TIDMGENI
RNS Number : 0436G
GENinCode PLC
22 July 2021
NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE
UNITED STATES, CANADA, AUSTRALIA, THE REPUBLIC OF IRELAND OR
JAPAN
The distribution of this document outside the UK may be
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directly or indirectly, in or into the United States, Canada,
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disseminated to any or national citizen or resident of the United
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materials and the information contained herein do not constitute an
offer or the solicitation of an offer, to subscribe or buy the
securities discussed herein in any jurisdiction in which such offer
or solicitation is unlawful. Recipients of this announcement who
intend to purchase or subscribe for securities in the Company
following publication of the final admission document are reminded
that any such purchase or subscription must only be made solely on
the basis of the information contained in the admission document
relating to the Company in its final form.
This announcement and the information contained herein is not an
offer to sell or a solicitation of an offer to buy the securities
in the United States. The securities mentioned herein have not
been, and will not be, registered under the U.S. Securities Act of
1933, as amended (the "Securities Act"), and may not be offered or
sold in the United States (as such term is defined in Regulation S
under the Securities Act) unless they are registered under the
Securities Act or pursuant to an exemption from registration. No
public offer of the Securities is being made in the United
States.
22 July 2021
GENinCode plc
("GENinCode" or the "Company")
Admission to trading on AIM
& First Day of Dealings
GENinCode plc (AIM: GENI), the cardiovascular disease ("CVD")
company focused on predictive genetics for the prevention of
cardiovascular disease, announces that admission to trading on AIM
("Admission") will take place and dealings will commence at 8.00
a.m. today under the ticker GENI and ISIN GB00BL97B504.
The Company's Admission Document is available here:
https://investors.genincode.com/docs/genincodelibraries/default-document-library/final-admission-document.pdf
The Company will host a live presentation via the Investor Meet
Company platform at 10am today. To register to attend, please use
this link:
https://www.investormeetcompany.com/genincode-plc/register-investor
Summary and Highlights
-- Successful Fundraising for gross proceeds of GBP17 million before expenses
-- Placing price per GENinCode Share of 44 pence
-- Market capitalisation of approximately GBP42.2 million on Admission
-- 38,636,366 New Ordinary Shares made up of:
- 31,818,184 Placing Shares and;
- 6,818,182 Subscription Shares
-- The 38,636,366 New Ordinary Shares represent 40.32 per cent. of the Enlarged Share Capital
-- 95,816,866 Ordinary Shares in issue on Admission
-- Stifel Nicolaus Europe Limited acted as Sole Global
Coordinator and Joint Bookrunner in relation to the Placing, with
Cenkos Securities plc also acting as Joint Bookrunner. Stifel
Nicolaus Europe will be the Company's Nominated Adviser and Joint
Corporate Broker from Admission. Cenkos Securities will be the
Company's Joint Corporate Broker.
Reasons for Admission and Use of Proceeds
The Directors believe that Admission will:
-- Enhance GENinCode's profile and product awareness amongst
current and prospective customers, partners, suppliers and academic
institutions
-- Provide the potential to access capital to fund future growth
plans as and when the Board deems suitable
-- Provide a platform for any future acquisitions of companies,
products and/or intellectual property
-- Provide an increased ability to attract, retain and
incentivise high calibre employees, including by way of
equity-linked schemes
The net proceeds from the Fundraise, receivable by the Company,
is expected to be approximately GBP15.4 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(R), Lipid inCode(R), Thrombo
inCode(R) and Sudd inCode(R). The Directors believe that
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 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(R) and Thrombo inCode(R) 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(R): focused on assessing the coronary genetic
risk and cardiovascular risk stratification;
-- Lipid inCode(R): focused on the diagnosis and management of hypercholesterolemia;
-- Thrombo inCode(R): focused on the diagnosis and management of
genetic thrombophilia and thrombosis risk;
-- Sudd inCode(R): focused on the diagnosis of the cause of
sudden cardiac death and familial heart disease.
The Directors expect Cardio inCode(R), Lipid inCode(R) and
Thrombo inCode(R) (all CE-Marked) to be the primary products of
commercialisation focus over the immediate term.
Matthew Walls, CEO of GENinCode commented: "We are delighted
with the level of interest and strong support generated from new
institutional investors ahead of our admission to trading on AIM.
The additional funds raised will allow us to further exploit the
significant market opportunity to deliver clinically-proven genomic
precision testing products for the CVD market to improve the
current standard of care and enhance the assessment of the risk of
the onset of CVD in what is globally the leading cause of
death.
"Our products and technology have been developed with the aim of
providing a personalised treatment pathway for patient management
predicting the onset of CVD with clinical evidence on over 75,000
patients to date. CVD accounts for over 17.9 million deaths
annually, representing approximately 31 per cent. of all deaths
worldwide with the global cost of CVD estimated to reach
approximately $1.04 trillion by 2030."
For further information please contact:
GENinCode plc www.genincode.com
Matthew Walls, CEO Via Walbrook PR
Paul Foulger, CFO
Stifel Nicolaus Europe Limited (Nomad Tel: +44 (0)20 7710
and Joint Broker) 7600
Alex Price / Ben Maddison /
Richard Short
Cenkos Securities Plc (Joint Tel: +44 (0)20 7397 8900
Broker)
Giles Balleny
Dale Bellis / Michael Johnson
(Sales)
Walbrook PR Limited Tel: 020 7933 8780 or genincode @walbrookpr.com
Anna Dunphy / Paul McManus / Tel: +44 (0)7876 741 001 /
Louis Ashe-Jepson +44 (0)7980 541 893 / 44 (0)7813
867 655
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(R), Lipid inCode(R), Thrombo
inCode(R) and Sudd inCode(R). The Directors believe that
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 certain European countries and is
also targeting the UK and US.
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END
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