Cizzle Biotechnology Holdings PLC
Annual Report for the year ended 31 December 2024
Company registered number: 06133765
Cizzle Biotechnology Holdings PLC
Annual Report for the year ended 31 December 2024
Contents
Page
Company Information ............................................................................................................ 1
Chair’s Statement ................................................................................................................... 2
Board of Directors .................................................................................................................. 6
Strategic Report ..................................................................................................................... 7
Directors' Report .................................................................................................................. 18
Statement of Directors’ responsibilities .................................................................................. 21
Corporate Governance Statement ........................................................................................ 22
Directors’ Remuneration Report ............................................................................................ 28
Independent Auditor’s report to the members of Cizzle Biotechnology Holdings PLC ............ 35
Consolidated Statement of Comprehensive Income .............................................................. 42
Consolidated Statement of Financial Position........................................................................ 43
Company Statement of Financial Position ............................................................................. 44
Consolidated Statement of Cash Flows................................................................................. 45
Company Statement of Cash Flows ...................................................................................... 46
Consolidated Statement of Changes in Equity....................................................................... 47
Company Statement of Changes in Equity ............................................................................ 48
Notes to the Financial Statements ........................................................................................ 49
Cizzle Biotechnology Holdings PLC
1
Company Information
Directors
Allan Syms
Nigel Lee
Prof. Dawn Coverley
John Treacy
Matt Bower
Executive Chair
Finance Director
Chief Scientific Officer
Non- Executive
Non-Executive
Company Secretary
SGH Company Secretaries Limited
Registered Number
Registered Office
06133765
6th floor, 60 Gracechurch Street
London, EC3V 0HR
Financial Public Relations
IFC Advisory Limited
Birchin Court, 20 Birchin Lane
London
EC3V 9DU
Broker and Financial Adviser
Allenby Capital Limited
5 St. Helen’s Place
London,
EC3A 6AB
Solicitors
Cooley (UK) LLP
Shakespeare Martineau
22 Bishopsgate
No 1 Colmore Square
London
Birmingham
EC2N 4BQ
B4 6AA
Independent Auditor
PKF Littlejohn LLP
Statutory Auditor
15 Westferry Circus
London
E14 4HD
Registrar
Neville Registrars Limited
Neville House
Steelpark Road
Halesowen
B62 8HD
Bankers
National Westminster Bank PLC,
27, Market Place,
Romsey, SO51 8ZH
2
Cizzle Biotechnology Holdings PLC
Chair’s Statement
The Group continued throughout 2024 to develop a blood test to measure the CIZ1B cancer biomarker.
CIZ1B is a variant of CIZ1, a naturally occurring cell nuclear protein involved in protecting DNA, and the
targeted CIZ1B variant has been shown to be highly correlated with early-stage lung cancer.
Based on the original published research by Professor Coverley and her team at the University of York, it
has been shown that CIZ1B can be measured with high sensitivity, and that it can report on the presence
of lung cancer in a high-throughput, hospital-friendly blood test format. The Directors believe that this
development addresses an important unmet clinical need for a simple scalable test that can help with the
detection of lung cancer in its early stages, which is essential to improve a patient’s chance of survival.
The Group’s initial commercial product for a non-invasive, cost effective and simple blood test will be based
on an immunoassay platform that can be readily performed by hospitals and reference laboratories.
Shareholder value will be created through a global commercial strategy of developing corporate
partnerships generating royalty-bearing licence fees, sales of proprietary antibodies and molecular tools to
support the blood test, plus equity participation in partners where possible. In a highly regulated market
appropriate for clinical diagnostics, and to ensure the earliest availability to patients, the group has adopted
a first to market approach by working with accredited laboratories that perform assays as laboratory
developed tests (“LDT”).
The Group is now well positioned to advance its vision to help make a global shift in lung cancer survival
through accurate, low cost, non-invasive early detection at scale and to deliver its mission to transform lung
cancer survival, by empowering healthcare professionals and patients to enable curative medical
intervention using a groundbreaking and affordable diagnostic blood test that can detect lung cancer early.
Product Development, Clinical Evaluation and Future Research
Throughout 2024, the Group continued to work with external expert partners and suppliers and in July
entered into a strategic agreement with BBI Solutions ("BBI"), the world's largest independent producer of
immunodiagnostic reagents, to supply its first order of commercial propriety monoclonal antibodies – which
are required and provide a unique means to measure the level of CIZ1B in blood samples. The initial order
was manufactured at their ISO 13485-certified facilities and is expected to support up to 5,000 assays.
Supplies have now been validated and distributed to our US partners, and are crucial for advancing the
clinical evaluation process and in meeting a key milestone in bringing the test to market.
The continuing agreement with the University of York and extended access to state-of-the-art facilities and
world leading scientists has again achieved important technical and product milestones including the
production of molecular tools, development and quality assessment of monoclonal antibodies, clinical
evaluation studies and in optimising the standard operating procedure (“SOP”) which together with our
commercial grade monoclonal antibodies provides the basis for rolling out of a scalable, non-invasive, cost
effective immunoassay for CIZ1B biomarker testing for early lung cancer.
In terms of future research, the team at the University of York under the leadership of the Group’s Chief
Scientific Officer, Professor Dawn Coverley will be evaluating how the Group’s CIZ1B biomarker may be
used in point of care devices, and for other types of cancer.
In September 2024, the Group announced it had been selected by the Moffitt Cancer Center (“Moffitt”), the
number one cancer hospital in Florida and the Southeast USA, to test patients with suspicious lung nodules
in a clinical evaluation using the Company’s proprietary CIZ1B biomarker assay.
With multiple sites and over 7,000 employees, Moffitt is the only US National Cancer Institute-designated
‘Comprehensive Cancer Center’ based in Florida. They have developed a comprehensive lung cancer
screening programme that is among the best in the United States, which has resulted in them being named
a Screening Center of Excellence by the GO2 Foundation for Lung Cancer.
Moffitt’s Phase 2 programme, “Using Biomarkers for Diagnosis, Risk Stratification of Post-treatment
Recurrence and Long Term Survival of Lung Cancer”, is a large observational prospective study in patients
with suspicious indeterminate (undiagnosed) lung nodules found in the Lung Cancer Early
Cizzle Biotechnology Holdings PLC
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Chair’s Statement continued
Detection (LEAD) Center Lung Nodule Clinic, directed by Dr. Lary Robinson. As part of this study the
Company will for the first time be analyzing unknown patient blood samples to determine biomarker
accuracy in predicting whether or not a nodule is likely to be cancer. The blood sample tests for CIZ1B will
be conducted in Professor Dawn Coverley’s laboratory at the University of York. The study follows US
nationally recommended guidelines and will be using the first batch of the Company’s new commercial
monoclonal antibody, to provide new sensitivity and specificity data for the CIZ1B biomarker blood test. It
will provide blinded clinical real-world data about the tests value in the diagnostic process, for people with
indeterminant lung nodules that might be cancer. Future studies will evaluate the CIZ1B biomarker blood
test in other clinical contexts.
Global Market Access through Building Strong Partnerships
The Group has continued to develop its collaborations with existing partners in the USA and China as part
of its global licensing strategy to deliver shareholder value through royalty payments and potential benefits
arising from equity participation in the partner companies where possible.
On 21 October 2024 the Group announced an exclusive licensing and partnership agreement with Cizzle
BIO for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA
and Canada. The Group has since received payments of US$400,000 due from initial exclusivity fees and
advanced royalties as part of guaranteed payments totalling US$2.4 million over the period ending April
2027. In addition, the Group will benefit from its equity participation in Cizzle BIO.
The Group has now extended that agreement, as announced on 16 December 2024, to cover the 14
Sovereign States of the Caribbean and the Cayman Islands ("Caribbean") triggering early payments
totalling US$250,000 in July 2025 and US$250,000 in September 2025 of the advanced minimum royalty
of US$1 million previously all due on 21 January 2026. As announced by the Company on 28 April 2025
BIO has executed its first Laboratory Services Agreement with Doctors Hospital (Chrissie Tomlinson
Memorial Hospital (CTMH) in the Cayman Islands.
On 24 March 2025, the Group announced that its licensing partner Cizzle Bio had appointed iGenomeDX,
a specialist clinical diagnostics laboratory to launch the Group’s first commercial CIZ1B biomarker test in
the USA. iGenomeDX is a Commission on Office Laboratory Accreditation (“COLA”) accredited and Clinical
Laboratory Improvement Amendments (“CLIA”) certified clinical laboratory and has been establishing
operating and quality systems ahead of offering the test to clinicians for the first time.
The appointment of iGenomeDX by BIO, is an important step in the Group’s plan to achieve commercial
sales by providing an accredited facility to launch the CIZ1B biomarker test. The accreditation process
involved an evaluation of a laboratory’s operations, including its testing procedures, quality control,
personnel qualifications, and compliance with regulatory requirements. Labs that achieve COLA
accreditation demonstrate a commitment to maintaining high standards of accuracy, reliability, and patient
safety in diagnostic testing to ensure they meet CLIA standards and can legally operate. Cizzle Bio intends
to complete CLIA accreditation shortly and then secure first commercial sales immediately thereafter.
The appointment of these initial clinical laboratories is the start of BIO’s strategy to build a network across
the USA and its accreditation and launch plans are being synchronised to enable a co-ordinated and
comprehensive campaign to roll out the CIZ1B biomarker test to help detect early-stage lung cancer.
The successful completion of the operational and quality systems programme, that demonstrates rigorous
quality control and reproducibility and sensitivity standards, is necessary for launching a cost-effective and
scalable version of the CIZ1B biomarker assay. This will validate that the test is commercially scalable and
can be rolled out as a global solution to help reduce premature cancer deaths and improve survival rates
and quality of life for cancer patients.
Strengthening the Board and Leadership Team
Professor Dawn Coverley (Chief Scientific Officer, “CSO”)
On 1 Jan 2025, to directly support and accelerate the Company’s global licensing and partnership strategy
to bring its non-invasive, cost effective, CIZ1B biomarker lung cancer blood test to market in 2025,
Professor Dawn Coverley, Founder and Non-Executive Director (“NED”) of Cizzle Biotechnology was
appointed Chief Scientific Officer (“CSO”), an executive role on the board of the Company.
Cizzle Biotechnology Holdings PLC
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Chair’s Statement continued
The change in role from NED to CSO, enables Dawn to allocate more of her expert time to directly support
the Company’s licensing partners, particularly in the USA, to accredited laboratory partners, helping them
to achieve CLIA (Clinical Laboratory Improvement Amendments) LDT (Laboratory Developed Test)
accreditation and identify and lead new non-dilutive grant funded research and clinical evaluations.
Dawn is currently a professor and principal investigator of a research laboratory at the University of York,
studying how specialised cells are protected from age-related decay. After a first degree in Genetics
(Leicester), and a PhD in Biochemistry (Cancer Research UK), she completed postdoctoral training at the
University of Cambridge, then moved to the University of York to establish an independent research group
in 2002, supported by the Lister Institute of Preventive Medicine.
Dawn will reduce a number of her current teaching and scientific roles at the University of York in order to
devote sufficient time to the Company’s activities, whilst maintaining a number of key roles, including
leadership of her research group and management of the Company’s existing research and development
contract at the University of York.
The timing of this appointment coincides with the successful completion of the technical programme which
confirms that the most cost-effective and scalable version of the CIZ1B biomarker assay for CLIA
accreditation is an ELISA. The rigorous quality control programme undertaken has been able to
demonstrate equivalence with initial manual laboratory tests and with the BioTechne ProteinSimple
capillary Western system. Results have shown sensitivity equivalent to published CIZ1B lung cancer
studies *, and an ability to correctly identify people with lung cancer with few false negative results. This is
another major step in demonstrating that the Company’s lung cancer blood test is both cost effective and
a commercially scalable global solution that could reduce premature cancer deaths and improve survival
rates and quality of life for cancer patients.
Matthew Bower (Non-Executive Director, “NED”)
Matt Bower is an experienced company executive and adviser with a track record as a director and
secretary of private equity backed and listed companies, across a broad range of company and technology
related activities, was appointed as a Non-Executive Director of the Board on 21 March 2025. He is
engaged as a strategic advisor and mentor to the board of directors of a number of high growth trading and
technology companies, and a director of a number of private companies.
Matt will sit on both the Company's audit and remuneration committees, alongside the Company's
independent Non-Executive Director, John Treacy, replacing Prof Dawn Coverley who recently moved
from her role as a NED to Chief Scientific Officer, as announced on 2 January 2025.
Matt is a Director of Makabo Limited ("Makabo"), a strategic consultancy and board advisory business. On
the 24 June 2024, the Company entered into an agreement (the "Agreement") with Makabo to support the
Board in the areas of strategy, partnerships, licensing and shareholder communications. With Matt joining
the Board, the Agreement has now been terminated. Pursuant to the Agreement, Makabo waived payment
of more than 85 per cent of its contracted fees to link remuneration directly to the success of the Company,
by accepting 2,464,625 options over new Ordinary Shares (the "Options") with an exercise price of
1.622965p per ordinary share. The Options were granted on a pro-rata monthly basis and will all vest and
become exercisable on 25 June 2025 assuming that the VWAP of the Ordinary Shares for the period 25
May 2025 to 24 June 2025 is equal or greater than 3.24593p, being twice or greater than the Options grant
price. The Options remain exercisable until 25 June 2027.
Funding
On 26 March 2024 the Group announced that it had undertaken a conditional placing of 31,050,000 new
ordinary shares of 0.01p each (“Ordinary Shares”) in the Company (the “Placing”) at a price of 2 pence per
share (the “Issue Price”) raising approximately £0.62 million before expenses for the Group. The net
proceeds of the Placing are being utilised towards completing the Group’s first proposed commercial test
to detect CIZ1B, further protect the Group’s Intellectual Property (IP), progress the Group’s research with
the University of York and for general corporate purposes.
At the same time, upon completion of the Placing, the Group terminated the £500,000 loan facility
agreement with E3 Fund SP entered into on 20 September 2022. This facility had not been drawn down.
Cizzle Biotechnology Holdings PLC
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Chair’s Statement continued
The Group also agreed to issue 1,500,000 new Ordinary Shares at 2p per new Ordinary Share in
satisfaction of a payment of £30,000 for professional advisory services to Novum Securities Limited.
Financial overview
The financial results for the year ended 31 December 2024 are summarized below:
-
Corporate expenses, before share option charge and exceptional items: £687,000 (2023: £669,000)
-
Share option charge: £189,000 (2023: £307,000);
-
Exceptional corporate expenses relating to net measurement losses on the current asset investment
and the transfer of intangible asset: £1,391,000 (2023: £831,000);
- Total comprehensive loss: £2,166,000 (2023: Loss £1,717,000); and
- Loss per share 0.6 (2023: Loss 0.5p).
The Group has now met its major research and development milestones, required to launch its first
commercial product. The appointment of iGenomeDX by Cizzle BIO, to achieve CLIA accreditation and
securing its first hospital contract in the Caribbean enables provides a base for the first paid for clinical
test for the CIZ1B biomarker which will be a pivotal moment. The Group is now entering a new business
growth phase, securing further licensing partners, generating licensing revenue and bringing this
important innovation to benefit of patients through early lung cancer diagnosis and enabling curative
intervention.
Allan Syms
Executive Chair
30 April 2025
Cizzle Biotechnology Holdings PLC
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Board of directors
Dr Allan Syms (Executive Chair), appointed 21 May 2019
Allan is an experienced international life sciences and technology senior executive, with over 30 years of
experience at Board level often as founder or chief executive officer in creating, funding and building
emerging technology businesses through to trade sale and IPO. After gaining a PhD in cancer biology at
the Tenovus Institute of Cancer Research and postdoctoral fellowships at Baylor College of Medicine in
Houston and Oxford University, he began his corporate career at GE Healthcare (formerly Amersham
International PLC) to develop novel diagnostic detection systems. He then worked with a number of UK
leading universities to spin out and develop technology businesses. Allan has extensive experience in M&A,
licensing and managing strategic change, becoming corporate marketing director at Integra Biosciences
AG a leading Swiss laboratory and diagnostics supplies company. He was previously a specialist adviser
on China to the Department of International Trade.
Allan was appointed Non-Executive Chair on 21 May 2019 and was appointed Executive Chair with effect
from 14 May 2021.
John Treacy (Non-Executive Director), appointed 29 January 2019
John is a London-based experienced financier who specialises in working with growing companies. He
qualified as a solicitor in the London office of a major international law firm where he specialised in Capital
Markets and Mergers & Acquisitions. From there he moved to practice corporate finance in the advisory
teams of several prominent UK brokerages where he acted as an adviser to a number of AIM companies
and advised on numerous IPOs, acquisitions, debt restructurings and placings.
John is also the Chair of the Audit and Risk Committee and the Chair of the Remuneration Committee.
Professor Dawn Coverley (Chief Scientific Officer), appointed 14 May 2021
Dawn is a cell biologist with over 20 years’ experience in cancer-related research. After a first degree in
Genetics (Leicester), and a PhD in biochemistry (Cancer Research UK), she completed postdoctoral
training at the University of Cambridge, then moved to the University of York to establish an independent
research group in 2002, supported by the Lister Institute of Preventive Medicine. Her research exploits
experimental systems that reconstitute fundamental processes associated with genome and epigenome
stability, and their contribution to the earliest stages of human cancers. She founded Cizzle Biotechnology
Limited and raised early-stage funding in 2006 to begin development of her research findings into clinically
useful products, focused on CIZ1B and the early detection of lung cancer. She is currently principal
investigator of an academic research laboratory at the University of York and Scientific Director of Cizzle
Biotechnology.
Dawn was a member of the Audit and Risk Committee and Remuneration Committee until her appointment
as an executive director on 1 January 2025.
Nigel Lee (Finance Director), appointed 14 May 2021
Nigel has been a director of CFO Solutions Limited since 2003 which has provided financial advisory
services to the Group since 2010, as well as company secretarial services since 2012. CFO Solutions
Limited ceased providing these services to the Group on 14 May 2021. He is also a part-time Finance
Director of Kent Surrey Sussex AHSN Limited. He was financial director/controller in two IT services and
software companies between 1999 to 2003 and prior to that had 11 years of audit and business advisory
experience at PricewaterhouseCoopers. Nigel qualified as a Chartered Accountant in 1988.
Matt Bower (Non- Executive Director), appointed 21 March 2025
Matt is a highly experienced executive, director, and company secretary with extensive experience in
private equity-backed and publicly listed companies. He specialises in delivering transactional and
commercial strategies that drive growth and value. As a strategic advisor and mentor, Matt brings
expertise in operational, financial, and risk management to support high-growth businesses across
innovation, technology, and trading sectors. A Class 1 Master Mariner, he earned his qualification from
Solent University, Southampton.
Matt will sit on both the Company’s audit and remuneration committees, alongside the Company’s
independent Non-Executive Director, John Treacy, replacing Prof Dawn Coverley who recently moved
from her role as a NED to Chief Scientific Officer, as announced on 2 January 2025.
Cizzle Biotechnology Holdings PLC
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Strategic Report for the year ended 31 December 2024
The directors present their strategic report for the year ended 31 December 2024.
Business review
The review of the Group is detailed in the Chair’s Statement on pages 2 to 5.
Principal risks and uncertainties
The principal risks and uncertainties of the Group are as follows:
Early-stage revenue business
The Group is still at an early stage of its development cycle, has not received some initial royalty revenues
from Bio which it expects to account as income in the Statement of Comprehensive Income in 2025. The
generation of revenues can be difficult to predict and although there is no guarantee that the Group will
generate significant revenues in the foreseeable future, revenue is expected in 2025. There are a number
of operational, strategic and financial risks associated with early-stage companies. The Group will face risks
frequently encountered by pre-revenue companies looking to bring new medical devices to the market. For
the foreseeable future, the Group will have significant reliance upon the success of the CIZ1B biomarker in
the detection of lung cancer. There is no guarantee that the Group’s intellectual property will ultimately
protect a commercially viable test for the detection of lung cancer. It is also possible that technical and/or
regulatory hurdles could lengthen the time required for the delivery of such a testing product.
The Group’s prospects, inter alia, rest initially upon the rate of consumer penetration for its test for the early
detection of lung cancer. The Group’s future growth and prospects will also depend on its ability to secure
further commercialisation partnerships on appropriate terms, to manage growth and to expand and improve
operational, financial and management information, quality control systems and its commercialisation
function on a timely basis, whilst at the same time maintaining effective cost controls. Any failure to expand
and improve operational, financial and management information and quality control systems in line with the
Group’s growth could have a material adverse effect on the Group’s business, financial condition and
results of operations.
