Vericel Corporation · NASDAQ:VCEL
Vericel — Aastrom Biosciences — Investor Presentation (June 2006)
26 slides from Vericel's investor presentation, Jun 26, 2006
Slide 1: Capturing the Therapeutic Potential of Bone Marrow Stem Cells
Capturing the Therapeutic Potential of Bone Marrow Stem Cells Investor Presentation June, 2006 (Nasdaq:ASTM)
Slide 2: Safe Harbor
This presentation contains forward-looking statements, including, without limitation, statements concerning product-development objectives and anticipated timing, clinical trial strategies, timing and expected results, potential market opportunities and revenue models, market development plans, anti
Slide 3: Overview
Overview Pipeline of autologous tissue regeneration products in clinical development Proprietary bone marrow stem, progenitor and stromal cell technology: Tissue Repair Cells ("TRCs") Proprietary manufacturing platform for regulatory compliance Clinical trials and development programs in orthopedics
Slide 4: Bone Marrow Stem Cells Generate Tissue
Bone Marrow Stem Cells Generate Tissue Therapy requires a Large Number of bone marrow stem cells Normal Tissue Maintenance Tissue Trauma or Disease Native cells are potent in small numbers in the body
Slide 5: The TRC Advantage
The TRC Advantage Opportunity for TRCs as a regenerative treatment
Slide 6: TRC Production Process
TRC Production Process Small aspirate from patient Office procedure TRCs regenerate human tissues 225 patients treated to date TRCs produced in AastromReplicell(r) System Centralized GMP manufacturing facility Autologous stem cell product in 12 days
Slide 7: Commercialization Model
Commercialization Model Bone Grafting Vascular Osteonecrosis REGULATORY Biologic (BLA) Engineered Tissue Pharmaceutical EMEA FDA Japan
Slide 8: Clinical Development Pipeline
Clinical Development Pipeline RESEARCH CLINICAL PHASE I/II PRECLINICAL Proof of Concept Multi- Center REGISTRATION Bone Grafting ^ Long Bone Fractures ^ Jaw Bone Reconstruction ^ Spine Fusion Osteonecrosis - Hip Diabetic Limb Ischemia Cardiac Repair Joint Repair BONE VASCULAR TISSUE JOINTS Completed
Slide 9: TRC Development Strategy
TRC Development Strategy Rationale Market with multiple areas of use May offer earliest/safest market entry for TRCs Strategy Complete Phase I/II trials for 3 types of bone Select single indication for registration trial Niche market for severe injury/problem where current care standards failed or a
Slide 10: TRC Clinical Trial - Bone Grafting
TRC Clinical Trial - Bone Grafting Patients who had failed to heal after one or more standard of care treatments Phase I/II trial completed (6 treatments) 6/6 positive for bone growth; healing and safety Multi-center study ongoing in U.S. (36 patients) Positive interim results reported for first 7 p
Slide 11: TRCs for Bone Grafting Non-Union Fracture Indication
TRCs for Bone Grafting Non-Union Fracture Indication
Slide 12: 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 13: Non-Union Fracture Trial
Non-Union Fracture Trial Fracture Site with Previous Fixation Removed
Slide 14: Non-Union Fracture Trial
Non-Union Fracture Trial TRCs and Matrix Applied at Fracture Site TRCs and Matrix
Slide 15: TRC Non-Union Fracture Trial Patient Recovery
TRC Non-Union Fracture Trial Patient Recovery Fracture Site 5 Month 12 Month
Slide 16: TRC Clinical Trial - Bone Grafting Spine Fusion Indication
TRC Clinical Trial - Bone Grafting Spine Fusion Indication IND approved for lead U.S. trial Posterolateral lumbar spine fusion (PLF) 5 patients to be evaluated for safety before expanding to multi-centers EU trial (lead center) expected Q3-4 CY2006 Transforaminal lumbar interbody spine fusion (TLIF)
Slide 17: TRC Development Strategy - Osteonecrosis
TRC Development Strategy Rationale Up to 20,000 patients in U.S. with limited therapeutic options Necrosis of bone, marrow and vascular tissues Leads to collapse of bone TRC capability to generate all 3 tissues Other Factors Orphan market opportunity Strategy Obtained Orphan Drug Designation from FD
Slide 18: TRCs for Vascular Tissue Critical Limb Ischemia Indication
TRCs for Vascular Tissue Critical Limb Ischemia Indication
Slide 19: TRCs for Peripheral Vascular Tissue
TRCs for Peripheral Vascular Tissue Regeneration of Blood Vessels in Ischemic Limbs Sources: U.S. Census 2000; United Nations 2002 World Population Report; Weitz JI, Byrne J, Clagett P, et al. Diagnosis and Treatment of Chronic Arterial Insufficiency of the Lower Extremities: A Critical Review. Circ
Slide 20: TRC Development Strategy - Peripheral Arterial Disease
TRC Development Strategy Rationale Large market opportunity with limited therapeutic competition Large volume bone marrow injections showing effectiveness Strategy Controlled lead trials to determine effect of TRCs on ischemic vasculature Expand trials to establish method of use for therapeutic bene
Slide 21: 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 22: TRC Clinical Trial - Peripheral Vascular
TRC Clinical Trial - Peripheral Vascular Phase I/II single-center randomized trial initiated in EU (Q4 CY2005) 25 patients with severe diabetic limb ischemia 5 patients per arm of study Controls are both bone marrow and standard of care Intramuscular or intra-arterial routes of administration U.S. P
Slide 23: Targeted Milestones
Targeted Milestones Initiate Phase I/II osteonecrosis clinical trial Initiate Phase I/II multi-center spine fusion clinical trial Report additional interim and final patient data from multi- center U.S. fracture clinical trial Announce target indication for registration trial for bone regeneration I
Slide 24: Aastrom Balance Sheet Data (March 31, 2006 - Proforma)
Aastrom Balance Sheet Data (March 31, 2006 - Proforma *) Cash and Investments $ 46,200,000 Total Assets $ 48,000,000 Debt $ -0- Shareholders' Equity $ 46,300,000 Average Cash Usage Per Month $ 1,200,000 * Per Aastrom Biosciences, Inc. 3rd Q FY2006 Form 10-Q, as filed with the SEC; includes net proce
Slide 25: Aastrom Opportunity
Aastrom Opportunity TRCs are unique as an expanded autologous tissue product with solid tissue, blood vessel and blood cell regeneration capability Positive clinical results reported for safety and tissue regeneration Proprietary therapeutic product pipeline for a variety of treatment and prevention
Slide 26: Thank you!
Capturing the Therapeutic Potential of Bone Marrow Stem Cells Thank you! (Nasdaq:ASTM)
Aastrom Biosciences — Investor Presentation (June 2006) on 6ix