March 2011

Version 42

Forward looking statements

This presentation contains certain forward-looking statements that 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. Examples of such forward-looking statements include statements concerning the target dates for completing the companys ongoing preclinical studies and clinical trials for dermal, ophthalmic, cardiovascular, neurovascular and orphan indications, the potential size of addressable markets, including the market for topical gels, sterile eye drops and parenteral delivery products, the companys ability to enter into any collaborations with respect to the development or commercialization of its product candidates, and the therapeutic potential of T4 for dermal, ophthalmic, cardiovascular and neurovascular wounds. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that although T4 has demonstrated potential therapeutic benefit for dermal, ophthalmic, cardiovascular and neurovascular wounds, the companys product candidates may not demonstrate safety and/or efficacy in clinical trials, the risk that encouraging results from early research, preclinical studies, compassionate use or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study, compassionate use or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that the companys or its collaborators will not obtain approval to market the companys product candidates in the U.S. or abroad, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with reliance on collaborators for the funding or conduct of further development and commercialization activities relating to the companys product candidates, and such other risks described in the companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, and other filings the company makes with the SEC. Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

The RegeneRx value proposition

Thymosin beta 4 (T4) is a critical component of tissue protection, repair and regeneration
Numerous published studies validate its broad biological activities

Various T4 formulations developed to optimize clinical potential Conducting and supporting multiple clinical trials in 2011
Phase 2 trial in patients after acute myocardial infarction (RGN-352 injectable solution)* Phase 2 trial in patients with dry eye associated with GvHD (RGN-259 eye drops) Phase 2 epidermolysis bullosa (EB) trial scheduled for completion in 2011 (RGN-137 topical gel)

2012 - Phase 1/2 trial in patients with multiple sclerosis (RGN-352 injectable solution) Several T4 fragments being developed for cosmeceutical products Over 20 active research collaborations worldwide, most of which support current clinical programs Broad worldwide IP portfolio with patents/applications expiring from 2019 - 2030 Commitment to optimizing commercial value and investor return via strategic licensing and partnerships

* In March 2011 the FDA placed a clinical hold on our Phase 2 AMI trial due to cGMP issues at a contract manufacturers site formulating RGN-352. The timing for the resumption of this trial is unclear. The reader is referred to our press release dated March 16, 2011. 3

Validation of RGN product candidates

Cardiovascular & Central Nervous System RGN-352
(injectable for acute myocardial infarction, multiple sclerosis, stroke, traumatic brain injury)
About the cover July 2, 2009 The cover image, by Paul R. Riley, illustrating a heart wrapped in a layer of regenerating cells, is from a study showing that thymosin 4 guides progenitor cells from the outer layer of the heart to tissue repair sites.

Cosmeceuticals
(T4 peptide fragments)

Dermal RGN-137
(topical gel for dermal wound healing)

Ophthalmic RGN-259
(eye drop for corneal indications)

RegeneRx Product/Patients U.S.

Product
RGN-137 RGN-259

Disease
Epidermolysis Bullosa* Neurotrophic Keratitis Physician-Sponsored Dry Eye* Sjgrens Dry Eye**

US treatable population/yr
12K 4K

3,000 K 650K 300K 700K

RGN-352

Acute Myocardial Infarction* Multiple Sclerosis Ischemic Stroke

Traumatic Brain Injury

* Currently the subject of Phase 2 clinical trials

500K

** Larger Phase 2 dry eye trial planned for H2 2011.

Clinical targets
Initiation of Phase 2 Dry Eye trial First patient screened Initiation of Phase 2 AMI trial First patient in Completion of Phase 2 EB trial targeted Initiation of Phase 1/2 MS trial Physician-sponsored To be funded by institution and grants Data from dry eye and EB trials Begun Q4 2010 Begun TBD 2011 TBD

2011

Product candidates time-lines

RegeneRx Drug Candidates

Acute Myocardial Infarction (Phase 2) Multiple Sclerosis (Phase 1/2) Neurotrophic Keratitis (Compassionate Use) RGN-259 Eye drops Dry Eye (Proof-of-Concept) Dry Eye 2nd Phase 2)

2010

H1 2011

H2 2011

H1 2012

H2 2012

RGN-352 Injectable

RGN-137 Topical

Epidermolysis Bullosa (Phase 2)

Note, the first patient enrolled in our Phase 2 AMI trial along with the trials duration is not determinable, given the clinical hold currently in force by the FDA.

