425

Filed by Cell Therapeutics, Inc.
Pursuant to Rule 425 under the Securities Act of 1933
And deemed filed pursuant to Rule 14a-12
Of the Securities and Exchange Act of 1934
Subject Company: Cell Therapeutics, Inc.
Commission File No: 001-12465

“The following slides are excerpts from a presentation given by Cell Therapeutics, Inc. (“CTI”) at its annual meeting of shareholders, held on June 20, 2003, and relate to the proposed business combination between CTI and Novuspharma S.p.A.”

 

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. 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, the proposed CTI/Novuspharma merger, and risk 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. For example, if either of the companies do not receive required stockholder approvals or fail to satisfy other conditions to closing, the transaction will not be consummated. 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 to meet TRISENOX® revenue goals, the potential failure of XYOTAX™ to prove safe and effective for treatment of non-small cell lung and ovarian cancers, the potential failure of TRISENOX® to continue to be safe and effective for cancer patients, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling TRISENOX® and CTI’s products under development in addition to the risk that the CTI and Novuspharma businesses will not be integrated successfully; costs related to the proposed merger, failure of the CTI or Novuspharma stockholders to approve the proposed merger; and other economic, business, competitive, and/or regulatory factors affecting CTI’s and Novuspharma’s businesses 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. 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.

 


Where You Can Find
Additional Information

Cell Therapeutics, Inc. (CTI) will file a proxy statement/prospectus and other documents concerning the proposed merger transaction with the Securities and Exchange Commission (SEC). Investors and security holders are urged to read the proxy statement/prospectus when it becomes available and other relevant documents filed with the SEC because they will contain important information. Security holders may obtain a free copy of the proxy statement/prospects (when it is available) and other documents filed by CTI with the SEC at the SEC’s website at http://www.sec.gov. The proxy statement/prospectus and these other documents may also be obtained for free from CTI, Investor Relations: 501 Elliott Avenue West, Suite 400 Seattle, WA 98119, www.cticseattle.com.

CTI and Novuspharma S.p.A. and their respective directors and executive officers and other members of their management and their employees may be deemed to be participants in the solicitation of proxies from the shareholders of CTI and Novuspharma with respect to the transactions contemplated by the merger agreement. Information about the directors and officers of CTI is included in CTI’s Proxy Statement for its 2003 Annual Meeting of Stockholders filed with the SEC on May 14, 2003.

This document is available free of charge at the SEC’s website at http://www.sec.gov and from CTI.

 


Oncology Strategy

 

  Improve the safety and efficacy of existing agents which provide the cornerstone for standard of care  
    Taxanes (>$2B) XYOTAX™  
    Camptothecins (>$1B) CT-2106  
    Anthracyclines (>$500M) Pixantrone  
           
  Develop new agents with unique mechanisms of tumor cell killing without more side effects  
    TRISENOX®    
    LPAAT-ß inhibitors    
           
  Develop significant sales and marketing presence in cancer market segments where leverage is possible  
    Blood-related cancer market    
           
  Consider co-marketing relationship where size matters  
    Solid tumor indications    
           
           


Commercial Synergies

 

  Key Products Hematology Solid Tumors  
         
  TRISENOX® APL, CML, MDS,
Multiple myeloma
 
   
  Pixantrone Aggressive NHL
Indolent NHL
Breast cancer
Prostate cancer
 
   
  XYOTAX™ NSC lung cancer
Ovarian cancer
 
   
  CT-2106 Colorectal cancer
Small cell lung cancer
 
         
         


Hematology
Commercial opportunity

 

   
2002 Incidence
2002 Prevalence
 
             
      Total Hematologic
94,850
 
423,564
   
   
 
   
  TRISENOX®
 
   
      APL
1,050
 
2,535
   
      Myelodysplastic
    Syndromes
15,200
 
35,562
   
      Multiple Myeloma
14,600
 
49,542
   
   
 
   
  Pixantrone
 
   
      AML
10,600
 
18,980
   
      Indolent NHL
24,030
 
142,625
   
      Aggressive NHL
29,370
 
174,320
   
             
             


Selected Companies
Focused on Hematology Market

 

  Company Key Products Market Cap
         
  Genentech Rituxan®
$38 B
 
     
 
  Berlex* Campath®, Fludara®, Leukine®
$10 B
 
     
 
  Idec Zevalin®, Rituxan®
$6.3 B
 
     
 
  Millennium Velcade™
$4.7 B
 
     
 
  Celgene Thalomid®, Revimid™
$2.7 B
 
     
 
  CTI TRISENOX®, Pixantrone
$ 518 M
1
         
         
        *Schering AG
      1 ProForma market cap
         


Oncology
Commercial opportunity

 

