Biorestorative Therapies, Inc. · NASDAQ:BRTX
Biorestorative Therapies — Investor Presentation (May 2018)
19 slides from Biorestorative Therapies's investor presentation, May 24, 2018
Slide 1: BRTX-100 Overview Spring 2018
CONFIDENTIAL Bierastoratve therapies BRTX-100 Overview Spring 2018
Slide 2: Forward Looking Statements; Restrictions on Use
FORWARD LOOKING STATEMENTS; RESTRICTIONS ON USE Statements in this BRTX-100 Overview (“Presentation”), including the information set forth as to the future financial or operating performance of BioRestorative Therapies, Inc. (“we" or the “Company’), that are not current or historical factual stateme
Slide 3: Company Background
COMPANY BACKGROUND BioRestorative Therapies, Inc. (“BRT”) develops therapeutic treatments from adult stem cells Full-service research lab, based in Melville, NY Publicly-listed (OTC: BRTX) 10 employees, most with technical/science backgrounds Leadership and scientific advisors are pioneers in stem c
Slide 4: Low Back Pain Is a Leading Cause of Disability and Has Enormous Social and Economic Impact
LOW BACK PAIN IS ALEADING CAUSE OF DISABILITY AND HAS ENORMOUS SOCIAL AND ECONOMIC IMPACT Chronic Lumbar Disc Disease is degenerative: * Compromised disc with lower back pain * Over time, functionality is also limited * Disc degeneration is presently irreversible 80% of adults experience lower back
Slide 5: Current Treatment Options Include Conservative Interventions That Often Lead to Invasive Surgical Procedures
CURRENT TREATMENT OPTIONS INCLUDE CONSERVATIVE INTERVENTIONS THAT OFTEN LEAD TO INVASIVE SURGICAL PROCEDURES Conservative Treatment Options * OTC pain medications (NSAIDs, analgesics) * Narcotics (codeine, oxycodone-acetaminophen combination) * Nerve pain medications (gabapentin, pregabalin, Oral Me
Slide 6: BRTX-100 Shows Great Promise to Treat Compromised Discs Without Surgery
BRTX-100 SHOWS GREAT PROMISE TO TREAT COMPROMISED DISCS WITHOUT SURGERY Description * Targeted for patients whose pain and disabilities have not been alleviated by conservative treatments and face the prospect of surgery * Product formulated from autologous hypoxic cultured mesenchymal stem cells (o
Slide 7: Human Data from Studies of Therapies Similar to BRTX-100 Show Reduced Pain
HUMAN DATA FROM STUDIES OF THERAPIES SIMILAR TO BRTX-100 SHOW REDUCED PAIN, INCREASED FUNCTION, AND AN ABSENCE OF SIGNIFICANT SAFETY ISSUES Journal of Translational Medicine Treatment of lumbar degenerative © disc disease-associated radicular pain with culture- expanded autologous mesenchymal stem c
Slide 8: Independent Consulting Firm Has Validated BRTX-100 Approach
INDEPENDENT CONSULTING FIRM HAS VALIDATED BRTX-100 APPROACH oe DefinedHealth a CELLO HEALTH business In May 2018, Defined Health conducted a study with relevant key opinion leaders (KOLs) to provide an informed, independent review of BRTX-100, its supporting data, and its potential to treat cLDD. Ke
Slide 9: BRTX-100 Is Safer and More Potent Than Its Closest Comparable
BRTX-100 IS SAFER AND MORE POTENT THAN ITS CLOSEST COMPARABLE Drug name and description Key attributes Stage of Development oe biorestordt\ve BRTX-100: adult stem cell biologic, administered via 30-minute outpatient intradiscal injection Autologous - uses patients own stem cells Hypoxic cultured - i
Slide 10: Chronic Back Pain Is a $100B Market in U.S. Alone
