Biorestorative Therapies, Inc. · NASDAQ:BRTX
Biorestorative Therapies — Q1 2025 Earnings Presentation
27 slides from Biorestorative Therapies's earnings presentation, May 14, 2025
Slide 1: Regenerative Biology for Healthier Lives
Regenerative Biology for Healthier Lives Investor Presentation June 2025
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 cosm
Slide 4: Experienced Leadership
Experienced Leadership Lance Alstodt Robert Kristal Chairman & CEO Chief Financial Officer • 30+ years leading, advising and operating companies within the • 25+ years on Bay Street and Wall Street Healthcare sector • Most recently was the DOR for a Healthcare focused Investment Bank • Founder of Me
Slide 5: ThermoStem BRTX-100 BioCosmeceuticals
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 cosmetic applications 5
Slide 6: Going Commercial: Biologics Based Cosmetic Products
Going Commercial: Biologics Based Cosmetic Products The Market • Global Cosmetic market $63 B and growing • Global injectable market 12% CAGR 2021-2026 Est $11.9 B • Derms need differentiated product • Bundle with current procedures Key Features of Cosmetics & Manufacturing Hair Growth • cGMP ISO 7
Slide 7: ThermoStem BRTX-100 BioCosmeceuticals
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 CLINICAL for cosmetic applications 7
Slide 8: Robust Preclinical & Clinical Pipeline
Robust Preclinical & Clinical Pipeline PRECLINICAL PHASE 1 PHASE 2 PHASE 3 COMMERCIAL Lumbar PHASE 2 ONGOING Spine Cervical CLEARED TO B EGIN PHASE 2 AUTOLOGOUS Thoracic Hips/Knees Musculoskeletal Extremities System Avascular Zones Type 2 Diabetes Metabolic Obesity ALLOGENEIC PCOS ARDS Brown Adipose
Slide 9: Chronic Lumbar Disc Disease
Chronic Lumbar Disc Disease (cLDD) 258 M U.S. adult population 64.5 M American adults with chronic lower back pain 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
Slide 10: The Problem: Clinical & Economic
The Problem: Clinical & Economic Conservative Surgical Treatments Treatments ORAL MEDICATION TREATMENT / OPIOIDS SPINAL FUSION SURGERY $1,000 - $2,000 / annu ally $110,000 INJECTION TREATMENT DISCECTOMY $8,000 / a nnu ally $20,000 - $2,000 per injection, 2 injections per treatment-semi-annual treatm
Slide 11: Our Solution: BRTX-100
Our Solution: BTRX-100 Regenerative Conservative Medicine Surgical Treatments Treatments ORAL MEDICATION TREATMENT / OPIOIDS SPINAL FUSION SURGERY $1,000 - $2,000 / annu ally Introduce Hypoxic Cultured $110,000 Autologous MSCs INJECTION TREATMENT DISCECTOMY $8,000 $20,000 - BRTX-100 / a nnu ally $2,
Slide 12: BRTX-100: Clinical Snapshot
BRTX-100: Clinical Snapshot Lead investigational therapeutic product 30 O2 min Autologous Hypoxic (low oxygen) Single intradiscal injection (patient’s own) cultured, bone – anticipated 30 minute cell-based biologic marrow-derived in-office procedure Prior human data provides Ongoing FDA Large growin
Slide 13: BRTX-100: Key Differentiating Factors
BRTX-100: Key Differentiating Factors BRTX-100 Advantages Allogeneic Autologous uses human derived stem uses patients own • Autologous cells means low to no risk of SOURCE cells (not from patient) stem cells rejection, greater safety profile (introduction - 6 million - 40 million of viral/genetic),
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 14
Slide 15: BRTX-100 in cLDD: Phase 2 Trial Design
BRTX-100 in cLDD: Phase 2 Trial Design FDA Cleared IND 17275: Phase 2 Randomized, Controlled Study Design in Patients with cLDD Design Primary Efficacy Endpoint Patient Population • Study includes 99 subjects 12 m, F/U at 24 m • Subjects must have current (2:1 product to placebo) diagnosis of cLDD,