RGN-352 (inject.) development

Developing RGN-352 in cardiovascular and CNS indications
Phase 1 completed RGN-352 safe and well-tolerated at 4 dose levels
Study supports systemic use of RGN-352

Phase 2 in patients post-acute myocardial infarction underway

First patient targeted in TBD Interim data targeted in TBD Final enrolled patient targeted in TBD

Phase 1/2 trial in patients with multiple sclerosis

Collaboration with major U.S. medical institution applying for funding to conduct trial in 2012

Other supporting activities

Conducting non-clinical studies funded by $3 million NIH grant to support cardiovascular program and pursuing other sources of Federally-funded research.

Continue collaborating with academic researchers on myocardial infarction and central nervous system indications
Continue strategic partnership discussions with large pharma

RGN-259 (ophthal.) first signs of human efficacy

First compassionate use of topical eye drop Patient
Middle-age female Severe diabetic Serious cardiac and liver disease Underwent vitrectomy surgery Non-healing cornea after 23 days post-surgery Wound healed after topical administration of T4 by Day 11 Immediate reduction of irritation and inflammation

Dr. Gabriel Sosne, Associate Professor of Ophthalmology, Wayne State University, Detroit Michigan

RGN-259 administered to 10 patients

RGN-259 shows signs of efficacy Compassionate use report from 10 patients
1 patient with non-healing surgical wound treated with RGN-259 healed in 11 days 6 patients with non-healing corneal ulcers that had not healed for 6 weeks to several years either completely healed (4) or demonstrated significant improvement (2) by end of treatment 3 additional patients enrolled with diffuse punctate erosions did not demonstrate significant improvement, although did report reduced ocular irritation

10

Patients Wound Closure (first 4 patients with discrete geographical lesions)

Treatment period

11

End of treatment

RGN-259 (Ophthalmic) development

Ophthalmic clinical program expands Phase 1 not required due to safety profile Phase 2 physician-sponsored study in patients with dry eye underway
20 patients in a Phase 2, double-blind, placebo-controlled study Data expected in latter part of 2011

Other supporting activities

Completed 1st non-clinical dry eye study with statistically significant benefit
Continue collaborating with U.S. military for prevention/reduction of eye damage caused by chemical warfare agents Continue discussions with potential ophthalmic partners Pursuing other sources of Federal funding for expanded research.

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RGN-137 (topical) clinical development

Orphan drug candidate offers potentially faster market approval
Phase 1 completed RGN-137 safe and well-tolerated at 3 dose levels Phase 2 two studies in venous stasis and pressure ulcers indicate that RGN-137 can accelerate healing in mid-dose group Phase 2 epidermolysis bullosa study completion targeted for 2011 Intend to meet with FDA to discuss converting current Phase 2 trial to a pivotal study when data is unblinded
Precedent due to small patient population Will require robust data in current trial FDA could require small supplemental trial and/or Phase 4 studies

Other supporting activities

Evaluating RGN-137 for reduction of scarring Continue collaborations with academic researchers Continue discussions with potential strategic partners

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RGN-137 Orphan Indications Rationale

Orphan drug candidate offers potentially faster market approval Seven additional years of marketing exclusivity in the U.S. (10 in the EU) Opportunities for additional indications

Attractive pricing and margins compensate for low patient numbers

Healthcare legislation favorable to orphan and rare indications
Precedent for Orphan Drug Strategy

Drug
Myozyme Sabril Naglazyme Remicade

Company
Genzyme Ovation BioMarin Centocor

WW $ Sales
~1B ~60M ~$60M ~$200M

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Research and development

Over 20 active research collaborations under MTAs or CRADAs 16 U.S. universities, medical schools, hospitals, government 4 European universities, research centers, and hospital

Include U.S. military, NIH, pharmaceutical company, cosmetic company, and Canadian university
Multiple areas of clinical focus
Neurologic & stroke Cardiovascular & cardiac repair

Ophthalmology
Dermatology Pulmonary Tropical disease Thrombosis Cosmeceuticals

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Recent Non-dilutive funding

Awarded $733,000 from U.S. Government under Patient and Affordable Care Act Received $3 million NIH award for supporting studies required for RGN-352 development for AMI and other intravenous uses such as multiple sclerosis, stroke and traumatic brain injury ($1 million/year for three year Applied for additional grants ranging from $200,000 to $3 million

