For Immediate Release
|
26 September 2024
|
ANGLE plc
("ANGLE"
or "the Company")
Interim Results for the six
months ended 30 June 2024
LARGE PHARMA STRATEGY
IMPLEMENTED SUCCESSFULLY
Three Large Pharma contracts
secured each with substantial revenue potential
Strategic decision post
period end to focus resources on pharma services
ANGLE plc (AIM: AGL OTCQX: ANPCY),
a world-leading liquid biopsy company with
innovative circulating tumour cell (CTC) solutions for use in
research, drug development and clinical oncology, today
announces unaudited interim results for the six months ended 30
June 2024.
Financial Highlights
·
Revenues for the half-year of £1.0 million (H1
2023: £1.2 million)
- sold
order book of up to £1.9 million at period end
·
Business re-shaped and streamlined with major
focus on large pharma
- cost
savings of c. £8 million by end of 2024 (as previously
announced)
- focus on large pharma contracts delivered three relationships
with potential to deliver long-term large-scale revenues
- other large pharma relationships under development
·
Loss for the half-year reduced by 21% at £7.7
million, or 2.89 pence per share (H1 2023: loss £9.8 million, or
3.77 pence per share)
·
Fundraise completed in June 2024 raising £9.3
million (gross) to capitalise on the
Company's position to develop the current three large pharma
opportunities towards large scale commercialisation along with
other large pharma and corporate opportunities under
discussion
·
Cash and cash equivalents at 30 June 2024 of £17.9
million (31 December 2023: £16.2 million). R&D Tax Credits due
at 30 June 2024 of £2.1 million (31 December 2023: £1.5
million)
Operational Highlights
Pharma Services
· Pharma
services business refocused on large pharma, with the deployment of
the Parsortix technology to deliver key pharma objectives for
targeted cancer drugs and improved clinical trial
efficiencies
· Three
agreements signed with two large pharma customers, Eisai and
AstraZeneca
- pilot study for HER2 assay
for Eisai as first step towards a companion
diagnostic for their HER2 antibody drug conjugate (ADC) under
development; progressing as planned with
the HER2 assay working well to assess breast cancer HER2
status
- development of a DNA damage response (DDR) assay for
AstraZeneca with the potential for deployment in multiple
AstraZeneca DDR drug trials; showing
encouraging results and moving to the next stage of testing on
patient samples
- development of an Androgen Receptor (AR) assay for AstraZeneca
with the potential for deployment in multiple prostate cancer
clinical trials; development progressing well. Testing on patient
samples will commence shortly with the aim to move the assay into
the clinical lab so that it is available for AstraZeneca clinical
trials early in 2025
· Significant increase in number of prospective customers since
completion of successful fundraise in June 2024, with discussions
progressing with multiple additional large pharma
companies
Product sales
·
Product sales have been impacted by the 29 April
2024 announcement by the US Food and Drug Administration (FDA) to
regulate laboratory developed tests (LDTs), the initial reaction
was muted but has recently led to clinical laboratories cancelling
or pausing their new LDT development programmes. In addition, the
global slowdown in research funding has worsened and has continued
to delay customers' commitment to new contracts
·
The market is expecting both the LDT and research
funding conditions to improve but timescales are unclear. In the
meantime, ANGLE intends to support and grow its translational and
research use products customers to ensure third party development
of uses of the Parsortix system by leading researchers continues
and the body of evidence builds, but will prioritise its investment
towards the growth of our successful large pharma
strategy
Content (applications)
·
Good progress made in clinical studies:
- INFORM
study on track with 419 patients recruited and 4,459 blood samples
collected as of 30 June 2024, building a liquid biopsy biobank in
four major cancer types for assay development and
validation
- recruitment in ovarian and prostate cancer studies completed
and Parsortix cell harvest stored for
future molecular analysis
- biobank of
samples to be used to provide data to drive pharma sales
·
Ongoing development of molecular assay for dual
analysis of CTCs and ctDNA from a single blood sample:
- research
study results have shown that clinically relevant DNA variants were
identified in CTCs that were absent in plasma ctDNA in the same
blood sample
- dual
analysis of CTC-DNA and ctDNA has potential to expand clinically
relevant information driving improved targeted treatment
selection
·
Four peer-reviewed scientific papers were
published in H1 2024 bringing the total number of peer-reviewed
publications at period end to 96 from 41 independent international
research centres. As announced today the number of publications has
now reached 100, spanning a decade of research and the evolution of
CTC analysis from simple enumeration for prognosis to highly
sensitive next generation sequencing for molecular analysis of
cancer
Outlook
·
Encouraging momentum with growing pipeline of
large pharma and corporate opportunities to build future
large-scale revenue opportunities
·
All three large pharma agreements with Eisai and
AstraZeneca are progressing well and, if successful, have the
