MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--May. 14, 2012-- Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the "Company"), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced financial results for three month ended March 31, 2012, and the filing with the U.S. Securities and Exchange Commission ("SEC") of the Company's Quarterly Report on Form 10-Q. The Form 10-Q includes audited consolidated financial statements containing the information highlighted below, as well as additional information regarding the Company. The Form 10-Q is available at www.sec.gov and at www.medgenics.com.

First Quarter Financial Results

Gross research and development ("R&D") expense for the first quarter of 2012 increased to $1.59 million from $1.17 million for same period in 2011. This increase is due to increased use of materials and sub-contractors in anticipation of four planned trials, including two Phase II trials of EPODURE™ one in Israel and one in the U.S., and two trials of INFRADURE™ in Israel; and an increase in R&D headcount.

General and administrative expense for the first quarter of 2012 was $1.36 million compared with $0.78 million for the first quarter of 2011, primarily due to higher legal and professional services fees and to increased activities in the U.S. as part of forthcoming clinical trials.

Financial expense for the first quarter of 2012 increased to $0.80 million from $0.11 million for the same period in 2011; and financial income for the first quarter of 2012 decreased to $0.02 million from $1.70 million in the same period of 2011. Both of these changes are mainly a result of changes in valuation of the warrant liability.

The Company reported a net loss for the first quarter of 2012 of $2.71 million or $0.28 per share, compared with a net loss for the first quarter of 2011 of $0.34 million or $0.06 per share.

As of March 31, 2012Medgenics had cash and cash equivalents of $2.59 million, compared with $5.00 million as of December 31, 2011. Net cash used in operating activities in the first quarter of 2012 was $2.36 million compared with $1.53 million used in the first quarter of 2011.

"We have executed well on our plan, progressing as forecasted, particularly on clinical and regulatory milestones. We have recently been awarded an Israeli government grant of up to an approximately $2.2 million from the Office of the Chief Scientist to advance our manufacturing process in Israel and to advance the establishment of a U.S. center to process Biopumps in a GMP facility to supply our planned clinical trial needs in the US," stated Andrew L. Pearlman, Ph.D., Chief Executive Officer of Medgenics.

About Medgenics

Medgenics is developing and commercializing Biopump™, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis and hemophilia, among others. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.

Medgenics has three long-acting protein therapy products in development based on this technology:

  • EPODURE™ to produce and deliver erythropoietin for many months from a single administration, has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for six to more than 36 months in a Phase I/II dose-ranging trial, and is about to commence a Phase IIa safety/efficacy trial in dialysis patients in Q2 2012 in Israel. An Investigational New Drug application has been filed with the FDA to initiate a Phase IIb study to evaluate the safety and efficacy of EPODURE in the treatment of anemia in dialysis patients in the U.S.
  • INFRADURE™ for sustained production and delivery of interferon-alpha for use in the treatment of hepatitis is awaiting final approval of two Phase I/II trials in Israel in hepatitis C, slated to commence in Q3 2012, and is filed for Orphan Drug Designation with the FDA to treat hepatitis D.
  • HEMODURE™ for sustained production and delivery of clotting Factor VIII therapy for the sustained prophylactic treatment of hemophilia is now in development.

Medgenics is focused on the development and manufacturing of its innovative Biopumps, aiming to bring them to market via strategic partnerships with major pharmaceutical and/or medical device companies. In addition to treatments for anemia, hepatitis and hemophilia, 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 $132 billion in 2013. Other potential applications for Biopumps include multiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity and diabetes.

Forward-looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. 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.

MEDGENICS, INC. AND ITS SUBSIDIARY

 (A Development Stage Company)

CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
March 31, December 31,
2012 2011
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 2,593 $ 4,995
Accounts receivable and prepaid expenses 1,807 1,122
Total current assets 4,400 6,117
LONG-TERM ASSETS:
Restricted lease deposits 57 52
Severance pay fund 267 259
Total long-term assets 324 311
PROPERTY AND EQUIPMENT, NET 435 434
DEFERRED ISSUANCE EXPENSES 42 -
Total assets $ 5,201 $ 6,862
March 31, December 31,
2012 2011
Unaudited
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables $ 824 $ 903
Other accounts payable and accrued expenses 1,146 1,156
Total current liabilities 1,970 2,059
LONG-TERM LIABILITIES:
Accrued severance pay 1,422 1,328
Liability in respect of warrants 1,274 478
Total long-term liabilities 2,696 1,806
Total liabilities 4,666 3,865
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:
Common stock - $0.0001 par value;

100,000,000 shares authorized; 9,772,725 and 9,722,725 shares issued and outstanding at March 31, 2012 and December 31, 2011, respectively

1 1
Additional paid-in capital 52,751 52,501
Deficit accumulated during the development stage (52,217 ) (49,505 )
Total stockholders' equity 535 2,997
Total liabilities and stockholders' equity $ 5,201 $ 6,862

MEDGENICS, INC. AND ITS SUBSIDIARY

 (A Development Stage Company)

CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Three months ended March 31,

Period from
January 27, 2000
(inception)
through
March 31,

2012 2011 2012
Unaudited
Research and development expenses $ 1,592 $ 1,174 $ 32,034
Less - Participation by the Office of the Chief

Scientist

(1,022 ) - (6,315 )
U.S. Government grant - - (244 )
Participation by third party - - (1,067 )
Research and development expenses, net 570 1,174 24,408
General and administrative expenses 1,359 780 27,757
Other income:
Excess amount of participation in research and development from third party - - (2,904 )
Operating loss (1,929 ) (1,954 ) (49,261 )
Financial expenses (801 ) (106 ) (3,682 )
Financial income 18 1,722 373
Loss before taxes on income (2,712 ) (338 ) (52,570 )
Taxes on income - - 76
Loss $ (2,712 ) $ (338 ) $ (52,646 )
Basic and diluted loss per share $ (0.28 ) $ (0.063 )
Weighted average number of Common stock used in computing basic and diluted loss per share 9,753,725 5,370,270

Source: Medgenics, Inc.

Medgenics, Inc.
Dr. Andrew L. Pearlman, +972 4 902 8900
Andrew.pearlman@medgenics.com
or
LHA
Anne Marie Fields, 212-838-3777
afields@lhai.com
@LHA_IR_PR
or
Abchurch Communications
+44 207 398 7719
Adam Michael
Joanne Shears
Jamie Hooper
jamie.hooper@abchurch-group.com
or
SVS Securities plc (Joint Broker)
+44 207 638 5600
Alex Mattey
Ian Callaway
or
Nomura Code Securities (Joint Broker)
Jonathan Senior, +44 207 776 1219


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