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Cell Therapeutics
1. Investor Update
esto
Charting the path to profitability
James A Bi
J A. Bianco, M D
M.D.
Chief Executive Officer
2. Forward Looking Statement
This presentation contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995. The forward-looking statements contained in this presentation include
statements about future financial and operating results and risks and uncertainties that could affect CTI’s product and
results, CTI s
products under development.These statements are based on management’s current expectations and beliefs and are
subject to a number of factors and uncertainties that could cause actual results to differ materially from those described
in the forward-looking statements. These statements are not guarantees of future performance, involve certain risks,
uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may
not prove accurate. Therefore, actual outcomes and results may differ materially from what is expressed h i I any
t t Th f t l t d lt diff t i ll f h ti d herein. In
forward-looking statement in which CTI expresses an expectation or belief as to future results, such expectation or
belief is expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the
statement or expectation or belief will result or be achieved or accomplished.
The following factors, among others, could cause actual results to differ materially from those described in the forward
factors others forward-
looking statements: risks associated with preclinical, clinical and sales and marketing developments in the
biopharmaceutical industry in general and in particular including, without limitation, the potential failure of Opaxio™ to
prove safe and effective for treatment of non-small cell lung and ovarian cancers, the potential failure of Pixuvri
(pixantrone dimaleate) to prove safe and effective (including complete and overall response rates) for treatment of non-
Hodgkin’s lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive
factors, technological developments, costs of developing, producing and selling CTI’s products under development; and
other economic, business, competitive, and/or regulatory factors affecting CTI’s business generally, including those set
forth in CTI’s filings with the SEC, including its Annual Report on Form 10-K for its most recent fiscal year and its most
recent Quarterly Report o Form 10-Q, espec a y in the “Factors Affecting Ou Ope at g Results” a d “Management’s
ece t Qua te y epo t on o 0 Q, especially t e acto s ect g Our Operating esu ts and a age e t s
Discussion and Analysis of Financial Condition and Results of Operations” sections, and its Current Reports on Form 8-
K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a
result of new information, future events, or otherwise.
3. Overview
Focused on Profitability
Successfully turning around the business
Reduced Opex 72% y/y while advancing key assets toward market
Raised $68mm YTD
R i d $68
$31.5mm without selling stock (Zevalin asset sale)
Removed $52.9mm of debt increased shareholder equity by$43.7mm
q y y
Listed on Russell 3000, Russell 2000 and Russell Global Indexes
Positioned to break even in Q4 2009 attractive EPS growth 2010
Successful Pixuvri phase III trial, NDA submission and
product launch will drive near term value
Attractive Oncology Pipeline
Management team experienced in oncology product sales
4. Building a Powerful Cancer Drug Portfolio
Phase
Preclinical Phase I Phase II Marketed
III
NDA review
i
NP sales EU
NSCL Lung cancer MAA review
1° line Ovarain cancer Phase 3
Brostallicin
Bisplatinates
NP sales = named patient sales
7. Charting the Path to Profitability
Cleaned up Capital Structure
• Retired all preferred; only common stock & warrants to purchase
p ; y p
common stock outstanding
Cleaning up Balance Sheet
• Removed $52.9 mm ($1.89/share) of debt increased shareholder
$52 9 ($1 89/share)
equity by $43.7 million
Increasing Shareholder Equity*
Historical Proforma
Proforma**
Accumulated Deficit $1,325,444 $1,318,342
CTI Total Shareholder Deficit <$115,984> <$54,131>
Total Liabilities & Shareholder Deficit $42,933 $54,572
*All values thousands
**Proforma based on unaudited financial data for quarter ended March 31, 2009 adjusted
for sale of shares in May 2009 and debt redemption.
