RegeneRx Joint Venture Requests Pre-BLA Meeting with FDA For RGN-259 for Dry Eye Syndrome

ROCKVILLE, Md., Nov. 29, 2021 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration), today announced that its U.S. joint venture, ReGenTree LLC, has submitted a letter to the U.S. FDA requesting a pre-BLA meeting pursuant to RGN-259, its novel product candidate for dry eye syndrome. A BLA (Biologics License Application) is FDA's standard "full approval" mechanism for biological products, including therapeutics and vaccines.

The purpose of a pre-BLA meeting is to discuss with FDA the format, content, and acceptability of the anticipated BLA application. If the meeting requested is granted, the Sponsor (ReGenTree LLC) must provide the briefing document to the agency no later than 30 days before the scheduled date of the meeting. According to FDA's guidance regarding formal meetings, when the applicant submits a meeting request for the pre-BLA meeting, FDA may either deny the pre-BLA meeting or change it to a different type of meeting if either the provided information is premature for the stage of product development or the meeting package does not provide an adequate basis for the meeting discussion.

As previously reported, ReGenTree has been working with two third-party FDA consulting firms prior to requesting the pre-BLA meeting. This includes a review of clinical studies, non-clinical studies, CMC (manufacturing) requirements, and previous meeting minutes between RegeneRx, ReGenTree and FDA.

"I am pleased ReGenTree has submitted the pre-BLA request to FDA regarding RGN-259, which is based on our results to date and on FDA's draft development guidelines for dry eye syndrome established in December of 2020. We expect to know in the next few weeks if the FDA agrees with our meeting proposal and look forward to receiving their comments regarding a number of questions/clarifications typical in such requests. If all goes well, we expect to meet with the Agency around the end of January 2022. We look forward to keeping our investors apprised of our progress along the way," stated J.J. Finkelstein, RegeneRx president and chief executive officer.

ReGenTree, LLC is a U.S. joint venture owned by HLB Therapeutics (formerly GtreeBNT) and RegeneRx Biopharmaceuticals, Inc. ReGenTree previously licensed RGN-259 from RegeneRx and is the entity (Sponsor) responsible for clinical and regulatory development of the product candidate.

RGN-259 is a sterile, preservative-free eye drop that in controlled clinical trials has been shown to quickly reduce certain signs and symptoms of dry eye syndrome and having no significant side effects that are commonly associated with other  products approved for dry eye.

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.

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 statements from us or within research published by third parties. There can be no assurance that positive results from any research or clinical trial by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can be no assurance that the U.S. FDA will meet with the Sponsor or that the data currently intended to be submitted to the FDA is adequate for approval of a BLA for RGN-259. There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country. Please view 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 press release 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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