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Cytori Corporate Overview
NASDAQ: CYTX

October 2013
Safe 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 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 involve known and unknown risks that relate to
Cytori’s future events or future financial performance and the actual results could differ materially from those
discussed in this presentation. Risks and uncertainties that may cause Cytori's actual results to differ
materially from those discussed in the presentation can be found in the "Risk Factors" section of Cytori’s Form
10-K, Forms 10-Q and other filings with the United States Securities and Exchange Commission. We would
advise reading our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the
United 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 assumptions
only as of the date of this presentation and Cytori undertakes no duty or obligation to update or revise publicly
any forward-looking statements contained in this presentation as a result of new information, future events or
changes in Cytori’s expectations.
Cytori Technology
Therapeutic, 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: Leverage
Transformative Technology Platform
Cardiac

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

USA / BARDA
New opportunities
leveraging the
platform

• Up to $106 in development funding
• Commercial preparedness contract
with US Government
• Potential to fully fund PMA for burns

Commercial

• Japan approval
• EU ‘Vascular’ approval
• Clinical experience in thousands of patients
Cytori’s Cardiac Cell Therapy

• Completed proof-of-concept trial
• Enrolling ATHENA I & II US Phase 2 heart failure trials
Cytori Cardiac Cell Therapy
Mechanism of Action in Ischemic Heart Disease
Cell Sub Type
•
•
•
•
•
•

ADRC
Mixed Cell
Population

ADSCs
EPCs
Mø
Endo
VSMCs
Pericytes

•
•
•

ADSCs
Mø
T cells

•
•
•

Mø
EPCs
Endo
ADSCs

Mediator

Mechanism

 VEGF, PlGF, bFGF

 Vessel density

 NOS,  ROS

 Endothelial
dysfunction
Vessel stabilization
& expansion

Clinical Effect & Patient Benefit

Pericyte differentiation
& recruitment,
SDF-1, PlGF
 IL-10,  IL-6
 PGE2

 MMP1, TGFβ,
 TIMP1
 SDF-1, IGF-1
 HGF, IGF-1

 WBC recruitment
& activation
Mø switch to M2

 Perfusion

 Inflammation

 Scar remodeling
 Recruitment of
cardiac stem cells
 Myocardial
apoptosis

 Fibrosis

Disease
(VO2 Max)
Stabilization.
QOL Benefit
Cardiac Cell Therapy
PRECISE Pilot Showed Proof-of-Concept
Proof-ofObjective:
• safety and feasibility of ADRCs delivered via intramyocardial injections in
patients with chronic myocardial ischemia not amenable to revascularization
Study Design:
• double-blind, randomized, parallel group, placebo-controlled
Sample 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 Therapy
PRECISE Trial: Exercise Tolerance
Cardiac Cell Therapy
PRECISE 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 Therapy
ATHENA 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
Cardiac Cell Therapy
ATHENA 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 Contract

Discussions
Begin
2010

Award
3 Proof-of-concept Objectives
Announcement Ongoing
Fall, 2012
Cell viability

Pre-Award, White Papers,
Proposal, Negotiation

3 Objectives Trigger
Option 1 & 3
Q1, 2014

Option 1 Objective
Triggers Option 2
Q4, 2015

$32.6 M Option 1
Animal model POC
$45.5M Option 2
Next Gen device feasibility
$4.7M Phase 1 Proof of Concept

$23.4M Option 3

Commercial Acquisition at
BARDA’s Discretion
Commercial
• Emphasis:

Currently selling systems and consumables primarily
for researchers conducting independently funded
clinical 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.
Commercial
Research Customers Worldwide
50+ investigator studies (in process or completed)
SUI data published
Aug. 2013

USA

EU

AP

3

34

11

Positive scleroderma data Sep 2013
Diabetic ulcer data published May 2013

Soft Tissue
Wound
Ischemia
Ortho/Sport
Vital Organ Australian approval July 2013 based
on extensive clinical case work

EM

3
Cytori Cell Therapy: Intellectual Property
Meg
64 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)

US: (1)
CELUTION & FUTURE
GENERATIONS (‘075)

EUROPE: (2)
ADRCS FOR CARDIAC (‘382) OPPOSED
DEVICE FOR RESTORING BLOOD FLOW
(‘575) OPPOSED

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

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

(‘716)
CELUTION FOR TREATING
WOUND HEALING (‘580)
ADRC’S FOR RENAL
(‘229)

INDIA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘529)

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)

