Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 14, 2016 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | Cyclacel Pharmaceuticals, Inc. | |
Entity Central Index Key | 1,130,166 | |
Trading Symbol | cycc | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 4,251,229 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 18,029 | $ 20,440 |
Prepaid expenses and other current assets | 4,521 | 4,051 |
Current assets of discontinued operations | 29 | 75 |
Total current assets | 22,579 | 24,566 |
Property, plant and equipment (net) | 73 | 198 |
Total assets | 22,652 | 24,764 |
Current liabilities: | ||
Accounts payable | 1,979 | 1,940 |
Accrued and other current liabilities | 3,562 | 3,738 |
Current liabilities of discontinued operations | 29 | 75 |
Total current liabilities | 5,570 | 5,753 |
Other liabilities | 141 | 176 |
Total liabilities | 5,711 | 5,929 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2015 and September 30, 2016; 335,273 shares issued and outstanding at December 31, 2015 and September 30, 2016. Aggregate preference in liquidation of $4,006,511 at December 31, 2015 and September 30, 2016. | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2015 and September 30, 2016; 2,965,208 and 4,251,229 shares issued and outstanding at December 31, 2015 and September 30, 2016, respectively. | 4 | 3 |
Additional paid-in capital | 349,897 | 342,587 |
Accumulated other comprehensive loss | (760) | (596) |
Accumulated deficit | (332,200) | (323,159) |
Total stockholders' equity | 16,941 | 18,835 |
Total liabilities and stockholders' equity | $ 22,652 | $ 24,764 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parentheticals) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
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) | $ 4,006,511 | $ 4,006,511 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 4,251,229 | 2,965,208 |
Common stock, shares outstanding | 4,251,229 | 2,965,208 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenues: | ||||
Grant revenue | $ 205 | $ 462 | $ 566 | $ 1,270 |
Collaboration and research and development revenue | 253 | 253 | ||
Total revenues | 205 | 715 | 566 | 1,523 |
Operating expenses: | ||||
Research and development | 2,409 | 2,904 | 7,545 | 9,826 |
General and administrative | 1,273 | 1,205 | 4,002 | 4,006 |
Total operating expenses | 3,682 | 4,109 | 11,547 | 13,832 |
Operating loss | (3,477) | (3,394) | (10,981) | (12,309) |
Other income (expense): | ||||
Change in valuation of financial instruments associated with stock purchase agreement | (27) | (51) | ||
Foreign exchange gains (losses) | 51 | 219 | 369 | (354) |
Interest income | 8 | 2 | 31 | 5 |
Other income, net | 18 | 13 | 56 | 95 |
Total other income (expense) | 77 | 207 | 456 | (305) |
Loss before taxes | (3,400) | (3,187) | (10,525) | (12,614) |
Income tax benefit | 454 | 478 | 1,573 | 1,646 |
Net loss | (2,946) | (2,709) | (8,952) | (10,968) |
Dividend on convertible exchangeable preferred shares | (50) | (50) | (150) | (150) |
Net loss applicable to common shareholders | $ (2,996) | $ (2,759) | $ (9,102) | $ (11,118) |
Basic and diluted earnings per common share: | ||||
Net loss per share - basic and diluted (in dollars per share) | $ (0.86) | $ (0.95) | $ (2.89) | $ (4.20) |
Weighted average common shares outstanding (in shares) | 3,473,696 | 2,889,893 | 3,145,730 | 2,645,159 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (2,946) | $ (2,709) | $ (8,952) | $ (10,968) |
Translation adjustment | (4,881) | 5,107 | (19,928) | 2,880 |
Unrealized foreign exchange (loss) gain on intercompany loans | 4,860 | (5,259) | 19,766 | (2,940) |
Comprehensive loss | $ (2,967) | $ (2,861) | $ (9,114) | $ (11,028) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Operating activities: | ||
Net loss | $ (8,952) | $ (10,968) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Change in valuation of financial instruments associated with stock purchase agreement | 51 | |
Depreciation | 109 | 157 |
Stock-based compensation | 614 | 464 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 629 | 583 |
Accounts payable and other current liabilities | 464 | (2,071) |
Net cash used in operating activities | (7,136) | (11,784) |
Investing activities: | ||
Purchase of property, plant and equipment | (32) | |
Minimum royalty payments received from termination of ALIGN license agreement | 23 | |
Net cash used in investing activities | (9) | |
Financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 5,241 | 10,576 |
Payment of preferred stock dividend | (150) | (150) |
Net cash provided by financing activities | 5,091 | 10,426 |
Effect of exchange rate changes on cash and cash equivalents | (366) | (94) |
Net decrease in cash and cash equivalents | (2,411) | (1,461) |
Cash and cash equivalents, beginning of period | 20,440 | 24,189 |
Cash and cash equivalents, end of period | 18,029 | 22,728 |
Cash received during the period for: | ||
Interest | 31 | 6 |
Taxes | 1,965 | 2,875 |
Non cash financing activities: | ||
Accrual of preferred stock dividends | 50 | $ 50 |
Receivable from issuance of common stock | $ 1,518 |
NATURE OF OPERATIONS AND BASIS
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | 1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION Nature of Operations Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or “the Company”), 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 and the cyclin dependent kinase (“CDK”) inhibitor program. Sapacitabine is being evaluated in the SEAMLESS Phase 3 study, which completed enrollment in December 2014 and is 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. In December 2014, the study’s Data Safety Monitoring Board, or DSMB, conducted a planned interim analysis for futility after 247 events, or patient deaths, and the final safety review of 470 randomized patients. The DSMB found no safety concerns. However, the planned futility boundary has been crossed and the DSMB determined that, based on available interim data, it would be unlikely for the study to reach statistically significant improvement in survival. The DSMB saw no reasons why patients should discontinue treatment on their assigned arm and recommended that recruited patients stay on treatment. In accordance with the DSMB’s recommendations, the Company continued to follow-up patients as per the study protocol. The required number of events has been reached and the Company is conducting so-called data cleaning and validation operations prior to determining that the study data base can be locked. Study data will then be transferred to the Company’s independent statistical analysis vendor. When final analysis becomes available, the Company will report outcomes for the primary and secondary endpoints and determination of submissibility of the SEAMLESS data set to regulatory authorities in Europe and the United States. The procedures to be followed prior to reporting topline data and determination of submissibility to regulatory authorities may take several months. As of September 30, 2016, 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 has incurred recurring operating losses since inception. For the nine months ended September 30, 2016, the Company incurred a net loss applicable to common stockholders of $9.1 million and as of September 30, 2016 the Company had generated an accumulated deficit of $332.2 million. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to the clinical development of its drug candidates, its preclinical programs and its administrative organization. At September 30, 2016, the Company had cash and cash equivalents of $18.0 million. The Company will need to raise substantial additional capital to pursue a regulatory strategy for the potential approval and commercialization of sapacitabine, its product candidate for the potential treatment of AML, and to continue the development of sapacitabine in other indications and the CDK inhibitor program. The Company has funded all of its operations and capital expenditures with proceeds from the issuance of public equity securities, private placements of securities, interest on investments, government grants, research and development tax credits, product revenue and licensing revenue. Additional funding may not be available to the Company on favorable terms, or at all. If the Company is unable to obtain additional funds, it will need to reduce operating expenses, enter into a collaboration or other similar arrangement with respect to development and/or commercialization rights to sapacitabine or its CDK inhibitors, if available, or be forced to delay or reduce the scope of its sapacitabine or CDK inhibitor development programs, potentially including any potential regulatory filings related to the SEAMLESS study, and/or limit or cease its operations. On June 23, 2016, the Company entered into an At Market Issuance Sales Agreement (the “FBR Sales Agreement”) with FBR Capital Markets & Co. (“FBR”) under which it may issue and sell shares of its common stock, from time to time, through FBR, acting as its sales agent, under the Company’s effective “shelf” registration statement on Form S-3, which became effective on June 8, 2016. The Company has sold 766,149 shares of common stock under the sales agreement for net proceeds of approximately $3.9 million pursuant to a prospectus supplement dated as of June 23, 2016. The Company has sold 477,876 shares of common stock under the sales agreement for net proceeds of approximately $2.8 million pursuant to a prospectus supplement dated as of August 30, 2016, and there are a further approximately $1.2 million shares that may be sold pursuant to this prospectus supplement. Basis of Presentation The consolidated balance sheet as of September 30, 2016, the consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2015 and 2016, the consolidated statements of cash flows for the nine months ended September 30, 2016, and all related disclosures contained in the accompanying notes are unaudited. The consolidated balance sheet as of December 31, 2015 is derived from the audited consolidated financial statements included in the 2015 Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”). The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of September 30, 2016, and the results of operations and comprehensive loss for the three and nine months ended September 30, 2016, and the consolidated statements of cash flows for the nine months ended September 30, 2016, have been made. The interim results for the three and nine months ended September 30, 2016 are not necessarily indicative of the results to be expected for the year ending December 31, 2016 or for any other year. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2015 that are included in the Company’s Annual Report on Form 10-K filed with the SEC. Reverse Stock Split On May 27, 2016, the Company completed a one-for-twelve reverse stock split (the “Reverse Stock Split”), which reduced the number of shares of the Company’s common stock that were issued and outstanding immediately prior to the effectiveness of the Reverse Stock Split. The number of shares of the Company’s authorized common stock was not affected by the Reverse Stock Split and the par value of Cyclacel’s common stock remained unchanged at $0.001 per share. The Reverse Stock Split reduced the number of shares of the Company’s common stock that were outstanding at May 27, 2016 from 36,075,730 to 3,006,311 after the cancellation of fractional shares. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who otherwise held fractional shares of the Company’s common stock as a result of the Reverse Stock Split received a cash payment in lieu of such fractional shares. All amounts related to number of shares and per share amounts have been retroactively restated in these consolidated financial statements. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
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 expenses and the fair value of financial instruments. 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. Risks and Uncertainties Drug candidates developed by the Company typically will require approvals or clearances from the FDA, EMA 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 is denied approval or clearance or if such approval was delayed, or the Company 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. The Company has relied upon government grants to fund its earlier stage programs and does not expect to be able to continue to rely on obtaining government grants to fund the Company’s research and development activities. 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: 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. The Company maintains its cash and cash equivalents in bank deposits and other interest bearing accounts, the balances of which exceeded federally insured limits. Fair Value of Financial Instruments Financial instruments consist of cash and cash equivalents, accounts payable, accrued liabilities, 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 are measured at fair value using applicable inputs as described in Note 3 — Fair Value Revenue Recognition Collaboration, supply and licensing agreements Consideration received is allocated to each of the separable elements in an arrangement using the relative selling price method. An element is separable if it has value to the customer on a stand-alone basis. The selling price used for each separable element will be based on vendor-specific objective evidence (“VSOE”) if available, third party evidence if VSOE is not available, or estimated selling price if neither VSOE nor third party evidence is available. Revenue is recognized for each separate element when persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the fee is fixed or determinable; and collectability is reasonably assured. Grant revenue 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. CROs and CRAs typically bill monthly for services performed, although some 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. 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 Accounting Standards Codification Topic 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 more likely than not probability threshold that 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. Stock-based Compensation The Company grants stock options, restricted stock units and restricted stock to officers, employees and directors under the 2015 Equity Incentive Plan (“2015 Plan”), which was approved on May 22, 2015 and which replaced the Amended and Restated Equity Incentive Plan (“2006 Plan”). Under both plans, the Company has granted various types of awards, which are described more fully in Note 6 — Stock-Based Compensation Arrangements. ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on the 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 forfeitures, using the straight-line attribution method. Effective January 1, 2016, the Company has elected to account for forfeitures as they occur, as permitted by Accounting Standards Update (“ASU”) 2016-09, Compensation — Stock Compensation (Topic 718), Improvements to Employee Share-Based Payment Accounting. See the Accounting Standards Adopted in the Period Prior to the adoption of ASU 2016-09, the Company estimated the number of stock-based awards that were expected to vest, and only recognized compensation expense for such awards. The estimation of stock awards that will ultimately vest required judgment, and to the extent actual results or updated estimates differed from current estimates, such amounts were recorded as a cumulative adjustment in the period during which estimates were revised. The Company considered many factors when estimating expected forfeitures, including type of awards granted, employee class, and historical experience. 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 shares of common stock outstanding during the period. The following table represents the potential common shares issuable pursuant to outstanding securities as of the related period end dates that have not been included in the computation of diluted net loss per share, as the result would be anti-dilutive: Three months ended Nine months ended September 30, 2015 2016 2015 2016 Stock options 111,163 393,723 111,163 393,723 Convertible preferred stock 1,698 1,698 1,698 1,698 Common stock warrants 94,886 - 94,886 - Total shares excluded from calculation 207,747 395,421 207,747 395,421 Comprehensive Income (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 (loss). Accounting Standards Adopted in the Period In March 2016, the Financial Accounting Standards Boards (“FASB”) issued ASU 2016-09, which simplified several aspects of employee share-based payment accounting. In particular, the ASU permits entities to make an accounting policy election to either estimate forfeitures on share-based payment awards, as previously required, or to recognize forfeitures as they occur. Effective January 1, 2016, the Company elected to recognize forfeitures as they occur. The impact of that change in accounting policy has been recorded as an $89,000 cumulative effect adjustment to accumulated deficit, as of January 1, 2016. The Company expects that it will recognize slightly higher share-based payment expense for the remainder of 2016, relative to prior periods, as the effects of forfeitures will not be recognized until they occur, rather than being estimated at the time of grant and subsequently adjusted as and when necessary. The effects of adopting the remaining provisions in ASU 2016-09 affecting the income tax consequences of share-based payments, classification of awards as either equity or liabilities when an entity partially settles the award in cash in excess of the employer’s minimum statutory withholding requirements and classification in the statement of cash flows did not have any impact on the Company’s financial position, results of operations or cash flows. The Company has adopted guidance issued by the FASB in April 2015 which clarifies a customer’s accounting for fees paid in a cloud computing arrangement (ASU 2015-05, Intangibles — Goodwill and Other — Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement). The guidance provides a customer with guidance on whether a cloud computing arrangement includes a software license and clarifies that the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. The guidance has been adopted prospectively to all arrangements entered into or materially modified after January 1, 2016. The adoption of this guidance did not have any impact on the financial position, results of operations or cash flows. In November 2014 the FASB issued ASU 2014-16 (“ASU 2014-16”), Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share Is More Akin to Debt or to Equity, which provides guidance on whether a derivative embedded in preferred stock must be bifurcated and accounted for separately from its host contract. ASU2014-16 applies to to existing instruments issued prior to the effective date. The guidance has been adopted effective January 1, 2016. The adoption of this guidance did not have any impact on the consolidated financial position, results of operations or cash flows. The Company has adopted guidance issued by the FASB in June 2014 which requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition (ASU 2014-12, Compensation — Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period (a consensus of the FASB Emerging Issues Task Force)). The guidance has been adopted prospectively to all awards granted or modified after January 1, 2016. The adoption of this guidance did not have any impact on the consolidated financial position, results of operations or cash flows. Recent Accounting Pronouncements Not Yet Effective 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. In August 2015, the FASB deferred the effective date of the guidance, which will now be effective for the Company on January 1, 2018, for both interim and annual periods. Early adoption is permitted for both interim and annual periods commencing on January 1, 2017. 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. The Company has yet to evaluate which adoption method it plans to use or the potential effect of the new standard on its consolidated financial statements. In March 2016 the FASB issued further clarification on the principal versus agent considerations (reporting revenue gross versus net) included within the new revenue recognition guidance. This guidance will be effective upon the adoption of the new revenue recognition guidance. In April 2016 the FASB issued further clarification on identifying performance obligations in a contract with a customer and provided implementation guidance on whether licenses are satisfied at a point in time or over time. This guidance will be effective upon the adoption of the new revenue recognition guidance. In May 2016, the FASB issued further guidance, which provided clarification on the new revenue recognition guidance. This clarification did not change the core principles but provided narrow-scope improvements to the guidance and certain practical expedients available upon transitioning to the guidance. The Company is currently assessing the impact of adopting the guidance. 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 revenues from collaboration, supply and licensing agreements, and the Company is evaluating the effects of the new standard on these types of revenue streams. 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 the annual period ending after 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 November 2015, the FASB issued guidance on the classification of deferred taxes on the balance sheet. The guidance is effective for fiscal periods beginning after December 15, 2016, and interim periods within those annual periods. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. In February 2016, the FASB issued guidance on the accounting for leases. The guidance requires that lessees recognize a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term at the commencement date. The guidance also makes targeted improvements to align lessor accounting with the lessee accounting model and guidance on revenue from contracts with customers. The guidance is effective for the fiscal year beginning January 1, 2019, including interim periods within that fiscal year. Early application is permitted. The guidance must be adopted on a modified retrospective transition approach for leases existing, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company is currently evaluating the impact of the guidance on the consolidated financial statements. In August 2016, the FASB issued guidance clarifying the classification of certain cash receipts and cash payments within the cash flow statement where current GAAP either is unclear or does not include specific guidance. The amendments are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted. The amendments must be adopted using a retrospective transition method to each period presented. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. |
