Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 13, 2019 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | Cyclacel Pharmaceuticals, Inc. | |
Entity Central Index Key | 0001130166 | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Entity Common Stock, Shares Outstanding | 17,199,974 | |
Entity Emerging Growth Company | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 12,967 | $ 17,504 |
Prepaid expenses and other current assets | 2,869 | 2,283 |
Total current assets | 15,836 | 19,787 |
Property and equipment, net | 28 | 36 |
Right-of-use lease asset | 1,213 | |
Total assets | 17,077 | 19,823 |
Current liabilities: | ||
Accounts payable | 887 | 2,719 |
Accrued and other current liabilities | 1,184 | 1,732 |
Total current liabilities | 2,071 | 4,451 |
Lease liability | 1,154 | |
Other liabilities | 100 | |
Total liabilities | 3,225 | 4,551 |
Stockholders' equity: | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2018 and September 30, 2019; 12,497,447 and 17,199,974 shares issued and outstanding at December 31, 2018 and September 30, 2019. | 17 | 12 |
Additional paid-in capital | 370,071 | 365,817 |
Accumulated other comprehensive loss | (913) | (760) |
Accumulated deficit | (355,323) | (349,797) |
Total stockholders' equity | 13,852 | 15,272 |
Total liabilities and stockholders' equity | 17,077 | 19,823 |
Convertible Exchangeable Preferred Stock [Member] | ||
Stockholders' equity: | ||
Preferred stock, value | ||
Series A Convertible Preferred Stock [Member] | ||
Stockholders' equity: | ||
Preferred stock, value |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parentheticals) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, liquidation preference value (in dollars) | $ 4,006,512 | $ 4,006,512 |
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 | 17,199,974 | 12,497,447 |
Common stock, shares outstanding | 17,199,974 | 12,497,447 |
Convertible Exchangeable Preferred Stock [Member] | ||
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% | 6.00% |
Series A Convertible Preferred Stock [Member] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares issued | 264 | 264 |
Preferred stock, shares outstanding | 264 | 264 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenues: | ||||
Total revenues | $ 0 | $ 0 | ||
Operating expenses: | ||||
Research and development | $ 1,063,000 | $ 1,205,000 | 3,227,000 | 3,185,000 |
General and administrative | 1,285,000 | 1,250,000 | 3,661,000 | 3,898,000 |
Total operating expenses | 2,348,000 | 2,455,000 | 6,888,000 | 7,083,000 |
Operating loss | (2,348,000) | (2,455,000) | (6,888,000) | (7,083,000) |
Other income (expense): | ||||
Foreign exchange gains (losses) | 79,000 | 1,000 | 115,000 | (42,000) |
Interest income | 42,000 | 85,000 | 177,000 | 238,000 |
Other income, net | 53,000 | 223,000 | 632,000 | |
Total other income, net | 174,000 | 86,000 | 515,000 | 828,000 |
Loss before taxes | (2,174,000) | (2,369,000) | (6,373,000) | (6,255,000) |
Income tax benefit | 273,000 | 301,000 | 848,000 | 985,000 |
Net loss | (1,901,000) | (2,068,000) | (5,525,000) | (5,270,000) |
Dividend on convertible exchangeable preferred shares | (50,000) | (50,000) | (151,000) | (151,000) |
Net loss applicable to common stockholders | $ (1,951,000) | $ (2,118,000) | $ (5,676,000) | $ (5,421,000) |
Basic and diluted earnings per common share: | ||||
Net loss per share - basic and diluted (in dollars per share) | $ (0.11) | $ (0.18) | $ (0.35) | $ (0.45) |
Weighted average common shares outstanding (in shares) | 17,199,974 | 11,997,447 | 16,025,786 | 11,997,447 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (1,901) | $ (2,068) | $ (5,525) | $ (5,270) |
Translation adjustment | 5,434 | 2,266 | 5,990 | 5,559 |
Unrealized foreign exchange gain on intercompany loans | (5,540) | (2,261) | (6,143) | (5,562) |
Comprehensive loss | $ (2,007) | $ (2,063) | $ (5,678) | $ (5,273) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Total |
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 | ||||||
Stock-based compensation | 79 | 79 | ||||
Preferred stock dividends | (50) | (50) | ||||
Unrealized foreign exchange on intercompany loans | 6,276 | 6,276 | ||||
Translation adjustment | (6,328) | (6,328) | ||||
Loss for the period | (1,348) | (1,348) | ||||
Balance at Mar. 31, 2018 | $ 12 | 365,086 | (846) | (343,857) | 20,395 | |
Balance (in shares) at Mar. 31, 2018 | 335,537 | 11,997,447 | ||||
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 | ||||||
Unrealized foreign exchange on intercompany loans | (5,562) | |||||
Translation adjustment | 5,559 | |||||
Loss for the period | (5,270) | |||||
Balance at Sep. 30, 2018 | $ 12 | 365,160 | (796) | (347,778) | 16,598 | |
Balance (in shares) at Sep. 30, 2018 | 335,537 | 11,997,447 | ||||
Balance at Mar. 31, 2018 | $ 12 | 365,086 | (846) | (343,857) | 20,395 | |
Balance (in shares) at Mar. 31, 2018 | 335,537 | 11,997,447 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation | 87 | 87 | ||||
Preferred stock dividends | (50) | (50) | ||||
Unrealized foreign exchange on intercompany loans | (9,578) | (9,578) | ||||
Translation adjustment | 9,623 | 9,623 | ||||
Loss for the period | (1,853) | (1,853) | ||||
Balance at Jun. 30, 2018 | $ 12 | 365,123 | (801) | (345,710) | 18,624 | |
Balance (in shares) at Jun. 30, 2018 | 335,537 | 11,997,447 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation | 87 | 87 | ||||
Preferred stock dividends | (50) | (50) | ||||
Unrealized foreign exchange on intercompany loans | (2,261) | (2,261) | ||||
Translation adjustment | 2,266 | 2,266 | ||||
Loss for the period | (2,068) | (2,068) | ||||
Balance at Sep. 30, 2018 | $ 12 | 365,160 | (796) | (347,778) | 16,598 | |
Balance (in shares) at Sep. 30, 2018 | 335,537 | 11,997,447 | ||||
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 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issue of common stock on At Market Issuance sales agreement | $ 5 | 4,106 | 4,111 | |||
Issue of common stock on At Market Issuance sales agreement (in shares) | 4,702,527 | |||||
Stock-based compensation | (85) | (85) | ||||
Preferred stock dividends | (50) | (50) | ||||
Unrealized foreign exchange on intercompany loans | 3,876 | 3,876 | ||||
Translation adjustment | (3,897) | (3,897) | ||||
Loss for the period | (1,842) | (1,842) | ||||
Balance at Mar. 31, 2019 | $ 17 | 369,958 | (781) | (351,639) | 17,555 | |
Balance (in shares) at Mar. 31, 2019 | 335,537 | 17,199,974 | ||||
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 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Unrealized foreign exchange on intercompany loans | (6,143) | |||||
Translation adjustment | 5,990 | |||||
Loss for the period | (5,525) | |||||
Balance at Sep. 30, 2019 | $ 17 | 370,071 | (913) | (355,323) | 13,852 | |
