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Cell Therapeutics, Inc. (CTI) Decreases Net Loss by 42% in 2009

February 11, 2010

SEATTLE, Feb. 11 /PRNewswire-FirstCall/ — Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today reported recent accomplishments and financial results for the fourth quarter and year ended December 31, 2009.

Review of 2009 Key Accomplishments and Targeted 2010 Milestones

  • Pixantrone New Drug Application (“NDA”) for relapsed/refractory aggressive non-Hodgkin’s lymphoma filed with the U.S. Food and Drug Administration (the “FDA”) and accepted for review in 2009. The FDA established Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
  • Initiated a Marketing Authorization Application (“MAA”) for pixantrone in Europe in 2009 and received Orphan Drug Designation by the European Medicines Agency. CTI expects to file a Marketing Authorization Application in mid-2010.
  • Phase II clinical data on OPAXIO demonstrated high rates of pathologic complete remissions for treatment of patients with advanced esophageal cancer paving way for potential registration trial as radiation sensitizer. CTI expects to meet with the FDA in the first half of 2010 to discuss a potential registration trial for OPAXIO as a radiation sensitizer.
  • Decreased debt in 2009 by $57.4 million through exchanges and eliminated all of outstanding preferred stock.
  • Added in 2009 to the Russell 2000, 3000 and Global Indices as well as the Nasdaq Global Biotechnology Index.
  • Adopted Shareholder Rights Plan designed to deter coercive takeover tactics, and to prevent an acquirer from gaining control of CTI without offering a fair price to all of CTI’s shareholders.
  • Received net proceeds of $136 million in 2009 through sale of Zevalin and investments by institutions to fund operations and decrease debt.

“In 2009 we focused on streamlining our operations, improving our balance sheet and supporting our late stage product to position us for the potential commercialization of a CTI product,” stated James A. Bianco, M.D., CEO of CTI. “We look forward to presenting the benefit-risk pixantrone data to the Oncologic Drugs Advisory Committee at the meeting which is being rescheduled especially in light of the completion of the updated study overall survival results.”

Financial Results

For the quarter ended December 31, 2009, total net operating expenses were approximately $26.2 million, compared to $11.2 million for the same period in 2008. The increase in total net operating expenses was mainly a result of a non-cash equity based compensation expense of $11.7 million for the quarter ended December 31, 2009 and a $9.4 million gain on the sale of Zevalin to a 50/50 owned joint venture with Spectrum that was recognized in the quarter ended December 31, 2008. Research and development expenses decreased by 15% to $7.3 million compared to $8.6 million for the same period in 2008. Net loss attributable to common shareholders decreased by 34% to $27.4 million ($0.05 per share), compared to a net loss attributable to common shareholders of $41.3 million ($0.52 per share) for the same period in 2008. The decrease in net loss for the quarter ended December 31, 2009 is mainly a result of the decrease in expenses associated with financings for the quarter ended December 31, 2009 compared to the expenses associated with financings incurred in the same period in 2008.

For the year ended December 31, 2009, total net operating expenses decreased to $81.6 million, compared to $88.7 million for the same period in 2008. Research and development expenses decreased by 42% to $30.2 million compared to $51.6 million for the same period in 2008. Net loss attributable to common shareholders decreased 42% to $116.8 million ($0.25 per share), compared to a net loss attributable to shareholders of $202.9 million ($7.00 per share) for the same period in 2008. The decrease in net loss for the year ended December, 31, 2009 compared to the same period in 2008 is mainly the result of a decrease in research and development expenses and expenses associated with financings.

CTI had approximately $37.8 million in cash, cash equivalents and securities available-for-sale as of December 31, 2009. This does not include approximately $28.2 million in net proceeds, the Company received in January 2010 in connection with a registered offering of preferred stock and warrants.

Conference Call Information

On Thursday, February 11, 2010, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of CTI’s management team will host a conference call to discuss CTI’s 2009 fourth quarter and year end achievements and financial results.


    Conference Call Numbers

    Thursday, February 11, 2010
    8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
    1-877-941-6009 (US Participants)
    1-480-629-9770 (International)

    Call-back numbers for post-listening available at 11:30 a.m. Eastern:
    1-800-406-7325 (US Participants)
    1-303-590-3030 (International)
    Passcode: 4199432

Live audio webcast at www.celltherapeutics.com 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 www.celltherapeutics.com.