FAIR VALUE
FAIR VALUE | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE | 3. 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, 2015 (in $000s): Level 1 Level 2 Level 3 Total Carrying Value ASSETS Cash equivalents $ 11,953 $ — $ — $ 11,953 $ 11,953 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 September 30, 2016 (in $000s): Level 1 Level 2 Level 3 Total Carrying Value ASSETS Cash equivalents $ 11,181 $ — $ — $ 11,181 $ 11,181 |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 9 Months Ended |
Sep. 30, 2016 | |
Prepaid Expenses And Other Current Assets [Abstract] | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 4. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following (in $000s): December 31, September 30, 2015 2016 Research and development tax credit receivable $ 2,093 $ 1,392 Prepayments 893 845 Grant receivable 326 249 Sales tax receivable 607 366 Deposits 132 132 Other current assets — 1,537 $ 4,051 $ 4,521 Other current assets is a receivable for the proceeds from the sales of common stock under the FBR sales agreement, which were received in October 2016. The Company accounts for shares sold using “Trade Date Accounting”. The $1.5 million represents stock issued prior to September 30, 2016 but for which settlement occurred in October, 2016. |
ACCRUED AND OTHER CURRENT LIABI
ACCRUED AND OTHER CURRENT LIABILITIES | 9 Months Ended |
Sep. 30, 2016 | |
Payables And Accruals [Abstract] | |
ACCRUED AND OTHER CURRENT LIABILITIES | 5. ACCRUED AND OTHER CURRENT LIABILITIES Accrued and other current liabilities consisted of the following (in $000s): December 31, September 30, 2015 2016 Accrued research and development $ 3,284 $ 3,221 Accrued legal and professional fees 291 208 Other current liabilities 163 133 $ 3,738 $ 3,562 |
STOCK BASED COMPENSATION
STOCK BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure Of Compensation Related Costs Share-Based Payments [Abstract] | |
STOCK BASED COMPENSATION | 6. STOCK BASED COMPENSATION 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 one to four years. Effective January 1, 2016, the Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Forfeiture will be recognized in the periods when they occur. Refer to Note 2, Summary of Significant Accounting Policies, for further information. In prior periods, ASC 718 required 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 evaluated its forfeiture assumptions quarterly and the expected forfeiture rate 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 the three and nine months ended September 30, 2015 and 2016 as shown in the following table (in $000s): Three Months Ended Nine months Ended 2015 2016 2015 2016 General and administrative $ 97 $ 113 $ 312 $ 376 Research and development 44 79 152 238 Stock-based compensation costs before income taxes $ 141 $ 192 $ 464 $ 614 The Company does not expect to be able to benefit from a tax deduction for stock option exercises that may occur during the year ended December 31, 2016 because the company has tax loss carryforwards from prior periods that would be expected to offset any potential taxable income for the year ended December 31, 2016. 2015 Plan On May 22, 2015, the Company’s stockholders approved the 2015 Equity Incentive Plan (the “2015 Plan”), under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The company has reserved 291,667 shares of the Company’s common stock under the 2015 Plan. The 2015 Plan replaces the 2006 Equity Incentive Plan (the “2006 Plan”), under which there were no remaining reserved shares as of June 30, 2016. Stock option awards granted under the Company’s equity incentive plans have a maximum life of 10 years and generally vest over a one to four-year period from the date of grant. There were 197,841 options granted during the nine months ended September 30, 2016. Of these options, 189,091 are performance based, which will vest upon the fulfilment of certain clinical conditions and will terminate if they have not vested by December 31, 2020. The Company determined that the satisfaction of the vesting criteria was not probable as of September 30, 2016 and, as a result, did not record any expense related to these awards for the nine months ended September 30, 2016. 2006 Plan On March 16, 2006, Cyclacel adopted the 2006 Plan, under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The Company had reserved 119,047 shares of the Company’s common stock under the 2006 Plan. 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. There were 27,221 options granted under the 2006 Plan during the nine months ended September 30, 2015. There were no stock options exercised during each of the nine months ended September 30, 2015 and 2016, respectively. Outstanding Options A summary of the share option activity and related information is as follows: Number of Weighted Weighted Aggregate Options outstanding at December 31, 2015 206,298 $ 72.60 8.09 $ — Granted 197,841 $ 4.68 Cancelled/forfeited (10,416 ) $ 335.19 Options outstanding at September 30, 2016 393,723 $ 31.52 6.02 $ 262 Unvested at September 30, 2016 (280,287 ) $ 5.96 5.83 $ 262 Vested and exercisable at September 30, 2016 113,436 $ 94.67 6.51 $ — The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718. The expected term assumption is estimated using past history of early exercise behavior and expectations about future behaviors. 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. In periods prior to January 1, 2016, estimates of pre-vesting option forfeitures were based on the Company’s experience. The Company used a forfeiture rate of 0 - 30% depending on when and to whom the options are granted. The Company adjusted 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 were recognized through a cumulative adjustment in the period of change. The Company considered many factors when estimating expected forfeitures, including types of awards, employee class, and historical experience. Restricted Stock Units Summarized information for restricted stock unit activity for the nine months ended September 30, 2015 is as follows: Restricted Stock Weighted Average Non-vested at December 31, 2014 7,418 $ 66.72 Granted — $ — Vested (7,418 ) $ 66.72 Non-vested at September 30, 2015 — $ — During the nine months ended September 30, 2015, 7,418 restricted stock units vested. The Company did not issue any restricted stock units during the nine months ended September 30, 2015 and 2016, respectively. |
DISTRIBUTION, LICENSING AND RES
DISTRIBUTION, LICENSING AND RESEARCH AGREEMENTS | 9 Months Ended |
Sep. 30, 2016 | |
Distribution, Licensing And Research Agreements [Abstract] | |
