TIDMAGL
RNS Number : 4550N
Angle PLC
30 September 2021
For Immediate Release 30 September 2021
ANGLE plc
("ANGLE" or "the Company")
Interim Results for the six months ended 30 June 2021
FDA REVIEW PROGRESSING WITH RESPONSE ANTICIPATED IN THE SECOND
HALF OF THE YEAR
SUCCESSFUL LAUNCH OF GLOBAL PHARMA SERVICES BUSINESS
OVARIAN CANCER CLINICAL VERIFICATION STUDY NEARING
COMPLETION
ANGLE plc (AIM: AGL OTCQX: ANPCY), a world leading liquid biopsy
company, today announces its unaudited interim financial results
for the six months ended 30 June 2021.
Operational Highlights
-- Substantive review by United States Food and Drug
Administration (FDA) of the Parsortix(R) system for capturing and
harvesting circulating tumour cells from metastatic breast cancer
patients making good progress
- comprehensive response made to FDA Additional Information
Request
- regulatory response anticipated in H2 2021
-- Global pharma services business launched with clinical
laboratories opened in the UK and United States
- contracts now in progress with three pharma / biotech
customers
- discussions ongoing with multiple other potential customers,
including large global pharma companies
-- Ovarian cancer clinical verification study with leading
United States cancer centre nearing completion
- patient enrolment completed during the period and sample
analysis in preparation
- study expected to report headline results in Q4 2021 ahead of
anticipated launch of the ovarian cancer test as ANGLE's first LDT
(laboratory developed test)
Financial Highlights
-- Revenue for the half-year GBP0.3 million (H1 2020: GBP0.2 million)
-- Loss for the half-year GBP7.7 million (H1 2020 restated: loss
GBP3.4 million) reflecting planned investment
-- Cash and cash equivalents and short-term deposits combined
balance at 30 June 2021 of GBP21.0 million (31 December 2020:
GBP28.6 million)
-- A further GBP20.0 million (GBP18.9 million net of expenses)
was raised in a placing which was well supported by new and
existing institutional investors in both the UK and United States.
Proceeds of the placing will be used to support expansion of
commercial and management infrastructure and initiation of new
studies in prostate cancer
Garth Selvey, Non-Executive Chairman of ANGLE plc,
commented:
"ANGLE continues to make good progress in its aim to achieve the
first ever FDA product clearance, the gold standard for medical
devices globally, for a system to harvest cancer cells from patient
blood for subsequent analysis, initially in metastatic breast
cancer.
At the beginning of June 2021, ANGLE confirmed that it had
completed the work required to answer questions raised by FDA in
its Additional Information Request and that a comprehensive
response was submitted to FDA. Despite FDA resources being under
pressure due to the COVID-19 pandemic, the FDA review is
progressing, and ANGLE continues to anticipate a regulatory
response from FDA during H2 2021.
The launch of the Company's clinical laboratories and pharma
services business was a key highlight of the first half and early
signs of demand have been encouraging, with significant contracts
already agreed including a Phase III global clinical trial in
prostate cancer and the development of bespoke CTC-based
assays.
ANGLE's ovarian cancer detection test which, in trials to date,
has shown the potential to out-perform the current standard of care
by greatly reducing the level of false positives, is now nearing
conclusion. Patient enrolment was 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, addressing a
large unmet medical need.
I was delighted that, shortly after the period end, ANGLE
successfully completed fundraising of a further GBP20.0 million
from both new and existing shareholders in both the UK and United
States. The funds raised will support ANGLE's commercial plans,
particularly in the United States, and enable the Company to
initiate a new programme focused on prostate cancer, adding to the
Company's programmes in metastatic breast cancer and ovarian
cancer."
Details of webcast
A virtual meeting and webcast for analysts will be held at 10:00
am BST today. If you wish to attend, please register in advance and
log on to the webcast approximately 5 minutes before 10.00 am.
Details of how to attend can be accessed via
https://angleplc.com/investor-relations/corporate-presentations/
.
