to carcinogenesis. In his current role, Prof.
Venkitaraman aims to achieve a deeper understanding
of the steps that underlie carcinogenesis to find new
strategies to intercept cancer development before
the disease reaches an advanced and hard-to-treat
stage. To help translate such fundamental insights
to clinical practice, Prof. Venkitaraman has worked
with colleagues from many different disciplines to
develop new approaches for the discovery and early
development of next-generation medicines.
In his previous role Prof. Venkitaraman held the
Ursula Zoellner Professorship of Cancer Research
at the University of Cambridge and was Director
of the Medical Research Council’s Cancer Cell
Unit and Joint Director of the Medical Research
Council Hutchison Cancer Research Centre. 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.
41
GovernanceANGLE plc Annual Report and Financial Statements 2020 Directors’ Report
For the year ended 31 December 2020
The Directors present their audited Report and Financial Statements for the year ended 31 December 2020 for ANGLE plc (the “Company”) and its subsidiaries
(the “Group” or “ANGLE”). ANGLE plc, Company registration number 04985171, is a public limited company limited by shares, incorporated and domiciled in the
United Kingdom 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.
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 37 reports on the Group’s performance during the past financial
year 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 37 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 24 and 25.
Results and dividends
The Consolidated Statement of Comprehensive Income for the year is set out on page 62.
The Group made a loss for the year of £11.6 million (eight months ended 31 December 2019 restated: loss £7.6 million).
The Directors do not recommend the payment of a dividend for the year (eight months ended 31 December 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 year including both third-party research and development costs and own staff costs amounted to £7.8 million
(eight months ended 31 December 2019: £6.0 million).
Directors and their interests
The Directors of the Company who were in office during the year and up to the date of approval of the Financial Statements were:
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 54 and 55.
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. The cover was in place for the duration of the reporting period and is in place at
the date of approval of these Financial Statements. No cover is provided in respect of any fraudulent or dishonest acts.
42
GovernanceANGLE plc Annual Report and Financial Statements 2020
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 Argus Vickers Share Register
Analysis dated 1 April 2021:
Fund manager/shareholder
Conifer Management LLC
Morgan Stanley Investment Management
Dermot Keane
FIL Limited*
Chelverton Asset Management Limited
Andrew D W Newland
M E Denning
Number of shares
Holding
20,728,174
14,003,446
12,777,088
11,298,000
8,500,000
7,054,686
6,497,658
9.62%
6.50%
5.93%
5.24%
3.95%
3.27%
3.02%
* 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
26 to 31.
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 year. 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") in conformity with the
requirements of the Companies Act 2006 and have elected to prepare the Company Financial Statements in accordance with IFRS in conformity with the requirements
of the Companies Act 2006.
The Group and Company Financial Statements are required by law and IFRS in conformity with the requirements of the Companies Act 2006 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 year.
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 in conformity with the requirements of the Companies Act 2006; 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.
43
GovernanceANGLE plc Annual Report and Financial Statements 2020
Directors’ Report
For the year ended 31 December 2020
continued
Directors’ representation
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.
Post reporting date event
As reported in Note 24, the Chairman’s Statement and elsewhere, the Group has opened clinical laboratories in the UK and United States initially to support pharma
services and then to provide laboratory developed tests once the appropriate accreditations have been received. In addition, the first significant contract with a major
pharma company has been announced that could generate up to US$1.2 million of revenues over the next 18 months and patient enrolment has been completed in
the ovarian cancer study.
Going concern
The Directors have considered the uncertainties, risks and potential impact on the business associated with Brexit, COVID-19 impacts and potential FDA delays 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 approval 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.
Independent auditor
The auditor PricewaterhouseCoopers LLP, Chartered Accountants was appointed by the Board during the year and 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 Wednesday 30 June 2021 at ANGLE plc, 10 Nugent Road, Surrey Research Park,
Guildford, Surrey GU2 7AF. In line with the UK Government’s COVID-19 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 97 to 101. The Company will continue to monitor the ongoing situation with regard
to COVID-19 and any changes to the format of the AGM, including the ability for shareholders to attend in person, will be notified through a regulatory news
service (“RNS”).
This report was approved by the Board of Directors on 29 April 2021 and is signed on its behalf by:
Andrew D W Newland
Chief Executive
29 April 2021
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GovernanceANGLE plc Annual Report and Financial Statements 2020 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 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 37, 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 the Parsortix system 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 continued with its sustained focus on its four-pronged strategy for achieving widespread adoption of its Parsortix system in the emerging multi-US$ billion
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 the blood of patients (initially metastatic breast cancer patients) for subsequent
analysis
3) 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
4) Establishing partnerships with large healthcare companies for market deployment and development of multiple other clinical applications incorporating the
Parsortix system.
ANGLE has also made excellent progress in establishing accredited clinical laboratories in the US and UK that will have the capability of offering validated clinical tests.
These will be used as accelerators and demonstrators in support of the Company’s established plan for product sales of Parsortix instruments and cassettes and to
provide services to pharmaceutical and biotech customers running drug trials.
ANGLE’s ultimate objective is the widespread adoption of the Parsortix system in the diagnosis, treatment and monitoring of cancer patients.
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GovernanceANGLE plc Annual Report and Financial Statements 2020 Corporate Governance Report
continued
ANGLE has made a submission to the FDA and 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 virtual non-deal roadshows in the year and a virtual deal roadshow resulting
in a successful fundraise in November 2020.
The Company has recruited a Head of Investor Relations to increase shareholder engagement and IR activities. The ongoing development of a Corporate Responsibility
Report on pages 32 to 35 is in response to shareholder requests to better understand how the Group deals with sustainability and 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 wider stakeholders including employees, clinical study partners, contractors, key opinion leaders,
trading partners, research and laboratory customers, suppliers and regulatory authorities. The Corporate Responsibility Report on pages 32 to 35 provides more details
and Principle 8 also talks about our values-based corporate culture.
Employees
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.
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. The Company has 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 ongoing initiatives across the Group including a refined structured promotions process, a coaching
programme to support managers and a New Manager training course. Weekly one-to-one support is being provided to all managers with teams working from home.
Contractors and suppliers
ANGLE operates 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.
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 through “frame” orders.
46
GovernanceANGLE plc Annual Report and Financial Statements 2020 Key opinion leaders, customers and clinical study partners
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. We contract with leading cancer centres to run clinical studies
on our behalf as they have access to the necessary patient blood samples and subsequent outcome data.
Eleven peer-reviewed publications were issued in the year by KOLs and customers (eight months ended 31 December 2019: six) taking the total to 37 publications
as at 31 December 2020. A further four publications have been issued since the year end. Due to COVID-19, conference attendance has been of a virtual nature.
Regulatory authorities
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 year, we maintained ISO 13485:2016 accreditation (Europe) and CE marking (IVDD) for the intended use. In addition, ANGLE Biosciences Inc., our Toronto
facility, has now (March 2021) secured ISO 13485:2016 certification (assessed by BSI North America) under the Health Canada regulations and will also continue to
receive annual compliance assessments by BSI under the terms of its certification. The scope of certification for the site includes the design, development, manufacture,
sale, distribution, installation and service of instruments and test methods, consumables and reagents for cellular and molecular diagnostics. The UK and Canadian
ISO 13485 certifications are independently maintained and enable the businesses to pursue a wide range of medical device development and manufacturing activities
in line with the Company’s strategic objectives.
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 26 to 31.
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 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 (Note 1.22 Critical accounting estimates and judgements), 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.
In response to the restatements in the current year Financial Statements, the Board has put in place a quarterly review process for early identification of new accounting
issues arising from the introduction of new areas of business and/or the adoption of new or amended accounting standards. The process will ensure the impacts are
assessed, advice or training is obtained if required and policies (new or revised) are agreed and documented on a timely basis.
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.
47
GovernanceANGLE plc Annual Report and Financial Statements 2020 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. During the year “Delegation of Authority” processes
were reviewed and updated and introduced with the new budget in the new year.
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) extensive cyber security training to support home/remote working in line with COVID-19 restrictions;
2) implementation of COVID-19 secure working practices; 3) continued improvements in segregation of duties; 4) improvements to systems for supplier and
equipment control within the quality system; 5) rollout of electronic forms, document signatures and signing authorities; 6) improvements to purchasing procedures
and inbound/outbound goods inspections; and 7) continued to develop a new project 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, operating clinical laboratories and 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 38 and 39.
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.
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GovernanceANGLE plc Annual Report and Financial Statements 2020 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 43) or represent a major shareholder, they receive
no remuneration from the Company other than directors’ fees and occasional consultancy fees (see page 54), 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 and became Chairman in September 2007. 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 38 and 39.
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 30 years of experience in setting up, leading and building technology-based businesses, over 20 years leading specialist
medtech businesses, and over 11 years in the liquid biopsy space.
• Ian Griffiths, Finance Director – over 30 years of experience in finance and technology-based businesses, and over 11 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 advisers 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 recently undertaken in 2021. 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.
49
GovernanceANGLE plc Annual Report and Financial Statements 2020 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 Corporate Responsibility Report on pages 32 to 35 provides more details and Principle 3 also talks about our responsibilities to wider stakeholders.
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 in normal times, although
the pandemic has resulted in virtual teams. 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% (December 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 43%:57% (December 2019: 48%:52%) Male:Female.
• Different nationalities, with 35 (December 2019: 31) 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 twelve-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.
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GovernanceANGLE plc Annual Report and Financial Statements 2020 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.
Risks have been described in more detail in QCA Principle 4. Note 1.22 describes the Critical accounting estimates and judgements. The Committee 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. Following a tender process, PricewaterhouseCoopers LLP were appointed as auditors
of the Company. 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 auditors’ 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.
A new ethical standard for auditors came into force with effect from 15 March 2020 which restricts the non-audit services that auditors can provide.
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 Financial Statements as recommended by the QCA 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 Remuneration Policy as set out on page 53 is therefore due
for re-approval as an advisory vote at the 2021 AGM. The Directors’ Annual Remuneration Report is subject to an advisory vote by Shareholders at each AGM.
The Remuneration Report on pages 53 to 55 provides details of the Remuneration Policy and the Directors’ Annual 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 supplies 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;
• management accounts, 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.
51
GovernanceANGLE plc Annual Report and Financial Statements 2020 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. Due to COVID-19 restrictions meetings have been held
primarily by video conference. Certain Directors may be appointed as a Committee of the Board of Directors. Directors’ attendance at Board and Committee
meetings during the year ended 31 December 2020 is set out below:
Board
Committee of the Board*
Audit
Remuneration
Nomination
Garth
Selvey
14/14
N/A
5/5
2/2
0/0
Brian
Howlett
14/14
N/A
5/5
2/2
0/0
Jan
Groen
14/14
N/A
5/5
2/2
0/0
Andrew
Newland
Ian
Griffiths
14/14
3/3
N/A
N/A
N/A
13/14
3/3
N/A
N/A
N/A
* the Board appointed Andrew Newland and Ian Griffiths as a Committee of the Board of Directors in relation to the fundraise and employee option exercises during the year.
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 members and role of the Remuneration Committee are described in QCA Principle 9. The Remuneration Report on pages 53 to 55 describes the Remuneration
Policy for the Group as well as detailing the Directors’ remuneration for the year. Discussions are held with significant shareholders ahead of any significant changes
in Remuneration Policy and Shareholders are able to make an advisory vote annually on the Directors’ Remuneration Report and every three years on the
Remuneration Policy.
The Annual General Meeting (AGM) presents an opportunity for shareholders to vote on the various resolutions proposed.
52
GovernanceANGLE plc Annual Report and Financial Statements 2020
Remuneration Report
The Company is not required by either the AIM Listing Rules or the Companies Act to produce a remuneration report but has provided the information below
as recommended by the QCA 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.
The Remuneration Policy is due for re-approval as an advisory vote at the 2021 AGM.
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 in an RNS at the time of award and also in the subsequent Annual Report and Financial Statements. 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.
