Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 28, 2019 | Jun. 29, 2018 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Cyclacel Pharmaceuticals, Inc. | ||
Entity Central Index Key | 0001130166 | ||
Trading Symbol | cycc | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Common Stock, Shares Outstanding | 17,199,974 | ||
Entity Public Float | $ 15,117,872 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Ex Transition Period | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 17,504 | $ 23,910 |
Prepaid expenses and other current assets | 2,283 | 2,064 |
Total current assets | 19,787 | 25,974 |
Property and equipment, net | 36 | 29 |
Total assets | 19,823 | 26,003 |
Current liabilities: | ||
Accounts payable | 2,719 | 1,558 |
Accrued and other current liabilities | 1,732 | 2,555 |
Total current liabilities | 4,451 | 4,113 |
Other liabilities | 100 | 124 |
Total liabilities | 4,551 | 4,237 |
Commitments and contingencies (Notes 3 and 9) | ||
Stockholders' equity: | ||
Preferred stock, value | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2017 and December 31, 2018; 11,997,447 and 12,497,447 shares issued and outstanding at December 31, 2017 and December 31, 2018, respectively | 12 | 12 |
Additional paid-in capital | 365,817 | 365,057 |
Accumulated other comprehensive loss | (760) | (794) |
Accumulated deficit | (349,797) | (342,509) |
Total stockholders' equity | 15,272 | 21,766 |
Total liabilities and stockholders' equity | 19,823 | 26,003 |
6% Convertible Exchangeable preferred stock | ||
Stockholders' equity: | ||
Preferred stock, value | ||
Series A convertible preferred stock | ||
Stockholders' equity: | ||
Preferred stock, value |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parentheticals) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
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 | 12,497,447 | 11,997,447 |
Common stock, shares outstanding | 12,497,447 | 11,997,447 |
6% Convertible Exchangeable preferred stock | ||
Preferred stock, shares issued | 335,273 | 335,273 |
Preferred stock, shares outstanding | 335,273 | 335,273 |
Preferred stock, liquidation preference value (in dollars) | $ 4,006,512 | $ 4,006,512 |
Series A Preferred Stock | ||
Preferred stock, shares issued | 264 | 264 |
Preferred stock, shares outstanding | 264 | 264 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | ||
Collaboration and research and development revenue | $ 150 | $ 0 |
Operating expenses: | ||
Research and development | 4,327 | 4,237 |
General and administrative | 5,371 | 5,254 |
Total operating expenses | 9,698 | 9,491 |
Operating loss | (9,548) | (9,491) |
Other income (expense): | ||
Foreign exchange losses | (90) | (39) |
Interest income | 331 | 118 |
Other income, net | 682 | 949 |
Total other income (expense), net | 923 | 1,028 |
Loss from continuing operations before taxes | (8,625) | (8,463) |
Income tax benefit | 1,337 | 993 |
Net loss | (7,288) | (7,470) |
Dividend on convertible exchangeable preferred shares | (201) | (201) |
Beneficial conversion feature of Series A convertible stock | 0 | (3,638) |
Conversion of Series A convertible preferred stock | 0 | (3,537) |
Net loss applicable to common shareholders | $ (7,489) | $ (14,846) |
Basic and diluted earnings per common share: | ||
Net loss per share - basic and diluted (in dollars per share) | $ (0.62) | $ (1.95) |
Weighted average common shares outstanding (in shares) | 12,094,131 | 7,631,152 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | $ (7,288) | $ (7,470) |
Translation adjustment | 9,370 | (14,687) |
Unrealized foreign exchange gain (loss) on intercompany loans | (9,336) | 14,636 |
Comprehensive loss | $ (7,254) | $ (7,521) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Balance at Dec. 31, 2016 | $ 4 | $ 350,051 | $ (743) | $ (335,039) | $ 14,273 | |
Balance (in shares) at Dec. 31, 2016 | 335,273 | 4,256,829 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issue of common stock, preferred stock and associated warrants on underwritten offering, net of expenses | $ 3 | 13,681 | 13,684 | |||
Issue of common stock, preferred stock and associated warrants on underwritten offering, net of expenses (in shares) | 8,872 | 3,154,000 | ||||
Series A Preferred stock conversions | $ 4 | (4) | ||||
Series A Preferred stock conversions (in shares) | (8,608) | 4,304,000 | ||||
Warrant exercise | 199 | 199 | ||||
Warrant exercise (in shares) | 99,500 | |||||
Issue of common stock on At Market Issuance sales agreement | 1,066 | 1,066 | ||||
Issue of common stock on At Market Issuance sales agreement (in shares) | 183,118 | |||||
Stock-based compensation | 266 | 266 | ||||
Preferred stock dividends | (201) | (201) | ||||
Unrealized foreign exchange on intercompany loans | 14,636 | 14,636 | ||||
Translation adjustment | (14,687) | (14,687) | ||||
Loss for the period | (7,470) | (7,470) | ||||
Balance at Dec. 31, 2017 | $ 12 | 365,057 | (794) | (342,509) | 21,766 | |
Balance (in shares) at Dec. 31, 2017 | 335,537 | 11,997,447 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issue of common stock on At Market Issuance sales agreement | 630 | 630 | ||||
Issue of common stock on At Market Issuance sales agreement (in shares) | 500,000 | |||||
Stock-based compensation | 331 | 331 | ||||
Preferred stock dividends | (201) | (201) | ||||
Unrealized foreign exchange on intercompany loans | (9,336) | (9,336) | ||||
Translation adjustment | 9,370 | 9,370 | ||||
Loss for the period | (7,288) | (7,288) | ||||
Balance at Dec. 31, 2018 | $ 12 | $ 365,817 | $ (760) | $ (349,797) | $ 15,272 | |
Balance (in shares) at Dec. 31, 2018 | 335,537 | 12,497,447 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (7,288) | $ (7,470) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 29 | 32 |
Stock-based compensation expense | 331 | 266 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (327) | 1,232 |
Accounts payable and other current liabilities | 554 | (1,540) |
Net cash used in operating activities | (6,701) | (7,480) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (39) | (13) |
Net cash used in investing activities | (39) | (13) |
Cash flows from financing activities: | ||
Proceeds from issuance of equity securities, net of issuance costs | 630 | 14,749 |
Proceeds from the exercise of stock options and warrants, net of issuance costs | 200 | |
Payment of preferred stock dividend | (201) | (201) |
Net cash provided by financing activities | 429 | 14,748 |
Effect of exchange rate changes on cash and cash equivalents | (95) | 135 |
Net increase/(decrease) in cash and cash equivalents | (6,406) | 7,390 |
Cash and cash equivalents at beginning of period | 23,910 | 16,520 |
Cash and cash equivalents at end of period | 17,504 | 23,910 |
Cash received during the period for: | ||
Interest | 331 | 118 |
Taxes | 1,158 | 1,815 |
Non cash financing activities: | ||
Accrual of preferred stock dividends | $ 50 | $ 50 |
Organization of the Company and
Organization of the Company and Basis of Presentation | 12 Months Ended |
Dec. 31, 2018 | |
Organization of the Company | |
Organization of the Company and Basis of Presentation | 1. Organization of the Company and Basis of Presentation Cyclacel Pharmaceuticals Inc., (“Cyclacel” or “the Company”) is a clinical-stage biopharmaceutical company using its expertise in cell cycle, transcriptional regulation and DNA damage response biology in cancer cells to develop innovative medicines. The transcriptional regulation program is evaluating CYC065, a CDK inhibitor, in patients with advanced solid cancers and in combination with venetoclax in patients with advanced hematological malignancies, including CLL and AML. The DNA damage response program is evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in BRCA positive patients with advanced solid cancers and a concomitant regimen of sapacitabine and olaparib, a PARP inhibitor, in BRCA positive patients with breast cancer. CYC140, a PLK inhibitor, is in a Phase 1 first-in-human study in patients with advanced leukemias. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. As of December 31, 2018, 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. The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, drug candidates developed by the Company typically will require approvals or clearances from the FDA, EMA or other similar regulatory agencies in other countries prior to commercial sales. There can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If the Company was denied approval or clearance or such approval was delayed, or is unable to obtain the necessary financing to complete development and approval, there will be a material adverse impact on the Company’s financial condition and results of operations. Through December 31, 2018, the Company has funded all of its operations and capital expenditures with proceeds from the issuance of public equity securities, private placements of securities, government grants, research and development tax credits, interest on investments, royalty income, product revenue and licensing revenue. The Company has incurred recurring losses since its inception, including net losses of $7.5 million and $7.3 million for the years ended December 31, 2017 and 2018, respectively. As of December 31, 2018, the Company had an accumulated deficit of $349.8 million. The Company expects to continue to generate operating losses 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. Going Concern Management considers that there are no conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern for a period of at least one year from the date the financial statements are issued. The Company expects that its cash of $17.5 million as of December 31, 2018 will be sufficient to fund its operating expenses and capital expenditure requirements through the second quarter of 2020. This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued, including: a. The Company’s current financial condition, including its liquidity sources b. The Company’s conditional and unconditional obligations due or anticipated within one year c. The funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows, and d. Other conditions and events, when considered in conjunction with the above that may adversely affect the Company’s ability to meet its obligations. The future viability of the Company beyond the second quarter of 2020 is dependent on its ability to raise additional capital to finance its operations. The Company will need to raise substantial additional capital to pursue the transcriptional regulation program, evaluating CYC065, a CDK inhibitor, in patients with advanced cancers or the DNA damage response program, evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in patients with BRCA positive, advanced solid cancers 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 CDK inhibitors and sapacitabine development programs, including any potential regulatory filings related to the SEAMLESS study, and/or limit or cease its operations. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. 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. Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the financial statements of Cyclacel Pharmaceuticals, Inc. and all of the Company’s wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical estimates include inputs used to determine clinical trial accruals, stock-based compensation expense and the recognition of revenue. 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. 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. Cash and Cash Equivalents Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. 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. 