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Stem Cell Meeting on the Mesa 2013

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SVP of Operations Doug Arm presents at the 2013 Stem Cell Meeting on the Mesa on October 15, 2013.
17
Cytori Cytori Corporate Overview Corporate Overview NASDAQ: CYTX NASDAQ: CYTX October 2013
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Page 1: Stem Cell Meeting on the Mesa 2013

CytoriCytori Corporate OverviewCorporate OverviewNASDAQ: CYTXNASDAQ: CYTX

October 2013

Page 2: Stem Cell Meeting on the Mesa 2013

Safe Harbor StatementSafe Harbor Statement

This presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. 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 statementsare based upon certain assumptions and assessments made by our management in light of their experienceand their perception of historical trends, current conditions, expected future developments and other factorsthey believe to be appropriate.

The forward-looking statements included in this presentation involve known and unknown risks that relate toCytori’s future events or future financial performance and the actual results could differ materially from thosediscussed in this presentation. Risks and uncertainties that may cause Cytori's actual results to differmaterially from those discussed in the presentation can be found in the "Risk Factors" section of Cytori’s Form10-K, Forms 10-Q and other filings with the United States Securities and Exchange Commission. We wouldadvise reading our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with theUnited States Securities and Exchange Commission for a more detailed description of these risks.

The forward-looking statements contained in this presentation represent Cytori’s estimates and assumptionsonly as of the date of this presentation and Cytori undertakes no duty or obligation to update or revise publiclyany forward-looking statements contained in this presentation as a result of new information, future events orchanges in Cytori’s expectations.

This presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. 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 statementsare based upon certain assumptions and assessments made by our management in light of their experienceand their perception of historical trends, current conditions, expected future developments and other factorsthey believe to be appropriate.

The forward-looking statements included in this presentation involve known and unknown risks that relate toCytori’s future events or future financial performance and the actual results could differ materially from thosediscussed in this presentation. Risks and uncertainties that may cause Cytori's actual results to differmaterially from those discussed in the presentation can be found in the "Risk Factors" section of Cytori’s Form10-K, Forms 10-Q and other filings with the United States Securities and Exchange Commission. We wouldadvise reading our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with theUnited States Securities and Exchange Commission for a more detailed description of these risks.

The forward-looking statements contained in this presentation represent Cytori’s estimates and assumptionsonly as of the date of this presentation and Cytori undertakes no duty or obligation to update or revise publiclyany forward-looking statements contained in this presentation as a result of new information, future events orchanges in Cytori’s expectations.

Page 3: Stem Cell Meeting on the Mesa 2013

CytoriCytori TechnologyTechnologyTherapeutic, Regulated as a DeviceTherapeutic, Regulated as a Device

• Regulatory Path: US PMA Device (CBER), EU-Device (Notified body)• Per treatment consumable MSRP $2,000 - $10,000• Cells processed available at bedside in about 1 hour• Adipose tissue yields unique mixed cell population

Page 4: Stem Cell Meeting on the Mesa 2013

Cytori Priorities: LeverageCytori Priorities: LeverageTransformative Technology PlatformTransformative Technology Platform

USA / BARDA

Cardiac• Completed proof-of-concept trial• Enrolling US Phase II Heart Failure trial

New opportunitiesleveraging the

platform

Commercial• Japan approval• EU ‘Vascular’ approval• Clinical experience in thousands of patients

• Up to $106 in development funding• Commercial preparedness contract

with US Government• Potential to fully fund PMA for burns

Page 5: Stem Cell Meeting on the Mesa 2013

Cytori’s Cardiac Cell Therapy

• Completed proof-of-concept trial• Enrolling ATHENA I & II US Phase 2 heart failure trials

