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Regenex Biopharmaceuticals (RGRX)

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 Company Overview
 
RegeneRx is a publicly traded, clinical-stage, biopharmaceutical company engaged in the design, research and development of novel peptides targeted at diseases with unmet medical needs. RegeneRx's mission is to research and develop novel pharmaceuticals that protect and repair tissue and organ damage caused by disease, trauma or other pathology.

RegeneRx acquired the rights to a novel peptide from the NIH in 1999. This intellectual property for Thymosin Beta 4 (Tβ4) allowed the company to direct its focus on tissue protection and repair in multiple disease indications.

RegeneRx's management team is focused on moving three distinct Tβ4-based drug candidates through the clinic: RGN-137, RGN-259 and RGN-352. RegeneRx also holds over 60 issued patents or filed patent applications worldwide in order to enable and protect multiple indications and applications for its product candidates.

In addition to Tβ4, RegeneRx is developing Tβ4 peptide fragments for cosmeceutical applications, separate and distinct from the pharmaceutical peptide and formulations. RegeneRx intends to pursue strategic business relationships to develop these smaller peptides for the cosmeceutical market.

 





 



RGN-352
 

RegeneRx is developing RGN-352, an injectable product for the treatment of cardiac tissue damage post-acute myocardial infarction and the management of multiple sclerosis.

RGN-352 represents a new approach to the treatment of acute heart attacks, as there is currently no pharmaceutical agent available that has shown both myocardial salvage and angiogenic properties in at-risk myocardial tissue. More specifically, preclinical studies have identified Tβ4's ability to promote cell migration, anti-apoptosis, anti-inflammation and myocardial stem cell differentiation.

Additionally, recently published data demonstrate for the first time that Tβ4 treatment of EAE mice (experimental autoimmune encephalomyelitis - an animal model for multiple sclerosis) significantly improves neurological function recovery. In addition to this functional benefit, the researchers reported a significant reduction of inflammation and induction of oligodendrogenesis (development of cells insulating axons in the central nervous system) and remyelination (regeneration of the nerve sheath which is damaged in MS patients), the control of which are important therapeutic goals for patients with MS.

RegeneRx has successfully completed a Phase 1 clinical trial in healthy subjects using an acute dosing regimen.


 


 

RGN-259
 

RegeneRx is developing RGN-259, a Tβ4-based sterile eye drop, as a novel treatment for corneal healing.

RGN-259 represents a new approach to corneal healing, as there is currently no pharmaceutical agent that has shown corneal repair and anti-inflammation properties. Preclinical studies have identified cell migration, anti-apoptotic and anti-inflammatory activities of Tβ4 in the cornea.

RegeneRx conducted a Phase 2 clinical trial of RGN-259 in diabetic patients who underwent corneal epithelial debridement during vitrectomy surgery. However, due to very slow enrollment and new clinical data generated under a "Compassionate Use" IND (see below), this phase 2 trial was closed in January 2009.

No Phase 1 ophthalmic trial was required for RGN-259 by the FDA after its assessment of our dermal Phase 1 safety data and relevant preclinical data.

RegeneRx has successfully completed animal studies to support the initiation of dry eye studies in humans. A Phase 2 dry eye study will complete in Q4 2011.


 


 

RGN-137        
 

 

RegeneRx is developing RGN-137, a topical gel formulation of the peptide Tβ4, as a novel treatment to accelerate dermal healing.

RGN-137 represents a new approach to dermal healing as it is not a growth factor. Unlike growth factors, RGN-137 has been shown in preclinical studies to affect multiple dermal healing pathways, such as apoptosis, angiogenesis, collagen deposition, and inflammation. The gene for Tβ4 has also been shown in preclinical studies to be one of the first to be upregulated when an injury occurs, suggesting that the peptide may contribute to the healing process.

A Phase 1 clinical trial, completed in 2004, showed no serious adverse events (SAEs) and no drug-related adverse events (AEs) in healthy, normal subjects. To date, over 170 patients have been dosed with RGN-137 with no drug-related AEs or SAEs.

Phase 2 clinical trials for the treatment of pressure ulcers and venous stasis ulcers were completed in 2009. A Phase 2 trial for the treatment of Epidemolysis Bullosa will complete in mid-2011.
 

 


    RGN-457
   

RegeneRx is developing RGN-457 as a novel nebulized treatment for cystic fibrosis and bronchiectasis. RGN-457's anti-inflammatory and mucolytic properties make it a unique therapeutic candidate for both of these pulmonary orphan diseases. Preclinical studies have indicated that RGN-457 reduces sputum length and cohesivity by depolymerizing and inhibiting f-actin formation in sputum.

