BioRestorative Therapies, Inc. · NASDAQ:BRTX
BioRestorative Therapies — Investor Presentation (June 2022)
25 slides from BioRestorative Therapies's investor presentation, June 2022
Slide 1: BioRestorative Therapies
Nomen therapies
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT 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 WITH
Slide 3: Leadership
LEADERSHIP LANCE ALSTODT ROBERT KRISTAL FRANCISCO SILVA Chairman & CEO Chief Financial Officer Vice President of R&D Lance leads BRTX’s mission to improve the Robert has a versatile background of over 25 Francisco has over 20 years of experience in lives of patients through the use of years on Bay S
Slide 4: Company Highlights
COMPANY HIGHLIGHTS Disruptive Platform Technologies in Cellular Therapy Strong Preliminary Data Indicative of Positive Trial Outcomes Active Phase 2 Trial in Spine Addressing Multi-Billion Dollar Markets with Unmet Needs Opportunity for Key Strategic Partnerships Multiple Near-Term Value Enhancing I
Slide 5: A Platform Technology
A Platform Technology Preclinical Phase 1 Phase 2 Phase 3 Spine Lumbar Cervical Autologous Thoracic Osteoarthritis Hips/Knees Extremities Avascular Zones Metabolic Type 2 Diabetes Obesity Allogeneic PCOS Brown Adipose Stem Cells ARDS Long Hauler Covid Gene Modification BRTX 200 Polymer/Crispr 5
Slide 6: Chronic Lumbar Disc Disease Program – Phase 2
CHRONIC LUMBAR DISC DISEASE PROGRAM – PHASE 2 • Lead investigational therapeutic product • Autologous (patient’s own) cell-based biologic • Hypoxic (low oxygen) cultured, bone marrow-derived • Single intradiscal injection – anticipated 30 minute in-office procedure DISC/SPINE • Prior human data prov
Slide 7: Market Opportunity – BRTX-100
MARKET OPPORTUNITY – BRTX 100 258 MILLION American adult population American adults with chronic lower back 64.5 MILLION pain prevalence American adults with diagnosed and treated 32 MILLION disc degeneration Americans have pain caused by a protruding or 15 MILLION injured disc 2.5 MILLION Invasive
Slide 8: BRTX-100: Standard of Care, Clinical and Economic Problem
STANDARD OF CARE: CLINICAL AND ECONOMIC PROBLEM CONSERVATIVE TREATMENTS SURGICAL TREATMENTS OFTEN RECURRENT WITH RE-OP RATES OFTEN 10-20% ORAL MEDICATION TREATMENT SIMPLE ELEGANT SOLUTION SPINAL FUSION SURGERY $1,000 - $2,000 INTRODUCE HYPOXIC CULTURED Annually AUTOLOGOUS MSCs $110,000 1, 5 INJECTIO
Slide 9: Logistical/Clinical Process
LOGISTICAL/CLINICAL PROCESS 1 Shipping 3 Shipping 5 Cryoport Cryoport . Bone marrow and Sample shipped at BRTX-100® BRTX-100® shipped Intradiscal delivery blood collected ambient to Manufactured, and frozen to clinical site of BRTX-100® from subject. BioRestorative QC released Therapies Clinical Sit
Slide 10: Positive Human Data
POSITIVE HUMAN DATA Human data from studies of therapies similar to brtx-100 show reduced pain, increased function, and an absence of significant safety issues with a durable response. 10
Slide 11: Defined Health Report
DEFINED HEALTH REPORT In May 2018, Defined Health (a bio-consulting company) conducted a company sponsored blinded study with relevant key opinion leaders to provide an independent review of BRTX-100 Key Findings Include: Stem-cell therapies have “great potential” to treat cLDD (and related therapeu
Slide 12: Trial Design
TRIAL DESIGN FDA Cleared IND 17275: Phase 2 Randomized, Controlled Study Design in Patients with CLDD Study Design and Patient Population • Study includes 99 subjects (2:1 product to placebo) • 40.000.000 cells/dose • Included subjects will have only one symptomatic diseased disc • Primary efficacy
Slide 13: Trial Design: Primary and Secondary Endpoints
