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CFO Mark Saad presents at Biocentury's Future Leaders in the Biotech Industryon Friday, April 5
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Personalized Cell Therapy C Y T O R I
BioCentury Future Leaders Conference April 5, 2013
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.
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Cytori Cell Therapy
① Game changing technology platform
② Arriving at points of leverage
• US Cardiac Data
• Barda Contract
• International Revenues
③ Expansive IP portfolio protects technology long-term
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Proprietary formulation of a patient’s own adipose-derived stem and regenerative cells
• Autologous
• Virtual ‘off the shelf’
• Mixed population
• Multiple mechanisms
• Patented process
Cytori Cell Therapy
Tissue
Macrophages
23%
White Blood
Cells
22%
Stem
Cells 2%
CD34+/CD31
- 37%
Endothelial
cells 7%
Vascular
Smooth
Muscle Cells
9%
Cytori Cell Therapy: Multiple Cell Types
5 Heterogeneous Cell Therapy uniquely leverages multiple mechanisms
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15
30
45
Total Nucleated Cells in Adipose
Cytori Cell Therapy: System + Single-Use Cartridge
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Processing System: Low six figure ASP
Per-procedure consumable: $2,000-$12,000
Dependent on indications and formulation
60-80% Margin
Cytori Cell Therapy: Business Overview
• US heart failure trial
• Up to $106 in development funding
• US Government large end-customer
• Cytori to sell into all other burn markets
• Japan research market
• EU vascular approval
• EU tissue ischemia approvals
• Cell & tissue banking
Cardiac
BARDA Commercial
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
ADRC’s
N=27; 21 active, 6 control
PRECISE Trial
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Transplant List
Reflects the degree of impairment in:
• Ventricular function (pumping
capacity)
• Vascular function (O2 delivery),
• Skeletal muscle metabolic capacity
(O2 utilization).
Pts with Max VO2 ≤ 14 ml/kg/min had
a 1 year survival rate of only 47%.
Mancini et al, Circulation 1991
Figure: Survival curves for all patients
subdivided by Max VO2 & EF
(p<0.05; VO2 ≤ 10 vs. > 14 ml/kg/min)
PRECISE Trial: Max VO2 a Predictor of 1 Yr. Survival
U.S. Refractory Heart Failure Trial
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Status:
All centers actively screening
• Minneapolis Heart Institute (Timothy Henry MD)
• Texas Heart Institute (Emerson Perin MD, PhD, James, Willerson, MD)
• University of Florida (Carl Pepine MD)
• University of South Florida (Leslie W. Miller MD)
• Scripps Green Hospital (Richard Schatz MD)
• Cardiology P.C. (Farrell Mendlesohn MD)
On-track to complete mid-Summer 2013
6-month data first half 2014
Pivotal Trial Design
• Detailed protocol and trial size to be determined by ATHENA outcomes
• Likely endpoints to include a functional and composite clinical outcome
• $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
BARDA: Up to $106 MM for Thermal Burn Development
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BARDA: Supporting Desktop System Development
Smaller. Faster. Cheaper. Higher Yields.
Celution® System product and technological evolution 1. Cytori developed interim Celution 800 System (Cytori)
2. Olympus designed Celution One System (OC-JV)
3. Cytori designed Next Gen System (BARDA) 1. 2. 3.
Translational Medicine: Near-Term Revenue Driver
Pivotal trials, grants (BARDA), partnerships, regulatory
approvals, reimbursement
Incontinence
Radiation injury
Vascular CE Mark
Investigator-initiated trials resulting in:
• Meaningful sales to offset burn
• Expansion of physician and
hospital network
• Strategic benefit of development
of new applications/pipeline
Financials
Current Select Data
PF cash & AR (YE 2012) $32 MM
Senior Term Loan (GE) $22 MM maturing in 2015
Shares outstanding 67 MM
Warrants 10 MM @ $3.25 avg. exercise price
2013 Guidance
Revenue $15 MM ($12 m product, $3 m contract)
SG&A Flat for year
R&D Slight increase, more than offset by BARDA revenue
Present / Publish PRECISE long-term data (18 months)
Complete patient enrollment in ATHENA by mid-summer 2013
Advance BARDA toward Phase II
Achieve $15 million revenue target for 2013 (incl $2.5 - 3m Barda)
Expand Celution approvals ( ie Canada, Australia)
2013 Milestones
Personalized Cell Therapy
Q&A