Medgenics(Regs) (LSE:MEDG)
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Medgenics (AIM:MEDG), the US-incorporated biopharmaceutical company
developing the 'Biopump’ sustained-action
protein therapy for the treatment of chronic diseases, is pleased to
announce its first full year results since the admission of the Company’s
shares to trading on AIM. The Annual Report and Accounts of the Company
and its subsidiary (the Group) for the year ended 31 December 2007 will
be posted to shareholders during the week commencing 23 June 2008 and
will be available on the Company’s website (www.medgenics.com).
Key Points for the period:
Successful fund raising and admission to AIM on 4 December 2007,
raising gross proceeds of £3.28 million (US
$6.72 million)1.
The proceeds of the fund raising are being used to fund the second
clinical trial, which will be a Phase I/II safety and efficacy study
of its lead sustained-action protein therapy to treat anaemia, and to
further develop and test its Biopump platform technology and products.
Increased consolidated net assets of $3.3 million (2006: $987,000)
Increased cash on hand at 31 December 2007 of US $4.7 million (2006:
$1.6 million).
Net loss after tax of US $3.9 million (2006: US $2.6 million).
Highlights since admission:
Appointment of Lord Steinberg as Non-Executive Director in February
2008.
Application submitted for approval of the Phase I/II trial of its
EPODURE protein therapy to the Israel Ministry of Health (MoH) in
February 2008.
Appointment of Dr. Ehud Shoshani, former CEO of Quintiles, Israel, as
Vice President of Clinical Affairs and addition of key scientific and
engineering personnel in accordance with its plan and preparation for
the Phase I/II clinical trial for EPODURE.
Successful manufacture of the key 'gutless' adenoviral vector in a GMP
(Good Manufacturing Practice) vector production facility. This vector
will be used to prepare EPODURE Biopumps capable of producing
sufficient daily amounts of erythropoietin (EPO) to meet the Group's
requirements for use in its forthcoming Phase I/II clinical trial in
anaemic patients with chronic kidney disease.
Completion of the design, fabrication and evaluation of the key
proprietary patient contact devices that will be used both to enable
Medgenics to conduct its current Phase I/II clinical trial and to
assist in future clinical trials.
Successful move to a new larger facility, allowing the corporate and
R&D operations to be housed in one location.
Commenting on the results Dr. Andrew Pearlman, Chief Executive Officer
of Medgenics, said:
“2007 was an important year for Medgenics,
culminating in our successful fund raising and admission to AIM in
December 2007 in what was and still remains a turbulent economic
climate. Since then, we have made excellent progress with our
preparations for the start of the Phase I/II safety and efficacy
clinical trial of our EPODURE Biopump for treating anaemia. We remain on
track to begin this important trial mid-year and are expecting further
guidance from the Israel Ministry of Health following its meeting on 1
July 2008. Key initial safety and efficacy data for EPODURE is expected
3-5 months after the trial commences. The next few months, therefore,
will be very exciting for the Company and I look forward to reporting
further progress over the coming weeks and months.”
1 Exchange rate: £1.00
= $2.06 as at 26 November 2007
NOTES TO EDITORS:
Medgenics, Inc. is a clinical-stage biopharmaceutical company developing
its unique tissue-based Biopump platform technology to provide
sustained-action protein therapy for the treatment of a range of chronic
diseases.
Medgenics currently has two products in development based on this
technology:
EPODURE – producing erythropoietin (EPO) to
treat anaemia
INFRADURE – producing interferon-alpha (IFN-?)
to treat hepatitis C
The Company has demonstrated proof of principle of the Biopump treatment
procedure in a clinical trial using a short-acting version of EPODURE in
anaemic patients. A long-acting version of EPODURE, designed to produce
and deliver a therapeutic dose of EPO steadily for six months or more,
is scheduled to enter a Phase I/II trial in mid-2008. The Company plans
to follow with a clinical trial of INFRADURE in 2009.
Medgenics intends to develop its innovative products and bring them to
market via multiple strategic partnerships with major pharmaceutical
and/or medical device companies, starting with EPODURE and INFRADURE.
Beyond these, Medgenics plans to develop and/or out-license a pipeline
of future Biopump products targeting the large and rapidly growing
global protein therapy market, which is forecast to reach US $87 billion
by 2010. Other potential areas include multiple sclerosis (interferon-?),
haemophilia (Factor XIII), paediatric growth hormone deficiency (human
growth hormone) and diabetes (insulin).
Founded in 2000, Medgenics is a US-incorporated company with major
operations in Misgav, Israel. Medgenics was admitted to AIM in December
2007 (AIM:MEDG).
www.medgenics.com
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, which include all
statements other than statements of historical fact, including (without
limitation) those regarding the Company’s
financial position, business strategy, plans and objectives of
management for future operations. These statements relate to future
events, prospects, developments and strategies. Forward-looking
statements are sometimes identified by their use of the terms and
phrases such as “estimate,”
“project,” “intend,”
“forecast,” “anticipate,”
“plan,” “planning,
“expect,” “believe,”
“will,” “will
likely,” “should,”
“could,” “would,”
“may” or the
negative of such terms and other comparable terminology. All such
forward-looking statements are based on current expectations and are
subject to risks and uncertainties. Should any of these risks or
uncertainties materialize, or should any of the Company’s
assumptions prove incorrect, actual results may differ materially from
those included within these forward-looking statements. Accordingly, no
undue reliance should be placed on these forward-looking statements,
which speak only as of the date made. The Company expressly disclaims
any obligation or undertaking to disseminate any updates or revisions to
any forward-looking statements contained herein to reflect any change in
the Company’s expectations with regard
thereto or any change in events, conditions or circumstances on which
any such statements are based. As a result of these factors, the events
described in the forward-looking statements contained in this release
may not occur.
FULL ANNOUNCEMENT AND FINANCIAL INFORMATION CAN BE VIEWED AT: www.medgenics.com