REG - Cizzle Biotechnology - Interim Results
30/09/2025 07:00
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RNS Number : 2934B Cizzle Biotechnology Holdings PLC 30 September 2025
30 September 2025
Cizzle Biotechnology Holdings Plc
("Cizzle", the "Company" or the "Group")
Interim results for the six months ended 30 June 2025
Cizzle Biotechnology Holdings PLC (LSE: CIZ), the UK based healthcare
diagnostics developer, is pleased to announce its interim results for the six
months ended 30 June 2025.
Highlights
· January 2025: Professor Dawn Coverley, Founder and Non-Executive
Director was appointed Chief Scientific Officer. This followed the completion
of major research and development milestones for the CIZ1B Biomarker test, and
to facilitate support to the Company's global licensing partners as they enter
the commercialisation phase.
· January 2025: Research Agreement extension: The Group's research
agreement with the University of York was extended until 28 June 2026.
· March 2025: Pathfinder lab appointed: Cizzle's North America
Licensing Partner, Cizzle Bio Inc ("BIO") appointed its first pathfinder
laboratory.
· March 2025: Board appointment: Matt Bower was appointed as a
Non-Executive Director to strengthen the Board by adding his experience in
advising and mentoring high technology businesses globally, to enhance
corporate governance and replace Professor Coverley on the Audit and
Remuneration Committees.
· April 2025: Hospital contract secured: BIO 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 with Doctors
Hospital Cayman, triggering early royalty payments of which US$125,000 was
received in July 2025.
· June 2025: Up-front fees and advanced royalty payments: During
the period ended June 2025, the Company received US$400,000 of the agreed and
guaranteed US$2.4 million payments due. A further payment of US$125,000 in
July 2025 meant that the total receipts amounted to US$525,000.
· April 2025: New website: The Company launched its new website to
allow all stakeholders, shareholders, investors and customers to access a wide
range of information and latest news on the Company's status and products.
· May 2025: Fund raise of £150,000: Through the issue of a
convertible loan note to provide additional funding to support the Company's
growth strategy, in particular to seek partnerships for its CIZ1B early cancer
test in the UK and elsewhere in Europe. The note was subscribed for by Frazer
Lang, an existing investor in the Company and is convertible at any time at a
price of 1.4 pence per share.
· Financial results: Loss for the period of £368,000 (H1 2024:
loss of £1,411,000).
Post Period Highlights
· Commercial Launch: In August 2025, following progress achieved at
their pathfinder lab, BIO realigned their accreditation and market launch
strategy with a new multi-site clinical laboratory, enabling a much wider
co-ordinated and comprehensive campaign to roll out the CIZ1B biomarker test
in North America. Omni Health Diagnostics ("Omni") announced in September 2025
that the roll out programme will be nationwide in at least six states with
potential further expansion. This demonstrates how BIO intends to scale its
operations to meet expected demand in the USA.
· Moffitt Cancer Center Collaboration: On 9 September 2024, the Group
was selected by Moffitt Cancer Center ("Moffitt"), Florida's leading cancer
hospital, to test patients with suspicious lung nodules in a clinical
evaluation using the Group's proprietary CIZ1B biomarker assay. Since then,
Moffitt has been recruiting patients and collecting blood samples to ship to
the University of York. We expect samples to be received shortly and testing
to begin in Q4 2025. This important study to test patients for the presence of
the CIZ1B Biomarker is part of a major clinical evaluation for suspected lung
cancer patients.
Commenting Allan Syms, Chairman of Cizzle Biotechnology, said:
"The first half of 2025 has been a period focussed on validation,
accreditation and building, together with our licensing partner Cizzle BIO in
the USA, a comprehensive base from which our simple blood test to help in the
early detection of lung cancer can be launched for commercial use. Enabled by
the Company's agreement with BBI Solutions ("BBI"), an established accredited
supplier who now manufacture our antibodies in their ISO 13485-certified
facilities, BIO has completed its pathfinder programme and entered into an
agreement with Omni Health Diagnostics to launch the test across the USA
through multiple sites to meet expected demand. BIO have invested in
significant marketing and partnership campaigns to build awareness through a
co-ordinated campaign and are now poised for commercial launch. The
accreditation process is underway at Omni, who expect to obtain CLIA
accreditation and launch in the near future. The Company continues to receive
payments from BIO as part of the advanced royalty schedule, which demonstrates
the close working relationship we have as we create a platform to help detect
lung cancer early. The Company is now expanding its licensing activities
elsewhere, including in the UK, and we look forward to updating our
shareholders with progress in due course."
