Biorestorative Therapies, Inc. · NASDAQ:BRTX
Biorestorative Therapies — Investor Presentation (September 2022)
26 slides from Biorestorative Therapies's investor presentation, Sep 13, 2022
Slide 1: BioRestorative Therapies
hlomeain sities therapies
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT biorestoratlve 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” I
Slide 3: Leadership
LEADERSHIP LANCE ALSTODT Chairman & CEO Lance leads BRTX’s mission to improve the lives of patients through the use of Regenerative Medicine Lance spent over 30 years leading, advising and operating companies within the Healthcare sector. He is the founder of MedVest Capital, a Healthcare fund creat
Slide 4: Company Highlights
COMPANY HIGHLIGHTS renerenre therapies Disruptive Platform Technologies in Cellular Therapy Strong Preliminary Data Indicative of Positive Trial Outcomes Active Phase 2 Trial in Spine Addressing Multi-Billion Dollar Markets with Unmet Needs Opportunity for Key Strategic Partnerships Multiple Near-Te
Slide 5: Allogeneic and autologous platform technology pipeline
a = fe) D xe} ° £ =] < Allogeneic A Platform Technology Spine Lumbar Cervical Thoracic Musculoskeletal System Hips/Knees Extremities Avascular Zones Metabolic Type 2 Diabetes Obesity PCOS Brown Adipose Stem Cells ARDS Long Hauler Covid Gene Modification BRTX 200 Polymer/Crispr Preclinical Phase 1 Ph
Slide 6: Chronic Lumbar Disc Disease Program
CHRONIC LUMBAR DISC DISEASE PROGRAM — PHASE 2 blomeorece Lead investigational therapeutic product 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 insig
Slide 7: Market Opportunity — BRTX
eS MARKET OPPORTUNITY — BRTX 100 piorenerenea therapies @ 258 MILLION American adult population e e American adults with chronic lower back 64.5 MILLION pain prevalence e American adults with diagnosed and treated 32 MILLION disc degeneration —_ e 15MILLION Americans have pain caused by a protruding
Slide 8: Standard of Care: Clinical and Economic Problem
STANDARD OF CARE: CLINICAL AND ECONOMIC PROBLEM restorat fa CONSERVATIVE TREATMENTS OFTEN RECURRENT ORAL MEDICATION TREATMENT SIMPLE ELEGANT SOLUTION $1,000 - $2,000 INTRODUCE HYPOXIC CULTURED Annually AUTOLOGOUS MSCs INJECTION TREATMENT $8,000 > fl Annually a) $2,000 per injection, 2 injections per
Slide 9: Logistical/Clinical Process
LOGISTICAL/CLINICAL PROCESS biorestorat|ve therapies Shipping BD. Shipping _ OQ \ Y | \ \ \ / / Bone marrow and Sample shipped at / BRTX-100® BRTX-100® shipped | Intradiscal delivery \ blood collected ambient to Manufactured, and frozen to clinical site of BRTX-100® from subject. BioRestorative QC r
Slide 10: Positive Human Data
Se POSITIVE HUMAN DATA biorestordtlve therapies 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. Sorvoneastanr ona ____ Journal of Translational Medicine Treatment of lumbar degenerati
Slide 11: Defined Health Report
eS DEFINED HEALTH REPORT meee ee therapies 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 Include: » Stem-cell therapies have “great potential” to treat cLDD (and relate
Slide 12: Trial Design
TRIAL DESIGN FDA Cleared IND 17275: Phase 2 Randomized, Controlled Study Design in Patients with CLDD Study Design and Patient Population + 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
Slide 13: Trial Design: Endpoints
TRIAL DESIGN FDA Cleared IND 17275: Phase 2 Randomized, Controlled St Design in Patients with CLDD Primary and Secondary Endpoints: Primary Efficacy Endpoint: The primary efficacy endpoint is clinical response, defined as at least a 30% decrease in pain as measured on the VAS scale and at least a 30
Slide 14: Competitive Landscape Key Differentiating Factors
COMPETITIVE LANDSCAPE KEY DIFFERENTIATING FACTORS mij: ecoraiva Hypoxic cultured — in low oxygen environment (5%) Autologous — uses patients own stem cells - 40 million KEY ATTRIBUTES Autologous Platelet Lysate Carrier 100% Animal-Free Manufacturing Process pmesoblast Normoxic cultured — with normal
