Biorestorative Therapies, Inc. · NASDAQ:BRTX
Biorestorative Therapies — Investor Presentation (March 2024)
30 slides from Biorestorative Therapies's investor presentation, Mar 12, 2024
Slide 1: Regenerative Biology for Healthier Lives: Investor Presentation
piorestercie therapies Regenerative Biology for Healthier Lives Investor Presentation March 2024
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 wit
Slide 3: Fully Integrated Regenerative Medicine Company
Fully Integrated Regenerative Medicine Company DEVELOPMENT COMMERCIAL ThermoStem BRTX-=100 BioCosmeceuticals Brown adipose derived Bone marrow derived Secretome (novel EXOSOME, stem cells mesenchymal stem cells growth factor/cytokine) biologics based technology PRECLINICAL MID-STAGE CLINICAL for cos
Slide 4: Experienced Leadership
Experienced Leadership Lance Alstodt Chairman & CEO » 30+ years leading, advising and operating companies within the Healthcare sector Founder of MedVest Capital, a Healthcare fund created in 2013 Prior to that led the Medical Technology investment banking group at Bank of America Merrill Lynch and
Slide 5: Commercial
COMMERCIAL ThermoStem BRTX-100 BioCosmeceuticals Secretome (novel exosome, growth factor/cytokine) biologics based technology for cosmetic applications biorestorailve
Slide 6: Going Commercial: Biologics Based Cosmetic Products
Going Commercial: Biologics Based Cosmetic Products The Market D * Global Cosmetic market $63 B and growing q * Global injectable market 12% CAGR 2021-2026 Est $11.9 B RS + Derms need differentiated product * Bundle with current procedures Key Features of Cosmetics & ° Manufacturing Hair Growth + CG
Slide 7: Development
DEVELOPMENT ThermoStem BRTX-100 Brown adipose derived Bone marrow derived ¢ ne \ Y stem cells mesenchymal stem cells y 1 Fa tokin I cs | inol PRECLINICAL MID-STAGE CLINICAL cosmeti bi orestordilve
Slide 8: Robust Preclinical & Clinical Pipeline
Robust Preclinical & Clinical Pipeline AUTOLOGOUS ALLOGENEIC PRECLINICAL PHASE1 PHASE2 PHASE3 COMMERCIAL Musculoskeletal System Lumbar Cervical Thoracic Hips/Knees Extremities Avascular Zones Phase 2 IND’ SUBMITTED" oe Metabolic Brown Adipose Stem Cells Secretome / Exosome Type 2 Diabetes Obesity PC
Slide 9: Chronic Lumbar Disc Disease (cLDD) U.S. adult population
Chronic Lumbar Disc Disease (cLDD) 258 M U.S. adult population 64.5 M snerbackpain prevalence. 32 M American adults with diagnosed and treated disc degeneration 15 M Americans suffering pain caused by a protruding or injured disc 2 5 M Invasive Surgical Procedures per e year $40 billion in surgeries
Slide 10: The Problem: Clinical & Economic
The Problem: Clinical & Economic Conservative Surgical Treatments Treatments TAIT ee ar \ d SPINAL FUSION SURGERY $1,000 - $2,000. 4 $110,000 INJECTION TREATMENT Ve i a DISCECTOMY $8,000 joc, UNMET N . ED $20,000 - $2,000 I 1, 2i ic iseeimatcaiaat Mupl SeTE ROE CRTUNLEY ZONE $50,000 PHYSICAL MEASURE
Slide 11: Our Solution: BRTX-100
Our Solution: BTRX-100 Conservative Treatments ORAL MEDICATION TREATMENT J oPioips $1,000 - $2,000 ,..., INJECTION TREATMENT $8,000 ....2, $2,000 per injection, 2 injections per treatment-semi-annual treatment PHYSICAL MEASURES $20,000 ,.,..c1, $200 per session, 2 sessions per week Often Recurrent @
Slide 12: BRTX-100: Clinical Snapshot
BRTX-100: Clinical Snapshot Lead investigational therapeutic product o° eo Autologous Hypoxic (low oxygen) Single intradiscal injection (patient’s own) cultured, bone — anticipated 30 minute cell-based biologic marrow-derived in-office procedure * Ne) lal ail Prior human data provides FDA authorized
Slide 13: BRTX-100: Key Differentiating Factors
BRTX-100: Key Differentiating Factors SOURCE CULTURING CARRIER MANUFACTURING pmesoblast Allogeneic uses human derived stem cells (not from patient) - 6 million Normoxic cultured with normal oxygen environment (~20%) Hyaluronic Acid Carrier Animal Products Used Autologous uses patients own stem cells
Slide 14: BRTX-100: Positive Human Data
BRTX-100: 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 Centono etal sons Med 201715197 ‘O01 To. Hearst 967-017-1300 Journal of Translational Medicine Original Cl
Slide 15: BRTX-100: Phase 2 Trial Design
BRTX-100: Phase 2 Trial Design FDA Cleared IND 17275: Phase 2 Randomized, Controlled Study Design in Patients with cLDD Design + 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 Endpoint 12m,
Slide 16: BRTX-100: Logistical/Clinical Process
BRTX-100: Logistical /Clinical Process Collection Collection and Shipment of Patient's Bone Marrow and Blood to Cell Production Manufacturer Clinical Site Production Thawing and Injection of Production of BRTX-100 Hypoxic BRTX-100 into Patient's Disc BRTX-100 Culturing of Stem Cells Production Proce
