ARISE-3 Phase 3 Trial Completion Expected by End of 2020

ROCKVILLE, Md., Oct. 14, 2020 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration announced today that enrollment in the 700-patient, phase 3 clinical trial for dry eye syndrome (ARISE-3) is expected to be completed in November, 2020, and that the estimated study completion date and collection of data for the primary and secondary outcome measures will be in December, 2020.  Additional information may be found on www.clinicaltrials.gov.

"We are pleased ARISE-3 is near completion, despite the challenges posed by the COVID-19 pandemic.  This phase 3 trial is a critical milestone in the development of RGN-259 for dry eye syndrome and crucial to our future success.  We look forward to announcing top line results as soon as practicable upon completion of the trial," stated J.J. Finkelstein, president and chief executive.

About ReGenTree, LLC

ReGenTree is a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc., specifically to develop RGN-259 in both the USA and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015 and has completed two phase 3 studies in the U.S. for dry eye: ARISE-1 and ARISE-2. Currently, the company is conducting a third phase 3 study (ARISE-3) for dry eye syndrome.  In addition to dry eye, the ReGenTree has successfully completed a phase 3 study (SEER-2) for neurotrophic keratopathy (NK), an orphan indication in ophthalmology. For additional information about ReGenTree, please visit www.regentreellc.com.

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/TBI and dermal indications, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and the EU, and has patents and patent applications covering its products in many countries throughout the world.  RGN-259, the Company's ophthalmic eye drop, is currently in phase 3 development in the U.S. for dry eye syndrome and neurotrophic keratitis.  The Company is also considering initiating a program to evaluate RGN-352, an injectable formulation of Tβ4 for the treatment of patients with COVID-19, if it is able to obtain the requisite funding. The Company previously successfully completed phase 1 with RGN-352.

Forward Looking Statements

Any statements in this shareholder letter 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. Forward-looking statements in this press release include, but are not limited to, competitive products, statements from us or our joint venture regarding strategic and research partnerships, status of clinical trials, regulatory applications and approvals, the development and value of our drug candidates, and the use of our drug candidates to treat various conditions. All forward-looking statements are expectations and estimates based upon information obtained and calculated by the Company at this time and are subject to change. Moreover, there is no guarantee any clinical trial will be successful or confirm previous clinical results. 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, 2019, 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 shareholder letter 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.