TIDMAGL
RNS Number : 6193J
Angle PLC
28 April 2022
For Immediate Release 28 April 2022
ANGLE plc
("ANGLE" or "the Company")
Preliminary Results for the year ended 31 December 2021
FDA REVIEW PROGRESSING WITH RESPONSE AWAITED
CLINICAL LABORATORIES ESTABLISHED AND GLOBAL PHARMA SERVICES
BUSINESS LAUNCHED
OVARIAN CANCER CLINICAL VERIFICATION STUDY ENROLMENT COMPLETED
AND ANALYSIS IN PROCESS
ANGLE plc (AIM: AGL OTCQX: ANPCY), a world-leading liquid biopsy
company, today announces audited preliminary results for the year
ended 31 December 2021.
Operational Highlights
-- US Food and Drug Administration (FDA) substantive review made
good progress in the year with a comprehensive response made to
FDA's Additional Information Request and continued constructive and
supportive dialogue with the Agency throughout
-- Clinical laboratories opened in the UK and United States and
global pharma services business launched
- contracts in place with three pharma and biotech customers,
with two new customers onboarded post year end
- discussions continue with multiple other potential customers,
including large global pharma companies
- Clinical Laboratory Improvement Amendments (CLIA) and UKAS
accreditation submissions initiated in the United States and UK
and, post year end, CLIA Registration Certificate awarded to United
States clinical laboratory
-- Ovarian cancer clinical verification study with leading
United States cancer centre nearing completion
- patient enrolment completed during the year but sample
analysis was delayed due to COVID-19 related disruption to supplies
of key reagents
-- Prostate cancer study design completed and discussions
progressed with a major group of United States urology clinics,
with a view to partnering in studies and providing access to a
significant patient base
-- Over 26,000 samples processed during the year and a further
17 peer-reviewed publications from internationally recognised
cancer centres with key developments in breast, ovarian, head and
neck, non-small cell lung and prostate cancers
Financial Highlights
-- Revenue GBP1.0 million (2020: GBP0.8 million)
-- Loss for the year GBP15.0 million reflecting planned investment (2020: loss GBP11.6 million)
-- Fundraising from institutional investors, including existing
and new US institutional investors, raising gross proceeds of
GBP20.0 million (GBP18.9 million net of expenses)
-- Cash and cash equivalents and short-term deposits combined
balance at 31 December 2021 of GBP31.8 million (2020: GBP28.6
million)
Outlook
-- Regular constructive dialogue continues with FDA and a regulatory response is awaited
-- Reagents required to complete the ovarian cancer study
analysis have been received and are being validated so that
analysis of ovarian samples can be resumed and headline results
from the study are anticipated mid-year ahead of potential launch
of the ovarian cancer test as ANGLE's first laboratory developed
test (LDT)
-- The pharma services business continues to build with a total
of five independent customers onboarded. Deployment of the
Parsortix system in the first contracts with these customers is
progressing well and two early customers have already agreed
additional contracts for further clinical trials
Garth Selvey, Non-Executive Chairman of ANGLE plc,
commented:
"With the help of our staff, external researchers and investors,
in 2021 we made good progress on all our major initiatives. We
maintained the momentum on our FDA submission with additional
analytical studies, launched our clinical laboratories in the
United States and UK and secured our first pharma services
contracts, added a further 17 peer-reviewed publications, outlined
a new prostate cancer study and completed enrolment on our ovarian
cancer clinical verification study.
The strong operational momentum seen in 2021 has continued into
2022. Since the start of the year, we have maintained regular and
constructive dialogue with FDA on our De Novo application and our
United States laboratory has been registered with CLIA and is
progressing towards full accreditation. We look forward to a
successful year ahead."