   
2002 Incidence
2002 Prevalence
 
             
      Total Oncologic
516,144
 
3,132,334
   
   
 
   
  XYOTAX™
 
   
      Advanced NSC lung
137,600
 
162,352
   
      Ovarian
25,400
 
145,831
   
   
 
   
  CT-2106
 
   
      Small cell lung
34,380
 
57,983
   
      Colorectal
147,500
 
930,083
   
             
  Pixantrone          
      Breast
212,600
 
1,836,085
   
             
             


Companies Focused on Oncology-
Chemotherapy Market

 

  Company Key Products Market Cap
         
  Pfizer Camptosar®
$285 B
 
         
  Glaxo Smith
      Kline
Hycamtin®, Navelbine®
$77 B
 
         
  Novartis Femara™, Aredia®, Gleevec™, Sandostatin®, Zometa™
$156 B
 
 
 
  Astra-Zeneca Arimidex®, Casodex®, Faslodex®,
IRESSA®, Nolvadex®, Zoladex®
$78 B
 
 
 
  Eli Lilly Gemzar®
$78 B
 
 
 
  Bristol Myers Taxol®, Ifex®, Paraplatin®
$56 B
 
     
  Aventis Taxotere®, Campto®, Genasense™
$42 B
 
     
  CTI XTOTAX™, Pixantrone
$348 M
 
         
         


CTI-Novuspharma Merger
Immediate realizable synergies

 

  Pixantrone: commercially attractive phase III product  
    May qualify for FDA fast track  
    Potential NDA 2005, market launch 2006  
    US sales could reach $150M+  
         
  Financially attractive  
    $120M in cash  
    $18-$20M in cost savings  
         
  Significant operating synergies  
    Critical mass in “global” oncology drug development  
    Increases commercial capabilities and sales potential in EU for expanded TRISENOX® label  
         


Strong Financial Position

 

  Pro-forma end Q1 cash position $306 million  
    $111M cash Q1-2003  
    $120M Novuspharma cash Q1-2003  
    $75M convertible offering*  
    Exchange offer 12/02 retired $60M convertible debt  
         
  Merger offers potential for cost synergies  
    $18M to $20M savings in 2004  
         
  TRISENOX® U.S. business becoming profitable  
    Allows ability to grow TRISENOX® sales in EU with new
 
      indication (MDS)  
         
  Creates critical mass in cancer drug development and  
    commercialization  
         
    * Gross proceeds  
         
         


Commercial Growth

 

  TRISENOX® TRISENOX® TRISENOX®  
  APL label, > 40 trials Potential MDS label Potential myeloma label  
   
  XYOTAX™ XYOTAX™ XYOTAX™  
  Phase III trials Potential NDA Potential NSCLC label  
   
  Pixantrone Pixantrone Pixantrone  
  Phase III trials Potential NDA Potential aggressive NHL label  
           
           


Oncology Pipeline

 

         Preclinical       Phase I         Phase II         Phase III        NDA        Marketed  
 
 
  TRISENOX®     
 Approved for relapsed or refractory acute  promyelocytic
leukemia (APL)
 
 
           
   Multiple myeloma,  myelodysplasia, myelogenous  leukemia and other cancers          
 
 
 
  XYOTAX™  Non-small cell lung and ovarian cancers          
 
 
 
  Pixantrone  Non-Hodgkin’s lymphoma                      
 
 
 
  CT-2106  Advanced solid
 tumors
         
 
 
 
  LPAAT-ß inhibitors          
 
             
             


Pixantrone
(from Novuspharma merger)

 

  New DNA intercalator with  
    improved efficacy and safety  
     
  Now in phase III for NHL  
       
       
 
 
 
 
 
 
 
 
 
 
         
         


DNA Intercalators

 

  Established efficacy  
    Cornerstone of chemotherapy for breast cancer,  
      leukemias, and lymphomas  
    Standard treatment in blood-born tumors – curative  
    Breast cancer – highly effective as adjuvant and frontline therapy  
    Only therapy for advanced forms of multiple sclerosis  
         
  However – problems with cardiotoxicity  
    Irreversible damage to heart muscle  
    Maximum cumulative dose in patient’s lifetime  
    Prevents use as repeat therapy  
         
         


DNA Intercalators
with improved efficacy and safety

 

  Novuspharma’s approach  
    Alter chemical groups responsible for free-radical  
      production and cardiac toxicity  
     
       
  Target markets  
    Unmet clinical need in second-line therapy (NHL)  
    Replace current DNA intercalators as safer treatment in first-line  
         
         


