View
1.194
Download
1
Category
Preview:
DESCRIPTION
CEO Chris Calhoun presents at Biotech Showcase 2013 on January 8, 2013
Citation preview
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
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
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
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
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
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
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
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
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
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
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
• 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
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
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
• 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
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
• $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
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
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
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
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
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
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