Regulatory environment and the process for obtaining regulatory clearance
The Group’s prospective future products will be subject to various laws, regulations and standards in each
of the jurisdictions in which products are to be manufactured and distributed. The Board intends to launch
its first commercial product in the USA, with commercial grade antibody, and operating protocols for the
CIZ1B biomarker test to be delivered through its partnership with Cizzle Bio Inc as a Laboratory Developed
Test (LDT).
Verifying Accurate Leading-edge IVCT Development (VALID) Act
On 29 September 2023, the Food and Drug Administration (FDA) announced the publication of a proposed
rule to “clarify” that LDTs are medical devices subject to FDA regulation. LDTs are diagnostic tests that are
developed and offered by high-complexity laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA). While FDA has asserted that it has authority to regulate LDTs as medical
devices, it has never broadly exercised that authority. In the proposed rule, FDA seeks to amend its
regulation defining “in vitro diagnostic products” (IVDs) to add the words “including when the manufacturer
of these products is a laboratory” which would mean LDTs would be treated as medical devices and require
FDA approval. Currently the VALID Act bill has not been enacted to enable Congress to work with key
stakeholders on legislative proposals for regulating diagnostics, including LDTs especially those within the
laboratory community and others have long taken the position that FDA does not have authority under the
FDCA to regulate LDTs.
On 1 April 2025 U.S. District Court Judge Sean D. Jordon has ruled that the U.S. Food and Drug
Administration (FDA) lacks the statutory authority to regulate laboratory developed tests (LDTs), finding
squarely in favour of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories
Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting
the plaintiffs. The court stated that the "proper remedy is vacatur of the final rule" and remanded the case
to the FDA for further consideration in light of the opinion.
Cizzle Biotechnology Holdings PLC
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Strategic Report for the year ended 31 December 2024
Principal risks and uncertainties (continued)
Regulatory environment and the process for obtaining regulatory clearance (continued)
Judge Jordon’s order to vacate the rule means that the Final Rule issued by FDA is no longer legally
binding. As a result, clinical laboratories with LDTs are not required to comply with FDA’s implementation
requirements for LDT oversight. It is unclear whether the Trump Administration will seek to appeal the
ruling. However, ASCP has urged the Trump Administration to rescind the rule and will urge the
Administration not to appeal the ruling.
Globally, the use of LDTs or in House Developed Tests vary from country to country. In Europe, to be
exempted from most of the provisions of Regulations (EU) 2017/745 (medical devices Regulation, MDR)
and (EU) 2017/746 (in vitro diagnostic medical devices Regulation, IVDR), provided the health institution
adheres to the conditions laid out in Article 5(5) of the relevant Regulation. Laboratories have to be
considered as a health institution and be accredited to ISO 15189.
The Group’s future products are likely to require UKCA, CE Marking, or FDA 510(k) clearance, There can
be no guarantee that the Group’s products will obtain UKCA, CE marking, LDT or FDA 510(k) clearance,
or that they can be obtained within the timescales or the budgets anticipated by the Directors.
The Group intends to pursue UKCA, CE marking approval, LDT accreditation or FDA 510(k) clearance via
the use of retrospective testing data. However, if retrospective testing data is not sufficient to obtain UKCA,
CE marking approval, LDT accreditation and/or FDA 510(k) clearance, then the Group may need to
complete a prospective study, which it is anticipated would be more expensive and would take longer.
Any other potential delays in obtaining the UKCA CE marking approval, LDT accreditation or potentially
FDA 510(k) clearance would adversely affect the timing of the Group’s future product sales into the EU (or
the USA in the case of a LDT or FDA 510(k) clearance). There is no guarantee that there will not be an
extended period of requests for information or supporting data that could add to the timing for receiving the
UKCA/CE mark (or potentially a LDT or FDA 510(k) clearance).
There remain significant uncertainties associated with the exit by the UK from its membership of the
European Union. Since 1 January 2021, there have been a number of changes, introduced through
secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales
and Scotland). On 9 January 2024, the MHRA released a Roadmap towards the future regulatory
framework for medical devices. This provides an update on the intended timelines to implement the future
core regulations.
UK Notified Bodies are not able to issue CE certificates (other than for the purposes of the “CE UKNI”
marking, which is valid in Northern Ireland) – and have become UK Approved Bodies.
a new route to market and product marking is available for manufacturers wishing to place a device on
the Great Britain market;
since 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on
the Great Britain market need to be registered with the MHRA. There is a grace period for registering:
-
Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A
products must be registered from 1 May 2021;
-
other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be
registered from 1 September 2021;
-
Class I devices, custom-made devices and general IVDs (that do not currently need to be
registered) must be registered from 1 January 2022; and
manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021,
were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country
manufacturers with Northern Ireland-based Authorised Representatives) must continue to register their
devices from 1 January 2021 on the same basis as they do now rather than in line with the above dates.
The Group’s lung cancer blood test may be classed as an IVD List B product. It is anticipated that the
MHRA wishes to strengthen regulation to protect patients post-Brexit. Changes to regulation could lead to
potential delays in obtaining the UKCA CE marking approval, LDT accreditation or potentially FDA 510(k)
clearance and there can be no guarantee that the Group’s future products will ultimately obtain UKCA, CE
marking, LDT or FDA 510(k) clearance or that future UKCA, CE marking, LDT or FDA 510(k) clearance
can be obtained within the timescales or the budgets anticipated by the Directors. The Group will closely
monitor changes to regulation brought about by the MHRA and work with the MHRA to try to ensure that
the Group’s products meet any changes in the standards.
Cizzle Biotechnology Holdings PLC
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Strategic Report for the year ended 31 December 2024 (continued)
Principal risks and uncertainties (continued)
Regulatory environment and the process for obtaining regulatory clearance (continued)
On 21 October 2022, the MHRA announced a 12-month extension of the standstill period on the future
Medical Device regime which is a substantial reform of the current framework. This is to ensure that the
future regime is robust and reflects the detail required to avoid disruption to supplies, support innovation
and enable safe access to Medical Devices for UK patients. It is anticipated that the new regulations will
come into force in July 2024. This will provide additional time to develop the legislation and support system
readiness.
There are possible further uncertainties as to the current and future fiscal, monetary and regulatory
landscape in the UK. There is also uncertainty as to how, when and to what extent the continuing impact
of Brexit, the COVID-19 pandemic, risk of a trade war with the USA in response to tariffs, the ongoing
armed conflict in Ukraine, the Middle East and potential low levels of economic growth, will have an impact
more generally on the economy of the UK and the growth of various industries, consumer confidence, levels
of investor activity and confidence in market performance.
Currently the Company’s product (monoclonal antibody) is manufactured in the USA and would not
therefore be subject to tariffs when sold to US markets.
The UK’s exit from the EU may yet lead to a more complicated and uncertain process for obtaining
regulatory clearance to market the Group’s future products in the UK and the EU. In the event of such
complications or delays in obtaining regulatory clearance for marketing in the UK or the EU, the Group will
consider giving higher priority to compliance with the LDT and FDA 510(k) clearance process.
Following Brexit, the Group will need to comply with the Medical Devices (Amendment etc.) (EU Exit)
Regulations 2019 if it is to market its future products in the UK. Failure to comply with additional
requirements as a result of regulatory change and/or failure to receive regulatory clearance may adversely
impact the Group’s ability to develop and market its products which in turn may have an adverse impact on
the business of the Group.
Complex research and development processes
Certain elements of the reagents and other components which are planned to be used in the Group’s test
for lung cancer are complex and bespoke in their nature and may be difficult to reproduce in an optimised
manner. Any unexpected delays or issues with this process may have an impact on the Group’s anticipated
development and commercialisation strategy and its timeline.
Competition and the pace of development in the healthcare industry
The Directors are aware of a number of competitor companies which are seeking to develop, commercialise
or market alternative types of tests for the detection of cancer, including lung cancer. Certain competitors
already have UKCA, CE of FDA 510K marking or LDT accreditation for lung cancer detection products.
Existing or new competitors may have larger resources, greater market presence, economies of scale or a
lower cost base than the Group. Diagnosis of lung cancer needs to be made at a much earlier stage through
the availability of an accurate in vitro diagnostic test. This is being addressed by a number of different
technologies to the Group, for example autoantibody technology and tests on circulating DNA including
those based on single nucleotide polymorphisms (SNPs) and gene panels. It is therefore possible that the
market may evolve and other tests and companies may provide alternative solutions. Few tests are aimed
at early detection (cancer stages 1 and 2) or on reducing significantly the number of false positives achieved
via X-Ray and chest CT scans. While many blood tests to detect tumour markers are available or under
development, many are hampered as markers may also be produced by normal cells. In contrast, the
Group’s test is based on technology to find a biomarker in early -stage tumours..
The Group operates within the biotechnology sector, a complex area of the healthcare industry. Rapid
scientific and technological change within the biotechnology sector could lead to other market participants
creating approaches, products and services equivalent or superior to the diagnostic testing products and
services than those to be offered by the Group, which could adversely affect the Group’s performance and
success. Better resourced competitors may be able to devote more time and capital towards the research
and development process, which, in turn, could lead to scientific and/or technological breakthroughs that
may materially alter the outlook or focus for markets in which the Group will operate.
Cizzle Biotechnology Holdings PLC
10
Strategic Report for the year ended 31 December 2024 (continued)
Principal risks and uncertainties (continued)
Competition and the pace of development in the healthcare industry (continued)
If the Group is unable to keep pace with the changes in the biotechnology sector and in the wider healthcare
industry, the demand for its prospective future testing platforms and associated products and services could
fall, which may have a material adverse effect on the Group’s business, financial condition, capital
resources, results and/or future operations. In addition, certain of the Group’s competitors may have
significantly greater financial and human resource capacity and, as such, better manufacturing capability
or sales and marketing expertise. New companies with alternative technologies and products may also
emerge. Any of these events may have a material adverse effect on the Group’s business, financial
condition, capital resources, results and/or future operations.
Attraction and retention of key management and employees
The successful operation of the Group will depend partly upon the performance and expertise of its current
and future management and employees. The loss of the services of certain of these members of the
Company’s key management, particularly Professor Dawn Coverley and Dr Allan Syms or the inability to
identify, attract and retain a sufficient number of suitably skilled and qualified employees may have a
material adverse effect on the Group.
CE Marking
If there are restrictions on using the Company’s assay as a ‘In-House In Vitro Diagnostic device’ (IH-IVD)
then this would delay the timing of future product sales within the EU.
Complex research and development processes
Certain elements of the reagents and other components which are planned to be used in the Group’s test
for lung cancer are complex and bespoke in their nature and may be difficult to manufacture at scale in an
optimised manner. Any unexpected delays or issues with this process may have an impact on the Group’s
anticipated development and commercialisation strategy and its timeline.
Ownership and protection of intellectual property rights
The Group’s ability to compete will depend in part upon the successful protection of its intellectual property,
in particular its patents and know-how. The Group seeks to protect its intellectual property through the filing
of patent applications, as well as robust confidentiality obligations on its employees. Filing, prosecuting and
defending patents in all countries throughout the world would be prohibitively expensive. It is possible that
competitors will use the technologies in jurisdictions where the Group has not yet obtained patent protection
in order to develop its own products which will then directly compete against the Group’s product.
Future product liability risks
The Group’s future business may expose it to potential product liability and indemnity risks. There can be
no assurance that the necessary insurance cover will be available to the Group at a commercially
acceptable cost or that, in the event of any claim, the level or extent of insurance carried by the Group now
or in the future will be adequate, or that a product liability or other claim would not materially and adversely
affect the business of the Group.
Lack of manufacturing process
The Group currently has no manufacturing process. Future manufacturing process will be outsourced to a
partner specialising in manufacture. These arrangements usually provide for an adequate volume of
manufacturing capability. No assurance can be given that a future manufacturing partner (i) can be found
to provide a product on commercially acceptable terms and (ii) will achieve and sustain the production
yields required to meet the Group’s future customers’ demand for the Group’s products; in either case this
could have a material and adverse effect on the Group’s business.
Future funding requirements
The Company has raised approximately £0.62m of funds through the issue of new shares in April 2024 and
on 21 October 2024 the Group announced an exclusive licensing and partnership agreement with Cizzle
BIO for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA
and Canada. The Group has since received payments of US$400,000 due from initial exclusivity fees and
advanced royalties as part of guaranteed payments totalling US$2.4 million over the period ending April
2027. The Group has now extended that agreement, as announced on 16 December 2024,
Cizzle Biotechnology Holdings PLC
11
Strategic Report for the year ended 31 December 2024 (continued)
Principal risks and uncertainties (continued)
Future funding requirements (continued)
to cover the 14 Sovereign States of the Caribbean and the Cayman Islands ("Caribbean") triggering early
payments totalling US$250,000 in July 2025 and US$250,000 in September 2025.
If the Company is unable to raise additional capital when needed or on suitable terms, the Group could be
forced to delay, reduce or eliminate future plans or aspirations should the current activity deliver potentially
commercially viable results in the future. Any additional equity fundraising to finance opportunities arising
may be dilutive for Shareholders. Any debt-based funding, should it be achievable,
may bind the Group to restrictive covenants and curb its operating activities and ability to pay potential
future dividends even when profitable. Finally, changes in interest rates could have an adverse impact on
the Group’s business by increasing the cost of capital and may negatively impact the Group’s ability to
secure financing on favourable terms.
Timely completion of project milestones to commercialise the Group’s technology
The Group must meet project milestones in order to commercialise its technology in line with market
expectations and to ensure that its first product reaches the market at the most appropriate time to maximise
the market opportunity. The Directors continually review project milestones and action to be undertaken at
monthly operational and board meetings but no guarantee can be given that such milestones shall be
achieved on time or at all. Material delays to project delivery may, among other things, damage relationships
with key suppliers and other business partners and may risk other market entrants building market share
which may have an adverse effect of the Group’s business. Delays in meeting project milestones may also
delay the Group from generating potential revenue from licensing, current royalty deals and antibody sales.
Economic uncertainty
There are significant uncertainties as to the current and future fiscal, monetary and regulatory landscape in
the UK. Economic and global political uncertainty, including the continuing impact of Brexit, post COVID-
19 pandemic economic correction, the risk of a trade war with the USA, the ongoing armed conflict in
Ukraine and potential low levels of economic growth, are likely to put cost pressures on services which the
Group requires for both research, development and professional advisory. The Group will continue to
negotiate fixed price contracts with its professional advisors, however such contracts will need to be
renewed and renegotiated periodically. In addition new adviser contracts may need to be entered into from
time to time, most likely on a project to project basis. In each case, fixed prices may be higher than those
prices paid by the Group in the past.
Reliance on single source of royalty revenues
If there are delays in the receipt of royalties from a single source this would impact on the Group’s expected
cash flows.
Key performance indicators (KPI’s)
The directors have identified the following KPI’s that they feel are the most vital measurements for the
Group to monitor given its current stage of development. These KPI’s are considered at each board and
monthly operational meeting.
Cash management
The directors consider the cash flows for the previous month and the updated rolling cash flow forecast for
the Group. At 31 December 2024 the Group had cash balances amounting to £365,000 (2023: £144,000)
and no borrowings.
Intellectual Property
Each month the directors review the Group’s Intellectual Property Portfolio and the applications and
renewals required to maintain this portfolio. The Group’s patent portfolio currently includes:
-
CIZ1 Replication Protein
-
Methods and Compounds for diagnosis and treatment of cancer; and
-
Use of a Fibrinogen Capture Agent to detect a CIZ1B variant.
Cizzle Biotechnology Holdings PLC
12
Strategic Report for the year ended 31 December 2024 (continued)
Diversity
The Group is aware of the importance of workplace diversity which includes but is not limited to sex, gender,
age, ethnicity and cultural background. The Group’s only employees are the directors, which consists of
four men and one woman.
Under the FCA’s Listing Rule 22, as an Equity shares (transition) entity, the Group is subject to certain
Diversity and Inclusion targets. These include: i) at least 40% of the individuals on its board of directors are
women; (ii) at least one senior position (chair, chief executive, senior independent director or chief financial
officer) on its board of directors is held by a woman; and (iii) at least one individual on its board of directors
is from a minority ethnic background. Unfortunately, the Group has been unable to meet these targets
during the period, largely due to the small, early-stage nature of the business and the short time since its
formation. The Group recognises the benefits of diversity across all areas and believes that a diverse Board
is a positive factor in business success, brings a broader, more rounded perspective to decision making,
and makes the Board more effective. When recruiting, the Board will endeavour to consider a wide and
diverse talent pool whilst also taking into account the optimum make-up of the Board, including the benefits
of differences in skills, industry experience, business model experience, sex, race, disability, age,
nationality, background and other attributes that individuals may bring.
Corporate Responsibility
The Group consists of five directors who all work from their homes and one director also works at the
University of York. As we undertake our research and development activities and manage the affairs of the
business and develop our plans for the future our business practices focus on the following areas:
-
Health and Safety, and ensuring that all of our employees operate in a safe environment;
-
Environment, managing our environmental impact in areas of waste, energy and water;
-
Employee support, to ensure that all employees flourish;
-
Ethical Standards, operating at the highest level in all business dealings; and
-
Human Rights Issues, so as to ensure that we carefully select all trading partners with such
issues in our minds.
Whist our current levels of engagement do not enable much engagement with the local community, we
wish, as our business grows, to have positive interaction with the communities in which we operate.
Climate-Related matters
There is limited scope for the Group to have a major impact on environmental matters at the current phase
of the Group but we do undertake and take actions on recycling and energy conservation in our daily
activities.
We have considered the Financial Stability Board’s Task Force on Climate-related Financial Disclosures
(TCFD) recommendations and have reported below our status against the following pillars:
-
Governance – the governance around climate- related risks and opportunities;
-
Strategy – the actual and potential impacts of climate-related risks and opportunities for the business,
strategy, and financial planning;
-
Risk Management – the processes for identifying, assessing and managing climate-related risks;
and
-
Metrics and Targets – the metrics and targets used to assess and manage relevant climate-related
risks and opportunities.
We are aware of nature-related matters as we undertake our business but do not believe that this is
currently applicable for the current stage of operations in our Group.
a.
Governance
The Boards oversight of climate-related risks and opportunities – due to the stage of the business the
Group’s operations are at a relatively small scale and so therefore its environmental impact is low. The
Group consists of five directors with most of its research and development activity outsourced to third party
organisations. The Group recognises its responsibility to protect the environment now and as the business
scales up into its next phase.
Cizzle Biotechnology Holdings PLC
13
Strategic Report for the year ended 31 December 2024 (continued)
Climate-Related matters (continued)
Managements role in assessing and managing climate-related risks and opportunities – The Board
is responsible for the oversight of climate-related matters and for keeping under review the adequacy and
effectiveness of the Group’s internal control and risk management systems, which include climate-related
risks. It is also supported by the work undertaken by our Audit Committee.
b.
Strategy
Climate-related risks and opportunities identification – The Group is committed to a net-zero planet
and undertaking sustainable research.
Climate-related risks and opportunities impacts – the Board is committed to conserving its natural
resources and engaging with those partners and suppliers that have similar objectives. The main part of
our research and development activity is undertaken at the University of York and overseen by Professor
Dawn Coverley. This work is governed by strict policies on climate-related matters, outlined in
Yorks Sustainability Plan (https://www.york.ac.uk/about/sustainability/strategy/). In particular, excessive
use of single-use plastics is an issue that concerns the Coverley laboratory. They have adopted a rigorous
recycling regime for polypropylene and polystyrene items, which involves decontamination and partitioning
of almost all cell culture consumables. This feeds into a department-wide drive and is part of a wider
sustainability strategy for a range of items from batteries to equipment. Some of the Group’s research and
development activity at the University of York involves mammalian cell culture, which uses single-use
plastic items, all now recycled. This and other research in the Coverley laboratory at York, is currently in
the process of Green Impact Award accreditation.
During 2025 we anticipate that clinical trials will be undertaken by one of our partners. We will seek to
ensure that Environmental, Social and Governance (“ESG”) will be an important consideration as part of
this work.
Resilience of the organisations strategy – the information collected during its work will allow the Board
to challenge the Group’s strategy to ensure that it is as resilient as possible.
c.
