Interim Results

Cizzle Biotechnology Holdings PLC

30 September 2026

 

30 September 2026

Cizzle Biotechnology Holdings Plc

(“Cizzle", “Cizzle Biotechnology”, the “Company” or the “Group”)

Interim results for the six months ended 30 June 2026

Cizzle Biotechnology Holdings PLC (LSE: CIZ), the UK based diagnostics developer of early cancer tests, is pleased to announce its interim results for the six months ended 30 June 2026.

H1 2026 Highlights

•  The Company’s CIZ1B Biomarker Blood-Test for Lung Cancer successfully accredited for clinical use in the U.S.A., the world’s largest diagnostics market, under the Clinical Laboratory Improvement Amendments (“CLIA”).

•  Delivery via a CLIA accredited laboratory marks the beginning of Cizzle Biotechnology’s commercialisation phase.

•  New patent granted in the U.S., covering the Company’s core methods to measure CIZ1B strengthening protection of the Company’s core technology in one of its most important commercial markets.

•  New patent granted in Canada, which together with U.S. patent protection, enhances the Company’s commercial position across North America and provides additional protection for its licensing partners as commercial activities continue to expand.

•  Aggregate guaranteed minimum royalty receipts under the agreement with Cizzle Bio Inc (“BIO”) increased to approximately US$5.9 million on renewal of the existing licensing agreement for a further seven years commencing on 18 October 2031, reflecting the Company’s licensing partner BIO‘s continued commitment to commercialising the CIZ1B technology in North America.

• In February 2026 the Research Agreement with the University of York was renewed until 30 June 2027.

• Funding:  During the period, the Group received £350,000 through the issue of convertible loan notes.

• Loss for the period of £329,000 (H1 2025: loss of £368,000).

Post Period Highlights

Update on Sales in USA

On 22 July 2026 the Group announced that following the validation of the Company’s proprietary CIZ1B Biomarker Blood Test for Lung Cancer, its licensing partner BIO, had made the test available for sale to licensed healthcare providers across the Dallas-Fort Worth and San Antonio metropolitan areas in Texas through its laboratory partner, OmniHealth Diagnostics (“Omni Health”), a CLIA-certified, COLA-accredited clinical laboratory. BIO selected the Dallas-Fort Worth and San Antonio markets. This initial market was chosen because of their large at-risk populations, strong physician networks and strategic importance to their commercialisation plans.

On 3 August 2026 BIO, announced it had executed a further laboratory agreement with BioBridge Global (“BBG”), a San Antonio-based healthcare services organisation with expertise in laboratory medicine, biomanufacturing, blood banking and translational science. This is the second commercial agreement with a clinical laboratory group as BIO rolls out its implementation programme to deliver the Company’s proprietary CIZ1B Biomarker Blood Test for Lung Cancer. Under the terms of the agreement, BBG Advanced Therapies, a subsidiary of non-profit BBG, will serve as a CLIA certified laboratory partner offering the test for lung cancer to licensed healthcare providers across South Texas, USA. Because the test is a laboratory-developed test (“LDT”), each CLIA-certified laboratory performing the assay must complete independent validation to verify analytical performance and meet rigorous quality standards. Upon completion, BBG will become an additional CLIA-certified laboratory offering the test to licensed healthcare providers in South Texas. The agreement is designed to advance BIO’s broader commercialisation strategy to expand national access to a high-impact, minimally invasive biomarker blood test in regions facing a significant lung cancer burden and health disparities. This collaboration is part of BIO’s phased national strategy to build a network of high-quality laboratory partners offering the test to licensed healthcare providers across North America.

Outlook

In a major milestone in the first half of 2026, the Company achieved successful laboratory accreditation of its proprietary test for the CIZ1B biomarker which is highly associated with early-stage lung cancer detection. This moves the Company from its development phase to commercialisation and making the test available to people in North America is a first step to enable the possibility of global adoption. 

The successful achievement of validation in a CLIA accredited facility and the commencement of Cizzle Biotechnology’s commercial phase, brings with it an intense period to ensure early adoption and roll out.  This includes working with our partners, key opinion leaders, clinicians, patient advocacy groups, occupational health groups, insurance companies and payers and here in the UK with the NHS. As part of our global licensing strategy, the Board continues to investigate and negotiate further strategic commercial partnerships and royalty bearing agreements in the UK, Europe and in the Asia-Pacific region. 

