March 18, 2020 Advisory: Update on Phase 3 Dry Eye Trial Amid COVID-19 Virus
ARISE-3 Trial Remains on Schedule; Planning for Contigencies if Needed

ROCKVILLE, Md. (March 18, 2020) – RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug development company focused on tissue protection, repair and regeneration, announced today that GtreeBNT, its Korean partner in the U.S. for development of RGN-259 for the treatment of dry eye disease, issued an update on the status of our U.S. phase 3 dry eye clinical trial.  The update has been summarized as follows:

Within the past 24 hours, the GtreeBNT team met with the contract research organization (CRO) managing the ARISE-3 trial, to discuss any changes or projected changes in enrollment associated with the COVID-19 virus.  They are also developing contingency plans based on future developments or restrictions enacted by the U.S. and/or World Health Organization.

GtreeBNT and our CRO continue working to achieve the goal of completing the ARISE-3 trial and obtaining results within the initial planned schedule.  To date, there has been little to no effect on the enrollment and continued treatment of dry eye patients entered into the trial.  They have discussed contingency plans that may be implemented if the COVID-19 virus begins to materially affect patient enrollment or patient treatment schedules, such as travel or other restrictions. The parties will continue to closely monitor the changing conditions in the U.S. and respond accordingly.

Thus, there have been no major disruptions or delays in ARISE-3 and, if modifications are needed in the clinical plan due to COVID-19, GtreeBNT will notify its stockholders immediately through the GtreeBNT web-site.

“I am pleased with the attention and oversight the GtreeBNT team has given to the ARISE-3 clinical trial under these extraordinary circumstances and that, to date, there has been little to no impact by the COVID-19 virus on its progress.  However, given the fast-changing circumstances surrounding the virus, there could be an impact on the ARISE-3 clinical trial in the future.  In developing contingency plans, I am confident that if any critical issues do develop, they will be addressed in an effective and well-advised manner.  If there is any material change affecting the situation, we will notify stockholders as soon as possible.  Our thoughts and prayers go out to the patients and families affected by this virus,” stated J.J. Finkelstein, president and chief executive officer.