potential to lead to substantially larger contracts for deployment
in clinical trials
·
Fourth agreement signed with Recursion
Pharmaceuticals in H2, 2024 for a fully funded pilot study with the
potential to flow into their partnerships with multiple large
pharma companies
·
As exemplified by the second agreement with
AstraZeneca, large pharma customers provide significant opportunity
to cross-sell within each organisation, leading to execution of new
agreements in a relatively short timeframe
·
Agreement with NuProbe signed in H2, 2024 securing
an option to an exclusive global licence (outside of China) for
their pan-cancer next generation sequencing (NGS) panel. This is by
far the best performing panel tested by the Company to date,
enabling low-cost and highly sensitive and specific detection of
6,500 DNA mutations in 61 clinically relevant genes. This test
enables dual analysis of CTCs and ctDNA from a single blood sample
and is expected to open up a broad range of pharma services
opportunities
·
Despite the recent unexpected constraints on
product sales, revenues for H2 are expected to double compared to
H1 with the full year revenue expected to be between £3.0 million
and £3.7 million, materially lower than previously anticipated
·
In the medium term with the strategic focus on
pharma services, the Company is anticipated to be in a stronger
cash generative position supported by multiple large pharma
relationships advancing to the next contractual phase coupled with
a substantially lower cost base
·
Prioritising investment towards growth of the
large pharma strategy and reducing investment in the products side
is intended to maximise ANGLE's commercial opportunity and is now
anticipated to deliver cashflow positive trading in the second half
of 2026; and the Company is funded to execute on this
plan
ANGLE Chief Executive, Andrew Newland,
commented:
"Having identified a key unmet
demand for CTC analysis to support drug discovery and development
progressing through to companion diagnostics, ANGLE has proactively
re-shaped its business, focusing its best-in-class liquid biopsy
solution to meet large pharma business needs. This, together with
cost-cutting and the recent successful fundraise, has put ANGLE in
a position to deliver future growth through the adoption of the
Parsortix system and assays for pharma drug trials across multiple
cancer types leading to companion diagnostics.
By securing large pharma services
contracts, the Company does not need to fund all assay development,
regulatory and business development costs on its own. The Company's
validated, regulatory approved, product-based solution and ISO
accreditation has been key to attracting pharma
customers.
Although product sales headwinds and
its impact on our market expectations are disappointing, I am
pleased that the Company's targeted large pharma services strategy
has resulted in three new contracts with two large pharma
customers, Eisai and AstraZeneca, and a fourth contract with
Recursion, which may progress through to large pharma application.
We look forward to managing the transition to large pharma focus
and building on this commercial momentum further in the second half
of the year and into 2025."
For
further information:
ANGLE plc
|
+44
(0) 1483 343434
|
Andrew Newland, Chief
Executive
Ian Griffiths, Finance
Director
|
|
Berenberg (NOMAD and Broker)
Toby Flaux, Ciaran Walsh, Milo
Bonser
|
+44
(0) 20 3207 7800
|
FTI
Consulting
Simon Conway, Ciara
Martin
Matthew Ventimiglia (US)
|
+44
(0) 203 727 1000
+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 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
and services by customers.
CHAIRMAN'S AND CHIEF EXECUTIVE'S STATEMENT
Introduction
The Company is at the forefront of
the liquid biopsy revolution in cancer, with unique and innovative
CTC solutions that have the potential to transform cancer care.
With an increasing range of pharma services contracts, the Company
is well-positioned for strong growth.
Overview of Financial Results
Revenue for H1 2024 of £1.0 million
(H1 2023: £1.2 million) reflects a challenging market environment
for product sales. With the large pharma strategy now in place,
revenues are expected to be driven by this in future periods. Gross
margins in the period averaged 59% (H1 2023: 62%) reflecting the
product-service mix.
Pharma services revenues in the
period increased to £0.5 million (H1 2023: £0.4 million). The sold
order book for future pharma services and
corporate partnerships revenues, increased to £1.9 million at
period end.
As previously announced, management
has identified cost reductions expected to result in cash savings
of c. £8 million in the period to 31 December 2024, as the US
clinical laboratory was closed, and non-critical R&D and other
activities are deferred or reduced. This has resulted in
reduced operating costs for the period of £8.9
million (H1 2023: £11.4 million). The loss for the period reduced
by 21% to £7.7 million (H1 2023: loss £9.8 million).
A fundraise was completed in June
2024 raising £9.3 million (gross), £8.6 million (net). This
funding is being deployed to support the Company's expansion of
large pharma relationships with potential to deliver long-term
large-scale revenues.
Cash and cash equivalents were £17.9
million at 30 June 2024 (31 December 2023: £16.2 million) with
R&D Tax Credits due at 30 June 2024 of £2.1 million (31
December 2023: £1.5 million).
