BioRestorative Therapies, Inc. · NASDAQ:BRTX
BioRestorative Therapies — Investor Presentation (February 2016)
25 slides from BioRestorative Therapies's investor presentation, February 2016
Slide 1: Corporate Presentation 2016
CORPORATE PRESENTATION 2016
Slide 2: Forward Looking Statements
Forward Looking Statements Statements in this presentation, including the information set forth as to the future financial or operating performance of BioRestorative Therapies, Inc. (the “Company”), that are not current or historical factual statements may constitute “forward looking” information wi
Slide 3: BioRestorative Therapies: Company Overview
BioRestorative Therapies: Company Overview • Focused on cell therapies to treat disc / spine and metabolic diseases Cell-Based Therapies • High level of expertise in developing proprietary biologics • Strong skills in cell biology and cell culturing • Novel autologous biologic 30 minute outpatient p
Slide 4: Strong Management Team
Strong Management Team • Pioneer in regenerative and cellular medicine / science Mark Weinreb • Former President of NeoStem (now Caladrius Biosciences); Owner, BioHealth Labs (now Enzo BioChem Labs) President and CEO • Bachelor of Arts, Northwestern University • Master of Science in Medical Biology,
Slide 5: Advisory Board
Advisory Board • Physiatrist-in-Chief Emeritus for Hospital for Special Surgery Gregory E. Lutz, M.D., (HSS) • Member of HSS Board of Trustees Chief Medical Advisor • Founded Physiatry Dept. at HSS/Physical Med & Rehab at For Spine Medicine Mayo Clinic • Former Director, CBER (Center for Biologics E
Slide 6: Disc Target Product Profile
Disc Target Product Profile n BRTX-100 is a cryopreserved autologous cell therapy product consisting of hypoxic cultured mesenchymal stem cells (MSCs) and a proprietary carrier. n BRTX-100 is intended for patients who have chronic lower lumbar disease caused by protruding/bulging discs. n BRTX-10
Slide 7: BRTX-100: Mechanism of Action
BRTX-100: Mechanism of Action Aim is to change disease pathology and improve disc morphology. brtxDISC™ Key Factors Multiple Mechanisms Anti-inflammatory VEGF FGFs Structural repair Resulting Neovascularization Express EGF PDGF Promote endogenous repair Type II Collagen SDF-1 7
Slide 8: Previous Human Data
Previous Human Data n A physician-sponsored, IRB-approved study investigated the effect of hypoxic cultured MSCs on disc protrusions (from 2008-2010) n Safety observations: w No adverse events observed w Maximum dose of 40 million cells well tolerated w MRI results interpreted by an independent
Slide 9: Pain Improvements
Pain Improvements 67% (8 of 12) of Subjects Had ≥ 30% Improvement in Pain Score NRS Changes (n=12)* 10 9 n Numerical Rating Scale 8 (NRS) is a standardized patient reported measure of Pain Score 7 6 pain score from 1 -10 5 4 n Minimally clinical important 3 2 difference (MCID) in NRS is 1 defined
Slide 10: Functional Rating Index Improvements
Functional Rating Index Improvements 56% (5 of 9) of Subjects Had ≥ 30% Improvement in FRI n Functional Rating Index (FRI) is a standardized measure of measuring subjects’ ability to do everyday activities n Minimally clinical important difference (MCID) in functional rating scales is defined as ≥
Slide 11: Quality Of Life Improvements
Quality Of Life Improvements Mean Improvement of ~60% in patient Quality of Life*, Patient Quality Mean of Life time(QOL) sinceImprovements* Graphed by Time Points treatment 2.3 yrs. n Quality of Life (QOL) is a % Improvement standardized questionnaire measuring subjects’ functional and mental well
Slide 12: Disc Treatment: Case Study
Disc Treatment: Case Study Therapy May Have a Significant Impact on the Morphology of the Disc BEFORE AFTER n 56% (9 of 16) of Subjects had ≥ 50% Reduction in Disc Bulge Size 12
Slide 13: Summary of Retrospective Analysis
Summary of Retrospective Analysis 80% Reported Improvement in Range of Motion and 100% Reported Improvement in Strength Post-Treatment % QOL Improvement Post- % Improvement vs Cell Treatment Dose 100 100 Improvement (%) Improvement (%) 80 80 60 60 40 40 20 20 0 0 1 2 3 4 5 0 10 20 30 40 Patient Cell