53
GovernanceANGLE plc Annual Report and Financial Statements 2020 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 year was as follows:
Number of Ordinary shares of £0.10 each
31 December 2020
31 December 2019
703,832
–
10,000
7,054,686
50,000
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
Year ended
31 December 2020
Total
£’000
Bonus
£’000
8 months ended
31 December 2019
Total
£’000
25
117
240
25
25
432
–
2
8
–
–
10
–
40
–
–
–
40
–
92
144
–
–
236
25
251
392
25
25
718
17
106
164
17
17
321
Benefits include amounts in respect of private medical insurance and taxation advice.
Performance bonuses were awarded in the current financial year under the terms of the Annual Bonus Plan. The Executives were deemed to have met the
performance criteria in relation to a 60% performance bonus, major factors of which were: submission to FDA for clearance of the Parsortix system, keeping the
Group working effectively through the COVID-19 pandemic and a successful fundraise.
Performance bonuses were not awarded in the prior 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.
I F Griffiths sacrificed salary during the current year and in the prior period. The Company elected to make contributions to his personal pension.
Directors’ interests – options
The Directors’ interests in LTIP Options and Share options over the Ordinary shares of the Company were as stated below.
LTIP Options
A Long-Term Incentive Plan (LTIP) was established in 2018. The intention of the LTIP is to reward tangible increases in shareholder value. 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.
Award #1 – 20 December 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.
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
Number
0
720,000
1,800,000
3,600,000
Ian
Griffiths
Number
0
480,000
1,200,000
2,400,000
Total
Number
0
1,200,000
3,000,000
6,000,000
Share price CAGR
< 40%
> 40%
> 55%
> 75%
54
GovernanceANGLE plc Annual Report and Financial Statements 2020
Award #2 – 25 September 2020
The Remuneration Committee approved a grant of nil-cost options to Executive Directors on 25 September 2020 over a maximum of 3,000,000 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.
The performance conditions for the LTIP Options relate to i) the Company achieving FDA clearance for its Parsortix system and ii) the compound annual growth rate
(CAGR) of the share price over the three-year performance period. The mid-market share price on 25 September 2020 was £0.53 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:
Share price CAGR
< 20%
> 20%
> 35%
> 50%
Share options
Name
I F Griffiths
A D W Newland
Multiple of
share price
(at 3 years)
< 1.7
> 1.7
> 2.5
> 3.4
Proportion
vesting
0%
20%
50%
100%
Andrew
Newland
Number
0
360,000
900,000
1,800,000
Ian
Griffiths
Number
0
240,000
600,000
1,200,000
Total
Number
0
600,000
1,500,000
3,000,000
At
Date of 1 January
grant
2020 Granted
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
12/11/2015
73,826
25/11/2016 1,000,000
4,023,826
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
Lapsed Cancelled Exercised
At 31 Vested –
December capable of
exercise
2020
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
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
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)
Expiry
date
29/08/2021
17/11/2021
29/08/2021
17/11/2021
09/11/2024
11/11/2025
24/11/2026
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 (this condition has not yet
been met) 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 (this condition has not yet been met) and b) a time/event condition with options vesting after five years or on the sale of the Parsortix business, whichever is earliest
(this condition has been met).
(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 (this condition has
not yet been met), and b) a service condition with options vesting over a three-year period (this condition has been met).
No share options were issued to Directors in the current year or prior period. No Directors’ share options were forfeited, lapsed, cancelled or exercised in the current
year or prior period.
Note 19 provides additional information on share options and LTIP Options.
Shareholder return
The market price of the Company’s shares on 31 December 2020 was £0.478 and the range of market price during the year from 1 January until 31 December 2020
was between £0.398 (low) and £0.755 (high).
This report was approved by the Board of Directors on 29 April 2021 and is signed on its behalf by:
Garth Selvey
Remuneration Committee Chairman
29 April 2021
55
GovernanceANGLE plc Annual Report and Financial Statements 2020
Independent Auditors’ Report
To the Members of ANGLE plc
Report on the audit of the Financial Statements
Opinion
In our opinion, ANGLE plc’s Group Financial Statements and Company Financial Statements (the “Financial Statements”):
• give a true and fair view of the state of the Group’s and of the Company’s affairs as at 31 December 2020 and of the Group’s and Company’s loss and the Group’s
and Company’s cash flows for the year then ended;
• have been properly prepared in accordance with international accounting standards in conformity with the requirements of the Companies Act 2006; and
• have been prepared in accordance with the requirements of the Companies Act 2006.
We have audited the Financial Statements, included within the Annual Report and Financial Statements (the “Annual Report”), which comprise: Consolidated and
Company Statements of Financial Position, Consolidated and Company Statements of Cash Flows, Consolidated and Company Statements of Changes in Equity as at
31 December 2020; Consolidated Statement of Comprehensive Income for the year then ended; and the notes to the Financial Statements, which include a description
of the significant accounting policies.
Basis for opinion
We conducted our audit in accordance with International Standards on Auditing (UK) (“ISAs (UK)”) and applicable law. Our responsibilities under ISAs (UK) are further
described in the Auditors’ responsibilities for the audit of the Financial Statements section of our report. We believe that the audit evidence we have obtained is sufficient
and appropriate to provide a basis for our opinion.
Independence
We remained independent of the Group in accordance with the ethical requirements that are relevant to our audit of the Financial Statements in the UK, which includes
the FRC’s Ethical Standard, as applicable to listed entities, and we have fulfilled our other ethical responsibilities in accordance with these requirements.
Our audit approach
Context
This is the first year of PricewaterhouseCoopers LLP being the auditors of the ANGLE Group and our risk assessment has been driven by our discussions with
management and those charged with governance as well as our understanding of the industry and environment ANGLE operates in. We did not plan to nor test any
controls in our audit. Due to the existing restrictions as a result of the COVID-19 pandemic, our audit has been performed virtually and we have performed additional
audit procedures to ensure we could rely on the audit evidence obtained.
Overview
Audit scope
• The ANGLE Group’s finance function is in the UK. The Group’s head office is located in the UK where our work over the Group consolidation was performed.
• In total, locations where we performed audit work accounted for 95% of the Group loss before tax
Key audit matters
• Going concern (Group and Parent)
• Treatment of expenditure on FDA approval and the next generation Parsortix instrument (Group)
• Impairment assessment of goodwill (Group)
• Impairment assessment of intangibles subject to amortisation (Group)
• Expected credit loss on amounts due from Group undertakings (Parent)
• Valuation of share-based payments (Group and Parent)
• COVID-19 (Group and Parent)
Materiality
• Overall Group materiality: £693,000 based on 5% of loss before tax.
• Overall Company materiality: £745,000 based on 1% of Total assets.
• Performance materiality: £520,000 (Group) and £558,750 (Company).
The scope of our audit
As part of designing our audit, we determined materiality and assessed the risks of material misstatement in the Financial Statements.
56
Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Capability of the audit in detecting irregularities, including fraud
Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with our responsibilities, outlined in the Auditors’
responsibilities for the audit of the Financial Statements section, to detect material misstatements in respect of irregularities, including fraud. The extent to which our
procedures are capable of detecting irregularities, including fraud, is detailed below.
Based on our understanding of the Group and industry, we identified that the principal risks of non-compliance with laws and regulations related to tax legislation, and
we considered the extent to which non-compliance might have a material effect on the Financial Statements. We also considered those laws and regulations that have a
direct impact on the preparation of the Financial Statements such as the Companies Act 2006. We evaluated management’s incentives and opportunities for fraudulent
manipulation of the Financial Statements (including the risk of override of controls), and determined that the principal risks were related to posting inappropriate journal
entries to increase revenue and misappropriation of cash. We have also identified a risk of misappropriation of intellectual property (IP) and lack of governance over
publications and regulatory announcements. Audit procedures performed by the engagement team included:
• Discussions with the Directors, including considerations of known or suspected instances of non-compliance with laws and regulations and fraud.
• Performing detailed testing over compliance with tax legislation including evaluating the Group’s transfer pricing arrangements and auditing R&D tax credits.
• Evaluation of management’s controls designed to prevent and detect irregularities.
• Identifying and testing journal entries, in particular any journal entries that credit cash or credit revenues where the offsetting entry was to an unexpected account
based on the normal flow of transactions for these financial statement line items.
• Understanding and obtaining evidence for the measures the Directors have taken to protect IP.
• Testing the governance process around publications and review and approval of any regulatory announcements that may have a significant impact on the share price
and thus the Directors compensation for example via the LTIP.
There are inherent limitations in the audit procedures described above. We are less likely to become aware of instances of non-compliance with laws and regulations
that are not closely related to events and transactions reflected in the Financial Statements. Also, the risk of not detecting a material misstatement due to fraud is
higher than the risk of not detecting one resulting from error, as fraud may involve deliberate concealment by, for example, forgery or intentional misrepresentations,
or through collusion.
Key audit matters
Key audit matters are those matters that, in the auditors’ professional judgement, were of most significance in the audit of the Financial Statements of the current period
and include the most significant assessed risks of material misstatement (whether or not due to fraud) identified by the auditors, including those which had the greatest
effect on: the overall audit strategy; the allocation of resources in the audit; and directing the efforts of the engagement team. These matters, and any comments we
make on the results of our procedures thereon, were addressed in the context of our audit of the Financial Statements as a whole, and in forming our opinion thereon,
and we do not provide a separate opinion on these matters.
This is not a complete list of all risks identified by our audit.
Key audit matter
How our audit addressed the key audit matter
For our audit response and conclusions in respect of going concern, see the
‘Conclusions relating to going concern’ section below.
Going concern (Group and Parent)
For the year ended 31 December 2020, the Group used net cash in operating
activities of £7.8m and the Company used net cash in operations of £nil. Cash
and cash equivalents and short-term deposits at 31 December 2020 were
£28.6m for the Group and £26.6m for the Company.
The Board considered the application of the going concern basis in the
preparation of the Financial Statements and in doing so have prepared forecasts
and plans, including modelling a severe but plausible downside scenario under
which cash may need to be conserved due to a significant delay in generating
material revenues. After considering these forecasts and plans and the cash
and cash equivalents and short-term deposits held at 31 December 2020, the
Directors concluded that the Group and Company have sufficient funding for
the foreseeable future and at least one year from the date of approval of the
Financial Statements and have therefore continued to adopt the going concern
basis in preparing the Financial Statements.
57
Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Independent Auditors’ Report
To the Members of ANGLE plc
continued
Key audit matter
How our audit addressed the key audit matter
Treatment of expenditure on FDA approval and the next
generation Parsortix instrument (Group)
IAS 38 requires development costs to be capitalised where they meet the
recognition criteria. There is often a significant degree of judgement when
early stage, loss making companies without regulatory clearance capitalise
development costs given the regulatory uncertainty surrounding approval of
products and demonstrating technical feasibility as required by the standard.
In the current year, the Directors have concluded that the technical feasibility
hurdle is not met until regulatory clearance is achieved and that the costs
associated with obtaining FDA clearance and developing the next generation
Parsortix instrument should be expensed.
The Directors have therefore determined that a prior period restatement
is required to product development within Note 11 (intangible assets).
The restatement as recognised in accordance with IAS 8 has been detailed
within Note 21 (restatement and reclassification).
Impairment assessment of goodwill (Group)
Under IAS 36, the Directors are required to perform an impairment review
for goodwill at each reporting date.
Goodwill in the Group Financial Statements totals £2.2m and arose from an
acquisition of assets. The Directors have assessed the recoverability of goodwill
by comparing the book value of the single cash generating unit (CGU) in the
ANGLE Group to the market capitalisation as a proxy for fair value less costs
to sell. On the basis of this assessment, no impairment is recognised by the
Directors as market capitalisation as at 31 December 2020 totals £102.9m
which significantly exceeds the carrying value of the Group measured by net
assets of £34.3m.
We have reviewed the requirements of IAS 38 against the costs previously
capitalised by the Directors as development expenditure.
In particular, we have focused on the extent to which FDA clearance is a binary
outcome as well as whether the decision to invest in the next generation
Parsortix instrument was directly linked to an expectation of receiving FDA
clearance and significantly growing sales.
