Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Mar. 27, 2015 | Jun. 30, 2014 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Cyclacel Pharmaceuticals, Inc. | ||
Entity Central Index Key | 1130166 | ||
Trading Symbol | cycc | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Current Fiscal Year End Date | -19 | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Common Stock, Shares Outstanding | 34,388,485 | ||
Entity Public Float | $68,370,466 | ||
Document Type | 10-K | ||
Document Period End Date | 31-Dec-14 | ||
Amendment Flag | FALSE | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $24,189 | $31,146 |
Prepaid expenses and other current assets | 4,640 | 3,388 |
Current assets of discontinued operations | 171 | 639 |
Total current assets | 29,000 | 35,173 |
Property, plant and equipment (net) | 387 | 275 |
Long-term assets of discontinued operations | 72 | |
Total assets | 29,387 | 35,520 |
Current liabilities: | ||
Accounts payable | 2,792 | 2,545 |
Accrued and other current liabilities | 4,626 | 4,431 |
Other liabilities measured at fair value | 20 | |
Current liabilities of discontinued operations | 75 | 260 |
Total current liabilities | 7,493 | 7,256 |
Other liabilities | 206 | 241 |
Total liabilities | 7,699 | 7,497 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2013 and 2014; 335,273 shares issued and outstanding at December 31, 2013 and 2014. Aggregate preference in liquidation of $3,989,749 at December 31, 2013 and 2014. | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2013 and 2014; 19,369,332 and 23,199,469 shares issued and outstanding at December 31, 2013 and 2014, respectively. | 23 | 19 |
Additional paid-in capital | 330,962 | 317,543 |
Accumulated other comprehensive income (loss) | -480 | -109 |
Accumulated deficit | -308,817 | -289,430 |
Total stockholders' equity | 21,688 | 28,023 |
Total liabilities and stockholders' equity | $29,387 | $35,520 |
CONSOLIDATED_BALANCE_SHEETS_Pa
CONSOLIDATED BALANCE SHEETS (Parentheticals) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 335,273 | 335,273 |
Preferred stock, shares outstanding | 335,273 | 335,273 |
Preferred stock, liquidation preference value (in dollars) | $3,989,749 | $3,989,749 |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 23,199,469 | 19,369,332 |
Common stock, shares outstanding | 23,199,469 | 19,369,332 |
CONSOLIDATED_STATEMENTS_OF_OPE
CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 12 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Revenues: | ||
Grant revenue | $1,734 | $1,084 |
Total revenues | 1,734 | 1,084 |
Operating expenses: | ||
Research and development | 18,277 | 11,277 |
General and administrative | 5,894 | 7,781 |
Total operating expenses | 24,171 | 19,058 |
Operating loss | -22,437 | -17,974 |
Other income (expense): | ||
Change in valuation of financial instruments associated with stock purchase agreement | -342 | -98 |
Change in valuation of Economic Rights | 570 | |
Change in valuation of liabilities measured at fair value | 20 | |
Foreign exchange gains | -10 | 62 |
Interest income | 6 | 13 |
Other income, net | 114 | 5,547 |
Total other income (expense), net | -212 | 6,094 |
Loss from continuing operations before taxes | -22,649 | -11,880 |
Income tax benefit | 3,243 | 1,670 |
Net loss from continuing operations | -19,406 | -10,210 |
Discontinued operations: | ||
Income from discontinued operations | 29 | 91 |
Income tax on discontinued operations | -10 | -34 |
Net income from discontinued operations | 19 | 57 |
Net loss | -19,387 | -10,153 |
Deemed dividend on convertible exchangeable preferred shares | -9,027 | |
Dividend on convertible exchangeable preferred shares | -200 | -298 |
Net loss applicable to common shareholders | ($19,587) | ($19,478) |
Basic and diluted earnings per common share: | ||
Net loss per share, continuing operations - basic and diluted (in dollars per share) | ($0.89) | ($1.29) |
Net income per share, discontinued operations - basic and diluted (in dollars per share) | $0 | $0 |
Net loss per share - basic and diluted (in dollars per share) | ($0.89) | ($1.28) |
Weighted average common shares outstanding (in shares) | 21,955,381 | 15,158,225 |
CONSOLIDATED_STATEMENTS_OF_COM
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss from continuing operations | ($19,406) | ($10,210) |
Net income from discontinued operations, net of tax | 19 | 57 |
Net loss | -19,387 | -10,153 |
Translation adjustment | 8,020 | -2,908 |
Unrealized foreign exchange gain (loss) on intercompany loans | -8,391 | 2,751 |
Comprehensive loss | ($19,758) | ($10,310) |
CONSOLIDATED_STATEMENTS_OF_STO
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (USD $) | Preferred Stock | Common stock | Additional paid-in capital | Accumulated other comprehensive income/(loss) | Accumulated Deficit | Total |
In Thousands, except Share data, unless otherwise specified | ||||||
Balance at Dec. 31, 2012 | $1 | $9 | $280,211 | $48 | ($270,250) | $10,019 |
Balance (in shares) at Dec. 31, 2012 | 1,213,142 | 8,686,484 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issue of common stock for cash in an underwritten public offering / on registered direct offering, net of expenses | 6 | 19,000 | 19,006 | |||
Issue of common stock for cash in an underwritten public offering / on registered direct offering, net of expenses (in shares) | 6,833,334 | |||||
Issue of common stock on share purchase agreement | 2 | 9,124 | 9,126 | |||
Issue of common stock on share purchase agreement (in shares) | 2,133,401 | |||||
Issue of shares in lieu of cash bonus | 181 | 181 | ||||
Issue of shares in lieu of cash bonus (in shares) | 31,642 | |||||
Preferred stock conversion | -1 | 2 | 9,026 | -9,027 | ||
Preferred stock conversion (in shares) | -877,869 | 1,684,471 | ||||
Stock-based compensation | 357 | 357 | ||||
Preferred stock dividends | -356 | -356 | ||||
Unrealized foreign exchange on intercompany loans | 2,751 | 2,751 | ||||
Translation adjustment | -2,908 | -2,908 | ||||
Loss for the year | -10,153 | -10,153 | ||||
Balance at Dec. 31, 2013 | 19 | 317,543 | -109 | -289,430 | 28,023 | |
Balance (in shares) at Dec. 31, 2013 | 335,273 | 19,369,332 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issue of common stock for cash in an underwritten public offering / on registered direct offering, net of expenses | 3 | 9,286 | 9,289 | |||
Issue of common stock for cash in an underwritten public offering / on registered direct offering, net of expenses (in shares) | 2,857,143 | |||||
Issue of common stock on share purchase agreement | 1 | 3,131 | 3,132 | |||
Issue of common stock on share purchase agreement (in shares) | 950,000 | |||||
Stock-based awards exercised | -21 | -21 | ||||
Stock-based awards exercised (in shares) | 22,994 | |||||
Stock-based compensation | 1,223 | 1,223 | ||||
Preferred stock dividends | -200 | -200 | ||||
Unrealized foreign exchange on intercompany loans | -8,391 | -8,391 | ||||
Translation adjustment | 8,020 | 8,020 | ||||
Loss for the year | -19,387 | -19,387 | ||||
Balance at Dec. 31, 2014 | $23 | $330,962 | ($480) | ($308,817) | $21,688 | |
Balance (in shares) at Dec. 31, 2014 | 335,273 | 23,199,469 |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Operating activities: | ||
Net loss | ($19,387) | ($10,153) |
Change in valuation of liabilities at fair value | -20 | -1,120 |
Change in valuation of financial instruments associated with stock purchase agreement | 342 | 98 |
Depreciation | 174 | 70 |
Gain on sale of patents | -5,500 | |
Stock-based compensation | 1,223 | 357 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | -1,700 | -1,201 |
Accounts payable and other current liabilities | 666 | -750 |
Net cash used in operating activities | -18,702 | -18,199 |
Investing activities: | ||
Purchase of property, plant and equipment | -309 | -208 |
Minimum royalty payments received from termination of ALIGN license agreement | 384 | 396 |
Proceeds from sale of patents | 5,500 | |
Net cash provided by investing activities | 75 | 5,688 |
Financing activities: | ||
Proceeds from issuance of common stock and warrants, net of issuance costs | 12,421 | 27,637 |
Proceeds from the exercise of stock options and warrants, net of issuance costs | -21 | |
Payment of preferred stock dividend | -200 | -305 |
Net cash provided by financing activities | 12,200 | 27,332 |
Effect of exchange rate changes on cash and cash equivalents | -530 | -87 |
Net decrease in cash and cash equivalents | -6,957 | 14,734 |
Cash and cash equivalents, beginning of period | 31,146 | 16,412 |
Cash and cash equivalents, end of period | 24,189 | 31,146 |
Cash received during the period for: | ||
Interest | 6 | 12 |
Taxes | 1,811 | 970 |
Schedule of non-cash transactions: | ||
Issuance of Ordinary shares in lieu of cash bonus | $181 |
Organization_of_the_Company
Organization of the Company | 12 Months Ended | ||
Dec. 31, 2014 | |||
Organization of the Company | |||
Organization of the Company | 1 | Organization of the Company | |
Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or “the Company”), a biopharmaceutical company, is a pioneer in the field of cell cycle biology with a vision to improve patient healthcare with orally available innovative medicines. Cyclacel’s goal is to develop and commercialize small molecule drugs that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, particularly those of high unmet medical need. | |||
Cyclacel’s clinical development priorities are focused on sapacitabine, an orally available, cell cycle modulating nucleoside analog. | |||
Sapacitabine is being evaluated in the SEAMLESS Phase 3 study 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 Phase 1 study in combination with seliciclib, the Company’s second clinical candidate, in patients with solid tumors, in particular those carrying gBRCA mutations. The FDA and the European Medicines Agency (“EMA”) have designated sapacitabine as an orphan drug for the treatment of both AML and MDS. | |||
In Cyclacel’s second development program, the Company is evaluating cyclin dependent kinase, or CDK, inhibitors. CDKs are involved in cancer cell growth, metastatic spread and DNA damage repair. Seliciclib, the Company’s most advanced CDK inhibitor, is an oral, highly selective inhibitor of CDK enzymes. To date, seliciclib has been evaluated in several Phase 1 and 2 studies in various cancers, including NSCLC and nasopharyngeal cancer (“NPC”), and has shown signs of anti-cancer activity. Seliciclib will also be evaluated in an investigator-initiated clinical study to treat rheumatoid arthritis (“RA”) supported by an approximately $1.6 million grant from the United Kingdom's Medical Research Council. | |||
Cyclacel’s 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 (“IND”) enabling studies with CYC065 have been completed with support from a $1.8 million grant from the Biomedical Catalyst of the United Kingdom government. | |||
In addition to these development programs, in Cyclacel’s polo-like kinase (“PLK”) inhibitor program, the Company has discovered CYC140 and other potent and selective small molecule inhibitors of PLK1, a kinase active during cell division, targeting the mitotic phase of the cell cycle. PLK was discovered by Professor David Glover, the Company’s Chief Scientist. The Company has received a grant award of approximately $3.5 million from the Biomedical Catalyst of the United Kingdom government to complete IND-directed preclinical development of CYC140. | |||
Cyclacel currently retains virtually all marketing rights worldwide to the compounds associated with the Company’s drug programs. | |||
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 resources are expected to be sufficient beyond the availability of mature data for final analysis of the SEAMLESS Phase 3 trial but not sufficient to complete development of other indications or product candidates or to commercialize any of the Company’s product candidates. | |||
Basis of Presentation | |||
The accompanying consolidated financial statements as of December 31, 2013 and 2014, and for each of the two years in the period ended December 31, 2014, have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP. The consolidated financial statements include the financial statements of Cyclacel Pharmaceuticals, Inc. and all of the Company’s wholly owned subsidiaries. All intercompany balances and transactions have been eliminated. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Summary of Significant Accounting Policies | |||||||||
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies | ||||||||
Use of Estimates | |||||||||
The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical estimates include inputs used to determine stock-based compensation expense and the fair value of financial instruments and other liabilities measured at fair value. Cyclacel reviews its estimates on an ongoing basis. The estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results may differ from these estimates. Cyclacel believes the judgments and estimates required by the following accounting policies to be significant in the preparation of the Company’s consolidated financial statements. | |||||||||
Reclassification | |||||||||
Certain amounts in prior period financial statements have been reclassified to conform to current period financial statement presentation. On the consolidated balance sheet as of December 31, 2013, certain amounts have been reclassified from “Accrued and other current liabilities” to “Other liabilities.” | |||||||||
Risks and Uncertainties | |||||||||
Drug candidates developed by the Company typically will require approvals or clearances from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If the Company was denied approval or clearance or such approval was delayed, or is unable to obtain the necessary financing to complete development and approval, there will be a material adverse impact on the Company’s financial condition and results of operations. | |||||||||
Foreign Currency and Currency Translation | |||||||||
Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses) gains in the statement of operations. | |||||||||
The assets and liabilities of the Company’s international subsidiary are translated from its functional currency into United States dollars at exchange rates prevailing at the balance sheet date. Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. | |||||||||
Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive loss. | |||||||||
Segments | |||||||||
After considering its business activities and geographic reach, the Company has concluded that it operates in just one operating segment being the discovery, development and commercialization of novel, mechanism-targeted drugs to treat cancer and other serious disorders, with development operations in two geographic areas, namely the United States and the United Kingdom. | |||||||||
Cash and Cash Equivalents | |||||||||
Cash equivalents are stated at cost, which is substantially the same as fair value. The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents and categorizes such investments as held to maturity. The objectives of the Company’s cash management policy are to safeguard and preserve funds, to maintain liquidity sufficient to meet Cyclacel’s cash flow requirements and to attain a market rate of return. | |||||||||
Fair Value of Financial Instruments | |||||||||
Financial instruments consist of cash and cash equivalents, accounts payable, accrued liabilities, common stock warrants, financial instruments associated with stock purchase agreements and other arrangements. The carrying amounts of cash and cash equivalents, accounts payable, and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities. The financial instruments associated with stock purchase agreements and certain other liabilities are measured at fair value using applicable inputs as described inNote 5 - Fair Value. | |||||||||
Property, Plant and Equipment | |||||||||
The components of property, plant and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets, which are generally three to five years. Amortization of leasehold improvements is performed using the straight-line method over the shorter of the remaining lease term or the estimated useful life of the related assets, currently between five and fifteen years. Upon sale or retirement of assets, the costs and related accumulated depreciation and amortization are removed from the balance sheet and the resulting gain or loss on sale is reflected as a component of operating income or loss. Expenditures for maintenance and repairs are charged to operating expenses as incurred. | |||||||||
The Company did not sell any fixed assets during the years ended December 31, 2013 or 2014. | |||||||||
Impairment of Long-lived Assets | |||||||||
The Company reviews property, plant and equipment for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company assesses the recoverability of the potentially affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. | |||||||||
Impairment, if any, is measured as the amount by which the carrying amount of a long-lived asset (or asset group) exceeds its fair value. | |||||||||