Executive Chairman's Statement
Operational and strategic overview
In Cancer Research UK's report on 'Early Detection and Diagnosis of Cancer: A Roadmap to the Future' *Professor Chris Whitty, Chief Medical Officer for England and Chief Scientific Adviser for the Department of Health and Social Care said "The early detection and diagnosis of serious disease, including cancer, changes outcomes substantially. If cancer can be intercepted at the earliest clinically relevant timepoint this gives a much better chance of survival and an improved quality of life."
With over 5,000 people daily losing their lives to lung cancer and the main
reason being the lack of early detection, the Group's technology aims to
eliminate barriers, empowering patients and healthcare providers with a
cutting-edge solution to one of the greatest challenges in modern medicine.
The Group's vision is a global shift in lung cancer survival through accurate,
low cost, non-invasive early detection at scale. The Group remains focussed on
the systematic development and commercialisation of novel and proprietary
clinical diagnostic tests for the early detection of cancer particularly where
there is an unmet clinical need.
The Group's platform technology is based on the ability to detect a stable
plasma biomarker, a variant of a normal protein, CIZ1, which is a naturally
occurring cell nuclear protein involved in DNA replication. The targeted CIZ1B
variant is highly correlated with early-stage lung cancer and since the
Group's admission to the London Stock Exchange in 2021, it has invested in the
development of its technology to enable its full commercialisation through a
global licensing and partnership strategy.
With the commercial manufacture of CIZ1B monoclonal antibodies now
established, and a guaranteed royalty stream being generated by our first
licensing partner BIO in North America and the Caribbean, and validation of
the test in progress, it is anticipated that commercial sales will begin in
the near future followed by further licensing and partnership deals elsewhere
in the world.
*https://assets.ctfassets.net/u7vsjnoopqo5/2Q32Uv00MxEAUS34Gw8WHk/68ee767b745332d8ce1daf81037807dc/early_detection_diagnosis_of_cancer_roadmap.pdf
Research and Development Progress
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 that should allow for non-intrusive, cost-effective testing in a
high-throughput, hospital-friendly format, and in the future a potential rapid
point of care test for use in doctors' offices and pharmacies. During the
period, Cizzle continued to support its research agreement and collaboration
with the University of York which has been extended to 28 June 2026. The Group
has reported the successful generation and subsequent manufacture of its
proprietary monoclonal antibodies by BBI, the world's largest independent
producer of immunodiagnostic reagents. Entry into production of this central
component of the Company's test to detect the presence of the CIZ1B biomarker,
was an inflexion point in enabling the clinical validation process to be
undertaken.
Professor Coverley's team have been instrumental in their support to BIO's
pathfinder laboratory and to Omni Health Diagnostics in providing a Standard
Operating Procedure (SOP) which serves as an operational guide for the
clinical laboratories that will seek CLIA accreditation of the CIZ1B test as a
LDT in North America. This ensures uniformity in performance, quality control,
and adherence to regulations, which reduces errors, improves safety, and
preserves institutional knowledge within an organisation and is essential in
obtaining regulatory validation in the near term.
The Group announced on 9 September 2024 that it had been selected by the
Moffitt Cancer Center, the number one cancer hospital in Florida and the
Southeast USA, to test patients with suspicious lung nodules in a clinical
evaluation using the Group's proprietary CIZ1B biomarker assay. Since then,
Moffitt has been recruiting a large patient cohort and will send the first
batch of blood samples to be tested for the CIZ1B Biomarker at the University
of York. As previously reported, this will for the first time be analysing
patient blood samples to determine biomarker accuracy in predicting whether or
not a lung nodule is likely to be cancer as part of a real-world clinical
evaluation in a hospital setting.
Licensing Strategy and Commercial Progress
The Company continues to operate a global licensing and partnership strategy
because the directors believe this is the fastest and most cost-effective
means to bring its technology to market. For product solutions, an outsourcing
approach has been adopted which aims to leverage external partners expertise
and to provide an effective cost management process. As such the Group has
benefited from its research and development agreement with the University of
York through access to skilled scientists and laboratory facilities. It has
also produced commercial antibodies through agreement with an industry leading
and iso 13485 accredited facility, and has secured its first royalty bearing
licensing agreement in North America and the Caribbean. The licensing approach
of up-front fees and guaranteed royalties has generated important revenue for
the Group, avoided the need to fund and build an expert team in the licensed
territory and as such accelerated market deployment and installation of
laboratory testing accreditation and testing capability.