10. CTI’s Successful Cancer Treatments
Highly effective therapy for first and subsequent relapse in
acute promyelocytic leukemia (APL)
Excellent Return on Investment
• Purchased in 2000 for $12mm in stock
• Stock price appreciation 5000% ($1.50 to $77.00)
• Peak sales $22mm
• Sold to Cephalon in 2005 for $70mm cash
Highly effective therapy for patients with relapsed or
refractory, low-grade non-Hodgkin's lymphoma (NHL)
Excellent Return on Investment
• Purchased from Biogen-Idec $10mm December 2007
• Sold to Spectrum in March 2009 $31.5mm
11. CTI’s Successful Cancer Treatments
Highly effective therapy for patients with relapsed
aggressive NHL
Pixuvri History
• Discovered by Novuspharma, acquired by CTI in January 2004
y p q y y
Patient benefit
• Initial Label Indication - 9,760 US patients + 6,832 EU patients
• Label expansion could reach additional 51,000 patients US/EU
Potential to Take Company to Profitability
• T t l Potential Market Size 66,592 patients/yr
Total P t ti l M k t Si 66 592 ti t /
• $44,000 per patient/yr
12. The superior choice for
Th i h i f
an anthracycline
an anthracycline in NHL
Successful Phase III Trial results
13. Opportunity Assessment
• Anthracyclines – 3rd most commonly used class anti-
y y
cancer agents
• >300,000 pts receive an anthracycline each year
• Potentially curative in
– Lymphoma (NHL)
– Leukemia ((AML)
)
– Breast cancer
– Sarcoma
• Cornerstone class in 1st line treatment regimens
14. Anthracycline Use (US+EU)
231,417
302,000 Patients/year
tients
Pat
20,200 15,794 11,706 11,650 11,346
Source: Tandem Cancer Audit 2004
15. Aggressive NHL – Treatment Regimens (US data)
Aggressive NHL –
Anthracyclines Standard of Care in 1st line Treatment
Standard of Care in 1 line Treatment
120,0%
Other
bortezomib
100,0% 12,3% R‐CNOP
0,8% CVP
1,4%
3,0%
0,4% 37,8% R‐CHOPM
80,0% 8,9% 45,7%
lenalidomide
11,3%
CAV
2,9%
1,7%
1,7%
60,0% 3,5% Treanda+
1,1% 4,5%
3,4% 3,5% R‐ESHAP
5,2% 1,8%
5,4% RF
11,2% 1,8%
40,0%
40 0% 3,3%
60,9% 3,3% RICE
4,5%
R‐CVP
25,2% 19,1%
20,0% R
R + CHOP
6,3% 7,1%
0,0%
1st LOT 2nd LOT 3rd+ LOT
1st Line 2nd Line 3rd Line+
Patient # 30,029 10,150 9,767
™
IntrinsiQ March 09
18. Next Generation Anthracycline
• Rationally Designed to Reduce Oxygen Radical
Rationally Designed to Reduce Oxygen Radical
Generation
– Significant reduction in cardiac damage in animal models Vs
Significant reduction in cardiac damage in animal models Vs
current marketed anthracyclines
– No extravasation concerns‐ peripheral vein infusion
No extravasation concerns‐ peripheral vein infusion
O OH O
OH H NH 2
OH N O HN
OH O HN OH COOH
N
O O OH O 2 HCl 2
O COOH
HO
H OH O HN OH O HN
N NH 2
H
H2N
Doxorubicin Mitoxantrone pixantrone
19. PIX 301Phase III Study Design
‐ Randomized Controlled International Multicenter Phase III trial
‐ Relapsed or refractory aggressive NHL >2nd relapse
‐ 140 patients
• Treatment every
month up to 6 cycles Primary Endpoint*
Standard • CT scan every 2 cycles
CT scan every 2 cycles
Chemotherapy ‐ Complete Remission (CR/CRu)
Complete Remission (CR/CRu)
x 3 then every 3
months Secondary Endpoints*
‐ Overall Response Rate (ORR)
‐ Responses > 4months
• Treatment every 21 ‐ Time to response
days up to 6 cycles ‐ Progression Free Survival
Pixantrone
Pi t • CT
CT scan every 2 cycles
2 l
‐ Safety
x 3 then every 3
months
*All response and progression data determined by IAP
19
20. PIX 301 Phase III Trial in Relapsed NHL
p
Intent to Treat :Primary endpoint achieved
Pixantrone (n=70) Control (n=70) P‐value
CR 11.4%
