REG - GENinCode PLC - CARDIO inCode® publication & Trading Update

GenincodeAnnouncement

05/12/2024 07:00

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RNS Number : 8802O  GENinCode PLC  05 December 2024

5 December 2024

 

 

GENinCode Plc

("GENinCode" or the "Company")

 

CARDIO inCode® publication in International Journal of Cardiology
Cardiovascular Risk and Prevention

and 2024 Pre-Close Trading Update

 

Individuals with a high polygenic risk are likely to derive the most benefit

from lifestyle change and/or therapeutic intervention

 

Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the
prevention of cardiovascular disease, announces the publication in the
International Journal of Cardiology Cardiovascular Risk and Prevention of a
clinical research study on the 'Interplay between Lifestyle Factors and
Polygenic Risk for Incident Coronary Heart Disease in a Large Multiethnic
Cohort' (1).

 

The publication investigated a subset of over 60,000 adult individuals with no
history of Coronary Heart Disease (CHD) from the Genetic Epidemiology Resource
in Adult Health and Aging (GERA) multi-ethnic cohort at Kaiser Permanente
Northern California, USA. The study followed the individuals over an average
follow-up of 14 years, using CARDIO inCode-Score® (CIC-SCORE) to assess the
interplay of polygenic risk with lifestyle on the incidence of Coronary Heart
Disease (CHD).

 

Following the March 2024 publication in the American Society of Preventive
Cardiology journal, this latest study shows that genetic and lifestyle
(smoking, diet, exercise) factors are independently associated with incident
CHD and lifestyle and genetic predisposition both influence the risk of
incidence of coronary heart disease. The results also showed that individuals
with high polygenic risk are likely to derive the most benefit from lifestyle
change and/or therapeutic intervention, supporting the inclusion of polygenic
risk assessment in lifestyle interventions.  For individuals with a high
polygenic risk, a favourable lifestyle is associated with a 52% lower rate of
CHD compared with an unfavourable lifestyle. This means that identifying
individuals with an unfavourable lifestyle and high polygenic risk score and
changing their behaviour to adopt a favourable lifestyle following a
Mediterranean diet, regular physical exercise and  non-smoking would halve
their risk of a CHD event including non-fatal AMI, angina and coronary
revascularisation procedures (coronary by-pass or percutaneous intervention)
or CHD death. This research will be presented at the ESC CardioGenomics 2024
conference on 6 December 2024 in Antwerp, Belgium.

 

Professor Ahmet Fuat, Honorary Professor of Primary Care Cardiology and NHS GP
said: "With the heritability of Coronary Heart Disease estimated at between
40-60%, I am delighted to see this milestone publication showing the
importance of polygenic risk as an independent risk factor to identify and
stratify individuals and prevent Coronary Heart Disease."

 

Jules Payne, CEO, HEART UK said: "This publication raises the importance
of both genetic and secondary factors to predict
risk of  Coronary Heart Disease. Genetic factors are not modifiable,
therefore it is very important to identify modifiable risk factors like
lifestyle, smoking, obesity, high cholesterol and high blood pressure
in individuals at risk of coronary and other arterial diseases and address
these factors as soon as possible. Prevention of heart disease is core to the
HEART UK charity and this advance will help us better educate, support and
influence families and health professionals on cardiovascular disease
prevention."

 

GENinCode specialises in polygenic risk assessment to prevent Coronary Heart
Disease (CHD). CHD is the most common form of heart disease and the leading
cause of death worldwide and in the United Kingdon and United States.

 

CARDIO inCode-Score is being clinically adopted in leading US healthcare
institutions and has received the grant of its CPT PLA code from the American
Medical Association for health insurance coverage and reimbursement. CARDIO
inCode-Score will also be included in the Centers for Medicare and Medicaid
Services (CMS) Clinical Lab Fee Schedule from 2025.

 

CARDIO inCode-Score is a in-vitro diagnostic test used to assess an
individual's genetic (DNA) risk of Coronary Heart Disease. The test is based
on published clinical evidence amassed over 16 years which in conjunction with
traditional clinical risk factors provides a comprehensive risk assessment
(clinical + genetic) of Coronary Heart Disease for use in primary preventive
care. GENinCode labs process patient DNA samples and deliver the CARDIO
inCode-Score® test results to physicians via its online international
reporting system ('SITAB').

 

CARDIO inCode-Score also addresses the well-recognised need for improvement in
the cardiovascular disease (CVD) standard of care across ethnicities and in
borderline or intermediate CVD risk patients. A significant proportion of CHD
events take place in individuals classified as being at borderline or
intermediate CVD risk, and thus not candidates for aggressive clinical
management. The CIC-SCORE test provides an improved estimation of an
individual's risk of heart disease in conjunction with traditional clinical
risk scoring. CIC-SCORE provides a major step change in patient risk
assessment for CVD enabling improvement in risk assessment, preventive care
and personalised treatment.

 

In the UK around 7.6m people live with heart and circulatory disease, which
causes 25% of all deaths annually. CVD can be reduced by identifying and
treating individuals at risk, and the NHS 10 Year Plan (2019) focused on
addressing CVD prevention.

 

Matthew Walls, CEO of GENinCode PLC said: "This lifestyle publication
continues to strengthen the importance of polygenic risk assessment to prevent
Coronary Heart Disease. Heart disease is the leading cause of death globally
and CHD is the most common form of the disease. We are delighted with the
publication showing the clinical utility of polygenic risk assessment to
identify individuals most at risk of Coronary Heart Disease, thereby enabling
targeted treatment and a breakthrough in preventive care.