Risk Management
Identifying and assessing climate-related risks – the main current risk on environmental matters is to
ensure that we undertake our research in a sustainable way. This can be done through our partners to
whom this work is outsourced. In the future, we recognise that when we develop a ‘Point of Care test’,
perhaps similar to the Covid-19 tests, that such products are likely to be regarded as ‘Bio Waste’ and
therefore difficult to recycle. It will also be important one day to ensure that such products are packaged
and distributed in an environmentally sustainable manner.
Managing climate-related risks – these risks will continue to be managed by the Board as part of its Risk
Management Procedures.
Integration into overall risk management – as operations scale up in the future the identification,
assessment and effective management of climate-related risks and opportunities will be discussed at board
meetings.
d.
Metrics and targets
Climate-related metrics - as the Group’s operations scale up we will seek to collect, structure and
effectively disclose related performance data for material climate-related risks and opportunities identified
where relevant.
Scope 1, Scope 2 and Scope 3 emissions -the board will consider adopting Sustainability Accounting
Standards Board (SASB) recommended disclosures but this may be dependent upon the business model
that the Group adopts in order to seek to maximise shareholder value. E.g. it may be that the Group pursues
a licensing model.
Climate-related targets – we have already mentioned that all directors mainly work from home apart from
one that is based at the University of York, so business travel is already minimised. This means that energy
use and emissions, through remote working, are already minimised. Consequently, no separate disclosures
relating to energy consumption and efficiency have been made as the entity consumed less than 40,000
kWh of energy during the period.
Cizzle Biotechnology Holdings PLC
14
Strategic Report for the year ended 31 December 2024 (continued)
Promotion of the Company for the benefit of the Members as a whole
S172 of the Companies Act 2006 requires the Board to promote the Company for the benefit of the
members as a whole. In particular, the requirements of s172 are for the Directors to:
Consider the likely consequences of any decision in the long term;
Act fairly between the members of the Company;
Maintain a reputation for high standards of business conduct;
Consider the interests of the Company’s employees;
Foster the Company’s relationships with suppliers, customers and others; and
Consider the impact of the Company’s operations on the community and the environment.
The directors have strived to ensure that these considerations are embedded within its decision-making
process.
Decision-making
The day to day operation decisions of the Group have been made by the executive directors. All key
decisions of the Group have been made at board meetings involving all directors. The Directors believe
that during the year they have acted in the way most likely to promote the success of the Company for the
benefit of its members as a whole and have adhered to the requirements set out above that are applicable
to the Company given its scope of operations. For example, the Company, does not have any employees
other than the directors, so considering employee interests is not currently relevant.
The principal decisions taken by the Group during the year ended 31 December 2024 and since the year
end have been summarised in the Chair’s Statement on pages 2 to 4 and are summarised as follows:
Decision: to raise new monies for the Company to ensure a sound financial base.
Context
On 26 March 2024 the Company announced that it has undertaken a conditional placing of
31,050,000 new ordinary shares of 0.01p each (“Ordinary Shares”) in the Company (the “Placing”) at
a price of 2 pence per share (the “Issue Price”) raising approximately £0.62 million before expenses
for the Company. The net proceeds of the Placing will be utilised towards completing the Company’s
first proposed commercial test to detect CIZ1B, further protect the Company’s Intellectual Property
(IP), progress the Company’s research with the University of York and for general corporate
purposes. Upon completion of the Placing, the Company intends to terminate the £500,000 loan
facility agreement with E3 Fund SP entered into on 20 September 2022. This facility has not been
drawn down. The Company also agreed to issue 1,500,000 new Ordinary Shares at 2p per new
ordinary share in satisfaction of a payment of £30,000 for professional advisory services to Novum
Securities Limited.
Stakeholder considerations (Shareholders)
The raising of new finance ensures that the Company has a sound financial platform from which to
develop the Group’s activities.
Cizzle Biotechnology Holdings PLC
15
Strategic Report for the year ended 31 December 2024 (continued)
Decision-making (continued)
Decision: to invest in Product Development , Clinical Evaluation and future research.
Context
Throughout 2024, the Group continued to work with external expert partners and suppliers and in July
entered into a strategic agreement with BBI Solutions ("BBI"), the world's largest independent producer
of immunodiagnostic reagents, to supply its first order of commercial propriety monoclonal antibodies.
The initial order was manufactured at their ISO 13485-certified facilities and is expected to support up
to 5000 assays. This has now been delivered and distributed to our US partners and is crucial for
advancing the clinical evaluation process and in meeting a key milestone in bringing the test to market.
The continuing agreement with the University of York and extended access to state-of-the-art facilities
and world leading scientists has again achieved important technical and product milestones including
the production of molecular tools, development and quality assessment of monoclonal antibodies,
clinical evaluation studies and in optimising the standard operating procedure (“SOP”) which together
with our commercial grade monoclonal antibodies provides the basis for rolling out a scalable, non-
invasive, cost effective immunoassay for CIZ1B biomarker testing in early lung cancer.
In terms of future research, the team at the University of York under the leadership of Professor Dawn
Coverley will be evaluating how the Group’s CIZ1B biomarker may have use point of care devices and
in other cancers.
In September, the Group announced it had been selected by the Moffitt Cancer Center (“Moffitt”), the
number one cancer hospital in Florida and the Southeast USA, to test patients with suspicious lung
nodules in a clinical evaluation using the Company’s proprietary CIZ1B biomarker assay.
With multiple sites and over 7000 employees, Moffitt is the only US National Cancer Institute-
designated ‘Comprehensive Cancer Center’ based in Florida. They have developed a comprehensive
lung cancer screening programme that is among the best in the United States, which has resulted in
them being named a Screening Center of Excellence by the GO2 Foundation for Lung Cancer.
As part of Moffitt’s Phase 2 programme, “Using Biomarkers for Diagnosis, Risk Stratification of Post-
treatment Recurrence and Long Term Survival of Lung Cancer”, a large observational prospective
study in patients with suspicious indeterminant (undiagnosed) lung nodules seen in the Lung Cancer
Early Detection (LEAD) Center Lung Nodule Clinic, led by its Director Dr. Lary Robinson, the
Company will for the first time be analyzing patient blood samples to determine biomarker accuracy
in predicting whether or not a nodule is likely to be cancer. The study follows US nationally
recommended guidelines and will be using the first batch of the Company’s new commercial
monoclonal antibody, to provide new sensitivity and specificity data of the CIZ1B biomarker blood test
in the diagnosis of early-stage lung cancer in people with indeterminant lung nodules. The blood
sample tests for CIZ1B will be conducted in Professor Dawn Coverley’s laboratory at the University
of York.
Stakeholder considerations (Shareholders)
The decisions taken have enhanced the Group’s Product Development, Clinical Evaluation and
research and development capabilities.
Cizzle Biotechnology Holdings PLC
16
Strategic Report for the year ended 31 December 2024 (continued)
Decision-making (continued)
Decision: to achieve Global Market Access through building strong partnerships.
Context
The Group has continued to develop its collaborations with existing partners in the USA and China
as part of its global licensing strategy to deliver shareholder value through royalty payments and
potential benefits arising from equity participation in the partner companies where possible.
On 21 October 2024 the Group announced an exclusive licensing and partnership agreement with
Cizzle BIO for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout
the USA and Canada. The Group has since received payments of US$400,000 due from initial
exclusivity fees and advanced royalties as part of guaranteed payments totalling US$2.4 million over
the period ending April 2027. The Group has now extended that agreement, as announced on 16
December 2024, to cover the 14 Sovereign States of the Caribbean and the Cayman Islands
("Caribbean") triggering early payments totalling US$250,000 in July 2025 and US$250,000 in
September 2025.
In addition, the Group will benefit from its equity participation in Cizzle BIO.
On 24 March 2025, the Group announced that its licensing partner Cizzle Bio had appointed
iGenomeDX, a specialist clinical diagnostics laboratory to launch the Group’s first commercial CIZ1B
biomarker test in the USA. iGenomeDX is a Commission on Office Laboratory Accreditation (“COLA”)
accredited and Clinical Laboratory Improvement Amendments (“CLIA”) certified clinical laboratory and
has been establishing operating and quality systems ahead of offering the test to clinicians for the first
time.
The appointment of iGenomeDX by BIO, is an important step in the Group’s plan to achieve commercial
sales by providing an accredited facility to launch the CIZ1B biomarker test. The accreditation process
involved an evaluation of a laboratory’s operations, including its testing procedures, quality control,
personnel qualifications, and compliance with regulatory requirements. Labs that achieve COLA
accreditation demonstrate a commitment to maintaining high standards of accuracy, reliability, and
patient safety in diagnostic testing to ensure they meet CLIA standards and can legally operate.
The successful completion of the operational and quality systems programme is necessary for
launching a cost-effective and scalable version of the CIZ1B biomarker assay with rigorous quality
control requirements to meet expected reproducibility and sensitivity. This will demonstrate the test is
commercially scalable and can be rolled out as a global solution to help reduce premature cancer
deaths and improve survival rates and quality of life for cancer patients.
Stakeholder considerations (Shareholders)
The decisions taken have enhanced the Group’s Global Market Access.
Cizzle Biotechnology Holdings PLC
17
Strategic Report for the year ended 31 December 2024 (continued)
Decision-making (continued)
Decision: to strengthen the Board and Leadership Team
Context
Professor Dawn Coverley (Chief Scientific Officer, “CSO”)
On 2 Jan 2025, to directly support and accelerate the Company’s global licensing and partnership
strategy to bring its non-invasive, cost effective, CIZ1B biomarker lung cancer blood test to market in
2025, Professor Dawn Coverley, Founder and Non-Executive Director (“NED”) of Cizzle Biotechnology
was appointed Chief Scientific Officer (“CSO”), an executive role on the board of the Company.
The change in role from NED to CSO, enables Dawn to allocate more of her expert time to directly
support the Company’s licensing partners, particularly in the USA, to accredited laboratory partners,
helping them to achieve CLIA (Clinical Laboratory Improvement Amendments) LDT (Laboratory
Developed Test) accreditation and identify and lead new non-dilutive grant funded research and clinical
evaluations.
Dawn is currently a professor and principal investigator of a research laboratory at the University of
York, studying how specialised cells are protected from age-related decay. After a first degree in
Genetics (Leicester), and a PhD in Biochemistry (Cancer Research UK), she completed postdoctoral
training at the University of Cambridge, then moved to the University of York to establish an
independent research group in 2002, supported by the Lister Institute of Preventive Medicine.
Dawn will reduce a number of her current teaching and scientific roles at the University of York in order
to devote sufficient time to the Company’s activities, whilst maintaining a number of key roles, including
leadership of her research group and management of the Company’s existing research and
development contract at the University of York.
The timing of this appointment coincides with the successful completion of the technical programme
which confirms that the most cost-effective and scalable version of the CIZ1B biomarker assay for CLIA
accreditation is an ELISA. The rigorous quality control programme undertaken has been able to
demonstrate equivalence with initial manual laboratory tests and with the BioTechne ProteinSimple
capillary Western system. Results have shown sensitivity equivalent to published CIZ1B lung cancer
studies *, and an ability to correctly identify people with lung cancer with few false negative results. This
is another major step in demonstrating that the Company’s lung cancer blood test is both cost effective
and a commercially scalable global solution to reduce premature cancer deaths and improve survival
rates and quality of life for cancer patients.
Matthew Bower (Non-Executive Director, “NED”)
Matt Bower is an experienced company executive and adviser with a track record as a director and
secretary of private equity backed and listed companies, across a broad range of company and
technology related activities was appointed as a Non-Executive Director of the Board on 21 March
2025. He is engaged as a strategic advisor and mentor to the board of directors of a number of high
growth trading and technology companies, and a director of a number of private companies.
Matt will sit on both the Company's audit and remuneration committees, alongside the Company's
independent Non-Executive Director, John Treacy, replacing Prof Dawn Coverley who recently
moved from her role as a NED to Chief Scientific Officer, as announced on 2 January 2025.
Stakeholder considerations (Shareholders)
The decisions taken have enhanced the Group’s Board and Leadership Team.
This report was approved by the board on 30 April 2025 and was signed on its behalf by:
Allan Syms
Director
Cizzle Biotechnology Holdings PLC
18
Directors’ Report for the year ended 31 December 2024
The directors present the annual report and audited financial statements for the year ended 31 December
2024.
Principal activity, business review and future developments
On 14 May 2021, the Company’s ordinary shares were admitted to the Standard-Listing of the London
Stock Exchange. Also on that date, the Company completed the reverse acquisition of CBL. On 29 July
2024, the new UK Listing Rules published by the FCA came into effect and the Company’s listing moved
to a new FCA listing category, the Equity Shares (transition) category.
The Group’s principal activity since 14 May 2021 has been the early detection of lung cancer via the
development of an immunoassay test for the CIZ1B biomarker.
The Statement of Group Comprehensive Income is set out on page 42. A review of the Group’s trading
during the year, its position at the year-end, post balance sheet events, and its prospects for the future are
set out in the Chair’s Statement and the Strategic Report.
Dividends
No dividend is proposed in respect of the year (2023: £Nil).
Financial risk management
Information in respect of financial risk management objectives and policies, exposure to price, credit,
liquidity and cash flow risks, and current trading and trading outlook for the Group are outlined in Note 4.
Directors
The directors of the Company who served during the year and since 31 December 2024 are listed below:
Directors
Function
Allan Syms
Executive Chair
Nigel Lee
Finance Director
Dawn Coverley
Chief Scientific Officer
John Treacy
Matt Bower
Non-Executive Director
Non-Executive Director since 21 March 2025
Board Responsibility and Corporate Governance Statement
The Board is responsible for approving the interim and annual financial statements, formulating and
monitoring the Group’s strategy, approving financial plans and reviewing performance, as well as complying
with legal, regulatory and corporate governance matters. The Board is committed to maintaining
appropriate standards of corporate governance and, as detailed below on page 22, has concluded that it
will continue to adopt the Quoted Companies Alliance’s Corporate Governance Code.
Employees
At 31 December 2024 the total number of employees in the Company comprised of 4 employees (2023: 4),
who were all directors.The Group’s employment policies are designed to attract, retain and motivate the
very best staff for each role in the Group, recognising that this can only be achieved through equal
opportunities regardless of sex, gender, race, religion or disability. Regular meetings were held by the
directors to discuss the performance of the Group as a whole. Financial and economic factors were dealt
with in this context. Information concerning employees and their remuneration is given in Note 8.
Climate-related matters
We believe that the Company has made climate-related financial disclosures consistent with the Task
force on Climate-related Financial Disclosures (“TCFD”) recommendations and recommended
disclosures within its Strategic Report on pages 12 and 13.
Cizzle Biotechnology Holdings PLC
19
Directors’ Report for the year ended 31 December 2024 (continued)
Capital structure
Details of the issued share capital are set out in Note 15. On recognition of the reverse takeover of CBL
on 14 May 2021 the Group had 3 classes of share:
-
New Ordinary Shares of 0.01p each.
-
Deferred ‘A’ shares of 0.01p each.
-
Deferred ‘A’ Shares of 0.99p each.
None of these shares have any rights to fixed income and only new ordinary shares carry the right to one
vote per share at general meetings of the Company. There are no specific restrictions on the size of a
holding or on the transfer of New Ordinary Shares, which are both governed by the general provisions of
the Articles of Association and prevailing legislation. The directors are not aware of any agreements
between holders of the Company’s shares that may result in restrictions on the transfer of securities or
on voting rights.
Details of employee share option schemes are set out in Note 1. No share options were exercised during
the year (2023: Nil).
No person has any special right of control over the Company’s share capital and all issued shares are
fully paid.
The appointment and replacement of directors of the Company is governed by its Articles of Association,
the Companies Act 2006 and related legislation. The Articles themselves may be amended by special
resolution of the shareholders. The current Articles have been in place for some years and are in the
process of being reviewed and updated. It is anticipated that updated articles will be proposed for approval
at the forthcoming Annual General Meeting.
Directors’ Interests
The Interest of the Directors in the Company’s shares is noted in the Remuneration Report and has not
changes since 31 December 2024.
Donations
No charitable or political donations were made during the year (2023: £Nil).
Share issues
Details of shares issued during the year are set out in Note 16.
Going concern
Current Funding
The Group’s cash balance as at 31 December 2024 was £365,000 and there were no borrowing facilities at
that date. On 26 March 2024 the Group announced that it has undertaken a conditional placing of 31,050,000
new ordinary shares of 0.01p each (“Ordinary Shares”) in the Company (the “Placing”) at a price of 2 pence
per share (the “Issue Price”) raising approximately £0.62 million before expenses for the Company. The net
proceeds of the Placing will be utilised towards completing the Company’s first proposed commercial test to
detect CIZ1B, further protect the Company’s Intellectual Property (IP), progress the Company’s research with
the University of York and for general corporate purposes.
The Directors have adopted the going concern basis in preparing the financial statements for the year ended
31 December 2024. In reaching this conclusion, the Directors have considered current trading and the current
and projected funding position for approximately 20 months from the date of approval of the financial
statements through to 31 December 2026. The forecasts have been prepared using a number of scenarios –
a base case assumes receipt of minimum royalty payments and an ‘Accelerated Growth’ model assumes that
revenues will be earned from royalties in Europe and the Rest of the World, more investment into research
and development activities and expanding the UK team.
These scenarios show that the Group is reliant upon the timely receipt of the first $1m (approx. £570,000) of
Guaranteed Minimum Royalty Payments (GMP) from Cizzle Bio Inc (“Bio”), in respect of the Group’s Royalty
Agreement covering North America and The Caribbean. The receipt of two GMP instalments of $250,000
Cizzle Biotechnology Holdings PLC
20
Directors’ Report for the year ended 31 December 2024 (continued)
(approx. £190k) in July and September 2025 is dependent on Bio signing a deal with a Caribbean hospital
(recently signed) and would represent an advance of the first $1m with the balance of a further receipt of GMP
of $500k (approx. £380k) is expected to be received in January 2026.The receipt of these royalties is not
dependent upon Bio’s appointed Research Laboratory, iGenomeDX, achieving a CLIA accreditation. However,
there remains uncertainty if Bio will be able to make these payments as it is dependent on raising further funds.
Should these royalty payments be delayed or not materialise, then the company may be required to raise
additional funding to continue to meet its obligations.
Conclusion
After taking into account these conditions, it indicates that a material uncertainty exists that may cast significant
doubt on the group and company’s ability to continue as a going concern. These financial statements do not
include any adjustments that would result from the going concern basis of preparation being inappropriate.
Post Balance Sheet event
The Group announced on 28 April 2025 that its licensing partner Cizzle Bio Inc (“BIO” or “Cizzle Bio”) has
executed its first contract in the Caribbean as part of the extension to its exclusive licensing and partnership
agreement with the Company for the USA and Canada, as announced on 16 December 2024. The non-
exclusive Laboratory Services Agreement signed by BIO with Doctors Hospital (Chrissie Tomlinson Memorial
Hospital - CTMH) in the Cayman Islands triggers the early royalty payments due to the Company from BIO,
totalling US$500,000 in July and September 2025, as part of the advanced minimum royalty of US$1 million
previously all due on 21 January 2026.
Disclosure of information to auditor
The directors who held office at the date of approval of this Directors’ report confirm that, so far as they are
aware, there is no relevant audit information of which the Company’s auditor is unaware; and each Director
has taken all steps that he ought to have taken as a Director to make himself aware of any relevant audit
information and to establish that the Company’s auditor is aware of that information.
Auditor
The existing auditors of the Company are PKF Littlejohn LLP and a resolution for their re-appointment will
be put to the Annual General Meeting.
Annual General Meeting
The Annual Report is made available to shareholders at least 21 clear days’ notice before the Annual General
Meeting (“AGM”) along with the notice of the AGM. Shareholders are given the opportunity to vote on each
separate resolution proposed at the AGM. The Company counts all proxy votes and will indicate the level of
proxies lodged for each resolution, after it has first been dealt with by a show of hands.
Website publication
The Directors are responsible for ensuring the annual report and the financial statements are made
available on a website. Financial statements are published on the Group’s website in accordance with
legislation in the United Kingdom governing the preparation and dissemination of financial statements,
which may vary from legislation in other jurisdictions. The maintenance and integrity of the Group’s
website is the responsibility of the Directors. The Directors’ responsibility also extends to the ongoing
integrity of the financial statements contained therein.
