Vericel Corporation · NASDAQ:VCEL
Vericel — Aastrom Biosciences — Shareholder Meeting (November 2005)
36 slides from Vericel's shareholder meeting presentation, Nov 2, 2005
Slide 1: Annual Meeting of Shareholders Presentation
Proprietary Cell Products for Tissue Regeneration (Nasdaq:ASTM) Annual Meeting of Shareholders Presentation November 2, 2005
Slide 2: Safe Harbor
This presentation contains forward-looking statements, including, without limitation, statements concerning product-development objectives and anticipated timing, clinical trial timing and expected results, potential market opportunities and revenue models, market development plans, anticipated key
Slide 3: FY 2005 Progress
FY 2005 Progress Operational Progress Strengthened management team with 5 new additions Jim Cour - President and COO Transition of Company into multi-national clinical trial stage Clinical Trial Progress Reported positive results from lead trial in bone fracture healing Active multi-center US trial
Slide 4: Month Performance vs Comps
12 Month Performance vs Comps ASTM = Aastrom Biosciences, Inc. STEM = StemCells, Inc. TGEN = Targeted Genetics Corp. XCYT = Xcyte Therapies Inc. ILE = Isolagen Inc.
Slide 5: Trends: How is Our Industry Changing?
Trends: How is Our Industry Changing? Recognition of "Cells" as valuable therapeutic tools Stem cell initiatives, developmental progress, new companies Regulatory shifts now recognize cells as drugs (trial and manufacturing requirements) However, questions in moving from "technology to product" Manu
Slide 6: Personalized Medicine Trend
Personalized Medicine Trend
Slide 7: How is Aastrom Responding?
How is Aastrom Responding? Clinical program designed to establish functional capability of TRCs in standard indications, but with transition to new treatment approaches and indications Increase development focus on vascularization, joints/inflammation and tissue injuries that impair quality of life
Slide 8: Capturing the Therapeutic Potential of Bone Marrow Stem Cells
Capturing the Therapeutic Potential of Bone Marrow Stem Cells Therapy requires a large number of bone marrow cells at the injury site
Slide 9: Tissue Repair Cells Replaces 1+ Liter of Native Bone Marrow
Tissue Repair Cells Replaces 1+ Liter of Native Bone Marrow Mature Cells Late Stage Early Stage Regeneration Effectiveness Least Best Stem Cells with Stroma Bone Marrow Aastrom's TRCs Typical Cultured Cells Multi-Lineage Progenitor Cells Precursor Cells
Slide 10: Tissue Repair Cells: Bone Marrow ... Plus
Tissue Repair Cells: Bone Marrow ... Plus Small aspirate from patient Office procedure Cell manufacturing facility Proprietary stem cell production technology TRCs generate healthy tissues > 200 patients treated to date TRCs produced in AastromReplicell System Patented stem cell product in 12 days U
Slide 11: Aastrom Tissue Repair Cell Product
Aastrom Tissue Repair Cell Product TRCs Multi-Lineage Stem/Progenitor Cells Bone Vascular Others Growth Factor Production BMPs VEGF SCGF Others Bone Marrow- Derived Cells Natural Tissue Regeneration Process New Capability in Tissue Regeneration
Slide 12: Aastrom's Business Model
Aastrom's Business Model TRCs Aastrom Core Business Infrastructure Tissue Repair Cell Products Developed for Multiple Indications Centralized Facilities for Patient-Specific Cell Manufacturing and Distribution Development & Marketing Alliances Bone Grafting Fractures Jaw Reconstruction Spine Fusion
Slide 13: Development Strategy
Development Strategy Develop TRCs to respond to unmet needs in medicine with a specialty pharmaceutical business model Establishing TRCs in today's tissue regeneration markets, then moving to new opportunities that stem cells should enable Treatments where traditional medicine and pharma have failed
Slide 14: Development Approach for TRCs
TRCs in Medicine Development Approach for TRCs First Stage Demonstrate ability of TRCs to form multiple lineages of solid tissues Second Stage Demonstrate clinical safety and ability of TRCs to substitute for large volume bone marrow Fourth Stage Registration and marketing trials New product and use
Slide 15: TRC Tissue Regeneration
