Mesoblast Limited · ASX:MSB
Mesoblast — J.P. Morgan 30th Annual Healthcare Conference (January 2012)
27 slides from Mesoblast's conference presentation, Jan 12, 2012
Slide 1: Leading the world in novel adult stem cell therapies
For personal use only Leading the world in novel adult stem cell therapies J.P. Morgan 30th Annual Healthcare Conference San Francisco January 2012
Slide 2: Forward looking statements
Forward looking statements CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS For personal use only This presentation, including any comments made during or following the presentation, may contain forward-looking statements that are inherently subject to risks and uncertainties, some of which cann
Slide 3: A risk managed business model
A risk managed business model proprietary platform technology delivers multi-product pipeline For personal use only – multiple shots on goal – not dependent on success of any one product corporate partnerships manage execution risk – Teva provides global distribution capability, regulatory and c
Slide 4: Technology
4 For personal use only Technology
Slide 5: Overview of current stem cell universe
Overview of current stem cell universe For personal use only stem cells are unspecialized cells that can renew themselves – can mature into specialized cell types such as muscle, nerve, bone, blood cells, etc – stem cells constantly renew and repair tissues in the body our mesenchymal precursor
Slide 6: We own the IP on Mesenchymal Precursor Cells (MPCs)
We own the IP on Mesenchymal Precursor Cells (MPCs) For personal use only Heart Products for muscle cardiovascular Blood diseases vessels Pancreas Products for diabetes & immunologic/ MPC highly-expandable, Immune inflammatory non-immunogenic system conditions Bone Products for orthopedic Culture- I
Slide 7: Our proprietary adult stem cells
Our proprietary adult stem cells For personal use only potent, purified adult mesenchymal precursor cells – strong safety profile – avoid ethical and safety issues associated with embryonic stem cells – backed by strong patent position “off the shelf” – classic pharmaceutical drug model – batch
Slide 8: Product Pipeline
8 For personal use only Product Pipeline
Slide 9: Platform technology delivers multi-product pipeline
Platform technology delivers multi-product pipeline For personal use only Cardiovascular and neurologic products Teva alliance delivers proven execution capability in major global markets cash from corporate partnership to fund rest of Mesoblast pipeline Products for Type 2 diabetes and metaboli
Slide 10: "Off-the-shelf" product franchises driving value creation
“Off-the-shelf” product franchises driving value creation IND clearance FDA approval For personal use only Lead products Pre-clinical Phase II Phase III Cardiovascular product Congestive heart failure Acute myocardial infarction Chronic refractory angina Neurologic products Stroke/Parkinson’s/MS Dia
Slide 11: Strategic Partnerships
For personal use only Strategic Partnerships 11
Slide 12: Teva strategic alliance
Teva strategic alliance For personal use only Teva has exclusive worldwide commercialization rights to selected cardiovascular and neurologic indications, holds 19.99% stake in Mesoblast Teva responsible for funding Phase 2b and Phase 3 clinical development Mesoblast eligible to receive up to
Slide 13: Lonza manufacturing alliance is central to profitability
Lonza manufacturing alliance is central to profitability State-of-the-art manufacturing plant via strategic alliance with Lonza For personal use only Lonza will supply clinical and long-term commercial MPC product needs globally Lonza to construct a purpose-built manufacturing facility exclusive
Slide 14: Program Update
For personal use only 14 Program Update
Slide 15: Cardiovascular franchise – congestive heart failure (CHF)
Cardiovascular franchise – congestive heart failure (CHF) prevalence 6.2 million in US, > 670,000 new For personal use only patients annually 60 patient multi-center, randomized, controlled Phase 2 trial Class II-IV CHF, ejection fraction < 40% (high 6- and 12-month mortality) randomized 3:1 c
Slide 16: Congestive heart failure – positive results presented at AHA 2011
Congestive heart failure – positive results presented at American Heart Association 2011 Annual Meeting For personal use only “In general, Phase 3 studies should use endpoints such as mortality and cardiovascular or heart failure hospitalizations, whereas endpoints, such as ejection fraction, that h
Slide 17: Congestive heart failure – Kaplan Meier plots
Congestive heart failure – Kaplan Meier plots For personal use only 17
Slide 18: Intravenous product franchise – Type 2 diabetes pre-clinical study
Intravenous product franchise – Type 2 diabetes pre-clinical study 17 non-human primates with natural Type 2 diabetes associated with For personal use only obesity dose-ranging study evaluating effect of single intravenous injection of Mesoblast's allogeneic MPCs over twelve weeks controls (n=
Slide 19: Sustained reduction in fasting blood glucose after single MPC injection
Sustained and significant reduction in fasting blood glucose levels 12 weeks after single MPC injection of 1 or 2 million MPC/kg For personal use only Control (n=3) 0.1 million MPC/kg (n=3) Fasting Glucose mg/dL 250 250 Fasting Glucose mg/dL 200 200 150 150 100 100 50 50 0 0 -3 2 7 12 0 2 4 6 8 10 1
Slide 20: Reduction in mean fasting blood glucose over 12 week study
Significant reduction in mean fasting blood glucose levels over 12 week study period relative to baseline after single MPC injection of 1 or 2 million MPC/kg For personal use only 300 250 200 Fasting Blood Glucoe mg/dL 150 Pre-Treatment Baseline * * Mean Fasting Glucose over 12 weeks post-MPC treatm
Slide 21: Single injections maintain mean CRP levels below 3 mg/l
Single injections of 0.3, 1 or 2 million MPC/kg maintain mean CRP levels below 3 mg/l for entire 12 week study period; controls maintain CRP levels > 3mg/l for 8/12 weeks For personal use only 10 9 8 7 6 hsCRP mg/L Control 5 0.1 million MPC/kg 0.3 million MPC/kg 4 1 million MPC/kg 2 million MPC/kg 3
Slide 22: Summary and Conclusions from Type 2 Diabetes Pre-Clinical Study
Summary and Conclusions from Type 2 Diabetes Pre-Clinical Study For personal use only Single injection of 1 or 2 million MPC/kg caused significant and sustained reductions in fasting blood glucose levels over 12 weeks; no reductions in blood glucose levels were seen in controls C-reactive protei
Slide 23: Corporate Overview
For personal use only 23 Corporate Overview
Slide 24: Investment snapshot
Investment snapshot Mesoblast is a public company, listed on the Issued shares 280m For personal use only Australian Securities Exchange since 2004. Current share price US$6.67 Cash available (approx) US$260m It is included in the S&P/ASX 200 Index. Market capitalization US$1,870m Results (A$m excep
Slide 25: 2011 - major accomplishments
2011 - major accomplishments strategic alliance with Teva/Cephalon for selected product commercialization For personal use only strategic alliance with Lonza for long-term manufacturing capacity expanded cardiovascular franchise to cover heart failure, heart attack and chronic angina complet
Slide 26: Value inflexion points – near term
Value inflexion points – near term Teva + Mesoblast meeting with FDA re commencement Phase 3 trial for For personal use only congestive heart failure completion of Phase 2 spinal fusion trials completion of Phase 2 disc repair trial FDA clearance of IND to begin Phase 2 trial in Type 2 Diabe
Slide 27: Leading the world in novel adult stem cell therapies
For personal use only Leading the world in novel adult stem cell therapies
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