Medgenics Announces Preliminary Results for the Year Ended 31 December 2007
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MISGAV, Israel & LONDON--(Business Wire)--
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 GBP 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: GBP 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-alpha) 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-beta), 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
Medgenics, Inc.
Dr. Andrew L. Pearlman, +972 4 902 8900
or
Citigate Dewe Rogerson
Dr. Mark Swallow, +44 207 638 9571
Jonathan Shillington, +44 207 638 9571
(Global Consulting Group)
or
Blomfield Corporate Finance Limited
James Pinner or Alan MacKenzie, +44 207 489 4500
Copyright Business Wire 2008
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