From the procedures performed, we concluded that the Directors’ decision to
expense costs attributable to obtaining FDA clearance and developing the next
generation Parsortix instrument is appropriate and that a prior year restatement
as detailed within Note 21 should be recognised. We have audited the
disclosures in Note 21 and are satisfied they are appropriate.
We have assessed the Directors’ judgement that there is a single CGU against
the information reported to the Board.
We have considered the appropriateness of using market cap as a proxy
for fair value.
We have considered the potential size of any “costs to sell” that should be
taken into account when determining the recoverable amount of the CGU
based on fair value less costs to sell as well as any “control premium” that
another party may pay that should be reflected in fair value over and above
the market capitalisation.
We have considered post year-end changes in the market capitalisation and the
extent to which such movements should be reflected in the year-end valuation.
From the procedures performed, we found that the Directors’ assessment
is supportable and that the disclosures within the Financial Statements are
appropriate.
Impairment assessment of intangibles subject
to amortisation (Group)
Under IAS 36, for intangible assets subject to amortisation, the Directors are
required to identity whether there are any indications of impairment that
would require a formal impairment review.
We audited a breakdown of intangible assets subject to amortisation to
identify the territories to which various patents belong as well as understanding
the assets that make up the acquired intangible assets from the acquisition
of Axela’s assets in November 2017 to ensure these were still in use and
expected to provide economic benefits.
The Directors have not identified any impairment indicators for these intangible
assets aside from a small impairment for unused IP. The majority of the
intangible assets relate to patents which the business requires to commercialise
its Parsortix system as well as intangible assets recognised from the acquisition
of Axela Inc. (principally the HyCEAD technology) which is used for
downstream molecular analysis.
We considered whether there are any further impairment indicators as set
out in IAS 36.
From the procedures performed, we are satisfied that the intangible assets
subject to amortisation continue to be used by the business and there are
no additional impairment indicators.
Expected credit loss on amounts due from Group
undertakings (Parent)
Companies adopting IFRS in their stand-alone financial statements are required
to calculate expected credit losses on all financial assets, including intercompany
loans within the scope of IFRS 9.
The Directors have calculated an expected credit loss on the amounts due
from Group undertakings by assigning probabilities of recovery to various
scenarios including default, a partial success of the business and full recovery
of the amount due to determine the expected credit loss.
We obtained the Directors’ calculation, checked for mathematical accuracy and
assessed the probabilities assigned to each scenario by comparing it to available
third-party data and challenging the Directors.
From the procedures performed, we found that the Directors’ expected credit
loss provision is supportable and that the disclosures within the Company
Financial Statements are appropriate.
58
Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Key audit matter
How our audit addressed the key audit matter
Valuation of share-based payments (Group and Parent)
The accounting treatment for share options can be complex and involves
judgement.
The Company has granted 5.195m share options under the enterprise
management incentive (EMI) share option scheme and unapproved share
option scheme as well as 3m new share options under the Long-term incentive
plan (LTIP) in the year.
The Directors have had to form a judgement to determine the appropriate
valuation model to use for each share option scheme as well as estimate future
volatilities as well as the likelihood of performance conditions being met.
We obtained the Directors’ calculations of the fair value of share options
granted during the year.
We assessed the valuation models used for each type of share option
for appropriateness and engaged our specialist valuations team to assist
in performing this work.
We re-performed calculations to independently calculate the fair value
of the share options in question.
We assessed key inputs into the valuation models to ensure they were
appropriate.
COVID-19 (Group and Parent)
The Directors are required to consider the impact of the ongoing COVID-19
pandemic on the Financial Statements, including in their forecasts where those
are used to justify recoverable amounts, wider impairment considerations
as well as the use of the going concern assumption. The Directors have
considered the main risks to be delays in the approval of products, ability
to conduct clinical trials and the disruption of product supply, promotion,
distribution and sales. In order to mitigate these risks, management keeps
in close contact with customers and regulators, maintains sufficient levels
of inventory and has put in place appropriate business continuity and disaster
recovery plans as needed.
From the procedures performed, we are satisfied that the Directors’ valuation
of share options granted during the year is materially correct.
Held discussions with the Directors to understand, in qualitative and
quantitative terms, the impact of COVID-19 on business operations.
Evaluated the Directors’ sensitivities/modelling and challenged the key
assumptions contained within cash flow forecasts.
Read the Directors’ disclosures in the Financial Statements.
From the procedures performed, we found that the Directors’ COVID-19
impact assessment is supportable and that the disclosures within the Financial
Statements are appropriate.
How we tailored the audit scope
We tailored the scope of our audit to ensure that we performed enough work to be able to give an opinion on the Financial Statements as a whole, taking into account
the structure of the Group and the Company, the accounting processes and controls, and the industry in which they operate.
In establishing the overall approach to the Group audit, we assessed the audit significance of each entity in the Group by reference to both its financial significance and
other indicators of audit risk, such as the complexity of operations and the degree of estimation and judgement in the financial results.
Following this assessment, we determined that we needed to focus our audit work on ANGLE Europe Limited and ANGLE Biosciences Inc. Through discussions with
the Group finance team, we obtained an understanding of the operational activities of these entities, and appropriately determined the audit risks for each entity based
on the size of individual financial statement line items and the judgements/estimates made by the Directors. This, together with additional procedures performed at the
Group level over the consolidation process, gave us the evidence we needed for our opinion on the Financial Statements as a whole.
The financially significant components for the audit were ANGLE Europe Limited and ANGLE Biosciences Inc. as these were the only two components that contributed
more than 15% to the loss before tax. We also performed audit work on ANGLE plc for cash and cash equivalents and total equity and for ANGLE North America Inc.
we audited payroll costs in order to ensure we had sufficient coverage over these Financial Statement line items from a Group perspective.
All work was done by the group audit team and no component auditors were involved in the audit.
59
Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Independent Auditors’ Report
To the Members of ANGLE plc
continued
Materiality
The scope of our audit was influenced by our application of materiality. We set certain quantitative thresholds for materiality. These, together with qualitative
considerations, helped us to determine the scope of our audit and the nature, timing and extent of our audit procedures on the individual Financial Statement line items
and disclosures and in evaluating the effect of misstatements, both individually and in aggregate on the Financial Statements as a whole.
Based on our professional judgement, we determined materiality for the Financial Statements as a whole as follows:
Financial Statements – Group
Financial Statements – Company
Overall materiality
£693,000.
How we determined it
5% of loss before tax
£745,000.
1% of Total assets
Rationale for benchmark
applied
Whilst the Group has generated revenue in the
year ended 31 December 2020 it is still loss
making for the year. Given this and based on
the benchmarks used in the Annual Report,
we believe that loss before tax is the primary
measure used by the shareholders in assessing
the financial performance of the Group, and
is a generally accepted auditing benchmark.
The entity fulfils the role of the holding company
within the Group. The entity’s main function in the
Group has historically been the raising of funds
through equity issues to fund the Group’s
development activities and manage the Group’s cash
reserves. As such, we believe that total assets is the
most appropriate measure to assess the financial
position of the Company, and is a generally accepted
auditing benchmark.
For each component in the scope of our Group audit, we allocated a materiality that is less than our overall Group materiality. The range of materiality allocated across
components was £290,000 to £520,600.
We use performance materiality to reduce to an appropriately low level the probability that the aggregate of uncorrected and undetected misstatements exceeds overall
materiality. Specifically, we use performance materiality in determining the scope of our audit and the nature and extent of our testing of account balances, classes of
transactions and disclosures, for example in determining sample sizes. Our performance materiality was 75% of overall materiality, amounting to £520,000 for the Group
Financial Statements and £558,750 for the Company Financial Statements.
In determining the performance materiality, we considered a number of factors – the history of misstatements, risk assessment and aggregation risk and the effectiveness
of controls – and concluded that an amount at the upper end of our normal range was appropriate.
We agreed with those charged with governance that we would report to them misstatements identified during our audit above £34,650 (Group audit) and £37,250
(Company audit) as well as misstatements below those amounts that, in our view, warranted reporting for qualitative reasons.
Conclusions relating to going concern
Our evaluation of the Directors’ assessment of the Group’s and the Company’s ability to continue to adopt the going concern basis of accounting included:
• Testing the mathematical integrity of the cash flow forecasts and reconciling these to Board approved budgets.
• Assessing the completeness and accuracy of costs included within the cash flow forecasts based on historical expenditure and committed future costs.
• Assessing the reasonableness of assumptions within the models around sales growth, based on our understanding of the business and by comparing against
historical results.
• Evaluating the severe but plausible downside scenario under which regulatory clearance of the Parsortix system is significantly delayed and ANGLE may need to
conserve cash. We evaluated the levers available to the Directors in order to conserve costs, considering the timing of when such decisions would have to be made
in order to have the desired effect on the cash run rate of the business.
Based on the work we have performed, we have not identified any material uncertainties relating to events or conditions that, individually or collectively, may cast
significant doubt on the Group’s and the Company’s ability to continue as a going concern for a period of at least twelve months from when the Financial Statements
are authorised for issue.
In auditing the Financial Statements, we have concluded that the Directors’ use of the going concern basis of accounting in the preparation of the Financial Statements
is appropriate.
However, because not all future events or conditions can be predicted, this conclusion is not a guarantee as to the Group’s and the Company’s ability to continue
as a going concern.
Our responsibilities and the responsibilities of the Directors with respect to going concern are described in the relevant sections of this report.
60
Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Reporting on other information
The other information comprises all of the information in the Annual Report other than the Financial Statements and our auditors’ report thereon. The Directors are
responsible for the other information. Our opinion on the Financial Statements does not cover the other information and, accordingly, we do not express an audit
opinion or, except to the extent otherwise explicitly stated in this report, any form of assurance 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 an
apparent material inconsistency or material misstatement, we are required to perform procedures to conclude whether there is a material misstatement of 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 based on these responsibilities.
With respect to the Strategic Report and Directors’ Report, we also considered whether the disclosures required by the UK Companies Act 2006 have been included.
Based on our work undertaken in the course of the audit, the Companies Act 2006 requires us also to report certain opinions and matters as described below.
Strategic Report and Directors’ Report
In our opinion, based on the work undertaken in the course of the audit, the information given in the Strategic Report and Directors’ Report for the year ended
31 December 2020 is consistent with the Financial Statements and has been prepared in accordance with applicable legal requirements.
In light of the knowledge and understanding of the Group and Company and their environment obtained in the course of the audit, we did not identify any material
misstatements in the Strategic Report and Directors’ Report.
Responsibilities for the Financial Statements and the audit
Responsibilities of the Directors for the Financial Statements
As explained more fully in the Directors’ responsibilities, the Directors are responsible for the preparation of the Financial Statements in accordance with the applicable
framework and for being satisfied that they give a true and fair view. The Directors are also responsible for such internal control as they 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 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 Company
or to cease operations, or have no realistic alternative but to do so.
Auditors’ 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 auditors’ 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.
Our audit testing might include testing complete populations of certain transactions and balances, possibly using data auditing techniques. However, it typically involves
selecting a limited number of items for testing, rather than testing complete populations. We will often seek to target particular items for testing based on their size
or risk characteristics. In other cases, we will use audit sampling to enable us to draw a conclusion about the population from which the sample is selected.
A further description of our responsibilities for the audit of the financial statements is located on the FRC’s website at: www.frc.org.uk/auditorsresponsibilities.
This description forms part of our auditors’ report.
Use of this report
This report, including the opinions, has been prepared for and only for the Company’s members as a body in accordance with Chapter 3 of Part 16 of the Companies
Act 2006 and for no other purpose. We do not, in giving these opinions, accept or assume responsibility for any other purpose or to any other person to whom this
report is shown or into whose hands it may come save where expressly agreed by our prior consent in writing.
Other required reporting
Companies Act 2006 exception reporting
Under the Companies Act 2006 we are required to report to you if, in our opinion:
• we have not obtained all the information and explanations we require for our audit; or
• adequate accounting records have not been kept by the Company, or returns adequate for our audit have not been received from branches not visited by us; or
• certain disclosures of Directors’ remuneration specified by law are not made; or
• the Company Financial Statements are not in agreement with the accounting records and returns.
We have no exceptions to report arising from this responsibility.
