Company Overview

RegeneRx is a publicly traded, clinical-stage, biopharmaceutical company engaged in the design, research and development of novel peptides targeted at diseases with unmet medical needs. RegeneRx’s mission is to research and develop novel pharmaceuticals that protect and repair tissue and organ damage caused by disease, trauma or other pathology.

RegeneRx acquired the rights to a novel peptide from the NIH in 1999. This intellectual property for Thymosin Beta 4 (Tβ4) allowed the company to direct its focus on tissue protection and repair in multiple disease indications.

RegeneRx’s management team is focused on moving three distinct Tβ4-based drug candidates through the clinic: RGN-137, RGN-259 and RGN-352. RegeneRx also holds over 60 issued patents or filed patent applications worldwide in order to enable and protect multiple indications and applications for its product candidates.

Currently, RegeneRx has active partnerships in three major territories: the U.S., China and Pan Asia. Our partners have been moving forward and making significant progress in each territory with RGN-259 and are prepared to initiate their clinical trials programs this year (2015). In each case, the cost of development is being borne by our partners with no financial obligation for RegeneRx. Patient accrual, treatment, and follow-up for the ophthalmic trials are relatively fast, as opposed to most other clinical efforts, so data should be forthcoming in months, not years, after patients begin enrollment. We, therefore, should be able to maintain our existing operations at the current level while we await results from these trials and continue to seek additional partnership opportunities.

We still have significant clinical assets to develop, primarily RGN-352 (injectable formulation of Tβ4 for cardiac and CNS/PNS disorders) in the U.S., Pan Asia, and Europe, and RGN-259 in the EU. Our goal is to wait until the results are obtained from the current ophthalmic clinical trials before moving into the EU with RGN-259. We intend to continue to develop RGN-352, either by obtaining grants to fund a Phase IIa clinical trial in the cardiovascular or central nervous system fields or finding a suitable partner with the resources and capabilities to develop it as we have with RGN-259.