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:
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Cizzle Biotechnology Holdings plc
|
Via IFC Advisory
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Allan Syms (Executive
Chairman)
|
|
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Allenby Capital Limited
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+44(0) 20 3328 5656
|
|
John Depasquale
|
|
|
George Payne
|
|
|
Novum Securities Limited
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+44(0) 20 7399 9400
|
|
Colin Rowbury
Jon Bellis
|
|
|
IFC
Advisory Limited
|
+44(0) 20 3934 6630
|
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Tim Metcalfe
|
|
|
Florence Chandler
|
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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
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.
