Cizzle Biotechnology Holdings plc (LON:CIZ) is rapidly expanding the global footprint of its innovative CIZ1B biomarker test for early-stage lung cancer detection, with significant developments in both the Caribbean and United States markets.
Caribbean Expansion Triggers Early Royalties
The UK-based diagnostics developer announced that its licensing partner, Cizzle Bio Inc (BIO), has executed its first contract in the Caribbean with Doctors Hospital (Chrissie Tomlinson Memorial Hospital – CTMH) in the Cayman Islands. This milestone activates early royalty payments totaling US$500,000, to be paid in July and September 2025, as part of an advanced minimum royalty of US$1 million previously due in January 2026.
This Caribbean contract follows the December 16, 2024 extension of BIO's exclusive licensing agreement, which originally covered the USA and Canada, to include 14 Sovereign States of the Caribbean and the Cayman Islands.
"The launch programme for our CIZ1B biomarker test to help in the early diagnosis of lung cancer by our licensing partner in North America and the Caribbean continues to progress at pace," said Allan Syms, Executive Chairman of Cizzle Biotechnology. "By securing its first contract in the Caribbean, this also facilitates early royalty payments generating early revenues to the Company."
US Market Entry Through Accredited Laboratory Partner
In parallel with its Caribbean expansion, Cizzle Bio has appointed iGenomeDX as the first clinical diagnostics laboratory to offer commercial CIZ1B biomarker testing in the United States. iGenomeDX is both Commission on Office Laboratory Accreditation (COLA) accredited and Clinical Laboratory Improvement Amendments (CLIA) certified, meeting the rigorous regulatory requirements for clinical diagnostic testing in the US.
The appointment follows successful collaboration between Cizzle, iGenomeDX, and BIO to complete an operational and quality systems program designed to validate CIZ1B as a laboratory developed test for commercial use. This accreditation process involved comprehensive evaluation of testing procedures, quality control measures, personnel qualifications, and regulatory compliance.
"In the short time since we began our exclusive licensing partnership with Cizzle Bio, they have initiated multiple ongoing partnerships with several National Cancer Institute (NCI) designated cancer centers throughout the United States, with the goal of enhancing early detection capabilities for lung cancer," Syms noted.
Commercial Strategy and Timeline
BIO's commercial strategy involves working with multiple specialist clinical laboratories to maximize market penetration and make the CIZ1B biomarker test widely available to clinicians and patients. While BIO's initial target was to complete CLIA accreditation and secure the first commercial sale by the end of April 2025, the launch date has been slightly extended to accommodate a more coordinated and comprehensive campaign.
The successful completion of the operational and quality systems program is crucial for launching a cost-effective and scalable version of the CIZ1B biomarker assay with rigorous quality control requirements. This will ensure the test is commercially viable and can be implemented globally to help reduce premature cancer deaths and improve survival rates for lung cancer patients.
Financial Impact and Future Outlook
The licensing agreement with BIO has already generated US$400,000 in initial exclusivity fees and advanced royalties for Cizzle Biotechnology, as part of guaranteed payments totaling US$2.4 million through April 2027. The Caribbean expansion has accelerated some of these payments, with US$250,000 now due in July 2025 and another US$250,000 in September 2025.
BIO is also making progress in expanding its laboratory network across the USA, with accreditation and launch plans being synchronized for a coordinated rollout of the CIZ1B biomarker test. The company expects to announce additional sites and commercial launch plans shortly.
"We look forward to sharing updates on the expansion of sites and reporting on the success of the first commercially available tests in the near future," Syms concluded.
About the CIZ1B Biomarker Test
The CIZ1B biomarker test is designed to help detect early-stage lung cancer, potentially addressing a critical need in oncology diagnostics. Early detection of lung cancer significantly improves survival rates and treatment outcomes, making this test a potentially valuable tool in the fight against one of the deadliest forms of cancer.
The test's development and commercialization represent Cizzle Biotechnology's commitment to its global licensing strategy, which aims to deliver shareholder value through royalty payments and potential benefits from equity participation in partner companies where possible.
