Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG)
(the “Company”), the developer of Biopump™, a novel technology for
the sustained production and delivery of therapeutic proteins in
patients using their own tissue, today announced financial results
for three and six months ended June 30, 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
unaudited 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.
Second Quarter Financial Results
Gross research and development (“R&D”) expense for the
second quarter of 2012 increased to $1.64 million from $1.54
million for same period in 2011. Higher R&D expense is due to
an increase in the use of materials and sub-contractors in
connection with preparations for the Company’s planned Phase II
EPODURE clinical trials in Israel and the U.S., preparations for
the trials of INFRADURE in Israel and an increase in R&D
personnel. Net R&D expense for the 2012 second quarter was
$1.18 million compared with net R&D expense of $1.04 million
for the prior year’s second quarter.
General and administrative expense for the second quarter of
2012 was $2.77 million compared with $1.05 million for the second
quarter of 2011, reflecting higher legal and professional services
fees, increased activities in the U.S. and stock-based compensation
expenses related to shares granted to consultants and to the newly
appointed Chairman of the Board.
Financial expense for the second quarter of 2012 increased to
$2.97 million from $0.23 million for the same period in 2011,
mainly a result of changes in valuation of the warrant liability.
Financial income for the second quarter of 2012 increased to
$17,000 from $4,000 in the same period of 2011.
The Company reported a net loss for the second quarter of 2012
of $6.91 million or $0.69 per share, compared with a net loss for
the second quarter of 2011 of $2.32 million or $0.26 per share.
“The past several months have been transformative for Medgenics
and featured a number of accomplishments delivering key milestones
in our 2012 plan, and enhancing Medgenics’ ability to move forward
on strategic priorities,” stated Andrew L. Pearlman, Ph.D., Chief
Executive Officer of Medgenics. “We substantially advanced our
clinical development program for EPODURETM and INFRADURETM in both
the U.S. and Israel, launched our first U.S. Biopump processing
center, expanded our management team with seasoned professionals
and strengthened our balance sheet to provide the financial support
to allow us to continue to execute to our plan. These are greatly
augmented by the addition of our new Chairman, Dr Sol Barer, whose
accomplishments and experience will significantly help accelerate
the company’s efforts towards execution of our strategic plan. We
look forward to building on the momentum of the first half of the
year, particularly with important clinical progress in the months
to come.”
Six Month Financial Results
Gross R&D expense for the six months ended June 30, 2012 was
$3.23 million, up from $2.72 million for the same period in 2011.
For the six months ended June 30, 2012, net R&D expense
decreased to $1.75 million from $2.22 million for the comparable
prior-year period due to the participation by the Israeli Office of
the Chief Scientist of $1.49 million in the 2012 period compared
with $0.50 million for the 2011 period, which was partially offset
by higher gross R&D expenses as detailed above. General and
administrative expense for the first six months of 2012 was $4.13
million compared with $1.83 million for the first six months of
2011. The Company’s net loss for the first six months of 2012 was
$9.66 million or $0.98 per share, compared with a net loss of $2.66
million or $0.37 per share for the same period of 2011.
Medgenics ended the second quarter of 2012 with $9.04 million in
cash and cash equivalents, compared with $5.00 million as of
December 31, 2011. For the six months ended June 30, 2012, the
Company used $4.34 million in net cash to fund operating
activities, compared with $3.00 million for the six months ended
June 30, 2011. In June 2012 the Company raised $9.50 million of
gross proceeds (approximately $8.40 million, net) in a Private
Placement.
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, which
has demonstrated elevation and stabilization of hemoglobin levels
in anemic patients for periods of six months to more than 36 months
in a Phase I/II dose-ranging trial in Israel and has launched a
Phase IIa trial in dialysis patients in Israel. An Investigational
New Drug application has been cleared by 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 the Israeli Ministry of Health of two
Phase I/II trials in Israel in hepatitis C, slated to commence Q3
2012; and which received Orphan Drug Designation from the FDA for
the treatment of hepatitis D.
- HEMODURE™ for sustained production and
delivery of clotting Factor VIII therapy for the sustained
prophylactic treatment of hemophilia is 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.
CONSOLIDATED BALANCE
SHEETS U.S. dollars in thousands June 30,
December 31, 2012 2011
2011 (Unaudited) ASSETS
CURRENT ASSETS: Cash and cash equivalents $ 9,040 $
10,116 $ 4,995 Accounts receivable and prepaid expenses
1,702 1,026 1,122 Total
current assets 10,742 11,142
6,117 LONG-TERM ASSETS: Restricted lease
deposits 57 49 52 Severance pay fund 264 353
259 Total long-term assets 321
402 311 PROPERTY
AND EQUIPMENT, NET 407 378 434
Total assets $ 11,470 $ 11,922 $ 6,862
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES: Trade payables $ 917 $ 869 $ 903 Other
accounts payable and accrued expenses 1,249
1,272 1,156 Total current liabilities
2,166 2,141 2,059
LONG-TERM LIABILITIES: Accrued severance pay 1,387 1,146
1,328 Liability in respect of warrants 4,107
1,321 478 Total long-term liabilities
5,494 2,467 1,806
Total liabilities 7,660 4,608
3,865 STOCKHOLDERS' EQUITY: Common stock -
$0.0001 par value;
100,000,000 shares authorized; 11,746,251,
9,638,948 and 9,722,725 shares issued and outstanding at June 30,
2012, June 30, 2011 and December 31, 2011, respectively
1
1
1
Additional paid-in capital 62,972 51,383 52,501 Deficit accumulated
during the development stage
(59,163
)
(44,070
)
(49,505
)
Total stockholders' equity 3,810 7,314
2,997 Total liabilities and
stockholders' equity $ 11,470 $ 11,922 $ 6,862
CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in
thousands (except share and per share data) Six
months ended
June 30,
Three months ended
June 30,
Period from January 27,
2000 (inception) through
2012 2011
2012 2011 June 30, 2012
Unaudited
Research and development
expenses $ 3,231 $ 2,718 $ 1,639 $ 1,544 $ 33,673 Less -
Participation by the Office of the Chief Scientist (1,486 ) (503 )
(464 ) (503 ) (6,779 ) U.S. Government grant - - - - (244 )
Participation by third party - -
- - (1,067 ) Research and
development expenses, net 1,745 2,215 1,175 1,041 25,583
General and administrative expenses 4,133 1,832 2,774 1,052 30,531
Other income: Excess amount of participation in research and
development from third party - -
- - (2,904 ) Operating loss
(5,878 ) (4,047 ) (3,949 ) (2,093 ) (53,210 ) Financial
expenses (3,773 ) (133 ) (2,972 ) (232 ) (7,053 ) Financial income
1 1,521 17 4
755 Loss before taxes on income (9,650
) (2,659 ) (6,904 ) (2,321 ) (59,508 ) Taxes on income
8 2 8 2
84 Loss $ (9,658 ) $ (2,661 ) $ (6,912 ) $
(2,323 ) $ (59,592 ) Basic and diluted loss per share $
(0.98 ) $ (0.37 ) $ (0.69 ) $ (0.26 ) Weighted average
number of shares of Common stock used in computing basic and
diluted loss per share 9,893,072 7,212,074
10,032,760 9,033,672
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