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Selected financial data

OTC symbol: Cash (01/31/11) est. RGRX $5.0 M

Shares outstanding
Fully diluted shares Share price (03/11/11)

79.9 M
101.3 M $0.23

52-week price range

Market capitalization (03/11/11)

$0.20 - $0.79
~$19 M

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Summary
Major studies show T4s significant effects in cardiac, multiple sclerosis, stroke, and traumatic brain injury models RGN clinical trial targets in 2011
Phase 2 trial in patients after acute myocardial infarction*
Phase 2 trial in patients with dry eye Phase 2 trial in patients with epidermolysis bullosa (EB)

2012 - Phase 1/2 trial in patients with multiple sclerosis (RGN-352 injectable solution)

Continue productive research collaborations world-wide

Continue to build and maintain broad patent portfolio Have received nearly $4.5 million in grants from NIH, FDA and US Treasury and actively soliciting similar funding in 2011-2012 Continuing to pursue licensing and partnership deals in each clinical area
* In March 2011 the FDA placed a clinical hold on our Phase 2 AMI trial due to cGMP issues at a contract manufacturers site formulating RGN-352. The timing for the resumption of this trial is unclear. The reader is referred to our press release dated March 16, 2011. 18

Appendix

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RGN Management
Dr. Allan Goldstein Chairman & Chief Scientific Advisor
Founder of RegeneRx, Discoverer of T1 and T4 Professor and Former Chair, Dept of Biochemistry and Molecular Biochemistry, GWU Med School, Washington, DC Author of over 400 scientific articles; inventor of more than 25 U.S. Patents Former President and CEO, Cryomedical Sciences, Inc., Member of Board, TCM & MdBio 28 years senior management experience in biotechnology industry Brought several medical products through FDA and to the market Practiced public accounting with Deloitte for over 10 years Senior financial executive with HFS, Inc. (major defense contractor), Bell Atlantic, and SkyBridge, LP, (an international satellite broadband startup that raised $400 million in equity) Accomplished in financial management, SEC regulations and corporate strategy 28 years global regulatory and clinical affairs experience in pharmaceutical industry Responsible for obtaining marketing approval for numerous drugs and in vitro diagnostics Negotiated corporate partnerships and licensing agreements with major pharmaceutical firms

J.J. Finkelstein President & CEO

C. Neil Lyons, C.P.A. Chief Financial Officer

David Crockford Vice President, Clinical & Regulatory Affairs

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RGN Employee Experience

10-30 years of experience per employee Participated in clinical development and/or launch of over 60 drug products and medical devices Expertise in:
Drug, Device & Diagnostic Development Formulation, Manufacturing (Biologics & Small Molecule) QA, QC Clinical Development, Trial Conduct, Trial Monitoring, Investigator Support Regulatory and Safety Management Strategic Planning, Product P&Ls Licensing and Alliance Management Sales & Marketing, Market Research and Product Launch Marketing Approvals and Product Registrations

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Scientific Advisory Board

Allan Goldstein, PhD Chairman & Chief Scientific Advisor
Professor and Former Chair, Dept of Biochemistry and Molecular Biochemistry, GWU Med School, Washington, DC Ophthalmologist, editorial board of several ophthalmic journals, New York, NY Professor of Medicine, Div of Dermatology, Vanderbilt Univ Med Ctr; specialist in EB, Nashville, TN Professor of Biochemistry, University of Erlangen, Nuremberg, Germany Clinical Professor, Dept of Ophthalmology, Cornell University Medical School, New York, NY

Herve Byron, MD, MSc

Jo-David Fine, MD, MPH

Ewald Hannappel, PhD Barrett Katz, MD, MBA Hynda Kleinman, PhD

Former Chief of the Cell Biology Section at the NIDCR, Bethesda, Maryland
Assistant Professor, Dept of Medicine, Division of Nephrology, Medical College of Wisconsin, Vice President, Medical Affairs, Sigma Tau Pharmaceuticals, Gaithersburg, Maryland Associate Professor, Dept of Ophthalmology, Wayne State Univ. School of Med and Kresge Eye Institute, Detroit, MI Director, Gladstone Inst of Cardiovascular Disease, Prof, Pediatrics and Biochemistry & Biophysics, Pirag Distinguished Professor in Pediatric Dev Cardiology, Univ of California, San Francisco, CA

Brian Schreiber, MD Gabriel Sosne, MD

Deepak Srivastava, MD

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RGN-259 Ophthalmic Preclinical Studies

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Mechanisms of Cellular Processes of Corneal Wound Healing promoted by T4

7 days PBS

7 days Tb4

Representative day 7 Slit lamp photographs of mouse eyes following alkali injury. (A) PBS-treated eye demonstrating dense corneal opacification and inflammation. (B) T4-treated eye with evident red reflex, indicating increase corneal clarity and healing.

