Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2013)
29 slides from Mesoblast's shareholder meeting presentation, Nov 15, 2013
Slide 1: Annual General Meeting 15 November 2013
For personal use only Annual General Meeting 15 November 2013
Slide 2: Cautionary Note Regarding Forward-Looking Statements
For personal use only CAUTIONARY NOTE REGARDING FORWARD‐LOOKING STATEMENTS 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 cannot be predicted or quantifi
Slide 3: Shareholder value and ownership
Shareholder value and ownership For personal use only Market valuation Issued shares 317 million Current share price (market close, 14 November 2013) $6.15 Market capitalization, circa $1.95 billion Cash reserves (at 30 September 2013) $292 million Shareholder ownership 18% Institutions/sophisticate
Slide 4: Financial Results 2013
Financial Results 2013 For personal use only 3
Slide 5: Mesoblast's corporate strategy
Mesoblast’s corporate strategy is to: For personal use only Leverage proprietary cell‐based and complementary biologic technologies to develop products for unmet medical needs Bring multiple products to market within a parallel timeframe Enhance the likelihood of commercial success through str
Slide 6: Mesoblast proprietary technologies
Mesoblast proprietary technologies For personal use only Mesenchymal Precursor Cell (MPC) technology platform (Stro‐1/Stro‐3 pos cells) Culture‐expanded Mesenchymal Stem Cells (MSCs) Dental Pulp Stem Cells (DPSCs) Expanded Hematopoietic Stem Cells (HSCs) Soluble factors derived from propri
Slide 7: Strategic benefits of acquisition of Osiris' cultured MSC business
Strategic benefits of acquisition of Osiris’ cultured MSC therapeutic business For personal use only Firms up Mesoblast’s position as leader in regenerative medicine Accelerates Mesoblast’s time to first product launch Broadens market opportunities with new Phase 3 programs Facilitates lever
Slide 8: Robust mesenchymal cell lineage intellectual property estate
Robust mesenchymal cell lineage intellectual property estate For personal use only Mesoblast has ownership of or exclusive rights to 61 patent families, which provide major commercial advantages and long‐term protection across mesenchymal cell lineage platforms Mesoblast’s patents include MPC an
Slide 9: Strategic partnerships
Strategic partnerships For personal use only Focus on cardiovascular and neurological programs in partnership with Teva Pharmaceutical Industries Ltd Focus on Graft‐versus‐Host‐Disease (GvHD) programs in children and adults in Japan in partnership with JCR Pharmaceuticals Focus on developing a
Slide 10: Mechanisms of Action Drives Product Development
Mechanisms of Action (MOA) Drives Product Development For personal use only Mesoblast's strategic product focus is guided by specific MOAs of our cellular therapies. The mesenchymal lineage stem cells respond to signals from inflammation and /or tissue damage by releasing a range of factors whic
Slide 11: Inflammation-dependent induction of mesenchymal-lineage stem cells
Inflammation-dependent induction of mesenchymal-lineage stem cells and regulation of both macrophages and Th17 cell functions For personal use only TNFα IL-1 LPS IFN-gamma Acidosis Collagen Type II M2 IL-10Hi PGE2 MPC IDO PGE2 TGF-beta IL-1 M1 IL-6 FoxP3 TNFα Th17 T reg cell cell IL-17 IL-10
Slide 12: Key target areas for proprietary mesenchymal cell-based technologies
Key target areas for proprietary mesenchymal cell-based technologies For personal use only The Company’s lead product candidates use its MPC or MSC platform technologies to focus on four major and distinct areas: i. Systemic diseases of inflammation and immunity ii. Orthopedic diseases of the spine
Slide 13: Clinical development pipeline across four core therapeutic areas
Clinical development pipeline across four core therapeutic areas For personal use only 12
Slide 14: Programs in Immune-Mediated/Inflammatory Conditions
For personal use only Programs in Immune-Mediated/ Inflammatory Conditions 13
Slide 15: MSC program using Prochymal for refractory Crohn's disease