AUSTRALIA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘937)

JAPAN: (1)
CELUTION AND NEXT GEN DEVICES
FOR MIXING ADRCS PLUS FAT (‘041)

HONG KONG: (1)
ADRCS FOR RESTORING BLOOD FLOW
(‘085)

INDIA: (1)
CELUTION DEVICE (‘706)

SINGAPORE: (1)
CELUTION & FUTURE
GENERATIONS (‘683)

RUSSIA: (1)
CELUTION FOR RESTORING BLOOD FLOW
(‘924)

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

ISRAEL: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘800)

KOREA: (3)
ADRCS PLUS FAT (‘454)
CELUTION OR NEXT GEN DEVICES FOR
SOFT TISSUE DEFECTS (‘508)
ADRCS PLUS FAT METHOD
(‘666)

CHINA: (1)
CELUTION DEVICE (‘689)

MEXICO: (1)
CELUTION & FUTURE
GENERATIONS (‘348)

JAPAN: (2)
CELUTION DEVICE (‘952)
CELUTION FOR CLINICALLY SAFE OUTPUT
(‘556)
KOREA: (3)
CELUTION DEVICE (‘995)
STEMSOURCE DEVICE (‘812)
CELUTION DEVICE (‘139)

OLYMPUS-CYTORI PATENTS
NEXT GENERATION DEVICE - JAPAN
CENTRIFUGAL CONTAINER (‘020)
DIGESTIVE ENZYMES (‘861)

CHINA: (1)
CELUTION & FUTURE
GENERATIONS (‘241)
HONG KONG (1)
CELUTION & FUTURE
GENERATIONS (‘322)

KOREA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘305)
JAPAN: (1)
CELUTION BUSINESS METHOD

SINGAPORE: (1)
ADRCS FOR RESTORING BLOOD
FLOW(‘309)
CHINA: (1)
ADRCS FOR RESTORING BLOOD FLOW
(‘104)

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

PROSTHETIC
FOR BONE RELATED DISORDERS

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 CONTINUED
KOREA (1)
ADRCS FOR VENTRICULAR
DILATION (‘170)
Upcoming 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
Thank You

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Stem Cell Meeting on the Mesa 2013

