REG - Angle PLC - Preliminary Results
05/06/2024 07:00
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240605:nRSE1898Ra&default-theme=true
RNS Number : 1898R Angle PLC 05 June 2024
For Immediate Release 5 June 2024
ANGLE plc
("ANGLE" or "the Company")
Preliminary Results for the year ended 31 December 2023
COMMERCIALISATION BUILDING, WITH REVENUE MORE THAN DOUBLED
New products and services launched; and breakthrough studies completed on
combined ctDNA and CTC-DNA analysis
Strong start to 2024 with two global pharmaceutical customers announced
ANGLE plc (AIM: AGL OTCQX: ANPCY), a world-leading liquid biopsy company with
innovative circulating tumour cell (CTC) diagnostic solutions for use in
research, drug development and clinical oncology, today announces unaudited
preliminary results for the year ended 31 December 2023.
Financial Highlights
· Revenues for the full year more than doubled to £2.2 million (2022:
£ 1.0 million)
· Loss for the year £20.1 million, or 7.73 pence per share (2022: loss
£21.7 million or 8.79 pence per share)
· Cash and cash equivalents at 31 December 2023 of £16.2 million
(2022: £31.9 million) with R&D Tax Credits due at 31 December 2023 of
£1.5 million (2022: £2.9 million)
· Fundraise announced today raising £8.50 million (gross) with an Open
Offer to shareholders initiated raising up to £2.06 million
Operational Highlights
Pharma Services
· Contracts signed with new and repeat customers including:
- services agreement signed at year end and announced early 2024 with global
Japanese pharma company, Eisai, for use of ANGLE's quantitative HER2 assay in
a Phase II trial
- new contract with Crescendo Biologics to use ANGLE's Portrait Flex assay
in a Phase I clinical study in prostate cancer
- follow-on contract with Artios Pharma for use of DNA Damage Response (DDR)
assays in a Phase I clinical trial in multiple advanced cancers
· Launch of Portrait Flex, Portrait DDR (γH2AX and pKAP1), and
Portrait PD-L1 assays from the Company's GCLP-compliant laboratory
Products
· Expansion of global distribution network and associated
infrastructure (including product management, logistics, service, and
maintenance) across Europe, Africa, the Middle East and Asia-Pacific with
first commercial sales in fourth quarter
· Launch of Portrait+ CTC Staining Kit as first sample-to-answer
product providing laboratories with a fully validated, standardised protocol
for CTC identification and analysis across multiple cancer types
· Strategic partnership with BioView to develop a quantitative breast
cancer CTC HER2 assay kit. Development work generating revenue for ANGLE of
£1.2 million
· Installed base of over 290 Parsortix(®) instruments with 210,000
cumulative samples processed at year end
Content (applications)
· 16 peer-reviewed scientific papers published in 2023 bringing the
total number of peer-reviewed publications as at 31 December 2023 to 92 (2022:
76)
· Good progress made in clinical studies:
- recruitment on track in INFORM study across four major cancer types building
a biobank of samples for assay development and validation
- recruitment in ovarian and prostate cancer studies completed and Parsortix
cell harvest stored for future molecular analysis
· Development of a dual analysis solution for comprehensive DNA
molecular analysis of CTCs and ctDNA from a single blood sample:
- research study results found that clinically relevant DNA variants were
identified in CTCs that were not present in ctDNA from the same blood draw
- potential to expand clinically relevant information to inform personalised
therapy when the two are analysed together
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 to the positions of
Chief Commercial Officer and Chief Scientific Officer
Outlook
· Strong start to 2024 with product and services customer relationships
developing well and significant expansion of pharma services business
- three service agreements signed with two large pharma customers, Eisai and
AstraZeneca
- development of HER2 assay for Eisai to detect and assess HER2 low
and HER2+ cancers in a Phase II study at a value to ANGLE of US$250,000
- development of a DDR assay for AstraZeneca with the initial 6-month
development phase worth £150,000 to ANGLE
- development of an Androgen Receptor assay for AstraZeneca with the initial
12-month development phase worth £550,000 to ANGLE
- active discussion ongoing with multiple prospective pharma customers
including six large pharma customers
- product sales building with expansion of direct salesforce and highly
engaged network of global distributors
· Revenue for H1 2024 is expected to be between £1.0 million and
£1.3 million with a total of c.40% of FY24 market expectations for revenue(1)
already contracted year to date. The Company has a strong current pipeline of
opportunities that has more than doubled year to date, with significant
potential growth opportunities across a variety of end customers, including
large pharma. As such, the management remains confident in delivering strong
growth in 2024 in line with current market expectations
· Completion of the fundraising, announced separately today,
alongside delivery of market expectations is anticipated by the Company to
secure cashflow breakeven on a monthly basis by the end of 2025
ANGLE Chief Executive, Andrew Newland, commented:
"ANGLE has made considerable commercial progress in 2023 through the ongoing
execution of our strategy. Major efforts have been focused on both the
products and services commercialisation channels and on the development of
"content" to provide applications of the Parsortix system for customers. This
has resulted in the launch of four imaging assays, a strategic partnership
with BioView for the development of a quantitative HER2 assay kit, repeat and
new business with pharmaceutical customers for services and positive research
study results for the Company's comprehensive solution for dual molecular
analysis of CTC-DNA and ctDNA from a single blood sample.
