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REG - Angle PLC - Interim Results for the period ended 30 June 2023

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RNS Number : 6281L  Angle PLC  07 September 2023

 For Immediate Release  7 September 2023

 

ANGLE plc

("ANGLE" or "the Company")

 

Interim Results for the six months ended 30 June 2023

 

BUILDING COMMERCIAL MOMENTUM DELIVERS REVENUE GROWTH

 

Cash runway extended into Q1 2025

 

 

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company with
innovative circulating tumor cell (CTC) diagnostic solutions for the research
and diagnostic oncology market, today announces its unaudited interim
financial results for the six months ended 30 June 2023.

 

Financial Highlights

 

·      Revenues for the half-year trebled to £1.2 million (H1 2022:
£0.4 million)

-  product-related revenue £0.8 million (H1 2022: £0.3 million)

-  services-related revenue £0.4 million (H1 2022: £0.1 million)

-  services-related sales of up to £2.5 million have already been made for
revenues in future periods

 

·     Loss for the half-year £9.8 million, or 3.77 pence per share (H1
2022: loss £9.2 million, or 3.92 pence per share)

 

·     Focus on near term opportunities and deferral of some longer-term
growth objectives generates c. £5 million of cash savings by end of 2024
extending cash runway into Q1 2025

 

·     Cash and cash equivalents at 30 June 2023 of £22.2 million (30
June 2022: £20.5 million). R&D Tax Credits due at 30 June 2023 of £3.7
million (30 June 2022: £5.9 million)

 

 

Operational Highlights

 

Pharma services

 

·      Contracts signed with new and repeat customers including

-  new contract with Crescendo Biologics to use ANGLE's Portrait Flex assay
in a Phase 1 clinical study in prostate cancer

-  follow-on contract with Artios Pharma for use of DNA Damage Repair (DDR)
assay in a Phase 1 clinical study in multiple advanced cancers

 

Products

 

·     Global distribution network established across Europe, the Middle
East and Asia Pacific with work progressed on distributor training and
maintenance and support infrastructure

 

·     Installed base of Parsortix(®) systems increased to over 290 with
cumulative samples processed of 192,000 as at 30 June 2023

 

 

Content (applications)

 

·     Prostate cancer clinical study patient enrolment complete and
breast cancer HER2 assay development progressing well

 

·     Portrait Flex proprietary EMT assay established in ANGLE clinical
laboratories and Portrait(+) imaging assay kit under development for sale as a
product

 

·     Encouraging results from major development effort in progress
using third-party molecular platforms with Parsortix harvests

 

·     Eight peer-reviewed publications published during the half-year,
bringing the total Parsortix publications to 84 from 35 independent cancer
centres

 

 

Corporate Highlights

 

·     Board strengthened for the next phase of the Company's development
with the appointment of a new Non-executive Chairman and two new Non-executive
Directors

 

·     Senior management team strengthened with the appointment of highly
experienced, commercially focused industry professionals in the positions of
Chief Commercial Officer and Chief Scientific Officer

 

 

Outlook

 

·     Pipeline for products and services businesses building well and H2
2023 expected to continue the strong momentum seen in the first half,
delivering revenue in-line with market expectations for the full year

 

·     Headline results from the Company's major clinical studies expected
by the year end demonstrating key clinical applications of the Parsortix
system for patient care

 

·     Careful control of costs and deferring some discretionary
expenditure expected to deliver cash ahead of forecast at the year end and
extend cash runway into Q1 2025 without impacting revenues over the next 24
months

 

 

ANGLE Founder and Chief Executive, Andrew Newland, commented:

 

"Encouraging progress was made on multiple levels during the half-year.  This
was reflected in the beginnings of the post-FDA anticipated revenue ramp
delivering revenues trebled year-on-year.  Major efforts have been focused on
both the products and services commercialisation channels and on the
development of "content" in terms of applications for which customers can use
the Parsortix system.

 

The management team has been broadened to drive commercialisation with the
appointment of highly experienced Chief Commercial and Chief Scientific
Officers and, following a detailed review, resources have been focused to
maximise commercialisation and extend the cash runway into Q1 2025.

 

In the second half, momentum is expected to accelerate further as major
streams of work to demonstrate analysis of Parsortix CTC harvests utilising
major third-party molecular systems are completed generating new large scale
revenue opportunities."

 

Details of analyst meeting and webcast

A meeting for analysts will be held at 11:00 am today at the offices of FTI
Consulting, 200 Aldersgate, Aldersgate Street, London EC1A 4HD.

