Cizzle Biotech Regulatory News (CIZ)

22 October 2021

Cizzle Biotechnology Holdings Plc

("Cizzle Biotechnology" or the "Company")

Companion Diagnostic Supply Agreement with St George Street Capital

Research and Development agreement worth up to £1 million signed for potential autoimmune disease testing and possible additional companion diagnostics

Cizzle Biotechnology, the UK based diagnostics developer, is pleased to announce it has executed a research and development agreement to develop a companion diagnostic test for autoimmune disease with St George Street Capital ("SGSC"), the UK-based biomedical charity. The new diagnostic platform will be used to develop tests that will operate alongside SGSC's programme for the development of therapeutic assets licensed to SGSC from one of the world's largest pharmaceutical companies, Astra Zeneca. This seeks to address unmet clinical needs in a wide variety of autoimmune diseases which will significantly broaden the Company's product pipeline and for which SGSC will pay Cizzle Biotechnology up to £1 million in development fees.

As announced on 20 September 2021, Cizzle Biotechnology signed an agreement with SGSC to grant Cizzle Biotechnology potential future royalty payments from the commercialisation of St George Street's therapeutic asset AZD1656 of up to £5 million. This followed SGSC's announcement on 9 September 2021 of encouraging clinical trial results arising from their existing collaboration with AstraZeneca and funded by international investment through Excalibur Medicines Ltd and an HM Government grant through the UKRI/Innovate UK programme.

This new commercial contract with SGSC will seek to provide valuable diagnostic information on patients based on the proposed mechanism of action of AZD1656 which may be linked to the regulation of inflammation through activating migration of T regulatory cells to sites of damaging inflammation. Migration of T regulatory cells amplify the body's own mechanism of damping down an inappropriate inflammatory overreaction and hence may have important clinical benefits in managing autoimmune disease.

Under the commercial contract entered into, the parties will collaborate closely in the design and development of the test and in consideration SGSC will pay Cizzle Biotechnology £200,000 upfront on commencement of the project and then further milestone payments totalling up to £1 million. A further announcement will be made when the project commences.

Commenting, Allan Syms, Executive Chairman of Cizzle Biotechnology, said: "We announced on 20 September following SGSC's successful ARCADIA clinical trial, a royalty agreement related to AZD1656. We are now also delighted to sign a new R&D agreement with SGSC to develop a companion diagnostic which has fees payable to Cizzle Biotechnology of up to £1 million. This will strengthen the two parties' close relationship through the development of a companion diagnostic test for the use of their therapeutic asset that is aimed at addressing unmet needs in the area of autoimmune disease. A potential pipeline of new diagnostic tests for SGSC will significantly broaden Cizzle Biotechnology's product portfolio as we continue to develop our simple blood test for the early detection of lung cancer based on the C1Z1B biomarker."

Commenting, Professor John Martin of UCL, Chairman of SGSC, said: "We announced last month the encouraging clinical trial results of our new treatment for COVID-19 and completed our formal royalty sharing agreement with Cizzle Biotechnology. Today we are pleased to extend that relationship through the signing of a new agreement to collaborate in the development of a companion diagnostic for use with our therapeutic asset AZD 1656 for autoimmune disease. We continue to be impressed with the progress of this long-term relationship with Cizzle Biotechnology, which combines unique skills, experience and capabilities from each party to build complimentary diagnostic and therapeutic products of important clinical utility."

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 ("UK MAR"). Upon the publication of this announcement this inside information is now considered to be within the public domain.

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About Cizzle Biotechnology

Cizzle Biotechnology is developing a blood test for the early detection of a majority of the different forms of lung cancer. Cizzle Biotechnology is a spin- out from the University of York, founded in 2006 around the work of Professor Coverley and colleagues. Its proof-of-concept prototype test is 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 the cell growth and division cycle, and the targeted CIZ1B variant is highly correlated with early stage lung cancer.

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

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

About St George Street Capital

St George Street Capital is a biomedical research charity on a mission to fast-track clinical trials so we can get new treatments as quickly as possible to the people who need them. We apply bold new thinking to unlock the therapeutic potential of therapies and science currently sitting on the shelf in pharma. We are a new type of charity, sourcing investment to accelerate clinical trials, where new science shows great potential and where patients and clinicians are calling out for treatments. St George Street Capital was established in 2017 and brings together a powerful mix of expertise, from investors and business managers to academics and clinicians.