2023 also saw the first product sales from our newly established global
distribution network and we are optimistic about the growth in global sales of
the Parsortix system, consumables, and assay kits during the current financial
year.
I am delighted that 2024 has started strongly with three new contracts with
two large pharma customers and we look forward to continuing this commercial
momentum in the year ahead."
1. Current consensus revenue is £6.45m for FY24. (Source: Bloomberg)
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Berenberg (NOMAD and Broker) +44 (0) 20 3207 7800
Toby Flaux, Ciaran Walsh, Milo Bonser
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/glossary/
The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the EU Market Abuse
Regulation (596/2014). Upon the publication of this announcement via a
regulatory information service, this information is considered to be in the
public domain.
These Preliminary Results may contain forward-looking statements. These
statements reflect the Board's current view, are subject to a number of
material risks and uncertainties and could change in the future. Factors that
could cause or contribute to such changes include, but are not limited to, the
general economic climate and market conditions, as well as specific factors
including the success of the Group's research and development,
commercialisation strategies, the uncertainties related to clinical study
outcomes and regulatory clearance, obtaining reimbursement and payor coverage,
acceptance into national guidelines and the acceptance of the Group's products
and services by customers.
The Company values communications with its shareholders and, as soon as
feasible, will organise a webcast and other communications with
shareholders.
CHAIRMAN'S AND CHIEF EXECUTIVE'S STATEMENT
Introduction
We are pleased to report the unaudited financial results for the year ended 31
December 2023. The Company has made significant commercial progress and has
remained resilient and adaptive in challenging economic conditions. Over the
year, the Company delivered significant revenue growth through execution of
our strategic plans achieving key milestones.
Overview of Financial Results
Following FDA clearance, the beginning of the anticipated revenue ramp is
reflected in revenues more than doubling to £2.2 million (2022: £1.0
million) and was driven by a combination of product sales of the Parsortix
system, pharma services contracts and corporate partnerships. Gross margins
averaged 70% (2022: 59%) reflecting the product-service mix.
Product-related revenues were £1.4 million (2022: £0.7 million) while
services-related revenues were £0.8 million (2022: £0.3 million). In
addition, sales of up to £1.8 million had been booked at the year end for
future periods. The installed base of Parsortix systems is over 290 with
cumulative samples processed of 210,000 as at 31 December 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
carefully controlling operating costs and the expected cost savings from the
closure of the Canadian operations in late 2022, resulting in reduced
operating costs of £23.3 million (2022: £24.8 million). The loss for the
year reduced to £20.1 million (2022: loss £21.7 million).
Cash and cash equivalents were £16.2 million at 31 December 2023 (2022:
£31.9 million) with R&D Tax Credits due at 31 December 2023 of £1.5
million (2022: £2.9 million).
The Company is committed to carefully controlling costs and focusing on
near-term commercialisation. This includes building sales capability,
investing in molecular solutions and enhancing the UK-based clinical
laboratory centre of excellence. 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.
The Company continues 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.
Completion of the fundraising, announced separately today, alongside delivery
of market expectations is anticipated by the Company to secure cash flow
breakeven on a monthly basis by the end of 2025.
Executing business strategy to drive growth
ANGLE has made robust progress in the year as the Company continues to execute
its strategy to commercialise the Parsortix system through its products
business (for Parsortix instruments and consumables) and its services business
(to utilise the Parsortix system in cancer drug trials).
Product sales have been particularly busy, with the expansion of the Company's
direct salesforce and the establishment of an international network of
oncology focused distribution partners. First product sales by distributors
were achieved in Q4 2023, with sales of products, associated consumables, and
the newly launched Portrait+ CTC Staining Kit expected to grow in 2024.
