Medgenics Announces Preliminary Results for the Year Ended 31 December 2007
June 19 2008 - 3:34AM
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 �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
Medgenics(Regs) (LSE:MEDG)
Historical Stock Chart
From Jun 2024 to Jul 2024
Medgenics(Regs) (LSE:MEDG)
Historical Stock Chart
From Jul 2023 to Jul 2024