Mesoblast Limited · ASX:MSB
Mesoblast — Investor Presentation (November 2007)
31 slides from Mesoblast's investor presentation, Nov 21, 2007
Slide 1: Road to Stem Cell Commercialisation
For personal use only Road to Stem Cell Commercialisation November, 2007
Slide 2: Stem Cells - Sources
Stem Cells - Sources For personal use only Embryonic stem cell: present in inner cell mass of the blastocyst; pluripotential, easily grown to very large numbers, easily manipulated Embryonic germ cell: primordial germ cells in the 5-10 week fetus; pluripotential, difficult to grow and access Adult s
Slide 3: Advantages Of Stem Cells Over Other Medical Therapies
For personal use only Advantages Of Stem Cells Over Other Medical Therapies • natural biologicals, safer, less side-effects • building blocks for wide range of tissues (blood, bone, cartilage, fat, vessels, heart muscle) • regenerate tissues, reducing long-term health care costs • restore function a
Slide 4: Embryonic Stem Cells: Major Concerns vs Mesoblast's Adult Stem Cells
For personal use only Embryonic Stem Cells: Major Concerns • ethical concerns • need cloning to prevent immune rejection • uncontrolled growth and risk of cancer Mesoblast’s Adult Stem Cells: Significant Advantages • no ethical issues • more mature, easier to regulate growth • avoid immune rejection
Slide 5: Our patented adult stem cells deliver an efficient high margin business
For personal use only our patented adult stem cells deliver an efficient high margin business an off the shelf product with margins equivalent to a pharmaceutical • one donor -- thousands of patient doses • unrelated recipients • frozen product immediately available -- good physician uptake • low ma
Slide 6: Major Accomplishments Since Listing
For personal use only Major Accomplishments Since Listing 1. Granted composition-of-matter stem cell patent in United States, world’s largest market, with further international patents pending 2. Demonstrated scale-up of stem cell manufacturing process 3. Demonstrated safety of manufacturing and cel
Slide 7: Major Accomplishments Since Listing, cont'd
For personal use only Major Accomplishments Since Listing, c’td 6. Shown effectiveness of allogeneic (“off-the-shelf”) stem cells in fracture repair, spinal fusion, knee osteoarthritis pre-clinical models 7. Shown effectiveness of allogeneic (“off-the-shelf”) stem cells in heart attack and heart fai
Slide 8: Enhancing Shareholder Value Through Corporate Structure
For personal use only Enhancing Shareholder Value Through Corporate Structure Assignment of MPC IMVS/Hanson Institute Intellectual Property (Australia) ANGIOBLAST Systems, Inc. (USA) Approx. 5% Shareholding MPC Licence for Based on Licensed IP Orthopaedic Applications Approx. 4% Shareholding Based o
Slide 9: Proprietary MPC Isolation
Proprietary MPC Isolation 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 large-scale e
Slide 10: Our Experience Proves Efficient Commercial Stem Cell Production
Our Experience Proves Efficient Commercial Stem Cell Production,With High Safety Profile For personal use only bone marrow + antibody Orthopaedic magnetic bone beads cartilage NON-IMMUNOGENIC magnet other cell types Isolated Cultured heart muscle cells cells Cardiac smooth muscle Stem cell Different
Slide 11: For personal use only
For personal use only
Slide 12: Road To FDA Approvals For An Allogeneic Stem Cell Product
For personal use only Road To FDA Approvals For An Allogeneic Stem Cell Product Preclinical • characterize stem cell population • proof-of-principle small animal studies • optimize ex vivo culture process in GMP facility • safety/dose-ranging studies in appropriate large animal model (e.g sheep) Cli
Slide 13: Lead Clinical Programs
QuickTime™ and a TIFF (LZW) decompressor are needed to see this picture. For personal use only Lead Clinical Programs 1. Non-union long bone fracture repair Phase 1b clinical trial completed, IND submission for Phase 2a clinical trial early 2008 2. Spinal Fusion Phase 2a clinical trial IND cleared b
Slide 14: Treatment Of Non-Union Long Bone Fractures
For personal use only Treatment OfOf Treatment Non -Union Non Long -Union Bone Long Fractures Bone Fractures • pilot trial at Royal Melbourne Hospital • 10 patients with non-union of long bone fractures • safety of own (autologous) culture-expanded MPC • evaluate manufacturing process in a clinical
