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C Y TherapyIPersonalized Cell TOR         THE TRUSTED LEADER           IN CELL THERAPY              NASDAQ: CYTX    1
Safe Harbor StatementThis presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. Allst...
Mission: Improve the quality & length of lifethrough innovative CELL THERAPY products   CYTORI CELL THERAPY               ...
i.     Business and Technology Overviewii.    Cardiovascular Pipelineiii.   Soft Tissue Pipelineiv.    Commercial       CY...
Cytori Cell Therapy                         Your tissue is processed right                            at the side of your ...
Clinical Leadership                   Thousands of patients around the world                             have been treated...
Cytori Cell Therapy Development Pipeline                    Preclinical   Phase I/II   Pivotal   Full Market              ...
54 Worldwide Issued Patents; 75+ PendingDEVICES                                 DEVICES                    COSMETIC & RECO...
i.     Business and Technology Overviewii.    Cardiovascular Pipelineiii.   Soft Tissue Pipelineiv.    Commercial       CY...
Refractory Heart FailureCondition: Severe form of coronary artery disease due to chronicmyocardial ischemia and leads to d...
28 Month Mortality RatePRECISE Trial                                                  Treated                             ...
U.S. Refractory Heart Failure Trial• Device-based PMA/IDE study• Multi-center, prospective, randomized, double-blind, blin...
Acute Myocardial InfarctionCondition: Artery blockage inhibits blood flow to heart muscleresulting in left ventricular dam...
APOLLO: EU AMI Pilot TrialPotential new approach for treatment of heart attacks   Safe & feasible   Strong trends in fav...
ADVANCE: EU AMI Approval Trial• Device-based trial predominately in EU - G6 & Canada• Multi-center, prospective, randomize...
i.     Business and Technology Overviewii.    Cardiovascular Pipelineiii.   Soft Tissue Pipelineiv.    Commercial       CY...
Thermal Burns: Up to $106 Million from BARDA  U.S. Govt. contract: Thermal burns combined with radiation injury   • Nation...
Burn & Radiation Injury Clinical Experience                                                                 90% cells to c...
i.     Business and Technology Overviewii.    Cardiovascular Pipelineiii.   Soft Tissue Pipelineiv.    Commercial       CY...
Expanding Claims,   Accelerating Revenue Growth2012 Revenue Target of $9 Million   Target exceeded based on products ship...
FinancialsCash & Accts Receivable (Q3 2012) $20 MMPublic offering (Dec 2012)           $20 MMSenior Term Loan (GE)        ...
Milestones2012 Milestones AchievedPublished APOLLO primary endpoints (6-months)              √Published RESTORE 2 12-month...
CYTORIPersonalized Cell Therapy     THE TRUSTED LEADER       IN CELL THERAPY
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Biotech Showcase 2013

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CEO Chris Calhoun presents at Biotech Showcase 2013 on January 8, 2013

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Transcript of "Biotech Showcase 2013"

  1. 1. C Y TherapyIPersonalized Cell TOR THE TRUSTED LEADER IN CELL THERAPY NASDAQ: CYTX 1