Details of webcast
A meeting for analysts will be held at 10:00 am BST today at the
offices of Berenberg, 60 Threadneedle Street, London EC2R 8HP. A
live webcast of the analyst meeting can be accessed via ANGLE's
Investor Centre page,
https://angleplc.com/investor-relations/regulatory-news/ , with
Q&A participation reserved for analysts only. Please register
in advance and log on to the webcast approximately 5 minutes before
10:00 am on the day of the results. A recording of the webcast will
be made available on ANGLE's website following the results
meeting.
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Andrew Holder, Head of Investor Relations
Berenberg (NOMAD and Joint Broker)
Toby Flaux, Ciaran Walsh, Milo Bonser +44 (0) 20 3207 7800
Jefferies (Joint Broker)
Max Jones, Thomas Bective +44 (0) 20 7029 8000
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/glossary/
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the EU Market Abuse Regulation (596/2014). Upon the publication of
this announcement via a regulatory information service, this
information is considered to be in the public domain.
These Preliminary Results may contain forward-looking
statements. These statements reflect the Board's current view, are
subject to a number of material risks and uncertainties and could
change in the future. Factors that could cause or contribute to
such changes include, but are not limited to, the 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, commercialisation strategies,
the uncertainties related to clinical study outcomes and regulatory
clearance, obtaining reimbursement and payor coverage, acceptance
into national guidelines and the acceptance of the Group's products
by customers.
CHAIRMAN'S STATEMENT
Following the De Novo submission to FDA in September 2020, FDA's
progress in reviewing ANGLE's submission was encouraging despite
the well-publicised pressures on FDA resources due to the COVID-19
pandemic. ANGLE completed the additional analytical work required
to provide a comprehensive response in June 2021 to the Additional
Information Request from FDA.
ANGLE made excellent progress in establishing clinical
laboratories in the UK and United States. They are being used as
accelerators and demonstrators in support of the Company's product
sales of Parsortix instruments and cassettes and to provide
services to pharmaceutical and biotech customers running cancer
drug trials. The laboratories are already offering pharma services
and, once accreditation is in place, will be able to offer
validated clinical tests. First submissions have been made in
relation to CLIA and UKAS accreditation of the laboratories and, in
the United States, a CLIA registration certificate was awarded post
year end, an important step towards accreditation allowing samples
to be processed for patient management.
Initial demand for pharma services has been encouraging and
contracts are now in progress with five different customers, after
two new customers were onboarded post year end. Discussions are
ongoing with a number of other potential customers, and we are
pleased with the level of interest being generated by the
commercial teams in the UK and United States.
Patient enrolment for the Company's ovarian cancer assay
clinical verification study was completed during the year but
sample analysis was hindered by a shortage of key reagents due to
COVID-19 related supply chain issues. These issues have been
addressed and the required reagents have been received and are
being validated before resuming sample analysis, with headline
results anticipated mid-year. A laboratory developed test is
scheduled for launch pending the results of the study and once the
clinical laboratories have received accreditation.
In line with its strategy, ANGLE continues to explore potential
new clinical applications for the Parsortix system and identify
opportunities to develop additional assays for specific high-risk
groups. To this end, ANGLE initiated discussions with a large-scale
group of urology clinics in the United States and completed the
design of a new study in prostate cancer, which is scheduled to
start as soon as terms have been finalised.
Overview of Financial Results
Revenue of GBP1.0 million in the year ( 2020: GBP0.8 million)
came mainly from research use sales of the Parsortix system with a
small initial contribution from the newly established pharma
services business. Research sales continued to be impacted by the
COVID-19 pandemic but there was an encouraging improvement towards
the end of the year as these pressures began to be alleviated.
Importantly, both pharma services and research use product sales
are expected to accelerate should the Company receive FDA clearance
of the Parsortix system. ANGLE continued its investment in studies
to develop and validate the clinical application and commercial use
of the Parsortix system and to launch its new clinical laboratories
and pharma services business, resulting in operating costs of
GBP18.0 million (2020: GBP14.4 million) and a loss for the year of
GBP15.0 million (2020: loss GBP11.6 million).
