Cizzle Biotechnology announced that following progress with its pathfinder laboratory, the Company's North American Licensing partner Cizzle Bio Inc. ("BIO") has now entered into an agreement with a full scale commercial multi-site clinical diagnostics laboratory group to make the Company's CIZ1B biomarker test available throughout the USA in the near future. Alongside this, BIO and the Company have agreed to a revised regular payment schedule that will result in the remaining advance royalties due to the Company being paid by the end of 2026, ahead of the previously agreed schedule, being end of April 2027. BIO has entered into a new agreement with multi-site full scale COLA and CLIA accredited laboratory group to launch the Company's CIZ1 B biomarker test throughout the USA.
As part of agreed advance exclusivity and royalty fees, BIO paid an early payment of USD 125,000 to the Company bringing total receipts to date of USD 525,000 of the guaranteed advance payments of USD 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. On 21 October 2024, the Company announced an exclusive licensing and partnership agreement with BIO to market its proprietary CIZ1B biomarker tests to help detect early-stage lung cancer, throughout the USA and Canada as a Laboratory Developed Test ("LDT") in Clinical Laboratory Improvement Amendments ("CLIA") accredited laboratories.
The Company extended the territory; to cover the 14 Sovereign States of the Caribbean and the Cayman Islands ("Caribbean") on 16 December 2024 and at the same time announced they had executed an agreement with a Commission on Office Laboratory Accreditation ("COLA") accredited laboratory partner to validate and register the CIZ1B biomarker as a CLIA LDT. On 24 March 2025, the Company announced that iGenomeDX had been establishing operating and quality systems with a target of offering the test to clinicians in April 2025. At the time, BIO's strategy was to then complete further contracts with other laboratory partners to roll out the test more widely once iGenomeDX had completed their work.
However, following the progress made by iGenomeDX as the pathfinder clinical laboratory, BIO's strategy has developed to more appropriately reflect the large market opportunity they are seeing for the Company's CIZ1b biomarker test in North America. They have therefore realigned their accreditation and market launch strategy to the new multi-site clinical laboratory, enabling a much wider co-ordinated and comprehensive campaign to roll out the CIZ1B biomarkers test in North America to help detect early-stage Lung cancer. The new multi-site laboratory capability is designed to ensure operational and quality systems can deliver expected reproducibility and sensitivity in a cost-effective and scalable version of the CIZ1B biomarkER assay.
This will now meet BIO's demand for commercial sales at scale and thereby achieve the goal of education premature cancer deaths and improving survival rates and quality of life for cancer patients. The Company has now received payments totaling USD 525,000 from BIO for initial exclusivity fees and advanced royalties as part of guaranteed payments due to the Company totaling USD 2.4 million over the period ending April 2027. BIO made a payment of USD 125,000 in early July 2025 ahead of the planned advance royalty schedule.
They have therefore realigned its accreditation and market launch plans to the new multi- site clinical laboratory to enable a much wider co-ordination and comprehensive campaign to roll out The CIZ1B biomarker assay. This new agreement with a significantly larger multi-site clinical laboratory demonstrates how BIO intends to scale its operations throughout the USA.
