Admission to AIM
EpiStem Holdings plc
04 April 2007
4th April 2007
EpiStem Holdings Plc.
Fundraising and Placing by Teather and Greenwood
2.5m of new Ordinary Shares at 124 pence per share
Highlights
• EpiStem Holdings Plc Admission to AIM 4th April 2007
• 2.5 million shares successfully placed at 124 pence per share raising
£2.6 million net of expenses
• EpiStem is a biotechnology company commercialising adult stem cells in
the areas of oncology and gastrointestinal diseases
• Money will be used to:
o enable the partnering of novel therapeutic compounds
o widen the diagnostic platform of the existing cash-flow positive fee
for service business
o general corporate services.
• Institutional investors include:
o Calculus
o Yorkshire Fund Managers
o Rensburg Sheppards
o Zeus Capital
o New Star
o Octopus
Commenting on the completion of the placing, David Evans, Chairman of EpiStem
said:
'We are delighted at the positive response that we have had from both our
existing investors and new institutions in supporting the development plans of
the Company. Alongside our existing list of investors including, Calculus,
Yorkshire Fund Managers, Rensburg Sheppards and Jon Moulton, we welcome as new
shareholders established institutional investors such as New Star and Octopus.
The money raised will allow us to advance our therapeutic candidates leading to
licensing partnerships. We believe candidate therapeutics will enable us to
regulate and repair tissue renewal processes providing a new development
approach for oncology based diseases. Epithelial cancers account for over 80% of
adult cancers. Our integrated discovery and preclinical platform will enable
pharmaceutical companies to access data and therapeutics based on the company's
unrivalled research knowledge in stem cells which has been amassed over 30 years
originally starting at the Paterson Institute at Christie's Hospital,
Manchester, UK.'
Commenting on his new role as CEO, Matthew Walls said:
The Company has been able to build a profitable and cash generative service
support business alongside an innovative discovery program based on its core
technology. An AIM quotation gives us the profile to expand our service support
business as well as become a leading supplier of validated candidate novel
therapeutics for a pharmaceutical industry increasingly demanding such targets.
The Board has a clear vision of how we will drive both sides of the business to
generate shareholder value. The team is highly professional and has an acute
sense of how to commercialise its technology for both short-term expansion and
the long-term growth of the Company. '
History
EpiStem is a biotechnology company commercialising adult stem cells in the areas
of oncology and gastrointestinal diseases as well as cosmeceutical applications.
EpiStem develops innovative therapeutics and diagnostic biomarkers and provides
contract research services to drug development companies. The Group's expertise
is focused on the regulation of adult stem cells located in epithelial tissue,
which includes the gastrointestinal tract, skin, hair follicles, breast and
prostate. EpiStem does not conduct research in the areas of embryonic stem cells
or stem cell transplantation.
Fundraising and Placing
Under the Fundraising and Placing, EpiStem Holdings Plc is issuing 2.5m New
Ordinary Shares representing approximately 38 per cent of the Enlarged Share
Capital.
Reasons for Admission and the Placing
The Company intends to raise approximately £2.6 million net of expenses pursuant
to the Fundraising. The net proceeds of the Fund raising will be used to:
• fund further research to enable the commercial partnering of
therapeutic candidate(s) from the Novel Therapies Division;
• fund the development of the Company's diagnostic platform based on
epithelial stem cell biology; and
• general corporate purposes.
The Directors also believe that the profile of the Group will be significantly
enhanced as a UK quoted public company.
For more information please contact:
EpiStem: 0161 606 7263
Matthew Walls, Chief Executive Officer
Teather & Greenwood: 020 7426 9000
Robert Naylor
Thilo Hoffmann
Simon Brown
MC Bio-Communications Limited: 020 7744 7711
Mike Wort, Anna Dunphy
In this release reference is made to the Admission Document which is available
on request from the Company at 48 Grafton Street, Manchester M3 9XX or the
Company's website www.epistem.co.uk.
Additional Information
EpiStem is a biotechnology company commercialising adult stem cells in the areas
of oncology and gastrointestinal diseases as well as cosmeceutical applications.
EpiStem develops innovative therapeutics and diagnostic biomarkers and provides
contract research services to drug development companies. The Group's expertise
is focused on the regulation of adult stem cells located in epithelial tissue,
which includes the gastrointestinal tract, skin, hair follicles, breast and
prostate. EpiStem does not conduct research in the areas of embryonic stem cells
or stem cell transplantation.
