RegeneRx Issues 2022 Letter To Stockholders

Rhea-AI Summary

RegeneRx Biopharmaceuticals (OTCQB: RGRX) provides a stockholder update detailing its drug development strategy, FDA regulatory plans, and ongoing operations. The company focuses on therapeutic peptides for tissue protection and has three candidates in clinical development targeting various medical conditions. It maintains multiple strategic licensing agreements across the U.S. and Asia and holds extensive patents for its products. The company emphasizes potential risks and uncertainties related to its forward-looking statements regarding clinical trials and financial stability.

Positive

• Three drug candidates in clinical development targeting ophthalmic, acute inflammatory, and dermal indications.
• Active strategic licensing agreements in the U.S., China, Pan Asia, and EU.
• Extensive patents and applications covering products worldwide.

Negative

• No assurance of successful outcomes for proposed clinical trials.
• Potential challenges in raising necessary operating capital by end of 2022.

Update on Product Candidates, FDA Regulatory Strategy, Operations

ROCKVILLE, Md., Aug. 22, 2022 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, has issued a Letter to Stockholders updating development of product candidates, FDA regulatory strategy, and its ongoing operating strategy.  The Letter may be viewed at RegeneRx's homepage: www.regenerx.com.

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, acute inflammatory 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 the 2022 Stockholder 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 the stockholder letter include, but are not limited to, statements regarding our strategic and research partnerships, regulatory applications and approvals, the development and timing of clinical trials for our drug candidates, the use of our drug candidates to treat various conditions, our operating strategies, and our financial needs.  The proposed clinical trials and costs to operate the Company during such trials, as well as any other 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 of these trials will be successful or confirm previous clinical results.  There also is no assurance that by the end of 2022 we can successfully raise the capital required to continue our business operations in the normal course.  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, 2021, 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 stockholder 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.

View original content:https://www.prnewswire.com/news-releases/regenerx-issues-2022-letter-to-stockholders-301609278.html

SOURCE RegeneRx Biopharmaceuticals, Inc.

FAQ

What is RegeneRx Biopharmaceuticals' focus?

RegeneRx Biopharmaceuticals focuses on developing therapeutic peptides for tissue protection, repair, and regeneration.

What drug candidates are currently in development at RegeneRx?

RegeneRx has three drug candidates in clinical development for ophthalmic, acute inflammatory, and dermal indications.

What are the risks mentioned by RegeneRx in their 2022 stockholder letter?

The risks include potential failures in clinical trials and uncertainties in raising required capital by the end of 2022.

Where does RegeneRx have strategic licensing agreements?

RegeneRx has licensing agreements in the U.S., China, Pan Asia (including Korea, Japan, Australia), and the EU.

What is the significance of RegeneRx's patent portfolio?

RegeneRx holds patents and patent applications for its products in numerous countries, which is crucial for protecting its intellectual property and market position.