|Cell Therapeutics: Turnaround Remains On Track|
|Thursday, 07 May 2009 17:56|
Company announced its 1Q09 results today, which included a 76% reduction of net loss and expected completion of the pixantrone NDA filing this June. Earlier this week, CTIC announced that pixantrone was made available through a compassionate use program in Europe on a named-patient basis for use in the treatment of aggressive non-Hodgkin's lymphoma (NHL) that has either relapsed or is refractory to standard treatment options.
CTIC achieved its objective thus far during 1H09, including the initiation of the rolling NDA submission for pixantrone, reducing net loss through cost cutting initiatives, raising gross proceeds of $44.3M, and cleaning up the Company's capital structure through the elimination of all previously issued preferred stock. CTIC is on target to complete the pixantrone NDA filing by June and
if the FDA grants a priority revew, the Company could receive an approval decision before year-end in December.
|In 2004, European approval for Roche's MabThera marked a major advance in the treatment of indolent non-Hodgkin's lymphoma (NHL), a disease that affects 1.5 million people worldwide. [See Video Below]|
|Animation of MabThera's effect on the human body|
The Company riased $23.8M through the sale of newly-issued preferred stock to a single institutional investor and
CTIC reduced its total net operating expenses by $21.8M to $6.6M for 1Q09, compared to $28.4M in the year-ago period due to the $10.2M one-time gain on the Zevalin joint venture sale along with a decline in R&D spending (down by 50% to $8M versus the year-ago period). Exlcuding the one-time gain, operating expenses still decreased by 41% from the year-ago period. The net loss attributable to common shareholders decreased by 76% or $41.5M to $13.1M or ($0.05) per share, compared to $54.6M or ($7.68) per share in the year-ago period.
Below are links to my previous articles on CTIC at BioMedReports.com:
1.) Cell Therapeutics: Down, but Not Out - 2/20/09
2.) A Resurgence in Cell Therapeutics - 4/2/09
3.) FDA, Clinical Trial Calendar Updates - 4/21/09
4.) FDA Calendar Updates - 5/5/09
Disclosure: No positions.