Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2009)
24 slides from Mesoblast's shareholder meeting presentation, Nov 30, 2009
Slide 1: Executive Director's Presentation, Annual General Meeting
For personal use only Executive Director’s Presentation Annual General Meeting 30 November 2009
Slide 2: Mesoblast Capital Overview
For personal use only Mesoblast Capital Overview Fund Raisings $m Shares on Issue 138.3m IPO @ 50 cents 21.0 Current Share Price $1.43 Equity Placements: Current Market Cap (circa) $200m Jul-06 17.4 Dec-07 13.4 Apr-09 10.8 Option funds 3.2 Total Funds Raised $65.8 Use of capital: • Mesoblast Preclin
Slide 3: MSB Financials
For personal use only MSB Financials Cash Balance at 30 Sep 09* $15.8m Cash Burn (annual) $m G&A & Clinical Support 5.5 Capital Expenditure 0.1 Intellectual Property 0.2 Interest Revenue (0.6) Total Net Overheads, IP & Clinical Support 5.2 Clinical Development/R&D (external)** 3.0 Total Annual Spend
Slide 4: Our Cells are Highly Expandable and Non-Immunogenic
Our Cells are Highly Expandable and Non-Immunogenic; For personal use only Potential for “Off-the-Shelf” Allogeneic Products bone marrow + antibody Orthopaedic magnetic bone beads cartilage NON-IMMUNOGENIC magnet other indications eg eye, bone marrow, metabolic Isolated Cultured heart muscle cells c
Slide 5: Industrial-Scale Manufacturing Process
Industrial-Scale Manufacturing Process For personal use only Bone Marrow (BM) BM + stem cell-binding antibody magnetic beads Competitive Advantages: Precise identification, magnet ease of isolation and scale-up fresh, • purer initial stem cell pool quiescent • homogeneous population MPC • efficient
Slide 6: Lead Orthopaedic Programs
For personal use only Lead Orthopaedic Programs
Slide 7: Lead Non-Orthopaedic Programs, In Association With Angioblast Systems
For personal use only Lead Non-Orthopaedic Programs, In Association With Angioblast Systems
Slide 8: Commercialisation and Revenue Generation Strategies
For personal use only Commercialisation and Revenue Generation Strategies 1. Broad-based Partnering of Platform Technology e.g. For Pharma Licensing 2. Partnering Specific Applications e.g. For Medtech Applications 3. Taking Individual Applications to Market on Our Own e.g. For Orphan Drug Applicati
Slide 9: Commercial Strategies For MPC-Based Biologicals
For personal use only Commercial Strategies For MPC-Based Biologicals
Slide 10: Congestive Heart Failure
For personal use only Congestive Heart Failure in United States alone, existing 5.5M plus 0.55M new-onset/year Class II-IV patients with EF < 35% (a) have highest mortality at 6 and 12 months (b) account for 40% of all CHF patients product effective in this group will generate premium pricing
Slide 11: Cardiac Resynchronization Therapy: A Good Model For Product Success
Cardiac Resynchronization Therapy (CRT): A Good Model For Product Success In CHF Patients With EF < 35%. For personal use only At 6 Months, CRT Increases EF In Patients With Conduction Defects (15% Of Total CHF Pool)… 4 point difference from controls impacts on mortality! Change in LVEF From Baselin
Slide 12: Phase 2a Trial Of Allogeneic MPC In CHF Patients EF<40%
For personal use only Phase 2a Trial Of Allogeneic MPC In CHF Patients EF<40% 60 patient multi-center, randomized, controlled trial class II-IV CHF, EF < 40%, high 6- and 12-month mortality three cohorts of 20 patients, each cohort testing progressively increasing allogeneic MPC dose cells i
Slide 13: MPC Treatment Results In Sustained 10-Point Increase In EF
MPC Treatment Results In Sustained 10-Point Increase In EF Relative To Controls… For personal use only ?Impact On Mortality 40 36.5 35 33.4 30.5 30 27.4 27.8 25.7 25 20 -3.1, - 4.8 +8.7, + 4.8 15 10 11.8 9.6 5 0 Control Treated Baseline 3 months 6 months
Slide 14: Commercial Strategies For MPC-Based Biologicals
For personal use only Commercial Strategies For MPC-Based Biologicals
Slide 15: Disc Degeneration Number One Cause of Chronic Back Pain
For personal use only Disc Degeneration Number One Cause of Chronic Back Pain 100 million Experience Low Back Pain 12.5 million Experience Chronic Low Back Pain Neurological & Imaging Studies 80% 20% Discogenic Nerve Blocks & Discography Disc Herniation, Sacroilliac Discogenic Facet Joint Other Spon
Slide 16: Sheep model to evaluate re-constitution of degenerate discs
Sheep model to evaluate the re-constitution of degenerate discs by injections of MPC + hyaluronan (HA) For personal use only L-1 L-1 Un-injected control L-2 L-2 Un-injected control L-3 L-3 Inject Chondroitinase-ABC Disc Degeneration (loss of GAGs) L-4 L-4 Inject Chondroitinase-ABC (loss of GAGs) Dis
Slide 17: MRI of an ovine spine after injecting MPC
MRI of an ovine spine 6 months after injecting 0.5 million MPC showing similar H2O signal (white) to normal control ovine disc. Note: L4L5 & L5L6 low H2O signal For personal use only
Slide 18: Aggregate Histopathology Scores Show MPC Return Disc Pathology To Normal
Aggregate Histopathology Disc Degeneration Scores Show MPC Return Disc Pathology To Normal For personal use only Means of Aggregate Histopathology Disc Degeneration Scores at 6 Mean and Standard Error 2.75 # Ω # Ω 2.50 2.25 # = significantly different from control p < 0.001; 2.00 Ω = from MPC p< 0.0
Slide 19: Commercial Strategies For MPC-Based Biologicals
For personal use only Commercial Strategies For MPC-Based Biologicals
Slide 20: Bone Marrow Transplantation
For personal use only Bone Marrow Transplantation • 139,000 new cases hematologic cancers each year in US alone • 17,500 BMTs in USA in 2008 • 39,000 BMTs in EU in 2008 • Allogeneic BMT could increase BMT market by > three-fold if an effective alternative to adult bone marrow existed, without risk o
Slide 21: MPC-Expanded Cord Blood For Bone Marrow Transplantation
For personal use only MPC-Expanded Cord Blood For Bone Marrow Transplantation • Our proprietary MPC induce 40-fold expansion of Hematopoietic Stem Cells (HSC) in co-culture • Orphan Drug designation received for increasing HSC in cancer patients needing allogeneic BMT • NIH-funded FDA-cleared trial
Slide 22: Clinical Trial Results
Clinical Trial Results • 18 patients transplanted to date, mean age 40 yrs For personal use only • median time to neutrophil engraftment 16.5 days (historic controls approx. 30 days) • median time to platelet engraftment 38.5 days (historic controls >90 days) • one patient has Grade III GVHD (histor
Slide 23: Timelines For Lead Programs
For personal use only Timelines For Lead Programs IND FDA Clearance Approval Mesoblast Programs Preclinical Phase I Phase II Phase III Spinal Fusion Intervertebral Disc Repair Long Bone Fracture Repair Knee Osteoarthritis Angioblast Programs Congestive Heart Failure Bone Marrow Transplantation Acute
Slide 24: Australian Regulatory Approval May Mean Earlier Revenues
For personal use only Australian Regulatory Approval May Mean Earlier Revenues Approval Process Underway • Manufacturing process contracted with TGA-approved manufacturer • Documents for product manufacturing license submitted to TGA • Decision expected within months Commercial Advantages • Early re