REG - Cizzle Biotechnology - Commercial Progress in USA

Cizzle Biotechnology HoldingsAnnouncement

Mon 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250818:nRSR6822Va&default-theme=true

RNS Number : 6822V  Cizzle Biotechnology Holdings PLC  18 August 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").

18 August 2025

Cizzle Biotechnology Holdings plc

 

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

 

Commercial Progress in USA

Advance Royalty Schedule Revised for Earlier Payment

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."

 

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 Staton

 

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
(https://cizzlebiotechnology.com)

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.

For more information, please see https://www.cizzlebio.com
(http://www.cizzlebio.com)

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDBRGDICDBDGUR