cytx corporate presentation, biotech showcase
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CYTX Corporate Presentation at the Biotech Showcase 2012 - 1.9.12TRANSCRIPT
Cell Therapy
CytoriCorporate Presentation
January 2012
Cell Therapy
Safe Harbor
This presentation may contain certain ‘forward-looking statements’. 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 are also subject to a number of material risks and uncertainties. We caution investors not to place undue reliance on the forward-looking statements contained in this presentation.
We would advise reading our annual report filed with the United States Securities and Exchange Commission on Form 10-K for a more detailed description of these risks.
Cell Therapy
To improve the quality and length of life
by providing innovative cell therapy products
Our Company Mission
Cell Therapy
Real-time Access to a Patient’s Own Regenerative Cells
Our Innovation
Regenerative Cells Derived from
Adipose Tissue (Fat)
Syringe of Patient’s Own Cells
Cell Therapy
2011 : Year in Review March Shareholder Letter – 12 month milestones
• Expand CE Mark Claims to include NO-CMI
On track for early 2012 claims expansion
• Report 18 month APOLLO data
Reported highly positive long-term Data
• Expand number of sites & ongoing enrollment of ADVANCE
Initiated ADVANCE, 4 sites on-line & 23 in process
• Define & prepare to initiate a US clinical trial for CMI
Successful pre-IDE meeting & IDE for CMI filed in Q4
• Expand efforts with FDA to gain approval or clearance for Celution
3 - 510ks, 2 appeals, pre-IDE, IDE filing, 3 HUD rounds, ++mtgs
• CE Mark & European commercial launch for Celution One
CE Mark for Celution One received in November
• Complete development of next generation aesthetics device
- Development on hold to focus on cardiac pipeline
Cell Therapy
2011 : Year in Review March Shareholder Letter – 12 month milestones
• Increase system installed base & consumable usage rates
Grew installed based of systems, shifted sales to hospitals
• Increase hospital-based customers, with emphasis on breast recon
More than half the systems went to hospital based customers
• Pursue payment for breast reconstruction in Europe
NIC support UK, Italy grant Breast recon, NICE filing Q1
• Grow PureGraft product sales
More than doubled PG; anticipate ongoing growth in 2012
• Expand selectively into emerging markets
Opened India, Australia, So. Africa, Bulgaria & Russia
Cell Therapy
2012 : Key steps to increase shareholder value
• Commercial Business
• Product Pipeline
• Corporate
Cell Therapy
2012 : Key steps to increase shareholder value
Commercial Business
1. Manage into a profitable segment in near term
2. 20+% annual revenue growth until inflection point
3. Focus reimbursement efforts in UK
4. Building market access for NO-CMI
5. Japan – cell therapy guidelines & help dev approved studies for translational applications; MHLW approval for breast reconstruction
Cell Therapy
2012 : Key steps to increase shareholder value
Product Pipeline
1. No-option CMI CE Mark (EU)
2. Focus on ADVANCE centers: 30 Centers on-line by year-end
3. Publish results of Apollo, Precise & Restore II
4. Initiate Athena (U.S. Chronic Ischemia)
Cell Therapy
2012 : Key steps to increase shareholder value
Corporate
1. Bring in non-dilutive / strategic funding
2. Average Cash Operating Loss to $7 mm / qtr
3. Continue to expand global regulatory approvals
Cell Therapy
Cell Therapy via Device
Acute Heart Attack
4,000+ Patients Treated
Chronic Heart Failure
Cardiovascular Soft Tissue
Breast Reconstruction
Wounds, Fistula
Cell Therapy
Chronic Myocardial Ischemia
Patrick Serruys, MD, PhDRotterdam, The Netherlands
PRECISE TRIAL• Prospective European Multicenter Trial• Randomized (3:1) • Double Blind • Placebo controlled• Blinded independent core labs• Safety & Feasibility Trial• n= 27 (6 placebo, 21 treated)
Cell Therapy
Chronic Myocardial Ischemia
MVO2: statistically significant change at 18 months
METS: statistically significant change at 18 months
Infarct size: 8.2% change at 6 months
Cytori procedure safe and feasible through 18-months
Lower cardiac mortality rate:• At avg. follow up of 28 months:
- 1 of 21 treated vs. 2 of 6 placebo
0% 10% 20% 30% 40%
Placebo
Treated
28 Month Mortality Rate
Under review by Notified BodyFor CE Mark claims expansion
Cell Therapy
‚No Option‛ Heart Failure
Estimated Market Size for No Option Patients in Europe
Region # of Patients (Incidence) # of Patients (10-Yr Prevalence)
United Kingdom 40,000 400,000
Italy 40,000 400,000
Germany 55,000 550,000
France 40,000 400,000
Spain 30,000 300,000
Total G5 205,000 2,050,000
G5 Market $ 20 Billion*
* Estimated price per treatment: $ 10,000
Cell Therapy
ATHENA Trial
US FDA Trial
Chronic Myocardial Ischemia
• IDE Filed Q4, 2011
• Trial design under negotiation with FDA
• Anticipate IDE approval Summer, 2012
Emerson Perin, MDTexas Heart Institute
Cell Therapy
Acute Heart Attack
