+ All Categories
Home > Documents > Biotech Showcase 2013

Biotech Showcase 2013

Date post: 05-Dec-2014
Category:
Upload: cytori-therapeutics-inc
View: 1,193 times
Download: 1 times
Share this document with a friend
Description:
CEO Chris Calhoun presents at Biotech Showcase 2013 on January 8, 2013
23
Personalized Cell Therapy C Y T O R I T H E T R U S T E D L E A D E R I N C E L L T H E R A P Y NASDAQ: CYTX 1
Transcript
Page 1: Biotech Showcase 2013

Personalized Cell Therapy C Y T O R I

T H E T R U S T E D L E A D E R I N C E L L T H E R A P Y

NASDAQ: CYTX 1

Page 2: Biotech Showcase 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.

2

Page 3: Biotech Showcase 2013

Mission: Improve the quality & length of life through innovative CELL THERAPY products

3 C Y T O R I C E L L T H E R A P Y

Page 4: Biotech Showcase 2013

i. Business and Technology Overview

ii. Cardiovascular Pipeline

iii. Soft Tissue Pipeline

iv. Commercial

C Y T O R I C E L L T H E R A P Y

Page 5: Biotech Showcase 2013

Celution® System:

point-of-care device

Adipose-derived stem &

regenerative cells (ADRCs) Fat (adipose) tissue

from minor liposuction

Cytori Cell Therapy

5

Your tissue is processed right at the side of your bed

Page 6: Biotech Showcase 2013

ADRCs: becoming the “go to” source for Clinical Cell Therapy

Thousands of patients around the world have been treated

using their own (ADRC) cells 5 Company-Sponsored Trials

3 Complete (2 cardiovascular, 1 Breast)

2 Ongoing (2 cardiovascular)

40+ Investigator-Sponsored Studies Chronic burns, radiation wounds, fistula

repair, urinary incontinence, breast

reconstruction, PVD, heart failure, liver,

scleroderma, & others

Clinical Leadership

6

Page 7: Biotech Showcase 2013

Cytori Cell Therapy Development Pipeline

Preclinical Phase I/II Pivotal Full Market

Access Private Pay/

Reimbursement

Refractory Heart Failure

U.S.

Vascular Delivery Europe

Acute Myocardial Infarction

Europe

BARDA (Burns) U.S.

Breast Recon & Soft Tissue

Europe/AP

Independent App Development

Europe/AP

7

Page 8: Biotech Showcase 2013

54 Worldwide Issued Patents; 75+ Pending

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)

US: (1)

CELUTION & FUTURE

GENERATIONS (‘075)

CHINA: (1)

CELUTION & FUTURE

GENERATIONS (‘241)

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)

US: (6)

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 +

FAT (‘947)

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)

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: (1)

CELUTION FOR RESTORING BLOOD

FLOW(‘787)

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: (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)

8

Page 9: Biotech Showcase 2013

i. Business and Technology Overview

ii. Cardiovascular Pipeline

iii. Soft Tissue Pipeline

iv. Commercial

9

C Y T O R I C E L L T H E R A P Y

Page 10: Biotech Showcase 2013

Condition: Severe form of coronary artery disease due to chronic

myocardial ischemia and leads to death

Disease Course: Declining cardiac function leads to heart

transplantation or death

Size of Market: Approx.120K to 250K diagnosed each year in U.S.

(subset of approx. 5.8 MM heart failure patients)

Cytori Cell Therapy: Potential to revive living but stressed heart

tissue; Halt progressive disease & keep patient off transplant list; overcome limits of existing drugs, devices and surgical options

Refractory Heart Failure

10

Page 11: Biotech Showcase 2013

Change in Peak Oxygen Consumption (VO2Max) from Baseline to 6 & 18 months

Baseline 6 Mos 18 Mos

20.0

18.0

16.0

14.0

19.0

15.5 15.3

16.6

17.1 17.2

Standard of Care

P<0.05 P<0.02

VO

2M

ax

Increased

Mortality

0% 50%

Placebo

Treated

28 Month Mortality Rate

ADRC’s

N=27; 21 active, 6 control

PRECISE Trial

11

Transplant List

Page 12: Biotech Showcase 2013

• Device-based PMA/IDE study

• Multi-center, prospective, randomized, double-blind, blinded core labs

• Up to 45 patients with 2:1 randomization at six sites

- Texas Heart, Minneapolis Heart, USF, Scripps, Alabama, U. Florida

• Dose: 0.4 million cells/kg body weight

• Endpoints: - Clinical Safety through 12 months

- Peak oxygen consumption (VO2 Max) at 6 months

- Perfusion defect at 6 months

- Left ventricle end-systolic and diastolic volume at 6 months

- Ejection fraction at 6 months

- Re-hospitalization, heart failure symptoms & quality of life @ 12 mo

• Enrollment initiated Sept 2012 / complete enrollment by mid-2013

U.S. Refractory Heart Failure Trial

12

Page 13: Biotech Showcase 2013

Condition: Artery blockage inhibits blood flow to heart muscle

resulting in left ventricular damage

Disease Course: More damage to the heart correlates to a higher

rate of progression toward heart failure

Size of Market: Approx.1 million heart attack patients admitted to

hospital each year, 38% are STeMI’s

Cytori Cell Therapy: Minimize heart damage and reduce rate to

progressive disease; additive to existing treatments; potential to

reduce healthcare costs & re-hospitalizations linked to heart failure (leading healthcare cost in US & leading cause of death globally)