Executing business strategy to drive growth
Over time, the Board expects that
the Parsortix-based CTC liquid biopsy solutions will become an
integral part of pharma drug discovery and clinical development
with the aim of widespread clinical use as companion diagnostics to
support targeted cancer drugs to deliver personalised
medicine.
The Company has taken the strategic
decision post-period end to prioritise investment on its large
pharma strategy and reduce costs in other areas, such as
product-related activities, to substantially lower the ongoing cost
base. While the first contract with a large pharma customer can
take significant time to secure and the timing of the progression
of a particular contract through the clinical trial process is
uncertain, these contracts offer the potential for very large-scale
long-term revenue. The Company is working towards securing numerous
such large pharma contracts to drive the Company's progress towards
profitability. Excellent progress has been made with the large
pharma strategy during the period with three such agreements
announced with two pharma customers, Eisai and
AstraZeneca.
·
In January 2024, ANGLE announced an agreement with
the global Japanese pharmaceutical company Eisai. Under the terms
of the agreement worth an initial US $250,000, ANGLE is providing CTC analysis with its Portrait HER2 assay
in a pilot study. The study drug is an
antibody-drug conjugate (ADC) that is composed of Eisai's
proprietary anticancer agent, eribulin, conjugated to an anti-HER2
antibody. It is expected to have anti-tumour effects on breast,
lung and other solid tumours that express HER2. The study is in
progress and the Company has received and processed blood samples
identifying the expression of HER2 on CTCs. Success of the assay in
this study has the potential to build through to larger revenues
through inclusion in their Phase II and Phase III trials, with the
ultimate goal of approval as a companion diagnostic.
·
In April 2024, ANGLE announced an agreement, worth
an initial £150,000, with, AstraZeneca, for the development and
validation of an assay based on the Company's existing pKAP1 DDR
assay. Early proof of principle with AstraZeneca's test compounds
has been achieved and the assay is now undergoing further
refinement. If successful AstraZeneca could implement this assay in
large-scale clinical studies to assess the efficacy of DDR
therapeutics, and enable longitudinal, repeat monitoring of
treatment response.
·
In May 2024, ANGLE announced a second services
contract with AstraZeneca. Under the terms
of this agreement, worth an initial £550,000, the Company is
developing a CTC-based Androgen Receptor (AR) assay.
There is wide applicability, both to AstraZeneca
and other pharma customers, for an AR assay to measure protein
expression, which can only be undertaken on intact cancer cells. A
successful development phase, anticipated in Q1 2025, will
demonstrate the importance of the Parsortix system in assessing the
efficacy of AR-targeted prostate cancer therapeutics and offers the
potential for long-term, ongoing revenues for the Company
supporting prostate cancer clinical trials. The Androgen Receptor
Inhibitor Market size was valued at US$ 10.3 billion in 2023 and is
projected to reach US$ 12.5 billion by 2030.
The Company continues to focus on
delivering "content" through the development and validation of
assays utilising CTCs. Good progress was made in developing bespoke
imaging assays to investigate protein targets on the CTCs and in
the development of molecular assays that will enable dual
sequencing of CTC-DNA and ctDNA, from a single blood sample.
Preliminary study results and subsequent validation by the Company,
demonstrate that clinically relevant DNA variants were identified
in CTCs that were not found in ctDNA from the same blood sample,
potentially expanding the actionable information available to guide
targeted treatment selection. This finding has been validated
further by a third-party study in melanoma patients published by
Hamburg-Eppendorf University in June 2024. The authors conclude
that the integration of a multi-analyte approach to the patient
care has the potential to further the delivery of personalised
medicine. These findings are of high importance to ANGLE as they
cannot be achieved without using the Parsortix system.
The installed base of Parsortix
systems stands at over 260 with 224,000 cumulative samples
processed of as of 30 June 2024. The reduction in the installed
base from 290 at 31 December 2023 reflects the closure of the US
facilities and a reduction in paid-for KOL activities.
Outlook
ANGLE is successfully building
strong relationships with large pharma offering the potential for
substantial long-term growth as we can help large pharma address
some of their critical issues including identifying patients that
will respond to new classes of drugs such as ADCs (antibody drug
conjugates) and DDR (DNA damage response) inhibitors. Year to date
the Company has already secured four such pharma service
agreements.
CTCs are a unique liquid biopsy
analyte that provide intact living cancer cells from a blood
sample. The Company's ability to evaluate these intact cancer cells
has been instrumental in securing large pharma customers. Strong
sustained revenue growth is expected over the long term as CTCs,
either alone or in combination with ctDNA, become routinely
incorporated into clinical studies and eventually become fully
incorporated into the cancer care pathway.
