BioRestorative Therapies, Inc. · NASDAQ:BRTX
BioRestorative Therapies — Investor Presentation (August 2018)
17 slides from BioRestorative Therapies's investor presentation, August 2018
Slide 1: BRTX-100 Investor Overview
CONFIDENTIAL BRTX-100 Investor Overview Summer 2018 CONFIDENTIAL
Slide 2: Forward Looking Statements; Restrictions on Use
FORWARD LOOKING STATEMENTS; RESTRICTIONS ON USE Statements in this BRTX-100 Investor 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 factua
Slide 3: Company Background
COMPANY BACKGROUND BioRestorative Therapies, Inc. We have developed BRTX-100®, a stem-cell based treatment for chronic lumbar disc disease (“BRT”) develops therapeutic (“cLDD”): treatments from adult stem cells • Autologous stem cell-based biologic • Hypoxic cultured, bone marrow-derived • Single in
Slide 4: Low back pain is a leading cause of disability and has enormous social and economic impact
LOW BACK PAIN IS A LEADING CAUSE OF DISABILITY AND HAS ENORMOUS SOCIAL AND ECONOMIC IMPACT Chronic Lumbar Disc Disease is degenerative: • Compromised disc is associated with lower back pain • Over time, functionality is also limited • Disc degeneration is presently irreversible 80% of adults experie
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 Surgical Treatment Options • OTC pain medications (NSAIDs, analgesics) • Posterior lumbar fusion (PLF) • Narcotics (codeine, oxycodone-acetaminophen • Posterior
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 Key Attributes • Targeted for patients whose pain and disabilities have not been • One-time, intradiscal injection performed as a 30- alleviated by conservative treatments and face the prospect of minute outpatient p
Slide 7: Human data from studies of therapies similar to BRTX-100 show reduced pain, increased function
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 • Description: 33 patients diagnosed with degenerative disc disease received an intradiscal injection of autologous, hypoxic cultured, b
Slide 8: Independent consulting firm has validated BRTX-100 approach
INDEPENDENT CONSULTING FIRM HAS VALIDATED BRTX-100 APPROACH 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. Key findings include: • Stem-cell therapies
Slide 9: BRTX-100 is safer and more potent than its closest comparable
BRTX-100 IS SAFER AND MORE POTENT THAN ITS CLOSEST COMPARABLE BRTX-100’s Advantages BRTX-100: adult stem cell biologic, MPC-06-ID: adult stem cell biologic, Drug name and administered via 30-minute outpatient administered via 30-minute outpatient description intradiscal injection intradiscal injecti
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 pain is a “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.” 1
Slide 11: Pricing can exceed $25K per treatment, achieving higher quality outcomes at lower cost
OUR ANALYSIS INFERS PRICING CAN EXCEED $25K PER TREATMENT, ACHIEVING HIGHER QUALITY OUTCOMES AT LOWER COST THAN CURRENT STANDARDS OF CARE Conservative Treatments Surgical Treatments (OFTEN RECURRENT) (WITH RE-OP RATES OFTEN 10-20%) $80,000- $25,000 for a single $1,000-$2,000 treatment using BRTX-100
Slide 12: BRTX-100 has an active IND and FDA authorization to begin a Phase 2 trial
BRTX-100 HAS AN ACTIVE IND AND AUTHORIZATION FROM THE FDA TO BEGIN A PHASE 2 TRIAL Today FDA Approval Pre-clinical R&D Phase 1 (not required) Phase 2 Phase 3 2015-2017 2017 2018-2022 Contingent on Phase 2 • BRT secures relevant • BRT submits IND • BRT ready to begin • In the event of a successful li
Slide 13: BRTX-100's Phase 2 trial is a double-blinded, placebo controlled, randomized study
BRTX-100’S 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 function • Considered by FDA and key op
Slide 14: Patents pending and data exclusivity represent barriers to competition
PATENTS PENDING AND DATA EXCLUSIVITY REPRESENT BARRIERS TO COMPETITION AND ENHANCE 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 U
Slide 15: Phase 2 clinical trial to cost $18M
PHASE 2 CLINICAL TRIAL TO COST $18M (thousands) Year 1 Year 2 Year 3 Total Clinical Development Patient Costs $3,089 $3,089 Salaries/Consultants $313 $313 $250 $875 CRO $598 $2,763 $2,357 $5,717 Manufacturing/Quality $1,593 $3,286 $738 $5,617 G&A $510 $720 $720 $1,950 R&D $200 $300 $500 Total $3,213
Slide 16: 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 BRT is offering a partner the Independent review was optimistic that existing clinical results are opportunity to acquire an likely to be mirrored in Phase 2 trial interest
Slide 17: Contact
40 Marcus Drive, Suite One Melville, NY 11747 www.biorestorative.com Mark Weinreb, CEO mweinreb@biorestorative.com (516) 359-4422 CONFIDENTIAL 17
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