MSC program using Prochymal for refractory Crohn’s disease For personal use only Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract – Over 700,000 people in the US have Crohn's disease, with 20,000 new cases annually – Approx. 60,000 patients in the US alone are into
Slide 16: Immune/inflammatory diseases − MPC programs
Immune/inflammatory diseases − MPC programs For personal use only Type 2 diabetes and renal complications Completed enrollment of 60‐patient Phase 2 safety study evaluating single intravenous MPC injection in patients with early type 2 diabetes inadequately controlled on oral glucose‐reducing agen
Slide 17: Programs in Orthopedic Conditions of the Spine
For personal use only Programs in Orthopedic Conditions of the Spine 16
Slide 18: Spine diseases – MPC programs
Spine diseases – MPC programs For personal use only Spinal fusion Phase 2 trial in lumbar fusion demonstrated equivalence of MPC treatment at 12 months with autogenous hip autograft in terms of radiographic fusion, pain reduction, and improvement in function Data being used in discussions with F
Slide 19: Programs in Cardiac and Vascular Conditions
For personal use only Programs in Cardiac and Vascular Conditions 18
Slide 20: Heart disease programs
Heart disease programs For personal use only US FDA cleared commencement of Phase 3 trial of MPCs for chronic congestive heart failure within minimum 30‐day period after filing of IND by development and commercialization partner Teva – Multi‐center, 1700 patient trial being conducted by Teva and i
Slide 21: Neurologic disease – MPC program for ischemic stroke
Neurologic disease – MPC program for ischemic stroke For personal use only Stroke is a leading cause of death in the United States and a leading cause of serious long‐ term disability, costing an estimated $38.6 billion each year. More than 795,000 people annually have a stroke in the United Sta
Slide 22: Programs in Oncology Conditions and Bone Marrow Transplantation
For personal use only Programs in Oncology Conditions and Bone Marrow Transplantation 21
Slide 23: Oncology – bone marrow transplantation
Oncology – bone marrow transplantation Prochymal® for acute GvHD For personal use only Approx. 25,000 allogeneic hematopoietic stem cell transplants (HSCTs) are performed each year for the treatment of diseases including hematologic malignancies, certain forms of anemia, and immunological deficien
Slide 24: Life threatening GvHD in children − Prochymal
Life threatening GvHD in children − Prochymal® For personal use only Peer‐reviewed publication in November 2013 issue of Biology of Blood and Marrow Transplantation showed significantly improved response rates and survival benefit in Prochymal®‐treated children with severe GvHD following bone marr
Slide 25: Historical controls—Low probability of survival in grades C-D or III-IV GvHD
Historical controls—Low probability of survival in grades C-D or III-IV GvHD. For personal use only Cahn J et al. Blood 2005;106:1495-1500
Slide 26: Life threatening GvHD in children − Prochymal
Life threatening GvHD in children − Prochymal® For personal use only Key findings in the trial were: At day 28, 61% of patients were responders to Prochymal® (improvement in at least one grade of organ involvement) Responses to Prochymal® were seen across all disease grades and involved organs
Slide 27: Acute GvHD - Prochymal
Acute GvHD - Prochymal® For personal use only Patients who responded to therapy by day 28 had a higher Kaplan‐Meier estimated probability of 100‐day survival than patients who did not respond (78% vs. 28%, p<0.001) 26
Slide 28: The year ahead, what we expect
The year ahead, what we expect: For personal use only Active recruitment in Phase 3 trial for congestive heart failure Continued recruitment in Phase 3 trial for biologic‐refractory Crohn’s disease Commencement of Phase 3 trial in orthopedic spine disease Continued recruitment in Phase 3 tri
Slide 29: Leading the world in the development of adult stem cell therapies
For personal use only Leading the world in the development of adult stem cell therapies