For further information ANGLE:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Andrew Holder, Head of Investor Relations
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon Hicks,
Teddy Whiley +44 (0)20 7220
ECM - Alice Lane, Sunila de Silva 0500
WG Partners (Joint Broker) +44 (0) 203 705
Nigel Barnes, Nigel Birks 9330
FTI Consulting +44 (0) 203 727
Simon Conway, Ciara Martin 1000
Matthew Ventimiglia (United States) +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 Interim 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 and commercialisation strategies, the
uncertainties related to regulatory clearance and the acceptance of
the Group's products by customers.
CHAIRMAN'S STATEMENT
Following ANGLE's FDA Submission in September 2020, the progress
in reviewing ANGLE's submission has been encouraging, despite the
well-publicised pressures on FDA resources due to the ongoing
COVID-19 pandemic. As planned, ANGLE completed the additional
analytical work required to provide a comprehensive response to the
Additional Information Request and FDA is now continuing its review
process.
As previously reported, ANGLE made excellent progress in
establishing clinical laboratories in the UK and United States,
which were opened ahead of schedule. These laboratories are
offering pharma services and, once accredited, will be able to
offer validated clinical tests. They 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.
Initial demand for these services has been encouraging and
contracts are now in progress with three different customers.
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 period and
headline results are expected in Q4 2021. 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 has initiated discussions with a leading
group of urology clinics in the United States to assist in the
design and execution of a new study in prostate cancer. We expect
to update the market with further details in due course.
Overview of Financial Results
As explained in the full year results for 2020, following a
detailed review, a number of areas were identified for restatement
or reclassification and the prior period numbers have been amended
accordingly. These had no cash impact and the restatement related
to certain capitalised product development costs and exchange
differences on certain overseas Group loans and the
reclassification of certain short-term deposits.
Revenue of GBP0.3 million in the period (six months ended 30
June 2020: GBP0.2 million) came mainly from research-use sales of
the Parsortix system. Sales were again impacted by the COVID-19
pandemic through closures at customer sites and budgetary
pressures. ANGLE continued its investment in studies to develop and
validate the clinical application and commercial use of the
Parsortix system and completed the investment required to launch
its new clinical laboratories and pharma services business,
resulting in operating costs of GBP8.9 million (six months ended 30
June 2020 restated: GBP4.6 million) and a loss for the period of
GBP7.7 million (six months ended 30 June 2020 restated: loss GBP3.4
million).
The cash and cash equivalents and short-term deposits combined
balance was GBP21.0 million at 30 June 2021 (31 December 2020:
GBP28.6 million) with R&D Tax Credits due at 30 June 2021 of
GBP3.2 million (31 December 2020: GBP2.1 million). Post period end,
the cash position was further strengthened with a successful
placing of new shares with demand from new and existing UK and
United States institutional investors, which raised gross proceeds
of GBP20.0 million. Proceeds net of expenses were GBP18.9
million.
FDA De Novo Submission review progressing
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 during the period as
planned and a comprehensive response to the AIR was announced in
early June 2021. FDA is making progress with its review process and
a regulatory response is anticipated during H2 2021.
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
response is entirely dependent on FDA's review. As previously
reported, 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
complete its review.
Clinical laboratories and pharma services
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 now processing
clinical samples for global clinical trials for pharma services.
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 that the laboratories are accredited under the
appropriate regulatory regimes for the region of operation.
Applications in relation to ISO 15189 (Medical laboratories -
Requirements for quality and competence) have already been
submitted for both laboratories and CLIA / UKAS accreditation is
being pursued with the aim of securing this around the end of the
year.
Global pharma services business
The Parsortix liquid biopsy has particular advantages in
capturing intact cancer cells including mesenchymal cells and CTC
clusters and provides the 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 three
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. All three customers have the potential to expand their
requirements with ongoing repeat contracts. Meanwhile discussions
are progressing with multiple additional pharma services customers,
some of which are very large global companies.
The incorporation of bespoke assay development as a first phase
in pharma services is a major development and 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.
Clinical applications
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(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). Patient
enrolment for this pivotal study was completed during the period
and, following 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.
There is already a significant body of evidence in the published
literature supporting the use of the Parsortix system in prostate
cancer. Liquid biopsy utilising CTCs could be used to help identify
men who, whilst recording a high level of protein specific antigen
(PSA) in a routine blood test, may not in fact have prostate cancer
or whose prostate cancer is indolent. A successful test using the
Parsortix system would help men avoid experiencing a highly
invasive and potentially risky tissue biopsy before it is
required.
