Slide 1: Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases
mesoblast For personal use only Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Key Opinion Leader Event Series for Investors & Analysts Chronic Low Back Pain due to Degenerative Disc Disease June 2022 ASX: MSB; Nasdaq: MESO
Slide 2: Cautionary Note Regarding Forward-Looking Statements
For personal use only CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, le
Slide 3: Agenda – CLBP KOL Event
Agenda – CLBP KOL Event Introduction to Mesoblast – Tim McCarthy, LifeSci Advisors For personal use only 01 02 CLBP Program Overview – Silviu Itescu 03 KOL Presentation – Dr. Douglas Beall 04 KOL Presentation – Dr. Hyun Bae 05 Q&A mesoblast
Slide 4: Our Mission
For personal use only Our Mission Mesoblast is committed to bringing to market innovative cellular medicines to treat serious and life-threatening inflammatory diseases
Slide 5: Speaker Biographies - Douglas P. Beall, MD
Speaker Biographies - Douglas P. Beall, MD, FIPP, FSIR, DAAPM Douglas P. Beall, MD, FIPP, FSIR, DAAPM attended medical school at Georgetown University School of For personal use only Medicine in Washington, DC, and completed his residency at The Johns Hopkins Hospital in Baltimore, Maryland. Followi
Slide 6: Speaker Biographies - Hyun W. Bae, MD
Speaker Biographies - Hyun W. Bae, MD Hyun W. Bae, MD is an orthopedic and spine fellowship trained board-certified orthopedic surgeon. Dr Bae joined the Spine-Center at Cedars-Sinai Medical Center in 2010. He is currently Professor of Surgery in the Department of For personal use only Orthopedic Su
Slide 7: The Unmet Need in Treating Chronic Low Back Pain
The Unmet Need in Treating Chronic Low For personal use only Back Pain Douglas P. Beall, M.D., AAIPM, FIPP Director of Clinical Research, Clinical Investigations Oklahoma City, Oklahoma
Slide 8: Chronic Low Back Pain Impacts Society
Chronic Low Back Pain Impacts Society For personal use only LBP is the most common cause of job-related disability1 • Impacts 29% of the population2 • $150-200 billion in annual healthcare expenditures3 • 33 million people disabled4 Chronic Low Back Pain is the single greatest cause of Years Lived w
Slide 9: The Largest Population Segment
The Largest Population Segment For personal use only 34% OF THE PATIENTS DEGENERATIVE DISC DISEASE AND AXIAL BACK PAIN Spinal Deformity 2% Spondylolisthesis 3% Disc Herniations Dislocations 3% Vertebral Fractures 7% 28% Lumbar Stenosis 11% Spondylosis 12% Primary Spine Diagnosis, 2008
Slide 10: The problem is getting worse with time…
The problem is getting worse with time… For personal use only
Slide 11: Identifying Discogenic LBP
For personal use only Identifying Discogenic LBP
Slide 12: Huge Gap in Treatment Options
For personal use only Huge Gap in Treatment Options Surgical Interventions •Fusion Non-Surgical Mgt •Non-steroid Anti-Inflammatory •Disc arthroplasty Drugs (NSAIDs), Narcotics, •Injections: ESIs1, nerve blocks •Chiropractic, Physical Therapy, Acupuncture, etc 1. Epidural steroid injections are not a
Slide 13: Effectiveness of Current Analgesic Therapies for Treating CLBP
Effectiveness of Current Analgesic Therapies for Treating CLBP Randomized controlled trials of currently approved analgesics show little to no difference in pain intensity when compared to placebo at short-term follow-up For personal use only • Cochrane Systematic Review of Randomized Controlled Tri
Slide 14: Adjacent Segment Disease
Adjacent Segment Disease For personal use only • The incidence of ASD in the Lumbar Spine ranges up to 14% per year • Damage to the posterior ligamentous complex and sagittal imbalances are important risk factors Harrop JS, Youssef JA, Maltenfort M, Vorwald P, Jabbour P, Bono CM, Goldfarb N, Vaccaro
Slide 15: What about Surgical Treatment for LBP: Even in Positive Studies Results are Mixed
What about Surgical Treatment for LBP: Even in “Positive” Studies Results are Mixed For personal use only Fritzell – Swedish Spine Study, 2001 “RESULTS: Lumbar fusion in pts with severe CLBP can ↓ pain & ↓ disability more efficiently than nonsurgical treatment.” • In surgical group only 63% rated th
Slide 16: Conclusions
Conclusions • Discogenic CLBP is a serious condition that results in significant For personal use only disability, reduced quality of life and suffering for patients • Direct and indirect costs associated with CLBP are significant • Patients who do not improve with conservative therapy have limited
Slide 17: Thank You for Your Attention
Thank You for Your Attention For personal use only Douglas P. Beall, M.D., FIPP, FSIR, DAIPM Chief of Interventional Spine Services www.clinrad.org www.drdouglasbeall.com https://twitter.com/dougbeall
Slide 18: Mesoblast KOL Webinar - Dr. Hyun Bae
For personal use only Mesoblast KOL Webinar Dr. Hyun Bae Professor of Orthopaedic Surgery Department of Orthopaedic Surgery Co-Medical Director Cedars Spine Center Director of Education Cedars Spine Center Cedars Sinai Medical Center
Slide 19: Disclaimer
Disclaimer For personal use only Rexlemestrocel-L is an investigational therapy that has not been approved for commercial use by any Health Authority. Conclusions concerning its safety or efficacy should not be made.