David Farmer (Senior Statutory Auditor)
for and on behalf of PricewaterhouseCoopers LLP
Chartered Accountants and Statutory Auditors
Reading
29 April 2021
61
Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Consolidated Statement of Comprehensive Income
For the year ended 31 December 2020
Revenue
Cost of sales
Gross profit
Other operating income
Operating costs
Operating profit/(loss)
Finance income
Finance 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
Earnings/(loss) per share attributable to owners of the parent
Basic and Diluted (pence per share)
* The impact of the restatement is described in Note 21.
All activity arose from continuing operations.
Year ended
31 December 2020
£’000
762
(165)
597
79
(14,407)
(13,731)
78
(92)
(13,745)
2,139
(11,606)
562
562
(11,044)
Note
2
3
3
7
7
8
9
8 months ended
31 December 2019
(Restated*)
£’000
581
(142)
439
61
(9,512)
(9,012)
40
(66)
(9,038)
1,482
(7,556)
241
241
(7,315)
(6.52)
(4.62)
62
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Consolidated Statement of Financial Position
As at 31 December 2020
Assets
Non-current assets
Intangible assets
Property, plant and equipment
Right-of-use assets
Total non-current assets
Current assets
Inventories
Trade and other receivables
Taxation
Short-term deposits
Cash and cash equivalents
Total current assets
Total assets
Non-current liabilities
Lease liabilities
Total non-current liabilities
Current liabilities
Lease liabilities
Trade and other payables
Total current liabilities
Total liabilities
Net assets
Equity
Share capital
Share premium
Share-based payments reserve
Other reserve
Translation reserve
Accumulated losses
ESOT shares
Total equity
31 December 2020
Note
£’000
31 December 2019
(Restated*)
£’000
30 April 2019
(Restated*)
£’000
11
12
13
15
16
13
13
17
18
20
3,710
1,176
1,233
6,119
742
1,443
2,127
16,538
12,080
32,930
3,974
1,508
1,514
6,996
788
627
3,398
15,009
3,757
23,579
4,149
1,347
–
5,496
988
942
1,900
–
11,010
14,840
39,049
30,575
20,336
(928)
(928)
(434)
(3,343)
(3,777)
(1,201)
(1,201)
(352)
(2,425)
(2,777)
–
–
–
(3,684)
(3,684)
(4,705)
(3,978)
(3,684)
34,344
26,597
16,652
21,540
81,532
1,745
2,553
(3,785)
(69,139)
(102)
34,344
17,277
67,272
1,518
2,553
(4,347)
(57,574)
(102)
26,597
14,349
53,273
1,266
2,553
(4,588)
(50,099)
(102)
16,652
* The impact of the restatement is described in Note 21.
The Consolidated Financial Statements on pages 62 to 90 were approved by the Board of Directors and authorised for issue on 29 April 2021 and signed on its
behalf by:
Ian F Griffiths
Director
Andrew D W Newland
Director
63
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Consolidated Statement of Cash Flows
For the year ended 31 December 2020
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
(Restated*)
£’000
(13,745)
(9,038)
661
421
2
337
268
565
14
(11,477)
14
(658)
872
(11,249)
3,410
(9)
(7,848)
(412)
(94)
(1,530)
70
(1,966)
18,650
–
(463)
(44)
18,143
8,329
3,757
(6)
12,080
4,074
8,006
12,080
12,080
16,538
28,618
432
219
13
240
333
235
26
(7,540)
90
314
(1,171)
(8,307)
–
(59)
(8,366)
(529)
(66)
(15,009)
40
(15,564)
16,921
(2)
(231)
(13)
16,675
(7,255)
11,010
2
3,757
1,556
2,201
3,757
3,757
15,009
18,766
Operating activities
Profit/(loss) before tax
Adjustments for:
Depreciation of property, plant and equipment
Depreciation and impairment 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
Transfer to short-term deposits
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
Cash at bank – immediate access
Cash at bank – restricted access (35 day notice)
Cash and cash equivalents at end of period
Cash and cash equivalents at end of period
Short-term deposits
Cash and cash equivalents and short-term deposits
* The impact of the restatement is described in Note 21.
64
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Consolidated Statement of Changes in Equity
For the year ended 31 December 2020
Equity attributable to owners of the parent
Share
capital
Share-based
payments
reserve
Share
premium
£’000
£’000
£’000
Other Translation Accumulated
losses
reserve
reserve
(Restated*)
(Restated*)
£’000
£’000
£’000
At 1 May 2019 as originally reported
Restatement – IAS 38 adjustment
Restatement – retranslation of Group balances
At 1 May 2019 restated
14,349
53,273
1,266
2,553
14,349
53,273
1,266
2,553
For the 8 months to 31 December 2019
Consolidated profit/(loss) as originally reported
Restatement – IAS 38 adjustment
Restatement – retranslation of Group balances
Other comprehensive income/(loss):
Exchange differences on translating foreign operations as originally reported
Restatement – IAS 38 adjustment
Restatement – retranslation of Group balances
Total comprehensive income/(loss) restated
Issue of shares (net of costs)
Share-based payments
Released on forfeiture
Released on exercise
2,928
13,999
333
(78)
(3)
106
(9)
(4,685)
(4,588)
(52,109)
(2,675)
4,685
(50,099)
(6,248)
(1,046)
(262)
(24)
3
262
241
(7,556)
78
3
ESOT
shares
£’000
(102)
(102)
Total
equity
(Restated*)
£’000
19,336
(2,684)
–
16,652
(6,248)
(1,046)
(262)
(24)
3
262
(7,315)
16,927
333
–
–
At 31 December 2019 restated
17,277
67,272
1,518
2,553
(4,347)
(57,574)
(102)
26,597
At 31 December 2019 as originally reported
Restatement – IAS 38 adjustment
Restatement – retranslation of Group balances
At 31 December 2019 restated
For the year to 31 December 2020
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
17,277
67,272
1,518
2,553
17,277
67,272
1,518
2,553
82
(6)
(4,423)
(4,347)
(58,276)
(3,721)
4,423
(57,574)
(102)
(102)
30,324
(3,727)
–
26,597
4,263
14,260
268
(37)
(4)
(11,606)
562
562
(11,606)
37
4
(11,606)
562
(11,044)
18,523
268
–
–
At 31 December 2020
21,540
81,532
1,745
2,553
(3,785)
(69,139)
(102)
34,344
* The impact of the restatement is described in Note 21.
Share premium
Represents amounts subscribed for share capital in excess of nominal value, net of directly attributable share issue costs.
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 accumulated losses as the related share options are exercised, forfeited, lapse
or expire.
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 accumulated losses.
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.
Accumulated losses
Represents cumulative profit and loss net of distribution to owners.
65
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Consolidated Financial Statements
For the year ended 31 December 2020
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 conformity with the requirements
of the Companies Act 2006 for the year ended 31 December 2020 (including comparatives for the eight months 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 Financial Statements of the Parent Company have been prepared in accordance with IFRS and are presented on pages 91 to 96.
Accounting standards adopted in the year
The following standards relevant to the Group have been amended or implemented during the year:
Amendments to IFRS 3
Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 and IFRS 16
Amendments to IAS 1 and IAS 8
Amendments to IFRS 10 and IAS 28
Various
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
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. 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.
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 2021. The Directors have not yet
assessed the impact of the adoption of these Standards and Interpretations for future periods.
Amendments to IFRS 16
Amendments to IFRS 17 and IFRS 4
Amendments to IAS 1
Various narrow-scope amendments to IFRS 3, IAS 16, IAS 17 and some annual improvements on IFRS 1, IFRS 9, IAS 41 and IFRS 16
Leases – COVID-19 related rent concessions
Insurance contracts – deferral of IFRS 9
Presentation of financial statements on classification of liabilities
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 Strategic Report on pages 02 to 37. The principal risks and uncertainties are stated on pages 26 to 31. In addition Note 14 to the Financial Statements
includes details of the Group’s exposure to capital risk, liquidity risk, credit risk, interest rate risk and foreign currency risk. The Chairman’s Statement 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 Brexit, COVID-19 impacts and potential FDA delays
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 approval 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.
66
Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Accounting policies continued
1
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.
Intra-group transactions and balances are eliminated fully on consolidation and the consolidated accounts reflect external transactions only.
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.
Where contracts contain multiple deliverables, and the volume of each deliverable can be determined with reasonable certainty, then the transaction price, assessed
against a standard price list, will be allocated to each performance obligation based on the expected cost of each item.
Sale of products
Revenue from the sale of products is recognised when control over the products has 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.
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Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Notes to the Consolidated Financial Statements
continued
Accounting policies continued
1
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.
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
Optionholder 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 year comprises current and deferred tax.
Current tax is the expected tax payable on the taxable income for the year, 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 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.
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Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Accounting policies continued
1
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, when
originally assessed, 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 when originally assessed, 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.
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Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Notes to the Consolidated Financial Statements
continued
Accounting policies continued
1
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 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.
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
at 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.
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Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Accounting policies continued
1
1.14 Leases continued
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.
Net investment in sublease
The Group classifies a sublease as a finance lease or an operating lease by reference to the head lease. Net investment in a sublease is created initially by derecognising
the right-of-use asset and recognising a receivable equal to the amount of lease payments receivable discounted by the interest rate implicit in the lease.
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 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.
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 year 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.
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Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Notes to the Consolidated Financial Statements
continued
Accounting policies continued
1
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 cash equivalents 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.
Short-term deposits
Short-term deposits in the statement of financial position comprise deposits with an original maturity of greater than three months and less than 12 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.
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.
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Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Accounting policies continued
1
1.22 Critical accounting estimates and judgements continued
Valuation and amortisation of internally generated intangible assets (Notes 1.12, 11 and 21)
IAS 38 Intangible Assets contains specific criteria that if met mean development expenditure must be capitalised as an internally generated intangible asset. Judgements
are required in both assessing whether the criteria are met, (for example, differentiating between enhancements and maintenance) and then in applying the rules
(for example, determining an estimated useful life). Intangible assets are amortised over their useful lives.
IAS 38 criteria are reviewed at the end of each accounting period. The Group assessed the cumulative capitalised product development expenditure and determined
that some of these costs did not meet the required IAS 38 criteria as it is now considered that the technical feasibility of a product in development is not proven until
regulatory clearance is achieved. This approach is consistent with other companies in the sector. A prior year adjustment has been made to restate the previously
capitalised costs not meeting IAS 38’s recognition criteria on technical feasibility. Restated intangible assets had a carrying value of £4.0 million at 31 December 2019
and £4.1 million at 30 April 2019. Note 21 has further detail.
Share-based payments (Notes 1.10 and 19)
In calculating the fair value of equity-settled share-based payments the Group uses options pricing models. 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 key input
parameters are expected volatility, expected life of the options and the number of options expected to vest.
Leases – extension and/or termination options (Notes 1.1, 1.14 and 13)
The Group has three 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 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 £0.8 million (2019: £0.9 million).
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Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Notes to the Consolidated Financial Statements
continued
Operating segment and revenue analysis
2
Operating segment
The Group’s principal trading activity is undertaken in relation to the commercialisation of its Parsortix cell separation system and its HyCEAD multiplex analysis
system. There are separate work streams on the Parsortix and HyCEAD systems however the HyCEAD 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.
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 no significant customer who contributed 10% or more of Group revenues in the year (eight months ended 31 December 2019: one customer
contributing more than 10% of revenues).
Analysis of revenue from contracts with customers
The Group derives revenues from the sale of products and services in the following geographical regions:
Year ended
31 December 2020
8 months ended
31 December 2019
Product-
related
£’000
30
490
121
641
Service-
related
£’000
6
80
35
121
Total
£’000
36
570
156
762
Product-
related
£’000
73
215
180
468
Service-
related
£’000
5
62
46
113
Total
£’000
78
277
226
581
UK
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 £nil (2019: £3,000) 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 start of period
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
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
54
(42)
48
60
47
(39)
46
54
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.