ANGLE is in discussion with a leading chain of urology clinics
in the United States, who would be able to assist ANGLE in
designing and executing the necessary clinical studies, providing
access to patients, securing blood samples for analysis in ANGLE
labs and, assuming the test succeeds in demonstrating utility, in
marketing the test to its substantial patient base. Funds raised in
the institutional placing post period end will allow ANGLE to
progress these studies and study designs are now being planned.
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 127,000 samples have been processed using the Parsortix
system as at 30 June 2021, with some 12,000 samples in the period.
There were 46 peer-reviewed publications as at 30 June 2021 with
nine new publications announced
during the period (see https://angleplc.com/library/publications/ ) .
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. As the
potential for FDA clearance becomes closer, ANGLE has intensified
its discussions with companies in relevant fields.
Outlook
ANGLE is making encouraging progress with its FDA submission and
made a comprehensive response to the expected AIR. FDA is now
reviewing the additional information provided. Whilst previous
communication with FDA indicated a potential delay to their review
processes, we continue to anticipate a regulatory response 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.
With three contracts already signed, the launch of our
commercial laboratory and pharma services business is highly
promising. Adding a bespoke assay development capability to already
well characterised targets such as PD-L1 is expected to prove
attractive to new customers and, with multiple discussions already
underway, ANGLE looks forward to announcing further 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 addressing a large unmet medical need.
The start of 2021 has seen momentum building and, through its
new services business, ANGLE is starting 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 add to this momentum and
the successful capital raise will allow for the potential
initiation of new studies, which will further strengthen the ANGLE
offering.
Garth Selvey
Chairman
29 September 2021
ANGLE plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHSED 30 JUNE 2021
Six months
Six months ended ended Year ended
30 June 30 June 31 December
2021 2020 2020
(Unaudited)
(Unaudited) (Restated*) (Audited)
Note GBP'000 GBP'000 GBP'000
Revenue 296 235 762
Cost of sales (77) (59) (165)
------------ ------------- ------------
Gross profit 219 176 597
Other operating
income 16 33 79
Operating costs (8,897) (4,645) (14,407)
------------ ------------- ------------
Operating profit/(loss) (8,662) (4,436) (13,731)
Finance income 16 60 78
Finance costs (73) (45) (92)
------------ ------------- ------------
Profit/(loss)
before tax (8,719) (4,421) (13,745)
Tax (charge)/credit 2 1,036 1,022 2,139
------------ ------------- ------------
Profit/(loss)
for the period (7,683) (3,399) (11,606)
Other comprehensive
income/(loss)
Items that may be
subsequently reclassified
to profit or loss
Exchange differences
on translating foreign
operations 172 (2,200) 562
------------ ------------- ------------
Other comprehensive
income/(loss) 172 (2,200) 562
------------ ------------- ------------
Total comprehensive
income/(loss)
for the period (7,511) (5,599) (11,044)
============ ============= ============
Earnings/(loss) per share attributable to owners of the
parent
Basic and Diluted
(pence per share) 3 (3.57) (1.97) (6.52)
All activity arose from continuing operations
* The impact of the restatement is described in Note 5.
ANGLE PLC
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE 2021
30 June 31 December
30 June 2020 2020
2021 (Unaudited) (Audited)
(Unaudited) (Restated*)
Note GBP'000 GBP'000 GBP'000
Assets
Non-current assets
Intangible assets 3,653 3,834 3,710
Property, plant and equipment 2,005 1,460 1,176
Right-of-use assets 2,404 1,593 1,233
--------- ------------- ------------
Total non-current assets 8,062 6,887 6,119
--------- ------------- ------------
Current assets
Inventories 1,076 905 742
Trade and other receivables 1,388 710 1,443
Taxation 3,195 2,605 2,127
Short-term deposits 11,550 9,829 16,538
Cash and cash equivalents 9,481 3,957 12,080
--------- ------------- ------------
Total current assets ` 26,690 18,006 32,930
--------- ------------- ------------
Total assets 34,752 24,893 39,049
========= ============= ============
Liabilities
Non-current liabilities
Lease liabilities (1,926) (1,096) (928)
Trade and other payables (1,645) - -
--------- ------------- ------------
Total non-current liabilities (3,571) (1,096) (928)
Current liabilities
Lease liabilities (683) (515) (434)
Trade and other payables (3,026) (2,133) (3,343)
--------- ------------- ------------
Total current liabilities (3,709) (2,648) (3,777)
Total liabilities (7,280) (3,744) (4,705)
--------- ------------- ------------
Net assets 27,472 21,149 34,344
========= ============= ============
Equity
Share capital 4 21,586 17,280 21,540
Share premium 81,731 67,285 81,532
Share-based payments reserve 2,058 1,641 1,745
Other reserve 2,553 2,553 2,553
Translation reserve (3,613) (6,547) (3,785)
Accumulated losses (76,741) (60,961) (69,139)
ESOT shares (102) (102) (102)
--------- ------------- ------------
Total equity 27,472 21,149 34,344
========= ============= ============
* The impact of the restatement is described in Note 5. In
addition, the Group had classified short-term deposits within cash
and cash equivalents in the Financial Statements at 30 June 2020.