RegeneRx has conducted multiple preclinical studies to date in preparation for an FDA IND filing.

 


 


 

Cosmeceutical Peptides

Based on its work with Tβ4, RGN has developed several peptide fragments that may serve as a basis for new cosmeceutical products. We have tested these derivatives in numerous in vitro models and have filed patents on their composition and activities. We are actively seeking and engaged in discussions with prospective cosmetics and cosmeceutical partners for development and commercialization of new peptided-based products.




 




Management

 

J.J. Finkelstein, President and Chief Executive Officer:

Mr. Finkelstein has served as our President and Chief Executive Officer and a member of our Board of Directors since 2002. Mr. Finkelstein also served as our Chief Executive Officer from 1984 to 1989 and as the Vice Chairman of our Board of Directors from 1989 to 1991. Mr. Finkelstein has worked as an executive officer and consultant in the bioscience industry for the past 30 years, including serving from 1989 to 1996 as chief executive officer of Cryomedical Sciences, Inc., a publicly-traded medical device company. Mr. Finkelstein has significant experience in developing early-stage companies. He has been responsible for the regulatory approval and marketing of several medical devices in the U.S. and abroad. Mr. Finkelstein has served on the executive committee of the Board of Directors of the Technology Council of Maryland since 2006, MdBio, Inc. since 1998 and currently chairs the MdBio Foundation, all of which are non-profit entities that support bioscience development and education in the State of Maryland. Mr. Finkelstein received a business degree in finance from the University of Texas. The Board believes that Mr. Finkelstein's history and long tenure as our Chief Executive Officer positions him to contribute to the Board his extensive knowledge of our company and to provide Board continuity. In addition, the Board believes that his experience at prior companies has provided him with operational and industry expertise, as well as leadership skills that are important to the Board.

David Crockford, Vice President of Clinical and Regulatory Affairs:

Mr. Crockford has served as our Vice President of Clinical and Regulatory Affairs since March 2005 and was a consultant to the Company from 2000 until his appointment as Vice President. He has more than 25 years of experience in the biotechnology and pharmaceutical industries. During his career as a clinical and regulatory affairs professional, Mr Crockford has established strategic plans, implemented and obtained marketing approval for various drug products, including one of the first human growth hormone preparations sold in the U.S., in vitro diagnostic tests, and an intraoperative medical device to detect and treat cancer. Mr. Crockford's other clinical and regulatory achievements include the cost-effective and timely development of a number of innovative investigational drugs. Mr. Crockford is the author of a number of publications, including Development of Thymosin ß4 for Treatment of Patients with Ischemic Heart Disease, and is an inventor or co-inventor on approximately two dozen patents related to drug development. Mr Crockford has a B.A. degree in biology and chemistry from Boston University. He also completed biochemistry and clinical chemistry course studies in Princeton, New Jersey, and seminars in reproductive medicine at medical schools at Wayne State University and UCLA.


 

       





 
Board of Directors

Allan L. Goldstein, Ph.D.

Dr. Goldstein has served as the Chairman of our Board of Directors and our Chief Scientific Advisor since he founded our company in 1982. Dr. Goldstein has been a Professor of Biochemistry since 1978 and served as Chairman of the Department of Biochemistry and Molecular Biology at the George Washington University School of Medicine and Health Sciences until 2009. Dr. Goldstein is a recognized expert in the field of immunology and protein chemistry, having authored over 430 scientific articles in professional journals. He is also the inventor on over 25 issued and/or pending patents in biochemistry, immunology, cardiology, cancer and wound healing. Dr. Goldstein discovered several important compounds, including T a1, which is marketed worldwide, and Tß4, which is the basis for RegeneRx's clinical program. Dr. Goldstein has served on the Board of Trustees of the Sabin Vaccine Institute since 2000 and on the Board of Directors of the Richard B. and Lynne V. Cheney Cardiovascular Institute since 2006. Dr. Goldstein has also done pioneering work in the area of medical education, developing distance learning programs offered through "Frontiers in Medicine," a medical education series that Dr. Goldstein developed. The Board believes that Dr. Goldstein's scientific expertise, industry background and prior experience as our founder all position him to make an effective contribution to the medical and scientific understanding of the Board, which the Board believes to be particularly important as we continue our Tß4 development efforts.

