June 19, 2008
Medgenics Announces Preliminary Results for the Year Ended 31 December 2007
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).
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