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T4 Promotes Human Corneal Epithelial Cell Migration

Human Corneal Epithelial Cells

Rat Cornea Scrape Wound

Media

Tb4
Sosne et al., 2001

Day 0

Day 4

24 hours

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T4 Promotes Superior Corneal Epithelial Healing After Scrape Injury

Rat Corneas 36 Hours after wounding 20x MAG

control

T4

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T4 Promotes Corneal Epithelial Cell Adhesion to Basal Lamina and Intercellular Contacts in vivo

Mouse cornea heptanol debridement 42hrs

Control

T4

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T4 Promotes Improved Corneal Epithelial Intercellular Adhesions Following Injury

Mouse cornea heptanol debridement 42hrs

Control
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T4

T4 shows statistically significant improvement in dry eye model

* P 0.04

Baseline Pre-CAE

Day 7 CAE Pre-dose

Day 15 Day 18 CAE + Scop CAE + Scop 9th day of dosing End of Dosing

Animals were subjected to a controlled adverse environment (CAE) for 18 days. Dosing started on day 7. On days 15-18 animals were injected with scopolamine to induce severe dry eye. On day 15 T4 reduced corneal staining back to baseline levels. On day 18, after induction of severe dry eye, T4 maintained corneal staining at baseline levels (P0.04) while the positive control, doxycycline, increased corneal staining at day 18.

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RGN-352 MS Preclinical Studies

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Thymosin 4 Biologic Activities

Preclinical studies have shown several key activities for T4 in MS

Biological Activities
Increases oligodendrocyte progenitor cells (OPCs) and mature oligodendrocytes in brain7 Reduces inflammatory infiltrates7

Mechanisms of Action
Stimulates oligodendrogenesis/OPC differentiation7 Unknown

Induction of remyelination*

Alignment of newly differentiated OPCs along axons*

* Unpublished results

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Preclinical Overview
RGN-352 Animal Proof of Principle data7 Results
OPCs increased by >200 % in brain SVZ and >80% in white matter (p<0.05, NG2+ immunostaining) Mature oligodendrocyte cells increased 90% in white matter (p<0.05, CNPase+ immunostaining) Neurological relative functional recovery 50% greater in TB4 treatment group (p<0.01) Oligodendrogenesis increased in brain approximately 100% (BrdU+-NG2+ and BrdU+CNPase+ double immunostaining) Inflammatory infiltrates adjacent to vessels in brain reduced 30% (p<0.05, H&E staining)

Experimental
EAE induced with myelin PLP dissolved in Freunds adjuvant 10 mice in treatment group and 11 in control (saline) group 6 mg/kg IP administration Dosed on day 1 of EAE induction and then once every three days for 4 more doses Evaluated daily

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T4 Increases Progenitor Cells in Brain after Stroke

Figure 1 Tb4 Increases Progenitor Cells in the Brain After Stroke

T4 increases progenitor cells after stroke. NG-2 staining is increased in the ipsilateral SVZ, striatum and corpus callosum (CC) adjacent to the ischemic core of the T4 treated rats when compared to saline control (see arrows). Quantitative data show significantly increased density in these areas in the T4 treated rats compared to the saline control.

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RGN-352 Cardiac Preclinical Studies

About the cover July 2, 2009 The cover image, by Paul R. Riley, illustrating a heart wrapped in a layer of regenerating cells, is from a study showing that thymosin 4 guides progenitor cells from the outer layer of the heart to tissue repair sites.