 

A live webcast of the analyst meeting can be accessed via ANGLE's Investor
Centre page, https://angleplc.com/investor-relations/corporate-presentations/
(https://angleplc.com/investor-relations/corporate-presentations/) , with
Q&A participation for analysts. Please register in advance and log on to
the webcast approximately 5 minutes before 11:00 am on the day of the results.
A recording of the webcast will be made available on ANGLE's website following
the 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

 Thomas Bective, Shaam Vora

 FTI Consulting

 Simon Conway, Ciara Martin                  +44 (0) 203 727 1000

 Matthew Ventimiglia (US)                    +1 (212) 850 5624

 

 

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.

 

For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/glossary/
(https://angleplc.com/investor-relations/glossary/)

 

 

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 general
economic climate and market conditions, as well as specific factors including
the success of the Group's research and development activities,
commercialisation strategies, the uncertainties related to clinical study
outcomes and regulatory clearance, obtaining reimbursement and payor coverage,
acceptance into national guidelines and the acceptance of the Group's products
by customers.

 

 

CHAIRMAN AND CHIEF EXECUTIVE'S STATEMENT

 

Introduction

 

We are pleased to report the unaudited interim financial results for the six
months ended 30 June 2023. In this period, the Company delivered significant
revenue growth in line with our strategy. Our product business has been
particularly busy, expanding our global footprint by signing up more
distributors and experiencing continued growth in instrument and cassette
sales. Our ongoing sales efforts through our direct sales force and
distribution network, combined with pharma contracts, give ANGLE confidence of
continued revenue growth in the second half.

 

 

Overview of Financial Results

 

Following FDA clearance, the beginning of the anticipated revenue ramp is
reflected in half-year revenues trebling to £1.2 million (six months ended 30
June 2022: £0.4 million) and was driven by a combination of product sales of
the Parsortix system, pharma services contracts and corporate partnerships.

 

Product-related revenues were £0.8 million (six months ended 30 June 2022:
£0.3 million) while services-related revenues were £0.4 million (six months
ended 30 June 2022: £0.1 million).  In addition, services-related sales of
up to £2.5 million have already been made for revenues in future periods.
The installed base of Parsortix systems has increased to over 290 with
cumulative samples processed of 192,000 as at 30 June 2023.

 

Continued investment in studies to develop and validate the clinical
application and commercial use of the Parsortix system as well as the ongoing
growth of the commercial team and infrastructure was partly offset by the
expected cost savings from the closure of the Canadian operations in late
2022, resulting in operating costs of £11.4 million (six months ended 30 June
2022: £10.6 million). The loss for the period was £9.8 million (six months
ended 30 June 2022: loss £9.2 million).

 

Cash and cash equivalents were £22.2 million at 30 June 2023 (30 June 2022:
£20.5 million) with R&D Tax Credits due at 30 June 2022 of £3.7 million
(30 June 2022: £5.9 million).

 

The Company is committed to carefully controlling costs and focusing on
near-term commercialisation. Management has identified cost reductions
expected to result in cash savings of c. £5 million in the period to 31
December 2024, as non-critical R&D and other activities are deferred or
reduced. Whilst some longer-term growth objectives and planned investment for
2024 will be delayed, the proposed cash savings are not expected to have any
impact on revenues over the next 24 months, which continue to be expected to
grow strongly.

 

The Company will continue to invest in its commercialisation strategy to
support customers for Parsortix products and services and its R&D
activities on downstream analysis of CTCs using third-party molecular
platforms and commercially available diagnostic assays.

 

 

Near term direction to drive growth

 

Pharma services contracts are important, not only as a revenue generator, but
also in increasing the awareness of the value of CTC analysis for therapy
selection and disease monitoring, eventually providing clinicians with
actionable information for patient treatment. The use of circulating tumor DNA
(ctDNA, fragments of dead cancer cells) testing for cancer patients is
increasing not only in clinical trials but also in clinical centres. ANGLE has
developed protocols for the Parsortix system where the same blood samples
obtained for ctDNA testing can also be used for CTC DNA molecular analysis.
Being intact living cancer cells, CTCs can provide additional DNA prospective
insight not possible with ctDNA alone. Importantly, CTCs can also provide
crucial RNA and protein information, which is not possible at all with ctDNA.

 

The mode of action, role and function of selected DNA mutations have been
identified in relation to the prognosis, prediction, and therapy selection for
patients. Specific molecular in vitro diagnostic (IVD) ctDNA cancer gene panel
kits have been developed and are commercially available. These kits can also
be used for CTCs and independent scientific studies utilising the Parsortix
system have already shown that the results provide additional clinically
relevant information beyond that provided by ctDNA analysis alone.

