RegeneRx Comments on ARISE-3 Clinical Trial

ROCKVILLE, Md., Jan. 26, 2021 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc., (OTCQB: RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug development company focused on tissue protection, repair and regeneration, is addressing rumors in the market regarding its ARISE-3 phase 3 dry eye trial.

“Based on current communication with GtreeBNT, our partner in the 700-patient ARISE-3 clinical trial, the patient database is continuing to be cleaned prior to its being locked. This is talking a little longer than expected but should be completed very soon. The patient database will then be locked, and the trial data analyzed shortly thereafter followed by the release of top line results,” stated J.J. Finkelstein, RegeneRx president and chief executive.

About RegeneRx Biopharmaceuticals, Inc.

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, recently complete a phase 3 clinical trial for dry eye syndrome in the U.S. and is expected to report top line results for the ARISE-3 clinical trial in early 2021.

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. 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, reclassification of our drug candidates from drugs to biologics, 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.