The services business is also performing strongly. Four downstream assays were
launched in 2023, Portrait Flex, Portrait DDR (γH2AX and pKAP1), and Portrait
PD-L1, available as a service to pharma customers from our GCLP-compliant
laboratory. These assays have the potential for substantial revenues in the
large and rapidly growing cancer drug trials market. During 2023, the Company
announced two new pharma contracts. Crescendo Biologics is using ANGLE's
Portrait Flex assay in an ongoing Phase I clinical prostate cancer study and
Artios Pharma signed a further contract for use of ANGLE's Portrait DDR assays
in a Phase I study in multiple advanced cancers.
In addition to our commercial achievements the Company has also made
significant progress in R&D, developing sample-to-answer solutions
utilising commercially available third-party molecular platforms for the
analysis of CTCs harvested by the Parsortix system. This has included the
development of a solution for dual sequencing of CTC-DNA and ctDNA, from a
single blood sample. Study results demonstrated that clinically relevant DNA
variants were identified in CTCs that were not present in ctDNA from the same
blood draw, potentially expanding the actionable information available to
guide personalised therapy.
Outlook
ANGLE plans to build revenues in 2024 by continued expansion of pharma
services customers, strategic partnerships and global distributors. The
Company will continue to drive near-term revenue through sales of products and
services contracts.
Product sales are gaining momentum through our established and growing global
distribution network, with the Parsortix system now registered in the US, EU,
UK, and New Zealand. The pharma services business has made a strong start in
2024 with revenues expected to build further and discussions ongoing with
multiple potential customers. Three services agreements with two large
pharmaceutical companies, Eisai and AstraZeneca, have been announced year to
date at a combined contract value of c.£900,000 over the life of the
contracts.
In addition to its bespoke imaging assays, the Company plans to capitalise on
the high-value molecular diagnostic market by developing assays which can be
run on well-established and widely available third-party molecular platforms
for downstream analysis. ANGLE is particularly excited about the encouraging
results being achieved from analysis of Parsortix CTC harvests using digital
PCR and high multiplex next-generation sequencing 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
pan-cancer assays that ANGLE believes will address a substantial and growing
market need.
With the continued drive to further sales of our products and services,
continued assay development and the move towards third-party molecular
systems, the Company is now well positioned to successfully deliver against
its strategic objectives. It is against this backdrop of scientific and
commercial momentum, alongside careful control of costs, that the Board is
confident in the Company's commercial future delivering increasing value to
shareholders.
Dr. Jan
Groen
Andrew D W Newland
Chairman
Chief Executive
4 June 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. To drive
commercialisation, ANGLE has established both a product business and a
services business.
1. Product business area: ANGLE's Parsortix system including instruments
and one-time use cassettes, that are sold to third-party laboratories for
their use in translational research and clinical use. In December 2023,
ANGLE's quality management system was re-certified as meeting ISO/EN/BSI
13485:2016 with the exemplary condition of our laboratories commended. To
enable customers to carry out downstream analysis of the Parsortix harvest,
ANGLE now offers the Portrait+ CTC Staining Kit and CellKeep(TM) Slide for
enhanced cell recovery and imaging. ANGLE will continue to develop further
assay kits and protocols for third-party molecular platforms.
2. Services business area: ANGLE has established a GCLP-compliant
laboratory in the UK, with the capability, capacity and required quality
systems to provide biopharma customers with assay services to support drug
discovery and development. In the longer term, ANGLE's clinical laboratory
will process patient samples and offer validated assays to support clinical
decision making.
Both business areas are supported by a growing body of internal and published
evidence and content from leading cancer centres showing the utility of the
system through peer-reviewed publications, scientific data, and clinical
research evidence, highlighting a wide range of potential applications.
Parsortix products and services
In 2023, ANGLE launched multiple downstream assays available to customers as a
service from our GCLP-compliant laboratory.
· The Portrait Flex assay is designed to allow the detection of CTCs
regardless of EMT status, with the opportunity to include an additional
protein biomarker tailored to individual customer needs. The clinical utility
of CTC biomarkers is a rapidly growing field facilitating the identification
of druggable targets to guide treatment selection throughout the patient care
pathway, as well as providing prognostic information, predicting treatment
response, resistance, and patient relapse. 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. ANGLE is
offering a flexible, full-service solution to help unlock personalised
medicine for patients.
· The Portrait 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, for use in the research setting, make longitudinal,
repeatable monitoring of treatment response possible.