Cizzle continues to work closely with the Company's North American licensing partner BIO with the test approved for use under CLIA accreditation at OmniHealth.  The Board believes that now accreditation is in place, resources and efforts with its North Amercian partner, BIO, can be focused on the marketing and deployment of the CIZ1B biomarker tests into clinics with plans to scale through multiple clinical laboratory sites across North America and in the Caribbean. The Company is also actively engaged with a cancer hospital in the UK and is now progressing technical options to accelerate throughput to be able to roll-out more widely.

It is expected that any new agreements will continue to reflect the existing low cash burn by the Company, with minimal distribution, service or supply costs incurred by Cizzle. The Board is excited for the next stage of the Company’s growth as it moves from the validation phase to the commercialisation phase, which the directors believe, significantly de-risks the business.

Commenting Allan Syms, Chairman of Cizzle Biotechnology, said:

“After decades of research and development, the first half of 2026 was a landmark period in the Company’s history as we reported that our CIZ1B biomarker test for early-stage lung cancer had been validated for clinical use in a CLIA accredited laboratory in the USA. The pioneering research by Professor Coverley and her team at the University of York is now available as a commercial blood test through our licensing and laboratory partners in the USA. This success is a breakthrough in providing additional means to improving detection rates and ultimately saving lives. The Company is now focused on early adoption and roll out across North America and in validating the test for use in the UK with leading cancer centres and the NHS.”

Commenting, Professor Dawn Coverley, Founder and CSO of Cizzle Biotechnology, said:

“After years of work by dedicated scientists here in York, seeing the CIZ1B test finally move from bench to clinic is wonderful. We hope that its many practical advantages over other methods, including low cost and the need for very small quantities of blood, will mean that its use can be expanded into rapid and regular screening for lung cancer.”

Executive Chairman’s Statement

Commercial Progress

The National Cancer Plan for England notes that “One in two of us will experience cancer directly during our lives and only a tiny number of people will be untouched by the country’s biggest killer. Sometimes it hits the ones we love even harder than those of us who receive the diagnosis.” With the loss of life, stress and economic cost of cancer this is why transforming cancer outcomes is not just a priority it is a necessity. The plan makes a clear commitment “We will improve and modernise the early detection pathway” and that is why Cizzle Biotechnology is also committed to improving early diagnosis through its proprietary blood test to save lives.

On 16 June 2026, the Company announced that its proprietary CIZ1B biomarker test for early-stage lung cancer had been accredited for clinical use at OmniHealth . Working with its North American licensing partner, BIO, the Company secured approval under the CLIA, confirming that the test and laboratory processes meet U.S. federal standards for clinical accuracy, reliability and patient safety. The accreditation enables access for licensed U.S. healthcare providers and allows the laboratory to receive Medicare and Medicaid reimbursements.

Lung cancer remains the leading cause of cancer-related deaths in the United States and worldwide, with more than 234,000 new U.S. cases and over 2.2 million cases globally each year. Five-year survival can be as high as 90% when detected at Stage I but may fall to approximately 10% at later stages. Although around 14.2 million Americans are eligible for annual screening, uptake remains low and low-dose CT scans produce false positives and unnecessary follow-up procedures.

CIZ1B is an ELISA-based blood test designed to complement existing screening and diagnostic approaches by detecting a stable protein biomarker associated specifically with early-stage lung cancer. Validation at OmniHealth confirms its analytical performance and operational readiness, providing an accredited base for scalable U.S. rollout and a foundation for expansion into other markets.

Research and Development Progress

Translating decades of research into clinical practice, the CIZ1B biomarker test is built on foundational research into cancer origins, and the CIZ1 protein’s role in epigenetic stability, led by Professor Dawn Coverley at the University of York. Her work led to the discovery of the CIZ1B protein variant and its strong association with lung cancer, and the development of molecular tools that can measure CIZ1B with high sensitivity in patients with early-stage lung cancer. With CLIA accreditation, clinicians and patients will now have access to a scalable test that can help with the detection of lung cancer in its early stages and improve a patient’s chance of survival.