11 4% (8) 0% (0)
CRu 8.6% (6) 5.7% (4)
CR/CRu 20.0% (14)
20.0% (14) 5.7% (4)
5.7% (4) 0.021
Intent to Treat : Secondary endpoint achieved
Population Pixantrone Control P‐value
ORR (PR+CR/CRu) 37% (26/70) 14.3% (10/70) 0.003
21. PIX 301 Phase III Trial in Relapsed NHL
PIX 301 Phase III Trial in Relapsed NHL
Pixantrone increased progression free survival > 80% (ITT)
Median PFS 4.7 Vs 2.6 months
HR 0.60 (p=0.007)
Pixantrone
Standard
py
Chemotherapy
22. Lifetime Anthracycline/Anthracenedione Exposure
(Doxorubicin Equivalent Dose)
(Doxorubicin Equivalent Dose)
Treatment Pixantrone Treatment Lifetime
Cycle Cumulative Dose* Cumulative Dose**
N Median (mg/m2) Median (mg/m2)
1 68 74 365.2
2 54 148 430.2
3 43 209 498.1
498 1
4 36 275 571.8
5 25 356 631.5
631 5
6 22 427 695.0
* Pixantrone dose converted to dox equivalent dose by factor 3.4
** Dox equivalent dose based on “P. McLaughlin JCO Vol14, No 4, 1996”
23. Encouraging Cardiac Safety Data
Frequency % CHF Expected Vs Observed by Total
Doxorubicin Equivalent Exposure
Doxorubicin
Doxorubicin Doxorubicin Pixantrone
Equivalent N=620 N=70
Exposure (mg/m2)
<300 5.6% 2/68
500
500 15% 2/43
600 32% 0/36
>600 48% 1/25
* Swain, et al. Cancer 2003; 97(11): 2869-2879; Sonnenveld et al. JCO 1995, 13:2530-2539
23
24. Summary & Implications PIX301 Phase III Results
• Superior efficacy over standard of care
• First trial in relapsed/refractory aNHL to demonstrate
• Superior CR rates 24% Vs. 7% p=0.009*
• Superior ORR 40% Vs. 14% p=0.001*
Superior ORR 40% Vs 14% p=0 001*
• Superior PFS 4.7 months Vs. 2.6 months p=0.007
• Superior duration of CR 7 months Vs. 3.5 months p=0.03
• Unprecedented cardiac safety profile despite median dox‐
equivalent exposure of 515mg/m2
• Non‐dose dependant occurrence of CHF (5 Vs 2) drug relationship unlikely
• Cumulative occurrence 7% Vs expected 25% to 48% standard doxorubicin
• Activity preserved even among patients with extensive prior doxorubicin and
yp g p p
rituximab treatment
• Available for named patient sales in Europe
*Includes both treatment and follow‐up periods
*Includes both treatment and follow up periods
™
26. Commercial Analysis
Assumptions
• Pricing $24/mg – $1 200 vial, = average use 36 vials/patient
$1,200 vial
• Exclusivity in the market to 2018 (US) / 2020(EU)
• Regulatory approval – aggressive relapsed NHL
g y pp gg p
• US Q4-2009, EU Q3-2010
Modeling assumptions (US only)
CTI peak Market Research
• O
Only NHL is included NHL in model Peak
• 1st line 30,029 patients Aggressive
• 2nd line 10,150 patients 1st-line 15% 26%
• 3rd line 9,767 patients
9 767 2nd-line
line 20% 38%
3 rd-line+ 25% 36%
Peak Penetration Indolent
1st-line 4% 27%
• Assumes EU ~70% US market 2nd-line
line 8% 34%
3 rd-line+ 8% 32%
• 15,800 pts US +10,600 pts EU
• Total peak patients/yr = 26,400
• Cost per patient/yr = $44,000
$44 000
27. Novartis – CTI Agreement(s)
If NVS exercises its option for Pixantrone the License
would have the following features
• Reimburses CTI for 50% of expenses from 9/06* >$25,000,000
p $ , ,
• Pays CTI $7,500,000 option fee upon license execution
• Pays $10,000,000 FDA approval milestone in 3rd line aNHL
• Pays additional $94 000 000 in potential future registration & sales
$94,000,000
milestones
• Controls future development and commercialization of product & 100%
future expenses
f t
• CTI may field 35 FTE in US at Novartis’ expense up to $9M
• Pays CTI royalties 28% to 32% on net sales beyond $50 million
*from date of execution of license agreement
28.
