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, 2012 Medgenics 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 fromJanuary
27, 2000(inception)throughMarch
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
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