Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 25, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | CTI BIOPHARMA CORP. | |
Entity Central Index Key | 0000891293 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity Common Stock, Shares Outstanding | 57,978,725 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 35,364 | $ 36,439 |
Short-term investments | 18,297 | 30,599 |
Receivables from license and development services arrangements | 356 | 13,679 |
Prepaid expenses and other current assets | 2,617 | 1,775 |
Total current assets | 56,634 | 82,492 |
Property and equipment, net | 1,516 | 1,793 |
Other assets | 8,093 | 5,547 |
Total assets | 66,243 | 89,832 |
Current liabilities: | ||
Accounts payable | 1,095 | 4,498 |
Accrued expenses | 10,251 | 12,852 |
Current portion of long-term debt | 4,812 | 4,812 |
Other current liabilities | 1,823 | 893 |
Total current liabilities | 17,981 | 23,055 |
Long-term debt, less current portion | 6,861 | 9,267 |
Other liabilities | 6,416 | 4,571 |
Total liabilities | 31,258 | 36,893 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value per share: Authorized shares - 33,333 as of June 30, 2019 and December 31, 2018, Series O Preferred Stock, 12,575 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively (Aggregate liquidation preference of $25,150 as of June 30, 2019 and December 31, 2018, respectively) | 0 | 0 |
Common stock, $0.001 par value per share: Authorized shares - 131,500,000 and 101,500,000 as of June 30, 2019 and December 31, 2018, respectively, Issued and outstanding shares - 57,978,725 and 57,986,075 as of June 30, 2019 and December 31, 2018, respectively | 58 | 58 |
Additional paid-in capital | 2,296,637 | 2,294,025 |
Accumulated other comprehensive loss | (10,622) | (10,643) |
Accumulated deficit | (2,245,328) | (2,224,746) |
Total CTI stockholders' equity | 40,745 | 58,694 |
Noncontrolling interest | (5,760) | (5,755) |
Total stockholders' equity | 34,985 | 52,939 |
Total liabilities and stockholders' equity | $ 66,243 | $ 89,832 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (in shares) | 33,333 | 33,333 |
Preferred stock issued (in shares) | 12,575 | 12,575 |
Preferred stock outstanding (in shares) | 12,575 | 12,575 |
Preferred stock liquidation preference | $ 25,150 | $ 25,150 |
Common stock par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 131,500,000 | 101,500,000 |
Common stock issued (in shares) | 57,978,725 | 57,986,075 |
Common stock outstanding (in shares) | 57,978,725 | 57,986,075 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Income Statement [Abstract] | ||||
License and contract revenues | $ 416 | $ 613 | $ 1,056 | $ 11,459 |
Operating costs and expenses: | ||||
Research and development | 6,356 | 9,124 | 11,528 | 18,809 |
Selling, general and administrative | 5,053 | 5,490 | 10,259 | 10,987 |
Restructuring expenses | 0 | 0 | 794 | 0 |
Total operating costs and expenses | 11,409 | 14,614 | 22,581 | 29,796 |
Loss from operations | (10,993) | (14,001) | (21,525) | (18,337) |
Non-operating income (expense): | ||||
Interest income | 347 | 364 | 727 | 364 |
Interest expense | (269) | (297) | (563) | (585) |
Amortization of debt discount and issuance costs | (130) | (130) | (260) | (264) |
Foreign exchange gain (loss) | 69 | (1,575) | (169) | (852) |
Other non-operating income | 0 | 4,295 | 0 | 4,295 |
Total non-operating income (expense), net | 17 | 2,657 | (265) | 2,958 |
Net loss before noncontrolling interest | (10,976) | (11,344) | (21,790) | (15,379) |
Noncontrolling interest | 5 | 8 | 5 | 22 |
Net loss | (10,971) | (11,336) | (21,785) | (15,357) |
Deemed dividends on preferred stock | 0 | 0 | 0 | (80) |
Net loss attributable to common stockholders | $ (10,971) | $ (11,336) | $ (21,785) | $ (15,437) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.19) | $ (0.20) | $ (0.38) | $ (0.29) |
Shares used in calculation of basic and diluted net loss per common share (in shares) | 57,973 | 57,941 | 57,973 | 54,148 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss before noncontrolling interest | $ (10,976) | $ (11,344) | $ (21,790) | $ (15,379) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | (424) | (2,682) | 238 | (3,492) |
Unrealized foreign exchange gain (loss) on intercompany balance | 428 | (400) | (251) | (122) |
Net unrealized gain (loss) on available-for-sale securities | 8 | (12) | 34 | (12) |
Other comprehensive income (loss) | 12 | (3,094) | 21 | (3,626) |
Comprehensive loss | (10,964) | (14,438) | (21,769) | (19,005) |
Comprehensive loss attributable to noncontrolling interest | 5 | 8 | 5 | 22 |
Comprehensive loss attributable to CTI | $ (10,959) | $ (14,430) | $ (21,764) | $ (18,983) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Noncontrolling Interest |
Beginning Balance (in shares) at Dec. 31, 2017 | 1 | 42,969 | |||||
Beginning Balance at Dec. 31, 2017 | $ 16,090 | $ 0 | $ 43 | $ 2,223,388 | $ (6,272) | $ (2,195,346) | $ (5,723) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of common stock, net of issuance costs (in shares) | 23,012 | ||||||
Issuance of common stock, net of issuance costs | 64,189 | $ 23 | 64,166 | ||||
Exchange of common stock for preferred stock (in shares) | 12 | (8,000) | |||||
Exchange of common stock for preferred stock | 0 | $ (8) | 8 | ||||
Value of beneficial conversion features related to preferred stock | 0 | 80 | (80) | ||||
Equity-based compensation | 1,336 | 1,336 | |||||
Other | (1) | (1) | |||||
Noncontrolling interest | (14) | (14) | |||||
Net loss | (4,021) | (4,021) | |||||
Other comprehensive income (loss) | (532) | (532) | |||||
Ending Balance (in shares) at Mar. 31, 2018 | 13 | 57,981 | |||||
Ending Balance at Mar. 31, 2018 | 77,047 | $ 0 | $ 58 | 2,288,977 | (6,804) | (2,199,447) | (5,737) |
Beginning Balance (in shares) at Dec. 31, 2017 | 1 | 42,969 | |||||
Beginning Balance at Dec. 31, 2017 | 16,090 | $ 0 | $ 43 | 2,223,388 | (6,272) | (2,195,346) | (5,723) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net loss | (15,357) | ||||||
Other comprehensive income (loss) | (3,626) | ||||||
Ending Balance (in shares) at Jun. 30, 2018 | 13 | 57,985 | |||||
Ending Balance at Jun. 30, 2018 | 63,648 | $ 0 | $ 58 | 2,290,017 | (9,898) | (2,210,783) | (5,746) |
Beginning Balance (in shares) at Mar. 31, 2018 | 13 | 57,981 | |||||
Beginning Balance at Mar. 31, 2018 | 77,047 | $ 0 | $ 58 | 2,288,977 | (6,804) | (2,199,447) | (5,737) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of common stock, net of issuance costs | (19) | (19) | |||||
Equity-based compensation | 1,040 | 1,040 | |||||
Other (in shares) | 4 | ||||||
Other | 19 | 19 | |||||
Noncontrolling interest | (9) | (9) | |||||
Net loss | (11,336) | (11,336) | |||||
Other comprehensive income (loss) | (3,094) | (3,094) | |||||
Ending Balance (in shares) at Jun. 30, 2018 | 13 | 57,985 | |||||
Ending Balance at Jun. 30, 2018 | 63,648 | $ 0 | $ 58 | 2,290,017 | (9,898) | (2,210,783) | (5,746) |
Beginning Balance (in shares) at Dec. 31, 2018 | 13 | 57,986 | |||||
Beginning Balance at Dec. 31, 2018 | 52,939 | $ 0 | $ 58 | 2,294,025 | (10,643) | (2,224,746) | (5,755) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Equity-based compensation (in shares) | (7) | ||||||
Equity-based compensation | 1,257 | 1,257 | |||||
Net loss | (10,814) | (10,814) | |||||
Other comprehensive income (loss) | 9 | 9 | |||||
Ending Balance (in shares) at Mar. 31, 2019 | 13 | 57,979 | |||||
Ending Balance at Mar. 31, 2019 | 44,587 | $ 0 | $ 58 | 2,295,275 | (10,634) | (2,234,357) | (5,755) |
Beginning Balance (in shares) at Dec. 31, 2018 | 13 | 57,986 | |||||
Beginning Balance at Dec. 31, 2018 | 52,939 | $ 0 | $ 58 | 2,294,025 | (10,643) | (2,224,746) | (5,755) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net loss | (21,785) | ||||||
Other comprehensive income (loss) | 21 | ||||||
Ending Balance (in shares) at Jun. 30, 2019 | 13 | 57,979 | |||||
Ending Balance at Jun. 30, 2019 | 34,985 | $ 0 | $ 58 | 2,296,637 | (10,622) | (2,245,328) | (5,760) |
Beginning Balance (in shares) at Mar. 31, 2019 | 13 | 57,979 | |||||
Beginning Balance at Mar. 31, 2019 | 44,587 | $ 0 | $ 58 | 2,295,275 | (10,634) | (2,234,357) | (5,755) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Equity-based compensation (in shares) | 0 | ||||||
Equity-based compensation | 1,361 | 1,361 | |||||
Other | 1 | 1 | |||||
Noncontrolling interest | (5) | (5) | |||||
Net loss | (10,971) | (10,971) | |||||
Other comprehensive income (loss) | 12 | 12 | |||||
Ending Balance (in shares) at Jun. 30, 2019 | 13 | 57,979 | |||||
Ending Balance at Jun. 30, 2019 | $ 34,985 | $ 0 | $ 58 | $ 2,296,637 | $ (10,622) | $ (2,245,328) | $ (5,760) |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Operating activities | ||
Net loss before noncontrolling interest | $ (21,790) | $ (15,379) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 2,618 | 2,376 |
Depreciation and amortization | 276 | 302 |
Write-off of deferred financing costs | 213 | 0 |
Reserve for excess, obsolete or unsalable inventory | 0 | 535 |
Gain on dissolution of a foreign entity | 0 | (4,288) |
Noncash interest expense | 260 | 264 |
Noncash rent benefit | (316) | (977) |
Other | (102) | 306 |
Changes in operating assets and liabilities: | ||
Receivables from license and development services arrangements | 13,322 | 568 |
Prepaid expenses and other current assets | 429 | 295 |
Other assets | 1,157 | (78) |
Accounts payable | (3,402) | 1,141 |
Accrued expenses | (2,599) | 435 |