Revenue Recognition | |||||||||
Grant revenues from government agencies and private research foundations are recognized as the related qualified research and development costs are incurred, up to the limit of the prior approval funding amounts. Grant revenues are not refundable. | |||||||||
Clinical Trial Accounting | |||||||||
Data management and monitoring of the Company’s clinical trials are performed with the assistance of contract research organizations (“CROs”) or clinical research associates (“CRAs”) in accordance with the Company’s standard operating procedures. Typically, CROs and CRAs bill monthly for services performed, and others bill based upon milestones achieved. For outstanding amounts, the Company accrues unbilled clinical trial expenses based on estimates of the level of services performed each period. Costs of setting up clinical trial sites for participation in the trials are recognized upon execution of the clinical trial agreement and expensed immediately as research and development expenses. Clinical trial costs related to patient enrollment are accrued as patients are entered into and progress through the trial. | |||||||||
Research and Development Expenditures | |||||||||
Research and development expenses consist primarily of costs associated with the Company’s product candidates, upfront fees, milestones, compensation and other expenses for research and development personnel, supplies and development materials, costs for consultants and related contract research, facility costs and depreciation. Expenditures relating to research and development are expensed as incurred. | |||||||||
Patent Costs | |||||||||
Patent prosecution costs are charged to operations as incurred as recoverability of such expenditure is uncertain. | |||||||||
Leased Assets | |||||||||
The costs of operating leases are charged to operations on a straight-line basis over the lease term. | |||||||||
Income Taxes | |||||||||
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. | |||||||||
The Company applies the accounting guidance codified in ASC 740 “Income taxes” (“ASC 740”) related to accounting for uncertainty in income taxes. ASC 740 specifies the accounting for uncertainty in income taxes recognized in a company’s financial statements by prescribing a minimum probability threshold a tax position is required to meet before being recognized in the financial statements. | |||||||||
Credit is taken in the accounting period for research and development tax credits, which will be claimed from H.M. Revenue & Customs (“HMRC”), the United Kingdom’s taxation and customs authority, in respect of qualifying research and development costs incurred in the same accounting period. | |||||||||
Net Loss Per Common Share | |||||||||
The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, restricted stock, restricted stock units, convertible preferred stock and common stock warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive. | |||||||||
Year Ended | Year Ended | ||||||||
December 31, | December 31, | ||||||||
2013 | 2014 | ||||||||
Stock options | 949,685 | 1,010,298 | |||||||
Restricted Stock Units | 119,248 | 89,016 | |||||||
Convertible preferred stock | 20,381 | 20,381 | |||||||
Common stock warrants | 1,591,795 | 1,341,129 | |||||||
Total shares excluded from calculation | 2,618,109 | 2,460,824 | |||||||
Fair Value Measurements | |||||||||
Inputs used to determine fair value of financial and non-financial assets and liabilities are categorized using a fair value hierarchy that prioritizes observable and unobservable inputs into three broad levels, from Level 1, for quoted prices (unadjusted) in active markets for identical assets or liabilities, to Level 3, for unobservable inputs (see Note 5 — Fair Value). Management reviews the categorization of fair value inputs on a periodic basis and may determine that it is necessary to transfer an input from one level of the fair value hierarchy to another based on changes in events or circumstances, such as a change in the observability of an input. Any such transfer will be recognized at the end of the reporting period. | |||||||||
Stock-based Compensation | |||||||||
The Company grants stock options, restricted stock units and restricted stock to officers, employees and directors under the Amended and Restated Equity Incentive Plan (“2006 Plan”), which was approved on March 16, 2006, as amended on May 21, 2007, subsequently amended and restated on April 14, 2008 and later amended on May 23, 2012. Under the 2006 Plan, the Company has granted various types of awards, which are described more fully in Note 11 - Stock-Based Compensation Arrangements. The Company accounts for these awards under ASC 718“Compensation — Stock Compensation” (“ASC 718”). | |||||||||
ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on date of grant and recognition of compensation over the requisite service period for awards expected to vest. The fair value of restricted stock and restricted stock units is determined based on the number of shares granted and the quoted price of the Company’s common stock on the date of grant. The determination of grant-date fair value for stock option awards is estimated using the Black-Scholes model, which includes variables such as the expected volatility of the Company’s share price, the anticipated exercise behavior of employees, interest rates, and dividend yields. These variables are projected based on historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line attribution method. The estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from current estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised. The Company considers many factors when estimating expected forfeitures, including type of awards granted, employee class, and historical experience. Actual results and future estimates may differ substantially from current estimates. | |||||||||
Comprehensive Loss | |||||||||
In accordance with ASC 220 “Comprehensive Income” (“ASC 220”), all components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income. | |||||||||
Accounting Standards Adopted in the Period | |||||||||
On January 1, 2014 we adopted guidance issued by the Financial Accounting Standards Board (FASB) relating to the presentation of an unrecognized tax benefit when a net operating loss carryforward (NOL), a similar tax loss, or a tax credit carryforward exists. The guidance states that an unrecognized tax benefit, or a portion of an unrecognized tax benefit, should be presented in the financial statements as a reduction to a deferred tax asset for a NOL, a similar tax loss, or a tax credit carryforward, except as follows. To the extent an NOL, a similar tax loss, or a tax credit carryforward is not available at the reporting date under the tax law of the applicable jurisdiction to settle any additional income taxes that would result from the disallowance of a tax position or the tax law of the applicable jurisdiction does not require the entity to use, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit should be presented in the financial statements as a liability and should not be combined with deferred tax assets. The adoption of this guidance has not had a material impact on the Company’s consolidated financial statements. | |||||||||
On January 1, 2014 we adopted guidance issued by the FASB relating to certain foreign currency matters. This guidance clarifies the parent company’s accounting for the cumulative translation adjustment when a reporting entity ceases to have a controlling financial interest in a subsidiary or group of assets that is a nonprofit activity or a business within a foreign entity or of an investment in a foreign entity. The adoption of this guidance has not had a material impact on the Company’s consolidated financial statements. | |||||||||
On January 1, 2014 we adopted guidance issued by the FASB relating to obligations resulting from joint and several liability arrangements for which the total amount of the obligation is fixed at the reporting date. This provides guidance for the recognition, measurement, and disclosure of obligations resulting from joint and several liability arrangements for which the total amount of the obligation is fixed at the reporting date, except for obligations addressed within existing guidance in GAAP. The guidance should be applied retrospectively to all prior periods presented for those obligations resulting from joint and several liability arrangements that exist at the beginning of an entity’s fiscal year of adoption. The adoption of this guidance has not had a material impact on the Company’s consolidated financial statements. | |||||||||
On June 10, 2014 we adopted guidance issued by the FASB relating to financial reporting for development stage entities. The guidance eliminates certain financial reporting requirements for development stage entities, including the presentation of inception-to-date information about income statement line items, cash flows, and equity transactions, and also eliminates an exception provided to development stage entities for determining whether an entity is a variable interest entity on the basis of the amount of equity that is at risk. The adoption of this guidance has resulted in the elimination of inception-to-date information. | |||||||||
Recent Accounting Pronouncements Not Yet Effective | |||||||||
In February 2015, the FASB issued guidance on consolidation, which changes the analysis an entity must perform to determine whether it should consolidate certain legal entities. This guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2015. Early adoption is permitted. The guidance can be adopted using either a full retrospective or a modified retrospective method of transition. The Company is currently evaluating the impact of the guidance on its consolidated financial statements. | |||||||||
In November 2014, the FASB issued guidance on how current US GAAP should be interpreted in evaluating the economic characteristics and risks of a host contract in a hybrid financial instrument that is issued in the form of a share. The guidance clarifies that an entity should include all relevant terms and features, including the embedded derivative feature being evaluated for bifurcation, in evaluating the nature of the host contract. The guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2015. Early adoption is permitted. The guidance can be adopted on prospectively or on a modified retrospective basis. The Company is currently evaluating the impact of the guidance on its consolidated financial statements. | |||||||||
In August 2014, the FASB issued guidance on management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and the provision of related footnote disclosures. This guidance is effective for annual period ending December 15, 2016 and for annual and interim periods thereafter. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. | |||||||||
In June 2014, the FASB issued guidance on accounting for share based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The guidance requires that a performance target that affects vesting and that could be achieved after the requisite service period should be treated as a performance condition. This guidance is effective for annual periods, and interim periods within those annual periods, after December 15, 2015. The Company is currently evaluating the impact of the guidance on its consolidated financial statements. | |||||||||
In May 2014, the FASB issued new guidance on accounting for revenue from contracts with customers. This new guidance will replace existing revenue guidelines with a new model, in which revenue is recognized upon transfer of control over goods or services to a customer. The new standard will be effective for the Company on January 1, 2017, for both interim and annual periods. The guidance can be adopted using either a full retrospective (with certain practical expedients) or a modified retrospective method of transition. Under the modified retrospective approach, financial statements will be prepared for the year of adoption using the new standard, but prior periods will not be adjusted. Instead, companies will recognize a cumulative catch-up adjustment to the opening balance of retained earnings at the effective date for contracts that still require performance by the company, and disclose all line items in the year of adoption as if they were prepared under current revenue requirements. At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position. For the foreseeable future, the Company’s revenues will be limited to grants received from government agencies or nonprofit organizations, and the Company is evaluating the effects of the new standard on these types of revenue streams. |
Significant_Contracts
Significant Contracts | 12 Months Ended | |
Dec. 31, 2014 | ||
Significant Contracts Disclosure [Abstract] | ||
Significant Contracts | 3 | Significant Contracts |
Distribution, Licensing and Research Agreements | ||
The Company has entered into licensing agreements with academic and research organizations. Under the terms of these agreements, the Company has received licenses to technology and patent applications. The Company is required to pay royalties on future sales of products employing the technology or falling under claims of patent applications. | ||
Pursuant to the Daiichi Sankyo license under which the Company licenses certain patent rights for sapacitabine, its lead drug candidate, the Company is under an obligation to use reasonable endeavors to develop a product and obtain regulatory approval to sell a product and has agreed to pay Daiichi Sankyo an up-front fee, reimbursement for Daiichi Sankyo’s enumerated expenses, milestone payments and royalties on a country-by-country basis. The up-front fee, Phase 3 entry milestone, and certain past reimbursements have been paid. A further $10.0 million in aggregate milestone payments could be payable subject to achievement of all the specific contractual milestones which are primarily related to regulatory approval in various territories, and the Company’s decision to continue with these projects. Royalties are payable in each country for the term of patent protection in the country or for ten years following the first commercial sale of licensed products in the country, whichever is later. Royalties are payable on net sales. Net sales are defined as the gross amount invoiced by the Company or its affiliates or licensees, less discounts, credits, taxes, shipping and bad debt losses. The agreement extends from its commencement date to the date on which no further amounts are owed under it. If the Company wishes to appoint a third party to develop or commercialize a sapacitabine-based product in Japan, within certain limitations, Daiichi Sankyo must be notified and given a right of first refusal, with the right of first refusal ending sixty days after notification, to develop and/or commercialize in Japan. In general, the license may be terminated by the Company for technical, scientific, efficacy, safety, or commercial reasons on six months’ notice, or twelve months’ notice, if after a launch of a sapacitabine-based product, or by either party for material default. |
Cash_and_Cash_Equivalents
Cash and Cash Equivalents | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Cash and Cash Equivalents | |||||||||
Cash and Cash Equivalents | 4 | Cash and Cash Equivalents | |||||||
The following is a summary of cash and cash equivalents at December 31, 2013 and 2014 (in $000s): | |||||||||
December 31, | |||||||||
2013 | 2014 | ||||||||
Cash | $ | 4,670 | $ | 5,870 | |||||
Investments with original maturity of less than three months at the time of purchase | 26,476 | 18,319 | |||||||
Total cash and cash equivalents | $ | 31,146 | $ | 24,189 | |||||
Investments with original maturity of less than three months at time of purchase are made up of money market funds and commercial paper. |
Fair_Value
Fair Value | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Fair Value | |||||||||||||||||
Fair Value | 5 | Fair Value | |||||||||||||||
Fair Value Measurements | |||||||||||||||||
As defined in ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”), fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: | |||||||||||||||||
· | Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. | ||||||||||||||||
· | Level 2: Inputs other than quoted prices within Level 1 that are observable for the asset or liability, either directly or indirectly. | ||||||||||||||||
· | Level 3: Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. | ||||||||||||||||
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considering counterparty credit risk in its measurement of fair value. | |||||||||||||||||
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2013 (in $000s): | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
ASSETS | |||||||||||||||||
Cash equivalents | $ | 26,476 | $ | — | $ | — | $ | 26,476 | |||||||||