The cash and cash equivalents and short-term deposits combined
balance was GBP31.8 million at 31 December 2021 (2020: GBP28.6
million) with R&D Tax Credits due at 31 December 2021 of GBP4.5
million (2020: GBP2.1 million).
Strategy
ANGLE has continued with its sustained focus on its four-pronged
strategy for achieving widespread adoption of its Parsortix system
in the emerging multi-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 approvals with the emphasis on FDA
clearances as the de facto global gold standard. ANGLE is seeking
to become the first ever company to gain FDA product clearance for
a system which harvests circulating tumour cells (CTCs) from
patient blood for subsequent analysis and will look to build on the
initial metastatic breast cancer clearance for specific clinical
assays and, where appropriate, for additional cancer types,
additional products and additional geographies through further
regulatory submissions
3) 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
4) Establishing a significant pharma services business and
building partnerships with large healthcare companies for market
deployment and development of multiple clinical applications
utilising the Parsortix system, including our own laboratory
developed tests from our clinical laboratories, once accredited, in
the United States and the UK
FDA response awaited
ANGLE is seeking to become the first ever company to receive FDA
product clearance for a medical device that harvests intact
circulating tumour cells from the blood of metastatic breast cancer
(MBC) patients for subsequent analysis. A full De Novo FDA
Submission for its Parsortix PC1 system seeking FDA clearance for
use with MBC patients was submitted in September 2020.
Following substantive review, FDA 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 necessitated
some targeted additional analytical studies. These studies did not
require patient samples and were completed as planned and a
comprehensive response to the AIR was announced in early June 2021.
Regular and constructive dialogue with FDA continues and a
regulatory response is awaited.
Clinical laboratories
ANGLE made excellent progress in establishing clinical
laboratories in the UK and United States 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 engaged in
processing clinical samples. In line with the Company's strategy,
the laboratories are being 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.
Processing of patient samples for clinical purposes (treating
patients) requires the laboratories to be accredited under the
appropriate local regulatory regimes. During the year, first
submissions were made in relation to accreditation of the Company's
United States and UK clinical laboratories respectively. Post year
end, the Centers for Medicare and Medicaid Services (CMS) issued a
Certificate of Registration, under the CLIA process, to the
Company's United States clinical laboratory. This is a key step
towards achieving CLIA accreditation of the laboratory. Following
CMS audit, including an inspection of the facilities and
documentation on the validation of assays to be performed together
with associated quality control procedures, a Certificate of
Compliance will be issued. This will complete the accreditation
process that permits the Laboratory to process samples for patient
management from the majority of the United States, with a small
number of States requiring additional procedures which will be
progressed separately.
Global pharma services business
The Parsortix liquid biopsy has particular advantages in
capturing intact cancer cells including mesenchymal cells and CTC
clusters and provides an opportunity for longitudinal testing
(before, during and after drug intervention) 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.
Despite lengthy initial sales processes (detailing the analysis
capability, evidencing the laboratory quality systems, and agreeing
the sampling handling and reporting requirements), ANGLE has
already successfully secured pharma services contracts with five
pharma and biotech companies including a Phase III prostate cancer
trial for one customer and the development of bespoke
immunofluorescence (IF) assays to detect specific target proteins
for another.
The incorporation of bespoke assay development as a first phase
in pharma services is a major development and is expected to
significantly increase the attractiveness of the Parsortix CTC
analysis offering, as pharma clients can look at proteins on CTCs
which directly align with the mechanism of operation of their drug
under investigation.
Once developed, the new assays will remain in the ownership of
ANGLE and be added to ANGLE's menu of pre-developed tests that can
be offered to other pharma customers. Pharma companies are commonly
interested in investigating protein markers on actual cancer cells.
These cannot be investigated using the alternative liquid biopsy
approach ctDNA (fragments of dead cancer cells) since protein
cannot be measured on ctDNA. Tissue biopsies provide cancer cells
but cannot be used for longitudinal monitoring since only a single
time point is usually possible with tissue biopsy. Consequently,
pharma companies are unable to access this analysis without
analysing CTCs.