Deferred revenue | 0 | (600) |
Other liabilities | (807) | (5) |
Net cash used in operating activities | (10,741) | (15,105) |
Investing activities | ||
Purchases of property and equipment | 0 | (33) |
Purchases of short-term investments | (3,510) | (27,443) |
Proceeds from maturities of short-term investments | 15,900 | 0 |
Net cash provided by (used in) investing activities | 12,390 | (27,476) |
Financing activities | ||
Proceeds from common stock offering, net of issuance costs | 0 | 64,170 |
Repayment of debt | (2,667) | 0 |
Payment of tax withholding obligations related to stock compensation | 0 | (19) |
Proceeds from stock option exercises | 0 | 32 |
Proceeds from sales of common stock under employee stock purchase plan | 1 | 6 |
Cash paid for issuance costs | (45) | (95) |
Net cash (used in) provided by financing activities | (2,711) | 64,094 |
Effect of exchange rate changes on cash and cash equivalents | (13) | 643 |
Net (decrease) increase in cash and cash equivalents | (1,075) | 22,156 |
Cash and cash equivalents at beginning of period | 36,439 | 43,218 |
Cash and cash equivalents at end of period | 35,364 | 65,374 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 582 | 580 |
Supplemental disclosure of noncash activities | ||
Right-of-use assets obtained in exchange for operating lease liabilities | 4,208 | 0 |
Exchange of common stock and preferred stock for preferred stock | $ 0 | $ 24,080 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Description of Business and Summary of Significant Accounting Policies | 1. Description of Business and Summary of Significant Accounting Policies CTI BioPharma Corp., together with its wholly-owned subsidiary, also referred to collectively in this Quarterly Report on Form 10-Q as “we,” “us,” “our,” the “Company” and “CTI,” is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. Our goal is to build a profitable company by generating income from products we develop and commercialize, either alone or with partners. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. We operate in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products requires approval from, and is subject to, ongoing oversight by the Food and Drug Administration, or the FDA, in the U.S., the European Medicines Agency, or the EMA, in the European Union, or the E.U., and comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain, may take many years and may involve expenditure of substantial resources. Basis of Presentation The accompanying unaudited financial information as of and for the three and six months ended June 30, 2019 and 2018 has been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial position at such date and the operating results and cash flows for such periods. Operating results for the three and six months ended June 30, 2019 are not necessarily indicative of the results that may be expected for the entire year or for any other subsequent interim period. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to the rules of the U.S. Securities and Exchange Commission, or the SEC. These unaudited financial statements and related notes should be read in conjunction with our audited financial statements for the year ended December 31, 2018 included in our Annual Report on Form 10-K filed with the SEC on March 13, 2019. The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by generally accepted accounting principles in the U.S. for complete financial statements. Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of CTI and its wholly-owned subsidiary, CTI Life Sciences Limited, or CTILS. As of June 30, 2019 , we also had an approximately 60% interest in our majority-owned subsidiary, Aequus Biopharma, Inc., or Aequus. The remaining interest in Aequus not held by CTI is reported as noncontrolling interest in the condensed consolidated financial statements. All intercompany transactions and balances are eliminated in consolidation. Liquidity The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the condensed consolidated financial statements are issued. Our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued. We will need to continue to conduct research, development, testing and regulatory compliance activities with respect to pacritinib and ensure the procurement of manufacturing and drug supply services, the costs of which, together with projected general and administrative expenses, is expected to result in operating losses for the foreseeable future. In October 2016, we resumed primary responsibility for the development and commercialization of pacritinib as a result of the termination of a Development, Commercialization and License Agreement, or the Pacritinib License Agreement, with Baxalta and are no longer eligible to receive cost sharing or milestone payments for pacritinib's development. We have incurred a net operating loss every year since our formation. As of June 30, 2019 , we had an accumulated deficit of $2.2 billion , and we expect to continue to incur net losses for the foreseeable future. Our available cash, cash equivalents and short-term investments were $53.7 million as of June 30, 2019 . We completed the evaluation about our ability to continue as a going concern as required by Accounting Standards Update No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. Based on this analysis, we expect that our present financial resources will be sufficient to meet our obligations as they come due and to fund our operations at least for one year after the date that this Quarterly Report on Form 10-Q is filed with the SEC. We will need to acquire additional funds in order to develop our business. We may seek to raise such capital through public or private equity financings, partnerships, collaborations, joint ventures, disposition of assets, debt financings or restructurings, bank borrowings or other sources of financing. However, we have a limited number of authorized shares of common stock available for issuance and additional funding obtained through the sale of such shares or otherwise may not be sufficient, available on favorable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing stockholders may result. If we fail to obtain additional capital when needed, our ability to operate as a going concern will be harmed, and we may be required to delay, scale back or eliminate some or all of our research and development programs, reduce our selling, general and administrative expenses, be unable to attract and retain highly-qualified personnel, be unable to obtain and maintain contracts necessary to continue our operations and at affordable rates with competitive terms, refrain from making our contractually required payments when due (including debt payments) and/or may be forced to cease operations, liquidate our assets and possibly seek bankruptcy protection. The accompanying condensed consolidated financial statements do not include adjustments, if any, that may result from the outcome of this uncertainty. Cash, Cash Equivalents and Short-term Investments As of June 30, 2019 and December 31, 2018 , our cash, cash equivalents and short-term investments consisted of cash, money market funds, U.S. government and agency securities and corporate debt securities. Cash equivalents and short-term investments are recorded at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest: • Level 1—Valuations based on unadjusted quoted prices for identical assets and liabilities in active markets. • Level 2—Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Valuations based on unobservable inputs that are supported by little or no market activity, reflecting our own assumptions. These valuations require significant judgment or estimation. We measure the fair value of money market funds based on the closing price reported by a fund sponsor from an actively traded exchange. We value all other securities using broker quotes that utilize observable market inputs. We did not hold cash, cash equivalents and short-term investments categorized as Level 3 assets as of June 30, 2019 and December 31, 2018 . The following table summarizes, by major security type, our cash, cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): June 30, 2019 December 31, 2018 Cost or Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Estimated Fair Value Total Estimated Fair Value Cash $ 817 $ — $ — $ 817 $ 919 Level 1 securities: Money market funds 30,049 — — 30,049 20,525 Level 2 securities: U.S. government and agency securities 9,255 8 — 9,263 15,213 Corporate debt securities 13,521 11 — 13,532 30,381 Total cash, cash equivalents and short-term investments $ 53,642 $ 19 $ — $ 53,661 $ 67,038 Receivables from License and Development Services Arrangements Our receivables relate to amounts payable or reimbursable to us under the terms of license and development services arrangements with our partners. The receivable balance as of June 30, 2019 primarily related to royalties from our partners Les Laboratoires Servier and Institut de Recherches Internationales Servier, or together Servier. The receivable balance as of December 31, 2018 primarily related to a milestone receivable from Servier for the attainment of a regulatory milestone in November 2018 as well as a milestone receivable from Teva for the attainment of a worldwide net sales milestone of TRISENOX in December 2018. Receivables are reviewed for collectability whenever circumstances indicate