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Financial StatementsANGLE plc Annual Report and Financial Statements 2020
3
Costs
Employment costs (Note 5)
Depreciation of property, plant and equipment (Note 12)
Depreciation and impairment 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 – low value and short-term (Note 13)
Auditors’ 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
Year ended
31 December 2020
£’000
6,369
661
421
2
282
55
56
220
3,302
152
357
460
596
1,474
14,407
136
29
165
8 months ended
31 December 2019
(Restated*)
£’000
3,537
432
219
13
240
–
27
93
2,760
74
445
281
298
1,093
9,512
106
36
142
14,572
9,654
* The prior period research and development costs (employee and third-party) have been adjusted for a change in accounting treatment following a review of the application of IAS 38.
The prior period foreign exchange costs have been adjusted for the retranslation of US Group loans at the prevailing balance sheet rate. The impact of these restatements is described
in Note 21.
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.
Auditors’ remuneration
Audit services
Statutory audit of parent and consolidated financial statements
Statutory audit of subsidiaries
Non-audit services
Tax compliance services
Total
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
210
10
–
220
65
10
18
93
The Group changed auditors from RSM UK Audit LLP to PricewaterhouseCoopers LLP for the year ended 31 December 2020.
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 financial statements”.
75
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Consolidated Financial Statements
continued
4
Directors’ emoluments
Aggregate emoluments for qualifying services
Employer pension contributions (Note 6)
Subtotal per Directors’ Remuneration Report (page 54)
Employer’s National Insurance contributions
Total
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
678
40
718
84
802
311
10
321
36
357
LTIP Options were issued to Directors in the current year (prior period – nil). No Directors LTIP Options were forfeited, lapsed, cancelled or exercised in the year
or prior period. No share options were issued to Directors in the current year or prior period. No Directors share options were forfeited, lapsed, cancelled or
exercised in the year or prior period.
The above includes the following amounts paid in respect of the highest paid Director:
Emoluments for qualifying services
Employer’s National Insurance contributions
Total
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
392
52
444
164
21
185
Disclosures relating to individual Directors’ emoluments are given in the Directors’ Remuneration Report on pages 54 and 55.
Employment
5
Employment costs
The aggregate of employment costs of employees (including Directors) for the year was:
Wages and salaries
Social security costs
Other pension costs (Note 6)
Share-based payment charge (Note 19)
Total staff costs in operating costs (Note 3)
Year ended
31 December 2020
£’000
5,293
643
165
6,101
268
6,369
8 months ended
31 December 2019
(Restated*)
£’000
2,830
309
65
3,204
333
3,537
* The prior period research and development employee costs have been adjusted for a change in accounting treatment following a review of the application of IAS 38. As a result, previously
capitalised employee costs of £0.2m have been expensed. Details of the impact of the restatement are described in Note 21.
The key management personnel are the Directors and their remuneration is disclosed in Note 4 and within the Directors’ Remuneration Report on pages 54 and 55.
Number of employees
The average monthly number of employees (including Directors) during the year was:
Research and development, engineering, manufacturing, quality control and regulatory
Commercial and administrative
Total
Year ended
31 December 2020
Number
8 months ended
31 December 2019
Number
75
27
102
67
20
87
Pension costs
6
The Group incurred UK pension contribution charges for the year of £131,638 (eight months ended 31 December 2019: £44,832) for payment directly to personal
pension plan schemes and £33,731 to the ANGLE auto-enrolment pension scheme (eight months ended 31 December 2019: £19,686).
Contributions to personal pension plan schemes for the year of £21,086 (31 December 2019: £17,518) and to the ANGLE auto-enrolment pension scheme
of £6,319 (31 December 2019: £5,858) 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 (eight months ended 31 December 2019: one) – see Directors’ Remuneration
Report on page 54.
76
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
7
Finance income and costs
Finance income
Interest on cash and cash equivalents and short-term deposits
Other interest
Total
Finance costs
Lease liability finance charges (Note 13)
Other interest charges
Total
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
71
7
78
(92)
–
(92)
40
–
40
(64)
(2)
(66)
Tax
8
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% (8 months ended 31 December 2019: 19.0%)
Factors affecting charge:
Disallowable expenses
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)
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
(2,126)
(13)
–
(2,139)
(1,553)
71
–
(1,482)
Year ended
31 December 2020
£’000
(13,745)
(2,612)
33
32
(941)
51
1,367
(56)
(13)
(2,139)
8 months ended
31 December 2019
(Restated*)
£’000
(9,038)
(1,717)
–
(40)
(625)
63
749
17
71
(1,482)
* The restatement (detailed in Note 21) has no impact on the tax charge/(credit) for the prior period.
The Group has accumulated losses available to carry forward against future trading profits of £51.4 million (31 December 2019 restated: £41.8 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 20.6% (31 December 2019: 18.9%)
is £7.5 million (31 December 2019 restated: £7.9 million). Following the announcement in Budget 2020, on 11 March 2020, Finance Act 2020 maintains the main
rate of Corporation Tax for the financial years 2020 and 2021 at 19% rather than reducing it to 17% from 1 April 2020 as had been previously enacted. This was
substantively enacted on 17 March 2020. An increase in the main rate of Corporation Tax to 25% from 1 April 2023 was also announced and included in Finance
Bill 2021.
77
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Consolidated Financial Statements
continued
Earnings/(loss) per share
9
The basic and diluted earnings/(loss) per share is calculated by dividing the after tax loss for the year attributable to the owners of the parent of £11.6 million
(eight months ended 31 December 2019 restated: £7.6 million) by the weighted average number of shares in the year.
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 2020 and 2019, 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
Adjusted weighted average number of Ordinary shares – diluted
Earnings/(loss) per share attributable to owners of the parent
Basic and Diluted (pence per share)
* The impact of the restatement is described in Note 21.
Investments
10
The Company has investments in the following subsidiaries:
Company name
ANGLE Biosciences Incorporated(1)
ANGLE Europe Limited(1)
ANGLE North America Incorporated(2)
ANGLE Technology Limited(1)
ANGLE Technology Ventures Limited
ANGLE EU BV
ANGLE Partnerships Limited(1)
ANGLE Technology Licensing Limited
ANGLE Technology LLC
ANGLE Technology Ventures LLC
(1) Subsidiary held directly
(2) Direct holding in subsidiary of 9.47%
Year ended
31 December 2020
£’000
(11,606)
8 months ended
31 December 2019
(Restated*)
£’000
(7,556)
Number of shares
Number of shares
178,149,352
(113,259)
178,036,093
–
163,795,270
(113,259)
163,682,011
–
178,036,093
163,682,011
(6.52)
(4.62)
Principal activity
Medical diagnostics
Medical diagnostics
Medical diagnostics
Medical diagnostics
Medical diagnostics
Medical diagnostics
Dormant
Dormant
Dormant
Dormant
Class of
share held
Holding %
Common
Ordinary
Common & Preferred
Ordinary
Ordinary
Ordinary
Ordinary
Ordinary
Membership units
Membership units
100
100
100
100
100
100
100
100
100
100
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 the United Kingdom. Their registered address is 10 Nugent Road, Surrey Research Park, Guildford, Surrey, GU2 7AF, UK.
ANGLE EU BV is incorporated in The Netherlands. Its registered address is Joop Geesinkweg 701, Rembrandt Kantoor, 1114 AB, Amsterdam-Duivendrecht,
The Netherlands.
ANGLE North America Incorporated, ANGLE Technology LLC and ANGLE Technology Ventures LLC are registered in the United States. ANGLE North America
Incorporated’s registered address is 5100 Campus Drive, Suite 120, Plymouth Meeting, PA 19462, USA. ANGLE Technology LLC and ANGLE Technology Ventures
LLC registered address is Rees Broome, PC, 1900 Gallows Road STE 700, Tysons Corner, VA 22182, USA.
78
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
11
Intangible assets
Cost
At 1 May 2019 as originally reported
Restatement
At 1 May 2019 restated
Additions
Exchange movements
At 31 December 2019 restated
At 31 December 2019 as originally reported
Restatement
At 31 December 2019 restated
Additions
Exchange movements
At 31 December 2020
Accumulated amortisation and impairment
At 1 May 2019
Charge for the period
Exchange movements
At 31 December 2019
Charge for the year
Impairment
Exchange movements
At 31 December 2020
Net book value
At 31 December 2020
At 31 December 2019 restated
At 1 May 2019 restated
Acquired
intangible
assets
Goodwill
£’000
£’000
2,207
–
2,207
–
–
2,207
2,207
–
2,207
–
–
1,214
–
1,214
–
2
1,216
1,216
–
1,216
–
(1)
Intellectual
Product
property development
(Restated*)
£’000
£’000
916
–
916
57
(3)
970
970
–
970
77
(7)
4,019
(2,684)
1,335
6
(19)
1,322
5,049
(3,727)
1,322
–
(42)
Total
(Restated*)
£’000
8,356
(2,684)
5,672
63
(20)
5,715
9,442
(3,727)
5,715
77
(50)
2,207
1,215
1,040
1,280
5,742
–
–
–
–
–
–
–
–
2,207
2,207
2,207
230
96
1
327
140
–
(1)
466
749
889
984
276
25
(2)
299
58
55
(5)
1,017
119
(21)
1,115
84
–
(40)
1,523
240
(22)
1,741
282
55
(46)
407
1,159
2,032
633
671
640
121
207
318
3,710
3,974
4,149
* A prior period adjustment has been made in relation to the capitalisation of research and development product development costs as intangible assets where the expenditure in relation
to these costs was previously capitalised under IAS 38. See Note 21 for further detail.
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 the Parsortix system and HyCEAD technologies enabling sample-to-answer tests, capturing more of the value chain and competitive differentiation.
Goodwill is deemed to have an indefinite useful life, is carried initially 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 2020 stood at £102.9 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. Acquired IP includes a carrying value of £0.8 million (2019: £0.9 million)
in relation to Technology IP and has a remaining amortisation period of six years and ten months (2019: seven years and ten months).
79
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Consolidated Financial Statements
continued
Intangible assets continued
11
“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 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.
IAS 38 criteria are reviewed at the end of each accounting period. The Group assessed the cumulative capitalised product development expenditure and determined
that some of these costs did not meet the required IAS 38 criteria as it is now considered that the technical feasibility of a product in development is not proven until
regulatory clearance is achieved. This approach is consistent with other companies in the sector. A prior year adjustment has been made to restate the previously
capitalised costs not meeting IAS 38’s recognition criteria on technical feasibility. Restated intangible assets had a carrying value of £4.0 million at 31 December 2019
and £4.1 million at 30 April 2019. Note 21 provides information on the impact of the adjustment on the Financial Statements.
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. No indications of impairment have been identified.
Amortisation and impairment charges are charged to operating costs in the consolidated statement of comprehensive income.
12 Property, plant and equipment
Leasehold
improvements
£’000
Computer
equipment
£’000
Laboratory
equipment
and tooling
£’000
Fixtures,
fittings and
equipment
£’000
Total
£’000
2,816
475
(13)
66
4
3,348
309
(136)
(56)
(20)
92
20
–
–
–
112
37
(12)
–
(1)
2,251
451
(13)
66
5
2,760
74
(124)
(56)
(15)
154
3
–
–
(1)
156
27
–
–
(3)
136
2,639
180
3,445
44
22
–
–
66
33
(12)
–
(1)
86
50
46
1,231
350
(54)
(6)
1,521
466
(122)
(83)
(11)
93
18
–
(1)
110
31
–
–
(3)
1,469
432
(54)
(7)
1,840
661
(134)
(83)
(15)
1,771
138
2,269
868
1,239
42
46
1,176
1,508
Cost
At 1 May 2019
Additions
Disposals
Transfers (to)/from inventories
Exchange movements
At 31 December 2019
Additions
Disposals
Transfers (to)/from inventories
Exchange movements
At 31 December 2020
Accumulated depreciation
At 1 May 2019
Charge for the period
Transfers (to)/from inventories
Exchange movements
At 31 December 2019
Charge for the year
Disposals
Transfers (to)/from inventories
Exchange movements
At 31 December 2020
Net book value
At 31 December 2020
At 31 December 2019
80
319
1
–
–
–
320
171
–
–
(1)
490
101
42
–
–
143
131
–
–
–
274
216
177
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
12 Property, plant and equipment continued
Laboratory equipment includes a carrying value of £0.2 million (31 December 2019: £0.3 million) 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.
