RegeneRx Biopharmaceuticals, Inc. Information

RegeneRx is a publicly traded, clinical-stage, biopharmaceutical company focused on tissue protection, repair and regeneration. 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’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 75 issued patents or 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. and Canada, China, and Pan Asia. Our partners have been moving forward and making significant progress in each territory with RGN-259, our ophthalmic drug candidate, and are preparing to initiate their clinical trials programs. 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 is typically forthcoming in months after patients begin enrollment. We have other 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. With respect to RGN-259, our goal is to wait until Phase 3 is completed in the U.S. before moving into the EU with RGN-259 in order to maximize value for the EU market. 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.