Vericel Corporation · NASDAQ:VCEL
Vericel — Aastrom Biosciences — IPO Roadshow (August 2013)
33 slides from Vericel's IPO roadshow presentation, Aug 7, 2013
Slide 1: Aastrom Biosciences: The Future of Cell Therapy
Aastrom Biosciences The Future of Cell Therapy August 2013 Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration NO. 333-188186 August 6, 2013
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements, including, without limitation, statements concerning product-development objectives, clinical trial strategies, clinical trial timing and expected results, market data, potential market opportunities, market development plans, antici
Slide 3: Free Writing Prospectus Statement
Free Writing Prospectus Statement This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing. We have filed a registration statement (including a prospectus) with the SEC for
Slide 4: Offering Summary
Issuer Offering Size Use of Proceeds Offering Summary Aastrom Biosciences, Inc. 4 Clinical development of ixmyelocel-T; preclinical studies; technology platform development; working capital; general corporate purposes $15,000,000 of Common Stock (100 % Primary) Sole Book-Runner Aegis Capital Corp. O
Slide 5: Aastrom Biosciences Investment Highlights
Consistent Positive Efficacy Data Highly Differentiated Product Phase 2b Study Enrolling Aastrom Biosciences Investment Highlights Lead indication is for the treatment of advanced heart failure due to ischemic DCM U.S. orphan drug designation with $1+ billion peak revenue opportunity Study results e
Slide 6: Board of Directors and Management Team
6 Board of Directors Robert Zerbe, M.D Chairman of the Board CEO, QUATRx Pharmaceuticals Executive, Eli Lilly & Pfizer Nelson Simms Director CEO, Novavax; Executive, Lilly Ronald Cresswell, Ph D. Director CSO, Warner-Lambert; COO, Laporte Industries; COO Burroughs Wellcome Alan Rubino Director CEO,
Slide 7: World-Class Scientific Advisory Board and ixCELL-DCM Steering Committee
World-Class Scientific Advisory Board and ixCELL-DCM Steering Committee Scientific Advisory Board Daniel R. Salomon, M.D., Chairman Professor, Dept. of Molecular and Experimental Medicine and Medical Program Director, Scripps Center for Organ and Cell Transplantation, The Scripps Research Institute
Slide 8: Ixmyelocel-T is a unique multicellular therapy; key effector cells are M2-like macrophages and MSCs
Ixmyelocel-T is a unique multicellular therapy; key effector cells are M2-like macrophages and MSCs 8
Slide 9: Ixmyelocel-T has multiple biological activities that promote repair & regeneration of ischemic tissue
Ixmyelocel-T has multiple biological activities that promote repair & regeneration of ischemic tissue 9
Slide 10: Aastrom's therapeutic platform provides for efficient cell collection, production and delivery
Aastrom’s therapeutic platform provides for efficient cell collection, production and delivery 10
Slide 11: Ixmyelocel-T GMP manufacturing platform is highly automated and expandable, with low COGS
Ixmyelocel-T GMP manufacturing platform is highly automated and expandable, with low COGS Automated, Fully-Closed GMP Manufacturing System Single-use disposable bioreactor cassette Application key Incubator Processor System manager Highly Scalable Modular Expansion Enables COGS < 10% at commercial s
Slide 12: Ixmyelocel-T final product is convenient and easy to use
Ixmyelocel-T final product is convenient and easy to use Manufactured to finished product specifications Streamlined logistics Shipped via FedEx overnight in a qualified container Ready to use when received No freezing or thawing No refrigeration No reconstitution 72-hour shelf life Easy to administ
Slide 13: Comprehensive patent estate covers technology and therapeutic platforms
Aastrom’s technology and therapeutic platforms are covered by a comprehensive patent estate Intellectual Property Comprehensive patent portfolio covering: Composition of Matter Provides protection through 2029 Manufacturing Methods 13 13 Composition of Matter patents issued in US and EU in 2011 with
Slide 14: Multicellular platform offers potential for multiple therapeutic applications
Aastrom’s unique multicellular platform offers potential for multiple therapeutic applications Bone Cardiac Liver Pancreas Kidney Joints Bone Marrow Neural Vascular Muscle Lung Autoimmune Disease Atherosclerosis Ixmyelocel-T Potential Therapeutic Applications 14
Slide 15: Current focus is developing ixmyelocel-T for advanced heart failure due to ischemic DCM
Current focus is on developing ixmyelocel-T to treat advanced heart failure due to ischemic DCM
Slide 16: Heart failure represents a significant unmet medical need and growing public health problem
ADD AHA CHF Forecast Heart failure represents a significant unmet medical need and growing public health problem CRT $25,000-$50,000 initial LVAD2 $150,000 initial, $225,000 1st year Transplantation3 $200,000 initial, $1M 1st year Sources: Health Research International; Heidenreich et al. Circulatio
Slide 17: Ischemic DCM is a leading cause of heart failure and heart transplantation
Ischemic DCM is a leading cause of heart failure and heart transplantation Description Disease of the heart muscle characterized by weakened and enlarged chambers, reduced wall thickness, and inability to sufficiently pump blood 3rd most common cause of heart failure Leading cause of heart transplan
Slide 18: Heart Failure patient population and product positioning
