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Ovarian Cancer

Ovarian Cancer

JamesJames A.A. Bianco,Bianco, M.D.M.D. PresidentPresident andand CEOCEO

C E L L T H E R A P E U T I C S, I N C. (N A S D A Q : C T I C) ForwardForward LookingLooking StatementStatement

This presentation contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. 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. 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 products under development. 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 herein. In any 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-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 XYOTAX™ to prove safe and effective for treatment of non-small cell lung and ovarian cancers, the potential failure of to prove safe and effective 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 on Form 10-Q, especially in the “Factors Affecting Our Operating Results” and “Management’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 Italian law, CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise. AgendaAgenda

•• General corporate overview •• Current portfolio status: development stage, time horizons to commercial launch •• New product acquisitions, portfolio synergies and status •• Commercial Opportunity: Pixantrone, XYOTAX® •• Capital Structure, financials, stock performance •• Milestones next 12 months: key messages GeneralGeneral OverviewOverview ••CTI- Incorporated 1991: University of Washington and Fred Hutchinson Cancer Research Center Seattle, WA (Nobel Prize recipient E.D.Thomas) - Founders: Former Chief of Oncology and Former Director Marrow Transplant Program ••Selected biotech companies originating from the UW/Fred Hutchinson Cancer Center - Immunex 1987, purchased by Amgen 2004 $16B - ICOS 1991, purchased by Eli Lilly 2005 $3.5B - Pathogenesis 1991, purchased by Chiron 2003 $650M ••Average time and expenditure for biotech companies to become profitable: 15 to 17 years >$1B • Most significant Value Appreciation in Biotech Stocks occurs between phase III results and NDA approval - CTIC: In 2000 was 2nd best performing stock on NASDAQ: (~1500% annual return) following Trisenox® NDA GeneralGeneral OverviewOverview

••Established operations March 1992, Seattle WA ••Singular focus: build profitable cancer company - Bring to market less toxic more effective cancer drugs ••Initial Public Offering : March 1997 ••Growth through acquisition strategy - Successful product acquisition track record • 1 product (Trisenox®) approved and marketed in US/EU/Japan • Sold to CEPH in 2005 for $70,000,000 and potential $80,000,000 earnouts • 1 product (XYOTAX) pending MAA filing • 2 products (Xyotax, pixantrone) completing phase III trials ••Merged with Novuspharma January 2004

TRISENOX® () IntegratedIntegrated DevelopmentDevelopment CapabilitiesCapabilities Post-Novuspharma merger • Former oncology drug development unit of Boehringer Mannheim, and later part of Roche oncology - Expertise in pre-development, pharmacology, CMC, Phase I/II - Cost efficient, pharma drug development expertise

ResearchResearch DevelopmentDevelopment

Target Target Lead Lead Pharmacology Clinical Sales & Manufacture Regulatory Identification Validation Generation Optimization Preclinical Trials Marketing

MergerMerger gavegave CTICTI fullyfully integratedintegrated capabilitiescapabilities fromfrom targettarget discoverydiscovery throughthrough commercializationcommercialization InternationalInternational ReachReach

United States Europe - SEATTLE, WASHINGTON - BRESSO, ITALY ••~140 FTEs in, clinical, regulatory ••~80 employees in and commercial operations pharmacology, toxicology, preclinical studies, CMC, QA/QC PortfolioPortfolio StrategyStrategy

•• Improve the safety and effectiveness of the most frequently prescribed anti-cancer drugs - Taxanes - - Platinates •• Develop new agents with unique mechanisms of tumor cell killing without more side effects - Bis-platinates - Hif-1α inhibitors CommercialCommercial StrategyStrategy

•• BloodBlood--relatedrelated CancerCancer MarketMarket (lymphoma, leukemia, myeloma, MDS) - Typical market size between 10,000 to 60,000 patients/year - Middle-tier companies have been successful with product entries - Strategy: Establish sales and marketing presence to promote CTI products •• SolidSolid TumorTumor MarketMarket (NSCLC, breast, ovarian, CRC, prostate) - Typical market size between 120,000 to 200,000 patients/year - Dominated by top 5 multi-national pharma-companies - Strategy: Establish commercial partnerships with co-promotion option CurrentCurrent ProductProduct PipelinePipeline StatusStatus

