Cell Therapeutics 2010 third quarter total net operating expense decreases 52% to $13.0 million

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Cell Therapeutics, Inc. ("CTI" or the "Company") (Nasdaq and MTA: CTIC) today reported recent accomplishments and financial results for the third quarter ended September 30, 2010.

"We have made solid progress in controlling costs with a 52% decrease in net operating expense and a 68% decrease in net loss for the quarter compared to the same period last year while strengthening the balance sheet with the recent financing," said James A. Bianco, M.D., Chief Executive Officer of the Company. "We continue to advance pixantrone toward a Marketing Authorization Application submission in the E.U. and readying the clinical trial networks for initiating the PIX 306 follow-on pivotal clinical study."

Recent Highlights

  • Received positive opinion agreeing to the Pediatric Investigation Plan for pixantrone from the Pediatric Committee (PDCO) of the European Medicines Agency (EMA). Additionally, the PDCO also recommended deferral of the initiation of the clinical studies until after the drug receives EMA approval.
  • Announced intention to appeal the U.S. Food and Drug Administration's (the "FDA") decision on New Drug Application (NDA) for pixantrone, which submission is targeted for November.
  • Submitted PIX306 follow-on pivotal study to the newly created Division of Hematologic Products at FDA for review.
  • Retired all convertible debt due in 2010
  • The Mayo Clinic's clinical trial network, the North Central Cancer Treatment Group ("NCCTG"), initiated patient enrollment in two phase II programs conducted by the NCCTG: one clinical trial with pixantrone in metastatic breast cancer and one clinical trial using brostallicin in triple negative metastatic breast cancer.

For the quarter ended September 30, 2010, total net operating expenses decreased 52% to $13.0 million compared to $27.1 million for the same period in 2009.  The decrease was mainly due to decreased expenses related to non-cash equity based compensation and a reduction in research and development expense. Net loss attributable to common shareholders also decreased 68% to $15.6 million ($0.02 per share) for the quarter ended September 30, 2010 compared to a net loss attributable to common shareholders of $48.8 million ($0.09 per share) for the same period in 2009. The reduction in net loss is mainly due to lower operating expenses, lower deemed dividends on preferred stock issuances and a one-time milestone modification expense accounted for in 2009.

For the nine months ended September 30, 2010, total net operating expenses were $58.8 million, compared to $55.4 million for the same period in 2009. The increase in net operating expenses is mainly a result of an increase in non-cash equity based compensation expense in 2010 and a $10.2 million gain on the sale of the Company's investment in the Zevalin joint venture in the first quarter of 2009. Net loss attributable to common shareholders was $113.4 million ($0.17 per share), compared to a net loss attributable to common shareholders of $89.4 million ($0.21 per share) for the same period in 2009. For the nine month period, the increase in net loss is mainly due to an increase in non-cash expenses including deemed dividends on preferred stock issuances and equity based compensation for 2010.  

CTI had approximately $17.3 million in cash and cash equivalents as of September 30, 2010.  This amount was before the receipt of $21.0 million in gross proceeds received from the Company's equity financing in October 2010.



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