Acute Myocardial Infarction

13

Page 14: Biotech Showcase 2013

Baseline 6 Months

35%

30%

25%

20%

15%

10%

5%

32%

15%

25% 25% Placebo % Left

Ventricle

infarct size

7% of patients

Progress to

Heart Failure

ADRC

46% of patients

Progress to

Heart Failure

P < 0.05 for change from BL for ADRCs

Potential new approach for treatment of heart attacks

Safe & feasible

Strong trends in favor of efficacy: improvement in perfusion, reduced infarct size

Less remodeling toward heart failure at 18 months

APOLLO: EU AMI Pilot Trial

14

Page 15: Biotech Showcase 2013

• Device-based trial predominately in EU - G6 & Canada

• Multi-center, prospective, randomized, double-blind

• Up to 216 patients with 2:1 randomization at up to 35 sites

• Dose: 20 million ADRCs (or placebo) delivered intracoronary

• Endpoints:

- Primary

o Reduction of Infarct size at six months (MRI)

- Secondary

o Clinical endpoints of MACCE, improvement in perfusion (SPECT)

o Additional assessments in LVEF, Volumes, Holter monitoring for

ventricular arrhythmias, & quality of life

• Trial enrollment resumed in the 4th quarter of 2012

• 10-15 trial sites selected and committed

• Multiple patients have been enrolled under new protocol

ADVANCE: EU AMI Approval Trial

15

Page 16: Biotech Showcase 2013

C Y T O R I C E L L T H E R A P Y

i. Business and Technology Overview

ii. Cardiovascular Pipeline

iii. Soft Tissue Pipeline

iv. Commercial

Page 17: Biotech Showcase 2013

• $4.7 MM in funding

• Preclinical model

• Next-Gen Celution® development

• Up to 2 years

Proof-of-Concept

• Up to $55 MM

• Development including clinical

• Govt. has procurement ability

Options 1 & 2 • Up to $45 MM

• Pivotal trial

• FDA submission

Option 3

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

Thermal Burns: Up to $106 Million from BARDA

17

Page 18: Biotech Showcase 2013

Exposed Sacrum

Note sig. inflammation, redness, swelling

1 Year Post Op Immediate Pre Op Intra Op, Debrided

90% cells to circular area around sore

10% cells to sore itself

Intra Op, Post-Cell Rx

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

Burn & Radiation Injury Clinical Experience

18

Page 19: Biotech Showcase 2013

i. Business and Technology Overview

ii. Cardiovascular Pipeline

iii. Soft Tissue Pipeline

iv. Commercial

C Y T O R I C E L L T H E R A P Y

Page 20: Biotech Showcase 2013

2012 Revenue Target of $9 Million Target exceeded based on products shipped (pending auditor review of revenue)

Class I Device Clearance in Japan Facilitates system & bank sales

Academic customers performing investigator-led studies

Shipments under new approval began in late Q3 2012

Cell cryopreservation & tissue banking

CE Mark Expansion New soft tissue indications in Q3 2012: fistula, sports injury, tissue ischemia

EU Vascular delivery indication pending

2013 Revenue Expectations • Continue to delivery year over year revenue growth

Expanding Claims,

Accelerating Revenue Growth

20

Page 21: Biotech Showcase 2013

Financials

Cash & Accts Receivable (Q3 2012) $20 MM

Public offering (Dec 2012) $20 MM

Senior Term Loan (GE) $25 MM

Shares outstanding 65 MM

Multiple partnership opportunities under negotiation

21

Page 22: Biotech Showcase 2013

2012 Milestones Achieved

Published APOLLO primary endpoints (6-months) √

Published RESTORE 2 12-month results √

Partnership with BARDA (contract for up to $106 mm) √

Initiated patient enrollment in ATHENA √

Re-initiated ADVANCE enrollment √

Expanded Claims in EU & Class 1 Approval in Japan √

Achieve $9 million revenue target for 2012 pending

2013 Milestones

CE Mark expansion for intravascular use

Complete enrollment in ATHENA

Complete the Proof of Concept Phase of BARDA contract

Significant revenue growth, reduce cash op loss

Publish PRECISE outcomes

Milestones

Page 23: Biotech Showcase 2013

Personalized Cell Therapy

C Y T O R I

T H E T R U S T E D L E A D E R I N C E L L T H E R A P Y


Recommended