Approved by the Board of Directors and signed by order of the Board
Allan Syms
Director, 30 April 2025
Cizzle Biotechnology Holdings PLC
21
Statement of Directors’ Responsibilities
The directors are responsible for preparing the strategic report, the directors’ report and the financial
statements in accordance with applicable law and regulations.
Company law requires the directors to prepare financial statements for each financial year. Under that
law the directors have elected to prepare the Group and Company financial statements in accordance
with UK-adopted international accounting standards. Under company law the directors must not approve
the financial statements unless they are satisfied that they give a true and fair view of the state of affairs
of the Group and Company and of the profit or loss of the Group and Company for that period.
In preparing these financial statements, the Directors are required to:
select suitable accounting policies and then apply them consistently;
make judgements and accounting estimates that are reasonable and prudent;
state whether they have been prepared in accordance with UK-adopted international accounting
standards, subject to any material departures disclosed and explained in the financial statements;
and
prepare the financial statements on the going concern basis unless it is inappropriate to presume
that the Group and Company will continue in business.
The Directors are responsible for keeping adequate accounting records that are sufficient to show and
explain the Group and Company’s transactions and disclose with reasonable accuracy at any time the
financial position of the Group and Company and enable them to ensure that the financial statements
comply with the requirements of the Companies Act 2006. They are also responsible for safeguarding the
assets of the Group and Company and hence for taking reasonable steps for the prevention and detection
of fraud and other irregularities.
They are also responsible to make a statement that they consider that the Annual Report and Financial
Statements, taken as a whole is fair, balanced and understandable and provides the information
necessary for the shareholders to assess the Group and Company’s position and performance, business
model and strategy.
Directors’ Responsibility Statement Pursuant to Disclosure and Transparency Rules
Each of the Directors, whose names and functions are listed on page 1, confirm that, to the best of their
knowledge and belief:
the financial statements prepared in accordance with UK-adopted international accounting
standards, give a true and fair view of the assets, liabilities, financial position and loss of the
Group and Company; and
The Annual Report and financial statements, including the Business review, includes a fair review
of the development and performance of the business and the position of the Group and Parent
Company, together with a description of the principal risks and uncertainties that they face.
Cizzle Biotechnology Holdings PLC
22
Corporate Governance Statement
The Directors recognise the importance of sound corporate governance. The directors continue to adopt
the Quoted Companies Alliance’s Corporate Governance Code (“the QCA Code”). The Directors intend
adopting the QCA Code published on 13 November 2023 (“2023 Code”) in the Company’s Annual Report
for the year ended 31 December 2025. As is permitted by the guidance set out by the QCA, the transition
period of 12 months following 1 April 2024 is being utilised to put in place measures to embrace the key
updates to the QCA code where possible. In addition, the Directors have adopted a code of conduct for
dealings in the shares of the Company by directors and employees and are committed to maintaining the
highest standards of corporate governance. During 2024 Allan Syms has continued as Executive Chair of
the Company.
The corporate governance arrangements that the Board has adopted are designed to ensure that the
Company delivers long term value to its shareholders and that shareholders have the opportunity to express
their views and expectations for the Company in a manner that encourages open dialogue with the Board.
The Board recognises that their decisions regarding strategy and risk will impact the corporate culture of
the Company as a whole and that this will impact the performance of the Company. The Board is very
aware that the tone and culture set by the Board will greatly impact all aspects of the Company as a whole
and the way that employees behave.
The Company’s activities have been focussed on translating the research and development activities of the
Group that have been developed over many years by Professor Dawn Coverley and her team at The
University of York, into a marketable product. The Company is committed to respectful dialogue with its
suppliers, partners and potential customers. It is a crucial part of the Company to have sound ethical values
and behaviours in its undertakings to successfully achieve its corporate objectives.
The Board places great importance on this aspect of corporate life and seeks to ensure that this flows
through all that the Company does.
After the end of the financial period under review, the Company announced the appointment
Professor Dawn Coverley as Chief Scientific Officer and Edwin Matthew (Matt) Bower as a Non-Executive
Director, The Board currently consists of three executive and two non-executive directors and does not
have a CEO. The Board continues to consider whether it would be appropriate to seek to appoint additional
non-executive and/or executive directors but at this time believes that appropriate oversight of the Company
is provided by the currently constituted Board. This view will continue to be reviewed by the Board.
John Treacy
Non-Executive Director
Cizzle Biotechnology Holdings PLC
23
Corporate Governance Statement (continued)
The QCA Code sets out 10 principles which should be applied. These are listed below together with a short
explanation of how the Company applies each of the principles. Where the Company does not fully apply
each principle an explanation as to why has also been provided:
Principle One–- Business Model and Strategy
The Group’s vision to help make a global shift in lung cancer survival through accurate, low cost, non-
invasive early detection at scale and to deliver its mission to transform lung cancer survival, by empowering
healthcare professionals and patients to enable curative medical intervention using a groundbreaking and
affordable diagnostic blood test that can detect lung cancer early. The Board’s strategy to deliver its mission
during 2024 has been able to continue with its research and development activity and in particular had
adopted a strategy of developing the Group’s prototype test into a commercial LDT, CE marked and/or FDA
510(k) cleared diagnostic immunoassay that can be licensed globally and readily performed as a sufficiently
reliable test in a hospital setting.
Principle Two–- Understanding Shareholder Needs and Expectations
The Board is committed to maintaining good communication and having constructive dialogue with its
shareholders. Institutional shareholders and analysts have the opportunity to discuss issues and provide
feedback at meetings with the Company. In addition, all shareholders are encouraged to attend the
Company’s Annual General Meeting. Investors also have access to current information on the Company
though its website, https://cizzlebiotechnology.com and via Allan Syms, Executive Chair who is available
to answer investor relations enquiries through IFC Advisory Limited (cizzle@investor-focus.co.uk).
Principle Three–- Stakeholder Responsibilities
The Board recognises that the long-term success of the Company is reliant upon the efforts of the
employees of the Company and its contractors, suppliers and regulators. The Board has put in place a
range of processes and systems to ensure that there is close Board oversight and contact with its key
resources and relationships. Currently the directors of the Company are the Group’s only employees but it
has systems in place whereby the effectiveness of the board is reviewed and discussed.
Principle Four–- Risk Management
In addition to its other roles and responsibilities the Audit and Compliance Committee is responsible to the
Board for ensuring that procedures are in place, and are being effectively implemented to identify, evaluate
and manage the significant risks faced by the Company. The risk assessment matrix below sets out those
risks, and identifies their ownership and the controls that are in place. This matrix is updated as changes
arise in the nature of risks or the controls that are implemented to mitigate them. The Audit Committee
reviews the risk matrix and the effectiveness of scenario testing on a regular basis. The following principal
risks, and controls to mitigate them, have been identified during 2024:
Activity
Risk
Impact
Control(s)
Financial
Early-stage revenue
business
Revenues are not generated
to support the development
and commercialisation of the
Group’s technology.
Regular appraisal of
project milestones.
Healthcare Industry
Pace of development
in
the
healthcare
industry
The Group’s technology may
be
superseded
by
other
competitor technologies.
Continual
monitoring
of competitor products
and
alternative
solutions.
Management
and
employees
Retention of key
staff
The loss of key members of
staff could have an adverse
impact
on
the
pace
of
development.
Ensuring
that
key
employees
have
incentives to ensure
that they do not wish to
leave.
Research
and
Development
Complex processes
.
Additional
costs
if
development takes longer
than anticipated.
Regular appraisal of
project milestones and
consideration of a
variety of strategies.
Patents
and
other
intellectual
property
rights (IPR)
Infringement of other
patents, IPR
Additional costs of defending
any IPR claims and/or delays/
additional costs in current
programme of research and
development.
Regular monitoring of
third party patents/
IPR with patent
advisers.
Cizzle Biotechnology Holdings PLC
24
Corporate Governance Statement (continued)
Principle Four–- Risk Management (continued)
The Company has already established procedures, as represented by this and previous years’ statements,
for the purpose of providing a system of internal control. In addition, there were a range of Company policies
that were reviewed at least annually by the Board. These Company policies covered matters such as share
dealing, insider legislation and expenses. The directors consider that an internal audit function is not
considered necessary or practical due to the size of the Company and the close day to day control exercised
by the directors. The directors will continue to monitor the need for new systems of internal control and an
internal audit function.
The annual review of internal control and financial reporting procedures did not highlight any issues
warranting the introduction of an internal audit function.
Principle Five–- A Well-Functioning Board of Directors
During 2024 the composition of the board has been two executive directors and two non-executive
directors. Allan Syms is Executive Chair and Nigel Lee is the Finance Director. The non-executive directors
have continued to be John Treacy and Professor Dawn Coverley. The time commitment formally required
by the Company is an overriding principal that each director will devote as much time as is required to carry
out the roles and responsibilities that the director has agreed to take on. All directors of the Company are
part-time. On 1 January 2025 Professor Dawn Coverley, Chief Scientific Officer, became an executive
director. On 21 March 2025 Matt Bower became a non-executive director. Biographical details of the current
directors are set out on page 4.
Executive and non-executive directors are subject to re-election intervals as prescribed in the Company’s
Articles of Association. At each Annual General Meeting one-third of the Directors, who are subject to
retirement by rotation shall retire from office. They can then offer themselves for re-election. The letters of
appointment of all directors are available for inspection at the Company’s registered office during normal
business hours.
The Executive Chair and Finance Director both receive a salary for their services as a director which is
approved by the Board, being mindful of the time commitment and responsibilities of their roles and of
current market rates for comparable organisations and appointments. They are also reimbursed for
travelling and other incidental expenses incurred on Group business.
The Non-Executive Directors receive payments under appointment letters which are terminable by three
months’ notice by either party.
The Board encourages the ownership of shares in the Company by Executive and Non-Executive Directors
alike and in normal circumstances does not expect Directors to undertake dealings of a short-term nature.
The Board considers ownership of Company shares by Non-Executive Directors as a positive alignment of
their interest with shareholders. The Board will periodically review the shareholdings of the Non-Executive
Directors and will seek guidance from its advisors if, at any time, it is concerned that the shareholding of
any Non-Executive Director may, or could appear to, conflict with their duties as an independent Non-
Executive Director of the Company or their independence itself. Directors’ emoluments, including Directors’
interest in share options over the Company’s share capital, are set out in Note 15.
The Board has established that it will meet on at least 6 times throughout the year. It has established an
Audit Committee and a Remuneration Committee, particulars of which appear hereafter. The Board agreed
that appointments to the Board are made by the Board as a whole and so has not created a Nominations
Committee.
Cizzle Biotechnology Holdings PLC
25
Corporate Governance Statement (continued)
Principle Five–- A Well-Functioning Board of Directors (continued)
Attendance at Board and Committee Meetings
The Board retains full control of the Company with day-to-day operational control delegated to Executive
Directors. The full Board meets at least every other month and on any other occasions it considers
necessary. During 2024 there were twelve Board meetings, one Remuneration Committee meeting and
one Audit Committee meeting. All Board meetings were attended by all existing directors during 2024. The
Audit Committee meeting was attended by both members of the Audit Committee with the executive
directors in attendance. The Remuneration Committee meeting was attended by only members of the
Remuneration Committee.
Principle Six–- Appropriate Skills and Experience of the Directors
Directors who served during 2024:
Throughout 2024 the executive directors have been Allan Syms (Executive Chair) and Nigel Lee (Finance
Director). The Non-Executive directors have been John Treacy (specialising in corporate governance,
capital markets, legal matters) and Professor Dawn Coverley (cell biologist and expert in cancer related
research).
On 1 January 2025, Professor Dawn Coverley (Chief Scientific Officer), was appointed an executive director
and on 21 March 2025, Matt Bower was appointed a non-executive director (specialising as a strategic
advisor).
As a small business, the Group does not have a formal diversity policy. The Group recognises the benefits
of diversity across all areas and believes that a diverse Board is a positive factor in business success,
brings a broader, more rounded perspective to decision making, and makes the Board more effective.
When recruiting, the Board will endeavour to consider a wide and diverse talent pool whilst also taking into
account the optimum make-up of the Board, including the benefits of differences in skills, industry
experience, business model experience, sex, gender, race, disability, age, nationality, background and
other attributes that individuals may bring.
The current directors of the Company are as follows are detailed on page 6.
Principle Seven–- Evaluation of Board Performance
Internal evaluation of the Board, the Committee and individual directors is seen as an important step in the
development of the Board. During 2024 separate meetings were held with the Chair and each director to
review the effectiveness of the board. Evaluation criteria take into account business planning and financial
reporting together with performance against key milestones, board composition, constitution, diversity and
succession planning. As we further progress the commercialisation of the Group’s technology, the
Company recognises the need to draw further expertise into the board when appropriate. This will be
undertaken on an annual basis in the form of peer appraisal, questionnaires and discussions to determine
the effectiveness and performance in various areas as well as the directors’ continued independence.
Principle Eight–- Corporate Culture
During 2024, the Board recognised that their decisions regarding strategy and risk will impact the corporate
culture of the Company as a whole and that this will impact the performance of the Company. The Board is
very aware that the tone and culture set by the Board will greatly impact all aspects of the Company as a
whole and the way that employees behave. A large part of the Company’s activities was centred upon
addressing customer and market needs. Therefore, the importance of sound ethical values and behaviours
is crucial to the ability of the Company to successfully achieve its corporate objectives. The Board places
great importance on this aspect of corporate life and seeks to ensure that this flows through all that the
Company does. The Board assessment of the culture within the Company at the present time is one where
there is respect for all individuals and there is open dialogue within the Company.
Cizzle Biotechnology Holdings PLC
26
Corporate Governance Statement (continued)
Principle Nine–- Maintenance of Governance Structures and Processes
Ultimate authority for all aspects of the Company’s activities rests with the Board. The Board has adopted
a Financial Position and Prospects Board Memorandum which summarises financial reporting procedures
and establishes procedures to ensure that it meets all regulatory requirements for accounting, financial
reporting and related obligations. This includes matters which are reserved to the Board and the division of
responsibilities between the executive and non-executive directors. The Chair is responsible for the
effectiveness of the Board.
Audit Committee
During 2024 the Audit Committee has consisted of John Treacy (Chair) and Professor Dawn Coverley. It
meets as required and specifically to review the Interim Report and Annual Report, and to consider the
suitability and monitor the effectiveness of internal control processes. There was one meeting of the Audit
Committee during 2024. The Audit Committee also reviews the findings of the external auditor and reviews
accounting policies, material accounting judgements and risk and control framework. On 1 January 2025
Professor Dawn Coverley became an executive director and so stepped down from the Audit Committee.
During March 2025 Matt Bower joined the Audit Committee.
The independence and effectiveness of the external auditor is reviewed annually. The possibility of
undertaking an audit tender process is considered on a regular basis. The Company’s policy is to ensure
that the Company’s audit is put out to tender at least once in every 10 years. The Current auditors were
appointed in respect of the Company’s audit for the year ended 31 December 2018. At each Annual General
Meeting a resolution is proposed for the re-appointment of auditors. There are no contractual restrictions
existing on the choice of auditors. The Audit Committee meets at least once a year with the auditor to
discuss their independence and objectivity, the Annual Report, any audit issues arising, internal control
processes, appointment and fee levels and any other appropriate matters. The fees in respect of audit
services are set out in Note 7.
Remuneration Committee
During 2024 the Remuneration Committee has consisted of John Treacy (Chair) and Professor Dawn
Coverley. The purpose of the Remuneration Committee is to ensure that the Executive Directors and other
employees are fairly rewarded for their individual contribution to the overall performance of the Company.
The Committee considers and recommends to the Board the remuneration of the Executive Directors and
is kept informed of the remuneration packages of senior staff and invited to comment on these. There was
one Remuneration Committee meeting during 2024. The Board retains responsibility for overall
remuneration policy. The Remuneration Committee recommends to the Board the remuneration packages
by reference to individual performance and uses the knowledge and experience of the Committee members,
published surveys relating to similar companies and market changes generally. The Remuneration
Committee has responsibility for recommending any long-term incentive schemes.
On 1 January 2025 Dawn Coverley ceased to be a member of the Remuneration Committee and Matt
Bower became a member on 21 March 2025.
The Board determines whether or not Executive Directors are permitted to serve in roles with other
companies. Such permission would only be granted on a strictly limited basis, where there are no conflicts
of interest or competing activities and providing there is not an adverse impact on the commitments required
to the Company. Earnings from such roles would be required to be disclosed to the Chair.
During 2024 there were two main elements of the remuneration package for Executive and Non-Executive
Directors and former employees:
1.
Basic salaries: Basic salaries are recommended to the Board by the Remuneration Committee,
taking into account the performance of the individual and the rates for similar positions in comparable
companies. No benefits in kind are currently available to Executive Directors. The directors agreed to freeze
their remuneration for two years until March 2025 (now expired) as noted in the Directors Remuneration
Report on page 32.
2.
Share options: The Company operates unapproved share option schemes for Executive Directors
and some non-executive directors to motivate those individuals through equity participation. Exercise of
share options under the schemes is subject to specified exercise periods and compliance with the Scheme
Rules and the rules of the London Stock Exchange. The schemes are overseen by the Remuneration
Committee which recommends to the Board all grants of share options based on the Remuneration
Committee’s assessment of personal performance and specifying the terms under which eligible individuals
may be invited to participate. It is intended that the performance related elements of
Cizzle Biotechnology Holdings PLC
27
Corporate Governance Statement (continued)
remuneration form a significant proportion of the total remuneration package of Executive Directors and be
designed to align their interests with those of shareholders. In this development phase of the Company the
Remuneration Committee currently considers that the best alignment of these interests is through the
continued use of incentives for performance through the award of share options.
Non-executive Directors
The Board has adopted guidelines for the appointment of non-executive directors which have been in place
and which have been observed throughout the year. These provide for the orderly and constructive
succession and rotation of the non-executive directors insofar as they will be appointed for an initial term of
three years and may, at the Board’s discretion believing it to be in the best interests of the Company, be
appointed for subsequent terms. In accordance with the Companies Act 2006, the Board complies with: a
duty to act within their powers; a duty to promote the success of the Company; a duty to exercise
independent judgement; a duty to exercise reasonable care, skill and diligence; a duty to avoid conflicts of
interest; a duty not to accept benefits from third parties and a duty to declare any interest in a proposed
transaction or arrangement.
Principle Ten–- Shareholder Communication
The Board is committed to maintaining good communication and having constructive dialogue with its
shareholders. Institutional shareholders and analysts have the opportunity to discuss issues and provide
feedback at meetings with the Company. In addition, all shareholders are encouraged to attend the
Company’s Annual General Meeting. Investors also have access to current information on the Company
though its website, https://cizzlebiotechnology.com and via Allan Syms, executive Chair who is available to
answer investor relations enquiries through IFC Advisory Limited (cizzle@investor-focus.co.uk).
Cizzle Biotechnology Holdings PLC
28
Directors’ Remuneration Report for the year ended 31 December 2024
The Company has established a remuneration committee. The Committee reviews the scale and structure
of the Directors’ fees, taking into account the interests of shareholders and the performance of the Group
and directors.
The items included in this report are unaudited unless otherwise stated.
Statement of Cizzle Biotechnology Holdings PLC Policy on Directors’ Remuneration by the Chair of
the Remuneration Committee
As Chair of the Remuneration Committee, I have pleasure in introducing our Directors’ Remuneration
Report. One of the Remuneration Committee’s aims is to provide clear, transparent remuneration reporting
for our shareholders which adheres to the best practice corporate governance principles that are required
for listed companies.
A key focus of the Directors’ Remuneration Policy is to align the interests of the Directors to the long-term
interests of the shareholders and aims to support a high-performance culture with appropriate rewards for
meeting the Group’s objectives without unnecessary risk-taking. This is underpinned through the operation
of incentive plans.