J.J. Finkelstein

Mr. Finkelstein has served as our President and Chief Executive Officer and a member of our Board of Directors since 2002. Mr. Finkelstein also served as our Chief Executive Officer from 1984 to 1989 and as the Vice Chairman of our Board of Directors from 1989 to 1991. Mr. Finkelstein has worked as an executive officer and consultant in the bioscience industry for the past 30 years, including serving from 1989 to 1996 as chief executive officer of Cryomedical Sciences, Inc., a publicly-traded medical device company. Mr. Finkelstein has significant experience in developing early-stage companies. He has been responsible for the regulatory approval and marketing of several medical devices in the U.S. and abroad. Mr. Finkelstein has served on the executive committee of the Board of Directors of the Technology Council of Maryland since 2006, MdBio, Inc. since 1998 and currently chairs the MdBio Foundation, all of which are non-profit entities that support bioscience development and education in the State of Maryland. Mr. Finkelstein received a business degree in finance from the University of Texas. The Board believes that Mr. Finkelstein's history and long tenure as our Chief Executive Officer positions him to contribute to the Board his extensive knowledge of our company and to provide Board continuity. In addition, the Board believes that his experience at prior companies has provided him with operational and industry expertise, as well as leadership skills that are important to the Board.

Joseph C. McNay

Mr. McNay has served as a member of our Board of Directors since 2002. He is currently Chairman, Chief Investment Officer and Managing Principal of Essex Investment Management Company, LLC, positions he has held since 1976 when he founded Essex. He has direct portfolio management responsibilities for a variety of funds and on behalf of private clients. He is also a member of the firm's Management Board. Prior to founding Essex, Mr. McNay was Executive Vice President and Director of Endowment Management & Research Corp. from 1967. Prior to that, Mr. McNay was Vice President and Senior Portfolio Manager at the Massachusetts Company. Currently he is serving as Trustee of National Public Radio, Trustee of the Dana Farber Cancer Institute, and is a Trustee and member of the Children's Hospital Investment Committee. He received his A.B. degree from Yale University and his M.B.A. degree in finance from the Wharton School of the University of Pennsylvania. The Board believes that Mr. McNay's extensive financial experience is valuable to our business and also positions him to contribute to the audit committee's understanding of financial matters.

Mauro Bove

Mr. Bove has served as a member of our Board of Directors since 2004 and has more than 25 years of business and management experience within the pharmaceutical industry. Mr. Bove is currently the Head of Corporate & Business Development and serves on the board of Sigma-Tau Finanziaria S.p.A., the holding company of Sigma-Tau Group, a leading international pharmaceutical company, and certain Sigma-Tau affiliates, positions he has held since 1993. Sigma-Tau Finanziaria S.p.A. and its affiliates are collectively our largest stockholder. Mr. Bove has also held a number of senior positions in business, licensing and corporate development within Sigma-Tau Group, which has subsidiaries in most European countries and the United States. Mr. Bove obtained his law degree at the University of Parma, Italy, in 1980. In 1985, he attended the Academy of American and International Laws at the International and Comparative Law Center, Dallas, Texas. The Board believes that Mr. Bove's extensive business and management experience within the pharmaceutical industry allows him to recognize and advise the Board with respect to recent industry developments.

L. Thompson Bowles, M.D.

Dr. Bowles has served as a member of our Board of Directors since 2006. He retired from his career as a thoracic surgeon in 1988. Dr. Bowles served as Dean of Medicine and Professor of Surgery at The George Washington University ("GWU") School of Medicine and Health Sciences from 1976 to 1988 and as Vice President for Medical Affairs and Executive Dean of the GWU Medical Center from 1988 to 1992. Dr. Bowles previously served as President of the National Board of Medical Examiners, a medical accrediting organization, from 1992 to 2000. He has also been a member of the National Academy of Sciences Institute of Medicine since 1988 and currently serves as a member of several other national medical societies including: The American College of Surgeons, The American Association for Thoracic Surgery, The Society of Thoracic Surgeons, The American College of Chest Physicians, The American Gerontological Society, The Society of Medical Administrators, The College of Physicians of Philadelphia, and The Washington Academy of Surgeons. Dr. Bowles has served on the editorial board of a number of medical journals, including the Journal of Medical Education and continued on as chairman of its newly revised updated version, Academic Medicine. Dr. Bowles has been President of the District of Columbia's medical licensing board called the Healing Arts Commission (1977-1979), and was a member of the National Library of Medicine's Board of Regents (1982-1986), chairman (1984-1986), member of the Special Medical Advisory Group of Veterans Administration (now Dept. of Veterans Affairs) 1984-1992, chairman 1992-1994. Dr. Bowles was also chairman of the National Committee on Foreign Medical Education and Accreditation, 1994-1996. Dr. Bowles received his medical degree from Duke University and his Ph.D. in higher education from New York University. The Board believes that Dr. Bowles' distinguished medical career positions him to bring extensive medical and clinical trial experience to the Board. The Board expects that this experience will permit Dr. Bowles to provide leadership and insight as we translate our laboratory discoveries into human clinical trials and advance our product candidates through clinical development toward commercialization.

