RegeneRx Biopharmaceuticals, Inc. (OTCBB: RGRX), announced today the results of its year ended December 31, 2002. The Company had a net loss of $1,404,547 or $0.05 per share for the year ended December 31, 2002, compared with net loss of $150,609 or $0.01 per share for the year ended December 31, 2001. The net loss for 2002 resulted primarily from the increase in research and development expenditures related to the filing of an Investigational New Drug Application (IND) in November to study the Company's product, Thymosin Beta 4 (Tß4), for the treatment of chronic dermal wounds. The IND was allowed by FDA in December 2002 and the Company's Phase 1 clinical trial is currently being initiated.

Highlights for 2002, and subsequently, include:

• Securing a prominent lead investor in our $1.7 million financing, Defiante Farmaceutica Unipossoal, L.p.a., a wholly owned subsidiary of the Sigma Tau Group, a leading Italian pharma company; Completing preclinical toxicology, pharmacology, and product formulation and stability studies required for human clinical trials for Tß4; Submitting an Investigational New Drug ("IND") application to the U.S. FDA in November; Receiving FDA allowance for the IND in December and subsequently initiating a Phase 1 clinical trial during the first quarter of 2003; Filing for Orphan Drug Status for Tß4 for the treatment of Epidermolysis Bullosa (EB); Filing multiple follow-on patents for Tß4; Publication of several key scientific papers related to Tß4;
• Presentation of Tß4 data at key scientific meetings around the world.

"We are very pleased with our progress throughout 2002 and have accomplished a tremendous amount with the expenditure of relatively little capital. We eagerly await results of our clinical trials program and to ultimately determine the efficacy of Tß4 for the treatment of chronic dermal wounds, as well as for a number of other types of wounds and tissue damage for which this molecule may be particularly useful," said J.J. Finkelstein, President and CEO. "Outsourcing key aspects of our product development efforts has provided a very effective way in which to rapidly move our technology forward without investment in substantial infrastructure and overhead. However, as with most early stage biopharmaceutical companies, we will need to raise additional capital or enter partnerships in certain territories to fund expanded clinical trials and continue operations at the current level. We have made this a high priority over the coming months."

RegeneRx is a biopharmaceutical company, founded in 1982, whose primary focus is on products to treat acute and chronic wounds. The Company has initiated Phase 1 human clinical trials for dermal wounds and the first subjects are expected to be enrolled shortly.

Tß4 is a naturally occurring 43-amino acid peptide present in virtually all human cells. It has been the subject of a significant amount of research at the NIH and a number of other academic institutions, and has been reported to be effective in the repair of dermal and corneal wounds in numerous animal models under a variety of conditions. Tß4 represents a new class of wound healing drug and is different from other wound repair factors, such as growth factors, in that it promotes endothelial and keratinocyte cell migration, down regulates a number of inflammatory cytokines and chemokines, and has a very low molecular weight, allowing it to diffuse relatively long distances through tissues. One of its key mechanisms of action is Tß4's ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton. Further, it has been delivered both topically and systemically with both routes of administration showing similar activity for dermal wounds.

The information in this press release may include certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements concern the Company's current expectations regarding future events, including the ongoing and prospective development and commercialization of Tß4 and possible future benefits to the Company, its shareholders, and patients. Due to the nature of product development and the regulatory approval process, the forward-looking statements contained in this press release are subject to risks and uncertainties, including those reflected in the Company's filings with the Securities and Exchange Commission, particularly its most recent Annual Report on Form 10-KSB. The Company assumes no obligation to update or revise any forward-looking statements made herein or any other forward-looking statements made by the Company.

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