Pixantrone

 

       
Doxorubicin
Mitoxantrone
Pixantrone
 
       
 
  Efficacy in
hematology
+++
++
++++
 
     
 
  Efficacy in
solid tumors
++/+++
++
++
 
     
 
  Safety
(esp. cardiac)
+
++
++++
 
               
               
    Superior anti-tumor activity in P388 and L1210 murine  
      leukemias vs. Dx and Mitox  
         
    Curative in YC-8 murine lymphoma  
       
    Wide therapeutic window – effective from 1/3 of MTD  
       
    Synergism with Cisplatin and Rituxan  
               
               


Effect of pixantrone and mitoxantrone (MITOX) on
survival in the YC-8 lymphoma model (iv/iv + 1,5,9)

 

 


Pixantrone
Experimental cardiotoxicity

 

 


Pixantrone
Target product profile

 

  Superior safety  
    Cardiac toxicity profile superior to existing agents  
    Not toxic to tissues, eliminates need for central line  
    Less severe nausea and vomiting  
         
  Impressive efficacy  
    Long lasting complete remissions in heavily treated NHL patients  
    As single agent or in combination with chemotherapy  
         
  Potential to be used where other anthracyclines cannot  
    Breast cancer in combination with Herceptin  
    Breast cancer salvage after prior anthracycline therapy  
    Late-stage lymphomas  
         
         


Pixantrone

 

  Extensive clinical trial experience  
    >170 patients  
    7 phase I, II trials  
         
  Initial market entry into area of high unmet need  
    3rd-line aggressive NHL  
    Currently no approved therapies  
    Market size ~15,000 patients  
         
  Potential label expansion  
    Relapsed indolent NHL + Rituxan (phase III)  
    2nd-line combination in high grade NHL (phase II)  
    Salvage breast cancer ± Herceptin (planned)  
         
         


Pixantrone
Impressive single agent activity (NHL)

 

  High response rates in relapsed/resistant aggressive NHL  
    ORR= >30% (7CRs/5PRs + 5uPRs)  
    Durable responses: TTP >8 months for responders  
         
  Well tolerated  
    Grade 4 neutropenia 13/33 (40%)  
    Grade 4 anemia/thrombocytopenia 0-1/33 (<3%)  
         
  28/33 (85%) had maximum prior anthracycline exposure  
         
  14/33 (42%) received >1,000-1500mg/m2 Pixantrone  
         
  Encouraging low incidence of cardiac events despite prior  
    anthracycline exposure  
         


Pixantrone
Combination trials

 

  Highly active in combination regimens for relapsed/refractory  
    NHL replacing doxorubicin  
    CHOP n=17  
      13 patients evaluable; 6CRs/1PR  
    ESHAP n=21  
      19 patients evaluable; 7CRs/4PRs  
           
  Highly active in relapsed/refractory indolent NHL  
    FND-R n=9  
    6 patients evaluable; 5CRs/1PR  
           
           


Preliminary Market Study
% of physicians who would prescribe Pixantrone
by line of therapy

 

       
First Line
Second Line
Third Line
 
       
 
 
Aggressive
47%
100%
100%
 
     
 
 
Indolent
27%
67%
67%
 
               
               
    Almost half of the physicians would try Pixantrone in place of  
      doxorubicin in first line therapy for aggressive patients –  
      mostly for patients with cardiovascular risk factors  
               
               


Last 12 Months in Review

 

 
Objective
Status
 
               
  Acquire late stage or   Novuspharma merger  
    commercial product     Pixantrone in phase III  
        $18-$20m in annual operating  
  Reduce burn rate and secure       synergies  
    adequate capital to grow     $120M balance sheet  
    commercial operations          
    and see XYOTAX™ to NDA   $75M notes offering  
               
  Advance discussions toward   Partnership discussions for  
    potential XYOTAX™ partner     XYOTAX™ ongoing  
             
  Initiate pivotal XYOTAX™   STELLAR-2, -3, -4 trials FDA  
    phase III trials     approved and enrolling  
             
  TRISENOX® - profitable   Sales targeted to double to  
    operating business     $24M this year  
               
  Highlight clinical data at key   ASH, AACR, ASCO, MM, MDS  
    scientific meetings          
               
               
               


Key Objectives
Next 12-18 Months

 

  Gynecologic Oncology Group to initiate phase III study of  
    XYOTAX™ in ovarian cancer  
         
  Complete enrollment of pivotal trials in non-small cell lung cancer  
         
  Successful merger with Novuspharma to maximize cost synergies  
    and efficiencies  
         
  Initiate pivotal trial of Pixantrone in aggressive relapsed NHL