EpiStem operates two distinct business divisions, Contract Research Services and
Novel Therapies.
Contract Research Services
Contract Research Services provides specialised preclinical efficacy testing
primarily for drug development companies on a fee for service basis. This
division on a standalone basis is cash generative and profitable, with an
established five-year track record of providing testing services to over 65
company clients primarily in Europe and the United States.
Novel Therapies
Novel Therapies is focused on developing its own innovative therapeutics and
diagnostic biomarkers. Through its discovery platform, Novel Therapies has
identified 250 potential drug candidates, of which a subset will undergo further
evaluation as stem cell regulators for the Group's emerging drug development
pipeline. Novel Therapies is also conducting feasibility studies with two drug
development companies using its clinical diagnostic biomarker technology.
Combined Business Model
The Group is exploiting its combined business model to advance its own
therapeutic candidates to late preclinical stage development. The business model
integrates the discovery efforts of Novel Therapies with the efficacy testing
assays of its Contract Research Services Division, to identify and characterise
new drug candidates. Revenues generated by Contract Research Services will
assist in offsetting Novel Therapies' investment requirements for the discovery
and development of therapeutics. In February 2007, EpiStem licensed its first
drug candidate to a clinical development company. With the validation of the
Novel Therapies discovery platform and the achievement of discovery milestones,
the Directors believe that additional licensing partnerships will be forthcoming
for therapeutics, diagnostics and cosmeceuticals starting in 2008.
Company background
EpiStem was founded in 2000 by Professor Chris Potten and Dr. Catherine Booth,
its co-founders having previously been based in the Paterson Institute at the
Christie Hospital in Manchester, UK. Its offices are located in the Manchester
Incubator Building, which is part of the University of Manchester. The Company's
expertise is based on over three decades of experience in relation to discovery
research on the behaviour of adult epithelial stem cells by Professor Potten.
Professor Potten received a lifetime fellowship from Cancer Research UK and has
published over 350 scientific publications, written two and edited nine books.
He has received two prestigious prizes for his contributions to radiobiological
research, the Madame Marie Sklodowska-Curie Medal in 1998 and the Weiss Prize in
2003. Professor Potten is the Chief Scientific Adviser to the Group.
Stem cell assays developed by the founders attracted the attention of drug
development companies and these assays created the core platform for the
formation of the Contract Research Services Division. Dr. Booth has built a team
of 13 scientists alongside a business development team of five led by Dr. Mark
Bryant. Six of the Contract Research Services team have Ph.D. degrees.
Dr. Gerard Brady joined EpiStem as Research Director of the Novel Therapies
Division in 2001. Dr. Brady has applied over two decades of expertise developing
specialised molecular biology tools, including gene profiling of individual
cells, with the goal to identify the key regulators of epithelial stem cells. In
September 2005, EpiStem hired Dr. Jeffrey Moore to lead the commercialisation of
the Novel Therapies' technology. Prior to joining EpiStem, Dr. Moore discovered
a blood stem cell regulator, founded Phylogix Inc., a therapeutics biotechnology
company, and raised over $15 million to advance the drug candidate to late
preclinical development. The Novel Therapies team has seven scientists, five of
whom have Ph.D.degrees.
In February 2007, Matthew Walls, an experienced Chief Executive most recently at
Oxford Biosignals Limited, took on the role of Chief Executive Officer. Matthew
has extensive experience of building and commercialising biotechnology products
and services across the United States and United Kingdom. He succeeds David
Evans, who had been Executive Chairman since March 2006. David will continue in
the role of Non-executive Chairman, which he fulfils for three other AIM-quoted
companies in the healthcare sector. John Rylands, now Financial Director, joined
EpiStem in 2002 and has successfully completed several rounds of investment
supporting the growth of EpiStem.
Dr.Robert Nolan, the other Non-executive Director, has extensive pharmaceutical
licensing experience and an active involvement with early stage healthcare
companies.
Contract Research Services Division
Contract Research Services provides specialised preclinical assays for drug
development in the areas of oncology supportive care, oncology, inflammatory
bowel disease (IBD), and new emerging applications.
