REG - GENinCode PLC - Trading update

GenincodeAnnouncement

25/11/2021 07:00

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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® in 2022. In summary:

 

 

·    Cardio inCode® 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® -
Discussions continue to progress with the FDA to advance Cardio inCode® 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® 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® 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® 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® 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® and Thrombo inCode®
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® 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® - The NHS
'Evaluation of novel rapid genomic test (Lipid inCode®) 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® 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 (http://www.genincode.com) or via Walbrook PR
 Matthew Walls, CEO
 Paul Foulger, CFO

 Stifel Nicolaus Europe Limited (Nomad and Joint Broker)                  Tel: +44 (0)20 7710 7600
 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®, Lipid inCode®,
Thrombo inCode® and Sudd inCode®. Approximately €50 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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