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 deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any significant credit risk on cash and cash equivalents. The Company’s cash and cash equivalents balance at December 31, 2018 was $17.5 million and it maintains its cash accounts in several entities both within the United States and the United Kingdom. The total cash balances for amounts held in the United States are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 per account. The Company has cash balances exceeding the balance insured by the FDIC that totaled approximately $16.8 million at December 31, 2018. The total cash balances for amounts held in the United Kingdom are insured by the UK Government Financial Services Compensation Scheme (“FSCS”) up to £75,000 per account. The Company has cash balances exceeding the balance insured by the FSCS that totaled approximately $0.2 million at December 31, 2018. Property and Equipment The components of property and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets, which are generally three to five years. Amortization of leasehold improvements is performed using the straight-line method over the shorter of the remaining lease term or the estimated useful life of the related assets, currently between five and fifteen years. Upon sale or retirement of assets, the costs and related accumulated depreciation and amortization are removed from the balance sheet and the resulting gain or loss on sale is reflected as a component of operating income or loss. Expenditures for maintenance and repairs are charged to operating expenses as incurred. Impairment of Long-lived Assets The Company reviews property and equipment for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company assesses the recoverability of the potentially affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. Impairment, if any, is measured as the amount by which the carrying amount of a long-lived asset (or asset group) exceeds its fair value. Fair Value of Financial Instruments Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Assets and liabilities measured at fair value are classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1 — Quoted prices in active markets for identical assets or liabilities. • Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying values of cash and cash equivalents, other receivables, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. Segments The Company is managed and operated as one business which is focused on using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases .The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information with respect to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment with development operations in two geographic areas, namely the United States and the United Kingdom. Revenue Recognition On January 1, 2018, the Company adopted new guidance on revenue recognition, which has been codified within Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers With effect from January 1, 2018, the Company recognizes revenue using the five step model provided in ASC 606, which involves: (1) identifying the contract with a customer; (2) identifying the performance obligations in the contract; (3) determining the transaction price; (4) allocating the transaction price to the performance obligations in the contract; and (5) recognizing revenue when, or as, the Company satisfies a performance obligation. The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers: • Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies; • Whether the uncertainty about the achievement of a milestone is not expected to be resolved for a long period of time; • Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and • The complexity and inherent uncertainty underlying the achievement of a milestone. The transaction price is allocated to each performance obligation based on the relative standalone selling price of each performance obligation. The best estimate of the standalone selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives. The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation, which could be at a point in time, or over time, depending on the nature of the performance obligation. During 2018, the Company recognized $150,000 from a milestone payment in respect to a collaboration, licensing and supply agreement with ManRos Therapeutics SA or ManRos, entered into in June 2015. The Company had no revenue in 2017 relating to this agreement. The 2018 revenue recognized related to a license, and related know-how, that was transferred to ManRos in 2015. As discussed in the following section, prior to the adoption of ASC 606, the Company recognized revenues from milestone payments in the period where the milestone was achieved. As the events triggering the $150,000 milestone payment did not occur until 2018, no revenue had been recognized for this contingent payment prior to the adoption of ASC 606. Similarly, under ASC 606, the Company will typically wait to include any potential milestone payments in the transaction price until satisfaction of the milestone becomes probable, consistent with the notion of the constraint discussed previously. Revenue Recognition Prior to the Adoption of ASC 606 Prior to the adoption of ASC 606, the Company recognized revenue in accordance with ASC Topic 605, Revenue Recognition In regards to the ManRos agreement, upfront and non-contingent milestone payments have been allocated to the separate deliverables within the arrangement and recognized over the period in which the deliverables were transferred to ManRos, which occurred in 2015. The consideration allocated to the main deliverable — the transfer of the Company’s know-how — was determined based on its estimated standalone selling price, using a market approach that identified similar license deals for a Phase 1/2 asset. The Company reviewed various licensing transactions in the public domain in the CF area and similar stage of asset development. Milestone payments which are non-refundable, non-creditable and contingent on achieving clinical milestones are recognized as revenues either on achievement of such milestones if the milestones are considered substantive or over the period the Company has continuing performance obligations, if the milestones are not considered substantive. When determining if a milestone is substantive, the Company considers the following factors: • The degree of certainty in achieving the milestone • The frequency of milestone payments • The Company’s efforts, which result in achievement of the milestone • The amount of the milestone payment relative to the other deliverables and payment terms, and • Whether the milestone payment is related to future performance or deliverables In the year ended December 31, 2017, the Company recognized no revenue from milestone payments. However, the Company records as deferred revenue any amounts received prior to satisfying the revenue recognition criteria. Deferred revenue not expected to be recognized within the next twelve months is reported as non-current deferred revenue. The Company recognized $0 and $0.2 million deferred revenue as of December 31, 2017 and 2018 respectively. The deferred revenue reported as of December 31, 2017 relates to a prepayment received from ManRos Therapeutics SA for a development milestone that is not expected to be achieved until mid-2018 (see Note 3 for additional details). Royalty income is recognized when the licensee sells the underlying product. Other Income Other income is primarily related to royalty income received under a historical Asset Purchase Agreement for activities which are not part of the Company’s ongoing operations and activities. 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. Clinical Trial Accounting Data management and monitoring of the Company’s clinical trials are performed with the assistance of contract research organizations (“CROs”) or clinical research associates (“CRAs”) in accordance with the Company’s standard operating procedures. Typically, CROs and CRAs bill monthly for services performed, and others bill based upon milestones achieved. For outstanding amounts, the Company accrues unbilled clinical trial expenses based on estimates of the level of services performed each period. Costs of setting up clinical trial sites for participation in the trials are recognized upon execution of the clinical trial agreement and expensed immediately as research and development expenses. Clinical trial costs related to patient enrollment are accrued as patients are entered into and progress through the trial. Patent Costs Patent prosecution costs are charged to general and administrative expenses as incurred as recoverability of such expenditure is uncertain. Leased Assets The costs of operating leases are charged to operations on a straight-line basis over the lease term. Operating leases relate primarily to the Company’s research and development facilities and corporate headquarters. Stock-based Compensation The Company measures all stock options and other stock-based awards granted to employees and directors based on the fair value on the date of the grant and recognizes compensation expense of those awards 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 three or four years. However, certain awards granted to members of the Company’s Board of Directors vest in their entirety on the one-year anniversary following the date of grant. Generally, the Company issues stock options and restricted stock awards to employees with only service-based vesting conditions and records the expense for these awards using the straight-line method. However, in certain years, the Company granted restricted stock units to employees that were dependent upon the fulfillment of certain clinical and financial conditions. In such instances where the performance condition must be met for the award to vest, the company only recognizes compensation expense when the award is probable of vesting (See Note 11 — Stock-Based Compensation). The Company classifies stock-based compensation expense in its statement of operations in the same manner in which the award recipient’s payroll costs are classified. The Company accounts for forfeitures as they occur. 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, expected term of the award, interest rates, and dividend yields. The Company relies exclusively on its historical volatility as an input to the option pricing model as management believes that this rate will be representative of future volatility over the expected term of the options. 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. The expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. Income Taxes The Company accounts for income taxes using 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 accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. Credit is taken in the accounting period for research and development tax credits, which will be claimed from H.M. Revenue & Customs (“HMRC”), the United Kingdom’s taxation and customs authority, in respect of qualifying research and development costs incurred in the same accounting period. Net Loss Per Common Share The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for the years ended December 31, 2017 and 2018. Comprehensive Income (Loss) 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 as applicable, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income (loss). There were no reclassifications out of other comprehensive income (loss) during the years ended December 31, 2017 and 2018. Recently Issued Accounting Pronouncements In July 2017, the FASB issued Accounting Standards Update (“ASU”) No. 2017-11, Accounting for Certain Financial Instruments with Down Round Features (“ASU 2017-11”), which simplifies the accounting for certain financial instruments with down-round features. A down round feature is a provision in a financial instrument that reduces the strike price of an issued financial instrument if the issuer sells shares of its stock for an amount less than the currently stated strike price of the issued financial instrument or issues an equity-linked financial instrument with a strike price below the currently stated strike price of the issued financial instrument. ASU 2017-11 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted, including adoption in an interim period. ASU 2017-11 should be adopted retrospectively for each prior reporting period presented or retrospectively as of the beginning of the year of adoption. The Company anticipates this standard will not have a material impact on its consolidated financial statements. In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfer of Assets Other than Inventory (“ASU 2016-16”), which requires the recognition of the income tax consequences of an intra-entity transfer of an asset, other than inventory, when the transfer occurs. The standard is effective for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. This standard did not have a material impact on the company’s consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), to address diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The standard is effective for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. This standard did not have a material impact on the company’s consolidated financial statements. In February 2016, the FASB issued guidance on accounting for leases in ASU No, 2016-02. 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 is effective for fiscal years beginning after December 15, 2018. The Company plans to initially apply the new leases standard at the adoption date by recognizing any necessary cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. That is, the Company will not recast prior period financial statements for the effects of this new standard. The Company is still finalizing its evaluation of the new standard, but expects that it will initially recognize an operating lease liability, and a corresponding right-of-use asset, of approximately $1.6 million on transition to the new guidance. |
Significant Contracts
Significant Contracts | 12 Months Ended |
Dec. 31, 2018 | |
Significant Contracts Disclosure [Abstract] | |