DISTRIBUTION, LICENSING AND RESEARCH AGREEMENTS | 7. 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. Daiichi Sankyo license Pursuant to the Daiichi Sankyo license under which the Company licenses certain patent rights for sapacitabine, its lead drug candidate, the Company has agreed to pay Daiichi Sankyo an up-front fee, to reimburse Daiichi Sankyo for enumerated expenses, and to make milestone payments and to pay 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. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2016 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | 8. STOCKHOLDERS’ EQUITY Preferred Stock As of September 30, 2016, there were 335,273 shares of the Company’s 6% Convertible Exchangeable Preferred Stock (“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 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 0.00507 shares of common stock for each share of Preferred Stock based on a price of $1,974.00 per share. The Company has reserved 1,698 shares of common stock for issuance upon conversion of the remaining shares of Preferred Stock outstanding on September, 2016. 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 $2,961.00 per share, 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 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. On March 29, 2016, the Board of Directors (the “Board”) of the Company declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend was paid on May 2, 2016 to the holders of record of the Preferred Stock as of the close of business on April 18, 2016. On May 26, 2016, the Board of the Company declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend was paid on August 1, 2016 to the holders of record of the Preferred Stock as of the close of business on July 17, 2016. On September 6, 2016, the Board of the Company declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend was be paid on November 1, 2016 to the holders of record of the Preferred Stock as of the close of business on October 17, 2016. Common Stock June 2016 At Market Issuance On June 23, 2016, the Company entered into the FBR Sales Agreement, under which the Company may issue and sell shares of its common stock, from time to time through FBR, acting as its sales agent, under the Company’s effective “shelf” registration statement on Form S-3 which became effective on June 8, 2016. Under the FBR Sales Agreement, FBR may sell the shares of common stock by any method that is deemed to be an “at the market offering”. The Company will pay FBR a commission of 3.0% of the gross sales price per share sold. The Company is not obligated to make any sales of common stock under the FBR Sales Agreement. As of September 30, 2016, pursuant to a prospectus supplement dated June 23, 2016, the Company has sold 766,149 shares of common stock under the sales agreement for net proceeds of approximately $3.9 million, and pursuant to a prospectus supplement dated August 30, 2016, the Company has sold 477,876 shares of common stock under the sales agreement for net proceeds of approximately $2.8 million. There are a further approximately $1.2 million of our shares of common stock that may be sold pursuant to the prospectus supplement dated as of August 30, 2016. July 2015 Controlled Equity Offering SM On July 10, 2015, the Company entered into a Controlled Equity Offering SM Cantor”), under which the Company was able, from time to time, to sell shares of its common stock having an aggregate offering price of up to $8.35 million through Cantor. March 2015 Public Offering On March 9, 2015, the Company completed a public offering of 833,333 shares of its common stock at a price to the public of $12.00 per share for proceeds, net of certain fees and expenses, of approximately $9.2 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 42,626 shares of common stock for an aggregate purchase price of $2.0 million. Under the terms of the Purchase Agreement, Aspire committed to purchase up to an additional 253,503 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 was 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 13,842 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 remeasured each reporting period, until the agreement expired on July 8, 2015, with gains or losses reported in the consolidated statements of operations. On July 8, 2015, all of the available shares under the Aspire Agreement were sold and the Aspire Agreement has automatically terminated by its terms. Common Stock Warrants There are no outstanding warrants at September 30, 2016. The 45,343 warrants outstanding at June 30, 2016 related to the July 2011 stock issuance and these warrants lapsed in July 2016. There were no exercises of warrants during the nine months ended September 30, 2015 and 2016. |
SUMMARY OF SIGNIFICANT ACCOUN15
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
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 expenses and the fair value of financial instruments. 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. |
Risks and Uncertainties | Risks and Uncertainties Drug candidates developed by the Company typically will require approvals or clearances from the FDA, EMA 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 is denied approval or clearance or if such approval was delayed, or the Company 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. The Company has relied upon government grants to fund its earlier stage programs and does not expect to be able to continue to rely on obtaining government grants to fund the Company’s research and development activities. |
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: 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. The Company maintains its cash and cash equivalents in bank deposits and other interest bearing accounts, the balances of which exceeded federally insured limits. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Financial instruments consist of cash and cash equivalents, accounts payable, accrued liabilities, 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 are measured at fair value using applicable inputs as described in Note 3 — Fair Value |
Revenue Recognition | Revenue Recognition Collaboration, supply and licensing agreements Consideration received is allocated to each of the separable elements in an arrangement using the relative selling price method. An element is separable if it has value to the customer on a stand-alone basis. The selling price used for each separable element will be based on vendor-specific objective evidence (“VSOE”) if available, third party evidence if VSOE is not available, or estimated selling price if neither VSOE nor third party evidence is available. Revenue is recognized for each separate element when persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the fee is fixed or determinable; and collectability is reasonably assured. Grant revenue 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. CROs and CRAs typically bill monthly for services performed, although some 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. |
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 Accounting Standards Codification Topic 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 more likely than not probability threshold that 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. |
Stock-based Compensation | Stock-based Compensation The Company grants stock options, restricted stock units and restricted stock to officers, employees and directors under the 2015 Equity Incentive Plan (“2015 Plan”), which was approved on May 22, 2015 and which replaced the Amended and Restated Equity Incentive Plan (“2006 Plan”). Under both plans, the Company has granted various types of awards, which are described more fully in Note 6 — Stock-Based Compensation Arrangements. ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on the 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 forfeitures, using the straight-line attribution method. Effective January 1, 2016, the Company has elected to account for forfeitures as they occur, as permitted by Accounting Standards Update (“ASU”) 2016-09, Compensation — Stock Compensation (Topic 718), Improvements to Employee Share-Based Payment Accounting. See the Accounting Standards Adopted in the Period Prior to the adoption of ASU 2016-09, the Company estimated the number of stock-based awards that were expected to vest, and only recognized compensation expense for such awards. The estimation of stock awards that will ultimately vest required judgment, and to the extent actual results or updated estimates differed from current estimates, such amounts were recorded as a cumulative adjustment in the period during which estimates were revised. The Company considered many factors when estimating expected forfeitures, including type of awards granted, employee class, and historical experience. |
