Special Meeting in Lieu of Annual Meeting of Shareholders

Transcription

1 Special Meeting in Lieu of Annual Meeting of Shareholders Thursday, June 19, 2008 James A. Bianco, M.D. President and CEO

2 Agenda Call meeting to order Introduction of the inspector of elections, secretary, officers, directors, and accountants Discussion of business items as set forth in proxy Voting on proposals submitted to shareholders Adjournment of business portion of meeting Corporate review 2

3 Business Items Confirmation of quorum 3

4 Business Items Approval of Class II Directors Dr. Jim Bianco Dr. Vartan Gregorian Dr. Frederick Telling Ratification of Class III Director Mr. Richard Love 4

5 Business Items Vote on proposal to approve the increase in the number of authorized stock from 210,000,000 shares to 410,000,000 shares and increase the number of shares of our common stock authorized for issuance from 200,000,000 to 400,000,000 5

6 Business Items Vote on proposal to amend our articles of incorporation to reduce the quorum required for shareholders meetings from a majority to one-third of outstanding shares entitled to vote 6

7 Business Items Vote on proposal to amend our articles of incorporation at the discretion of our Board of Directors to effect a reverse stock split of our outstanding common stock in the range of one-for-two to one-for-ten without further approval of our shareholders. 7

8 Business Items Vote on proposal to amend our 2007 Equity Incentive Plan to increase the number of shares available for issuance under the plan by an additional 10,000,000 shares of common stock. 8

9 Business Items Ratify the selection of Stonefield Josephson, Inc., as independent auditors for

10 Business Items Polls are open Questions and answers on business items Specific to proxy proposals, process Limited to shareholders of record or proxies Identify yourself, limit question to 2 minutes 10

11 Business Items Results of voting Conclusion of business portion of meeting 11

12 12 Corporate Review

13 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 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 forwardlooking 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 forwardlooking 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 pixantrone to prove safe and effective for treatment of non-hodgkin s lymphoma, the risk that we may not recognize the full expected value of Zevalin in future years, determinations by regulatory, patent and administrative governmental authorities, including determination by the Food and Drug Administration or the European Medicines Agency relating to review or approval of any applications, 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 law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise. 13

14 A 30 month perspective Restructured & Re-focused resources Sold Trisenox for $70 million, Cut burn rate 60% Focused resources on phase III candidates Opaxio, pixantrone Recruited seasoned industry veterans to Board of Directors Validation of Opaxio and pixantrone opportunities Novartis world wide license agreement for Opaxio and option to pixantrone - Potential $285 million agreement for Opaxio - Potential $111 million license to pixantrone $7.5 million option fee to negotiate license Positive opinion from scientific working group of EMEA for Opaxio - Provides potential route for submission of marketing application for approval in EU to treat lung cancer GOG212 study in Ovarian Cancer - Cost effective, higher probability investment for US registration purposes 14

15 A 30 month perspective 2007 Strategic Acquisitions Systems Medicine LLC - Betting on genomic technology to guide oncology clinical trial - Higher probability of success, less time and less costs - Brostallicin - novel phase II cancer drug candidate U.S. Rights to Zevalin - Under-appreciated asset with significant commercial potential - Strong portfolio fit with pixantrone - Returns CTI to commercial operating business 15

16 Building a Diversified Oncology Portfolio Preclinical Phase I Phase II Phase III Marketed Cephalon Partnered w/novartis Pixantrone Brostallicin Novel Platinum Complexes 16 *Trisenox was sold to Cephalon, Inc. in 2005

17 2008: Accomplishments Year-to-Date Commercial Pipeline Zevalin - Reported $3.8 million in gross product sales of Zevalin in Q1 - On target to reach $15 million in net sales for 2008 Stand alone P&L targeting break-even - Agreement with Bayer to access phase III FIT trial data for FDA Submission Meeting with FDA Q3 to discuss supplemental BLA filing Potential to expand Zevalin label to include use for first-line consolidation therapy in follicular NHL Potential to significantly broaden market for Zevalin 36,000 US patients receive front-line treatment for follicular NHL - Working with CMS/Congress to seek continued appropriate reimbursement and patient access 17

18 2008: Accomplishments Year-to-Date Development Pipeline Opaxio - EMEA accepted for review MAA for first-line PS2 NSCLC - Maintenance therapy following front line treatment in Ovarian Cancer Phase III pivotal trial (GOG212) on track for interim results 2009 Pixantrone - Enrollment completed in EXTEND (PIX301) Phase III pivotal trial for patients with relapsed diffuse large B-Cell non-hodgkin s lymphoma - Timing of data analysis dependent on when last patient completes treatment - Current target late Q3-early Q4 Brostallicin - EORTC completing enrollment of randomized phase II study in treating newly diagnosed advanced or metastatic soft tissue sarcoma - Phase I combination trial with Avastin generating encouraging results - Genomic guided phase II trial getting underway 18