22 LateLate StageStage ProductsProducts NearingNearing ApprovalApproval ƒƒ Maturing phase III programs for pixantrone and XYOTAX ƒ Pixantrone results in DBCL and Follicular have high probability of success ƒ Phase III results 2007 ƒ Potential NDA late 2008 ƒ XYOTAX has good likelihood of approval in EU with existing STELLAR data ƒ MAA filing early ’08 with potential approval 1H-‘09 ƒ XYOTAX gender based Lung and Ovarian trials have high probability of success ƒ NDA potential filing for NSCLC 1-H ’09, Ovarian 2H- ’09 ƒƒ Commercial Launch in 12-18 months ƒƒ Clinical Pipeline Gap ƒ Only pre-clinical candidates after pixantrone and Xyotax ƒ 2 new “first in class” cancer drugs OncologyOncology PipelinePipeline CurrentCurrent ApprovalApproval && LaunchLaunch DateDate TargetsTargets

2007 2008 2009 2010 2011 Pixantrone Phase III Phase III Launch Q1-3rd Launch Launch results results line DBCL Year +1 Year +2 DBCL Follicular Launch Q4-2nd File NDA line Follicular Xyotax File MAA EU launch Q2 Launch – Launch File NDA (NI)-Lung Ovarian Year +2 US launch-Q4 Year +1 Lung-women Bis- Select File IND Start phase II Start Pivotal lead, Start trial(s) pivotal trial(s) platinate Start phase IND I trial trial(s) continue studies HIF-1α Lead Lead Start IND File IND Start phase II Optimize selection studies Start phase trial(s) preclinical I trial studies

= commercial 20072007 ProductProduct PipelinePipeline StrategyStrategy

ƒƒ “Jump start” commercial effort in blood related cancer market ƒ Acquire marketed product that has synergies with pixantrone ƒ Re-establish commercial infrastructure in advance of pixantrone launch ƒ Generates awareness of pixantrone trials and indications ƒ Synergies in selling to same target audience ƒ Sales training, MSL support, clinical trial support ƒƒ Add additional phase II/III product to pipeline that could permit a focused selling effort in targeted solid tumor applications ƒ Initial indications <20,000 patients annually ƒ Allows utilization of the 35FTE’s under NVS agreement ƒ Allows CTI to back integrate into the larger solid tumor market once resources and infrastructure permit OncologyOncology PipelinePipeline ProposedProposed AdditionsAdditions andand TargetTarget DatesDates 2007 2008 2009 2010 2011 2012 2013

Marketed Phase III Phase Expand Expand PRODUCT A st Relapsed 1 line III’s Label- Label DBCL st st Follicular results 1 line 1 line st NHL 1 line DBCL Follicular Follicular Pixantrone Launch Launch Launch DBCL Year +1 Year +2 Follicular

XYOTAX Launch Launch Launch Lung Ovarian Year +2

PRODUCT B Phase II- Pivotal File Launch Launch III Lipo- Year +1 Lipo- NDA Lipo- sarcoma sarcoma sarcoma

Bis-platinates Select File IND Start Start Phase III NDA Launch lead Start Phase phase continues filing Phase 1 II III Hif-1α Lead Select Start File IND Start Start Phase Optimize Lead IND Start phase II Phas III Start studies phase I e III (cont) preclin

= commercial ByBy yearyear endend --20072007

ƒƒ CTI will have marketed product with annual sales ~$15M ƒ Market expansion phase III studies in progress ƒƒ CTI will have reported on pixantrone Phase II/III trial results ƒ Meet with FDA to discuss NDA timing ƒƒ CTI will be completing its MAA filing for XYOTAX® in EU ƒƒ CTI will be advancing phase III trials of XYOTAX® in NSCLC and Ovarian cancer toward results in 2008 ƒƒ CTI will advance a new product into phase II/III trial CTICTI OncologyOncology PipelinePipeline

2+ Cl + NH H N + NH Pt 3 R 2 Pt 3 H N Cl 3 NH2 H3N

Taxanes Anthracyclines Bisplatinates

XYOTAXXYOTAX™ PixantronePixantrone CTCT--21062106 CTCT--4760947609 PixantronePixantrone PixantronePixantrone PhasePhase IIIIII StatusStatus Randomized,Randomized, controlledcontrolled clinicalclinical trialstrials

