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REG - Angle PLC - Preliminary Results

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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 £1.0 million (2020: £0.8 million)

 

·    Loss for the year £15.0 million reflecting planned investment (2020:
loss £11.6 million)

 

·    Fundraising from institutional investors, including existing and new
US institutional investors, raising gross proceeds of £20.0 million (£18.9
million net of expenses)

 

·    Cash and cash equivalents and short-term deposits combined balance at
31 December 2021 of £31.8 million (2020: £28.6 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/
(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)            +44 (0) 20 3207 7800

 Toby Flaux, Ciaran Walsh, Milo Bonser

 Jefferies (Joint Broker)                      +44 (0) 20 7029 8000

 Max Jones, Thomas Bective

 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 £1.0 million in the year (2020: £0.8 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 £18.0 million (2020: £14.4 million) and a
loss for the year of £15.0 million (2020: loss £11.6 million).

 

The cash and cash equivalents and short-term deposits combined balance was
£31.8 million at 31 December 2021 (2020: £28.6 million) with R&D Tax
Credits due at 31 December 2021 of £4.5 million (2020: £2.1 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(®) 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).
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/
(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(®))

 

·    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 YEAR ENDED 31 DECEMBER 2021

 

 

 

                                                                                    2021                          2020
                                                                                    Note           £'000                         £'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                     6              (6.67)                        (6.52)

 Basic and Diluted (pence per share)

 All activity arose from continuing operations.

 

 

 

ANGLE PLC

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 DECEMBER 2021

 

 

                                              2021          2020
                                Note          £'000         £'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 YEAR ENDED 31 DECEMBER 2021

 

 

 2021                                                                     2020

 £'000                                                                    £'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

 

                                                    31,839      12,080

 Cash and cash equivalents
 Short-term deposits                                -           16,538
 Cash and cash equivalents and short-term deposits  31,839      28,618

 at 31 December

 

 

 

ANGLE PLC

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE YEAR ENDED 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
     £'000       £'000       £'000        £'000       £'000        £'000        £'000       £'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):                                                              562                            562

 Exchange differences on translating foreign operations
 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):                                                              (175)                          (175)

 Exchange differences on translating foreign operations
 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 £15.0
million (2020: £11.6 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 £0.10 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 £0.10 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
£0.10 at an issue price of £1.16 per share in a placing of shares realising
gross proceeds of £20.0 million. Associated costs of £1.1 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
£0.10 at exercise prices between £0.10 to £0.8625 per share as a result of
the exercise of share options by employees realising gross proceeds of £0.9
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 (http://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 Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
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.

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.   END  FR PPUPACUPPPPM

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