Significant Contracts | 3. Significant Contracts Distribution, Licensing and Research Agreements The Company has entered into licensing agreements with academic and research organizations. Under the terms of these agreements, the Company has received licenses to technology and patent applications. The Company is required to pay royalties on future sales of products employing the technology or falling under claims of patent applications. The most significant licensing agreement is with Daiichi Sankyo. Pursuant to the Daiichi Sankyo license under which the Company licenses certain patent rights for sapacitabine the Company is under an obligation to use reasonable endeavors to develop a product and obtain regulatory approval to sell a product and has agreed to pay Daiichi Sankyo an up-front fee, reimbursement for Daiichi Sankyo’s enumerated expenses, milestone payments and royalties on a country-by-country basis. The up-front fee, Phase 3 entry milestone, and certain past reimbursements have been paid. A further $10.0 million in aggregate milestone payments could be payable subject to achievement of all the specific contractual milestones which are primarily related to regulatory approval in various territories, and the Company’s decision to continue with these projects. Royalties are payable in each country for the term of patent protection in the country or for ten years following the first commercial sale of licensed products in the country, whichever is later. Royalties are payable on net sales. Net sales are defined as the gross amount invoiced by the Company or its affiliates or licensees, less discounts, credits, taxes, shipping and bad debt losses. The agreement extends from its commencement date to the date on which no further amounts are owed under it. If the Company wishes to appoint a third party to develop or commercialize a sapacitabine-based product in Japan, within certain limitations, Daiichi Sankyo must be notified and given a right of first refusal, with the right of first refusal ending sixty days after notification, to develop and/or commercialize in Japan. In general, the license may be terminated by the Company for technical, scientific, efficacy, safety, or commercial reasons on six months’ notice, or twelve months’ notice, if after a launch of a sapacitabine-based product, or by either party for material default. There were no milestones earned in 2017 or 2018. On October 1, 2018, the Company entered into a three-year Clinical Collaboration Agreement, or CCA with The University of Texas MD Anderson Cancer Center, or MD Anderson. The main objective of the CCA is to clinically evaluate the safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemias, acute myeloid leukemias, myelodysplastic syndromes and other advanced leukemias. Under the terms of the CCA, MD Anderson will conduct four clinical studies with a total projected enrollment of up to 170 patients. Under the risk-sharing agreement MD Anderson will assume the patient costs for all studies and Cyclacel, who is the sponsor, will provide investigational drugs and other limited support. Upon first commercial sale in specific indications studied in the alliance, Cyclacel will make certain payments to MD Anderson. Collaboration, Supply and Licensing Agreements In June 2015, the Company entered into a collaboration, licensing and supply agreement with ManRos Therapeutics SA (“ManRos”), for the exclusive development and commercialization of the Company’s oral seliciclib capsules by ManRos as a treatment for cystic fibrosis (“CF”). Among other terms of the agreement, ManRos licensed rights to the Company’s proprietary clinical data to enable clinical development of seliciclib for CF indications. The agreement provides for supply of seliciclib investigational product for initial and later stage clinical trials of seliciclib in CF and technical assistance related to the Company’s know-how to facilitate these trials. The Company received an up-front payment in July 2015 and reached a development milestone in September 2015. Another milestone was achieved in the first quarter of 2018. The Company will receive further milestone payments, as well as tiered royalties if seliciclib is commercialized for the treatment of CF. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 12 Months Ended |
Dec. 31, 2018 | |
Cash and Cash Equivalents | |
Cash and Cash Equivalents | 4. Cash and Cash Equivalents The following is a summary of cash and cash equivalents at December 31, 2017 and 2018 (in thousands): December 31, 2017 2018 Cash $ 1,103 $ 816 Investments with original maturity of less than three months at the time of purchase 22,807 16,688 Total cash and cash equivalents $ 23,910 $ 17,504 Investments with original maturity of less than three months at time of purchase are made up of money market funds and commercial paper. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value | |
Fair Value of Financial Assets and Liabilities | 5. Fair Value of Financial Assets and Liabilities The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 22,807 $ — $ — $ 22,807 Total Assets $ 22,807 $ — $ — $ 22,807 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 16,688 $ — $ — $ 16,688 Total Assets $ 16,688 $ — $ — $ 16,688 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2018 | |
Prepaid Expenses And Other Current Assets [Abstract] | |
Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets The following is a summary of prepaid expenses and other current assets at December 31, 2017 and 2018 (in thousands): December 31, 2017 2018 Research and development tax credit receivable $ 1,054 $ 1,148 Prepayments 363 543 VAT receivable 409 356 Deposits 132 66 Other current assets 106 170 Prepaid expenses and other current assets $ 2,064 $ 2,283 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment | |
Property and Equipment | 7. Property and Equipment Property and equipment consisted of the following at December 31, 2017 and 2018 (in thousands): Lives in years December 31, 2017 2018 Leasehold improvements 5 to 15 $ 835 $ 807 Research and laboratory equipment 3 to 5 4,854 4,209 Office equipment and furniture 3 to 5 1,236 1,140 6,925 6,156 Less: accumulated depreciation and amortization (6,896 ) (6,120 ) $ 29 $ 36 Depreciation and amortization expense for property and equipment was $32,000 and $29,000 for the years ended December 31, 2017 and 2018, respectively. The Company sold fully depreciated assets for proceeds of $0 and $16,000 during the years ended December 31, 2017 and 2018 respectively. |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Accrued and Other Current Liabilities | |
Accrued and Other Current Liabilities | 8. Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following at December 31, 2017 and 2018 (in thousands): December 31, 2017 2018 Accrued research and development $ 1,645 $ 1,110 Accrued legal and professional fees 248 259 Other current liabilities 662 363 $ 2,555 $ 1,732 Other current liabilities in 2017 include $150,000 deferred income in respect of payment received in advance of achieving a milestone under the ManRos agreement (see Note 3 — Significant Contracts). |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies | |
Commitments and Contingencies | 9. Commitments and Contingencies General Please refer to Note 3 — Significant Contracts Leases In October 2000, the Company entered into a twenty-five year lease for its research and development facility in Dundee, Scotland. Rent expense, which includes lease payments related to the Company’s research and development facilities and corporate headquarters and other rent related expenses was $0.5 and $0.4 million for each of the years ended December 31, 2017 and 2018, respectively. The following is a summary of the Company’s future contractual obligations and commitments relating to its facilities leases as at December 31, 2018 (in thousands): Operating Lease 2019 $ 321 2020 321 2021 321 2022 321 2023 321 thereafter 581 Total future minimum lease obligations $ 2,186 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity | |
Stockholders' Equity | 10. Stockholders’ Equity The Company has completed the following equity issuances during the periods presented in the consolidated financial statements. October 2018 At Market Issuance On October 4, 2018, the Company entered into a Common Stock Sales Agreement, or the Sales Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, as sales agent, pursuant to which Wainwright may sell shares of our common stock, par value $0.001 per share, having an aggregate offering price of up to $5,000,000, by any method that is deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. Shares sold under the Sales Agreement will be offered and sold pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 and a prospectus supplement and accompanying base prospectus. The Company will pay Wainwright a commission of 3.0% of the gross sales price per share sold. During 2018, the Company sold 500,000 shares under the Sales Agreement for gross proceeds of approximately $0.7 million. July 2017 Underwritten Public Offering On July 21, 2017, the Company issued (i) 3,154,000 Class A Units for $2 per unit, each consisting of one share of the Company’s common stock, and a warrant to purchase one share of common stock (the “Class A Warrants”), and (ii) 8,872 Class B Units, each consisting of one share of the Company’s Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), convertible into 500 shares of Common Stock at the initial conversion price, and a warrant to purchase a number of shares of common stock equal to $1,000.00 divided by the conversion price (the “Class B Warrants”) for $1,000 per unit. The net proceeds to the Company after the underwriters’ exercise in full of the over-allotment option were approximately $13.7 million, after deducting underwriting discounts, commissions and other estimated offering expenses. The Class A Units and Class B Units have no stand-alone rights and the shares of common stock, Series A Preferred Stock and the Class A and Class B Warrants comprising those units were immediately separable. The common stock, Class A Warrants and Class B Warrants (together the “Warrants”) and Series A Preferred Stock are freestanding financial instruments. The Warrants are classified within equity (as a component of additional paid-in capital) in the consolidated balance sheet and are not remeasured on a recurring basis. The Series A Preferred Stock is classified within permanent equity in the consolidated balance sheet. The proceeds from the Class A Units were allocated to common stock and Class A Warrants on a relative fair value basis. Similarly, the proceeds from the Class B Units were allocated to the Series A Preferred Stock and the Class B Warrants based on their relative fair values. Following the allocation of the offering proceeds associated with the Class B units, the Company determined that the Series A Preferred Stock had a beneficial conversion feature with an aggregate intrinsic value of approximately $3,638,000. As the Series A Preferred Stock contained no stated redemption date, and the conversion feature could be exercised at any time, the discount associated with the beneficial conversion feature was immediately charged against additional paid-in capital and treated as a deemed dividend for both financial reporting and earnings per share purposes. The following is a description of the Company’s outstanding equity instruments. Warrants As of December 31, 2018, there were 7,490,500 warrants outstanding, each with an exercise price of $2.00. All such warrants were issued in connection with the July 2017 Underwritten Public Offering and are immediately exercisable. The Warrants expire in 2024. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of its warrants if the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of common stock in excess of 4.99% (or, at the election of the purchaser, 9.99%) of the shares of our Common Stock then outstanding after giving effect to such exercise. The exercise price and the number of shares issuable upon exercise of the warrants is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock. The warrant holders must pay the exercise price in cash upon exercise of the warrants, unless such warrant holders are utilizing the cashless exercise provision of the warrants. On the expiration date, unexercised warrants will automatically be exercised via the “cashless” exercise provision. Prior to the exercise of any warrants to purchase common stock, holders of the warrants will not have any of the rights of holders of the common stock purchasable upon exercise, including the right to vote, except as set forth therein. Warrants exercised during the years ended December 31, 2017 and 2018 were 99,500 and 0, respectively. Series A Preferred Stock 8,872 shares of the Company’s Series A Preferred Stock were issued in the July 2017 Underwritten Public Offering. Each share of Series A Preferred Stock is convertible at any time at the option of the holder thereof, into a number of shares of common stock determined by dividing $1,000 by the initial conversion price of $2.00 per share, subject to a 4.99% blocker provision, or, upon election by a holder prior to the issuance of shares of Series A Preferred Stock, 9.99%, and is subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations. During the year ended December 31, 2017, 8,608 shares of the Series A Preferred Stock were converted into 4,304,000 shares of common stock. As of December 31, 2018, 264 shares of the Series A Preferred Stock remain issued and outstanding. The 264 shares of Series A Preferred Stock issued and outstanding at December 31, 2018, are convertible into 132,000 shares of common stock. In the event of a liquidation, the holders of shares of the Series A Preferred Stock may participate on an as-converted-to-common-stock basis in any distribution of assets of the Company. The Company shall not pay any dividends on shares of common stock (other than dividends in the form of common stock) unless and until such time as dividends on each share of Series A Preferred Stock are paid on an as-converted basis. There is no restriction on the Company’s ability to repurchase shares of Series A Preferred Stock while there is any arrearage in the payment of dividends on such shares, and there are no sinking fund provisions applicable to the Series A Preferred Stock. Subject to certain conditions, at any time following the issuance of the Series A Preferred Stock, the Company has the right to cause each holder of the Series A Preferred Stock to convert all or part of such holder’s Series A Preferred Stock in the event that (i) the volume weighted average price of our common stock for 30 consecutive trading days (the “Measurement Period”) exceeds 300% of the initial conversion price of the Series A Preferred Stock (subject to adjustment for forward and reverse stock splits, recapitalizations, stock dividends and similar transactions), (ii) the daily trading volume on each Trading Day during such Measurement Period exceeds $500,000 per trading day and (iii) the holder is not in possession of any information that constitutes or might constitute, material non-public information which was provided by the Company. The right to cause each holder of the Series A Preferred Stock to convert all or part of such holder’s Series A Preferred Stock shall be exercised ratably among the holders of the then outstanding preferred stock. The Series A Preferred Stock has no maturity date, will carry the same dividend rights as the common stock, and with certain exceptions contains no voting rights. In the event of any liquidation or dissolution of the Company, the Series A Preferred Stock ranks senior to the common stock in the distribution of assets, to the extent legally available for distribution. 6% Convertible Exchangeable Preferred Stock As of December 31, 2018, there were 335,273 shares of the Company’s 6% Convertible Exchangeable (“Preferred Stock”) issued and outstanding at an issue price of $10.00 per share. Dividends on the Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the Preferred Stock, payable quarterly on the first day of February, May, August and November, commencing February 1, 2005. Any dividends must be declared by the Company’s Board of Directors and must come from funds that are legally available for dividend payments. The Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends. The Company’s Board of Directors considers numerous factors in determining whether to declare the quarterly dividend pursuant to the Certificate of Designations governing the terms of the Company’s Preferred Stock, including the requisite financial analysis and determination of a surplus. Accrued and unpaid dividends in arrears on preferred stock were $0.7 million, or $1.95 per share, of preferred stock, as of December 31, 2017 and 2018. 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. The Company has reserved 1,698 shares of common stock for issuance upon conversion of the remaining shares of Preferred Stock outstanding at December 31, 2017. 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, which is 150% of the conversion price of the Preferred Stock, for at least 20 trading days during any 30-day trading period, ending within five trading days prior to notice of automatic conversion. The Certificate of Designations governing the Preferred Stock provides that if the Company fails to pay dividends on its Preferred Stock for six quarterly periods, holders of Preferred Stock are entitled to nominate and elect two directors to the Company’s Board of Directors. This right accrued to the holders of Preferred Stock as of August 2, 2010 and two directors were nominated and elected at the annual meeting held on May 24, 2011. The Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances. The Company may, at its option, redeem the Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share. The Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on any dividend payment date beginning on November 1, 2005 (the “Exchange Date”) for the Company’s 6% Convertible Subordinated Debentures (“Debentures”) at the rate of $10.00 principal amount of Debentures for each share of Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have terms substantially similar to those of the Preferred Stock. No such exchanges have taken place as of December 31, 2018. For the year ended December 31, 2018, the company declared dividends of $0.15 per share quarterly on its Preferred Stock. These dividends were paid on May 1, August 1 and November 1, 2018, and February 1, 2019, respectively. Common Stock Exercise of Stock Options No stock options were exercised during the years ended December 31, 2017 and 2018. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Stock-Based Compensation Arrangements | |
Stock-Based Compensation | 11. Stock-Based Compensation Stock based compensation has been reported within expense line items on the consolidated statement of operations for the years ended 2017 and 2018 as shown in the following table (in thousands): Year Ended Year Ended Research and development $ 72 $ 88 General and administrative 194 243 Stock-based compensation costs before income taxes $ 266 $ 331 2018 Plan In May 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”), under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The 2018 Plan replaces the 2015 Equity Incentive Plan (the “2015 Plan”). The 2018 Plan allows for the issuance of up to 1,500,000 shares of the Company’s common stock pursuant to various types of award grants, including stock options and restricted stock units. In addition, the 2018 Plan allows up to 709,889 additional shares to be issued if awards outstanding under the 2018 Plan are cancelled or expire on or after the date of the Company’s 2018 annual meeting of stockholders. As of December 31, 2018, the Company has reserved 1,662,739 shares of the Company’s common stock under the 2018 Plan, including shares that were available under the 2015 Plan and carried forward to the 2018 Plan. 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 170,853 options granted during the year ended December 31, 2017. Exactly 158,853 of these options are performance based, which will vest upon the fulfillment of certain clinical conditions. The Company determined that the satisfaction of one criterion, the commencement of the HEM study by December 31, 2018 occurred as of December 31, 2018, but that the other vesting criteria related to these awards were not probable as of December 31, 2018. As such, the Company recognized compensation cost for these grants under the expectation that 25% of these awards (the portion associated with the HEM study) will vest. There were 306,304 options granted during the year ended December 31, 2018. Exactly 174,272 of these options are performance based, which will vest upon the fulfillment of certain clinical conditions. The Company determined that the satisfaction of one criterion, the commencement of the HEM study by December 31, 2018, occurred as of December 31, 2018, but that the other vesting criteria related to these awards were not probable as of December 31, 2018. As such, the Company recognized compensation cost for these grants under the expectation that 25% of these awards (the portion associated with the HEM study) will vest. The weighted average grant-date fair values of options granted during the years ended December 31, 2017 and 2018 were $1.59 and $1.25, respectively. As of December 31, 2018, the total remaining unrecognized compensation cost related to the non-vested, non-performance related stock options with service conditions amounted to approximately $0.1 million, which will be amortized over the weighted-average remaining requisite service period of 2.05 years. During the years ended December 31, 2017 and 2018, the Company did not settle any equity instruments with cash. There were no stock option exercises during the years ended 2017 and 2018. No income tax benefits were recorded for the years ended December 31, 2017 and 2018 because the Company has accumulated net operating losses for tax purposes and is not likely to benefit from any deductions associated with exercises of granted option awards. 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, 2016 389,379 $ 25.80 5.83 $ 121 Granted 170,853 $ 1.93 Exercised — Cancelled/forfeited (24,615 ) $ 179.92 Options outstanding at December 31, 2017 535,617 $ 11.10 8.23 $ — Granted 306,304 $ 1.51 Exercised — Cancelled/forfeited (10,310 ) $ 82.38 Options outstanding at December 31, 2018 831,611 $ 6.68 8.13 $ — Unvested at December 31, 2018 573,830 $ 2.57 8.59 $ — Vested and exercisable at December 31, 2018 257,781 $ 15.84 7.10 $ — The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718 using the following assumptions: Year ended Year ended Expected term (years) 6 6 Risk free interest rate 1.890% – 2.265% 2.730% – 2.855% Volatility 108% 105% – 107% Expected dividend yield over expected term 0.00% 0.00% Resulting weighted average grant date fair value $1.59 $1.25 |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2018 | |
Employee Benefit Plans | |
Employee Benefit Plans | 12. Employee Benefit Plans Pension Plan The Company operates a defined contribution group personal pension plan for all of its UK based employees. Company contributions to the plan totaled approximately $54,000 and $55,000 for the years ended December 31, 2017 and 2018, respectively. 401(k) Plan The 401(k) Plan provides for matching contributions by the Company in an amount equal to the lesser of 100% of the employee’s deferral or 6% of the U.S. employee’s qualifying compensation. The 401(k) Plan is intended to qualify under Section 401(k) of the Internal Revenue Code, so that contributions to the 401(k) Plan by employees or by the Company, and the investment earnings thereon, are not taxable to the employees until withdrawn. Company matching contributions are tax deductible by the Company when made. Company employees may elect to reduce their current compensation by up to the statutorily prescribed annual limit of $18,500 if under 50 years old and $24,500 if over 50 years old and to have those funds contributed to the 401(k) Plan. The Company made contributions of approximately $28,000 and $36,000 to the 401(k) Plan for the years ended December 31, 2017 and 2018, respectively. |
Taxes
Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Taxes | |
Taxes | 13. Taxes (Loss) income from continuing operations before taxes is comprised of the following components for the years ended December 31, 2017 and 2018 (in thousands): Year Ended December 31, 2017 2018 Domestic $ (127 ) $ 20 Foreign (8,336 ) (8,645 ) Loss from continuing operations before taxes $ (8,463 ) $ (8,625 ) The benefit (provision) for income taxes from continuing operations consists of the following (in thousands): Year Ended December 31, 2017 2018 Current – domestic $ — $ (5 ) Current – foreign 993 1,342 Current – total 993 1,337 Deferred – domestic — — Income tax benefit $ 993 $ 1,337 The Company has incurred a taxable loss in each of the operating periods since incorporation. The income tax credits of $1.0 million and $1.3 million for the years ended December 31, 2017 and 2018, respectively, represent UK research and development (“R&D”) tax credits for expenditures in the United Kingdom that are refundable. A reconciliation of the (benefit) provision for income taxes from continuing operations with the amount computed by applying the statutory federal tax rate to loss from continuing operations before income taxes is as follows (in thousands): Year Ended December 31, 2017 2018 Loss from continuing operations before taxes $ (8,463 ) $ (8,625 ) Income tax expense computed at statutory federal tax rate (2,877 ) (1,811 ) Disallowed expenses and non-taxable income 3 310 Loss surrendered to generate R&D credit 856 1,519 Additional research and development tax relief (1,262 ) (1,342 ) Change in valuation allowance (4,487 ) (7,440 ) Foreign items, including change in tax rates, and other 1,901 (1,700 ) Change in US Tax Rate 4,112 — Section 382 Limitation — 9,985 Other foreign items 761 (858 ) $ (993 ) $ (1,337 ) On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act (“Tax Act”), which made significant changes to U.S. federal income tax law. The Company expects that certain aspects of the Tax Act will positively impact the Company’s future after-tax earnings in the U.S., primarily due to the lower federal statutory tax rate. Set forth below is a discussion of certain provisions of the Tax Act and our preliminary assessment of the effect of such provisions on the Company’s results of operations, cash flows and consolidated financial statements. The Tax Act will affect 2018 and forward, including but not limited to a reduction in the federal