Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2011)
24 slides from Mesoblast's shareholder meeting presentation, Nov 24, 2011
Slide 1: A Year of Transformation – Chairman's Address
For personal use only A YEAR OF TRANSFORMATION Address by Mesoblast Chairman Brian Jamieson 2011 Annual General Meeting On behalf of the Board of Directors, I am very pleased to welcome you to the 2011 Annual General Meeting of Mesoblast Limited. I am proud to report the progress we’ve made over the
Slide 2: Chairman's address: clinical program progress
For personal use only I mentioned the progress of our development programs, and indeed we’ve seen very encouraging clinical and preclinical results for our adult stem cell products across major indications where this a critical need for novel and more efficacious therapies – heart failure, heart att
Slide 3: Chairman's address: outstanding year and cash position
For personal use only And this month, we reported very promising preclinical results of our MPC product for Type 2 diabetes, which showed that a single injection of our off-the-shelf cells significantly lowered blood sugar levels for up to eight weeks in non-human primates with Type 2 diabetes. A di
Slide 4: Leading the world in novel adult stem cell therapies
For personal use only Leading the world in novel adult stem cell therapies Annual General Meeting 24 November 2011 Silviu Itescu Chief Executive
Slide 5: 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 6: 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 A$6.64 Cash available (approx) A$256m It is included in the S&P/ASX 200 Index. Market capitalization A$1,860m Results ($m except pe
Slide 7: 2011 - major accomplishments
2011 - major accomplishments strategic alliance with Cephalon Inc. 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 8: Our proprietary adult stem cells
Our proprietary adult stem cells For personal use only potent, purified adult mesenchymal precursor cells – strong safety profile – no immune reactions – avoid ethical and safety issues associated with embryonic stem cells – backed by strong patent position “off the shelf” – classic pharmaceutic
Slide 9: Building a successful biologics life sciences company: managing corporate risk
Building a successful biologics life sciences company: understanding and managing corporate risk For personal use only Platform technology delivers multi-product pipeline - Multiple shots on goal - Not dependent on success of any one product Corporate partnerships manage execution risk - Teva/Ce
Slide 10: The Mesoblast value proposition – the three pillars
The Mesoblast value proposition – the three pillars For personal use only The Teva alliance delivers proven execution capability in major global markets drives clinical programs in key therapeutic areas – experienced team cash from milestone payments to fund Mesoblast pipeline Orthopedic pipel
Slide 11: Teva (Cephalon) strategic alliance
Teva (Cephalon) strategic alliance Teva/Cephalon received exclusive worldwide commercialization rights to selected For personal use only cardiovascular and neurologic indications Teva/Cephalon responsible for funding Phase 2b and Phase 3 clinical development Mesoblast received upfront fee of U
Slide 12: Global manufacturing alliance is central to profitability
Global 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 exclusiv
Slide 13: 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 Intravenous Product Type 2 Diabetes Neurologi
Slide 14: Cardiovascular franchise – congestive heart failure (CHF)
Cardiovascular franchise – congestive heart failure (CHF) 60 patient multi-center, randomized, controlled Phase 2 trial For personal use only Class II-IV CHF, ejection fraction < 40% (high 6- and 12-month mortality) randomized 3:1 controls to MPCs at 25M, 75M or 150M cell doses cells injecte
Slide 15: Congestive Heart Failure – AHA 2011 Phase 2 results
Congestive Heart Failure – American Heart Association Annual Meeting 2011: Phase 2 trial successfully met the only endpoints FDA accepts for Phase 3 approval For personal use only “In general, Phase 3 studies should use endpoints such as mortality and cardiovascular or heart failure hospitalizations
Slide 16: MACE: All Subjects
For personal use only MACE: All Subjects 100 MACE-Free Survival Probability 80 MPC 60 Control 40 20 Log Rank P-value = 0.036 0 0 10 20 30 40 Time To MACE (Months)
Slide 17: Cardiac Death: All Subjects
For personal use only Cardiac Death: All Subjects 100 Cardiac Survival Probability 80 MPC 60 Control 40 20 Log Rank P-value = 0.020 0 0 10 20 30 40 Time To Cardiac Death
Slide 18: Intravenous franchise – preclinical development
Intravenous franchise – preclinical development high value product using systemic administration For personal use only applications: – Type 2 diabetes – Lung diseases (inflammatory conditions, asthma) – Osteoporosis – Inflammatory joint diseases (rheumatoid arthritis) – Neurological diseases (MS
Slide 19: Intravenous franchise – Type 2 Diabetes Pre-Clinical Study
Intravenous franchise – Type 2 Diabetes Pre-Clinical Study For personal use only 17 non-human primates with obesity and Type 2 diabetes dose-ranging study evaluating effect of single intravenous injection of Mesoblast's allogeneic MPCs over eight weeks controls (n=3) received a single saline i
Slide 20: Effect of MPC or Saline Injection on Fasting Glucose in Nonhuman Primates
Effect of MPC or Saline Injection on Fasting Glucose in Nonhuman Primates With Type 2 Diabetes For personal use only 220 Control (3) 0.1 M MPC/kg (3) 0.3 M MPC/kg (4) 1.0 M MPC/kg (4) Fasting Glucose (mg/dL) 2.0 M MPC/kg (3) 180 140 100 Injection 60 Baseline 2 4 6 8 Week
Slide 21: Dose-Dependent Effect of Single Intravenous MPC Injection on Blood Glucose
For personal use only Dose-Dependent Effect Of Single Intravenous MPC Injection On Mean Fasting Blood Glucose Levels Over Eight Weeks 200 180 Fasting Blood Glucose (mg/dL) 160 140 * ** 120 100 80 60 40 20 0 0 0.1 0.3 1 2 x Million MPC/kg ** P<0.05 compared to controls
Slide 22: Dose-Dependent Effects on Blood Glucose and CRP Levels
Dose-Dependent Effects On Blood Glucose And CRP Levels Eight Weeks After A Single Injection Of Allogeneic MPCs: Are MPCs Cardioprotective In Type 2 Diabetes? For personal use only 200 6 Fasting Blood Glucose (mg/dL) 180 5 160 140 4 hsCRP mg/dL 120 100 3 80 2 60 40 1 20 0 0 0 0.1 0.3 1 2 0 0.1 0.3 1
Slide 23: Value inflexion points – near term
Value inflexion points – near term For personal use only completion of Phase 2 heart failure trial - progression to Phase 3 pivotal trial completion of orthopedic Phase 2 spinal fusion trials completion of disc repair Phase 2 trial moving diabetes into Phase 2 trials building the intraveno
Slide 24: Leading the world in novel adult stem cell therapies
For personal use only Leading the world in novel adult stem cell therapies