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 shares of common stock outstanding during the period. The following table represents the potential common shares issuable pursuant to outstanding securities as of the related period end dates that have not been included in the computation of diluted net loss per share, as the result would be anti-dilutive: Three months ended Nine months ended September 30, 2015 2016 2015 2016 Stock options 111,163 393,723 111,163 393,723 Convertible preferred stock 1,698 1,698 1,698 1,698 Common stock warrants 94,886 - 94,886 - Total shares excluded from calculation 207,747 395,421 207,747 395,421 |
Comprehensive Income (Loss) | Comprehensive Income (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 (loss). |
Accounting Standards Adopted in the Period | Accounting Standards Adopted in the Period In March 2016, the Financial Accounting Standards Boards (“FASB”) issued ASU 2016-09, which simplified several aspects of employee share-based payment accounting. In particular, the ASU permits entities to make an accounting policy election to either estimate forfeitures on share-based payment awards, as previously required, or to recognize forfeitures as they occur. Effective January 1, 2016, the Company elected to recognize forfeitures as they occur. The impact of that change in accounting policy has been recorded as an $89,000 cumulative effect adjustment to accumulated deficit, as of January 1, 2016. The Company expects that it will recognize slightly higher share-based payment expense for the remainder of 2016, relative to prior periods, as the effects of forfeitures will not be recognized until they occur, rather than being estimated at the time of grant and subsequently adjusted as and when necessary. The effects of adopting the remaining provisions in ASU 2016-09 affecting the income tax consequences of share-based payments, classification of awards as either equity or liabilities when an entity partially settles the award in cash in excess of the employer’s minimum statutory withholding requirements and classification in the statement of cash flows did not have any impact on the Company’s financial position, results of operations or cash flows. The Company has adopted guidance issued by the FASB in April 2015 which clarifies a customer’s accounting for fees paid in a cloud computing arrangement (ASU 2015-05, Intangibles — Goodwill and Other — Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement). The guidance provides a customer with guidance on whether a cloud computing arrangement includes a software license and clarifies that the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. The guidance has been adopted prospectively to all arrangements entered into or materially modified after January 1, 2016. The adoption of this guidance did not have any impact on the financial position, results of operations or cash flows. In November 2014 the FASB issued ASU 2014-16 (“ASU 2014-16”), Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share Is More Akin to Debt or to Equity, which provides guidance on whether a derivative embedded in preferred stock must be bifurcated and accounted for separately from its host contract. ASU2014-16 applies to to existing instruments issued prior to the effective date. The guidance has been adopted effective January 1, 2016. The adoption of this guidance did not have any impact on the consolidated financial position, results of operations or cash flows. The Company has adopted guidance issued by the FASB in June 2014 which requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition (ASU 2014-12, Compensation — Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period (a consensus of the FASB Emerging Issues Task Force)). The guidance has been adopted prospectively to all awards granted or modified after January 1, 2016. The adoption of this guidance did not have any impact on the consolidated financial position, results of operations or cash flows. |
Recent Accounting Pronouncements Not Yet Effective | Recent Accounting Pronouncements Not Yet Effective 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. In August 2015, the FASB deferred the effective date of the guidance, which will now be effective for the Company on January 1, 2018, for both interim and annual periods. Early adoption is permitted for both interim and annual periods commencing on January 1, 2017. 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. The Company has yet to evaluate which adoption method it plans to use or the potential effect of the new standard on its consolidated financial statements. In March 2016 the FASB issued further clarification on the principal versus agent considerations (reporting revenue gross versus net) included within the new revenue recognition guidance. This guidance will be effective upon the adoption of the new revenue recognition guidance. In April 2016 the FASB issued further clarification on identifying performance obligations in a contract with a customer and provided implementation guidance on whether licenses are satisfied at a point in time or over time. This guidance will be effective upon the adoption of the new revenue recognition guidance. In May 2016, the FASB issued further guidance, which provided clarification on the new revenue recognition guidance. This clarification did not change the core principles but provided narrow-scope improvements to the guidance and certain practical expedients available upon transitioning to the guidance. The Company is currently assessing the impact of adopting the guidance. 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 revenues from collaboration, supply and licensing agreements, and the Company is evaluating the effects of the new standard on these types of revenue streams. 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 the annual period ending after 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 November 2015, the FASB issued guidance on the classification of deferred taxes on the balance sheet. The guidance is effective for fiscal periods beginning after December 15, 2016, and interim periods within those annual periods. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. In February 2016, the FASB issued guidance on the accounting for leases. The guidance requires that lessees recognize a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term at the commencement date. The guidance also makes targeted improvements to align lessor accounting with the lessee accounting model and guidance on revenue from contracts with customers. The guidance is effective for the fiscal year beginning January 1, 2019, including interim periods within that fiscal year. Early application is permitted. The guidance must be adopted on a modified retrospective transition approach for leases existing, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company is currently evaluating the impact of the guidance on the consolidated financial statements. In August 2016, the FASB issued guidance clarifying the classification of certain cash receipts and cash payments within the cash flow statement where current GAAP either is unclear or does not include specific guidance. The amendments are effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted. The amendments must be adopted using a retrospective transition method to each period presented. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. |
