Biorestorative Therapies, Inc. · NASDAQ:BRTX
Biorestorative Therapies — IPO Roadshow (October 2015)
28 slides from Biorestorative Therapies's IPO roadshow presentation, Oct 19, 2015
Slide 1: Corporate Presentation October 2015
October 2015 CORPORATE PRESENTATION
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 securi
Slide 3: Free Writing Prospectus Statement
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 registration statement and
Slide 4: BioRestorative Therapies: Company Overview and Offering
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 1,834,862 shares of Common Stock together with Class A Warrants to Purchase 1,834,862 sh
Slide 5: Company overview: cell therapies for disc/spine and metabolic diseases
• 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 treatment of chronic lum
Slide 6: Management team
• 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 President and CEO • Adv
Slide 7: Advisory Board
• 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., Regulatory Aff
Slide 8: 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™ will be injected into damaged lumbar
Slide 9: brtxDISC: Advantage of Hypoxic Culture
brtxDISC™ – Advantage of Hypoxic Culture Hypoxic Culture Primes Cells for Chondrocyte Repair 9
Slide 10: brtxDISC: Mechanism of Action
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 Resulting 10
Slide 11: 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
Slide 12: brtxDISC: Pain Improvements
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 ( 1 - 3 months ) Numerical Rating Scale (NRS) is a standardized patient reported measure of pain score from 1 - 10 Min
Slide 13: brtxDISC: FRI Improvements
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 defined as ≥ 30% i
Slide 14: brtxDISC: QOL Improvements
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 improvement Quality
Slide 15: brtxDISC Treatment: Case Study
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
Slide 16: brtxDISC: Summary of Retrospective Analysis
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 retrospective analysis.
Slide 17: 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
Slide 18: 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 1Q 2016 IND Clearance 2Q 2016
Slide 19: 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 sp
Slide 20: Market Opportunity: Obesity and Metabolic Disorders
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 Opportunities for Popula
Slide 21: ThermoStem Program
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 library • Initial pr
Slide 22: Published research in International Journal of Cell Differentiation and Proliferation
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
Slide 23: Preclinical Metabolic Results: Glucose and Body Weight
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 transplantation Body Weight
Slide 24: Preclinical Metabolic Results: Triglycerides and Cholesterol
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 24
Slide 25: 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 metabolic function of cell lines Bi
Slide 26: Investment Highlights
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 Develop biologics p
Slide 27: Cap Table
Cap Table 27 Outstanding Shares Preferred Stock - Common Stock 3,081,950 [1] Options 1,315,450 Warrants 1,020,016 [2] Convertible Debt 50,783 [3] 5,468,199 [1] Gives effect to the issuance of 227,682 shares of Common Stock upon the exchange of certain notes, to be effected immediately preceding the
Slide 28: Thank You
OTCQB: BRTX biorestorative.com Thank You 28
BioRestorative Therapies — IPO Roadshow (October 2015) on 6ix