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2011 Annual Shareholder Meeting Presentation
Cytori Cell Therapy aims to improve quality and length of life through innovative cell therapy. The company has treated over 4,000 patients for conditions like cardiovascular disease and soft tissue disorders. Recent clinical trials show promise for treating chronic myocardial ischemia and acute heart attack. For chronic heart failure, cell therapy may help improve heart condition, activity, and reduce mortality for "no option" patients, representing a large potential market.
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2011 Annual Shareholder Meeting Presentation
- 1. Cell Therapy Cytori CellTherapy Shareholder Presentation August 16, 2011
- 2. Safe Harbor Thispresentation may contain certain ‘forward-looking statements’. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this presentation are also subject to a number of material risks and uncertainties. We caution investors not to place undue reliance on the forward-looking statements contained in this presentation. We would advise reading our annual report filed with the United States Securities and Exchange Commission on Form 10-K for a more detailed description of these risks. Cell Therapy
- 3. Our Company Mission To improve the quality and length of life by providing innovative cell therapy for patients CYTORI - The Leader in Cell Therapy. Cell Therapy
- 4. Cytori Restored myLife . . . Gary’s Story
- 5. Pathway to MarketAccess Clinical Data / Trials Indications for Use Reimbursement Translational Studies Growing Data on Fistulas > 100 wound pts treated CE Mark Claims for High success rate fistula - 2010 Most difficult cases Healthcare economic Expansion of claims for evaluation in process wounds in process Innovation funding Specific DRGs over time Cell Therapy
- 6. Pioneers: Translational Medicine North Tees & Hartlepool NHS Foundation Trust is looking for scientific appreciation through peer review and has not yet confirmed a significant benefit in a study that Involved sufficient numbers of patients Dr. Borowski North Tees, UK
- 7. ~ 4,000 PatientsTreated Cardiovascular Soft Tissue F O C U S Cell Therapy
- 8. Chronic Myocardial Ischemia PRECISE TRIAL • Prospective European Multicenter • Randomized (3:1) • Double Blind • Placebo controlled • Blinded independent core labs • Safety & Feasibility Trial • n= 27 (6 placebo, 21 treated) Dr. Aviles Madrid, Spain Cell Therapy
- 9. Chronic Myocardial Ischemia Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months The Precise Trial 20.0 19.0 P<0.05 P<0.05 18.0 17.2 17.1 16.0 16.6 15.5 15.3 14.0 Transplant List Baseline 6 Mos 18 Mos ADRC’s Standard of Care Cell Therapy
- 10. Chronic Myocardial Ischemia MVO2:significant change at 18 months • MVO2 correlates to improved survival • MVO2 ≤ 14 = 47% 1 yr survival rate METS: significant change at 18 months Infarct size: 8.2% change at 6 months Cytori procedure safe and feasible through 18-months Lower cardiac mortality rate: • At avg. follow up of 28 months: - 2/6 placebo - 1/21 treated Next Steps: Applying for European Approval * On-site Review completed in May Initiating US IDE Clinical Trial: ATHENA * Successful pre-IDE meeting with FDA Cell Therapy
- 11. Chronic Heart Failure What Really Matters For Patients Improved Reduced Improved Heart Mortality Activity Condition Cell Therapy
- 12. “No Option” HeartFailure Estimated Market Size for No Option Patients in Europe Region # of Patients (Incidence) # of Patients (10-Yr Prevalence) United Kingdom 40,000 400,000 Italy 40,000 400,000 Germany 55,000 550,000 France 40,000 400,000 Spain 30,000 300,000 Total G5 205,000 2,050,000 * Estimated price per treatment: $ 10,000 G5 Market $ 20 Billion* Cell Therapy
- 13. Acute Heart Attack APOLLO TRIAL • Prospective European Multicenter Trial • Randomized (3:1) • Double Blind • Placebo controlled • Blinded independent core labs • Safety & Feasibility Trial • n = 14 (4 placebo, 10 treated) Eric Duckers, MD, PhD Rotterdam, The Netherlands Cell Therapy