CHRONIC BACK PAIN IS A $100B MARKET IN U.S. ALONE, WITH SPINAL FUSION COSTS APPROACHING $40B ANNUALLY “Back painisa “Spinal fusion surgery is the form of elective $100-billion-per- surgery that people spend the most on in the year industry in US, costing a total of $40 billion per year. the US.”: Th
Slide 11: Our Analysis Infers Pricing Can Exceed $25K per Treatment
OUR ANALYSIS INFERS PRICING CAN EXCEED $25K PER TREATMENT, ACHIEVING HIGHER QUALITY OUTCOMES AT LOWER COST THAN CURRENT SUBSTITUTES Conservative Treatments Surgical Treatments — $1,000-$2,000 $80,000- annually $150,000 Oral Medication Spinal Fusion Surgery Treatment o $8,000 y4 $20,000- annually $50
Slide 12: Conservative Projections Show $13B+ Market Potential for BRTX-100
CONSERVATIVE PROJECTIONS SHOW $13B+ MARKET POTENTIAL FOR BRTX-100 Total Sales Potential (Billions) Stem-cell therapies for chronic disc degeneration 13.0 10.3 5.9 2.8 1.3 0.4 == 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 Treated 17 53 112 235 412 518 Patients (000s) ‘L Surgeries in Hospital-B
Slide 13: BRTX-100 Has Active IND and FDA Authorization to Begin Phase 2 Trial
BRTX-100 HAS BEEN DEVELOPED, HAS AN ACTIVE IND, AND AUTHORIZATION FROM THE FDA TO BEGIN ITS PHASE 2 TRIAL Today FDA Approval Pre-clinical R&D 2015-2017 + BRT secures relevant license frorn Regenerative Sciences in 2012 + Develops commercial and scalable BRTX-100 product + Proceeds with clinical stra
Slide 14: BRTX-100 Has a Favorable Phase 2 Trial Design
BRTX-100 HAS A FAVORABLE PHASE 2 TRIAL DESIGN The Phase 2 trial is a double-blinded, placebo controlled, randomized study Study includes 72 subjects (2:1 product to placebo) Included subjects will have only one diseased disc Endpoints are based on a 30% reduction in pain and a 30% increase in functi
Slide 15: Patents Pending and Data Exclusivity Should Allow BRTX-100 to Exploit the Market Opportunity
PATENTS PENDING AND DATA EXCLUSIVITY SHOULD ALLOW BRTX-100 TO EXPLOIT THE MARKET OPPORTUNITY IP and legislative protections include: ¢ Licensed patent application covering methods of culturing cells under hypoxic conditions and their use in avascular areas, currently being reviewed by the US Patent
Slide 16: Experienced Leadership and Recognized Advisors
EXPERIENCED LEADERSHIP AND RECOGNIZED ADVISORS ‘ bP Pp Mark Weinreb, M.S., CEO & Chairman Mr, Weinreb is an early pioneer in the field of regenerative medicine and cellular therapy and has significant experience in running public companies. He has been CEO since 2010 and board Chairman since 2011. H
Slide 17: Phase 2 Clinical Trial to Cost $18M
PHASE 2 CLINICAL TRIAL TO COST $18M (thousands) Clinical Development Patient Costs Salaries/Consultants CRO Manufacturing/Quality G&A R&D Total Year 1 $313 $598 $1,593 $510 $200 $3,213 Year 2 $3,089 $313 $2,763 $3,286 $720 $300 $10,470 Year 3 $250 $2,357 $738 $720 Total $3,089 $875 $5,717 $5,617 $1,
Slide 18: Summary and Key Takeaways
SUMMARY AND KEY TAKEAWAYS FDA granted authorization to commence a Phase 2 clinical trial using BRTX-100 under active IND 17275 Independent review was optimistic that existing clinical results are likely to be mirrored in Phase 2 trial BRTX-100 is targeting a large indication that has few comparable
Slide 19: BioRestorative Therapies Contact
biorestorat\|ve therapies 40 Marcus Drive, Suite One Melville, NY 11747 www.biorestorative.com Adam Bergstein, SVP, Planning & Development abergstein@biorestorative.com (312) 445-8880
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