SUMMARY OF SIGNIFICANT ACCOUN16
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Schedule of antidilutive shares excluded from computation of diluted net loss per share | Three months ended Nine months ended September 30, 2015 2016 2015 2016 Stock options 111,163 393,723 111,163 393,723 Convertible preferred stock 1,698 1,698 1,698 1,698 Common stock warrants 94,886 - 94,886 - Total shares excluded from calculation 207,747 395,421 207,747 395,421 |
FAIR VALUE (Tables)
FAIR VALUE (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
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, 2015 (in $000s): Level 1 Level 2 Level 3 Total Carrying Value ASSETS Cash equivalents $ 11,953 $ — $ — $ 11,953 $ 11,953 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 September 30, 2016 (in $000s): Level 1 Level 2 Level 3 Total Carrying Value ASSETS Cash equivalents $ 11,181 $ — $ — $ 11,181 $ 11,181 |
PREPAID EXPENSES AND OTHER CU18
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Prepaid Expenses And Other Current Assets [Abstract] | |
Schedule of prepaid expenses and other current assets | December 31, September 30, 2015 2016 Research and development tax credit receivable $ 2,093 $ 1,392 Prepayments 893 845 Grant receivable 326 249 Sales tax receivable 607 366 Deposits 132 132 Other current assets — 1,537 $ 4,051 $ 4,521 |
ACCRUED AND OTHER CURRENT LIA19
ACCRUED AND OTHER CURRENT LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Payables And Accruals [Abstract] | |
Schedule of accrued and other current liabilities | December 31, September 30, 2015 2016 Accrued research and development $ 3,284 $ 3,221 Accrued legal and professional fees 291 208 Other current liabilities 163 133 $ 3,738 $ 3,562 |
STOCK BASED COMPENSATION (Table
STOCK BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure Of Compensation Related Costs Share-Based Payments [Abstract] | |
Schedule of stock based compensation expense | Three Months Ended Nine months Ended 2015 2016 2015 2016 General and administrative $ 97 $ 113 $ 312 $ 376 Research and development 44 79 152 238 Stock-based compensation costs before income taxes $ 141 $ 192 $ 464 $ 614 |
Schedule of share option activity | Number of Weighted Weighted Aggregate Options outstanding at December 31, 2015 206,298 $ 72.60 8.09 $ — Granted 197,841 $ 4.68 Cancelled/forfeited (10,416 ) $ 335.19 Options outstanding at September 30, 2016 393,723 $ 31.52 6.02 $ 262 Unvested at September 30, 2016 (280,287 ) $ 5.96 5.83 $ 262 Vested and exercisable at September 30, 2016 113,436 $ 94.67 6.51 $ — |
Schedule of restricted stock units activity | Restricted Stock Weighted Average Non-vested at December 31, 2014 7,418 $ 66.72 Granted — $ — Vested (7,418 ) $ 66.72 Non-vested at September 30, 2015 — $ — |
NATURE OF OPERATIONS AND BASI21
NATURE OF OPERATIONS AND BASIS OF PRESENTATION (Detail Textuals) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Aug. 30, 2016 | Jun. 23, 2016 | May 27, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Nature Of Operations And Basis Of Presentation [Line Items] | |||||||||
Net loss applicable to common stockholders | $ (2,996) | $ (2,759) | $ (9,102) | $ (11,118) | |||||
Accumulated deficit | (332,200) | (332,200) | $ (323,159) | ||||||
Cash and cash equivalents | $ 18,029 | $ 22,728 | $ 18,029 | $ 22,728 | $ 20,440 | $ 24,189 | |||
Sale of stock, value | $ 1,200 | ||||||||
Stockholders' equity, Reverse stock split | one-for-twelve | ||||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Common stock, shares outstanding | 4,251,229 | 4,251,229 | 2,965,208 | ||||||
Before Reverse Stock Split | |||||||||
Nature Of Operations And Basis Of Presentation [Line Items] | |||||||||
Common stock, shares outstanding | 36,075,730 | ||||||||
After Reverse Stock Split | |||||||||
Nature Of Operations And Basis Of Presentation [Line Items] | |||||||||
Common stock, shares outstanding | 3,006,311 | ||||||||
FBR Sales Agreement | |||||||||
Nature Of Operations And Basis Of Presentation [Line Items] | |||||||||
Shares sold (in shares) | 477,876 | 766,149 | |||||||
Sale of stock, value | $ 2,800 | $ 3,900 |
SUMMARY OF SIGNIFICANT ACCOUN22
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Net loss per common share | ||||
Total shares excluded from calculation | 395,421 | 207,747 | 395,421 | 207,747 |
Stock options | ||||
Net loss per common share | ||||
Total shares excluded from calculation | 393,723 | 111,163 | 393,723 | 111,163 |
Convertible preferred stock | ||||
Net loss per common share | ||||
Total shares excluded from calculation | 1,698 | 1,698 | 1,698 | 1,698 |
Common stock warrants | ||||
Net loss per common share | ||||
Total shares excluded from calculation | 94,886 | 94,886 |
SUMMARY OF SIGNIFICANT ACCOUN23
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Detail Textuals) | 9 Months Ended |
Sep. 30, 2016USD ($)Segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Number of geographic areas for development operations | 2 |
Cumulative effect adjustment to accumulated deficit | $ | $ 89,000 |
FAIR VALUE (Details)
FAIR VALUE (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
ASSETS | ||
Cash equivalents | $ 11,181 | $ 11,953 |
Recurring basis | Level 1 | ||
ASSETS | ||
Cash equivalents | 11,181 | 11,953 |
Recurring basis | Level 2 | ||
ASSETS | ||
Cash equivalents | ||
Recurring basis | Level 3 | ||
ASSETS | ||
Cash equivalents | ||
Recurring basis | Total | ||
ASSETS | ||
Cash equivalents | $ 11,181 | $ 11,953 |
PREPAID EXPENSES AND OTHER CU25
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Research and development tax credit receivable | $ 1,392 | $ 2,093 |
Prepayments | 845 | 893 |
Grant receivable | 249 | 326 |
Sales tax receivable | 366 | 607 |
Deposits | 132 | 132 |
Other current assets | 1,537 | |
Prepaid expenses and other current assets | $ 4,521 | $ 4,051 |
PREPAID EXPENSES AND OTHER CU26
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Detail Textuals) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | |
Aug. 30, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | |
Prepaid Expenses And Other Current Assets [Line Items] | |||
Proceeds from sales of common stock | $ 2,800 | $ 5,241 | $ 10,576 |
FBR Sales Agreement | Common stock | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Proceeds from sales of common stock | $ 1,500 |
ACCRUED AND OTHER CURRENT LIA27
ACCRUED AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Payables And Accruals [Abstract] | ||
Accrued research and development | $ 3,221 | $ 3,284 |
Accrued legal and professional fees | 208 | 291 |
Other current liabilities | 133 | 163 |
Total | $ 3,562 | $ 3,738 |
STOCK BASED COMPENSATION (Detai
STOCK BASED COMPENSATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Stock-based compensation | ||||
Stock-based compensation costs before income taxes | $ 192 | $ 141 | $ 614 | $ 464 |
General and administrative | ||||
Stock-based compensation | ||||
Stock-based compensation costs before income taxes | 113 | 97 | 376 | 312 |
Research and development | ||||
Stock-based compensation | ||||
