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Cytori Cytori Corporate Overview Corporate Overview NASDAQ: CYTX NASDAQ: CYTX December 5, 2013 LD Micro Main Event
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CytoriCytori Corporate OverviewCorporate OverviewNASDAQ: CYTXNASDAQ: CYTX
December 5, 2013LD Micro Main Event
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.
SummarySummary
Transformative technology platform– Cell therapy regulated as a device– Business model: single use consumables
Clinical experience in thousands of patients
Strong IP protection
Near term value drivers– U.S. government contract milestones (BARDA)– Phase II U.S. cardiovascular trial data– International approvals and revenue growth
Transformative technology platform– Cell therapy regulated as a device– Business model: single use consumables
Clinical experience in thousands of patients
Strong IP protection
Near term value drivers– U.S. government contract milestones (BARDA)– Phase II U.S. cardiovascular trial data– International approvals and revenue growth
Proprietary Formulation of Cells• Autologous (Patient’s own cells)
• Point-of-care availability (no offsite manufacturing)
• Patented process
• Virtually ‘off the shelf’ – ideal for physician workflow
AdiposeAdipose--Derived Regenerative Cells:Derived Regenerative Cells:Easily Accessible in Hospital & ClinicEasily Accessible in Hospital & Clinic
Proprietary Formulation of Cells• Autologous (Patient’s own cells)
• Point-of-care availability (no offsite manufacturing)
• Patented process
• Virtually ‘off the shelf’ – ideal for physician workflow
System:• Low six figure ASP (current generation)• Next-generation system COGS < $10,000
Cell therapies offered via device & single-use consumable…allows for favorable pricing, reimbursement, and margins
AdiposeAdipose--Derived Regenerative Cells:Derived Regenerative Cells:Commercial Model & EconomicsCommercial Model & Economics
System:• Low six figure ASP (current generation)• Next-generation system COGS < $10,000
Per-procedure consumable:• $8,000-$12,000 for vascular indications• $2,000-$3,000 for soft tissue• >80% GM
AdiposeAdipose--Derived Regenerative Cells:Derived Regenerative Cells:Available via Innovative Device TechnologyAvailable via Innovative Device Technology
• Regulatory Path: U.S. PMA Device, EU and ROW Device• Per treatment consumable MSRP $2,000 - $10,000 (indication specific)• More than just “stem cells”
– Device output yields multiple cell types– Benefit from multiple mechanisms-of-action
AdiposeAdipose--Derived Regenerative Cells:Derived Regenerative Cells:Areas of FocusAreas of Focus
Soft Tissue
Cardiac• Completed proof-of-concept trial• Enrolling U.S. Phase II Heart Failure trial
CommercialResearch Market
New opportunitiesleveraging the
platform
• Japan approval• EU ‘Vascular’ approval• Clinical experience in thousands of patients
• Up to $106 MM in developmentfunding
• Commercial preparedness contractwith U.S. Government
• Potential to fully fund PMA for burns
Damage from acute MI andchronic ischemia causes:
reduced functionleft ventricular failure
.
.
.Death
Need for Cardiac Cell Therapy
Damage from acute MI andchronic ischemia causes:
reduced functionleft ventricular failure
.
.
