RegeneRx Biopharmaceuticals, Inc. · OTC:RGRX
RegeneRx Biopharmaceuticals — The Fall Investor Summit 2019
18 slides from RegeneRx Biopharmaceuticals's conference presentation, Sep 16, 2019
Slide 1: The Fall Investor Summit September 16-17, 2019
The Fall Investor Summit September 16-17, 2019
Slide 2: Forward-Looking Statements
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-looking statements
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 outsourced partnership business model. Market Data
Slide 4: Investment Highlights
Investment 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 800 scientific and medical publications and mul
Slide 5: How Does Tβ4 Work?
How Does Tβ4 Work? Tβ4 is a peptide that circulates naturally in the bloodstream and is found in all cells of the body except red blood cells. Endogenous levels of Tβ4 are reduced as we age or as a result of certain disorders Independent researchers have published data in hundreds of scientific
Slide 6: Utilize Outsourced/Partnership Business Model
Utilize Outsourced/Partnership Business Model Objectives: Demonstrate proof-of-concept with R&D and early clinical trials Partner with companies with clinical development and/or commercialization strengths • Strategy enables multiple paths to commercialization • Mitigates risks and facilitates
Slide 7: International Partners Aligned with RegeneRx
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 development • RGRX retai
Slide 8: Worldwide Clinical Development
Worldwide Clinical Development RGN-259 Preservative-Free Eye Drops RGN-137 Dermal Gel Clinical Development Plan Dry Eye - U.S. NK - U.S. EB Dry Eye - China Dry Eye - S. Korea Phase 3, ARISE-3 Phase 3, SEER-1 Open Trial Ph 2 Initiation Dependent on U.S. Ongoing Evaluating Initiated 2018 Undetermined1
Slide 9: Clinical Trials – Over 1,700 patients
Clinical Trials – Over 1,700 patients RegeneRx Drug Candidates Preclinical Phase 1 Phase 2 Phase 3 NDA Neurotrophic Keratopathy Completion – 2020 U.S. (Orphan, Phase 3, “SEER-1”) Moderate to Severe Dry Eye U.S. Targeted Completion Summer 2020 (3rd Phase 3, “ARISE-3”) Moderate to Severe Dry Eye U.S.
Slide 10: ARISE-3 Designed to Replicate Efficacy in ARISE-1 & 2
ARISE-3 Designed to Replicate Efficacy in ARISE-1 & 2 ARISE-3 (P3) ARISE-2 (P3) ARISE-1 (P2/3) Subjects ~700 (CAE Model*) 601( CAE Model*) 317 (CAE Model*) Improvement in staining from Improvement in staining from base- Improvement in staining from Sign Efficacy baseline to Day 15 in patient line to
Slide 11: U.S. Neurotrophic Keratopathy Clinical Trial
U.S. Neurotrophic Keratopathy Clinical Trial Neurotrophic Keratopathy (NK) − Chronic degenerative disease characterized by decreased corneal sensitivity and limited or no corneal healing − Approximately 175,000 cases of NK in the U.S.(1) • Estimated 10,000 stage 2 and 3 cases − Estimated $500 mill
Slide 12: Worldwide Target Markets for RGN-259 in Ophthalmology
Worldwide Target Markets for RGN-259 in Ophthalmology Dry Eye Syndrome (prevalence) NK - Stage 2 & 3 (prevalence) 250,000,000 50,000 44,700 45,000 194,000,000 40,000 200,000,000 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 28,000,000 10,000 6,618 23,
Slide 13: U.S. Dry Eye Market Competition
U.S. Dry Eye Market Competition Restasis® and Lifitegrast (Xiidra™) are only Rx products in U.S. for dry eye − >$1 billion annual Restasis® sales(1) − Patients experience burning & stinging with Restasis® − Efficacy typically not seen for 6 months − Package insert states Restasis® is only 15% effe
Slide 14: Key Projected Milestones Over Next 15 Months
Key Projected Milestones Over Next 15 Months Q2 2018 – Positive FDA response on U.S. Phase 3 dry eye protocol (ARISE-3) with RGN- 259 topical eye drop product Q4 2018 – GtreeBNT to begin open EB trial (orphan indication) in U.S. Q1 2019 – ReGenTree initiates 700-patient ARISE-3 clinical trial
Slide 15: RGN-352 Multiple Opportunities in Cardiac, CNS and PNS Disorders
RGN-352 Multiple Opportunities in Cardiac, CNS and PNS Disorders and Severe Sepsis OTCQB: RGRX 15
Slide 16: Potential New Paradigm in the Treatment of Cardiac and CNS Disorders
Potential New Paradigm in the Treatment of Cardiac and Central Nervous System Disorders RGN-352 (Tβ4 injectable formulation) developed to rapidly repair damaged heart and CNS tissue by multiple mechanisms of action Independent in vitro and in vivo animal models have shown that Tβ4… − increases s
Slide 17: Potential Future Markets for RGN-352 for Acute Systemic Injuries
Potential Future Markets for RGN-352 for Acute Systemic Injuries and Wound Repair U.S. Annual Incidence 1,600,000 1,500,000 1,400,000 1,200,000 1,050,000 1,000,000 795,000 800,000 600,000 400,000 175,000 200,000 - ACUTE MYOCARDIAL STROKE TRAUMATIC BRAIN SEVERE SEPSIS INFARCTION (STEMI) INJURY The in
Slide 18: Financial Highlights and Capitalization
Financial Highlights and Capitalization Financial Summary and Capitalization ($/000s) June 30, 2019 Cash $1,350 Current Liabilities 232 Full time Equivalent Employees 4 Monthly Cash Burn ~100 Projected Cash Runway Thru Q2 2020 Fully Diluted Shares Outstanding 142,907 Insider and Closely Held Shares
RegeneRx Biopharmaceuticals — The Fall Investor Summit 2019 on 6ix