Page 6: Stem Cell Meeting on the Mesa 2013

Cytori Cardiac Cell TherapyMechanism of Action in Ischemic Heart Disease

• ADSCs• EPCs• Mø• Endo• VSMCs• Pericytes

VEGF, PlGF, bFGF

NOS, ROS

Pericyte differentiation& recruitment,SDF-1, PlGF

Vessel density

Vessel stabilization& expansion

Endothelialdysfunction

Perfusion

Cell Sub Type Mediator Mechanism Clinical Effect & Patient Benefit

ADRCMixed CellPopulation

• ADSCs• Mø• T cells

• Mø• EPCs

Endo• ADSCs

Inflammation

Fibrosis

IL-10, IL-6

PGE2 Mø switch to M2

WBC recruitment& activation

MMP1, TGFβ, TIMP1

SDF-1, IGF-1

HGF, IGF-1

Scar remodeling

Myocardialapoptosis

Recruitment ofcardiac stem cells

Disease(VO2 Max)

Stabilization.QOL Benefit

Page 7: Stem Cell Meeting on the Mesa 2013

Cardiac Cell TherapyCardiac Cell TherapyPRECISE Pilot Showed ProofPRECISE Pilot Showed Proof--ofof--ConceptConcept

Objective:• safety and feasibility of ADRCs delivered via intramyocardial injections in

patients with chronic myocardial ischemia not amenable to revascularizationStudy Design:• double-blind, randomized, parallel group, placebo-controlledSample Size• 27 subjects (Spain, The Netherlands, Denmark) (21 ADRC, 6 Placebo)Procedure• electromechanical mapping (NOGASTAR®)• ≤ 15 intramyocardial injections in the area with inducible ischemia via the

MYOSTAR® Injection Catheter :– ADRCs (n=21, median dose of ADRCs 42 x 106 per subject)– Placebo (n=6: indistinguishable solution)

Objective:• safety and feasibility of ADRCs delivered via intramyocardial injections in

patients with chronic myocardial ischemia not amenable to revascularizationStudy Design:• double-blind, randomized, parallel group, placebo-controlledSample Size• 27 subjects (Spain, The Netherlands, Denmark) (21 ADRC, 6 Placebo)Procedure• electromechanical mapping (NOGASTAR®)• ≤ 15 intramyocardial injections in the area with inducible ischemia via the

MYOSTAR® Injection Catheter :– ADRCs (n=21, median dose of ADRCs 42 x 106 per subject)– Placebo (n=6: indistinguishable solution)

Page 8: Stem Cell Meeting on the Mesa 2013

Cardiac Cell TherapyCardiac Cell TherapyPRECISE Trial: Exercise TolerancePRECISE Trial: Exercise Tolerance

Page 9: Stem Cell Meeting on the Mesa 2013

Results• Holter: no adverse effects on rhythm at 6 and 18 months• VO2max: improvement (p<0.05 vs. placebo)

– Supported by NYHA improvement trend

• MRI: reduction in infarct size (p<0.05 vs. placebo)• No safety issues• Mortality [36 months]: placebo 33% (2/6) , ADRC 14% (3/21)

Cardiac Cell TherapyCardiac Cell TherapyPRECISE Trial: Data SummaryPRECISE Trial: Data Summary

Results• Holter: no adverse effects on rhythm at 6 and 18 months• VO2max: improvement (p<0.05 vs. placebo)

– Supported by NYHA improvement trend

• MRI: reduction in infarct size (p<0.05 vs. placebo)• No safety issues• Mortality [36 months]: placebo 33% (2/6) , ADRC 14% (3/21)

Page 10: Stem Cell Meeting on the Mesa 2013

Cardiac Cell TherapyCardiac Cell TherapyATHENA I & II US Heart Failure TrialsATHENA I & II US Heart Failure Trials

• Heart failure due to ischemic heart disease

• Phase II Trials based on EU Pilot (PRECISE)

• Prospective, double-blind, placebo-controlled trials– 90 patients: 45 patients at low dose, 45 patients at high dose– Up to 10 centers

