2014 ARM Regen Med Investor Day

23
Cytori Corporate Overview NASDAQ: CYTX

description

Cytori President Dr. Marc Hedrick presents at the Alliance for Regenerative Medicine's Regen Med Investor Day in New York

Transcript of 2014 ARM Regen Med Investor Day

Page 1: 2014 ARM Regen Med Investor Day

Cytori Corporate Overview NASDAQ: CYTX

Page 2: 2014 ARM Regen Med Investor Day

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.

NASDAQ: CYTX

Page 3: 2014 ARM Regen Med Investor Day

Cytori Overview

Upcoming Highlights

• Phase II U.S. heart failure data

• Expansion U.S. government contract (BARDA)

• Pipeline expansion from independent studies

Autologous cell therapy with device model

• Cardiovascular disease & soft tissue disorders

• Product & contract revenue partially offsets cash burn

• Thousands of patients treated worldwide

NASDAQ: CYTX

Page 4: 2014 ARM Regen Med Investor Day

Cytori Cell Therapy

• Autologous, mixed cell population from adipose tissue

• Cells processed in real time - virtually ‘off the shelf’

• Multiple cell types: ADRCs (adipose derived regenerative cells)

• Mechanism predominately via paracrine action, increased blood flow

and enhanced wound healing

NASDAQ: CYTX

Page 5: 2014 ARM Regen Med Investor Day

System:

• Low six figure ASP

• Next-generation system COGS < $10,000

Per-procedure consumable:

• $8,000-$12,000 for intra vascular indications

• $2,000-$3,000 for soft tissue

• >80% GM

Cell therapy via proprietary device & single-use consumables =

Favorable pricing and margin opportunity

Cytori Cell Therapy:

Commercial Model & Economics

NASDAQ: CYTX

Page 6: 2014 ARM Regen Med Investor Day

Therapeutic Focus

CARDIAC SOFT TISSUE COMMERCIAL

RESEARCH SALES

• U.S. Phase II in CHF

• Long term data from CHF

and AMI trials in EU

• Burns & Radiation:

U.S. gov’t contract

• Sports Medicine

• EU/Japan approvals

• Research sales

• 50+ studies completed,

ongoing or planned

NASDAQ: CYTX

Page 7: 2014 ARM Regen Med Investor Day

Cytori Cell Therapy- Cardiovascular

• Damage to the heart leads to

reduced function, heart failure

and death

• Current therapy does not

address damage to the heart

muscle

NASDAQ: CYTX

Page 8: 2014 ARM Regen Med Investor Day

PRECISE- Pilot Trial

PRECISE TRIAL:

• 27 patient double-blind, randomized, placebo controlled European trial

• Intramyocardial injection using electromechanical mapping in area with

inducible ischemia

• 18 month data presented, publication in process

DATA SUMMARY:

Feasibility (Exercise Tolerance)

• VO2Max (maximum oxygen consumption): improvement (p<0.05

vs. placebo)

• METS (metabolic equivalent): improvement (p<0.05 vs. placebo)

Safety

• No safety issues

• Mortality [36 mo]: placebo 33%, ADRCs 14%

NASDAQ: CYTX

Page 9: 2014 ARM Regen Med Investor Day

12

14

16

18

20

Baseline 6 months 18 months

VO

2 M

ax

Change in VO2Max at 6 and 18 Months

ADRCs

Placebo

PRECISE Pilot Trial: Exercise Tolerance

NASDAQ: CYTX

Page 10: 2014 ARM Regen Med Investor Day

ATHENA I & II:

U.S. Ischemic Heart Failure Trials

• Prospective, double-blind, placebo-controlled trials

– ATHENA I: 45 patients, 2:1 randomization at lower dose

– ATHENA II: 45 patients, 2:1 randomization at higher dose

– Up to 10 centers

Development Pipeline

Ischemic

Heart

Failure Pilot Complete

U.S. Phase II

(ATHENA I & II)

Pivotal

2015

NASDAQ: CYTX

Page 11: 2014 ARM Regen Med Investor Day

ATHENA I Endpoints

NASDAQ: CYTX

SAFETY

• Serious Adverse Events (SAEs)

• Arrhythmia assessment

• MACE (Cardiac Death or Hospitalization for Heart Failure)

EFFICACY

• VO2 Max (6 mo)

• LVEF, LVESV/LVEDV (6 mo)

• Perfusion defect (6 mo)

• Heart failure symptoms, angina, and quality of life (3, 6, 12 mo)

