Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2017 | May 12, 2017 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | Cyclacel Pharmaceuticals, Inc. | |
Entity Central Index Key | 1,130,166 | |
Trading Symbol | cycc | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 4,272,947 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2017 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 12,729 | $ 16,520 |
Prepaid expenses and other current assets | 4,305 | 3,097 |
Total current assets | 17,034 | 19,617 |
Property, plant and equipment (net) | 39 | 45 |
Total assets | 17,073 | 19,662 |
Current liabilities: | ||
Accounts payable | 1,652 | 2,497 |
Accrued and other current liabilities | 2,476 | 2,762 |
Total current liabilities | 4,128 | 5,259 |
Other liabilities | 127 | 130 |
Total liabilities | 4,255 | 5,389 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2016 and March 31, 2017; 335,273 shares issued and outstanding at December 31, 2016 and March 31, 2017. Aggregate preference in liquidation of $4,006,512 at December 31, 2016 and March 31, 2017. | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2016 and March 31, 2017; 4,256,829 and 4,272,947 shares issued and outstanding at December 31, 2016 and March 31, 2017 respectively. | 4 | 4 |
Additional paid-in capital | 350,156 | 350,051 |
Accumulated other comprehensive loss | (748) | (743) |
Accumulated deficit | (336,594) | (335,039) |
Total stockholders' equity | 12,818 | 14,273 |
Total liabilities and stockholders' equity | $ 17,073 | $ 19,662 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parentheticals) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 335,273 | 335,273 |
Preferred stock, shares outstanding | 335,273 | 335,273 |
Preferred stock, liquidation preference value (in dollars) | $ 4,006,512 | $ 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 | 4,272,947 | 4,256,829 |
Common stock, shares outstanding | 4,272,947 | 4,256,829 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Revenues: | ||
Grant revenue | $ 139 | |
Total revenues | 139 | |
Operating expenses: | ||
Research and development | $ 1,312 | 2,499 |
General and administrative | 1,381 | 1,384 |
Total operating expenses | 2,693 | 3,883 |
Operating loss | (2,693) | (3,744) |
Other income (expense): | ||
Foreign exchange gains (losses) | (59) | 180 |
Interest income | 12 | 10 |
Other income, net | 879 | 20 |
Total other income, net | 832 | 210 |
Loss before taxes | (1,861) | (3,534) |
Income tax benefit | 306 | 493 |
Net loss | (1,555) | (3,041) |
Dividend on convertible exchangeable preferred shares | (50) | (50) |
Net loss applicable to common stockholders | $ (1,605) | $ (3,091) |
Basic and diluted earnings per common share: | ||
Net loss per share - basic and diluted (in dollars per share) | $ (0.38) | $ (1.04) |
Weighted average common shares outstanding (in shares) | 4,271,324 | 2,965,208 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | $ (1,555) | $ (3,041) |
Translation adjustment | (1,940) | 4,295 |
Unrealized foreign exchange gain on intercompany loans | 1,935 | (4,361) |
Comprehensive loss | $ (1,560) | $ (3,107) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Operating activities: | ||
Net loss | $ (1,555) | $ (3,041) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 9 | 42 |
Stock-based compensation | 69 | 221 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (1,137) | (182) |
Accounts payable and other current liabilities | (1,196) | (187) |
Net cash used in operating activities | (3,810) | (3,147) |
Investing activities: | ||
Purchase of property, plant and equipment | (2) | |
Net cash used in investing activities | (2) | |
Financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 86 | |
Payment of preferred stock dividend | (50) | (50) |
Net cash used in financing activities | 36 | (50) |
Effect of exchange rate changes on cash and cash equivalents | (15) | (128) |
Net increase / (decrease) in cash and cash equivalents | (3,791) | (3,325) |
Cash and cash equivalents, beginning of period | 16,520 | 20,440 |
Cash and cash equivalents, end of period | 12,729 | 17,115 |
Cash received during the period for: | ||
Interest | 12 | 10 |
Taxes | 8 | |
Non cash financing activities: | ||
Accrual of preferred stock dividends | $ 50 | $ 50 |
Company Overview
Company Overview | 3 Months Ended |