corporate rate from 35.0% to 21.0%, elimination of the corporate alternative minimum tax, a new limitation on the deductibility of certain executive compensation, limitations on net operating losses generated after December 31, 2017 and various other items. These changes did not have a material impact on our financial statements due to the accumulated net operating losses in the U.S. The Tax Act provides for a one-time “deemed repatriation” of accumulated unrepatriated foreign earnings determined as of November 2, 2017 or December 31, 2017, whichever is greater. We were not subject to this provision due to the accumulated deficit in our foreign earnings for tax purposes. The Tax Act also created a new requirement that certain income earned by controlled foreign corporations must be included currently in the gross income of the U.S. shareholder under the Global Intangible Low-Taxed Income (GILTI) provision. Our foreign earnings are not subject to GILTI due to our current deficit in the UK. In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”), which addresses how a company recognizes provisional amounts when a company does not have the necessary information available, prepared or analyzed (including computations) in reasonable detail to complete its accounting for the effect of the changes in the Act. SAB 118 provides for a measurement period that should not extend beyond one year from the Act enactment date for companies to complete the accounting under Accounting Standards Codification Topic 740, Income Taxes (“ASC 740”). In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the Act for which the accounting under ASC 740 is complete. To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but it is able to determine a reasonable estimate, it must record a provisional estimate to be included in the financial statements. If a company cannot determine a provisional estimate to be included in the financial statements, it should continue to apply ASC 740 on the basis of the provision of the tax laws that were in effect immediately before the enactment of the Act. Based on our analysis of the Tax Act, the Company made reasonable estimates of its 2017 impact. As a result of the federal corporate tax rate reduction from 35% to 21%, we re-measured certain deferred tax assets and liabilities, which resulted in a reduction in our DTA of approximately $4.4 million that was offset by a decrease in our valuation allowance. No adjustments were made as a result of the Tax Act for the year ended December 31, 2018. The primary difference between the income tax benefit at the statutory rate and the Company’s effective income tax expense for the year ended December 31, 2018 was primarily attributable to the change in our valuation allowance and foreign operations. Significant components of the Company’s deferred tax assets are shown below (in thousands): Year Ended December 31, 2017 2018 Net operating loss and tax credit carryforwards $ 38,948 $ 33,835 Depreciation, amortization and impairment of property and equipment 111 109 Stock options 1,807 1,482 Research and development credits 4,021 — Other — — Deferred tax assets 44,887 35,426 Valuation allowance for deferred tax assets (44,887 ) (35,426 ) Net deferred tax assets $ — $ — A valuation allowance has been established, as realization of such assets is uncertain. The Company’s management evaluated the positive and negative evidence bearing upon the realizability of its deferred assets, and has determined that, at present, the Company may not be able to recognize the benefits of the deferred tax assets under the more likely than not criteria. Accordingly, a valuation allowance of approximately $35.4 million has been established at December 31, 2018. The valuation allowance has decreased by approximately $9.4 million in 2018. As specified in the Tax Reform Act of 1986, due to ownership changes, the Company’s ability to utilize its net operating loss (“NOL”) carryforwards may be limited. Utilization of the NOLs may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company completed a Section 382 study and has concluded that an ownership changed occured on March 4, 2015 and July 21, 2017. As a result of the ownership changes, the NOLs are limited. As of December 31, 2017 and 2018, the Company had federal NOLs of $28.4 million and $0.0 million, respectively. The Company has state NOLs of $18.7 million which will begin to expire in 2028. As of December 31, 2017 and 2018, the Company had foreign NOLs of $186.2 million and $191.2 million, respectively. The Company’s foreign NOL’s do not expire under UK tax law however the use of these NOLs is restricted to an annual £5 million allowance in each standalone company or group and above this allowance, there will be a 50% restriction in the profits that can be covered by losses brought forward. Management has evaluated all significant tax positions at December 31, 2017 and 2018 and concluded that there are no material uncertain tax positions. The Company would recognize both interest and penalties related to unrecognized benefits in income tax expense. The Company has not recorded any interest and penalties on any unrecognized tax benefits since its inception. Tax years 2015, 2016 and 2017 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the United Kingdom and the United States, as carryforward attributes generated in years past may still be adjusted upon examination by the United Kingdom’s H.M. Revenue & Customs, the Internal Revenue Service (“IRS”) or state tax authorities. The Company is currently not under examination by the IRS or any other jurisdictions for any tax years. We have not provided a deferred tax liability on the cumulative amount of unremitted foreign earnings of international subsidiaries because it is our intent to permanently reinvest such earnings outside of the United States. The Company has an aggregate deficit in foreign earnings and therefore has not provided any deferred tax liability on its outside book-tax basis difference in its foreign subsidiaries and because it is also our intent to permanently reinvest any earnings outside of the United States. We would recognize this deferred tax liability if we were to experience a change in circumstances producing a change in that intention. As a result of the repeal of the Section 902 foreign tax credit under the Tax Act, future distributions would not be offset by a foreign tax credit. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 14. Net Loss Per Share Basic and diluted net loss per share attributable to common stockholders was calculated as follows: Years ended December 31, 2017 2018 Numerator: Net loss $ (7,470 ) $ (7,288 ) Dividend on convertible exchangeable preferred shares $ (201 ) $ (201 ) Beneficial conversion feature of Series A convertible stock $ (3,638 ) $ — Conversion of Series A convertible preferred stock $ (3,537 ) $ — Net loss attributable to common shareholders $ (14,846 ) $ (7,489 ) Denominator: Weighted-average number of common shares used in loss per share – basic and diluted 7,631,152 12,094,131 Loss per share – basic and diluted $ (1.95 ) $ (0.62 ) Potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Year ended December 31, 2017 2018 Stock options 535,616 831,611 Convertible preferred stock 1,698 1,698 Series A preferred stock 132,000 132,000 Common stock warrants 7,490,500 7,490,500 Total shares excluded from calculation 8,159,814 8,455,809 |
Geographic Information
Geographic Information | 12 Months Ended |
Dec. 31, 2018 | |
Geographic Information | |
Geographic Information | 15. Geographic Information Geographic information for the years ended December 31, 2017 and 2018 is as follows (in thousands): Year Ended December 31, 2017 2018 Revenue United Kingdom $ — $ 150 Total Revenue $ — $ 150 Net loss United States $ (127 ) $ 15 United Kingdom (7,343 ) (7,303 ) Total Net Loss $ (7,470 ) $ (7,288 ) December 31, 2017 2018 Total Assets United States $ 23,522 $ 17,384 United Kingdom 2,481 2,439 Total Assets $ 26,003 $ 19,823 Long Lived Assets, net United States $ 0 $ 3 United Kingdom 29 33 Total Long Lived Assets, net $ 29 $ 36 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events | |
Subsequent Events | 16. Subsequent Events During the first quarter of 2019, the Company sold a further 4.7 million shares under the Sales Agreement with Wainwright for gross proceeds of approximately $4.3 million. The Company has now reached the maximum aggregate offering price and there will be no further sale of shares under the Sales Agreement. On March 7, 2019, the Board of Directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend is due to be paid on May 1, 2019 to the holders of record of the Preferred Stock as of the close of business on April 15, 2019. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Summary of Significant Accounting Policies | |
Use of Estimates | Use of Estimates The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical estimates include inputs used to determine clinical trial accruals, stock-based compensation expense and the recognition of revenue. 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. |
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. |
Cash and Cash Equivalents | Cash and Cash Equivalents Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. 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. 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 deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any significant credit risk on cash and cash equivalents. The Company’s cash and cash equivalents balance at December 31, 2018 was $17.5 million and it maintains its cash accounts in several entities both within the United States and the United Kingdom. The total cash balances for amounts held in the United States are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 per account. The Company has cash balances exceeding the balance insured by the FDIC that totaled approximately $16.8 million at December 31, 2018. The total cash balances for amounts held in the United Kingdom are insured by the UK Government Financial Services Compensation Scheme (“FSCS”) up to £75,000 per account. The Company has cash balances exceeding the balance insured by the FSCS that totaled approximately $0.2 million at December 31, 2018. |
Property and Equipment | Property and Equipment The components of property and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets, which are generally three to five years. Amortization of leasehold improvements is performed using the straight-line method over the shorter of the remaining lease term or the estimated useful life of the related assets, currently between five and fifteen years. Upon sale or retirement of assets, the costs and related accumulated depreciation and amortization are removed from the balance sheet and the resulting gain or loss on sale is reflected as a component of operating income or loss. Expenditures for maintenance and repairs are charged to operating expenses as incurred. |
Impairment of Long-lived Assets | Impairment of Long-lived Assets The Company reviews property and equipment for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company assesses the recoverability of the potentially affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. Impairment, if any, is measured as the amount by which the carrying amount of a long-lived asset (or asset group) exceeds its fair value. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Assets and liabilities measured at fair value are classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1 — Quoted prices in active markets for identical assets or liabilities. • Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying values of cash and cash equivalents, other receivables, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. |
Segments | Segments The Company is managed and operated as one business which is focused on using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases .The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information with respect to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment with development operations in two geographic areas, namely the United States and the United Kingdom. |
