RegeneRx Biopharmaceuticals, Inc. · OTC:RGRX
RegeneRx Biopharmaceuticals — Rodman & Renshaw 18th Annual Global Investment Conference 2016
28 slides from RegeneRx Biopharmaceuticals's conference presentation, Sep 12, 2016
Slide 1: Rodman & Renshaw 18th Annual Global Investment Conference
Rodman & Renshaw 18 th Annual Global Investment Conference September 2016
Slide 2: Forward-Looking Statements
2 OTCQB: RGRX Forward - Looking Statements This investor 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
Slide 3: Overview
3 OTCQB: RGRX Overview RegeneRx (RGRX) is a clinical - stage, biopharmaceutical company engaged in the design, research and development of novel peptides targeted at diseases with unmet medical needs . The Company conducts its research and clinical trials through an outsourced partnership business m
Slide 4: Investment Highlights
4 OTCQB: RGRX Investment Highlights ▪ Developing Thymosin beta 4 (T β4) , a novel therapeutic peptide for tissue and organ protection, repair, and regeneration. − Potential new paradigm for treatment of ophthalmic, cardiac, central nervous system (CNS), peripheral nervous system (PNS), and dermal di
Slide 5: Management and Board
5 OTCQB: RGRX J.J. Finkelstein President & CEO Board Member • President, CEO and member of Board of Directors since 2002 • 34 years of experience financing and building early - stage biopharma and medical device companies • Achieved F DA regulatory clearance for several medical devices; conducted nu
Slide 6: Strategic Outsourced/Partnership Business Model
6 OTCQB: RGRX Strategic Outsourced/Partnership Business Model ▪ Objectives: − Partner with companies with clinical development and/or commercialization strengths • Strategy enables multiple paths to commercialization • Mitigates risks and facilitates efficiency − Obtain royalties and development and
Slide 7: International Partners Aligned with RegeneRx
7 OTCQB: RGRX International Partners Aligned with RegeneRx ▪ 3 active strategic partnerships and a U.S. joint venture in place − ReGenTree Joint Venture • Exclusive U.S. and Canadian ophthalmic license to RGN - 259 from RegeneRx • GtreeBNT, as majority partner in JV, is funding all clinical developm
Slide 8: Core Technology – Thymosin Beta
8 OTCQB: RGRX Core Technology – Thymosin Beta 4 ▪ Thymosin beta 4 (T β 4) is a naturally - occurring, highly active molecule − Essential for the protection , repair and regeneration of tissue following injury ▪ Synthetic copy developed for clinical use − Safe and well - tolerated in over 650 patient
Slide 9: Tβ4's Activities and Mechanisms of Action
9 OTCQB: RGRX T β 4’s Activities and Mechanisms of Action Biological Activities Mechanisms of Action Reduces inflammation Down - regulates inflammatory cytokines and chemokines; Inhibits activation of NF κ B Promotes stem cell recruitment and differentiation (regenerates skin, heart and nerve tissue
Slide 10: Market Opportunities
10 OTCQB: RGRX Market Opportunities Product Disease/application Est. U.S. Treatable Pop./year 1 Est. Annual U.S. Market Value 1 Est. Annual World Mkt Value 1 (excluding U.S.) RGN - 259 Dry Eye Syndrome 20M $2.8B $1.6B (T β4 eye drop) Neuro. Keratopathy (orphan) 2 10K $100 M $400M Recurrent Corneal E
Slide 11: Intense Focus on Ophthalmology
11 OTCQB: RGRX Intense Focus on Ophthalmology RGN - 259 Preservative - Free Eye Drops Clinical Trials with 3 Partners Dry Eye U. S. - 2 nd Phase 3 Trial Initiated ReGenTree J.V. Dry Eye China - Phase 2 2017 Target Lee’s Pharma NK U. S. - Phase 3 Enrolling Pts ReGenTree J.V. Multiple Partners Create
Slide 12: Efficacy Results from Phase 2b/3 Dry Eye Trial
12 OTCQB: RGRX Efficacy Results from Phase 2b/3 Dry Eye Trial ▪ RGN - 259 demonstrated statistically significant improvement in both signs and symptoms of dry eye − 317 patient, double - masked, placebo - controlled U.S. dry eye trial in controlled adverse environment (CAE) model − Patients had a st
Slide 13: Key Elements of Second Phase 3 Trial with RGN-259 in CAE Model
13 OTCQB: RGRX Key Elements of Second Phase 3 Trial with RGN - 259 in CAE Model Phase 3 Phase 2b/3 Subjects with DES ~500 317 Primary Endpoint (sign) Change in inferior corneal staining from baseline to end of treatment Significant efficacy assess - ment in 2b/3 (p=0.0025) Primary Endpoint (symptom)
Slide 14: U.S. Dry Eye Market
14 OTCQB: RGRX U.S. Dry Eye Market ▪ Restasis ® and Lifitegrast (Xiidra™) are only Rx products in U.S. for dry eye − >$1 billion annual Restasis ® sales (1) − Patients experience burning & stinging with Restasis ® − Efficacy typically not seen for 6 months − Package insert states Restasis ® is only