Balance (in shares) at Sep. 30, 2019 | 335,537 | 17,199,974 | ||||
Balance at Mar. 31, 2019 | $ 17 | 369,958 | (781) | (351,639) | 17,555 | |
Balance (in shares) at Mar. 31, 2019 | 335,537 | 17,199,974 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issue of common stock on At Market Issuance sales agreement | (56) | (56) | ||||
Stock-based compensation | 93 | 93 | ||||
Preferred stock dividends | (50) | (50) | ||||
Unrealized foreign exchange on intercompany loans | (4,480) | (4,480) | ||||
Translation adjustment | 4,453 | 4,453 | ||||
Loss for the period | (1,783) | (1,783) | ||||
Balance at Jun. 30, 2019 | $ 17 | 369,944 | (808) | (353,422) | 15,731 | |
Balance (in shares) at Jun. 30, 2019 | 335,537 | 17,199,974 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issue of common stock on At Market Issuance sales agreement | (6) | (6) | ||||
Stock-based compensation | 184 | 184 | ||||
Preferred stock dividends | (50) | (50) | ||||
Unrealized foreign exchange on intercompany loans | (5,540) | (5,540) | ||||
Translation adjustment | 5,434 | 5,434 | ||||
Loss for the period | (1,901) | (1,901) | ||||
Balance at Sep. 30, 2019 | $ 17 | $ 370,071 | $ (913) | $ (355,323) | $ 13,852 | |
Balance (in shares) at Sep. 30, 2019 | 335,537 | 17,199,974 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities: | ||
Net loss | $ (5,525) | $ (5,270) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 15 | 22 |
Gain on disposal of property and equipment | (29) | |
Stock-based compensation | 361 | 255 |
Changes in lease liability | (61) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (676) | 320 |
Accounts payable and other current liabilities | (2,415) | 8 |
Net cash used in operating activities | (8,330) | (4,665) |
Investing activities: | ||
Purchase of property, plant and equipment | (7) | (33) |
Proceeds from sale of property and equipment | 29 | |
Net cash provided by (used in) investing activities | 22 | (33) |
Financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 4,049 | |
Payment of preferred stock dividend | (151) | (151) |
Net cash provided by (used in) financing activities | 3,898 | (151) |
Effect of exchange rate changes on cash and cash equivalents | (126) | (88) |
Net (decrease) in cash and cash equivalents | (4,536) | (4,937) |
Cash and cash equivalents at beginning of period | 17,504 | 23,910 |
Cash and cash equivalents at end of period | 12,968 | 18,973 |
Supplemental cash flow information: | ||
Cash received during the period for: Interest | 177 | 238 |
Cash received during the period for: Taxes | 1,158 | |
Non cash financing activities: | ||
Accrual of preferred stock dividends | $ 50 | $ 50 |
Company Overview
Company Overview | 9 Months Ended |
Sep. 30, 2019 | |
Company Overview [Abstract] | |
Company Overview | 1. Company Overview Nature of Operations Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or the “Company”) is a clinical-stage biopharmaceutical company using cell cycle control, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases. Cyclacel is a pioneer company in the field of cell cycle biology with a vision to improve patient healthcare by translating cancer biology into medicines. As of September 30, 2019, 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The consolidated balance sheet as of September 30, 2019, the consolidated statements of operations, comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2019 and 2018 and the consolidated statements of cash flows for the nine months ended September 30, 2019 and 2018, and all related disclosures contained in the accompanying notes, are unaudited. The consolidated balance sheet as of December 31, 2018 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2018 filed with the Securities and Exchange Commission (the “SEC”). The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of September 30, 2019, and the results of operations and, comprehensive loss for the three and nine months ended September 30, 2019, and cash flows for the nine months ended September 30, 2019, have been made. The interim results for the three and nine months ended September 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other reporting period. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2018 that are included in the Company’s Annual Report on Form 10-K filed with the SEC. 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 approximately $13.0 million as of September 30, 2019 will be sufficient to fund its operating expenses and capital expenditure requirements through the end 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 sources of liquidity; 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 that, when considered in conjunction with the above, may adversely affect the Company’s ability to meet its obligations. The future viability of the Company beyond the end of 2020 is dependent on its ability to raise additional capital to finance its operations. The Company does not currently have sufficient funds to complete development and commercialization of any of its drug candidates. Additional funding may not be available to the Company on favorable terms, or at all. If the Company is not able to secure additional funding when needed, it may have to delay, reduce the scope of or eliminate one or more of its clinical trials or research and development programs or make changes to its operating plan. In addition, it may have to partner one or more of its product candidate programs at an earlier stage of development, which would lower the economic value of those programs to the Company. 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. Accounting standards adopted in the period On January 1, 2019, the Company adopted the guidance on accounting for leases (“ASC 842”) in Accounting Standards Update No, 2016‑02, Leases, as amended by subsequent updates issued in 2018 and 2019. The guidance requires that lessees recognize both 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 Company has elected the package of practical expedients permitted in ASC 842. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance, without reassessing (a) whether the contracts contain a lease under ASC 842, (b) whether classification of the operating leases would be different in accordance with ASC 842, or (c) whether any unamortized initial direct costs would have met the definition of initial direct costs in ASC 842 at lease commencement. The Company transitioned to the new guidance at the adoption date by recognizing a lease liability of $1.5 million for the present value of the remaining minimum rental payments, as defined under prior accounting rules, and a corresponding right-of-use asset. In addition, the Company reclassified an existing deferred rent obligation of $120,000 created under prior accounting rules against the opening right-of-use asset. Because the Company adopted the new leasing guidance on a cumulative catch-up basis effective January 1, 2019, the Company has not recast prior period financial statements for the effects of this new standard. Accordingly, the Company’s financial condition as of December 31, 2018 and September 30, 2019 may not be comparable. Recently Issued Accounting Pronouncements In August 2018, the FASB issued ASU 2018‑15, “Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract.” ASU 2018‑15 requires implementation costs incurred by customers in cloud computing arrangements to be deferred over the non-cancellable term of the cloud computing arrangements plus any optional renewal periods (1) that are reasonably certain to be exercised by the customer or (2) for which exercise of the renewal option is controlled by the cloud service provider. The effective date of this pronouncement is for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, and early adoption is permitted. The standard can be adopted either using the prospective or retrospective transition approach. The Company is currently evaluating the impact of this pronouncement on the Company’s consolidated financial statements and disclosures. Fair Value of Financial Instruments Financial instruments consist of cash equivalents, accounts payable and accrued liabilities. The carrying amounts of cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities. 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, 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 three months ended September 30, 2018 and 2019. Revenue recognition With effect from January 1, 2018, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (“ASC 606”): (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize 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 the 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 the milestone. The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the 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. The Company recognizes a contract asset, when the value of satisfied (or part satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or part satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable. With effect from January 1, 2018, grant revenue is presented as a reduction against the related research and development expenses. Leases Effective from January 1, 2019, the Company accounts for lease contracts in accordance with ASC 842. As of September 30, 2019, all of the Company’s leases are classified as operating leases. The Company recognizes an asset for the right to use an underlying leased asset for the lease term and records lease liabilities based on the present value of the Company’s obligation to make lease payments under the lease. As the Company’s leases do not indicate an implicit rate, the Company uses a best estimate of its incremental borrowing rate to discount the future lease payments. The Company estimates its incremental borrowing rate based on observable information about risk-free interest rates that are the same tenure as the lease term, adjusted for various factors, including the effects of assumed collateral, the nature of how the loan is repaid (e.g., amortizing versus bullet), and the Company’s credit risk. The Company evaluates options included in its lease agreements to extend or terminate the lease. The Company will reflect the effects of exercising those options in the lease term when it is reasonably certain that the Company will exercise that option. In assessing whether it is reasonably certain that the Company will exercise an option, the Company considers factors such as: · The lease payments due in any optional period; · Penalties for failure to exercise (or not exercise) the option; · Market factors, such as the availability of similar assets and current rental rates for such assets; · The nature of the underlying leased asset and its importance to the Company’s operations; and · The remaining useful lives of any related leasehold improvements. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Variable lease payments, if any, are recognized in the period when the obligation to make those payments is incurred. Lease incentives received prior to lease commencement are recorded as a reduction in the right-of-use asset. Fixed lease incentives received after lease commencement reduce both the lease liability and the right-of-use asset. The Company has elected an accounting policy to account for the lease and non-lease components as a single lease component. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2019 | |
Revenue Recognition [Abstract] | |
Revenue | 3. Revenue Revenue recognized in the three and nine months ended September 30, 2018 and 2019 was $0. The aggregate transaction price that is allocated to performance obligations that are unsatisfied (or partially unsatisfied) as of September 30, 2019 was $0. |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2019 | |
Net Loss per Common Share [Abstract] | |
Net Loss Per Common Share | 4. Net Loss per Common Share The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period. The following potentially dilutive securities have not been included in the computation of diluted net loss per share for the three and nine months ended September 30, 2018 and 2019, as the result would be anti-dilutive: September 30, September 30, 2018 2019 Stock options 836,849 2,266,017 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 8,461,048 9,890,215 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2019 | |
Prepaid Expenses And Other Current Assets [Abstract] | |
Prepaid Expenses and Other Current Assets | 5. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in $000s): December 31, September 30, 2018 2019 Research and development tax credit receivable $ 1,148 $ 1,929 Prepayments and VAT receivable 899 821 Other current assets 236 119 $ 2,283 $ 2,869 $53,000 of receivables are included in other current assets as at September 30, 2019. This relates to royalty payments receivable under a December 2005 Asset Purchase Agreement, or APA, whereby Xcyte Therapies, Inc., or Xcyte, (a business acquired by the Company in March 2006) sold certain assets and intellectual property to ThermoFisher Scientific Company, or TSC, (formerly Invitrogen Corporation) through the APA and other related agreements. The assets and technology were not part of the Company’s product development plan following the transaction between Xcyte and Cyclacel in March 2006. Accordingly, the company recognized $223,000 of other income related to this transaction during the nine months ended September 30, 2019. |
Accrued and Other Liabilities