Achieving CLIA accreditation is necessarily a complex and challenging task and was made possible through working closely with OmniHealth, bringing together the necessary research, development, regulatory, clinical and commercial expertise to deliver a vision to transform lung cancer survival through accurate, low cost, non-invasive early detection at scale.

As part of the Company’s global licensing strategy, the focus has been to launch its first commercial test in the USA, the world’s largest clinical oncology market. The goal is now to continue to work with the Company’s partners to deliver early adoption and scale up. Having established a regulatory approved route to market in the USA, the Company is now focussed on commercial relationships in the UK, and seeking opportunities elsewhere in Europe and Asia. This strategy aims to continue to deliver shareholder value through licensing-based royalty payments and potential benefits arising from equity participation in the partner companies where possible.

During the period, Cizzle continued to support its research agreement and collaboration with the University of York which has been extended to 30 June 2027.

In addition, the Company continues to evaluate patients in the Moffitt Clinical Study which is ongoing. In August 2026, Dr Lary Robinson, Director of the Lung Cancer Early Detection (LEAD) Center at Moffitt Cancer Center, presented “Potential of the CIZ1B Biomarker to Redefine Early Lung Cancer Detection,” examining the potential role of CIZ1B in lung cancer detection and patient management and providing an overview of the clinical study underway at Moffitt.

Patent protection

On 12 June 2026 the Company announced that a patent application covering the Company’s core methods to measure the CIZ1B lung cancer biomarker has now been allowed by the U.S. Patent and Trademark Office (“USPTO”). This additional patent further enhances the Company’s strong patent portfolio, especially in the key market of the USA and follows the grant of a patent in Canada, as announced on 4 February 2026.

Funding

During the period, the Group received £350,000 through the issue of convertible loan notes. Of this balance £100,000 was received in relation to the final tranches due under a loan note dated 4 November 2025. An additional £250,000 was raised through a convertible loan note dated 1 April 2026 issued to Frazer Lang, an existing investor in the Company. This loan note could, at the election of the note holder, be converted into new ordinary shares in the Company at a price of 1.4p per share. In connection with this £250,000 facility the Company also issued warrants over 10,000,000 shares at an exercise price of 2.5p, to be exercised within two years of the date of issue.

On 6 May 2026, the Company announced that a total of £400,000 convertible loan notes were being converted at 1.4p per share through the issue of 28,571,429 New Ordinary Shares in the Company.

Financial overview

During the six months ended 30 June 2026, 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 2026 are summarised as follows:

• Other income and interest receivable: £Nil (H1 2025: £1,000)
• Corporate expenses, before exceptional items: £354,000 (H1 2025: £346,000).
• Taxation credit: £25,000 (H1 2025: £13,000)
• Total comprehensive loss of £329,000 (H1 2025:- Loss £368,000).
• Loss per share 0.08p (H1 2025: - Loss of 0.09p).
• Cash balances as at 30 June 2026: £81,000 (30 June 2025: £182,000).

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 2026.

Enquiries:

Cizzle Biotechnology Holdings plc	Via IFC Advisory
Allan Syms (Executive Chairman)

Allenby Capital Limited (Financial Adviser)	[phone]
John Depasquale (Corporate Finance)
IFC Advisory Limited	[phone]
Tim Metcalfe Florence Staton
Zeus (Corporate Broker)	[phone]
James Hornigold, Alex Slater (Investment Banking)
Nick Searle (ECM)

About Cizzle Biotechnology

The CIZ1B biomarker is a naturally occurring variant of the cell nuclear protein CIZ1, which is linked with the preservation of epigenetic integrity. CIZ1B is highly associated with the presence of early-stage lung cancer and can be measured in small quantities of blood. The Company has developed CIZ1B into a non-invasive, cost-effective blood test to help in the early detection of lung cancer. In June 2026, the test was successfully accredited for clinical use in the United States under the Clinical Laboratory Improvement Amendments (CLIA) at OmniHealth Diagnostics, providing a regulated laboratory route to market and enabling licensed US healthcare providers to order the test.