· The Portrait PD-L1 assay is designed to allow the detection of CTCs
and determine their PD-L1 status, which has the potential to not only
facilitate efficient, timely and cost-effective drug discovery, but may also
enable the more accurate identification of suitable candidates for
immunotherapy studies and provide longitudinal monitoring of patient response
to therapy.
In addition, in December 2023 the Portrait+ CTC Staining Kit was launched as
our first sample-to-answer product. The launch follows extensive development,
optimisation and validation to provide advanced immunofluorescence (IF)
staining of CTCs harvested from a patient blood sample by the Parsortix system
in multiple cancer types including breast, lung, prostate and ovarian cancers.
The performance of current CTC protocols being used by academic and research
institutions varies considerably. ANGLE has developed its test for reliable
repeatable results with a fully validated, standardised protocol to make it
easy for customers to adopt in their laboratories.
Capitalising on newly established global distribution network
With a view to driving longer-term product revenues, during the year ANGLE has
continued to expand its commercial operations team, including product
management, logistics and service and maintenance, as it seeks to capitalise
on the FDA clearance and UK and European product registrations received in May
2022. ANGLE has successfully established an international network of oncology
focused distribution partners, covering major territories in Europe, Africa,
the Middle East and Asia-Pacific, with additional geographies in discussion.
Training programmes for distributor representatives were initiated, new
marketing materials developed, and service and support infrastructure
strengthened. These partners will open distribution channels for Parsortix
instruments and consumables globally. In addition to sales these partners
provide invaluable market access and service and maintenance support in their
jurisdictions.
Expansion of 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. The pipeline of opportunities has
continued to progress, and ANGLE secured Crescendo Biologics as a new
customer. Crescendo Biologics is a UK-based, clinical stage immune-oncology
company and will use ANGLE's Portrait Flex assay in an ongoing Phase I
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. In May
2023, Artios Pharma signed a new contract with ANGLE to utilise the two DDR
assays, developed and validated by ANGLE, in a Phase I clinical trial expected
to commence shortly and complete towards the end of 2024. The assays identify
two target proteins on CTCs that are implicated in DNA damage response, γH2AX
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.
While the pharma services business continued to gain commercial traction, the
negative funding environment and slowdown in biopharma spending regrettably
led to multiple biopharma expected sales falling away as these companies found
themselves unable to pursue their expansion plans, for which they had intended
to contract ANGLE's Parsortix-based pharma services, until their own funding
environment stabilises. ANGLE has responded proactively to this market
pressure by increasing its focus on large pharma customers (where there are no
such funding issues). This proactive strategy is delivering and has so far
led to three contracts with large pharma with major long-term potential with
multiple others in discussion.
Late December 2023 (announced 4 January 2024), ANGLE signed an agreement with
the global Japanese pharmaceutical company Eisai. Under the terms of the
agreement worth an initial US $250,000, ANGLE will provide CTC analysis with
its Portrait HER2 assay in a Phase II breast cancer study of BB-1701. BB-1701
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. Success in this study has the potential to build through to much
larger revenues for Phase II and Phase III studies, with the ultimate goal of
approval as a companion diagnostic.
In April 2024, ANGLE announced an agreement, worth an initial £150,000, with
the global pharmaceutical company AstraZeneca for the development and
validation of an assay based on the existing pKAP1 DDR assay. This assay is
being developed for use in subsequent large-scale clinical studies run by
AstraZeneca to assess the efficacy of DDR therapeutics enabling longitudinal,
repeatable monitoring of treatment response. Success in the development phase
offers the potential for large scale revenues for multiple clinical trials and
follow-up studies.
In May 2024, the Company was delighted to announce a second services contract
with AstraZeneca. Under the terms of this agreement, worth an initial
£550,000, the Company will develop a CTC-based Androgen Receptor (AR) assay.
Assay development will take place in ANGLE's UK laboratories, with project
completion expected in Q1 2025. A successful development phase will
demonstrate the importance of the Parsortix system in assessing the efficacy
of prostate cancer therapeutics and offers the potential for long-term,
ongoing revenues for the Company supporting prostate cancer clinical
trials. 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. There are currently
135 active, interventional oncology clinical studies specifically involving
the androgen receptor listed on clinicaltrials.gov involving
~39,000 participants.
The use of CTC biomarkers in clinical trials is a rapidly growing field
enabling longitudinal monitoring of genomic, transcriptomic and proteomic
changes. 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 continue to be signed throughout 2024.
Strategic partnerships
Addressing a large and complex healthcare market with a new technology
requires significant resources and ANGLE is seeking long-term strategic
partnerships with healthcare companies for market deployment and development
of clinical applications incorporating the Parsortix system.
