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Personalized Cell Therapy C Y T O R I A TRUSTED LEADER IN CELL THERAPY NASDAQ: CYTX
36

25th Annual ROTH Conference

Dec 05, 2014

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CEO Chris Calhoun presents at the annual ROTH conference on Monday, March 18 in Dana Point, CA
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Page 1: 25th Annual ROTH Conference

Personalized Cell Therapy C Y T O R I

A TRUSTED LEADER IN CELL THERAPY NASDAQ: CYTX

Page 2: 25th Annual ROTH Conference

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.

Page 3: 25th Annual ROTH Conference

i. Business & Technology Overview

ii. ATHENA Trial

iii. BARDA

iv. Commercial Growth

v. Corporate

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

Page 4: 25th Annual ROTH Conference

The Future of Medicine: Cell Therapy

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

Page 5: 25th Annual ROTH Conference

Unique Device Model: Point-of-Care

Your tissue is processed right at the side of your bed

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

CE Mark Approved in EU for tissue ischemia & wounds

Page 6: 25th Annual ROTH Conference

Recurring Revenue Model

A proprietary single-use consumable set is required

for each procedure

(Concept: Razor-blade)

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

Page 7: 25th Annual ROTH Conference

Platform: Many Indications

VASCULAR Heart failure Heart attack PVD / PAD Liver Cirrhosis Kidney Injury Stroke Other

TISSUE Fistula

Wounds Incontinence

Sports / Ortho Tissue Ischemia

Breast Recon/Aug Radiation / Burn

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

Page 8: 25th Annual ROTH Conference

Clinical Leadership Today

Thousands of patients around the world have been treated

using their own cells with Cytori products

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

Page 9: 25th Annual ROTH Conference

% Hospitals Penetrated

Number of Hospitals

Proc. Per Week

Cartridge ASP ** Annual Revenue

10% 2,500 3 $5,000 $2 billion

20% 5,000 3 $5,000 $4 billion

30% 7,500 3 $5,000 $6 billion

**Cartridge ASP expected to be at least $5,000; Est. $2,500 in tissue, $8-12,000 in vascular

Worldwide Opportunity (Est. 25,000 Hospitals)

Annuity Business Model

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

A few uses per week drives Significant revenue

Page 10: 25th Annual ROTH Conference

i. Establish ADRC’s as the standard for

cells in the emerging Regenerative

Medicine field (Device / Tool claims)

ii. Develop market access for specific

targeted indications (Therapeutic

Claims)

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

Strategy

Page 11: 25th Annual ROTH Conference

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

Page 12: 25th Annual ROTH Conference

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

Page 13: 25th Annual ROTH Conference

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

Operating System Application Software

Page 14: 25th Annual ROTH Conference

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

Operating System Application Software

TRANSLATIONAL MEDICINE

Page 15: 25th Annual ROTH Conference

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

Device / Tool Claims

Page 16: 25th Annual ROTH Conference

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

Device / Tool Claims

Page 17: 25th Annual ROTH Conference

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

Device / Tool Claims

Page 18: 25th Annual ROTH Conference

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

Device / Tool Claims

Device INTRAVASE

Broad Vascular Access - AMI - PVD / PAD - CHF - Liver - Stroke - Kidney

No Option CMI

Tissue

Page 19: 25th Annual ROTH Conference

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

Therapeutic Products

Tissue

Page 20: 25th Annual ROTH Conference

i. Business and Technology Overview

ii. ATHENA Trial

iii. BARDA

iv. Commercial Growth

v. Corporate

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

Page 21: 25th Annual ROTH Conference

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

Page 22: 25th Annual ROTH Conference

ADRCs may preserve functional capacity,

improve perfusion, reduce scar, improve left ventricular

contractility and lead to lower mortality

• Safety: No malignant arrhythmias, adverse events similar in both groups; Harvesting ADRCs and transendocardial delivery is safe

and feasible in patients with CAD

• MVO2 & METS: Preserved function in ADRC at 6 & 18 months

compared to controls (p=0.03, p=0.01)

• Total Left Ventricular Mass (MRI): ADRCs demonstrated

significant improvement over controls (p<0.001)

• Wall Motion Score Index: ADRCs demonstrated significant

improvement in wall motion score index (p<0.04) with a

stabilization of scar size compared to controls

• Inducible Ischemia (SPECT): was reduced in ADRCs patients up

to 18 months (p<0.05)

• Patient Age: Patient’s in ADRCs group are 10 years older than

placebo (65.8 vs 55.7 years; p=0.002)