Cizzle has entered into commercial royalty-bearing licensing arrangements covering North America and the Caribbean and continues to work with commercial partners and centres of excellence in cancer care to support the clinical adoption and wider commercialisation of its proprietary diagnostic technologies.

Cizzle was admitted to the Official List and Main Market of the London Stock Exchange in May 2021. 

For more information, please see https://cizzlebiotechnology.com

You can also follow the Company through its X (formerly twitter)  account @CizzlePlc and on LinkedIn.

Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2026

		Group Six months ended	Group Six months ended	Group Year ended
		30 June 2026	30 June 2025	31 December 2025
		Unaudited	Unaudited	Audited
	Notes	£’000	£’000	£’000
Revenue		-	-	-
Cost of Sales		-	-	-
Gross Profit		-	-	-
Interest receivable		-	1	2
Administrative Expenses
-on going administrative expenses		(354)	(346)	(711)
-share option charge		-	(10)	(20)
- loss on sale of investment		-	(26)	-
Net fair value loss on financial asset measured at fair value through profit or loss		-	-	(22)
Total administrative expenses including exceptional items		(354)	(382)	(753)
Operating Loss and loss before income tax		(354)	(381)	(751)
Income tax	3	25	13	60
Loss and total comprehensive income for the period attributable to the equity shareholders of the parent		(329)	(368)	(691)
Earnings per share Loss- basic and diluted – pence	4	(0.08)p	(0.09)p	(0.17)p

Consolidated Statement of Financial Position

as at 30 June 2026

		Group 30 June	Group 30 June		Group 31 Dec
		2026	2025		2025
		Unaudited	Unaudited		Audited
		£’000	£’000		£’000
Non-Current Assets
Property, plant and equipment		1	2		2
Total Non-Current Assets		1	2		2
Current Assets
Inventories		-	1		-
Trade and other receivables		109	72		127
Cash and cash equivalents		81	182		116
Total Current Assets		190	255		243
Total Assets		191	257		245
Equity
Ordinary shares		3,510	3,507	3,507
Share premium		36,139	35,911	35,911
Share capital reduction reserve		10,081	10,081	10,081
Share option reserve		519	650	519
Convertible loan reserve		270	-	186
Share warrant reserve		80	-	63
Reverse acquisition reserve		(40,021)	(40,021)	(40,021)
Retained losses		(10,915)	(10,404)	(10,586)
Total equity		(337)	(276)	(340)
Liabilities
Current liabilities
Trade and other payables		528	383		585
Convertible debt		-	150		-
Total current liabilities		528	533		585
Total equity and liabilities		191	257		245

Consolidated Statement of Cash Flows

For the six months ended 30 June 2026

					Group 6 Months			Group 6 Months			Group 12 Months
					ended			ended			ended
					30 June			30 June			31 Dec
					2026			2025			2025
					Unaudited			Unaudited			Audited
					£’000			£’000			£’000
Cash flow from operating activities
Operating loss before tax					(354)			(381)			(751)
Adjustment for:
Net fair value loss on financial assets measured at fair value through profit or loss					-			-			22
Loss on sale of investment					-			22			-
Share option charge					-			10			20
Depreciation charge					1			-			-
Operating cash flow before working capital movements						(353)			(349)			(709)
Decrease in inventories						-			1			2
Decrease / (increase) in trade and other receivables					12			6			(3)
(Decrease) / increase in trade and other payables					(57)			(27)			176
Cash used in operations					(398)			(369)			(534)
Tax received					31			38			38
Net cash used in operating activities					(367)			(331)			(496)
Cash flow from financing activities
Conversion of debt to equity (net of issue costs)					(18)			-			-
Issue of convertible debt					350			150			249
Net cash inflow from financing activities					332			150			249
Cash flow from investing activities
Purchase of laboratory equipment					-			(2)			(2)
Net cash expended in investing activities					-			(2)			(2)
Net (decrease) / increase in cash and cash equivalents					(35)			(183)			(249)
Cash and cash equivalents at the start of the period					116			365			365
Cash and cash equivalents at the end of the period					81			182			116

Consolidated Statement of Changes in Equity

For the six months ended 30 June 2026 (unaudited)

