GENinCode PLC Trading update (5213T)
25 November 2021 - 05:59PM
UK Regulatory
TIDMGENI
RNS Number : 5213T
GENinCode PLC
25 November 2021
25 November 2021
GENinCode Plc
("GENinCode" or the "Company")
Trading and progress update
GENinCode Plc (AIM: GENI), the predictive genetics company
focused on the prevention of cardiovascular disease, provides the
following trading and progress update ahead of its financial year
end on 31 December 2021.
Following the successful admission to AIM in July 2021 and
ramp-up in operations over the second half of this financial year,
the Company is now moving towards a number of important milestones
which will drive its growth and profile over the coming years.
These milestones are expected to accelerate the Company's
commercial programme to lift the Standard of Care for
cardiovascular disease ("CVD") by enabling more precise patient
diagnosis and risk stratification to improve preventative care.
The Company is focused on delivering the plans set out in its
admission document, especially around the preparation for the US
launch of Cardio inCode(R) in 2022. In summary:
-- Cardio inCode(R) de-novo submission for US regulatory
approval with the FDA - The Company continues to have constructive
and ongoing discussions with the FDA and is finalising its de-novo
application. The de-novo submission is expected to be filed by the
end of this year.
-- Breakthrough Device Designation (FDA) for Cardio inCode(R) -
Discussions continue to progress with the FDA to advance Cardio
inCode(R) as a 'Breakthrough device'. Discussions have been
extended partly due to FDA workload, but also resulting from a
detailed assessment of GENinCode's CVD prognostic device which, in
turn, has given the Company confidence to file its de-novo
submission earlier than it might otherwise have planned. The
Company remains well placed to complete this process over the
coming months.
-- Cardio inCode(R) launch programme with EVERSANA Life Sciences
LLC for introduction to US market in 2022 - The Company is working
closely with its new collaborative partner EVERSANA to finalise the
programme for the Cardio inCode(R) launch, expected in H2 2022. The
EVERSANA health team comprises of a multi-disciplined group of
experts covering market access, reimbursement, regulatory and field
sales, supporting the commercial development of the Company's US
programme.
-- CPT coding for Cardio inCode(R) and commencement of CMS payer
and reimbursement discussions - The Company is now finalising the
CPT-PLA coding draft and expects to file its coding application in
Q1 2022. CMS discussions are anticipated to commence regarding
reimbursement in the New Year.
-- Royal Brompton & Harefield set-up and commissioning for
Lipid inCode(R) hypercholesterolemia testing - The Company has
successfully completed the validation of its hypercholesterolemia
testing at the Royal Brompton Hospital Genetic Labs in London and
expects to start commercial testing with UK private payers and NHS
Academic Health Science Networks (AHSNs) over the coming month.
-- Indiana University and New York Presbyterian collaborations -
The Company is finalising collaborative agreements with both these
flagship facilities to advance the clinical diagnosis of CVD.
Initial collaborative work will focus on the introduction of Cardio
inCode(R) and Thrombo inCode(R) products for CVD and COVID-19
clinical study assessment.
-- US CLIA (Clinical Laboratory Improvement Amendments)
authorised testing facility - Discussions are ongoing with a number
of CLIA labs to implement Cardio inCode(R) genetic test service
delivery for the US market. The Company expects to announce further
CLIA developments over the coming months.
-- UK Hypercholesterolemia study for Lipid inCode(R) - The NHS
'Evaluation of novel rapid genomic test (Lipid inCode(R)) including
polygenic risk scores for the diagnosis and management of Familial
Hypercholesterolaemia' study is due to report its findings in the
international journal ' Global Cardiology Sciences and Practice'
over the coming months. The publication is currently with the
editorial board.
-- First COVID-19 Thrombo inCode(R) evaluation study for genetic
predisposition to thrombosis - St. Pau hospital, Barcelona -
Preliminary data from the Company's first COVID-19 study indicates
that there is a correlation between inherited thrombophilia (blood
clotting) and more severe complications for individuals suffering
with COVID-19. Preliminary data from a second COVID-19 study is
anticipated over the coming months.
-- Trading outlook - Over the H2 2021 reporting period the
Company has seen increased EU product revenues in line with market
guidance.
Matthew Walls, CEO of GENinCode Plc said: " Since admission in
July, we have made solid progress in delivering the key milestones
set out in our business plan. The business is developing swiftly
and we are increasing our investment in key resources and expertise
to take advantage of growth opportunities opening to us and
strengthening our Board to include a greater US market presence,
awareness, and expertise to reflect our long-term goals. We look
forward to updating the market and our shareholders in due
course."
For further information please contact:
GENinCode Plc www.genincode.com or via Walbrook
PR
Matthew Walls, CEO
Paul Foulger, CFO
Stifel Nicolaus Europe Limited (Nomad Tel: +44 (0)20 7710 7600
and Joint Broker)
Alex Price / Ben Maddison / Richard Short
Cenkos Securities Plc (Joint Broker) Tel: +44 (0)20 7397 8900
Giles Balleny
Dale Bellis / Michael Johnson (Sales)
Walbrook PR Limited
Tel: 020 7933 8780 or genincode@walbrookpr.com
Anna Dunphy / Paul McManus / Louis Ashe-Jepson
About GENinCode plc
GENinCode plc is engaged in the risk assessment, prediction and
prevention of cardiovascular disease ("CVD"). CVD is the leading
cause of death worldwide accounting for approximately 18 million
deaths annually. The Company's products and technology have been
developed with the aim of predicting the onset of CVD and providing
a personalised treatment pathway for patient management. Its
products have been the subject of clinical studies on over 75,000
patients to assess and predict the onset of CVD.
The Company was incorporated in September 2018 to acquire the
assets, intellectual property and know-how of the Ferrer inCode and
Gendiag.exe businesses, which were then part of Grupo Ferrer
Internacional S.A., a large Spanish multinational private
pharmaceutical and healthcare company. The technology and products
acquired included Cardio inCode(R), Lipid inCode(R), Thrombo
inCode(R) and Sudd inCode(R). Approximately EUR50 million has been
invested in the research and development of these products since
2007. The Company has begun to commercialise these products in
Europe and is also targeting the UK and US.
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