Page 12: 2014 ARM Regen Med Investor Day

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

New pharmaceutical approaches for IHD limited

NASDAQ: CYTX

Page 13: 2014 ARM Regen Med Investor Day

Soft Tissue Disorders

• Thermal burns with

concomitant radiation injury

• Gateway to wound repair

indication

• Sports medicine

NASDAQ: CYTX

Page 14: 2014 ARM Regen Med Investor Day

BARDA Contract

Pre-Treatment 18 Mo. Post-Treatment

U.S. Government contract to develop treatment for thermal

burns concomitant with radiation injury

• Definitive review contract options anticipated in 1H2014

• Contract option for additional development including clinical trial

• Cytori maintains commercial rights, possibility of government

procurement purchases

NASDAQ: CYTX

Page 15: 2014 ARM Regen Med Investor Day

BARDA Development Pathway

Discussions

Begin

2010

Award

Announcement

Fall, 2012

3 Objectives Trigger

Option 1 & 3

Q2, 2014

3 Proof-of-concept Objectives

Ongoing

Cell viability

Animal model POC

Next Gen device feasibility

Up to $32.6 M

Option 1

Up to $23.4M

Option 3

Commercial Acquisition at

BARDA’s Discretion

Up to $45.5M

Option 2

Option 1 Objective

Triggers Option 2

Q4, 2015

Pre-Award, White Papers,

Proposal, Negotiation

$4.7M Phase 1 Proof of Concept

NASDAQ: CYTX

Page 16: 2014 ARM Regen Med Investor Day

• Broad range of indications, including:

• Ex: Chronic wound from external beam radiation

16

Wound Repair

Investigator-led Research

Promising data from multiple independent research studies

- Cryptoglandular peri-anal fistula - Fistula post gastroenterological surgery

- Diabetic foot ulcer - Scleroderma associated digital ulcers

- Crohn’s fistula

Exposed Sacrum

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

Page 17: 2014 ARM Regen Med Investor Day

Commercial Research Market: Overview

• Targeted commercial sales ex-US to

researchers performing independently

funded studies

• System and consumables sales

generate commercial revenue and gross

margin, ultimately contribution margin

• Expands pipeline R&D to identify

potential indications for future

development, 3rd party funding and

partnering

NASDAQ: CYTX

Page 18: 2014 ARM Regen Med Investor Day

Worldwide Investigator-led Research

50+ studies worldwide completed, in process or planned

• Publications of independent

research using Cytori Cell Therapy

• Broad range of study indications

including:

• Stress urinary incontinence

• Scleroderma associated

sclerodactyly

• Musculotendinous injury

• Parry Romberg syndrome

• Others

NASDAQ: CYTX

Page 19: 2014 ARM Regen Med Investor Day

Global Intellectual Property

• 65 patents issued worldwide; 85 applications pending

• Cover current & future Celution® Systems, methods, use of

adipose-derived regenerative cells for soft tissue, cardiac and

pipeline indications

29%

15%

7%

33%

16%

Geographic Distribution

U.S.

Japan

Europe

Asia-Pacific - Other

Other

41%

23%

18%

18%

Patent Type

Devices - Current/Next-Gen

Cardiovascular

Reconstructive Surgery

Pipeline Therapies

NASDAQ: CYTX

Page 20: 2014 ARM Regen Med Investor Day

Financials

Current Select Data

Cash $24.5 MM (pro forma as of 12/31/13)

Senior Term Loan $27 MM (Matures 2017)

Shares Outstanding 75 MM

Warrants

Outstanding

8.6MM @$2.63

(7.6 MM expire by Sept 2014)

NASDAQ: CYTX

Page 21: 2014 ARM Regen Med Investor Day

Upcoming Milestones

CARDIOVASCULAR

– Complete enrollment in the U.S. ATHENA trial

– Report six-month outcomes from the U.S. ATHENA trial

– Publish PRECISE chronic ischemic heart failure trial long-term data

SOFT TISSUE

– BARDA contract expansion

– Expand orthopedics, sports

COMMERCIAL RESEARCH SALES

– Growth in product & contract sales in 2014

– Achieve product registration for the Celution® System in China

NASDAQ: CYTX

Page 22: 2014 ARM Regen Med Investor Day

Cytori Overview

Upcoming Highlights

• Phase II U.S. heart failure data

• Expansion U.S. government contract (BARDA)

• Pipeline expansion from independent studies

Adipose-derived cell therapy with device model

• Cardiovascular disease & soft tissue disorders

• Product & contract revenue partially offsets cash burn

• Thousands of patients treated worldwide

NASDAQ: CYTX

Page 23: 2014 ARM Regen Med Investor Day

Cytori Corporate Overview NASDAQ: CYTX

Thank you!

NASDAQ: CYTX