Introduction to oncology supportive care
The effectiveness of chemotherapy and radiation to eradicate cancer depends in
part on oncologists' ability to manage toxic side effects to the
gastrointestinal tract, a condition called mucositis. Destruction of the
epithelial lining, leading to ulceration and functional impairment, increases
the risk of infection and treatment delays and causes suffering for the patient
manifested by loss of appetite, diarrhoea, and wasting. Pain induced by
ulceration in the mouth (oral mucositis) is a major reason why patients either
delay or halt chemotherapy and radiotherapy. Better management of mucositis
during cancer treatment would decrease the risk of serious, sometimes
life-threatening infections, reduce overall treatment costs and patient
suffering. Reducing the toxic side effects of cancer therapy remains a major
unmet clinical need.
Oncology supportive care
The core intestinal stem cell assays used by EpiStem evaluate efficacy, optimise
drug dose/scheduling, and elucidate mode of action in the area of oncology
supportive care. These assays, established over the past decade, have been used
to evaluate more than a dozen supportive care drug candidates in preclinical
development. Following earlier testing involving Professor Potten and Dr. Booth,
two drug candidates have gone on to enter clinical trials, one of which (Amgen's
Kepivance(R)) is the first and currently the only drug approved to reduce oral
mucositis.
Oncology and Inflammatory Bowel Disease
Contract Research Services provides a range of established preclinical efficacy
testing services to assess anticancer compounds on tumour growth in oncology and
the severity of tissue damage in IBD. The team has developed a variety of
analytical tools to evaluate drug candidates and is also extending its services
in oncology and IBD to better assess the nature of these chronic diseases.
New emerging areas
Intestinal injury is a major component of radiation sickness and the National
Institutes of Health in the United States is funding the development of drugs
that will prevent and treat radiation sickness following a nuclear terrorist
event. EpiStem is currently evaluating the efficacy of candidate drugs to
protect and/or repair intestinal injury in the radiation/nuclear medical
countermeasure development programme. Contract Research Services has a
specialised understanding and expertise in the area of skin testing. It provides
bespoke skin assays, designed to assess a drug's ability to protect against
tissue damage from chemical and ultraviolet sources. The group has a specific
competence in growth and differentiation of various skin tissue types.
Market overview and opportunity
The Directors believe that Contract Research Services' core assays for oncology
supportive care and biodefence will provide the foundation for the division's
future sustainability and growth.
Oncology supportive care
The worldwide market for supportive care products exceeds £6 billion per annum,
primarily from Amgen and Johnson & Johnson's blood cell growth regulators. The
growing sales of Amgen's Kepivance(R) for oral mucositis reflect an opportunity
for additional therapeutics in this area. Contract Research Services is
currently evaluating several anti-mucositis candidates.
Biodefense
EpiStem's biodefense subcontract, which is funded through the University of
Maryland School of
Medicine's prime contract with the National Institute of Allergy and Infectious
Diseases of the National Institutes of Health, in the United States, involves
screening of drug candidates to protect and/or repair intestinal injury followed
by more comprehensive studies on selected drugs and is anticipated to continue
over three years. EpiStem is currently the primary laboratory in the University
of Maryland consortium that is evaluating the efficacy of candidate drugs to
protect the epithelial lining in the gut from radiation damage for the radiation
/nuclear medical countermeasure development programme. Independently two drug
development companies with biodefence compounds have contracted EpiStem to
conduct parallel studies in oncology supportive care.
Competition
The Directors believe that the Group's intestinal stem cell assays in supportive
care and biodefence have few competitors. The Directors believe that limited
oral mucositis models are conducted through a private contract research
organisation in the United States. Contract Research Services' oncology and IBD
assays operate in a more competitive market with success based on providing an
established quality of interactive service leading to repeat business. The team
has built a track record and profitable business based on its expertise in assay
design, execution and interpretation of results with its customers.
Novel Therapies Division
EpiStem intends to unlock the commercial value of adult epithelial stem cells by
discovering the key regulators of stem cells and developing candidate
therapeutics through commercial partnerships with drug development companies.
