Biorestorative Therapies, Inc. · NASDAQ:BRTX
Biorestorative Therapies — Investor Presentation (January 2016)
25 slides from Biorestorative Therapies's investor presentation, Jan 15, 2016
Slide 1: Corporate Presentation January 2016
piorestorve CORPORATE PRESENTATION January 2016
Slide 2: 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 within the meaning of securit
Slide 3: BioRestorative Therapies: Company Overview
BioRestorative Therapies: Company Overview Cell-Based Therapies Disc/Spine Program Lead Product: brixDISC™ Metabolic Program ThermoStem® Validating Collaborations + Focused on cell therapies to treat disc/ spine and metabolic diseases + High level of expertise in developing proprietary biologics + S
Slide 4: Management Team
g Management Team + Pioneerin 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, C. W
Slide 5: Advisors
Gregory E. Lutz, M.D., . [gig PST SHTE TENTS for Hospital for Special Surgery Chief Medical Advisor + Member of HSS Board of Trustees For Spine Medicine + Founded Physiatry Dept. at HSS/Physical Med & Rehab at Mayo Clinic Joy Cavagnaro, Ph.D + Former Director, CBER, FDA . + Former V.P., Regulatory A
Slide 6: brtxDISC is a cryopreserved autologous cell therapy
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™ will be injected into damaged lumbar dis
Slide 7: Aim is to change disease pathology and improve disc morphology
er im is to change disease pathology and improve disc morpholog! Key Factors VEGF FGFs EGF PDGF Type Il Collagen SDF-1 ] Multiple Mechanisms Anti-inflammatory Structural repair Neovascularization Promote endogenous repair
Slide 8: Physician-sponsored, IRB-approved study of hypoxic cultured MSCs
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 independent radiologist in a subset of
Slide 9: Pain Score improvement
Pain Score 67% (8 of 12) of Subjects Had 2 30% Improvement in Pain Score NRS Changes (n=12) Pre-injection Follow-up (1-3 months) “Two patients had similar NRS changes Numerical Rating Scale (NRS) is a standardized patient reported measure of pain score from 1-10 Minimally clinical important differen
Slide 10: Functional Rating Index improvement
r 56% (5 of 9) of Subjects Had 2 30% Improvement in FRI % Improvement in FRI ™@ Functional Rating Index (FRI) is a standardized measure of : measuring subjects’ ability to 01 do everyday activities *° @ Minimally clinical important ° difference (MCID) in “ functional rating scales is : 8 : = defined
Slide 11: Quality of Life over years since procedure
100 . * ry + = 80 = x tT —@ Quality of Life (QOL) is a 2 60 + pe 4 standardized questionnaire $ ° measuring subjects’ 3 j 5 40 + functional and mental = + wellness = 20 + 0 + + 0 1 2 3 4 5 Years Since Procedure (Last Available Outcome Endpoint) * Patientreported improvement
Slide 12: Therapy impact on disc morphology
Nel S Therapy May Have a Significant Impact on the Morphology of the Disc mR KA \ M@ 56% (9 of 16) of Subjects had = 50% Reduction in Disc Bulge Size
Slide 13: Improvement in Range of Motion and Strength
80% Reported Improvement in Range of Motion and 100% Report Improvement in Strength Post-Treatment % QOL Improvement Post- % Improvement vs Cell Treatment Dose | =| == fT * | = [= | 1 2 3 4 5 10 20 30 40 Patient Cell Dose (1 x 106) m@ We believe there is a correlation between the QOL improvement per
Slide 14: Phase 2 prospective, double-blinded, placebo controlled study
m@ 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 a single dose intradiscal injec
Slide 15: Milestones Target Timeline
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/October First Patient Enrolled October/No
Slide 16: Pre-clinical allogeneic cell-based therapy for metabolic disorders
Pre-clinical allogeneic cell-basedtherapy to target obesity, diabetes and metabolic disorders using brown adipose (fat) derived stem cells (BADSC) to generate brown adipose tissue (BAT) BATisa specialized adipose tissue foundin the human body that plays a key role in the evolutionarily conserved mec
Slide 17: Pandemic of obesity and metabolic disorders
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 38% 9 USA 30% 25% England Australia Canada 20% 18% Spain 10% . a Fre 5% o% + New Diabetes US cases annually (MM) 1970 1980 1990 2000
Slide 18: ThermoStem Program
ThermoStem® Program Program + Advance pre-clinical development, leading to IND filing Obiecti + Demonstrate that BAT derived from differentiated human stem cells can be JEctive used{to treat or prevent metabolic disorders andrestore homeostasis + Established unique human brown fat library + Initial
Slide 19: 2014 Publication in STEM CELLS
2014 Publication in STEM CELLS Volume 22. sry 2018 ‘STEM CELLS 572. Metabolically Active Human Brown Adipose Tissue-Derived Stem Cells Francisco J Silva, Dolly J Holt, Vanessa Vargas et al. 1s TAANSLAGLONAL MLDINE 19
Slide 20: Glucose and Body Weight
Glucose and Body Weight Blood Glucose Levels Body Weight 600 40 st - 00 28. at = = 400 + 5 Be | z 220 | @ 300 a Ss | 8 B15 + © 200 - 40 [ 100 = e I Le en 0 123945 6789011219 2 12346567 8 9 1011 1213 Weeks after transplantation ent ‘Weeks after transplanta 2 Contral -s-BADSC feoks after transplantati
Slide 21: Triglycerides and Cholesterol Levels
Triglycerides (mg/dl) 8 Triglycerides and Cholesterol Levels Cholesterol Level Triglycerides Level control —eBansc 1 2 3 4 Months after transplantation Mice fed high chow diet throughout experiment and transplanted with brown 200 150 Cholesterol (mg/dl) ———_,__ 0 1 2 3 4 ‘Months after transplantatio
Slide 22: Collaboration study on human brown adipose cell model
ort = 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 metabolic function of cell lines
Slide 23: Milestones Target Timeline
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 December Pre-IND filing with FDA January/
Slide 24: Multiple Cell Therapy Programs
MULTIPLE CELL THERAPY PROGRAMS ™ DISC/SPINE PROGRAM (brtxDISC™): * Complete requirements to submit IND and commence trials * Develop additional brtxDISC™ indications m@ METABOLIC PROGRAM (ThermoStem®): ¢ Finalize clinical indication and delivery mechanism and drive to IND filing * Develop biologics
Slide 25: biorestorative.com
plorestordtive OTCQB: BRTX * biorestorative.com
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