Slide 20: Phase 3 Trial: Regulatory Background
Phase 3 Trial: Regulatory Background FDA provided substantial guidance regarding the design of the Phase 3 clinical trial to evaluate the safety and potential benefits of MPCs for the treatment of CLBP associated with moderate DDD For personal use only • Phase 2 study demonstrated that 6-million MPC
Slide 21: Phase 3 Trial: Study Design
Phase 3 Trial: Study Design For personal use only • A single 2mL intra-discal treatment injection § Rexlemestrocel-L+HA: 6-million Mesenchymal Precursor Cells (MPC) mixed 1:1 by volume with HA § Rexlemestrocel-L: 6-million Mesenchymal Precursor Cells (MPC) mixed 1:1 by volume with saline § Saline Co
Slide 22: Phase 3 Trial: Safety Outcomes
Phase 3 Trial: Safety Outcomes For personal use only Summary of Adverse Events Through 36 Months Rexlemestrocel-L Rexlemestrocel-L + HA Placebo Category of TEAE N=140 N=128 N=130 n (%) n (%) n (%) Subjects with any AE 111 (79.3%) 100 (78.1%) 102 (78.5%) Subjects with any AE by Maximum Severity Mild
Slide 23: Phase 3 Trial: Primary Efficacy Endpoint
Phase 3 Trial: Primary Efficacy Endpoint For personal use only Overall Treatment Success Composite at both 12 and 24 months: • FDA specified use of a 24 month composite § At least 50% reduction from baseline in average LBP at both 12- & endpoint typically used for evaluation of 24-months post-treatm
Slide 24: Pre-Specified Exploratory Efficacy Outcome
Pre-Specified Exploratory Efficacy Outcome LS Mean Change in Low Back Pain from Baseline - Entire Study (n=404) Rexlemestrocel-L reduces pain durably through 36 months, addition of HA enhances the effect For personal use only P = MPC + HA vs. Placebo CI)CI) -10 -10 * * (95% Baseline (95% Absence of
Slide 25: Pre-Specified Exploratory Efficacy Outcome: Shorter Duration Subgroup
Pre-Specified Exploratory Efficacy Outcome LS Mean VAS Change in Low Back Pain from Baseline – Pre-specified Subgroup of Subjects (n=202) with Duration CLBP < Median (68 months) For personal use only Effects of Rexlemestrocel-L are maximal in subjects with shorter duration of low back pain, addition
Slide 26: Pre-Specified Exploratory Efficacy Outcome: 30% Reduction Pain Responders
Pre-Specified Exploratory Efficacy Outcome: 30% Reduction Pain Responders Pre-specified Subgroup of Subjects (n=202) with Duration CLBP < Median (68 months) For personal use only Rexlemestrocel-L effects durable through 12 months, addition of HA enhances the effect and extends durability through 36
Slide 27: Pre-Specified Exploratory Efficacy Outcome - Cessation of Opioid Use
Pre-Specified Exploratory Efficacy Outcome - Cessation of Opioid Use Rexlemestrocel-L + HA Associated with Greater Proportions of Subjects Ceasing Opioid Use Through 36 Months For personal use only Baseline Opioid Users Achieving No Opioid Use 30.0% * * 25.0% Baseline Opioid Users • Subjects were in
Slide 28: Pre-Specified Exploratory Efficacy Outcome on Quality Life Limitations Associated with DDD
Pre-Specified Exploratory Efficacy Outcome on Quality Life Limitations Associated with DDD LS Mean Change in Quality of Life (EQ-5D) from Baseline – Pre-specified Subgroup of Subjects (n=202) with Duration CLBP < Median (68 months) For personal use only Rexlemestrocel-L effects durable through 36 mo
Slide 29: The Patient Treatment Journey
The Patient Treatment Journey Rexlemestrocel-L has Potential to be First-Line in Choice for Treatment of Discogenic CLBP For personal use only Refractory to Conservative Treatment Rexlemestrocel-L targeting moderate-to-severe CLBP Conservative Opioid Interventional Surgery Treatments Analgesics Ther
Slide 30: Questions
For personal use only Questions