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Cyclacel Pharmaceuticals Reports Fourth Quarter And Full Year 2010 Financial Results

BERKELEY HEIGHTS, N.J., March 23, 2011 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company), announced today its financial results for the fourth quarter and year ended December 31, 2010. Cyclacel also provided an overview of its recent achievements and planned 2011 milestones.

The Company's net loss applicable to common stockholders for the fourth quarter of 2010 was $3.4 million or $0.07 per basic and diluted share, compared to a net loss applicable to common stockholders of $4.6 million or $0.19 per basic and diluted share for the fourth quarter of 2009. For the year ended December 31, 2010, the Company reported a net loss applicable to common stockholders of $19.7 million or $0.52 per basic and diluted share, compared to a net loss of $20.8 million or $0.94 per basic and diluted share for the year ended December 31, 2009.  As of December 31, 2010, cash and cash equivalents totaled $29.5 million.

"With the initiation of the SEAMLESS Phase 3 trial in January 2011, we believe that Cyclacel has moved closer to its goal of bringing sapacitabine to market as a front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel.

Fourth Quarter 2010 and Recent Highlights

  • Announced one-year survival data at the 2010 American Society of Hematology (ASH) annual meeting from a Phase 2 randomized trial of oral sapacitabine capsules for older patients with myelodysplastic syndromes refractory to the hypomethylating agents azacitidine and/or decitabine;
  • Announced topline survival data from the "APPRAISE", Phase 2b, randomized discontinuation, double-blinded, placebo-controlled study of oral seliciclib capsules as a third line or later treatment in patients with Non-Small Cell Lung Cancer (NSCLC) showing no difference in median progression free survival between the seliciclib and placebo arms, but an increase in median overall survival favoring seliciclib over placebo;
  • Announced publication of preclinical data demonstrating that sapacitabine works synergistically with HDAC inhibitors and also BRCA1/2 or PARP Inhibitors to induce tumor cell death;
  • Announced publication of preclinical data showing that cyclin E, a target of CYC065 and seliciclib, plays a major role in making HER2+ breast cancer resistant to trastuzumab;
  • Announced preclinical data at the 2010 ASH annual meeting demonstrating that CYC065 has anticancer activity at sub-micromolar concentrations against myeloma cells derived from patients, even in the presence of growth stimulatory effects of both cytokines and stromal cells in the bone marrow; and
  • Raised approximately $15.2 million in gross proceeds through a private placement.

Cyclacel's Milestones for 2011

  • Report Data Safety Monitoring Board (DSMB) review of safety data from the SEAMLESS Phase 3 AML study;
  • Present additional sapacitabine data in hematological malignancies both as a single agent and in combination with other anticancer agents;
  • Report topline Phase 2 sapacitabine data in NSCLC; and
  • Report patient biomarker analysis from the APPRAISE Phase 2b randomized discontinuation study of seliciclib in patients with NSCLC.

Fourth Quarter and Full Year 2010 Financial Results

For the fourth quarter of 2010, Cyclacel reported a net loss applicable to common stockholders of $3.4 million or $0.07 per basic and diluted share, compared to a net loss applicable to common stockholders of $4.6 million or $0.19 per basic and diluted share for the fourth quarter of 2009. Total research and development (R&D) expenses in the fourth quarter of 2010 were $1.4 million compared to $2.6 million in the fourth quarter of 2009. The decrease in R&D expenses in the fourth quarter of 2010 compared to the fourth quarter of 2009 was primarily related to costs associated with sapacitabine capsules for clinical trials which were manufactured in the fourth quarter of 2009. Total selling, general and administrative expenses (SG&A) amounted to $2.0 million in the fourth quarter of 2010 compared to $1.8 million for the fourth quarter of 2009. The increase is primarily due to increased stock-based compensation costs, consultancy and other professional costs.

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