Slide 15: MPCs Induce New Bone Growth And Union In A Patient With Femoral Fracture
For personal use only MPCs Induce New Bone Growth And Union In A Patient With Femoral Fracture And Non-Union After 9 Months baseline 6 wks post-MPC 12 wks post-MPC implantation implantation
Slide 16: MPC repair of distal tibia fracture non-union
MPC repair of distal tibia fracture non-union For personal use only Pre-Implant 12 weeks Post-Implant
Slide 17: Knee Osteoarthritis
Knee Osteoarthritis For personal use only Compression / traction Lateral instability Osteophyte formation High impact stresses Focal erosion
Slide 18: Ovine Meniscectomy Model and Progressive Osteoarthritis
For personal use only Ovine Meniscectomy Model and Progressive Osteoarthritis
Slide 19: MPC Protect Femoral Condyle Against Cartilage Erosion
For personal use only MPC Protect Femoral Condyle Against Cartilage Erosion
Slide 20: MPC Protect Hyaline Cartilage Against Degradation And Prevent Osteophyte Formation
MPC Protect Hyaline Cartilage Against For personal use only Degradation And Prevent Osteophyte Formation Mean cartilage morphological scores for high d Mean Femoral and Tibial Osteophyte (OP) scor (100Million + HA) injections relative to HA dose MPC (100Million + HA) injections relative HA HA+MPCx10
Slide 21: MPC Increase Thickness Of Tibial Cartilage
MPC Increase Thickness Of Tibial Cartilage For personal use only Cartilage thickness - tib HA HA+ 100m cell 1.8 1.6 P = 0.057 1.4 1.2 P = 0.028 mm2 1 0.8 0.6 0.4 0.2 0 Inner Middle Outer
Slide 22: Cardiac Programs In Partnership With Angioblast Systems, Inc.
QuickTime™ and a TIFF (LZW) decompressor are needed to see this picture. For personal use only Cardiac Programs In Partnership With Angioblast Systems, Inc. 1. Congestive Heart Failure (CHF): Phase 1b clinical trial completed Phase 2a clinical trial to commence 2008 2. Acute Myocardial Infarction (A
Slide 23: Allogeneic Sheep MPC For Heart Failure
Allogeneic Sheep MPC For Heart Failure For personal use only Day 0 4 weeks post MI 12 weeks post MI 10 sheep MPC vs Saline Sacrifice Balloon Occlusion Echocardiography Echocardiography Echocardiography Angiography Epicardial Injection Angiography 90 min LAD of Saline or MPC Histology Balloon Occlusi
Slide 24: Allogeneic MPC Reverse Established Heart Failure
Allogeneic MPC Reverse Established Heart Failure saline MPC 70. For personal use only injection injection Ejection Fraction (%) 60. saline 50. MPC 40. 30. 20. 50 . 10. % change in LV End Diastolic Pressure 40 0. from baseline to 12 weeks baseline 4 weeks 12 weeks baseline 4 weeks 12 weeks 30 pre-MI
Slide 25: Treatment Of Chronic Angina/Heart Failure
For personal use only TreatmentOfOfNon Treatment Chronic -UnionAngina/Heart Failure Long Bone Fractures • pilot trial at John Hunter Hospital • 6 patients with coronary artery disease, angina, heart failure • safety of own (autologous) culture-expanded MPC • evaluate manufacturing process in a clini
Slide 26: MPC Increase Perfusion In A Patient With Chronic Ischemia
MPC Increase Perfusion In A Patient With Chronic Ischemia For personal use only baseline Six months post-MPC injection CONFIDENTIAL
Slide 27: Episodes of Angina per Week
al use only FOr person EPISODES OF ANGINAWEEK 15 30 25 20 10 ANGINA n = z w — < a G BASELINE 3 MONTHS
Slide 28: GTN Use per Week
For personal use only GTNUSEWEEK 10 GTN USE 20 18 16 14 12 8 6 PATIENTS O BASELINE 3 MONTHS
Slide 29: NYHA Values
VALUES 3.5 25 1.4 0.5 NYHA PATIENTS O BASELINE 3 MONTHS
Slide 30: Tracking Clear Value Drivers
For personal use only Tracking Clear Value Drivers Allogeneic Phase 2 Clinical Trials • spinal fusion • heart attack • tibial fractures • heart failure • knee osteoarthritis IP Devt/ Pre-Clin R&D Corporate Partnerships 2007 2008 2009
Slide 31: Stem cells can deliver market leadership: opportunities for strategic partnerships
For personal use only Stem cells can deliver market leadership: opportunities for strategic partnerships • major pharmaceutical and medical device companies with market share of orthopaedic and cardiovascular fields proactively seeking transforming technologies • Biologicals can convert generic devi