AggressiveAggressive (DBCL)(DBCL) NHLNHL •• 1st line R-CHOP vs R-CPOP: PIX203 (RAPID) Trial - Enrollment up to 280 patients - Primary endpoint: non-inferior CR rate, Superior cardiac safety - Interim analysis: July •• >3rd line single agent: PIX301 (EXTEND) Trial - Fast Track Designated - Primary endpoint : CR/uCR rate - FDA meeting planned Q3 prior to interim - Interim analysis: Q3- 2007 - Potential NDA filing: 2008 PixantronePixantrone PhasePhase IIIIII StatusStatus Randomized,Randomized, controlledcontrolled clinicalclinical trialstrials

IndolentIndolent (Follicular)(Follicular) NHLNHL •• >2nd line Rituximab/Fludara® +/- Pixantrone - Fast Track Designated - Study initiates Q3 - Interim analysis: 2H-2008 - sNDA for label extension 1H-2009 CommercialCommercial OpportunityOpportunity PatientsPatients ReceivingReceiving AnthracyclinesAnthracyclines Patients 350000 314,351 566,444 Patients 300000

250000

200000

150000 135,119

100000

50000 39,874 31,933 26,324 18,843 0 Breast NHL Myeloma AML Bone & Hodgkins % Sarcoma Of Chemo Treated: 49% 39% 24%55% 34% 93%

Source: Tandem Cancer Audit 2004 TaxanesTaxanes

•• Most widely used class of chemotherapeutic agents - >320,000 U.S. patients per year - >$2.0 Billion U.S.market •• 85% of taxane use is in 5 tumor types - 1st line NSCL lung cancer (34%) - 1st line and relapsed Ovarian cancer (10%) - Adjuvant and relapsed (30%) - 1st line Head & Neck cancer +XRT (5%) - Relapsed (5%) •• However all taxanes cause severe toxicities - Bone marrow : neutropenia, anemia - Nervous system: neuropathy - Constitutional: Hair loss, fatigue, hypersensitivity reactions

* Swain et al. # Herceptin® package insert

A subunit of the macromolecular complex

Paclitaxel

Macromolecular poly–Lcomplex–glutamate of XYOTAX backboneTM

Singer et al. In: Adv Exp Med Biol. 2003; 519:81-99 XYOTAX 15-20 minute infusion 3 to 24 hour infusion XyotaxXyotax ClinicalClinical TrialsTrials SummarySummary ofof phasephase II--IIIIII clinicalclinical experienceexperience

••>3,500 patients treated - 1,400 patients in phase I/II trials - 2,100 patients in phase III trials ••Extensive experience in 1st line and relapsed NSCLC, Ovarian, Prostate, Breast cancer ••Significant decrease in majority of taxane side effects - Hair loss, neutropenia, anemia, fatigue - Rare (<0.01%) hypersensitivity despite no pre-medication requirement ••Superior survival in women with NSCL cancer - Equivalent survival in men XyotaxXyotax RegulatoryRegulatory StatusStatus-- EUEU

NSCLNSCL LungLung CancerCancer •• MAA filing :Q1-2008 with Stellar 4 phase III results - SAWP agreed to non-inferior survival with superior side effect profile •• Indication: 1st line advanced NSCL, single agent PS=2 •• 10-15 month review •• Potential approval: late 2008 – early 2009 •• Novartis would market in the EU XyotaxXyotax RegulatoryRegulatory StatusStatus-- USUS

OvarianOvarian andand NSCLNSCL LungLung CancerCancer •• 1st line NSCLC- Gender specific trial: PGT-307 - Conducted under FDA approved SPA - Xyotax/carbo Vs. paclitaxel/Carbo women with normal estrogen levels - Study should start Q3 - Interim results 2H- 2008 •• Potential NDA filing late 2008 •• 1st line maintenance ovarian cancer trial: GOG-212 - Conducted under FDA approved SPA - Xyotax maintenance x 12 mos Vs. observation - Interim PFS results 2H-2008 •• Potential NDA filing 1H-2009 XyotaxXyotax CommercialCommercial OpportunityOpportunity