Slide 15: U.S. Neurotrophic Keratopathy Clinical Trial
15 OTCQB: RGRX U.S. Neurotrophic Keratopathy Clinical Trial ▪ Neurotrophic Keratopathy (NK) − Chronic degenerative disease characterized by decreased corneal sensitivity and limited or no corneal healing − Approximately 50,000 cases of NK in EU and U.S. (1) • Estimated 10,000 stage 2 and 3 cases − E
Slide 16: Key Milestones Over Next Months
16 OTCQB: RGRX Key Milestones Over Next 15 Months x Q3 2016 – Positive FDA communication on Phase 3 Dry Eye Protocol x Q3 2016 - Begin 2 nd U.S. Phase 3 Dry Eye Trial ▪ Mid - 2017E - Lee’s Pharma to Start Phase 2b Dry Eye Trial in China ▪ H2 2017E - Complete Enrollment of Phase 3 Dry Eye Trial ▪ H2
Slide 17: RGN-352 Multiple Opportunities in Cardiac, CNS and PNS Disorders
17 OTCQB: RGRX RGN - 352 Multiple Opportunities in Cardiac, CNS and PNS Disorders
Slide 18: Potential New Paradigm in the Treatment of MI
18 OTCQB: RGRX Potential New Paradigm in the Treatment of MI* ▪ Designed to protect myocardium and repair damaged heart tissue from STEMI, the deadliest form of heart attack ▪ Promotes cardiac repair and regeneration by multiple mechanisms in various in vitro and in vivo models − In vivo and human s
Slide 19: Similar Regenerative Effects in CNS & PNS Models
19 OTCQB: RGRX Similar Regenerative Effects in CNS & PNS Models ▪ Preclinical data support potent regenerative and protective effects of Tβ4 on the central nervous and peripheral nervous systems − Data show statistical significance and dose responses in all injury models ▪ Tβ4 acts to increase stem
Slide 20: Cash Runway Through Completion of Phase 3 Trial
20 OTCQB: RGRX Cash Runway Through Completion of Phase 3 Trial Financial Highlights and Capitalization (1) Majority of notes held by insiders (Management, Board, and Affiliates). (2) Cash on hand will fund through completion of second Ph 3 trial for dry eye in H2 2017 . ($/000s) June 30, 2016 Cash $
Slide 21: Approaching Commercialization in Ophthalmology
21 OTCQB: RGRX Approaching Commercialization in Ophthalmology Preclinical Phase 1 Phase 3 RegeneRx Drug Candidates RGN - 259 Eye drops RGN - 352 Injectable AMI, Peripheral Neuropathy, Stroke (Phase 2 - ready) Neurotrophic Keratopathy U.S. (Orphan, Phase 3) Moderate to Severe Dry Eye U.S. (2 nd Phase
Slide 22: Appendix
Appendix OTCQB: RGRX 22 REGENERX
Slide 23: Prestigious Scientific Advisory Board
23 OTCQB: RGRX Prestigious Scientific Advisory Board Allan L. Goldstein, Ph.D. Chairman of the Board & Chief Scientific Advisor • Founder, Chairman of the Board of Directors and Chief Scientific Advisor since 1982 • Emeritus Professor & former Chairman of the Department of Biochemistry and Molecular
Slide 24: ReGenTree U.S. Joint Venture
24 OTCQB: RGRX ReGenTree U.S. Joint Venture ▪ ReGenTree − Joint Venture with GtreeBNT, a Korean biopharmaceutical co. − Exclusive U.S. and Canadian ophthalmic license to RGN - 259 from RegeneRx − Currently RGRX owns 42% and GtreeBNT owns 58% of equity − GtreeBNT, as operating partner in JV, is oblig
Slide 25: Compassionate NK Study Results
25 OTCQB: RGRX Compassionate NK Study Results 0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0 lesion size (mm 2) Pt. 1 Pt. 2 Pt. 3 Pt. 4 Pt. 5 Pt. 6 Translation from Animals to Humans: 6 Patients with Neurotrophic Keratopathy Successfully Treated with RGN - 259 End of 49 Day Treatment Period (2 pts.) End
Slide 26: Promotes Cardiac Repair and Regeneration After an MI
26 OTCQB: RGRX Promotes Cardiac Repair and Regeneration After an MI Control Tβ4 i.p. Tβ4 i.c. Bock - Marquette I, Saxena A, White MD, DiMaio JM, Srivastava D. 2004. Nature 432; 466 - 72 Significant Improvement in Fractional Shortening at 4 Weeks Significant Improvement in Ejection Fraction at 4 Week
Slide 27: Potential CNS Treatment Opportunities
27 OTCQB: RGRX Potential CNS Treatment Opportunities ▪ Published research shows Tβ4 promotes tissue repair/regeneration and increases function in numerous CNS animal models − Similar repair and regeneration mechanisms are involved in each model Spinal cord injury • Decreased scar size and inflammati
Slide 28: Extensive IP Portfolio
28 OTCQB: RGRX Extensive IP Portfolio ▪ Key U.S. patent recently granted for maintaining blood concentrations of T β 4 through injection or infusion that has broad range of coverage − Expires in late 2031, or longer, depending on USPTO extensions ▪ >75 total patents and patent applications within 14
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