TRIAL DESIGN FDA Cleared IND 17275: Phase 2 Randomized, Controlled Study Design in Patients with CLDD Primary and Secondary Endpoints: Primary Efficacy Endpoint: The primary efficacy endpoint is clinical response, defined as at least a 30% decrease in pain as measured on the VAS scale and at least a
Slide 14: Competitive Landscape Key Differentiating Factors
COMPETITIVE LANDSCAPE KEY DIFFERENTIATING FACTORS BRTX-100 ADVANTAGES: • Autologous cells means low to no risk of rejection, Normoxic cultured – with greater safety profile (introduction of viral/genetic), Hypoxic cultured – in low potentially streamlined regulatory path normal oxygen environment ox
Slide 15: Autologous Platform
AUTOLOGOUS PLATFORM MULTIPLE OPPORTUNITIES BRTX 100 is a platform technology with multiple applications First Indication is cLDD currently approved for a Phase 2 Clinical Study Applications include all avascular zones in the body Cervical application expected to be initiated Q4 2022 Stem Cell proces
Slide 16: Metabolic Program
METABOLIC PROGRAM THERMOSTEM PROGRAM “Off the shelf” allogeneic cell-based therapy targeted to treat obesity, Type 2 diabetes and metabolic disorders using brown fat stem cells Brown fat has been shown to regulate metabolic homeostasis in the body Large library of human brown adipose tissue (BAT), w
Slide 17: Metabolic Program Highlights
METABOLIC PROGRAM HIGHLIGHTS First human stem cell derived BAT transfer Creation of first human 3D engineered artificial brown adipose tissue construct (aBAT) Successful delivery of 3D aBAT construct in mouse model Transplantation of aBAT lowered blood glucose levels Transplantation of aBAT decrease
Slide 18: Metabolic Program Clinical Timeline
METABOLIC PROGRAM CLINICAL TIMELINE 2022 2022 2023 Pre-IND Initiate File DMF Meeting Phase 1/2 with FDA with FDA Clinical Trial Expected filing a Drug Master File (“DMF”) with the FDA to facilitate licensing opportunities Schedule pre-IND (Investigational New Drug) meeting with FDA to discuss first-
Slide 19: Intellectual Property
INTELLECTUAL PROPERTY PROGRAM: PROGRAM: DISC/SPINE METABOLIC (THERMOSTEM) PATENT TITLES PATENT TITLES • Methods and Compositions to facilitate repair • Brown Fat Compositions and Methods of avascular tissue • Human Brown Adipose Derived Stem Cells and Uses • Surgical Methods and Compositions to • No
Slide 20: Near-Term Goals
NEAR-TERM GOALS Q1 2022 Announce Contracts with Clinical Research Organization (CRO) Announce opening of Cell cGMP Manufacturing Facility Q2 Filings of New BRTX-100 Patents 2022 Product Manufacturing Clearance Clinical Sites Established for Disc Trial Complete BRTX-100 Engineering Runs Q3 First Pati
Slide 21: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD Wayne Marasco, M.D., Ph.D. is a principal faculty member of Harvard Stem Cell Institute as well as a Professor in the WAYNE MARASCO, MD, PhD Department of Cancer Immunology & AIDS at the Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Chairman of SAB Med
Slide 22: Company Highlights
COMPANY HIGHLIGHTS Disruptive Platform Technologies in Cellular Therapy Strong Preliminary Data Indicative of Positive Trial Outcomes Active Phase 2 Trial in Spine Addressing Multi-Billion Dollar Markets with Unmet Needs Opportunity for Key Strategic Partnerships Multiple Near-Term Value Enhancing I
Slide 23: Financial Summary
FINANCIAL SUMMARY Current Capitalization Shares Basic Shares Outstanding 3,642,000 Cash on Hand $19 MILLION Debt $0 Sufficiently funded for Ph2 BRTX-100 TRIAL 23
Slide 24: Leadership
LEADERSHIP Lance Alstodt Francisco Silva Robert Kristal Chairman & CEO Vice President of R&D CFO Lance Alstodt joined BioRestorative Therapies as its Francisco Silva joined BRT in April 2011 and is Vice President Mr. Kristal is an experienced and versatile professional Chairman and Chief Executive O
Slide 25: porectoraice
porectoraice therapies
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