• First data readout targeted for 2014

• Potential for pivotal trial initiation in 2015

• Heart failure due to ischemic heart disease

• Phase II Trials based on EU Pilot (PRECISE)

• Prospective, double-blind, placebo-controlled trials– 90 patients: 45 patients at low dose, 45 patients at high dose– Up to 10 centers

• First data readout targeted for 2014

• Potential for pivotal trial initiation in 2015

Page 11: Stem Cell Meeting on the Mesa 2013

• Safety• Treatment emergent Serious Adverse Events (SAEs)• Arrhythmia assessment via 24-hour Holter monitoring• MACE defined as Cardiac Death or Hospitalization for Heart Failure

• Efficacy• VO2 max (treadmill) (6 mo)• LVEF, LVESV/LVEDV assessed by Echo (6 mo)• Perfusion defect by Rest/Pharmacologic Stress SPECT (6 mo)• Heart failure symptoms, angina, and quality of life (3, 6, 12 mo):

• NYHA and CCS classifications• Minnesota Living with Heart Failure Questionnaire (MLHFQ)• SF-36 Health Survey

Cardiac Cell TherapyCardiac Cell TherapyATHENA EndpointsATHENA Endpoints

• Safety• Treatment emergent Serious Adverse Events (SAEs)• Arrhythmia assessment via 24-hour Holter monitoring• MACE defined as Cardiac Death or Hospitalization for Heart Failure

• Efficacy• VO2 max (treadmill) (6 mo)• LVEF, LVESV/LVEDV assessed by Echo (6 mo)• Perfusion defect by Rest/Pharmacologic Stress SPECT (6 mo)• Heart failure symptoms, angina, and quality of life (3, 6, 12 mo):

• NYHA and CCS classifications• Minnesota Living with Heart Failure Questionnaire (MLHFQ)• SF-36 Health Survey

Page 12: Stem Cell Meeting on the Mesa 2013

BARDA ContractBARDA Contract

DiscussionsBegin2010

AwardAnnouncementFall, 2012

3 Objectives TriggerOption 1 & 3Q1, 2014

3 Proof-of-concept ObjectivesOngoing

Cell viability

$32.6 M Option 1

Option 1 ObjectiveTriggers Option 2Q4, 2015

Animal model POC

Next Gen device feasibility

$32.6 M Option 1

$23.4M Option 3

Commercial Acquisition atBARDA’s Discretion

$45.5M Option 2

Pre-Award, White Papers,Proposal, Negotiation

$4.7M Phase 1 Proof of Concept

Page 13: Stem Cell Meeting on the Mesa 2013

CommercialCommercial

• Emphasis: Currently selling systems and consumables primarilyfor researchers conducting independently fundedclinical studies.

• Rationale: Expand Cytori’s bandwidth to validate new indications;Build brand presence with leading physicians;Offset burn as revenues grow.

• Driving Growth: Japan Class I designation / pending legislation;Approval in Australia;Intravase (cardiac reagent) approval in Europe;Ischemic tissue and muscle CE Mark claim expansion.

• Emphasis: Currently selling systems and consumables primarilyfor researchers conducting independently fundedclinical studies.

• Rationale: Expand Cytori’s bandwidth to validate new indications;Build brand presence with leading physicians;Offset burn as revenues grow.

• Driving Growth: Japan Class I designation / pending legislation;Approval in Australia;Intravase (cardiac reagent) approval in Europe;Ischemic tissue and muscle CE Mark claim expansion.

