Contact:

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

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN), a biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration in cardiovascular diseases, central nervous system injuries, ophthalmic indications and dermal wounds, announced today that it intends to offer units consisting of shares of its common stock and warrants to purchase shares of its common stock in a public offering. The number of units to be issued, the price of each unit, the portion of a common share underlying each warrant and the exercise price per warrant, as well as the size of the offering, will be determined at the time of pricing the offering. Maxim Group LLC is acting as the lead manager for this offering, with Boenning & Scattergood as co-manager. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The company plans to use the net proceeds from this proposed offering to support and fund several clinical trials, including a proposed Phase 2 clinical trial of its product candidate RGN-352 for the treatment of patients with acute myocardial infarction, an ongoing Phase 2 clinical trial of its product candidate RGN-137 in patients with the skin defect epidermolysis bullosa, compassionate use studies of its product candidate RGN-259 in patients with neurotrophic keratitis and a proposed physician-sponsored trial in patients with dry eye associated with graft versus host disease, as well as a proposed Phase 1/2 trial of RGN-352 in patients with multiple sclerosis. The company also plans to use the net proceeds for general corporate purposes, including working capital.

The offering is being made pursuant to a registration statement on Form S-1 filed today with the Securities and Exchange Commission. The registration statement has not yet become effective. The securities to be sold in the offering may not be sold, nor may any offers to buy be accepted, prior to the time the registration statement becomes effective. The offering of the securities will be made only by means of a prospectus. When available, copies of the prospectus relating to this offering may be obtained from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, or by telephone at 800-724-0761.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, units, shares of common stock or warrants. Furthermore, RegeneRx will not sell any of the units and has been advised by Maxim Group that the underwriters and their affiliates will not sell any of the units in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of the securities under the securities laws of any such state or jurisdiction.

About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tβ4, for tissue and organ protection, repair and regeneration. Currently, RegeneRx has formulated three product candidates in clinical development: RGN-137, a topically applied gel for chronic dermal wounds and reduction of scar tissue that is currently in a Phase 2 clinical trial for the treatment of epidermolysis bullosa; RGN-259, a sterile, preservative-free topical eye drop for ophthalmic indications that is currently being supported in compassionate use studies; and RGN-352, an injectable formulation for systemic delivery to treat cardiovascular diseases, central nervous system diseases, and other medical indications that require administration by injection, that has completed a Phase 1 clinical trial. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack, although recent animal research suggests that this formulation may also benefit patients with multiple sclerosis and stroke. RegeneRx has a fourth product candidate, RGN-457, which is an inhaled formulation targeting cystic fibrosis and other pulmonary diseases, in pre-clinical development. These product candidates are based on Tβ4, a synthetic copy of a 43-amino acid, naturally occurring peptide that is the subject of an exclusive worldwide license from the National Institutes of Health. In addition to the four pharmaceutical product candidates described above, RegeneRx is pursuing the commercial development of peptide fragments of Tβ4 for potential cosmeceutical use. RegeneRx holds over 60 worldwide patents and patent applications related to its product candidates.

Forward-Looking Statements
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the proposed offering and the efficacy, safety and intended utilization of our product candidates and the proposed offering. You are urged to consider statements that include the words "project," "believe," "anticipate," "plan," "expect," "estimate," "intend," "should," "would," "could," "will," "may," "potential" or the negative of those words or other similar expressions words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include market conditions and investor interest in the offering, as well as the risks and uncertainties inherent in our business, including, without limitation the risk that our product candidates do not demonstrate safety and/or efficacy in future clinical trials; risks related to our ability to obtain financing to support our operations on commercially reasonable terms; the progress, timing or success of our clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing our product candidates; regulatory developments; the size and growth potential of the markets for our product candidates and our ability to serve those markets; the scope and validity of patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" sections of the annual report on Form 10-K for the year ended December 31, 2009, filed with the SEC on March 31, 2009, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

SOURCE
RegeneRx Biopharmaceuticals, Inc.

Back To 2010 Press Release Archives