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Nature of Operations and Basis of Presentation
9 Months Ended
Sep. 30, 2011
Nature of Operations and Basis of Presentation [Abstract] 
NATURE OF OPERATIONS AND BASIS OF PRESENTATION
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Nature of Operations
Cyclacel Pharmaceuticals, Inc. (‘‘Cyclacel’’ or the ‘‘Company’’) is a development-stage biopharmaceutical company dedicated to the development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious diseases. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a portfolio of commercial products and a development pipeline of novel drug candidates.
Cyclacel’s clinical development priorities are focused on sapacitabine in the following indications:
  •   Acute myeloid leukemia, or AML, in the elderly;
 
  •   Myelodysplastic syndromes, or MDS; and
 
  •   Non-small cell lung cancer, or NSCLC.
On January 11, 2011, the Company opened enrollment of the SEAMLESS pivotal Phase 3 trial for the Company’s sapacitabine oral capsules as a front-line treatment of elderly patients aged 70 years or older with newly diagnosed AML who are not candidates for intensive induction chemotherapy under a Special Protocol Assessment, or SPA, reached with the U.S. Food & Drug Administration, or FDA. SEAMLESS is a randomized study against an active control drug with the primary objective of demonstrating an improvement in overall survival. In October 2011, the independent Data Safety Monitoring Board, or DSMB, of SEAMLESS recommended that the study should enter the randomized stage as planned and, following this recommendation, the Company has implemented an improvement in the SEAMLESS trial design, converting it into a 2-arm from a 3-arm design. The Company received written confirmation from the FDA that, following the modification in the trial design, the previously agreed SPA agreement remains valid.
The Company has advanced two additional product candidates, seliciclib in Phase 2 for NSCLC and nasopharyngeal cancer or NPC, and CYC116 in Phase 1 clinical development. The combination of sapacitabine with seliciclib is also being evaluated in a Phase 1 clinical trial. The Company will determine the feasibility of pursuing further development and/or partnering these assets depending on the availability of funding and further clinical data. In addition, the Company markets directly in the United States Xclair® Cream for radiation dermatitis and Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia.
As a development stage enterprise, substantially all efforts of the Company to date have been devoted to performing research and development, conducting clinical trials, developing and acquiring intellectual property and raising capital.
Basis of Presentation
The condensed consolidated balance sheet as of September 30, 2011, the condensed consolidated statements of operations for the three and nine months ended September 30, 2011 and 2010 and for the period from August 13, 1996 (inception) to September 30, 2011, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2011 and 2010 and for the period from August 13, 1996 (inception) to September 30, 2011, and related disclosures contained in the accompanying notes are unaudited. The condensed consolidated balance sheet as of December 31, 2010 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2010 filed with the Securities and Exchange Commission (“SEC”). The condensed consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC; accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments, necessary to present fairly the condensed consolidated balance sheet as of September 30, 2011, the results of operations for the three and nine months ended September 30, 2011 and 2010 and for the period from August 13, 1996 (inception) to September 30, 2011, and the consolidated statements of cash flows for the nine months ended September 30, 2011 and 2010 and for the period from August 13, 1996 (inception) to September 30, 2011, have been made. The interim results for the three and nine months ended September 30, 2011 are not necessarily indicative of the results to be expected for the year ending December 31, 2011 or for any other year. The condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010 filed with the SEC.
Recent Developments
July 2011 Underwritten Offering
On July 7, 2011, the Company closed an underwritten offering for an aggregate of 7,617,646 units, at an offering price of $1.36 per unit, for gross proceeds of approximately $10.4 million. Each unit consists of (i) one share of common stock and (ii) a five-year warrant to purchase 0.5 of a share of common stock at an exercise price of $1.36 per share, exercisable beginning six months after the date of issuance, or after January 7, 2012. The shares of common stock and warrants were immediately separable and were issued separately such that no units were issued. The net proceeds, after underwriting discounts and commissions and other fees and expenses, were approximately $9.3 million.
NASDAQ Notification
On September 16, 2011, the Company received a NASDAQ Staff Deficiency Letter indicating the Company was not in compliance with the minimum bid price requirement for continued listing on the NASDAQ exchange because the bid price for the Company’s common stock had closed under $1.00 for 30 consecutive business days. The Company may achieve compliance if, at any time before March 14, 2012, the bid price of its common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days. Failure to achieve compliance may result in the removal of Company’s common stock listing on the NASDAQ exchange.
Preferred Stock Dividend
On October 6, 2011, the Board of Directors (the “Board”) decided not to declare the quarterly cash dividend on the Company’s 6% Convertible Exchangeable Preferred Stock (“Preferred Stock”) with respect to the third quarter of 2011 that would have otherwise been payable on November 1, 2011.