REG - Cizzle Biotechnology - Progress on Launch of Biomarker Test in USA

Cizzle Biotechnology HoldingsAnnouncement

23/02/2026 07:00

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RNS Number : 9193T  Cizzle Biotechnology Holdings PLC  23 February 2026

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")

23 February 2026

 

Cizzle Biotechnology Holdings Plc

 

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

 

Progress on Commercial Launch of Biomarker Test in USA

 

New Additional US$3.5m Guaranteed Royalty Payments and Advance Royalty
Payments Schedule

 

Cizzle Biotechnology, the UK based diagnostics developer of early cancer
tests, is pleased to provide an update on progress towards the accreditation
and launch of its proprietary test for the CIZ1B biomarker which is highly
associated with early-stage lung cancer. The Company's North American
licencing partner Cizzle Bio Inc ("BIO") is now in the final stages of the
Clinical Laboratory Improvement Amendments ("CLIA") accreditation process and
expect to submit an application for approval in Q2 2026. Given the positive
progress, BIO and the Company have strengthened their commitment with a new
payment schedule which includes a further minimum US$3.5m advanced royalty
schedule to reflect the commencement of sales and long-term growth of the test
at scale.

 

Highlights

 

•     BIO and the Company have been working on site, together with BIO's
clinical testing partner, Omni Health Diagnostics Inc ("Omni") in their
facility in in Richardson, Texas, USA to establish operating procedures ahead
of submitting a full validation package for CLIA accreditation. On submission,
accreditation is usually immediate unless any clarification is sought.

 

•     As part of the previously agreed advance exclusivity and royalty
fees, BIO has to date paid US$590,000 of the guaranteed advance payments of
US$2.4m due by 31 December 2026. The Company and BIO have now agreed to a
minimum of US$3.5m of guaranteed further payments over the seven years
following an extension of the current agreement in 2031. This will ensure that
there are guaranteed payments beyond the initial seven year period of the
licence and aligned regular payments after the commercial launch of the test.

 

·    The new schedule of payments reconfirms the Company will receive the
remaining US$1.81m of the initial advance royalty payments due by 31 December
2026.

 

CLIA Accreditation

 

BIO's strategy is to achieve CLIA accreditation and market launch of the
Company's CIZ1B biomarker test with its clinical diagnostics partner Omni in
the shortest time possible, thus enabling a roll out campaign across North
America. The CLIA accreditation process is necessarily detailed requiring
rigorous validation following strict operating procedures. The results
generated provide information on analytical accuracy and precision, that
together with Omni's own quality assurance processes, provide the basis for
submitting the accreditation application. Key personnel from the Company have
been working alongside Omni's team in the laboratory in Texas, who expect to
complete the testing programme shortly. On submission, accreditation is
usually immediate unless any clarification is sought.

 

Following CLIA accreditation, BIO expects immediate take up based on patient
requests for early access to the CIZ1B test. BIO will report when first
commercial sales have occurred.

 

Additional Guaranteed Royalties and Advance Royalty Payments

 

The Company has now received payments totalling US$590,000 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 31 December
2026. A revised payment schedule has been agreed whereby the remaining
payments of US$1.81m of the initial guaranteed advance royalty payments will,
as previously reported, be paid before the end of 2026. As noted in the
Company's Annual Report for 2024, if these payments are delayed or not
received, the Company may need to seek alternative funding. These are the
minimum royalties to be paid as part of the Company's licensing agreement with
BIO, whereby the Company will receive 10% on gross sales over the initial
7-year period of the agreement which commenced on 18 October 2024. As part of
committing to the long-term aim of saving lives through early cancer
detection, the Company and BIO have now agreed a further minimum guaranteed
royalty payment of US$3.5m on extension of the current agreement in 2031,
equivalent to a minimum of US$500,000 per year as part of the ongoing 10%
royalty on all sales.

 

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

 

"I am pleased to announce that the process of preparing for submission of the
Company's CIZ1B test for CLIA accreditation is nearing completion. I want to
thank our team at the University of York along with BIO and the clinical
laboratory team at Omni, all working together in Texas, for their diligent
efforts in establishing the test in their laboratories. Upon CLIA
accreditation we can begin the important commercialisation of our CIZ1B
biomarker which we believe will enable clinicians to detect lung cancer
earlier and ultimately save lives.

 

"The Company and BIO are committed to provide clinicians with an important
cost-effective tool in early cancer detection which, to become scalable and
widely available, requires a long-term collaborative approach. The further
guaranteed minimum royalty payments to be paid by BIO over the long term,
along with a payment plan aligned with the launch and commercialisation of the
test, means that BIO has now confirmed the Company will receive a minimum of
US$5.9m over the contract term."

 

Enquiries:

 

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

 

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

 

 IFC Advisory Limited  +44(0) 20 3934 6632
 Tim Metcalfe
 Florence Staton

 

Notes to Editors:

About Cizzle Biotechnology

 

The CIZ1B biomarker is a naturally occurring variant of the cell nuclear
protein CIZ1, which is linked with the preservation of epigenetic integrity.
CIZ1B is highly associated with the presence of early-stage lung cancer and
can be measured in small quantities of blood.  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 Cizzle 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.

www.cizzlebio.com (http://www.cizzlebio.com)

 

 

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