Biorestorative Therapies, Inc. · NASDAQ:BRTX

Biorestorative Therapies — ORS PSRS 7th International Spine Research Symposium 2024

19 slides from Biorestorative Therapies's conference presentation, Nov 13, 2024

  1. Slide 1: BioRestorative Therapies - ORS PSRS 7th International Spine Research Symposium

    biorestorat\|ve therapies ORS PSRS 7th International Spine Research Symposium November 2024 Francisco Silva Vice President of Research and Development RA ome Ui disc age Oi Nasdaq: BRTX

  2. 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

  3. Slide 3: Disc Microenvironment

    Disc Microenvironment ¢ Avascular: The IVD is avascular, meaning the nearest blood vessel can be up to 8mm away. This makes it difficult to transport nutrients and waste. High osmolarity: Low glucose : . . . 430-496 1 mmol/L * Hypoxic: The IVD has low oxygen tension, with mOsm/L an average concentra

  4. Slide 4: Targeting Disc Microenvironment

    Targeting Disc Microenvironment HYPOXIA & Poorly ‘MTissue Remodeling & ENP Celtularity t ise | yte Cells Angi i Sox9,ACAN,BGLAP,ALPL,KRT1 VEGF,FGF1,TGFB1,MDK SFN,TNFAIP6,Low SFN,DES,ACAN, TIMP *GRN,SPHK1,Desmin,RA CXCLS, Low 1/3,ADAMTS4,MMP2, chemokines ANKH 9,BARX1,MDFI,DCHS1,TGFB3, BMP-4,GDF-5, VE

  5. Slide 5: Figure 1. Chondrocyte Differentiation

    Figure 1. Chondrocyte Differentiation "SOx! N mCOLIAl =COL2AI mSOX9 HACAN MCOLIAI =COL Expression of SOX9, Aggrecan (ACAN), Collagen Type | Alpha 1 Chain (COL1A1) and Collagen Type I Alpha 1 Chain (COL2A1) by gPCR. A) Hypoxic cultured bone marrow derived mesenchymal stem cells (HC-BMMSCs) at day 0 (

  6. Slide 6: BRTX-100 Hypoxic BM-MSCs

    BRTX-100 Hypoxic BM-MSCs cout Atmospheric Hypoxic “Atmospheric ayo can a 2 LD Amopsrere 2 Di tiypoxe coLzat - Table 1. Chondrogenic Growth Factor and Notochord Transcripts Expressed by HC-BMMSCs Hypoxia (H) | Normxia(N) Fold Diference Human Notochord Markers Value (FPKM) Value (FPKM)|_H versus KRTg

  7. Slide 7: BRTX-100 Hypoxic BM-MSCs

    BRTX-100 Hypoxic BM-MSCs PIK3REXLOC_021790 DESKLOC_028338 LDLRADAHLOG_023140 GUCATARP-13008.6) uyo7ej COxcLspL00 038178 AP 002026-1,0L629KL0¢ 009748 Atmopsheric Hypoxic logo FPKM + 1 20 Chondrogenesis Cartilage Metabolism Inflammation immunomodulation CXCL5 SFN Hypoxic Culturing Vasculogenesis Angio

  8. Slide 8: Phase 2 Clinical Trial - BRTX-100 Overview

    > Bit, Ae) Phase 2 Clinical Trial — BRTX-100/IND 17275 dis ¢ A Phase 2, Double-Blind, Sham-Controlled, Randomized Study to Evaluate the Safety and Preliminary Efficacy of a Single Dose Intradiscal Injection of BRTX-100 for Patients with Chronic Lumbar Disc Disease (cLDD) * BRTX-100 (40x10°/1.5cc) ¢

  9. Slide 9: Phase 2 Clinical Trial - BRTX-100/IND 17275

    br Phase 2 Clinical Trial - BRTX-100/IND 17275 dISC Collection Collection and Shipment of Patient’s Bone Marrow and Blood to Cell Production Manufacturer Clinical Site Production Thawing and Injection of BRTX-100 rs | Production of BRTX-100 Hypoxic into Patient’s Disc BRTX-100 Culturing of Stem Cell