Group			Ordinary Share Capital	Share Premium		Reverse Acquisition Reserve	Convertible Loan Note Reserve			Share Warrant Reserve	Share Reduction Reserve		Share Option Reserve		Retained Losses						Total
	£’000			£’000		£’000	£’000			£’000	£’000		£’000		£’000			£’000
At 1 January 2026		3,507		35,911		(40,021)	186			63	10,081		519		(10,586)					(340)
Issue of convertible loan notes		-			-	-	350		-			-		-			-		350
Recognition of share warrants		-			-	-	(80)		80			-		-			-		-
Conversion of loan notes into equity		3			246	-	(186)		(63)			-		-			-		-
Issue costs of equity		-			(18)	-	-		-			-		-			-		(18)
		3,510			36,139	(40,021)		270		80		10,081		519		(10,586)				(8)
Comprehensive Loss for the period		-			-	-		-		-		-		-		(329)				(329)
At 30 June 2026		3,510			36,139	(40,021)		270		80		10,081		519		(10,915)				(337)

For the six months ended 30 June 2025 (unaudited) Group Ordinary Share Capital Share Premium Capital Redemption Reserve Share Option Reserve Reverse Acquisition Reserve Retained Losses     Total £’000 £’000 £’000 £’000 £’000 £’000 £’000 At 1 January 2025 3,507 35,911 10,081 640                    (40,021) (10,036) 82 Share option charge - - - 10 - - 10 3,507 35,911 10,081 650 (40,021) (10,036) 92 Comprehensive Loss for the period - - - - - (368) (368) At 30 June 2025 3,507 35,911 10,081 650 (40,021) (10,404) (276)

Consolidated Statement of Changes in Equity (continued)

For the year ended 31 December 2025 (Audited)

Group			Ordinary Share Capital	Share Premium		Reverse Acquisition Reserve	Convertible Loan Note Reserve			Share Warrant Reserve	Share Reduction Reserve			Share Option Reserve			Retained Losses			Total
	£'000			£'000		£’000	£’000			£’000	£’000			£'000			£'000	£'000
At 1 January 2025		3,507		35,911		(40,021)	-			-	10,081			640			(10,036)		82
Issue of convertible loan notes		-			-	-	250		-			-	-			-		250
Costs of issue of loan notes		-			-	-	(1)		-			-	-			-		(1)
Recognition of share warrants		-			-	-	(63)		63			-	-			-		-
Share option charge for year		-			-	-	-		-			-	20			-		20
Share option transfer on lapsed options		-			-	-	-		-			-	(141)			141		-
		3,507			35,911	(40,021)		186		63		10,081	519		(9,895)			351
Comprehensive Loss for the year		-			-	-		-		-		-	-		(691)			(691)
At 31 December 2025		3,507			35,911	(40,021)		186		63		10,081	519		(10,586)			(340)

Notes to the financial statements

For the six months ended 30 June 2026 (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 2025.

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 2026.

The results for the six months ended 30 June 2026 are the Group results.

The financial information for the six months ended 30 June 2026 is unaudited and does not constitute statutory financial statements for those periods. The financial information for the year ended 31 December 2025 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 2025.

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 £25,000 for the six months ended 30 June 2026 relates to accrued income for the recovery of tax on qualifying research and development expenditure. For the six months ended 30 June 2025 there was an income tax credit of £13,000 and a credit of £60,000 for the year ended 31 December 2025.

4. Earnings per share

	Group 6 months	Group 6 months	Group Year
	ended	ended	ended
	30 June 2026	30 June 2025	31 December 2025
	Unaudited	Unaudited	Audited
Basic loss per share:
Total comprehensive loss - £’000	(329)	(368)	(691)
Weighted number of Ordinary Shares – ‘000	404,398	396,392	396,392
Loss per share - operations - pence	(0.08p)	(0.09p)	(0.17p)

As the Group result for the six months ended 30 June 2026, 30 June 2025 and year ended 31 December 2025 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, c/o Ampa Holdings LLP, Level 19, The Shard, 32 London Bridge Street, London, SE1 9SG. This interim report can also be viewed on the Group's website: https://cizzlebiotechnology.com.

 

END