In April 2023, ANGLE entered into an agreement 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 Portrait+ HER2 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 kit, 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.
Unlike current standard of care tests developed for use on FFPE tissue, 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. 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 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
the initial development work is complete. ANGLE plans to continue to grow its
HER2 pharma services business and capitalise on expanded HER2 use due to the
development of ADCs, that allow targeted delivery of chemotherapy agents to
cancer cells.
Development of cutting-edge molecular solutions
ANGLE has developed a research use sample-to-answer solution for dual
sequencing of DNA from CTCs and ctDNA from a single patient blood sample. This
method enables parallel DNA profiling of CTCs and ctDNA for comprehensive
molecular analysis utilising third-party downstream technologies. Originally
thought to be competing analytes, CTCs and ctDNA are now known to provide
additional and complementary information which has the potential to expand
clinically actionable information, for personalised therapy, when the two are
analysed together.
In ANGLE's study of 47 samples from breast, lung, ovarian and prostate cancer
patients the dual analyte assay utilised a pan-cancer panel run on a
high-throughput Illumina Next Generation Sequencing (NGS) system. This study
found that clinically relevant DNA variants were identified in CTCs that were
not present in ctDNA from the same blood draw in 70% of breast cancer patient
samples, 70% of lung cancer patient samples and 60% of ovarian cancer patient
samples, highlighting the potential benefit of CTC-DNA analysis alongside
ctDNA analysis.
ANGLE will expand both its product sales and pharma services offerings with
this new sample-to-answer molecular solution combining CTC-DNA and ctDNA
analysis from a single blood sample. The Company is engaging with Illumina and
working closely with KOLs and clinicians to seek input and consideration of
the benefits of this assay in providing unique insight into cancer clonal
evolution. Moreover, ANGLE is working with these contacts to expedite the
adoption of this combined molecular profiling approach to establish key
performance data under analytical conditions and design of robust clinical
studies to build on the data presented.
ANGLE will continue the development of downstream molecular solutions, in
collaboration with leaders in the molecular field, so that CTCs harvested by
the Parsortix system can be sequenced using existing laboratory instruments.
This will allow ANGLE to benefit from the existing installed base of digital
PCR and sequencing instruments and for the molecular assays to be easily
incorporated into existing workflows and, in the longer term, clinical
practice. ANGLE plans to offer a molecular solution for Research Use Only in
2024, which will then be implemented in ongoing clinical studies (see below).
The molecular assays in development include the following:
· DNA Digital PCR Assays, a solution for low-multiplexing assays for
specific targets such as EGFR and KRAS. This includes the evaluation of Stilla
Technologies solutions, utilising their EGFR 6-color Crystal Digital PCR™
Kit and naica(®) system
· DNA NGS Assays, two solutions for high-multiplexing assays using a
pan-cancer NGS panel with Illumina's NextSeq 2000, which is now installed in
ANGLE's R&D laboratory
Parsortix 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 37% of solid cancer cases.
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 during their
diagnosis, treatment, and follow-up. As of the year end, 299 patients had been
enrolled into the INFORM study, with a total of 1,037 blood draws performed
and 2,835 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), multiplex gene expression analyses,
mutational analyses and sequencing
· Evaluate changes in CTCs and other rare cells in cancer patients
over the course of their treatment
· Perform additional development and refinement of ANGLE's Parsortix
system
· Utilise blood samples for assay development and validation
Prostate cancer
In May 2022, ANGLE partnered with the US based, specialist clinical service
provider, MidLantic Urology part of Solaris Health Partners, to undertake a
study in prostate cancer. The study, known as DOMINO, is based on the highly
successful pilot studies conducted independently by Barts Cancer Institute
(Queen Mary University London). DOMINO has completed the initial enrolment of
100 men with either an elevated blood PSA or an abnormal rectal exam, who were
scheduled to undergo a prostate tissue biopsy. The blood tubes drawn from each
patient have been processed using the Parsortix system and the cell harvest
stored for future molecular analysis for comparison with the results of the
prostate tissue biopsy. Third-party molecular systems are under assessment
for the processing of these samples. The timescales will be confirmed once
this assessment is complete.
Ovarian cancer
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. Study recruitment completed
in September 2023 after reaching 400 patients with 1,400 blood tubes processed
on the Parsortix system. The cell harvest has been stored for future molecular
analysis. Third-party molecular systems are under assessment for the
processing of these samples. The timescales will be confirmed once this
assessment is complete.