Financial instrument associated with stock purchase agreement | — | 397 | — | 397 | |||||||||||||
Total assets | $ | 26,476 | $ | 397 | $ | — | $ | 26,873 | |||||||||
LIABILITIES | |||||||||||||||||
Other liabilities measured at fair value: | |||||||||||||||||
Scottish Enterprise agreement | — | — | 20 | 20 | |||||||||||||
Other liabilities measured at fair value | — | — | 20 | 20 | |||||||||||||
Total liabilities | $ | — | $ | — | $ | 20 | $ | 20 | |||||||||
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2014 (in $000s): | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
ASSETS | |||||||||||||||||
Cash equivalents | $ | 18,319 | $ | — | $ | — | $ | 18,319 | |||||||||
Financial instrument associated with stock purchase agreement | — | 51 | — | 51 | |||||||||||||
Total assets | $ | 18,319 | $ | 51 | $ | — | $ | 18,370 | |||||||||
The following table reconciles the beginning and ending balances of Level 3 inputs for the year ended December 31, 2014 (in $000s): | |||||||||||||||||
Level 3 | |||||||||||||||||
Balance as of December 31, 2013 | 20 | ||||||||||||||||
Change in valuation of Scottish Enterprise agreement | (20 | ) | |||||||||||||||
Balance as of December 31, 2014 | — | ||||||||||||||||
Financial Instrument Associated with Stock Purchase Agreement | |||||||||||||||||
On November 14, 2013, the Company entered into a common stock purchase agreement with Aspire Capital Fund, LLC (“Aspire”) (the “Purchase Agreement”) under which Aspire purchased 511,509 shares of common stock for an aggregate purchase price of $2.0 million and committed to purchase up to an additional 3,042,038 shares from time to time as directed by the Company over the next two years at prices derived from the market prices on or near the date of each sale (see Note 10 – Stockholders’ Equity). | |||||||||||||||||
The Company has accounted for the right to sell additional shares under the Purchase Agreement based on the guidance of ASC 815 “Derivative Financial Instruments” (“ASC 815”), which requires the instrument to be measured at fair value with changes in fair value reported in earnings each reporting period until the agreement is exhausted or expired. The instrument had a fair value of $0.5 million at the date of the transaction and a fair value of $0.4 million and $0.1 million as of December 31, 2013 and December 31, 2014, respectively. The $0.3 million decrease in the fair value of the Purchase Agreement during the year ended December 31, 2014 was recognized as a loss in the consolidated statements of operations. The primary inputs used to determine fair value are the price of the Company’s common stock, the remaining term, and aggregate share purchases on the measurement date. | |||||||||||||||||
Liabilities Measured at Fair Value | |||||||||||||||||
Scottish Enterprise Agreement | |||||||||||||||||
On June 22, 2009, the Company amended an agreement with Scottish Enterprise (“SE”) (the “Amendment”) pursuant to which, if the Company failed to maintain minimum staff levels before July 1, 2014 without SE’s prior consent, the Company would have been obligated to pay up to £4 million to SE, calculated as a maximum of £4 million (approximately $6.5 million at December 31, 2013) less the market value of the shares held by SE at the time staffing levels in Scotland fell below the prescribed minimum levels. The staffing levels did not fall below the minimum level before July 1, 2014 and the Company is no longer liable to make any payments under the Amendment. | |||||||||||||||||
This arrangement was accounted for as a liability under ASC Topic 480 “Distinguishing Liabilities from Equity” (“ASC 480”), and is measured at fair value. Changes in fair value are recognized in earnings. Due to the nature of the associated contingency and the likelihood of occurrence, the Company concluded the fair value of this liability was approximately $20,000 at December 31, 2013. The most significant inputs in estimating the fair value of this liability were the probabilities that staffing levels would fall below the prescribed minimum and that the Company would be unable or unwilling to replace such employees within the prescribed time period. At December 31, 2013, the Company used a scenario analysis model to arrive at the fair value of the Scottish Enterprise Agreement and assumed a 30% probability of falling below a minimum staffing level and a 1% probability that the occurrence of such an event would not be cured within the prescribed time period. At December 31, 2014, the Company had no further liability under the agreement and the fair value of the liability was $0. Changes in the value of this liability have been recorded in the consolidated statement of operations. |
Prepaid_Expenses_and_Other_Cur
Prepaid Expenses and Other Current Assets | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Prepaid Expense and Other Assets, Current [Abstract] | |||||||||
Prepaid Expenses and Other Current Assets | 6 | Prepaid Expenses and Other Current Assets | |||||||
The following is a summary of prepaid expenses and other current assets at December 31, 2013 and 2014 (in $000s): | |||||||||
December 31, | |||||||||
2013 | 2014 | ||||||||
Research and development tax credit receivable | $ | 1,744 | $ | 3,017 | |||||
Prepayments | 427 | 902 | |||||||
Grant receivable | 357 | 134 | |||||||
Sales tax receivable | 209 | 309 | |||||||
Deposits | 132 | 132 | |||||||
Other current assets | 519 | 146 | |||||||
$ | 3,388 | $ | 4,640 | ||||||
Property_Plant_and_Equipment
Property, Plant and Equipment | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Property, Plant and Equipment | |||||||||||
Property, Plant and Equipment | 7 | Property, Plant, and Equipment | |||||||||
Property, plant and equipment consisted of the following (in $000s): | |||||||||||
Useful lives in years from | December 31, | ||||||||||
date of acquisition | 2013 | 2014 | |||||||||
Leasehold improvements | 5 to 15 years | $ | 922 | $ | 914 | ||||||
Research and laboratory equipment | 3 to 5 years | 5,668 | 5,881 | ||||||||
Office equipment and furniture | 3 to 5 years | 1,338 | 1,302 | ||||||||
7,928 | 8,097 | ||||||||||
Less: accumulated depreciation and amortization | (7,653 | ) | (7,710 | ) | |||||||
$ | 275 | $ | 387 | ||||||||
The depreciation and amortization of property, plant and equipment amounted to $0.2 million for each of the years ended December 31, 2013 and 2014. |
Accrued_and_Other_Current_Liab
Accrued and Other Current Liabilities | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued and Other Current Liabilities | |||||||||
Accrued and Other Current Liabilities | 8 | Accrued and Other Current Liabilities | |||||||
Accrued and other current liabilities consisted of the following (in $000s): | |||||||||
December 31, | |||||||||
2013 | 2014 | ||||||||
Accrued research and development | $ | 3,421 | $ | 4,161 | |||||
Accrued legal and professional fees | 265 | 303 | |||||||
Other current liabilities | 745 | 162 | |||||||
$ | 4,431 | $ | 4,626 | ||||||
Commitments_and_Contingencies
Commitments and Contingencies | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies | |||||
Commitments and Contingencies | 9 | Commitments and Contingencies | |||
General | |||||
Please refer to Note 3 — Significant Contracts for further discussion of certain of the Company’s commitments and contingencies. | |||||
Leases | |||||
The following is a summary of the Company’s contractual obligations and commitments relating to its facilities leases as at December 31, 2014 (in $000s): | |||||
Operating | |||||
Lease | |||||
Obligations | |||||
2015 | $ | 560 | |||
2016 | 560 | ||||
2017 | 432 | ||||
2018 | 405 | ||||
2019 | 397 | ||||
Thereafter | 2,304 | ||||
Total | $ | 4,658 | |||
Rent expense, which includes lease payments related to the Company’s research and development facilities and corporate headquarters and other rent related expenses was $0.8 million and $0.5 million for each of the years ended December 31, 2013 and 2014, respectively. | |||||
In October 2000, the Company entered into a twenty-five year lease for its research and development facility in Dundee, Scotland. In November 2013, the Company entered into a one year commitment to sublease the aforementioned research and development facility in Dundee, Scotland and recognized approximately $23,000 and $0.1 million in sublease income for the years ended December 31, 2013 and 2014, respectively. In May 2011, the Company extended its lease for office space at its headquarters in Berkeley Heights, New Jersey, through February 2017. | |||||
Preferred Dividends | |||||
The Company’s Board of Directors considers numerous factors in determining whether to declare the quarterly dividend pursuant to the certificate of designations governing the terms of the Company’s outstanding 6% Convertible Exchangeable (“Preferred Stock”), including the requisite financial analysis and determination of a surplus. Accrued and unpaid dividends in arrears on preferred stock were $0.6 million, or $1.90 per share, of preferred stock, as of December 31, 2013 and 2014. |
Stockholders_Equity
Stockholders' Equity | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Stockholders' Equity | |||||||||||
Stockholders' Equity | 10 | Stockholders’ Equity | |||||||||
Preferred Stock | |||||||||||
As of December 31, 2014, there were 335,273 shares of Preferred Stock issued and outstanding at an issue price of $10.00 per share. Dividends on the Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the Preferred Stock, payable quarterly on the first day of February, May, August and November, commencing February 1, 2005. Any dividends must be declared by the Company’s Board of Directors and must come from funds that are legally available for dividend payments. The Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends. | |||||||||||
The Preferred Stock is convertible at the option of the holder at any time into the Company’s shares of common stock at a conversion rate of approximately 0.06079 shares of common stock for each share of Preferred Stock based on a price of $164.50. The Company has reserved 20,381 shares of common stock for issuance upon conversion of the remaining shares of Preferred Stock outstanding at December 31, 2014. The shares of previously-converted Preferred Stock have been retired, cancelled and restored to the status of authorized but unissued shares of preferred stock, subject to reissuance by the Board of Directors as shares of Preferred Stock of one or more series. | |||||||||||
The Company may automatically convert the Preferred Stock into common stock if the closing price of the Company’s common stock has exceeded $246.75, which is 150% of the conversion price of the Preferred Stock, for at least 20 trading days during any 30-day trading period, ending within five trading days prior to notice of automatic conversion. | |||||||||||
The Certificate of Designations governing the Preferred Stock provides that if the Company fails to pay dividends on its Preferred Stock for six quarterly periods, holders of Preferred Stock are entitled to nominate and elect two directors to the Company’s Board of Directors. This right accrued to the holders of Preferred Stock as of August 2, 2010 and two directors were nominated and elected at the annual meeting held on May 24, 2011. | |||||||||||
The Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances. | |||||||||||
The Company may, at its option, redeem the Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share. | |||||||||||
The Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on any dividend payment date beginning on November 1, 2005 (the “Exchange Date”) for the Company’s 6% Convertible Subordinated Debentures (“Debentures”) at the rate of $10.00 principal amount of Debentures for each share of Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have terms substantially similar to those of the Preferred Stock. No such exchanges have taken place to date. | |||||||||||
Conversion of Convertible Preferred Stock | |||||||||||
During 2013, Cyclacel entered into agreements to exchange the Company’s Preferred Stock into shares of common stock. There were no exchanges of the Company’s Preferred Stock into shares of common stock during the year ended December 31, 2014. The table below provides details of the aggregate activities in 2013: | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2013 | |||||||||||
Preferred shares exchanged | 877,869 | ||||||||||
Shares of common stock issued: | |||||||||||
At stated convertible option | 53,366 | ||||||||||
Incremental shares issued under the exchange transaction | 1,631,105 | ||||||||||
Total shares of common stock issued | 1,684,471 | ||||||||||
As the Preferred Stock stockholders received additional shares of common stock issued to them upon conversion as compared to what they would have been entitled to receive under the stated rate of exchange, the Company recorded the excess of (1) the fair value of all securities and other consideration transferred to the holders of the Preferred Stock and (2) the fair value of securities issuable pursuant to the original conversion terms as a deemed dividend resulting in an increase in the net loss attributable to common shareholders. Specifically, the Company recorded deemed dividends related to the additional shares issued under the exchange transactions of $9.0 million for the year ended December 31, 2013. | |||||||||||
Common Stock | |||||||||||
April 2014 Underwriting Agreement | |||||||||||
On April 3, 2014, the Company entered into an underwriting agreement relating to the public offering and sale of 2,857,143 shares of the Company’s common stock, par value $0.001 per share, at a price to the public of $3.50 per share, for proceeds, net of certain fees and expenses, of approximately $9.3 million. | |||||||||||
November 2013 Stock Purchase Agreement | |||||||||||
On November 14, 2013, the Company entered into a common stock Purchase Agreement with Aspire (the “Purchase Agreement”). Upon execution of the Purchase Agreement, Aspire purchased 511,509 shares of common stock for an aggregate purchase price of $2.0 million. Under the terms of the Purchase Agreement, Aspire has committed to purchase up to an additional 3,042,038 shares from time to time as directed by the Company or, in certain instances, as agreed to by both parties, over the next two years at prices derived from the market prices on or near the date of each sale. However, such commitment is limited to an additional $18.0 million of share purchases. In consideration for entering into the Purchase Agreement, concurrent with the execution of the Purchase Agreement, the Company issued 166,105 shares of the Company’s common stock to Aspire in lieu of a commitment fee. The fair value of these shares has been recorded as a component of other assets and will continue to be remeasured each reporting period, until the agreement is exhausted or expired, with gains or losses reported in the consolidated statements of operations. During the year ended December 31, 2014, the Company sold 950,000 shares to Aspire under the Purchase Agreement for proceeds of $3.1 million. | |||||||||||
May 2013 Underwriting Agreement | |||||||||||
On May 16, 2013, the Company entered into an underwriting agreement relating to the public offering and sale of up to 6,666,667 shares of the Company’s common stock, par value $0.001, at a price to the public of $3.00 per share. On May 21, 2013, the Company closed the public offering and completed the sale of 6,833,334 shares of its common stock, which includes 166,667 shares that were subject to the underwriters’ over-allotment option, at a price to the public of $3.00 per share, for proceeds, net of certain fees and expenses, of approximately $19.0 million. | |||||||||||
Summary of Outstanding Warrants | |||||||||||
The following table summarizes information about warrants outstanding at December 31, 2014: | |||||||||||
Issued in Connection With | Expiration | Common | Weighted | ||||||||
Date | Shares | Average | |||||||||
Issuable | Exercise | ||||||||||
Price | |||||||||||
January 2010 stock issuance | 2015 | 101,785 | $ | 22.82 | |||||||
January 2010 stock issuance | 2015 | 100,714 | $ | 19.95 | |||||||
October 2010 stock issuance | 2015 | 594,513 | $ | 13.44 | |||||||
July 2011 stock issuance | 2016 | 544,117 | $ | 9.52 | |||||||
Total | 1,341,129 | $ | 13.05 | ||||||||
There were no exercises of warrants during the years ended December 31, 2013 and 2014. Warrants for 151,773 shares of common stock, issued in connection with the February 2007 stock issuance and warrants for 98,893 shares of common stock, issued in connection with the July 2009 Series II stock issuance, expired during the year ended December 31, 2014. | |||||||||||
Exercise of Stock Options | |||||||||||
No stock options were exercised during the years ended December 31, 2013 and 2014. |
StockBased_Compensation_Arrang
Stock-Based Compensation Arrangements | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Stock-Based Compensation Arrangements | |||||||||||||||||