These deposits required a notice period of 95 days in order to
access the cash and therefore do not strictly comply with the
"readily convertible" requirements of IAS 7. These deposits have
therefore been reclassified from cash and cash equivalents to
short-term deposits and are shown as a separate line item in the
Consolidated Statement of Financial Position.
ANGLE plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHSED 30 JUNE 2021
Six months Six months Year
ended ended ended
30 June 30 June 31 December
2021 2020 2020
(Unaudited)
(Unaudited) (Restated*) (Audited)
GBP'000 GBP'000 GBP'000
Operating activities
Profit/(loss) before tax from
continuing operations (8,719) (4,421) (13,745)
Adjustments for:
Depreciation of property, plant
and equipment 313 350 661
Depreciation of right-of-use assets 260 200 421
(Profit)/loss on disposal of property,
plant and equipment - - 2
Amortisation and impairment of
intangible assets 114 193 337
Share-based payments 394 135 268
Exchange differences 171 (2,261) 565
Net finance (income)/costs 57 (15) 14
------------ ------------- --------------
Operating cash flows before movements
in working capital: (7,410) (5,819) (11,477)
(Increase)/decrease in inventories (355) (141) 14
(Increase)/decrease in trade and
other receivables 105 (352) (658)
Increase/(decrease) in trade and
other payables 1,331 73 872
------------ ------------- --------------
Operating cash flows (6,329) (6,239) (11,249)
Research and development tax credits
received - 1,840 3,410
Overseas corporation tax payments (11) (14) (9)
------------ ------------- --------------
Net cash from/(used in) operating
activities (6,340) (4,413) (7,848)
Investing activities
Purchase of property, plant and
equipment (1,007) (314) (412)
Purchase of intangible assets (53) (61) (94)
Transfer (to)/from short-term
deposits 4,989 5,180 (1,530)
Interest received 13 60 70
------------ ------------- --------------
Net cash from/(used in) investing
activities 3,942 4,865 (1,966)
Financing activities
Net proceeds from issue of share
capital 124 23 18,650
Principal elements of lease payments (309) (279) (463)
Interest elements of lease payments (19) (8) (44)
------------ ------------- --------------
Net cash from/(used in) financing
activities (204) (264) 18,143
Net increase/(decrease) in cash
and cash equivalents (2,602) 188 8,329
Cash and cash equivalents at start
of period 12,080 3,757 3,757
Effect of exchange rate fluctuations 3 12 (6)
------------ ------------- --------------
Cash and cash equivalents at end
of period 9,481 3,957 12,080
============ ============= ==============
Cash at bank - immediate access 6,473 1,252 4,074
Cash at bank - restricted access
(35 day notice) 3,008 2,705 8,006
------------ ------------- ------------
Cash and cash equivalents at end
of period 9,481 3,957 12,080
============ ============= ============
Cash and cash equivalents at end
of period 9,481 3,957 12,080
Short-term deposits 11,550 9,829 16,538
------------ ------------- ------------
Cash and cash equivalents and
short-term deposits 21,031 13,786 28,618
============ ============= ============
* The impact of the restatement is described in Note 5. In
addition, the Group had classified short-term deposits within cash
and cash equivalents in the Financial Statements at 30 June 2020.