The pharma services business continues to build with a total of
five independent customers now onboarded. Deployment of the
Parsortix system in the first contracts with these customers is
progressing well and two early customers have already agreed
additional contracts for further clinical trials.
Clinical applications
Patient enrolment for ANGLE's ovarian cancer clinical
verification study, which is being undertaken by the University of
Rochester Medical Center (URMC) Wilmot Cancer Institute, New York,
USA was completed during the year. The study is designed to
evaluate the use of ANGLE's combined Parsortix(R) and HyCEAD(TM)
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). Once the new
performance data is available and, assuming positive results, ANGLE
intends to establish this test as a laboratory developed test (LDT)
in its accredited clinical laboratories. The test has the potential
to significantly improve patient outcomes whilst also reducing
overall healthcare costs.
While good progress was made in many areas of the study, towards
the year end there were some third-party supply chain difficulties
attributed to COVID-19 with a key supplier unable to deliver
certain reagents as scheduled. Post year end, the reagents required
to complete the ovarian cancer study analysis have been received
and are being validated so that analysis of ovarian samples can be
resumed and headline results from the study are anticipated
mid-year.
Discussions regarding the initiation of a new study in prostate
cancer with one of the largest groups of specialist urology clinics
in the United States are well advanced and it is anticipated the
study will start promptly once final terms for the collaboration
have been agreed. ANGLE believes that compelling data from this
study could form the basis for a further LDT to be offered from
ANGLE's clinical laboratories and that the urology group concerned
would provide the first route to market in the United States.
Building a body of published evidence
The Company continues to build momentum around the research use
adoption of the Parsortix system by leading cancer research
centres, in line with its strategy to drive independent third
parties to use Parsortix for the development of new clinical
applications.
Over 141,000 samples have been processed using the Parsortix
system as at 31 December 2021, with some 26,000 samples in the
year. There were 54 peer-reviewed publications as at 31 December
2021 with 17 new publications
announced during 2021 (see https://angleplc.com/library/publications/ ) .
-- 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(R) )
-- University Medical Centre 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
-- Istituto Nazionale dei Tumori, Milan, Italy, utilising the
Parsortix system together with whole genome sequencing to uncover
therapeutic targets in patients with triple negative breast
cancer
-- University Hospital Ghent, Belgium, demonstrating the use of
the Parsortix system in oesophageal cancer for the first time,
consistently harvesting high-quality CTCs and validating a
workstream that could enable targeted treatment in this
hard-to-treat cancer
-- Washington University, St Louis, Missouri, United States,
supporting the potential use of the Parsortix system in the
prevention of relapse of breast cancer patients in remission. The
Parsortix system was successfully used to harvest cancer cells
"hibernating" in the bone marrow
-- National and Kapodistrian University of Athens, Greece,
highlighting differences in EGFR mutations between ctDNA and CTCs
in matched liquid biopsies from non-small cell lung cancer patients
and supporting the view that CTCs can provide perspective insight
into a patient's cancer, which may not be possible with ctDNA
alone
-- University Medical Centre Hamburg-Eppendorf, Germany, using
the Parsortix system to successfully harvest CTCs for analysis from
patients with brain metastasis, potentially enabling more
personalised care where traditional tissue biopsy is not
possible
-- Institute of Oncology, Ljubljana, Slovenia, highlighting the
ease of use and superior performance of the Parsortix system in
harvesting CTCs from metastatic breast cancer patients compared to
an alternative antibody-based approach
-- University College London, UK, demonstrating the use of the
Parsortix system to enable whole-genome sequencing of single CTCs
from neuroendocrine neoplasms
-- Medical University of Innsbruck, Austria, demonstrating the
use of the Parsortix system to enable gene expression analysis of
metastatic prostate cancer patients where longitudinal patient
monitoring showed reduction in CTCs with patient drug response
-- Health Research Institute of Santiago, Santiago de
Compostela, Spain, demonstrating the use of the Parsortix system to