The core value generator in this division is its high resolution, gene
expression profiling technology used to analyse the behaviour of epithelial stem
cells. This know how has been generated over five years, profiling a wide range
of epithelial tissues to elucidate the fundamental mechanisms of stem cell
regulation. The Directors believe that control over the regulation of intestinal
stem cells will enable EpiStem to develop novel therapeutics to treat mucositis,
cancer, IBD, and other epithelial stem cell disorders. The Directors believe
that the regulators of intestinal stem cells are largely unknown due to the
difficulties in accessing and evaluating intestinal tissues. Through the
combination of its gene profiling technology and its intestinal stem cell
expertise, the Directors believe that they will be able to overcome these
technical obstacles. At the initial proof-of-concept stage, this technology
approach resulted in the identification of ten potential cell receptor targets
regulated by small molecule drugs. Biological activity was demonstrated in three
out of the ten receptors. One small molecule drug was then selected and
characterised. In 2004, EpiStem applied for patent protection for its
application as an anti-mucositis therapy. In February 2007, EpiStem entered into
its first licensing partnership with a clinical stage company to develop this
small molecule drug for oncology supportive care and biodefence applications.
With the confirmation in 2004 that EpiStem's discovery technology could
successfully identify relevant therapeutic targets, the Novel Therapies team
embarked on a comprehensive programme to identify the key regulators of
intestinal stem cells. The stem cell regulators will themselves be novel protein
therapeutic
candidates. In June 2006, the division completed its gene profiling programme of
intestinal stem cells and selected 250 genes that are likely to include
candidate stem cell regulators. EpiStem engaged Eden Biodesign, a contractor at
the National Biomanufacturing Centre in Liverpool, to produce the recombinant
proteins. These proteins will initially be evaluated directly in the Contract
Research Services Division's intestinal stem cell assays. EpiStem intends to
apply for patent protection of candidate therapeutics identified and
characterised in these assays. The Directors believe that it is likely that some
of the 250 proteins will also regulate epithelial stem cells in other tissues,
such as hair follicles to turn on and off hair growth for use in cosmeceutical
applications.
Developing innovative diagnostic biomarkers
EpiStem is applying its gene expression profiling technology to determine the
feasibility of using plucked human hairs to guide the clinical development of
new oncology drugs. Specifically, it is focusing on obtaining proof-of-concept
for this diagnostic biomarker method to determine drug exposure, dose and dose
scheduling, onset of intestinal toxicity, and patient selection. EpiStem already
has two feasibility studies supported by drug development companies to determine
the diagnostic biomarker's technical and biological robustness. The Directors
believe that these initial feasibility studies are likely to lead to development
partnerships in which EpiStem's plucked hair diagnostic biomarker will be
evaluated as part of oncology clinical trials starting in 2007.
Market overview and opportunity
EpiStem's business model for therapeutics draws on the scientific and commercial
validation of Amgen Inc.'s blood cell growth regulators. Both companies exploit
the body's own regulators that bind cellular receptors to activate cells. Amgen
generates over £5 billion in annual worldwide revenue from blood regulators that
stimulate production of the oxygen-carrying red blood cells and the infection
fighting white blood cells. The Directors believe that Amgen has sustained and
extended its market position over nearly two decades by introducing improved
versions of their patented protein therapeutics. The Directors believe that this
intellectual property strategy coupled with the complexity of protein
manufacturing processes has protected Amgen from generic drug competition.
EpiStem intends to adopt a similar strategic approach for its epithelial stem
cell regulator programmes.
Wide range of tissue targets and clinical opportunities
The potential commercial opportunity to exploit the body's own regulators of
epithelial stem cells could surpass that of the blood cell growth regulators.
The epithelium offers a wide range of tissue targets, clinical disorders, and
routes of drug delivery. In oncology alone, over 80 per cent. of all adult
cancers originate from the epithelium.
Commercialisation strategy for therapeutics
EpiStem intends to advance its candidate therapeutics to the stage of
proof-of-concept in late preclinical development and then enter into commercial
partnerships with clinical stage development companies. This strategy leverages
the Company's strengths - discovery through to preclinical efficacy - and
provides an early opportunity to obtain scientific and commercial validation of
its therapeutic business model. The Directors believe the Company is on track to
identify 1-4 candidate stem cell regulators for preclinical development in 2007
and enter into additional commercial partnerships in 2008.