Services contracts with large pharma
offer the potential for substantial expansion of the Company's
assay portfolio, with development funded by the customer. The
assays developed by the Company provide our pharma services
customers with the ability to undertake repeatable, longitudinal
assessment of drug efficacy. Furthermore, these assays have the
potential to be provided as a service to other companies with drugs
targeting the same biomarker or molecular pathway.
Success in any of these programmes
has the potential to yield significant benefits to pharma in
clinical trials, regulatory clearance, pricing and competitive
positioning of their drugs. ANGLE is working to secure
multiple contracts of a similar structure with large pharma to
maximise the number of major revenue opportunities. Prioritising
investment towards growth of the large pharma strategy and reducing
investment in the products side is intended to maximise ANGLE's
commercial opportunity and is now anticipated to deliver cashflow
positive trading in the second half of 2026; and the Company is
funded to execute on this plan.
Dr.
Jan Groen
|
Andrew D W Newland
|
Chairman
|
Chief Executive
|
|
|
25 September 2024
|
|
Operational Update
Commercial strategy
ANGLE's vision is to secure
widespread adoption of the Parsortix system by providing
circulating tumour cells (CTCs) as the "best sample" for analysis
coupled with state-of-the-art molecular and imaging assays to
provide high-throughput, low cost, highly sensitive, downstream
analysis.
ANGLE sells the Parsortix system to
laboratories investigating CTCs and this has successfully driven a
wide body of evidence in the form of peer-reviewed
publications.
The primary commercialisation route
for the Parsortix system is through long-term relationships with
large pharma who need liquid biopsy assays to support drug
discovery and clinical development with a view to adoption as a
companion diagnostic to support the prescription of their targeted
cancer drugs.
ANGLE has established a
GCLP-compliant laboratory in the UK, with the capability, capacity
and required quality systems to provide pharma customers with assay
services to support drug discovery and development. ANGLE's
clinical laboratory processes patient samples and offer validated
assays to support clinical decision making.
Parsortix content (applications)
ANGLE has launched multiple
downstream assays available to customers as a service from our
GCLP-compliant laboratory. These include:
· Portrait Flex assay, designed to allow the detection of CTCs
regardless of EMT status. Combining the use of the Parsortix system
and the Portrait Flex assay allows for testing that is specific to
customer needs and can enhance their clinical study
evaluations.
· DNA Damage Response (DDR) assays were developed to identify
two DNA damage markers, phosphorylated histone variant H2AX (γH2AX)
and phosphorylated KRAB-associated protein 1 (pKAP1) on CTCs
enriched using the Parsortix system. The increasing investigation
of DDR/PARP inhibitors, alone and in combination with chemotherapy
or immunotherapy, broadens the utility of γH2AX and pKAP1 assays as
indicators of DNA damage and clinical effectiveness. The assays
make longitudinal, repeatable monitoring of treatment response
possible for pharma trials.
· The Portrait PD-L1 assay was developed to allow the detection
of CTCs and determine their PD-L1 status, which may enable better
identification of suitable candidates for immunotherapy studies and
provide longitudinal monitoring of patient response to
therapy.
ANGLE has also started work with
encouraging results on the application of AI in cell image analysis
(both immunofluorescence and FISH). This has the potential to
automate the labour element of microscopic analysis of the CTCs
ensuring consistency and reducing costs for high volume
adoption.
Pharma services
The pharma services business
utilising the Parsortix system offers the potential for substantial
revenues in the large cancer drug trials market followed by
adoption as a companion diagnostic to support drug prescription.
The use of CTC biomarkers in clinical trials is a rapidly growing
field enabling longitudinal monitoring of genomic, transcriptomic,
and proteomic changes.
CTCs are increasingly being
recognised for the additional and complementary information they
can provide, with multi-analyte assessment having the potential to
unlock the full clinical capabilities of liquid biopsy. A recent
high impact review article summarising the evidence from across two
decades concludes that 'CTCs represent a transformative biomarker
in precision oncology, offering extraordinary opportunities to
translate scientific discoveries into tangible improvements in
patient care'1.
The Company has focused its business
development on large pharma customers where there is a large unmet
market and no funding constraints. This resulted in the
announcement of three service agreements, with two large pharma
customers, Eisai and AstraZeneca in the six months ending 30 June
2024.
Post period end, the Company has
signed an agreement with Recursion Pharmaceuticals. Recursion is a
clinical-stage biotechnology company leveraging technology,
including machine learning and AI, to industrialise drug discovery.
Under the terms of the agreement, ANGLE will undertake a pilot
study, fully funded by Recursion, with the potential for larger
follow-on contracts in the event of a successful pilot study.
Recursion has partnerships with multiple leading large pharma
companies and has five research programmes in clinical development,
two in preclinical development and twelve in early
discovery.