that the carrying amount of the receivable may not be recoverable. We had no allowance for doubtful accounts from license and development services arrangements as of June 30, 2019 or December 31, 2018 . Italian Value Added Tax Receivable We historically carried out research and development activities in Italy and incurred value added tax, or VAT, from Italian suppliers on the acquisition of goods and services in Italy. This VAT should be considered as an input VAT credit. We treated the majority of our sales made in Italy without output VAT (on the basis that the supplies should be considered outside the scope of Italian VAT). This resulted in the value of input VAT exceeding the value of output VAT, and accordingly we submitted a refund claim for the VAT. The Italian Tax Authority, or the ITA, has challenged the treatment of the sales transactions and claimed that the sales transactions made by us should have been subject to output VAT. Our Italian VAT receivable was approximately $4.5 million as of June 30, 2019 and December 31, 2018 . Substantially all of our VAT receivable is included in Other assets . As disclosed in Note 10. Contingencies , the ITA assessed us for additional VAT payments for services we provided in Italy, which we do not believe we owe. We have not recorded an amount in the financial statements for this contingent liability as we do not believe the potential payment of up to €4.2 million (or approximately $4.8 million converted using the currency exchange rate as of June 30, 2019 ), to the ITA is probable at this time. Leases As discussed in Recently Adopted Accounting Standards below, we adopted Accounting Standards Codification, or ASC, Topic 842 - Leases, on January 1, 2019. Under ASC 842, we determine if an arrangement is a lease at inception. We recognize a right-of-use asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as operating or finance at lease commencement, which will affect the pattern and classification of expense recognition in our condensed consolidated statements of operations. Right-of-use assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As our leases do not provide a readily determinable implicit rate of return, we use our incremental borrowing rate to derive the present value of lease payments, which is the rate of interest that we would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. An operating lease right-of-use asset is measured at the amount of the lease liability, adjusted for prepaid or accrued lease payments, lease incentives received, unamortized initial direct costs and the impairment of the right-of-use asset. A lease may include options to extend or terminate the lease. When it is reasonably certain that we will exercise such an option, it is considered in the lease term. Right-of-use assets are tested for impairment in the same manner as long-lived assets used in operations. Leasehold improvements are capitalized at cost and amortized over the lesser of their expected useful life or the lease term. Lease expense for operating leases is recognized on a straight-line basis over the lease term as part of Research and development expenses and Selling, general and administrative expenses in our condensed consolidated statements of operations. The current portion of right-of-use assets and the non-current portion of right-of-use assets are included in Prepaid expenses and other current assets and Other assets , respectively, and the current portion of lease liabilities and the non-current portion of lease liabilities are included in Other current liabilities and Other liabilities , respectively, in our condensed consolidated balance sheets. Revenue Recognition We adopted ASC 606 - Revenue from Contracts with Customers , on January 1, 2018, using a modified retrospective method. This standard applies to all contracts with customers, except for contracts that are within the scope of other authoritative literature. Under ASC 606, we recognize revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) we satisfy a performance obligation. We apply the five-step model to arrangements that meet the definition of a contract under ASC 606 including when it is probable that we will collect the consideration we are entitled to in exchange for goods or services we transfer to the customer. At contract inception, we assess the goods or services promised within each contract and determine those that are performance obligations, and assesses whether each promised good or service is distinct. We recognize revenue for the amount of the transaction price that is allocated to the respective performance obligation as the performance obligation is satisfied. License and Development Services Arrangements We recognize license and contract revenue under license and development services arrangements that are within the scope of ASC 606. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. We evaluate these agreements under ASC 606 to determine distinct performance obligations. Prior to recognizing revenue, we make estimates of the transaction price, including any variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that there will not be a significant reversal in the amount of cumulative revenue recognized and when the uncertainty associated with the variable consideration is subsequently resolved. Variable consideration may include nonrefundable upfront license fees, payments for research and development activities, reimbursement of certain third-party costs, payments based upon the achievement of specified milestones, and royalty payments based on product sales derived from the arrangement. If there are multiple, distinct performance obligations, we allocate the transaction price to each distinct performance obligation based on its relative standalone selling price. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure in accordance with ASC-340-40, Other Assets and Deferred Costs: Contracts with Customers . Foreign Currency Translation and Transaction Gains and Losses We record foreign currency translation adjustments and transaction gains and losses in accordance with ASC 830 - Foreign Currency Matters. For our operations that have a functional currency other than the U.S. dollar, gains and losses resulting from the translation of the functional currency into U.S. dollars for financial statement presentation are not included in determining net loss, but are accumulated in the cumulative foreign currency translation adjustment account as a separate component of stockholders’ equity, except for intercompany transactions that are of a short-term nature with entities that are consolidated, combined or accounted for by the equity method in our condensed consolidated financial statements. We and our subsidiary also have transactions in foreign currencies other than the functional currency. We record transaction gains and losses in our condensed consolidated statements of operations related to the recurring measurement and settlement of such transactions. The intercompany balance due from CTILS is considered to be of a long-term nature. An unrealized foreign exchange gain of $0.4 million and an unrealized foreign exchange loss of $0.3 million for the three and six months ended June 30, 2019 , respectively, and an unrealized foreign exchange loss of $0.4 million and $0.1 million for the same periods in 2018 were recorded in the cumulative foreign currency translation adjustment account. As of June 30, 2019 and December 31, 2018 , the intercompany balance due from CTILS was €28.9 million (or $32.8 million upon conversion from euros as of June 30, 2019 ) and €28.7 million (or $32.8 million upon conversion from euros as of December 31, 2018 ), respectively. Net Loss per Share Basic net loss per share is calculated based on the net loss attributable to common stockholders divided by the weighted average number of our common shares outstanding for the period. Diluted net income per share assumes the conversion of all dilutive convertible securities using the if-converted method and assumes the exercise or vesting of other dilutive securities, such as warrants and stock awards, using the treasury stock method. In periods when we have a net loss, stock awards, warrants and convertible securities are excluded from our calculation of net loss per share as their inclusion would have an anti-dilutive effect. Common shares underlying stock awards, warrants and convertible preferred stock aggregating 18.9 million shares and 17.9 million shares for the three and six months ended June 30, 2019 , respectively, and 15.8 million shares and 13.4 million shares for the same periods in 2018 , respectively, were excluded from the calculation of diluted net loss per share because they were anti-dilutive. Recently Adopted Accounting Standards In February 2016, the FASB issued ASC 842 - Leases , which requires lessees to recognize virtually all of their leases (other than leases that meet the definition of a short-term lease) on the balance sheet. On January 1, 2019, we adopted ASC 842 using the modified retrospective approach with a cumulative-effect adjustment as of January 1, 2019 in accordance with ASU No. 2018-11, Leases (Topic 842) - Targeted Improvements . Prior period amounts are not adjusted and continue to be reported under previous lease guidance, ASC 840 - Leases . We have performed an evaluation of our contracts with customers and suppliers in accordance with ASC 