Cell Therapeutics Reports 76% Decrease in First Quarter 2009 Net Loss Attributable to Common Shareholders; Completion of Pixantrone NDA Submission on Track for Second Quarter 2009
SEATTLE, May 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reported recent accomplishments and financial results for the quarter ended March 31, 2009.
"Our focus for the first half of 2009 was to initiate and complete the NDA submission for pixantrone while we implemented final steps in our cost cutting efforts and raised much needed operating capital on the least dilutive terms possible -- all while cleaning up the Company's capital structure," said James A. Bianco, M.D., CEO of CTI. "We are pleased with our results as reflected in our first quarter financials. We have cut our net operating losses attributable to common shareholders by 76%, raised gross proceeds of $44.3 million in 2009 and eliminated all of our outstanding preferred stock, while staying on track to complete the NDA submission for pixantrone in June 2009."
Recent Highlights
Initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone and are targeting completing this NDA submission in June 2009, which if granted priority review could lead to an FDA approval decision as early as December 2009.
Pixantrone Phase III study results to be presented at the American Society of Clinical Oncology Conference on June 1, 2009.
Pixantrone is now available through a named-patient program in Europe.
Raised $23.8 million through the sale of Series 1 Preferred Stock to a single institutional investor and upon the exercise of the associated common stock warrants. The investor subsequently converted 100% of the Series 1 Preferred Stock to common stock. CTI has no remaining issued or outstanding preferred stock.
Received $20.5 million in gross proceeds in 2009 from Spectrum Pharmaceuticals, Inc. associated with the initial divestiture of Zevalin to the joint venture with Spectrum and the subsequent sale of CTI's remaining interest in this joint venture (total $28.0 million received to date with up to an additional $3.5 million owed).
Total net operating expenses decreased $21.8 million, or 77%, to $6.6 million for the quarter ended March 31, 2009 compared to $28.4 million for the same period in 2008 as a result of a $10.2 million one-time gain on the sale CTI's investment in the Zevalin joint venture coupled with a decrease in research and development expenses. Excluding the one-time gain, total net operating expenses decreased 41% over the same period last year. Research and development expenses decreased 7.9 million, or 50%, to $8.0 million for the current quarter compared to $15.9 million for the same period in 2008 as the result of cost reduction initiatives and expenses related to our clinical trial programs. Net loss attributable to common shareholders decreased $41.5 million, or 76%, to $13.1 million ($0.05 per share) for the quarter ended March 31, 2009, compared to $54.6 million ($7.68 per share) for the comparable period in 2008. The reduction in net loss per share is primarily due to an increase in the number of shares outstanding, reduction of expenses and gain on sale of CTI's investment in the Zevalin joint venture.
CTI had approximately $0.7 million in cash and cash equivalents, securities available-for-sale, and interest receivable as of March 31, 2009. In addition, on April 3, 2009, CTI received $6.5 million in gross proceeds from Spectrum associated with the sale of its interest in the Zevalin joint venture and expects to receive up to an additional $3.5 million upon the completion of Spectrum's payment obligations to CTI. In April 2009 CTI received $20.0 million in gross proceeds upon the sale of its Series 1 Preferred Stock and an additional $3.8 million upon the exercise of the associated common stock warrants in May 2009.
Net een paar interessante reacties gelezen op google finance. Toekomst kan idd zeer rooskleurig zijn.
Btw, in die commentaren gevonden: VNDA, 800% omhoog in after hours nu. Das wel hard dat FDA zo'n grote impact heeft op die bedrijven. 
ad: maar ben al zeer content.