These deposits required a notice period of 95 days in order to
access the cash and therefore do not strictly comply with the
"readily convertible" requirements of IAS 7. These deposits have
therefore been reclassified from cash and cash equivalents to
short-term deposits and are shown as a separate line item in the
Consolidated Statement of Financial Position.
ANGLE plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHSED 30 JUNE 2021
Share-based
Share Share payments Other
capital premium reserve reserve
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000
At 1 January 2020 (As originally
reported, Audited) 17,277 67,272 1,518 2,553
Restatement - IAS 38 adjustment
Restatement - retranslation
of Group balances
------------------------------------- -------------- ------------ ------------ ------------
At 1 January 2020 (Restated*,
Audited) 17,277 67,272 1,518 2,553
For the period to 30 June
2020
------------------------------------- -------------- ------------ ------------ ------------
Consolidated profit/(loss)
Restatement - IAS 38 adjustment
Restatement - retranslation
of Group balances
Other comprehensive income/(loss):
Exchange differences in translating
foreign operations as originally
reported
Restatement - IAS 38 adjustment
Restatement - retranslation
of Group balances
------------------------------------- -------------- ------------ ------------ ------------
Total comprehensive income/(loss)
Issue of shares (net of costs) 3 13
Share-based payments 135
Released on forfeiture (8)
Released on exercise (4)
------------------------------------- -------------- ------------ ------------ ------------
At 30 June 2020 (Restated*,
Unaudited) 17,280 67,285 1,641 2,553
For the period to 31 December
2020
------------------------------------- -------------- ------------ ------------ ------------
Consolidated profit/(loss)
Other comprehensive income/(loss):
Exchange differences in translating
foreign operations
------------------------------------- -------------- ------------ ------------ ------------
Total comprehensive income/(loss)
Issue of shares (net of costs) 4,260 14,247
Share-based payments 133
Released on forfeiture (29)
------------------------------------- -------------- ------------ ------------ ------------
At 31 December 2020 (Audited) 21,540 81,532 1,745 2,553
For the period to 30 June
2021
------------
Consolidated profit/(loss)
Other comprehensive income/(loss):
Exchange differences in translating
foreign operations
------------------------------------- -------------- ------------ ------------ ------------
Total comprehensive income/(loss)
Issue of shares (net of costs) 46 199
Share-based payments 394
Released on forfeiture (59)
Released on exercise (22)
------------------------------------- -------------- ------------ ------------ ------------
At 30 June 2021 (Unaudited) 21,586 81,731 2,058 2,553
===================================== ============== ============ ============ ============
ANGLE plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHSED 30 JUNE 2021 (continued)
Translation Retained ESOT Total
reserve earnings shares equity
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000 GBP'000
At 1 January 2020 (As originally
reported, Audited) 82 (58,276) (102) 30,324
Restatement - IAS 38 adjustment (6) (3,721) (3,727)
Restatement - retranslation
of Group balances (4,423) 4,423 -
------------------------------------- ------------ ------------ ------------ ------------
At 1 January 2020 (Restated*,
Audited) (4,347) (57,574) (102) 26,597
For the period to 30 June
2020
------------------------------------- ------------ ------------ ------------ ------------
Consolidated profit/(loss) (4,763) (4,763)
Restatement - IAS 38 adjustment (875) (875)
Restatement - retranslation
of Group balances 2,239 2,239
Other comprehensive income/(loss):
Exchange differences in translating
foreign operations as originally
reported 51 51
Restatement - IAS 38 adjustment (12) (12)
Restatement - retranslation
of Group balances (2,239) (2,239)
------------------------------------- ------------ ------------ ------------
Total comprehensive income/(loss) (2,200) (3,399) (5,599)
Issue of shares (net of costs) 16
Share-based payments 135
Released on forfeiture 8 -
Released on exercise 4 -
------------------------------------- ------------ ------------ ------------ ------------
At 30 June 2020 (Restated*,
Unaudited) (6,547) (60,961) (102) 21,149
For the period to 31 December
2020
------------------------------------- ------------ ------------ ------------ ------------
Consolidated profit/(loss) (8,207) (8,207)
Other comprehensive income/(loss):
Exchange differences in translating
foreign operations 2,762 2,762
------------------------------------- ------------ ------------ ------------
Total comprehensive income/(loss) 2,762 (8,207) (5,445)
Issue of shares (net of costs) 18,507
Share-based payments 133
Released on forfeiture 29 -