Accrued and Other Liabilities | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Accrued and Other Liabilities | 6. Accrued and Other Liabilities Accrued and other current liabilities consisted of the following (in $000s): December 31, September 30, 2018 2019 Accrued research and development $ 1,110 $ 753 Accrued legal and professional fees 259 233 Other current liabilities 363 198 $ 1,732 $ 1,184 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | 7. Leases The Company has a single lease related to its facility in Dundee, Scotland. As of and for the nine months ended September 30, 2019 The Company recognized operating lease expenses of $227,853. Cash payments made during the nine months ended September 30, 2019 totaled $240,846 and were presented as cash outflows from operating activities. The remaining lease term is approximately 6.1 years as of September 30, 2019. The discount rate used by the Company in determining the lease liability was 12%. Remaining lease payments under the lease are: 2019 $ 79,318 2020 317,272 2021 317,272 2022 315,988 2023 313,421 Thereafter 562,463 $ 1,905,734 As of and for the twelve months ended December 31, 2018 Prior to January 1, 2019, the Company accounted for its Dundee facility lease under ASC 840, Leases . 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: Operating Lease Obligation 2019 $ 321,000 2020 321,000 2021 321,000 2022 321,000 2023 321,000 thereafter 581,000 Total future minimum lease obligations $ 2,186,000 |
Stock Based Compensation
Stock Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Share-Based Payments [Abstract] | |
Stock Based Compensation | 8. Stock Based Compensation ASC 718 requires compensation expense associated with share-based awards to be recognized over the requisite service period, which for the Company is the period between the grant date and the date the award vests or becomes exercisable. Most of the awards granted by the Company (and still outstanding) vest ratably over one to four years. The Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Forfeitures are recognized in the periods when they occur. Stock based compensation has been reported within expense line items on the consolidated statement of operations for the three and nine months ended September 30, 2018 and 2019 as shown in the following table (in $000s): Three Months Ended Nine Months Ended September 30, September 30, 2018 2019 2018 2019 General and administrative $ 66 123 $ 188 235 Research and development 22 61 67 126 Stock-based compensation costs before income taxes $ 88 184 $ 255 361 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 replaced 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 September 30, 2019, the Company has reserved 228,334 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 1,550,270 options granted during the nine months ended September 30, 2019. These options had a grant date fair value ranging between $0.52-$0.61 per option. There were 306,304 options granted during the year ended December 31, 2018. These options had grant date fair values ranging between $1.17-$1.29 per option. Of these options, approximately 174,272 are performance based and will vest upon the fulfillment of certain clinical objectives. The satisfaction of one criterion, occurred as of December 31, 2018, with 36,537 awards vesting at that time. In addition, the Company believes that an additional 36,537 performance awards, along with 39,713 performance awards granted in 2017, became probable of vesting in the quarter ended September 30, 2019. The Company recorded a catch-up adjustment related to this change in estimate of approximately $91,000 in the quarter ended September 30, 2019. Other vesting criteria related to these awards were not probable as of September 30, 2019. As such, the Company has not recognized compensation cost for performance awards that are not probable of vesting. There were no stock options exercised during each of the nine months ended September 30, 2018 and 2019, respectively. The Company does not expect to be able to benefit from the deduction for stock option exercises that may occur because the company has tax loss carryforwards from prior periods that would be expected to offset any potential taxable income. Outstanding Options A summary of the share option activity and related information is as follows: Weighted Weighted Average Number of Average Remaining Aggregate Options Exercise Contractual Intrinsic Outstanding Price Per Share Term (Years) Value ($000) Options outstanding at December 31, 2018 831,611 $ 6.68 8.13 $ — Granted 1,550,270 $ 0.71 Cancelled/forfeited (115,864) $ 2.03 Options outstanding at September 30, 2019 2,266,017 $ 2.84 8.66 $ — Unvested at September 30, 2019 1,613,280 $ 1.27 8.90 $ — Vested and exercisable at September 30, 2019 652,737 $ 6.71 8.08 $ — 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 Nine Months Ended December 31, 2018 September 30, 2019 Expected term (years) 6 5 – 6 Risk free interest rate 2.730% – 2.855% 2.105 – 2.610% Volatility 105% – 107% 103 – 110% Expected dividend yield over expected term 0.00% 0.00% Resulting weighted average grant date fair value $1.25 $0.52 – $0.61 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
Stockholders Equity | 9. Stockholders Equity 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 was authorized to sell shares of 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 were 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 paid Wainwright a commission of 3.0% of the gross sales price per share sold. The Sales Agreement was concluded during the first quarter of 2019, pursuant to which the Company sold 4,702,527 shares for gross proceeds of approximately $4.3 million. Aggregate net proceeds to the Company were approximately $4.7 million, after deducting commissions and other expenses. Warrants As of September 30, 2019, 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. There was no exercise of warrants during the three and nine months ended September 30, 2019. Series A Preferred Stock 8,872 shares of the Company’s Series A Preferred Stock were issued in the July 2017 underwritten public offering. 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 September 30, 2019, 264 shares of the Series A Preferred Stock remain issued and outstanding. 