assess PD-L1 status of CTCs in non-small cell lung cancer
patients
-- University of Birmingham, UK, exploring the use of the
Parsortix system in harvesting CTCs for gene expression analysis,
potentially providing markers of disease and prognosis in head and
neck squamous cell carcinoma patients
-- Medical University of Vienna, Austria, showing the Parsortix
system as key in demonstrating RNA analysis of CTCs as a prognostic
tool in non-small cell lung cancer patients. Multi-marker
transcriptomic analysis of CTCs revealed multiple subtypes with
different prognostic significance
-- National and Kapodistrian University of Athens, Greece,
supporting the analysis of CTCs captured using the Parsortix
system, together with ctDNA, from serial liquid biopsies to provide
information on disease progression and drug resistance in non-small
cell lung cancer patients
-- Edith Cowan University, Perth, Australia, using CTCs isolated
with the Parsortix system to highlight the relationship between
PD-L1 expression and epithelial to mesenchymal transition in
ovarian cancer patients
Following the year end, there have been eight further
publications, including the following of note:
-- University of Southern California Norris Cancer Center,
United States, a breakthrough study demonstrating, for the first
time, concordance of a Parsortix liquid biopsy test with invasive
tissue biopsy of the metastatic site and the potential for a
Parsortix blood test to be used as an alternative to tissue biopsy
in metastatic breast cancer
-- IRCCS Istituto Nazionale dei Tumori, Milano, Italy, published
their work in early-stage triple negative breast cancer,
demonstrating how longitudinal monitoring of CTCs isolated by the
Parsortix system can provide information on tumour evolution and
identify actionable genes that could help determine future
treatment options for patients with chemo-resistant disease
-- Marlene and Stewart Greenebaum NCI Comprehensive Cancer
Center, University of Maryland, Baltimore, United States, used the
Parsortix system to isolate CTCs in a preclinical model of
metastasis. The authors demonstrated how drug treatment with an
approved therapeutic could significantly reduce the metastatic
potential of CTCs. As metastasis is the leading cause of cancer
deaths, drugs reducing or preventing metastatic spread could
significantly improve patient survival
-- University of Basel and University Hospital Basel,
Switzerland, published ground-breaking research into the use of
CRISPR to identify genes required for metastatic invasion of CTCs
and CTC clusters isolated by the Parsortix system. The team were
able to identify actionable gene pathways which could be targeted
by novel or existing drugs to reduce metastatic spread
As at 31 December 2021, 29 separate cancer centres from around
the world have published positive reports on their use of the
Parsortix system. Using the Parsortix system, leading independent
cancer centres across Europe, North America and elsewhere have
undertaken research in 24 different cancer types.
Outlook
ANGLE gathered significant momentum in 2021 and this has carried
through into the start of 2022. We look forward to a busy year
ahead with the prospect of the first ever FDA product clearance for
a system to harvest cancer cells for subsequent analysis,
laboratory accreditation in both the United States and the UK,
major expansion of our pharma services business, clinical data in
ovarian cancer and the initiation of a new study in prostate cancer
as well as the deployment of our sample-to-answer solutions within
our clinical laboratories and directly with customers.
Globally, operating costs are rising with inflationary pressures
and some areas are experiencing supply chain constraints. In
addition, there is considerable competition in the sector for
talent and some cancer centres are facing a lack of availability of
grant funding for cancer research. ANGLE is taking the necessary
steps to address these challenges and does not anticipate any
significant impact on its growth trajectory. The Company is
strongly positioned in a large, fast growing market with a highly
differentiated product that has the potential to improve cancer
patient care and at the same time reduce healthcare costs and we
expect to see the Company grow significantly as this product
becomes widely adopted.
Clinical adoption of liquid biopsy solutions for cancer
diagnosis is building in all major markets and drug developers are
increasingly looking for new tools to improve clinical trial
efficiency and support market acceptance for novel cancer
treatments. The commercialisation of our unique liquid biopsy
platform to support personalised cancer care is underway and we
look forward to significant growth in the coming year and
beyond.