BIO is now completing validation of the test with its new clinical diagnostics
laboratory group, Omni Health Diagnostics ("Omni"), as part of a national
expansion strategy based on Omni's active laboratory acquisitions and
partnerships programme to provide testing capability in Texas, New York,
California, South Carolina, Tennessee and Florida which will provide
nationwide testing coverage. It is expected that BIO will add further clinical
laboratory partners as required to be able to meet anticipated market demand
across North America when the test completes Clinical Laboratory Improvement
Amendments ("CLIA") accreditation as a Laboratory Developed Test ("LDT").
The anticipated commercial launch of the Group's CIZ1B test in the USA is
expected to be followed by the Group's expansion into different geographies,
and maximise speed and scale of market entry through specialist licensing
partners globally. The Group's next focus will be in the UK and Europe.
Funding
During the period, the Group announced that it has raised £150,000 through
the issue of a convertible loan note (the "Note"), to provide additional
funding to support the Company's growth strategy, in particular to seek
partnerships for its CIZ1B early cancer test in the UK and elsewhere in
Europe, following the successful licensing agreement with BIO in North
America. The Note, which was subscribed for by Frazer Lang, an existing
investor in the Company, is convertible at any time, at the election of the
Note holder, during its 24-month term into new ordinary shares in the Company
at a price of 1.4 pence per share. No interest is payable on the Note.
On 18 August 2025, the Company announced BIO's appointment of a new multi-site
full scale COLA and CLIA accredited laboratory group (later announced as Omni)
to launch the Company's CIZ1B biomarker test throughout the USA. As part of
agreed advance exclusivity and royalty fees, BIO paid an early payment of
US$125,000 to the Company bringing total receipts at that date of US$525,000
of the guaranteed advance payments of US$2.4m. The Company and BIO have now
agreed to a new regular payment schedule that will result in all remaining
advance royalties being received by the end of 2026.
Financial overview
During the six months ended 30 June 2025, the Company continued its focus on
being a healthcare diagnostics developer. The Group consists of Cizzle
Biotechnology Holdings PLC as the parent company with wholly owned
subsidiaries, Cizzle Biotechnology Ltd ("CBL") and Cizzle Biotech Ltd
(formerly Enfis Ltd). The current Group structure was formed when the Company
completed the acquisition of CBL on 14 May 2021 and was admitted to trading on
the Main Market of the London Stock Exchange.
The financial results for the six months to 30 June 2025 are summarised as
follows:
· Other income and interest receivable: £1,000 (H1 2024: £79,000)
· Corporate expenses, before exceptional items: £346,000 (H1 2024:
£299,000).
· Non-cash administrative expenses relating to:
o share option charge: £10,000 (H1 2024: £120,000)
o Net fair value loss on financial asset: £Nil (H1 2024: £1,081,000)
(related to a current asset investment in Conduit Pharmaceuticals Inc
("Conduit"), a NASDAQ listed company, that was sold in H1 2025 for a loss on
sale of investment £26,000 (H1 2024: £Nil).
· Taxation credit: £13,000 (H1 2024: £10,000)
· Total comprehensive loss of £368,000 (H1 2024, Loss £1,411,000).
· Loss per share 0.09p, (H1 2024, Loss of 0.37p).
· Cash balances as at 30 June 2025: £182,000 (30 June 2024:
£484,000).
Responsibility Statement
We confirm that to the best of our knowledge:
· the interim financial statements have been prepared in accordance
with International Accounting Standards 34, Interim Financial Reporting;
· give a true and fair view of the assets, liabilities, financial
position and loss of the Company;
· the Interim report includes a fair review of the information required
by DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of
important events that have occurred during the first six months of the
financial year and their impact on the set of interim financial statements;
and a description of the principal risks and uncertainties for the remaining
six months of the year; and
· the Interim report includes a fair review of the information required
by DTR 4.2.8R of the Disclosure and Transparency Rules, being the information
required on related party transactions.
The interim report was approved by the Board of Directors and the above
responsibility statement was signed on its behalf by Allan Syms on 30
September 2025.