The Company's investment in these clinical studies and the collection of the
associated patient records has provided a tremendous resource for large-scale
evaluation of the third-party molecular platforms that are currently under
investigation. These studies will have a major impact on ANGLE's
commercialisation strategy providing data to support the ANGLE laboratory
services and assay development.
Peer-reviewed publications update
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.
ANGLE's product-based approach means that we can deploy our system to leading
cancer centres for use by key opinion leaders and research customers. ANGLE's
unique approach to capturing and harvesting CTCs is enabling translational
researchers to undertake a wide range of research leading to new uses and
applications for the Parsortix system as well as achieving breakthrough
research. This deployment of the Parsortix system for translational research
now means that the system is widely presented and discussed at leading cancer
conferences around the world.
There were 92 peer-reviewed publications as of 31 December 2023 with 15 new
publications announced during the year. These publications span 41 independent
study centres across 14 countries. ANGLE's unique approach to capturing and
harvesting CTCs has enabled researchers to leverage a diverse array of
downstream techniques for cell analysis. This includes cutting-edge DNA and
RNA sequencing, mass-array protein analysis and digital PCR. In addition to
furthering our understanding of the metastatic process, these studies continue
to build upon the evidence that CTCs can provide complementary information to
ctDNA.
Andrew D W Newland
Chief Executive
4 June 2024
ANGLE PLC
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2023
2023 2022
(Unaudited) (Audited)
Note £'000 £'000
Revenue 2,186 1,041
Cost of sales (658) (428)
Gross profit 1,528 613
Other operating income - 1
Operating costs (23,287) (24,821)
Operating profit/(loss) (21,759) (24,207)
Finance income 463 136
Finance costs (336) (368)
Profit/(loss) before tax (21,632) (24,439)
Tax (charge)/credit 5 1,500 2,753
Profit/(loss) for the year (20,132) (21,686)
Other comprehensive income/(loss)
Items that may be subsequently reclassified to profit or loss:
Exchange differences on translating foreign operations 1,114 (2,023)
Other comprehensive income/(loss) 1,114 (2,023)
Total comprehensive income/(loss) for the year (23,709)
(19,018)
Earnings/(loss) per share attributable to owners of the parent 6 (7.73) (8.79)
Basic and Diluted (pence per share)
All activity arose from continuing operations.
ANGLE PLC
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2023
2023 2022
(Unaudited) (Audited)
Note £'000 £'000
Assets
Non-current assets
Intangible assets 2,741 2,764
Property, plant and equipment 2,922 3,505
Right-of-use assets 4,304 4,971
Total non-current assets 9,967 11,240
Current assets
Inventories 1,679 2,059
Trade and other receivables 1,807 1,797
Taxation 1,512 2,876
Cash and cash equivalents 16,218 31,896
Total current assets ` 21,216 38,628
Total assets 31,183 49,868
Liabilities
Non-current liabilities
Lease liabilities (3,905) (4,339)
Provisions (370) (157)
Trade and other payables (26) (59)
Total non-current liabilities (4,301) (4,555)
Current liabilities
Lease liabilities (649) (662)
Provisions (544) (610)
Trade and other payables (2,750) (3,978)
Total current liabilities (3,943) (5,250)
Total liabilities (8,244) (9,805)
Net assets 22,939 40,063
Equity
Share capital 7 26,058 26,058
Share premium 115,918 115,918
Share-based payments reserve 5,709 5,321
Other reserve 2,553 2,553
Translation reserve (4,869) (5,983)
Accumulated losses (122,328) (103,702)
ESOT shares (102) (102)
Total equity 22,939 40,063
ANGLE PLC
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 31 DECEMBER 2023
2023 2022
(Unaudited) (Audited)
£'000 £'000
Operating activities
Profit/(loss) before tax (21,632) (24,439)
Adjustments for:
Depreciation and impairment of property, plant and equipment 1,093 920
Depreciation and impairment of right-of-use assets 1,147 940
(Profit)/loss on disposal of property, plant and equipment 84 172
Amortisation and impairment of intangible assets 68 978
Share-based payment charge 1,894 4,386
Exchange differences 1,183 (2,072)
Net finance (income)/costs (127) 232
Operating cash flows before movements in working capital (16,290) (18,883)
(Increase)/decrease in inventories 90 (580)
(Increase)/decrease in trade and other receivables (74) (650)
Increase/(decrease) in trade and other payables (1,011) (978)
Increase/(decrease) in provisions (36) 594
Operating cash flows (17,321) (20,497)
Research and development tax credits received 2,863 4,506
Overseas tax payments - (59)
Net cash from/(used in) operating activities (14,458) (16,050)
Investing activities
