ROCKVILLE, Md. (April 20, 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 following is a summary of the current status of ARISE-3 and ReGenTree’s response plan to the coronavirus.

The number of patients infected with the coronavirus in the United States has increased rapidly in March and the FDA has issued guidelines for the conduct of clinical trials, and the American Academy of Ophthalmology has issued recommendations to limit infections. In accordance with these guidelines and recommendations, ReGenTree and its CRO managing the trial have implemented a plan to manage the distance between patients enrolling at clinical sites for ARISE-3 and adjusting visit intervals to minimize the number of people at each location.

The ReGenTree team is also updating the clinical data collection system and modifying statistical analysis methods to minimize the potential impact of errors and omissions in clinical data due to the impact of the coronavirus. This should help reduce the time it takes to review and “clean” the patient database upon completion of patient enrollment and treatment.

Even as all 50 states in the United States have declared a state of emergency due to the coronavirus outbreak, we have recently started recruiting patients at an additional eye center located in Virginia, and are expected to register 30 to 40 patients there. Despite this difficult environment, we anticipate completing enrollment of 700 patients as planned, and are expecting to reach our interim enrollment target of 500 patients very soon.

Since our clinical trials are carried out at one site and then sequentially started at another site, we will continue to proceed with sequential initiation, but emphasize the areas where the coronavirus situation is less prevalent.

The ReGenTree team is doing its best to ensure that ARISE-3 proceeds as scheduled and more details will be announced to stockholders and investors when the next interim target is achieved.