 

Having implemented the strategic decision to move away from the in-house
molecular platform last year, ANGLE is making significant progress in
utilising commercially available third-party molecular platforms, both PCR and
NGS, to establish reliable protocols for analysis of CTCs harvested by the
Parsortix system.  This has been possible because of the now increased
sensitivity and lower costs of such platforms as well as the development by
their manufacturers of cancer panels for ctDNA, which also work with CTCs.
The key commercial advantage of utilising third-party molecular platforms is
that they already have an installed base of customers that can adopt the
Parsortix system to provide samples for analysis.  They also have dedicated
sales teams in place who will benefit from increased test volumes on their
molecular platforms if they encourage the adoption of the Parsortix system by
their customers to provide samples for analysis.

 

Independent scientific studies have recently shown that combined detection of
ctDNA and CTC DNA from the same patient blood sample using NGS significantly
improves the identification of DNA mutations in cancer patients.  Early
in-house clinical studies have confirmed these findings.  ANGLE's available
bio-bank of samples from its INFORM (multi-cancer), ovarian and prostate
clinical studies will allow the Company to fast-track larger scale evaluation
of the significant added value of CTC molecular analysis using existing
available ctDNA cancer gene panel kits.  The major advantages of this
strategy are:

 

·    information provided by CTCs harvested with the Parsortix system
enables third-party manufacturers to further leverage their significant
investment in the development of proprietary IVD assays for the clinical
market

 

·    ctDNA kits are provided by several large diagnostics companies and
adoption is increasing

·    alongside the Company's own investigation, multiple independent
studies have shown that using cancer gene panel assays on CTCs provides
additional, complementary information not available from ctDNA alone

 

·    ctDNA testing is becoming accepted by oncologists and a combined
ctDNA / CTC DNA approach is additive to the diagnostic information provided.
DNA extracted from CTCs harvested using the Parsortix system can be analysed
using the same laboratory processes

 

·    in the United States, Medicare and private commercial health
insurance organisations have already established positive medical policies and
reimbursement rates for molecular diagnostic assays, including liquid biopsy
testing, helping pave the way for future reimbursement for ANGLE's clinical
applications.

 

 

Outlook

 

The combination of molecular testing of CTCs and ctDNA from the same blood
sample is a key opportunity to drive ANGLE's future revenue for both pharma
services and product sales.

 

ANGLE is progressing its strategy to focus on the high-value oncology
molecular diagnostic market. The aim of this strategy is to reap the full
benefits of the Company's FDA cleared Parsortix CTC platform and clinical
scientific evidence linking this to existing commercially available NGS and
PCR cancer gene panels.

 

This approach enables the Company to offer product-based solutions for
clinical applications utilising third-party molecular platforms already in the
market.  This leverages the product-based approach and removes the need for
large scale clinical test service offerings, reducing the capital required to
grow the business and accelerating the route to wider market scale-up as well
as meeting a key market preference for the clinical market to offer tests from
their own laboratories rather than as a send out to commercial service
laboratories. Molecular solutions are also in demand from our growing pipeline
of pharma services customers, including large pharma, for use in clinical
trials and as potential companion diagnostics.

 

With the move towards third-party molecular systems, the Company is now well
positioned in the market to successfully deliver against its strategic
objectives and careful control of costs and deferral of discretionary
expenditure extends the cash runway into Q1 2025.  It is against this
backdrop of momentum that the Board is confident in ANGLE's commercial future
delivering increasing value to all stakeholders.

 

 

 Dr Jan Groen  Andrew Newland
 Chairman      Chief Executive

 

6 September 2023

 

 

OPERATIONAL UPDATE

 

Commercial strategy

 

ANGLE's vision is to secure widespread adoption of the Parsortix system by
providing CTCs as the "best sample" for analysis in the emerging multi-US$
billion liquid biopsy market. To drive commercialisation, ANGLE has
established both a product business and a services business.

 

1.   Product business area

 

ANGLE has developed the Parsortix system including instruments and one-time
use cassettes that are sold to third-party laboratories for their use in
research, pharmaceutical development and clinical use. To enable customers to
carry out downstream analysis of the Parsortix harvest, ANGLE will also offer
assay kits for cell imaging and use protocols for third-party molecular
platforms.

 

2.  Services business area

 

ANGLE has established clinical laboratories in the UK and United States as
accelerators and demonstrators that have the capability and required quality
systems to process patient samples and offer validated clinical tests using
the Parsortix system. The laboratories, in Guildford, UK and Plymouth Meeting,
Pennsylvania, United States are being used to provide services to pharma and
biotech customers running clinical trials (pharma services) and will be able
to offer clinical tests as a first step towards product roll-out of such
tests.

 

Both business areas are supported by a growing body of published evidence and
content from leading cancer centres showing the utility of the system through
peer-reviewed publications (see below), scientific data and clinical research
evidence, highlighting a wide range of potential applications.

