Cizzle Biotechnology Holdings plc (LON:CIZ), the UK based diagnostics developer of early cancer tests, has provided an update on progress towards the accreditation and launch of its proprietary test for the CIZ1B biomarker which is highly associated with early-stage lung cancer. The Company’s North American licencing partner Cizzle Bio Inc (BIO) is now in the final stages of the Clinical Laboratory Improvement Amendments (CLIA) accreditation process and expect to submit an application for approval in Q2 2026. Given the positive progress, BIO and the Company have strengthened their commitment with a new payment schedule which includes a further minimum US$3.5m advanced royalty schedule to reflect the commencement of sales and long-term growth of the test at scale.
Highlights
• BIO and the Company have been working on site, together with BIO’s clinical testing partner, Omni Health Diagnostics Inc in their facility in in Richardson, Texas, USA to establish operating procedures ahead of submitting a full validation package for CLIA accreditation. On submission, accreditation is usually immediate unless any clarification is sought.
• As part of the previously agreed advance exclusivity and royalty fees, BIO has to date paid US$590,000 of the guaranteed advance payments of US$2.4m due by 31 December 2026. The Company and BIO have now agreed to a minimum of US$3.5m of guaranteed further payments over the seven years following an extension of the current agreement in 2031. This will ensure that there are guaranteed payments beyond the initial seven year period of the licence and aligned regular payments after the commercial launch of the test.
· The new schedule of payments reconfirms the Company will receive the remaining US$1.81m of the initial advance royalty payments due by 31 December 2026.
CLIA Accreditation
BIO’s strategy is to achieve CLIA accreditation and market launch of the Company’s CIZ1B biomarker test with its clinical diagnostics partner Omni in the shortest time possible, thus enabling a roll out campaign across North America. The CLIA accreditation process is necessarily detailed requiring rigorous validation following strict operating procedures. The results generated provide information on analytical accuracy and precision, that together with Omni’s own quality assurance processes, provide the basis for submitting the accreditation application. Key personnel from the Company have been working alongside Omni’s team in the laboratory in Texas, who expect to complete the testing programme shortly. On submission, accreditation is usually immediate unless any clarification is sought.
Following CLIA accreditation, BIO expects immediate take up based on patient requests for early access to the CIZ1B test. BIO will report when first commercial sales have occurred.
Additional Guaranteed Royalties and Advance Royalty Payments
The Company has now received payments totalling US$590,000 from BIO for initial exclusivity fees and advanced royalties as part of guaranteed payments due to the Company totalling US$2.4 million over the period ending 31 December 2026. A revised payment schedule has been agreed whereby the remaining payments of US$1.81m of the initial guaranteed advance royalty payments will, as previously reported, be paid before the end of 2026. As noted in the Company’s Annual Report for 2024, if these payments are delayed or not received, the Company may need to seek alternative funding. These are the minimum royalties to be paid as part of the Company’s licensing agreement with BIO, whereby the Company will receive 10% on gross sales over the initial 7-year period of the agreement which commenced on 18 October 2024. As part of committing to the long-term aim of saving lives through early cancer detection, the Company and BIO have now agreed a further minimum guaranteed royalty payment of US$3.5m on extension of the current agreement in 2031, equivalent to a minimum of US$500,000 per year as part of the ongoing 10% royalty on all sales.
Commenting, Allan Syms, Executive Chairman of Cizzle Biotechnology, said:
“I am pleased to announce that the process of preparing for submission of the Company’s CIZ1B test for CLIA accreditation is nearing completion. I want to thank our team at the University of York along with BIO and the clinical laboratory team at Omni, all working together in Texas, for their diligent efforts in establishing the test in their laboratories. Upon CLIA accreditation we can begin the important commercialisation of our CIZ1B biomarker which we believe will enable clinicians to detect lung cancer earlier and ultimately save lives.
“The Company and BIO are committed to provide clinicians with an important cost-effective tool in early cancer detection which, to become scalable and widely available, requires a long-term collaborative approach. The further guaranteed minimum royalty payments to be paid by BIO over the long term, along with a payment plan aligned with the launch and commercialisation of the test, means that BIO has now confirmed the Company will receive a minimum of US$5.9m over the contract term.”