Stock-based compensation costs before income taxes | $ 79 | $ 44 | $ 238 | $ 152 |
STOCK BASED COMPENSATION (Det29
STOCK BASED COMPENSATION (Details 1) - Stock options - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Number of Options Outstanding | ||
Options outstanding at December 31, 2015 | 206,298 | |
Granted | 197,841 | |
Cancelled/forfeited | (10,416) | |
Options outstanding at September 30, 2016 | 393,723 | 206,298 |
Unvested at September 30, 2016 | 280,287 | |
Vested and exercisable at September 30, 2016 | 113,436 | |
Weighted Average Exercise Price Per Share | ||
Options outstanding at December 31, 2015 | $ 72.60 | |
Granted | 4.68 | |
Cancelled/forfeited | 335.19 | |
Options outstanding at September 30, 2016 | 31.52 | $ 72.60 |
Unvested at September 30, 2016 | 5.96 | |
Vested and exercisable at September 30, 2016 | $ 94.67 | |
Weighted Average Remaining Contractual Term (Years) | ||
Options outstanding | 6 years 7 days | 8 years 1 month 2 days |
Unvested at September 30, 2016 | 5 years 9 months 29 days | |
Vested and exercisable at September 30, 2016 | 6 years 6 months 4 days | |
Aggregate Intrinsic Value | ||
Options outstanding | $ 262 | |
Unvested at September 30, 2016 | 262 | |
Vested and exercisable at September 30, 2016 |
STOCK BASED COMPENSATION (Det30
STOCK BASED COMPENSATION (Details 2) - Restricted Stock Units | 9 Months Ended |
Sep. 30, 2015$ / sharesshares | |
Nonvested activity | |
Non-vested at December 31, 2014 | shares | 7,418 |
Granted | shares | |
Vested | shares | (7,418) |
Non-vested at September 30, 2015 | shares | |
Weighted Average Grant Date Value Per Share | |
Non-vested at December 31, 2014 | $ / shares | $ 66.72 |
Granted | $ / shares | |
Vested | $ / shares | 66.72 |
Non-vested at September 30, 2015 | $ / shares |
STOCK BASED COMPENSATION (Det31
STOCK BASED COMPENSATION (Detail Textuals) - shares | 1 Months Ended | 9 Months Ended | ||
May 22, 2015 | Mar. 16, 2006 | Sep. 30, 2016 | Sep. 30, 2015 | |
Stock options | ||||
Stock-based compensation | ||||
Options granted (in shares) | 197,841 | |||
Stock options | 2015 plan | ||||
Stock-based compensation | ||||
Number of shares reserved for issuance | 291,667 | |||
Expiration period | 10 years | |||
Options granted (in shares) | 197,841 | |||
Stock options | 2015 plan | Minimum | ||||
Stock-based compensation | ||||
Vesting period | 1 year | |||
Stock options | 2015 plan | Maximum | ||||
Stock-based compensation | ||||
Vesting period | 4 years | |||
Stock options | 2006 plan | ||||
Stock-based compensation | ||||
Number of shares reserved for issuance | 119,047 | |||
Expiration period | 10 years | |||
Options granted (in shares) | 27,221 | |||
Stock options | 2006 plan | Minimum | ||||
Stock-based compensation | ||||
Vesting period | 1 year | |||
Stock options | 2006 plan | Maximum | ||||
Stock-based compensation | ||||
Vesting period | 4 years | |||
Performance based share | 2015 plan | ||||
Stock-based compensation | ||||
Options granted (in shares) | 189,091 |
STOCK BASED COMPENSATION (Det32
STOCK BASED COMPENSATION (Detail Textuals 1) - shares | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2016 | |
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 | ||
Restricted stock units vested | 7,418 |
DISTRIBUTION, LICENSING AND R33
DISTRIBUTION, LICENSING AND RESEARCH AGREEMENTS (Detail Textuals) $ in Millions | Sep. 30, 2016USD ($) |
Distribution, Licensing And Research Agreements [Abstract] | |
Future milestone payments payable | $ 10 |
STOCKHOLDERS' EQUITY (Detail Te
STOCKHOLDERS' EQUITY (Detail Textuals) | Sep. 06, 2016$ / shares | May 26, 2016$ / shares | Mar. 29, 2016$ / shares | Sep. 30, 2016Conversion_rateSeries$ / sharesshares | Dec. 31, 2015$ / sharesshares |
Stockholders' equity | |||||
Preferred stock, shares issued | shares | 335,273 | 335,273 | |||
Preferred stock, shares outstanding | shares | 335,273 | 335,273 | |||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Convertible Exchangeable Preferred Stock | |||||
Stockholders' equity | |||||
Preferred stock, shares issued | shares | 335,273 | ||||
Preferred stock, shares outstanding | shares | 335,273 | ||||
Share issue price per share | $ 10 | ||||
Dividend rate on convertible exchangeable preferred stock (in percent) | 6.00% | ||||
Liquidation preference (in dollars per share) | $ 10 | ||||
Number of shares to be issued for each preferred stock upon conversion | Conversion_rate | 0.00507 | ||||
Conversion price (in dollars per share) | $ 1,974 | ||||
Common stock shares reserved for future issuance upon conversion | shares | 1,698 | ||||
Number of series of Preferred Stock | Series | 1 | ||||
Minimum bid price per share | $ 2,961 | ||||
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 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 | ||||
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 | ||||
Redemption price per share (in dollars per share) | $ 10 | ||||
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 dividend declared, amount per share | $ 0.15 | $ 0.15 | $ 0.15 |
STOCKHOLDERS' EQUITY (Detail 35
STOCKHOLDERS' EQUITY (Detail Textuals 1) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Aug. 30, 2016 | Jun. 23, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | |
Nature Of Operations And Basis Of Presentation [Line Items] | ||||
Sale of stock, value | $ 1,200 | |||
Proceeds from issuance of common stock | $ 2,800 | $ 5,241 | $ 10,576 | |
FBR Sales Agreement | ||||
Nature Of Operations And Basis Of Presentation [Line Items] | ||||
Number of common shares sold into underwriting agreement (in shares) | 477,876 | 766,149 | ||
Sale of stock, value | $ 2,800 | $ 3,900 | ||
Percentage of commission on gross equity sales | 3.00% |
STOCKHOLDERS' EQUITY (Detail 36
STOCKHOLDERS' EQUITY (Detail Textuals 2) - USD ($) $ in Thousands | Jul. 10, 2015 | Aug. 30, 2016 | Sep. 30, 2016 | Sep. 30, 2015 |
Equity Offering [Line Items] | ||||
Proceeds from Issuance of Common Stock | $ 2,800 | $ 5,241 | $ 10,576 | |
Controlled Equity Offering Sales Agreement | Cantor Fitzgerald & Co., ("Cantor") | ||||
Equity Offering [Line Items] | ||||
Maximum amount of offering price for common stock | $ 8,350 | |||
Number of common shares sold into underwriting agreement (in shares) | 114,078 | 40,779 | ||
Proceeds from Issuance of Common Stock | $ 200 |
STOCKHOLDERS' EQUITY (Detail 37
STOCKHOLDERS' EQUITY (Detail Textuals 3) - USD ($) $ / shares in Units, $ in Millions | Mar. 09, 2015 | Aug. 30, 2016 |
Equity Offering [Line Items] | ||
Issue of common stock of certain fees and expenses | $ 1.2 | |
Common stock | March 2015 Public Offering | ||
Equity Offering [Line Items] | ||
Number of common shares sold into underwriting agreement (in shares) | 833,333 | |
Share price per share | $ 12 | |
Issue of common stock of certain fees and expenses | $ 9.2 |
STOCKHOLDERS' EQUITY (Detail 38
STOCKHOLDERS' EQUITY (Detail Textuals 4) - November 2013 Stock Purchase Agreement - Common stock - Aspire Capital Fund, LLC $ in Millions | Nov. 14, 2013USD ($)shares |
Common Stock | |
Number of shares issued under purchase agreement | 42,626 |
Purchase price for shares issued under purchase agreement | $ | $ 2 |
Period of common stock purchase agreement | 2 years |
Stock issued in lieu of a commitment fee | 13,842 |
Maximum | |
Common Stock | |
Maximum additional shares committed to purchase | 253,503 |
Common stock purchase agreement, purchase commitment | $ | $ 18 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textuals 5) - July 2011 stock issuance | 6 Months Ended |
Jun. 30, 2016shares | |
Warrants outstanding | |
Expiration Date | 2,016 |
Warrants outstanding | 45,343 |