Contact Information:

At RegeneRx:
J.J. Finkelstein
jjfnk@regenerx.com
301.280.1992

At the Financial
Relations Board:
Tim Grace
Media Inquiries
312.640.6741

Leslie Loyet
Analyst Inquiries
312.640.6672

Kathy Waller
General Inquiries
312.640.6696

RegeneRx Biopharmaceuticals, Inc. (OTCBB: RGRX), announced today the results of its year ended December 31, 2003. The Company had a net loss of $1,659,875 or $0.06 per share for the year ended December 31, 2003, compared with net loss of $1,404,547 or $0.05 per share for the year ended December 31, 2002. The net loss for 2003 resulted primarily from the continued research and development expenditures related to the conduct of Phase I clinical trials to study the Company's product, Thymosin Beta 4 (Tß4) for the treatment of chronic dermal wounds, and the administrative costs associated with managing the Company's various projects. The approximately $1.0 million cash position at December 31, 2003 does not include the $2.3 million raised in a private offering in January 2004. The Phase I study was completed in the Fall of 2003 and the Company's Phase II clinical trials are currently scheduled for the 2nd Quarter of 2004.

Highlights for 2003, and subsequently, include:

• Completion of two private equity financings securing $4.3 million in operating capital, primarily for clinical trials and related projects, at successively higher valuations; Participation in each of these financings by Defiante Farmaceutica, Lda, a wholly owned subsidiary of the Sigma-Tau Group, a leading Italian pharmaceutical company; Successful completion of Phase I clinical trials with our Tß4 platform for chronic dermal wounds; RegeneRx's first issued wound healing patent and submission of several additional patents covering various newly identified aspects of the Tß4 platform; Scientific publications relating to Tß4 by independent research institutions and collaborators, who continued to obtain data supporting the dermal and ocular wound healing properties of Tß4; A sublicensing and supply agreement with Defiante/Sigma-Tau for the clinical development of Tß4 for certain fields of use in Europe and certain contiguous countries which, we believe, will help us broaden our platform and complement the clinical work we are undertaking in the U.S.;
• etention of the Financial Relations Board, a well-known and highly respected investor relations firm headquartered in Chicago to increase our visibility among institutional and retail investors as we enter Phase II.

"We were very pleased with our progress throughout 2003 as we began an important period in our business plan - the initiation of human clinical trials using our Tß4 platform. We continue to be encouraged with the significant body of scientific data emanating from outside, independent researchers that not only supports the scientific rationale behind our clinical work, but also helps us identify additional ways Tß4 may be used therapeutically," said J.J. Finkelstein, President and CEO. "Outsourcing key aspects of our product development efforts continues to be an effective way in which to move our technology forward without investment in substantial infrastructure and overhead. Additionally, we raised $4.3 million to fund our operations from two private placements and entered a key European partnership during 2003 through the first month of 2004."

RegeneRx is a biopharmaceutical company developing Tß4 as a platform technology for the treatment of acute and chronic wounds and for the treatment of a variety of human diseases involving tissue and organ repair under an exclusive world-wide license from the NIH. The Company holds several patents related to the technology and has numerous world-wide patent applications pending. RegeneRx successfully completed Phase I human clinical trials with Tß4 for the treatment of chronic dermal wounds and expects Phase II trials to begin in the second quarter of 2004.

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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