REG - Cizzle Biotechnology - LOI with leading UK Clinical Diagnostic Group

Cizzle Biotechnology HoldingsAnnouncement

05/11/2025 07:00

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RNS Number : 1967G  Cizzle Biotechnology Holdings PLC  05 November 2025

 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")

5 November 2025

Cizzle Biotechnology Holdings plc

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

Letter of Intent signed with leading UK Clinical Diagnostic Group Providing
Laboratory Services to the NHS

Cizzle Biotechnology, the UK based diagnostics developer of early cancer
tests, is pleased to announce it has entered into a Letter of Intent ("LOI")
with a leading medical diagnostic services provider (the "Provider") acting in
partnership with the NHS. The LOI covers the verification and validation of
the Company's CIZ1B biomarker test with a NHS Foundation Trust partner in
state-of-the-art laboratories which may lead to the Provider being appointed
as the Company's exclusive UK supplier of the CIZ1B test.

The discovery and development of the CIZ1B biomarker test is the result of
many years of pioneering work by Professor Dawn Coverley, the Company's
founder and CSO, and her research team at the University of York.  Initially
supported by Yorkshire Cancer Research it has always been the ambition to
ensure patients and healthcare professionals in the NHS and elsewhere should
benefit from the Company's work in early cancer detection as part of its
commercial roll out plans.

As part of the Company's commercial strategy to licence its proprietary test
for the CIZ1B biomarker for use in the early detection of lung cancer
globally, it has already secured a licence agreement in North America and the
Caribbean, with guaranteed royalties and up-front fees of US$2.4 million, of
which US$530,000 has already been received.

On 20 May 2025, the Company secured funding of £150,000 through the issue of
convertible loan notes from the Company's existing shareholder, Frazer Lang to
provide additional funding to support the Company's growth strategy, in
particular to roll out its CIZ1B early cancer test in the UK and elsewhere in
Europe.  The intended partnership with the Provider, which for commercial
reasons is confidential at this time, is a result of that programme.

Having established a route to market in North America and the Caribbean, the
Company was keen to ensure that patients in the UK and then elsewhere in
Europe, will also benefit from how the CIZ1B biomarker test can help in early
lung cancer detection.  This aligns with the current NHS cancer plan to
improve cancer survival by increasing the proportion of cancers diagnosed at
stages 1 and 2 with an aim to save 55,000 lives per year by 2028.  A key
element of this is improving access to early diagnosis, and increasing the
number of cancers identified through screening.

Under the terms of the LOI, the Provider will immediately carry out a
validation exercise with the Company and provide clinical input for the
intended clinical indication of CIZ1B.  Cizzle will provide on-site technical
support under the guidance of Professor Coverley to confirm assay performance
data.  Following agreed success criteria, the parties will negotiate a
Partnership Agreement for the commercialisation of the CIZ1B test.  The
Provider may then be appointed as the exclusive UK supplier of the CIZ1B test
(subject to regulatory frameworks, including CE/UKCA/HIE requirements) and
together, Cizzle and the Provider will jointly develop a go-to-market
strategy, including co-branding and aligned communications.  A commercial
distribution model based on revenue share or a licensing structure, with a
rollout strategy beyond the UK into Europe across private and NHS markets,
will be negotiated.

The Company will also continue to focus on supporting its US partner Cizzle
BIO Inc, to secure CLIA accreditation to take the test live in the near term,
and on completing the ongoing Moffitt study to test patients with suspicious
lung nodules in a clinical evaluation, as announced on 9 September 2024.

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

"We announced in May 2025 that while continuing to support the Company's
licensing partner in North America, we would now be seeking an additional
licensing partnership in the UK and rest of Europe. We are excited to report
we have now entered a LOI with a leading UK provider with partnerships with
NHS Foundation Trusts.  Our goal is to provide a first-class service to help
drive early cancer detection at scale globally.  We are now pleased that the
UK will be the next phase of our growth plans in making the test available to
many patients as soon as possible.

Enquiries:

 

 Cizzle Biotechnology Holdings plc  Via IFC Advisory
 Allan Syms (Executive Chairman)

 

 Allenby Capital Limited                               +44(0) 20 3328 5656
 John Depasquale / Piers Shimwell (Corporate Finance)
 Amrit Nahal (Sales and Corporate Broking)

 

 IFC Advisory Limited            +44(0) 20 3934 6630
 Tim Metcalfe
 Florence Chandler

 

About Cizzle Biotechnology

 

The CIZ1B biomarker test for early-stage lung cancer is based on the
pioneering work of Professor Coverley, the Founder and CSO of the Company, and
her research team at the University of York. CIZ1 is a naturally occurring
cell nuclear protein and the CIZ1B variant form is highly associated with the
presence of early-stage lung cancer. The Company has developed CIZ1B into a
non-invasive, cost-effective blood test to help in the diagnosis and 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 trading on the Main Market
of the London Stock Exchange in May 2021.

 

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

 

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

 

 

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