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. The 264 shares of Series A Preferred Stock issued and outstanding at September 30, 2019, 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 shall be permitted to 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 September 30, 2019, there were 335,273 shares of the Company’s 6% Convertible Exchangeable Preferred Stock (the “6% Preferred Stock”) issued and outstanding at an issue price of $10.00 per share. Dividends on the 6% Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the 6% 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 6% Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends. The Company may automatically convert the 6% Preferred Stock into common stock if the per share closing price of the Company’s common stock has exceeded $2,961, which is 150% of the conversion price of the 6% 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 6% 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 6% Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share. The 6% 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 (the “Debentures”) at the rate of $10.00 principal amount of Debentures for each share of 6% Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have terms substantially similar to those of the 6% Preferred Stock. No such exchanges have taken place to date. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events On September 5, 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 was paid on November 1, 2019 to the holders of record of the Preferred Stock as of the close of business on October 14, 2019. On January 8, 2019, the Company received a written notification from the Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the minimum bid price of the Company’s shares of common stock was below $1.00 per share for the previous 30 consecutive business days. The Company was provided an initial period of 180 calendar days, or until July 7, 2019, to regain compliance with the minimum bid price rule. The Company did not regain compliance with the minimum closing bid price requirement by July 7, 2019. The Company was previously notified by Nasdaq that it might be afforded a second 180 calendar days period to regain compliance with the minimum closing bid price requirement under certain circumstances if the Company notified Nasdaq of its intent to cure the deficiency. As a result, the Company applied for an extension of the cure period, as permitted under the notification, and received an extension until January 6, 2020 to regain compliance with the minimum bid price rule. To regain compliance, the closing bid price of the Company’s shares of common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this additional 180-day grace period. If the Company does not regain compliance with the minimum bid price rule by January 6, 2020, Nasdaq will provide written notification that the common stock may be delisted. At that time, the Company may appeal Nasdaq’s delisting determination to a Nasdaq hearings panel. If timely appealed, the common stock would remain listed pending the panel’s decision. The Company’s board of directors determined that an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split is necessary to the continued listing of the common stock on Nasdaq, and on October 28, 2019, a Special Meeting of Stockholders was convened, and the Company’s stockholders considered and approved a proposal to adopt and approve an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the common stock, par value $0.001 per share (the “common stock”) at a ratio of not less than 1-for-5 and not greater than 1-for-20, with the exact ratio and effective time of the reverse stock split to be determined by the Company’s board of directors at any time within one year of the date of the Special Meeting (the “Split Proposal”). The Split Proposal was approved, and the reverse stock split will be effected, if at all, only upon a subsequent determination of the Company’s board of directors that such reverse stock split is in the best interests of the Company and its stockholders. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated balance sheet as of September 30, 2019, the consolidated statements of operations, comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2019 and 2018 and the consolidated statements of cash flows for the nine months ended September 30, 2019 and 2018, and all related disclosures contained in the accompanying notes, are unaudited. The consolidated balance sheet as of December 31, 2018 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2018 filed with the Securities and Exchange Commission (the “SEC”). The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of September 30, 2019, and the results of operations and, comprehensive loss for the three and nine months ended September 30, 2019, and cash flows for the nine months ended September 30, 2019, have been made. The interim results for the three and nine months ended September 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other reporting period. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2018 that are included in the Company’s Annual Report on Form 10-K filed with the SEC. |
Going Concern | 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 approximately $13.0 million as of September 30, 2019 will be sufficient to fund its operating expenses and capital expenditure requirements through the end 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 sources of liquidity; 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 that, when considered in conjunction with the above, may adversely affect the Company’s ability to meet its obligations. The future viability of the Company beyond the end of 2020 is dependent on its ability to raise additional capital to finance its operations. The Company does not currently have sufficient funds to complete development and commercialization of any of its drug candidates. Additional funding may not be available to the Company on favorable terms, or at all. If the Company is not able to secure additional funding when needed, it may have to delay, reduce the scope of or eliminate one or more of its clinical trials or research and development programs or make changes to its operating plan. In addition, it may have to partner one or more of its product candidate programs at an earlier stage of development, which would lower the economic value of those programs to the Company. 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. |
