CTI fourth quarter net loss decreases to $17.9 million

Cell Therapeutics, Inc.Mar 7 2012

Cell Therapeutics, Inc. ("CTI" or the "Company") (NASDAQ and MTA: CTIC) today reported financial results and recent accomplishments for the fourth quarter and year ended December 31, 2011.

Fourth Quarter and Year End Results

For the quarter ended December 31, 2011, total net operating expenses were $9.9 million compared to $16.3 million for the same period in 2010. Net loss attributable to common shareholders was $17.9 million ($0.09 per share) for the quarter ended December 31, 2011 compared to a net loss attributable to common shareholders of $34.1 million ($0.27 per share) for the same period in 2010. The decrease in net loss attributable to our common shareholders is mainly due to a $11.0 million gain related to a litigation settlement and decrease in non-cash deemed dividends on preferred stock issuances in the quarter ended December 31, 2011.

For the year ended December 31, 2011, total net operating expenses declined to $62.2 million, which included an upfront payment of $5.0 million related to the licensing of tosedostat from Chroma Therapeutics Ltd., compared to $75.1 million for the same period in 2010.  Net loss attributable to common shareholders was $121.1 million ($0.71 per share), compared to a net loss attributable to common shareholders of $147.6 million ($1.29 per share) for the same period in 2010. For the year ended December 31, 2011, the decrease in net loss attributable to common shareholders is mainly due to a decrease in selling, general and administrative expenses, a $11.0 million gain related to a litigation settlement and decrease in non-cash deemed dividends on preferred stock issuances.  

CTI had approximately $47.1 million in cash and cash equivalents as of December 31, 2011.

Recent Highlights

In February 2012, the European Medicines Agency's ("EMA") Committee for Human Medicinal Products ("CHMP") granted a positive opinion for conditional approval of CTI's marketing authorization application (the "MAA") for Pixuvri to treat adult patients with multiple relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL").

"We expect that in the next few months the European Commission should adopt the CHMP's opinion for this unmet medical need and for the first time patients with multiple relapsed or refractory aggressive NHL in the E.U. will have an approved therapy to treat their disease," stated James A. Bianco, M.D., CEO of Cell Therapeutics, Inc. "We are working with consultants on developing a staffing, resource and product launch plan for Europe so upon marketing authorization and national reimbursement approvals, we can be in a position to bring Pixuvri to these patients.  With approximately 12,000 potential patients each year in the EU(1) this represents an attractive initial commercial opportunity for CTI."

"At the same time, we are moving our other late stage product candidates forward including a March meeting with the U.S. Food and Drug Administration for the phase 3 tosedostat trial in myelodysplastic syndrome ("MDS"), a precursor of acute myeloid leukemia ("AML"). Additionally a multi-center, phase 2 study with OPAXIO treating malignant brain cancer is underway based on encouraging results from the previous study in this disease. With the potential commercial launch of Pixuvri, coupled with the successful in-licensing of tosedostat, we continue to explore additional novel clinical stage compounds to expand our hematologic cancer product pipeline," Bianco added.

• EMA's CHMP granted a positive opinion for conditional approval of CTI's MAA for Pixuvri as monotherapy for the treatment of adult patients with multiple relapsed or refractory aggressive NHL.
• The final OPAL phase 2 results of tosedostat, which demonstrated significant response rates in elderly patients with refractory or relapsed AML, were presented in an oral session at the American Society of Hematology's Annual Meeting in 2011. CTI believes that encouraging survival rates in secondary AML provides rationale for phase 3 study in relapsed or refractory MDS.  
• Retired all convertible debt.