Heart Failure 6 Million U.S. Patients Class III/IV NYHA 1.8 Million Patients Ischemic DCM Patients Refractory to Rx Therapy 170,000 Patients Sources: Heidenreich et al. Circulation 2011;123:933-944; Health Research International; America Heart Association Heart Transplants 2,000/yr A majority of adv
Slide 19: Refractory ischemic DCM market is a significant commercial opportunity
The refractory ischemic DCM market represents a significant commercial opportunity for ixmyelocel-T Ixmyelocel-T Commercial Opportunity First to market to treat advanced heart failure due to ischemic DCM Orphan indication •Premium pricing > $1B peak sales opportunity –$40,000 price –27% peak market
Slide 20: Ixmyelocel-T reduced tissue damage in a murine model of heart failure
Ixmyelocel-T significantly and reproducibly reduced tissue damage in a murine model of heart failure Naïve Mouse Week 6 Vehicle Study 2 Week 6 Control Week 6 ixmyelocel-T Week 0 LAD Ligation N=6 N=5 N=11 Murine Non-Acute Infarct Model Study conducted at Medigenix, LLC; data presented at the 18th Ann
Slide 21: Ixmyelocel-T reduced apoptosis in infarct border zone and increased plasma nitrates
Ixmyelocel-T treatment reduced apoptosis in the infarct border zone and increased plasma nitrates Murine Non-Acute Infarct Model Percent Tunnel Positive Nuclei Plasma Nitrates (mM) Study conducted at Medigenix, LLC; data presented at the 18th Annual International Society for Cellular Therapy Meeting
Slide 22: Phase 2a DCM clinical objectives and study parameters
Phase 2a DCM clinical objectives focused on safety, optimizing delivery and patient selection Phase 2a Clinical Objectives Demonstrate ixmyelocel-T safety in DCM patients Evaluate delivery approaches Gain clinical insight into patient selection Phase 2a Study Parameters: Two 12-month randomized open
Slide 23: Phase 2a safety results: ixmyelocel-T well-tolerated in DCM patients
Phase 2a safety results demonstrated that ixmyelocel-T was well-tolerated in DCM patients Summary Safety and Tolerability Conclusions Overall, ixmyelocel-T was well-tolerated in patients with DCM IMPACT-DCM: Post-surgery, adverse event incidence was comparable between the ixmyelocel-T and control gr
Slide 24: Ischemic DCM subjects on ixmyelocel-T had fewer MACE events
Subjects treated with ixmyelocel-T in the ischemic DCM group had a lower number of MACE events Note: MACE = cardiac death, cardiac arrest, myocardial infarction, sustained ventricular arrhythmia, pulmonary edema, CHF exacerbation (hospitalization), unstable angina, major bleed within one week of inj
Slide 25: Ischemic DCM subjects less likely to have MACE events
Subjects treated with ixmyelocel-T in the ischemic DCM groups were less likely to have MACE events *Combined IMPACT-DCM and CATHETER-DCM data in the ischemic DCM groups. 25 45% reduction in the number of patients having a MACE event at 12 months
Slide 26: Ischemic DCM subjects had a lower number of MACE events
Subjects treated with ixmyelocel-T in the ischemic DCM groups had a lower number of MACE events *Combined IMPACT-DCM and CATHETER-DCM data in the ischemic DCM groups. 26 61% reduction in the average number of MACE events per patient at 12 months
Slide 27: Positive trends in secondary efficacy measures in ischemic DCM groups
Consistent positive trends observed in secondary efficacy measures in the ischemic DCM groups* *Combined IMPACT-DCM and CATHETER-DCM data in the ischemic DCM groups. 27
Slide 28: ixCELL-DCM Phase 2b study design
Objectives To evaluate the efficacy, safety and tolerability of ixmyelocel-T compared to placebo in patients with heart failure due to ischemic DCM Patients Males and females, age 30-85 Diagnosis of ischemic DCM according to WHO criteria Not a candidate for reasonable revascularization procedures LV
Slide 29: ixCELL-DCM Phase 2b study execution is highly achievable
ixCELL-DCM Phase 2b study execution is highly achievable Well-defined patient population at a well-defined point in disease progression Advanced heart failure patients refractory to medical therapy Strong coordination between heart failure specialists and interventional cardiologists Existing relati
Slide 30: Value-creating clinical milestones over the financing period
Aastrom has several value-creating Phase 2 clinical milestones over the financing period Study Results Complete Patient Enrollment First Patient Enrolled 30 Heart Failure Peripheral Arterial Disease Craniofacial Reconstruction REVIVE CLI Study Cell Therapy for Craniofacial Defects Study Study Result
Slide 31: Financial Summary
Financial Summary Cash Balance $9.2 million at March 31, 2013 Cash Burn ~$4.5 expected in Q2 ~$3.5-$4.5 million per quarter Q3 2013 through Q1 2014 (ixCELL-DCM enrollment) ~$3 million per quarter thereafter Market Cap ~$32 million public float ~$40 million including preferred stock 31
Slide 32: Capital Structure
Capital Structure Shares Outstanding (in millions) – June 2013 Common 45.7 Series B Preferred 14.3 Total 60.0 Employee Options 7.3 (WAV exercise price = $2.05) Warrants 4.8 (4.5M at $2.44 ; 0.3M at $1.25) Series B Preferred Stock Accruing PIK dividends at 11.1% through March 2017 Preferred shares co
Slide 33: Aastrom Biosciences Investment Highlights
Consistent Positive Efficacy Data Highly Differentiated Product Phase 2b Study Enrolling Aastrom Biosciences Investment Highlights Lead indication is for the treatment of advanced heart failure due to ischemic DCM U.S. orphan drug designation with $1+ billion peak revenue opportunity Study results e