842 and have determined that the agreements for our office space, parking and office equipment contained a lease. All identified leases are classified as operating leases. We had no finance or capital leases as of June 30, 2019 and December 31, 2018 and for the three and six months ended June 30, 2019 and 2018 . We also elected a package of practical expedients permitted under the transition guidance within the new standard. The impact of the adoption of ASC 842 on our condensed consolidated balance sheet as of January 1, 2019 was as follows (in thousands): December 31, 2018 Adjustments due to adoption of ASC 842 January 1, 2019 Right-of-use assets, current $ — $ 1,034 $ 1,034 Right-of-use assets, non-current $ — $ 3,174 $ 3,174 Lease liabilities, current $ — $ 1,687 $ 1,687 Lease liabilities, non-current $ — $ 4,946 $ 4,946 Deferred rent, current $ 893 $ (893 ) $ — Deferred rent, non-current $ 2,157 $ (2,157 ) $ — Accumulated deficit $ (2,224,746 ) $ 1,196 $ (2,223,550 ) The adoption of the standard did not materially impact our condensed consolidated statements of operations or condensed consolidated statements of cash flows. See Note 4. Leases for further details about our leases. In June 2018, the FASB issued new accounting guidance which simplifies the accounting for share-based payments granted to nonemployees for goods and services by aligning it with the accounting for share-based payments to employees, with certain exceptions. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. We adopted this guidance on January 1, 2019. The adoption of this accounting guidance did not have a material impact on our condensed consolidated financial statements. Recently Issued Accounting Standards In June 2016, the FASB issued new accounting guidance which amends the impairment model for most financial assets and certain other instruments. For trade and other receivables, held-to-maturity debt securities, loans and other financial instruments, the standard requires the use of a new forward-looking "expected credit loss" model that generally will result in the earlier recognition of allowances for losses. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. We do not expect the adoption of this accounting guidance to have a material impact on our condensed consolidated financial statements. In August 2018, the FASB issued new accounting guidance which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted for either the entire standard or any eliminated or modified disclosures. We do not expect the adoption of this accounting guidance to have a material impact on our condensed consolidated financial statements. Although there were several other new accounting pronouncements issued or proposed by the FASB, we do not believe any of these have had or will have material impact on our condensed consolidated financial statements. Reclassifications Certain prior year items have been reclassified to conform to current year presentation. |
Other Assets
Other Assets | 6 Months Ended |
Jun. 30, 2019 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Assets | 2. Other Assets Other assets consisted of the following (in thousands): June 30, 2019 December 31, 2018 Right-of-use assets, non-current $ 2,578 $ — Italian VAT receivables 4,446 4,480 Italian VAT deposit 489 493 Rent deposit 194 194 Other 386 380 Other assets $ 8,093 $ 5,547 On January 1, 2019, we adopted ASC 842 - Leases and recorded right-of-use assets for our operating leases. See Note 1. Description of Business and Summary of Significant Accounting Policies - Recently Adopted Accounting Standards and Note 4. Leases for further details. For details regarding our Italian VAT receivables and Italian VAT deposit, see Note 1. Description of Business and Summary of Significant Accounting Policies - Italian Value Added Tax Receivable and Note 10. Contingencies . |
Other Liabilities
Other Liabilities | 6 Months Ended |
Jun. 30, 2019 | |
Other Liabilities Disclosure [Abstract] | |
Other Liabilities | 3. Other Liabilities Other liabilities consisted of the following (in thousands): June 30, 2019 December 31, 2018 Lease liabilities, non-current $ 4,002 $ — Deferred rent, non-current — 2,157 Other long-term obligations 2,414 2,414 Total other liabilities $ 6,416 $ 4,571 On January 1, 2019, we adopted ASC 842 - Leases and recorded lease liabilities and corresponding right-of-use assets for our operating leases. Deferred rent, less current portion as of December 31, 2018 included amounts related to lease incentives associated with our operating lease for office space. Under ASC 842, such lease incentives are accounted for as a reduction to the right-of-use asset balance. See Note 1. Description of Business and Summary of Significant Accounting Policies - Recently Adopted Accounting Standards and Note 4. Leases for further details. Other long-term obligations as of June 30, 2019 and December 31, 2018 included a fee in the amount of $1.4 million payable to Silicon Valley Bank. See Part II, Item 8, "Notes to Consolidated Financial Statements, Note 7. Long-term debt" of our Annual Report on Form 10-K for the year ended December 31, 2018 for additional information. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Leases | 4. Leases In January 2012 , we entered into an agreement with Selig Holdings Company LLC, or Selig, to lease approximately 66,000 square feet of office space in Seattle, Washington for a term of 10 years , commencing May 2012 . We have two five -year options to extend the term of the lease at a market rate determined according to the lease. We also had an option to early terminate the lease after the fifth anniversary from the commencement date. We were provided with a total of $3.9 million for certain tenant improvements and other lease incentives. The options to extend or terminate the lease were not considered in the determination of the right-of-use asset and the lease liability as we did not consider it reasonably certain that we would exercise such options. We also lease parking space and certain of our office equipment. We have elected not to separate a non-lease component from a lease component for these leases. In December 2017 , we entered into an agreement to sublease approximately 44,000 square feet of our office space. No payments were due through May 2018 , after which monthly rent is due through the sublease termination date in April 2022 . The operating lease for our office space includes common area maintenance services provided by Selig, which are considered a non-lease component. Since the payments for these services are based on the actual costs incurred by Selig in providing the services, we consider these payments as variable lease expenses. The components of lease expense, which were included in our condensed consolidated statements of operations, were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Operating lease expense, net $ 426 $ 344 $ 853 $ 701 Variable lease expense 37 59 87 95 Sublease income (312 ) (312 ) (624 ) (624 ) Total lease expense, net $ 151 $ 91 $ 316 $ 172 The balance sheet classification of operating lease right-of-use assets and operating lease liabilities were as follows (in thousands): June 30, 2019 Right-of-use assets, current (included in Prepaid expenses and other current assets ) $ 1,138 Right-of-use assets, non-current (included in Other assets ) 2,578 Total right-of-use assets $ 3,716 Lease liabilities, current (included in Other current liabilities ) $ 1,823 Lease liabilities, non-current (included in Other liabilities ) 4,002 Total lease liabilities $ 5,825 As June 30, 2019 , the maturities of operating lease liabilities were as follows (in thousands): Operating Leases 2019 $ 1,207 2020 2,443 2021 2,437 2022 820 Total lease payments 6,907 Less imputed interest (1,082 ) Total lease liabilities $ 5,825 The schedule above does not contemplate any sublease income from subleasing of our office space. As of June 30, 2019 , the total remaining scheduled sublease payments were $4.0 million . Supplemental information relating to our operating leases is as follows (in thousands): June 30, 2019 Supplemental cash flow information Cash paid for amounts included in the measurement of lease liabilities $ 1,185 Right-of-use assets obtained in exchange for operating lease liabilities $ 4,208 Weighted-average remaining lease term of operating leases (years) 2.80 Weighted-average discount rate of operating leases 12.4 % |
Termination of Equity Offering
Termination of Equity Offering Program | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Termination of Equity Offering Program | 5. Termination of Equity Offering Program In November 2018 , we entered into a Sales Agreement with Cowen and Company, LLC, or Cowen, to sell shares of our common stock, having aggregate sales proceeds of up to $50.0 million , from time to time, through an “at the market” equity offering program under which Cowen acted as sales agent. The Sales Agreement could be terminated by us upon five days ’ notice to Cowen for any reason or by Cowen upon five days ’ notice to us for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company. We had no obligation to sell any shares under the Sales Agreement, and could at any time suspend solicitation and offers under the Sales Agreement. In March 2019 , we provided notice to Cowen, and the Sales Agreement was terminated. In connection with the termination of the Sales Agreement, deferred financing costs of $0.2 million were written off and recorded in Selling, general and administrative expenses for the six months ended June 30, 2019 . No shares of common stock were sold under the Sales Agreement during the six months ended June 30, 2019 . |
