2012 Stem Cell Meeting on the Mesa

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NASDAQ: CYTX 1 Douglas Arm, Ph.D. Senior Vice President, Operations Meeting on the Mesa October 29, 2012

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Presented by Doug Arm, Sr. VP of Operations on October 30, 2012

Transcript of 2012 Stem Cell Meeting on the Mesa

Page 1: 2012 Stem Cell Meeting on the Mesa

NASDAQ: CYTX

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Douglas Arm, Ph.D.Senior Vice President, Operations

Meeting on the MesaOctober 29, 2012

Page 2: 2012 Stem Cell Meeting on the Mesa

Safe Harbor Statement

This presentation may contain certain ‘forward-looking statements’. Allstatements, other than statements of historical fact, that address activities, eventsor developments that we intend, expect, project, believe or anticipate will ormay occur in the future are forward-looking statements. Such statements arebased upon certain assumptions and assessments made by our management inlight of their experience and their perception of historical trends, currentconditions, expected future developments and other factors they believe to beappropriate.

The forward-looking statements included in this presentation are also subject to anumber of material risks and uncertainties. We caution investors not to placeundue reliance on the forward-looking statements contained in this presentation.

We would advise reading our annual report filed with the United States Securitiesand Exchange Commission on Form 10-K for a more detailed description of theserisks.

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This presentation may contain certain ‘forward-looking statements’. Allstatements, other than statements of historical fact, that address activities, eventsor developments that we intend, expect, project, believe or anticipate will ormay occur in the future are forward-looking statements. Such statements arebased upon certain assumptions and assessments made by our management inlight of their experience and their perception of historical trends, currentconditions, expected future developments and other factors they believe to beappropriate.

The forward-looking statements included in this presentation are also subject to anumber of material risks and uncertainties. We caution investors not to placeundue reliance on the forward-looking statements contained in this presentation.

We would advise reading our annual report filed with the United States Securitiesand Exchange Commission on Form 10-K for a more detailed description of theserisks.

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i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership

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i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership

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Cytori Cell Therapy: Innovative & Affordable

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Celution® System:point-of-care device

Adipose-derived stem &regenerative cells (ADRCs)

Fat (adipose) tissuefrom minor liposuction

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Cytori Cell Therapy: Unique Attributes

• Autologous

• Virtual ‘off the shelf’

• Mixed population

• Multiple mechanisms

0

0.25

0.5

Multipotent Cells in AdiposeMultipotent Cells in BM

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Cytori Cell Therapy: Multiple Applications

Proprietary Indication:• US refractory heart failure trial• EU heart attack trial

Proprietary Indication:• US Govt. Contract• EU approval: Breast recon/soft tissue

HeartDisease

ThermalBurns &TissueInjury

Proprietary Indication:• US Govt. Contract• EU approval: Breast recon/soft tissue

Licensing/Translational Medicine:• Co-development partnerships• Academic ctrs explore new Rx apps

ThermalBurns &TissueInjury

OtherIschemic

Conditions

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Outcomes from PRECISE European RHF Trial

Soft Tissue RepairSoft Tissue RepairSoft Tissue Repair

Change in Peak Oxygen Consumption (V02 Max) from Baseline to 6 & 18 months20.0

18.0

16.0

14.0

19.0

17.117.2

P<0.05 P<0.05

0% 10% 20% 30% 40%

Placebo

Treated

33%

5%

28 Month Mortality Rate

7Baseline 6 Mos 18 Mos

Transplant List

20.0

18.0

16.0

14.015.5 15.3

16.6

ADRC’sStandard of Care

N = 27 pts(6 placebo/21 treated)

0% 10% 20% 30% 40%

Placebo

Treated

33%

5%

28 Month Mortality Rate

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i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership

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i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership

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BARDA Mission and Contract Focus

BARDA• Biomedical Advanced Research and Development Authority• Mission: To develop and procure advanced medical countermeasures

against public health threats such as pandemic influenza, emergingdiseases, and CBRN agents

Thermal Burn and Combined Injury• Detonation of an Improvised Nuclear Device could lead to as many as

10,000 patients in need specialist burn care• However, there are only 1,850 burn beds in 126 burn units across the USA• Approximately 40% of these beds are occupied at any given time• Many of these burns will be complicated by simultaneous radiation

exposure

BARDA• Biomedical Advanced Research and Development Authority• Mission: To develop and procure advanced medical countermeasures

against public health threats such as pandemic influenza, emergingdiseases, and CBRN agents