Future strategy
The Company's future strategy is predicated on the continued growth of its
Contract Research Services and Novel Therapies Divisions. Based on the already
profitable Contract Research Services Division, the new funding will primarily
underpin drug development in the Novel Therapies Division. Where appropriate,
the Company may consider the acquisition of complementary technologies to
strengthen its business model and accelerate product and service development.
Summary financial information
6 months
ended
Year ended 30 June 31 December
2004 2005 2006 2006
£000's £000's £000's £000's
Turnover 704 1,245 901 667
PBT (250) 48 (756) (481)
Net assets 99 1,634 1,095 714
Cash at bank 90 1,517 681 328
Current trading statement
Since 31 December 2006, the trading of EpiStem's Contract Research Services
Division has been in line with management expectations and the Novel Therapies
Division has concluded an agreement with a clinical stage company to
commercialise its first therapeutic candidate. The Board remains confident that
overall trading will continue to meet internal expectations.
Directors and employees
The Board consists of eight Directors in respect of whom brief biographies are
set out below.
David Evans (aged 46), Non-Executive Chairman
David was executive Chairman of EpiStem from 2006 until February 2007. As the
former CFO he guided Shield Diagnostics Ltd. through its IPO and then, as its
CEO, through its merger with Axis Biochemical ASA to form Axis-Shield plc, a
Fully Listed diagnostics company. In addition to being Chairman of the Company
he is currently non-executive Chairman of BBI Holdings plc, Immunodiagnostic
Systems Holdings plc and Omega Diagnostics Group plc, all of which are AIM
listed diagnostic companies.
MatthewWalls (aged 43), Chief Executive Officer
Matthew joined EpiStem in February 2007 as Chief Executive Officer. Matthew is
an experienced CEO most recently with Oxford BioSignals Limited where he led the
strategic 'diagnostic' collaboration with Rolls Royce Plc and Covance Inc and
completed the recent fundraising and repositioning of the medical diagnostic
business to the United States. Matthew spent the early part of his career with
ICI plc progressing through the executive development programme and several
senior management positions. Matthew headed up the corporate financial and
commercial development of plant biotechnology at AstraZeneca plc prior to its
merger with Novartis to form Syngenta plc. Matthew has led the growth and
development of several technology and biotechnology companies as CEO including
Internexus Limited and Zylepsis Limited. Matthew holds a non-executive role at
Riyada Oxford Investments Limited and is a chartered accountant and a member of
CIMA.
John Rylands (aged 52), Financial Director
John originally joined EpiStem in 2002 as an investor and non-executive director
and in 2005 he took over his current role. Mr. Rylands worked at Northern
Venture Management, providing corporate finance advice to private companies
before joining EpiStem. Until 1999 he was an investor in and consultant to the
SDS group of companies. John holds a degree in Economics and Accountancy from
Manchester University and is a member of ICAEW.
Jeffrey Moore, Ph.D. (aged 47), Managing Director, Novel Therapies
Jeffrey joined EpiStem in 2005 in his current role. Prior to joining EpiStem he
had been at Phylogix, a US biotech company based in the Boston area that he had
founded in 1998. Phylogix business was based on a stem cell preservation factor
that he discovered while leading a team at ImClone Systems Incorporated. Until
1992, when he joined ImClone, he had held two postdoctoral fellowships at
different research institutes, DNAX Research Institute of Molecular and Cellular
Biology, Inc. and the Walter and Eliza Hall Institute of Medical Research.
Throughout his career Jeffrey has kept a strong interest in stem cell regulation
and the potential commercial application of these factors. He holds a Ph.D. from
George Washington University.
Professor Chris Potten, Ph.D. (aged 67), Chief Scientific Adviser
Chris is a co-founder of EpiStem and the Company capitalises on the results of
the research that was produced by him and his team at the Paterson Institute
over the past three decades. While not involved in the day to day management of
EpiStem Chris keeps a strong interest in the progress and success of EpiStem and
prior to Admission has been its biggest individual shareholder.
Catherine Booth, Ph.D. (aged 41), Managing Director, Contract Research Services
Catherine is a co-founder of EpiStem and prior to starting EpiStem she worked
for 10 years with Professor Chris Potten at the Paterson Institute. While at the
Paterson Institute she developed many of the pre-clinical assays that today are
the core of EpiStem's Contract Research Services Division. Catherine received
her Ph.D. from the Emmanuel College, University of Cambridge.