- 14. The APOLLO trial 6 & 18 month follow-up Percent of Left Ventricle Infarcted: Infarct size normalized to ventricle size (%LVI) improved more in ADRC patients compared to placebo control patients (late enhancement cMRI): +5,1% abs. and +59% rel. improvement compared to placebo control, PTE) change in rel.infarct size (I/LV) (matched pairs) all pts baseline 6 mo control Tx 24,7% 24,7% ADRC Tx 31,6% 15,4% all patients p=NS matched pairs Slides & Data provided by: All MRI images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
- 15. The APOLLO trial 6 & 18 month follow-up Perfusion defect: Reduction in perfusion defect in patients treated with ADRC compared to placebo control patients (3,5-fold improvement) as analyzed by MIBI SPECT (visual rest scores, PTE) MIBI SPECT TSS change (matched pairs) +253% +87% improvement improvement p=NS Slides & Data provided by All SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
- 16. The APOLLO trial 6 & 18 month follow-up Perfusion defect in LAD territory: Reduction in perfusion defect in patients treated with ADRC compared to placebo patients (9,7-fold improvement in LAD perfusion territory) as analyzed by MIBI SPECT (TSS scores) MIBI SPECT TSS change (matched pairs) +867% +800% improvement improvement p=NS Slides & Data provided by: All SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA) Duckers, MD, PhD Eric
- 17. The APOLLO trial 6 & 18 month follow-up Change in ESV ESV was markedly reduced in ADRC patients as compared to placebo control patients (as measured by 2D TTE, cMRI and SPECT, PTE) change in ESV (cc, 2D TTE) 24,4 cc improvement (-72,2%) Slides & Data provided by: All TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
- 18. The APOLLO trial 6 & 18 month follow-up Change in EDV i.c.c. post-AMI adverse remodeling EDV was significantly reduced in ADRC patients compared to placebo-control patients (as measured by 2D TTE, cMRI and SPECT, PTE), indicating a significant reduction of adverse post-AMI adverse cardiac remodeling change in EDV (cc, 2D TTE) 39,1 cc improvement (-56,9%) Slides & Data provided by: All TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
- 19. The APOLLO trial Ventricular Tachyarrhythmias and Ventricular Extra Systoles as manifestations of developing post-AMI Cardiomyopathy up to 18 mo Placebo ADRC P-value (n=4) (n=9) Ventricular TachyArrhythmia patients w documented VT 2 / 4 (50%) 3 / 10 (30%) NS total episodes of VT 11 5 < 0.05 average episodes/ patient 2.8 0.5 < 0.05 Placebo ADRC P-value (n=4) (n=9) Premature Contractions (PVC) patients w > 10 PVC/ hr 3 / 4 (75%) 0 / 10 (0%) < 0.05 total PVC / patient at 18 mo FU 1607 284 < 0.001 average PVC / 24 hr / patient 146 24 < 0.05 Continuous telemetric/ holter registration in first 6 days post AMI 48 hr holter registrations weekly in first month 24 hr holter registrations monthly in first 6 months Analysis by Student-t- tests Slides & Data provided by: All Holter registrations were assessed by an independent, blinded core lab Post hoc analysis by Thoraxcenter/ MCL Eric Duckers, MD, PhD
- 20. The APOLLO trial Ventricular ectopy in post-AMI patients as manifestations of developing cardiomyopathy cum. ventricular ectopy per 24 hr registration P < 0.001 Weeks after AMI Analysis by Student-t-test All Holter registrations were assessed by an independent, blinded core lab Slides & Data provided by: Post hoc analysis by Thoraxcenter/ MCL Eric Duckers, MD, PhD
- 21. APOLLO: Summary ADRCs are safe in the treatment of STEMI No safety concerns No new Major Adverse Cardiac Events No Deaths Efficacy Concordant improvement in infarct and ischemia: Mean reduction in Infarct Size is maintained to 18 months Improvement in cardiac perfusion is maintained to 18 months Long-term data indicates slowing progression toward heart failure Positive impact on arrhythmia in cell-treatment patents Cell Therapy
- 22. Acute Heart Attack “We show if you protect the muscle in the acute phase of MI you will indeed have sustained improvement” Eric Duckers, MD, PhD Rotterdam, The Netherlands Cell Therapy