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Thymosin 4 Biologic Activities

Preclinical Studies Have Shown Several Key Activities for T4 to Support Cardiac Tissue Protection & Repair

Biological Activities
Promotes cell migration 1,2,4,6

Mechanisms of Action
Regulates G- and F-actin

Promotes angiogenesis and stem cell differentiation 2,5,7,11 Prevents apoptosis and promotes cell survival 7,9,13

Unknown

Activates the PI 3K/Akt signaling pathway Upregulates the survival kinase, Akt Down-regulates inflammatory cytokines and chemokines Inhibits leukocyte invasion and adhesion Suppresses activation of NFB

Reduces inflammation 1,10,12,13

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Preclinical Pharmacology
T4 Significantly Improves Ventricular Function
~65% Improvement of Fractional Shortening at 4 Weeks ~100% Improvement of Ejection Fraction at 4 Weeks

45 mice evaluated I.P., I.C., I.P. + I.C. Evaluated at 2 & 4 wks

Bock-M arquette, et. al, Thymosin B4 activates integrin-linked kinase and promotes cardiac cell migration, survival and repair, NATURE, 2004

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Preclinical Pharmacology
T4 Reduces Heart Muscle Damage After Heart Injury
~53% Reduction in Scar Volume

p < 0.02

Blue staining indicates scar tissue, red indicates viable myocardium 20 mice I.P., I.C. Evaluated at 14 days post-ligation Biologic Activities 1. Prevents apoptosis 2. Enhanced myocardial salvage

Bock-M arquette, et. al, Thymosin B4 activates integrin-linked kinase and promotes cardiac cell migration, survival and repair, NATURE, 2004

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Preclinical Pharmacology
T4 Affects Cardiomyocyte and Endothelial Cell Survival and Inflammation
T4 Enhances Posthypoxic Cardiomyocyte Survival T4 Reduces Endothelial Cell Apoptosis

T4 Reduces Leukocyte Adhesion In Vitro

T4 Reduces Leukocyte Adhesion After Retroinfusion In Vivo

# p<0.05 vs control
Hinkel R et al., (2008) Thymosin beta4 is an essential paracrine factor of embryonic endothelial progenitor cell-mediated cardioprotection; Circulation Apr 29;117(17):2232-40.

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Preclinical Cardiac
Preclinical Dosing and Regimen Overview
Animal
Permanently ligated mouse (25-30 g) Permanently ligated mouse (25-30 g) Mouse embryos with heartspecific T4 deficiency and epicardial explants

T4 Dose
150 g 15 g 150 g 1500 g NA

Regimen
Once every 3rd day for 28 days

ROA
Intraperitoneal

Pub
Nature 2004

QD for 14 days

Intravenous (tail vein)

Ann NY Acad Sci 2007

NA

NA - in vitro exposure of epicardial explants to T4 Pressure-regulated 10-minute retroinfusion into the anterior interventricular vein Intraperitoneal

Nature 2007

Ischemia-reperfusion (LAD) pig model (24-26 kg)

Permanently ligated mouse (25-30 g)

15 mg

Single dose

Circulation 2008

150 g

Single dose

J Mol Cell Cardiology 2009

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Preclinical Cardiac
RGN-352/T4 Preclinical Cardiac Data Highlights
T4-treated neonatal cardiomyocytes migrate further, beat more rhythmically, more rapidly and more vigorously and survive for up to 28 days vs 7-14 days compared to controls (p<0.0001-<0.05) T4 showed a statistically significant improvement in myocardial function (p<0.0001) and reduction in scar volume (p <0.02) when administered immediately following coronary artery ligation in the mouse heart failure model T4 improved survival post-AMI by 70% in mouse heart failure model (p<0.03) T4 deemed responsible for all aspects of coronary vessel development in a cardiac-specific mouse T4 knock-down model and the stimulation of outgrowths from quiescent adult epicardium explants, restoring pluripotency and triggering the differentiation of fibroblasts, smooth muscle and endothelial cells T4 reduced infarct size, increased subendocardial shortening and dP/dtmax in the ischemiareperfusion pig model, and revealed a pleiotropic pattern of cardioprotection via the activation of cardiomyocyte survival pathways, inhibition of endothelial apoptosis, and suppression of inflammatory cell recruitment in vitro and in vivo T4 shown to essentially replicate eEPC-mediated cardioprotection

T4 supports cardiac regeneration by inhibiting myocardial cell death after infarction, inducing vessel growth and myocardial progenitor mobilization and by organ-wide activation of the embryonic coronary development program in adult epicardium in vivo

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