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").

16 December 2024

Cizzle Biotechnology Holdings plc

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

Update on Strategic Partnership in North America

Extension of Strategic Licensing and Partnership Agreement for North America to include the Caribbean

Early Payment of US$500,000 Royalties due under existing Agreement

First Contract with CAP and CLIA Accredited Laboratory

Cizzle Biotechnology, the UK based diagnostics developer, is pleased to announce that it has signed an extension (the "Extension") to its exclusive licensing and partnership agreement ("Agreement") for the USA and Canada, executed on 21 October 2024, with Cizzle Bio Inc ("BIO") for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, to include the 14 Sovereign States of the Caribbean and the Cayman Islands ("Caribbean").  As a result of this increased market opportunity to bring Cizzle's non-invasive, cost effective CIZ1B biomarker lung cancer blood test to market next year, BIO will make early payments totalling US$500,000 in July and September 2025 of the advanced minimum royalty of US$1 million previously all due on 21 January 2026.

Additionally, BIO have executed their first agreement with a CAP (College of American Pathologists) accredited laboratory partner and expect to register the CIZ1B biomarker as a CLIA (Clinical Laboratory Improvement Amendments) LDT (Laboratory Developed Test) in January 2025.  Full product launch remains on track for April 2025.  Details of this first agreement with a CAP accredited laboratory partner are confidential at this time and BIO expects to complete further contracts with other laboratory partners in due course.

Key Highlights

·    Exclusive extension of North American license to include the Caribbean: The Agreement grants an extension to BIO's exclusive rights to the CIZ1B biomarker technology for early lung cancer detection in North America, to now include the Caribbean.

·    Caribbean royalty payments: same level as for the rest of North America at 10% of gross sales less any taxes due in the Caribbean.

·    Early Payment of Advanced Royalty Fees due under Existing Agreement for North America: Cizzle has already received an initial exclusivity fee of US$100,000 and an upfront royalty payment of US$300,000 from BIO and is due a further minimum US$1 million advanced royalty on 21 January 2026.  The extension and advance payment is subject to BIO executing its first revenue bearing laboratory partner in the Caribbean by 31 July 2025 and provides an early payment of the US$1 million in tranches of US$250,000 on 31 July 2025 and US$250,000 on September 2025, with the remaining US$500,000 payable on 21 January 2026.  A further minimum royalty payment of US$1 million is due in April 2027.  The July and September 2025 advances are only creditable against royalties payable in North America and any royalties payable in the Caribbean will be in addition.

·    Revenue streams for growth: Through the Extension, Cizzle is accelerating its market entry timetable and revenue generation in a broader geographic region as the Company delivers its strategic milestones.

·    Value-creating partnership: The Extension continues to strengthen the close working relationship between Cizzle and BIO in bringing the CIZ1B biomarker test to market.

·    First laboratory contract: BIO has executed its first and confidential agreement with a CAP approved clinical laboratory and intends to register the CIZ1B biomarker as a CLIA accredited test in January 2025 with plans for commercial launch in April 2025.

The Company continues to support BIO as it builds relationships with clinicians, hospitals and US cancer centres of excellence in North America, and through their investors were introduced to influential healthcare providers within the Caribbean with a key interest in early cancer detection.  The Caribbean, including Antigua and Barbuda, Bahamas, Barbados, Cuba, Dominica, Dominican Republic, Grenada, Haiti, Jamaica, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines and Trinidad and Tobago and the Cayman Islands, has a diverse population of nearly 45 million people, representing an important opportunity to increase ethnic representation in data sets and for commercial expansion.

Further Information

Cizzle's vision is to meet the challenges of early lung cancer detection, reduce premature cancer deaths, improve survival rates and increase quality of life for cancer patients by helping detect cancer as early as possible through a simple blood test.

It is widely considered that to beat cancer, early detection and diagnosis is arguably the single most important and impactful objective, with patients diagnosed early having the best chance of curative treatment and long-term survival, reducing patient stress and improving healthcare economic performance.

By focussing on the systematic development and commercialisation of novel and proprietary clinical non-invasive and cost effective diagnostic tests for the early detection of cancer, particularly where there is an unmet clinical need, the Company now has a platform technology based on the ability to detect a stable plasma biomarker, a variant of CIZ1 known as CIZ1B.  CIZ1 is a naturally occurring cell nuclear protein involved in DNA replication, and the targeted CIZ1B variant is highly correlated with early-stage lung cancer.

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

"We are delighted with the progress and developing partnership with Cizzle Bio.  They have been working hard to deliver their milestones to bring our non-invasive, cost effective, CIZ1B biomarker lung cancer blood test to market in 2025.  The signing of their first CAP approved clinical laboratory is an important step in achieving CLIA accreditation and this will be expanded to other laboratories in due course.  The extension of our agreement to include the Caribbean was driven by BIO investor interest and connections within the healthcare sector in the Caribbean and represents a logical progression in our global licensing and partnership strategy, offering the Company a broader geographical region for sales and revenue, with the accelerated royalty payments supporting the Company's cash flow and growth in other regions.  Working closely with BIO's executive team provides a transparent view of the excellent progress being made in North America and expanding activities in the Caribbean is both timely and permits BIO to bring forward our guaranteed royalty payments to positively impact our cashflow projections in 2025."   

Bill Behnke, Chairman and CEO of BIO, commented:

"We have been making excellent progress in developing partnerships with clinicians, hospitals and clinical laboratories who have a need for early cancer diagnostics.  Securing our first agreement with a CAP approved clinical laboratory is an important step to achieve CLIA accreditation for the CIZ1B biomarker and we have plans to sign further clinical laboratories next year.  The extension to the Caribbean arises from specific interest from some of our investors with connections to hospital groups requiring early cancer diagnostic tests.  Our goal remains to screen patients for lung cancer early and save lives.  This has also created interest to add further tests for other cancers and we will work closely with Cizzle and other clinical groups to identify complimentary tests that may be required to provide a full suite of cancer tests that will widen our customer base and thereby increase the uptake of the CIZ1B biomarker test."

Enquiries:

About Cizzle Biotechnology

Cizzle is developing a blood test to help in the early detection of lung cancer. Based on the pioneering work of Professor Coverley and colleagues, at the University of York, on a naturally occurring cell nuclear protein involved in DNA replication called CIZ1, they discovered that a variant called CIZ1B is highly associated with the presence of early-stage cancer. The company has now entered into commercial royalty bearing licensing agreements and collaborations with leading centres of excellence in cancer for the use of its proprietary technology as part of its strategy to bring its non-intrusive, cost-effective blood test to market. 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 Inc

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.