• Cardiac Mortality: At 27 month follow-up, fewer ADRC patient

deaths compared to controls

(1 of 21 in ADRCs vs 2 of 6 Controls; p=0.10)

PRECISE TRIAL

Page 23: 25th Annual ROTH Conference

U.S. Refractory Heart Failure Trial

Adipose-derived regenerative cells in the Treatment of patients

with chronic ischemic HEart disease Not Amenable to surgical or

interventional revascularization Objective To assess the safety and feasibility of Adipose-Derived Regenerative

Cells delivered via an intramyocardial route in the treatment of

chronic ischemic heart disease in patients who are not eligible for

percutaneous or surgical revascularization

Design Device-based (PMA/IDE) prospective, randomized, placebo-

controlled, double-blind safety and feasibility clinical trial

Sample Size 45 Subjects, randomized 2:1 (ADRCs:Placebo)

Study Location 6 centers in the United States

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

- LV end-systolic and diastolic volume at 6 months

- Ejection fraction at 6 months

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

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Refractory Heart Failure

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)

Complete enrollment mid-Summer 2013

6-month data first half 2014

Define Pivotal Trial Design

• Detailed protocol and trial size to be determined by ATHENA outcomes

• Likely endpoints to include a functional and composite clinical outcome

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

i. Business and Technology Overview

ii. ATHENA Trial

iii. BARDA

iv. Commercial Growth

v. Corporate

Page 26: 25th Annual ROTH Conference

• $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

1. ADRCs can be extracted from patients with thermal burn injury

Availability 2. CT-X2 is as good as Celution 800

Processing 3. ADRCs from an irradiated animal improve healing of concomitant thermal burn

Function

BARDA: Proof-of-Concept

Proof-of-Concept Success unlocks Options 1 & 2 – up to $ 55 Million

Page 27: 25th Annual ROTH Conference

Product Evolution

Smaller. Faster. Cheaper. Higher Yields.

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.

Page 28: 25th Annual ROTH Conference

i. Business and Technology Overview

ii. ATHENA Trial

iii. BARDA

iv. Commercial Growth

v. Corporate

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

Page 29: 25th Annual ROTH Conference

Commercial Growth to Profitability

Japan

Profitable region

Class 1 device designation 2H

2012

Distributors and translation med to

drive sales

Europe

vascular & translational med

3 people

Tissue Ischemia CE Mark

Intravascular CE Mark

Intravascular IRB & translational

medicine to drive sales

North America

Low-cost distributor model

2 people

Puregraft approved in US & Canada

CE Mark in Canada Pending

PG extension + growing fat transfer to drive growth & build relationships

Emerging Markets

Minimal 2012 loss, Profitable in 2013

1 person

Targeting select countries that

recognize CE Mark

Intravascular IRB sales

Australia TGA approval pending

% Rev ‘12: 52% 24% 13% 11% profitable investing near B/E near B/E ‘13: Profitable investing break-even profitable

Page 30: 25th Annual ROTH Conference

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

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

Page 31: 25th Annual ROTH Conference

2013 Revenue Guidance of $15 Million

$12 million in product sales

$ 3 million in contract revenue (BARDA)

Accelerate year over year revenue growth

Positive contribution margin for full year 2013

2012 Revenue

Total product revenue of $8.7 million

BARDA contract revenue of $0.4 million

Total cash revenue of $9.1 million, 14% growth over 2011

Q4 gross profit of $2.6 million exceeded S&M expenses of $2.1 million

Accelerating Revenue Growth

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

Page 32: 25th Annual ROTH Conference

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

i. Business and Technology Overview

ii. ATHENA Trial

iii. BARDA

iv. Commercial Growth

v. Corporate

Page 33: 25th Annual ROTH Conference

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

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

Page 34: 25th Annual ROTH Conference

57 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)

Page 35: 25th Annual ROTH Conference

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

Present / Publish PRECISE long-term data (18 months) -

Advance BARDA toward Phase II -

Partnership with Cash upfront -

Complete patient enrollment in ATHENA by mid-summer 2013 -

Achieve 25 pts enrolled in ADVANCE; Add Canada -

Achieve $15 million revenue target for 2013 (incl $2.5 - 3m Barda) -

Expand PG line (PG-50) with 510k clearance & market launch -

Define approval path with FDA for Refractory Heart Failure in US -

Expand Celution approvals ( ie Canada, Australia) -

2013 Milestones

Page 36: 25th Annual ROTH Conference

Personalized Cell Therapy

C Y T O R I

A 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