2014 ARM Regen Med Investor Day
-
Upload
cytori-therapeutics-inc -
Category
Health & Medicine
-
view
2.176 -
download
5
description
Transcript of 2014 ARM Regen Med Investor Day
Cytori Corporate Overview NASDAQ: CYTX
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
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
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
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
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
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
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
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
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
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)
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
Soft Tissue Disorders
• Thermal burns with
concomitant radiation injury
• Gateway to wound repair
indication
• Sports medicine
NASDAQ: CYTX
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
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
• 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
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
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
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
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
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
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
Cytori Corporate Overview NASDAQ: CYTX
Thank you!
NASDAQ: CYTX