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'Mesoblast Limited is a corporation whose sole focus is the rapid and successful ... Prof. Silviu Itescu - Columbia (USA) and Melb. Uni., Corp & FDA advisor ... – PowerPoint PPT presentation

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Title: Title to go here


1
The Adult Stem Cell Company Building Blocks for
Better Health
2
Our Mission
  • Mesoblast Limited is a corporation whose sole
    focus is the rapid and successful
    commercialisation of a proprietary, high-margin,
    adult stem cell therapy platform for orthopaedic
    applications in a very large, unmet international
    market.

3
Presentation Agenda
  • 1. Organisational History
  • 2. Corporate Structure
  • 3. Stem Cells - why and what?
  • 4. Mesenchymal Precursor Cells (MPC)
  • 5. The MPC technology
  • novel isolation technique
  • technology advantages
  • applications (orthopaedic, cardiovascular)
  • 6. Business model
  • 7. Commercial strategy
  • 8. Focus on delivery
  • 9. Board of Directors
  • 10. Details of the offer

4
Organisational History
  • company founder and Chief Scientist world
    authority
  • 2001, founder established Angioblast Systems Inc.
    to commercialise state-of-the-art adult stem cell
    technology
  • 3. 2003, identified IMVS/Hanson Institute stem
    cell technology
  • world-leading technology
  • over 10 years in development
  • substantial RD investment
  • outstanding commercial prospects
  • 2004, Angioblast acquired the platform technology
  • 2004, Mesoblast established to exclusively
    develop and commercialize Orthopaedic
    Applications

5
Enhancing Shareholder Value Through Corporate
Structure
Assignment of Platform Technology (subject to
Mesoblast Licence)
ANGIOBLAST Systems, Inc. (USA)
IMVS/Hanson Institute (MEDVET)

Proprietary Licence for Orthopaedic Applications
10m investment for 33.3 Shareholding
MESOBLAST LTD. (Australia)
6
Stem Cells Are Human Building Blocks
  • Stem Cells
  • building blocks for blood, bone, cartilage, fat,
    vasculature, heart muscle
  • can be extracted from various sites
  • can be used to repair and regenerate a wide range
    of tissues and organs
  • Advantages Of Stem Cells Over Other Medical
    Therapies
  • natural biologicals, safer, less likely to have
    side-effects
  • regenerate tissues, reducing long-term health
    care costs
  • restore function and quality of life

7
Adult Stem Cells The Right Building Blocks
  • Advantages Of Adult Stem Cells Over Embryonic
    Stem Cells
  • no ethical issues surrounding embryo creation and
    destruction
  • more mature, hence shorter and less costly
    development processes
  • significantly reduced risk of cancer formation
  • not recognized as foreign by immune system of an
    unrelated party
  • Therefore, Adult Stem Cells Are Much Closer To
    Market

8
Adult Stem Cells Haematopoietic vs Mesenchymal
  • Adult Tissue Contains Two Types of Stem Cells
  • haematopoietic precursor cells
  • frequent blood, bone marrow precursors
  • mesenchymal precursor cells (MPC)
  • rare bone, cartilage, fat, muscle, artery
    precursors
  • Advantages Of Mesenchymal Precursors Over
    Haematopoietic Precursors
  • if isolated, can be easily cultured and expanded
  • can generate various tissue types needed for
    functional restoration
  • not recognized as foreign by immune system of an
    unrelated party

9
Proprietary MPC Isolation
Bone Marrow
Bone Marrow (BM)
adhere to dish
spin
BM stem cell-binding antibody
1 hour, on ice
second binding reagent
density solution
1/2 hour, on ice

microbeads (Miltenyi)
mixed cell culture
1/4 hour, on ice
MACS magnet
Historical Isolation Method
  • Competitive Advantages
  • Precise identification, ease of isolation and
    scale-up
  • 1000-fold purer initial stem cell pool
  • homogeneous population, high rate cell division
  • efficient large-scale expansion
  • lower costs of cell culture process
  • greater potency of expanded, cultured product

10
MPCs Give Rise To Various Tissue
Types Potential Therapeutic Markets!
Orthopaedic
Mesenchymal Precursor Cell, MPC
bone
MPC Isolated and Cultured
cartilage
other cell types
heart muscle
Adult Stem Cell Self-Renewing
Cardiac
artery wall
Stem cell
Differentiated cell
11
Very Large, Unmet Orthopaedic Markets
  • Poorly Healing Bone Fractures
  • gt500,000 delayed or non-union fractures in US
    annually
  • existing therapies not effective, significant
    adverse events
  • Chronic Cartilage Degeneration and Acute Meniscal
    Tears
  • gt800,000 patients undergo arthroscopic knee
    surgery in US annually
  • existing therapies do not repair lost
    cartilage, offer temporary relief
  • Vertebral Disc Degeneration
  • affects 20 of population, back pain and nerve
    impingement
  • existing therapies - anti-inflammatory drugs,
    surgical spinal fusion

12
Does The MPC Therapy Work?
  • 25-30 of the mid portion of the femur is
    resected.
  • Structural stability maintained by
    intramedullary nail locked proximally and
    distally by transfixing screws.

