CTI receives positive reception from EMEA clinical experts for pixantrone MAA

Cell Therapeutics, Inc.Apr 28 2010

Cell Therapeutics, Inc. ("CTI" or the "Company") (Nasdaq and MTA: CTIC) today reported recent accomplishments and financial results for the first quarter ended March 31, 2010.

"It was encouraging to receive a positive reception from the European Medicinal Agency's (EMEA) clinical experts regarding our plans to submit a Marketing Authorization Application (MAA) for pixantrone in the European Union. Concurrently, we are working with leading lymphoma treatment practices across the U.S. and look forward to working with the U.S. Food and Drug Administration (FDA) on the design of a follow-on pivotal clinical trial in an effort to fulfill the requirements for marketing approval of pixantrone in the U.S.," said James A. Bianco, M.D., Chief Executive Officer of the Company. "We firmly believe that given the strength of evidence across clinically meaningful primary and secondary endpoints that pixantrone would fulfill a significant unmet medical need for patients who have no other approved options through establishing an expanded access program in the U.S. We remain committed to patients with non-Hodgkin's lymphoma (NHL) and in bringing this important new therapeutic option to them in as expeditious manner as possible."

Recent Highlights

• In preparation for its submission of a MAA for pixantrone in Europe, the Company met with the EMEA's Committee for Medicinal Products for Human Use (CHMP) clinical experts (rapporteurs) and the EMEA's medical reviewers. Discussion and feedback from those meetings was supportive of filing the MAA on the basis of the PIX301 trial. The Company expects to submit the MAA in the second half of 2010.
• The Company met with the EMEA's Pediatric Committee (the "PDCO") who recommended that the Company should submit an updated Pediatric Investigation Plan ("PIP") for pixantrone following discussions about the preclinical and clinical pixantrone data, including PIX301, and the desire to explore the potential benefits pixantrone may offer to children with hematologic cancers. The Company expects to submit a revised PIP to the EMEA by the end of the second quarter of 2010.
• The Company successfully raised gross proceeds of $30 million in January 2010 and additional gross proceeds of $20 million in April 2010 through financings with institutional investors.
• The Company implemented a cost reduction plan in April 2010, aimed at reducing planned operating expenses that are expected to result in savings of approximately $16 million in 2010. The Company's total projected operating expenses, excluding equity based compensation, are expected to be approximately $60 million in 2010, which is a 21% reduction from its previously projected estimates. As a result of reducing these expenses, the Company is targeting an average net operating burn rate of approximately $4.4 million per month starting in the second quarter of 2010.

For the quarter ended March 31, 2010, total net operating expenses were $25.8 million compared to $6.6 million for the same period in 2009. The increase in total net operating expenses is mainly a result of expenses related to preparation for the potential pixantrone regulatory approval in the U.S. and Europe, a $7.8 million non-cash equity-based compensation expense recognized in 2010, and a $10.2 million gain on the sale of the Company's  investment in the Zevalin joint venture that was recognized in 2009. Research and development expenses decreased to $7.4 million compared to $8.0 million for the same period in 2009. Net loss attributable to common shareholders was $44.2 million ($0.07 per share) for the quarter ended March 31, 2010 compared to a net loss attributable to common shareholders of $13.1 million ($0.05 per share) for the same period in 2009.

CTI had approximately $41.5 million in cash and cash equivalents as of March 31, 2010. This does not include approximately $18.5 million in net proceeds the Company received in April 2010 in connection with a registered offering of preferred stock and warrants.