Revenue Recognition | Revenue Recognition On January 1, 2018, the Company adopted new guidance on revenue recognition, which has been codified within Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers With effect from January 1, 2018, the Company recognizes revenue using the five step model provided in ASC 606, which involves: (1) identifying the contract with a customer; (2) identifying the performance obligations in the contract; (3) determining the transaction price; (4) allocating the transaction price to the performance obligations in the contract; and (5) recognizing revenue when, or as, the Company satisfies a performance obligation. The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers: • Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies; • Whether the uncertainty about the achievement of a milestone is not expected to be resolved for a long period of time; • Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and • The complexity and inherent uncertainty underlying the achievement of a milestone. The transaction price is allocated to each performance obligation based on the relative standalone selling price of each performance obligation. The best estimate of the standalone selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives. The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation, which could be at a point in time, or over time, depending on the nature of the performance obligation. During 2018, the Company recognized $150,000 from a milestone payment in respect to a collaboration, licensing and supply agreement with ManRos Therapeutics SA or ManRos, entered into in June 2015. The Company had no revenue in 2017 relating to this agreement. The 2018 revenue recognized related to a license, and related know-how, that was transferred to ManRos in 2015. As discussed in the following section, prior to the adoption of ASC 606, the Company recognized revenues from milestone payments in the period where the milestone was achieved. As the events triggering the $150,000 milestone payment did not occur until 2018, no revenue had been recognized for this contingent payment prior to the adoption of ASC 606. Similarly, under ASC 606, the Company will typically wait to include any potential milestone payments in the transaction price until satisfaction of the milestone becomes probable, consistent with the notion of the constraint discussed previously. Revenue Recognition Prior to the Adoption of ASC 606 Prior to the adoption of ASC 606, the Company recognized revenue in accordance with ASC Topic 605, Revenue Recognition In regards to the ManRos agreement, upfront and non-contingent milestone payments have been allocated to the separate deliverables within the arrangement and recognized over the period in which the deliverables were transferred to ManRos, which occurred in 2015. The consideration allocated to the main deliverable — the transfer of the Company’s know-how — was determined based on its estimated standalone selling price, using a market approach that identified similar license deals for a Phase 1/2 asset. The Company reviewed various licensing transactions in the public domain in the CF area and similar stage of asset development. Milestone payments which are non-refundable, non-creditable and contingent on achieving clinical milestones are recognized as revenues either on achievement of such milestones if the milestones are considered substantive or over the period the Company has continuing performance obligations, if the milestones are not considered substantive. When determining if a milestone is substantive, the Company considers the following factors: • The degree of certainty in achieving the milestone • The frequency of milestone payments • The Company’s efforts, which result in achievement of the milestone • The amount of the milestone payment relative to the other deliverables and payment terms, and • Whether the milestone payment is related to future performance or deliverables In the year ended December 31, 2017, the Company recognized no revenue from milestone payments. However, the Company records as deferred revenue any amounts received prior to satisfying the revenue recognition criteria. Deferred revenue not expected to be recognized within the next twelve months is reported as non-current deferred revenue. The Company recognized $0 and $0.2 million deferred revenue as of December 31, 2017 and 2018 respectively. The deferred revenue reported as of December 31, 2017 relates to a prepayment received from ManRos Therapeutics SA for a development milestone that is not expected to be achieved until mid-2018 (see Note 3 for additional details). Royalty income is recognized when the licensee sells the underlying product. |
Other Income | Other Income Other income is primarily related to royalty income received under a historical Asset Purchase Agreement for activities which are not part of the Company’s ongoing operations and activities. |
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. |
Clinical Trial Accounting | Clinical Trial Accounting Data management and monitoring of the Company’s clinical trials are performed with the assistance of contract research organizations (“CROs”) or clinical research associates (“CRAs”) in accordance with the Company’s standard operating procedures. Typically, CROs and CRAs bill monthly for services performed, and others bill based upon milestones achieved. For outstanding amounts, the Company accrues unbilled clinical trial expenses based on estimates of the level of services performed each period. Costs of setting up clinical trial sites for participation in the trials are recognized upon execution of the clinical trial agreement and expensed immediately as research and development expenses. Clinical trial costs related to patient enrollment are accrued as patients are entered into and progress through the trial. |
Patent Costs | Patent Costs Patent prosecution costs are charged to general and administrative expenses as incurred as recoverability of such expenditure is uncertain. |
Leased Assets | Leased Assets The costs of operating leases are charged to operations on a straight-line basis over the lease term. Operating leases relate primarily to the Company’s research and development facilities and corporate headquarters. |
Stock-based Compensation | Stock-based Compensation The Company measures all stock options and other stock-based awards granted to employees and directors based on the fair value on the date of the grant and recognizes compensation expense of those awards 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 three or four years. However, certain awards granted to members of the Company’s Board of Directors vest in their entirety on the one-year anniversary following the date of grant. Generally, the Company issues stock options and restricted stock awards to employees with only service-based vesting conditions and records the expense for these awards using the straight-line method. However, in certain years, the Company granted restricted stock units to employees that were dependent upon the fulfillment of certain clinical and financial conditions. In such instances where the performance condition must be met for the award to vest, the company only recognizes compensation expense when the award is probable of vesting (See Note 11 — Stock-Based Compensation). The Company classifies stock-based compensation expense in its statement of operations in the same manner in which the award recipient’s payroll costs are classified. The Company accounts for forfeitures as they occur. 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, expected term of the award, interest rates, and dividend yields. The Company relies exclusively on its historical volatility as an input to the option pricing model as management believes that this rate will be representative of future volatility over the expected term of the options. 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. The expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. |
Income Taxes | Income Taxes The Company accounts for income taxes using 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 accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. Credit is taken in the accounting period for research and development tax credits, which will be claimed from H.M. Revenue & Customs (“HMRC”), the United Kingdom’s taxation and customs authority, in respect of qualifying research and development costs incurred in the same accounting period. |
Net Loss Per Common Share | Net Loss Per Common Share The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for the years ended December 31, 2017 and 2018. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) 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 as applicable, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income (loss). There were no reclassifications out of other comprehensive income (loss) during the years ended December 31, 2017 and 2018. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In July 2017, the FASB issued Accounting Standards Update (“ASU”) No. 2017-11, Accounting for Certain Financial Instruments with Down Round Features (“ASU 2017-11”), which simplifies the accounting for certain financial instruments with down-round features. A down round feature is a provision in a financial instrument that reduces the strike price of an issued financial instrument if the issuer sells shares of its stock for an amount less than the currently stated strike price of the issued financial instrument or issues an equity-linked financial instrument with a strike price below the currently stated strike price of the issued financial instrument. ASU 2017-11 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted, including adoption in an interim period. ASU 2017-11 should be adopted retrospectively for each prior reporting period presented or retrospectively as of the beginning of the year of adoption. The Company anticipates this standard will not have a material impact on its consolidated financial statements. In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfer of Assets Other than Inventory (“ASU 2016-16”), which requires the recognition of the income tax consequences of an intra-entity transfer of an asset, other than inventory, when the transfer occurs. The standard is effective for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. This standard did not have a material impact on the company’s consolidated financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), to address diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The standard is effective for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. This standard did not have a material impact on the company’s consolidated financial statements. In February 2016, the FASB issued guidance on accounting for leases in ASU No, 2016-02. 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 is effective for fiscal years beginning after December 15, 2018. The Company plans to initially apply the new leases standard at the adoption date by recognizing any necessary cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. That is, the Company will not recast prior period financial statements for the effects of this new standard. The Company is still finalizing its evaluation of the new standard, but expects that it will initially recognize an operating lease liability, and a corresponding right-of-use asset, of approximately $1.6 million on transition to the new guidance. |
Cash and Cash Equivalents (Tabl
Cash and Cash Equivalents (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Cash and Cash Equivalents | |
Schedule of summary of cash and cash equivalents | December 31, 2017 2018 Cash $ 1,103 $ 816 Investments with original maturity of less than three months at the time of purchase 22,807 16,688 Total cash and cash equivalents $ 23,910 $ 17,504 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value | |
Schedule of financial assets and liabilities measured on a recurring basis | Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 22,807 $ — $ — $ 22,807 Total Assets $ 22,807 $ — $ — $ 22,807 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 16,688 $ — $ — $ 16,688 Total Assets $ 16,688 $ — $ — $ 16,688 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Prepaid Expenses And Other Current Assets [Abstract] | |
Schedule of prepaid expenses and other current assets | December 31, 2017 2018 Research and development tax credit receivable $ 1,054 $ 1,148 Prepayments 363 543 VAT receivable 409 356 Deposits 132 66 Other current assets 106 170 Prepaid expenses and other current assets $ 2,064 $ 2,283 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment | |
Schedule of property and equipment | Lives in years December 31, 2017 2018 Leasehold improvements 5 to 15 $ 835 $ 807 Research and laboratory equipment 3 to 5 4,854 4,209 Office equipment and furniture 3 to 5 1,236 1,140 6,925 6,156 Less: accumulated depreciation and amortization (6,896 ) (6,120 ) $ 29 $ 36 |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accrued and Other Current Liabilities | |
Schedule of accrued and other current liabilities | December 31, 2017 2018 Accrued research and development $ 1,645 $ 1,110 Accrued legal and professional fees 248 259 Other current liabilities 662 363 $ 2,555 $ 1,732 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies | |
Schedule of the Company's contractual obligations and commitments relating to its facilities leases | Operating Lease 2019 $ 321 2020 321 2021 321 2022 321 2023 321 thereafter 581 Total future minimum lease obligations $ 2,186 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Stock-Based Compensation Arrangements | |
Schedule of stock based compensation expense | Year Ended Year Ended Research and development $ 72 $ 88 General and administrative 194 243 Stock-based compensation costs before income taxes $ 266 $ 331 |