Accounting Standards Adopted in the Period | Accounting standards adopted in the period On January 1, 2019, the Company adopted the guidance on accounting for leases (“ASC 842”) in Accounting Standards Update No, 2016‑02, Leases, as amended by subsequent updates issued in 2018 and 2019. The guidance requires that lessees recognize both 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 Company has elected the package of practical expedients permitted in ASC 842. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance, without reassessing (a) whether the contracts contain a lease under ASC 842, (b) whether classification of the operating leases would be different in accordance with ASC 842, or (c) whether any unamortized initial direct costs would have met the definition of initial direct costs in ASC 842 at lease commencement. The Company transitioned to the new guidance at the adoption date by recognizing a lease liability of $1.5 million for the present value of the remaining minimum rental payments, as defined under prior accounting rules, and a corresponding right-of-use asset. In addition, the Company reclassified an existing deferred rent obligation of $120,000 created under prior accounting rules against the opening right-of-use asset. Because the Company adopted the new leasing guidance on a cumulative catch-up basis effective January 1, 2019, the Company has not recast prior period financial statements for the effects of this new standard. Accordingly, the Company’s financial condition as of December 31, 2018 and September 30, 2019 may not be comparable. Recently Issued Accounting Pronouncements In August 2018, the FASB issued ASU 2018‑15, “Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract.” ASU 2018‑15 requires implementation costs incurred by customers in cloud computing arrangements to be deferred over the non-cancellable term of the cloud computing arrangements plus any optional renewal periods (1) that are reasonably certain to be exercised by the customer or (2) for which exercise of the renewal option is controlled by the cloud service provider. The effective date of this pronouncement is for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, and early adoption is permitted. The standard can be adopted either using the prospective or retrospective transition approach. The Company is currently evaluating the impact of this pronouncement on the Company’s consolidated financial statements and disclosures. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Financial instruments consist of cash equivalents, accounts payable and accrued liabilities. The carrying amounts of cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities. |
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, 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 three months ended September 30, 2018 and 2019. |
Revenue recognition | Revenue recognition With effect from January 1, 2018, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (“ASC 606”): (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize 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 the 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 the milestone. The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the 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. The Company recognizes a contract asset, when the value of satisfied (or part satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or part satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable. With effect from January 1, 2018, grant revenue is presented as a reduction against the related research and development expenses. |
Leases | Leases Effective from January 1, 2019, the Company accounts for lease contracts in accordance with ASC 842. As of September 30, 2019, all of the Company’s leases are classified as operating leases. The Company recognizes an asset for the right to use an underlying leased asset for the lease term and records lease liabilities based on the present value of the Company’s obligation to make lease payments under the lease. As the Company’s leases do not indicate an implicit rate, the Company uses a best estimate of its incremental borrowing rate to discount the future lease payments. The Company estimates its incremental borrowing rate based on observable information about risk-free interest rates that are the same tenure as the lease term, adjusted for various factors, including the effects of assumed collateral, the nature of how the loan is repaid (e.g., amortizing versus bullet), and the Company’s credit risk. The Company evaluates options included in its lease agreements to extend or terminate the lease. The Company will reflect the effects of exercising those options in the lease term when it is reasonably certain that the Company will exercise that option. In assessing whether it is reasonably certain that the Company will exercise an option, the Company considers factors such as: · The lease payments due in any optional period; · Penalties for failure to exercise (or not exercise) the option; · Market factors, such as the availability of similar assets and current rental rates for such assets; · The nature of the underlying leased asset and its importance to the Company’s operations; and · The remaining useful lives of any related leasehold improvements. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Variable lease payments, if any, are recognized in the period when the obligation to make those payments is incurred. Lease incentives received prior to lease commencement are recorded as a reduction in the right-of-use asset. Fixed lease incentives received after lease commencement reduce both the lease liability and the right-of-use asset. The Company has elected an accounting policy to account for the lease and non-lease components as a single lease component. |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Net Loss per Common Share [Abstract] | |
Schedule of company's potential anti dilutive securities | September 30, September 30, 2018 2019 Stock options 836,849 2,266,017 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 8,461,048 9,890,215 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Prepaid Expenses And Other Current Assets [Abstract] | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consisted of the following (in $000s): December 31, September 30, 2018 2019 Research and development tax credit receivable $ 1,148 $ 1,929 Prepayments and VAT receivable 899 821 Other current assets 236 119 $ 2,283 $ 2,869 |
Accrued and Other Liabilities (
Accrued and Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of accrued and other current liabilities | Accrued and other current liabilities consisted of the following (in $000s): December 31, September 30, 2018 2019 Accrued research and development $ 1,110 $ 753 Accrued legal and professional fees 259 233 Other current liabilities 363 198 $ 1,732 $ 1,184 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Schedule of remaining lease payments | 2019 $ 79,318 2020 317,272 2021 317,272 2022 315,988 2023 313,421 Thereafter 562,463 $ 1,905,734 |
Schedule of the Company's contractual obligations and commitments relating to its facilities leases | The following is a summary of the Company’s future contractual obligations and commitments relating to its facilities leases as at December 31, 2018: Operating Lease Obligation 2019 $ 321,000 2020 321,000 2021 321,000 2022 321,000 2023 321,000 thereafter 581,000 Total future minimum lease obligations $ 2,186,000 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Share-Based Payments [Abstract] | |