TRC Tissue Regeneration Cartilage formation capability Preclinical Cartilage Improved function of infarcted tissue Animal Cardiac Vascular tubule formation Preclinical Vascular Repair of non-union fractures Clinical Bone - Local Skeletal bone generation in hypophosphatasia patient Clinical Bone - Sy
Slide 16: Development Pipeline
Development Pipeline ICLINICAL DEVELOPMENT PIPELINE RESEARCH PRECLINICAL CLINICAL COMMENTS BONE GRAFTING ‘Long Bone Fractures ie First stage enrollment completed; results in 2006 cy Positive results reported Jaw Reconstruction — EU Results expected in C2005 Spine Fusions — US Preparing fr cla wil VA
Slide 17: Potential for TRCs in Bone Grafting
Potential for TRCs in Bone Grafting
Slide 18: Bone Graft Market Opportunity
Autograft Allograft & DBM BMPs Synthetics East 0.48 0.27 0.09 0.16 TRCs East 0.05 0.95 Bone Graft Market Opportunity Target the Surgical Autograft Segment for Severe Indications Source: Millennium Research Group CY2009 projections (U.S., Europe and Japan) BMP = Bone Morphogenic Proteins DBM = Demine
Slide 19: TRCs for Bone Grafting Bone Fracture Indications
TRCs for Bone Grafting Bone Fracture Indications
Slide 20: Automated Production Process
Automated Production Process
Slide 21: Non-Union Fracture Trial
Non-Union Fracture Trial * Clinical Situation: Non-union fracture of humerus which failed fixation and autograft (> 8 months) Candidate Patient X-Rays * Point of Fracture
Slide 22: Non-Union Fracture Trial: Fixation Removed
Non-Union Fracture Trial Fracture Site with Previous Fixation Removed
Slide 23: Non-Union Fracture Trial: New Fixation Applied
Non-Union Fracture Trial Fracture Site with New Fixation Applied
Slide 24: Non-Union Fracture Trial: TRCs and Matrix Applied
Non-Union Fracture Trial TRCs and Matrix Applied at Fracture Site TRCs and Matrix
Slide 25: Non-Union Fracture Trial: Recovery (5 Months)
Non-Union Fracture Trial Patient Recovery (5 Months) Fracture Site
Slide 26: Non-Union Fracture Trial: Recovery (12 Months)
Non-Union Fracture Trial Post-Treatment Patient Recovery (12 Months)
Slide 27: TRCs for Vascular Tissue Limb Ischemia Indication
TRCs for Vascular Tissue Limb Ischemia Indication
Slide 28: Limb Ischemia: Rationale for TRC Development
Limb Ischemia Large market opportunity, with limited therapeutic competition Clinical problem: foot ulcers, pain, infections and amputation Published clinical results suggest effectiveness of large volume bone marrow injections Similar reports for cardiac ischemia TRCs now active in clinical trial R
Slide 29: Limb Ischemia: Over 80,000 Amputations Per Year in US
Limb Ischemia Sources: Centers for Disease Control, National Center for Health Statistics Over 80,000 Amputations Per Year in US
Slide 30: Limb Ischemia: Effect of Large Volume Bone Marrow
Limb Ischemia Effect of Large Volume Bone Marrow Sources: Lancet 360: 427-435, 2002 (left panel) Eur J. Vasc Endovasc Surg 00, 1-3, 2002 (right panel)
Slide 31: Vascular Tissue Clinical Plan
Vascular Tissue Clinical Plan Lead Trial (Phase II-level) Patient enrollment began in October 2005 (Germany) Diabetic patients with severe limb ischemia and ulcers Complete 25 patients, evaluate data for protocol modifications, and expand with selected criteria Trial Objectives Evaluate TRCs vs Bone
Slide 32: Manufacturing: Stuttgart, Germany
Manufacturing Stuttgart, Germany Pilot scale / Clinical trial supply Awaiting inspection
Slide 33: Manufacturing: Planned Location near Dublin, Ireland
Manufacturing Planned location near Dublin, Ireland Limited commercial scale operation Now in detailed planning phase
Slide 34: Aastrom Balance Sheet Data
Aastrom Balance Sheet Data (June 30, 2005 *) Cash and Investments $ 32,400,000 Total Assets $ 33,900,000 Shareholders' Equity $ 33,000,000 Average Cash Usage Per Month $ 1,000,000 * Per Aastrom Biosciences, Inc. 4th Q and FYE 2005 Financial Results Press Release
Slide 35: Twelve-Month Milestones
Twelve-Month Milestones Report results from jaw bone reconstruction trial (EU) Initiation of spine fusion clinical trial (US) Expansion of fracture trial in Spain Operations begin at licensed, centralized cell manufacturing facility in the EU Report patient data from first stage of US fracture clini
Slide 36: Thank you!
Proprietary Cell Products for Tissue Regeneration Thank you!
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