Slide 17: BRTX-100: Cleared DSMB June 2023
BRTX-100: Cleared DSMB June 2023 Unanimous approval by the DSMB to continue trial without changes 3:1 randomization BRTX-100 is safe and well tolerated No Significant Adverse Events All 4 subjects successfully dosed with either 40 mil NMSCs or placebo VAS, ODI, SF-12, RMDQ, and FRI scores to measure
Slide 18: Preliminary Phase 2 Clinical Data: Meaningful Signals
Preliminary Phase 2 Clinical Data: Meaningful Signals “Autologous Stem Cell Therapy for Chronic Lumbar Disc Disease, Initial Phase 2 Clinical Safety and Feasibility Data of intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells,” presented at ORS 2024 + 4subjects underwent successful dosi
Slide 19: Raw Data
Raw 40-4 20 Data FRI 60-5 T T T T T Baseline wk2 wk12 wk26 wk 52 ODI T T T + T Baseline wk2 wki2— 0 wk26 wk52 —@- Subject! T y u uy r —fl- Subject 2 Baseline wk2 wki2— wk26 wk52 " RMDQ —t- Subject 3 —¥ Subject 4 T T T T T Baseline wk2 wkiI2 9 wk26 wk52 bi orestordilve
Slide 20: Relative Change
Relative Change Relative FRI Relative VAS 2.57 2.05 2.0- 1s 18 104 10 0.55 0.5- oO. oO. T T T T 7 Baseline = wk2 wki2—0 wk26 ~wk52 Relative ODI T T T iu T Baseline wk2 wki2— wk26 wk52 T T Baseline wk2 Relative RMDQ T wki2 T wk 26 T wk 52 T Baseline T wk 2 T wk 12 T wk 26 T wk 52, —@- Subject! —f- Su
Slide 21: ThermoStem Program: Allogeneic Cell-based Therapy
ThermoStem Program: Allogeneic Cell-based Therapy Target Conditions: Obesity, Type 2 diabetes, and Metabolic disorders Cell Type: Brown Fat * Has been shown to regulate metabolic homeostasis in the body Components of Library: + Human Brown Adipose Tissue (BAT) * White Adipose Tissue (WAT) * Brown Ad
Slide 22: Metabolic Program Highlights
Metabolic Program Highlights First human stem cell derived BAT transfer WHITE FAT Creation of first human 3D engineered artificial brown adipose tissue construct (aBAT) SAR Se CBN Successful delivery of 3D aBAT construct in mouse model BEIGE FAT View Transplantation of aBAT lowered blood glucose lev
Slide 23: File DMF / Initiate Phase 1/2 Clinical Trial
File DMF with FDA Expect filing a Drug Master File (“DMF”) with the FDA to facilitate licensing opportunities around Thermostem. Initiate Phase 1/2 Clinical Trial Pre-IND Meeting Upon FDA approval commence with FDA Phase 1/2 clinical trial. Scheduling Pre-IND meeting with FDA to discuss first-in-man
Slide 24: Our Opportunities are Well-Protected
Our Opportunities are Well-Protected PROGRAM INDICATION PATENT TITLES NO. OF APPLICATIONS STATUS «Dn disc Disc / Spine + Methods and Compositions to facilitate repair of avascular tissue + Surgical Methods and Compositions to facilitate repair of avascular tissue + Therapeutic Delivery Device 12 2 I
Slide 25: Scientific Advisory Board
Scientific Advisory Board Wayne Marasco, MD, PDt Chairman of SAB Principal Faculty Member of Harvard Stem Cell Institute Professor in the Department of Cancer Immunology & AIDS at the Dana-Farber Cancer Institute Professor of Medicine at Harvard Medical School Wayne Olan, MD Clinical Director of Reg
Slide 26: Financial Summary
Financial Summary Common Shares a Outstanding | 6.7 Million Cosh | $12.2 Million’ Debt | $0 * As of 09/30/2023; does not include approx. net proceeds of $7.6 million from 02/06/2024 warrant exchange biorestoratlve
Slide 27: 2023 Accomplishments
27 2023 Accomplishments (V} Expanded ThermoStem patent portfolio in U.S. and Japan @ Two Notice of Allowances @ completed 4 patient Safety Run-in component for Phase 2 @ Announced a filing and execution of an ATM (V} Announced Northwell Healthcare Partnership — Largest Healthcare System in the North
Slide 28: Upcoming Milestones: Provide Multiple Potential Value Inflection Points
Upcoming Milestones: Provide Multiple Potential Value Inflection Points PLATFORM Cell-Based Secretome Derived BRTX-100 Brown Fat Derived Adipose Tissues | procram/activity | Skin remodeling, facial application /hair growth cLDD Obesity, PCOS and Metabolic Disorders Expand Patent Portfolio SITUATION
Slide 29: In Conclusion
In Conclusion CGMP ISO-7 Certified Clean room Addressing Multi-Billion Dollar Markets with Unmet Needs Disruptive Platform Technologies in Cellular Therapy Opportunity for Key Strategic Partnerships in Cosmetic Space Strong Preliminary Data Indicative of Positive Trial Outcomes Strong Intellectual P
Slide 30: BioRestorative Therapies contact details
miorectorcive therapies 40 Marcus Drive, Suite 1 Melville, NY 11747 (631) 760-8100 biorestorative.com
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