BioRestorative Therapies, Inc. · NASDAQ:BRTX
BioRestorative Therapies — Investor Presentation (November 2015)
25 slides from BioRestorative Therapies's investor presentation, November 2015
Slide 1: Corporate Presentation
CORPORATE PRESENTATION November 2015
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) Chief Medical Advisor • Member of HSS Board of Trustees • Founded Physiatry Dept. at HSS/Physical Med & Rehab at For Spine Medicine Mayo Clinic Joy Cavagnaro, Ph.D., • Former Director, CBER,
Slide 6: brtxDISC: Target Product Profile
brtxDISC™: Target Product Profile brtxDISC™ is a cryopreserved autologous cell therapy consisting of hypoxic cultured mesenchymal stem cells (MSCs) and a proprietary carrier brtxDISC™ is intended for patients who have chronic lower lumbar disease caused by protruding/bulging discs brtxDISC™ wi
Slide 7: brtxDISC – Advantage of Hypoxic Culture
brtxDISC™ – Advantage of Hypoxic Culture Hypoxic Culture Primes Cells for Chondrocyte Repair 7
Slide 8: Mechanism of Action
brtxDISC™: Mechanism of Action Aim is to change disease pathology and improve disc morphology. brtxDISC™ Key Factors Multiple Mechanisms VEGF Anti-inflammatory FGFs Structural repair Resulting Express EGF Neovascularization PDGF Promote endogenous Type II repair Collagen SDF-1 8
Slide 9: brtxDISC: Previous Human Data
brtxDISC™: Previous Human Data A physician-sponsored, IRB-approved study investigated the effect of hypoxic cultured MSCs on disc protrusions (from 2008-2010) Safety observations: No adverse events observed Maximum dose of 40 million cells well tolerated MRI results interpreted by an indep
Slide 10: Pain Improvements
brtxDISC™: Pain Improvements 67% (8 of 12) of Subjects Had ≥ 30% Improvement in Pain Score NRS Changes (n=12)* 10 9 Numerical Rating Scale 8 (NRS) is a standardized Pain Score 7 patient reported measure of 6 5 pain score from 1 -10 4 Minimally clinical important 3 2 difference (MCID) in NRS is 1
Slide 11: FRI Improvements
brtxDISC™: FRI Improvements 56% (5 of 9) of Subjects Had ≥ 30% Improvement in FRI Functional Rating Index (FRI) is a standardized measure of measuring subjects’ ability to do every day activities Minimally clinical important difference (MCID) in functional rating scales is defined as ≥ 30% impro
Slide 12: QOL Improvements
brtxDISC™: QOL 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. Quality of Life (QOL) is a % Improvement standardized questionnaire measuring subjects’ functional and mental wellne
Slide 13: brtxDISC Treatment: Case Study
brtxDISC™ Treatment: Case Study Therapy May Have a Significant Impact on the Morphology of the Disc BEFORE AFTER 56% (9 of 16) of Subjects had ≥ 50% Reduction in Disc Bulge Size 13
Slide 14: Summary of Retrospective Analysis
brtxDISC™: 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 P
Slide 15: brtxDISC: Clinical Trial Design
brtxDISC™: Clinical Trial Design A Phase 2 prospective, double-blinded, placebo controlled, randomized study, n=62 12 patient dose escalation cohort with 10mm, 20mm and 40mm cell dose cohorts 50 patient safety and efficacy cohort with maximum dose – Evaluate safety and preliminary efficacy of
Slide 16: brtxDISC: Key Milestones
brtxDISC™: Key Milestones Milestones Target Timeline Pre-IND meeting with FDA Completed Finalize product formulation Completed Build clean room for product manufacturing Completed Required animal studies In progress Manufacturing qualification runs 4Q 2015 Submit IND 2Q 2016 IND Clearance 3Q 2016 16
Slide 17: 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, or BAT BAT is a special
Slide 18: Market Opportunity: Obesity and Metabolic Disorders Market
Market Opportunity: Obesity and Metabolic Disorders Market The pandemic of obesity and metabolic disorders is large 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 20% Au
Slide 19: 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 20: 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 n sI d e Th I s I ssu e See
Slide 21: 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 22: 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 22
Slide 23: 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 and m
Slide 24: Investment Highlights
Investment Highlights MULTIPLE CELL THERAPY PROGRAMS DISC/SPINE PROGRAM (brtxDISCTM): Complete requirements to submit IND and commence trials Develop additional brtxDISCTM indications METABOLIC PROGRAM (ThermoStem®): Finalize clinical indication and delivery mechanism and drive to IND fili
Slide 25: Thank You
Thank You OTCQB: BRTX biorestorative.com 25
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