Termination of Servier Agreemen
Termination of Servier Agreement | 6 Months Ended |
Jun. 30, 2019 | |
Termination Of Agreement [Abstract] | |
Termination of Servier Agreement | 6. Termination of Servier Agreement In February 2019 , we entered into a Termination and Transfer Agreement, or the Termination Agreement, among, on the one hand, the Company and its subsidiary, CTILS, and, on the other hand, Servier. The Termination Agreement terminates the Amended and Restated Exclusive License and Collaboration Agreement, dated as of April 21, 2017 by and among the Company, CTILS and Servier. Under the Termination Agreement, we will continue to be responsible for non-U.S. pharmacovigilance for PIXUVRI (pixantrone), the submission of a marketing authorization application for PIXUVRI and wind down of the PIX306 clinical trial during a transition period. Servier agreed to reimburse us €620,000 (of which, €65,000 was reimbursed and recognized as license and contract revenue in 2018 ) for costs to be incurred in connection with transition period activities on or before May 31, 2019 and to provide additional reimbursement to us for transition period activities occurring after May 31, 2019, not to exceed €50,000 per month or €200,000 in the aggregate. For the three and six months ended June 30, 2019 , we recognized $0.2 million and $0.6 million , respectively, of license and contract revenue related to the transition period activities, which does not include the aforementioned additional reimbursement. In April 2019, Servier announced that the EMA's Committee for Medicinal Products for Human Use, or CHMP, issued a positive opinion for PIXUVRI to convert its conditional approval into a standard marketing authorization as a single agent for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma, and in June 2019, the European Commission adopted the decision to grant non-conditional marketing authorization for PIXUVRI. Pursuant to the Termination and Transfer Agreement between us and Servier, which we refer to as the Termination Agreement, we will transfer and assign all of our rights and responsibilities for PIXUVRI globally to Servier pursuant to an asset purchase agreement. The Termination Agreement provides that entering into the asset purchase agreement will require, among other things, Servier to pay us €2.0 million and assume responsibility for all of the obligations related to PIXUVRI, including the Company’s remaining royalty payments to Novartis International Pharmaceutical Ltd. and the University of Vermont. |
Restructuring Activities
Restructuring Activities | 6 Months Ended |
Jun. 30, 2019 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Activities | 7. Restructuring Activities In December 2018, we announced a restructuring plan to improve efficiencies and reduce costs within the Company, which impacted a total of 21 positions. The restructuring activities were substantially completed as of March 31, 2019 , and we have incurred total restructuring expenses of approximately $1.5 million to date, of which $0.8 million was incurred during the six months ended June 30, 2019 . The following table summarizes the accrual balance and utilization for the six months ended June 30, 2019 (in thousands): Employee Separation Costs Restructuring accruals - December 31, 2018 $ 660 Restructuring expenses 794 Cash payments (1,268 ) Restructuring accruals - June 30, 2019 $ 186 |
Share-based Compensation Expens
Share-based Compensation Expense | 6 Months Ended |
Jun. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Share-based Compensation Expense | 8. Share-based Compensation Expense The following table summarizes share-based compensation expense, which was allocated as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Research and development $ 223 $ 164 $ 252 $ 543 Selling, general and administrative 1,138 876 2,366 1,833 Total share-based compensation expense $ 1,361 $ 1,040 $ 2,618 $ 2,376 We incurred share-based compensation expense (reversals) due to the following types of awards (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Restricted stock $ 1 $ (60 ) $ (15 ) $ 109 Options 1,360 1,100 2,633 2,267 Total share-based compensation expense $ 1,361 $ 1,040 $ 2,618 $ 2,376 |
Other Comprehensive Loss
Other Comprehensive Loss | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Other Comprehensive Loss | 9. Other Comprehensive Loss Total accumulated other comprehensive loss consisted of the following (in thousands): Net Unrealized (Loss) Gain on Available-For- Sale Securities Foreign Currency Translation Adjustments Unrealized Foreign Exchange Loss on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2018 $ (14 ) $ (9,672 ) $ (957 ) $ (10,643 ) Current period other comprehensive income (loss) 34 238 (251 ) 21 June 30, 2019 $ 20 $ (9,434 ) $ (1,208 ) $ (10,622 ) |
Contingencies
Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies | 10. Contingencies In April 2009, December 2009 and June 2010, the Italian Tax Authority, or the ITA, issued notices of assessment to CTI - Sede Secondaria, or CTI (Europe), based on the ITA’s audit of CTI (Europe)’s value added tax, or VAT, returns for the years 2003, 2005, 2006 and 2007, or, collectively, the VAT Assessments. The ITA audits concluded that CTI (Europe) did not collect and remit VAT on certain invoices issued to non-Italian clients for services performed by CTI (Europe). The assessments, including interest and penalties, for the years 2003, 2006 and 2007 are €0.6 million , €2.7 million and €0.9 million , respectively. We believe that the services invoiced were non-VAT taxable consultancy services and that the VAT returns are correct as originally filed. We have appealed all of the assessments and are defending ourselves against the assessments both on procedural grounds and on the merits of the cases, although we can make no assurances regarding the ultimate outcome of these cases. There have been no changes to the status of the legal proceedings surrounding each respective VAT year return at issue since the filing of our Annual Report on Form 10-K for the year ended December 31, 2018. See Part II, Item 8, "Notes to Consolidated Financial Statements, Note 18. Commitments and Contingencies" of our Annual Report on Form 10-K for the year ended December 31, 2018 for additional information. If the final decision of the Italian Supreme Court is unfavorable to us, or if, in the interim, the ITA were to make a demand for payment and we were to be unsuccessful in suspending collection efforts, we may be requested to pay the ITA an amount up to €4.2 million , or approximately $4.8 million converted using the currency exchange rate as of June 30, 2019 , including interest and penalties for the period lapsed between the date in which the assessments were issued and the date of effective payment. We have not recorded this contingent liability in the financial statements as we do not believe the potential payment to the ITA is probable at this time. |
Description of Business and S_2
Description of Business and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Description of Business | We operate in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products requires approval from, and is subject to, ongoing oversight by the Food and Drug Administration, or the FDA, in the U.S., the European Medicines Agency, or the EMA, in the European Union, or the E.U., and comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain, may take many years and may involve expenditure of substantial resources. |
Basis of Presentation | Basis of Presentation The accompanying unaudited financial information as of and for the three and six months ended June 30, 2019 and 2018 has been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial position at such date and the operating results and cash flows for such periods. Operating results for the three and six months ended June 30, 2019 are not necessarily indicative of the results that may be expected for the entire year or for any other subsequent interim period. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to the rules of the U.S. Securities and Exchange Commission, or the SEC. These unaudited financial statements and related notes should be read in conjunction with our audited financial statements for the year ended December 31, 2018 included in our Annual Report on Form 10-K filed with the SEC on March 13, 2019. The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by generally accepted accounting principles in the U.S. for complete financial statements. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of CTI and its wholly-owned subsidiary, CTI Life Sciences Limited, or CTILS. As of June 30, 2019 , we also had an approximately 60% interest in our majority-owned subsidiary, Aequus Biopharma, Inc., or Aequus. The remaining interest in Aequus not held by CTI is reported as noncontrolling interest in the condensed consolidated financial statements. All intercompany transactions and balances are eliminated in consolidation. |