Stock-Based Compensation Arrangements | 11 | Stock-Based Compensation Arrangements | |||||||||||||||
ASC 718 requires compensation expense associated with share-based awards to be recognized over the requisite service period, which for the Company is the period between the grant date and the date the award vests or becomes exercisable. Most of the awards granted by the Company (and still outstanding), vest ratably over four years. | |||||||||||||||||
The Company recognizes all share-based awards under the straight-line attribution method. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company evaluates its forfeiture assumptions quarterly and the expected forfeiture rate is adjusted when necessary. Ultimately, the actual expense recognized over the vesting period is based on only those shares that vest. | |||||||||||||||||
Stock based compensation has been reported within expense line items on the consolidated statement of operations for 2013 and 2014 as shown in the following table (in $000s): | |||||||||||||||||
Year Ended | Year Ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2013 | 2014 | ||||||||||||||||
Research and development | $ | 75 | $ | 392 | |||||||||||||
General and administrative | 282 | 831 | |||||||||||||||
Stock-based compensation costs before income taxes | $ | 357 | $ | 1,223 | |||||||||||||
2006 Plan | |||||||||||||||||
On March 16, 2006, the 2006 Plan was adopted, under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. Stock option awards granted under the 2006 Plan have a maximum life of 10 years and generally vest over a one to four-year period from the date of grant. | |||||||||||||||||
During 2014, the Company granted approximately 63,000 options to employees and directors with a grant date fair value of approximately $0.2 million, of which approximately $0.1 million has been recorded as compensation cost for the year ended December 31, 2014. During 2013, the Company granted approximately 494,663 options to employees and directors with a grant date fair value of approximately $1.6 million, of which approximately $0.4 million has been recorded as compensation cost in the consolidated statement of operations for the year ended December 31, 2013. The weighted average grant-date fair values of options granted during the year ended December 31, 2013 and 2014 were $3.25 and $2.48, respectively. | |||||||||||||||||
As of December 31, 2014, the total remaining unrecognized compensation cost related to the non-vested stock options amounted to approximately $0.9 million, which will be amortized over the weighted-average remaining requisite service period of 1.89 years. | |||||||||||||||||
During the years ended December 31, 2013 and 2014, the Company did not settle any equity instruments with cash. | |||||||||||||||||
There were no stock option exercises during the years ended 2013 and 2014. No income tax benefits were recorded for the years ended December 2013 and 2014 because ASC 718 prohibits recognition of tax benefits for exercised stock options until such benefits are realized. The Company was not able to benefit from the deduction for exercised stock options for the years ended December 31, 2013 and 2014 because the Company incurred tax losses in each of those years. | |||||||||||||||||
Outstanding Options | |||||||||||||||||
A summary of the share option activity and related information is as follows: | |||||||||||||||||
Number of | Weighted | Weighted | Aggregate | ||||||||||||||
Options | Average | Average | Intrinsic | ||||||||||||||
Outstanding | Exercise | Remaining | Value ($000s) | ||||||||||||||
Price Per Share | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Options outstanding at December 31, 2012 | 463,023 | $ | 26.61 | 5.58 | $ | 347 | |||||||||||
Granted | 494,663 | $ | 4.22 | ||||||||||||||
Exercised | — | ||||||||||||||||
Cancelled/forfeited | (8,001 | ) | $ | 18.55 | |||||||||||||
Options outstanding at December 31, 2013 | 949,685 | $ | 15.02 | 7.38 | $ | 152 | |||||||||||
Granted | 63,000 | $ | 3.11 | ||||||||||||||
Exercised | — | ||||||||||||||||
Cancelled/forfeited | (2,387 | ) | $ | 31.08 | |||||||||||||
Options outstanding at December 31, 2014 | 1,010,298 | $ | 14.24 | 6.58 | $ | — | |||||||||||
Unvested at December 31, 2014 | 402,900 | $ | 4.07 | 8.95 | $ | — | |||||||||||
Vested and exercisable at December 31, 2014 | 607,395 | $ | 20.99 | 5 | $ | — | |||||||||||
The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718 using the following assumptions: | |||||||||||||||||
Year ended | Year ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2013 | 2014 | ||||||||||||||||
Expected term (years) | 5 —6 | 6 | |||||||||||||||
Risk free interest rate | 0.84% - 1.865% | 1.835% - 2.005% | |||||||||||||||
Volatility | 97—108% | 101% | |||||||||||||||
Expected dividend yield over expected term | 0.00% | 0.00% | |||||||||||||||
Resulting weighted average grant date fair value | $3.25 | $2.48 | |||||||||||||||
The expected term assumption was estimated using past history of early exercise behavior and expectations about future behaviors. Starting with the December 2010 annual grants to the Company’s employees, the Company relied exclusively on its historical volatility as an input to the option pricing model as management believes that this rate will be representative of future volatility over the expected term of the options. | |||||||||||||||||
Estimates of pre-vesting option forfeitures are based on the Company’s experience. Currently the Company uses a forfeiture rate of 0 — 30% depending on when and to whom the options are granted. The Company adjusts its estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures are recognized through a cumulative adjustment in the period of change and may impact the amount of compensation expense to be recognized in future periods. | |||||||||||||||||
The Company considers many factors when estimating expected forfeitures, including types of awards, employee class, and historical experience. During the years ended December 31, 2013 and 2014, the Company recognized an expense of approximately $40,000 and $0.5 million, respectively, as a result of revised forfeiture rates. | |||||||||||||||||
The weighted average risk-free interest rate represents interest rate for treasury constant maturities published by the Federal Reserve Board. If the term of available treasury constant maturity instruments is not equal to the expected term of an employee option, Cyclacel uses the weighted average of the two Federal Reserve securities closest to the expected term of the employee option. | |||||||||||||||||
Restricted Stock Units | |||||||||||||||||
The Company issued 85,097 restricted stock units to employees during the year ended December 31, 2013, the vesting of which is dependent upon the fulfillment of certain clinical and financial conditions. The Company determined that the satisfaction of the clinical and financial conditions was probable at December 31, 2014 and, as a result, recorded an expense of $0.5 million related to 80,969 restricted stock units, net of forfeitures, for the year ended December 31, 2014. The restricted stock units were valued based on the fair value at the date of grant, which is equivalent to the market price of a share of the Company’s common stock. The expense was recognized entirely in the fourth quarter of 2014 as the awards both became probable of vesting, and actually vested, in that quarter. Summarized information for restricted stock units activity for the years ended December 31, 2013 and 2014 is as follows: | |||||||||||||||||
Restricted Stock | Weighted Average | ||||||||||||||||
Units | Grant | ||||||||||||||||
Date Value Per Share | |||||||||||||||||
Non-vested at December 31, 2012 | 39,377 | $ | 5.34 | ||||||||||||||
Granted | 85,097 | $ | 5.71 | ||||||||||||||
Forfeited | (5,226 | ) | $ | 5 | |||||||||||||
Non-vested at December 31, 2013 | 119,248 | $ | 5.62 | ||||||||||||||
Granted | — | $ | — | ||||||||||||||
Vested | (29,999 | ) | $ | 5.81 | |||||||||||||
Forfeited | (233 | ) | $ | 5.39 | |||||||||||||
Non-vested at December 31, 2014 | 89,016 | $ | 5.56 |
Employee_Benefit_Plans
Employee Benefit Plans | 12 Months Ended | |
Dec. 31, 2014 | ||
Employee Benefit Plans | ||
Employee Benefit Plans | 12 | Employee Benefit Plans |
Pension Plan | ||
The Company operates a defined contribution group personal pension plan for all of its UK based employees. Company contributions to the plan totaled approximately $0.1 million and $28,000 for the years ended December 31, 2013 and 2014, respectively. | ||
401(k) Plan | ||
The 401(k) Plan provides for matching contributions by the Company in an amount equal to the lesser of 100% of the employee’s deferral or 6% of the U.S. employee’s qualifying compensation. The 401(k) Plan is intended to qualify under Section 401(k) of the Internal Revenue Code, so that contributions to the 401(k) Plan by employees or by the Company, and the investment earnings thereon, are not taxable to the employees until withdrawn. Company matching contributions are tax deductible by the Company when made. Company employees may elect to reduce their current compensation by up to the statutorily prescribed annual limit of $17,500 if under 50 years old and $23,000 if over 50 years old in 2012 and to have those funds contributed to the 401(k) Plan. The | ||
Company made contributions of approximately $0.1 million and $14,000 to the 401(k) Plan for the years ended December 31, 2013 and 2014, respectively. |
Discontinued_Operations
Discontinued Operations | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Discontinued Operations | |||||||||
Discontinued Operations | 13 | Discontinued Operations | |||||||
On August 10, 2012, the Company entered into an agreement with Sinclair Pharmaceuticals Limited (“Sinclair”) to terminate, effective September 30, 2012, the distribution agreements relating to the promotion and sale of Xclair®, Numoisyn® Lozenges and Numoisyn® Liquid (collectively, the “ALIGN products”). | |||||||||
Product revenue, cost of goods sold and selling, general and administrative costs related to the promotion and sale of the ALIGN products have been reclassified from operating results from continuing operations to income from discontinued operations in the consolidated statement of operations for all periods presented as follows (in $000s): | |||||||||
Year ended | Year ended | ||||||||
December 31, | December 31, | ||||||||
2013 | 2014 | ||||||||
Interest income | 91 | 29 | |||||||
Income tax on discontinued operations | (34 | ) | (10 | ) | |||||
Net income from discontinued operations, net of tax | $ | 57 | $ | 19 | |||||
The assets and liabilities associated with product promotion and sales have been classified within assets and liabilities of discontinued operations in the accompanying consolidated balance sheets (in $000s): | |||||||||
December 31, | December 31, | ||||||||
2013 | 2014 | ||||||||
Current assets of discontinued operations: | |||||||||
Short term portion of minimum royalty arrangement receivable, net | $ | 379 | $ | 96 | |||||
Returns indemnification receivable | 260 | 75 | |||||||
Total current assets of discontinued operations | 639 | 171 | |||||||
Long-term assets of discontinued operations: | |||||||||
Long-term portion of minimum royalty arrangement receivable, net | 72 | — | |||||||
Total assets of discontinued operations | $ | 711 | $ | 171 | |||||
Current liabilities of discontinued operations: | |||||||||
Returns provision | $ | 260 | $ | 75 | |||||
Total current liabilities of discontinued operations | $ | 260 | $ | 75 |
Taxes
Taxes | 12 Months Ended | |||||||||||||||
Dec. 31, 2014 | ||||||||||||||||
Taxes | ||||||||||||||||
Taxes | 14 | Taxes | ||||||||||||||
(Loss) income from continuing operations before taxes is comprised of the following components for the years ended December 31, 2013 and 2014 (in $000s): | ||||||||||||||||
Year Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2013 | 2014 | |||||||||||||||
Domestic | $ | 1,132 | $ | (2,898 | ) | |||||||||||
Foreign | (13,012 | ) | (19,751 | ) | ||||||||||||
Loss from continuing operations before taxes | $ | (11,880 | ) | $ | (22,649 | ) | ||||||||||
The benefit (provision) for income taxes from continuing operations consists of the following (in $000s): | ||||||||||||||||
Year Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2013 | 2014 | |||||||||||||||
Current — domestic | $ | (25 | ) | $ | 34 | |||||||||||
Current — foreign | 1,695 | 3,209 | ||||||||||||||
Current — total | 1,670 | 3,243 | ||||||||||||||
Deferred — domestic | — | — | ||||||||||||||
Income tax benefit | $ | 1,670 | $ | 3,243 | ||||||||||||
The Company has incurred a taxable loss in each of the operating periods since incorporation. The income tax credits of $1.7 million and $3.2 million for the years ended December 31, 2013 and 2014, respectively, represent UK research and development (“R&D”) tax credits for expenditures in the United Kingdom that are refundable. | ||||||||||||||||
A reconciliation of the (benefit) provision for income taxes from continuing operations with the amount computed by applying the statutory federal tax rate to loss from continuing operations before income taxes is as follows (in $000s): | ||||||||||||||||
| | | Year Ended | | | Year Ended | | |||||||||
December 31, | December 31, | |||||||||||||||
2013 | 2014 | |||||||||||||||
Loss from continuing operations before taxes | | | | $ | -11,880 | | | | | $ | -22,649 | | | |||
Income tax expense computed at statutory federal tax rate | | | | | -4,039 | | | | | | -7,701 | | | |||
Disallowed expenses and non-taxable income | | | | | 62 | | | | | | 406 | | | |||
Loss surrendered to generate R&D credit | | | | | 4,833 | | | | | | 7,294 | | | |||
Additional research and development tax relief | | | | | -4,418 | | | | | | -7,262 | | | |||
Change in valuation allowance | | | | | 6,302 | | | | | | -4,963 | | | |||
Research and development credit – prior years | | | | | -4,530 | | | | | | — | | | |||
Foreign items, including change in tax rates, and other | | | | | 120 | | | | | | 3,555 | | | |||
Other foreign items | | | | | — | | | | | | 5,428 | | | |||
| | | | $ | -1,670 | | | | | $ | -3,243 | | | |||
| ||||||||||||||||
Significant components of the Company’s deferred tax assets are shown below (in $000s): | ||||||||||||||||
| | | December 31, | | ||||||||||||
| | | 2013 | | | 2014 | | |||||||||
Net operating loss carryforwards | | | | $ | 46,144 | | | | | $ | 45,060 | | | |||
Depreciation, amortization and impairment of property and equipment | | | | | 67 | | | | | | 81 | | | |||
Stock options | | | | | 1,651 | | | | | | 1,815 | | | |||
Accrued expenses | | | | | 3,373 | | | | | | 179 | | | |||
Research and development credits | | | | | 4,530 | | | | | | 4,332 | | | |||
Other | | | | | 82 | | | | | | 78 | | | |||
Translation adjustment | | | | | 660 | | | | | | — | | | |||
Deferred tax assets | | | | | 56,507 | | | | | | 51,545 | | | |||
Valuation allowance for deferred tax assets | | | | | -56,507 | | | | | | -51,545 | | | |||
Net deferred taxes | | | | $ | — | | | | | $ | — | | | |||
| ||||||||||||||||
Deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting and tax purposes. | ||||||||||||||||
A valuation allowance has been established, as realization of such assets is uncertain. The Company’s management evaluated the positive and negative evidence bearing upon the realizability of its deferred assets, and has determined that, at present, the Company may not be able to recognize the benefits of the deferred tax assets under the more likely than not criteria. Accordingly, a valuation allowance of approximately $49.6 million has been established at December 31, 2014. The valuation allowance decreased by approximately $6.9 million in 2014. | ||||||||||||||||
In certain circumstances, as specified in the Tax Reform Act of 1986, due to ownership changes, the Company’s ability to utilize its NOL carryforwards may be limited. The benefit of deductions from the exercise of stock options is included in the net operating loss (“NOL”) carryforwards. The benefit from these deductions will be recorded as a credit to additional paid-in capital if and when realized through a reduction of cash taxes. As of December 31, 2013 and 2014, the Company had federal NOLs of $22.1 million and $23.9 million and foreign NOLs of $162.4 million and $163.2 million, respectively. The Company’s federal NOLs will start to expire in 2026, and the state NOLs totaling $10.4 million will start expiring in 2023. The Company’s foreign NOL’s do not expire under UK tax law. | ||||||||||||||||
Utilization of the NOLs may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company completed a Section 382 study as of June 30, 2014 noting there was no ownership change since the Company’s formation. Management has evaluated all significant tax positions at December 31, 2013 and 2014 and concluded that there are no material uncertain tax positions. The Company would recognize both interest and penalties related to unrecognized benefits in income tax expense. The Company has not recorded any interest and penalties on any unrecognized tax benefits since its inception. | ||||||||||||||||