13
MPC Therapy Causes Long-Term Bone Regeneration
TEST ANIMAL 12 months post- MPC transplant
CONTROL ANIMAL 6 months post- sham transplant
TEST ANIMAL 6 months post- MPC transplant
14
Very Large, Unmet Cardiovascular Markets
  • 1. Acute Myocardial Infarction (AMI or Heart
    Attack)
  • gt1.1 million heart attacks in US annually
  • 46 develop heart failure due to loss of heart
    muscle lt6 years
  • existing therapies inadequate
  • MPC can increase blood flow, protect and rebuild
    heart muscle
  • 2. Congestive Heart Failure (CHF)
  • affects 5 million Americans (2 of the
    population)
  • 550,000 new US cases annually
  • existing therapies modest efficacy, symptomatic
    relief only
  • MPC can rebuild heart muscle, alleviating the
    condition
  • 3. Peripheral Artery Disease (PAD) and Wound
    Healing
  • gt8 million in US suffer from PAD
  • gt400,000 angioplasties annually to prevent limb
    amputation
  • gt800,000 diabetic foot ulcers annually
  • MPC increase blood flow

15
MPC Therapy Results In Improved Heart Function
  • Injection of MPC in heart results in
  • increased number of blood vessels
  • regeneration of heart muscle
  • reduced scar tissue
  • long-term improvement in heart function

14
12
10
arteriole number
8
6
4
2
0
0.2x106 MPC
saline
1x106 MPC
16
Delivering A High-Margin Business Model An
Off-the-Shelf Product
  • lack of immune activation
  • one universal donor provides MPC for multiple
    unrelated recipients (allogeneic), contrasting
    with other cell therapies (autologous)
  • purity of MPC starting material
  • one universal donor can provide easy
    scale-up, many dosages
  • easy access to source material
  • pay universal donors using existing FDA
    guidelines
  • centralised manufacture and distribution
  • commercial quantities of clinical-grade MPC
    product easily delivered to market as an off
    the shelf product
  • pharmaceutical range profit margins
  • proprietary MPC technology -- long term market
    protection

17
Executing Results-Oriented Commercial Strategy
  • milestone-driven and outcome-focused
  • continuous engagement of strategic corporate
    partners to generate early revenues in multiple
    fields, geographies
  • e.g. orthopaedic delivery companies,
  • cardiac catheter companies,
  • Big pharma
  • minimise corporate costs, whilst maximising
    intelligent use of outsourcing
  • deliver therapeutic products to increase
    quality of life and materially reduce health
    care costs

18
  • Clinical trial protocol
  • Australian human trials
  • orthopaedic
  • cardiovascular
  • Safety/toxicology
  • GMP process
  • FDA/IND filing
  • orthopaedic
  • cardiovascular
  • IND approval/US trials
  • IP development
  • Corporate partnerships

Milestone-Driven, Rapid Commercialisation
2006
2005
2007
19
Experienced Board of Directors
Chair Mesoblast Michael Spooner - ex
Ventracor MD CEO Directors Donal ODwyer -
ex worldwide President Cordis (JJ) Byron
McAllister - ex VP Ares-Serono (FDA
expert) Prof. Silviu Itescu - Columbia (USA)
and Melb. Uni., Corp FDA advisor Chair
Angioblast Carter Eckert - ex CEO Knoll, ex Pres
Baxter Pharmaceuticals Chair SAB Prof. Silviu
Itescu Members Prof. Stephen Graves -
Director Orthopaedic Research, Royal Melbourne
Prof. Robert Graham - Exec. Director Victor
Chang Institute, Sydney Prof. Henry Krum -
Pfizer Global Advisory Board Prof. Richard
Gilbert - Consultant LillyCo., Merck,
GlaxoSmithKline
20
Details of the Offer
Capital Raised 21 M Issue
price 0.50/share Market Cap (at issue price)
on listing 46.76 M Use of Funds Acquisition of
33.3 Angioblast 10.0 M Development of
Orthopaedic applications 7.7 M Working
capital 1.5 M Expenses of the offer
1.8 M TOTAL 21.0 M
21
Capital Structure
Founding Shareholders 47 Medvet
3 Pre-IPO Investors 6 IPO Investors
44 TOTAL 100 Total options on
issue - 5.48 million at exercise prices of
0.55/share and above
22
Indicative Timetable
Lodgement of Prospectus at ASIC 16/11 Opening
of Offer 24/11 Closing of Offer 10/12 Mes
oblast Ltd shares quoted on ASX 16/12 This
timetable is indicative only and may move in time
in accordance with the company, the
underwriters, ASIC the ASX.
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