REG - Cizzle Biotechnology - Update on Clinical Laboratory Partnerships in USA

Cizzle Biotechnology HoldingsAnnouncement

29/09/2025 07:00

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RNS Number : 0881B  Cizzle Biotechnology Holdings PLC  29 September 2025

29 September 2025

Cizzle Biotechnology Holdings plc

 

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

 

Update on Clinical Laboratory Partnerships in USA

Cizzle Biotechnology, the UK based diagnostics developer of early cancer
tests, is pleased to announce further progress on the commercial roll out of
the Company's CIZ1B biomarker test in North America by its exclusive licencing
partner Cizzle Bio Inc ("BIO").  BIO is now completing validation of the test
with its new clinical diagnostics laboratory group, Omni Health Diagnostics
("Omni"), as part of a national expansion strategy based on Omni's active
laboratory acquisitions and partnerships programme to provide testing
capability in Texas, New York, California, South Carolina, Tennessee and
Florida which will provide nationwide testing coverage. It is expected that
BIO will add further clinical laboratory partners as required to be able to
meet anticipated market demand across North America when the test completes
Clinical Laboratory Improvement Amendments ("CLIA") accreditation as a
Laboratory Developed Test ("LDT").

BIO continues to make regular payments as part of the revised advance royalty
payment schedule of US$2.4m to be paid in full by the end of 2026, as
announced on 18 August 2025.

Highlights

·    BIO, as part of a US wide roll out strategy, has partnered with Omni
to complete its validation programme for the Company's CIZ1B biomarker test to
help in the early detection of lung cancer. Omni intends to enable a multiple
site testing capability from COLA or CAP and CLIA accredited laboratories to
meet anticipated demand following the planned launch of the test in the near
term.

·    The Company has received further advance payments from BIO as part of
the revised royalty payment schedule.

BIO's strategy to launch the Company's CIZ1B biomarker test at multiple sites
throughout the USA

The Company has been working closely with its exclusive licensing partner BIO
to market its proprietary CIZ1B biomarker test to help detect early-stage lung
cancer, throughout the USA, Canada and the Caribbean as a LDT in CLIA
accredited laboratories.

As announced on 18 August 2025, BIO has initiated a US national strategy for
accreditation and market launch across multiple sites as part of a wider
co-ordinated and comprehensive campaign to roll out the CIZ1B biomarker test
in North America to help detect early-stage lung cancer. The Company can now
announce that BIO has teamed with Omni a CLIA-certified diagnostic laboratory
headquartered in Richardson, Texas. It specialises in a comprehensive range of
testing services, including pharmacogenomics, molecular diagnostics, clinical
testing, genetic testing, and diagnostics for medical fields such as
cardiology, oncology, neurology, and infectious diseases. Omni focuses on
delivering precise, accurate, and reliable results to support healthcare
providers and patients and has an active expansion programme to acquire or
partner with other accredited laboratories throughout the USA including New
York, California, South Carolina, Tennessee and Florida to enable a nationwide
testing capability. While initially to be offered as a private pay for test,
they intend to secure CPT (Current Procedural Terminology) codes to allow
payment by Medicare and Medicaid. BIO and Omni will engage in a progressive
marketing campaign, working closely with patient advocacy groups to enable
easy patient engagement and so reduce premature cancer deaths and improve
survival rates and quality of life for cancer patients.

Advance Royalty Agreement with BIO

On 18 August 2025, the Company announced that it had received initial payments
totalling US$525,000 from its exclusive licensing agreement with BIO as part
of a guaranteed payment schedule due to the Company totalling US$2.4 million
to be paid in full before the end of 2026. These payments are advance payments
from royalties of 10% on sales revenue in North America and the Caribbean. BIO
has since made further payments as part of a revised regular payment that
continues to support the Company's cash flow requirements.

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

"I am delighted to announce further details on the progress being made by our
partner BIO, especially as they implement their strategy to reach as many
people as possible who are at risk of lung cancer across multi-site accredited
clinical laboratories. The team at Omni have been working hard, and with
support from both BIO and the Company are striving to validate and get our
CIZ1B test launched in the near future. With over 14.5 million people
identified as being at high risk of getting lung cancer in the USA, it is
important to develop a nationwide testing capability and I am sure we will see
this develop further as demand increases.

"The important advance royalty payments received from BIO continue and
demonstrates the full commitment of BIO to this partnership, providing a
significant revenue line to the Company to meet its cash flow requirements.

"I had the pleasure of joining Bill Behnke, Chairman and CEO of BIO, and his
team as their guest at the Prevent Cancer Foundation(®) 40(th) Anniversary
and Gala on September 18(th), which they sponsored at the National Building
Museum in Washington, D.C.  With over 1,000 guests it marked four decades of
the Foundation's leadership in making prevention central to the fight against
cancer. The 2025 event spotlighted nationwide progress in prevention and early
detection while advancing the Foundation's goal of securing congressional
representation from all 50 states to honour the institutions, communities, and
advocates driving change. With other guests from the Saville Cancer Screening
and Prevention Center at Inova Schar Cancer Institute, a leading cancer center
offering comprehensive, patient-centered care across the full spectrum of
prevention, diagnosis, treatment, and survivorship and the LUNGevity
Foundation, the largest national lung cancer nonprofit, which accelerates
research and provides vital support for patients, the evening provided a
powerful platform to raise our profile and the importance of our CIZ1B
biomarker as a breakthrough tool in early lung cancer detection. To see more
visit
https://www.prnewswire.com/news-releases/cizzle-bio-champions-cancer-survivors-early-detection-as-sponsor-of-prevent-cancer-foundation-40th-anniversary-and-gala-302564695.html
(https://www.prnewswire.com/news-releases/cizzle-bio-champions-cancer-survivors-early-detection-as-sponsor-of-prevent-cancer-foundation-40th-anniversary-and-gala-302564695.html)
.

"I look forward to providing further updates on our partnerships as we
continue to develop our global licensing strategy to make the CIZ1B biomarker
test available globally."

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)

 

About Omni Health Diagnostics

 

Omni Health Diagnostics is a diagnostic laboratory based in Richardson, TX,
offering a comprehensive range of testing services, including
pharmacogenomics, molecular diagnostics, and clinical testing. The facility is
COLA accredited and CLIA-certified, ensuring precise and accurate testing with
a focus on providing high-quality care and reliable results. Their services
cater to various medical fields such as cardiology, oncology, neurology, and
infectious diseases, as well as genetic testing. Omni Health aims to support
both patients and healthcare providers with advanced diagnostic solutions.

For more information, please see https://www.omnihealthdx.com

 

 

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