Biorestorative Therapies, Inc. · NASDAQ:BRTX

Biorestorative Therapies — IPO Roadshow (September 2015)

28 slides from Biorestorative Therapies's IPO roadshow presentation, Sep 28, 2015

  1. Slide 1: Corporate Presentation September 2015

    CONFIDENTIAL September 2015 CORPORATE PRESENTATION

  2. Slide 2: Forward-looking statements

    - CONFIDENTIAL - 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

  3. Slide 3: Free Writing Prospectus Statement

    - CONFIDENTIAL - Free Writing Prospectus Statement We have filed a registration statement (including a prospectus) with the United States Securities and Exchange Commission (SEC) for the offering to which this communication relates. Before you invest, you should read the prospectus in that registrat

  4. Slide 4: BioRestorative Therapies: Company Overview and Offering Terms

    - CONFIDENTIAL - Issuer Exchange / Ticker Offering Size Over - Allotment Use of Proceeds Sole Book - Running Manager BioRestorative Therapies: Company Overview 4 BioRestorative Therapies, Inc. NASDAQ Capital Market *: BRTX/BRTXW 1,550,388 shares of Common Stock together with Warrants to Purchase 1,5

  5. Slide 5: Focused on cell therapies for disc/spine and metabolic diseases

    - CONFIDENTIAL - • Focused on cell therapies to treat disc / spine and metabolic diseases • High level of expertise in developing proprietary biologics • Strong skills in cell biology and cell culturing Cell - Based Therapies • Novel autologous biologic 30 minute outpatient procedure for the treatme

  6. Slide 6: Management team

    - CONFIDENTIAL - • Pioneer in regenerative and cellular medicine / science • Former President of NeoStem (now Caladrius Biosciences); Owner, BioHealth Labs (now Enzo BioChem Labs) • Bachelor of Arts, Northwestern University • Master of Science in Medical Biology, C. W. Post (LIU) Mark Weinreb Presid

  7. Slide 7: Advisory Board

    - CONFIDENTIAL - • Physiatrist - in - Chief Emeritus for Hospital for Special Surgery (HSS) • Member of HSS Board of Trustees • Founded Physiatry Dept. at HSS/Physical Med & Rehab at Mayo Clinic Gregory E. Lutz, M.D., Chief Medical Advisor For Spine Medicine • Former Director, CBER, FDA • Former V.P

  8. Slide 8: brtxDISC: Target Product Profile

    - CONFIDENTIAL -  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 in

  9. Slide 9: brtxDISC: Advantage of Hypoxic Culture

    - CONFIDENTIAL - brtxDISC™ – Advantage of Hypoxic Culture Hypoxic Culture Primes Cells for Chondrocyte Repair 9

  10. Slide 10: brtxDISC: Mechanism of Action

    - CONFIDENTIAL - brtxDISC™ : Mechanism of Action brtx DISC ™ VEGF FGFs EGF PDGF Type II Collagen SDF - 1 Aim is to change disease pathology and improve disc morphology. Key Factors Anti - inflammatory Structural repair Neovascularization Promote endogenous repair Multiple Mechanisms Express Resultin

  11. Slide 11: brtxDISC: Previous Human Data

    - CONFIDENTIAL - 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 result

  12. Slide 12: brtxDISC: Pain Improvements

    - CONFIDENTIAL - brtxDISC™ : Pain Improvements 67% (8 of 12) of Subjects Had ≥ 30% Improvement in Pain Score 12 Pre - injection Pain Score 0 1 2 3 4 5 6 7 8 9 10 NRS Changes (n=12) Follow - up  Numerical Rating Scale (NRS) is a standardized patient reported measure of pain score from 1 - 10  Minim

  13. Slide 13: brtxDISC: FRI Improvements

    - CONFIDENTIAL - brtxDISC™ : FRI Improvements 56% (5 of 9) of Subjects Had ≥ 30% Improvement in FRI 13  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 d

  14. Slide 14: brtxDISC: QOL Improvements

    - CONFIDENTIAL - brtxDISC™ : QOL Improvements Patient Quality of Life (QOL) Improvements* Graphed by Time Points Mean Improvement of ~ 60% in patient Quality of Life*, Mean time since treatment 2.3 yrs. 14 Years Since Procedure (Last Available Outcome Endpoint) % Improvement * Patient reported impro