Thermal Burn and Combined Injury• Detonation of an Improvised Nuclear Device could lead to as many as

10,000 patients in need specialist burn care• However, there are only 1,850 burn beds in 126 burn units across the USA• Approximately 40% of these beds are occupied at any given time• Many of these burns will be complicated by simultaneous radiation

exposure

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Burn and Radiation Injury Experience

Exposed Sacrum

Note sig. inflammation, redness, swelling

90% cells to circular area around sore

10% cells to sore itself

27 wks Post OpImmediate Pre Op Intra Op, Debrided Intra Op, Post-Cell Rx

Chronic burn injury: Pre-Op Chronic burn injury: Post-Op 18-mo

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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

• $4.7 MM in funding• Preclinical model• Next-gen product

development• ≤ 2 years

ProofProof--ofof--ConceptConcept

• Up to $55 MM• Development

including clinical• Govt. has

procurement ability

Options 1 & 2Options 1 & 2• Up to $45 MM• Pivotal trial• FDA submission

Option 3Option 3

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i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership

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i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership

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Objective

Further advance reputation as industry leader inadipose regenerative cell science

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miRNA Characterization of ADRCs

Objectives Establish scientific leadership in novel

characterization strategies for ADRC identityand potency determination Demonstrate capacity to execute cutting-edge

science, thereby establishing a higher bar forcompetitors to claim equivalence

Objectives Establish scientific leadership in novel

characterization strategies for ADRC identityand potency determination Demonstrate capacity to execute cutting-edge

science, thereby establishing a higher bar forcompetitors to claim equivalence

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miRNA Characterization Results

Each sample tested for expression of >1100 miRNAsequences. A total of 279 different miRNAs wereobserved in at least one of the 7 donor samples.233 miRNAs were detected in every sample.

miRNA fingerprints were assessed for relativeabundance of miRNA groups associated withdifferent cellular processes. A striking concordancewith preclinical MOA was observed.

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Stromal Vascular Cells: Sorting Fact from FictionNon-Enzymatic Methods to Obtain ADRCs: Possible?

Objectives: Advance leadership position by definitively reporting our

efforts to determine the basic truths about ADRCs (i.e.how many, what they are and are not, etc.)

Establish protease isolation as gold standard and onlymethod proven clinically safe for generating efficaciousADRCs

Discredit emergent competitors’ claims for isolation ofADRCs using mechanical (ultrasound) or non-enzymaticchemical (emulsifier) methods

Objectives: Advance leadership position by definitively reporting our

efforts to determine the basic truths about ADRCs (i.e.how many, what they are and are not, etc.)

Establish protease isolation as gold standard and onlymethod proven clinically safe for generating efficaciousADRCs

Discredit emergent competitors’ claims for isolation ofADRCs using mechanical (ultrasound) or non-enzymaticchemical (emulsifier) methods

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How Many SVF Cells Are There? What is SVF?

1 cm

1 cm

1 cc3 = 1 x 1012 µm3

EndothelialCells7%

VascularSmooth

Muscle Cells9%

TissueMacrophages

23%Stem Cells

2%

CD34+/CD31-37%

TissueMacrophages

23%WBCs22%

Stem Cells2%

• Excerpt from Online Cosmetic Surgery blog:Cytori… estimated the maximum theoretical number of adipose stem (and regenerative) cellsto be equal to 4 Million cells/cc. In a jab to exaggerated stem cell count claims by competitors,“anybody reporting cell counts higher than that number is ‘creating life’”.

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Celution versus Emulsification:Cell Output Composition & Viable Yield

CelutionEmulsification

• Output from emulsification kits contains two logs more red blood cells• Enzymatic digestion method generated ~10X more viable nucleated cells/g tissue• NO stem cells detected with emulsification method based on CFU-F

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Celution versus Ultrasound Processing:Viable Nucleated Cell Recovery and Content

Ultr

asou

ndCe

lutio

n

• Ultrasound yields NO more viable nucleated cells than the “no power” control• Yield from enzymatic processing is ~10X greater than that from ultrasound processing• More ultrasound power less nucleated cells, more tissue debris• Majority of the nucleated cells in ultrasound samples are granulocytic WBCs

Celu

tion

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Result: Technology Protected to mid-2020s

49 WORLDWIDE ISSUED PATENTS; MORE THAN 75 PENDINGDEVICESCURRENT

DEVICESNEXT 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)