Capital commitments at 31 December 2020 amounted to £0.5 million (2019: £nil).
Depreciation charges are charged to operating costs in the consolidated statement of comprehensive income.
Leases
13
The Group has lease contracts for office accommodation and specialist laboratories. These lease contracts generally have lease terms between 3 and 10 years,
with earlier break clauses in some cases. The Group’s obligations under its leases are secured by the lessor’s title.
The carrying amounts of right-of-use assets recognised and the movements during the year are shown below:
Right-of-use assets
Laboratory and office premises
At start of period
Additions
Transfer to net investment in sublease (Note 16)
Depreciation
Impairment
Exchange movements
At period end
The carrying amounts of lease liabilities and the movements during the period are shown below:
Lease liabilities
At start of period
Additions
Payments
Accretion of interest (Note 7)
Exchange movements
At period end
Non-current lease liability
Current lease liability
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
1,514
281
(136)
(385)
(36)
(5)
1,233
1,718
–
–
(219)
–
15
1,514
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
1,553
281
(556)
92
(8)
1,362
2020
£’000
928
434
1,362
1,718
–
(244)
64
15
1,553
2019
£’000
1,201
352
1,553
The Group had total cash outflows for leases of £0.5 million for the year (eight months ended 31 December 2019: £0.2 million).
The Group has three 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 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
year relating to such leases was £56,025 (eight months ended 31 December 2019: £27,351).
Maturity analysis of the undiscounted lease payments:
31 December 2020
31 December 2019
Within 1
year
£’000
434
375
1 to 2
years
£’000
387
432
2 to 5
years
£’000
495
742
More than
5 years
£’000
134
274
81
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Consolidated Financial Statements
continued
Financial risk management
14
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 short-term bank 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 short-term bank deposits and 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.
Capital risk management
The capital structure of the Group comprises cash and cash equivalents, short-term deposits and 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.
As part of achieving these objectives, the Group identifies the principal financial risk exposures to be foreign currency risk, credit risk and liquidity risk. The Group’s
approach to these risks is outlined below.
In order to maintain or adjust the capital structure the Group may issue new shares.
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
* The restatement is described in Note 21, and resulted in adjusting the equity ratio as previously reported at 88.4% at 31 December 2019.
2020
£’000
34,344
39,049
88.0%
2019
(Restated*)
£’000
26,597
30,575
87.0%
82
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Financial risk management continued
14
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.
Credit risk
The Group’s credit risk is attributable to its cash and cash equivalents, short-term deposits and trade receivables.
The Group’s risk on cash and cash equivalents and short-term deposits is limited as funds are held in banks with credit ratings of A-1 and above (S&P). The maximum
exposure to cash and cash equivalents and short-term deposits is £28.6 million (2019: £18.8 million).
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. The customer base is primarily academic institutions and large pharmaceutical businesses. The exposure
is managed centrally, and Group policy is to use judgement and past experience to assess the credit quality of each customer and where appropriate seek full or
part-payment in advance.
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.
The maximum exposure to trade and other receivables is £0.3 million (2019: £0.2 million).
Interest rate risk
There is currently no interest rate risk on financial assets and liabilities.
Cash at bank of £12.1 million earns interest at fixed rates of between 0.03% and 0.75% (2019: £3.8 million, between 0.01% and 0.75%). Short-term deposits
of £16.5 million earned interest at fixed rates of 0.85% to 31 May 2020 reduced to 0.15% thereafter (2019: £15.0 million at 0.85%).
There is currently no interest rate risk on financial liabilities as the Group has no interest bearing loans or borrowings.
All amounts, excluding lease liabilities, have maturity dates of less than 12 months (2019: £nil was greater than 12 months). Contractual maturities in respect of lease
obligations are disclosed in Note 13 on page 81.
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 for USD and Euro expenditure. Excess exposure, if any, may be managed for all significant foreign currencies using
forward currency contracts or currency swaps.
83
Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Notes to the Consolidated Financial Statements
continued
Financial risk management continued
14
Sensitivity analysis
The impact of a 5% variation in currency exchange rates on the profit/(loss) for the period is as follows:
Year ended
Year ended
31 December 2020 31 December 2020
CAD
USD
Profit/(loss) – 5% strengthening
Profit/(loss) – 5% weakening
* The impact of the restatement in the Financial Statements is described in Note 21.
£’000
(133)
143
£’000
(134)
148
8 months ended
31 December 2019
USD
(Restated*)
£’000
(113)
124
8 months ended
31 December 2019
CAD
£’000
(86)
95
Hedging
The Group did not hedge its financial transactions in the year ended 31 December 2020 or in the eight months ended 31 December 2019.
Currency profile
The Group’s financial assets and financial liabilities which are stated at amortised cost have the following currency profile:
Sterling
£’000
USD
£’000
Euro
£’000
CAD
£’000
Total
£’000
Sterling
£’000
USD
£’000
Euro
£’000
CAD
£’000
Total
£’000
2020
2019
(Restated*)
148
16,538
10,948
27,634
673
199
1,842
2,714
10
–
793
803
83
43
431
557
143
–
247
390
–
–
30
30
4
–
92
96
305
16,538
12,080
–
15,009
3,279
28,923
18,288
172
192
312
676
928
434
2,615
3,977
692
139
836
1,667
40
–
192
232
122
44
801
967
188
–
110
298
–
–
188
188
–
–
176
176
387
169
117
673
228
15,009
3,757
18,994
1,201
352
1,942
3,495
Financial assets:
Trade and other receivables
Short-term deposits
Cash and cash equivalents
Total
Financial liabilities:
Lease liabilities – non-current
Lease liabilities – current
Trade and other payables
Total
* The Group had classified short-term deposits within cash and cash equivalents in the Financial Statements at 31 December 2019. These deposits require a notice period of 95 days in order
to access the funds and therefore do not strictly comply to the “readily convertible” requirements of IAS 7. We have therefore reclassified these balances as short-term deposits. The impact
of the restatement is described in Note 21.
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.
84
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
15
Inventories
Raw materials and work in progress
Finished goods
Total
16 Trade and other receivables
Amounts receivable within one year
Trade receivables
Other receivables
Net investment in sublease
Prepayments and contract assets
Total
2020
£’000
36
706
742
2020
£’000
187
594
85
577
1,443
2019
£’000
–
788
788
2019
£’000
139
167
–
321
627
Other receivables comprises recoverable taxes (VAT and HST) and a Canadian COVID-19 relief subsidy (Canada Emergency Wage Subsidy). Contract assets include
amounts for services in progress but not yet invoiced (Note 2).
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
2020
£’000
179
3
2
3
187
2019
£’000
114
24
1
–
139
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.
The Group entered into a sublease arrangement in respect of half of a right-of-use asset leased in January 2020. The sublease is for the remaining life of the lease which
expires in April 2022.
Net investment in sublease
Transfer from right-of-use assets (Note 14)
Rental income received and receivable
Accretion of interest
At year end
17 Trade and other payables
Amounts payable within one year
Trade payables
Other taxes and social security costs
Other payables
Accruals and contract liabilities
Total
Year ended
31 December 2020
£’000
136
(58)
7
85
2019
£’000
914
294
23
1,194
2,425
2020
£’000
1,088
395
27
1,833
3,343
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.
85
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Consolidated Financial Statements
continued
Share capital
18
The share capital of the Company is shown below:
Allotted, called up and fully paid
215,405,178 (31 December 2019: 172,771,483) Ordinary shares of £0.10 each
The Company has one class of Ordinary shares which carry no right to fixed income.
2020
£’000
2019
£’000
21,540
17,277
The Company issued 42,608,695 new Ordinary shares with a nominal value of £0.10 at an issue price of £0.46 per share in a subscription of shares realising gross
proceeds of £19.6 million. Associated costs of £1.1 million were incurred. Shares were admitted to trading on AIM in November 2020.
The Company issued 25,000 new Ordinary shares with a nominal value of £0.10 at an exercise price of £0.645 per share as a result of the exercise of share options
by an employee. Shares were admitted to trading on AIM in February 2020.
Share-based payments
19
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 £268,417 (eight months ended
31 December 2019: £332,817).
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 beginning of period
During the period:
Granted
Exercised
Forfeited/lapsed
Outstanding at period end
Capable of being exercised at period end
Year ended 31 December
8 months ended 31 December
2020
Number
of share
Options
#
12,895,806
5,195,000
(25,000)
(221,666)
17,844,140
5,600,808
2020
Weighted
average
exercise
price (£)
0.5517
0.5357
0.6450
0.5705
0.5467
0.4562
2019
Number
of share
options
#
13,795,806
–
(16,667)
(883,333)
12,895,806
4,715,805
2019
Weighted
average
exercise
price (£)
0.5432
–
0.3850
0.4221
0.5517
0.4640
The options outstanding at 31 December 2020 had a weighted average remaining contractual life of six years and three months (2019: five years and ten months).
The Company uses a Trinomial option pricing model as the basis to determine the fair value of the Company’s share options.
86
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Share-based payments continued
19
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 2020:
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
21 May 2020
25 September 2020
25 September 2020
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
0.6150
0.5300
0.5300
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
0.6150
0.5300
0.5300
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%
61.40%
57.60%
57.60%
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%
(0.04)%
(0.12)%
(0.12)%
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
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
Nil
Nil
Nil
(1)
(2)
(1)
(2)
(3)
(4)
(5)
(4)
(4)
(6)
(4)
(4)
(7)
(8)
(4)
(4)
(4)
(4)
(9)
(4)
(4)
(10)
1,189,353
1,197,315
380,647
312,685
490,000
20,000
1,500,000
20,000
360,000
120,806
150,000
1,000,000
1,500,000
500,000
450,000
100,000
100,000
1,258,334
2,000,000
350,000
3,345,000
1,500,000
17,844,140
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 (this
condition has not yet been met) 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 (performance conditions have been met in relation to 100,000 of 200,000 share
options) and b) a service condition with options vesting over a three-year period (this condition has been met).
(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 (this condition has not yet been met) and b) a time/event condition with options vesting after five years or on the
sale of the Parsortix business, whichever is earliest (this condition has been met).
(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 (this condition has not yet been met), and b) a service condition with options vesting over a three-year period (this condition has been met).
(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, 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.
(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.
(10) Vesting is subject to a performance condition that the Company’s share price has risen to at least £0.916 on 25 September 2023.
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. 25,000 options were exercised in the year
(period ended 31 December 2019: 16,667).
87
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Consolidated Financial Statements
continued
Share-based payments continued
19
Long-Term Incentive Plan
The Company has a Long-Term Incentive Plan (LTIP) for Executive Directors. Disclosures for an award made during the year are set out in the Directors’ Remuneration
Report on pages 54 and 55.
The Company uses a Monte Carlo simulation 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 2020:
Date of grant
20 December 2018
20 December 2018
20 December 2018
25 September 2020
25 September 2020
25 September 2020
Total
20
ESOT shares
At period end
Exercise
price (£)
0.0000
0.0000
0.0000
0.0000
0.0000
0.0000
Share price
at date
of grant (£)
0.3850
0.3850
0.3850
0.5300
0.5300
0.5300
Expected
volatility
Risk free
interest rate
45.04%
45.04%
45.04%
53.46%
53.46%
53.46%
0.88%
0.88%
0.88%
(0.09)%
(0.09)%
(0.09)%
Expected
life of
option
(years)
Barrier
Expected
dividends
(Performance Outstanding
LTIP
Options
condition)
(£)
5.0
5.0
5.0
5.0
5.0
5.0
Nil
Nil
Nil
Nil
Nil
Nil
1.056
1.434
2.063
0.916
1.304
1.789
1,200,000
1,800,000
3,000,000
600,000
900,000
1,500,000
9,000,000
2020
£’000
102
2019
£’000
102
Employee Share Ownership Trust (ESOT) shares are ANGLE plc shares held by the ANGLE Employee Trust. At 31 December 2020 the Trust held 113,259 shares
(31 December 2019: 113,259 shares). The market value of these shares at 31 December 2020 was £54,081 (31 December 2019: £71,013). Shares purchased by the
ANGLE ESOT are used to assist in meeting the obligations under employee remuneration schemes.