19 2008: Accomplishments Year-to-Date Operations and Financials New Leadership: Craig Philips, President, joining in August Former VP and US General Manager Bayer Oncology ($350mm sales) Strategically realigned company to establish a commercial organization - Hired, trained and strategically deployed Sales Team for Zevalin targeting high potential, integrated ( Z ready) accounts Cleaned up capital structure, cut expenses - Retired/exchanged 100% current debt and retired or converted 75% of series A-D preferred securities - >2 years to execute on sales and product approvals before additional notes mature Spinning out NewCo - Combines cutting edge computational technologies with world class genomic screening capabilities and Bresso preclinical development skills - Potential to reduce CTI s burn by up to $15m and $23m in 2009 and Allows CTI to focus on commercial operating business, potential product launches and growing sales revenues 19

20 Phase III: Zevalin Consolidation for First Remission Following Chemotherapy FIT Trial Results First-Line Regimen CHOP (n=188) CVP (n=106) R-Chemo (n=59) Chlorambucil (n=39) Fludara combo (n=22) Response CR CRu PR Zevalin consolidation Observation Primary Endpoint : PFS 20

21 Remission After First-Line Chemotherapy Zevalin Converted 77% of PRs to CR/CRu Zevalin Resulted in 92% Molecular Remissions Arm A (n=208) Arm B (n=206) Arm A + Zevalin consolidation (n=208) Partial Response (PR) Complete Response (CR) 49% 47% 13% 51% 53% 87% 21

22 Zevalin Prolongs PFS Following First-Line Chemotherapy for Follicular NHL Zevalin (n=208) Control (n=206) P-value Hazard Ratio Median PFS 37.0 months 13.5 months < Median PFS after PR 29.7 months 6.3 months < Median PFS after CR 54.6 months 29.9 months

23 The Zevalin Commercial Opportunity US Incidence Follicular NHL 40,000 20, ,800 First-Line 10,700 Relapse *2007 U.S. Tandem data 23

24 Zevalin Commercial Opportunity Sales Revenues Could top $100 million Assumptions Compelling new clinical benefit data will drive use Current Indication 1 st relapse ~10,700 pts/yr <10% penetration ($15 million sales) Expanded community access could yield 30% penetration (potential for approx. $45 million sales) Expanded indication: additional 31,800 pts/yr Initial target population:12,000 patients don t achieve CR with R-CVP 50% penetration could represent $90 million sales Barriers to adoption by community oncologists could be reduced ZCAP allows Medical Oncologists to order & administer Zevalin in their oncology clinics Reimbursement is attractive in free standing cancer clinics 24

25 2008 Projected Zevalin P&L Excellent Cash Flow Leverage Expected 2008 Gross revenue aggressive NHL $1.7 Gross revenue indolent NHL 16.3 Gross revenue 18.0 Returns & allowances 0.6 Distribution charges 1.5 ZCAP rebate 0.1 Net revenue 15.8 Cost to manufacture 1.7 Existing royalties burden payable 3.0 Gross profit 11.1 R&D 2.4 S&M Operating profit $0.5

26 Projected Development Next Months Commercial and Development Pipeline Zevalin - FDA meeting on sbla submission - Possible sbla submission 2H-08 - Potential ODAC panel/ approval on Zevalin sbla 1H-09 Pixantrone - PIX301 results Q3/ Novartis option decision and potential $7.5 million payment - Potential NDA submission and potential approval 2H-2009 Opaxio - EMEA decision on MAA expected in 1 st line NSCLC (PS2) - GOG212 Ovarian Cancer Pivotal trial interim results expected 2H-09 Brostallicin - EORTC completes enrollment in randomized front line sarcoma trial Q3-08 Top line results report expected1h-09 26

27 Next 12 Months Operations and Financials Potential drivers of revenue growth - Increased sales of Zevalin if sbla approved for first-line consolidation therapy - Potential option fee from Novartis if they elect to exercise option following possible successful phase III results for pixantrone - Milestone from Novartis if OPAXIO is approved by EMEA Spin-off of Genomic Subsidiaries - Strategically positions select CTI assets to focus on cutting-edge genomics technology applied to clinical trial patient selection; may ultimately improve information-based decision making for the healthcare industry - May reduce future operating expenses for CTI due to contributions to new organization - Realign organizations to focus on strategic goals CTI Late-stage product development and commercialization New Organization Enabling technology for positioning candidates in early clinical development with intention of moving towards providing individual patient / consumer healthcare profiles 27

28 Summary CTI on target with Zevalin commercialization. Potential to significantly increase the market opportunity if successful in expanding the label. Could represent a stand alone successful profitable business Addition of Craig Philips as President will help drive CTI s transformation toward a profitable commercial organization Possible submission of applications for approval of multiple products in the near-term; expected phase III results with potential associated partner milestones and revenue if results are positive Decrease in operating expenses and clean up of capital structure expected to improve near-term financials Spin-off has the potential to provide significant future return on investment to shareholders and is expected to reduce CTI s operating expense 28

29 Resources Cell Therapeutics, Inc. (CTI) 501 Elliott Ave. W., Suite 400 Seattle, WA CTIC stock is listed on: NASDAQ (U.S.), MTA (Italy) Investors Contact: Ed Bell T: F: E: For the latest financial information, including investor updates, SEC filings, press releases, and webcasts, please visit our Web site at For more product and clinical trial information including references, clinical trial information, and product fact sheets for Zevalin, pixantrone, OPAXIO, and brostallicin, visit our Web site, 29 CTI 2008