RegeneRx Biopharmaceuticals, Inc. · OTC:RGRX
RegeneRx Biopharmaceuticals — Shareholder Meeting (November 2021)
17 slides from RegeneRx Biopharmaceuticals's shareholder meeting presentation, November 2021
Slide 1: 2021 Annual Stockholders Meeting
2021 Annual Stockholders Meeting
Slide 2: Forward-Looking Statements
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. Example
Slide 3: Overview
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 outsource/partnership business model. Market Data
Slide 4: Company Highlights
Company Highlights ▪ Thymosin beta 4 (Tβ4) is a novel therapeutic peptide for tissue and organ protection, repair, and regeneration. − 3 unique formulations for the treatment of ophthalmic, cardiac, CNS, PNS, and dermal disorders − Supported by over 900 peer-reviewed scientific and medical publicati
Slide 5: Outsource/Partnership Business Model
Outsource/Partnership Business Model Worldwide Clinical & Regulatory Commercialization/ Discovery Partnering Development Monetization of Asset ✓ Demonstrate proof-of-concept with R&D and early clinical trials ✓ Partner with companies with clinical development and/or commercialization strengths • Str
Slide 6: International Partners Aligned with RegeneRx
International Partners Aligned with RegeneRx ▪ 3 active strategic partnerships and a U.S. joint venture developing RegeneRx drug candidates − ReGenTree Joint Venture • Exclusive U.S. and Canadian ophthalmic license to RGN-259 from RegeneRx • GtreeBNT, as majority partner in JV, is funding all clinic
Slide 7: U.S. Dry Eye Clinical Trials with RGN-259
U.S. Dry Eye Clinical Trials with RGN-259 ▪ RGRX and its partners are developing RGN-259 (Thymosin beta 4) for the treatment of ocular disorders such as dry eye syndrome and neurotrophic keratopathy ▪ Based on its numerous mechanisms of action, Tβ4 is an excellent candidate to treat dry eye syndrome
Slide 8: Summary of Dry Eye Efficacy Results
Summary of Dry Eye Efficacy Results Summary of ARISE-1, -2, -3 and Pooled Data ▪ Ocular discomfort in ARISE-2 and Grittiness in ARISE-3, symptom parameters specified in FDA guidelines, showed statistically significance improvements with RGN-259. ▪ Statistically significant sign improvements were obs
Slide 9: Regulatory History of Dry Eye Drugs
Regulatory History of Dry Eye Drugs Previous FDA Approvals Based on Pooled Data, Subgroup Analysis, & Data Totality for Dry Eye Syndrome ▪ Restasis: multiple sub-group analyses and pooled data analysis were considered by FDA as evidence of efficacy; multiple submission with revised packages. ▪ Cyclo
Slide 10: Revised Regulatory Target Timeline – U.S. Dry Eye Syndrome
Revised Regulatory Target Timeline – U.S. Dry Eye Syndrome Q3 2021 Q4 2021 Q1 2022 GAP Analysis for Pre-BLA Meeting Working with regulatory consulting firm for preparation of Pre-BLA meeting with FDA Q4 2021: Pre-BLA meeting request (submit briefing document for FDA meeting) Q1 2022: Pre-BLA meeting
Slide 11: Neurotrophic Keratopathy (NK)
Neurotrophic Keratopathy (NK) NK is a rare degenerative corneal disease caused by impairment of the trigeminal nerve or its branches mostly due to herpes simplex virus and surgery and can lead to blindness. ▪ Neurotrophic Keratopathy (NK) − Chronic degenerative disease characterized by decreased cor
Slide 12: Seer-1 Results in NK
Seer-1 Results in NK ▪ Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study ▪ 18 patients enrolled − 0.1% RGN-259 (10 in RGN-259 group) vs. (8 in placebo group) ▪ Treatment 5x daily for 28 days + 14 days post treatment follow-up ▪ Primary Endpoint: Percentage of patients achieving compl
Slide 13: Worldwide Target Markets for RGN-259 in DES and NK
Worldwide Target Markets for RGN-259 in DES and NK Dry Eye Syndrome (prevalence) NK - Stage 2 & 3 (prevalence) 250,000,000 50,000 44,700 45,000 194,000,000 200,000,000 40,000 35,000 150,000,000 30,000 25,000 100,000,000 20,000 15,000 13,125 10,200 50,000,000 34,000,000 10,000 6,618 23,000,000 28,000
Slide 14: U.S. Dry Eye Market Competition
U.S. Dry Eye Market Competition ▪ Restasis® − >$1.1 billion annual Restasis® sales1 − Patients experience burning & stinging and efficacy typically not seen for 6 months − Package insert states Restasis® is only 15% effective vs. 5% for placebo ▪ Xiidra™ recently launched in U.S. − Estimated $400 mi
Slide 15: RGN-352 Injectable Solution
RGN-352 Injectable Solution ▪ RGN-352 injectable solution − Phase 1 completed; well-tolerated with no serious adverse events − Large body of published scientific data demonstrating in vivo effects in animals: • Cardiac tissue protection and repair including a recent study indicating prevention of ao
Slide 16: RegeneRx and Partners' IP Portfolio
RegeneRx and Partners’ IP Portfolio ▪ 7 granted patents for DES and/or NK − Compositions, methods of treating, methods of manufacturing and uses − Expiries from June 2026 to July 2037 ▪ 2 granted patents for other ophthalmic indications − Methods of use − Expiries from March 2030 to March 2032 ▪ 2 p
Slide 17: www.RegeneRx.com
www.RegeneRx.com J.J. Finkelstein, President & CEO jjfnk@RegeneRx.com 301.208.9191
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