  2. 2. Safe Harbor StatementThis presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. Allstatements, other than statements of historical fact, that address activities, events or developmentsthat 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 byour management in light of their experience and their perception of historical trends, currentconditions, expected future developments and other factors they believe to be appropriate.The forward-looking statements included in this presentation involve known and unknown risks thatrelate to Cytori’s future events or future financial performance and the actual results could differmaterially from those discussed in this presentation. Risks and uncertainties that may cause Cytorisactual results to differ materially from those discussed in the presentation can be found in the "RiskFactors" section of Cytori’s Form 10-K, Forms 10-Q and other filings with the United States Securitiesand Exchange Commission. We would advise reading our most recent annual report on Form 10-Kand quarterly report on Form 10-Q filed with the United States Securities and Exchange Commissionfor a more detailed description of these risks.The forward-looking statements contained in this presentation represent Cytori’s estimates andassumptions only as of the date of this presentation and Cytori undertakes no duty or obligation toupdate or revise publicly any forward-looking statements contained in this presentation as a result ofnew information, future events or changes in Cytori’s expectations. 2
  3. 3. Mission: Improve the quality & length of lifethrough innovative CELL THERAPY products CYTORI CELL THERAPY 3
  4. 4. i. Business and Technology Overviewii. Cardiovascular Pipelineiii. Soft Tissue Pipelineiv. Commercial CYTORI CELL THERAPY
  5. 5. Cytori Cell Therapy Your tissue is processed right at the side of your bed Fat (adipose) tissue Celution® System: Adipose-derived stem &from minor liposuction point-of-care device regenerative cells (ADRCs) 5
  6. 6. Clinical Leadership Thousands of patients around the world have been treated using their own (ADRC) cells 5 Company-Sponsored Trials  3 Complete (2 cardiovascular, 1 Breast)  2 Ongoing (2 cardiovascular) 40+ Investigator-Sponsored Studies  Chronic burns, radiation wounds, fistula repair, urinary incontinence, breast reconstruction, PVD, heart failure, liver, scleroderma, & othersADRCs: becoming the “go to” source for Clinical Cell Therapy 6
  7. 7. Cytori Cell Therapy Development Pipeline Preclinical Phase I/II Pivotal Full Market Access Private Pay/ ReimbursementRefractory HeartFailure U.S.Vascular Delivery EuropeAcute MyocardialInfarction EuropeBARDA (Burns) U.S.Breast Recon &Soft Tissue Europe/APIndependent AppDevelopment Europe/AP 7
  8. 8. 54 Worldwide Issued Patents; 75+ PendingDEVICES DEVICES COSMETIC & RECONSTRUCTIVE CARDIOVASCULAR THERAPIES PIPELINE THERAPIESCURRENT NEXT GENERATION SURGERYUS: (6) US: (1) US: (6) EUROPE: (2) US: (3)CELUTION DEVICE (‘484) CELUTION & FUTURE CELUTION FOR MIXING ADRCS ADRCS FOR CARDIAC (‘382) OPPOSED CELUTION FOR BONE (‘043)CELUTION DEVICE PLUS ADDITIVES (‘420) GENERATIONS (‘075) PLUS FAT (‘488) DEVICE FOR RESTORING BLOOD FLOW CELUTION OUTPUT PLUSSTEMSOURCE DEVICE (‘115) (‘575) OPPOSED CELUTION OR NEXT GEN DEVICES PROSTHETICCELUTION DEVICE PLUS SENSORS FOR CHINA: (1) FOR SOFT TISSUE DEFECTS (‘684) FOR BONE RELATEDCLINICALLY SAFE OUTPUT (‘670) AUSTRALIA: (1) CELUTION & FUTURE ADRCS PLUS FAT PLUS ADDITIVES ADRCS FOR CARDIAC (‘858) DISORDERS (‘716)BEDSIDE COMPREHENSIVE GENERATIONS (‘241) (‘795) ADRCS FOR WOUNDDEVICE (‘059) ADRCS PLUS FAT (‘672) SINGAPORE: (1) HEALING (‘580)CELUTION DEVICE CD31 POSITIVE CELLS INDIA: (1) ADRCS PLUS FAT ADRCS FOR RESTORING BLOOD(‘276) FLOW(‘309) CELUTION WITH CENTRIFUGE COMPOSITION (‘121) EUROPE: (2) OR FILTER (‘529) CURRENT CELUTION DEVICE + CELUTION FOR ACUTEJAPAN: (2) CHINA: (1)CELUTION DEVICE (‘952) FAT (‘947) TUBULAR NECROSIS (‘834) ADRCS FOR RESTORING BLOOD FLOWCELUTION FOR CLINICALLY SAFE OUTPUT AUSTRALIA: (1) (‘104) ADRCS