Tax years 2011, 2012 and 2013 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the United Kingdom and the United States, as carryforward attributes generated in years past may still be adjusted upon examination by the United Kingdom’s H.M. Revenue & Customs, the Internal Revenue Service (“IRS”) or state tax authorities. The Company is currently not under examination by the IRS or any other jurisdictions for any tax years. | ||||||||||||||||
We have not provided a deferred tax liability on the cumulative amount of unremitted foreign earnings of international subsidiaries because it is our intent to permanently reinvest such earnings outside of the United States. We would recognize this deferred tax liability if we were to experience a change in circumstances producing a change in that intention. The United States foreign tax credits which would arise upon such a distribution have also not been recognized. |
Geographic_Information
Geographic Information | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Geographic Information | |||||||||
Geographic Information | 15. Geographic Information | ||||||||
Geographic information for the years ended December 31, 2013 and 2014 is as follows (in $000s): | |||||||||
Year Ended | Year Ended | ||||||||
December 31, | December 31, | ||||||||
2013 | 2014 | ||||||||
Revenue | |||||||||
United Kingdom | $ | 1,084 | $ | 1,734 | |||||
Total Revenue | 1,084 | 1,734 | |||||||
Net loss | |||||||||
United States: | |||||||||
Continuing operations | 1,114 | (3,844 | ) | ||||||
Discontinued operations | 57 | 19 | |||||||
Total United States | 1,171 | (3,825 | ) | ||||||
United Kingdom | (11,324 | ) | (17,296 | ) | |||||
Total Net Loss | $ | (10,153 | ) | $ | 19,387 | ) | |||
December 31, | |||||||||
2013 | 2014 | ||||||||
Total Assets | |||||||||
United States: | |||||||||
Continuing operations | $ | 27,837 | $ | 18,923 | |||||
Discontinued operations | 711 | 171 | |||||||
Total United States | 28,548 | 19,094 | |||||||
United Kingdom | 6,972 | 10,293 | |||||||
Total Assets | 35,520 | 29,387 | |||||||
Long Lived Assets, net | |||||||||
United States: | |||||||||
Continuing operations | 5 | 6 | |||||||
Discontinued operations | — | — | |||||||
Total United States | 5 | 6 | |||||||
United Kingdom | 270 | 381 | |||||||
Total Long Lived Assets, net | $ | 275 | $ | 387 |
Subsequent_Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2014 | |
Subsequent Events | |
Subsequent Events | 16. Subsequent Events |
Public Offering of Common Stock | |
On March 9, 2015, the Company completed a public offering of 10,000,000 shares of its common stock at a price to the public of $1.00 per share for proceeds, net of certain fees and expenses, of approximately $9.2 million. | |
Preferred Stock Dividend | |
On February 18, 2015, the Company’s Board of Directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock with respect to the first quarter of 2015. The Company is expected to pay the dividend on May 1, 2015 to holders of record of the Preferred Stock as of the close of business on April 17, 2015. | |
The Board considered numerous factors in determining whether to declare the quarterly dividend, including the requisite financial analysis and determination of a surplus. While the Board will analyze the advisability of the declaration of dividends in future quarters, there is no assurance that future quarterly dividends will be declared. | |
Deficiency and Compliance Notices from The NASDAQ Stock Market | |
On February 2, 2015, the Company received a written notification from The NASDAQ Stock Market LLC indicating that the Company was not in compliance with NASDAQ Listing Rule 5450(a)(1) because the minimum bid price of its shares of common stock was below $1.00 per share for the previous 30 consecutive business days. Pursuant to the NASDAQ Listing Rule 5810(c)(3)(A), the Company has been granted a 180-calendar day compliance period, or until August 3, 2015, to regain compliance with the minimum bid price requirement. During the compliance period, the Company’s shares of common stock will continue to be listed and traded on The NASDAQ Global Market. To regain compliance, the closing bid price of the Company’s shares of common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180-day grace period. If the Company is not in compliance by August 3, 2015, the Company may be afforded a second 180-calendar day grace period if the Company transfers the listing of our shares of common stock to The NASDAQ Capital Market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The NASDAQ Capital Market, except for the minimum bid price. In addition, the Company would be required to notify NASDAQ of its intent to cure the minimum bid price deficiency by effecting a reverse stock split, if necessary. | |
If the Company does not regain compliance within the allotted compliance period(s), including any extensions that may be granted by NASDAQ, NASDAQ will provide notice that the Company’s shares of common stock will be subject to delisting. The Company would then be entitled to appeal NASDAQ’s determination to a NASDAQ Hearings Panel and request a hearing. | |
The Company intends to consider available options to resolve the noncompliance with the minimum bid price requirement. No determination regarding the Company’s response has been made at this time. There can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other NASDAQ listing criteria. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Summary of Significant Accounting Policies | |||||||||
Use of Estimates | Use of Estimates | ||||||||
The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical estimates include inputs used to determine stock-based compensation expense and the fair value of financial instruments and other liabilities measured at fair value. Cyclacel reviews its estimates on an ongoing basis. The estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results may differ from these estimates. Cyclacel believes the judgments and estimates required by the following accounting policies to be significant in the preparation of the Company’s consolidated financial statements. | |||||||||
Reclassification | Reclassification | ||||||||
Certain amounts in prior period financial statements have been reclassified to conform to current period financial statement presentation. On the consolidated balance sheet as of December 31, 2013, certain amounts have been reclassified from “Accrued and other current liabilities” to “Other liabilities.” | |||||||||
Risks and Uncertainties | Risks and Uncertainties | ||||||||
Drug candidates developed by the Company typically will require approvals or clearances from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If the Company was denied approval or clearance or such approval was delayed, or is unable to obtain the necessary financing to complete development and approval, there will be a material adverse impact on the Company’s financial condition and results of operations. | |||||||||
Foreign Currency and Currency Translation | Foreign Currency and Currency Translation | ||||||||
Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses) gains in the statement of operations. | |||||||||
The assets and liabilities of the Company’s international subsidiary are translated from its functional currency into United States dollars at exchange rates prevailing at the balance sheet date. Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. | |||||||||
Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive loss. | |||||||||
Segments | Segments | ||||||||
After considering its business activities and geographic reach, the Company has concluded that it operates in just one operating segment being the discovery, development and commercialization of novel, mechanism-targeted drugs to treat cancer and other serious disorders, with development operations in two geographic areas, namely the United States and the United Kingdom. | |||||||||
Cash and Cash Equivalents | Cash and Cash Equivalents | ||||||||
Cash equivalents are stated at cost, which is substantially the same as fair value. The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents and categorizes such investments as held to maturity. The objectives of the Company’s cash management policy are to safeguard and preserve funds, to maintain liquidity sufficient to meet Cyclacel’s cash flow requirements and to attain a market rate of return. | |||||||||
Fair Value of Financial Instruments | Fair Value of Financial Instruments | ||||||||
Financial instruments consist of cash and cash equivalents, accounts payable, accrued liabilities, common stock warrants, financial instruments associated with stock purchase agreements and other arrangements. The carrying amounts of cash and cash equivalents, accounts payable, and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities. The financial instruments associated with stock purchase agreements and certain other liabilities are measured at fair value using applicable inputs as described inNote 5 - Fair Value. | |||||||||
Property, Plant and Equipment | Property, Plant and Equipment | ||||||||
The components of property, plant and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets, which are generally three to five years. Amortization of leasehold improvements is performed using the straight-line method over the shorter of the remaining lease term or the estimated useful life of the related assets, currently between five and fifteen years. Upon sale or retirement of assets, the costs and related accumulated depreciation and amortization are removed from the balance sheet and the resulting gain or loss on sale is reflected as a component of operating income or loss. Expenditures for maintenance and repairs are charged to operating expenses as incurred. | |||||||||
The Company did not sell any fixed assets during the years ended December 31, 2013 or 2014. | |||||||||
Impairment of Long-lived Assets | Impairment of Long-lived Assets | ||||||||
The Company reviews property, plant and equipment for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company assesses the recoverability of the potentially affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. | |||||||||
Impairment, if any, is measured as the amount by which the carrying amount of a long-lived asset (or asset group) exceeds its fair value. | |||||||||
Revenue Recognition | Revenue Recognition | ||||||||
Grant revenues from government agencies and private research foundations are recognized as the related qualified research and development costs are incurred, up to the limit of the prior approval funding amounts. Grant revenues are not refundable. | |||||||||
Clinical Trial Accounting | Clinical Trial Accounting | ||||||||
Data management and monitoring of the Company’s clinical trials are performed with the assistance of contract research organizations (“CROs”) or clinical research associates (“CRAs”) in accordance with the Company’s standard operating procedures. Typically, CROs and CRAs bill monthly for services performed, and others bill based upon milestones achieved. For outstanding amounts, the Company accrues unbilled clinical trial expenses based on estimates of the level of services performed each period. Costs of setting up clinical trial sites for participation in the trials are recognized upon execution of the clinical trial agreement and expensed immediately as research and development expenses. Clinical trial costs related to patient enrollment are accrued as patients are entered into and progress through the trial. | |||||||||
Research and Development Expenditures | Research and Development Expenditures | ||||||||
Research and development expenses consist primarily of costs associated with the Company’s product candidates, upfront fees, milestones, compensation and other expenses for research and development personnel, supplies and development materials, costs for consultants and related contract research, facility costs and depreciation. Expenditures relating to research and development are expensed as incurred. | |||||||||
Patent Costs | Patent Costs | ||||||||
Patent prosecution costs are charged to operations as incurred as recoverability of such expenditure is uncertain. | |||||||||
Leased Assets | Leased Assets | ||||||||
The costs of operating leases are charged to operations on a straight-line basis over the lease term. | |||||||||
Income Taxes | Income Taxes | ||||||||
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. | |||||||||
The Company applies the accounting guidance codified in ASC 740 “Income taxes” (“ASC 740”) related to accounting for uncertainty in income taxes. ASC 740 specifies the accounting for uncertainty in income taxes recognized in a company’s financial statements by prescribing a minimum probability threshold a tax position is required to meet before being recognized in the financial statements. | |||||||||
Credit is taken in the accounting period for research and development tax credits, which will be claimed from H.M. Revenue & Customs (“HMRC”), the United Kingdom’s taxation and customs authority, in respect of qualifying research and development costs incurred in the same accounting period. | |||||||||
Net Loss Per Common Share | Net Loss Per Common Share | ||||||||
The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, restricted stock, restricted stock units, convertible preferred stock and common stock warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive. | |||||||||
Year Ended | Year Ended | ||||||||
December 31, | December 31, | ||||||||
2013 | 2014 | ||||||||
Stock options | 949,685 | 1,010,298 | |||||||
Restricted Stock Units | 119,248 | 89,016 | |||||||
Convertible preferred stock | 20,381 | 20,381 | |||||||
Common stock warrants | 1,591,795 | 1,341,129 | |||||||
Total shares excluded from calculation | 2,618,109 | 2,460,824 | |||||||
Fair Value Measurements | Fair Value Measurements | ||||||||
Inputs used to determine fair value of financial and non-financial assets and liabilities are categorized using a fair value hierarchy that prioritizes observable and unobservable inputs into three broad levels, from Level 1, for quoted prices (unadjusted) in active markets for identical assets or liabilities, to Level 3, for unobservable inputs (see Note 5 — Fair Value). Management reviews the categorization of fair value inputs on a periodic basis and may determine that it is necessary to transfer an input from one level of the fair value hierarchy to another based on changes in events or circumstances, such as a change in the observability of an input. Any such transfer will be recognized at the end of the reporting period. | |||||||||
Stock-based Compensation | Stock-based Compensation | ||||||||
The Company grants stock options, restricted stock units and restricted stock to officers, employees and directors under the Amended and Restated Equity Incentive Plan (“2006 Plan”), which was approved on March 16, 2006, as amended on May 21, 2007, subsequently amended and restated on April 14, 2008 and later amended on May 23, 2012. Under the 2006 Plan, the Company has granted various types of awards, which are described more fully in Note 11 - Stock-Based Compensation Arrangements. The Company accounts for these awards under ASC 718“Compensation — Stock Compensation” (“ASC 718”). | |||||||||
ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on date of grant and recognition of compensation over the requisite service period for awards expected to vest. The fair value of restricted stock and restricted stock units is determined based on the number of shares granted and the quoted price of the Company’s common stock on the date of grant. The determination of grant-date fair value for stock option awards is estimated using the Black-Scholes model, which includes variables such as the expected volatility of the Company’s share price, the anticipated exercise behavior of employees, interest rates, and dividend yields. These variables are projected based on historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line attribution method. The estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from current estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised. The Company considers many factors when estimating expected forfeitures, including type of awards granted, employee class, and historical experience. Actual results and future estimates may differ substantially from current estimates. | |||||||||
Comprehensive Loss | Comprehensive Loss | ||||||||
In accordance with ASC 220 “Comprehensive Income” (“ASC 220”), all components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income. | |||||||||
Accounting Standards Adopted in the Period | Accounting Standards Adopted in the Period | ||||||||