  • 2. Safe 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 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 involve known and unknown risks that relate to Cytori’s future events or future financial performance and the actual results could differ materially from those discussed in this presentation. Risks and uncertainties that may cause Cytori's actual results to differ materially from those discussed in the presentation can be found in the "Risk Factors" section of Cytori’s Form 10-K, Forms 10-Q and other filings with the United States Securities and Exchange Commission. We would advise reading our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the United 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 assumptions only as of the date of this presentation and Cytori undertakes no duty or obligation to update or revise publicly any forward-looking statements contained in this presentation as a result of new information, future events or changes in Cytori’s expectations.
  • 3. Cytori Technology Therapeutic, 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
  • 4. Cytori Priorities: Leverage Transformative Technology Platform Cardiac • Completed proof-of-concept trial • Enrolling US Phase II Heart Failure trial USA / BARDA New opportunities leveraging the platform • Up to $106 in development funding • Commercial preparedness contract with US Government • Potential to fully fund PMA for burns Commercial • Japan approval • EU ‘Vascular’ approval • Clinical experience in thousands of patients
  • 5. Cytori’s Cardiac Cell Therapy • Completed proof-of-concept trial • Enrolling ATHENA I & II US Phase 2 heart failure trials
  • 6. Cytori Cardiac Cell Therapy Mechanism of Action in Ischemic Heart Disease Cell Sub Type • • • • • • ADRC Mixed Cell Population ADSCs EPCs Mø Endo VSMCs Pericytes • • • ADSCs Mø T cells • • • Mø EPCs Endo ADSCs Mediator Mechanism  VEGF, PlGF, bFGF  Vessel density  NOS,  ROS  Endothelial dysfunction Vessel stabilization & expansion Clinical Effect & Patient Benefit Pericyte differentiation & recruitment, SDF-1, PlGF  IL-10,  IL-6  PGE2  MMP1, TGFβ,  TIMP1  SDF-1, IGF-1  HGF, IGF-1  WBC recruitment & activation Mø switch to M2  Perfusion  Inflammation  Scar remodeling  Recruitment of cardiac stem cells  Myocardial apoptosis  Fibrosis Disease (VO2 Max) Stabilization. QOL Benefit
  • 7. Cardiac Cell Therapy PRECISE Pilot Showed Proof-of-Concept Proof-ofObjective: • safety and feasibility of ADRCs delivered via intramyocardial injections in patients with chronic myocardial ischemia not amenable to revascularization Study Design: • double-blind, randomized, parallel group, placebo-controlled Sample 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)
  • 8. Cardiac Cell Therapy PRECISE Trial: Exercise Tolerance
  • 9. Cardiac Cell Therapy PRECISE 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)
  • 10. Cardiac Cell Therapy ATHENA 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
  • 11. Cardiac Cell Therapy ATHENA 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
  • 12. BARDA Contract Discussions Begin 2010 Award 3 Proof-of-concept Objectives Announcement Ongoing Fall, 2012 Cell viability Pre-Award, White Papers, Proposal, Negotiation 3 Objectives Trigger Option 1 & 3 Q1, 2014 Option 1 Objective Triggers Option 2 Q4, 2015 $32.6 M Option 1 Animal model POC $45.5M Option 2 Next Gen device feasibility $4.7M Phase 1 Proof of Concept $23.4M Option 3 Commercial Acquisition at BARDA’s Discretion
  • 13. Commercial • Emphasis: Currently selling systems and consumables primarily for researchers conducting independently funded clinical 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.
  • 14. Commercial Research Customers Worldwide 50+ investigator studies (in process or completed) SUI data published Aug. 2013 USA EU AP 3 34 11 Positive scleroderma data Sep 2013 Diabetic ulcer data published May 2013 Soft Tissue Wound Ischemia Ortho/Sport Vital Organ Australian approval July 2013 based on extensive clinical case work EM 3
  • 15. Cytori Cell Therapy: Intellectual Property Meg 64 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) US: (1) CELUTION & FUTURE GENERATIONS (‘075) EUROPE: (2) ADRCS FOR CARDIAC (‘382) OPPOSED DEVICE FOR RESTORING BLOOD FLOW (‘575) OPPOSED US: (4) CELUTION FOR BONE (‘043) CELUTION OUTPUT PLUS AUSTRALIA: (1) ADRCS FOR CARDIAC (‘858) ADRCS FOR REMODELING (‘046) (‘716) CELUTION FOR TREATING WOUND HEALING (‘580) ADRC’S FOR RENAL (‘229) INDIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘529) 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) AUSTRALIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘937) JAPAN: (1) CELUTION AND NEXT GEN DEVICES FOR MIXING ADRCS PLUS FAT (‘041) HONG KONG: (1) ADRCS FOR RESTORING BLOOD FLOW (‘085) INDIA: (1) CELUTION DEVICE (‘706) SINGAPORE: (1) CELUTION & FUTURE GENERATIONS (‘683) RUSSIA: (1) CELUTION FOR RESTORING BLOOD FLOW (‘924) AUSTRALIA: (2) CELUTION DEVICE (‘135) STEMSOURCE DEVICE (‘901) ISRAEL: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘800) KOREA: (3) ADRCS PLUS FAT (‘454) CELUTION OR NEXT GEN DEVICES FOR SOFT TISSUE DEFECTS (‘508) ADRCS PLUS FAT METHOD (‘666) CHINA: (1) CELUTION DEVICE (‘689) MEXICO: (1) CELUTION & FUTURE GENERATIONS (‘348) JAPAN: (2) CELUTION DEVICE (‘952) CELUTION FOR CLINICALLY SAFE OUTPUT (‘556) KOREA: (3) CELUTION DEVICE (‘995) STEMSOURCE DEVICE (‘812) CELUTION DEVICE (‘139) OLYMPUS-CYTORI PATENTS NEXT GENERATION DEVICE - JAPAN CENTRIFUGAL CONTAINER (‘020) DIGESTIVE ENZYMES (‘861) CHINA: (1) CELUTION & FUTURE GENERATIONS (‘241) HONG KONG (1) CELUTION & FUTURE GENERATIONS (‘322) KOREA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘305) JAPAN: (1) CELUTION BUSINESS METHOD SINGAPORE: (1) ADRCS FOR RESTORING BLOOD FLOW(‘309) CHINA: (1) ADRCS FOR RESTORING BLOOD FLOW (‘104) 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) RESTORING BLOOD FLOW(‘787) CELUTION FOR REMODELING (‘155) CELUTION FOR PROSTHETIC FOR BONE RELATED DISORDERS 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 CONTINUED KOREA (1) ADRCS FOR VENTRICULAR DILATION (‘170)
  • 16. Upcoming 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