Page 14: Stem Cell Meeting on the Mesa 2013

50+ investigator studies (in process or completed)

USAUSA

33EUEU

3434APAP

1111

CommercialCommercialResearch Customers WorldwideResearch Customers Worldwide

SUI data publishedAug. 2013

USAUSA

33EUEU

3434APAP

1111

EMEM

33

Soft TissueWound

IschemiaOrtho/SportVital Organ

Positive scleroderma data Sep 2013Diabetic ulcer data published May 2013

Australian approval July 2013 basedon extensive clinical case work

Page 15: Stem Cell Meeting on the Mesa 2013

MegMegCytori Cell Therapy:Cytori Cell Therapy: Intellectual PropertyIntellectual Property64 Patents Issued Worldwide; More than 75 Pending Applications

DEVICES

CURRENT

DEVICES

NEXT GENERATION

COSMETIC & RECONSTRUCTIVE

SURGERY

CARDIOVASCULAR THERAPIES PIPELINE THERAPIES

US: (6)CELUTION DEVICE (‘484)CELUTION DEVICE PLUS ADDITIVES (‘420)STEMSOURCE DEVICE (‘115)CELUTION DEVICE PLUS SENSORS FOR

CLINICALLY SAFE OUTPUT (‘670)BEDSIDE COMPREHENSIVE

DEVICE (‘059)CELUTION DEVICE CD31 POSITIVE CELLS

(‘276)

JAPAN: (2)CELUTION DEVICE (‘952)CELUTION FOR CLINICALLY SAFE OUTPUT

(‘556)

KOREA: (3)CELUTION DEVICE (‘995)STEMSOURCE DEVICE (‘812)CELUTION DEVICE (‘139)

INDIA: (1)CELUTION DEVICE (‘706)

AUSTRALIA: (2)CELUTION DEVICE (‘135)STEMSOURCE DEVICE (‘901)

CHINA: (1)CELUTION DEVICE (‘689)

OLYMPUS-CYTORI PATENTS

NEXT GENERATION DEVICE - JAPAN

CENTRIFUGAL CONTAINER (‘020)DIGESTIVE ENZYMES (‘861)

US: (1)CELUTION & FUTURE

GENERATIONS (‘075)

CHINA: (1)CELUTION & FUTURE

GENERATIONS (‘241)

HONG KONG (1)CELUTION & FUTURE

GENERATIONS (‘322)

INDIA: (1)CELUTION WITH CENTRIFUGE OR

FILTER (‘529)

AUSTRALIA: (1)CELUTION WITH CENTRIFUGE OR

FILTER (‘937)

SINGAPORE: (1)CELUTION & FUTURE

GENERATIONS (‘683)

ISRAEL: (1)CELUTION WITH CENTRIFUGE OR

FILTER (‘800)

MEXICO: (1)CELUTION & FUTURE

GENERATIONS (‘348)

KOREA: (1)CELUTION WITH CENTRIFUGE OR

FILTER (‘305)

JAPAN: (1)CELUTION BUSINESS METHOD

US: (7)CELUTION FOR MIXING ADRCS PLUS

FAT (‘488)CELUTION OR NEXT GEN DEVICES FOR

SOFT TISSUE DEFECTS (‘684)ADRCS PLUS FAT PLUS ADDITIVES

(‘795)ADRCS PLUS FAT (‘672)ADRCS PLUS FAT

COMPOSITION (‘121)CURRENT CELUTION DEVICE

PLUS FAT (‘947)ADRC’S PLUS FAT PLUS

BUFFER (‘834)

JAPAN: (1)CELUTION AND NEXT GEN DEVICES

FOR MIXING ADRCS PLUS FAT (‘041)

KOREA: (3)ADRCS PLUS FAT (‘454)CELUTION OR NEXT GEN DEVICES FOR

SOFT TISSUE DEFECTS (‘508)ADRCS PLUS FAT METHOD

(‘666)

EUROPE: (2)ADRCS FOR CARDIAC (‘382) OPPOSED

DEVICE FOR RESTORING BLOOD FLOW

(‘575) OPPOSED

AUSTRALIA: (1)ADRCS FOR CARDIAC (‘858)ADRCS FOR REMODELING (‘046)

SINGAPORE: (1)ADRCS FOR RESTORING BLOOD

FLOW(‘309)

