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CTI Readies Pixuvri® European Launch and Start of Pacritinib Phase 3 Trial

Published: Monday, December 31, 2012
Last Updated: Monday, December 31, 2012
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European launch of Pixuvri® targeted for Q4 2012.

Cell Therapeutics, Inc. has reported financial results and recent accomplishments for the second quarter of 2012.

Recent Company Highlights

• European Commission grants conditional marketing authorization for Pixuvri as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL").
• Steven E. Benner, M.D., M.H.S. named new Executive Vice President and Chief Medical Officer.
• Closed the acquisition of pacritinib, a highly selective JAK2 inhibitor, scheduled to enter phase 3 clinical trial for treatment of patients with myelofibrosis ("MF") in Q4 2012.
• Targeting cut in net operating burn rate from an average of $6.5 million per month to an average of $4.5 million per month for remainder of 2012 and focusing on commercial launch of Pixuvri and advancing phase 3 programs.

"Based on in-market research among more than 250 lymphoma specialists in the five major market countries in the European Union ("EU"), we are encouraged by the interest and potential adoption of Pixuvri for treatment," stated James A. Bianco, M.D., President and CEO of CTI.

Bianco continued, "We believe we can present an argument for Pixuvri to provide fair pricing reimbursement in an effort to address the commercial potential of Pixuvri in the E.U. On the heels of our projected fourth quarter launch of Pixuvri in the E.U., we expect to start pivotal studies of our recent JAK2 product acquisition, pacritinib. In the meantime, we are also advancing tosedostat toward its phase 3 clinical trial."

Financial Results

For the quarter ended June 30, 2012, total operating expenses were $49.4 million compared to $16.9 million for the same period in 2011. The increase is predominantly due to an acquired in-process research and development expense of $29.1 million relating primarily to the acquisition of pacritinib from S*BIO Pte Ltd. ("S*BIO"), in addition to equity-based compensation and expenses related to preparation for commercialization of Pixuvri in the E.U.

Net loss attributable to common shareholders was $58.6 million ($0.28 per share) for the quarter ended June 30, 2012 compared to a net loss attributable to common shareholders of $22.5 million ($0.14 per share) for the same period in 2011.

The increase in net loss attributable to CTI's common shareholders is primarily due to an increase in non-cash deemed dividends on preferred stock issuances and operating expenses, which includes the acquisition of pacritinib from S*BIO.

For the six months ended June 30, 2012, total operating expenses were $67.5 million compared to $37.0 million for the same period in 2011. Net loss attributable to common shareholders was $76.0 million ($0.37 per share) for the six months ended June 30, 2012 compared to a net loss attributable to common shareholders of $73.5 million ($0.47 per share) for the same period in 2011. The increase in net loss attributable to CTI's common shareholders is primarily due to an increase in total operating expenses, which includes the acquisition of pacritinib from S*BIO.

CTI had approximately $14.8 million in cash and cash equivalents as of June 30, 2012. This amount was before the receipt of $15 million in gross proceeds received from the sale of CTI's Series 15-2 convertible preferred stock and warrants in July 2012 as part of a $35 million financing.

As previously announced, CTI completed the first closing of $20 million of Series 15-1 convertible preferred stock and warrants in May 2012.

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