Navigation Links
Cell Therapeutics, Inc. Reports First Quarter Accomplishments and Financial Results

SEATTLE, April 27, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI" or the "Company") (NASDAQ and MTA: CTIC) today reported accomplishments and financial results for the first quarter ended March 31, 2011.

"In the first quarter, we raised $50 million through two financings, advanced pixantrone into a confirmatory pivotal trial and acquired an exclusive license from Chroma Therapeutics Ltd. ("Chroma") to co-develop and market Chroma's drug candidate, tosedostat, in the Americas all while reducing operating expenses compared to the same period last year," said James A. Bianco, M.D., Chief Executive Officer of CTI. "In March, we received the day 120 list of questions from the European Medicines Agency ("EMA") for our Marketing Authorization Application ("MAA") for pixantrone in Europe and are pleased with the review progress and the potential for a recommendation from the EMA's Medicinal Product Committee before the end of this year. We also expect to hear from the Office of New Drugs ("OND") this quarter relating to our appeal of the decision made on our New Drug Application ("NDA") for pixantrone. With an impressive portfolio of novel phase III drug candidates and the potential for regulatory approval for pixantrone, this year could be a pivotal year for the Company."

Review of 2011 Key Accomplishments

  • Completed two financings at a total offering price of $50 million in the first quarter 2011
  • Entered into a co-development and license agreement with Chroma, which is located in the United Kingdom.  This agreement provides CTI with exclusive marketing and co-development rights to Chroma's drug candidate, tosedostat, in North, Central and South America. Tosedostat is an oral, tumor selective inducer of amino acid depletion responses that has demonstrated encouraging single agent anti-tumor responses in blood-related cancers and solid tumors in phase I-II clinical trials.
  • Initiated a pivotal trial of pixantrone for the treatment of relapsed/refractory diffuse large B-cell lymphoma ("DLBCL").  The trial, referred to as the PIX-R or PIX 306 trial, will compare a combination of pixantrone plus rituximab to a combination of gemcitabine plus rituximab in patients with relapsed or refractory DLBCL who have received one to three prior lines of therapy.
  • Met with officials of the FDA's OND and presented arguments supporting CTI's belief that the data contained in its NDA 22-481 supports the conclusion that pixantrone is effective for its planned use. CTI expects a decision on its appeal during the second quarter of 2011.
  • Received the day 120 list of questions from the EMA relating to our MAA for pixantrone in Europe.

  • For the quarter ended March 31, 2011, total operating expenses decreased to $20.1 million compared to $25.8 million for the same period in 2010.  Research and development expenses increased to $11.5 million in the quarter ended March 31, 2011 compared to $7.4 million for the same period in 2010 due to a one-time upfront payment of $5.0 million related to the licensing of tosedostat from Chroma in 2011. Selling, general and administrative expenses decreased to $8.6 million in the quarter ended March 31, 2011 compared to $18.4 million for the same period in 2010 primarily related to a decrease in non-cash equity based compensation. Net loss attributable to common shareholders was $51.0 million ($0.06 per share) for the quarter ended March 31, 2011 compared to a net loss attributable to common shareholders of $44.2 million ($0.07 per share) for the same period in 2010. The increase in net loss attributable to common shareholders is mainly due to an increase in non-cash deemed dividends on preferred stock related to financing activities.

    CTI had approximately $43.8 million in cash and cash equivalents as of March 31, 2011.Conference Call InformationOn Wednesday, April 27, 2011, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time, members of CTI's management team will host a conference call to discuss CTI's 2011 first quarter financial results.Conference Call NumbersWednesday, April 27, 2011 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time1-888-549-7750 (US Participants)1-480-629-9866 (International)Call-back numbers for post-listening available at 11:30 a.m. Eastern Time:1-800-406-7325 (US Participants)1-303-590-3030  (International)Passcode: 4435562#Live audio webcast at will be archived for post-call listening approximately two hours after call ends.

    About Cell Therapeutics, Inc.Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit

    This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI's securities. Specifically, the risks and uncertainties that could affect CTI include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory aggressive NHL, relapsed or refractory DLBCL and/or other tumors (whether alone or in combination with rituximab) as determined by the FDA and/or the EMA, that if CTI conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that pixantrone may not be approved by the FDA or the EMA this year, the potential failure of tosedostat to prove safe and effective for the treatment of AML, multiple myeloma, blood-related cancers and solid tumors as determined by the FDA and/or the EMA, that the FDA may not accept the proposed clinical trial design of tosedostat (including a pivotal study targeting AML in the U.S. and Europe) and/or may request additional trials, that clinical trials may not demonstrate the safety and effectiveness of tosedostat, that tosedostat may not expand CTI's presence in the hematologic cancer space, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials or the total number of patients enrolled, that the EMA may not approve CTI's marketing authorization application for pixantrone after review, that CTI's MAA may not receive a recommendation from the EMA's Medicinal Product Committee before the end of 2011, that CTI cannot predict the outcome of the formal dispute resolution process with the FDA, that CTI's appeal of the FDA's decision regarding CTI's NDA may not be successful, that the FDA's OND may not make its decision regarding CTI's appeal during the second quarter of 2011, that CTI may not regain compliance with the NASDAQ Stock Market LLC's minimum bid price rule by May 2, 2011, that CTI may not be able to sustain its current cost controls, and that CTI may not be able to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone. Further risks and uncertainties include that CTI continues to have a substantial amount of debt outstanding and the quarterly interest expense associated with the debt is significant, CTI's operating expenses continue to exceed its net revenues, that CTI may not be able to further reduce its operating expenses, that CTI will continue to need to raise capital to fund its operating expenses and may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI's most recent filings with the U.S. Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.