Key activities of the Remuneration Committee
The key activities of the Remuneration Committee are to:
determine and agree with the board the framework or broad policy for the remuneration of the
Company’s Chair and the executive directors including pension rights and compensation
payments. The remuneration of non-executive directors shall be a matter for the board or the
shareholders (within the limits set in the articles of association). No director or senior manager shall
be involved in any decisions as to their own remuneration;
recommend and monitor the level and structure of remuneration for senior management taking into
account all factors which it deems necessary including relevant legal and regulatory requirements
and the provisions and recommendations of the UK Corporate Governance Code (insofar as it
applies to the Company) and other relevant guidance. These will be subject to annual review. The
objective of such policy shall be to attract, retain and motivate the executive management of the
Company without paying more than necessary. The remuneration policy bears in mind the
Company’s appetite for risk and be aligned to the Company’s long term strategic goals. A significant
proportion of remuneration should be structured so as to link rewards to corporate and individual
performance and be designed to promote the long term success of the Company;
review and have regard to the pay and employment conditions across the Company or Group,
especially when determining salary increases;
review the ongoing appropriateness and relevance of the remuneration policy;
approve the design of, and determine targets for, any performance related pay schemes operated
by the Company and approve the total annual payments made under such schemes;
review the Company’s arrangements for its employees to raise concerns, in confidence, about
possible wrongdoing in financial reporting or other matters. The Committee shall ensure that these
arrangements allow proportionate and independent investigation of such matters and appropriate
follow up action;
review the design of all share incentive plans for approval by the board and shareholders. For any
such plans, determine each year whether awards will be made, and if so, the overall amount of
such awards, the individual awards to executive directors, Company Secretary and other senior
executives and the performance targets to be used;
determine the policy for, and scope of, pension arrangements for each executive director and other
senior executives;
Cizzle Biotechnology Holdings PLC
29
Directors’ Remuneration Report for the year ended 31 December 2024 (cont’d)
Key activities of the Remuneration Committee (cont’d)
determine the total individual remuneration package of the Chair, each executive director, the
Company Secretary and other senior executives including bonuses, incentive payments and share
options or other share awards;
ensure that contractual terms on termination and any payments made are fair to the individual and
the Company; that failure is not rewarded and the duty to mitigate loss is fully recognised; oversee
any major changes in employee benefits structures throughout the Company or Group; and agree
the policy for authorising claims for expenses from the directors;
be responsible for establishing the selection criteria, selecting, appointing and setting the terms of
reference for any remuneration of consultants who advise the Committee;
obtain reliable, up-to-date information about remuneration in other companies of comparable scale.
The Committee shall have full authority to appoint remuneration consultants and to commission or
purchase any reports, surveys or information which it deems necessary to help it fulfil its obligations
within any budgetary restraints imposed by the board;
consider such other matters as may be requested by the board of directors; and
work and liaise as necessary with all other board committees.
Members
The Remuneration Committee comprises the following independent Non-Executive Directors:
Name
Position
Date
of
appointment
to
Committee
John Treacy
Chair
14 May 2021
Prof. Dawn Coverley *
Member
14 May 2021
*Prof. Dawn Coverley ceased to be a member of the Remuneration Committee on 1 January 2025.
Remuneration Components
The Company remunerates directors in line with best market practice in the industry in which it operates.
As the Group is currently a pre-revenue business the components of Director’s Remuneration consists of:
Base salaries
Pension benefits
Share incentive arrangements
These remuneration components will be reviewed at least annually by the Committee.
It is anticipated that once the Group becomes a revenue generating business that the following components
of Directors Remuneration are likely to be appropriate:
Other benefits
Annual bonus
Cizzle Biotechnology Holdings PLC
30
Directors’ Remuneration Report for the year ended 31 December 2024 (cont’d)
Recruitment policy
Base salaries take into account market data for the relevant role, internal relativities, their individual
experience and their current base salary. Where an individual is recruited at below market rates of
remuneration, they may be re-aligned over a period of time, subject to their performance in their role.
Service Agreements and Letters of Appointment
The Executive Directors’ service agreements are summarised below:
Executive
Director
Date of service
agreement
Initial term
Notice
period
by
Company (Months)
Notice
period
by
Director (Months)
Allan Syms
14 May 2021
6 months
6
6
Nigel Lee
14 May 2021
N/a
6
6
Post year end
Dawn Coverley
1 January 2025
N/a
6
6
The Non-Executive Directors’ service agreements are summarised below:
Non-Executive
Director
Date of service
agreement
Initial term
Notice
period
by
Company (Months)
Notice
period
by
Director (Months)
John Treacy
14 May 2021
3 years
3
3
Dawn Coverley
14 May 2021
3 years
3
3
Non-Executive directors are typically expected to serve two three-year terms but may be invited by the
Board to serve for an additional period. Any term renewal is subject to Board review and AGM re-election.
Remuneration of Executive Directors (audited)
The remuneration of the Executive Directors for the year ended 31 December 2024 was as follows:
Year ended 31 December 2024
Year ended 31 December 2023
Executive
Director
Basic salary
£’000
Pension
£’000
Total
£’000
Basic salary
£’000
Pension
£’000
Total
£’000
Allan Syms
90
3
93
90
3
93
Nigel Lee
36
1
37
36
1
37
TOTAL
126
4
130
126
4
130
Cizzle Biotechnology Holdings PLC
31
Directors’ Remuneration Report for the year ended 31 December 2024 (cont’d)
Share scheme interests of executive directors (audited)
The interests of the executive directors in share schemes are shown in the table below:
Executive
Director
Type of
scheme
Share
options at
31 Dec
2023
Granted
during the
year
Share options at
31 Dec 2024
Date from
which
exercisable
Expiry date
Allan
Syms
CSOP 23
CSOP 21
8,868,096
5,068,956
-
-
8,868,096
5,068,956
****
**
28 Jun 2033
2 Nov 2031
Nigel Lee
*
CSOP 23
CSOP 21
CSOP 17
CSOP 16
CSOP 15
6,224,233
2,000,000
500
800
300
-
-
-
-
-
6,224,233
2,000,000
500
800
300
****
**
9 Nov 2018 ***
27 Oct 2017 ***
25 May 2016 ****
28 Jun 2033
2 Nov 2031
8 Nov 2027
26 Oct 2026
25 Aug 2025
TOTAL
22,162,885
-
22,162,885
* Includes brought forward 1,600 beneficial interests in share options as director of CFO Solutions Limited.
** subject to achievement of certain Group objectives.
*** One-third of the total options vest on first, second and third anniversary from date of grant.
**** One third of the options vest on 25 May 2016, 25 February 2017 and 25 August 2017.
**** Granted in respect of salary freeze for 2 years to 3 March 2025 – 50% exercisable on both 3 March
2024 and 3 March 2025.
In addition to this Nigel Lee had a beneficial interest in 18,571 shares of the Company that are held by CFO
Solutions, a company that he is both a director and a shareholder. The have been no changes to this
shareholding since 31 December 2024.
Remuneration of Non-Executive Directors (audited)
The remuneration of the Non-Executive Directors for the year ended 31 December 2024 was as follows:
Year ended 31 December 2024
Year ended 31 December 2023
Non-
Executive
Director
Basic
salary
£’000
Bonus
£’000
Fees
£’000
Pension
£’000
Total
£’000
Basic
salary
£’000
Bonus
£’000
Fees
£’000
Pension
£’000
Total
£’000
John
Treacy
30
-
-
-
30
30
-
-
-
30
Dawn
Coverley
40
-
-
1
41
40
-
-
1
41
TOTAL
70
-
-
1
71
70
-
-
1
71
Cizzle Biotechnology Holdings PLC
32
Directors’ Remuneration Report for the year ended 31 December 2024 (cont’d)
Share scheme interests of non- executive directors (audited)
The interests of the Non-Executive directors in share schemes are shown in the table below:
Non-
executive
Director
Type of
scheme
Share options
at 31 Dec
2023
Granted
during the
year
Exercised
in year
Share options
at 31 Dec
2024
Date from
which
exercisable
Expiry date
Dawn
Coverley
***
CSOP 23
CSOP 21
7,614,540
12,672,389
-
-
-
-
7,614,540
12,672,389
**
*
28 Jun 2033
2 Nov 2031
John
Treacy
CSOP 23
6,235,629
-
-
6,235,629
**
28 Jun 2033
TOTAL
26,522,558
-
-
26,522,558
* subject to achievement of certain Group objectives.
** Granted in respect of salary freeze for 2 years to 3 March 2025 – 50% exercisable on both 3 March 2024
and 3 March 2025.
*** Note that Dawn Coverley became an executive director on 1 January 2025.
In addition to this Dawn Coverley owns 9,992,589 shares of the Company at 31 December 2024 and also
has a beneficial interest in 7,055,548 shares of the Company that are held by her husband, Dr Justin
Ainscough. There have been no changes to these shareholdings since 31 December 2024.
On 21 March 2025, Matt Bower, became a non-executive director of the Company and had previously been
providing consultancy services through his service company, Makabo Limited. At 31 December 2024
Makabo Limited held 2,464,625 options over shares in the Company with an exercise price of 1.622965.
These options were exercisable on the condition that VWAP of the Company’s Ordinary shares is at least
3.24593p , being at least twice the Options grant price, from 25 May 2025 to 24 June 2025. These options
will lapse on 25 June 2027.
Review of remuneration for all directors
On 7 March 2023 the Company announced director salary waivers and the award of share options. In
conducting a review of director remuneration, the Company’s remuneration committee was of the view that
the Company’s directors’ salaries are currently below market comparables. However, even in a period of
high inflation, the directors remain fully committed to maintaining low overheads and maximising the funds
available to the Group for the development of its CIZ1B early lung cancer test. The directors have therefore
agreed to waive any increase in basic salary for a period of two years from 3 March 2023 (which has now
ended). In compensation, and subject to shareholder approval at the next Annual General Meeting of the
Company, the Company has conditionally granted share options over new ordinary shares in the Company
(the “Options”) to the directors, with an exercise price equivalent to the volume weighted average price of
the Company’s ordinary shares for the month of February 2023 at 2.19376p per share. 50% of the Options
will vest and become exercisable after the 12-month anniversary of grant; the remaining 50% shall vest
and become exercisable on the 24-month anniversary of grant. The Options will have a 10 year life from
the date of grant and are subject to good and bad leaver provisions. The Options are unapproved for the
purposes of the enterprise management incentive and have been granted outside of, and in addition to,
grants made under the Company’s existing share option schemes.
Relative importance of total remuneration
The table below illustrates total employee remuneration compared to distributions to shareholders and
operational cash outflow, excluding proceeds from the issue of ordinary shares (before issue costs):
Distributions
to
shareholders
Total employee pay
(£’000)
Group Operational
cash outflow (£’000)
Year ended 31 December 2024
-
215
358
Operational cash outflow has been shown in the table above as cash flow monitoring and forecasting are
an important consideration for the Remuneration Committee and Board of Directors when determining
cash-based remuneration for directors and employees.
Cizzle Biotechnology Holdings PLC
33
Directors’ Remuneration Report for the year ended 31 December 2024 (cont’d)
Historical remuneration
The remuneration of the directors since 2019 is as follows:
2019
2020
*
2021
*
2022
*
£’000
Sal
Pen
Total
Sal
Pen
Total
%
Sal
Pen
Total
%
Sal
Bonus
Pen
Total
%
Allan Syms
18
-
18
30
-
30
66%
70
1
71
136
%
90
-
3
93
31
%
Nigel Lee
-
-
-
-
-
-
-
21
1
22
N/a
36
-
1
37
68
%
Dawn
Coverley
-
-
-
-
-
-
-
25
1
26
N/a
40
104
1
145
457%
John
Treacy
28
-
28
30
-
30
-
30
-
30
-
30
-
-
30
-
Total
46
-
46
60
-
60
30%
146
3
149
148%
196
104
5
305
105%
*represents percentage change over the previous two years.
2023
*
2024
*
£’000
Sal
Pen
Total
%
Sal
Pen
Total
%
Allan Syms
90
3
93
-
90
3
93
-
Nigel Lee
36
1
37
-
36
1
37
-
Dawn Coverley
40
1
41
(72%)
40
1
41
-
John Treacy
30
-
30
-
30
-
30
-
Total
196
5
204
(33%)
196
5
204
-
Pension Schemes
The Group and Company do not operate any defined benefit pension schemes. Any pension contributions
are paid into defined contribution schemes of individual employees.
Cizzle Biotechnology Holdings PLC
34
Directors’ Remuneration Report for the year ended 31 December 2024 (cont’d)
Historical share price performance comparison
The table below compares the share price performance (based on notional investment of £100) of Cizzle
Biotechnology Holdings PLC against the FTSE SmallCap and FTSE Techmark Mediscience based on
prices/indices at close of business from 1 January 2024 to 31 December 2024. Note that month end prices
are based on the last day of trading of each month. The FTSE SmallCap has been chosen to provide a
wider market comparator and the FTSE Techmark Mediscience chosen due to sector relevance:
Consideration of shareholder views
The Board considers shareholder feedback received and guidance from shareholder bodies. This feedback
is considered as part of the Company’s policy on remuneration.
Approved on behalf of the Board of Directors
John Treacy
Director and Chair of the Remuneration Committee
30 April 2025
Cizzle Biotechnology Holdings PLC
35
INDEPENDENT
AUDITOR’S
REPORT
TO
THE
MEMBERS
OF
CIZZLE
BIOTECHNOLOGY HOLDINGS PLC
Opinion
We have audited the financial statements of Cizzle Biotechnology Holdings Plc (the ‘company’) and its
subsidiaries (the ‘group’) for the year ended 31 December 2024 which comprise the Consolidated
Statement of Comprehensive Income, the Consolidated and Company Statements of Financial Position,
the Consolidated and Company Statements of Changes in Equity, the Consolidated and Company
Statements of Cash Flows and notes to the financial statements, including significant accounting policies.
The financial reporting framework that has been applied in their preparation is applicable law and UK-
adopted international accounting standards and as regards the company financial statements, as applied
in accordance with the provisions of the Companies Act 2006.
In our opinion:
the financial statements give a true and fair view of the state of the group’s and of the company’s
affairs as at 31 December 2024 and of the group’s loss for the year then ended;
the group financial statements have been properly prepared in accordance with UK-adopted
international accounting standards;
the company financial statements have been properly prepared in accordance with UK-adopted
international accounting standards and as applied in accordance with the provisions of the
Companies Act 2006; and
the financial statements have been prepared in accordance with the requirements of the
Companies Act 2006.
Basis for opinion
We conducted our audit in accordance with International Standards on Auditing (UK) (ISAs (UK)) and
applicable law. Our responsibilities under those standards are further described in the Auditor’s
responsibilities for the audit of the financial statements section of our report. We are independent of the
group and company in accordance with the ethical requirements that are relevant to our audit of the financial
statements in the UK, including the FRC’s Ethical Standard as applied to listed public interest entities, and
we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that
the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Material uncertainty related to going concern
We draw attention to note 2.2 in the financial statements, which indicates that the group and company is
reliant on the timely receipt of agreed royalty payments from a third party to be able to continue as a going
concern for at least the 12 months from the date of these financial statements. There remains uncertainty
if the third party will be able to make these payments as it is dependent on raising further funds. Should
these royalty payments be delayed or not materialise, then the company may be required to raise additional
funding to continue to meet its obligations. As stated in note 2.2, these events or conditions, along with the
other matters as set forth in note 2.2, indicate that a material uncertainty exists that may cast significant
doubt on the company’s ability to continue as a going concern. Our opinion is not modified in respect of this
matter.
In auditing the financial statements, we have concluded that the directors’ use of the going concern basis
of accounting in the preparation of the financial statements is appropriate. Our evaluation of the directors’
assessment of the company’s ability to continue to adopt the going concern basis of accounting included:
Testing the mathematical accuracy of the base case and a downside scenario forecasts;
Evaluating and challenging the appropriateness of the forecasting method by using our
understanding of the group and company and by considering past historical accuracy of the
directors’ forecasting and comparing the actual post year end results with the forecasts;
Understanding the forecasts including the key inputs used and sources of these inputs through
inquiries with the directors and management and, where possible, obtaining supporting
documentation for such key inputs;
Performing sensitivity analysis on the main assumptions and considering if whether there is still
sufficient cash on hand to cover their working capital;
Cizzle Biotechnology Holdings PLC
36
INDEPENDENT
AUDITOR’S
REPORT
TO
THE
MEMBERS
OF
CIZZLE
BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)
Reviewing the reasonableness of downside scenarios; and
Assessing the appropriateness and adequacy of the group’s and company’s going concern
disclosures included in the financial statements.
Our responsibilities and the responsibilities of the directors with respect to going concern are described in
the relevant sections of this report.
Our application of materiality
The scope of our audit was influenced by our application of materiality. We set certain quantitative
thresholds for materiality. These, together with qualitative considerations, helped us to determine the scope
of our audit and the nature, timing and extent of our audit procedures on the individual financial statement
line items and disclosures and in evaluating the effect of misstatements, both individually and in aggregate
on the financial statements as a whole. Based on our professional judgement, we determined the materiality
thresholds for the financial statements as follows:
Group Financial Statements
Company financial
statements
Material for the financial
statements as a whole
£16,300 (2023: £73,300)
£12,800 (2023: £69,600)
Performance materiality
£13,000 (2023: £51,300)
£10,200 (2023: £48,700)
Basis for materiality for the
financial statements as a
whole
2% of the group’s expenses (2023:
5% of the group’s net assets)
2% of the company’s expenses
(2023: 5% of the company’s net
assets, capped at 95% of group
materiality)
Rationale
The focus of the financial statement users is on the company's ability to
manage its operational expenses and maintain sufficient liquidity to
continue its research and development activities. Since the company
has not yet generated revenue, the primary financial metrics of interest
are the levels of expenses, the rate at which cash is being used, and
the efficiency of resource allocation. These metrics provide insights into
the company's operational sustainability and its progress towards
achieving commercial viability.
The percentage applied to the benchmark has been selected to bring
into scope all significant classes of transactions, account balances and
disclosures relevant for the members, and also to ensure that matters
that would have a significant impact on the results were appropriately
considered.
Performance materiality has been set at 80% of materiality for the
financial statements as a whole, for both the group and company. The
percentage applied was determined after considering the number and
quantum of identified misstatements in the prior year audit,
management’s attitude to correcting misstatements identified and our
cumulative knowledge of the group and company including the
environment they operate in.
Cizzle Biotechnology Holdings PLC
37
INDEPENDENT
AUDITOR’S
REPORT
TO
THE
MEMBERS
OF
CIZZLE
BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)
Our approach to the audit
In designing our audit approach, we determined materiality, as above, and assessed the risk of material
misstatement in the financial statements. In particular, we looked at significant risk areas being the valuation
of the investment held in subsidiary (Company only) and other income. As part of our work on going concern
we considered future events that are inherently uncertain such as future research and development
expenditure and the expected royalty payments to be received from the agreement entered into with third
party.
We also addressed the risk of management override of internal controls, including evaluating whether there
was evidence of bias by management that represented a risk of material misstatement due to fraud.
There are three components in the group being the company and two subsidiary undertakings, namely,
Cizzle Biotechnology Limited and Cizzle Biotech Limited (dormant entity). Of the trading components, both
were considered key based on size and containing the key audit risks identified during our planning and
accordingly, a full scope audit was performed on both these components. Our audit was performed from
our London office with regular contact with management and the directors throughout the audit. This, in
conjunction with additional procedures performed, gave us sufficient and appropriate evidence for our
opinion on the group and company financial statements.
Key audit matters
Key audit matters are those matters that, in our professional judgment, were of most significance in our
audit of the financial statements of the current period and include the most significant assessed risks of
material misstatement (whether or not due to fraud) we identified, including those which had the greatest
effect on: the overall audit strategy, the allocation of resources in the audit; and directing the efforts of the
engagement team. These matters were addressed in the context of our audit of the financial statements as
a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters.
In addition to the matter described in the Material uncertainty related to going concern section we have
determined the matters described below to be the key audit matters to be communicated in our report.
Cizzle Biotechnology Holdings PLC
38
INDEPENDENT
AUDITOR’S
REPORT
TO
THE
MEMBERS
OF
CIZZLE
BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)
Key Audit Matter
How our scope addressed this matter
Valuation of Investments (Company Only) –
Notes 2.6 and 11
The Company carries a material “Investment
in subsidiary undertakings” balance in its
Statement of Financial Position. There is a
risk that the carrying value of the
Investments is greater than the recoverable
amount and is therefore impaired.
As the estimated recoverable amount of
investments is subjective due to the inherent
uncertainty involved in ascertaining whether
any impairment indicators are met and if so,
forecasting and discounting future cashflows,
there is a risk that the carrying value of
investments are overstated.