FOR WOUND(‘556) CELUTION WITH CENTRIFUGE JAPAN: (1) HEALING (‘833) OR FILTER (‘937) CELUTION AND NEXT GEN DEVICES HONG KONG: (1)KOREA: (3) FOR MIXING ADRCS PLUS FAT ADRCS FOR RESTORING BLOOD FLOW JAPAN: (3)CELUTION DEVICE (‘995) SINGAPORE: (1) (‘041) (‘085) ADRCS FOR WOUNDSTEMSOURCE DEVICE (‘812) CELUTION & FUTURE HEALING (‘699)CELUTION DEVICE (‘139) GENERATIONS (‘683) KOREA: (3) RUSSIA: (1) CELUTION OUTPUT PLUS CELUTION FOR RESTORING BLOOD FLOW ADRCS PLUS FAT (‘454) PROSTHETICINDIA: (1) (‘924) ISRAEL: (1) CELUTION OR NEXT GEN DEVICES FOR BONE RELATEDCELUTION DEVICE (‘706) CELUTION WITH CENTRIFUGE FOR SOFT TISSUE DEFECTS (‘508) DISORDERS (‘119) SOUTH AFRICA: (1) OR FILTER (‘800) ADRCS PLUS FAT METHOD ADRCS FOR CARDIAC (‘446) CELUTION FOR PERIPHERALAUSTRALIA: (2) (‘666) VASCULAR DISEASE (‘511)CELUTION DEVICE (‘135) MEXICO: (1) MEXICO: (1)STEMSOURCE DEVICE (‘901) CELUTION FOR RESTORING BLOOD FLOW CELUTION & FUTURE INDIA: (1) GENERATIONS (‘348) (‘775) ADRCS FOR WOUNDCHINA: (1)CELUTION DEVICE (‘689) HEALING (‘580) ISRAEL: (1) KOREA: (1) ADRCS FOR CARDIAC (‘354) CELUTION WITH CENTRIFUGE OR FILTER (‘305) CANADA: (1) ADRCS FOR RESTORING BLOOD FLOW(‘510) 8 JAPAN: (1) CELUTION FOR RESTORING BLOOD FLOW(‘787)
  9. 9. i. Business and Technology Overviewii. Cardiovascular Pipelineiii. Soft Tissue Pipelineiv. Commercial CYTORI CELL THERAPY 9
  10. 10. Refractory Heart FailureCondition: Severe form of coronary artery disease due to chronicmyocardial ischemia and leads to deathDisease Course: Declining cardiac function leads to hearttransplantation or deathSize of Market: Approx.120K to 250K diagnosed each year in U.S.(subset of approx. 5.8 MM heart failure patients)Cytori Cell Therapy: Potential to revive living but stressed hearttissue; Halt progressive disease & keep patient off transplant list;overcome limits of existing drugs, devices and surgical options 10
  11. 11. 28 Month Mortality RatePRECISE Trial Treated Placebo 0% 50% 20.0 19.0 P<0.05 P<0.02 18.0 VO2Max 17.2 17.1 ADRC’s 16.6 Increased 16.0 Mortality 15.5 Standard of Care 15.3 14.0 Transplant List Baseline 6 Mos 18 MosChange in Peak Oxygen Consumption (VO2Max) from Baseline to 6 & 18 months 11 N=27; 21 active, 6 control
  12. 12. U.S. Refractory Heart Failure Trial• Device-based PMA/IDE study• Multi-center, prospective, randomized, double-blind, blinded core labs• Up to 45 patients with 2:1 randomization at six sites - Texas Heart, Minneapolis Heart, USF, Scripps, Alabama, U. Florida• Dose: 0.4 million cells/kg body weight• Endpoints: - Clinical Safety through 12 months - Peak oxygen consumption (VO2 Max) at 6 months - Perfusion defect at 6 months - Left ventricle end-systolic and diastolic volume at 6 months - Ejection fraction at 6 months - Re-hospitalization, heart failure symptoms & quality of life @ 12 mo• Enrollment initiated Sept 2012 / complete enrollment by mid-2013 12
  13. 13. Acute Myocardial InfarctionCondition: Artery blockage inhibits blood flow to heart muscleresulting in left ventricular damageDisease Course: More damage to the heart correlates to a higherrate of progression toward heart failureSize of Market: Approx.1 million heart attack patients admitted tohospital each year, 38% are STeMI’sCytori Cell Therapy: Minimize heart damage and reduce rate toprogressive disease; additive to existing treatments; potential toreduce healthcare costs & re-hospitalizations linked to heart failure(leading healthcare cost in US & leading cause of death globally) 13
