RegeneRx Announces New Board Member

ROCKVILLE, Md., March 21, 2019 /PRNewswire/ --RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (“the Company” or “RegeneRx”), 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 (Tβ4) 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 Asia through 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 Tβ4-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 Tβ4-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.

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. Any 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. There can be no assurance that any current or future animal studies or clinical trials, sponsored by the Company or its licensees, will start on time, be completed within a projection time-frame, or result in future value or approved products. There can also be no assurance that the Company or its licensees will apply for an NDA in the future or that if the Company or a licensee applies for an NDA, that it will be accepted by the FDA and/or that the product candidate will be approved for marketing in the U.S. or any other country. There can be no assurance that RegeneRx will be able to finance operations on a continual basis or through the completion of clinical development of its products by its licensees. Please view these and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” section of the annual report on Form 10-K for the year ended December 31, 2017, and subsequent quarterly reports filed on Form 10-Q, 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 specifically disclaims any obligation to update this information as a result of future events or otherwise, except as required by applicable law.

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SOURCE RegeneRx Biopharmaceuticals, Inc.