BERKELEY HEIGHTS, N.J., March 29, 2012 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC - News) (Nasdaq:CYCCP - News) ("Cyclacel" or the "Company") announced today its financial results and business highlights for the fourth quarter and full year 2011. The Company's net loss applicable to common stockholders for the fourth quarter of 2011 was $3.8 million, or $0.07 per basic and diluted share, compared to a net loss applicable to common stockholders of $3.4 million, or $0.07 per basic and diluted, share for the fourth quarter of 2010. For the year ended December 31, 2011, the Company reported a net loss applicable to common stockholders of $16.0 million, or $0.32 per basic and diluted share, compared to a net loss of $19.7 million or $0.52 per basic and diluted share, for the year ended December 31, 2010. As of December 31, 2011, cash and cash equivalents totaled $24.4 million.
"We were pleased in the fourth quarter of 2011 to achieve our major objective of opening the randomized stage of SEAMLESS, a registration-directed, Phase 3 study of sapacitabine in elderly patients with acute myeloid leukemia (AML)," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The randomized stage was initiated following a favorable review of the available data from a pilot Phase 1/2 study and the lead-in part of SEAMLESS by the independent monitoring committee as provided in our Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA). Beyond SEAMLESS, we reported encouraging clinical results showing that sapacitabine is active in patients with myelodysplastic syndromes (MDS) after treatment failures of front-line hypomethylating agents and in patients with solid tumors, including those found to be carriers of BRCA mutations."
Fourth Quarter 2011 and Recent Highlights
Cyclacel's Key Milestones for 2012
Fourth Quarter and Full Year 2010 Financial Results
For the fourth quarter of 2011, Cyclacel reported a net loss applicable to common stockholders of $3.8 million, or $0.07 per basic and diluted share, compared to a net loss applicable to common stockholders of $3.4 million, or $0.07 per basic and diluted share, for the fourth quarter of 2010. Total research and development (R&D) expenses in the fourth quarter of 2011 were $2.2 million compared to $1.4 million in the fourth quarter of 2010. The increase in R&D expenses in the fourth quarter of 2011 compared to the fourth quarter of 2010 was primarily related to costs associated with the SEAMLESS Phase 3 clinical trial. Total selling, general and administrative expenses (SG&A) amounted to $1.6 million in the fourth quarter of 2011 compared to $2.0 million for the fourth quarter of 2010. The decrease is primarily due to reduced stock-based compensation costs, consultancy and other professional costs.
For the year ended December 31, 2011, Cyclacel reported a net loss applicable to common stockholders of $16.0 million, or $0.32 per basic and diluted share, compared to a net loss applicable to common stockholders of $19.7 million, or $0.52 per basic and diluted share, for the year ended December 31, 2010. Total product revenues for the years ended December 31, 2011 and 2010 were $0.7 million and $0.6 million, respectively. In 2010, the Company recorded higher than anticipated product returns of approximately $0.2 million, related to expiring product with a two-year shelf-life that were previously sold into the marketplace. Total R&D expenses for the year ended December 31, 2011 were $9.2 million compared to $6.4 million for the year ended December 31, 2010. The $2.8 million increase in expenditures was primarily due to $1.6 million of contractual expenses, resulting from an achievement of a milestone triggered by the opening of enrollment in our SEAMLESS Phase 3 trial, pursuant to our license agreement with Daiichi Sankyo under which we licensed certain patent rights for sapacitabine, and an increase in sapacitabine related clinical trial expenses.
Total SG&A expenses for the year ended December 31, 2011 were $7.5 million compared to $10.1 million for the year ended December 31, 2010. The decrease was primarily due to decreased compensation costs, stock-based compensation charges and rent for our former Bothell, Washington facility, the lease for which terminated in December 2010. Total other income and expense, net, for the year ended December 31, 2011 was $0.6 million of income, compared to $0.4 million of expense for the same period in 2010. The net loss applicable to common stockholders for the year ended December 31, 2011, was $16.0 million, or $0.32 per basic and diluted share, compared to net loss applicable to common stockholders of $19.7 million, or $0.52 per basic and diluted share for the same period in 2010. The net loss for the year ended December 31, 2010 included a $3.5 million non-cash expense, with respect to a deemed dividend on convertible exchangeable preferred shares when these shares were converted into common stock during 2010.
Cash and cash equivalents totaled $24.4 million as of December 31, 2011. Cyclacel expects that its cash resources are sufficient to meet anticipated short-term working capital needs and fund on-going sapacitabine clinical trials for at least the next twelve months.
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Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2011 Financial Results