CHINA: (1)ADRCS FOR RESTORING BLOOD FLOW

(‘104)

HONG KONG: (1)ADRCS FOR RESTORING BLOOD FLOW

(‘085)

RUSSIA: (1)CELUTION FOR RESTORING BLOOD FLOW

(‘924)

SOUTH AFRICA: (1)ADRCS FOR CARDIAC (‘446)

MEXICO: (1)CELUTION FOR RESTORING BLOOD FLOW

(‘775)

ISRAEL: (1)ADRCS FOR CARDIAC (‘354)

CANADA: (1)ADRCS FOR RESTORING BLOOD

FLOW(‘510)

JAPAN: (2)CELUTION FOR RESTORING BLOOD

FLOW(‘787)CELUTION FOR REMODELING (‘155)

US: (4)CELUTION FOR BONE (‘043)CELUTION OUTPUT PLUS

PROSTHETIC

FOR BONE RELATED DISORDERS

(‘716)CELUTION FOR TREATING

WOUND HEALING (‘580)ADRC’S FOR RENAL

(‘229)

EUROPE: (2)CELUTION FOR ACUTE

TUBULAR NECROSIS (‘834)ADRCS FOR WOUND

HEALING (‘833)

JAPAN: (3)ADRCS FOR WOUND HEALING

(‘699)CELUTION OUTPUT PLUS

PROSTHETIC

FOR BONE RELATED DISORDERS

(‘119)CELUTION FOR PERIPHERAL

VASCULAR DISEASE (‘511)

INDIA: (1)ADRCS FOR WOUND HEALING

(‘580)

KOREA: (1)ADRCS FOR WOUND

HEALING (‘909)

CARDIAC CONTINUEDKOREA (1)ADRCS FOR VENTRICULAR

DILATION (‘170)

US: (6)CELUTION DEVICE (‘484)CELUTION DEVICE PLUS ADDITIVES (‘420)STEMSOURCE DEVICE (‘115)CELUTION DEVICE PLUS SENSORS FOR

CLINICALLY SAFE OUTPUT (‘670)BEDSIDE COMPREHENSIVE

DEVICE (‘059)CELUTION DEVICE CD31 POSITIVE CELLS

(‘276)

JAPAN: (2)CELUTION DEVICE (‘952)CELUTION FOR CLINICALLY SAFE OUTPUT

(‘556)

KOREA: (3)CELUTION DEVICE (‘995)STEMSOURCE DEVICE (‘812)CELUTION DEVICE (‘139)

INDIA: (1)CELUTION DEVICE (‘706)

AUSTRALIA: (2)CELUTION DEVICE (‘135)STEMSOURCE DEVICE (‘901)

CHINA: (1)CELUTION DEVICE (‘689)

OLYMPUS-CYTORI PATENTS

NEXT GENERATION DEVICE - JAPAN

CENTRIFUGAL CONTAINER (‘020)DIGESTIVE ENZYMES (‘861)

US: (1)CELUTION & FUTURE

GENERATIONS (‘075)

CHINA: (1)CELUTION & FUTURE

GENERATIONS (‘241)

HONG KONG (1)CELUTION & FUTURE

GENERATIONS (‘322)

INDIA: (1)CELUTION WITH CENTRIFUGE OR

FILTER (‘529)

AUSTRALIA: (1)CELUTION WITH CENTRIFUGE OR

FILTER (‘937)

SINGAPORE: (1)CELUTION & FUTURE

GENERATIONS (‘683)

ISRAEL: (1)CELUTION WITH CENTRIFUGE OR

FILTER (‘800)

MEXICO: (1)CELUTION & FUTURE

GENERATIONS (‘348)

KOREA: (1)CELUTION WITH CENTRIFUGE OR

FILTER (‘305)

