Cell Therapeutics’ (CTIC) fourth quarter loss per share came in at 5 cents, lower than the Zacks Consensus Estimate of 3 cents and a loss of 25 cents (prior to adjustment 52 cents) reported in the year-ago period. Although the net loss after adjustments has increased, the company has been able to reduce its loss per share due to huge equity dilution

Its number of shares has increased to 570.63 million compared to 80 million in the year-ago period. For the full year of 2009, the company reported a loss per share (after adjustments) of 26 cents compared to a loss of $3.88 in the year-ago quarter. 

Cell Therapeutics does not have any marketed product at present; it derives revenues primarily from licenses and contracts. The company recorded revenues of $0.02 million during the reported quarter compared to $2.5 million in the fourth quarter of 2008. Revenues in the year-ago period consisted of product sales of Zevalin, which was sold by the company to Spectrum Pharmaceuticals in 2009. 

Operating expenses during the reported quarter increased 27% to $26.2 million driven by a 69% increase in SG&A expenses. We believe the increase in SG&A expenses is related to preparations for the launch of pixantrone in 2010. 

Pixantrone is one of the lead pipeline candidates, which is currently under US Food and Drug Administration (FDA) review for the treatment of non-Hodgkin’s lymphoma (NHL). However, the path to approval is not smooth. The drug was supposed to be reviewed by the FDA’s Oncologic Drugs Advisory Committee in a meeting scheduled for Feb 10, which has been postponed due to bad weather conditions in the Washington region. 

The next date for the meeting is yet to be declared. In addition to the postponement, in an analysis the FDA reviewers have raised various issues related to the study design. A final decision on pixantrone is expected by April 23.
 
In July 2009, Cell Therapeutics initiated the process of obtaining marketing approval for pixantrone in Europe and received orphan drug status from the European Medicines Agency.
 
Cell Therapeutics exited 2009 with $37.8 million in cash and cash equivalents including securities available for sale. However, this does not include $28.2 million proceeds received by the company earlier this year associated with an offering of preferred stock and warrants. We have a Neutral recommendation on the stock.
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