Purchase of property, plant and equipment (611) (1,718)
Purchase of intangible assets (49) (169)
Interest received 457 136
Net cash from/(used in) investing activities (203) (1,751)
Financing activities
Net proceeds from issue of share capital - placing - 18,922
Proceeds from issue of share capital - share option exercises 14 123
Proceeds from disposal of property, plant and equipment 2 -
Principal elements of lease payments (959) (814)
Interest elements of lease payments (182) (135)
Net cash from/(used in) financing activities (1,125) 18,096
Net increase/(decrease) in cash and cash equivalents (15,786) 295
Cash and cash equivalents at 1 January 31,896 31,839
Effect of exchange rate fluctuations 108 (238)
Cash and cash equivalents at 31 December 16,218 31,896
ANGLE PLC
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2023 (continued on next page)
Equity attributable to owners of the parent
Accumulated ESOT Total
losses shares equity
£'000 £'000 £'000
At 1 January 2022 (83,808) (102) 40,330
For the year to 31 December 2022
Consolidated profit/(loss) (21,686) (21,686)
Other comprehensive income/(loss): (2,023)
Exchange differences on translating foreign operations
Total comprehensive income/(loss) (21,686) (23,709)
Issue of shares (net of costs) 19,056
Share-based payment charge 4,386
Released on exercise 43 -
Released on forfeiture/lapse 1,749 -
At 31 December 2022 (Audited) (103,702) (102) 40,063
For the year to 31 December 2023
Consolidated profit/(loss) (20,132) (20,132)
Other comprehensive income/(loss): 1,114
Exchange differences on translating foreign operations
Total comprehensive income/(loss) (20,132) (19,018)
Share-based payment charge 1,894
Released on forfeiture/lapse 1,506 -
At 31 December 2023 (Unaudited) (122,328) (102) 22,939
ANGLE PLC
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2023 (continued)
Accumulated ESOT Total
losses shares equity
£'000 £'000 £'000
At 1 January 2022 (83,808) (102) 40,330
For the year to 31 December 2022
Consolidated profit/(loss) (21,686) (21,686)
Other comprehensive income/(loss): (2,023)
Exchange differences on translating foreign operations
Total comprehensive income/(loss) (21,686) (23,709)
Issue of shares (net of costs) 19,056
Share-based payment charge 4,386
Released on exercise 43 -
Released on forfeiture/lapse 1,749 -
At 31 December 2022 (Audited) (103,702) (102) 40,063
For the year to 31 December 2023
Consolidated profit/(loss) (20,132) (20,132)
Other comprehensive income/(loss): 1,114
Exchange differences on translating foreign operations
Total comprehensive income/(loss) (20,132) (19,018)
Share-based payment charge 1,894
Released on forfeiture/lapse 1,506 -
At 31 December 2023 (Unaudited) (122,328) (102) 22,939
ANGLE PLC
NOTES TO THE PRELIMINARY ANNOUNCEMENT
FOR THE YEAR ENDED 31 DECEMBER 2023
1 Preliminary announcement
The unaudited preliminary results for the year ended 31 December 2023 were
approved by the Board of Directors on 4 June 2024.
The preliminary announcement set out above does not constitute ANGLE plc's
statutory Financial Statements for the years ended 31 December 2023 or 31
December 2022 within the meaning of section 434 of the Companies Act 2006 but
is derived from those unaudited and audited Financial Statements
respectively.
The auditor's report on the statutory Financial Statements for the year ended
31 December 2023 has not yet been made. The auditor's report on the statutory
Financial Statements for the year ended 31 December 2022 is unqualified and
does not contain statements under s498(2) or (3) of the Companies Act 2006.
The accounting policies used for the year ended 31 December 2023 are unchanged
from those used for the statutory Financial Statements for the year ended 31
December 2022. The 31 December 2023 statutory Financial Statements will be
delivered to the Registrar of Companies.
2 Compliance with accounting standards
While the financial information included in this preliminary announcement has
been computed in accordance with the measurement principles of UK-adopted
international accounting standards, this announcement does not itself contain
sufficient information to comply with these accounting standards.
Accounting standards adopted in the year
No new accounting standards that have become effective and adopted in the year
have had a significant effect on the Group's Financial Statements.
Accounting standards issued but not yet effective
At the date of authorisation of the Financial Statements, there were a number
of other Standards and Interpretations (International Financial Reporting
Interpretation Committee - IFRIC) which were in issue but not yet effective,
and therefore have not been applied in these Financial Statements. The
Directors have not yet assessed the impact of the adoption of these standards
and interpretations for future periods.