JAPAN: (1)CELUTION BUSINESS METHOD

US: (7)CELUTION FOR MIXING ADRCS PLUS

FAT (‘488)CELUTION OR NEXT GEN DEVICES FOR

SOFT TISSUE DEFECTS (‘684)ADRCS PLUS FAT PLUS ADDITIVES

(‘795)ADRCS PLUS FAT (‘672)ADRCS PLUS FAT

COMPOSITION (‘121)CURRENT CELUTION DEVICE

PLUS FAT (‘947)ADRC’S PLUS FAT PLUS

BUFFER (‘834)

JAPAN: (1)CELUTION AND NEXT GEN DEVICES

FOR MIXING ADRCS PLUS FAT (‘041)

KOREA: (3)ADRCS PLUS FAT (‘454)CELUTION OR NEXT GEN DEVICES FOR

SOFT TISSUE DEFECTS (‘508)ADRCS PLUS FAT METHOD

(‘666)

EUROPE: (2)ADRCS FOR CARDIAC (‘382) OPPOSED

DEVICE FOR RESTORING BLOOD FLOW

(‘575) OPPOSED

AUSTRALIA: (1)ADRCS FOR CARDIAC (‘858)ADRCS FOR REMODELING (‘046)

SINGAPORE: (1)ADRCS FOR RESTORING BLOOD

FLOW(‘309)

CHINA: (1)ADRCS FOR RESTORING BLOOD FLOW

(‘104)

HONG KONG: (1)ADRCS FOR RESTORING BLOOD FLOW

(‘085)

RUSSIA: (1)CELUTION FOR RESTORING BLOOD FLOW

(‘924)

SOUTH AFRICA: (1)ADRCS FOR CARDIAC (‘446)

MEXICO: (1)CELUTION FOR RESTORING BLOOD FLOW

(‘775)

ISRAEL: (1)ADRCS FOR CARDIAC (‘354)

CANADA: (1)ADRCS FOR RESTORING BLOOD

FLOW(‘510)

JAPAN: (2)CELUTION FOR RESTORING BLOOD

FLOW(‘787)CELUTION FOR REMODELING (‘155)

US: (4)CELUTION FOR BONE (‘043)CELUTION OUTPUT PLUS

PROSTHETIC

FOR BONE RELATED DISORDERS

(‘716)CELUTION FOR TREATING

WOUND HEALING (‘580)ADRC’S FOR RENAL

(‘229)

EUROPE: (2)CELUTION FOR ACUTE

TUBULAR NECROSIS (‘834)ADRCS FOR WOUND

HEALING (‘833)

JAPAN: (3)ADRCS FOR WOUND HEALING

(‘699)CELUTION OUTPUT PLUS

PROSTHETIC

FOR BONE RELATED DISORDERS

(‘119)CELUTION FOR PERIPHERAL

VASCULAR DISEASE (‘511)

INDIA: (1)ADRCS FOR WOUND HEALING

(‘580)

KOREA: (1)ADRCS FOR WOUND

HEALING (‘909)

CARDIAC CONTINUEDKOREA (1)ADRCS FOR VENTRICULAR

DILATION (‘170)

Page 16: Stem Cell Meeting on the Mesa 2013

Upcoming MilestonesUpcoming Milestones

• Achieve BARDA proof-of-concept objectives

– Qualify for up to $56 MM in further development funding

• Complete enrollment in the US ATHENA trial

• Report six-month outcomes from the US ATHENA trial

• Publish 3-year data from the EU PRECISE chronic ischemic heart failure trial

• Accelerate growth in product and contract revenues

• Additional international approvals and patents

• Achieve BARDA proof-of-concept objectives

– Qualify for up to $56 MM in further development funding

• Complete enrollment in the US ATHENA trial

• Report six-month outcomes from the US ATHENA trial

• Publish 3-year data from the EU PRECISE chronic ischemic heart failure trial

• Accelerate growth in product and contract revenues

• Additional international approvals and patents

Page 17: Stem Cell Meeting on the Mesa 2013

Thank YouThank YouThank YouThank You


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