  10. Slide 10: Phase 2 Clinical Trial - Primary Objective: Safety

    Bit, Phase 2 Clinical Trial - BRTX-100/IND 17275 dIS ¢ Double-blind, sham-controlled, randomized study with blinded assessments using a single dose. * BRTX-100 (40x109/1.5cc) ¢ Primary Objective: Safety * To investigate the safety of a single dose of BRTX-100 via intradiscal injection in patients wi

  11. Slide 11: Phase 2 Clinical Trial - Secondary Objective and Endpoints

    Bit, Phase 2 Clinical Trial - BRTX-100/IND 17275 dIS * Secondary Objective: * Secondary Efficacy Endpoints * To investigate the preliminary efficacy of * Clinical Response at Weeks 26 and 104 single dose of BRTX-100 delivered via . ; ; intradiscal injection in patients with chronic * VAS - Pain: A f

  12. Slide 12: Phase 2 Clinical Trial - Inclusion and Exclusion Criteria

    Phase 2 Clinical Trial — BRTX-100/IND 172 ¢ Inclusion Criteria: * High index of suspicion degenerative disc disease (DDD)/discogenic pain Chronic lower back pain for at least 6 mos Failure of at least 6 mos of conservative back pain care Modified Pfirrmann score of 2 to 7 on MRI, may contain a conta

  13. Slide 13: Adverse Events

    Phase 2 Clinical Trial — BRTX-100/IND 17275 ait Adverse Events me ¢« No serious adverse events (SAEs) in any of the 10 safety run-in subjects * 9 adverse events (AEs) in 3 of the 10 safety run-in subjects ¢ 5 AEs (2 subjects) related to treatment * 3 episodes of increased post-procedural back pain i

  14. Slide 14: VAS

    Phase 2 Clinical Trial — BRTX-100/IND 17275 ait VAS ¢ At 26 weeks 70% of patients report > 30% improvement VAS score (n=10). ¢ At 52 weeks 100% of patients report > 30% Improvement VAS score (n=4) 30% Improvement A VAS from baseline rn Mixed-effects analysis, with Geisser-Greenhouse correction and D

  15. Slide 15: ODI

    Phase 2 Clinical Trial — BRTX-100/IND 17275 ait ODI « At 12 & 26 weeks 70% of patients 207 had >30% improvement in reported ODI from their baseline (n=10). ¢ At 52 weeks all patients reported greater than 30% improvement in reported ODI (n=4) 30% @ |mprovement A ODI from baseline Mixed-effects analy

  16. Slide 16: Relative ODI and Relative VAS

    Bit, Phase 2 Clinical Trial - BRTX-100/IND 17275 dIS Relative ODI Relative VAS * ** Patients with >30% -A of ODI and VAS >30% improvement ~ t 0.0 0.5 1.0 1.5 A ODI from baseline Mixed-effects analysis, with Geisser-Greenhouse correction and Dunnett’s multiple comparison test (*p< 0.05, **p<0.01)

  17. Slide 17: RMDQ

    Phase 2 Clinical Trial — BRTX-100/IND 17275 ait RMDQ ISC Relative RMDQ = o Relative RMDQ i= * ® 254 . “1 8 20- = Subject 1 4 ge 11 Subject 2 >, & 4T -* Subject 3 i—j £ F) 34 Subject 4 2 , il £ 44 Subject 5 ut eS a) 4% Subject 6 0 fa. = 2° 14 , o = Subject 7 ot T T T T 2 0 T T T Y 7 -¥ Subject 8 Re R

  18. Slide 18: FRI

    Phase 2 Clinical Trial — BRTX-100/IND 17275 ait FRI Relative FRI Relative FRI * oO | £4 . @ 4 ** a -® Subject 1 o 2 3] Subject 2 8 3 5 -- Subject 3 5 ‘9 24 Subject 4 = oa ‘o 2 5 Subject 5 es i s 3414 © Subject 6 S |B -APt abs ots 3 - Subject 7 no} eS 2 0 al fete zo T T T Y T -&- Subject 8 iL ; eo ow

  19. Slide 19: Preliminary Safety and Efficacy End Points

    Ae) Phase 2 Clinical Trial — BRTX-100/IND 17275 dis Preliminary Safety End Points * Blinded clinical data of a single dose of BRTX-100 (40x10) is well tolerated with no SAE or dose limiting toxicity at 26-52 weeks (n=10) Preliminary Efficacy End Points ¢ Blinded clinical data of preliminary efficacy

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