The Company has developed bespoke
assays for all its existing pharma customers, targeting pathways
which are undergoing significant commercial growth. This offers
considerable potential for further business both with existing
customers across their oncology pipeline and with other pharma
companies developing oncology therapeutics targeting the same or
similar biomarkers.
Corporate partnerships
Medical diagnostic and precision medicine
companies
ANGLE is proactively engaging with a
range of large medical diagnostic and precision medicine companies
with a view to working with them to port existing tissue-based
assays to a liquid biopsy format. Similar to large pharma
contracts, this has the potential to deliver substantial services
revenues followed by larger scale sales once the customer
implements the solution. From the customer's perspective a liquid
biopsy offering will enable them to move from one time use tests to
repeat longitudinal monitoring of patient status delivering repeat
revenue potential from the same patient.
BioView
ANGLE continues to progress its
collaboration with BioView to develop a CTC HER2 (human epidermal
growth factor receptor 2) assay kit for breast cancer using a
combination of ANGLE's Parsortix system and BioView's automated
microscopy systems and software.
The HER2 assay kit 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 kit, to assess HER2 protein
expression and/or gene amplification levels by analysing
fluorescence intensities. Unlike current standard of care tests
developed for use with tissue samples, a CTC HER2 assay kit could
be used for longitudinal monitoring of HER2 status throughout
disease progression, thereby ensuring the patient receives the most
appropriate targeted treatment at every stage.
Given the significant third-party
interest in a new assay kit 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
assay development is complete.
Development of cutting-edge molecular
solutions
Post period end, the Company signed
an agreement with NuProbe,
a cutting-edge genomics
and molecular diagnostics company,
for the use of their proprietary pan-cancer next
generation sequencing (NGS) panel. The agreement grants ANGLE
an option to take an exclusive global license (outside
of China) to the NGS panel for the analysis of CTCs and the
dual analysis of CTCs and ctDNA.
The NGS panel, which has been validated on the Illumina sequencers, enables
highly sensitive and specific detection of over 6,500 DNA mutations
in 61 clinically relevant genes and been found to be the highest
performing multi-gene assay of those evaluated by the Company.
These genes include those with matched targeted therapies currently
selected using assays which use tumour tissue or circulating tumour
DNA (ctDNA) and aligns with many key drug targets under development
by large pharma. This agreement will
help accelerate the Company's ability to commercialise its
first pan-cancer multi-analyte molecular sequencing assay
which will provide pharma services customers with unparalleled
and repeatable insights across many cancer types.
Using the NuProbe NGS panel, ANGLE
has developed a sample-to-answer workflow for dual analysis of
CTC-DNA and ctDNA from a single blood sample for comprehensive
molecular analysis. CTCs and ctDNA provide additional and
complementary information which has the potential to expand
clinically actionable information, for personalised therapy, when
the two are analysed together.
The Company is engaging with
Illumina and approaching large pharma to expedite the adoption of
this combined molecular profiling approach. This is supported by
increasing recognition that a multi-analyte approach will be
critical to unlock the full potential of liquid
biopsies.
Clinical studies
ANGLE is conducting clinical studies
to generate patient data demonstrating the value of Parsortix CTC
analysis and has established a substantial biobank of clinical
samples for this purpose. The aim is to generate data in four major
cancer types, breast, prostate, ovarian and lung, which globally
account for 40% of solid cancer cases, to support sales to large
pharma.
INFORM is ANGLE's largest study,
targeting enrolment of up to 1,000 patients with advanced stage
cancer over a five-year period in four different cancer types
(breast, prostate, ovarian and lung), involving six NHS Trusts. Up
to 1,000 patients will have blood drawn across multiple time points
(up to six) during their diagnosis, treatment, and follow-up. As of
30 June 2024, 419 patients had been enrolled into the INFORM study,
with a total of 1,528 blood draws performed and 4,459 tubes of
blood 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.
The objectives of this study are to
evaluate and characterise cells harvested from cancer patients
using multiple downstream techniques (such as imaging, protein
analyses, fluorescent in-situ hybridization (FISH), PCR and NGS)
and to evaluate changes in CTCs and other rare cells in cancer
patient blood samples over the course of their
treatment.
Prostate and ovarian cancer studies
Recruitment of participants for the
Company's prostate cancer study (DOMINO) and ovarian cancer study
(EMBER2) has completed. DOMINO resulted in the collection of
>400 blood samples from 100 prostate cancer patients whilst
EMBER2 collected >1,400 blood samples from 400 ovarian cancer
patients. The blood tubes drawn from each patient have been
processed using the Parsortix system and the cell harvest stored
for future molecular analysis.
Peer-reviewed publications
The medical devices industry is
evidence led, and in addition to the clinical studies and
regulatory studies described previously, peer-reviewed publications
from independent research groups are a key performance metric.