.Death
Current therapy does not addressdamage to the heart
Need for Cardiac Cell Therapy
No Current “Regenerative Therapies” approved for Heart
Chronic Myocardial IschemiaCells delivered intra-myocardial
Acute MICells delivered intra-coronarywithin 24 hours of AMI
Cytori Cell Therapy
Need for Cardiac Cell Therapy
Chronic Myocardial IschemiaCells delivered intra-myocardial
Acute MICells delivered intra-coronarywithin 24 hours of AMI
Cytori Cell TherapyIschemic Heart Disease: Market Dynamics
Ischemic heart disease in the United States• Direct & indirect costs of heart failure estimated at $19.5B (2009)• $11.7B paid to Medicare beneficiaries (2006)• Medical costs of IHD expected to double 2013 to 2030• Estimated incidence is 200,000 – 500,000 patients/year in the U.S. alone
Ischemic heart disease in Europe• IHD expected to cost EU economies €60B/yr• Estimated that 34.4M and 12.1M disability adjusted life years are lost in Europe
and the EU respectively each year due to IHD
Few, if any, new pharmaceutical approaches for IHD
Ischemic heart disease in the United States• Direct & indirect costs of heart failure estimated at $19.5B (2009)• $11.7B paid to Medicare beneficiaries (2006)• Medical costs of IHD expected to double 2013 to 2030• Estimated incidence is 200,000 – 500,000 patients/year in the U.S. alone
Ischemic heart disease in Europe• IHD expected to cost EU economies €60B/yr• Estimated that 34.4M and 12.1M disability adjusted life years are lost in Europe
and the EU respectively each year due to IHD
Few, if any, new pharmaceutical approaches for IHD
Cardiac Cell TherapyCardiac Cell TherapyDevelopment PipelineDevelopment Pipeline
Development Pipeline
Chronic Pilot CompleteU.S. Phase II
(ATHENA)Pivotal2015
Pilot trial:• Cells shown to be safe; no adverse effects on rhythm at 6 & 18 months• Statistically significant stabilization in VO2Max vs placebo
Phase II ATHENA trials:• 90 patients, multi-center, double blind, placebo-controlled• Advance to pivotal in 2015
Cardiac Cell TherapyCardiac Cell TherapyPRECISE Pilot Showed ProofPRECISE Pilot Showed Proof--ofof--ConceptConcept
Objective: Safety and feasibility of intramyocardial injection inpatients not amenable to revascularization
Design: Double-blind, randomized, parallel group, placebo-controlled
Size 27 subjects (Spain, Netherlands, Denmark; 21 Treated, 6 Placebo)
Procedure• Electromechanical mapping (NOGASTAR®)• ≤ 15 intramyocardial injections of cells (median dose = 42 x 106 per
subject) or placebo (indistinguishable solution) in the area withinducible ischemia via MYOSTAR® Injection Catheter
Note: Higher doses not consistently achieved – all doses combined into onetreatment group
Objective: Safety and feasibility of intramyocardial injection inpatients not amenable to revascularization
Design: Double-blind, randomized, parallel group, placebo-controlled
Size 27 subjects (Spain, Netherlands, Denmark; 21 Treated, 6 Placebo)
Procedure• Electromechanical mapping (NOGASTAR®)• ≤ 15 intramyocardial injections of cells (median dose = 42 x 106 per
subject) or placebo (indistinguishable solution) in the area withinducible ischemia via MYOSTAR® Injection Catheter
Note: Higher doses not consistently achieved – all doses combined into onetreatment group
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 TherapyPRECISE Pilot Trial: Data SummaryPRECISE Pilot Trial: Data Summary
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)
12
14
16
18
20
Baseline 6 months 18 months
VO2M
ax
Change in VO2Max at 6 and 18 Months
ADRCs
Placebo
Cardiac Cell TherapyCardiac Cell TherapyPRECISE Pilot Trial: Exercise TolerancePRECISE Pilot Trial: Exercise Tolerance
12
14
16
18
20
Baseline 6 months 18 months
VO2M
ax
Change in VO2Max at 6 and 18 Months
ADRCs
Placebo
Cardiac Cell TherapyCardiac Cell TherapyATHENA I & II U.S. Heart Failure TrialsATHENA I & II U.S. 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 lower dose, 45 patients at higher 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 lower dose, 45 patients at higher 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
Contract objective: National preparedness grant worth up to $106 million inreimbursed development funding to create a treatment forthermal burns combined with radiation
Clinical development:» PMA-based pathway for traditional burns» Development from preclinical to FDA approval fully funded» Cytori’s first U.S. soft tissue indication
Commercialization & Procurement» Cytori maintains commercial rights for approved label» Government can make direct purchases or facilitate orders
from hospitals for preparedness purposes» Procurement potential is above and beyond contract funding
Contract objective: National preparedness grant worth up to $106 million inreimbursed development funding to create a treatment forthermal burns combined with radiation