3 Going concern
The Financial Statements have been prepared on a going concern basis which
assumes that the Group and Company will be able to continue its operations for
the foreseeable future.
The Group's business activities, together with the factors likely to affect
its future
development, performance and financial position, are set out in the Chairman's
and Chief Executive's Statement and Operational Update.
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 Group has announced today a Placing and Subscription of £8.50 million and
an Open Offer of up to £2.06 million.
The Directors have prepared and reviewed the financial projections for a
period in excess of 12 months from the date of approval of these Financial
Statements with discretionary expenditure carefully controlled in line with
available resources, as certain projects may be deferred until additional
resources are available. Based on the level of existing cash, the net proceeds
from the Placing and Subscription element of the fundraise announced today 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.
4 Critical accounting estimates and judgements
The preparation of the Financial Statements requires the use of estimates,
assumptions and judgements that affect the reported amounts of assets and
liabilities at the date of the Financial Statements and the reported amounts
of revenues and expenses during the reporting year. Although these estimates,
assumptions and judgements are based on the Directors' best knowledge of the
amounts, events or actions, and are believed to be reasonable, actual results
ultimately may differ from those estimates.
The estimates that have a significant risk of causing a material adjustment to
the carrying amounts of assets and liabilities are described below.
Share-based payment charge
In calculating the fair value of equity-settled share-based payments the Group
uses options pricing models. The Directors are required to exercise their
judgement in choosing an appropriate options pricing model and determining
input parameters that may have a material effect on the fair value calculated.
These key input parameters are expected volatility, expected life of the
options and the number of options expected to vest.
5 Tax
The Group undertakes research and development (R&D) activities. In the UK
these activities qualify for tax relief and result in R&D tax credits.
6 Earnings/(loss) per share attributable to owners of the parent
The basic and diluted earnings/(loss) per share is calculated by dividing the
after tax loss for the year attributable to the owners of the parent of £20.1
million (2022: £21.7 million) by the weighted average number of shares in the
year.
In accordance with IAS 33 Earnings per share, 1) the "basic" weighted average
number of Ordinary shares calculation excludes shares held by the Employee
Share Ownership Trust (ESOT) as these are treated as treasury shares and 2)
the "diluted" weighted average number of Ordinary shares calculation considers
potentially dilutive Ordinary shares from instruments that could be converted.
Share options are potentially dilutive where the exercise price is less than
the average market price during the year. Due to losses in the 2023 and 2022
reporting years, share options are non-dilutive for those years as adding them
would have the effect of reducing the loss per share and therefore the diluted
loss per share is equal to the basic loss per share.
The basic and diluted earnings/(loss) per share are based on 260,467,288
weighted average ordinary £0.10 shares for the year (2022: 246,579,644).
7 Share capital
The Company has one class of Ordinary shares which carry no right to fixed
income and at 31 December 2023 had 260,580,547 Ordinary shares of £0.10 each
allotted, called up and fully paid (2022: 260,580,547).
8 Shareholder communications
Copies of this announcement are posted on the Company's website
www.ANGLEplc.com (http://www.ANGLEplc.com) .
The Annual General Meeting (AGM) of the Company will be held at 2:00 pm on 10
July 2024 at the Surrey Technology Centre, 40 Occam Road, Guildford, Surrey,
GU2 7YG. The Board is looking forward to welcoming shareholders to the AGM in
person. Details will be included in the notice of AGM.
Notice of the AGM will be enclosed with the audited statutory Financial
Statements.
The audited statutory Financial Statements for the year ended 31 December 2023
are expected to be distributed to shareholders no later than 17 June 2024 and
will subsequently be available on the Company's website or from the registered
office, 10 Nugent Road, Surrey Research Park, Guildford, GU2 7AF.
This preliminary announcement was approved by the Board of Directors on 4 June
2024.
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END FR UPUQUQUPCUAARecent news on Angle
See all newsRCS - Angle PLC - RESULTS SUPPORTING ANGLE’S HER2 ASSAY PROGRAMME
AnnouncementREG - Angle PLC - Results of Eisai Phase 2 pilot study
AnnouncementREG - Angle PLC - Issue of LTIP Options and Share Options
AnnouncementRCS - Angle PLC - Novel findings using Parsortix
AnnouncementREG - Angle PLC - Analysis of CTC-DNA and ctDNA using Illumina assay
Announcement