There were 96 peer-reviewed publications from 41 independent cancer
centres as of 30 June 2024 with 4 new publications announced during
the reporting period. Key studies in 2024 have demonstrated the
Parsortix system's efficacy across various cancer types, including
lung, ovarian and melanoma. Researchers have highlighted the
system's ability to provide real-time insights into tumor dynamics
and genetic heterogeneity, which are crucial for personalised
medicine. Moreover, publications have explored the integration of
the Parsortix system with downstream molecular analysis techniques
such as quantitative PCR and next-generation sequencing (NGS).
These integrations have enabled detailed characterisation of CTCs
at a molecular level, enabling real-time assessment of clinically
relevant biomarkers.
Andrew D W Newland
Chief Executive
25 September 2024
1. Reduzzi C. et al. Unveiling the
impact of circulating tumor cells: Two decades of discovery and
clinical advancements in solid tumors. Critical Reviews in
Oncology/Hematology, (2024) Volume 203,
10.1016/j.critrevonc.2024.104483
ANGLE plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE
INCOME
FOR THE SIX MONTHS ENDED 30
JUNE 2024
|
|
Six months
ended
|
Six
months ended
|
Year
ended
|
|
|
30 June
|
30
June
|
31
December
|
|
|
2024
|
2023
|
2023
|
|
|
(Unaudited)
|
(Unaudited)
|
(Audited)
|
|
Note
|
£'000
|
£'000
|
£'000
|
Revenue
|
|
1,034
|
1,196
|
2,186
|
Cost of sales
|
|
(423)
|
(455)
|
(658)
|
Gross profit
|
|
611
|
741
|
1,528
|
Operating costs
|
|
(8,914)
|
(11,375)
|
(23,287)
|
Operating profit/(loss)
|
|
(8,303)
|
(10,634)
|
(21,759)
|
Finance income
|
|
187
|
190
|
463
|
Finance costs
|
|
(140)
|
(168)
|
(336)
|
Profit/(loss) before tax
|
|
(8,256)
|
(10,612)
|
(21,632)
|
Tax (charge)/credit
|
2
|
543
|
799
|
1,500
|
Profit/(loss) for the period
|
|
(7,713)
|
(9,813)
|
(20,132)
|
Other comprehensive income/(loss)
Items that may be subsequently
reclassified to profit or loss
|
|
|
|
Exchange differences on translating
foreign operations
|
(162)
|
1,058
|
1,114
|
Other comprehensive income/(loss)
|
|
(162)
|
1,058
|
1,114
|
Total comprehensive income/(loss) for the
period
|
|
(7,875)
|
(8,755)
|
(19,018)
|
|
|
=======
|
=======
|
=======
|
Earnings/(loss) per share attributable to owners of the
parent
|
Basic and Diluted (pence per
share)
|
3
|
(2.89)
|
(3.77)
|
(7.73)
|
All activity arose from continuing
operations
ANGLE PLC
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE
2024
|
|
30 June
2024
(Unaudited)
|
|
30
June
2023
(Unaudited)
|
31
December
2023
(Audited)
|
|
Note
|
£'000
|
|
£'000
|
|
£'000
|
Assets
|
|
|
|
|
|
|
Non-current assets
|
|
|
|
|
|
|
Intangible assets
|
|
2,659
|
|
2,748
|
|
2,741
|
Property, plant and
equipment
|
|
2,685
|
|
3,376
|
|
2,922
|
Right-of-use assets
|
|
4,018
|
|
4,511
|
|
4,304
|
Total non-current assets
|
|
9,362
|
|
10,635
|
|
9,967
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
Inventories
|
|
1,761
|
|
2,256
|
|
1,679
|
Trade and other
receivables
|
|
1,922
|
|
1,436
|
|
1,807
|
Taxation
|
|
2,055
|
|
3,675
|
|
1,512
|
Cash and cash equivalents
|
|
17,882
|
|
22,162
|
|
16,218
|
Total current assets
|
|
23,620
|
|
29,529
|
|
21,216
|
|
|
|
|
|
|
|
Total assets
|
|
32,982
|
|
40,164
|
|
31,183
|
Liabilities
|
|
|
|
|
|
|
Non-current liabilities
|
|
|
|
|
|
|
Lease liabilities
|
|
(3,513)
|
|
(3,961)
|
|
(3,905)
|
Provisions
|
|
(363)
|
|
(162)
|
|
(370)
|
Trade and other payables
|
|
(50)
|
|
(39)
|
|
(26)
|
Total non-current liabilities
|
|
(3,926)
|
|
(4,162)
|
|
(4,301)
|
Current liabilities
|
|
|
|
|
|
|
Lease liabilities
|
|
(707)
|
|
(613)
|
|
(649)
|
Provisions
|
|
(424)
|
|
(439)
|
|
(544)
|
Trade and other payables
|
|
(3,419)
|
|
(2,882)
|
|
(2,750)
|
Total current liabilities
|
|
(4,550)
|
|
(3,934)
|
|
(3,943)
|
|
|
|
|
|
|
|
Total liabilities
|
|
(8,476)
|
|
(8,096)
|
|
(8,244)
|
Net
assets
|
|
24,506
|
|
32,068
|
|
22,939
