BioRestorative Therapies, Inc. · NASDAQ:BRTX
BioRestorative Therapies — Investor Presentation (November 2019)
23 slides from BioRestorative Therapies's investor presentation, November 2019
Slide 1: BioRestorative Therapies: Biologic Problems - Biologic Solutions
Qo > restordtlve therapies “BIOLOGIC PROBLEMS - BIOLOGIC SOLUTIONS”
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 THE U.S.
Slide 3: Who is BRTX?
Who is BRTX? • BioRestorative Therapies, Inc. (”BRTX”) was founded by a team of scientists and researchers committed to developing stem cell therapies to address unmet medical needs • We believe that our advances in cell biology harbor great promise in conditioning our bodies’ own regenerative poten
Slide 4: Disruptive Platform Technology in Cellular Therapy
Disruptive Platform Technology in Cellular Therapy Addressing Large Unmet Needs; Multi-Billion Dollar Market Opportunities Exploring Diverse Pipeline Opportunities within and outside of Spine and Obesity We Believe that Preliminary Data May Be Indicative of Positive Trial Outcomes Many Clinical & Re
Slide 5: Corporate History & Accomplishments
CORPORATE HISTORY & AC COMPLISHMENTS 2019 Established Disc Advisory Committee. Published safety study for BRTX-100 2015 Established relationship with University of Pennsylvania 2017 Filed IND application with FDA - obtained approval to commence P2 study for BRTX-100 for cLDD 2016 2012 Established Sc
Slide 6: Disc/Spine and Metabolics Programs
DISC/SPINE • Lead investigational therapeutic product BRTX-100 • Autologous (patient’s own) cell-based biologic • Hypoxic (low oxygen) cultured, bone marrow-derived • Single intradiscal injection – anticipated 30 minute in-office procedure • Prior human data provides insight into the potential safet
Slide 7: Anticipated Milestones 2019-2020
Q4 2019 Announce Contracts with Clinical Research Organization (CRO) & Initiate cGMP Manufacturing Operations Initiate Pre-Clinical Animal Study for Metabolic Program Issuance of New Metabolic Patents Q1 2020 Product Manufacturing Clearance Clinical Sites Expected to be Established for Disc Trial An
Slide 8: Defined Health Independent Review of BRTX-100
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 therapeutic areas) • KOLs ha
Slide 9: Scientific Advisory Board and Disc Advisory Board
Clinical Director of WAYNE MARASCO, MD, PhD Chairman of SAB WAYNE OLAN, MD Regenerative Disc / Spine Program Wayne Marasco, M.D., Ph.D. is a principal faculty member of Harvard Stem Cell Dr. Olan is a board-certified Interventional Neuroradiologist and the director of Institute as well as a Professo
Slide 10: Impact on Public Health & Cost of National Opioid Crisis
IMPACT ON PUBLIC HEALTH & COST ASSOCIATED WITH NATIONAL OPIOID CRISIS Healthcare Costs Curbed National Life Expectancy (age 25-54) Total annual pain costs (healthcare / lost productivity) approximately • 99% of global consumption of hydrocodone occurs in the United States $600 Billion 5 (4.6% of the
Slide 11: Degenerative Disc Disease US Market Assessment
1 1 1 1 1. Trinity Partners Report, “Degenerative Disc Disease US Market Assessment (Phase I),” Feb. 2016, Slide 9 of report. 11
Slide 12: BRTX-100 Cost Versus Alternative Treatments
CONSERVATIVE TREATMENTS SURGICAL TREATMENTS OFTEN RECURRENT WITH RE-OP RATES OFTEN 10-20% THE BRTX-100 ORAL MEDICATION TREATMENT SPINAL FUSION SURGERY DIFFERENCE $1,000 - $2,000 1, 4 $110,000 1, 5 Annually A single treatment using BRTX-100 is justifiable INJECTION TREATMENT based on the cost of alte
Slide 13: FDA Cleared IND: Phase 2 Randomized Controlled Study Design
FDA Cleared IND 17275: Phase 2 Randomized, Controlled Study Design in Patients with cLDD Study Design and Patient Population Primary Endpoints: • Study includes 99 subjects (randomized 2:1 BRTX-100 to placebo) Primary Outcome Measure: Safety • 40,000,000 cells/dose Efficacy Endpoint: The efficacy en
Slide 14: BRTX-100 Treatment Process
Collection and Shipment of Patient’s Bone Marrow and Blood to Cell Production Manufacturer Thawing and Injection of Production of BRTX-100 BRTX-100 into Patient’s Disc Hypoxic Culturing of Stem Cells Shipment of BRTX-100 Formulation and Cryopreservation to Clinical Site/Physician of BRTX-100 14
Slide 15: Positive Human Data from Similar Therapies
POSITIVE HUMAN DAT, 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 Treatment of lumbar degenerative = disc disease-associated radicular pain with culture- expanded autologous mesenchymal stem
Slide 16: BRTX-100 Advantages
BRTX-100 BRTX-100 adult stem cell biologic, MPC-06-ID: adult stem cell biologic, ADVANTAGES PRODUCT • Autologous cells means low to no risk of rejection, administered via anticipated administered via 30-minute outpatient & DESCRIPTION 30-minute in-office intradiscal injection intradiscal injection g
Slide 17: ThermoStem 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), white adipo
Slide 18: Intellectual Property Portfolio
• Methods and Compositions to facilitate repair of avascular tissue • Brown Fat Compositions and Methods • Surgical Methods and Compositions to facilitate repair of avascular tissue • Human Brown Adipose Derived Stem Cells and Uses • Therapeutic Delivery Device • Non-naturally occurring three-dimens
Slide 19: Research & Development
RESEARCH & DEVELOPMENT Hypoxic BM-MSC HRONIC LUMBAR DISC DISEASE BADSC THERMOSTEM® @ cues a) TYPE 2 DIABETES OLYCYSTIC OVARIAN SYNDROME QED — SS 19
Slide 20: Management Team
Lance Alstodt joined BioRestorative Therapies as its Executive Vice President Francisco Silva joined BRT in April 2011 and is Vice President of Research and Mark Weinreb has served as CEO of the Company since October 2010 and and Chief Strategy Officer in October 2018. Mr. Alstodt is responsible for
Slide 21: Board of Directors
A. JEFFREY RADOV Director CHARLES RYAN, JD, PHD Director Mr. Radov is an entrepreneur and businessman with 35 years of experience in Dr. Ryan is an experienced executive with an extensive background in media, communications and financial endeavors. He was a founding executive of pharmaceuticals and
Slide 22: Disruptive Platform Technology in Cellular Therapy
Disruptive Platform Technology in Cellular Therapy Addressing Large Unmet Needs; Multi-Billion Dollar Market Opportunities Exploring Diverse Pipeline Opportunities within and outside of Spine and Obesity We Believe that Preliminary Data May Be Indicative of Positive Trial Outcomes Many Clinical & Re
Slide 23: Contact
Mark Weinreb, ceo mweinreb@biorestorative.com (631) 760-8401 www.BRTX.com yan —> restorative therapies “BIOLOGIC PROBLEMS - BIOLOGIC SOLUTIONS” Lance Alstodt, eve & Chief Strategy Officer lalstodt@biorestorative.com (631) 760-8406 40 Marcus Drive, Suite One, Melville, NY 11747
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