Schedule of stock based compensation expense | Stock based compensation has been reported within expense line items on the consolidated statement of operations for the three and nine months ended September 30, 2018 and 2019 as shown in the following table (in $000s): Three Months Ended Nine Months Ended September 30, September 30, 2018 2019 2018 2019 General and administrative $ 66 123 $ 188 235 Research and development 22 61 67 126 Stock-based compensation costs before income taxes $ 88 184 $ 255 361 |
Schedule of share option activity | A summary of the share option activity and related information is as follows: Weighted Weighted Average Number of Average Remaining Aggregate Options Exercise Contractual Intrinsic Outstanding Price Per Share Term (Years) Value ($000) Options outstanding at December 31, 2018 831,611 $ 6.68 8.13 $ — Granted 1,550,270 $ 0.71 Cancelled/forfeited (115,864) $ 2.03 Options outstanding at September 30, 2019 2,266,017 $ 2.84 8.66 $ — Unvested at September 30, 2019 1,613,280 $ 1.27 8.90 $ — Vested and exercisable at September 30, 2019 652,737 $ 6.71 8.08 $ — |
Schedule of fair value of the stock options granted | 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 Nine Months Ended December 31, 2018 September 30, 2019 Expected term (years) 6 5 – 6 Risk free interest rate 2.730% – 2.855% 2.105 – 2.610% Volatility 105% – 107% 103 – 110% Expected dividend yield over expected term 0.00% 0.00% Resulting weighted average grant date fair value $1.25 $0.52 – $0.61 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Narrative) (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Accounting Policies [Line Items] | ||
Lease liability | $ 1,154,000 | |
Deferred rent obligation | 120,000 | |
Cash and cash equivalents | 12,967,000 | $ 17,504,000 |
Tax on other comprehensive income (loss) | 0 | |
Reclassifications out of other comprehensive income (loss) | 0 | |
Right-of-use lease asset | $ 1,213,000 | |
Lease, practical expedients package | true | |
ASU 2016-02 [Member] | ||
Accounting Policies [Line Items] | ||
Lease liability | $ 1,500,000 |
Revenue (Narrative) (Details)
Revenue (Narrative) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue Recognition [Abstract] | ||
Revenue | $ 0 | $ 0 |
Aggregate price of transaction allocated to performance obligations | $ 0 |
Net Loss per Common Share (Sche
Net Loss per Common Share (Schedule of Company's Potential Anti Dilutive Securities) (Details) - shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 9,890,215 | 8,461,048 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 2,266,017 | 836,849 |
Convertible Exchangeable Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 1,698 | 1,698 |
Series A Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 132,000 | 132,000 |
Common Stock Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 7,490,500 | 7,490,500 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Other current assets | $ 119,000 | $ 119,000 | $ 236,000 | |
Other income, net | 53,000 | 223,000 | $ 632,000 | |
Accounts Receivable [Member] | ||||
Other current assets | $ 53,000 | $ 53,000 |
Prepaid Expenses and Other Cu_4
Prepaid Expenses and Other Current Assets (Schedule of Prepaid Expenses and Other Current Assets) (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Research and development tax credit receivable | $ 1,929 | $ 1,148 |
Prepayments and VAT receivable | 821 | 899 |
Other current assets | 119 | 236 |
Prepaid expenses and other current assets | $ 2,869 | $ 2,283 |
Accrued and Other Liabilities_2
Accrued and Other Liabilities (Schedule of accrued and other current liabilities) (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued research and development | $ 753 | $ 1,110 |
Accrued legal and professional fees | 233 | 259 |
Other current liabilities | 198 | 363 |
Accrued and other current liabilities | $ 1,184 | $ 1,732 |
Leases (Narrative) (Details)
Leases (Narrative) (Details) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Leases [Abstract] | |||
Operating lease expense | $ 227,853 | ||
Operating lease, payments | $ 240,846 | ||
Remaining lease term | 6 years 1 month 6 days | ||
Discount rate lease liability | 12.00% | ||
Other rent related expenses | $ 400,000 | $ 500,000 |
Leases (Schedule of Remaining L
Leases (Schedule of Remaining Lease Payments) (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Leases [Abstract] | |
2019 | $ 79,318 |
2020 | 317,272 |
2021 | 317,272 |
2022 | 315,988 |
2023 | 313,421 |
Thereafter | 562,463 |
Lease payments, Total | $ 1,905,734 |
Leases (Schedule of the Company
Leases (Schedule of the Company's Contractual Obligations and Commitments Relating to its Facilities Leases) (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Operating Lease Obligation | |
2019 | $ 321,000 |
2020 | 321,000 |
2021 | 321,000 |
2022 | 321,000 |
2023 | 321,000 |
thereafter | 581,000 |
Total future minimum lease obligations | $ 2,186,000 |
Stock-Based Compensation (Narra
Stock-Based Compensation (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | |
Stock-based compensation | |||
Fair value assumptions method used | Black-Scholes option-pricing model | ||
Stock Options [Member] | |||
Stock-based compensation | |||
Options granted (in shares) | 1,550,270 | ||
Resulting weighted average grant date fair value | $ 1.25 | ||
Stock Options [Member] | Minimum [Member] | |||
Stock-based compensation | |||
Resulting weighted average grant date fair value | $ 0.52 | ||
Stock Options [Member] | Maximum [Member] | |||
Stock-based compensation | |||
Resulting weighted average grant date fair value | $ 0.61 | ||
2015 Plan [Member] | Performance Share Options [Member] | |||
Stock-based compensation | |||
Stock awards expected to vest | 39,713 | 39,713 | |
Catch up adjustment related to the change in estimate | $ 91,000 | ||
2018 Equity Incentive Plan (the "2018 Plan") | |||
Stock-based compensation | |||
Number of authorized additional shares to be issued | 709,889 | ||
2018 Equity Incentive Plan (the "2018 Plan") | Minimum [Member] | |||
Stock-based compensation | |||
Life of stock option awards granted | 1 year | ||
2018 Equity Incentive Plan (the "2018 Plan") | Maximum [Member] | |||
Stock-based compensation | |||
Number of authorized shares | 1,500,000 | 1,500,000 | |
Life of stock option awards granted | 4 years | ||
2018 Equity Incentive Plan (the "2018 Plan") | Stock Options [Member] | |||
Stock-based compensation | |||
Number of shares reserved for issuance | 228,334 | 228,334 | |
Life of stock option awards granted | 10 years | ||
Options granted (in shares) | 1,550,270 | 306,304 | |
2018 Equity Incentive Plan (the "2018 Plan") | Stock Options [Member] | Minimum [Member] | |||
Stock-based compensation | |||
Vesting period | 1 year | ||
Resulting weighted average grant date fair value | $ 0.52 | $ 1.17 | |
