REG - Cizzle Biotechnology - Update on North American Strategic Licensing MoU

Cizzle Biotechnology HoldingsAnnouncement

17/06/2024 07:00

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RNS Number : 5808S  Cizzle Biotechnology Holdings PLC  17 June 2024

17 June 2024

Cizzle Biotechnology Holdings plc

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

Update on Strategic Licensing and Partnership Memorandum of Understanding for
North America

And

Extension of Research Agreement with the University of York to conduct
Clinical Evaluation with Leading US Cancer Centre.

Cizzle Biotechnology, the UK based diagnostics developer, is pleased to
announce that as a result of its early collaboration with its planned
strategic and exclusive licensing partner in the USA, Cizzle Bio Inc ("BIO"),
its proprietary test for the CIZ1B biomarker has been selected as part of a
major study being conducted at a leading cancer centre in the USA.

In addition, the Company's continuing assay development and clinical
evaluation of CIZ1B, which is is highly associated with early-stage lung
cancer, is underpinned by renewal of a research and development contract with
the University of York. Subject to local ethical approvals, a new phase of
work will provide clinical results on patients suspected to have early stage
lung cancer arising from CT scanning in the US cancer centre. The new research
agreement with the University of York will run until July 2025.

Following the Company's signing of a Memorandum of Understanding ("MoU") with
BIO, as announced on 2 April 2024, the Company received the initial
non-refundable upfront fee of US$100,000 and expects a binding legal agreement
to be completed within the envisaged 120 day period from signing the MoU, with
a further US$300,000 payment to Cizzle on signing the binding agreement. The
Company has been working closely with BIO's US management team to determine a
timetable with key milestones for bringing the company's CIZ1B biomarker test
to market. Further details on BIO's plans are outlined below. Details of the
first hospital locations, clinical trials and initial deployment sites are
confidential at this time, but will be announced in due course.

Key Highlights

•     Cizzle received an up-front payment of US$100,000 as a
non-refundable fee to grant BIO an exclusive negotiating period of 120 days
from the signing of the MoU on 1 April 2024.

•     It is anticipated that the binding agreement, together with an
initial royalty payment of US$300,000, will be completed within this 120 day
period and will grant BIO an exclusive licence to develop and market clinical
diagnostic assays based on the CIZ1B biomarker to facilitate the early
detection of lung cancer in North America.

•     Minimum advance royalty payments of US$2.3 million, as part of the
10% royalty to be paid on gross revenues minus taxes, are due over a period of
30 months following signing of a binding agreement.

•     On completion of the binding agreement, Cizzle will own 10% of BIO
for no cash consideration.

•     Cizzle has been selected by a major cancer centre in the US to
evaluate CIZ1B testing as part of an important clinical study, to confirm
whether lung nodules identified by CT scanning are positive for the CIZ1B
biomarker.

•     BIO expects to register its first US CLIA (Clinical Laboratory
Improvement Amendments) accredited lab with the FDA (US Food and Drug
Administration) for the CIZ1B LDT test in September 2024

•     BIO plan to achieve CLIA Certification for the LDT test in
November 2024, with insurer reimbursement code achievement and full product
launch April 2025.

Further Information

Lung cancer remains the biggest cause of cancer deaths worldwide, with nearly
5000 people losing their lives daily to the disease. Other than the ability of
pathologists to confirm the presence of cancer, the current gold standard for
detection remains CT scanning, which produces a high rate of false positive
results. To reduce premature cancer deaths, improve survival rates and
increase quality of life a simple blood test that can facilitate early cancer
detection is needed.

As part of the Company's global licensing strategy, and stated aims to deploy
its first commercial tests in the USA, the partnership with BIO is already
achieving significant results. The decision of a large cancer centre to select
Cizzle's CIZ1B biomarker as part of its clinical evaluation is a major
endorsement of the Company's technology. With clear milestones established to
roll out the commercial test by 2025, the Company is poised to help address
the current low uptake in cancer testing, in relation to the US Preventive
Services Task Force's target of screening 14.2 million at-risk adults.

With guaranteed royalties over a 30-month period, a potential upside in value
through the company's 10% ownership of BIO, Cizzle will accelerate the
development, regulatory approval and launch of its biomarker diagnostic tests
in North America. This will be followed by, and will enable, similar
strategies elsewhere in the world.

Allan Syms, Executive Chairman of Cizzle Biotechnology, said:

"After years of research at the University of York and further investment and
development by Cizzle, the Company is now at an exciting inflection point. The
partnership with BIO in North America has opened doors to work with major
cancer centres, brings clarity to route and time of first product launch and
generates guaranteed revenue streams going forward. This is an exciting time
for Cizzle Biotechnology and I look forward to completing the binding
agreement with BIO and providing more details on the significant clinical
trial programme with top hospitals in the territory, 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
 George Payne

 

 Novum Securities Limited  +44(0) 20 7399 9400
 Colin Rowbury

 Jon Bellis

 

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

 

About Cizzle Biotechnology

Cizzle is developing a blood test for the early detection of lung cancer. The
Company 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 DNA replication, and the targeted CIZ1B variant is highly
correlated with early-stage lung cancer. 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 Inc

Cizzle Bio Inc, a company registered in Texas USA, has been created by a group
of high-net-worth individuals with a passion to improve cancer patient
survival.  Recognising that one of the main causes of poor survival rates for
certain cancers, and in particular lung cancer, is because diagnosis is often
when the disease is at an advanced state, there is an unmet need for a simple
blood test that can be used to detect cancer early. BIO is led by Bill Behnke,
who has been pioneering Cizzle Biotechnology's marketing activities in the USA
and is an accomplished entrepreneur and performance-driven senior executive
with an extensive background of success in funding and building healthcare
businesses through direct sales, marketing, sales management, and business
development.  He is heavily engaged in charitable work for cancer, and
served a nine-year tenure on the national board of the Leukemia and Lymphoma
Society.  He currently serves on the boards of the ASCO Foundation's Conquer
Cancer; the AYA Cancer Foundation; The Wheeler Group; Children's Shelter of
San Antonio; South Texas Blood and Tissue Center; and the Leukemia and
Lymphoma Society.

 

 

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