Biorestorative Therapies, Inc. · NASDAQ:BRTX
Biorestorative Therapies — Investor Presentation (February 2025)
20 slides from Biorestorative Therapies's investor presentation, Feb 10, 2025
Slide 1: Next Generation Orthobiologic Therapy for Chronic Lumbar Disc Disease
Next Generation Orthobiologic Therapy for Chronic Lumbar Disc Disease: Initial Phase 2 Data of Hypoxic Cultured Mesenchymal Stem Cells Francisco Silva Founder Chief Scientific Officer Nasdaq: BRTX
Slide 2: Disclaimer
risnestene ie Disclaimer orestorat| This presentation contains "forward-looking statements" within the meaning of the federal securities laws, including statements concerning the ability of BioRestorative Therapies, Inc. (the “Company”) to develop its adult stem cell business, the future of regenera
Slide 3: Back Pain
Back Pain Conservative Treatments ORAL MEDICATION TREATMENT / OPIOIDS $1,000 - $2,000 INJECTION TREATMENT $8,000... $2,000 per injection, 2 injections per treatment-semi-annualtreatment PHYSICAL MEASURES $20,000 ...., $200 per session, 2 sessions per week Often Recurrent Fannualty Orthobiologics Int
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
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 (
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
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
Slide 8: Phase 2 Clinical Trial 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) ¢
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
Slide 10: Phase 2 Clinical Trial - Primary Objective
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
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
Slide 12: 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
Slide 13: Adverse Events
Phase 2 Clinical Trial — BRTX-100/IND 17275 ait Adverse Events AEE ¢ No serious adverse events (SAEs) * 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 in 2 subjects * 2 MRI changes (worsening
Slide 14: VAS
Phase 2 Clinical Trial — BRTX-100/IND 17275 ait VAS ** ¢ At 26 weeks 70% of patients report > 30% | oe improvement VAS score (n=10). ; ¢ At 52 weeks 100% of patients report > 30% @ ° Improvement VAS score (n=5) 3 24 * 12 week avg improvement - ° * 12 week avg improvement < 30% = -6.38% é ahs 3 30% .
Slide 15: ODI
Phase 2 Clinical Trial — BRTX-100/IND 17275 ait ODI ¢ At 12 & 26 weeks 70% of patients had >30% improvement in reported ODI from their | ee baseline (n=10). * At 52 weeks all patients reported greater than , 30% improvement in reported ODI (n=5) = * 12 week avg improvement 3 sox * 12 week avg improv
Slide 16: 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
Slide 17: 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
Slide 18: MRI Baseline vs Weeks
Phase 2 Clinical Trial — BRTX-100/IND 17275 ait MRI Baseline vs 52 Weeks cs L5/S1 disc 14/5 disc * Initial Screen vs 52 weeks: * Initial Screen vs 52 weeks: * Increased T2 signal ¢ Increase size of initial and * Decreased size protrusion more notable protrusion * Decreased annular tear signal ¢ Evol
Slide 19: BRTX-100/IND 17275 Summary
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=15) Preliminary Efficacy End Points ¢ Blinded clinical data of preliminary efficacy end
Slide 20: Thank you!
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