 

 

Parsortix products

 

In the first half of 2023, ANGLE has further invested in its commercial team,
as it seeks to capitalise on the FDA clearance and UK and European product
registrations received in May 2022. Its network of oncology focused
distribution partners has expanded and now covers major territories in Europe,
the Middle East, and Asia Pacific. Training programmes for distributor
representatives were initiated, new marketing materials developed, and service
and support infrastructure strengthened.

 

 

Parsortix content (applications)

 

To support adoption of its technology by adding "content", ANGLE has been
developing a menu of imaging assays (branded Portrait(™)) and molecular
assays (branded Landscape(™)) to analyse the cancer cells harvested by the
Parsortix system.  These assays support both ANGLE's pharma services business
and product business for third-party customers.

 

In the first half of the year, ANGLE progressed the development of its
sample-to-answer Portrait(+) imaging assay kit. The assay optimises the
identification and enumeration of epithelial and mesenchymal CTCs as well as
CTCs in the process of epithelial-to-mesenchymal transition (EMTing). The
assay components, including lyophilised antibodies and reagents have been
assembled as a kit to be sold to third-party laboratories for use with the
Parsortix system to allow for robust, repeatable results. The kits will be
sold directly and through ANGLE's distribution partners and, as a result of
their ease of use and reproducibility, are expected to substantially expand
the population of customers interested in purchasing the Parsortix system.

 

ANGLE has also completed the development of the Portrait Flex imaging assay
for use in its service laboratories. This assay not only allows for the
identification of epithelial, mesenchymal and EMTing CTCs, but also gives
pharma customers the ability to evaluate a further biomarker of their choice
specifically linked to their trial. The assay is already being used for
example by Crescendo Biologics in a clinical study (see below).

 

A Portrait PD-L1 assay has also been developed in-house using the Portrait
Flex imaging assay together with an antibody to stain for the PD-L1 protein on
CTCs for use in ANGLE's service laboratories. PD-1/PD-L1 interaction is a key
target for immunotherapy and ANGLE is now able to offer the assay to pharma
services customers looking to stratify patients or monitor drug efficacy
through measurement of PD-L1 expression on CTCs harvested using the Parsortix
system. ANGLE believes this is a significant market opportunity given the
large number of clinical trials (>2,800) where PD-1/PD-L1 interaction is
the target of approved drugs and new drugs in development.

 

Development of downstream molecular assays on third-party platforms continues
to make strong progress with several widely available DNA and RNA sequencing
technologies demonstrating sufficient sensitivity for successful use with
Parsortix harvests. ANGLE has been able to generate highly encouraging
results, sequencing for both cancer specific markers and with multi-cancer
panels. Once complete, the Company anticipates these molecular analysis
protocols will be utilised both as services from its own laboratories and by
its product-based customers further greatly extending the market applicability
of the Parsortix system.

 

 

Pharma services

 

The pharma services business utilising the Parsortix system offers the
potential for substantial revenues in the large cancer drug trials market
where ANGLE is strongly differentiated. Despite the challenging market
conditions for our customer base, the pipeline of opportunities has continued
to progress, and ANGLE secured Crescendo Biologics as a new customer in the
first half of the year. Crescendo is a UK-based, clinical stage
immuno-oncology company and will use ANGLE's Portrait Flex assay in an ongoing
Phase 1 clinical trial investigating the safety and efficacy of their drug for
the treatment of patients with PSMA positive prostate cancer.

 

ANGLE has also secured follow-on contracts with several existing customers
including Artios Pharma, its first bespoke assay development customer.
Following validation in ANGLE's clinical laboratories, Artios is now employing
two DNA Damage Response (DDR) assays developed by ANGLE in a Phase 1 clinical
trial expected to complete around the end of 2024. The assays identify two
target proteins on CTCs that are implicated in DDR, ɣ-H2AX and pKAP1. This is
an area of focus for drug companies developing PARP or DDR inhibitors for a
range of solid tumours and the assays have been added to the "menu" of
pre-developed tests and are being offered to other prospective customers.
Discussions with interested parties are in progress following the commercial
launch of the assays at DDR focused conferences earlier in the year.

 

ANGLE believes that there is considerable potential for further business with
all its existing pharma customers as they have a pipeline of drugs in
development where CTC assays could provide additional valuable information.
In addition, ANGLE anticipates that further new pharma services contracts will
be signed in the second half of the year, including for large pharma.

 

 

Parsortix clinical studies

 

ANGLE is conducting clinical studies to generate patient data demonstrating
the value of Parsortix CTC analysis and has established a substantial bio-bank
of clinical samples for this purpose.