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 1 Clinical Site Production Thawing and Injection of 5 2 Production of BRTX-100 Hypoxic BRTX-100 into Patient’s Disc BRTX-100 Culturing of Stem Cells Production
Slide 17: BRTX-100: Cleared DSMB June 2023
BRTX-100: Cleared DSMB June 2023 Unanimous approval by the DSMB 3:1 randomization to continue trial without changes BRTX-100 is safe and well tolerated No Significant Adverse Events All 4 subjects successfully dosed VAS, ODI, SF-12, RMDQ, and FRI scores to with either 40 mil hMSCs or placebo measure
Slide 18: Compelling Preliminary Phase 2 Clinical Data
Compelling Preliminary Phase 2 Clinical Data (36 Subjects): Presented at ISSCR 2025 Meaningful Signals FDA is requiring at least a greater than 30% improvement in function (ODI) and a greater than 80% 30% reduction in pain (VAS) in determining whether the clinical trial will be allowed to proceed an
Slide 19: ThermoStem Program: Allogeneic Cell-based Therapy
ThermoStem Program: Allogeneic Cell-based Therapy Target Conditions: Obesity, Type 2 diabetes, Platform Program: and Metabolic disorders For the development of cell & small molecule therapies Cell Type: Brown Fat • Has been shown to regulate metabolic homeostasis in the body Components of Library: •
Slide 20: Metabolic Program Highlights
Metabolic Program Highlights First human stem cell derived BAT transfer Creation of first human 3D engineered artificial brown WHITE FAT adipose tissue construct (aBAT) Successful delivery of 3D aBAT construct in mouse model BEIGE FAT Transplantation of aBAT lowered blood glucose levels BROWN FAT Tr
Slide 21: Metabolic Program Clinical Pathway
Metabolic Program Clinical Pathway Initiate Phase 1/2 Clinical Trial Pre-IND Meeting Upon FDA approval commence Phase 1/2 clinical trial. with FDA Scheduling Pre-IND meeting with FDA to discuss first-in-man File DMF fast-track regulatory pathways. with FDA Expect filing a Drug Master File (“DMF”) wi
Slide 22: Our Opportunities are Well-Protected
Our Opportunities are Well-Protected PROGRAM ThermoStem INDICATION Disc / Spine Metabolic • Brown Fat Compositions and Methods • Methods and Compositions to facilitate • Human Brown Adipose Derived Stem Cells repair of avascular tissue and Uses PATENT TITLES • Surgical Methods and Compositions to •
Slide 23: Scientific Advisory Board
Scientific Advisory Board Wayne Marasco, MD, PDt Jason Lipetz, MD Harvinder Sandhu, MD Chairman of SAB Sub Committee Chairman of SAB Member Disc Advisory Board Disc Advisory Board • Principal Faculty Member of Harvard Stem • Chief of Spine Medicine for the Northwell • Orthopedic Spine Surgeon at the
Slide 24: Financial Summary
Financial Summary C URREN T C APITA LI ZAT ION SHARES Common Shares 8.6 Million* Outstanding Preferred Series B Shares Convertible to 1.4 Million Common** Outstanding Cash $ 9.1 Million** Debt $0 * As of 05/13/2025; includes ~1.1 million common shares held in abeyance ** As of 03/31/2025 24
Slide 25: 2024 and Recent Accomplishments
2024 and Recent Accomplishments ✓ Announced FDA clearance of important BRTX-100 clinical study protocol amendment (replaces saline injection with sham injection in control arm) ✓ Reported positive preliminary Phase 2 BRTX-100 study data (36 patient) in cLDD ✓ Received FDA Fast Track Designation for
Slide 26: In Conclusion
In Conclusion Addressing Multi-Billion Dollar Markets cGMP ISO-7 Certified Clean room with Unmet Needs Disruptive Platform Technologies in Opportunity for Key Strategic Cellular Therapy Partnerships in Cosmetic Space Strong Preliminary Data Indicative of Strong Intellectual Property Protection Posit
Slide 27: 40 Marcus Drive, Suite 1 Melville, NY 11747 biorestorative.com
40 Marcus Drive, Suite 1 Melville, NY 11747 (631) 760-8100 biorestorative.com
BioRestorative Therapies — Q1 2025 Earnings Presentation on 6ix