Eric Duckers, MD, PhDRotterdam, The Netherlands
APOLLO TRIAL• Prospective European Multicenter Trial• Randomized (3:1) • Double Blind • Placebo controlled• Blinded independent core labs• Safety & Feasibility Trial• n = 14 (4 placebo, 10 treated)
Perfusion defect in LAD territory: Reduction in perfusion defect in patients treated with ADRC
compared to placebo patients (9,7-fold improvement in LAD perfusion territory) as analyzed by MIBI SPECT (TSS scores)
MIB
I S
PE
CT
TS
S c
han
ge
(m
atc
he
d p
airs)
+867%
improvement
+800%
improvement
All SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA)
Cell Treated: Better Perfusion of the Heart6 & 18 month follow-up
p=NSSlides & Data provided by:Eric Duckers, MD, PhD
p=NS
All MRI images were assessed by an independent, blinded core lab (CCL, Boston, MA)
Percent of Left Ventricle Infarcted:
Infarct size normalized to ventricle size (%LVI) improved more in ADRC patients
compared to placebo control patients (late enhancement cMRI): +5,1% abs. and +59% rel. improvement compared to placebo control, PTE)
all pts baseline 6 mo
control
Tx24,7% 24,7%
ADRC
Tx31,6% 15,4%
matched pairs
all patients
Cell Treated: Reduced Damage by > 50%6 & 18 month follow-up
ch
an
ge
in r
el.in
farc
t siz
e (
I/L
V)
(ma
tch
ed
pairs)
Slides & Data provided by:Eric Duckers, MD, PhD
All TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA)
ch
an
ge
in
ES
V (
cc, 2
D T
TE
)
Cell Treated – Not going into Heart Failure6 & 18 month follow-up
24,4 ccimprovement
(-72,2%)
Change in ESV
ESV was markedly reduced in ADRC patients as compared to placebo control patients (as measured by 2D TTE, cMRI and SPECT, PTE)
Slides & Data provided by:Eric Duckers, MD, PhD
Cell Therapy
APOLLO: Arrhythmias
Abnormal ventricular beats occur more often in Control patients
More Significant Ventricular Arrhythmias in control patients
Higher frequency of recordings with Ventricular Premature Bits (VPB) in Controls
Higher number of VPBs per recording in Controls
50%
30%
0%
10%
20%
30%
40%
50%
60%
Placebo Group1
PercentofPa entswithSignifica ntVentricularArrhythmias
0
100
200
300
400
500
600
700
0.5 1 2 3 4 8 12 16 25 52 77
PrematureVentricularContrac ons-MeanCountperPa ent
control
ADRC
0
500
1000
1500
2000
2500
3000
0.5 1 2 3 4 8 12 16 25 52 77
PrematureVentricularContrac ons-MeanCumula veCount
control
ADRC
Cell Therapy
APOLLO: Summary
ADRCs are safe in the treatment of STEMI No safety concerns
No new Major Adverse Cardiac Events
No Deaths
Efficacy Concordant improvement in infarct and ischemia:
Mean reduction in Infarct Size is maintained to 18 months
Improvement in cardiac perfusion is maintained to 18 months
May have positive impact on arrhythmia in cell-treatment patents
ADVANCE No changes to ADVANCE trial design are needed
Cell Therapy
Acute Heart Attack
Eric Duckers, MD, PhDRotterdam, The Netherlands
ADVANCE TRIAL• Currently enrolling & treating• 30 – 35 sites to treat up to 360 patients• 60 sites identified & interested; ½ in G-5• 23 sites selected & committed• Various states of regulatory process by country• Focus in 2012 to bringing sites online by YE
Cell Therapy
Advance Trial Timeline in EU
Cell Therapy
Acute Myocardial Infarction
Estimated Market Size for AMI Patients in Europe
EU AMI Market$ 7.2 Billion
Annual Heart Attack Incidence (EU) 1.9 million
% STEMI (large heart attacks) 38%
Target Addressable Procedures 720,000
Estimated Price per Treatment $ 10,000
Cell Therapy
US Regulatory
US IDE Trial for Cardiovascular: IDE Filed
US IDE Trial for Cardiovascular: Heart Attack to follow European Advance Trial
US HUD: Parry Rombergs Disease: Ongoing Process
Multiple 510(k) device applications filed in 2011
Filed 2 appeals on 510(k) NSE: Now to Merits Panel
Cell Therapy
38 Worldwide Issued Patents, > 100 pending
DevicesNext Generation
DevicesNext Generation
Cosmetic & ReconstructiveSurgery (CRS)
Cardiovascular Therapies Pipeline Therapies
US: (1)CELUTION FUTURE
GENERATIONS (‘075)
India: (1)CELUTION FUTURE
GENERATIONS (‘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
US: (1)CELUTION FUTURE
GENERATIONS (‘075)
India: (1)CELUTION FUTURE
GENERATIONS (‘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
US: (4)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)
Japan: (1)CELUTION AND NEXT GEN
DEVICES FOR MIXING ADRCS
PLUS FAT (‘041)
Europe: (1)ADRCS FOR CARDIAC
(‘382) <Opposition filed>
Australia: (1)CELUTION FOR
CARDIOVASCULAR (‘858)
Singapore: (1)CELUTION FOR
CARDIOVASCULAR (‘590)
China: (1)CELUTION FOR
CARDIOVASCULAR (‘104)
Russia: (1)CELUTION FOR
CARDIOVASCULAR (‘924)
South Africa: (1)CELUTION FOR
CARDIOVASCULAR (‘446)
Mexico: (1)CELUTION FOR
CARDIOVASCULAR (‘775)
US: (2)CELUTION FOR BONE
(‘043)CELUTION OUTPUT
PLUS PROSTHETIC
FOR BONE RELATED
DISORDERS (‘716)
Europe: (2)CELUTION FOR ACUTE
TUBULAR NECROSIS
(‘834)ADRCS FOR WOUND
HEALING (‘833)
Japan: (1)ADRCS FOR WOUND
HEALING (‘699)
India: (1)ADRCS FOR WOUND
HEALING (‘580)
Thank You !
Cell Therapy