BioRestorative Therapies, Inc. · NASDAQ:BRTX
BioRestorative Therapies — Investor Presentation (2016)
19 slides from BioRestorative Therapies's investor presentation, 2016
Slide 1: Presentation 2016
niorestordtlve therapies PRESENTATION 2016
Slide 2: Forward Looking Statements
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 wi
Slide 3: Company Overview
Company Overview BioRestorative Therapies, Inc. develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs relate to the treatment of disc/spine disease and metabolic disorders. MULTIPLE CELL THERAPY PROGRAMS DISC/SPINE PROGRAM (brtxD
Slide 4: Lower Back Pain Disc Therapy Program
Lower Back Pain Disc Therapy Program Lower Back Pain is the Most Common, the Most Disabling, and the Most Costly Musculoskeletal Problem Treated Protruding / Bulging Disc Spinal Fusion Surgery INTRODUCING A NEW STANDARD OF CARE TO TREAT CHRONIC LUMBAR DISC DISEASE 4
Slide 5: Cell-Based Lumbar Disc Therapeutic
Cell-Based Lumbar Disc Therapeutic Disc Therapy to Treat Chronic Lumbar Disc Disease (Protruding and Bulging Discs) BRTX-100 - Lead Cell Therapy Candidate Product Formulated from Autologous Cultured Mesenchymal Stem Cells (or MSCs) Collected from the Patient’s Bone Marrow Treatment is Intended f
Slide 6: BRTX-100: Production Process
BRTX-100: Production Process Collection and Shipment to BRT of Patient’s Bone Marrow and Blood Production of Thawing and BRTX-100 Injection of BRTX- 100 into Patient’s • Hypoxic Culturing Disc of MSCs Shipment of BRTX- Formulation and 100 to Clinical Cryopreservation of Site/Physician BRTX-100 6
Slide 7: BRTX-100: Engineered for the Disc
BRTX-100: Engineered for the Disc BRTX-100 Key Attributes: Contains Hypoxic (Low Oxygen) Cultured Mesenchymal Stem Cells Co-Administered with Biomaterial Carrier (Platelet Lysate) High Cell Viability for Disc Cryopreserved BRTX-100 Cell Based Therapy (2 step mechanism): Structural (Bio
Slide 8: Previous Human Data
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 Efficacy observations: Reduction in pain – 67% of subjects (n=12) had ≥ 30% improvement in pai
Slide 9: Disc Morphologic Changes
Disc Morphologic Changes Therapy May Have a Significant Impact on the Morphology of the Disc 42 yo Male needed epidural steroid Apr 2009-Sag T2 FRFSE FS 4/2009 ET-24, TR-4233, TE-105.2 injections multiple times annually PRE-TREATMENT for radiculopathy Large central, contained, broad based protru
Slide 10: BRTX-100: Clinical Trial Design
BRTX-100: Clinical Trial Design Trial Design: A Phase 2 Prospective, Double-Blinded, Placebo Controlled, Randomized Study, n=62 12 Patient Dose Escalation Cohort (Including Low Dose and Treatment Dose Cohorts) 50 Patient Safety and Efficacy Cohort with Treatment Dose 5-10 Clinical Trial Site
Slide 11: Key Milestones
Key Milestones Milestones Target Timeline Publish Human Retrospective Safety Study 3Q2016 Submit IND to FDA / IND Clearance 4Q2016 Patient Enrollment 1Q2017 Dose Escalation Cohort Data 3Q2017 Primary End Point Efficacy Data 3Q2018 11
Slide 12: 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 (BAT) BAT is a specializ
Slide 13: 2014 Publication in STEM CELLS Journal
2014 Publication in STEM CELLS Journal Volume 32, Number 2, February 2014 The International Journal of Cell Differentiation and Proliferation B 572. Metabolically Active Human Brown Adipose Tissue-Derived Stem Cells Francisco J Silva, Dolly J Holt, Vanessa Vargas et al. I n sI d e Th I s I ssu e See
Slide 14: Preclinical Metabolic Results: Glucose and Body Weight
Preclinical Metabolic Results Glucose and Body Weight Blood Glucose Levels Body Weight 600 40 35 500 30 Body weight (g) 400 25 Glucose (mg/dl) 20 300 15 200 10 5 100 0 1 2 3 4 5 6 7 8 9 10 11 12 13 0 Control 1 2 3 4 5 6 7 8 9 10 11 12 13 Weeks after transplantation Control BADSC Weeks after transpla
Slide 15: 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 15
Slide 16: Brown Fat Delivery Device
Brown PreclinicalFat Delivery Metabolic Results Device Encapsulation Device Brown Adipose Cells (live) UCP1 (red) Positive Cells
Slide 17: Metabolic Key 2016/17 Targeted Milestones
Metabolic Key 2016/17 Targeted Milestones Milestones Target Timeline Identify Key Cell Line for Pre-Clinical Testing 3Q 2016 Develop Delivery System for BAT 3Q 2016 Initiate Pre-Clinical Testing in Animals 4Q 2016 Identify Target Indication 4Q 2016 Complete Pre-Clinical Testing in Animals 2Q 2017 Pr
Slide 18: Key Highlights - Value Proposition
Key Highlights - Value Proposition Unique Product Engineered to Address the Challenges of the Targeted Application Autologous hypoxic-cultured cell product BRTX-100 is formulated and co-administered with biomaterial carrier Pending Clinical Trial Anticipated IND filing 4Q 2016 $7M to $8M
Slide 19: Thank You
Thank You OTCQB: BRTX biorestorative.com 19
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