Commercial Progress in USA

Cizzle Biotechnology, the UK based diagnostics developer of early cancer tests, is pleased to announce that following progress with its pathfinder laboratory, the Company's North American licencing 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.

Highlights

• BIO has entered into a new agreement with multi-site full scale COLA and CLIA accredited laboratory group to launch the Company's CIZ1B biomarker test throughout the USA.
• As part of agreed advance exclusivity and royalty fees, BIO paid an early payment of US$125,000 to the Company bringing total receipts to date of US$525,000 of the guaranteed advance payments of US$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.

BIO new agreement to launch the Company's CIZ1B biomarker test throughout the USA

On 21 October 2024, the Company announced an exclusive licensing and partnership agreement with BIO to market its proprietary CIZ1B biomarker test 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 biomarker test in North America to help detect early-stage lung cancer. This new agreement with a significantly larger multi-site clinical laboratory demonstrates how BIO intends to scale its operations throughout the USA.

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 reducing premature cancer deaths and improving survival rates and quality of life for cancer patients.

Advance Royalty Agreement with BIO

The Company has now received payments totalling US$525,000 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 April 2027. BIO made a payment of US$125,000 in early July 2025 ahead of the planned advance royalty schedule. Going forward, the Company and BIO have agreed a revised regular payment schedule that will result in the remaining US$1,875,000 guaranteed advance royalties due to the Company being paid by the end of 2026, instead of the end of April 2027. The new regular payment schedule reflects the cash flow requirements of both companies during that period.

Commenting, Allan Syms, Executive Chairman of Cizzle Biotechnology, said:

"I am pleased to announce further progress being made by our partner BIO. Following the progress made by their 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 plans to the new multi-site clinical laboratory to enable a much wider co-ordinated and comprehensive campaign to roll out the CIZ1B biomarker test in North America, to help detect early-stage lung cancer. This new agreement with a significantly larger multi-site clinical laboratory demonstrates how BIO intends to scale its operations throughout the USA.

"BIO's commitment to our strong partnership is also evident by the receipt of an early advance royalty payment which means the Company has now received US$525,000. We have since agreed to a more balanced payment schedule through to the end of 2026 which will see the remainder of the advance royalty fees being received by Cizzle Biotechnology earlier.

"I look forward to announcing further updates on BIO's commercial progress in North America and the Company's strategy to make its CIZ1B biomarker test available globally in due course."

You can also follow the Company through its twitter account @CizzlePlc and on LinkedIn.

About BIO

Cizzle Bio is a Texas-based biotechnology company dedicated to revolutionizing cancer diagnostics by advancing biomarker-based blood tests, starting with early detection of lung and gastric cancers. Our goal is to empower patients, equip clinicians, and improve outcomes through innovation, compassion, and life-saving solutions. We hold exclusive licensing rights for our groundbreaking CIZ1B biomarker test in the United States, Canada, and the Caribbean and a worldwide exclusive license for our DEX-G2 biomarker gastric cancer test. Cizzle Bio is commercializing both tests for U.S. clinical environments.