Gerard Brady, Ph.D. (aged 50), Research Director, Novel Therapies
Gerard joined EpiStem shortly after its inception from Manchester University
where he was a lecturer and was previously a Zeneca Fellow. He brought with him
important technological expertise gained through working on blood stem cells. Of
particular importance to EpiStem is his expertise in single cell gene analysis,
which enables the examination of rare cells such as stem cells. Gerard
previously held scientific positions in Canada and at EMBL, Heidelberg.
Robert Nolan (aged 64), Non-executive Director
Robert has been a Non-executive Director of the Company since 2004. He brings
with him a wealth of expertise in partnering and licensing negotiations both
with small biotech and large pharmaceutical companies. Prior to his retirement
he was Director, Global Licensing at AstraZeneca. He is also a non-executive
Director of f2g Ltd.
The Group employs 29 staff in total all of which are based at the Company's
premises in The Incubator Building, 48 Grafton Street, Manchester M3 9XX.
Details of the Placing
Under the Placing the Company is issuing 807,628 New Ordinary Shares. The
Placing Shares represent approximately 12.35 per cent. of the Enlarged Share
Capital immediately on Admission, on the assumption that all of the Placing
Shares are issued. The Placing is conditional upon, among other things,
Admission. The Placing is not being underwritten.
Application has been made for the existing issued Ordinary Shares (including the
Placing Shares and the Preflotation Fundraising Shares) to be admitted to
trading on AIM. Dealings on AIM are expected to commence on 4 April 2007 in
respect of the First Admission, 10 April 2007 in respect of the Second Admission
and 11 April 2007 in respect of the Third Admission. In aggregate, the Directors
will be interested in 33.40 per cent. of the Enlarged Share Capital following
Admission, on the assumption that all of the Placing Shares are issued and
completion of the Selling Shareholder Placing.
Reasons for Admission and the Placing
The Company intends to raise approximately £2,558,058 net of expenses pursuant
to the Placing and the Preflotation Fundraising. The net proceeds of the Placing
and the Pre-flotation Fundraising will be used to:
• fund further research to enable the commercial partnering of
therapeutic candidate(s) from the Novel Therapies Division;
• fund the development of the Company's diagnostic platform based on
epithelial stem cell biology; and
• general corporate purposes.
The Directors also believe that the profile of the Group will be significantly
enhanced as a UK listed public company. The Directors believe that Admission
will:
• enhance the Group's status;
• assist the Company in raising additional capital should this be
required; and
• provide liquidity for investors through the ability to buy and sell
Ordinary Shares.
Lock-in arrangements
Under the terms of the Placing Agreement, the Directors have undertaken that,
subject to certain limited exceptions, they will not sell or otherwise dispose
of, or agree to sell or dispose of, any of their interests in Ordinary Shares
held by them respectively until one month after the publication of the
preliminary results for the year ended 30 June 2008. In addition orderly market
arrangements apply for a period of 12 months following the expiry of the lock-in
period referred to above, whereby the Directors have undertaken to sell Ordinary
Shares through Teather & Greenwood.
Dividend Policy
In the medium term it is the Directors' intention to re-invest funds directly
into the Company rather than to fund the payment of dividends. Thereafter, the
payment of dividends will be subject to the availability of distributable
reserves whilst maintaining an appropriate level of dividend cover and having
regard to the need to retain sufficient funds to finance the development of the
Company's activities.
Employee Share Option Scheme
Immediately following Admission the Company will have granted share options and
warrants to subscribe for up to 1,374,850 Ordinary Shares representing 21.03 per
cent. of the Enlarged Share Capital. Taking this into account, an additional
458,224 Ordinary Shares remain available for reward as options under the Share
Option Schemes and any new share option schemes to be adopted by the Company in
the future. The Directors intend to introduce a Save as You Earn Share Option
Scheme and a new performance based EMI share option scheme for employees
following Admission.
Dealing arrangements
Application has been made for the issued Ordinary Shares (including the Placing
Shares and the Pre-flotation Fundraising Shares) to be admitted to trading on
AIM and it is anticipated that Admission will become effective and that dealings
will commence on 4 April 2007 in respect of the First Admission, on 10 April
2007 in respect of the Second Admission and on 11 April 2007 in respect of the
Third Admission.
This information is provided by RNS
The company news service from the London Stock Exchange D
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