Slide 15: Autologous Platform
AUTOLOGOUS PLATFORM THORACIC LUMBAR = > ny EXTREMITIES \ CERVICAL KNEES D EXTREMITIES / MULTIPLE OPPORTUNITIES BRTX 100 is a platform technology with multiple applications First Indication is CLDD currently approved for a Phase 2 Clinical Study Near term opportunities to leverage platform across oth
Slide 16: Metabolic Program
METABOLIC PROGRAM a MIGRAINES, DEPRES PSEUDOT Ub NON-ALCOHOUC FATTY LIVER DISEASE TYPE MERUTUS, can HYPERTENSION pysuripe HYPER Pew A, ESTEROLEMIA restorat|ve THERMOSTEM PROGRAM > “Off the shelf” allogeneic cell-based therapy targeted to treat obesity, Type 2 diabetes and metabolic disorders using b
Slide 17: Metabolic Program Highlights
eS METABOLIC PROGRAM HIGHLIGHTS meee ee therapies oO NO) i i oS First human stem cell derived BAT transfer ee Creation of first human 3D engineered artificial brown adipose tissue construct (aBAT) Successful delivery of 3D aBAT construct in mouse model eB Transplantation of aBAT lowered blood Ls glu
Slide 18: Metabolic Program Clinical Timeline
eS METABOLIC PROGRAM CLINICAL TIMELINE meee ee therapies 2022 2023 2023/2024 ; Pre-IND Initiate eae Meeting Phase 1/2 with FDA Clinical Trial Expected filing a Drug Master File (“DMF”) with the FDA to facilitate licensing opportunities Schedule pre-IND (Investigational New Drug) meeting with FDA to
Slide 19: Intellectual Property
INTELLECTUAL PROPERTY bioresterenya therapies PROGRAM: DISC/SPINE PROGRAM: METABOLIC (THERMOSTEM) PATENT TITLES Methods and Compositions to facilitate repair Brown Fat Compositions and Methods of avascular tissue Human Brown Adipose Derived Stem Cells and Uses Surgical Methods and Compositions to No
Slide 20: Near-Term Goals
NEAR-TERM GOALS -------------------( > Product Manufacturing Clearance Vv > Clinical Sites Established for Disc Trial Vv biorestora ive therapies > Announce Contracts with Clinical Research Organization (cro) > Announce opening of Cell cGMP Manufacturing Facility / > Filings of New BRTX-100 Patents
Slide 21: Company Highlights
COMPANY HIGHLIGHTS restorative therapies Disruptive Platform Technologies in Cellular Therapy Strong Preliminary Data Indicative of Positive Trial Outcomes Active Phase 2 Trial in Spine Addressing Multi-Billion Dollar Markets with Unmet Needs Opportunity for Key Strategic Partnerships Multiple Near-
Slide 22: Financial Summary
eS FINANCIAL SUMMARY meee ee therapies Current Capitalization Shares Basic Shares Outstanding 3,645,886 Cash on Hand $17.9 MILLION Debt $0 Sufficiently funded for Ph2 BRTX-100 TRIAL Data as of Q2 2022
Slide 23: Upcoming Milestones/Catalysts
BioRestorative Upcoming Milestones/Catalysts boreseraire therapies FDA se! Data Read out Ql/2023 Recommend patients continue in the study Enablable acceleration of enrollment Validate Safety Profile/ Program Approach Site Enrollment / Announcements Ongoing Continue to announce prestigious sites and
Slide 24: Scientific Advisory Board
eS SCIENTIFIC ADVISORY BOARD restordt\ve Wayne Marasco, M.D,, Ph.D. is a principal faculty member of Harvard Stem Cell Institute as well as a Professor in the MENGE EAE), ep ii) Department of Cancer Immunology & AIDS at the Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Chairman
Slide 25: Leadership
LEADERSHIP Lance Alstodt joined BioRestorative Therapies as its Chairman and Chief Executive Officer in November 2020. Mr. Alstodtt brings over 25 years of experience in operations, strategy, capital raising and mergers & acquisitions. Mr. Alstodt is the Founder and CEO of MedVest Consulting Corpora
Slide 26: sflorestercilee
sflorestercilee therapies
BioRestorative Therapies — Investor Presentation (September 2022) on 6ix