------------------------------------- ------------ ------------ ------------ ------------
At 31 December 2020 (Audited) (3,785) (69,139) (102) 34,344
For the period to 30 June
2021
------------
Consolidated profit/(loss) (7,683) (7,683)
Other comprehensive income/(loss):
Exchange differences in translating
foreign operations 172 172
------------------------------------- ------------ ------------ ------------
Total comprehensive income/(loss) 172 (7,683) (7,511)
Issue of shares (net of costs) 245
Share-based payments 394
Released on forfeiture 59 -
Released on exercise 22 -
------------------------------------- ------------ ------------ ------------ ------------
At 30 June 2021 (Unaudited) (3,613) (76,741) (102) 27,472
===================================== ============ ============ ============ ============
ANGLE plc
NOTES TO THE INTERIM FINANCIAL INFORMATION
FOR THE SIX MONTHSED 30 JUNE 2021
1 Basis of preparation and accounting policies
This Condensed Interim Financial Information is the unaudited
interim consolidated financial information (the "Condensed Interim
Financial Information") of ANGLE plc, a company incorporated in
Great Britain and registered in Great Britain and its subsidiaries
(together referred to as the "Group") for the six-month period
ended 30 June 2021 (the "interim period").
The Condensed Interim Financial Information should be read in
conjunction with the Financial Statements of the Group for the year
ended 31 December 2020, which have been prepared in accordance with
International Financial Reporting Standards (IFRS) in conformity
with the requirements of the Companies Act 2006. New and revised
IFRS and interpretations that became effective in the period did
not have or are not expected to have a significant impact on the
Group. Where necessary, comparative information has been
reclassified or expanded from the previously reported Condensed
Interim Financial Information to take into account any
presentational changes which were made in the Annual Report and
Financial Statements to 31 December 2020 and which may be made in
the Annual Report and Financial Statements to 31 December 2021.
The accounting policies used in the preparation of the Condensed
Interim Financial Information for the six months ended 30 June 2021
are in accordance with the recognition and measurement criteria of
IFRS, in conformity with the requirements of the Companies Act
2006, and are consistent with those which will be adopted in the
Financial Statements for the year ended 31 December 2021. While the
Condensed Interim Financial Information has been prepared in
accordance with the recognition and measurement criteria of IFRS,
in conformity with the requirements of the Companies Act 2006,
these Financial Statements do not contain sufficient information to
comply with IFRS.
This Condensed Interim Financial Information does not constitute
statutory financial statements as defined in section 434 of the
Companies Act 2006 and is unaudited and has not been reviewed. The
comparative information for the six months ended 30 June 2020 (as
restated) is also unaudited. The comparative figures for the year
ended 31 December 2020 have been extracted from the Group Financial
Statements as filed with the Registrar of Companies. The report of
the auditors on those Financial Statements was unqualified and did
not contain statements under sections 498(2) or (3) of the
Companies Act 2006.
The Condensed Interim Financial Information was approved by the
Board and authorised for issue on 30 September 2021.
Going concern
The Financial Information has been prepared on a going concern
basis which assumes that the Group will be able to continue its
operations for the foreseeable future.
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 financial projections
for the 12 month period from the date of approval of this Condensed
Interim Financial Information. Based on the level of existing cash
and expected R&D tax credits, and the projected income and
expenditure (the timing of some of which is at the Group's
discretion), 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 Condensed Interim Financial Information.
Note 6 provides additional information.
Critical accounting estimates and judgements
The preparation of the Condensed Interim Financial Information
requires the use of estimates, assumptions and judgements that
affect the reported amounts of assets and liabilities at the date
of the Financial Information 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 relate to 1) the valuation and
amortisation of internally generated intangible assets 2)
share-based payments and 3) IFRS 16 assessment of extension and/or
termination options of right-of-use asset and lease
liabilities.
2 Tax
The Group undertakes research and development activities. In the
UK these activities qualify for tax relief resulting in research
and development tax credits.