Our work in this area included:
Considering the existence of impairment indicators
per IAS 36 Impairment of Assets, which included
but were not limited to considering the external
and internal sources of information. This included:
o
Reviewing key assumptions and inputs
made by management’s expert in the
valuation of the subsidiary in previous years
and ascertaining whether there have been
any changes to the basis of these key
assumptions and inputs that would indicate
an impairment;
o
Reviewing and discussing the development
timelines of the Biomarker and the key
milestones that were estimated to be
reached since the acquisition of the
subsidiary;
o
Assessing the changes to the biotechnology
market and the technological and legal
environment and the implications to the
expected prices and costs included in the
valuation; and
o
Reviewing the progress of the underlying
research and development of the Biomarker
since the acquisition and assessing the
future plans of the group and company as
part of our going concern.
Reviewing the value of the net investment in
subsidiaries against the supporting underlying
assets;
Reviewing the associated disclosures in the
financial
statements
and
assessing
the
appropriateness of such disclosures.
Based on the procedures performed, we concluded that
management’s impairment assessment are reasonable.
Other Income (Group) Note 2.4
During the year the Group signed its first
license agreement on which it recognised
income.
The agreement involves significant upfront
and milestone payments, as well as royalty
payments. There is a risk that the amounts
may be recognised prematurely, inaccurately
or not disclosed correctly as revenue in the
financial statements. Given that Cizzle has not
had any of such agreements in the past, there
is currently no accounting policy in place to
handle the accurate recognition of the
amounts.
Our work in this area included:
Reviewing the terms of the agreement to ensure
revenue is recognised in accordance with
applicable accounting standards (e.g., IFRS 15).
Verifying the timing and amounts of upfront and
milestone payments.
Confirming the accuracy of royalty calculations
and ensure they are based on net sales as
stipulated.
Reviewing the associated disclosures in the
financial
statements
and
assessing
the
appropriateness of such disclosures.
Based on the procedures performed, we concluded that
management’s income recognition assessment is
reasonable.
Cizzle Biotechnology Holdings PLC
39
INDEPENDENT
AUDITOR’S
REPORT
TO
THE
MEMBERS
OF
CIZZLE
BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)
Other information
The other information comprises the information included in the annual report, other than the financial
statements and our auditor’s report thereon. The directors are responsible for the other information
contained within the annual report. Our opinion on the group and company financial statements does not
cover the other information and, except to the extent otherwise explicitly stated in our report, we do not
express any form of assurance conclusion thereon. Our responsibility is to read the other information and,
in doing so, consider whether the other information is materially inconsistent with the financial statements
or our knowledge obtained in the course of the audit, or otherwise appears to be materially misstated. If we
identify such material inconsistencies or apparent material misstatements, we are required to determine
whether this gives rise to a material misstatement in the financial statements themselves. If, based on the
work we have performed, we conclude that there is a material misstatement of this other information, we
are required to report that fact.
We have nothing to report in this regard.
Opinions on other matters prescribed by the Companies Act 2006
In our opinion the part of the directors’ remuneration report to be audited has been properly prepared in
accordance with the Companies Act 2006.
In our opinion, based on the work undertaken in the course of the audit:
the information given in the strategic report and the directors’ report for the financial year for which
the financial statements are prepared is consistent with the financial statements; and
the strategic report and the directors’ report have been prepared in accordance with applicable
legal requirements.
Matters on which we are required to report by exception
In the light of the knowledge and understanding of the group and the company and their environment
obtained in the course of the audit, we have not identified material misstatements in the strategic report or
the directors’ report.
We have nothing to report in respect of the following matters in relation to which the Companies Act 2006
requires us to report to you if, in our opinion:
adequate accounting records have not been kept by the company, or returns adequate for our audit
have not been received from branches not visited by us; or
the company financial statements and the part of the directors’ remuneration report to be audited are
not in agreement with the accounting records and returns; or
certain disclosures of directors’ remuneration specified by law are not made; or
we have not received all the information and explanations we require for our audit.
Responsibilities of directors
As explained more fully in the statement of directors’ responsibilities, the directors are responsible for the
preparation of the group and company financial statements and for being satisfied that they give a true and
fair view, and for such internal control as the directors determine is necessary to enable the preparation of
financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the group and company financial statements, the directors are responsible for assessing the
group’s and the company’s ability to continue as a going concern, disclosing, as applicable, matters related to
going concern and using the going concern basis of accounting unless the directors either intend to liquidate
the group or the company or to cease operations, or have no realistic alternative but to do so.
Auditor’s responsibilities for the audit of the financial statements
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free
from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our
Cizzle Biotechnology Holdings PLC
40
INDEPENDENT
AUDITOR’S
REPORT
TO
THE
MEMBERS
OF
CIZZLE
BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)
opinion. Reasonable assurance is a high level of assurance but is not a guarantee that an audit conducted in
accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise
from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be
expected to influence the economic decisions of users taken on the basis of these financial statements.
Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design
procedures in line with our responsibilities, outlined above, to detect material misstatements in respect of
irregularities, including fraud. The extent to which our procedures are capable of detecting irregularities,
including fraud is detailed below:
We obtained an understanding of the group and company and the sector in which they operate to
identify laws and regulations that could reasonably be expected to have a direct effect on the financial
statements. We obtained our understanding in this regard through discussions with management,
industry research, application of cumulative audit knowledge and experience of the biotechnology
sector.
We determined the principal laws and regulations relevant to the group and company in this regard to
be those arising from:
o
Companies Act 2006;
o
UK-adopted International Accounting Standards;
o
Health and Safety Act 1974;
o
Listing and Disclosure and Transparency Rules;
o
LSE Main Market Listing Regulations;
o
Anti-bribery and anti-money laundering regulations;
o
QCA Code; and
o
UK taxation law.
We designed our audit procedures to ensure the audit team considered whether there were any
indications of non-compliance by the group and company with those laws and regulations.
These procedures included, but were not limited to:
o
Holding discussions with management and the directors and considering whether there were
any known or suspected instances of non-compliance with laws and regulations or fraud;
o
Reviewing board meeting minutes;
o
Reviewing Regulatory News Service (RNS) announcements; and
o
Reviewing legal and regulatory correspondence and legal expenses.
We also identified the risks of material misstatement of the financial statements due to fraud. We
considered, in addition to the non-rebuttable presumption of a risk of fraud arising from management
override of controls, that the potential for management bias was identified in relation to the valuation
of investments and income recognition (detailed in the key audit matters section of our report). We
addressed this by challenging the assumptions and judgements made by management when auditing
that significant accounting estimate and ensuring that there were adequate disclosures included in the
respective notes.
As in all of our audits, we addressed the risk of fraud arising from management override of controls by
performing audit procedures which included, but were not limited to: the testing of journals; reviewing
accounting estimates for evidence of bias; and evaluating the business rationale of any significant
transactions that are unusual or outside the normal course of business.
Because of the inherent limitations of an audit, there is a risk that we will not detect all irregularities, including
those leading to a material misstatement in the financial statements or non-compliance with regulation. This
risk increases the more that compliance with a law or regulation is removed from the events and transactions
reflected in the financial statements, as we will be less likely to become aware of instances of non-compliance.
The risk is also greater regarding irregularities occurring due to fraud rather than error, as fraud involves
intentional concealment, forgery, collusion, omission or misrepresentation.
Cizzle Biotechnology Holdings PLC
41
INDEPENDENT
AUDITOR’S
REPORT
TO
THE
MEMBERS
OF
CIZZLE
BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)
A further description of our responsibilities for the audit of the financial statements is located on the Financial
Reporting Council’s website at: www.frc.org.uk/auditorsresponsibilities. This description forms part of our
auditor’s report.
Other matters which we are required to address
We were appointed by the directors on 13 February 2019 to audit the financial statements for the period ending
31 December 2018 and subsequent financial periods. Our total uninterrupted period of engagement is 7 years,
covering the periods ending 31 December 2018 to 31 December 2024.
The non-audit services prohibited by the FRC’s Ethical Standard were not provided to the group or the
company and we remain independent of the group and the company in conducting our audit.
Our audit opinion is consistent with the additional report to the audit committee.
Use of our report
This report is made solely to the company’s members, as a body, in accordance with Chapter 3 of Part 16 of
the Companies Act 2006. Our audit work has been undertaken so that we might state to the company’s
members those matters we are required to state to them in an auditor’s report and for no other purpose. To
the fullest extent permitted by law, we do not accept or assume responsibility to anyone, other than the
company and the company's members as a body, for our audit work, for this report, or for the opinions we
have formed.
Hannes Verwey (Senior Statutory Auditor)
15 Westferry Circus
For and on behalf of PKF Littlejohn LLP
Canary Wharf
Statutory Auditor
London E14 4HD
30 April 2025
Cizzle Biotechnology Holdings PLC
42
Consolidated Statement of Comprehensive Income
for the year ended 31 December 2024
Notes
Group
Year ended 31
December
2024
£’000
Group
Year ended 31
December
2023
£’000
Administrative expenses
- on-going administrative costs
6
(687)
(669)
- cost associated with put option
6
-
(120)
- share option charge
6
(189)
(307)
- gain on transfer of intangible asset
6
-
44
- net fair value loss on financial asset measured at
fair value through profit or loss
6
(1,391)
(711)
Total administrative expenses
Other income
(2,269)
82
(1,763)
-
Operating loss and loss before income tax
(2,187)
(1,763)
Income tax
9
21
46
Loss and total comprehensive income for the year
attributable to the equity shareholders of the parent
(2,166)
(1,717)
Loss per ordinary share (pence) attributable to the
equity shareholders:
Continued operations basic and diluted
10
(0.6p)
(0.5p)
Loss per ordinary share (pence) attributable to
the equity shareholders of the parent
10
(0.6p)
(0.5p)
The above results relate entirely to continuing activities. The Company has elected to take the exemption
provided under section 408, Companies Act 2006 from presenting the Company statement of comprehensive
income.
The notes on pages 49 to 66 are an integral part of these financial statements.
Cizzle Biotechnology Holdings PLC
43
Registered number: 06133765 (England and Wales)
Consolidated Statement of Financial Position
As at 31 December 2024
Notes
Group
2024
£’000
Group
2023
£’000
Non-current assets
Intangible asset
11
-
-
-
-
Current assets
Inventories
13
2
-
Investment held at fair value through profit or loss
12
22
1,413
Trade and other receivables
14
103
136
Cash and cash equivalents
15
365
144
492
1,693
Total assets
492
1,693
Equity
Capital and reserves attributable to equity holders
of the Company
Ordinary shares
16
3,507
3,504
Share premium
35,911
35,335
Reverse acquisition reserve
(40,021)
(40,021)
Share capital reduction reserve
10,081
10,081
Share option reserve
640
478
Retained losses
(10,036)
(7,870)
Total equity
82
1,507
Liabilities
Current liabilities
Trade and other payables
17
410
186
Total liabilities
410
186
Total equity and liabilities
492
1,693
The notes on pages 49 to 66 are an integral part of these financial statements.
The financial statements were approved and authorised for issue by the board on 30 April 2025
and were signed on its behalf by:
Nigel Lee
Director
Cizzle Biotechnology Holdings PLC
44
Registered number: 06133765 (England and Wales)
Company Statement of Financial Position
As at 31 December 2024
Notes
2024
£’000
2023
£’000
Non-current assets
Intangible asset
11
-
-
Investments
11
21,803
21,803
21,803
21,803
Current assets
Investment held at fair value through profit or loss
12
22
1,413
Trade and other receivables
14
990
830
Cash and cash equivalents
15
23
70
1,035
2,313
Total assets
22,838
24,116
Equity
Capital and reserves attributable to equity holders
of the company
Ordinary shares
16
3,507
3,504
Share premium
35,911
35,335
Share capital reduction reserve
10,081
10,081
Share option reserve
640
478
Accumulated losses
(27,433)
(25,407)
Total equity
22,706
23,991
Liabilities
Current liabilities
Trade and other payables
17
132
125
Total liabilities
132
125
Total equity and liabilities
22,838
24,116
The notes on pages 49 to 66 are an integral part of these financial statements. The loss for the year of the
Company was £2,026,000 (2023: loss of £1,540,000).
The financial statements were approved and authorised for issue by the board on 30 April 2025 and were
signed on its behalf by:
Nigel Lee
Director
Cizzle Biotechnology Holdings PLC
45
Consolidated Statement of Cash Flows for the year ended 31 December 2024
Notes
Group
2024
Group
2023
£'000
£'000
Cash flows from operating activities
Operating (loss) before tax
(2,188)
(1,763)
Movement on put option
-
120
Gain on transfer of intangible asset
-
(44)
Net fair value loss on financial assets measured at fair
value through profit or loss
1,391
711
Share option charge
162
307
Operating cash flow before working capital movements
(635)
(669)
Decrease in inventories
13
2
-
Decrease in trade and other receivables
14
6
(24)
Increase in trade and other payables
17
223
13
Cash used in operations
(404)
(680)
Tax received
46
41
Net cash used in operating activities
(358)
(639)
Cash flows from financing activities
Proceeds from the issue of ordinary shares (net of issue
costs)
16
579
305
Net cash generated from financing activities
579
305
Net increase / (decrease) in cash and cash equivalents
221
(334)
Cash and cash equivalents at the start of the year
15
144
478
Cash and cash equivalents at the end of the year
15
365
144
The notes on pages 49 to 66 are an integral part of these financial statements.
* For the year ended 31 December 2023, included in the movements in investing activities is a non-cash
movements of £2,080,000 explained further in note 11 and 12 related to the transfer of the intangible assets to
the investment in Conduit Pharmaceuticals Limited.
Cizzle Biotechnology Holdings PLC
46
Company Statement of Cash Flows for the year ended 31 December 2024
Notes
2024
2023
£'000
£'000
Cash flows from operating activities
Loss before tax
(2,026)
(1,540)
Share option charge
162
307
Movement on put option
-
120
Gain on transfer of intangible asset
-
(44)
Net fair value loss on financial assets measured at fair
value through profit or loss
1,391
711
Operating cash flow before working capital movements
(473)
(446)
Change in trade and other receivables
14
2
(14)
Change in trade and other payables
17
7
(27)
Net cash used in operating activities
(464)
(487)
Cash flows from investing activities
Change in intra group funding
(162)
(212)
Net cash used in investing activities
(162)
(212)
Cash flows from financing activities
Proceeds from the issue of ordinary shares (net of issue
costs)
16
579
305
Net cash generated from financing activities
579
305
Net (decrease) in cash and cash equivalents
(47)
(394)
Cash and cash equivalents at the start of the year
15
70
464
Cash and cash equivalents at the end of the year
15
23
70
The notes on pages 49 to 66 are an integral part of these financial statements.
Cizzle Biotechnology Holdings PLC
47
Consolidated statement of Changes in Equity
for the year ended 31 December 2024
Group
Ordinary
Share
Capital
Share
Premium
Shares
to be
issued
Capital
Redemption
Reserve
Share
Option
Reserve
Reverse
Acquisition
Reserve
Retained
Losses
Total
£'000
£'000
£’000
£’000
£'000
£'000
£'000
£'000
At 1 January 2023
3,502
34,917
115
10,081
199
(40,021)
(6,153)
2,640
Registration of shares to be issued
-
115
(115)
-
-
-
-
-
Issue of shares for cash
2
348
-
-
-
-
-
350
Costs of share issue
-
(45)
-
-
-
-
-
(45)
Share option charge
-
-
-
-
279
-
-
279
3,504
35,335
-
10,081
478
(40,021)
(6,153)
3,224
Comprehensive Loss for the year
-
-
-
-
-
-
(1,717)
(1,717)
At 31 December 2023
3,504
35,335
-
10,081
478
(40,021)
(7,870)
1,507
Issue of shares for cash
3
648
-
-
-
-
-
651
Costs of share issue
-
(72)
-
-
-
-
-
(72)
Share option charge
-
-
-
-
162
-
-
162
3,507
35,911
-
10,081
640
(40,021)
(7,870)
2,248
Comprehensive Loss for the year
-
-
-
-
-
-
(2,166)
(2,166)
At 31 December 2024
3,507
35,911
-
10,081
640
(40,021)
(10,036)
82
The notes on pages 49 to 66 are an integral part of these financial statements.
Cizzle Biotechnology Holdings PLC
48
Company statement of Changes in Equity
for the year ended 31 December 2024
Ordinary
Share
Capital
£’000
Share
premium
£’000
Shares
to be
issued
£’000
Share capital
reduction
reserve
£’000
Share
option
reserve
£’000
Retained
Losses
£’000
Total
£’000
At 1 January 2023
3,502
34,917
115
10,081
199
(23,867)
24,947
Registration of shares to be issued
-
115
(115)
-
-
-
-
Issue of shares cash
2
348
-
-
-
-
350
Costs of share issue
-
(45)
-
-
-
-
(45)
Share option charge for year
-
-
-
-
279
-
279
3,504
35,335
-
10,081
478
(23,867)
25,531
Comprehensive Loss for the year
-
-
-
-
-
(1,540)
(1,540)
At 31 December 2023
3,504
35,335
-
10,081
478
(25,407)
23,991
Issue of shares cash
3
648
-
-
-
-
651
Costs of share issue
-
(72)
-
-
-
-
(72)
Share option charge for year
-
-
-
-
162
-
162
3,507
35,911
-
10,081
640
(25,407)
24,732
Comprehensive Loss for the year
-
-
-
-
-
(2,026)
(2,026)
At 31 December 2024
3,507
35,911
-
10,081
640
(27,433)
22,706
The notes on pages 49 to 66 are an integral part of these financial statements.
Cizzle Biotechnology Holdings PLC
49
Notes to the financial statements for the year ended 31 December 2024
1
General information
Cizzle Biotechnology Holdings PLC (“the Company” of “the Group”) is a public limited company with its shares traded
on the Main Market of the London Stock Exchange. On 14 May 2021 the Company acquired through a share for
share exchange the entire share capital of Cizzle Biotechnology Limited. The Company is a holding company of a
group of companies (“the Group”) whose principal activity is the early detection of lung cancer via the development
of an immunoassay test for the CIZ1B biomarker.
The directors consider there to be no ultimate controlling shareholder of the Company.
The address of the registered office is 6th Floor, 60 Gracechurch Street, London, EC3V 0HR and the registered
number of the Company is 06133765.
2
Accounting policies
The principal accounting policies applied in the preparation of these financial statements are set out below. These
policies have been consistently applied to all the years presented, unless otherwise stated.
2.1
Basis of preparation
The financial statements of Cizzle Biotechnology Holdings PLC (“the Company”) including subsidiary undertakings
(together referred to as “the Group”) have been prepared in accordance with UK-adopted international accounting
standards and the Companies Act 2006 on a historical cost basis. All figures have been rounded to the nearest £’000.
The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting
estimates. It also requires management to exercise its judgement in the process of applying the Company’s
accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions
and estimates are significant to the financial statements are disclosed in Note 5.
The results for the year ended 31 December 2024 are the Group results.
(a)
New standards and interpretations
The IASB and IFRS Interpretations Committee have issued the following standards and interpretations with an
effective date of implementation of 1 January 2024.
i)
New standards and amendments – applicable 1 January 2024
The following standard and interpretations apply for the first time to financial reporting periods commencing on
or after 1 January 2024:
Effective for accounting
periods beginning on or after
Impact
Amendments to IAS 1: Presentation of Financial Statements:
Classification of Liabilities as Current or Non-current
1 January 2024
None
Amendments to IAS 1: Classification of Liabilities as Current
or Non-current - Deferral of Effective Date
1 January 2024
None
Amendments to IFRS 16 Leases: Lease Liability in a Sale
and Leaseback
1 January 2024
None
Amendments to IAS 1 Presentation of Financial Statements:
Non-current Liabilities with Covenants
1 January 2024
None
Amendments to IAS 7 Statement of Cash Flows and IFRS 7
Financial Instruments: Disclosures: Supplier Finance
Arrangements
1 January 2024
None
Cizzle Biotechnology Holdings PLC
50
Notes to the financial statements for the year ended 31 December 2024
2
Accounting policies (continued)
ii)
Forthcoming requirements
As at 31 December 2024, the following standards and interpretations had been issued but were not mandatory
for annual reporting periods ending on 31 December 2024 and not early adopted.
Effective for accounting periods
beginning on or after
Impact
Amendments to IAS 21 The Effects of Changes in
Foreign Exchange Rate: Lack of Exchangeability
1 January 2025
None
Amendments to IFRS 9 Financial Instruments and IFRS
7 Financial Instruments: Disclosures: Classification and
Measurement of Financial Instruments
1 January 2026
None
Annual Improvements to IFRS standards - Volume 11
1 January 2026
None
2.2 Going concern
Current funding
The Group’s cash balance as at 31 December 2024 was £365,000 and there were no borrowing facilities at that date.
