CTI's fourth quarter net loss increases to $34.1 million

Cell Therapeutics, Inc.Feb 16 2011

Cell Therapeutics, Inc. ("CTI" or the "Company") (Nasdaq and MTA: CTIC) today reported recent accomplishments and financial results for the fourth quarter and year ended December 31, 2010.

"We are pleased with the progress made on our pixantrone MAA in Europe since it was validated in December 2010, and as it undergoes active review.  This quarter we plan to meet with the U.S. Food and Drug Administration's (the "FDA") Office of New Drugs to discuss our appeal to the FDA for our New Drug Application ("NDA") for pixantrone as well as to reach final agreement on the design and regulatory utility of our planned pivotal trial," said James A. Bianco, M.D., Chief Executive Officer of the Company. "These developments coupled with our efforts to expand our pipeline by in-licensing a novel phase III drug candidate promise to make the next several months exciting."

Review of 2010 Key Accomplishments

• Pediatric Investigation Plan and MAA seeking approval for pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") was validated and accepted for review by the PedCo and the European Medicines Agency ("EMA").
• Initiated the dispute resolution process with the Office of New Drugs of FDA regarding our NDA for pixantrone.
• Reported pixantrone PIX301 end-of-study results demonstrating continued improvement in the clinical trial's primary and secondary endpoints with increased statistical confidence around prespecified endpoint results.
• Submitted proposed study design for PIX306 pivotal study to the newly created Division of Hematologic Products at FDA for review.
• 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.
• CTI's lead bisplatinate compound advances through process development toward preclinical/phase I testing. This product is a novel agent in the platinate class which is one of the most commonly used chemotherapeutic class.
• Received gross proceeds of $96.1 million in 2010 related to financing activities.
• Retired all convertible debt due in 2010.

For the quarter ended December 31, 2010, total net operating expenses decreased to $16.3 million compared to $26.2 million for the same period in 2009.  Net loss attributable to common shareholders was $34.1 million ($0.04 per share) for the quarter ended December 31, 2010 compared to a net loss attributable to common shareholders of $27.4 million ($0.05 per share) for the same period in 2009. 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.

For the year ended December 31, 2010, total net operating expenses were $75.1 million, compared to $81.6 million for the same period in 2009. The decrease in net operating expenses is mainly a result of a decrease in research and development and selling, general and administrative expenses in 2010. Additionally, in 2009 we recognized a $10.2 million gain on the sale of an asset and incurred $4.0 million in restructuring charges. Net loss attributable to common shareholders was $147.6 million ($0.22 per share), compared to a net loss attributable to common shareholders of $116.8 million ($0.25 per share) for the same period in 2009. 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 in 2010.  

CTI had approximately $22.6 million in cash and cash equivalents as of December 31, 2010.  This amount was before the receipt of $25.0 million in gross proceeds received from the Company's equity financing in January 2011.