TaxanesTaxanes useuse inin LungLung && OvarianOvarian cancercancer •• NSCL cancer ~ 139,000 patients/yr US - ~70% receive a taxane •• Ovarian cancer ~ 30,000 patients/yr US - 79% receive a taxane •• Pricing Benchmarks - Abraxane ~$23,000/treatment course - Taxotere ~ $13,000/treatment course •• Potential ~80,000 on-label U.S. Xyotax treated patients/year XYOTAXXYOTAX™ PotentialPotential CommercialCommercial ValueValue # Patients Treated 70,000

60,000

50,000

40,000

30,000

20,000

10,000

0 Year 1 Year 2 Year 3 Year 4 Year 5

Head and Neck Prostate Breast Ovarian NSCLC CommercializationCommercialization StrategyStrategy NovartisNovartis––CTICTI CollaborationCollaboration

•• Worldwide license to XYOTAX - $15M in common stock - $270M in potential registration and sales milestones • Approval in NSCLC $60.0 million • Approval in Ovarian $32.5 million • Approval in other $27.5 million • Sales $1B, $1.5B, $2B $25.0, $50.0, $75.0 million - WW Royalties - Expense reimbursement for all direct/indirect costs from Sept 2006 to point NVS commences commercial activities triggered by • MAA approval • Positive phase III data

*from date of execution of license agreement NovartisNovartis––CTICTI CollaborationCollaboration

•• Once Novartis commences XYOTAX development - Controls future development and commercialization of product & 100% expenses - CTI may field 35 sales/MA people in US at Novartis’ expense •• Option to pixantrone - Triggered by positive interim phase III data, Xyotax phase III data/MAA approval - $7.5M option fee (6 month right to negotiate license) - $104M in potential registration and sales milestones

*from date of execution of license agreement NovartisNovartis––CTICTI CollaborationCollaboration

•• Worldwide license to XYOTAX - $15M investment - $270M in potential registration and sales milestones • $50M for NSCLC registration (US/EU) •• Significant royalties on WW sales •• Upon Novartis Development Commencement Date - Reimburses CTI for 50% of expenses* - Controls future development and commercialization of product & 100% future expenses - CTI may field 35 sales/MA people in US at Novartis’ expense up to $9M •• Option to pixantrone - $7.5M option fee on successful phase III/interim data - $104M in potential registration and sales milestones

*from date of execution of license agreement FinancialFinancial ReviewReview •• CTIC listed: NASDAQ (US), MTAX (Italy) •• Outstanding shares: ~43 million •• Stock price - 52 week high: $10.12 - 52 week low: $3.01 •• Market cap: ~$132M •• Convertible debt ~$155M •• Cash1: ~$73M end 1Q`07 - Additional €60M (~$80M) Société Générale equity facility •• Potential milestones payments in 2007 - $10M Cephalon: TRISENOX sNDA - $7.5M Novartis: option payment

1Cash and cash equivalents, securities available-for-sale, and interest receivable MercatoMercato ExchangeExchange MilestonesMilestones NextNext 1212 monthsmonths

•• Pix 203 phase II/III interim results •• Co-development/Commercial agreement for Product B: - Start pivotal trial •• Acquisition of Product A - Start label expansion trial •• Fast track designation and initiation of gender specific XYOTAX Phase III trial in 1st line NSCLC •• FDA meeting : Phase III Pix 301 interim results •• Initiation of phase III pixantrone 2nd line follicular trial •• Xyotax MAA filing in 1st line NSCLC (non-inferiority) •• Pixantrone NDA filing KeyKey MessagesMessages

•• Valuation and ROI in Biotech is linked to phase III drug results and NDA approval - CTI expects Phase III results in 2H-2007 and 2H-2008 with NDA approvals in 2008, 2009 and 2010 •• Current share price does not reflect the intrinsic commercial value of our products - Markets with unmet needs and 100,000+ patients/year potential •• We are about to rejoin the ranks of commercial bio- pharmaceutical companies with revenues, earnings and profits on schedule of being profitable by 2010 © CTI 2006

C E L L T H E R A P E U T I C S, I N C. (N A S D A Q : C T I C)