  15. Slide 15: brtxDISC Treatment: Case Study

    - CONFIDENTIAL - brtxDISC ™ Treatment: Case Study Therapy May Have a Significant Impact on the Morphology of the Disc BEFORE AFTER 15  56% (9 of 16) of Subjects had ≥ 50% Reduction in Disc Bulge Size

  16. Slide 16: brtxDISC: Summary of Retrospective Analysis

    - CONFIDENTIAL - brtxDISC™ : Summary of Retrospective Analysis 80% Reported Improvement in Range of Motion and 100% Reported Improvement in Strength Post - Treatment 16  We believe there is a correlation between the QOL improvement percentage and dosage based on our finding in our 5 patient retrosp

  17. Slide 17: brtxDISC: Clinical Trial Design

    - CONFIDENTIAL - 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 prel

  18. Slide 18: brtxDISC: Key Milestones

    - CONFIDENTIAL - 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 1Q 2016 IND

  19. Slide 19: ThermoStem Program (Brown Adipose Stem Cells)

    - CONFIDENTIAL - 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

  20. Slide 20: Market Opportunity: Obesity and Metabolic Disorders

    - CONFIDENTIAL - Market Opportunity: Obesity and Metabolic Disorders Market Obesity Rates In Selected Countries New Diabetes US cases annually (MM) Source: OECD. The obesity epidemic: Analysis of past and projected future trends in selected OECD countries Source: CDC. Diabetes. Successes and Opportu

  21. Slide 21: ThermoStem Program

    - CONFIDENTIAL - ThermoStem ® Program • Advance pre - clinical development, leading to IND filing • Demonstrate that BAT derived from differentiated human stem cells can be used to treat or prevent metabolic disorders and restore homeostasis Program Objective • Established unique human brown fat lib

  22. Slide 22: International Journal of Cell Differentiation and Proliferation publication

    B The International Journal of Cell Differentiation and Proliferation Volume 32, Number 2, February 2014 InsIde ThIs Issue See Complete Table of Contents Inside 327 An Osteopontin-Integrin Interaction Plays a Critical Role in Directing Adipogenesis and Osteogenesis by Mesenchymal Stem Cells Qing Che

  23. Slide 23: Preclinical Metabolic Results: Glucose and Body Weight

    - CONFIDENTIAL - Preclinical Metabolic Results Glucose and Body Weight 0 100 200 300 400 500 600 1 2 3 4 5 6 7 8 9 10 11 12 13 Glucose (mg/dl) Weeks after transplantation Blood Glucose Levels Control BADSC 0 5 10 15 20 25 30 35 40 1 2 3 4 5 6 7 8 9 10 11 12 13 Body weight (g) Weeks after transplanta

  24. Slide 24: Preclinical Metabolic Results: Triglycerides and Cholesterol

    - CONFIDENTIAL - 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 - CONFIDENTIAL - 24

  25. Slide 25: BioRestorative / Pfizer Collaboration

    - CONFIDENTIAL - ▪ 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

  26. Slide 26: Investment Highlights

    - CONFIDENTIAL - Investment Highlights  DISC/SPINE PROGRAM ( brtxDISC TM ):  Complete requirements to submit IND and commence trials  Develop additional brtxDISC TM indications  METABOLIC PROGRAM ( ThermoStem ® ):  Finalize clinical indication and delivery mechanism and drive to IND filing  De

  27. Slide 27: Cap Table

    - CONFIDENTIAL - Cap Table 27 Overall Equity Plan Authorized Shares Preferred Stock 5,000,000 Common Stock 30,000,000 Equity Plan 2,000,000 Outstanding Shares Preferred Stock - Common Stock 2,854,268 45,000 Options 1,315,450 1,315,450 Warrants 792,334 - Convertible Debt 139,361 - 5,101,413 1,360,450

  28. Slide 28: Thank You

    - CONFIDENTIAL - OTCQB: BRTX  biorestorative.com Thank You - CONFIDENTIAL - 28

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