US: (1)CELUTION OR FUTURE

GENERATIONS (‘075)CHINA: (1)CELUTION OR FUTURE

GENERATIONS (‘241)INDIA: (1)CELUTION OR FUTURE

GENERATIONS (‘529)AUSTRALIA: (1)CELUTION WITH CENTRIFUGE

OR

FILTER (‘937)SINGAPORE: (1)CELUTION OR FUTURE

GENERATIONS (‘683)ISRAEL: (1)CELUTION WITH CENTRIFUGE

OR

FILTER (‘800)MEXICO: (1)CELUTION OR FUTURE

GENERATIONS (‘348)KOREA: (1)CELUTION WITH CENTRIFUGE

OR FILTER (‘305)

US: (5)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)JAPAN: (1)CELUTION AND NEXT

GEN DEVICES FOR

MIXING ADRCS PLUS

FAT (‘041)KOREA: (2)ADRCS PLUS FAT

(‘454)CELUTION OR NEXT GEN

DEVICES FOR SOFT

TISSUE DEFECTS (‘508)

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

DEVICE FOR RESTORING BLOOD FLOW

(‘575)OPPOSED

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

US: (3)CELUTION FOR BONE

(‘043)CELUTION OUTPUT PLUS

PROSTHETIC

FOR BONE RELATED

DISORDERS (‘716)ADRCS FOR WOUND

HEALING (‘580)EUROPE: (2)CELUTION FOR ACUTE

TUBULAR NECROSIS

(‘834)ADRCS FOR WOUND

HEALING (‘833)JAPAN: (2)ADRCS FOR WOUND

HEALING (‘699)CELUTION OUTPUT PLUS

PROSTHETIC FOR BONE

RELATED DISORDERS

(‘119)INDIA: (1)ADRCS FOR WOUND

HEALING (‘580)

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)

US: (1)CELUTION OR FUTURE

GENERATIONS (‘075)CHINA: (1)CELUTION OR FUTURE

GENERATIONS (‘241)INDIA: (1)CELUTION OR FUTURE

GENERATIONS (‘529)AUSTRALIA: (1)CELUTION WITH CENTRIFUGE

OR

FILTER (‘937)SINGAPORE: (1)CELUTION OR FUTURE

GENERATIONS (‘683)ISRAEL: (1)CELUTION WITH CENTRIFUGE

OR

FILTER (‘800)MEXICO: (1)CELUTION OR FUTURE

GENERATIONS (‘348)KOREA: (1)CELUTION WITH CENTRIFUGE

OR FILTER (‘305)

US: (5)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)JAPAN: (1)CELUTION AND NEXT

GEN DEVICES FOR

MIXING ADRCS PLUS

FAT (‘041)KOREA: (2)ADRCS PLUS FAT

(‘454)CELUTION OR NEXT GEN

DEVICES FOR SOFT

TISSUE DEFECTS (‘508)

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

DEVICE FOR RESTORING BLOOD FLOW

(‘575)OPPOSED

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

US: (3)CELUTION FOR BONE

(‘043)CELUTION OUTPUT PLUS

PROSTHETIC

FOR BONE RELATED

DISORDERS (‘716)ADRCS FOR WOUND

HEALING (‘580)EUROPE: (2)CELUTION FOR ACUTE

TUBULAR NECROSIS

(‘834)ADRCS FOR WOUND

HEALING (‘833)JAPAN: (2)ADRCS FOR WOUND

HEALING (‘699)CELUTION OUTPUT PLUS

PROSTHETIC FOR BONE

RELATED DISORDERS

(‘119)INDIA: (1)ADRCS FOR WOUND

HEALING (‘580)

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Summary

Scientific and Clinical Leadership

Processing and characterization of 3000+ human tissue samples

Deep understanding of ADRC content, and safety requirements

5000+ patients treated, primarily in soft tissue and translational

49 Patents WW; 75+ Pending

Recognized by BARDA through thermal burn contract

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Scientific and Clinical Leadership

Processing and characterization of 3000+ human tissue samples

Deep understanding of ADRC content, and safety requirements

5000+ patients treated, primarily in soft tissue and translational

49 Patents WW; 75+ Pending

Recognized by BARDA through thermal burn contract

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NASDAQ: CYTX

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Douglas Arm, Ph.D.Senior Vice President, Operations

Meeting on the MesaOctober 29, 2012