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SeeThruEquity Issues Update on RegeneRx Biopharmaceuticals, Inc. Highlighting Clinical Trial Progress
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October 28, 2015 9:15am
New York, NY--(Accesswire) - SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced it has issued an update on RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX).
The report is available here: RGRX October Update Note. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack's. The report will be available on these platforms. The firm also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX, "RegeneRX") is a Maryland-based clinical-stage biopharmaceutical company that focuses on the design, research and development of novel peptides targeted at diseases with unmet medical needs. Currently, RegeneRX and its partners are initiating Phase 2b and Phase 3 clinical trials in patients with dry eye syndrome and neurotrophic keratopathy (NK) in the U.S., Korea, and China.
"We see RegeneRx as an attractive company with a promising Phase 2 / Phase 3 clinical pipeline supported by a strong patent portfolio and several upcoming milestones. We see 2016E as a pivotal year for RegeneRX as the company should have clinical data from its key trials in the US during the year, as well as updates to its clinical programs in Korea, Taiwan, Hong Kong and China. As we indicated in our initiation on RegeneRx in June, we are currently expecting RegeneRx to commercially launch RGN-259 in 2018E and RGN-352 in 2021E. We are maintaining our price target of $4.52 at this time," stated Ajay Tandon, CEO of SeeThruEquity. "We are initiating coverage with a 12-month price target of $4.52 per share."
Additional highlights from the update are as follows:
Recent company highlights include:
- In September, RegeneRx announced that it had begun enrollment and enrolled the first patient in a 350-patient Phase 2b / 3 clinical trial for dry eye syndrome in the United States with RGN-259, its sterile, preservative-free eye drop formulation.
- RegeneRx received a $500,000 milestone payment from ReGenTree, LLC, its U.S. joint venture with Korean partner G-TreeBNT with the enrollment of the first patient in the US ophthalmic trial.
- The company quickly followed this announcement with news that it had also enrolled its first patient in a Phase 3 trial for RGN-259 for neurotrophic keratopathy (NK), a chronic degenerative disease characterized by decreased corneal sensitivity and poor or chronic corneal healing.
- RegeneRx expects to complete both trials during early 2016E, with data expected in the first half of the year.
Enrollment begins in two advanced RGN-259 trials
In our view, initial enrollment in RegeneRx's two key US-based clinical trials for RGN-259 represent a major milestone for the company and provide evidence that the company is making progress advancing its development pipeline of drugs based on active ingredient Thymosin beta 4 (Tβ4), a first-in-class, naturally occurring molecule with potential therapeutic applications in wound healing, repair, and tissue regeneration. Importantly, these US trials are being sponsored and 100% fully funded through NDA by ReGenTree LLC, a joint venture between RegeneRx and GtreeBNT Co. Ltd. a Korean biopharmaceutical company, and are being conducted by Ora Inc., an established contract research organization specializing in the field of ophthalmology. RegeneRx expects the trials to be complete in early 2016E with data expected in the first half of the year.
Update on dry eye clinical studies in Korea, China
RegeneRx recently announced that its licensee G-TreeBNT received permission from the Korean Ministry of Food and Drug Safety (MFDS) to begin its Phase 2b/3 clinical trial for RGN-259 for dry eye. Given its immediate focus on the US trial, G-TreeBNT is considering the best timing for the Korean trial. Also, the company received an unexpected regulatory setback in China. Lee's Pharmaceutical Ltd., RegeneRx's licensee in China, Hong Kong, Macau and Taiwan, received notice from China's FDA (CFDA) declining its investigational new drug (IND) application for a Phase 2b dry eye clinical trial because the API (active pharmaceutical ingredient or TB4) was manufactured outside of China (it was manufactured in the United States). Lee's is now pursuing its Phase 2b clinical program in Hong Kong and Taiwan, while awaiting the manufacturing of TB4 in China for a subsequent Phase 3 registration trial. The Hong Kong/Taiwan trial is expected to commence in 1H16E, and Lee's believes it should be able to begin a Phase 3 registration trial in China sooner rather than waiting on the production of TB4 in China for the Phase 2b trial.
Please review important disclosures on our website at www.seethruequity.com.
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About RegeneRx Biopharmaceuticals, Inc.
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RegeneRx Biopharmaceuticals, Inc. is a clinical stage company that focuses on developing Thymosin beta 4 for tissue and organ protection, repair and regeneration. Tβ4 has numerous clinical applications in ophthalmic, cardiac, central and peripheral nervous system, and dermal disorders. RegeneRx formulates Tβ4 into RGN-259, RGN-352, and RGN-137 that target diseases with unmet medical needs. It has partnered with Sigma-Tau (now Alfa Wassermann), Lee's Pharmaceuticals and G-treeBNT and formed the ReGenTree JV to develop and commercialize its product candidates in Asia-Pacific, Europe, and the U.S.
For more information on the company and its product candidates, please visit www.RegeneRx.com.
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SeeThruEquity is an equity research and corporate access firm focused on companies with less than $1 billion in market capitalization. The research is not paid for and is unbiased. SeeThruEquity does not conduct any investment banking or commission based business. SeeThruEquity is approved to contribute its research to Thomson One Analytics (First Call), Capital IQ, FactSet, Zacks and distribute its research to its database of opt-in investors. SeeThruEquity also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.
For more information visit www.seethruequity.com.
Contact:
Ajay Tandon
SeeThruEquity
info@seethruequity.com
DISCLOSURES
See www.seethruequity.com for important disclosures.
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