21 Restatement and reclassification
The Group has restated its Financial Statements as detailed below. These restatement amendments have no cash impact.
IAS 38 Capitalisation of product development expenditure
The Group has restated its Financial Statements at 31 December 2019 and 30 April 2019 following a detailed review of its policy for the capitalisation of product
development costs. “Product development” relates to internally generated intangible assets that are capitalised in accordance with IAS 38 Intangible Assets (Note 1.12).
IAS 38 criteria are reviewed at the end of each accounting period. The Group assessed the cumulative capitalised product development expenditure and determined
that some of these costs did not meet the required IAS 38 criteria as it is now considered that the technical feasibility of a product in development is not proven until
regulatory clearance is achieved. This approach is consistent with other companies in the sector. A prior year adjustment has been made to restate the previously
capitalised costs not meeting IAS 38’s recognition criteria on technical feasibility. Restated intangible assets had a carrying value of £4.0 million at 31 December 2019
and £4.1 million at 30 April 2019.
Retranslation of Group loans
The Group has restated its Financial Statements at 31 December 2019 and 30 April 2019 not to treat historic Group loans with US subsidiaries as part of the
Group’s net investment in those foreign operations. As a result, exchange differences previously recognised in other comprehensive income on consolidation have
been reclassified to the income statement. The restatement resulted in a reserve movement, decreasing accumulated losses and increasing translation reserve in the
Consolidated Statement of Financial Position by £4.4 million at 31 December 2019 and by £4.7 million at 30 April 2019.
IAS 7 Reclassification of short-term deposits
The Group had classified short-term deposits within cash and cash equivalents in the Financial Statements at 31 December 2019. These deposits require a notice
period of 95 days in order to access and therefore do not strictly comply to the “readily convertible” requirements of IAS 7. We have therefore reclassified these
as short-term deposits which are shown as a separate line item in the Consolidated Statement of Financial Position.
The restatement movements are shown below:
88
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
21 Restatement and reclassification continued
Consolidated Statement of Comprehensive Income (extract)
Operating costs
Profit/(loss) before tax
Other comprehensive income/(loss)
Total comprehensive income/(loss)
Earnings/(loss) per share
Basic and diluted (pence per share)
Consolidated Statement of Financial Position (extract)
8 months ended
31 December 2019
as originally reported
£’000
Restatement
IAS 38
£’000
Restatement
translation of
Group balances
£’000
8 months ended
31 December 2019
Restated
£’000
(8,204)
(7,730)
(24)
(6,272)
(3.82)
(1,046)
(1,046)
3
(1,043)
(0.64)
(262)
(262)
262
–
(0.16)
(9,512)
(9,038)
241
(7,315)
(4.62)
Year ended
30 April 2019
as originally reported
£’000
6,833
106
(52,109)
Restatement
IAS 38
£’000
(2,684)
(9)
(2,675)
Restatement
translation of
Group balances
£’000
–
(4,685)
4,685
Year ended
30 April 2019
Restated
£’000
4,149
(4,588)
(50,099)
Intangible assets
Translation reserves
Accumulated losses
Intangible assets
Short-term deposits
Cash and cash equivalents
Translation reserves
Accumulated losses
8 months ended
31 December 2019
as originally reported
£’000
7,701
–
18,766
82
(58,276)
Restatement
IAS 38
£’000
(3,727)
–
–
(6)
(3,721)
Restatement
translation of
Group balances
£’000
8 months ended
31 December 2019
Restated
£’000
Reclassification
£’000
–
–
–
(4,423)
4,423
–
15,009
(15,009)
–
–
3,974
15,009
3,757
(4,347)
(57,574)
Consolidated Statement of Cash Flows (extract)
8 months ended
31 December 2019
as originally reported
£’000
Restatement
IAS 38
£’000
Restatement
translation of
Group balances
£’000
8 months ended
31 December 2019
Restated
£’000
Reclassification
£’000
Operating cash flows before movements
in working capital
Operating cash flows
Purchase of intangible assets
Transfer to short-term deposits
Net increase/(decrease) in cash and cash equivalents
(6,494)
(6,942)
(1,431)
–
7,754
(1,046)
(1,365)
1,365
–
–
–
–
–
–
–
–
–
–
(15,009)
(15,009)
(7,540)
(8,307)
(66)
(15,009)
(7,255)
89
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Consolidated Financial Statements
continued
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 year, the Group entered into certain commitments in relation to the development of the Parsortix cancer diagnostic product and the new clinical
laboratories. In aggregate these gave rise to financial commitments at 31 December 2020 of up to £2.2 million over one year (2019: £1.0 million).
In addition, the Group signed a new ten year lease for a clinical laboratory in Pennsylvania, USA in December 2020, for occupation in March 2021. Lease payments
of US$0.3 million are payable within one year, US$0.9 million are payable in two to five years.
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.
Nat West Bank (the Group’s UK commercial bankers) have placed a charge over a short-term deposit account of £700,000 as security for a Bacstel-IP facility used
in the normal course of business.
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 54 and 55 and below, none of the Directors had any interest at any time during
the year ended 31 December 2020 in the share capital of the Company or its subsidiaries.
At the reporting date, £144,282 of remuneration (2019: £nil) was due to Andrew Newland and £91,816 of remuneration (2019: £nil) 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 year to Brian Howlett under this contract (eight months ended 31 December 2019: £nil).
SoBold Limited provides digital marketing services and website management to ANGLE with fees in the year of £37,700 (eight months ended 31 December 2019:
£25,450) and a balance of £6,220 (2019: £7,440) 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 year.
24 Post reporting date event
As reported in the Chairman’s Statement and elsewhere, the Group has opened clinical laboratories in the UK and United States initially to support pharma
services and then to provide lab developed tests once the appropriate accreditations have been received. In addition the first significant contract with a major
pharma company has been announced that could generate up to US$1.2 million of revenues over the next 18 months and patient enrolment has been
completed in the ovarian cancer study.
90
Financial StatementsANGLE plc Annual Report and Financial Statements 2020 Company Statement of Financial Position
As at 31 December 2020
Assets
Non-current assets
Investment in subsidiaries
Other receivables
Total non-current assets
Current assets
Other receivables
Short-term deposits
Cash and cash equivalents
Total current assets
Total assets
Current liabilities
Trade and other payables
Total current liabilities
Total liabilities
Net assets
Equity
Share capital
Share premium
Share-based payments reserve
Accumulated losses
Equity attributable to owners
31 December 2020
Note
£’000
31 December 2019
(Restated*)
£’000
C3
C4
C4
C5
C6
5,212
42,689
47,901
35
15,822
10,760
26,617
74,518
(155)
(155)
(155)
4,476
34,554
39,030
6
15,009
2,686
17,701
56,731
–
–
–
74,363
56,731
21,540
81,532
1,722
(30,431)
74,363
17,277
67,272
1,495
(29,313)
56,731
* The impact of the restatement is described on the Company Statement of Cash Flows on page 92.
The Company’s loss and total comprehensive loss for the year to 31 December 2020 were £1.2 million (eight months ended 31 December 2019: £6.7 million).
The Financial Statements on pages 91 to 96 were approved by the Board of Directors and authorised for issue on 29 April 2021 and signed on its behalf by:
Ian F Griffiths
Director
Andrew D W Newland
Director
Registered No. 04985171
91
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Company Statement of Cash Flows
For the year ended 31 December 2020
Operating activities
Profit/(loss) before tax
Adjustments for:
Impairment of loans
Net cash from/(used in) operations
Investing activities
Loans to subsidiaries
Transfer to short-term deposits
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
Cash at bank – immediate access
Cash at bank – restricted access (35 day notice)
Cash and cash equivalents at end of period
Cash and cash equivalents at end of period
Short-term deposits
Cash and cash equivalents and short-term deposits
Year ended
31 December 2020
£’000
(1,159)
1,159
–
(9,762)
(814)
(10,576)
18,650
18,650
8,074
2,686
10,760
2,754
8,006
10,760
10,760
15,822
26,582
8 months ended
31 December 2019
(Restated*)
£’000
(6,745)
6,745
–
(8,664)
(15,009)
(23,673)
16,921
16,921
(6,752)
9,438
2,686
485
2,201
2,686
2,686
15,009
17,695
* The Company had classified short-term deposits within cash and cash equivalents in the Financial Statements at 31 December 2019. These deposits require a notice period of 95 days in
order to access and therefore do not strictly comply to the “readily convertible” requirements of IAS 7. We have therefore reclassified these as short-term deposits which is shown as a
separate line item in the Company Statement of Financial Position.
92
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Company Statement of Changes in Equity
For the year ended 31 December 2020
At 1 May 2019
For the 8 months to 31 December 2019
Profit/(loss) for the period
Issue of shares (net of costs)
Share-based payments
Released on forfeiture
Released on exercise
At 31 December 2019
For the year to 31 December 2020
Profit/(loss) for the year
Issue of shares (net of costs)
Share-based payments
Released on forfeiture
Released on exercise
At 31 December 2020
Equity attributable to owners
Share-based
Share
capital
£’000
Share
premium
£’000
payments Accumulated
losses
£’000
reserve
£’000
Total
equity
£’000
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)
17,277
67,272
1,495
(29,313)
56,731
4,263
14,260
(1,159)
37
4
(1,159)
18,523
268
–
–
268
(37)
(4)
21,540
81,532
1,722
(30,431)
74,363
93
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Company Financial Statements
For the year ended 31 December 2020
C1 Accounting policies
C1.1 Basis of preparation
The Parent Company Financial Statements have been prepared in accordance with International Financial Reporting Standards (IFRS) conformity with the requirements
of the Companies Act 2006 for the year ended 31 December 2020. 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 year are the same as those of the Group and are presented on
pages 66 to 73.
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 £1.3 million (eight months ended 31 December 2019: £6.7 million)
was recognised in the year.
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 outcomes 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 year was £1.2 million (eight months ended 31 December 2019: £6.7 million).
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 54 and 55.
Administrative expenses, including auditors’ remuneration, are borne by other Group companies and are not recharged to the Company.
C3
Investment in subsidiaries
Cost
At start of period
Share-based payments charge
Additions
At period end
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
4,476
268
468
5,212
4,143
333
–
4,476
Details of the Company’s subsidiary undertakings at 31 December 2020 are shown in Note 10 to the Consolidated Financial Statements along with other interests held
indirectly through subsidiary undertakings.
Additions in the year represent a direct holding of 9.47% in ANGLE North America Inc. (a 100% owned Group company). This was incorrectly represented as a
holding by ANGLE Technology LLC since its acquisition in October 2018. Whilst the Group has a contractual right to transfer the holding between Group companies
this transfer had not been affected. The adjustment identified in the current year has not been treated as a prior period adjustment on the basis of materiality.
94
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
C4 Other receivables
Non-current assets
Amounts due from Group undertakings
Cost
At start of period
Additions/(repayments)
At period end
Provision
At start of period
Impairment charge
At period end
Net book value
At period end
At start of period
Year ended
31 December 2020
£’000
8 months ended
31 December 2019
£’000
65,973
9,294
75,267
31,419
1,159
32,578
42,689
34,554
57,309
8,664
65,973
24,674
6,745
31,419
34,554
32,635
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.
Current assets
Other receivables
Other receivables comprises recoverable taxes (VAT) at 31 December 2020.
C5 Trade and other payables
Amounts payable within one year
Trade payables
Accruals
Total
Trade and other payables relate to professional fees associated with the fundraise.
31 December 2020
£’000
31 December 2019
£’000
35
6
31 December 2020
£’000
31 December 2019
£’000
151
4
155
–
–
–
95
Financial StatementsANGLE plc Annual Report and Financial Statements 2020
Notes to the Company Financial Statements
continued
C6 Share capital
The share capital of the Company is shown below:
Allotted, called up and fully paid
215,405,178 (31 December 2019: 172,771,483) Ordinary shares of £0.10 each
31 December 2020
£’000
31 December 2019
£’000
21,540
17,277
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 86.