Don Elsey

Mr. Elsey has served as a member of our Board of Directors since September 2010. He has served as senior vice president and chief financial officer of Emergent BioSolutions Inc., a publicly held biopharmaceutical company, since May 2007, and as its chief financial officer since March 2006 and Treasurer since June 2005. Mr. Elsey previously served as vice president, finance of Emergent BioSolutions from June 2005 to May 2007. He served as the director of finance and administration at IGEN International, Inc., a publicly held biotechnology company, and its successor BioVeris Corporation, from April 2000 to June 2005. Prior to joining IGEN, Mr. Elsey served as director of finance at Applera, a genomics and sequencing company, and in several finance positions at International Business Machines, Inc. He received an M.B.A. in finance and a B.A. in economics from Michigan State University. Mr. Elsey is a certified management accountant. The Board believes that Mr. Elsey's experience as chief financial officer of a public company is particularly valuable to our business in that it positions him to contribute to our Board's and audit committee's understanding of financial matters.

 


 



Scientific Advisory Board
 

Allan Goldstein, PhD - Chairman of RegeneRx's Scientific Advisory Board, Professor and Chairman emeritus, Department of Biochemistry and Molecular Biochemistry, George Washington University Medical School, Washington, DC

Herve Byron, MD, MSc - Ophthalmologist, editorial board of several ophthalmic journals, New York, New York

Paolo Carminati, PhD - Former Director of Research and Development at Sigma-Tau Group, Rome, Italy; President of Sigma-Tau Research Inc., U.S.A.

Jo-David Fine, MD, MPH - Professor of Medicine, Division of Dermatology, Vanderbilt University Medical Center, Nashville, Tennessee

Ewald Hannappel, PhD - Professor of Biochemistry, University of Erlangen, Nuremberg, Germany

Barrett Katz, MD, MBA - Clinical Professor, Dept of Ophthalmology, Cornell University Medical School, New York, New York

Hynda K. Kleinman, PhD - Former Chief of the Cell Biology Section at the National Institute of Dental and Craniofacial Research, Bethesda, Maryland

Brian Schreiber, MD - Assistant Professor, Dept of Medicine, Division of Nephrology, Medical College of Wisconsin, Vice President, Medical Affairs, Sigma-Tau Pharmaceuticals, Gaithersburg, MD

Gabriel Sosne, MD - Associate Professor, Department of Ophthalmology, Wayne State University School of Medicine and Kresge Eye Institute, Detroit, Michigan

Deepak Srivastava, MD - Director, Gladstone Institute of Cardiovascular Disease, Professor, Pediatrics and Biochemistry & Biophysics, Wilma and Adeline Pirag Distinguished Professor in Pediatric Development Cardiology, University of California, San Francisco, California

 



Share Structure 

AS: 200,000,000
OS: 
 

101,596,251 shares of common stock, par value $0.001 per share, were outstanding as of May 14, 2015. 

 

 