On January 1, 2014 we adopted guidance issued by the Financial Accounting Standards Board (FASB) relating to the presentation of an unrecognized tax benefit when a net operating loss carryforward (NOL), a similar tax loss, or a tax credit carryforward exists. The guidance states that an unrecognized tax benefit, or a portion of an unrecognized tax benefit, should be presented in the financial statements as a reduction to a deferred tax asset for a NOL, a similar tax loss, or a tax credit carryforward, except as follows. To the extent an NOL, a similar tax loss, or a tax credit carryforward is not available at the reporting date under the tax law of the applicable jurisdiction to settle any additional income taxes that would result from the disallowance of a tax position or the tax law of the applicable jurisdiction does not require the entity to use, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit should be presented in the financial statements as a liability and should not be combined with deferred tax assets. The adoption of this guidance has not had a material impact on the Company’s consolidated financial statements. | |||||||||
On January 1, 2014 we adopted guidance issued by the FASB relating to certain foreign currency matters. This guidance clarifies the parent company’s accounting for the cumulative translation adjustment when a reporting entity ceases to have a controlling financial interest in a subsidiary or group of assets that is a nonprofit activity or a business within a foreign entity or of an investment in a foreign entity. The adoption of this guidance has not had a material impact on the Company’s consolidated financial statements. | |||||||||
On January 1, 2014 we adopted guidance issued by the FASB relating to obligations resulting from joint and several liability arrangements for which the total amount of the obligation is fixed at the reporting date. This provides guidance for the recognition, measurement, and disclosure of obligations resulting from joint and several liability arrangements for which the total amount of the obligation is fixed at the reporting date, except for obligations addressed within existing guidance in GAAP. The guidance should be applied retrospectively to all prior periods presented for those obligations resulting from joint and several liability arrangements that exist at the beginning of an entity’s fiscal year of adoption. The adoption of this guidance has not had a material impact on the Company’s consolidated financial statements. | |||||||||
On June 10, 2014 we adopted guidance issued by the FASB relating to financial reporting for development stage entities. The guidance eliminates certain financial reporting requirements for development stage entities, including the presentation of inception-to-date information about income statement line items, cash flows, and equity transactions, and also eliminates an exception provided to development stage entities for determining whether an entity is a variable interest entity on the basis of the amount of equity that is at risk. The adoption of this guidance has resulted in the elimination of inception-to-date information. | |||||||||
Recent Accounting Pronouncements Not Yet Effective | Recent Accounting Pronouncements Not Yet Effective | ||||||||
In February 2015, the FASB issued guidance on consolidation, which changes the analysis an entity must perform to determine whether it should consolidate certain legal entities. This guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2015. Early adoption is permitted. The guidance can be adopted using either a full retrospective or a modified retrospective method of transition. The Company is currently evaluating the impact of the guidance on its consolidated financial statements. | |||||||||
In November 2014, the FASB issued guidance on how current US GAAP should be interpreted in evaluating the economic characteristics and risks of a host contract in a hybrid financial instrument that is issued in the form of a share. The guidance clarifies that an entity should include all relevant terms and features, including the embedded derivative feature being evaluated for bifurcation, in evaluating the nature of the host contract. The guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2015. Early adoption is permitted. The guidance can be adopted on prospectively or on a modified retrospective basis. The Company is currently evaluating the impact of the guidance on its consolidated financial statements. | |||||||||
In August 2014, the FASB issued guidance on management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and the provision of related footnote disclosures. This guidance is effective for annual period ending December 15, 2016 and for annual and interim periods thereafter. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. | |||||||||
In June 2014, the FASB issued guidance on accounting for share based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The guidance requires that a performance target that affects vesting and that could be achieved after the requisite service period should be treated as a performance condition. This guidance is effective for annual periods, and interim periods within those annual periods, after December 15, 2015. The Company is currently evaluating the impact of the guidance on its consolidated financial statements. | |||||||||
In May 2014, the FASB issued new guidance on accounting for revenue from contracts with customers. This new guidance will replace existing revenue guidelines with a new model, in which revenue is recognized upon transfer of control over goods or services to a customer. The new standard will be effective for the Company on January 1, 2017, for both interim and annual periods. The guidance can be adopted using either a full retrospective (with certain practical expedients) or a modified retrospective method of transition. Under the modified retrospective approach, financial statements will be prepared for the year of adoption using the new standard, but prior periods will not be adjusted. Instead, companies will recognize a cumulative catch-up adjustment to the opening balance of retained earnings at the effective date for contracts that still require performance by the company, and disclose all line items in the year of adoption as if they were prepared under current revenue requirements. At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position. For the foreseeable future, the Company’s revenues will be limited to grants received from government agencies or nonprofit organizations, and the Company is evaluating the effects of the new standard on these types of revenue streams. |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Summary of Significant Accounting Policies | |||||||||
Schedule of antidilutive shares excluded from computation of diluted net loss per share | |||||||||
Year Ended | Year Ended | ||||||||
December 31, | December 31, | ||||||||
2013 | 2014 | ||||||||
Stock options | 949,685 | 1,010,298 | |||||||
Restricted Stock Units | 119,248 | 89,016 | |||||||
Convertible preferred stock | 20,381 | 20,381 | |||||||
Common stock warrants | 1,591,795 | 1,341,129 | |||||||
Total shares excluded from calculation | 2,618,109 | 2,460,824 | |||||||
Cash_and_Cash_Equivalents_Tabl
Cash and Cash Equivalents (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Cash and Cash Equivalents | |||||||||
Schedule of summary of cash and cash equivalents | |||||||||
December 31, | |||||||||
2013 | 2014 | ||||||||
Cash | $ | 4,670 | $ | 5,870 | |||||
Investments with original maturity of less than three months at the time of purchase | 26,476 | 18,319 | |||||||
Total cash and cash equivalents | $ | 31,146 | $ | 24,189 |
Fair_Value_Tables
Fair Value (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Fair Value | |||||||||||||||||
Schedule of financial assets and liabilities measured on a recurring basis | The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2013 (in $000s): | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
ASSETS | |||||||||||||||||
Cash equivalents | $ | 26,476 | $ | — | $ | — | $ | 26,476 | |||||||||
Financial instrument associated with stock purchase agreement | — | 397 | — | 397 | |||||||||||||
Total assets | $ | 26,476 | $ | 397 | $ | — | $ | 26,873 | |||||||||
LIABILITIES | |||||||||||||||||
Other liabilities measured at fair value: | |||||||||||||||||
Scottish Enterprise agreement | — | — | 20 | 20 | |||||||||||||
Other liabilities measured at fair value | — | — | 20 | 20 | |||||||||||||
Total liabilities | $ | — | $ | — | $ | 20 | $ | 20 | |||||||||
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2014 (in $000s): | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
ASSETS | |||||||||||||||||
Cash equivalents | $ | 18,319 | $ | — | $ | — | $ | 18,319 | |||||||||
Financial instrument associated with stock purchase agreement | — | 51 | — | 51 | |||||||||||||
Total assets | $ | 18,319 | $ | 51 | $ | — | $ | 18,370 | |||||||||
Schedule of reconciliation of the beginning and ending balance of Level 3 inputs | The following table reconciles the beginning and ending balances of Level 3 inputs for the year ended December 31, 2014 (in $000s): | ||||||||||||||||
Level 3 | |||||||||||||||||
Balance as of December 31, 2013 | 20 | ||||||||||||||||
Change in valuation of Scottish Enterprise agreement | (20 | ) | |||||||||||||||
Balance as of December 31, 2014 | — | ||||||||||||||||
Prepaid_Expenses_and_Other_Cur1
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Prepaid Expense and Other Assets, Current [Abstract] | |||||||||
Schedule of prepaid expenses and other current assets | |||||||||
December 31, | |||||||||
2013 | 2014 | ||||||||
Research and development tax credit receivable | $ | 1,744 | $ | 3,017 | |||||
Prepayments | 427 | 902 | |||||||
Grant receivable | 357 | 134 | |||||||
Sales tax receivable | 209 | 309 | |||||||
Deposits | 132 | 132 | |||||||
Other current assets | 519 | 146 | |||||||
$ | 3,388 | $ | 4,640 |
Property_Plant_and_Equipment_T
Property, Plant and Equipment (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Property, Plant and Equipment | |||||||||||
Schedule of property, plant and equipment | |||||||||||
Useful lives in years from | December 31, | ||||||||||
date of acquisition | 2013 | 2014 | |||||||||
Leasehold improvements | 5 to 15 years | $ | 922 | $ | 914 | ||||||
Research and laboratory equipment | 3 to 5 years | 5,668 | 5,881 | ||||||||
Office equipment and furniture | 3 to 5 years | 1,338 | 1,302 | ||||||||
7,928 | 8,097 | ||||||||||
Less: accumulated depreciation and amortization | (7,653 | ) | (7,710 | ) | |||||||
$ | 275 | $ | 387 | ||||||||
Accrued_and_Other_Current_Liab1
Accrued and Other Current Liabilities (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued and Other Current Liabilities | |||||||||
Schedule of accrued and other current liabilities | |||||||||
December 31, | |||||||||
2013 | 2014 | ||||||||
Accrued research and development | $ | 3,421 | $ | 4,161 | |||||
Accrued legal and professional fees | 265 | 303 | |||||||
Other current liabilities | 745 | 162 | |||||||
$ | 4,431 | $ | 4,626 | ||||||
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies | |||||
Schedule of the Company's contractual obligations and commitments relating to its facilities leases | |||||
Operating | |||||
Lease | |||||
Obligations | |||||
2015 | $ | 560 | |||
2016 | 560 | ||||
2017 | 432 | ||||
2018 | 405 | ||||
2019 | 397 | ||||
Thereafter | 2,304 | ||||
Total | $ | 4,658 | |||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Stockholders' Equity | |||||||||||
Schedule of conversion of convertible preferred stock | |||||||||||
Year Ended | |||||||||||
December 31, | |||||||||||
2013 | |||||||||||
Preferred shares exchanged | 877,869 | ||||||||||
Shares of common stock issued: | |||||||||||
At stated convertible option | 53,366 | ||||||||||
Incremental shares issued under the exchange transaction | 1,631,105 | ||||||||||
Total shares of common stock issued | 1,684,471 | ||||||||||
Schedule of warrants outstanding | |||||||||||
Issued in Connection With | Expiration | Common | Weighted | ||||||||
Date | Shares | Average | |||||||||
Issuable | Exercise | ||||||||||
Price | |||||||||||
January 2010 stock issuance | 2015 | 101,785 | $ | 22.82 | |||||||
January 2010 stock issuance | 2015 | 100,714 | $ | 19.95 | |||||||
October 2010 stock issuance | 2015 | 594,513 | $ | 13.44 | |||||||
July 2011 stock issuance | 2016 | 544,117 | $ | 9.52 | |||||||
Total | 1,341,129 | $ | 13.05 | ||||||||
StockBased_Compensation_Arrang1
Stock-Based Compensation Arrangements (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Stock-Based Compensation Arrangements | |||||||||||||||||
Schedule of stock based compensation expense | |||||||||||||||||
Year Ended | Year Ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2013 | 2014 | ||||||||||||||||
Research and development | $ | 75 | $ | 392 | |||||||||||||
General and administrative | 282 | 831 | |||||||||||||||
Stock-based compensation costs before income taxes | $ | 357 | $ | 1,223 | |||||||||||||
Schedule of stock option activity | |||||||||||||||||
Number of | Weighted | Weighted | Aggregate | ||||||||||||||
Options | Average | Average | Intrinsic | ||||||||||||||
Outstanding | Exercise | Remaining | Value ($000s) | ||||||||||||||
Price Per Share | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Options outstanding at December 31, 2012 | 463,023 | $ | 26.61 | 5.58 | $ | 347 | |||||||||||
Granted | 494,663 | $ | 4.22 | ||||||||||||||
Exercised | — | ||||||||||||||||
Cancelled/forfeited | (8,001 | ) | $ | 18.55 | |||||||||||||
Options outstanding at December 31, 2013 | 949,685 | $ | 15.02 | 7.38 | $ | 152 | |||||||||||
Granted | 63,000 | $ | 3.11 | ||||||||||||||
Exercised | — | ||||||||||||||||
Cancelled/forfeited | (2,387 | ) | $ | 31.08 | |||||||||||||
Options outstanding at December 31, 2014 | 1,010,298 | $ | 14.24 | 6.58 | $ | — | |||||||||||
Unvested at December 31, 2014 | 402,900 | $ | 4.07 | 8.95 | $ | — | |||||||||||
Vested and exercisable at December 31, 2014 | 607,395 | $ | 20.99 | 5 | $ | — | |||||||||||
Schedule of assumptions for stock option grants to employees and directors | |||||||||||||||||
Year ended | Year ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2013 | 2014 | ||||||||||||||||
Expected term (years) | 5 —6 | 6 | |||||||||||||||
Risk free interest rate | 0.84% - 1.865% | 1.835% - 2.005% | |||||||||||||||
Volatility | 97—108% | 101% | |||||||||||||||
Expected dividend yield over expected term | 0.00% | 0.00% | |||||||||||||||
Resulting weighted average grant date fair value | $3.25 | $2.48 | |||||||||||||||
Schedule of restricted stock units activity | |||||||||||||||||
Restricted Stock | Weighted Average | ||||||||||||||||
Units | Grant | ||||||||||||||||
Date Value Per Share | |||||||||||||||||
Non-vested at December 31, 2012 | 39,377 | $ | 5.34 | ||||||||||||||
Granted | 85,097 | $ | 5.71 | ||||||||||||||
Forfeited | (5,226 | ) | $ | 5 | |||||||||||||
Non-vested at December 31, 2013 | 119,248 | $ | 5.62 | ||||||||||||||
Granted | — | $ | — | ||||||||||||||
Vested | (29,999 | ) | $ | 5.81 | |||||||||||||
Forfeited | (233 | ) | $ | 5.39 | |||||||||||||
Non-vested at December 31, 2014 | 89,016 | $ | 5.56 |
Discontinued_Operations_Tables
Discontinued Operations (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Discontinued Operations | |||||||||
Schedule of assets and liabilities, and product revenue, cost of goods sold and selling, general and administrative costs of discontinued operations | |||||||||
Year ended | Year ended | ||||||||
December 31, | December 31, | ||||||||
2013 | 2014 | ||||||||
Interest income | 91 | 29 | |||||||
Income tax on discontinued operations | (34 | ) | (10 | ) | |||||
Net income from discontinued operations, net of tax | $ | 57 | $ | 19 | |||||
December 31, | December 31, | ||||||||
2013 | 2014 | ||||||||
Current assets of discontinued operations: | |||||||||
Short term portion of minimum royalty arrangement receivable, net | $ | 379 | $ | 96 | |||||
Returns indemnification receivable | 260 | 75 | |||||||
Total current assets of discontinued operations | 639 | 171 | |||||||
Long-term assets of discontinued operations: | |||||||||
Long-term portion of minimum royalty arrangement receivable, net | 72 | — | |||||||
Total assets of discontinued operations | $ | 711 | $ | 171 | |||||
Current liabilities of discontinued operations: | |||||||||
Returns provision | $ | 260 | $ | 75 | |||||
Total current liabilities of discontinued operations | $ | 260 | $ | 75 | |||||
Taxes_Tables
Taxes (Tables) | 12 Months Ended | |||||||||||||||
Dec. 31, 2014 | ||||||||||||||||
Taxes | ||||||||||||||||
Schedule of components of (loss) gain before taxes from continuing operations | ||||||||||||||||
Year Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2013 | 2014 | |||||||||||||||
Domestic | $ | 1,132 | $ | (2,898 | ) | |||||||||||
Foreign | (13,012 | ) | (19,751 | ) | ||||||||||||
Loss from continuing operations before taxes | $ | (11,880 | ) | $ | (22,649 | ) | ||||||||||
Schedule of benefit for income taxes from continuing operations | Year Ended | Year Ended | ||||||||||||||
December 31, | December 31, | |||||||||||||||
2013 | 2014 | |||||||||||||||
Current — domestic | $ | (25 | ) | $ | 34 | |||||||||||