Slide 14: Clinical Trial Design
Clinical Trial Design n A Phase 2 prospective, double-blinded, placebo controlled, randomized study, n=62 w 12 patient dose escalation cohort with 10mm, 20mm and 40mm cell dose cohorts w 50 patient safety and efficacy cohort with maximum dose – Evaluate safety and preliminary efficacy of a single
Slide 15: Disc Program Key 2016 Targeted Milestones
Disc Program Key 2016 Targeted Milestones Milestones Target Timeline Animal study data March/April Select CRO, clinical study start-up (sites, data) April - August cGMP facility certification/qualification April/May Manufacturing qualification runs June/July Submit IND August IND Clearance September
Slide 16: ThermoStem Program (Brown Adipose Stem Cells)
ThermoStem® Program (Brown Adipose Stem Cells) Potential Treatments for Metabolic Diseases § Pre-clinical allogeneic cell-based therapy to target obesity, diabetes and metabolic disorders using brown adipose (fat) derived stem cells (BADSC) to generate brown adipose tissue (BAT) § BAT is a special
Slide 17: Market Opportunity: Obesity and Metabolic Disorders Market
Market Opportunity: Obesity and Metabolic Disorders Market The pandemic of obesity and metabolic disorders is widespread and continues to grow worldwide, despite efforts to curb its progress Obesity Rates In Selected Countries New Diabetes US cases annually (MM) 35% USA 1.7 30% 1.5 25% England 1.1 2
Slide 18: ThermoStem Program
ThermoStem® Program Program • Advance pre-clinical development, leading to IND filing • Demonstrate that BAT derived from differentiated human stem cells can be Objective used to treat or prevent metabolic disorders and restore homeostasis • Established unique human brown fat library • Initial pre-c
Slide 19: 2014 Publication in STEM CELLS Journal
2014 Publication in STEM CELLS Journal Volume 32, Number 2, February 2014 The International Journal of Cell Differentiation and Proliferation B 572. Metabolically Active Human Brown Adipose Tissue-Derived Stem Cells Francisco J Silva, Dolly J Holt, Vanessa Vargas et al. I NSIDE THIS I SSUE See Compl
Slide 20: Preclinical Metabolic Results
Preclinical Metabolic Results Glucose and Body Weight Blood Glucose Levels Body Weight 600 40 35 500 30 Body weight (g) 400 25 Glucose (mg/dl) 20 300 15 200 10 5 100 0 1 2 3 4 5 6 7 8 9 10 11 12 13 0 Control 1 2 3 4 5 6 7 8 9 10 11 12 13 Weeks after transplantation Control BADSC Weeks after transpla
Slide 21: Preclinical Metabolic Results
Preclinical Metabolic Results Triglycerides and Cholesterol Levels Triglycerides Level Cholesterol Level Mice fed high chow diet throughout experiment and transplanted with brown adipose derived stem cells (BADSC)/scaffolds and controls 21
Slide 22: BioRestorative / Pfizer Collaboration
BioRestorative / Pfizer Collaboration § Jointly conducting a study entitled “Development and Validation of a Human Brown Adipose Cell Model” § BRT will leverage its human brown adipose tissue sample collection, pre-adipocyte cell lines and immortalized cell lines § Characterization of identity an
Slide 23: Metabolic Key 2016/17 Targeted Milestones
Metabolic Key 2016/17 Targeted Milestones Milestones Target Timeline Identify Key Cell Line for Pre-Clinical Testing Jan-March Develop Delivery System for BAT April - July Initiate Pre-Clinical Testing in Animals April/May Identify Target Indication June/July Complete Pre-Clinical Testing in Animals
Slide 24: Investment Highlights
Investment Highlights MULTIPLE CELL THERAPY PROGRAMS n DISC/SPINE PROGRAM (brtxDISCTM): w Complete requirements to submit IND and commence trials w Develop additional indications n METABOLIC PROGRAM (ThermoStem®): w Finalize clinical indication and delivery mechanism and drive to IND filing w
Slide 25: Thank You
Thank You OTCQB: BRTX w biorestora*ve.com 25
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