Float: 45,740,000
 
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RGRX News: Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) 11/15/2016 03:17:11 PM
RGRX News: Quarterly Report (10-q) 11/14/2016 05:10:00 PM
RGRX News: Current Report Filing (8-k) 11/02/2016 06:05:13 AM
RGRX News: Proxy Statement (definitive) (def 14a) 09/16/2016 05:22:07 PM
RGRX News: Current Report Filing (8-k) 09/12/2016 09:31:42 AM
PostSubject
#209   Somebody dumping this Big Time! Theboy56 07/27/16 10:19:15 AM
#208   RGRX set up well Chance 06/06/16 06:29:27 AM
#207   Here's the test of support again. dshade 05/28/16 11:37:09 PM
#206   And close to reload zone thereabouts. dshade 05/14/16 01:37:26 AM
#205   Looking good, wish I get a pullback here. RealGenius 03/29/16 11:38:08 PM
#204   Last week's run was only the beginning...I have Mprush 03/28/16 10:21:32 AM
#203   yep. patience paid here dshade 03/24/16 09:49:52 AM
#202   beauty IN The Mouth Of Madness 03/23/16 03:11:34 PM
#201   $RGRX recent news/filings stocktrademan 03/19/16 11:52:04 AM
#200   Interesting form 4s dshade 03/18/16 10:44:56 PM
#199   wish they would drop the notes to IN The Mouth Of Madness 01/17/16 12:43:03 AM
#198   Yes indeed. dshade 01/16/16 01:59:40 PM
#197   Yes, Q1 ends March 31. nathanial 01/09/16 10:56:38 AM
#196   when is end of Q1 2016 in march? IN The Mouth Of Madness 01/09/16 12:25:16 AM
#195   wish they would drop the notes now IN The Mouth Of Madness 12/29/15 03:03:41 PM
#194   the 500k award they got recently should help IN The Mouth Of Madness 12/19/15 02:03:32 PM
#193   I take it you like RGRX! Old Shatterhand 12/17/15 08:46:56 PM
#192   a KBIO in the making IN The Mouth Of Madness 12/15/15 01:35:10 PM
#191   hey peter, end of Q1 results hit, I'm IN The Mouth Of Madness 12/15/15 12:14:29 AM
#190   $RGRX ~ RegeneRx Biopharmaceuticals, Inc. due diligence $Pistol Pete$ 12/13/15 09:59:02 PM
#189   its a KBIO in the making, 2 wall IN The Mouth Of Madness 12/12/15 01:12:50 PM
#188   KBIO was a joke, pre clinical phase pipeline LOL IN The Mouth Of Madness 12/12/15 12:49:28 AM
#187   would be cool if we got it to IN The Mouth Of Madness 12/11/15 04:15:47 PM
#186   Put this one on my watch list. Awful nathanial 12/11/15 07:34:06 AM
#185   I can wait. BobsHobby 11/15/15 12:24:35 PM
#184   crappy 10k and a mini delay, its IN The Mouth Of Madness 11/14/15 11:59:23 AM
#183   last 10q sucked IN The Mouth Of Madness 11/12/15 08:26:49 PM
#182   can see .40 IN The Mouth Of Madness 11/10/15 12:20:36 PM
#181   trying to hit 1 good one and IN The Mouth Of Madness 11/09/15 12:51:24 PM
#180   bright future IN The Mouth Of Madness 11/05/15 02:34:19 PM
#179   You and me both! I love this stock. BobsHobby 11/02/15 06:09:37 AM
#178   wish i had 50,000 to buy this IN The Mouth Of Madness 11/01/15 09:11:18 PM
#177   this is a 40 dollar a share stock IN The Mouth Of Madness 10/28/15 01:10:47 AM
#176   China wants in on production. BobsHobby 10/23/15 10:37:22 PM
#175   gem IN The Mouth Of Madness 10/20/15 12:35:42 PM
#174   RegeneRx's TB4 Shown to Significantly Limit Brain Damage SPM555 10/20/15 10:41:13 AM
#173   Tough call short term, medium term this seems dshade 10/19/15 07:46:45 PM
#172   dshade, how ya been son? Anything going on nathanial 10/19/15 07:39:56 PM
#171   4,68 price target IN The Mouth Of Madness 10/16/15 04:15:47 PM
#170   possible december going into 2016 10 bagger IN The Mouth Of Madness 10/14/15 02:52:45 PM
#169   when does phse 3 start? IN The Mouth Of Madness 10/03/15 12:10:10 AM
#168   indeed. dshade 09/25/15 04:50:28 PM
#167   sleeper IN The Mouth Of Madness 09/25/15 04:04:53 PM
#166   hit 35 IN The Mouth Of Madness 09/17/15 01:44:12 PM
#165   my shit is dead money, its gay, this IN The Mouth Of Madness 08/26/15 12:45:54 PM
#164   assets less, liabilties up, not the best 10q IN The Mouth Of Madness 08/16/15 11:41:13 AM
#163   After extending the maturity date of our October IN The Mouth Of Madness 08/16/15 11:34:31 AM
#162   I hear ya. dshade 08/14/15 04:47:34 PM
#161   wish my plays ran its almost time IN The Mouth Of Madness 08/14/15 04:09:52 PM
#160   charts are ugly IN The Mouth Of Madness 08/05/15 09:19:15 PM
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