Current — foreign | 1,695 | 3,209 | ||||||||||||||
Current — total | 1,670 | 3,243 | ||||||||||||||
Deferred — domestic | — | — | ||||||||||||||
Income tax benefit | $ | 1,670 | $ | 3,243 | ||||||||||||
Schedule of reconciliation of the (benefit) provision for income taxes from continuing operations with the amount computed by applying the statutory federal tax rate to loss before income taxes | | | | Year Ended | | | Year Ended | | ||||||||
December 31, | December 31, | |||||||||||||||
2013 | 2014 | |||||||||||||||
Loss from continuing operations before taxes | | | | $ | -11,880 | | | | | $ | -22,649 | | | |||
Income tax expense computed at statutory federal tax rate | | | | | -4,039 | | | | | | -7,701 | | | |||
Disallowed expenses and non-taxable income | | | | | 62 | | | | | | 406 | | | |||
Loss surrendered to generate R&D credit | | | | | 4,833 | | | | | | 7,294 | | | |||
Additional research and development tax relief | | | | | -4,418 | | | | | | -7,262 | | | |||
Change in valuation allowance | | | | | 6,302 | | | | | | -4,963 | | | |||
Research and development credit – prior years | | | | | -4,530 | | | | | | — | | | |||
Foreign items, including change in tax rates, and other | | | | | 120 | | | | | | 3,555 | | | |||
Other foreign items | | | | | — | | | | | | 5,428 | | | |||
| | | | $ | -1,670 | | | | | $ | -3,243 | | | |||
| ||||||||||||||||
Schedule of significant components of the entity's deferred tax assets | | | | December 31, | | |||||||||||
| | | 2013 | | | 2014 | | |||||||||
Net operating loss carryforwards | | | | $ | 46,144 | | | | | $ | 45,060 | | | |||
Depreciation, amortization and impairment of property and equipment | | | | | 67 | | | | | | 81 | | | |||
Stock options | | | | | 1,651 | | | | | | 1,815 | | | |||
Accrued expenses | | | | | 3,373 | | | | | | 179 | | | |||
Research and development credits | | | | | 4,530 | | | | | | 4,332 | | | |||
Other | | | | | 82 | | | | | | 78 | | | |||
Translation adjustment | | | | | 660 | | | | | | — | | | |||
Deferred tax assets | | | | | 56,507 | | | | | | 51,545 | | | |||
Valuation allowance for deferred tax assets | | | | | -56,507 | | | | | | -51,545 | | | |||
Net deferred taxes | | | | $ | — | | | | | $ | — | | | |||
|
Geographic_Information_Tables
Geographic Information (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Geographic Information | |||||||||
Schedule of geographic information | |||||||||
Year Ended | Year Ended | ||||||||
December 31, | December 31, | ||||||||
2013 | 2014 | ||||||||
Revenue | |||||||||
United Kingdom | $ | 1,084 | $ | 1,734 | |||||
Total Revenue | 1,084 | 1,734 | |||||||
Net loss | |||||||||
United States: | |||||||||
Continuing operations | 1,114 | (3,844 | ) | ||||||
Discontinued operations | 57 | 19 | |||||||
Total United States | 1,171 | (3,825 | ) | ||||||
United Kingdom | (11,324 | ) | (17,296 | ) | |||||
Total Net Loss | $ | (10,153 | ) | $ | 19,387 | ) | |||
December 31, | |||||||||
2013 | 2014 | ||||||||
Total Assets | |||||||||
United States: | |||||||||
Continuing operations | $ | 27,837 | $ | 18,923 | |||||
Discontinued operations | 711 | 171 | |||||||
Total United States | 28,548 | 19,094 | |||||||
United Kingdom | 6,972 | 10,293 | |||||||
Total Assets | 35,520 | 29,387 | |||||||
Long Lived Assets, net | |||||||||
United States: | |||||||||
Continuing operations | 5 | 6 | |||||||
Discontinued operations | — | — | |||||||
Total United States | 5 | 6 | |||||||
United Kingdom | 270 | 381 | |||||||
Total Long Lived Assets, net | $ | 275 | $ | 387 |
Organization_of_the_Company_De
Organization of the Company (Details Textuals) (USD $) | 12 Months Ended |
In Millions, unless otherwise specified | Dec. 31, 2014 |
United kingdoms medical research council | NSCLC and Nasopharyngeal Cancer | |
Organization [Line Items] | |
Grant award amount | $1.60 |
United kingdoms medical research council | Investigational new drug (IND) | |
Organization [Line Items] | |
Grant award amount | 1.8 |
Biomedical catalyst of United Kingdom government | Investigational new drug (IND) | |
Organization [Line Items] | |
Grant award amount | $3.50 |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies (Details) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Net loss per common share | ||
Total shares excluded from calculation | 2,460,824 | 2,618,109 |
Stock options | ||
Net loss per common share | ||
Total shares excluded from calculation | 1,010,298 | 949,685 |
Restricted Stock Units | ||
Net loss per common share | ||
Total shares excluded from calculation | 89,016 | 119,248 |
Convertible preferred stock | ||
Net loss per common share | ||
Total shares excluded from calculation | 20,381 | 20,381 |
Common stock warrants | ||
Net loss per common share | ||
Total shares excluded from calculation | 1,341,129 | 1,591,795 |
Summary_of_Significant_Account4
Summary of Significant Accounting Policies (Detail textuals) | 12 Months Ended |
Dec. 31, 2014 | |
Segment | |
Country | |
Property, Plant and Equipment [Line Items] | |
Number of operating segments | 1 |
Number of geographic areas for development operations | 2 |
Property, plant and equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Property, plant and equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Leasehold improvements | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Leasehold improvements | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 15 years |
Significant_Contracts_Detail_t
Significant Contracts (Detail textuals) (Daiichi Sankyo, USD $) | 12 Months Ended |
In Millions, unless otherwise specified | Dec. 31, 2014 |
Daiichi Sankyo | |
Loss Contingencies [Line Items] | |
Future milestone payments payable | $10 |
Period for which royalties will be paid following first commercial sale of licensed products | 10 years |
Notice period for termination of license by the entity for technical, scientific, efficacy, safety, or commercial reasons | 6 months |
Notice period for termination of license after launch of a sapacitabine-based product by the entity, or by either party for material default | 12 months |
Cash_and_Cash_Equivalents_Deta
Cash and Cash Equivalents (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | |||
Cash and Cash Equivalents | |||
Cash | $5,870 | $4,670 | |
Investments with original maturity of less than three months at the time of purchase | 18,319 | 26,476 | |
Total cash and cash equivalents | $24,189 | $31,146 | $16,412 |
Fair_Value_Details
Fair Value (Details) (Recurring basis, USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Level 1 | ||
ASSETS | ||
Cash equivalents | $18,319,000 | $26,476,000 |
Financial instrument associated with stock purchase agreement | ||
Total assets | 18,319,000 | 26,476,000 |
Other liabilities measured at fair value: | ||
Scottish Enterprise agreement | ||
Other liabilities measured at fair value | ||
Total liabilities | ||
Level 2 | ||
ASSETS | ||
Cash equivalents | ||
Financial instrument associated with stock purchase agreement | 51,000 | 397,000 |
Total assets | 51,000 | 397,000 |
Other liabilities measured at fair value: | ||
Scottish Enterprise agreement | ||
Other liabilities measured at fair value | ||
Total liabilities | ||
Level 3 | ||
ASSETS | ||
Cash equivalents | ||
Financial instrument associated with stock purchase agreement | ||
Total assets | ||
Other liabilities measured at fair value: | ||
Scottish Enterprise agreement | 20,000 | |
Other liabilities measured at fair value | 20,000 | |
Total liabilities | 20,000 | |
Total | ||
ASSETS | ||
Cash equivalents | 18,319,000 | 26,476,000 |
Financial instrument associated with stock purchase agreement | 51,000 | 397,000 |
Total assets | 18,370,000 | 26,873,000 |
Other liabilities measured at fair value: | ||
Scottish Enterprise agreement | 20,000 | |
Other liabilities measured at fair value | 20,000 | |
Total liabilities | $20,000 |
Fair_Value_Details_1
Fair Value (Details 1) (Level 3, USD $) | 12 Months Ended |
In Thousands, unless otherwise specified | Dec. 31, 2014 |
Level 3 | |
Reconciliation of the beginning and ending balance of Level 3 inputs | |
Balance as of December 31, 2013 | $20 |
Change in valuation of Scottish Enterprise agreement | -20 |
Balance as of December 31, 2014 |
Fair_Value_Detail_Textuals
Fair Value (Detail Textuals) (USD $) | 12 Months Ended | 0 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | Nov. 14, 2013 | |
Fair value measurements | |||
Purchase price for shares issued under purchase agreement | $3,132,000 | $9,126,000 | |
Purchase Agreement | Aspire Capital Fund, LLC | |||
Fair value measurements | |||
Number of shares issued under purchase agreement | 511,509 | ||
Purchase price for shares issued under purchase agreement | 2,000,000 | ||
Shares committed to purchase | 3,042,038 | ||
Period of common stock purchase agreement | 2 years | ||
Fair value of financial instrument | 100,000 | 400,000 | 500,000 |
Decrease in the fair value of the purchase agreement | $300,000 |
Fair_Value_Detail_Textuals_1
Fair Value (Detail Textuals 1) (Scottish Enterprise Agreement) | 12 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2014 | |
USD ($) | GBP (£) | USD ($) | |
Scottish Enterprise Agreement | |||
Maximum guaranteed amount potentially due to SE | $6,500,000 | £ 4,000,000 | |
Fair value of the liability | $20,000 | $0 | |
Expected volatility (as a percent) | 30.00% | 30.00% | |
Probability of falling below a minimum staffing level within prescribed time period (as a percent) | 1.00% | 1.00% |
Prepaid_Expenses_and_Other_Cur2
Prepaid Expenses and Other Current Assets (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Prepaid Expense and Other Assets, Current [Abstract] | ||
Research and development tax credit receivable | $3,017 | $1,744 |
Prepayments | 902 | 427 |
Grant receivable | 134 | 357 |
Sales tax receivable | 309 | 209 |
Deposits | 132 | 132 |
Other current assets | 146 | 519 |
Prepaid expenses and other current assets | $4,640 | $3,388 |
Property_Plant_and_Equipment_D
Property, Plant and Equipment (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Property, plant and equipment | ||
Property, plant and equipment, gross | 8,097 | $7,928 |
Less: accumulated depreciation and amortization | -7,710 | -7,653 |
Property, Plant and Equipment, Net | 387 | 275 |
Leasehold improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 914 | 922 |
Leasehold improvements | Minimum | ||
Property, plant and equipment | ||
Useful lives in years from date of acquisition | 5 years | |
Leasehold improvements | Maximum | ||
Property, plant and equipment | ||
Useful lives in years from date of acquisition | 15 years | |
Research and laboratory equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 5,881 | 5,668 |
Research and laboratory equipment | Minimum | ||
Property, plant and equipment | ||
Useful lives in years from date of acquisition | 3 years | |
Research and laboratory equipment | Maximum | ||
Property, plant and equipment | ||
Useful lives in years from date of acquisition | 5 years | |
Office equipment and furniture | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 1,302 | $1,338 |
Office equipment and furniture | Minimum | ||
Property, plant and equipment | ||
Useful lives in years from date of acquisition | 3 years | |
Office equipment and furniture | Maximum | ||
Property, plant and equipment | ||
Useful lives in years from date of acquisition | 5 years |
Property_Plant_and_Equipment_D1
Property, Plant and Equipment (Detail Textuals) (USD $) | 12 Months Ended | |
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Property, Plant and Equipment | ||
Depreciation and amortization expense | $0.20 | $0.20 |
Accrued_and_Other_Current_Liab2
Accrued and Other Current Liabilities (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accrued and Other Current Liabilities | ||
Accrued research and development | $4,161 | $3,421 |
Accrued legal and professional fees | 303 | 265 |
Other current liabilities | 162 | 745 |
Total | $4,626 | $4,431 |
Commitments_and_Contingencies_1
Commitments and Contingencies (Details) (USD $) | Dec. 31, 2014 |
In Thousands, unless otherwise specified | |
Operating Lease Obligations | |
2015 | $560 |
2016 | 560 |
2017 | 432 |
2018 | 405 |
2019 | 397 |
Thereafter | 2,304 |
Total | $4,658 |
Commitments_and_Contingencies_2
Commitments and Contingencies (Detail Textuals) (USD $) | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2013 | Oct. 31, 2000 | Dec. 31, 2014 | Dec. 31, 2013 | |
Leases, related disclosures | ||||
Rent expense, net | $500,000 | $800,000 | ||
Lease term for research and development facility | 25 years | |||
Term of sublease | 1 year | |||
Sublease income recognized | $100,000 | $23,000 |
Commitments_and_Contingencies_3
Commitments and Contingencies (Detail Textuals 1) (USD $) | 12 Months Ended | |
In Millions, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Preferred Dividends | ||
Dividend rate (as a percent) | 6.00% | |
Accrued and unpaid dividends in arrears on preferred stock | $0.60 | $0.60 |
Accrued and unpaid dividends in arrears on preferred stock per share (in dollars per share) | $1.90 | $1.90 |
Stockholders_Equity_Details
Stockholders' Equity (Details) | 12 Months Ended |
Dec. 31, 2013 | |
Preferred stock | |
Conversion of Convertible Preferred Stock | |
Preferred shares exchanged (in shares) | 877,869 |
Common stock | |
Shares of common stock issued: | |
At stated convertible option (in shares) | 53,366 |
Incremental shares issued under the exchange transaction (in shares) | 1,631,105 |
Total shares of common stock issued | 1,684,471 |
Stockholders_Equity_Details_1
Stockholders' Equity (Details 1) (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
Warrants outstanding | |
Common Shares Issuable | 1,341,129 |
Weighted Average Exercise Price (in dollars per share) | $13.05 |
January 2010 stock issuance, one | |
Warrants outstanding | |
Expiration Date | 2015 |
Common Shares Issuable | 101,785 |
Weighted Average Exercise Price (in dollars per share) | $22.82 |
January 2010 stock issuance, two | |
Warrants outstanding | |
Expiration Date | 2015 |
Common Shares Issuable | 100,714 |
Weighted Average Exercise Price (in dollars per share) | $19.95 |
October 2010 stock issuance | |
Warrants outstanding | |
Expiration Date | 2015 |
Common Shares Issuable | 594,513 |
Weighted Average Exercise Price (in dollars per share) | $13.44 |
July 2011 stock issuance | |
Warrants outstanding | |
Expiration Date | 2016 |
Common Shares Issuable | 544,117 |
Weighted Average Exercise Price (in dollars per share) | $9.52 |
Stockholders_Equity_Detail_Tex
Stockholders' Equity (Detail Textuals) (USD $) | 12 Months Ended | 0 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Aug. 02, 2010 |
Director | |||
Stockholders' equity | |||
Preferred stock, shares issued | 335,273 | 335,273 | |
Preferred stock, shares outstanding | 335,273 | 335,273 | |
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 | |
Redemption price per share (in dollars per share) | $10 | ||
Dividend rate (as a percent) | 6.00% | ||
Deemed dividends recorded | $9,027 | ||
Preferred stock | |||
Stockholders' equity | |||
Preferred stock, shares issued | 335,273 | ||
Preferred stock, shares outstanding | 335,273 | ||
Preferred stock, par value (in dollars per share) | $10 | ||
Dividend rate (as a percent) | 6.00% | ||
Liquidation preference (in dollars per share) | $10 | ||
Number of shares to be issued for each preferred stock upon conversion | 0.06079 | ||
Conversion price (in dollars per share) | $164.50 | ||
Shares reserved for future issuance upon conversion | 20,381 | ||
Percentage of the closing sales price of the entity's common stock that the conversion price must exceed in order for the preferred stock to be convertible | 150.00% | ||
Number of trading days during which the closing price of the entity's common stock must exceed the conversion price for at least 20 days in order for the preferred stock to be convertible | 30 days | ||
Number of trading days prior to notice of automatic conversion | 5 days | ||
Number of quarters in which no preferred stock dividends have been paid | 6 | ||
Number of Board of Directors to be elected by Preferred Stock holders if entity fails to pay dividends on Preferred Stock | 2 | ||
Number of Board of Directors elected by the Preferred Stock holders when the entity failed to pay dividends on Preferred Stock | 2 | ||
Interest rate (as a percent) | 6.00% | ||
Debt principal amount per share, basis for exchange (in dollars per share) | $10 | ||
Debt instrument, term | 25 years | ||
Preferred stock | Minimum | |||
Stockholders' equity | |||
Number of series of Preferred stock | 1 | ||
Closing price of stock (in dollars per share) | $246.75 | ||
Number of trading days within 30 trading days in which the closing price of the entity's common stock must exceed the conversion price for the preferred stock to be convertible | 20 days |
Stockholders_Equity_Detail_Tex1
Stockholders' Equity (Detail Textuals 1) (USD $) | 12 Months Ended | 0 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Apr. 03, 2014 |
Equity Offering [Line Items] | |||