- 23. Acute Heart Attack ADVANCE TRIAL • European Pivotal Trial • Prospective • Randomized (2:2:1) • Double Blind • Placebo controlled • Blinded independent core labs • Up to 370 patients for STEMI • Currently enrolling & treating Eric Duckers, MD, PhD Rotterdam, The Netherlands Cell Therapy
- 24. Acute Myocardial Infarction Estimated Market Size for AMI Patients in Europe Annual Heart Attack Incidence (EU) 1.9 million % STEMI (large heart attacks) 38% Target Addressable Procedures 720,000 Estimated Price per Treatment $ 10,000 EU AMI Market $ 7.2 Billion Cell Therapy
- 25. Lumpectomy Reconstruction RESTORE II TRIAL • Prospective European Multicenter Trial • ‚No Option‛ Partial Mastectomy patients • 1 year primary follow up • Blinded independent core labs • 71 Patients treated Eva Weiler-Mithoff, MD Glasglow, United Kingdom Cell Therapy
- 26. Lumpectomy Reconstruction Clinical: • Safe & Persistent Therapy • 85% Investigator Satisfaction • 75% Patient Satisfaction • 36% (24/66) patients underwent 2nd procedure MRI – independent core laboratory: • High rate of improvement in breast shape • High rate of improvement in defect shape Eva Weiler-Mithoff, MD Glasglow, United Kingdom Cell Therapy
- 27. Lumpectomy Reconstruction Patient A PatientB Pre-treatment 6 12 months months Cell Therapy
- 28. Lumpectomy Reconstruction “The useof lipomodelling for reconstruction after breast cancer surgery has become a common technique. However, in the radiation injured patient, repeat procedures are often required. Cytori's Celution System supplements a fat graft with a patient's own adipose-derived regenerative cells to improve graft take and help regenerate damaged tissue. This minimally invasive treatment approach could reduce or eliminate the practice of repeat procedures, leading to significant cost savings for the NHS.” Brian Winn Head of Technology & Product Innovation NHS National Innovation Centre www.nic.nhs.uk Cell Therapy
- 29. Breast Reconstruction EstimatedMarket Size for Breast Reconstruction in Europe Annual Breast Cancer Incidence - Europe 332,000 % Lumpectomy eligible ~70% Target Addressable Market (Incidence) 230,000 Target Addressable Market (Prevalence) > 1,000,000 EU Lumpectomy Reconstruction Market: $ 3.7 Billion * Estimated price per treatment: $ 3,000 (USD) Cell Therapy
- 30. Progress Toward MarketAccess (EU) Clinical Data / Trials Indications for Use Reimbursement Soft Tissue / Breast Reconstruction Chronic Heart Disease Acute Heart Cell Therapy
- 31. Market Access Today Pre-Clinical / Clinical Data Indications for Use Private Pay / Grants Current Opportunities • Aesthetics Market • Translational Research Market • StemSource Cell Banks Cell Therapy
- 32. Market Access Today •Revenue growth yr / yr • Quarters remain lumpy • Steady growth of Celution installed base • No annuity sales growth • Shifting sales focus: Soft Tissue Reconstruction Current Opportunities • Aesthetics Market • Translational Research Market • StemSource Cell Banks Cell Therapy
- 33. Driving Toward MarketInflection Point Clinical Data / Trials Indications for Use Reimbursement REGENERATIVE MEDICINE MARKET Market Inflection Point Drive Consumable Utilization Efficiency of Sales & Service Cell Therapy
- 34. EU Regulatory STRATEGY PART I:Tool Claims PART II: Therapeutic Claims CE Mark Process Foundational Device: Approved 2007 Claims Expansion: Approved 2010 Breast Reconstruction Breast Augmentation Crohn’s Fistula Claims Expansion: In Process Chronic “No Option” Myocardial Ischemia Pivotal Clinical Trial: In Process ADVANCE: Acute Myocardial Infarction Cell Therapy
- 35. Japan Regulatory STRATEGY PART I:Tool Claims PART II: Therapeutic Claims Japan MHLW / PMDA Application for Device Approval in process Application for Breast Reconstruction in process - based on Restore I & Restore II data Various investigator led translational studies* including: Radiation wounds Incontinence Fistula /wounds * Translational studies in Japan require MHLW approval Cell Therapy
- 36. US Regulatory STRATEGY Path I: Therapeutic Claims Path II: Humanitarian Use Path III: Tool Claims Cell Therapy
