RegeneRx Biopharmaceuticals, Inc. (AMEX:RGN), Bethesda, Md., has
announced results for the fourth quarter and year ended December 31,
2007. The company reported a net loss of $11.2 million or $0.24 per
share for the year ended December 31, 2007, compared with a net loss of
$8.3 million or $0.21 per share for the year ended December 31, 2006.
For the fourth quarter 2007 the company's net loss was $3.5 million
or $0.08 per share compared with a net loss of $1.6 million or $0.04 per
share for the same period in 2006.
The net loss for the fourth quarter and the year ended December 31,
2007 resulted primarily from the continued research and development
expenditures related to ongoing Phase II clinical trials to study
RGN-137, the company's product candidate for the treatment of
chronic dermal wounds, research and development efforts related to its
technology platform, scale-up manufacturing and formulation efforts
related to RGN- 259 and RGN-352 for two clinical trials in the
ophthalmic and cardiovascular fields, respectively, and administrative
costs associated with managing the company's projects.
RegeneRx's product candidates are based on thymosin beta 4 (T?4), a
synthetic copy of a naturally-occurring peptide present in all mammals.
RegeneRx has approximately $13.3 million in cash and short- term
investments to finance operations through 2008, including approximately
$8.3 million at December 31, 2007 in addition to $5.0 million received
from the issuance of common stock and warrants to purchase common stock
at the end of February 2008.
Among the highlights during 2007 were: (1) the issuance of several
important patents in the U.S. and abroad, most notably the first U.S.
patent relating to the National Institutes of Health's dermal wound
healing research; (2) new scientific papers showing T?4's positive
effects on corneal wound healing and down-regulation of key inflammatory
molecules that are up-regulated when a wound occurs; (3) a presentation
at the American Heart Association meeting in Orlando, Florida by an
independent research team that, RegeneRx believes, is significant
because this was the first time the cardioprotective effects of T?4 have
been shown in a porcine (pig) ischemia-reperfusion model, confirming and
elaborating the results originally published in Nature by Dr. Deepak
Srivastava and his colleagues in 2004; and (4) the first ever
International Symposium on Thymosins in Health and Disease was held in
Washington, D.C. bringing together the leading researchers and
thought-leaders from the U.S., Europe and Asia to report on the advances
being made in scientific and clinical development of the thymosins.
The papers were published in the Annals of the New York Academy of
Sciences and a subsequent review of the meeting was reported in Science.
J.J. Finkelstein, president and chief executive officer commented,
"This is a very important and exciting time at RegeneRx. We are
making significant progress with our clinical trials and our research
and development efforts. While it has been challenging for a small
biotechnology company, I am proud that RegeneRx has been able to sponsor
five clinical trials, four of which are in Phase II, using three
distinct drug formulations. We are, therefore, pleased to be in the last
and highest dosing group for our two Phase II dermal trials in the U.S.
and Europe and expect to finish patient enrollment in the second quarter
of 2008 and report data in the third quarter this year. We also expect
to complete enrollment of our Phase Ia parenteral trial (injectable
administration of RGN-352 to support cardiovascular indications) in the
second quarter of 2008 and report data in the latter part of the third
quarter this year. The Phase II ophthalmic study is targeted for
complete enrollment in the fourth quarter of 2008, and our Phase II
epidermolysis bullosa trial in fourth quarter of 2008 or first quarter
of 2009, with reporting of data as soon as practicable thereafter. Our
team is very excited about the prospects of these trials and we look
forward to providing appropriate updates on our progress."
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of novel
molecules to accelerate tissue and organ repair. Currently, RegeneRx is
developing three product candidates, RGN-137, RGN-259 and RGN-352 for
dermal, ophthalmic, and cardiovascular wound healing, respectively.
These product candidates are based on T?4, a 43-amino acid peptide, in
part, under an exclusive world-wide license from the National Institutes
of Health. Preliminary research suggests that T?4 may prove efficacious
for multiple indications; therefore, RegeneRx is developing several
product candidates as part of a broad therapeutic platform. RegeneRx
holds over 60 world-wide patents and patent applications related to
dermal, ocular, and internal wounds and tissue repair, cardiac and
neurological protection and injuries, septic shock and several consumer
product areas. RegeneRx is currently sponsoring three Phase II chronic
dermal wound healing clinical trials, a Phase II ophthalmic wound
healing clinical trial, and a Phase Ia parenteral clinical trial in
support of systemic administration of RGN-352 for its cardiovascular
clinical development program.
The RegeneRx Technology Platform T?4 is a synthetic version of a
naturally occurring peptide present in virtually all human cells. It is
a first-in-class product candidate that promotes endothelial cell
differentiation, angiogenesis in dermal tissues, keratinocyte migration,
collagen deposition, and down-regulates inflammation. One of T?4's
key mechanisms of action is its ability to regulate the cell-building
protein, actin, a vital component of cell structure and movement. Of the
thousands of proteins in cells, actin represents up to 10% of the total
protein and, thus, plays a major role in the physiology of the cell.
RegeneRx has identified several molecular variations of T?4 that may
affect the aging of skin, among other properties, and could be important
candidates as active ingredients in pharmaceutical and consumer
products. Researchers at the National Institutes of Health, and at other
academic institutions throughout the U.S., have published numerous
scientific articles indicating that T?4 is effective in accelerating
dermal and corneal wound healing in several animal models, under a
variety of conditions. In two articles published in the scientific
journal, Nature, researchers found that T?4 protects heart tissue
following a myocardial infarction and can regenerate coronary vessels in
laboratory animals. A recent abstract presented at an American Heart
Association meeting showed that in a porcine model
For more information, visit http://www.regenerx.com or call
301/280-1992.
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