Clinical development:» PMA-based pathway for traditional burns» Development from preclinical to FDA approval fully funded» Cytori’s first U.S. soft tissue indication
Commercialization & Procurement» Cytori maintains commercial rights for approved label» Government can make direct purchases or facilitate orders
from hospitals for preparedness purposes» Procurement potential is above and beyond contract funding
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
CommercializationCommercialization
Emphasis: Researchers performing independently funded studies» 50+ studies worldwide completed, in process or planned using Celution®
Rationale: New indications and approvals expand pipeline and opportunitiesI. Ex: BARDA contract worth up to $106 MM (Sep. 2012)II. Ex: Lorem Vascular: $24 MM equity, $500 MM milestones (Nov. 2013)
III. Future additional pipeline indications and collaborations
Growth: International regulatory approvals and partnershipsI. Japan Class I clearance achieved / pending legislation to expandII. Europe: Vascular delivery & ischemic tissue and muscle approvalsIII. Asia Pacific:
» Australia & Singapore approvals
Emphasis: Researchers performing independently funded studies» 50+ studies worldwide completed, in process or planned using Celution®
Rationale: New indications and approvals expand pipeline and opportunitiesI. Ex: BARDA contract worth up to $106 MM (Sep. 2012)II. Ex: Lorem Vascular: $24 MM equity, $500 MM milestones (Nov. 2013)
III. Future additional pipeline indications and collaborations
Growth: International regulatory approvals and partnershipsI. Japan Class I clearance achieved / pending legislation to expandII. Europe: Vascular delivery & ischemic tissue and muscle approvalsIII. Asia Pacific:
» Australia & Singapore approvals
LoremLorem Vascular PartnershipVascular PartnershipAccelerates CardiacAccelerates Cardiac Business & Revenue GrowthBusiness & Revenue GrowthCelution® System Commercialization rights
Territories: Australia, China, Hong Kong, Malaysia, & SingaporeIndications: All indications w/initial focus on cardiac, diabetes and renal
Agreement TermsEquity: $24 million; 8 million shares at $3.00 per shareMilestones: Up to $500 million in commercial milestonesSupply agreement: Cytori receives transfer margin on long-term agreement
PartnerLorem Vascular: Newly formed company dedicated to Celution® productsResources: Founders committing capital to fund operationsDistribution Plan: Combination of direct sales and distributors
Celution® System Commercialization rightsTerritories: Australia, China, Hong Kong, Malaysia, & SingaporeIndications: All indications w/initial focus on cardiac, diabetes and renal
Agreement TermsEquity: $24 million; 8 million shares at $3.00 per shareMilestones: Up to $500 million in commercial milestonesSupply agreement: Cytori receives transfer margin on long-term agreement
PartnerLorem Vascular: Newly formed company dedicated to Celution® productsResources: Founders committing capital to fund operationsDistribution Plan: Combination of direct sales and distributors
MegMegCytori Cell Therapy:Cytori Cell Therapy: Intellectual PropertyIntellectual Property60 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)
FinancialFinancial
Current Select DataCash & AR (9/30/13) $13 MMLorem Vascular Equity $24 MM Commitment ($12 MM received)Senior Term Loan $27 MM (Matures 2017)Shares Outstanding 71 MM + 4 MM to be issued to Lorem VascularShares Outstanding 71 MM + 4 MM to be issued to Lorem VascularWarrants Outstanding 8.6MM @$2.63 (7.6MM expire by Sept 2014)
Guidance2013 Revenue Estimate $14 Million ($11 MM product + $3 MM BARDA)2014 Expenses SG&A flat
R&D to increase for BARDA; offset by dev. revenuesBurn to decrease with sales growth
Upcoming MilestonesUpcoming Milestones
• Achieve BARDA proof-of-concept objectives
– Qualify for up to $56 MM in further development funding
• Complete enrollment in the U.S. ATHENA trial
• Report six-month outcomes from the U.S. ATHENA trial
• Publish three year data from the EU PRECISE chronic ischemic heart failure trial
• Obtain product registration for the Celution® System in China
• Accelerate growth in product and contract revenues
• Achieve BARDA proof-of-concept objectives
– Qualify for up to $56 MM in further development funding
• Complete enrollment in the U.S. ATHENA trial
• Report six-month outcomes from the U.S. ATHENA trial
• Publish three year data from the EU PRECISE chronic ischemic heart failure trial
• Obtain product registration for the Celution® System in China
• Accelerate growth in product and contract revenues
CytoriCytori Corporate OverviewCorporate OverviewNASDAQ: CYTXNASDAQ: CYTX
Thank you!