- 37. US Regulatory US FDAin Process MOST IMPORTANT PROCESS WITH FDA US IDE Trial for Cardiovascular: ATHENA Chronic Ischemia pre-IDE meeting successful File IDE in Fall ’11 Plan to begin enrollment in mid-2012 Ultimately FDA’s IDE – PMA process: provides clinical trial data specific indications for use supports applications for reimbursement Cell Therapy
- 38. US Regulatory US FDAin Process US HUD: Perry Rombergs Disease Step 1: Humanitarian Use Designation Currently Negotiating HUD with FDA Step 2: Humanitarian Device Exemption Small trial, reimbursement usually available Clinical label in a soft tissue indication Restricted indications for use / market Orphan Indication Cell Therapy
- 39. US Regulatory US FDAin Process • Multiple 510(k) apps pending / in process of submission • These include various predicates / indications • FDA status quo remains negative on 510(k) pathway • We believe the pathway is appropriate • 2 applications are currently under appeal • Potential to utilize Circuit Courts • Cost effective, efficient, independent Cell Therapy
- 40. Patents: 35 Issued,100+ Pending North America/Europe Asia Emerging Markets US: Korea: Australia: CELUTION DEVICE (‘484) CELUTION DEVICE (‘995) CELUTION DEVICE (‘135) CELUTION PLUS ADDITIVES (‘420) STEMSOURCE DEVICE (‘812) STEMSOURCE DEVICE (‘901) CELUTION FOR CRS (‘488) CELUTION DEVICE (‘139) CELUTION FOR CARDIOVASCULAR (‘858) STEMSOURCE DEVICE (‘115) CELUTION DEVICE WITH CENTRIFUGE OR CELUTION FUTURE GENERATIONS (‘075) Singapore: FILTER (‘937) CELUTION PLUS SENSORS FOR CLINICALLY CELUTION DEVICE & FUTURE SAFE OUTPUT (‘670) South Africa: GENERATIONS (‘683) CELUTION FOR BONE (‘043) CELUTION FOR CARDIOVASCULAR (‘446) CELUTION FOR CARDIOVASCULAR CELUTION OR CELGRAFT FOR SOFT TISSUE (‘590) DEFECTS (‘684) Mexico: BEDSIDE COMPREHENSIVE CELUTION FUTURE GENERATIONS (‘348) China: CELUTION FOR CARDIOVASCULAR (‘775) DEVICE (‘059) CELUTION DEVICE (‘689) CELUTION OUTPUT PLUS PROSTHETIC CELUTION FOR FOR BONE RELATED DISORDERS (‘716) Russia: CARDIOVASCULAR (‘104) CELUTION FOR CARDIOVASCULAR (‘924) CELLS PLUS FAT PLUS ADDITIVES (‘795) CELLS PLUS FAT (‘672) Japan: India: CELUTION DEVICE (‘952) CELUTION DEVICE (‘706) Europe: DEVICES FOR CELLS PLUS FAT CELUTION FUTURE GENERATIONS (‘529) CELUTION FOR ACUTE (‘041) CELUTION DEVICE FOR TREATING WOUND TUBULAR NECROSIS (‘834) CLINICALLY SAFE (‘556) HEALING (‘580) Israel: CELUTION DEVICE WITH CENTRIFUGE OR FILTER (‘800) *PATENTS ISSUED IN 2011 IN RED Cell Therapy
- 41. Financial Information Cash (Q2,2011) $ 33 million Additional cash post Q2 6 million Shares Outstanding 52 million Warrants (average price $ 3.80) 12 million Options (vested; average price $5) 5 million GE Loan (maturity 2013) $ 17 million Operating cash loss average ~ $7 million / quarter over last 6 quarters Trended higher over the past 2 quarters Expect operating cash loss to move back down toward average 2H ’11 Actively reducing costs, narrowing focus, improving efficiency, investing in our future Additional partnership is a near term corporate goal Cell Therapy
- 42. Strong Partners SupportingGrowth of Business Olympus Corporation (Japan): Manufacturing Joint Venture (2004) • Co-design & manufacture next-generation Celution® One • Available for ADVANCE heart attack trial • Manufacturing expertise & service infrastructure • Committed Partner: invested $55+mm Green Hospital Supply (2007) • Co-selling StemSource® Cell Banks in Asia GE Healthcare (2008) • Co-distribute Celution & StemSource in select countries Astellas Pharmaceuticals (2010) • Equity investment ($10 mm) • Received right-of-first refusal for liver disease partnership Future Partnerships Opportunities • 10 Individual processes ongoing • 6 distinct therapeutic areas Cell Therapy
- 43. Many Near TermValue Drivers • Chronic myocardial ischemia indications-for-use in Europe • Celution One - CE Mark approval • PureGraft approval in Japan • Revenue growth for the full year 2011 Report of 18-month outcome data from APOLLO acute heart attack trial • Publish and Present complete RESTORE 2 trial 12-month data • US FDA clearance or trial approval • Design and prepare to begin ATHENA • Growth in targeted emerging markets • Establish a meaningful corporate partnership 43 Cell Therapy
- 44. Cell Therapy Thank You !