29. A bioengineered version of Taxol®(paclitaxel)
Singer et al. In: Adv Exp Med Biol. 2003; 519:81-99
30. PG Technology: Selective Delivery of
Cytotoxic Drugs
Macromolecules are
preferentially
distributed to and
retained in tumor
microvasculature
“EPR” effect
Enhanced
permeability and
bilit d
retention
They are then taken
up into the cancer
cell by a process
called endocytosis,
where they are
metabolized
releasing the
chemotherapy
32. Opaxio Regulatory Status
EU- 1st line single agent NSCLC, PS=2
MAA review nearing completion
• Submission based off non-inferior survival, better side effects
US/EU- 1st line maintenance in ovarian cancer
Pivotal trial (GOG212)
• Targeting interim PFS results early 2010: late 2010 NDA-approval
• Market size ~15,000 patients/year ($32,000/patient)
Additional Registration Trial- 2010
• Esophageal/Gastric- XRT sensitization
• I
Impressive rates of (45%) pathologic complete remission rates
i f h l i l i i
• Would be 1st radiation sensitizer approved in US/EU
• Phase II-III to start Q1-2010
Q
33. Novartis–CTI Agreement(s)
Worldwide license to OPAXIO
• $75M in potential development expense reimbursement*
• $
$270M in p potential registration and sales milestones
g
• CTI to field 35 FTE at NVS expense up to $9M
• NVS to assume all development and commercial expenses
• Royalties 20-25% on WW net sales
*50% expenses from date of execution of license agreement
34. Capital Structure/Financials
Dual Listed NASDAQ:CTIC, MTA:CTIC.MI
• Li id stock ~50mm shares/day US/EU
Liquid t k 50 h /d
Cleaned up Capital Structure
• Retired all preferred- only common stock outstanding
preferred
• 502mm shares outstanding
Cleaning up Balance Sheet
• Redeemed $$52.9mm debt@ $ $1.89/share
• Returned $43.7 mm to shareholder equity
Reduced OpEx to $2 5mm/month
$2.5mm/month
Cash end Q1- $750,000
• Raised ~$53mm April/May, $24mm non-stock based
Listed on Russell Indexes
35. Upcoming Milestones
Upcoming Milestones – 2H-09
• FDA acceptance NDA - grant priority (6month review)
• EMEA opinion on OPAXIO MAA for lung cancer
• Potential FDA approval
• Potential Novartis option exercise
• Up to $45mm in payments
• Phase III results on OPAXIO 1st line Ovarian cancer
ti l
trial
36. Charting the Path to Profitability
Closing Comments
Successfully turning around the business without
government bail out money!
• Si ifi
Significant cost reductions while advancing k assets t
t t d ti hil d i key t toward
d
market
• Smart negotiation of “Zevalin sale p right” to Spectrum Pharma
g put g p
• Provided attractive 215% 1 yr ROI ($21.5 million net of initial $10mm
investment)
• Raised $44 mm at increasing valuations limiting dilution
valuations,
• Raised $31.5mm without selling stock (Zevalin asset sale)
• International peer reviewed acknowledgement of Pixuvri
benefit to patients at Amercian Society of Clinical Oncology
(ASCO) Meetings
• Positioned to break even Q4 2009 and profitable in 2010