Mar. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Company Overview | 1. Company Overview Nature of Operations Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or “the Company”), is a clinical-stage 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 March 31, 2017, 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 | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The consolidated balance sheet as of March 31, 2017, the consolidated statements of operations, comprehensive loss and cash flows for the three months ended March 31, 2017 and 2016, and all related disclosures contained in the accompanying notes are unaudited. The consolidated balance sheet as of December 31, 2016 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed with the Securities and Exchange Commission (“SEC”). The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of March 31, 2017, and the results of operations, comprehensive loss and cash flows for the three months ended March 31, 2017, have been made. The interim results for the three months ended March 31, 2017 are not necessarily indicative of the results to be expected for the year ending December 31, 2017 or for any other year. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2016 that are included in the Company’s Annual Report on Form 10-K filed with the SEC. 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, research and development expenditures, stock-based compensation expense and the recognition of revenue, which Cyclacel reviews on an on going basis. The estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results may differ from these estimates. Cyclacel believes the judgments and estimates required by the following accounting policies to be significant in the preparation of the Company’s consolidated financial statements. Risks and Uncertainties Drug candidates developed by the Company typically will require approvals or clearances from the Food and Drug Administration (“FDA”), European Medicines Agency (“EMA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If the Company 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. The Company has relied upon government grants to fund its earlier stage programs and does not expect to be able to continue to be successful in obtaining government grants to fund the Company’s research and development activities. 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 $12.7 million as of March 31, 2017 will be sufficient to fund its operating expenses and capital expenditure requirements through to the end of 2018. 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 end of 2018 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. 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. 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’s cash and cash equivalents balance at March 31, 2017 was $12.7 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 $11.6 million at March 31, 2017. 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 $0.8 million at March 31, 2017. 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 March 31, 2016 and 2017. Recently Issued Accounting Pronouncements 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. The Company anticipates this standard will not have a material impact on 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. The Company anticipates this standard will not have a material impact on 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. Early application is permitted. The guidance must be adopted on a modified retrospective transition approach for leases existing, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company is currently evaluating the impact of the guidance on the consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (‘‘ASU 2014-09’’), which supersedes existing revenue recognition guidance. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The standard defines a five-step process to achieve this principle; (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. ASU 2014-09 also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts. The guidance is effective for annual periods beginning after December 15, 2017 and for interim periods within those fiscal years. ASU 2014-09 was amended by multiple accounting standards updates from 2014-2016. The Company anticipates this standard will not have a material impact on its consolidated financial statements. While the Company is continuing to assess all potential impacts of the standard, the Company currently believes the most significant impact relates to its accounting for revenues related to grants received from government agencies or nonprofit organizations and revenues from contingent “milestone” based payments. Under the new standard the Company expects to report grant revenue, if new grants are obtained, in other income or as a contra against expenses. Historically grants have been reported in revenue, but as the grantor is not likely to be receiving a good or service in exchange for the payment the grant cannot be reported in revenue. The Company also expects to recognize revenue associated with contingent milestone-based payments at the time the contingent event is highly probable to be met, rather than when the milestone is achieved. However, given the limited number of potential milestones owed to Cyclacel, and the inherent risk involved in developing drugs, the milestones are unlikely to be impacted. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). The Company currently intends to use the modified retrospective method when it adopts the new accounting standard. |
