Date post: | 05-Dec-2014 |
Category: |
Technology |
Upload: | cytori-therapeutics-inc |
View: | 900 times |
Download: | 0 times |
CytoriCytori Corporate OverviewCorporate OverviewNASDAQ: CYTXNASDAQ: CYTX
October 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.
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
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
Cytori’s Cardiac Cell Therapy
• Completed proof-of-concept trial• Enrolling ATHENA I & II US Phase 2 heart failure trials
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
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)
Cardiac Cell TherapyCardiac Cell TherapyPRECISE Trial: Exercise TolerancePRECISE Trial: Exercise Tolerance
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)
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
• 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
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
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.
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
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)
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
Thank YouThank YouThank YouThank You