 

Pre-Close Trading Update

 

2024 has seen the business continue to commercially scale its test revenues
across the US, UK and Europe and we expect consolidated revenues for the full
year of between £2.7m - £3.0m, (2023: £2.16m) delivering an annual revenue
growth of between 25%-39% with an improved gross margin. There is growing
recognition of our polygenic tests, technology and globally leading clinical
evidence to support genetic testing strategies for the prevention of Coronary
Heart Disease.

 

This year marks our first US revenues and health insurer billing claims and we
have taken a cautious approach to revenue recognition in the above anticipated
sales. We continue to broaden our NHS commercial relationships across the
North of England alongside expansion of our European business.

 

We have maintained tight operational cost control throughout the year and
expect to see a significant reduction in the adjusted EBITDA loss to £4.8m,
(2023: £6.7m) consistent with us targeting a breakeven position over the
medium term whilst offering significant international business growth and
opportunity. End of year cash remains in line with expectations.

 

On behalf of the Board, I would like to thank our valued shareholders for
their support as we look forward to accelerating our business programme in
2025."

 

1.    https://www.sciencedirect.com/science/article/pii/S2772487524001156
(https://www.sciencedirect.com/science/article/pii/S2772487524001156)

 

For more information visit www.genincode.com (http://www.genincode.com)

Enquiries:

 

 GENinCode Plc                                       www.genincode.com (http://www.genincode.com) or via Walbrook PR
 Matthew Walls, CEO

 Cavendish Capital Markets Limited                   Tel: +44 (0)20 7397 8900
 Giles Balleny / Dan Hodkinson (Corporate Finance)

 Nigel Birks (Life Sciences Specialist Sales)

 Ondraya Swanson (Corporate Broking)

 Dale Bellis / Michael Johnson (Sales)

 Walbrook PR Limited                                 Tel: 020 7933 8780 or
 Anna Dunphy / Louis Ashe-Jepson / Phillip Marriage  genincode@walbrookpr.com (mailto:genincode@walbrookpr.com)

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the
European Union (Withdrawal) Act 2018. The person responsible for arranging
the release of this announcement on behalf of GENinCode Plc is Matthew Walls,
Chief Executive Officer.

 

About GENinCode:

GENinCode Plc is a UK based company specialising in genetic risk assessment of
cardiovascular disease. Cardiovascular disease is the leading cause of death
and disability worldwide.

 

GENinCode operates business units in the UK, Europe through GENinCode S.L.U,
and in the United States through GENinCode U.S. Inc.

 

GENinCode predictive technology provides patients and physicians with globally
leading preventative care and treatment strategies. GENinCode CE marked
invitro-diagnostic molecular tests combine clinical algorithms and
bioinformatics to provide advanced patient risk assessment to predict
cardiovascular disease.

 

About Cardiovascular Disease (CVD):

Heart and circulatory disease known collectively as Cardiovascular disease
(CVD) are the leading cause of death globally, taking an estimated 17.9
million lives each year. CVD is a group of disorders of the heart and blood
vessels that include coronary heart disease, cerebrovascular disease,
rheumatic heart disease and other conditions. More than four out of five CVD
deaths are due to heart attacks and strokes, and one third of these deaths
occur prematurely in people under 70 years of age.

 

Coronary heart disease is the most common type of heart disease. In 2021 in
the US, coronary heart disease accounted for 375,476 deaths. About 1 in 20
adults age 20 and older have CHD (about 5%). In 2021, about 2 in 10 deaths
from CHD happened in adults less than 65 years old. Globally it is estimated
around 200 million people are living with coronary heart disease. Around 110
million men and 80 million women have coronary heart disease. Coronary heart
disease kills an estimated nine million people each year - in 2019 it was the
world's single biggest killer.

 

In the UK, cardiovascular disease causes a quarter of all deaths and is the
largest cause of premature mortality in deprived areas and the single biggest
area where the NHS can save lives over the next 10 years. CVD is largely
preventable, through lifestyle changes and a combination of public health and
NHS action on smoking and tobacco addiction, obesity, tackling alcohol misuse
and food reformulation.

 

Aside from the genetic risk of cardiovascular disease, the most important
behavioural risk factors of heart disease and stroke are unhealthy diet,
physical inactivity, tobacco use and harmful use of alcohol. The effects of
behavioural risk factors may show up in individuals as raised blood pressure,
raised blood glucose, raised blood lipids,  excess weight and obesity. These
"clinical risks factors" can be measured in primary care facilities and
indicate an increased risk of heart attack, stroke, heart failure and other
complications.

 

Identifying those at highest risk of coronary heart disease and ensuring they
receive appropriate treatment can prevent premature deaths. Access to
medicines and basic health technology in all primary health care facilities is
essential to ensure that those in need receive treatment and counselling.

 

Early detection and treatment of CVD can help patients live longer, healthier
lives is set out in the NHS 10 Year Plan. Too many people are still living
with undetected, high-risk conditions such as raised cholesterol, high blood
pressure and atrial fibrillation (AF). Globally, healthcare systems are making
progress on identification and diagnosis of high genetic risk individuals and
working towards people routinely knowing and understanding their 'ABC' (AF,
Blood pressure and Cholesterol risk). Replicating this approach is now
increasingly possible with advanced molecular testing and digital technology.

 

 

 

 

 

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