Liquidity | Liquidity The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the condensed consolidated financial statements are issued. Our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued. We will need to continue to conduct research, development, testing and regulatory compliance activities with respect to pacritinib and ensure the procurement of manufacturing and drug supply services, the costs of which, together with projected general and administrative expenses, is expected to result in operating losses for the foreseeable future. In October 2016, we resumed primary responsibility for the development and commercialization of pacritinib as a result of the termination of a Development, Commercialization and License Agreement, or the Pacritinib License Agreement, with Baxalta and are no longer eligible to receive cost sharing or milestone payments for pacritinib's development. We have incurred a net operating loss every year since our formation. As of June 30, 2019 , we had an accumulated deficit of $2.2 billion , and we expect to continue to incur net losses for the foreseeable future. Our available cash, cash equivalents and short-term investments were $53.7 million as of June 30, 2019 . We completed the evaluation about our ability to continue as a going concern as required by Accounting Standards Update No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. Based on this analysis, we expect that our present financial resources will be sufficient to meet our obligations as they come due and to fund our operations at least for one year after the date that this Quarterly Report on Form 10-Q is filed with the SEC. We will need to acquire additional funds in order to develop our business. We may seek to raise such capital through public or private equity financings, partnerships, collaborations, joint ventures, disposition of assets, debt financings or restructurings, bank borrowings or other sources of financing. However, we have a limited number of authorized shares of common stock available for issuance and additional funding obtained through the sale of such shares or otherwise may not be sufficient, available on favorable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing stockholders may result. If we fail to obtain additional capital when needed, our ability to operate as a going concern will be harmed, and we may be required to delay, scale back or eliminate some or all of our research and development programs, reduce our selling, general and administrative expenses, be unable to attract and retain highly-qualified personnel, be unable to obtain and maintain contracts necessary to continue our operations and at affordable rates with competitive terms, refrain from making our contractually required payments when due (including debt payments) and/or may be forced to cease operations, liquidate our assets and possibly seek bankruptcy protection. The accompanying condensed consolidated financial statements do not include adjustments, if any, that may result from the outcome of this uncertainty. |
Cash, Cash Equivalents and Short-term Investments | Cash, Cash Equivalents and Short-term Investments As of June 30, 2019 and December 31, 2018 , our cash, cash equivalents and short-term investments consisted of cash, money market funds, U.S. government and agency securities and corporate debt securities. Cash equivalents and short-term investments are recorded at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest: • Level 1—Valuations based on unadjusted quoted prices for identical assets and liabilities in active markets. • Level 2—Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Valuations based on unobservable inputs that are supported by little or no market activity, reflecting our own assumptions. These valuations require significant judgment or estimation. We measure the fair value of money market funds based on the closing price reported by a fund sponsor from an actively traded exchange. We value all other securities using broker quotes that utilize observable market inputs. We did not hold cash, cash equivalents and short-term investments categorized as Level 3 assets as of June 30, 2019 and December 31, 2018 . |
Receivables from License and Development Services Arrangements | Receivables from License and Development Services Arrangements Our receivables relate to amounts payable or reimbursable to us under the terms of license and development services arrangements with our partners. The receivable balance as of June 30, 2019 primarily related to royalties from our partners Les Laboratoires Servier and Institut de Recherches Internationales Servier, or together Servier. The receivable balance as of December 31, 2018 primarily related to a milestone receivable from Servier for the attainment of a regulatory milestone in November 2018 as well as a milestone receivable from Teva for the attainment of a worldwide net sales milestone of TRISENOX in December 2018. |
Italian Value Added Tax Receivable | Italian Value Added Tax Receivable We historically carried out research and development activities in Italy and incurred value added tax, or VAT, from Italian suppliers on the acquisition of goods and services in Italy. This VAT should be considered as an input VAT credit. We treated the majority of our sales made in Italy without output VAT (on the basis that the supplies should be considered outside the scope of Italian VAT). This resulted in the value of input VAT exceeding the value of output VAT, and accordingly we submitted a refund claim for the VAT. The Italian Tax Authority, or the ITA, has challenged the treatment of the sales transactions and claimed that the sales transactions made by us should have been subject to output VAT. Our Italian VAT receivable was approximately $4.5 million as of June 30, 2019 and December 31, 2018 . Substantially all of our VAT receivable is included in Other assets . As disclosed in Note 10. Contingencies , the ITA assessed us for additional VAT payments for services we provided in Italy, which we do not believe we owe. |
Leases | Leases As discussed in Recently Adopted Accounting Standards below, we adopted Accounting Standards Codification, or ASC, Topic 842 - Leases, on January 1, 2019. Under ASC 842, we determine if an arrangement is a lease at inception. We recognize a right-of-use asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as operating or finance at lease commencement, which will affect the pattern and classification of expense recognition in our condensed consolidated statements of operations. Right-of-use assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As our leases do not provide a readily determinable implicit rate of return, we use our incremental borrowing rate to derive the present value of lease payments, which is the rate of interest that we would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. An operating lease right-of-use asset is measured at the amount of the lease liability, adjusted for prepaid or accrued lease payments, lease incentives received, unamortized initial direct costs and the impairment of the right-of-use asset. A lease may include options to extend or terminate the lease. When it is reasonably certain that we will exercise such an option, it is considered in the lease term. Right-of-use assets are tested for impairment in the same manner as long-lived assets used in operations. Leasehold improvements are capitalized at cost and amortized over the lesser of their expected useful life or the lease term. Lease expense for operating leases is recognized on a straight-line basis over the lease term as part of Research and development expenses and Selling, general and administrative expenses in our condensed consolidated statements of operations. The current portion of right-of-use assets and the non-current portion of right-of-use assets are included in Prepaid expenses and other current assets and Other assets , respectively, and the current portion of lease liabilities and the non-current portion of lease liabilities are included in Other current liabilities and Other liabilities , respectively, in our condensed consolidated balance sheets. |
Revenue Recognition | Revenue Recognition We adopted ASC 606 - Revenue from Contracts with Customers , on January 1, 2018, using a modified retrospective method. This standard applies to all contracts with customers, except for contracts that are within the scope of other authoritative literature. Under ASC 606, we recognize revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) we satisfy a performance obligation. We apply the five-step model to arrangements that meet the definition of a contract under ASC 606 including when it is probable that we will collect the consideration we are entitled to in exchange for goods or services we transfer to the customer. At contract inception, we assess the goods or services promised within each contract and determine those that are performance obligations, and assesses whether each promised good or service is distinct. We recognize revenue for the amount of the transaction price that is allocated to the respective performance obligation as the performance obligation is satisfied. |
