BERKELEY HEIGHTS, N.J., Nov. 3, 2009 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company") announced today financial and operating results for the third quarter of 2009. The Company's net loss for the quarter was $3.1 million or $0.13 per share. This compared to a net loss of $17.6 million or $0.86 loss per share for the same period in 2008. As of September 30, 2009, the Company had $14.4 million in cash and cash equivalents.

"Our recent achievement of 30% one-year survival in two of the three randomized schedules of the Phase 2 study of sapacitabine as a treatment for elderly patients aged 70 and older with acute myeloid leukemia (AML) provides a strong rationale supporting the continued development of this novel agent," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are working with the FDA to design a registration study for sapacitabine in hematological malignancies. We continue to concentrate our efforts on advancing sapacitabine into Phase 3 development for AML and/or myelodysplastic syndromes (MDS) while preserving cash for the next twelve months. We are also looking forward to reporting in 2010 data from our ongoing Phase 2 studies of sapacitabine and seliciclib in lung cancer."

Recent Highlights:

  --  Reported 30% one-year survival from the Phase 2 sapacitabine
      trial in elderly patients with AML aged 70 and older in two
      out of three randomized schedules;
  --  Type A meeting granted by the FDA in the 4th quarter of 2009
      to discuss the design of Phase 3 registration studies in AML
      and/or MDS;
  --  Phase 3 study designs to be included in an upcoming submission
      requesting a Special Protocol Assessment or SPA;
  --  Raised $3.4 million in gross proceeds in a registered direct
      offering in July.

Key Financials:

Total revenues for the third quarter of 2009 were $0.2 million representing a decrease of 14% compared to $0.3 million for the same period in 2008. These revenues were mainly attributable to sales of the Xclair(r) and Numoisyn(r) products.

Total research and development (R&D) expenses in the third quarter of 2009 were $1.4 million, a 65% decrease as compared to $4.0 million in the third quarter of 2008. $1.6 million of the overall decrease was associated with the discontinuation of the Company's preclinical programs from the cost-containment measures implemented in September 2008 and June 2009. The Company recognized cost reductions of approximately $1.0 million in the third quarter 2009 as compared to the same period in 2008 due to the completion of patient enrollment in the APPRAISE trial in the third quarter of 2008.

Total selling, general and administrative expenses (SG&A) for the third quarter of 2009 were $2.2 million, a 32% decrease as compared to $3.2 million in the third quarter of 2008. The reduction in operating expenses in the third quarter of 2009 compared to the same period in 2008 is primarily attributable to the cost-containment measures implemented in September 2008 and June 2009 and the concentration of the Company's resources on the clinical development of sapacitabine.

Other operating expenses in the third quarter of 2008 also included a non-cash charge of $6.8 million for goodwill and intangibles impairment in respect of the acquisitions of Xcyte Therapies, Inc. and ALIGN following Cyclacel's annual test for impairment and restructuring costs.

Other income (expense) showed income of $0.2 million in the third quarter of 2009 as compared to expense of $4.1 million in the third quarter of 2008. The decrease in expense was primarily due to an unrealized foreign exchange loss of $4.8 million in the third quarter of 2008 compared to a $0.1 million foreign exchange gain in the same period in 2009 arising from intercompany loans with our wholly-owned subsidiaries due to the translation effects of the U.S. dollar against the British pound together with a change in the valuation of warrants and a reduction in interest income earned.

The net loss in the third quarter of 2009 was $3.1 million or $0.13 per share as compared to $17.6 million in the third quarter of 2008 or $0.86 per share.

Cyclacel also reported results of its operations for the nine months ended September 30, 2009. Total revenues for the nine months ended September 30, 2009 were $0.7 million representing an increase of 16% compared to $0.6 million for the same period in 2008. These revenues were mainly attributable to sales of the Xclair(R) and Numoisyn(R) products.

For the nine months ended September 30, 2009, R&D expenses were $7.2 million, a 54% decrease as compared to $15.7 million in the comparable period in 2008.

For the nine months ended September 30, 2009, SG&A expenses were $6.7 million, a 41% decrease as compared to $11.3 million in the comparable period in 2008.

The reduction in operating expenses in 2009 compared to 2008 is primarily attributable to the cost-containment measures implemented in September 2008 and June 2009 and the concentration of the Company's resources on the clinical development of sapacitabine.

Other operating expenses for the nine months ended September 30 2008 also included a non-cash charge of $6.8 million for goodwill and intangibles impairment in respect of the acquisitions of Xcyte and ALIGN and restructuring costs. For the nine months ended September 30, 2009, the Company recorded restructuring costs of $0.4 million.

Other income (expense) for the nine months ended September 30, 2009 showed an expense of $2.0 million as compared to $0.4 million for the same period in 2008. The 2009 loss included a non-operating expense of $1.7 million related to payments due under an agreement with Scottish Enterprise as a consequence of the headcount reductions implemented by the Company.