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. Summary
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
4. AdiposeAdipose-Derived Regenerative Cells:
Easily 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
5. AdiposeAdipose-Derived Regenerative Cells:
Commercial Model & Economics
Cell therapies offered via device & single-use consumable…
allows for favorable pricing, reimbursement, and margins
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
6. AdiposeAdipose-Derived Regenerative Cells:
Available 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
7. AdiposeAdipose-Derived Regenerative Cells:
Areas of Focus
Cardiac
• Completed proof-of-concept trial
• Enrolling U.S. Phase II Heart Failure trial
Soft Tissue
New opportunities
leveraging the
platform
• Up to $106 MM in development
funding
• Commercial preparedness contract
with U.S. Government
• Potential to fully fund PMA for burns
Commercial
Research Market
• Japan approval
• EU ‘Vascular’ approval
• Clinical experience in thousands of patients
8. Need for Cardiac Cell Therapy
Damage from acute MI and
chronic ischemia causes:
reduced function
left ventricular failure
.
.
.
Death
9. Need for Cardiac Cell Therapy
Current therapy does not address
damage to the heart
No Current “Regenerative Therapies” approved for Heart
10. Need for Cardiac Cell Therapy
Cytori Cell Therapy
Chronic Myocardial Ischemia
Cells delivered intra-myocardial
Acute MI
Cells delivered intra-coronary
within 24 hours of AMI
11. Cytori Cell Therapy
Ischemic 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
12. Cardiac Cell Therapy
Development Pipeline
Development Pipeline
Chronic
Pilot Complete
U.S. Phase II
(ATHENA)
Pivotal
2015
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
13. Cardiac Cell Therapy
PRECISE Pilot Showed Proof-of-Concept
Proof-ofObjective:
Safety and feasibility of intramyocardial injection in
patients 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 with
inducible ischemia via MYOSTAR® Injection Catheter
Note:
Higher doses not consistently achieved – all doses combined into one
treatment group
14. Cardiac Cell Therapy
PRECISE 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)
15. Cardiac Cell Therapy
PRECISE Pilot Trial: Exercise Tolerance
Change in VO2Max at 6 and 18 Months
20
VO2 Max
18
16
ADRCs
14
Placebo
12
Baseline
6 months
18 months
16. Cardiac Cell Therapy
ATHENA 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
17. 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
18. BARDA Contract
Contract objective: National preparedness grant worth up to $106 million in
reimbursed development funding to create a treatment for
thermal 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
19. 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
20. Commercialization
Emphasis: Researchers performing independently funded studies
» 50+ studies worldwide completed, in process or planned using Celution®
Rationale:
New indications and approvals expand pipeline and opportunities
I. 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 partnerships
I.
Japan Class I clearance achieved / pending legislation to expand
II. Europe: Vascular delivery & ischemic tissue and muscle approvals
III. Asia Pacific:
»
Australia & Singapore approvals
21. Lorem Vascular Partnership
Accelerates Cardiac Business & Revenue Growth
Celution® System Commercialization rights
Territories:
Australia, China, Hong Kong, Malaysia, & Singapore
Indications:
All indications w/initial focus on cardiac, diabetes and renal
Agreement Terms
Equity:
$24 million; 8 million shares at $3.00 per share
Milestones:
Up to $500 million in commercial milestones
Supply agreement:
Cytori receives transfer margin on long-term agreement
Partner
Lorem Vascular:
Newly formed company dedicated to Celution® products
Resources:
Founders committing capital to fund operations
Distribution Plan:
Combination of direct sales and distributors
22. Cytori Cell Therapy: Intellectual Property
Meg
60 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)
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)
EUROPE: (2)
ADRCS FOR CARDIAC (‘382) OPPOSED
DEVICE FOR RESTORING BLOOD FLOW (‘575)
US: (4)
CELUTION FOR BONE (‘043)
CELUTION OUTPUT PLUS
JAPAN: (2)
CELUTION DEVICE (‘952)
CELUTION FOR CLINICALLY SAFE OUTPUT
(‘556)
KOREA: (3)
CELUTION DEVICE (‘995)
STEMSOURCE DEVICE (‘812)
CELUTION DEVICE (‘139)
CHINA: (1)
CELUTION & FUTURE
GENERATIONS (‘241)
HONG KONG (1)
CELUTION & FUTURE GENERATIONS
(‘322)
INDIA: (1)
CELUTION WITH
FILTER (‘529)
CENTRIFUGE OR
AUSTRALIA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘937)
INDIA: (1)
CELUTION DEVICE (‘706)
SINGAPORE: (1)
CELUTION & FUTURE
GENERATIONS (‘683)
AUSTRALIA: (2)
CELUTION DEVICE (‘135)
STEMSOURCE DEVICE (‘901)
ISRAEL: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘800)
CHINA: (1)
CELUTION DEVICE (‘689)
MEXICO: (1)
CELUTION & FUTURE GENERATIONS
(‘348)
OLYMPUS-CYTORI PATENTS
NEXT GENERATION DEVICE - JAPAN
KOREA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘305)
CENTRIFUGAL CONTAINER (‘020)
DIGESTIVE ENZYMES (‘861)
JAPAN: (1)
CELUTION BUSINESS METHOD
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)
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)
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)
SOUTH AFRICA: (1)
ADRCS FOR CARDIAC (‘446)
JAPAN: (3)
ADRCS FOR WOUND HEALING
(‘699)
CELUTION OUTPUT PLUS
MEXICO: (1)
CELUTION FOR RESTORING BLOOD FLOW (‘775)
PROSTHETIC
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)
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)
23. Financial
Current Select Data
Cash & AR (9/30/13)
$13 MM
Lorem 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 Vascular
Warrants Outstanding
8.6MM @$2.63 (7.6MM expire by Sept 2014)
Guidance
2013 Revenue Estimate
$14 Million ($11 MM product + $3 MM BARDA)
2014 Expenses
SG&A flat
R&D to increase for BARDA; offset by dev. revenues
Burn to decrease with sales growth
24. Upcoming 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