2018 Equity Incentive Plan (the "2018 Plan") | Stock Options [Member] | Maximum [Member] | |||
Stock-based compensation | |||
Vesting period | 4 years | ||
Resulting weighted average grant date fair value | $ 0.61 | $ 1.29 | |
2018 Equity Incentive Plan (the "2018 Plan") | Performance Share Options [Member] | |||
Stock-based compensation | |||
Options granted (in shares) | 174,272 | ||
Stock awards vested | 36,537 | ||
Stock awards expected to vest | 36,537 | 36,537 |
Stock Based Compensation (Sched
Stock Based Compensation (Schedule of Stock Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation costs before income taxes | $ 184 | $ 88 | $ 361 | $ 255 |
General and Administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation costs before income taxes | 123 | 66 | 235 | 188 |
Research and Development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation costs before income taxes | $ 61 | $ 22 | $ 126 | $ 67 |
Stock-Based Compensation (Sched
Stock-Based Compensation (Schedule of Share Option Activity) (Details) - Stock Options [Member] - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Number of Options Outstanding | ||
Options outstanding at December 31, 2018 | 831,611 | |
Granted | 1,550,270 | |
Cancelled/forfeited | (115,864) | |
Options outstanding at September 30, 2019 | 2,266,017 | 831,611 |
Unvested at September 30, 2019 | 1,613,280 | |
Vested and exercisable at September 30, 2019 | 652,737 | |
Weighted Average Exercise Price Per Share | ||
Options outstanding at December 31, 2018 | $ 6.68 | |
Granted | 0.71 | |
Cancelled / forfeited (in dollars per share) | 2.03 | |
Options outstanding at September 30, 2019 | 2.84 | $ 6.68 |
Unvested at September 30, 2019 | 1.27 | |
Vested and exercisable at September 30, 2019 | $ 6.71 | |
Weighted Average Remaining Contractual Term (Years) | ||
Options outstanding | 8 years 7 months 28 days | 8 years 1 month 17 days |
Unvested at September 30, 2019 | 8 years 10 months 24 days | |
Vested and exercisable at September 30, 2019 | 8 years 29 days |
Stock Based Compensation (Sch_2
Stock Based Compensation (Schedule of Fair Value of the Stock Options Granted) (Details) - Stock Options [Member] - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected term (years) | 6 years | |
Expected dividend yield over expected term | 0.00% | 0.00% |
Resulting weighted average grant date fair value | $ 1.25 | |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected term (years) | 5 years | |
Risk free interest rate | 2.105% | 2.73% |
Volatility | 103.00% | 105.00% |
Resulting weighted average grant date fair value | $ 0.52 | |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected term (years) | 6 years | |
Risk free interest rate | 2.61% | 2.855% |
Volatility | 110.00% | 107.00% |
Resulting weighted average grant date fair value | $ 0.61 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) - USD ($) | Oct. 04, 2018 | Jul. 31, 2017 | Mar. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Stockholders Equity [Line Items] | |||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Proceeds from issuance of common stock | $ 4,049,000 | ||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
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 | ||||
Warrant [Member] | |||||
Stockholders Equity [Line Items] | |||||
Conversion percentage | 9.99% | ||||
Percentage of blocker provision | 4.99% | ||||
Sales Agreement [Member] | H.C. Wainwright & Co., LLC [Member] | |||||
Stockholders Equity [Line Items] | |||||
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 | 4,702,527 | ||||
Proceeds from issuance of common stock | $ 4,300,000 | ||||
Net proceeds from issuance of common stock | $ 4,700,000 |
Stockholders' Equity (Preferred
Stockholders' Equity (Preferred Stock) Narrative) (Details) - $ / shares | Sep. 05, 2019 | Jul. 31, 2017 | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Class of Stock [Line Items] | |||||
Preferred stock dividend declared, amount per share | $ 0.15 | ||||
Series A Convertible Preferred Stock [Member] | |||||
Class of Stock [Line Items] | |||||
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% | ||||
Convertible preferred stock, terms of conversion | (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. | ||||
Convertible Exchangeable Preferred Stock [Member] | |||||
Class of Stock [Line Items] | |||||
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% | 6.00% | |||
Share issue price per share | $ 10 | ||||
Liquidation preference (in dollars per share) | 10 | ||||
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 |
Subsequent Events (Narrative) (
Subsequent Events (Narrative) (Details) $ / shares in Units, $ in Thousands | Oct. 28, 2019 | Sep. 05, 2019$ / shares | Sep. 30, 2019USD ($)$ / shares | Dec. 31, 2018$ / shares |
Subsequent Event [Line Items] | ||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 4,049 | |||
Dividend declared, date | Sep. 5, 2019 | |||
Preferred stock dividend declared, amount per share | $ 0.15 | |||
Dividends payable, date to be paid | Nov. 1, 2019 | |||
Dividend, record date | Oct. 14, 2019 | |||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||
Compliance with Nasdaq Listing Rule 5550(a)(2), description | On January 8, 2019, the Company received a written notification from the Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the minimum bid price of the Company's shares of common stock was below $1.00 per share for the previous 30 consecutive business days. The Company was provided an initial period of 180 calendar days, or until July 7, 2019, to regain compliance with the minimum bid price rule. The Company did not regain compliance with the minimum closing bid price requirement by July 7, 2019. The Company was previously notified by Nasdaq that it might be afforded a second 180 calendar days period to regain compliance with the minimum closing bid price requirement under certain circumstances if the Company notified Nasdaq of its intent to cure the deficiency. As a result, the Company applied for an extension of the cure period, as permitted under the notification, and received an extension until January 6, 2020 to regain compliance with the minimum bid price rule. | |||
Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Stockholders' equity, reverse stock split | Certificate of Incorporation to effect a reverse stock split of the common stock, par value $0.001 per share (the "common stock") at a ratio of not less than 1-for-5 and not greater than 1-for-20 | |||
Minimum [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Stockholders' equity, reverse stock split conversion ratio | 5 | |||
Maximum [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Stockholders' equity, reverse stock split conversion ratio | 20 |