Net Loss Per Common Share
Net Loss Per Common Share | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | 3. 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 shares of common stock have not been included in the computation of diluted net loss per share for the three months ended March 31, 2016 and 2017, as the result would be anti-dilutive: March 31, March 31, Stock options 376,775 387,519 Convertible preferred stock 1,698 1,698 Common stock warrants 45,343 - Total shares excluded from calculation 423,816 389,217 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2017 | |
Prepaid Expenses And Other Current Assets [Abstract] | |
Prepaid Expenses and Other Current Assets | 4. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in $000s): December 31, March 31, 2016 2017 Research and development tax credit receivable $ 1,730 $ 2,053 Prepayments 867 705 Accounts receivable 10 879 Other taxes receivable 327 399 Deposits 132 132 Other current assets 31 137 $ 3,097 $ 4,305 Included in current assets as at March 31, 2017 is approximately $0.9 million of receivables. This relates to a transaction in December 2005, whereby Xcyte Therapies, Inc. sold certain asssets and intellectual property owned by Xcyte to Life Technologies Corporation, or LTC, (formerly Invitrogen Corporation) through an asset purchase agreement and other related agreements. The assets and technology were not part of the product development plan following the transaction between Xcyte Therapies, Inc. and Cyclacel in March 2006. The company recognized $0.9 million of income under this agreement during the three months ended March 31, 2017. |
Accrued and Other Liabilities
Accrued and Other Liabilities | 3 Months Ended |
Mar. 31, 2017 | |
Payables And Accruals [Abstract] | |
Accrued and Other Liabilities | 5. Accrued and Other Liabilities Accrued and other current liabilities consisted of the following (in $000s): December 31, March 31, 2016 2017 Accrued research and development $ 2,138 $ 1,855 Accrued legal and professional fees 194 271 Other current liabilities 430 350 $ 2,762 $ 2,476 |
Stock Based Compensation
Stock Based Compensation | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Share-Based Payments [Abstract] | |
Stock Based Compensation | 6. Stock Based Compensation ASC 718 requires compensation expense associated with share-based awards to be recognized over the requisite service period, which for the Company is the period between the grant date and the date the award vests or becomes exercisable. Most of the awards granted by the Company (and still outstanding) vest ratably over one to four years. The Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Forfeitures will be 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 months ended March 31, 2016 and 2017 as shown in the following table (in $000s): Three Months Ended 2016 2017 General and administrative $ 142 $ 50 Research and development 79 19 Stock-based compensation costs before income taxes $ 221 $ 69 2015 Plan On May 22, 2015, the Company’s stockholders approved the 2015 Equity Incentive Plan (the “2015 Plan”), under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The company has reserved 291,667 shares of the Company’s common stock under the 2015 Plan. The 2015 Plan replaces the 2006 Equity Incentive Plan (the “2006 Plan”), under which there were no remaining reserved shares to be granted. 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 no options granted during the three months ended March 31, 2017. In 2016, 189,091 options were granted that are performance based. These options will vest upon the fulfillment of certain clinical conditions and will terminate if they have not vested by December 31, 2020. The Company determined that the satisfaction of the vesting criteria was not probable as of March 31, 2017 and, as a result, did not record any expense related to these awards for the three months ended March 31, 2017. There were no stock options exercised during each of the three months ended March 31, 2016 and 2017, respectively. The Company does not expect to be able to benefit from the deduction for stock option exercises that may occur during the year ended December 31, 2017 because the company has tax loss carryforwards from prior periods that would be expected to offset any potential taxable income for the year ended December 31, 2017. 