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RGN News RegeneRx Biopharmaceuticals, Inc. Reports 2006 Year-End Results

BETHESDA, Md.--(BUSINESS WIRE)--REGENERX BIOPHARMACEUTICALS, INC. (AMEX: RGN), announced today the results for its year ended December 31, 2006. The company reported a net loss of $8.3 million or $0.21 per share for the year ended December 31, 2006, compared with a net loss of $5.4 million or $0.15 per share for the year ended December 31, 2005. For the fourth quarter 2006 the company’s net loss was $1.6 million or $0.04 per share. The net loss resulted primarily from the continued research and development expenditures related to ongoing Phase II clinical trials to study the company’s product (Tβ4) for the treatment of chronic dermal wounds, research and development efforts related to its technology platform, scale-up manufacturing and formulation efforts related to two anticipated clinical trials in the ophthalmic and cardiovascular fields, and administrative costs associated with managing the company’s projects. RegeneRx had approximately $17 million in cash and short-term investments at December 31, 2006.

Highlights over the past year include:

• Completion of two new sterile formulations and manufacturing for ophthalmic and cardiovascular clinical trials;
• Establishment of larger and more efficient production quantities of bulk Tβ4;
• Publication of several important scientific papers and abstracts in the ophthalmic and cardiovascular fields;
• Receipt of the first 50% of a $545,000 orphan drug grant for epidermolysis bullosa from the U.S. FDA;
• Issuance of additional patents for Tβ4 and submission of several new patent applications related to our technology platform;
• Initiation of several collaborative research and development relationships with major research institutions in the U.S. and abroad;
• Announcements that two collaborators confirmed that administration of Tβ4 improved cardiac function and survival in animal models after ischemic injury as reported in Nature;
• Completion of two private equity financings totaling approximately $17 million; and
• Filing of two INDs in the cardiovascular and ophthalmic fields.

“We were very pleased with our progress in 2006 as we moved our clinical program forward and completed two new drug formulations and finished manufacturing for our ophthalmic and cardiovascular clinical trials. We were also the beneficiary of a substantial amount of exciting new scientific data related to our technology platform that continues to support our clinical trial program,” said J.J. Finkelstein, president and chief executive officer. “In addition to the dermal trials, we look forward to initiating our cardiovascular and ophthalmic trials as soon as the recently filed INDs are cleared by the FDA.”

“During 2006 we raised approximately $17 million in gross proceeds from the sale of common stock, all of which remained at the end of 2006. These resources have been critical as they provide us with sufficient operating capital to implement our clinical strategy and fund operations through the second quarter of 2008,” stated Neil Lyons, RegeneRx’s chief financial officer.

Conference Call

The company will host a conference call and webcast today at 3:00 p.m. Eastern Time to discuss the results and its outlook for 2007. The call will be accessible by telephone and through the Internet. Interested individuals are invited to access the call by dialing 800-811-8845. To participate on the webcast, log on to the company’s website at www.regenerx.com (go to the investor relations home page) 15 minutes before the call to download software, if necessary.

For those unable to listen to the call live, a taped rebroadcast will be available via telephone beginning approximately two hours after completion of the live call on April 2, 2007 through April 9, 2007. To access the replay, dial 888-203-1112 and request reservation number 3491428. A replay of the call will also be available on the Internet at www.regenerx.com for 30 days.

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 Tβ4, a 43 amino acid peptide, in part, under an exclusive world-wide license from the National Institutes of Health. Preliminary research suggests that Tβ4 may prove efficacious for multiple indications; therefore, RegeneRx is developing Tβ4 as the cornerstone of its therapeutic platform. The technology platform has many potential applications in both the pharmaceutical and consumer products sectors. RegeneRx holds nearly 60 world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, cardiac and neurological injuries, septic shock and several consumer product areas. RegeneRx is currently sponsoring three Phase 2 chronic dermal wound healing clinical trials and has additionally targeted ophthalmic and cardiac trials in 2007 as part of its ongoing clinical development program.

The RegeneRx Technology Platform

Tβ4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class drug candidate that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. One of Tβ4'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 Tβ4 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 Tβ4 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 Tβ4 protects heart tissue following a myocardial infarction (heart attack) and can regenerate coronary vessels in laboratory animals. Abstracts of scientific papers related to Tβ4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.

Safe Harbor Statement

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 of Tβ4 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 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-K. 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.