 

The largest such study is ANGLE's INFORM study, which is targeting enrolment
of up to 1,000 patients with advanced disease over a five-year period in four
different cancers (breast, prostate, ovarian and lung) involving six NHS
Trusts.  Each patient will have blood drawn at up to six different time
points during the course of their treatment, with up to four tubes of blood
being drawn at each time point (a total of up to 24,000 tubes of blood).  As
of June 30, 2023, 210 patients had been enrolled into the INFORM study, with a
total of 591 blood draws being performed and 2,348 tubes of blood being
received for either storage or processing using the Parsortix system. Cells
harvested by the system are being evaluated using various immunofluorescence
and/or molecular assays or being stored for future molecular analysis.

 

Following the successful completion of the pelvic mass study for the detection
of ovarian cancer reported in 2022, ANGLE has continued enrolment of women
with a pelvic mass into the EMBER2 clinical study and now has 399 women
enrolled and over 1,000 tubes of blood that have been drawn and processed
using the Parsortix system, with cells harvested by the system being stored
for molecular analysis.

 

ANGLE's DOMINO prostate cancer study with Solaris Health has now completed its
initial enrolment of 100 patients, with the blood tubes drawn from each
patient having similarly been processed using the Parsortix system and the
output stored for future molecular analysis.

 

The Company's investment in these clinical studies and the collection of the
associated patient records has provided a tremendous resource for
fast-tracking large-scale evaluation of the third-party molecular platforms
that are currently under investigation, once their suitability for the purpose
has been demonstrated with controlled laboratory samples and then smaller
numbers of similar clinical samples.

 

We expect to be able to generate meaningful clinical data by year end in
multiple cancer types utilising these bio-banks in conjunction with
third-party molecular systems for multiple potential clinical uses, which may
include:

 

·    identification of key DNA mutations with associated targeted
therapies, which could be used to guide treatment decisions for later stage
cancer patients (breast, prostate, ovarian and lung)

 

·    highlighting the evolution of cancer and its likely progression for
prognostic purposes (breast, prostate, ovarian and lung)

 

·    assessment of the likelihood of the presence and severity of cancer
in undiagnosed patients (prostate and ovarian).

 

The positive output of these studies will have a major impact on the Company's
commercialisation strategy, providing data to support sales for the pharma
services and products businesses and demonstrating clinical applications of
the Parsortix system for patient care.

 

 

Parsortix corporate partnerships

 

In April 2023, ANGLE reached an agreement with BioView to develop a CTC HER2
assay for breast cancer using a combination of ANGLE's FDA cleared
Parsortix(®) PC1 Clinical System and BioView's automated microscopy systems
and software. The assay aims to detect and assess the HER2 expression and/or
gene amplification in CTCs and is another significant development for the
Company. The changing market dynamics of the HER2 breast cancer marketplace,
with the introduction of new drugs targeting tumours with low HER2 expression,
have provided a major commercial opportunity to develop a quantitative
CTC-based HER2 assay, to assess HER2 protein expression and/or gene
amplification levels by analysing fluorescence intensities.

 

This would be the only product-based solution on the market for this purpose,
leveraging both companies' previous FDA product clearances.  Unlike current
standard of care tests developed for use on FFPE tissue, a CTC HER2 assay
could be used for longitudinal monitoring of HER2 status throughout disease
progression, thereby ensuring the patient is targeted for the most appropriate
treatment at every stage. The development phase, which is already underway and
making very good progress, is estimated to take around a year to complete
generating revenue for ANGLE of £1.2 million.

 

Given the significant third-party interest in a new assay for quantitative
HER2 analysis based on CTCs, the agreement allows for the inclusion of third
parties in this project and its funding at the commercialisation stage after
the initial development work is complete.

 

 

Peer reviewed publications update

 

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
with eight new peer-reviewed publications published during the half-year,
bringing the total to 84 peer-reviewed publications as at 30 June 2023 (see
https:// (https://angleplc.com/library/publications/)
(https://angleplc.com/library/publications/)
https://angleplc.com/publications/
(https://angleplc.com/library/publications/) ). The new publications were:

 

·    Frontiers in Oncology: "The potential of using circulating tumour
cells and their gene expression to predict docetaxel response in metastatic
prostate cancer"

 

·    Cancer Cell International: "The role of the desmosomal protein
desmocollin 2 in tumour progression in triple negative breast cancer patients"

 

·    Cancers: "Preoperative Mutational Analysis of Circulating Tumor Cells
(CTCs) and Plasma-cfDNA Provides Complementary Information for Early
Prediction of Relapse: A Pilot Study in Early-Stage Non-Small Cell Lung
Cancer"

 