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 - - Cancelled/forfeited (1,860 ) 655.18 Options outstanding at March 31, 2017 387,519 22.78 5.61 — Unvested at March 31, 2017 (258,124 ) 5.28 5.08 — Vested and exercisable at March 31, 2017 129,395 57.68 6.68 — The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Distribution, Licensing and Research Agreements The Company has entered into licensing agreements with academic and research organizations. Under the terms of these agreements, the Company has received licenses to technology and patent applications. The Company is required to pay royalties on future sales of products employing the technology or falling under claims of patent applications. Pursuant to the Daiichi Sankyo license under which the Company licenses certain patent rights for sapacitabine, its lead drug candidate, the Company has agreed to pay Daiichi Sankyo an up-front fee, to reimburse Daiichi Sankyo for enumerated expenses, and to make milestone payments and to pay royalties on a country-by-country basis. The up-front fee, Phase 3 entry milestone, and certain past reimbursements have been paid. A further $10.0 million in aggregate milestone payments could be payable subject to achievement of all the specific contractual milestones, which are primarily related to regulatory approval in various territories and the Company’s decision to continue with these projects. Royalties are payable in each country for the term of patent protection in the country or for ten years following the first commercial sale of licensed products in the country, whichever is later. Royalties are payable on net sales. Net sales are defined as the gross amount invoiced by the Company or its affiliates or licensees, less discounts, credits, taxes, shipping and bad debt losses. The agreement extends from its commencement date to the date on which no further amounts are owed under it. If the Company wishes to appoint a third party to develop or commercialize a sapacitabine-based product in Japan, within certain limitations, Daiichi Sankyo must be notified and given a right of first refusal, with the right of first refusal ending sixty days after notification, to develop and/or commercialize in Japan. In general, the license may be terminated by the Company for technical, scientific, efficacy, safety, or commercial reasons on six months’ notice, or twelve months’ notice, if after a launch of a sapacitabine-based product, or by either party for material default. |
Stockholders Equity
Stockholders Equity | 3 Months Ended |
Mar. 31, 2017 | |
Stockholders' Equity Note [Abstract] | |
Stockholders Equity | 8. Stockholders Equity Preferred Stock As of March 31, 2017, there were 335,273 shares of the Company’s 6% Convertible Exchangeable Preferred Stock (“Preferred Stock”) issued and outstanding at an issue price of $10.00 per share. Dividends on the Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the Preferred Stock, payable quarterly on the first day of February, May, August and November, commencing February 1, 2005. Any dividends must be declared by the Company’s Board and must come from funds that are legally available for dividend payments. The Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends. The Preferred Stock is convertible at the option of the holder at any time into the Company’s shares of common stock at a conversion rate of approximately 0.00507 shares of common stock for each share of Preferred Stock based on a price of $1,974. The Company has reserved 1,698 shares of common stock for issuance upon conversion of the remaining shares of Preferred Stock outstanding at March 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 Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances. The Company may, at its option, redeem the Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share. The Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on any dividend payment date beginning on November 1, 2005 (the “Exchange Date”) for the Company’s 6% Convertible Subordinated Debentures (“Debentures”) at the rate of $10.00 principal amount of Debentures for each share of Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have terms substantially similar to those of the Preferred Stock. No such exchanges have taken place to date. On March 7, 2017, the Board declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s 6% Convertible Exchangeable Preferred Stock (“Preferred Stock”). The cash dividend was paid on May 1, 2017 to the holders of record of the Preferred Stock as of the close of business on April 14, 2017. Common Stock June 2016 At Market Issuance On June 23, 2016, the Company entered into a sales agreement with FBR (the “FBR Sales Agreement”), under which the Company may issue and sell shares of its common stock, from time to time through FBR, acting as its sales agent. Under the FBR Sales Agreement, FBR may sell the shares of common stock by any method that is deemed to be an “at the market offering”. The Company will pay FBR a commission of 3.0% of the gross sales price per share sold. The Company is not obligated to make any sales of common stock under the FBR Sales Agreement. In the three months ended March 31, 2017, the Company sold 16,118 shares of common