  14. 14. APOLLO: EU AMI Pilot TrialPotential new approach for treatment of heart attacks Safe & feasible Strong trends in favor of efficacy: improvement in perfusion, reduced infarct size Less remodeling toward heart failure at 18 months 35% 32% 46% of patients 30% Progress to % Left Placebo 25% 25% Heart Failure Ventricle 25%infarct size 20% 15% 7% of patients ADRC 15% Progress to P < 0.05 for change 10% from BL for ADRCs Heart Failure 5% Baseline 6 Months 14
  15. 15. ADVANCE: EU AMI Approval Trial• Device-based trial predominately in EU - G6 & Canada• Multi-center, prospective, randomized, double-blind• Up to 216 patients with 2:1 randomization at up to 35 sites• Dose: 20 million ADRCs (or placebo) delivered intracoronary• Endpoints: - Primary o Reduction of Infarct size at six months (MRI) - Secondary o Clinical endpoints of MACCE, improvement in perfusion (SPECT) o Additional assessments in LVEF, Volumes, Holter monitoring for ventricular arrhythmias, & quality of life• Trial enrollment resumed in the 4th quarter of 2012• 10-15 trial sites selected and committed• Multiple patients have been enrolled under new protocol 15
  16. 16. i. Business and Technology Overviewii. Cardiovascular Pipelineiii. Soft Tissue Pipelineiv. Commercial CYTORI CELL THERAPY
  17. 17. Thermal Burns: Up to $106 Million from BARDA U.S. Govt. contract: Thermal burns combined with radiation injury • National preparedness to counter radiological bomb • Funds complete development: preclinical to FDA submission • New soft tissue pipeline application in U.S. • Procurement potential above and beyond contract Options 1 & 2• $4.7 MM in funding • Up to $45 MM• Preclinical model • Pivotal trial • Up to $55 MM• Next-Gen Celution® • FDA submission • Development development including clinical• Up to 2 years • Govt. has Proof-of- procurement ability Option 3 Concept 17
  18. 18. Burn & Radiation Injury Clinical Experience 90% cells to circular area around sore Exposed SacrumNote sig. inflammation, redness, swelling 10% cells to sore itself Immediate Pre Op Intra Op, Debrided Intra Op, Post-Cell Rx 1 Year Post Op Chronic burn injury: Pre-Op Chronic burn injury: Post-Op 18-mo 18
  19. 19. i. Business and Technology Overviewii. Cardiovascular Pipelineiii. Soft Tissue Pipelineiv. Commercial CYTORI CELL THERAPY
  20. 20. Expanding Claims, Accelerating Revenue Growth2012 Revenue Target of $9 Million Target exceeded based on products shipped (pending auditor review of revenue)Class I Device Clearance in Japan Facilitates system & bank sales Academic customers performing investigator-led studies Shipments under new approval began in late Q3 2012 Cell cryopreservation & tissue bankingCE Mark Expansion New soft tissue indications in Q3 2012: fistula, sports injury, tissue ischemia EU Vascular delivery indication pending2013 Revenue Expectations• Continue to delivery year over year revenue growth 20
  21. 21. FinancialsCash & Accts Receivable (Q3 2012) $20 MMPublic offering (Dec 2012) $20 MMSenior Term Loan (GE) $25 MMShares outstanding 65 MMMultiple partnership opportunities under negotiation 21
  22. 22. Milestones2012 Milestones AchievedPublished APOLLO primary endpoints (6-months) √Published RESTORE 2 12-month results √Partnership with BARDA (contract for up to $106 mm) √Initiated patient enrollment in ATHENA √Re-initiated ADVANCE enrollment √Expanded Claims in EU & Class 1 Approval in Japan √Achieve $9 million revenue target for 2012 pending2013 MilestonesCE Mark expansion for intravascular useComplete enrollment in ATHENAComplete the Proof of Concept Phase of BARDA contractSignificant revenue growth, reduce cash op lossPublish PRECISE outcomes
  23. 23. CYTORIPersonalized Cell Therapy THE TRUSTED LEADER IN CELL THERAPY
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