License and Development Services Arrangements | License and Development Services Arrangements We recognize license and contract revenue under license and development services arrangements that are within the scope of ASC 606. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. We evaluate these agreements under ASC 606 to determine distinct performance obligations. Prior to recognizing revenue, we make estimates of the transaction price, including any variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that there will not be a significant reversal in the amount of cumulative revenue recognized and when the uncertainty associated with the variable consideration is subsequently resolved. Variable consideration may include nonrefundable upfront license fees, payments for research and development activities, reimbursement of certain third-party costs, payments based upon the achievement of specified milestones, and royalty payments based on product sales derived from the arrangement. If there are multiple, distinct performance obligations, we allocate the transaction price to each distinct performance obligation based on its relative standalone selling price. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure in accordance with ASC-340-40, Other Assets and Deferred Costs: Contracts with Customers . |
Foreign Currency Translation and Transaction Gains and Losses | Foreign Currency Translation and Transaction Gains and Losses We record foreign currency translation adjustments and transaction gains and losses in accordance with ASC 830 - Foreign Currency Matters. For our operations that have a functional currency other than the U.S. dollar, gains and losses resulting from the translation of the functional currency into U.S. dollars for financial statement presentation are not included in determining net loss, but are accumulated in the cumulative foreign currency translation adjustment account as a separate component of stockholders’ equity, except for intercompany transactions that are of a short-term nature with entities that are consolidated, combined or accounted for by the equity method in our condensed consolidated financial statements. We and our subsidiary also have transactions in foreign currencies other than the functional currency. We record transaction gains and losses in our condensed consolidated statements of operations related to the recurring measurement and settlement of such transactions. The intercompany balance due from CTILS is considered to be of a long-term nature. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated based on the net loss attributable to common stockholders divided by the weighted average number of our common shares outstanding for the period. Diluted net income per share assumes the conversion of all dilutive convertible securities using the if-converted method and assumes the exercise or vesting of other dilutive securities, such as warrants and stock awards, using the treasury stock method. In periods when we have a net loss, stock awards, warrants and convertible securities are excluded from our calculation of net loss per share as their inclusion would have an anti-dilutive effect. |
Recently Adopted and Issued Accounting Standards | Recently Adopted Accounting Standards In February 2016, the FASB issued ASC 842 - Leases , which requires lessees to recognize virtually all of their leases (other than leases that meet the definition of a short-term lease) on the balance sheet. On January 1, 2019, we adopted ASC 842 using the modified retrospective approach with a cumulative-effect adjustment as of January 1, 2019 in accordance with ASU No. 2018-11, Leases (Topic 842) - Targeted Improvements . Prior period amounts are not adjusted and continue to be reported under previous lease guidance, ASC 840 - Leases . We have performed an evaluation of our contracts with customers and suppliers in accordance with ASC 842 and have determined that the agreements for our office space, parking and office equipment contained a lease. All identified leases are classified as operating leases. We had no finance or capital leases as of June 30, 2019 and December 31, 2018 and for the three and six months ended June 30, 2019 and 2018 . We also elected a package of practical expedients permitted under the transition guidance within the new standard. The impact of the adoption of ASC 842 on our condensed consolidated balance sheet as of January 1, 2019 was as follows (in thousands): December 31, 2018 Adjustments due to adoption of ASC 842 January 1, 2019 Right-of-use assets, current $ — $ 1,034 $ 1,034 Right-of-use assets, non-current $ — $ 3,174 $ 3,174 Lease liabilities, current $ — $ 1,687 $ 1,687 Lease liabilities, non-current $ — $ 4,946 $ 4,946 Deferred rent, current $ 893 $ (893 ) $ — Deferred rent, non-current $ 2,157 $ (2,157 ) $ — Accumulated deficit $ (2,224,746 ) $ 1,196 $ (2,223,550 ) The adoption of the standard did not materially impact our condensed consolidated statements of operations or condensed consolidated statements of cash flows. See Note 4. Leases for further details about our leases. In June 2018, the FASB issued new accounting guidance which simplifies the accounting for share-based payments granted to nonemployees for goods and services by aligning it with the accounting for share-based payments to employees, with certain exceptions. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. We adopted this guidance on January 1, 2019. The adoption of this accounting guidance did not have a material impact on our condensed consolidated financial statements. Recently Issued Accounting Standards In June 2016, the FASB issued new accounting guidance which amends the impairment model for most financial assets and certain other instruments. For trade and other receivables, held-to-maturity debt securities, loans and other financial instruments, the standard requires the use of a new forward-looking "expected credit loss" model that generally will result in the earlier recognition of allowances for losses. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. We do not expect the adoption of this accounting guidance to have a material impact on our condensed consolidated financial statements. In August 2018, the FASB issued new accounting guidance which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted for either the entire standard or any eliminated or modified disclosures. We do not expect the adoption of this accounting guidance to have a material impact on our condensed consolidated financial statements. Although there were several other new accounting pronouncements issued or proposed by the FASB, we do not believe any of these have had or will have material impact on our condensed consolidated financial statements. |
Reclassifications | Reclassifications Certain prior year items have been reclassified to conform to current year presentation. |
Description of Business and S_3
Description of Business and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Cash and Cash Equivalents, Measured at Fair Value on a Recurring Basis | The following table summarizes, by major security type, our cash, cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): June 30, 2019 December 31, 2018 Cost or Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Estimated Fair Value Total Estimated Fair Value Cash $ 817 $ — $ — $ 817 $ 919 Level 1 securities: Money market funds 30,049 — — 30,049 20,525 Level 2 securities: U.S. government and agency securities 9,255 8 — 9,263 15,213 Corporate debt securities 13,521 11 — 13,532 30,381 Total cash, cash equivalents and short-term investments $ 53,642 $ 19 $ — $ 53,661 $ 67,038 |
Impact of Adoption of ASC 842 on Balance Sheet | The impact of the adoption of ASC 842 on our condensed consolidated balance sheet as of January 1, 2019 was as follows (in thousands): December 31, 2018 Adjustments due to adoption of ASC 842 January 1, 2019 Right-of-use assets, current $ — $ 1,034 $ 1,034 Right-of-use assets, non-current $ — $ 3,174 $ 3,174 Lease liabilities, current $ — $ 1,687 $ 1,687 Lease liabilities, non-current $ — $ 4,946 $ 4,946 Deferred rent, current $ 893 $ (893 ) $ — Deferred rent, non-current $ 2,157 $ (2,157 ) $ — Accumulated deficit $ (2,224,746 ) $ 1,196 $ (2,223,550 ) |
Other Assets (Tables)
Other Assets (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Other Assets | Other assets consisted of the following (in thousands): June 30, 2019 December 31, 2018 Right-of-use assets, non-current $ 2,578 $ — Italian VAT receivables 4,446 4,480 Italian VAT deposit 489 493 Rent deposit 194 194 Other 386 380 Other assets $ 8,093 $ 5,547 |
Other Liabilities (Tables)
Other Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Other Liabilities Disclosure [Abstract] | |
Components of Other Liabilities | Other liabilities consisted of the following (in thousands): June 30, 2019 December 31, 2018 Lease liabilities, non-current $ 4,002 $ — Deferred rent, non-current — 2,157 Other long-term obligations 2,414 2,414 Total other liabilities $ 6,416 $ 4,571 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Components of Lease Expenses | The components of lease expense, which were included in our condensed consolidated statements of operations, were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Operating lease expense, net $ 426 $ 344 $ 853 $ 701 Variable lease expense 37 59 87 95 Sublease income (312 ) (312 ) (624 ) (624 ) Total lease expense, net $ 151 $ 91 $ 316 $ 172 |
Balance Sheet Classification of Operating Lease Components | The balance sheet classification of operating lease right-of-use assets and operating lease liabilities were as follows (in thousands): June 30, 2019 Right-of-use assets, current (included in Prepaid expenses and other current assets ) $ 1,138 Right-of-use assets, non-current (included in Other assets ) 2,578 Total right-of-use assets $ 3,716 Lease liabilities, current (included in Other current liabilities ) $ 1,823 Lease liabilities, non-current (included in Other liabilities ) 4,002 Total lease liabilities $ 5,825 |
