RegeneRx Biopharmaceuticals, Inc. · OTC:RGRX
RegeneRx Biopharmaceuticals — Shareholder Meeting (September 2014)
15 slides from RegeneRx Biopharmaceuticals's shareholder meeting presentation, Sep 15, 2014
Slide 1: Corporate Presentation: Annual Shareholder's Meeting September 2014
Corporate Presentation Annual Shareholder’s Meeting September 2014
Slide 2: Forward-Looking Statements
2 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
Slide 3: RegeneRx and Thymosin Beta 4
3 RegeneRx and Thymosin Beta 4 ▪ Thymosin beta 4 (T β 4) is a highly active molecule and a critical component of t issue protection, repair and regeneration ▪ T β 4 is the subject of numerous published studies in high impact journals showing its broad activity in ophthalmic, cardiac, dermal, CNS and
Slide 4: Key Ophthalmic Clinical Objectives for 2014-2016
4 Key Ophthalmic Clinical Objectives for 2014 - 2016 ▪ Conduct U.S. Phase 3 trial in patients with neurotrophic keratopathy (NK), an orphan disease − RGRX received orphan designation for NK in December 2013 − RGRX will meet with FDA in 3 rd quarter 2014 − Planning to initiate trial with data project
Slide 5: Orphan Drug Opportunities
5 Orphan Drug Opportunities ▪ RGRX currently has two drug candidates with orphan designations − RGN - 259 for ophthalmic wound healing in patients with neurotrophic keratopathy (NK ) received in December 2013. − RGN - 137 for dermal wound healing in patients with epidermolysis bullosa (EB) that has
Slide 6: RegeneRx Product Candidates
6 Dermal RGN - 137 (topical gel for dermal wound healing) RegeneRx Product Candidates Ophthalmic RGN - 259 (eye drop for corneal indications) Cardiovascular & Central Nervous System Disorders RGN - 352 (injectable for acute myocardial infarction, peripheral neuropathy, stroke, TBI) About the cover :
Slide 7: Potential Clinical Applications
7 Potential Clinical Applications T β 4 is a versatile molecule with numerous potential clinical applications Product Disease/application US treatable population/yr.* RGN - 137 Epidermolysis Bullosa (orphan) 12K (T β4 dermal gel) Pressure and Venous Stasis Ulcers >3M Scarring/burns TBD Trauma/surgic
Slide 8: Clinical Experience and Future Plans
8 Clinical Experience and Future Plans Preclinical Phase 1 Phase 2 Phase 3 RegeneRx Drug Candidates Moderate to Severe Dry Eye China (Lee’s Pharma Phase 2) Severe Dry Eye associated with GvHD (Wayne State U. Phase 2b) Neurotrophic keratopathy (Compassionate Use) Severe Dry Eye Syndrome (Physician -
Slide 9: Summary of Neurotrophic Keratopathy (NK) Trial
9 Summary of Neurotrophic Keratopathy (NK) Trial ▪ Significant findings in neurotrophic keratopathy study: − Drug well - tolerated, no adverse events − 6 neurotrophic keratopathy patients with corneal ulcers that had not healed for 6 weeks to several years either completely healed or demonstrated si
Slide 10: Development Plans for NK 2014-2015
10 Development Plans for NK 2014 - 2015 ▪ Received orphan drug designation on December 31, 2013 ▪ Will meet with FDA to discuss plans for pivotal Phase 3 clinical trial in Q3 2014 ▪ Targeting initiation and completion of Phase 3 trial in 2015
Slide 11: RGN-259 Targeted Ophthalmic Markets
11 RGN - 259 Targeted Ophthalmic Markets ▪ Current worldwide dry eye market of $1.9 billion per year → $2.8 billion by 2017* − Restasis™, only Rx product available in U.S. for dry eye • Sales of >$700 million per year, typically patients have burning & stinging, usually takes 6 months until efficacy
Slide 12: Strategic Partnering Objectives
12 Strategic Partnering Objectives
Slide 13: RGRX Strategic Partnering Objective
13 RGRX Strategic Partnering Objective ▪ Currently we have 3 strategic partnerships via out - licensing agreements that include double - digit royalties, regulatory and commercial milestone payments, and API supply agreements. − Sigma - Tau in - licensed RGRX product candidates for wound healing in
Slide 14: Selected Financial Data at 9/9/2014
14 Selected Financial Data at 9/9/2014 ▪ OTC symbol RGRX ▪ Cash @ 6/30 $675K E st Use (275K) $1M from G - treeBNT 1.0M Est Cash at 8/30 $1.4M ▪ Shares outstanding 101M ▪ S hare price $0.12 ▪ Market capitalization $12M
Slide 15: Summary of Key Value Drivers
15 Summary of Key Value Drivers: ▪ RGN - 259 preservative - free eye drops are being studied in 4 critical clinical trials with patient data estimated in 2015/2016 − RegeneRx highest priority is developing and sponsoring a Phase 3 pivotal clinical trial in patients with neurotrophic keratopathy (NK)
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