On 26 March 2024 the Group announced that it has undertaken a conditional placing of 31,050,000 new ordinary
shares of 0.01p each (“Ordinary Shares”) in the Company (the “Placing”) at a price of 2 pence per share (the “Issue
Price”) raising approximately £0.62 million before expenses for the Company. The net proceeds of the Placing will
be utilised towards completing the Company’s first proposed commercial test to detect CIZ1B, further protect the
Company’s Intellectual Property (IP), progress the Company’s research with the University of York and for general
corporate purposes.
The Directors have adopted the going concern basis in preparing the financial statements for the year ended 31
December 2024. In reaching this conclusion, the Directors have considered current trading and the current and
projected funding position for approximately 20 months from the date of approval of the financial statements through
to 31 December 2026. The forecasts have been prepared using a number of scenarios – a base case assumes
receipt of minimum royalty payments and an ‘Accelerated Growth’ model assumes that revenues will be earned from
royalties in Europe and the Rest of the World, more investment into research and development activities and
expanding the UK team.
These scenarios show that the Group is reliant upon the timely receipt of the first $1m (approx. £570,000) of
Guaranteed Minimum Royalty Payments (GMP) from Cizzle Bio Inc (“Bio”), in respect of the Group’s Royalty
Agreement covering North America and The Caribbean. The receipt of two GMP instalments of $250,000 (approx.
£190k) in July and September 2025 is dependent on Bio signing a deal with a Caribbean hospital (recently signed)
and would represent an advance of the first $1m with the balance of a further receipt of GMP of $500k (approx.
£380k) is expected to be received in January 2026.The receipt of these royalties is not dependent upon Bio’s
appointed Research Laboratory, iGenomeDX, achieving a CLIA accreditation. However, there remains uncertainty if
Bio will be able to make these payments as it is dependent on raising further funds. Should these royalty payments
be delayed or not materialise, then the company may be required to raise additional funding to continue to meet its
obligations.
Conclusion
After taking into account these conditions, it indicates that a material uncertainty exists that may cast significant doubt
on the group and company’s ability to continue as a going concern. These financial statements do not include any
adjustments that would result from the going concern basis of preparation being inappropriate.
Cizzle Biotechnology Holdings PLC
51
Notes to the financial statements for the year ended 31 December 2024
2
Accounting policies (continued)
2.3 Segmental reporting
IFRS 8 requires that segmental information be disclosed on the basis of information reported to the chief operating
decision maker. The Company considers that the role of chief operating decision maker is performed by the
Company’s Board of Directors. The Group’s only business activity and single segment is the development of tests
for the early detection of lung cancer.
2.4 Revenue Recognition
Revenue is recognised in accordance with IFRS 15 – Revenue from Contracts with Customers, which establishes a
five-step model to determine the timing and amount of revenue to be recognised. The core principle is that revenue
is recognised to reflect the transfer of promised goods or services to customers in an amount that reflects the
consideration the entity expects to receive in exchange.
The five steps applied to revenue recognition are:
1.
Identify the contract with a customer
A contract is an agreement between two or more parties that creates enforceable rights and obligations.
2.
Identify the performance obligations in the contract
A performance obligation is a promise to transfer a distinct good or service to the customer.
3.
Determine the transaction price
The transaction price is the amount of consideration the company expects to be entitled to in exchange for
transferring promised goods or services.
4.
Allocate the transaction price to the performance obligations
The transaction price is allocated to each performance obligation based on relative standalone selling
prices.
5.
Recognise revenue when (or as) the entity satisfies a performance obligation
Revenue is recognised when control of the good or service is transferred to the customer, either at a point
in time or over time.
Royalty Income
For royalty income arising from licensing intellectual property, revenue is recognised according to the nature of the
license granted:
Right to use (static license): Revenue is recognised at a point in time when the customer can begin using
the IP.
Right to access (dynamic license): Revenue is recognised over time as the customer benefits from access
to the IP throughout the license period.
If royalties are usage- or sales-based, revenue is recognised only when (or as) the subsequent sales or usage
occurs, in accordance with the sales- or usage-based royalty exception in IFRS 15. B63–B63B.
Other income
Other income comprises an exclusivity fee in relation to a royalty agreement which is recognised on an accruals
basis.
2.5 Foreign currency translation
The functional currency of the Company and its subsidiaries is Sterling which is also the presentational currency of
the financial statements. Foreign currency assets and liabilities are converted into Sterling at the rates of exchange
ruling at the end of the financial year. Foreign currency transactions are translated into the functional currency using
the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the
settlement of such transactions and from the translation at year end exchange rates of monetary assets and liabilities
denominated in foreign currencies are recognised in the statement of comprehensive income.
2.6 Non-Current assets
Investments in intangible assets and subsidiaries are stated at cost less accumulated impairment.
Cizzle Biotechnology Holdings PLC
52
Notes to the financial statements for the year ended 31 December 2024
2
Accounting policies (continued)
2.7
Investments classified as current assets
Assets that do not meet the criteria for amortised cost or fair value through other comprehensive income (“FVOCI”)
are measured at fair value through profit or loss (“FVPL”). A gain or loss on a debt investment that is subsequently
measured at FVPL is recognised in profit or loss and presented net within other gains / (losses) in the period in which
it arises.
2.8 Cash and cash equivalents
Cash and cash equivalents include cash in hand, deposits held at call with banks and other short-term highly liquid
investments, with original maturities of three months or less.
2.9 Inventories
Raw materials, work in progress and finished goods are stated at the lower of cost and net realisable value on a 'first
in first out' basis. Cost comprises of direct materials and delivery costs, direct labour, import duties and other taxes,
an appropriate proportion of variable and fixed overhead expenditure based on normal operating capacity, and, where
applicable, transfers from cash flow hedging reserves in equity. Costs of purchased inventory are determined after
deducting rebates and discounts received or receivable.
Stock in transit is stated at the lower of cost and net realisable value. Cost comprises of purchase and delivery
costs, net of rebates and discounts received or receivable.Net realisable value is the estimated selling price in the
ordinary course of business less the estimated costs of completion and the estimated costs necessary to make
the sale.
2.10 Share capital
Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares or options
are shown in equity as a deduction, net of tax, from the proceeds. Note 23 describes all equity categories in further
detail.
2.11 Current and deferred income tax
Current income tax is calculated on the basis of the tax laws enacted or substantively enacted at the statement of
financial position date in the countries where the Company’s subsidiaries and associates operate and generate
taxable income. Management periodically evaluates positions taken in tax returns with respect to situations in which
applicable tax regulation is subject to interpretation and establishes provisions where appropriate on the basis of
amounts expected to be paid to the tax authorities. Research and Development tax credits are accounted for on an
accruals basis.
Deferred income tax is provided in full, using the liability method, on temporary differences arising between the tax
bases of assets and liabilities and their carrying amounts in the financial statements. However, deferred income tax
is not accounted for if it arises from initial recognition of an asset or liability in a transaction other than a business
combination that at the time of the transaction affects neither accounting nor taxable profit nor loss. Deferred income
tax is determined using tax rates (and laws) that have been enacted or substantively enacted by the statement of
financial position date and are expected to apply when the related deferred income tax asset is realised or the
deferred income tax liability is settled. Deferred income tax assets are recognised to the extent that it is probable that
future taxable profit will be available against which the temporary differences can be utilised.
2.12 Share based payments
The Company operates an equity-settled, share-based compensation plan. The fair value of the employee services
received in exchange for the grant of the options is recognised as an expense and credited to the share option
reserve within equity. The total amount to be expensed over the vesting period is determined by reference to the fair
value of the options granted, excluding the impact of any non-market vesting conditions (for example, profitability and
sales growth targets). Options that lapse before vesting are credited back to income. The proceeds received net of
any directly attributable transaction costs are credited to share capital (nominal value) and, if applicable, share
premium when the options are exercised.
Cizzle Biotechnology Holdings PLC
53
Notes to the financial statements for the year ended 31 December 2024
2.13
Financial instruments
i) Financial assets
The Company classifies its financial assets in the following measurement categories:
those to be measured subsequently at fair value through profit or loss; and
those to be measured at amortised cost.
The classification depends on the business model for managing the financial assets and the contracted terms of the
cash flows. Financial assets are classified as at amortised cost only if both of the following criteria are met:
the asset is held within a business model whose objective is to collect contracted cash flows; and
the contractual terms give rise to cash flows that are solely payments of principal and interest.
Financial assets, including trade and other receivables and cash and bank balances, are initially recognised at
transaction price, unless the arrangement constitutes a financing transaction, where the transaction is measured at
the present value of the future receipts discounted at a market rate of interest. Such assets are subsequently carried
at amortised cost using the effective interest method. At the end of each reporting period financial assets measured
at amortised cost are assessed for objective evidence of impairment. If an asset is impaired the impairment loss is
the difference between the carrying amount and the present value of the estimated cash flows discounted at the
asset’s original effective interest rate. The impairment loss is recognised in the consolidated income statement. The
Company applies the simplified approach in calculating the expected credit losses (ECLs) as permitted by IFRS 9.
Changes in credit risk is not tracked but instead a loss allowance is recognised at each reporting date based on the
financial asset’s lifetime ECL.
If there is a decrease in the impairment loss arising from an event occurring after the impairment was recognised the
impairment is reversed. The reversal is such that the current carrying amount does not exceed what the carrying
amount would have been had the impairment not previously been recognised. The impairment reversal is recognised
in the consolidated income statement.
Financial assets are derecognised when (a) the contractual rights to the cash flows from the asset expire or are
settled, or (b) substantially all the risks and rewards of the ownership of the asset are transferred to another party or
(c) despite having retained some significant risks and rewards of ownership, control of the asset has been transferred
to another party who has the practical ability to unilaterally sell the asset to an unrelated third party without imposing
additional restrictions
ii) Financial liabilities
Basic financial liabilities, being trade and other payables, are initially recognised at transaction price, unless the
arrangement constitutes a financing transaction, where the debt instrument is measured at the present value of the
future receipts discounted at a market rate of interest. Trade payables are obligations to pay for goods or services
that have been acquired in the ordinary course of business from suppliers. Accounts payable are classified as current
liabilities if payment is due within one year or less. If not, they are presented as non-current liabilities. Trade payables
are recognised initially at transaction price and subsequently measured at amortised cost using the effective interest
method.
Financial liabilities are derecognised when the liability is extinguished, that is when the contractual obligation is
discharged, cancelled or expires. The Company does not hold or issue derivative financial instruments.
Cizzle Biotechnology Holdings PLC
54
Notes to the financial statements for the year ended 31 December 2024
2.13
Financial instruments (continued)
iii) Offsetting
Financial assets and liabilities are offset and the net amounts presented in the financial statements when there is an
enforceable right to set off the recognised amounts and there is an intention to settle on a net basis or to realise the
asset and settle to liability simultaneously.
2.14
Pensions
For defined contribution schemes the amount charged to the statement of comprehensive income is the contribution
payable in the year. Differences between the contributions payable in the year and contributions actually paid are
shown either as accruals or prepayments.
3 Reverse acquisition
On 14 May 2021 the Company acquired through a share for share exchange the entire share capital of CBL whose
principal activity is the early detection of lung cancer through the development of tests to detect CIZ1B variant protein.
Although the transaction resulted in CBL becoming a wholly owned subsidiary of the Company, the transaction
constitutes a reverse acquisition as the previous shareholders of CBL own a substantial majority of the shares of the
Company.
In substance the shareholders of CBL acquired a controlling interest in the Company and the transaction has
therefore been accounted for as a reverse acquisition. As the Company’s activities prior to the acquisition were purely
the maintenance of the AIM listing, acquiring CBL and raising equity finance to provide the required funding for the
operations of the acquisition means it did not meet the definition of a business combination in accordance with IFRS
3.
Accordingly, this reverse acquisition does not constitute a business combination and was accounted for in
accordance with IFRS 2 “Share-based Payments” and associated IFRIC guidance. Although the reverse acquisition
is not a business combination, the Company has become a legal parent and is required to apply IFRS 10 and prepare
consolidated financial statements. The directors have prepared these financial statements using the reverse
acquisition methodology, but rather than recognise goodwill, the difference between the equity value given up by the
CBL shareholders is charged to the statement of comprehensive income as a share-based payment on reverse
acquisition, and represents in substance the cost of acquiring a quoted company.
In accordance with the reverse acquisition principles, these consolidated financial statements represent a
continuation of the consolidated statements of Cizzle Biotechnology Holdings Plc and its subsidiaries and include:
- The assets and liabilities of CBL at their pre-acquisition carrying value amounts and the results for all periods
reported; and
- The assets and liabilities of the Company as at 14 May 2021 and its results from the date of reverse acquisition (14
May 2021 to 31 December 2021).
On 14 May 2021 the Company issued 206,310,903 ordinary shares to acquire the 313,932 ordinary shares of CBL
Limited. At 14 May 2021 the valuation of the investment in CBL was £21,700,000.
Because the legal subsidiary, CBL, was treated on consolidation as the accounting acquirer and the legal parent
company, Cizzle Biotechnology Holdings Plc, was treated as an accounting subsidiary, the fair value of the shares
deemed to be issued by CBL was calculated at £2,587,000 based on an assessment of the purchase consideration
for a 100% holding of Cizzle Biotechnology Holdings plc.
The fair value of the net liabilities of Cizzle Biotechnology Holdings Plc at acquisition was as follows:
£’000
Cash and cash equivalents
46
Other assets
47
Liabilities
(310)
Net (Liabilities)
(217)
Cizzle Biotechnology Holdings PLC
55
Notes to the financial statements for the year ended 31 December 2024
3
Reverse acquisition (continued)
The difference between the deemed cost of £2,587,000 and the fair value of the net liabilities noted above of
£(217,000) resulted in £2,804,000 being expensed as “reverse acquisition expenses” in accordance with IFRS2,
Share- based Payments, reflecting the economic cost to CBL shareholders of acquiring a quoted entity.
The reverse acquisition reserve which arose from the reverse takeover is made up as follows:
£’000
Pre-acquisition equity1
(22,621)
CBL share capital at acquisition2
1,599
Investment in CBL3
(21,803)
Reverse acquisition expense4
2,804
(40,021)
1. Pre-acquisition equity of Cizzle Biotechnology Holdings PLC at 14 May 2021.
2. CBL had issued share capital and share premium of £1,599,000. As these financial statements represent
the capital structure of the legal parent entity, the equity of CBL is eliminated.
3. The value of the shares issued by the Company in exchange for the entire share capital of CBL plus stamp
duty expenses.
4. The reverse acquisition expense represents the difference between the value of the equity issued by the
Company, and the deemed consideration given by CBL to the Group.
4
Financial risk
The Group’s principal risk factors are as follows:
4.1 Capital risk management
The Company monitors capital which comprises all components of equity (i.e. share capital, share premium, capital
reduction reserve, share option reserve, and retained earnings/losses). Note 22 describes how capital is managed
in respect of the debt to equity ratio.
4.2
Financial risk factors
The Group’s operations exposed it to a variety of financial risks that had included the effects of Level One investment
risk, credit risk, liquidity risk and interest rate risk. The Company had in place a risk management programme that
attempted to limit the adverse effects on the financial performance of the Company by monitoring levels of debt
finance and the related finance costs. The Company did not use derivative financial instruments to manage interest
rate costs and as such, no hedge accounting was applied.
Given the size of the Company, the directors did not delegate the responsibility of monitoring financial risk
management to a sub-committee of the Board. The policies set by the board of directors were implemented by the
Company’s finance department.
(a)
Credit risk
The Company’s credit risk was primarily attributable to its trade receivables balance. The amounts presented
in the statement of financial position are net of allowances for impairment. The credit risk on the current asset
investment arises from the investment in a Nasdaq quoted company. The Group reviews the market price of
this investment on a daily basis.
(b)
Liquidity risk
Liquidity risk is the risk that an entity will encounter difficulty in meeting obligations associated with financial
liabilities. The Company’s financial liabilities included its trade and other payables shown in Note 17. The
Group manages this risk through the preparation of cash flow forecasts which are regularly reviewed by the
directors.
Cizzle Biotechnology Holdings PLC
56
Notes to the financial statements for the year ended 31 December 2024
5 Critical accounting estimates and judgements
In the preparation of the financial statements the directors must make estimates and assumptions that affect the
asset and liability items and revenue and expense amounts recorded in the financial statements. These estimates
are based on historical experience and various other assumptions that the Board believes are reasonable under
the circumstances. The results of this form the basis for making judgements about the carrying value of assets
and liabilities that are not readily available from other sources.
a)
Accounting judgement
The Company’s principal judgement in 2024 relate to its impairment review of its investment in its subsidiary
company, CBL. Following the review of these assets at 31 December 2024 the directors considered that there
was no indication of impairment loss is required to be made. The main indicators that no impairment loss arises
are the receipt of royalties from Bio in relation to North America, the extension of the royalty agreement with Bio
to cover The Caribbean and also the recent announcement that Bio has signed its first contract with a hospital in
the Caribbean.
b)
Accounting estimate
Share based payments
See Note 15 which explains the methods used to estimate the fair value of share options granted.
6
Operating expenses
Group
2024
£’000
Group
2023
£’000
Research and development
Professional advisers
213
139
214
173
Staff costs
Intellectual property renewal fees
143
22
146
22
Regulatory fees
36
13
Audit fees (Note 7)
41
36
Other expenditure
95
65
On-going administrative costs
689
669
Share option charge
189
307
Cost associated with put option
-
120
Gain on transfer of intangible asset
-
(44)
Net fair value loss on financial asset measured at fair
value through profit or loss
1,391
711
Total administrative expenses
2,269
1,763
7
Auditor’s remuneration
Group
2024
£’000
Group
2023
£’000
Fees payable to the Company’s auditor for the audit of the Group,
Company and subsidiary financial statements
41
36
41
36
8
Directors’ emoluments
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Wages and salaries
196
196
124
133
Social Security Costs
14
22
14
15
Pension Contributions
5
5
5
3
Share based payments*
186
307
186
307
401
530
329
458
Cizzle Biotechnology Holdings PLC
57
Notes to the financial statements for the year ended 31 December 2024
8. Directors’ emoluments (continued)
*Included in the share based payment charge is £27,000 (2023:£28,000) related to the employee contribution of
the national insurance which has been accrued for as the Company has taken on the obligation on the employee’s
behalf.
The Group does not have any employees other than the directors. The average number of directors during the
year was 4 (2023: 4).
9
Income tax credit
The tax credit for the year was as follows:
Group
2024
£’000
Group
2023
£’000
Research and development tax credits
-
Current year
(30)
(47)
-
Prior year
9
1
(21)
(46)
Research and Development tax credits are accounted for on an accruals basis.
The tax on the Group’s loss before tax differs from the theoretical amount that would arise using the tax rate
applicable to the losses of the Group as follows:
Group
2024
£’000
Group
2023
£’000
Loss before tax on continuing operations
(2,187)
(1,763)
Tax calculated at the domestic rate applicable of 19%* (2023: 19%)
(416)
(335)
Expenses not deductible for tax purposes
306
209
Tax losses for which no deferred tax credit was recognised
110
126
Research and development tax credit
(22)
(46)
Total income tax credit
(22)
(46)
*19% has been used as the Company generates profits of less than £50k
10
Loss per share
Basic loss per share
Group
2024
Group
2023
Loss for the year
(2,166,000)
(1,717,000)
Weighted average number of ordinary shares
387,473,965
355,861,445
Basic loss per share
(0.6p)
(0.5p)
The basic loss per share is derived by dividing the loss for the period attributable to ordinary shareholders by the
weighted average number of shares in issue.
Diluted earnings per share is calculated by dividing the loss attributable to ordinary shareholders by the weighted
average number of ordinary shares outstanding after adjusting these amounts for the effects of dilutive potential
ordinary shares. As the results for the years ended 31 December 2024 and 31 December 2023 are a loss, any
exercise of share options would have an anti-dilutive effect on earnings per share. Consequently, earnings per share
and diluted earnings per share are the same and the calculation has not been included.
As at 31 December 2024, there were share options over 48,685,443 shares (2023: 48,685,443 shares), which could
potentially have a dilutive impact in the future. In addition to this Makabo Limited , a service company operated by
Matt Bower who was appointed as a non-executive director on 21 March 2025, had 2,464,625 options outstanding
(2023: Nil).