stock under the sales agreement for net proceeds of approximately $0.1 million. During April 2017, the Company sold a further 167,000 shares of common stock for net proceeds of approximately $1.0 million. |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated balance sheet as of March 31, 2017, the consolidated statements of operations, comprehensive loss and cash flows for the three months ended March 31, 2017 and 2016, and all related disclosures contained in the accompanying notes are unaudited. The consolidated balance sheet as of December 31, 2016 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed with the Securities and Exchange Commission (“SEC”). The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of March 31, 2017, and the results of operations, comprehensive loss and cash flows for the three months ended March 31, 2017, have been made. The interim results for the three months ended March 31, 2017 are not necessarily indicative of the results to be expected for the year ending December 31, 2017 or for any other year. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2016 that are included in the Company’s Annual Report on Form 10-K filed with the SEC. |
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, research and development expenditures, stock-based compensation expense and the recognition of revenue, which Cyclacel reviews on an on going basis. The estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results may differ from these estimates. Cyclacel believes the judgments and estimates required by the following accounting policies to be significant in the preparation of the Company’s consolidated financial statements. |
Risks and Uncertainties | Risks and Uncertainties Drug candidates developed by the Company typically will require approvals or clearances from the Food and Drug Administration (“FDA”), European Medicines Agency (“EMA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If the Company 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. The Company has relied upon government grants to fund its earlier stage programs and does not expect to be able to continue to be successful in obtaining government grants to fund the Company’s research and development activities. |
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 $12.7 million as of March 31, 2017 will be sufficient to fund its operating expenses and capital expenditure requirements through to the end of 2018. 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 end of 2018 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. |
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. |
Cash and Cash Equivalents | 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’s cash and cash equivalents balance at March 31, 2017 was $12.7 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 $11.6 million at March 31, 2017. 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 $0.8 million at March 31, 2017. |
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 March 31, 2016 and 2017. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements 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. The Company anticipates this standard will not have a material impact on 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. The Company anticipates this standard will not have a material impact on 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. Early application is permitted. The guidance must be adopted on a modified retrospective transition approach for leases existing, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company is currently evaluating the impact of the guidance on the consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (‘‘ASU 2014-09’’), which supersedes existing revenue recognition guidance. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The standard defines a five-step process to achieve this principle; (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. ASU 2014-09 also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts. The guidance is effective for annual periods beginning after December 15, 2017 and for interim periods within those fiscal years. ASU 2014-09 was amended by multiple accounting standards updates from 2014-2016. The Company anticipates this standard will not have a material impact on its consolidated financial statements. While the Company is continuing to assess all potential impacts of the standard, the Company currently believes the most significant impact relates to its accounting for revenues related to grants received from government agencies or nonprofit organizations and revenues from contingent “milestone” based payments. Under the new standard the Company expects to report grant revenue, if new grants are obtained, in other income or as a contra against expenses. Historically grants have been reported in revenue, but as the grantor is not likely to be receiving a good or service in exchange for the payment the grant cannot be reported in revenue. The Company also expects to recognize revenue associated with contingent milestone-based payments at the time the contingent event is highly probable to be met, rather than when the milestone is achieved. However, given the limited number of potential milestones owed to Cyclacel, and the inherent risk involved in developing drugs, the milestones are unlikely to be impacted. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). The Company currently intends to use the modified retrospective method when it adopts the new accounting standard. |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of antidilutive shares excluded from computation of diluted net loss per share | March 31, March 31, Stock options 376,775 387,519 Convertible preferred stock 1,698 1,698 Common stock warrants 45,343 - Total shares excluded from calculation 423,816 389,217 |
Prepaid Expenses and Other Cu17
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Prepaid Expenses And Other Current Assets [Abstract] | |
Schedule of prepaid expenses and other current assets | December 31, March 31, 2016 2017 Research and development tax credit receivable $ 1,730 $ 2,053 Prepayments 867 705 Accounts receivable 10 879 Other taxes receivable 327 399 Deposits 132 132 Other current assets 31 137 $ 3,097 $ 4,305 |
Accrued and Other Liabilities (
Accrued and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Payables And Accruals [Abstract] | |
Schedule of accrued and other current liabilities | December 31, March 31, 2016 2017 Accrued research and development $ 2,138 $ 1,855 Accrued legal and professional fees 194 271 Other current liabilities 430 350 $ 2,762 $ 2,476 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Share-Based Payments [Abstract] | |
Schedule of stock based compensation expense | Three Months Ended 2016 2017 General and administrative $ 142 $ 50 Research and development 79 19 Stock-based compensation costs before income taxes $ 221 $ 69 |
Schedule of share option activity | Number of Weighted Weighted Aggregate Options outstanding at December 31, 2016 389,379 25.80 5.83 121 Granted - - Cancelled/forfeited (1,860 ) 655.18 Options outstanding at March 31, 2017 387,519 22.78 5.61 — Unvested at March 31, 2017 (258,124 ) 5.28 5.08 — Vested and exercisable at March 31, 2017 129,395 57.68 6.68 — |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Detail Textuals) | 3 Months Ended | ||||
Mar. 31, 2017USD ($)Segment | Mar. 31, 2017GBP (£)Segment | Dec. 31, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Accounting Policies [Abstract] | |||||
Cash and cash equivalents | $ 12,729,000 | $ 16,520,000 | $ 17,115,000 | $ 20,440,000 | |
Number of operating segments | Segment | 1 | ||||
Number of geographic areas for development operations | Segment | 2 | 2 | |||
Cash balances insured by FDIC | $ 250,000 | ||||
Cash exceeding balance insured by FDIC | 11,600,000 | ||||
Cash insured by the financial services compensation scheme | £ | £ 75,000 | ||||
Cash Exceeding Balance Insured By Financia Lservices Compensation Scheme | $ 800,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 389,217 | 423,816 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 387,519 | 376,775 |
Convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 1,698 | 1,698 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 45,343 |
Prepaid Expenses and Other Cu22
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Research and development tax credit receivable | $ 2,053 | $ 1,730 |
Prepayments | 705 | 867 |
Accounts receivable | 879 | 10 |
Other taxes receivable | 399 | 327 |
Deposits | 132 | 132 |
Other current assets | 137 | 31 |
Prepaid expenses and other current assets | $ 4,305 | $ 3,097 |
Prepaid Expenses and Other Cu23
Prepaid Expenses and Other Current Assets (Detail Textuals) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Prepaid Expenses And Other Current Assets [Abstract] | |||
Accounts receivable | $ 879 | $ 10 | |
Income recognized | $ 879 | $ 20 |
Accrued and Other Liabilities24
Accrued and Other Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Payables And Accruals [Abstract] | ||
Accrued research and development | $ 1,855 | $ 2,138 |
Accrued legal and professional fees | 271 | 194 |
Other current liabilities | 350 | 430 |
Total | $ 2,476 | $ 2,762 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Stock-based compensation | ||
Stock-based compensation costs before income taxes | $ 69 | $ 221 |
General and administrative | ||
Stock-based compensation | ||
Stock-based compensation costs before income taxes | 50 | 142 |
Research and development | ||
Stock-based compensation | ||
Stock-based compensation costs before income taxes | $ 19 | $ 79 |
Stock Based Compensation (Det26