Garth Selvey
Chairman
27 April 2022
ANGLE PLC
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEARED 31 DECEMBER 2021
2021 2020
Note GBP'000 GBP'000
Revenue 1,013 762
Cost of sales (302) (165)
--------- ---------
Gross profit 711 597
Other operating income 41 79
Operating costs (17,987) (14,407)
--------- ---------
Operating profit/(loss) (17,235) (13,731)
Finance income 29 78
Finance costs (157) (92)
--------- ---------
Profit/(loss) before tax (17,363) (13,745)
Tax (charge)/credit 5 2,351 2,139
--------- ---------
Profit/(loss) for the year (15,012) (11,606)
Other comprehensive income/(loss)
Items that may be subsequently reclassified to profit
or loss:
Exchange differences on translating
foreign operations (175) 562
--------- ---------
Other comprehensive income/(loss) (175) 562
Total comprehensive income/(loss)
for the year (15,187) (11,044)
========= =========
Earnings/(loss) per share attributable
to owners of the parent
Basic and Diluted (pence per share) 6 (6.67) (6.52)
All activity arose from continuing
operations.
ANGLE PLC
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2021
2021 2020
Note GBP'000 GBP'000
Assets
Non-current assets
Intangible assets 3,573 3,710
Property, plant and equipment 2,172 1,176
Right-of-use assets 2,204 1,233
----------- ------------
Total non-current assets 7,949 6,119
----------- ------------
Current assets
Inventories 1,748 742
Trade and other receivables 1,269 1,443
Taxation 4,510 2,127
Short-term deposits - 16,538
Cash and cash equivalents 31,839 12,080
----------- ------------
Total current assets 39,366 32,930
----------- ------------
Total assets 47,315 39,049
----------- ------------
Liabilities
Non-current liabilities
Lease liabilities (1,816) (928)
Trade and other payables (257) -
----------- ------------
Total non-current liabilities (2,073) (928)
----------- ------------
Current liabilities
Lease liabilities (522) (434)
Trade and other payables (4,390) (3,343)
----------- ------------
Total current liabilities (4,912) (3,777)
----------- ------------
Total liabilities (6,985) (4,705)
----------- ------------
Net assets 40,330 34,344
=========== ============
Equity
Share capital 7 23,514 21,540
Share premium 99,406 81,532
Share-based payments reserve 2,727 1,745
Other reserve 2,553 2,553
Translation reserve (3,960) (3,785)
Accumulated losses (83,808) (69,139)
ESOT shares (102) (102)
----------- ------------
Total equity 40,330 34,344
=========== ============
ANGLE PLC
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEARED 31 DECEMBER 2021
2021 2020
GBP'000 GBP'000
Operating activities
Profit/(loss) before tax (17,363) (13,745)
Adjustments for:
Depreciation of property, plant
and equipment 701 661
Depreciation and impairment of
right-of-use assets 532 421
(Profit)/loss on disposal of property,
plant and equipment 4 2
Amortisation and impairment of
intangible assets 254 337
Share-based payments 1,325 268
Exchange differences (170) 565
Net finance (income)/costs 128 14
--------- -----------
Operating cash flows before movements
in working capital (14,589) (11,477)
(Increase)/decrease in inventories (1,015) 14
(Increase)/decrease in trade and
other receivables 204 (658)
Increase/(decrease) in trade and
other payables 1,417 872
--------- -----------
Operating cash flows (13,983) (11,249)
Research and development tax credits
received - 3,410
Overseas tax payments (27) (9)
--------- -----------
Net cash from/(used in) operating
activities (14,010) (7,848)
Investing activities
Purchase of property, plant and
equipment (1,666) (412)
Purchase of intangible assets (122) (94)
Transfer to short-term deposits 16,538 (1,530)
Interest received 24 70
--------- -----------
Net cash from/(used in) investing
activities 14,774 (1,966)
Financing activities
Net proceeds from issue of share
capital - placing 18,765 18,627
Proceeds from issue of share capital
- share option exercises 925 23