|
Equity
|
|
|
|
|
|
|
Share capital
|
4
|
32,264
|
|
26,058
|
|
26,058
|
Share premium
|
|
118,362
|
|
115,918
|
|
115,918
|
Share-based payments
reserve
|
|
6,443
|
|
5,940
|
|
5,709
|
Other reserve
|
|
2,553
|
|
2,553
|
|
2,553
|
Translation reserve
|
|
(5,031)
|
|
(4,925)
|
|
(4,869)
|
Accumulated losses
|
|
(129,983)
|
|
(113,374)
|
|
(122,328)
|
ESOT shares
|
|
(102)
|
|
(102)
|
|
(102)
|
Total equity
|
|
24,506
|
|
32,068
|
|
22,939
|
|
|
|
|
|
|
| |
ANGLE plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHS ENDED 30
JUNE 2024
|
Six months
ended
|
Six
months
ended
|
Year
ended
|
|
30 June
|
30
June
|
31
December
|
|
2024
|
2023
|
2023
|
|
(Unaudited)
|
(Unaudited)
|
(Audited)
|
|
£'000
|
£'000
|
£'000
|
Operating activities
|
|
|
|
Profit/(loss) before tax
|
(8,256)
|
(10,612)
|
(21,632)
|
Adjustments for:
|
|
|
|
Depreciation of property, plant and
equipment
|
413
|
466
|
1,093
|
Depreciation and impairment of
right-of-use assets
|
293
|
378
|
1,147
|
(Profit)/loss on disposal of
property, plant and equipment
|
-
|
-
|
84
|
Amortisation and impairment of
intangible assets
|
105
|
31
|
68
|
Share-based payment
charge
|
792
|
760
|
1,894
|
Exchange differences
|
(166)
|
1,129
|
1,183
|
Net finance
(income)/costs
|
(47)
|
(21)
|
(127)
|
Operating cash flows before
movements in working capital:
|
(6,866)
|
(7,869)
|
(16,290)
|
(Increase)/decrease in
inventories
|
(75)
|
(333)
|
90
|
(Increase)/decrease in trade and
other receivables
|
(37)
|
348
|
(74)
|
Increase/(decrease) in trade and
other payables
|
321
|
(999)
|
(1,011)
|
Increase/(decrease) in
provisions
|
(138)
|
(152)
|
(36)
|
Operating cash flows
|
(6,795)
|
(9,005)
|
(17,321)
|
Research and development tax credits
received
|
-
|
-
|
2,863
|
Net cash from/(used in) operating
activities
|
(6,795)
|
(9,005)
|
(14,458)
|
Investing activities
|
|
|
|
Purchase of property, plant and
equipment
|
(114)
|
(378)
|
(611)
|
Purchase of intangible
assets
|
(19)
|
(27)
|
(49)
|
Interest received
|
191
|
194
|
457
|
Net cash from/(used in) investing
activities
|
58
|
(211)
|
(203)
|
Financing activities
|
|
|
|
Net proceeds from issue of share
capital - placing
|
8,828
|
-
|
-
|
Proceeds from issue of share capital
- share option exercises
|
-
|
14
|
14
|
Proceeds from disposal of property,
plant and equipment
|
-
|
-
|
2
|
Principal elements of lease
payments
|
(382)
|
(470)
|
(959)
|
Interest elements of lease
payments
|
(74)
|
(85)
|
(182)
|
Net cash from/(used in) financing
activities
|
8,372
|
(541)
|
(1,125)
|
Net
increase/(decrease) in cash and cash equivalents
|
1,635
|
(9,757)
|
(15,786)
|
Cash and cash equivalents at start
of period
|
16,218
|
31,896
|
31,896
|
Effect of exchange rate
fluctuations
|
29
|
23
|
108
|
Cash and cash equivalents at end of period
|
17,882
|
22,162
|
16,218
|
|
=======
|
=======
|
=======
|
ANGLE plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHS ENDED 30
JUNE 2024
|
|
Equity attributable to owners
of the parent
|
|
|
|
Share-based
|
|
|
Share
|
Share
|
payments
|
Other
|
|
capital
|
premium
|
reserve
|
reserve
|
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|
£'000
|
£'000
|
£'000
|
£'000
|
At
1 January 2023
|
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
|
For the period to 31 December
2023
|
|
|
|
|
Consolidated
profit/(loss)
|
|
|
|
|
Other comprehensive
income/(loss):
|
|
|
|
|
Exchange differences in translating
foreign operations
|
|
|
|
|
Total comprehensive income/(loss)
|
|
|
|
|
Share-based payment
charge
|
|
|
1,134
|
|
Released on
forfeiture/lapse
|
|
|
(1,365)
|
|
At
31 December 2023 (Audited)
|
26,058
|
115,918
|
5,709
|
2,553
|
For the period to 30 June
2024
|
|
|
|
|
Consolidated
profit/(loss)
|
|
|
|
|
Other comprehensive
income/(loss):
|
|
|
|
|
Exchange differences in translating
foreign operations
|
|
|
|
|
Total comprehensive income/(loss)
|
|
|
|
|
Issue of shares (net of
costs)
|
6,206
|
2,444
|
|
|