Stock Based Compensation (Details 1) - Stock options - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017 | Dec. 31, 2016 | |
Number of Options Outstanding | ||
Options outstanding at December 31, 2016 | 389,379 | |
Granted | ||
Cancelled/forfeited | (1,860) | |
Options outstanding at March 31, 2017 | 387,519 | 389,379 |
Unvested at March 31, 2017 | (258,124) | |
Vested and exercisable at March 31, 2017 | 129,395 | |
Weighted Average Exercise Price Per Share | ||
Options outstanding at December 31, 2016 | $ 25.80 | |
Granted | ||
Cancelled/forfeited | 655.18 | |
Options outstanding at March 31, 2017 | 22.78 | $ 25.80 |
Unvested at March 31, 2017 | 5.28 | |
Vested and exercisable at March 31, 2017 | $ 57.68 | |
Weighted Average Remaining Contractual Term (Years) | ||
Options outstanding | 5 years 7 months 10 days | 5 years 9 months 29 days |
Unvested at March 31, 2017 | 5 years 29 days | |
Vested and exercisable at March 31, 2017 | 6 years 8 months 5 days | |
Aggregate Intrinsic Value | ||
Options outstanding | $ 121 | |
Unvested at March 31, 2017 | ||
Vested and exercisable at March 31, 2017 |
Stock Based Compensation (Det27
Stock Based Compensation (Detail Textuals) - shares | 1 Months Ended | 3 Months Ended | 12 Months Ended |
May 22, 2015 | Mar. 31, 2017 | Dec. 31, 2016 | |
Stock options | |||
Stock-based compensation | |||
Options granted (in shares) | |||
Stock options | 2015 plan | |||
Stock-based compensation | |||
Number of shares reserved for issuance | 291,667 | ||
Expiration period | 10 years | ||
Stock options | 2015 plan | Minimum | |||
Stock-based compensation | |||
Vesting period | 1 year | ||
Stock options | 2015 plan | Maximum | |||
Stock-based compensation | |||
Vesting period | 4 years | ||
Performance based share | 2015 plan | |||
Stock-based compensation | |||
Options granted (in shares) | 189,091 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - Daiichi Sankyo $ in Millions | 3 Months Ended |
Mar. 31, 2017USD ($) | |
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 |
Stockholders Equity (Detail Tex
Stockholders Equity (Detail Textuals) | Mar. 07, 2017$ / shares | Mar. 31, 2017Conversion_rateSeries$ / sharesshares | Dec. 31, 2016$ / sharesshares |
Stockholders' equity | |||
Preferred stock, shares issued | shares | 335,273 | 335,273 | |
Preferred stock, shares outstanding | shares | 335,273 | 335,273 | |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |
Convertible Exchangeable Preferred Stock | |||
Stockholders' equity | |||
Preferred stock, shares issued | shares | 335,273 | ||
Preferred stock, shares outstanding | shares | 335,273 | ||
Share issue price per share | $ 10 | ||
Dividend rate on convertible exchangeable preferred stock (in percent) | 6.00% | 6.00% | |
Liquidation preference (in dollars per share) | $ 10 | ||
Number of shares to be issued for each preferred stock upon conversion | Conversion_rate | 0.00507 | ||
Conversion price (in dollars per share) | $ 1,974 | ||
Common stock shares reserved for future issuance upon conversion | shares | 1,698 | ||
Number of series of Preferred Stock | Series | 1 | ||
Minimum bid price per share | $ 2,961 | ||
Percentage of the closing sales price of the entity's common stock that the conversion price must exceed in order for the preferred stock to be convertible | 150.00% | ||
Number of trading days within 30 trading days in which the closing price of the entity's common stock must exceed the conversion price for the preferred stock to be convertible | 20 days | ||
Number of trading days during which the closing price of the entity's common stock must exceed the conversion price for at least 20 days in order for the preferred stock to be convertible | 30 days | ||
Number of trading days prior to notice of automatic conversion | 5 days | ||
Redemption price per share (in dollars per share) | $ 10 | ||
Interest rate (as a percent) | 6.00% | ||
Debt principal amount per share, basis for exchange (in dollars per share) | $ 10 | ||
Debt instrument, term | 25 years | ||
Preferred stock dividend declared, amount per share | $ 0.15 | ||
Dividend paid, date | May 1, 2017 | ||
Dividend, record date | Apr. 14, 2017 |
Stockholders Equity (Detail T30
Stockholders Equity (Detail Textuals 1) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Apr. 30, 2017 | Jun. 23, 2016 | Mar. 31, 2017 | |
Nature Of Operations And Basis Of Presentation [Line Items] | |||
Proceeds from issuance of common stock | $ 86 | ||
FBR Sales Agreement | |||
Nature Of Operations And Basis Of Presentation [Line Items] | |||
Percentage of commission on gross equity sales | 3.00% | ||
Number of common shares sold into underwriting agreement (in shares) | 16,118 | ||
Sale of stock, value | $ 100 | ||
FBR Sales Agreement | Subsequent event | |||
Nature Of Operations And Basis Of Presentation [Line Items] | |||
Number of common shares sold into underwriting agreement (in shares) | 167,000 | ||
Sale of stock, value | $ 1,000 |