Cizzle Biotechnology Holdings PLC (LON:CIZ), the UK based diagnostics developer of early cancer tests, has announced 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.
• 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.
