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NATURE OF OPERATIONS AND BASIS OF PRESENTATION
 3 Months Ended
Mar. 31, 2013
NATURE OF OPERATIONS AND BASIS OF PRESENTATION  
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 is focused on delivering leading edge therapeutic management of cancer patients based on a clinical development pipeline of novel drug candidates.

 

Cyclacel’s clinical development priorities are focused on sapacitabine, an orally available, cell cycle modulating nucleoside analogue.

 

Sapacitabine is being evaluated in the SEAMLESS Phase 3 trial being conducted under a Special Protocol Assessment (“SPA”) agreement with the US Food and Drug Administration (“FDA”) for the front-line treatment of acute myeloid leukemia (“AML”) in the elderly and in Phase 2 studies for AML, myelodysplastic syndromes (“MDS”), non-small cell lung cancer (“NSCLC”) and chronic lymphocytic leukemia. Sapacitabine is also being evaluated in a Phase1 study in combination with seliciclib, our second clinical candidate, in patients with solid tumors. The U.S. Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, have designated sapacitabine as an orphan drug for the treatment of both AML and MDS.

 

The Company has ongoing clinical programs with seliciclib, an oral, highly selective inhibitor of CDK enzymes, in NSCLC and nasopharyngeal cancer (“NPC”) and once data becomes available and is reviewed, the Company will determine the feasibility of pursuing further development and/or partnering these assets.

 

Our second generation CDK inhibitor, CYC065, is an oral, highly selective inhibitor of CDK enzymes. CYC065 has been shown to have increased anti-proliferative potency and improved pharmaceutical properties compared to seliciclib. Investigational new drug or IND-enabling studies with CYC065 are in progress supported by a $1.9 million grant from the UK Government’s Biomedical Catalyst.

 

In addition to these development programs, the Company has allocated limited resources to other programs allowing the Company to maintain and build on its core competency in cell cycle biology and related drug discovery, including its polo-like kinase, or PLK, inhibitor program, the Company discovered CYC140, a potent and selective, orally-available, small molecule inhibitor of PLK1, a kinase active during cell division, targeting the mitotic phase of the cell cycle.  In the Company’s Aurora kinase inhibitor program, CYC116, an internally-discovered, orally-available, small molecule inhibitor of Aurora kinases A and B and Vascular Endothelial Growth Factor Receptor 2, or VEGFR2, has completed a multicenter Phase 1 trial. PLK and Aurora are cancer drug targets discovered by Professor David Glover, the Company’s Chief Scientist.

 

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, raising capital and recruiting and training personnel.

 

Capital Resources

 

The Company’s existing capital is not sufficient to complete the development and commercialization of any of its product candidates.

 

Basis of Presentation

 

The condensed consolidated balance sheet as of March 31, 2013, the condensed consolidated statements of operations, comprehensive loss, and cash flows for the three months ended March 31, 2013 and 2012 and the period from August 13, 1996 (inception) to March 31, 2013, and all related disclosures contained in the accompanying notes are unaudited. The condensed consolidated balance sheet as of December 31, 2012 is derived from the audited consolidated financial statements included in the 2012 Annual Report on Form 10-K 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 March 31, 2013, and the results of operations, comprehensive loss and cash flows for the three months ended March 31, 2013 and 2012, have been made. The interim results for the three months ended March 31, 2013 are not necessarily indicative of the results to be expected for the year ending December 31, 2013 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 for the year ended December 31, 2012, included in the Company’s Annual Report on Form 10-K filed with the SEC.

 

Recent Developments

 

Preferred Stock Dividend

 

On January 11, 2013, the Company’s Board of Directors (the “Board”) declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s 6% Convertible Exchangeable Preferred Stock (“Preferred Stock”) with respect to the fourth quarter of 2012. The Company paid the dividend on February 1, 2013 to holders of record of the Preferred Stock as of the close of business on January 22, 2013.

 

Preferred Exchanges

 

During the first quarter of 2013, the Company settled three separate Securities Exchange Agreements with certain stockholders pursuant to which the Company agreed to issue an aggregate of 1,513,653 shares of its common stock to the preferred stockholders in exchange for their delivery to the Company an aggregate of 792,460 shares of the Company’s Preferred Stock. The Company issued 1,465,480 shares of common stock in excess of the number of shares the Preferred Stock was convertible into under the original conversion terms. Accordingly, deemed dividends in the amount of approximately $8.4 million were recorded during the first quarter of 2013. As a result of these transactions, a total of 420,862 shares of Preferred Stock remain outstanding as of March 31, 2013.

 

Stock Purchase Agreement

 

During the first quarter of 2013, the Company sold 650,000 shares of its common stock to Aspire Capital Fund, LLC (“Aspire”) under the Common Stock Purchase Agreement in consideration for aggregate proceeds of approximately $3.4 million.