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 include statements about CTI’s ability to continue to reduce CTI’s operating expenses, CTI’s ability to continue to raise capital as needed to fund CTI’s operations, the development of pixantrone, OPAXIO and brostallicin, which include risks associated with preclinical and clinical developments in the biopharmaceutical industry, in general, and with pixantrone, OPAXIO and brostallicin, in particular, including, without limitation, the potential failure of these product candidates to prove safe and effective for the treatment of ovarian cancer, esophageal cancer, non-Hodgkin’s lymphoma and sarcoma or to achieve market acceptance for such treatments, the possibility that FDA approval is not granted for pixantrone at all, the possibility that CTI does not file an MAA, that the potential registration trial for OPAXIO does not occur, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling pixantrone, OPAXIO and brostallicin, and the risk factors listed or described from time to time in CTI’s filings with the Securities and Exchange Commission, including, without limitation, CTI’s most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter CTI’s forward-looking statements whether as a result of new information, future events, or otherwise.


    Media Contact:
    Dan Eramian
    T: 206.272.4343
    C: 206.854.1200
    E: deramian@ctiseattle.com
    www.CellTherapeutics.com/press_room

    Investors Contact:
    Ed Bell
    T: 206.272.4345
    Lindsey Jesch Logan
    T: 206.272.4347
    F: 206.272.4434
    E: invest@ctiseattle.com
    www.CellTherapeutics.com/investors


                              Cell Therapeutics, Inc.

                 Condensed Consolidated Statements of Operations
                  (In thousands, except for per share amounts)
                                     (unaudited)

                               Three Months Ended         Year Ended
                                  December 31,           December 31,
                                  ------------           ------------
                                2009        2008       2009       2008
                                ----        ----       ----       ----
    Revenues:
      Product sales               $-      $2,528         $-    $11,352
      License and contract
       revenue                    20          20         80         80
                                 ---         ---        ---        ---
        Total revenues            20       2,548         80     11,432
                                 ---       -----        ---     ------
    Operating expenses, net:
      Cost of product sold         -         895          -      3,244
      Research and
       development             7,301       8,576     30,179     51,614
      Selling, general
       and administrative     18,728      11,081     57,725     41,643
      Amortization of
       purchased intangibles       -         118          -      1,658
      Restructuring charges
       and related gain on
       sale of assets, net       213           -      3,979          -
      Gain on sale of Zevalin      -      (9,444)         -     (9,444)
      Gain on sale of investment
       in joint venture            -           -    (10,244)         -
                                 ---         ---    -------        ---
        Total operating
         expenses, net        26,242      11,226     81,639     88,715
                              ------      ------     ------     ------
    Loss from operations     (26,222)     (8,678)   (81,559)   (77,283)
    Other income (expense):
      Investment and
       other income, net          36          50        133        549
      Interest expense          (780)     (1,604)    (4,806)    (8,559)
      Amortization of
       debt discount and
       issuance costs           (213)    (14,271)    (5,788)   (66,530)
      Foreign exchange
       gain (loss)              (245)      2,728         33      3,637
      Make-whole interest
       expense                     -     (17,731)    (6,345)   (70,243)
      Gain on derivative
       liabilities, net            -      13,647      7,218     69,739
      Gain (loss) on exchange
       of convertible notes        -      (9,223)     7,381    (25,103)
      Equity loss from investment
       in joint venture            -        (123)    (1,204)      (123)
      Milestone modification
       expense                     -           -     (6,000)         -
      Settlement expense, net      -      (2,594)    (4,710)    (3,393)
      Write-off of financing
       arrangement costs           -        (485)         -     (2,846)
                                 ---        ----        ---     ------
    Net loss before
     noncontrolling
     interest                (27,424)    (38,284)   (95,647)  (180,155)
      Noncontrolling interest     47          31        252        126
                                 ---         ---        ---        ---
    Net loss attributable
     to CTI                  (27,377)    (38,253)   (95,395)  (180,029)
      Gain on restructuring
       of preferred stock          -           -      2,116          -
      Preferred stock
       dividends                   -         (88)       (24)      (662)
      Deemed dividends
       on preferred stock          -      (3,000)   (23,460)   (22,216)
                                 ---      ------    -------    -------
    Net loss
     attributable to
     common shareholders    $(27,377)   $(41,341) $(116,763) $(202,907)
                            ========    ========  =========  =========
    Basic and diluted net
     loss per common share    $(0.05)     $(0.52)    $(0.25)    $(7.00)
                              ======      ======     ======     ======
    Shares used in
     calculation of basic
     and diluted net loss
     per common share        570,630      80,074    458,356     28,967
                             =======      ======    =======     ====== 

    Balance Sheet Data:             (amounts in thousands)         

                                            December 31,
                                          2009        2008
                                          ----        ----
    Cash and cash equivalents          (unaudited)
     and securities
      available-for- sale              $37,811     $10,671
    Restricted cash                          -       6,640
    Working capital                    (21,694)    (14,141)
    Total assets                        69,595      64,243
    Convertible debt                    62,142     142,373
    Accumulated deficit             (1,429,083) (1,312,320)
    Shareholders' deficit              (18,769)   (132,061)        

SOURCE Cell Therapeutics, Inc.


Source: newswire



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