GENINCODE PLC — Regulatory Filings 2021

Jul 13, 2021

National Storage Mechanism | Additional information

RNS Number : 0671F

GENinCode UK Limited

13 July 2021

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GENinCode plc

("GENinCode" or the "Company")

Announcement of intention to float on AIM

Cardiovascular disease company, focused on clinically-proven genomic precision testing products, to seek admission to AIM through an IPO

GENinCode plc, the cardiovascular disease ("CVD") risk assessment company focused on predictive genetics for the prevention of cardiovascular disease, is delighted to announce its intention to seek admission of its issued and to be issued Ordinary Shares to trading on AIM, a market of the London Stock Exchange plc ("Admission"). On admission, the Company is expected to have a market capitalisation of approximately £42 million.

The Company has conditionally raised £17.0 million by way of a placing of 38,636,364 New Ordinary Shares at a price of 44p per share (the "Fundraise") through Stifel Nicolaus Europe Limited, acting as nominated adviser, sole global coordinator and joint bookrunner, and Cenkos Securities plc, acting as joint bookrunner. The New Ordinary Shares are made up of 31,818,182 Placing Shares and 6,818,182 Subscription Shares. It is expected that Admission will become effective at 8 a.m. on or around 22 July 2021. The Ordinary Shares will trade under the AIM symbol 'GENI'.

Use of Funds

The net proceeds from the Fundraise, receivable by the Company, is expected to be approximately £15.4 million and will be used to assist the Company in achieving its stated objectives, principally to:

·    Focus on the US regulatory, reimbursement and commercialisation programme;

·    Expand the reach of the Company's business in the EU;

·    Fund the UK expansion programme and working capital; and

·    Fund corporate costs with a runway to early-2023.

Company background

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®. The Directors believe that 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 certain European countries and is also targeting the UK and US.

The Company's product portfolio draws on genomic precision testing using polygenic (multiple-genes) technology, advanced molecular testing, genotyping and sequencing. Through a simple blood or saliva sample, the Company can analyse a patient's medical information and genetic variants associated with CVD to determine a Genetic Risk Score which is used for the subsequent assessment of a patient's cardiovascular disease risk. The Company also provides risk assessment for thrombosis (genetic predisposition to blood clotting). The Company's SITAB system, a proprietary software, bioinformatics and algorithmic platform with online cloud-based reporting, is used to process and record test results and genetic information using algorithms and artificial intelligence to assess a patient's risk of a cardiovascular event. SITAB reports results directly via a web portal to healthcare practitioners, cardiologists and physicians, in a user-friendly format.

The current standard of care for primary prevention and assessment of the risk of CVD has been in use and largely unchanged for many years. It is based on risk assessment equations which evaluate 'classic' or 'traditional' cardiovascular risk factors such as age, gender, smoking, blood cholesterol levels and blood pressure among other factors for the onset of CVD. The equations enable physicians to categorise patients as being at low, moderate or high risk of a CVD event, usually over the subsequent 10-year period or sometimes using a 'lifetime' horizon from which the patient is then assessed for lifestyle changes or treatment.

It is recognised that these 'classic' or 'traditional' risk assessments are imperfect with events not infrequently occurring in those individuals categorised at 'low' or 'intermediate' risk. The advent of genetic risk assessment for CVD is now able to help identify and reclassify those individuals traditionally categorised in the 'low' or 'intermediate' risk populations who are at higher genetic risk of a CVD event than their current standard of care risk assessment suggests. This enables earlier in life preventative measures to be adopted to lower the future risk of a CVD event.

With CVD mortality levels continuing to rise globally, there is an increasing need for cardiologists to apply genetics to help advance patient prognosis and diagnosis to treat the onset of CVD. The Company's products combine predictive models of genetics and patient data using classic cardiovascular risk factors (CVRFs) and are designed to improve predictive capability and genetic risk assessment to provide a personalised and thereby tailored treatment pathway. Recent studies and scientific reports show the correlation between genetic load/burden and the onset of CVD. The Directors believe that GENinCode's technology is at the forefront of genetic risk assessment in the CVD space.

The Company's key products are CE-Marked with the core products Cardio inCode and Thrombo inCode having IP protection in the major growth markets of Europe, the UK and the United States. The Company has now commenced its commercial expansion programme in Europe, the UK and the United States.

On 28 April 2021, the Company announced a partnership to provide genetic testing from labs based at Royal Brompton and Harefield Hospitals. Following this, it was announced on 14 June 2021 that a product commercialisation agreement had been entered into with EVERSANA in the US. The Directors believe that the partnership with EVERSANA, a leading provider of global commercial services to the life science industry, will provide a significant opportunity for the Group to progress its commercialisation plans for the US.

The Company's commercialisation strategy in the US is a significant part of GENinCode's long-term growth and commercial strategy. The Directors expect Cardio inCode to be reviewed by the FDA as a De Novo device. The Company submitted an initial application to the FDA in February 2021 for Breakthrough Device designation for its Cardio inCode product. The FDA review is ongoing with a decision expected in Q3 2021.

The Directors believe GENinCode technology provides patients and physicians with a more comprehensive and accurate risk assessment of CVD than the current standard of care, enabling more tailored preventative care treatment strategies to be employed. The Company's molecular tests combine clinical algorithms and artificial intelligence to provide advanced patient risk assessment to predict the onset of CVD. The Directors believe that the Company's products benefit from over 10 years' of investment in the research and development of cardiovascular health genomics and a knowledge and understanding of the interactions between a patient's genetic profile, lifestyle and clinical risk factors.

The Company's core product portfolio is underpinned by clinical studies on over 75,000 patients. The product portfolio consists of:

·    Cardio inCode: focused on assessing the coronary genetic risk and cardiovascular risk stratification;

·    Lipid inCode: focused on the diagnosis and management of hypercholesterolemia;

·    Thrombo inCode: focused on the diagnosis and management of genetic thrombophilia and thrombosis risk;

·    Sudd inCode: focused on the diagnosis of the cause of sudden cardiac death and familial heart disease.

The Directors expect Cardio inCode, Lipid inCode and Thrombo inCode (all CE-Marked) to be the primary products of commercialisation focus over the immediate term.

Mathew Walls, Chief Executive Officer of GENinCode commented: "We would like to thank all our participating shareholders and our new institutional investors for providing us with the support to take GENinCode to the next stage of its development through our admission to AIM. We're looking forward to the exciting times ahead and the additional funding as a result of the placing will help us accelerate our growth strategy. We look forward to keeping our shareholders, and the market, updated on our progress."

For further information please contact:

GENinCode plc		www.genincode.com
Matthew Walls, Chief Executive Officer		Via Walbrook PR
Paul Foulger, Chief Financial Officer
Stifel Nicolaus Europe Limited (NOMAD, Sole Global Coordinator and Joint Bookrunner)				Tel: +44 (0)20 7710 7600
Alex Price / Ben Maddison / Richard Short
Cenkos Securities plc (Joint Bookrunner)		Tel: +44 (0)20 7397 8900
Giles Balleny
Walbrook PR Limited	Tel: 020 7933 8780 or genincode@walbrookpr.com
Anna Dunphy / Paul McManus / Louis Ashe-Jepson

About GENinCode plc

GENinCode plc (AIM: GENI) 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®. The Directors believe that 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 certain European countries and is also targeting the UK and US.

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