Details of the Company’s share options schemes can be found in Note 19 to the Consolidated Financial Statements on pages 86 to 88.
C7 Guarantees and other financial commitments
In December 2020 the Company entered into a guaranty agreement in favour of the landlord, who absorbed significant bespoke fit-out costs, for the clinical laboratory
in Plymouth Meeting, Pennsylvania, USA in respect of obligations under the lease, initially for $800,000 and then reducing by $80,000 per annum.
The Company provides financial support to its subsidiaries. Details of the Group’s financial commitments are given in Note 22 to the Consolidated Financial Statements
on page 90.
C8 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 90.
C9 Post reporting date event
Details are given in Note 24 to the Consolidated Financial Statements on page 90.
96
Notice of Annual General MeetingANGLE plc Annual Report and Financial Statements 2020
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)
4 June 2021
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 30 June 2021 at which
the following resolutions will be proposed:
1. Resolution 1 to receive the Annual Report and Financial Statements of the Company for the year ended 31 December 2020.
2. Resolution 2 to approve the Remuneration Policy (insofar as it relates to the Directors), as set out on page 53 of the Annual Report.
Note: this is an advisory vote only.
3. Resolution 3 to approve the Directors’ Remuneration Report for the year ended 31 December 2020 set out on pages 54 and 55 of the Annual Report.
Note: this is an advisory vote only.
4. Resolution 4 to allow the Remuneration Committee discretion to extend the performance period for existing LTIP awards.
Note: this is an advisory vote only.
5. Resolution 5 to allow the Remuneration Committee discretion to extend the date of expiry of share options due to expire in 2021.
Note: this is an advisory vote only.
6. Resolution 6 to re-appoint the auditors of the Company, PricewaterhouseCoopers LLP, and authorise the Directors to determine their level of remuneration.
7. Resolution 7 to grant the Directors authority to allot unissued shares in the capital of the Company up to an aggregate nominal amount of £7,195,595.
Note: the Directors wish to renew their authorisations with respect to the allotment of new shares.
8. Resolution 8 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.
9. Resolution 9 to grant the Directors authority to purchase issued shares in the capital of the Company up to an aggregate nominal amount of £2,158,679.
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 7, 8 and 9 will expire at the 2022 Annual General Meeting or, if earlier, 30 June 2022.
Coronavirus (COVID-19)
Due to the unprecedented situation with COVID-19 and in line with the UK Government’s current 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. The Company will continue to monitor
the ongoing situation with regard to COVID-19 and any changes to the format of the Meeting, including the ability for Shareholders to attend in person, will be notified
through a regulatory new service (“RNS”).
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 Tuesday 29 June 2021.
Details of how to join the Meeting and the business update presentation via an electronic platform are provided on page 101.
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.
97
Notice of Annual General MeetingANGLE plc Annual Report and Financial Statements 2020
Notice of Annual General Meeting
continued
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
(Company number 04985171)
NOTICE IS HEREBY GIVEN that the eighteenth ANNUAL GENERAL MEETING of ANGLE plc ("the Company") will be held at 2:00 pm on Wednesday
30 June 2021 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 7 will be proposed as ordinary resolutions and resolutions numbered 8 and 9 will be proposed as special
resolutions. 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 year ended 31 December 2020, and the reports of the Directors and auditors thereon.
2. TO approve the Directors’ Remuneration Policy (in so far as it relates to the Directors) as set out on page 53 of the Annual Report for the year ended
31 December 2020. Note: this is an advisory vote only.
3. TO approve the Directors’ Remuneration Report as set out on pages 54 and 55 of the Annual Report for the year ended 31 December 2020. Note: this is
an advisory vote only.
4. TO allow the Remuneration Committee discretion, until the earlier of the completion of the next Annual General Meeting of the Company or 30 June 2022,
to extend the performance period for existing LTIP awards. Note: this is an advisory vote only.
5. TO allow the Remuneration Committee discretion, until the earlier of the completion of the next Annual General Meeting of the Company or 30 June 2022,
to extend the date of expiry of share options due to expire in 2021. Note: this is an advisory vote only.
6. TO re-appoint PricewaterhouseCoopers 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
7. 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 £7,195,595 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 30 June 2022 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.
8. THAT, subject to and conditional upon the passing of Resolution 7, 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 7 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 £2,158,679,
and the power hereby conferred shall expire (unless previously renewed, varied or revoked by the Company in general meeting) on 30 June 2022 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.
98
Notice of Annual General MeetingANGLE plc Annual Report and Financial Statements 2020
9. 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 21,586,785 (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 30 June 2022 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 4 June 2021
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. The Company will continue to monitor the ongoing situation with regard to COVID-19
and any changes to the format of the Meeting, including the ability for Shareholders to attend in person, will be notified through a regulatory new service (“RNS”).
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 Group, 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 Group 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 Group,
PXS1, Central Square, 29 Wellington Street, Leeds, LS1 4DL. 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.
The Company will continue to monitor the ongoing situation with regard to COVID-19 and any changes to the format of the Meeting, including the ability
for Shareholders to attend in person, will be notified through a regulatory new service (“RNS”).
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 28 June
2021. 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.
99
Notice of Annual General MeetingANGLE plc Annual Report and Financial Statements 2020
Notice of Annual General Meeting
continued
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 year ended 31 December 2020.
Resolution 2: Remuneration Policy
As an AIM-quoted company the Company is not subject to the legislation requiring companies to submit their remuneration policy insofar as it relates to the directors
to a binding vote of Shareholders. However, the Company has on a voluntary basis prepared a forward-looking Remuneration Policy which is submitted to a vote of
shareholders on an advisory basis. If the Remuneration Policy insofar as it relates to the Directors is approved and remains unchanged, it will be valid for up to three
financial years without new Shareholder approval on an advisory vote being requested. The Remuneration Policy was approved by Shareholders at the 2018 Annual
General Meeting and is therefore due for re-approval as an advisory vote. If the Company wishes to change the policy in any material way, it intends to put the revised
policy to a Shareholder advisory vote before it is able to implement that revised policy.
Resolution 3: Directors’ Remuneration Report
This resolution seeks approval of the Directors’ Remuneration Report for the year ended 31 December 2020. The full text of the Directors’ Remuneration Report
is contained on pages 54 and 55 of the Company’s Annual Report.
This is an advisory vote and no entitlement to remuneration for the year ended 31 December 2020 is conditional on the resolution being passed.
Resolution 4: Performance period for existing LTIP awards
The unprecedented COVID-19 pandemic has disrupted the Company’s operations delaying certain near term key milestones. The Remuneration Committee believes
that, whilst the absolute share price performance target for the LTIP and the requirement for a five year performance and holding period should remain unchanged, the
Remuneration Committee should have the discretion, until the earlier of the completion of the next Annual General Meeting of the Company or 30 June 2022, to extend
the performance period for existing LTIP awards. This change is needed to allow flexibility to maintain the alignment of executive incentive with Shareholder interests for
events beyond the control of the executive as a consequence of the COVID-19 pandemic.
As an AIM-quoted company the Company is not required to seek Shareholder approval for discretion in relation to a possible extension of the performance period for
the LTIP awards, nor for any consequential amendments to the terms of the LTIP awards or to the Company’s Remuneration Policy. However, the Company has tabled
a resolution in respect of such proposals in the interests of transparency and which is submitted to a vote of Shareholders on an advisory basis.
Resolution 5: Date of expiry of certain share options
The unprecedented COVID-19 pandemic has disrupted the Company’s operations delaying certain near term key milestones. The Remuneration Committee believes
that the Remuneration Committee should have the discretion, until the earlier of the completion of the next Annual General Meeting of the Company or 30 June 2022,
to extend the expiry date of the Company’s share option schemes with performance conditions that were due to expire in 2021, with all performance conditions
unchanged. This change is needed to allow flexibility to maintain the alignment of executive and staff incentive with Shareholder interests as a consequence of the
COVID-19 pandemic.
As an AIM-quoted company the Company is not required to seek Shareholder approval for discretion in relation to a possible extension of the expiry date for the
options, nor for the consequential amendments to the terms of the share options or to the Company’s Remuneration Policy. However, the Company has tabled a
resolution in respect of such proposals in the interests of transparency and which is submitted to a vote of Shareholders on an advisory basis.
Resolution 6: 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 7: 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 30 June 2022 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 7 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 £7,195,595 representing approximately one-third of the Company's nominal value of the issued share capital at the date of this notice.
Resolution 8: 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 8 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 £2,158,679, 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 9: Authority for market purchase
Resolution 9 will permit the Company to purchase up to 21,586,785 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 30 June 2022 or at the conclusion of the next Annual General Meeting of the Company (whichever first occurs). This is proposed as a special resolution.
100
Notice of Annual General MeetingANGLE plc Annual Report and Financial Statements 2020 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 Wednesday 30 June 2021.
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 current 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. The Company
will continue to monitor the ongoing situation with regard to COVID-19 and any changes to the format of the Meeting, including the ability for Shareholders to attend
in person, will be notified through a regulatory new service (“RNS”).
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://www.investormeetcompany.com/angle-plc/register-investor. Details of how to attend can also be accessed
via ANGLE’s Investor Centre page, https://angleplc.com/investor-relations. Please register in advance and log on to the webcast approximately 5 minutes before 2:00pm
on Wednesday 30 June 2021.
As explained previously, the Company will continue to monitor the ongoing situation with regard to COVID-19 and any changes to the format of the Meeting, including
the ability for Shareholders to attend in person, will be notified through a regulatory news service (“RNS”).
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 Tuesday 29 June 2021.
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Notice of Annual General MeetingANGLE plc Annual Report and Financial Statements 2020 Explanation of Frequently Used Terms
Term
Analyte
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
The substance that is of interest in the analysis
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 www.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
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
Clinical use
Use in treating patients
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Additional InformationANGLE plc Annual Report and Financial Statements 2020 Term
Companion diagnostic
Explanation
A medical device which provides information that is essential for the safe and effective use of a corresponding drug
or biological product
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. Also abbreviated as CRO
ctDNA or cfDNA
Abbreviation for circulating tumour DNA also known as cell-free DNA
Cultured cells
Cytokeratin
CK
CK+
Cytopathological
DAPI
DEPArrayTM
Diagnosis
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
Cytokeratin
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
EMT
Epitope
FDA
FDA Class II Device
FDA 510(k)
FDA De Novo
Flow-Thru Chip®
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
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Additional InformationANGLE plc Annual Report and Financial Statements 2020 Explanation of Frequently Used Terms
continued
Term
Explanation
Fluorescence In-Situ Hybridization (FISH) 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
Gene expression
Genome
Genotyping
Gleason Score
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
HyCEADTM
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
104
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
Additional InformationANGLE plc Annual Report and Financial Statements 2020 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
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. ThermoFisher 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 recognized as
genomic disease management, or personalized 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
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Additional InformationANGLE plc Annual Report and Financial Statements 2020 Explanation of Frequently Used Terms
continued
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
106
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
Additional InformationANGLE plc Annual Report and Financial Statements 2020 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
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Additional InformationANGLE plc Annual Report and Financial Statements 2020 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
Joint Broker
Registrar
Secretary
Ian F Griffiths
Company number
04985171
Bank
Registered office and
Business address
Independent Auditor
Nominated Advisor
and Joint Broker
10 Nugent Road
Surrey Research Park
Guildford
Surrey
GU2 7AF
+44 (0)1483 343434
www.angleplc.com
PricewaterhouseCoopers LLP
4th Floor
One Reading Central
23 Forbury Road
Reading
RG1 3JH
finnCap Ltd
One Bartholomew Close
London
EC1A 7BL
Solicitor
Financial Public
Relations
WG Partners
85 Gresham Street
London
EC2V 7NQ
Link Group
10th Floor
Central Square
29 Wellington Street
Leeds
LS1 4DL
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
108
Additional InformationANGLE plc Annual Report and Financial Statements 2020
Design and Production
www.carrkamasa.co.uk
ANGLE plc
10 Nugent Road
Surrey Research Park
Guildford
Surrey
GU2 7AF
United Kingdom
T +44 (0)1483 343434
E investor@angleplc.com
www.angleplc.com