3 Earnings/(loss) per share
The basic and diluted earnings/(loss) per share is calculated by
dividing the after tax loss for the period attributable to the
owners of the parent of GBP7.7 million (six months to 30 June 2020
restated: loss GBP3.4 million, year ended 31 December 2020: loss
GBP11.6 million) by the weighted average number of shares in the
period.
In accordance with IAS 33 Earnings per share 1) the "basic"
weighted average number of Ordinary shares calculation excludes
shares held by the Employee Share Ownership Trust (ESOT) as these
are treated as treasury shares and 2) the "diluted" weighted
average number of Ordinary shares calculation considers potentially
dilutive Ordinary shares from instruments that could be converted.
Share options are potentially dilutive where the exercise price is
less than the average market price during the period. Due to the
losses in the periods, share options are non-dilutive for the
respective 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.
The basic and diluted earnings/(loss) per share are based on
215,440,711 weighted average Ordinary GBP0.10 shares (six months to
30 June 2020: 172,678,416; year ended 31 December 2020:
178,036,093).
4 Share capital
The Company has one class of Ordinary shares which carry no
right to fixed income and at 30 June 2021 had 215,867,845 Ordinary
shares of GBP0.10 each allotted, called up and fully paid.
During the period the Company issued 462,667 new Ordinary shares
with a nominal value of GBP0.10 at issue prices of between GBP0.258
and GBP0.730 per share as a result of the exercise of share options
by employees. 43,334 and 419,333 Ordinary shares were admitted to
trading on AIM in January 2021 and May 2021 respectively.
5 Restatement
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 30 June 2020
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. 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 period 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 GBP3.8 million at 30 June 2020.
These adjustments were made in the audited Financial Statements at
31 December 2020.
Retranslation of Group loans
The Group has restated its Financial Statements at 30 June 2020
to not 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 GBP6.7 million
at 30 June 2020. These adjustments were made in the audited
Financial Statements at 31 December 2020.
The restatement movements are shown below :
Consolidated Statement of Comprehensive Income (extract)
6 months ended Restatement Restatement 6 months
30 June 2020 IAS 38 translation ended
as originally reported of 30 June 2020
Group balances Restated
GBP'000 GBP'000 GBP'000 GBP'000
----------------------------------- ---------- ------------ ---------------- --------------
Operating costs (6,009) (875) 2,239 (4,645)
Profit/(loss) before
tax (5,785) (875) 2,239 (4,421)
Other comprehensive income/(loss) 51 (12) (2,239) (2,200)
Total comprehensive income/(loss) (4,712) (887) - (5,599)
Earnings/(loss) per share
Basic and diluted (pence
per share) (2.76) (0.51) 1.30 (1.97)
----------------------------------- ---------- ------------ ---------------- --------------
Consolidated Statement of Financial Position (extract)
Restatement Restatement
30 June 2020 IAS 38 translation 30 June 2020
as originally reported of Restated
Group balances
GBP'000 GBP'000 GBP'000 GBP'000
---------------------- --------- ------------ ---------------- ---------------
Intangible assets 8,448 (4,614) - 3,834
Translation reserves 133 (19) (6,661) (6,547)
Accumulated losses (63,027) (4,595) 6,661 (60,961)
---------------------- --------- ------------ ---------------- ---------------
Consolidated Statement of Cash Flows (extract)
6 months ended Restatement Restatement 6 months
30 June 2020 IAS 38 translation ended
as originally reported of 30 June 2020
Group balances Restated
GBP'000 GBP'000 GBP'000 GBP'000
------------------------ --------- ------------ ---------------- --------------
Operating cash flows
before movements in
working capital (4,944) (875) - (5,819)
Operating cash flows (5,389) (850) - (6,239)
Purchase of intangible
assets (911) 850 - (61)
------------------------ --------- ------------ ---------------- --------------
6 Post reporting date events
As explained in the Chairman's Statement, subsequent to the
reporting date the Company has completed a fundraise realising
gross proceeds of GBP20.0 million (GBP18.9 million net of
expenses).
Shareholder communications
This announcement is being sent to all shareholders on the
register at 29 September 2021. Copies of this announcement are
posted on the Company's website www.angleplc.com and are available
from the Company's registered office: 10 Nugent Road, Surrey
Research Park, Guildford, Surrey, GU2 7AF.
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END
IR FLFSDAIIAFIL
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