Enquiries:
Cizzle Biotechnology Holdings plc Via IFC Advisory
Allan Syms (Executive Chairman)
Allenby Capital Limited +44(0) 20 3328 5656
John Depasquale
Piers Shimwell
IFC Advisory Limited +44(0) 20 3934 6630
Tim Metcalfe
Florence Chandler
About Cizzle Biotechnology
Based on the pioneering work of Professor Coverley and colleagues, on a
naturally occurring variant of the cell nuclear protein CIZ1, the CIZ1B
biomarker is highly associated with the presence of early-stage cancer. The
company has developed CIZ1B into a non-invasive, cost-effective blood test to
help in the early detection of lung cancer and has now entered commercial
royalty-bearing arrangements to license its proprietary technology, and into
collaborations with centres of excellence in cancer care. Cizzle was admitted
to the Standard segment of the main market of the London Stock Exchange in May
2021.
For more information, please see https://cizzlebiotechnology.com
(https://cizzlebiotechnology.com)
You can also follow the Company through its twitter account @CizzlePlc and on
LinkedIn.
Consolidated Statement of Comprehensive Income
For the six months ended 30 June 2025
Group Group Group
Six months ended Six months ended Year ended
30 June 2025 30 June 2024 31 December 2024
Unaudited Unaudited Audited
Notes £'000 £'000 £'000
Revenue - - -
Cost of Sales - - -
Gross Profit - - -
Other income - 78 78
Interest receivable 1 1 4
Administrative Expenses
-on going administrative expenses (346) (299) (689)
-share option charge (10) (120) (189)
- loss on sale of investment (26) - -
Net fair value loss on financial asset measured at fair value through profit - (1,081) (1,391)
or loss
Total administrative expenses including exceptional items (382) (1,500) (2,269)
Operating Loss and loss before income tax (381) (1,421) (2,187)
Income tax 3 13 10 21
Loss and total comprehensive income for the period attributable to the equity
shareholders of the parent
(368) (1,411) (2,166)
Earnings per share Loss- basic and diluted - pence 4 (0.09)p (0.37)p (0.56)p
Consolidated Statement of Financial Position
as at 30 June 2025
Group Group Group
30 June 30 June 31 Dec
2025 2024 2024
Unaudited Unaudited Audited
£'000 £'000 £'000
Non-Current Assets
Property, plant and equipment 2 - -
Intangible asset - - -
Total Non-Current Assets 2 - -
Current Assets
Inventories 1 - 2
Investment held at fair value through profit or loss - 332 22
Trade and other receivables 72 107 103
Cash and cash equivalents 182 484 365
Total Current Assets 255 923 492
Total Assets 257 923 492
Equity
Ordinary shares 3,507 3,507 3,507
Share premium 35,911 35,910 35,911
Share capital reduction reserve 10,081 10,081 10,081
Share option reserve 650 598 640
Reverse acquisition reserve (40,021) (40,021) (40,021)
Retained losses (10,404) (9,281) (10,036)
Total equity
(276) 794 82
Liabilities
Current liabilities
Trade and other payables 383 129 410
Convertible debt 150 - -
Total current liabilities 533 129 410
Total equity and liabilities 257 923 492
Consolidated Statement of Cash Flows
For the six months ended 30 June 2025
Group Group Group
6 Months 6 Months 12 Months
ended ended ended
30 June 30 June 31 Dec
2025 2024 2024
Unaudited Unaudited Unaudited
£'000 £'000 £'000
Cash flow from operating activities
(381) (1,421) (2,188)
Operating loss before tax
Adjustment for:
Net fair value loss on financial assets measured at fair value through profit - 1,081 1,391
or loss
Loss on sale of investment 22 - -
Share option charge 10 120 162
Operating cash flow before working capital movements (349) (220) (635)
Decrease in inventories 1 - 2
Decrease / (increase) in trade and other receivables 6 (9) 6
(Decrease) / increase in trade and other payables (27) (55) 223
Cash used in operations (369) (284) (404)
Tax received 38 46 46
Net cash used in operating activities (331) (238) (358)
Cash flow from financing activities
Proceeds from the issue of ordinary shares (net of issue costs) - 578 579
Issue of convertible debt 150 - -
Net cash inflow from financing activities 150 578 579
Cash flow from investing activities
Purchase of laboratory equipment (2) - -
Net cash inflow from financing activities (2) - -
Net (decrease) / increase in cash and cash equivalents (183) 340 221
Cash and cash equivalents at the start of the period 365 144 144
Cash and cash equivalents at the end of the period 182 484 365
Consolidated Statement of Changes in Equity
For the six months ended 30 June 2025 (unaudited)
Group Ordinary Share Share Reverse Retained Total
