RegeneRx Biopharmaceuticals Appoints Alessandro Noseda to Board

3/21/19

RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced the appointment of Alessandro Noseda M.D. to the Company's Board of Directors, effective April 1, 2019. He will be the sixth member of the Company's Board.

Dr. Noseda is the Chief Scientific Officer of Leadiant Biosciences S.p.A. and has extensive scientific and medical experience in the global development of new medical technologies and drug products. He has held numerous managerial positions with the R&D and marketing organizations of multinational pharmaceutical companies during his career. Previously, Dr. Noseda was the Director of Scientific Office and Strategic Alliances with Sigma-Tau, where he managed key R&D projects and was involved in creating partnerships with Novartis and Debiopharm, among others. He has also been Chief Executive Officer of Leadiant Biosciences SA (formerly Sigma-tau Research Switzerland) from 2007 to 2017. While at Sigma-Tau and Leadiant, he developed proprietary technologies and guided the company through development of orphan drug designations and registration of new medical products. Dr. Noseda has served on the Board of Directors of numerous private biotech companies.

"We are pleased Dr. Noseda has joined our Board of Directors. We believe his expertise will enhance our ability to develop additional strategic and commercial partners in the future, while also helping us manage our current partnerships. As we get closer to commercialization with our current product candidates, we have substantial territories that are yet unlicensed and look forward to Dr. Noseda's guidance in helping identify new opportunities," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (T?4) and its constituent fragments, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world.

RegeneRx, through its U.S joint venture, ReGenTree LLC, sponsored its second Phase 3 clinical trial (ARISE-2) in approximately 600 patients with dry eye syndrome (DES) and reported positive clinical results with no safety issues. ReGenTree recently initiated ARISE-3, a follow-up Phase 3 trial in 700 patients with DES designed to confirm the positive results from ARISE-2. ReGenTree is also sponsoring a 46-patient Phase 3 clinical trial in patients with neurotrophic keratopathy (NK). Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asiathrough RegeneRx's two Asian partnerships. RGN-259 has been designated an orphan drug in the U.S. for the treatment of NK.

RGN-352, the Company's T?4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue disorders such as peripheral neuropathy, multiple sclerosis and traumatic brain injuries such as stroke. It may also have applications in patients with severe septic shock.

RGN-137, also designated an orphan drug in the U.S., is the Company's T?4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition. The Company's licensee, GtreeBNT, has initiated a small, open clinical trial in the U.S. for this indication.

For additional information about RegeneRx please visit www.regenerx.com.

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