THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF EU REGULATION 596/2014 (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 ("EUWA")) ("UK MAR")

28 April 2025

Cizzle Biotechnology Holdings plc

("Cizzle", "Cizzle Biotechnology", or the "Company")

First Hospital Laboratory Contract in Caribbean

Update on Launch of CIZ1B Biomarker Assay

Cizzle Biotechnology, the UK based diagnostics developer of early cancer tests, is pleased to announce that its licensing partner Cizzle Bio Inc ("BIO" or "Cizzle Bio") has executed its first contract in the Caribbean as part of the extension to its exclusive licensing and partnership agreement with the Company for the USA and Canada, as announced on 16 December 2024.  The non-exclusive Laboratory Services Agreement signed by BIO with Doctors Hospital (Chrissie Tomlinson Memorial Hospital - CTMH) in the Cayman Islands triggers the early royalty payments due to the Company from BIO, totalling US$500,000 in July and September 2025, as part of the advanced minimum royalty of US$1 million previously all due on 21 January 2026.

In addition to this further clinical laboratory appointment, BIO is making progress in expanding its network across the USA. Its accreditation and launch plans are now being synchronised to enable a more co-ordinated and comprehensive campaign to roll out the CIZ1B biomarker test to help detect early-stage lung cancer.  Cizzle Bio's initial target was to complete CLIA accreditation and secure the first commercial sale of the CIZ1B biomarker test by the end of April 2025. As a consequence of this broader campaign, the launch date has been slightly extended and is now expected to be finalised in the near term.

Key Highlights

·    Cizzle Bio appoints first clinical diagnostics laboratory to offer commercial CIZ1B biomarker testing in the Caribbean triggering early payments totalling US$250,000 in July 2025 and US$250,000 in September 2025.

·    The expansion of BIO's laboratory network follows the ongoing and successful collaboration between BIO and the Company to ensure the CIZ1B test for use in helping detect early-stage lung cancer meets the exacting standards as a laboratory developed test for commercial use. It is expected that further sites and commercial launch plans will be announced shortly.

Background

On 21 October 2024 the Company announced an exclusive licensing and partnership agreement with BIO for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA and Canada.  The Company has since received payments of US$400,000 from initial exclusivity fees and advanced royalties as part of guaranteed payments totalling US$2.4 million over the period ending April 2027.  The Company extended that agreement on 16 December 2024 to cover the 14 Sovereign States of the Caribbean and the Cayman Islands ("Caribbean") and the signing of BIO's first contract in the Cayman Islands triggers early payments totalling US$250,000 in July 2025 and US$250,000 in September 2025.

BIO's commercial strategy is to work with a number of specialist clinical laboratories to maximise market penetration and make the CIZ1B biomarker test available to as many clinicians and patients as possible.  The appointment of accredited facilities to launch the CIZ1B biomarker test involves evaluation of a laboratory's operations, including its testing procedures, quality control, personnel qualifications, and compliance with regulatory requirements.  The successful completion of the operational and quality systems programme is required for launching a cost-effective and scalable version of the CIZ1B biomarker that is commercially scalable and can be rolled out as a global solution to help reduce premature cancer deaths and improve survival rates and quality of life for cancer patients.

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

"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 and I am delighted to announce its success in appointing a further clinical laboratory as part of its strategy to build a network of accredited laboratories to make our innovative cancer test available to as many clinicians and patients as possible. As part of the Company's global licensing strategy to deliver shareholder value through royalty payments and potential benefits arising from equity participation in the partner companies where possible, by securing its first contract in the Caribbean, this also facilitates early royalty payments generating early revenues to the Company. 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."

Enquiries:

About Cizzle Biotechnology

Based on the pioneering work of Professor Coverley and colleagues, on a naturally occurring variant of the cell nuclear protein CIZ1, the CIZ1B biomarker is highly associated with the presence of early-stage cancer. 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.  Cizzle was admitted to the Standard segment of the main market of the London Stock Exchange in May 2021. 

For more information, please see https://cizzlebiotechnology.com

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

About Cizzle Bio

Cizzle Bio Inc, a company registered in Texas USA, stands at the forefront of biotechnological innovation, dedicated to revolutionizing the detection of lung cancer through groundbreaking diagnostic tools. With exclusive rights to detect the CIZ1B Biomarker in the USA and Canada, we are driven by a commitment to improve early cancer detection and enhance patient outcomes.

For more information, please see https://cizzlebio.com

About Doctors Hospital

Founded in 2000 as the Chrissie Tomlinson Memorial Hospital (CTMH) and located in the heart of George Town, Grand Cayman, Doctors Hospital is the leading provider of international-standard, private-sector hospital and healthcare services in the Caribbean.  The Mission of Doctors Hospital is to promote the health and well-being of all we serve through the provision of First World, International Standard Healthcare Services in collaboration with all physicians and other providers who share the same vision and values.

For more information, please see https://www.doctorshospital.ky