RegeneRx Provides Regulatory Update Regarding RGN-259

ROCKVILLE, Md., March 2, 2022 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration has posted information released by HLB Therapeutics in Korea pursuant to the pre-BLA meeting with the FDA on February 28, 2022. HLB recently acquired GtreeBNT and is RegeneRx's U.S. joint venture partner developing RGN-259 for the treatment of ophthalmic injuries and disorders, including dry eye syndrome and neurotrophic keratitis.

The following was received by HLB on March 2, 2022:

HLB Therapeutics and its subsidiary, ReGenTree, LLC, held a pre-BLA meeting with the U.S. FDA on February 28 to discuss a potential BLA submission for RGN-259 for dry eye syndrome.

The pre-BLA (Biologics License Application) meeting was held by the Office of New Drugs/Office of Specialty Medicine in CDER and the Department of Ophthalmology/Office of Specialty Medicine, including specialists from statistics, safety, pharmacology, CMC, GCP and RA at FDA. ReGenTree management responsible for clinical, CMC, preclinical and regulatory affairs, as well as its board of directors, attended the meeting.

Based on these discussions with the FDA, and after we receive minutes from the meeting, ReGenTree will determine its ongoing clinical strategy for RGN-259. We expect the final meeting minutes in 30 days.

"We intend to provide more detailed information regarding additional clinical work that may be required by FDA once we receive the meeting minutes and after we have had further discussions with our counterparts at HLB Therapeutics," stated J.J. Finkelstein, RegeneRx's 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/neuro 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.

About ReGenTree, LLC

ReGenTree is a U.S. joint venture company owned by HLB Therapeutics (which recently acquired GtreeBNT) and RegeneRx Biopharmaceuticals, Inc., specifically to develop RGN-259 in both the U.S. and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015. Thus far, ReGenTree has sponsored three Phase 3 studies in the U.S. for dry eye, which are ARISE-1 (Phase 2b/3), ARISE-2, and ARISE-3. In addition to dry eye, the Company completed a Phase 3 study (SEER-1) for neurotrophic keratopathy (NK), an orphan indication in ophthalmology. SEER-1's primary endpoint, "the ratio of corneal wound healed patients after four weeks' administration" showed a strong efficacy trend in only 18 patients (p = 0.0656 and p = 0.0400, Fisher's exact test and Chi square test, respectively) with a similar safety profile as demonstrated in our dry eye trials. For additional information about ReGenTree, please visit www.regentreellc.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. Forward-looking statements in this press release include, but are not limited to, information on phase 3 trial results, pooled data from several phase 3 trials, competitive products, statements from us, or HLB Therapeutics, Ora, Inc. and its biostatistics affiliates and expert physicians, or derived from independent market research reports, as well as meetings with regulatory agencies such as FDA. These statements may relate to strategic and research partnerships, status of clinical trials, timing and quality of 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/or calculated by the Company or its joint venture partner and their affiliates at this time and are subject to change. Moreover, there is no guarantee any product or licensing application to regulatory agencies in the U.S. or elsewhere will be successful. 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, 2020, 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.

SOURCE RegeneRx Biopharmaceuticals, Inc.

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