·    Molecular Oncology: "Comparative evaluation of PD-L1 expression in
cytology imprints, circulating tumour cells and tumour tissue in non-small
cell lung cancer patients"

 

·    International Journal of Molecular Sciences: "Transcriptome Profiling
of Circulating Tumor Cells to Predict Clinical Outcomes in Metastatic
Castration-Resistant Prostate Cancer"

 

·    Cancers: "Association of Circulating Tumor Cells, Megakaryocytes and
a High Immune-Inflammatory Environment in Metastatic Breast Cancer"

 

·    BMC Cancer: "Protocol for a prospective study evaluating circulating
tumour cells status to predict radical prostatectomy treatment failure in
localised prostate cancer patients (C‑ProMeta‑1)"

 

·    International Journal of Molecular Sciences: "Innovative Approach to
Isolate and Characterize Glioblastoma Circulating Tumor Cells and Correlation
with Tumor Mutational Status".

 

Subsequent to the period end, results of the Company's FDA analytical studies
were published in the Journal of Circulating Biomarkers demonstrating the
ability of the Parsortix system to harvest breast cancer cells in a sensitive,
reproducible, and linear fashion.

 

 

Operational plans for H2

 

ANGLE has enjoyed strong growth in the first half of the year and this
momentum is expected to continue in the second half and beyond.

 

ANGLE has developed a pipeline of assays that it will continue to roll-out in
the second half of the year, providing robust sample-to-answer solutions for
ANGLE's customer base and enabling the full capabilities of the Parsortix
system to be utilised. ANGLE is particularly excited about the encouraging
results being achieved from tests of the Parsortix CTC harvests on third-party
molecular platforms, including DNA and RNA digital PCR systems and high
multiplex Next Generation Sequencing (NGS) systems. Technical data from
evaluations, supported by patient data from ANGLE's ongoing clinical studies,
is expected to deliver a comprehensive offering of cancer specific and
multi-cancer CTC assays that ANGLE believes will address a substantial market
need.

 

 

Andrew Newland

Chief Executive

6 September 2023

 

 

 

 

ANGLE plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE SIX MONTHS ENDED 30 JUNE 2023

 

 

                                                                      Six months ended          Six months ended    Year ended

                                                                                 30 June        30 June             31 December
                                                                                 2023           2022                2022
                                                                                 (Unaudited)    (Unaudited)         (Audited)
                                                                      Note       £'000          £'000               £'000
 Revenue                                                                         1,196          419                 1,041
 Cost of sales                                                                   (455)            (160)             (428)
 Gross profit                                                                    741            259                 613
 Other operating income                                                          -              1                   1
 Operating costs                                                                 (11,375)         (10,626)          (24,821)
 Operating profit/(loss)                                                         (10,634)       (10,366)            (24,207)
 Finance income                                                                  190            32                  136
 Finance costs                                                                   (168)          (170)               (368)
 Profit/(loss) before tax                                                        (10,612)       (10,504)            (24,439)
 Tax (charge)/credit                                                  2          799            1,283               2,753
 Profit/(loss) for the period                                                    (9,813)        (9,221)             (21,686)
 Items that may be subsequently reclassified to profit or loss Other
 comprehensive income/(loss)
 Exchange differences on translating foreign operations                          1,058          (1,928)             (2,023)
 Other comprehensive income/(loss)                                               1,058          (1,928)             (2,023)
 Total comprehensive income/(loss) for the period                                (8,755)        (11,149)            (23,709)

 Earnings/(loss) per share attributable to owners of the parent
 Basic and Diluted (pence per share)                                  3          (3.77)         (3.92)              (8.79)

 

 

 All activity arose from continuing operations

 

 

 

 

ANGLE PLC

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2023

 

 

                                30 June                  30 June         31 December

                                2023                     2022            2022

                                (Unaudited)              (Unaudited)     (Audited)
                                Note     £'000           £'000                   £'000
 Assets
 Non-current assets
 Intangible assets                       2,748           3,590                   2,764
 Property, plant and equipment           3,376           3,183                   3,505
 Right-of-use assets                     4,511           5,083                   4,971
 Total non-current assets                10,635          11,856                  11,240

 Current assets
 Inventories                             2,256           1,734                   2,059
 Trade and other receivables             1,436           1,832                   1,797
 Taxation                                3,675           5,883                   2,876
 Cash and cash equivalents               22,162             20,497                  31,896
 Total current assets                    29,529          29,946                  38,628

 Total assets                            40,164          41,802                  49,868
 Liabilities
 Non-current liabilities
 Lease liabilities                       (3,961)          (4,672)                    (4,339)
 Provisions                              (162)           -                       (157)
 Trade and other payables                (39)               (686)                    (59)
 Total non-current liabilities           (4,162)             (5,358)                 (4,555)
 Current liabilities
 Lease liabilities                       (613)           (565)                   (662)
 Provisions                              (439)           -                       (610)
 Trade and other payables                (2,882)             (4,004)                 (3,978)
 Total current liabilities               (3,934)             (4,569)                 (5,250)

