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REGENEREX REPORTS 2007 4TH QTR NET LOSS OF $3.5 MILLION.


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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Publication:Biotech Financial Reports
Article Type:Financial report
Date:May 1, 2008
Words:1066
Previous Article:NEOPHARM REPORTS 2007 4TH QTR NET LOSS OF $1.1 MILLION.(Financial report)
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