Schedule of stock option activity | Number of Weighted Weighted Aggregate Options outstanding at December 31, 2016 389,379 $ 25.80 5.83 $ 121 Granted 170,853 $ 1.93 Exercised — Cancelled/forfeited (24,615 ) $ 179.92 Options outstanding at December 31, 2017 535,617 $ 11.10 8.23 $ — Granted 306,304 $ 1.51 Exercised — Cancelled/forfeited (10,310 ) $ 82.38 Options outstanding at December 31, 2018 831,611 $ 6.68 8.13 $ — Unvested at December 31, 2018 573,830 $ 2.57 8.59 $ — Vested and exercisable at December 31, 2018 257,781 $ 15.84 7.10 $ — |
Schedule of fair value of the stock options granted | Year ended Year ended Expected term (years) 6 6 Risk free interest rate 1.890% – 2.265% 2.730% – 2.855% Volatility 108% 105% – 107% Expected dividend yield over expected term 0.00% 0.00% Resulting weighted average grant date fair value $1.59 $1.25 |
Taxes (Tables)
Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Taxes | |
Schedule of components of (loss) income before taxes from continuing operations | Year Ended December 31, 2017 2018 Domestic $ (127 ) $ 20 Foreign (8,336 ) (8,645 ) Loss from continuing operations before taxes $ (8,463 ) $ (8,625 ) |
Schedule of benefit for income taxes from continuing operations | Year Ended December 31, 2017 2018 Current – domestic $ — $ (5 ) Current – foreign 993 1,342 Current – total 993 1,337 Deferred – domestic — — Income tax benefit $ 993 $ 1,337 |
Schedule of reconciliation of the (benefit) provision for income taxes from continuing operations with the amount computed by applying the statutory federal tax rate to loss before income taxes | Year Ended December 31, 2017 2018 Loss from continuing operations before taxes $ (8,463 ) $ (8,625 ) Income tax expense computed at statutory federal tax rate (2,877 ) (1,811 ) Disallowed expenses and non-taxable income 3 310 Loss surrendered to generate R&D credit 856 1,519 Additional research and development tax relief (1,262 ) (1,342 ) Change in valuation allowance (4,487 ) (7,440 ) Foreign items, including change in tax rates, and other 1,901 (1,700 ) Change in US Tax Rate 4,112 — Section 382 Limitation — 9,985 Other foreign items 761 (858 ) $ (993 ) $ (1,337 ) |
Schedule of significant components of the entity's deferred tax assets | Year Ended December 31, 2017 2018 Net operating loss and tax credit carryforwards $ 38,948 $ 33,835 Depreciation, amortization and impairment of property and equipment 111 109 Stock options 1,807 1,482 Research and development credits 4,021 — Other — — Deferred tax assets 44,887 35,426 Valuation allowance for deferred tax assets (44,887 ) (35,426 ) Net deferred tax assets $ — $ — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of basic and diluted net loss per share | Years ended December 31, 2017 2018 Numerator: Net loss $ (7,470 ) $ (7,288 ) Dividend on convertible exchangeable preferred shares $ (201 ) $ (201 ) Beneficial conversion feature of Series A convertible stock $ (3,638 ) $ — Conversion of Series A convertible preferred stock $ (3,537 ) $ — Net loss attributable to common shareholders $ (14,846 ) $ (7,489 ) Denominator: Weighted-average number of common shares used in loss per share – basic and diluted 7,631,152 12,094,131 Loss per share – basic and diluted $ (1.95 ) $ (0.62 ) |
Schedule of company's potential anti dilutive securities | Year ended December 31, 2017 2018 Stock options 535,616 831,611 Convertible preferred stock 1,698 1,698 Series A preferred stock 132,000 132,000 Common stock warrants 7,490,500 7,490,500 Total shares excluded from calculation 8,159,814 8,455,809 |
Geographic Information (Tables)
Geographic Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Geographic Information | |
Schedule of geographic information | Year Ended December 31, 2017 2018 Revenue United Kingdom $ — $ 150 Total Revenue $ — $ 150 Net loss United States $ (127 ) $ 15 United Kingdom (7,343 ) (7,303 ) Total Net Loss $ (7,470 ) $ (7,288 ) December 31, 2017 2018 Total Assets United States $ 23,522 $ 17,384 United Kingdom 2,481 2,439 Total Assets $ 26,003 $ 19,823 Long Lived Assets, net United States $ 0 $ 3 United Kingdom 29 33 Total Long Lived Assets, net $ 29 $ 36 |
Organization of the Company a_2
Organization of the Company and Basis of Presentation (Detail Textuals) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Organization of the Company | |||
Net loss | $ (7,288) | $ (7,470) | |
Accumulated deficit | (349,797) | (342,509) | |
Cash and cash equivalents | $ 17,504 | $ 23,910 | $ 16,520 |
Organization of the Company a_3
Organization of the Company and Basis of Presentation (Detail Textuals 1) - $ / shares | 1 Months Ended | ||
May 27, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | |
Organization Of Company And Basis Of Presentation Line Items | |||
Stockholders' equity, reverse stock split | one-for-twelve | ||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | |
Common stock, shares outstanding (in shares) | 12,497,447 | 11,997,447 | |
Before Reverse Stock Split | |||
Organization Of Company And Basis Of Presentation Line Items | |||
Common stock, shares outstanding (in shares) | 36,075,730 | ||
After Reverse Stock Split | |||
Organization Of Company And Basis Of Presentation Line Items | |||
Common stock, shares outstanding (in shares) | 3,006,311 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Detail Textuals) | 12 Months Ended | |||
Dec. 31, 2018USD ($)Segment | Dec. 31, 2018GBP (£)Segment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Accounting Policies [Line Items] | ||||
Cash and cash equivalents | $ 17,504,000 | $ 23,910,000 | $ 16,520,000 | |
Cash balances insured by FDIC | 250,000 | |||
Cash exceeding balance insured by FDIC | 16,800,000 | |||
Cash balance insured by FSCS | £ | £ 75,000 | |||
Cash exceeding balance insured by FSCS | $ 200,000 | |||
Number of operating segments | Segment | 1 | |||
Number of geographic areas for development operations | Segment | 2 | 2 | ||
Deferred revenue | $ 0 | $ 200,000 | ||
ManRos Therapeutics SA ("ManRos") | Collaboration, Supply and Licensing Agreements | ||||
Accounting Policies [Line Items] | ||||
Payment received from achieving a clinical milestone | $ 150,000 | |||
Property, plant and equipment | Minimum | ||||
Accounting Policies [Line Items] | ||||
Estimated useful life | 3 years | |||
Property, plant and equipment | Maximum | ||||
Accounting Policies [Line Items] | ||||
Estimated useful life | 5 years | |||
Leasehold improvements | Minimum | ||||
Accounting Policies [Line Items] | ||||
Estimated useful life | 5 years | |||
Leasehold improvements | Maximum | ||||
Accounting Policies [Line Items] | ||||
Estimated useful life | 15 years |
Significant Contracts (Detail T
Significant Contracts (Detail Textuals) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended |
Oct. 01, 2018 | Dec. 31, 2018 | |
Clinical Collaboration Agreement | The University of Texas MD Anderson Cancer Center | ||
Supply Commitment [Line Items] | ||
Term of agreement | 3 years | |
Daiichi Sankyo | ||
Supply Commitment [Line Items] | ||
Future milestone payments payable | $ 10 | |
Period for which royalties will be paid following first commercial sale of licensed products | 10 years | |
Notice period for termination of license by the entity for technical, scientific, efficacy, safety, or commercial reasons | 6 months | |
Notice period for termination of license after launch of a sapacitabine-based product by the entity, or by either party for material default | 12 months |
Cash and Cash Equivalents (Deta
Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Cash and Cash Equivalents | |||
Cash | $ 816 | $ 1,103 | |
Investments with original maturity of less than three months at the time of purchase | 16,688 | 22,807 | |
Total cash and cash equivalents | $ 17,504 | $ 23,910 | $ 16,520 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities (Details) - Recurring basis - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Assets: | ||
Cash equivalents | $ 16,688 | $ 22,807 |
Total Assets | 16,688 | 22,807 |
Level 1 | ||
Assets: | ||
Cash equivalents | 16,688 | 22,807 |
Total Assets | 16,688 | 22,807 |
Level 2 | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Total Assets | 0 | 0 |
Level 3 | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Total Assets | $ 0 | $ 0 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Research and development tax credit receivable | $ 1,148 | $ 1,054 |
Prepayments | 543 | 363 |
VAT receivable | 356 | 409 |
Deposits | 66 | 132 |
Other current assets | 170 | 106 |
Prepaid expenses and other current assets | $ 2,283 | $ 2,064 |
Property, Plant and Equipment (
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 6,156 | $ 6,925 |
Less: accumulated depreciation and amortization | (6,120) | (6,896) |
Property, Plant and Equipment, Net | 36 | 29 |
Leasehold improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 807 | 835 |
Leasehold improvements | Minimum | ||
Property, plant and equipment | ||
Lives in years | 5 years | |
Leasehold improvements | Maximum | ||
Property, plant and equipment | ||
Lives in years | 15 years | |
Research and laboratory equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 4,209 | 4,854 |
Research and laboratory equipment | Minimum | ||
Property, plant and equipment | ||
Lives in years | 3 years | |
Research and laboratory equipment | Maximum | ||
Property, plant and equipment | ||
Lives in years | 5 years | |
Office equipment and furniture | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 1,140 | $ 1,236 |
Office equipment and furniture | Minimum | ||
Property, plant and equipment | ||
Lives in years | 3 years | |
Office equipment and furniture | Maximum | ||
Property, plant and equipment | ||
Lives in years | 5 years |
Property, Plant and Equipment_2
Property, Plant and Equipment (Detail Textuals) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment | ||
Depreciation and amortization expense | $ 29,000 | $ 32,000 |
Proceeds from sale of asset | $ 16,000 | $ 0 |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Accrued and Other Current Liabilities | ||
Accrued research and development | $ 1,110 | $ 1,645 |
Accrued legal and professional fees | 259 | 248 |
Other current liabilities | 363 | 662 |
Total | $ 1,732 | $ 2,555 |
Accrued and Other Current Lia_4
Accrued and Other Current Liabilities (Detail Textuals) | 12 Months Ended |
Dec. 31, 2017USD ($) | |
ManRos Therapeutics SA ("ManRos") | |
Accrued And Other Current Liabilities [Line Items] | |
Deferred revenue yet to be recognition | $ 150,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Operating Lease Obligation | |
2019 | $ 321 |
2020 | 321 |
2021 | 321 |
2022 | 321 |
2023 | 321 |
thereafter | 581 |
Total future minimum lease obligations | $ 2,186 |
Commitments and Contingencies_3
Commitments and Contingencies (Detail Textuals) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Oct. 31, 2000 | |
Leases, related disclosures | |||
Lease term for research and development facility | 25 years | ||
Rent expense, net | $ 0.4 | $ 0.5 |
Stockholders' Equity (Detail Te
Stockholders' Equity (Detail Textuals) - USD ($) | Oct. 04, 2018 | Jul. 31, 2017 | Jul. 21, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Stockholders' equity | |||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Proceeds from issuance of common stock | $ 630,000 | $ 14,749,000 | |||
Common Stock | |||||
Stockholders' equity | |||||
Number of common stock issued | 3,154,000 | ||||
Sales Agreement | H.C. Wainwright & Co., LLC | |||||
Stockholders' equity | |||||
Common stock, par value (in dollars per share) | $ 0.001 | ||||
Aggregate offering price | $ 5,000,000 | ||||
Selling commissions, percentage | 3.00% | ||||
Number of share sold under the sales agreement | 500,000 | ||||
Proceeds from issuance of common stock | $ 700,000 | ||||
Underwritten Public Offering | |||||
Stockholders' equity | |||||
Proceeds from issuance of common stock | $ 13,700,000 | ||||
Underwritten Public Offering | Class A Units | |||||
Stockholders' equity | |||||
Share price per unit (in dollars per share) | $ 2 | ||||
Number of units authorized for issuance and sale | 3,154,000 | ||||
Underwritten Public Offering | Class A Units | Common Stock | |||||
Stockholders' equity | |||||
Number of securities called by each unit | 1 | ||||
Number of securities called by each warrant | 1 | ||||
Underwritten Public Offering | Class B Units | |||||
Stockholders' equity | |||||
Share price per unit (in dollars per share) | $ 1,000 | ||||
Number of units authorized for issuance and sale | 8,872 | ||||
Underwritten Public Offering | Class B Units | Common Stock | |||||
Stockholders' equity | |||||
Number of shares issued upon conversion | 500 | ||||
Price per share used to determine number of shares of common stock | $ 1,000 | ||||
Series A Preferred Stock | |||||
Stockholders' equity | |||||
Number of shares issued upon conversion | 4,304,000 | ||||
Price per share used to determine number of shares of common stock | $ 1,000 | ||||
Series A Preferred Stock | Underwritten Public Offering | |||||
Stockholders' equity | |||||
Aggregate intrinsic value of stock | $ 3,638,000 |
Stockholders' Equity (Detail _2
Stockholders' Equity (Detail Textuals 1) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stockholders' Equity | ||
Number of warrant outstanding | $ 7,490,500 | |
Warrant exercise price | $ 2 | |