 Total liabilities                       (8,096)             (9,927)                 (9,805)
 Net assets                              32,068              31,875                  40,063
 Equity
 Share capital                  4        26,058          23,529                  26,058
 Share premium                           115,918         99,467                  115,918
 Share-based payments reserve            5,940           5,057                   5,321
 Other reserve                           2,553           2,553                   2,553
 Translation reserve                     (4,925)         (5,888)                 (5,983)
 Accumulated losses                      (113,374)       (92,741)                (103,702)
 ESOT shares                             (102)               (102)                   (102)
 Total equity                            32,068              31,875                  40,063

 

 

 

 

ANGLE plc

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE SIX MONTHS ENDED 30 JUNE 2023

 

 

                                                                Six months     Six months                            Year

                                                                ended          ended                                  ended
                                                                30 June        30 June                               31 December
                                                                2023           2022                                  2022
                                                                (Unaudited)    (Unaudited)                           (Audited)
                                                                £'000          £'000                                 £'000
 Operating activities
 Profit/(loss) before tax                                       (10,612)       (10,504)                              (24,439)
 Adjustments for:
 Depreciation of property, plant and equipment                  466            415                                   920
 Depreciation and impairment of right-of-use assets             378            467                                   940
 (Profit)/loss on disposal of property, plant and equipment     -              -                                     172
     Amortisation and impairment of intangible assets           31             103                                   978
     Share-based payment charge                                 760            2,618                                 4,386
     Exchange differences                                       1,129          (2,030)                               (2,072)
     Net finance (income)/costs                                 (21)           138                                             232
 Operating cash flows before movements in working capital:      (7,869)        (8,793)                               (18,883)
     (Increase)/decrease in inventories                         (333)          (153)                                 (580)
 (Increase)/decrease in trade and other receivables             348            (691)                                 (650)
 Increase/(decrease) in trade and other payables                (999)          (445)                                 (978)
     Increase/(decrease) in provisions                           (152)                     -                           594
  Operating cash flows                                          (9,005)        (10,082)                              (20,497)
     Research and development tax credits received                             -                                     4,506
     Overseas corporation tax payments                                                                                  (59)
 Net cash from/(used in) operating activities                   (9,005)        (10,082)                              (16,050)

 Investing activities
 Purchase of property, plant and equipment                      (378)          (916)                                 (1,718)
 Purchase of intangible assets                                  (27)           (71)                                  (169)
 Interest received                                              194            31                                              136
 Net cash from/(used in) investing activities                   (211)          (956)                                 (1,751)

 Financing activities
 Net proceeds from issue of share capital - placing             -              -                                        18,922
 Proceeds from issue of share capital - share option exercises  14                87                                    123
 Principal elements of lease payments                           (470)              (369)                              (814)
 Interest elements of lease payments                             (85)                (62)                                   (135)
 Net cash from/(used in) financing activities                   (541)          (344)                                 18,096
                                                                (9,757)        (11,382)                              295

 Net increase/(decrease) in cash and cash equivalents
 Cash and cash equivalents at start of period                   31,896         31,839                                31,839
 Effect of exchange rate fluctuations                           23             40                                     (238)
 Cash and cash equivalents at end of period                     22,162         20,497                                31,896

 

 

 

 

ANGLE plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE SIX MONTHS ENDED 30 JUNE 2023

 

 

                                                                                           Share-based
                                                         Share            Share            payments         Other
                                                         capital          premium          reserve          reserve
                                                         (Unaudited)      (Unaudited)      (Unaudited)      (Unaudited)
                                                         £'000            £'000            £'000            £'000
 At 1 January 2022                                       23,514           99,406           2,727            2,553

 For the period to 30 June 2022
 Consolidated profit/(loss)
 Other comprehensive income/(loss):
 Exchange differences in translating foreign operations
 Total comprehensive income/(loss)
 Issue of shares (net of costs)                          15               61
 Share-based payment charge                                                                2,618
 Released on exercise                                                                      (21)
 Released on forfeiture/lapse                                                              (267)
 At 30 June 2022 (Unaudited)                             23,529           99,467           5,057            2,553

 For the period to 31 December 2022
 Consolidated profit/(loss)
 Other comprehensive income/(loss):
 Exchange differences in translating foreign operations
 Total comprehensive income/(loss)
 Issue of shares (net of costs)                          2,529            16,451
 Share-based payment charge                                                                1,768
 Released on exercise                                                                      (22)
 Released on forfeiture/lapse                                                              (1,482)
 At 31 December 2022 (Audited)                           26,058           115,918          5,321            2,553