Principal elements of lease payments (614) (463)
Interest elements of lease payments (85) (44)
--------- -----------
Net cash from/(used in) financing
activities 18,991 18,143
Net increase/(decrease) in cash
and cash equivalents 19,755 8,329
Cash and cash equivalents at start
of year 12,080 3,757
Effect of exchange rate fluctuations 4 (6)
Cash and cash equivalents at 31
December 31,839 12,080
========= ===========
Cash and cash equivalents 31,839 12,080
Short-term deposits - 16,538
------- -------
Cash and cash equivalents and short-term
deposits
at 31 December 31,839 28,618
======= =======
ANGLE PLC
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEARED 31 DECEMBER 2021
------------------------------ Equity attributable
to owners of the parent -------------------------------
Share-based
Share Share payments Other Translation Accumulated ESOT Total
capital premium reserve reserve reserve losses shares equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 January
2020 17,277 67,272 1,518 2,553 (4,347) (57,574) (102) 26,597
For the year
to 31 December
2020
Consolidated
profit/(loss) (11,606) (11,606)
Other comprehensive
income/(loss):
Exchange differences
on translating
foreign operations 562 562
------------------------ -------- -------- ------------ ------- --------- ----------- -------- ----------
Total comprehensive
income/(loss) 562 (11,606) (11,044)
Issue of shares
(net of costs) 4,263 14,260 18,523
Share-based payments 268 268
Released on exercise (4) 4 -
Released on forfeiture (37) 37 -
_______ _______ ___________ ______ ________ __________ _______ _________
At 31 December
2020 21,540 81,532 1,745 2,553 (3,785) (69,139) (102) 34,344
For the year
to 31 December
2021
Consolidated
profit/(loss) (15,012) (15,012)
Other comprehensive
income/(loss):
Exchange differences
on translating
foreign operations (175) (175)
------------------------ -------- -------- ------------ ------- --------- ----------- -------- ----------
Total comprehensive
income/(loss) (175) (15,012) (15,187)
Issue of shares
(net of costs) 1,974 17,874 19,848
Share-based payments 1,325 1,325
Released on exercise (295) 295 -
Released on forfeiture (48) 48 -
______ _______ ___________ ______ ________ __________ _______ _________
At 31 December
2021 23,514 99,406 2,727 2,553 (3,960) (83,808) (102) 40,330
====== ====== ========== ===== ======= ========= ======= ========
ANGLE PLC
NOTES TO THE PRELIMINARY ANNOUNCEMENT
FOR THE YEAR ENDED 31 DECEMBER 2021
1 Preliminary announcement
The preliminary results for the year ended 31 December 2021 were
approved by the Board of Directors on 27 April 2022.
The preliminary announcement set out above does not constitute
ANGLE plc's statutory Financial Statements for the years ended 31
December 2021 or 31 December 2020 within the meaning of section 434
of the Companies Act 2006 but is derived from those audited
Financial Statements.
The auditor's report on the Consolidated Financial Statements
for the years ended 31 December 2021 and 31 December 2020 is
unqualified and does not contain statements under s498(2) or (3) of
the Companies Act 2006.
The accounting policies used for the year ended 31 December 2021
are unchanged from those used for the statutory Financial
Statements for the year ended 31 December 2020. The 31 December
2021 statutory accounts will be delivered to the Registrar of
Companies following the Company's Annual General Meeting.
2 Compliance with accounting standards
While the financial information included in this preliminary
announcement has been computed in accordance with the measurement
principles of UK-adopted international accounting standards, this
announcement does not itself contain sufficient information to
comply with these accounting standards.
Accounting standards adopted in the year
No new accounting standards that have become effective and
adopted in the year have had a significant effect on the Group's
Financial Statements.