Share-based payment
charge
|
|
|
792
|
|
Released on
forfeiture/lapse
|
|
|
(58)
|
|
At
30 June 2024 (Unaudited)
|
32,264
|
118,362
|
6,443
|
2,553
|
|
|
|
|
|
| |
ANGLE plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
(continued)
FOR THE SIX MONTHS ENDED 30
JUNE 2024
|
|
Equity attributable to owners
of the parent
|
|
|
|
|
|
Translation
|
Accumulated
|
ESOT
|
Total
|
|
reserve
|
losses
|
shares
|
equity
|
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|
£'000
|
£'000
|
£'000
|
£'000
|
At
1 January 2023
|
(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
|
For the period to 31 December
2023
|
|
|
|
|
Consolidated
profit/(loss)
|
|
(10,319)
|
|
(10,319)
|
Other comprehensive
income/(loss):
|
|
|
|
|
Exchange differences in translating
foreign operations
|
56
|
|
|
56
|
Total comprehensive income/(loss)
|
56
|
(10,319)
|
|
(10,263)
|
Share-based payment
charge
|
|
|
|
1,134
|
Released on
forfeiture/lapse
|
|
1,365
|
|
-
|
At
31 December 2023 (Audited)
|
(4,869)
|
(122,328)
|
(102)
|
22,939
|
For the period to 30 June
2024
|
|
|
|
|
Consolidated
profit/(loss)
|
|
(7,713)
|
|
(7,713)
|
Other comprehensive
income/(loss):
|
|
|
|
|
Exchange differences in translating
foreign operations
|
(162)
|
|
|
(162)
|
Total comprehensive income/(loss)
|
(162)
|
(7,713)
|
|
(7,875)
|
Issue of shares (net of
costs)
|
|
|
|
8,650
|
Share-based payment
charge
|
|
|
|
792
|
Released on
forfeiture/lapse
|
|
58
|
|
-
|
At
30 June 2024 (Unaudited)
|
(5,031)
|
(129,983)
|
(102)
|
24,506
|
|
|
|
|
|
|
| |
ANGLE plc
NOTES TO THE CONDENSED INTERIM FINANCIAL
INFORMATION
FOR THE SIX MONTHS ENDED 30
JUNE 2024
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 2024 (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 2023, 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 2023 and which may be made in the Annual Report and
Financial Statements to 31 December 2024.
The accounting policies used in the
preparation of the Condensed Interim Financial Information for the
six months ended 30 June 2024 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
2024. 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 2023 is also unaudited. The comparative
figures for the year ended 31 December 2023 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
25 September 2024.
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. In these
circumstances discretionary expenditure within the business
provides flexibility to scale back operations to address adverse
events if required.
The Directors have prepared and
reviewed the financial projections for a period in excess of 12
months 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), the Directors have a
reasonable expectation that the Group and Company have adequate
resources to continue in business for the foreseeable future.
Accordingly, the going concern basis has been used in preparing the
Financial Statements.
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 £7.7 million (six months to 30 June 2023:
loss £9.8 million, year ended 31 December 2023: loss £20.1 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
267,032,826 weighted average Ordinary £0.10 shares (six months to
30 June 2023: 260,467,288; year ended 31 December 2023:
260,467,288).
4 Share
capital
The Company has one class of
Ordinary shares which carry no right to fixed income and at 30 June
2024 had 322,641,668 Ordinary shares of £0.10 each allotted, called
up and fully paid.
During the period the Company issued
62,061,121 new Ordinary shares with a nominal value of £0.10 at an
issue price of £0.15 per share in a placing of shares realising
gross proceeds of £9.3 million. Associated costs of £0.7 million
were incurred. Shares were admitted to trading on AIM in June
2024.
Shareholder communications
This announcement is being sent to
all shareholders on the register at 25 September 2024. 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.