CARDIO inCode® publication & 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."

• https://www.sciencedirect.com/science/article/pii/S2772487524001156