Cizzle Biotechnology Holdings PLC
58
Notes to the financial statements for the year ended 31 December 2024
11
Non- Current assets
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Investment in subsidiary undertakings
-
-
21,803
21,803
Intangible assets
-
-
-
-
Total investments
-
-
21,803
21,803
a.
Investments in subsidiary undertakings - Company
2024
£’000
2023
£’000
Opening balance
21,803
21,803
Acquisition during the year
-
-
Closing balance
21,803
21,803
The investment in subsidiary undertakings is in the following companies:
Name
Country of
incorporation
Proportion of ownership
interest
Principal activities/status
Cizzle Biotechnology
Limited
England and
Wales
100% interest in ordinary share
capital
Early detection of lung
cancer
Cizzle Biotech Limited
(formerly Enfis Limited)
England and
Wales
100% interest in ordinary share
capital
Dormant
The registered address for ongoing subsidiaries is 6th floor, 60 Gracechurch Street, London, EC3V 0HR.
Cizzle Biotechnology Limited - as mentioned in Note 3, this investment represents the value of the shares issued
by the Company in exchange for the entire share capital of CBL (£21,700,000 plus stamp duty expenses of
£103,000).
b.
Intangible assets – Group and Company
2024
£’000
2023
£’000
Opening balance
-
2,080
Acquisition during the year
-
-
Disposal (traded for investment measured at
fair value through profit or loss)*
-
(2,080)
Closing balance
-
-
* During 2023 the Company exercised a put option which meant that the intangible asset was traded for an
investment in Conduit Pharmaceuticals Limited (“Conduit”) as set out in Note 12 resulting in a gain of
£44,000.
On 14 February 2022, the Company entered into a definitive agreement (the "Agreement") with Conduit and St
George Street Capital Limited ("SGSC") to acquire a 5% economic interest in the commercialisation of the AZD
1656 asset or other such assets being developed by Conduit or SGSC to treat inflammatory pulmonary and
cardiovascular disease (the “Economic Interest”).
Cizzle Biotechnology Holdings PLC
59
Notes to the financial statements for the year ended 31 December 2024
11
Non- Current assets (continued)
b.
Intangible assets – Group and Company (continued)
Highlights of the Agreement are as follows:
-
Agreement with Conduit and SGSC to acquire a 5% economic interest for a total consideration of £1.88
million, to be settled in new Cizzle ordinary shares at a price of 4.0p per share, a 56.9% premium to
the closing mid-market price on 11 February 2022;
-
The Agreement is in addition to the Company’s existing interest in AZD 1656 as announced on 20
September 2021:
-
SGSC reported the successful completion of the AZD 1656 ARCADIA clinical trial in Covid-19 and
SGSC and Conduit are in discussions with multiple pharmaceutical companies about licensing
opportunities for AZD 1656 for Covid-19 and potentially for further indications; and
-
The Agreement supports the Company’s ambitions to expand its target customer base into the
pharmaceutical industry and is in line with its strategy of building a portfolio of early cancer detection
tests, companion diagnostics and royalty bearing stakes in significant drug assets.
Consideration for the Agreement (£1.88m) - non cash acquisition
Under the terms of the Agreement, Cizzle paid consideration of £1.88 million to SGS for the Economic Interest.
Of the consideration payable, £1.0 million (the “Initial Consideration”) was satisfied by the issue of 25,000,000
new ordinary shares in the Company (the “Consideration Shares”), at a price of 4.0 pence per Consideration
Share, being a premium of 56.9 per cent. to the Company’s closing mid-market price of 2.55 pence on 11 February
2022. The remaining consideration of £880,000 was settled in new ordinary shares in the Company issued at 4.0
pence per share, on 29 September 2022.
Consideration for Put Options (£0.12m)
On 19 December 2022 the Company agreed a put option to sell: (i) its 5% economic interest in the
commercialisation of the AZD 1656 asset to treat inflammatory pulmonary and cardiovascular disease (the
"Economic Interest"); and (ii) its royalty sharing agreement with St George Street Capital ("SGSC"), the UK-based
biomedical charity (the “Royalty Sharing Agreement’) to Conduit Pharmaceuticals Limited ("Conduit") for a total
expected value of £3.25 million to be satisfied through the issuance of new shares in Conduit (the “Option”). On
transfer of the shares to the Company, the shares were worth £2.12 million (refer to note 12). The Economic
Interest and Royalty Sharing Agreement were valued at cost, totalling £2,080,000. No profits or revenues were
attributable to the assets subject to the Option. The Option is exercisable solely at the discretion of Cizzle and
Cizzle has agreed to pay Conduit £120,000 in cash as the premium for the Option, which has a nine-month term.
The Company also raised proceeds of £115,586, net of expenses, by way of a subscription for 7,371,557 new
ordinary shares in the Company ("Ordinary Shares") at 1.6p per share (the “Issue Price”) with existing investors
(the “Subscription”), in order to provide funds to be put towards satisfying the Option premium.
This Put Option was paid for in cash and in 2022 was accounted for under prepayments ( see Note 13).
On 26 September 2023 the Company exercised the option to acquire £3,250,000 payable in shares in Conduit
Pharmaceuticals Inc, a company that was subsequently listed on NASDAQ during December 2023. The Company
were not able to have these shares registered with its custodian until January 2024.
At 1 January 2022, Intangible assets represents the fair value of an investment in a royalty sharing arrangement
with St George Street Capital (“SGSC”), a UK-based medical charity. This agreement grants the Company
potential future royalty payments from the commercialisation of St George Street’s therapeutic asset AZD1656 of
up to £5m, plus potentially further payments from the use of a companion diagnostic.
Cizzle Biotechnology Holdings PLC
60
Notes to the financial statements for the year ended 31 December 2024
12. Current asset investment
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Investment
22
1,413
22
1,413
Total investments
22
1,413
22
1,413
Investment – Group and Company
2024
£’000
2023
£’000
Transfer from intangible asset*
1,413
2,124
Measurement loss of level1 investment at
year end
(1,391)
(711)
Market
value
of
Investment
at
31
December 2023
22
1,413
* During 2023 the Company exercised a put option which meant that the intangible asset was traded for an
investment in Conduit Pharmaceuticals Limited (“Conduit”) as set out in Note 11 resulting in a gain of £44,000.
The investment noted above represents shares held in Conduit Pharmaceuticals Inc, a NASDAQ-listed company
as mentioned in Note 11. The investment is a level 1 investment and has been valued at its market value on 31
December 2024.
13
Inventories
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Raw materials
2
-
-
-
2
-
-
-
14
Trade and other receivables
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Amounts due from subsidiaries
-
-
963
801
Social security and other taxes
7
14
7
6
Corporation tax recoverable
69
95
-
-
Prepayments and other receivables
27
27
20
23
103
136
990
830
The fair value of trade and other receivables approximate to the net book values stated above. As of 31 December
2024, trade and other receivables of £Nil (2023: £Nil) were impaired.
Cizzle Biotechnology Holdings PLC
61
Notes to the financial statements for the year ended 31 December 2024
15
Cash and cash equivalents
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Cash on hand and balances with banks
365
144
23
70
365
144
23
70
16
Share capital
Numbers in 000s
New
Ordinary
Deferred ‘A’
shares
Deferred ‘A'
shares
Nominal value per share
Shares
0.01p
0.01p
0.99p
At 1 January 2024
363,842
12,383,626
225,158
Issued
32,550
-
-
At 31 December 2024
396,392
12,383,626
225,158
The above table reflects the full authorised and fully paid shares of the Company at 31 December 2024. There
are no shares issued that are partly paid. The following table reconciles the total nominal value of the shares in
issue:
New
Ordinary
shares
Deferred
£0.01p
‘A’ shares
Deferred ‘A'
shares
Nominal value per share
0.01p
0.01p
0.99p
Total
£000
£’000
£000
£000
At 1 January 2024
37
1,238
2,229
3,504
Issued during the year
3
-
-
3
At 31 December 2024
40
1,238
2,229
3,507
During the year ended 31 December 2024, the following shares were issued:
No of shares
Issue price
issued
per share
000s
Pence
11 April 2024 – Subscription (cash)
32,550
2.0p
Total issued
32,550
On 14 May 2021 the Company issued investor warrants to subscribe for 11,000,000 Ordinary Shares at a fixed
price of 15p per share valid for three years until 13 May 2024. On 14 May 2021 the Company issued broker and
adviser warrants to subscribe for 1,350,000 Ordinary Shares at a fixed price of 10p per share valid for three years
until 13 May 2024. 250,000 of these broker warrants are automatically exercisable upon the Company’s share
price equalling 20p per share. The fair value of these warrants at 31 December 2021 was £36,000 and in 2021
was accounted for as a cost to the Company and a reduction of the share premium account. These warrants
expired during the year.
On 11 April 2024 32,550,000 new Ordinary Shares were admitted to the Main Market of the London Stock
Exchange due to a share placing that raised gross proceeds of approximately £0.62m (before expenses) and the
settlement of £30,000 of professional fees. This is further explained in Note 24.
Cizzle Biotechnology Holdings PLC
62
16
Share capital (continued)
Rights attaching to shares
The rights of each type of share for the Company are as follows:
Rights
New Ordinary
0.01p
Deferred ‘A’
£0.01p
Deferred ‘A’
0.99p
Voting
Full voting
None
None
Dividend
Yes
None
None
Distribution on winding up
Yes
None
Right to a payment of return
of capital after £30m has
been paid in respect of
ordinary shares
Rights of redemption
None
None
None
Substantial shareholdings
At 31 December 2024, shareholders holding at least 3% of new ordinary shares were as follows:
Shareholder
Holding of New Ordinary shares
at 31 December 2024
% of New Ordinary Shares held
at 31 December 2024
Hargreaves Lansdowne
(Nominees ) Limited
43,418,921
11.00%
Yorkshire Cancer Research
32,382,330
8.20%
Interactive
Investor
Services
Nominees Limited
31,140,846
7.90%
Hargreaves Lansdown (Nominees)
Limited
28,550,950
7.20%
Hargreaves Lansdown (Nominees)
Limited
25,057,616
6.30%
Barclays
Direct
Investing
Nominees Limited
20,815,095
5.30%
HSDL Nominees Limited
18,880,568
4.80%
Interactive
Investor
Services
Nominees Limited
17,213,120
4.30%
Dawn Coverley *
17,048,137
4.30%
HSBC Global Custody Nominee
(UK) Limited
14,718,227
3.70%
The Bank of New York (Nominees)
Limited
13,083,292
3.30%
*includes holding of 7,055,548 shares held by Dawn Coverley’s husband, Dr Justin Ainscough.
Cizzle Biotechnology Holdings PLC
63
Notes to the financial statements for the year ended 31 December 2024
16
Share capital (continued)
Employee share scheme
The Company has an Executive Share Option Scheme. The exercise terms of all granted options as at 31 December
2024 are summarised below:
Date of grant
Number of
options
Exercise price
(pence per
share)
Exercise
dates from
2015
2016
300
800
5.02
1.85
2017
2017
2017
500
1.00
2018
2021
19,741,345
10.00
2021 (based on performance)
2023
28,942,498
2.19376p
2024
The number and weighted average exercise price of the options that were exercisable at 31 December 2024 were
48,685,443 and 5.35p respectively. The share based payment charge for the year was £307,000 (2023: £307,000).
Included in the share based payment charge for 2024 is £27,000 (2023: £28,000) related to the employee contribution
of the national insurance which has been accrued for as the Company has taken on the obligation on the employee’s
behalf. Movements in the number of share options outstanding and their related weighted average exercise prices
are as follows:
Average
exercise price
Options
(pence per
share)
number
At 1 January 2024
5.35
48,685,443
Granted during year
-
At 31 December 2024
5.35
48,685,443
Share options outstanding at the end of the year have the following expiry dates and exercise prices:
Expiry date
Exercise price
(pence per
share)
Options
2024
2025
5.02
300
2026
1.85
800
2027
1.00
500
2031
10.00
19,741,345
2033
2.19
28,942,498
48,685,443
The Company determines the fair value of its share option contracts on the grant date, adjusts this to reflect its
expectation of the options that will ultimately vest, and then expenses the calculated balance on a straight-line basis
through its statement of comprehensive income over the expected vesting period with a corresponding credit to its
share option reserve. Subsequent changes to the expectation of number of options that will ultimately vest are dealt
with prospectively such that the cumulative amount charged to the statement of comprehensive income is consistent
with latest expectations. Subsequent changes in market conditions do not impact the amount charged to the
statement of comprehensive income. The Company determines the fair value of its share option contracts using a
model based on the Black-Scholes-Merton methodology. In determining the fair value of its share option contracts,
the Company made the following assumptions (ranges are provided where values differ across tranches). Expected
volatility was determined by reference to historical volatility of the Company’s share price.
Grant date
Share
Price
Pence
Exercise
Price
Pence
Expected
Option
Life
Years
Expected
Volatility
%
Expected
Dividend
Yield
%
Risk free
Interest
Rate
%
Fair Value
At date of
Grant
Pence
2021
9.38p
1.53p
10 years
68%
0%
0.83%
1.60p
2021
4.40p
10.00p
10 years
32%
0%
0.83%
3.00p
2023
1.95p
2.19p
10 years
58.4%
0%
4.93%
1.32p
Cizzle Biotechnology Holdings PLC
64
Notes to the financial statements for the year ended 31 December 2024
17
Trade and other payables
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Trade payables
13
92
13
41
Social security and other taxes
7
7
7
7
Accruals and other payables
390
87
112
77
410
186
132
125
Accruals and other payables include £227,000 (2023: £Nil) of deferred income relating to royalty payments received
that are expected to be accounted for as income in the Statement of Comprehensive Income during 2025.
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Due or due in less than one month
13
68
13
17
Due between one and three months
-
17
-
17
Due in more than three months
-
7
-
7
13
92
13
41
18
Financial assets and liabilities
The tables below analyse the carrying value of financial assets and financial liabilities in the Group’s and Company’s
statements of financial position. Further information on the classes that make up each category is provided in the
notes indicated. The carrying value of each category is considered a reasonable approximation of its fair value. All
amounts are due within one year.
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Trade receivables (Note 14)
-
-
-
-
Amounts due from subsidiaries (Note 14)
-
-
963
801
Other receivables (Note 14)
27
27
20
-
Cash and cash equivalents (Note 15)
365
144
23
70
Financial assets at amortised cost
392
171
1,006
871
Financial assets at fair value through profit
or loss (Note12)
22
1,413
22
1,413
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Trade payables (Note 17)
13
92
13
41
Accruals and other payables (Note 17)
390
87
112
77
Financial liabilities at amortised cost
403
179
125
118
19 Deferred income tax
There is an un-provided deferred tax asset arising on taxable losses of £0.90m (2023: £0.72m). In accordance with
accounting standards, the deferred tax asset has not been recognised in the financial statements due to uncertainty
over the availability of sufficient future profits against which it could be recovered.
At 31 December 2024 there was no deferred tax liability (2023: £Nil).
Cizzle Biotechnology Holdings PLC
65
Notes to the financial statements for the year ended 31 December 2024
20
Commitments
The Group has no commitments as at 31 December 2024 (2023: £Nil).
21
Related party transactions
Transactions with directors
At 31 December 2024 there were no balances owed to directors other than recent expense claims totalling £3,934
which were paid during January 2024. During 2024 the group paid £4,250 (2023: £10,000) to Dr Justin Ainscough
for research and development consultancy work. Dr Ainscough is a shareholder and husband to Professor Dawn
Coverley, a director of the Company.
Intercompany transactions
During 2024 and 2023 there have been various intercompany transaction including the recharge of directors salaries
to Cizzle Biotechnology Limited that relate to research and development activities. These transactions are reflected
in the financial statements of the Company but are eliminated in the Group accounts.
22
Controlling party
The directors consider there to be no ultimate controlling party.
23
Capital management
In managing its capital structure, the Group and Company’s objective is to safeguard the Group and Company's
ability to continue as a going concern, managing cash flows so that it can continue to provide returns for shareholders.
The Company makes adjustments to its capital structure in the light of changes in economic conditions and the
requirements of the Company’s businesses. The Board has sought to maintain low levels of borrowing to reflect the
development stage of the Company’s businesses. Over time as the Company’s businesses mature and become
profitable the Board is likely to make increased use of borrowing facilities to fund working capital. In order to maintain
or adjust the capital structure, the Company may issue new shares or seek additional borrowing facilities. The
Company monitors capital on several bases including the debt to equity ratio. This ratio is calculated as debt ÷ equity.
Debt is calculated as total borrowings as shown in the consolidated statement of financial position.
Equity comprises all components of equity as shown in the consolidated statement of financial position. The debt-to-
equity ratio at 31 December 2022 and 31 December 2021 was as follows:
Group
2024
£’000
Group
2023
£’000
Company
2024
£’000
Company
2023
£’000
Total debt
-
-
-
-
Total equity
82
1,507
22,706
23,991
Debt-to-equity ratio
0.0%
0.0%
0.0%
0.0%
Cizzle Biotechnology Holdings PLC
66
Notes to the financial statements for the year ended 31 December 2024
24
Reserves
The following reserves describe the nature and purpose of each reserve within equity:
a.
Capital reduction reserve
The capital reduction reserve set out in the Statement of Changes in Equity arose in 2014 when the nominal
value of each share was reduced from 10p to 1p.
b.
Share premium
The amount subscribed for each share in excess of nominal value.
c.
Reverse acquisition reserve
The reverse acquisition reserve is explained in Note 3.
d.
Share option
The accumulated expense arising during their vesting period of share options granted to directors and
employees and warrants granted to third parties.
e.
Accumulated losses
All other net losses and gains not recognised elsewhere.
25
Post balance sheet event
The Group announced on 28 April 2025 that its licensing partner Cizzle Bio Inc (“BIO” or “Cizzle Bio”) has executed
its first contract in the Caribbean as part of the extension to its exclusive licensing and partnership agreement with
the Company for the USA and Canada, as announced on 16 December 2024. The non-exclusive Laboratory
Services Agreement signed by BIO with Doctors Hospital (Chrissie Tomlinson Memorial Hospital - CTMH) in the
Cayman Islands triggers the early royalty payments due to the Company from BIO, totalling US$500,000 in July
and September 2025, as part of the advanced minimum royalty of US$1 million previously all due on 21 January
2026.
In addition to this further clinical laboratory appointment, BIO is making progress in expanding its network across
the USA. Its accreditation and launch plans are now being synchronised to enable a more co-ordinated and
comprehensive campaign to roll out the CIZ1B biomarker test to help detect early-stage lung cancer. Cizzle Bio’s
initial target was to complete CLIA accreditation and secure the first commercial sale of the CIZ1B biomarker test
by the end of April 2025. As a consequence of this broader campaign, the launch date has been slightly extended
and is now expected to be finalised in the near term.
Key Highlights
Cizzle Bio appoints first clinical diagnostics laboratory to offer commercial CIZ1B biomarker testing in the
Caribbean triggering early payments totalling US$250,000 in July 2025 and US$250,000 in September
2025.
The expansion of BIO’s laboratory network follows the ongoing and successful collaboration between BIO
and the Company to ensure the CIZ1B test for use in helping detect early-stage lung cancer meets the
exacting standards as a laboratory developed test for commercial use. It is expected that further sites and
commercial launch plans will be announced shortly.
Background
On 21 October 2024 the Company announced an exclusive licensing and partnership agreement with BIO for its
proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA and Canada. The
Company has since received payments of US$400,000 from initial exclusivity fees and advanced royalties as part
of guaranteed payments totalling US$2.4 million over the period ending April 2027. The Company extended that
agreement on 16 December 2024 to cover the 14 Sovereign States of the Caribbean and the Cayman Islands
("Caribbean") and the signing of BIO’s first contract in the Cayman Islands triggers early payments totalling
US$250,000 in July 2025 and US$250,000 in September 2025.
BIO’s commercial strategy is to work with a number of specialist clinical laboratories to maximise market
penetration and make the CIZ1B biomarker test available to as many clinicians and patients as possible. The
appointment of accredited facilities to launch the CIZ1B biomarker test involves evaluation of a laboratory’s
operations, including its testing procedures, quality control, personnel qualifications, and compliance with
regulatory requirements. The successful completion of the operational and quality systems programme is required
for launching a cost-effective and scalable version of the CIZ1B biomarker that is commercially scalable and can
be rolled out as a global solution to help reduce premature cancer deaths and improve survival rates and quality
of life for cancer patients.