Condition related to exercising warrants | The Warrants expire in 2024. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of its warrants if the holder (together with such holder's affiliates, and any persons acting as a group together with such holder or any of such holder's affiliates) would beneficially own a number of shares of common stock in excess of 4.99% (or, at the election of the purchaser, 9.99%) of the shares of our Common Stock then outstanding after giving effect to such exercise. | |
Number of warrants exercised | 0 | 99,500 |
Stockholders' Equity (Detail _3
Stockholders' Equity (Detail Textuals 2) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |
Jul. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Series A Preferred Stock | |||
Stockholders' equity | |||
Preferred stock, shares issued | 8,872 | 264 | 264 |
Preferred stock, shares outstanding | 264 | 264 | |
Number of common shares issued upon conversion | 4,304,000 | ||
Number of shares converted | 132,000 | 8,608 | |
Price per share used to determine number of shares of common stock | $ 1,000 | ||
Conversion price of convertible preferred stock | $ 2 | ||
Percentage of blocker provision | 4.99% | ||
Conversion percentage | 9.99% | ||
Condition related to events occurrence for conversion of preferred stock | (i) the volume weighted average price of our common stock for 30 consecutive trading days (the "Measurement Period") exceeds 300% of the initial conversion price of the Series A Preferred Stock (subject to adjustment for forward and reverse stock splits, recapitalizations, stock dividends and similar transactions), (ii) the daily trading volume on each Trading Day during such Measurement Period exceeds $500,000 per trading day and (iii) the holder is not in possession of any information that constitutes or might constitute, material non-public information which was provided by the Company. | ||
6% Convertible Exchangeable preferred stock | |||
Stockholders' equity | |||
Preferred stock, shares issued | 335,273 | 335,273 | |
Preferred stock, shares outstanding | 335,273 | 335,273 | |
Dividend rate on convertible exchangeable preferred stock (in percent) | 6.00% | ||
Share issue price per share | $ 10 | ||
Liquidation preference (in dollars per share) | $ 10 | ||
Accrued and unpaid dividends in arrears on preferred stock | $ 0.7 | $ 0.7 | |
Accrued and unpaid dividends in arrears on preferred stock (in dollars per share) | $ 1.95 | $ 1.95 | |
Shares reserved for future issuance upon conversion | 1,698 | ||
Number of shares to be issued for each preferred stock upon conversion | 0.00507 | ||
Conversion price (in dollars per share) | $ 1,974 | ||
Share Price | $ 2,961 | ||
Percentage of closing sales price of common stock that conversion price must exceed in order for preferred stock to be convertible | 150.00% | ||
Number of trading days within 30 trading days in which the closing price of common stock must exceed conversion price for preferred stock to be convertible | 20 days | ||
Number of trading days during which closing price of common stock must exceed 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 of Convertible Subordinated Debentures (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 |
Stock-Based Compensation Arrang
Stock-Based Compensation Arrangements (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock-based compensation | ||
Stock-based compensation costs before income taxes | $ 331 | $ 266 |
Research and development | ||
Stock-based compensation | ||
Stock-based compensation costs before income taxes | 88 | 72 |
General and administrative | ||
Stock-based compensation | ||
Stock-based compensation costs before income taxes | $ 243 | $ 194 |
Stock-Based Compensation Arra_2
Stock-Based Compensation Arrangements (Details 1) - Stock options - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Number of Options Outstanding | |||
Options outstanding at the beginning of the period (in shares) | 535,617 | 389,379 | |
Granted (in shares) | 306,304 | 170,853 | |
Exercised (in shares) | 0 | 0 | |
Cancelled / forfeited (in shares) | (10,310) | (24,615) | |
Options outstanding at the end of the period (in shares) | 831,611 | 535,617 | 389,379 |
Unvested at December 31, 2018 | 573,830 | ||
Vested and exercisable at December 31, 2018 | 257,781 | ||
Weighted Average Exercise Price Per Share | |||
Options outstanding at the beginning of the period (in dollars per share) | $ 11.1 | $ 25.8 | |
Granted (in dollars per share) | 1.51 | 1.93 | |
Cancelled / forfeited (in dollars per share) | 82.38 | 179.92 | |
Options outstanding at the end of the period (in dollars per share) | 6.68 | $ 11.1 | $ 25.8 |
Unvested at the end of the period (in dollars per share) | 2.57 | ||
Vested and exercisable at the end of the period (in dollars per share) | $ 15.84 | ||
Weighted Average Remaining Contractual Term (Years) | |||
Options outstanding | 8 years 1 month 17 days | 8 years 2 months 23 days | 5 years 9 months 29 days |
Unvested at the end of the period | 8 years 7 months 2 days | ||
Vested and exercisable at the end of the period | 7 years 1 month 6 days | ||
Aggregate Intrinsic Value | |||
Options outstanding | $ 0 | $ 0 | $ 121 |
Unvested at the end of the period | 0 | ||
Vested and exercisable at the end of the period | $ 0 |
Stock-Based Compensation Arra_3
Stock-Based Compensation Arrangements (Details 2) - Stock options - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair value of the stock options granted calculated using Black-Scholes option-pricing model assumptions | ||
Expected term (years) | 6 years | 6 years |
Volatility (as a percent) | 108.00% | |
Expected dividend yield over expected term (as a percent) | 0.00% | 0.00% |
Resulting weighted average grant fair value (in dollars per share) | $ 1.25 | $ 1.59 |
Minimum | ||
Fair value of the stock options granted calculated using Black-Scholes option-pricing model assumptions | ||
Risk free interest rate (as a percent) | 2.73% | 1.89% |
Volatility (as a percent) | 105.00% | |
Maximum | ||
Fair value of the stock options granted calculated using Black-Scholes option-pricing model assumptions | ||
Risk free interest rate (as a percent) | 2.855% | 2.265% |
Volatility (as a percent) | 107.00% |
Stock-Based Compensation Arra_4
Stock-Based Compensation Arrangements (Detail Textuals) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock options | ||
Stock-based compensation | ||
Number of options granted | 306,304 | 170,853 |
Percentage of vesting of awards | 25.00% | 25.00% |
Vesting period | 4 years | |
Weighted average grant-date fair value (in dollars per share) | $ 1.25 | $ 1.59 |
Performance Based Options | ||
Stock-based compensation | ||
Number of options granted | 174,272 | 158,853 |
2018 Equity Incentive Plan (the "2018 Plan") | ||
Stock-based compensation | ||
Number of authorized shares | 1,500,000 | |
Number of authorized additional shares to be issued | 709,889 | |
2018 Equity Incentive Plan (the "2018 Plan") | Stock options | ||
Stock-based compensation | ||
Number of shares reserved for issuance | 1,662,739 | |
Maximum life of stock option awards granted | 10 years | |
Remaining unrecognized compensation cost of non-vested stock options | $ 0.1 | |
Weighted-average remaining requisite service period of recognition of unrecognized compensation cost | 2 years 18 days |
Employee Benefit Plans (Detail
Employee Benefit Plans (Detail Textuals) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Pension Plan | ||
Employee benefit plans | ||
Contribution made by the entity under the pension plan | $ 55,000 | $ 54,000 |
401 (k) Plan | ||
Employee benefit plans | ||
Matching contribution by employer as a percentage of the employee's deferral | 100.00% | |
Matching contribution by employer as a percentage of U.S. employee's qualifying compensation | 6.00% | |
Statutorily prescribed annual limit of contributions made by an employee before attaining age of 50 years | $ 18,500 | |
Statutorily prescribed annual limit of contributions made by an employee after attaining age of 50 years | $ 24,500 | |
Specified age limit of employees for calculation of statutorily prescribed annual limit of contribution | 50 years | |
Contribution made by the entity under the 401(k) Plan | $ 36,000 | $ 28,000 |
Taxes (Details)
Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Loss (income) from continuing operations before taxes | ||
Domestic | $ 20 | $ (127) |
Foreign | (8,645) | (8,336) |
Loss from continuing operations before taxes | $ (8,625) | $ (8,463) |
Taxes (Details 1)
Taxes (Details 1) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Benefit for income taxes from continuing operations | ||
Current - domestic | $ (5) | $ 0 |
Current - foreign | 1,342 | 993 |
Current - total | 1,337 | 993 |
Deferred - domestic | 0 | 0 |
Income tax benefit, total | $ 1,337 | $ 993 |
Taxes (Details 2)
Taxes (Details 2) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of the (benefit) provision for income taxes | ||
Loss from continuing operations before taxes | $ (8,625) | $ (8,463) |
Income tax expense computed at statutory federal tax rate | (1,811) | (2,877) |
Disallowed expenses and non-taxable income | 310 | 3 |
Loss surrendered to generate R&D credit | 1,519 | 856 |
Additional research and development tax relief | (1,342) | (1,262) |
Change in valuation allowance | (7,440) | (4,487) |
Foreign items, including change in tax rates, and other | (1,700) | 1,901 |
Change in US Tax Rate | 0 | 4,112 |
Section 382 Limitation | 9,985 | 0 |
Other foreign items | (858) | 761 |
Income tax benefit, total | $ (1,337) | $ (993) |
Taxes (Details 3)
Taxes (Details 3) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Net operating loss and tax credit carryforwards | ||
Net operating loss and tax credit carryforwards | $ 33,835 | $ 38,948 |
Depreciation, amortization and impairment of property and equipment | 109 | 111 |
Stock options | 1,482 | 1,807 |
Research and development credits | 0 | 4,021 |
Other | 0 | 0 |
Deferred tax assets | 35,426 | 44,887 |
Valuation allowance for deferred tax assets | (35,426) | (44,887) |
Net deferred tax assets | $ 0 | $ 0 |
Taxes (Detail Textuals)
Taxes (Detail Textuals) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Taxes | ||
Income tax credits | $ 1,300 | $ 1,000 |
US corporate income tax rate | 21.00% | 35.00% |
Valuation allowance for deferred tax assets | $ 35,426 | $ 44,887 |
Reduction in deferred tax assets | $ 4,400 | |
Use of these NOLs restricted to an annual allowance | The Company's foreign NOL's do not expire under UK tax law however the use of these NOLs is restricted to an annual £5 million allowance in each standalone company or group and above this allowance, there will be a 50% restriction in the profits that can be covered by losses brought forward. | |
(Decrease) in valuation allowance | $ (9,400) | |
Federal | ||
Taxes | ||
NOLs carryforward | 0 | 28,400 |
United Kingdom | ||
Taxes | ||
NOLs carryforward | 191,200 | $ 186,200 |
State | ||
Taxes | ||
NOLs carryforward | $ 18,700 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Numerator: | ||
Net loss | $ (7,288) | $ (7,470) |
Payment of preferred stock dividend | (201) | (201) |
Beneficial conversion feature of Series A convertible stock | 0 | (3,638) |
Conversion of Series A convertible preferred stock | 0 | (3,537) |
Net loss attributable to common shareholders | $ (7,489) | $ (14,846) |
Denominator: | ||
Weighted average common shares outstanding (in shares) | 12,094,131 | 7,631,152 |
Loss per share - basic and diluted (in dollars per share) | $ (0.62) | $ (1.95) |
Net Loss Per Share (Details 1)
Net Loss Per Share (Details 1) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 8,455,809 | 8,159,814 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 831,611 | 535,616 |
Convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 1,698 | 1,698 |
Series A Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 132,000 | 132,000 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 7,490,500 | 7,490,500 |
Geographic Information (Details
Geographic Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 150 | $ 0 |
Net loss | (7,288) | (7,470) |
Assets | 19,823 | 26,003 |
Long Lived Assets, net | 36 | 29 |
United Kingdom | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 150 | 0 |
Net loss | (7,303) | (7,343) |
Assets | 2,439 | 2,481 |
Long Lived Assets, net | 33 | 29 |
United States | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Net loss | 15 | (127) |
Assets | 17,384 | 23,522 |
Long Lived Assets, net | $ 3 | $ 0 |
Subsequent Events (Detail Textu
Subsequent Events (Detail Textuals) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | Mar. 07, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Subsequent Event [Line Items] | ||||
Proceeds from issuance of common stock | $ 630 | $ 14,749 | ||
Subsequent event | Sales Agreement with Wainwright | ||||
Subsequent Event [Line Items] | ||||
Number of share sold under the sales agreement | 4.7 | |||
Proceeds from issuance of common stock | $ 4,300 | |||
Subsequent event | Board of Directors | ||||
Subsequent Event [Line Items] | ||||
Preferred stock dividend declared, amount per share | $ 0.15 | |||
Dividend declared, date | Mar. 7, 2019 | |||
Dividend paid, date | May 1, 2019 | |||
Dividend, record date | Apr. 15, 2019 |