Announcement • Jun 16
Cizzle Biotechnology Holdings Plc CIZ1B Biomarker Test Approval For Clinical Use In USA Cizzle Biotechnology Holdings Plc announced the successful laboratory accreditation of its proprietary test for the CIZ1B biomarker which is highly associated with early-stage lung cancer. Working closely with the Company's North American licensing partner Cizzle Bio Inc, the test is now approved for use under Clinical Laboratory Improvement Amendments accreditation at OmniHealth Diagnostics, a CLIA-certified, COLA-accredited clinical laboratory based in Dallas, Texas. CLIA approval is regulated by the Centers for Medicare & Medicaid Services and signifies that a laboratory's testing processes and assays meet US federal standards for timely clinical accuracy, reliability, and patient safety and will now enable the test to be made available to licensed U.S. healthcare providers. CLIA compliance is also mandatory for a laboratory to receive Medicare and Medicaid reimbursements. The CIZ1B biomarker test is a novel, ELISA-based immunoassay that detects a specific protein variant associated with early-stage lung cancer through a simple blood draw. The test is designed to complement LDCT screening and other standard-of-care diagnostic approaches, helping clinicians assess cancer risk, clarify indeterminate findings, and make more informed clinical decisions. Unlike multi-cancer early detection tests that rely on detecting circulating tumor DNA bearing mutation or methylation signals, CIZ1B is designed to detect a stable tumor-associated protein biomarker linked to lung cancer at its earliest stage. This distinct biomarker approach offers important advantages in identifying disease when intervention has the greatest potential to improve outcomes. CIZ1B is offered as a laboratory developed test and is performed exclusively within CLIA-certified laboratory environments, ensuring rigorous quality oversight, analytical control, and compliance with applicable regulatory standards. The validation at OmniHealth confirms the test's analytical performance and operational readiness within a U.S. clinical laboratory environment, supporting scalability, reproducibility, and integration into routine diagnostic workflows. This provides an accredited base to roll the test out across the USA and establishes a strong foundation for growth in other global and home markets. 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 Cizzle's North American Licensing partner, BIO, and its clinical laboratory partner 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, there has been a first focus on the world's largest market in North America to launch its first commercial test. 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 also exploring new commercial relationships in the UK, 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. Announcement • Jun 13
U.S. Patent and Trademark Office Allows Patent Application Covering its Core Methods to Measure CIZ1B Lung Cancer Biomarker Cizzle Biotechnology Holdings plc 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. 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. The USPTO patent, 'Use of a fibrinogen capture agent to detect a CIZ1B variant', concerns a two-step test format developed by Cizzle at the University of York. This test format is licensed to Cizzle Bio Inc. for use in North America and the Caribbean, and these new patents strengthen Cizzle Bio Inc.'s position as they prepare to launch the test and establish a robust position for commercialising the Company's innovative and proprietary technology. The CIZ1B biomarker test is the product of work by Professor Dawn Coverley and her research team at the University of York, initially supported by both UK industry and charity sector research grants. The Company's commercial strategy is to licence globally its proprietary test for the CIZ1B biomarker for use in the early detection of lung cancer. Cizzle Biotechnology's patent portfolio and technology know-how is central to securing future licensing and royalty revenue. Developing a strong patent portfolio in North America is intended to enable Cizzle Bio Inc. to establish a leading market position and supports its partnership programme with specialist clinical laboratories and hospitals, enabling market penetration to ensure the test is available to as many clinicians and patients as possible. Cizzle Biotechnology also has been granted patent protection from the European Patent Office and intends to secure further licensing partnerships with accredited facilities in the UK and Europe, including the NHS. Bringing the CIZ1B biomarker test to market will provide valuable new solutions applicable to the current NHS cancer plan which aims to improve cancer survival by diagnosing 75% of cancers at stages 1 and 2 by 2028. 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 and has now entered commercial royalty-bearing arrangements to license its proprietary technology, and into collaborations with centres of excellence in cancer care. Announcement • May 21
Cizzle Biotechnology Holdings Plc, Annual General Meeting, Jun 16, 2026 Cizzle Biotechnology Holdings Plc, Annual General Meeting, Jun 16, 2026. Location: the offices of shakespeare martineau llp, c o ampa holdings llp, level 19, the shard, 32 london bridge street, se1 9sg, london United Kingdom 