 For the period to 30 June 2023
 Consolidated profit/(loss)
 Other comprehensive income/(loss):
 Exchange differences in translating foreign operations
 Total comprehensive income/(loss)
 Share-based payment charge                                                                760
 Released on forfeiture/lapse                                                              (141)
 At 30 June 2023 (Unaudited)                             26,058           115,918          5,940            2,553

 

 

 

ANGLE plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (continued)

FOR THE SIX MONTHS ENDED 30 JUNE 2023

 

 

                                                             Translation      Accumulated      ESOT             Total
                                                             reserve          losses           shares           equity
                                                             (Unaudited)      (Unaudited)      (Unaudited)      (Unaudited)
                                                             £'000            £'000            £'000            £'000
 At 1 January 2022                                           (3,960)          (83,808)         (102)            40,330

 For the period to 30 June 2022
 Consolidated profit/(loss)                                                   (9,221)                           (9,221)
 Other comprehensive income/(loss):
 Exchange differences in translating foreign operations      (1,928)                                            (1,928)
 Total comprehensive income/(loss)                           (1,928)          (9,221)                           (11,149)
 Issue of shares (net of costs)                                                                                 76
 Share-based payment charge                                                                                     2,618
 Released on exercise                                                         21                                -
 Released on forfeiture/lapse                                                 267                               -
 At 30 June 2022 (Unaudited)                                 (5,888)          (92,741)         (102)            31,875

 For the period to 31 December 2022
 Consolidated profit/(loss)                                                   (12,465)                          (12,465)
 Other comprehensive income/(loss):
 Exchange differences in translating foreign operations      (95)                                               (95)
 Total comprehensive income/(loss)                           (95)             (12,465)                          (12,560)
 Issue of shares (net of costs)                                                                                 18,980
 Share-based payment charge                                                                                     1,768
 Released on exercise                                                         22                                -
 Released on forfeiture/lapse                                                 1,482                             -
 At 31 December 2022 (Audited)                               (5,983)          (103,702)        (102)            40,063

 For the period to 30 June 2023
 Consolidated profit/(loss)                                                   (9,813)                           (9,813)
 Other comprehensive income/(loss):
 Exchange differences in translating foreign operations      1,058                                              1,058
 Total comprehensive income/(loss)                           1,058            (9,813)                           (8,755)
 Share-based payment charge                                                                                     760
 Released on forfeiture/lapse                                                 141                               -
 At 30 June 2023 (Unaudited)                                 (4,925)          (113,374)        (102)            32,068

 

 

 

ANGLE plc

NOTES TO THE CONDENSED INTERIM FINANCIAL INFORMATION

FOR THE SIX MONTHS ENDED 30 JUNE 2023

 

 

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 and domiciled in Great
Britain and its subsidiaries (together referred to as the "Group") for the six
month period ended 30 June 2023 (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 2022,
which have been prepared in accordance with UK-adopted international
accounting standards. New and revised accounting standards 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 2022
and which may be made in the Annual Report and Financial Statements to 31
December 2023.

 

The accounting policies used in the preparation of the Condensed Interim
Financial Information for the six months ended 30 June 2023 are in accordance
with UK-adopted accounting standards and are consistent with those which will
be adopted in the Financial Statements for the year ended 31 December 2023.
While the Condensed Interim Financial Information has been prepared in
accordance with the recognition and measurement criteria of UK-adopted
international accounting standards, these Financial Statements do not contain
sufficient information to comply with UK-adopted international accounting
standards.

 

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 2022 is also unaudited. The comparative figures for
the year ended 31 December 2022 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 7 September 2023.

 

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 potential negative trading scenarios, market and
geopolitical uncertainty (Ukraine-Russia conflict). 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 financial projections for the 12
month period from the date of approval of this Condensed Interim Financial
Information 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 Condensed Interim Financial 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 share-based payments.

 

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 £9.8 million (six months to 30 June 2022: loss £9.2 million,
year ended 31 December 2022: loss £21.7 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
260,467,288 weighted average Ordinary £0.10 shares (six months to 30 June
2022: 235,036,872; year ended 31 December 2022: 246,579,644).

 

4       Share capital

 

The Company has one class of Ordinary shares which carry no right to fixed
income and at 30 June 2023 had 260,580,547 Ordinary shares of £0.10 each
allotted, called up and fully paid.

 

Shareholder communications

 

This announcement is being sent to all shareholders on the register at 6
September 2023. Copies of this announcement are posted on the Company's
website www.angleplc.com (http://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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