Accounting standards issued but not yet effective
At the date of authorisation of the Financial Statements, there
were a number of other Standards and Interpretations (International
Financial Reporting Interpretation Committee - IFRIC) which were in
issue but not yet effective, and therefore have not been applied in
these Financial Statements. The Directors have not yet assessed the
impact of the adoption of these standards and interpretations for
future periods.
3 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.
The Directors have considered the uncertainties, risks and
potential impact on the business associated with potential negative
trading scenarios, market and geopolitical uncertainty
(Ukraine-Russia conflict), Brexit friction and residual COVID-19
impacts. Discretionary expenditure within the business provides
flexibility to scale back operations to address adverse events if
required. Mitigation measures to reduce costs could be taken if
needed and other potential sources of funding exist such as grants,
exclusivity and/or milestone payments for corporate partnerships
being developed and equity proceeds.
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 in line with available resources, as certain projects
may be deferred until additional resources are available. Based on
the level of existing cash and expected R&D tax credits, the
projected income and expenditure (the quantum and timing of some of
which is at the Group's discretion) and other potential sources of
funding, the Directors have a reasonable expectation that the
Company and Group have adequate resources to continue in business
for the foreseeable future. Accordingly, the going concern basis
has been used in preparing the Financial Statements.
4 Critical accounting estimates and judgements
The preparation of the Financial Statements requires the use of
estimates, assumptions and judgements that affect the reported
amounts of assets and liabilities at the date of the Financial
Statements and the reported amounts of revenues and expenses during
the reporting year. 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.
Share-based payments
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.
5 Tax
The Group undertakes R&D activities. In the UK these
activities qualify for tax relief and result in R&D tax
credits.
6 Earnings/(loss) per share attributable to owners of the parent
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 GBP15.0 million (2020: GBP11.6 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 year. Due to losses
in the 2021 and 2020 reporting years, share options are
non-dilutive for those years as adding them would have the effect
of reducing the loss per share and therefore the diluted loss per
share is equal to the basic loss per share.
The basic and diluted earnings/(loss) per share are based on
225,073,380 weighted average ordinary GBP0.10 shares for the year
(2020: 178,036,093).
7 Share capital
The Company has one class of Ordinary shares which carry no
right to fixed income and at 31 December 2021 had 235,143,050
Ordinary shares of GBP0.10 each allotted, called up and fully paid
(2020: 215,405,178).
The Company issued 17,241,380 new Ordinary shares with a nominal
value of GBP0.10 at an issue price of GBP1.16 per share in a
placing of shares realising gross proceeds of GBP20.0 million.
Associated costs of GBP1.1 million were incurred. Shares were
admitted to trading on AIM in July 2021.
The Company issued 2,496,492 new Ordinary shares with a nominal
value of GBP0.10 at exercise prices between GBP0.10 to GBP0.8625
per share as a result of the exercise of share options by employees
realising gross proceeds of GBP0.9 million. Shares were admitted to
trading on AIM at various dates across the year.
8 Shareholder communications
Copies of this announcement are posted on the Company's website
www.ANGLEplc.com .
The Annual General Meeting (AGM) of the Company will be held at
2:00 pm on Wednesday 29 June 2022 at the Holiday Inn Guildford,
Egerton Road, Guildford, GU2 7XZ. The Board is looking forward to
once again welcoming shareholders to the Meeting in person. As has
been the case in recent years, the Board is pleased to be able to
continue to offer shareholders the opportunity to follow
proceedings online via a live webcast. Details will be included in
the notice of AGM. 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 no longer
attend in person, will be notified through a regulatory news
service (RNS).
Notice of the meeting will be enclosed with the audited
Statutory Financial Statements.
The audited Statutory Financial Statements for the year ended 31
December 2021 are expected to be distributed to shareholders no
later than 1 June 2022 and will subsequently be available on the
Company's website or from the registered office, 10 Nugent Road,
Surrey Research Park, Guildford, GU2 7AF.
This preliminary announcement was approved by the Board of
Directors on 27 April 2022.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
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END
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