Share Premium Option Acquisition Losses
Capital Capital Reserve Reserve
Redemption
Reserve
£'000 £'000 £'000 £'000 £'000 £'000 £'000
At 1 January 2025 3,507 35,911 640 (40,021) (10,036) 82
10,081
Share option charge - - - 10 - - 10
3,507 35,911 650 (40,021) (10,036) 92
10,081
Comprehensive Loss for the Period - - - - (368) (368)
-
At 30 June 2025 3,507 35,911 650 (40,021) (10,404) (276)
10,081
For the six months ended 30 June 2024 (unaudited)
Group Ordinary Share Share Reverse Retained Total
Share Premium Capital Option Acquisition Losses
Capital Redemption Reserve Reserve
Reserve
£'000 £'000 £'000 £'000 £'000 £'000 £'000
At 1 January 2024 3,504 35,335 478 (40,021) (7,870) 1,507
10,081
Issue of shares for cash 3 648 - - - 651
-
Share issue costs - (73) - - - (73)
-
Share option charge - - - 120 - - 120
3,507 35,910 598 (40,021) (7,870) 2,205
10,081
Comprehensive Loss for the Period - - - - (1,411) (1,411)
-
At 30 June 2024 3,507 35,910 598 (40,021) (9,281) 794
10,081
Consolidated Statement of Changes in Equity (continued)
For the year ended 31 December 2024 (Audited)
Group Ordinary Share Share Reverse Retained Total
Share Premium Option Acquisition Losses
Capital Reserve Reserve
Capital
Redemption
Reserve
£'000 £'000 £'000 £'000 £'000 £'000
£'000
At 1 January 2024 3,504 35,335 (40,021) (7,870) 1,507
10,081 478
3 648 - - - 651
Issue of shares for cash
-
Costs of share issue - (72) - - - (72)
-
Share option charge - - 162 - - 162
-
3,507 35,911 640 (40,021) (7,870) 2,248
10,081
Comprehensive Loss for the year - - - - (2,166) (2,166)
-
At 31 December 2024 3,507 35,911 640 (40,021) (10,036) 82
10,081
Notes to the financial statements
For the six months ended 30 June 2025 (unaudited)
1. Basis of preparation
These condensed interim financial statements have been prepared in accordance
with IAS 34 - Interim Financial Reporting using the recognition and
measurement principles of UK-adopted International Accounting Standards and
should be read in conjunction with the audited consolidated financial
statements of the Group for the year ended 31 December 2024.
The principal accounting policies used in preparing these condensed interim
financial statements are those expected to apply to the Group's Consolidated
Financial Statements for the year ending 31 December 2025.
The results for the six-months ended 30 June 2025 are the Group results.
The financial information for the six months ended 30 June 2025 is unaudited
and does not constitute statutory financial statements for those periods. The
financial information for the year ended 31 December 2024 has been extracted
from the audited financial statements for this period. The financial
information has been prepared in accordance with accounting policies
consistent with those set out in the Group financial statements for the year
ended 31 December 2024.
2. Continuing and discontinued operations
The Group is considered to have one class of business which is focused on the
early detection of lung cancer via the development of an immunoassay test for
the CIZ1B biomarker.
3. Income Tax
The Income tax credit of £13,000 for the six months ended 30 June 2025
relates to accrued income for the recovery of tax on qualifying research and
development expenditure. For the six months ended 30 June 2024 there was an
income tax credit of £10,000 and a credit of £21,000 for the year ended 31
December 2024.
4. Earnings per share
Group Group Group
6 months 6 months Year
ended ended ended
30 June 2025 30 June 2024 31 December 2024
Basic loss per share:
Total comprehensive loss - £'000 (368) (1,411) (2,166)
Weighted number of Ordinary Shares - '000 396,392 378,328 355,861
Loss per share - operations - pence (0.09p) (0.37p) (0.56p)
As the Group result for the six months ended 30 June 2025, 30 June 2024 and
year ended 31 December 2024 is a loss, any exercise of share options or
warrants would have an anti-dilutive effect on earnings per share.
Consequently, earnings per share and diluted earnings per share are the same,
as potentially dilutive share options have been excluded from the calculation.
5. Copies of Interim Report
Copies of this interim report are available upon request to members of the
public from the Company Secretary, SGH Company Secretaries Limited, 6(th)
Floor, 60 Gracechurch Street, London, EC3V 0HR. This interim report can also
be viewed on the Group's website: https://cizzlebiotechnology.com
(https://cizzlebiotechnology.com) .
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