Common stock, par value (in dollars per share) | $0.00 | $0.00 | |
Proceed from public offering | $9,289 | $19,006 | |
Common stock | |||
Equity Offering [Line Items] | |||
Number of common shares sold into underwriting agreement (in shares) | 2,857,143 | 6,833,334 | |
Proceed from public offering | 3 | 6 | |
Common stock | April 2014 Underwriting Agreement | |||
Equity Offering [Line Items] | |||
Number of common shares sold into underwriting agreement (in shares) | 2,857,143 | ||
Common stock, par value (in dollars per share) | $0.00 | ||
Share price per share | $3.50 | ||
Proceed from public offering | $9,300 |
Stockholders_Equity_Detail_Tex2
Stockholders' Equity (Detail Textuals 2) (USD $) | 1 Months Ended | 12 Months Ended | 0 Months Ended | 12 Months Ended | 0 Months Ended | 1 Months Ended | |
Apr. 30, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Nov. 14, 2013 | Dec. 31, 2012 | 16-May-13 | 21-May-13 | |
Equity Offering [Line Items] | |||||||
Purchase price for shares issued under purchase agreement | $3,132,000 | $9,126,000 | |||||
Common stock, par value (in dollars per share) | $0.00 | $0.00 | |||||
Proceeds from sale of common stock, net of certain fees and expenses | 9,289,000 | 19,006,000 | |||||
Change in valuation of financial instruments associated with stock purchase agreement | 342,000 | 98,000 | |||||
Economic Rights settled for payments | 600,000 | ||||||
Common shares issued | 1,341,129 | ||||||
Common stock | |||||||
Equity Offering [Line Items] | |||||||
Number of shares issued under purchase agreement | 950,000 | 2,133,401 | |||||
Purchase price for shares issued under purchase agreement | 1,000 | 2,000 | |||||
Shares sold (in shares) | 2,857,143 | 6,833,334 | |||||
Proceeds from sale of common stock, net of certain fees and expenses | 3,000 | 6,000 | |||||
November 2013 Stock Purchase Agreement | Common stock | Aspire Capital Fund, LLC | |||||||
Equity Offering [Line Items] | |||||||
Number of shares issued under purchase agreement | 950,000 | 511,509 | |||||
Purchase price for shares issued under purchase agreement | 3,100,000 | 2,000,000 | |||||
Period of common stock purchase agreement | 2 years | ||||||
Stock issued for non-cash consideration | 166,105 | ||||||
November 2013 Stock Purchase Agreement | Common stock | Maximum | Aspire Capital Fund, LLC | |||||||
Equity Offering [Line Items] | |||||||
Shares committed to purchase | 3,042,038 | ||||||
Common stock purchase agreement, purchase commitment | 18,000,000 | ||||||
December 2012 Stock Purchase Agreement | Common stock | Aspire Capital Fund, LLC | |||||||
Equity Offering [Line Items] | |||||||
Change in valuation of financial instruments associated with stock purchase agreement | 400,000 | ||||||
May 2013 Underwriting Agreement | |||||||
Equity Offering [Line Items] | |||||||
Shares committed for sale under agreement | 6,666,667 | ||||||
Common stock, par value (in dollars per share) | $0.00 | ||||||
Offering price per unit (in dollars per unit) | $3 | $3 | |||||
Shares sold (in shares) | 6,833,334 | ||||||
Number of share sold that were subject to the underwriters' over-allotment option | 166,667 | ||||||
Proceeds from sale of common stock, net of certain fees and expenses | $19,000,000 | ||||||
July 2009 Stock Issuance | |||||||
Equity Offering [Line Items] | |||||||
Common shares issued | 98,893 | ||||||
February 2007 stock issuance | |||||||
Equity Offering [Line Items] | |||||||
Number of shares of common stock issued in connection with warrants | 151,773 |
StockBased_Compensation_Arrang2
Stock-Based Compensation Arrangements (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Stock-based compensation | ||
Stock-based compensation costs before income taxes | $1,223 | $357 |
Research and development | ||
Stock-based compensation | ||
Stock-based compensation costs before income taxes | 392 | 75 |
General and administrative | ||
Stock-based compensation | ||
Stock-based compensation costs before income taxes | $831 | $282 |
StockBased_Compensation_Arrang3
Stock-Based Compensation Arrangements (Details 1) (Stock options, USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Stock options | |||
Number of Options Outstanding | |||
Options outstanding at the beginning of the period (in shares) | 949,685 | 463,023 | |
Granted (in shares) | 63,000 | 494,663 | |
Exercised (in shares) | |||
Cancelled / forfeited (in shares) | -2,387 | -8,001 | |
Options outstanding at the end of the period (in shares) | 1,010,298 | 949,685 | 463,023 |
Unvested at December 31, 2014 | 402,900 | ||
Vested and exercisable at December 31, 2014 | 607,395 | ||
Weighted Average Exercise Price Per Share | |||
Options outstanding at the beginning of the period (in dollars per share) | $15.02 | $26.61 | |
Granted (in dollars per share) | $3.11 | $4.22 | |
Exercised (in dollars per share) | |||
Cancelled / forfeited (in dollars per share) | $31.08 | $18.55 | |
Options outstanding at the end of the period (in dollars per share) | $14.24 | $15.02 | $26.61 |
Unvested at the end of the period (in dollars per share) | $4.07 | ||
Vested and exercisable at the end of the period (in dollars per share) | $20.99 | ||
Weighted Average Remaining Contractual Term (Years) | |||
Options outstanding | 6 years 6 months 29 days | 7 years 4 months 17 days | 5 years 6 months 29 days |
Unvested at the end of the period | 8 years 11 months 12 days | ||
Vested and exercisable at the end of the period | 5 years | ||
Aggregate Intrinsic Value | |||
Options outstanding | $152 | $347 | |
Unvested at the end of the period | |||
Vested and exercisable at the end of the period |
StockBased_Compensation_Arrang4
Stock-Based Compensation Arrangements (Details 2) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Fair value of the stock options granted calculated using Black-Scholes option-pricing model assumptions | ||
Expected term | 6 years | |
Volatility (as a percent) | 101.00% | |
Expected dividend yield over expected term (as a percent) | 0.00% | 0.00% |
Resulting weighted average grant fair value (in dollars per share) | $2.48 | $3.25 |
Stock options | Minimum | ||
Fair value of the stock options granted calculated using Black-Scholes option-pricing model assumptions | ||
Expected term | 5 years | |
Risk free interest rate (as a percent) | 1.84% | 0.84% |
Volatility (as a percent) | 97.00% | |
Stock options | Maximum | ||
Fair value of the stock options granted calculated using Black-Scholes option-pricing model assumptions | ||
Expected term | 6 years | |
Risk free interest rate (as a percent) | 2.01% | 1.87% |
Volatility (as a percent) | 108.00% |
StockBased_Compensation_Arrang5
Stock-Based Compensation Arrangements (Details 3) (Restricted Stock Units, USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Restricted Stock Units | ||
Nonvested activity | ||
Non-vested at the beginning of the period (in shares) | 119,248 | 39,377 |
Granted (in shares) | 85,097 | |
Forfeited (in shares) | -29,999 | -5,226 |
Vested (in shares) | -233 | |
Non-vested at the end of the period (in shares) | 89,016 | 119,248 |
Weighted Average Grant Date Value Per Share | ||
Non-vested at the beginning of the period (in dollars per share) | $5.62 | $5.34 |
Granted (in dollars per share) | $5.71 | |
Forfeited (in dollars per share) | $5.81 | $5 |
Vested (in dollars per share) | $5.39 | |
Non-vested at the end of the period (in dollars per share) | $5.56 | $5.62 |
StockBased_Compensation_Arrang6
Stock-Based Compensation Arrangements (Detail Textuals 1) (USD $) | 0 Months Ended | 12 Months Ended | |
Mar. 16, 2006 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stock-based compensation | |||
Compensation cost | $1,223,000 | 357,000 | |
Weighted average grant-date fair value (in dollars per share) | $2.48 | 3.25 | |
Cash proceeds | -21,000 | ||
Stock options | |||
Stock-based compensation | |||
Vesting period | 4 years | ||
Total remaining unrecognized compensation cost | 900,000 | ||
Weighted-average remaining requisite service period of recognition of unrecognized compensation cost | 1 year 10 months 21 days | ||
Maximum life of stock option awards granted | 10 years | ||
Granted (in shares) | 63,000 | 494,663 | |
Stock option exercised (in shares) | |||
Stock options | Minimum | |||
Stock-based compensation | |||
Vesting period | 1 year | ||
Stock options | Maximum | |||
Stock-based compensation | |||
Vesting period | 4 years | ||
Stock options | Employees and directors | |||
Stock-based compensation | |||
Grant date fair value | 200,000 | 1,600,000 | |
Compensation cost | $100,000 | 400,000 | |
Weighted average grant-date fair value (in dollars per share) | $2.48 | 3.25 | |
Granted (in shares) | 63,000 | 494,663 |
StockBased_Compensation_Arrang7
Stock-Based Compensation Arrangements (Detail Textuals 2) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Stock options | ||
Stock based compensation, additional disclosures | ||
Income (expense) recognized due to revision of forfeiture rate | $500,000 | $40,000 |
Stock options | Minimum | ||
Stock based compensation, additional disclosures | ||
Forfeiture rate (as a percent) | 0.00% | |
Stock options | Maximum | ||
Stock based compensation, additional disclosures | ||
Forfeiture rate (as a percent) | 30.00% | |
Restricted Stock Units | ||
Stock based compensation, additional disclosures | ||
Income (expense) recognized due to revision of forfeiture rate | $500,000 | |
Granted (in shares) | 85,097 | |
Restricted stock units, net of forfeitures | 80,969 |
Employee_Benefit_Plans_Detail_
Employee Benefit Plans (Detail Textuals) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Pension Plan | ||
Employee benefit plans | ||
Contribution made by the entity under the pension plan | $28,000 | $100,000 |
401 (k) Plan | ||
Employee benefit plans | ||
Matching contribution by employer as a percentage of the employee's deferral | 100.00% | |
Matching contribution by employer as a percentage of U.S. employee's qualifying compensation | 6.00% | |
Statutorily prescribed annual limit of contributions made by an employee before attaining age of 50 years | 17,500 | |
Statutorily prescribed annual limit of contributions made by an employee after attaining age of 50 years | 23,000 | |
Specified age limit of employees for calculation of statutorily prescribed annual limit of contribution | 50 years | |
Contribution made by the entity under the 401(k) Plan | $14,000 | $100,000 |
Discontinued_Operations_Detail
Discontinued Operations (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Reclassification of operating results from continuing operations to loss from discontinued operations | ||
Income tax on discontinued operations | ($10) | ($34) |
Net income from discontinued operations, net of tax | 19 | 57 |
ALIGN products | ||
Reclassification of operating results from continuing operations to loss from discontinued operations | ||
Interest income | 29 | 91 |
Income tax on discontinued operations | -10 | -34 |
Net income from discontinued operations, net of tax | $19 | $57 |
Discontinued_Operations_Detail1
Discontinued Operations (Details 1) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets of discontinued operations: | ||
Total current assets of discontinued operations | $171 | $639 |
Current liabilities of discontinued operations: | ||
Total current liabilities of discontinued operations | 75 | 260 |
ALIGN products | ||
Current assets of discontinued operations: | ||
Short-term portion of minimum royalty arrangement receivable, net | 96 | 379 |
Returns indemnification receivable | 75 | 260 |
Total current assets of discontinued operations | 171 | 639 |
Long-term assets of discontinued operations: | ||
Long-term portion of minimum royalty arrangement receivable, net | 72 | |
Total assets of discontinued operations | 171 | 711 |
Current liabilities of discontinued operations: | ||
Returns provision | 75 | 260 |
Total current liabilities of discontinued operations | $75 | $260 |
Taxes_Details
Taxes (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Loss (income) from continuing operations before taxes | ||
Domestic | ($2,898) | $1,132 |
Foreign | -19,751 | -13,012 |
Loss from continuing operations before taxes | ($22,649) | ($11,880) |
Taxes_Details_1
Taxes (Details 1) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Benefit for income taxes from continuing operations | ||
Current - domestic | $34 | ($25) |
Current - foreign | 3,209 | 1,695 |
Current - total | 3,243 | 1,670 |
Deferred - domestic | ||
Income tax benefit | $3,243 | $1,670 |
Taxes_Details_2
Taxes (Details 2) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Reconciliation of the (benefit) provision for income taxes | ||
Loss from continuing operations before taxes | ($22,649) | ($11,880) |
Income tax expense computed at statutory federal tax rate | -7,701 | -4,039 |
Disallowed expenses and non-taxable income | 406 | 62 |
Loss surrendered to generate R&D credit | 7,294 | 4,833 |
Additional research and development tax relief | -7,262 | -4,418 |
Change in valuation allowance | -4,963 | 6,302 |
Research and development credit - prior years | -4,530 | |
Foreign items, including change in tax rates, and other | 3,555 | 120 |
Other foreign items | 5,428 | |
Current - total | ($3,243) | ($1,670) |
Taxes_Details_3
Taxes (Details 3) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Significant components of the entity's deferred tax assets | ||
Net operating loss carryforwards | $45,060 | $46,144 |
Depreciation, amortization and impairment of property and equipment | 81 | 67 |
Stock options | 1,815 | 1,651 |
Accrued expenses | 179 | 3,373 |
Research and development credits | 4,332 | 4,530 |
Other | 78 | 82 |
Translation adjustment | 660 | |
Deferred tax assets | 51,545 | 56,507 |
Valuation allowance for deferred tax assets | -51,545 | -56,507 |
Net deferred taxes |
Taxes_Detail_Textuals
Taxes (Detail Textuals) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Taxes | ||
Valuation allowance for deferred tax assets | $51,545,000 | $56,507,000 |
Change in valuation allowance | -4,963,000 | 6,302,000 |
Federal | ||
Taxes | ||
NOLs carryforward | 23,900,000 | 22,100,000 |
Foreign | ||
Taxes | ||
NOLs carryforward | 173,000,000 | 162,400,000 |
State | ||
Taxes | ||
NOLs carryforward | 10,400,000 | |
Research and development | Foreign | ||
Taxes | ||
Income tax credits | $3,200,000 | $1,700,000 |
Geographic_Information_Details
Geographic Information (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $1,734 | $1,084 |
Net loss | -19,387 | -10,153 |
Assets | 29,387 | 35,520 |
Long Lived Assets, net | 387 | 275 |
United States | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Net loss | -3,825 | 1,171 |
Assets | 19,094 | 28,548 |
Long Lived Assets, net | 6 | 5 |
United States | Continuing operations | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Net loss | -3,844 | 1,114 |
Assets | 18,923 | 27,837 |
Long Lived Assets, net | 6 | 5 |
United States | Discontinued operations | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Net loss | 19 | 57 |
Assets | 171 | 711 |
Long Lived Assets, net | ||
United Kingdom | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 1,734 | 1,084 |
Net loss | -17,296 | -11,324 |
Assets | 10,293 | 6,972 |
Long Lived Assets, net | $381 | $270 |
Subsequent_Events_Detail_Textu
Subsequent Events (Detail Textuals) (USD $) | 12 Months Ended | 0 Months Ended | |||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Mar. 09, 2015 | Feb. 02, 2015 | Feb. 18, 2015 |
Subsequent Event [Line Items] | |||||
Proceeds from sale of common stock, net of certain fees and expenses | $9,289 | $19,006 | |||
Subsequent event | |||||
Subsequent Event [Line Items] | |||||
Shares sold (in shares) | 10,000,000 | ||||
Price per share (in dollars per share) | $1 | ||||
Proceeds from sale of common stock, net of certain fees and expenses | $9,200 | ||||
Minimum bid price | $1 | ||||
Number of consecutive business days | 30 days | ||||
Compliance condition | Pursuant to the NASDAQ Listing Rule 5810(c)(3)(A), the Company has been granted a 180-calendar day compliance period, or until August 3, 2015, to regain compliance with the minimum bid price requirement. During the compliance period, the Company's shares of common stock will continue to be listed and traded on The NASDAQ Global Market. To regain compliance, the closing bid price of the Company's shares of common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180-day grace period. If the Company is not in compliance by August 3, 2015, the Company may be afforded a second 180-calendar day grace period if the Company transfers the listing of our shares of common stock to The NASDAQ Capital Market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The NASDAQ Capital Market, except for the minimum bid price. In addition, the Company would be required to notify NASDAQ of its intent to cure the minimum bid price deficiency by effecting a reverse stock split, if necessary. | ||||
Subsequent event | Preferred stock | |||||
Subsequent Event [Line Items] | |||||
Cash dividend declared per share (in dollars per share) | $0.15 | ||||
Dividend expected date to be paid | 1-May-15 |