RegeneRx


Contact:

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

or

At the Financial
Relations Board:

Analyst Inquiries:
Leslie Loyet
312.640.6672

or
General Inquiries
Kathy Waller
312.640.6696

RegeneRx Reports 2005 Year-End Results

RegeneRx Reports 2005 Year-End Results

March 31, 2006 — Bethesda, Md

RegeneRx Biopharmaceuticals, Inc. (AMEX:RGN), announced today the results of its year ended December 31, 2005. The company reported a net loss of $5.5 million or $0.15 per share for the year ended December 31, 2005, compared with a net loss of $3.3 million or $0.10 per share for the year ended December 31, 2004. For the fourth quarter the company's net loss was $2.2 million, which included a non-cash charge of $0.6 million for previously capitalized patents costs. The net loss for 2005 resulted primarily from the continued research and development expenditures related to ongoing Phase II clinical trials to study the company's product (TB4) 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 $7.6 million in cash and short-term investments at December 31, 2005. On March 16, 2006, the company further enhanced its cash position through a $7.3 million registered direct offering of common stock and has approximately $13.3 million of cash on hand as of March 31, 2006.

Highlights over the past year included:

  • Initiation of three Phase II clinical trials for dermal wound healing (patients with pressure ulcers, venous stasis ulcers, and the orphan indication, epidermolysis bullosa);
  • Substantial completion of new formulations for ophthalmic and cardiovascular clinical trials targeted for 2006;
  • Publication of several important scientific papers and abstracts by Drs. Sosne and Goldstein, among others;
  • Receipt of Frost & Sullivan 2005 Technology Innovation Award;
  • Grant of additional patents for TB4 and submission of several new patent applications related to our technology platform;
  • Listing on the American Stock Exchange and inclusion in the Russell MicroCap Index;
  • Several collaborative research and development relationships with major research institutions in the U.S. and abroad; and
  • Completion of two private equity financings for $10.8 million in 2005, in addition to our $7.3 million registered direct offering in 2006

"We were very pleased with our progress in 2005 as we continued to move our clinical program forward and substantially completed two new drug formulations for proposed clinical trials in the ophthalmic and cardiovascular fields. We were also the beneficiaries of a substantial amount of 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 our new clinical projects and will be meeting with the FDA shortly to discuss an Investigational New Drug (IND) submission for a proposed ophthalmic clinical trial, and later this year for a cardiovascular trial. It continues to be our goal to complete our dermal clinical trials in the U.S. and Europe by the end of this calendar year or the first quarter of 2007 and report the results shortly thereafter.

"Outsourcing tactical aspects of our product development efforts continues to be a cost-effective way in which to advance our research and development, without substantial investment in personnel, infrastructure, and overhead. Given our current cash position, we should have sufficient capital to implement our business plan for the next 12-18 months," stated Neil Lyons, RegeneRx's chief financial officer.

Conference Call
The company will host a conference call and webcast today at 11:00 a.m. Eastern Time to discuss the results and its outlook for 2006. The call will be accessible by telephone and through the Internet. Interested individuals are invited to access the call by dialing 800.289.0494. To participate on the webcast, log on to the company's website at www.regenerx.com (go to the investor relations home page) or www.viavid.com 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 March 31, 2006 through April 7, 2006. To access the replay, dial 888.203.1112 and request reservation number 8645794. A replay of the call will also be available on the Internet at www.regenerx.com or www.viavid.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. RegeneRx is developing TB4, in part, under an exclusive world-wide license from the National Institutes of Health. Current research suggests that TB4 may prove efficacious for multiple medical indications; therefore, the company is developing several TB4-based therapeutic products. RegeneRx holds over fifty world-wide patents and patent applications related to dermal, ophthalmic, and internal wounds and tissue repair, cardiac and neurological injuries, and septic shock. RegeneRx is currently sponsoring three Phase II chronic dermal wound healing clinical trials and has additionally targeted ophthalmic and cardiac trials in 2006 as part of its ongoing clinical development program.

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 TB4 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-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.

For more information please visit RegeneRx's web site at www.regenerx.com

                 BALANCE SHEETS
                      December 31, 2005 and 2004

                                                   December 31,
                                             -------------------------
                                                 2005         2004
                                             ------------ ------------
                           ASSETS

Current assets
  Cash and cash equivalents                  $ 4,896,143  $ 2,874,260
  Short-term investments                       2,679,693            -
  Due from related parties                         4,592       12,357
  Deferred offering costs                              -       75,884
  Other current assets                            72,894       30,338
                                             ------------ ------------

  Total current assets                         7,653,322    2,992,839

Fixed assets, net of accumulated
 depreciation of $22,918 and $10,001              54,234        2,587
Deferred patent costs net of accumulated
 amortization of $0 and $4,760                         -      293,075
Other assets                                      17,078            -
                                             ------------ ------------

  Total assets                               $ 7,724,634  $ 3,288,501
                                             ============ ============

         LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities
  Accounts payable                           $   187,666  $   426,043
  Accrued expenses                               526,461      153,879
                                             ------------ ------------

  Total current liabilities                      714,127      579,922
                                             ------------ ------------

Commitments                                            -            -

Stockholders' equity
  Preferred stock, $.001 par value per
   share, 1,000,000 authorized; no shares
   issued                                              -            -
  Common stock, par value $.001 per share,
   100,000,000 shares authorized; 37,629,024
   and 34,577,356 issued and outstanding          37,629       34,577
  Additional paid-in capital                  54,936,362   45,179,591
  Accumulated other comprehensive loss            (3,044)           -
  Accumulated deficit                        (47,960,440) (42,505,589)
                                             ------------ ------------

  Total stockholders' equity                   7,010,507    2,708,579
                                             ------------ ------------

  Total liabilities and stockholders' equity $ 7,724,634  $ 3,288,501
                                             ============ ============


                  RegeneRx Biopharmaceuticals, Inc.

                       STATEMENTS OF OPERATIONS
                Years ended December 31, 2005 and 2004

                                             Years ended December 31,
                                             -------------------------
                                                 2005         2004
                                             ------------ ------------

Revenue                                      $         -  $         -
                                             ------------ ------------

Expenses
  Research and development                     4,028,857    2,184,314
  General and administrative                   1,640,670    1,158,450
                                             ------------ ------------

Total expenses                                 5,669,527    3,342,764
                                             ------------ ------------

Operating loss                                (5,669,527)  (3,342,764)
                                             ------------ ------------
Interest income, net                             214,676       16,365
                                             ------------ ------------

Net loss                                     $(5,454,851) $(3,326,399)
                                             ============ ============


Basic and diluted net loss per common share  $     (0.15) $     (0.10)
                                             ------------ ------------

Weighted average number of common shares
 outstanding                                  36,843,609   32,909,753
                                             ============ ============

SOURCE: RegeneRx Biopharmaceuticals, Inc.

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