    Media Contact:
    Dan Eramian
    T: 206.272.4343
    C: 206.854.1200
    F: 206.272.4434

    Investors Contact:
    Ed Bell
    T: 206.282.7100
    Lindsey Jesch Logan
    T: 206.272.4347
    F: 206.272.4434

    Cell Therapeutics, Inc.Condensed Consolidated Statements of Operations(In thousands, except for per share amounts)(unaudited)Three Months EndedMarch 31,20112010Revenues:License and contract revenue

    20Total revenues

    -20Operating expenses:Research and development

    11,4947,360Selling, general and administrative

    8,57618,417Total operating expenses

    20,07025,777Loss from operations

    (20,070)(25,757)Other income (expense):Investment and other income, net

    63262Interest expense

    (389)(787)Amortization of debt discount and issuance costs

    (167)(215)Foreign exchange gain (loss)

    759(475)Net loss before noncontrolling interest

    (19,804)(26,972)Noncontrolling interest

    7052Net loss attributable to CTI

    (19,734)(26,920)Dividends and deemed dividends on preferred stock

    (31,283)(17,277)Net loss attributable to CTI common shareholders

    (44,197)Basic and diluted net loss per common share

    (0.07)Shares used in calculation of basic and dilutednet loss per common share

    878,261598,984Balance Sheet Data:

    (amounts in thousands)March 31,December 31,20112010(unaudited)Cash and cash equivalents

    22,649Working capital

    8,510(14,165)Total assets

    60,92353,592Convertible debt

    22,44522,308Accumulated deficit

    (1,644,717)(1,576,643)Total shareholders' equity (deficit)


    SOURCE Cell Therapeutics, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Vista Partners Updates Coverage on Opexa Therapeutics, Inc.; Maintains Target Price of $6.50
    2. Orexigen® Therapeutics, Inc. Announces Upcoming Departure of Chief Financial Officer
    3. Cell Therapeutics, Inc. (CTI) to Report Fourth Quarter and Year-End 2010 Financial Results on February 16
    4. Alpha-1 Foundation Awards Two Research Grants with Support from Talecris Biotherapeutics, Inc.
    5. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for Pixuvri®
    6. Veteran Pharmaceutical Executives Form New American Therapeutics, Inc.
    7. BioMolecular Therapeutics, a New Global Player in RNAi Therapeutics, Launches Company and Adds Key Advisors
    8. Precision Therapeutics, Inc. Named to Pittsburgh Business Times 2010 Top 100
    9. BioMarin Acquires ZyStor Therapeutics, Inc.
    10. Nonconformity of NOV002 Used in Phase 3 NSCLC Trial Sponsored by Novelos Therapeutics, Inc to NOV002 (Glutoxim(R)), Used in Phase 1/2 NSCLC and all Previous Trials
    11. Reportlinker Adds The Future of Ophthalmology Therapeutics, Analysis and Market Forecasts to 2016 - Strategies to Counter Generic Erosion in Key Markets
    Post Your Comments:
    (Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... --> adds "Global ... and "Investigation Report on China Repaglinide ... 2021 forecasts data and information to ... . --> ...
    (Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Italian therapeutic drug monitoring ...
    (Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... announced the addition of the  "2016 ... the European Cell Surface Marker Testing ... Opportunities"  report to their offering.  ... the addition of the  "2016 Future ...
    Breaking Medicine Technology:
    (Date:11/27/2015)... ... November 27, 2015 , ... Indosoft Inc., developer and distributor ... Asterisk 11 LTS (Long Term Support) into its Q-Suite 5.10 product line. , ... up-to-date with a version of Asterisk that will receive not only security fixes, ...
    (Date:11/26/2015)... ... November 26, 2015 , ... Inevitably when people think Thanksgiving, they also ... buy during the Black Friday and Cyber Monday massage chair sales to ... Internet high and low to find the best massage chair deals, they can see ...
    (Date:11/26/2015)... ... November 26, 2015 , ... Somu Sivaramakrishnan announced ... franchise owner, Somu now offers travelers, value and care based Travel Services, including ... sales, as well as, cabin upgrades and special amenities such as, shore excursions, ...
    (Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical ... professionals and offered by healthcare staffing agency Aureus Medical Group . ... of October 2015 among those searching for healthcare jobs through the company’s website, ...
    (Date:11/26/2015)... Mass. (PRWEB) , ... November 26, 2015 , ... ... thorough second medical opinion process, participated in the 61st annual Employee Benefits Conference. ... Plans and took place Sunday, November 8th through Wednesday, November 11th, 2015. The ...
    Breaking Medicine News(10 mins):