Schedule of Maturities of Operating Lease Liabilities | As June 30, 2019 , the maturities of operating lease liabilities were as follows (in thousands): Operating Leases 2019 $ 1,207 2020 2,443 2021 2,437 2022 820 Total lease payments 6,907 Less imputed interest (1,082 ) Total lease liabilities $ 5,825 |
Supplemental Information Relating to Operating Leases | Supplemental information relating to our operating leases is as follows (in thousands): June 30, 2019 Supplemental cash flow information Cash paid for amounts included in the measurement of lease liabilities $ 1,185 Right-of-use assets obtained in exchange for operating lease liabilities $ 4,208 Weighted-average remaining lease term of operating leases (years) 2.80 Weighted-average discount rate of operating leases 12.4 % |
Restructuring Activities (Table
Restructuring Activities (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Restructuring and Related Activities [Abstract] | |
Summary of the Accrual Balance and Utilization of Restructuring | The following table summarizes the accrual balance and utilization for the six months ended June 30, 2019 (in thousands): Employee Separation Costs Restructuring accruals - December 31, 2018 $ 660 Restructuring expenses 794 Cash payments (1,268 ) Restructuring accruals - June 30, 2019 $ 186 |
Share-based Compensation Expe_2
Share-based Compensation Expense (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Share-Based Compensation Expense | The following table summarizes share-based compensation expense, which was allocated as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Research and development $ 223 $ 164 $ 252 $ 543 Selling, general and administrative 1,138 876 2,366 1,833 Total share-based compensation expense $ 1,361 $ 1,040 $ 2,618 $ 2,376 |
Share-Based Compensation Expense (Reversals) by Types of Awards | We incurred share-based compensation expense (reversals) due to the following types of awards (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Restricted stock $ 1 $ (60 ) $ (15 ) $ 109 Options 1,360 1,100 2,633 2,267 Total share-based compensation expense $ 1,361 $ 1,040 $ 2,618 $ 2,376 |
Other Comprehensive Loss (Table
Other Comprehensive Loss (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Total Accumulated Other Comprehensive Loss | Total accumulated other comprehensive loss consisted of the following (in thousands): Net Unrealized (Loss) Gain on Available-For- Sale Securities Foreign Currency Translation Adjustments Unrealized Foreign Exchange Loss on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2018 $ (14 ) $ (9,672 ) $ (957 ) $ (10,643 ) Current period other comprehensive income (loss) 34 238 (251 ) 21 June 30, 2019 $ 20 $ (9,434 ) $ (1,208 ) $ (10,622 ) |
Description of Business and S_4
Description of Business and Summary of Significant Accounting Policies - Additional Information (Details) € in Millions, shares in Millions | 3 Months Ended | 6 Months Ended | |||||||
Jun. 30, 2019USD ($)shares | Jun. 30, 2018USD ($)shares | Jun. 30, 2019USD ($)shares | Jun. 30, 2018USD ($)shares | Jun. 30, 2019EUR (€) | Jun. 30, 2019USD ($) | Jan. 01, 2019USD ($) | Dec. 31, 2018EUR (€) | Dec. 31, 2018USD ($) | |
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
Accumulated deficit | $ 2,245,328,000 | $ 2,223,550,000 | $ 2,224,746,000 | ||||||
Cash, cash equivalents, and short-term investments | 53,700,000 | ||||||||
Allowance for doubtful accounts from collaborative arrangements | 0 | 0 | |||||||
VAT receivable | 4,500,000 | 4,500,000 | |||||||
Potential payment to tax authority | € 4.2 | 4,800,000 | |||||||
Unrealized foreign exchange gain (loss) on intercompany balance | $ 428,000 | $ (400,000) | $ (251,000) | $ (122,000) | |||||
Intercompany foreign currency balance, amount | € 28.9 | 32,800,000 | € 28.7 | 32,800,000 | |||||
Anti-dilutive securities excluded from computation of earnings per share (in shares) | shares | 18.9 | 15.8 | 17.9 | 13.4 | |||||
Finance leases | 0 | 0 | |||||||
Capital leases | $ 0 | $ 0 | |||||||
Aequus Biopharma, Inc | Affiliated Entity | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
Interest in majority-owned subsidiary | 60.00% | 60.00% |
Description of Business and S_5
Description of Business and Summary of Significant Accounting Policies - Cash and Cash Equivalents and Short-term Investments Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Level 2 securities: | ||
Gross Unrealized Gains | $ 19 | |
Gross Unrealized Losses | 0 | |
Total cash, cash equivalents and short-term investments | 53,700 | |
U.S. government and agency securities | Level 2 | ||
Level 2 securities: | ||
Gross Unrealized Gains | 8 | |
Gross Unrealized Losses | 0 | |
Corporate debt securities | Level 2 | ||
Level 2 securities: | ||
Gross Unrealized Gains | 11 | |
Gross Unrealized Losses | 0 | |
Cost or Amortized Cost | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash | 817 | |
Level 2 securities: | ||
Total cash, cash equivalents and short-term investments | 53,642 | |
Cost or Amortized Cost | Money market funds | Level 1 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market funds | 30,049 | |
Cost or Amortized Cost | U.S. government and agency securities | Level 2 | ||
Level 2 securities: | ||
Cost or Amortized Cost | 9,255 | |
Cost or Amortized Cost | Corporate debt securities | Level 2 | ||
Level 2 securities: | ||
Cost or Amortized Cost | 13,521 | |
Total Estimated Fair Value | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash | 817 | $ 919 |
Level 2 securities: | ||
Total cash, cash equivalents and short-term investments | 53,661 | 67,038 |
Total Estimated Fair Value | Money market funds | Level 1 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market funds | 30,049 | 20,525 |
Total Estimated Fair Value | U.S. government and agency securities | Level 2 | ||
Level 2 securities: | ||
Total Estimated Fair Value | 9,263 | 15,213 |
Total Estimated Fair Value | Corporate debt securities | Level 2 | ||
Level 2 securities: | ||
Total Estimated Fair Value | $ 13,532 | $ 30,381 |
Description of Business and S_6
Description of Business and Summary of Significant Accounting Policies - Impact of Adoption of ASC 842 (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Lessee, Lease, Description [Line Items] | |||
Right-of-use assets, current | $ 1,138 | $ 1,034 | $ 0 |
Right-of-use assets, non-current | 2,578 | 3,174 | 0 |
Lease liabilities, current | 1,823 | 1,687 | 0 |
Lease liabilities, non-current | 4,002 | 4,946 | 0 |
Deferred rent, current | 0 | 893 | |
Deferred rent, non-current | 0 | 0 | 2,157 |
Accumulated deficit | $ (2,245,328) | (2,223,550) | $ (2,224,746) |
Adjustments due to adoption of ASC 842 | |||
Lessee, Lease, Description [Line Items] | |||
Right-of-use assets, current | 1,034 | ||
Right-of-use assets, non-current | 3,174 | ||
Lease liabilities, current | 1,687 | ||
Lease liabilities, non-current | 4,946 | ||
Deferred rent, current | (893) | ||
Deferred rent, non-current | (2,157) | ||
Accumulated deficit | $ 1,196 |
Other Assets (Details)
Other Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||
Right-of-use assets, non-current | $ 2,578 | $ 3,174 | $ 0 |
Italian VAT receivables | 4,446 | 4,480 | |
Italian VAT deposit | 489 | 493 | |
Rent deposit | 194 | 194 | |
Other | 386 | 380 | |
Other assets | $ 8,093 | $ 5,547 |
Other Liabilities (Detail)
Other Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Other Liabilities Disclosure [Abstract] | |||
Lease liabilities, non-current | $ 4,002 | $ 4,946 | $ 0 |
Deferred rent, non-current | 0 | $ 0 | 2,157 |
Other long-term obligations | 2,414 | 2,414 | |
Total other liabilities | 6,416 | 4,571 | |
Silicon Valley Bank | Secured Debt | Loan and Security Agreement | |||
Debt Instrument [Line Items] | |||
Fee amount on term loan | $ 1,400 | $ 1,400 |
Leases - Additional Information
Leases - Additional Information (Details) ft² in Thousands | 1 Months Ended | ||
Jan. 31, 2012USD ($)ft²Option | Jun. 30, 2019USD ($) | Dec. 31, 2017USD ($)ft² | |
Leases [Abstract] | |||
Leased office space | ft² | 66 | 44 | |
Term of lease agreement | 120 months | ||
Number of options to extend lease | Option | 2 | ||
Renewal term | 5 years | ||
Option to early terminate, period | 5 years | ||
Tenant improvements allowance | $ 3,900,000 | ||
Sublease payments receivable within five months | $ 0 | ||
Remaining scheduled sublease payments | $ 4,000,000 |
Leases - Components of Lease Ex
Leases - Components of Lease Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Leases [Abstract] | ||||
Operating lease expense, net | $ 426 | $ 344 | $ 853 | $ 701 |
Variable lease expense | 37 | 59 | 87 | 95 |
Sublease income | (312) | (312) | (624) | (624) |
Total lease expense, net | $ 151 | $ 91 | $ 316 | $ 172 |
Leases - Balance Sheet Classifi
Leases - Balance Sheet Classification of Operating Lease Components (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Leases [Abstract] | |||
Right-of-use assets, current (included in Prepaid expenses and other current assets) | $ 1,138 | $ 1,034 | $ 0 |
Right-of-use assets, non-current (included in Other assets) | 2,578 | 3,174 | 0 |
Total right-of-use assets | 3,716 | ||
Lease liabilities, current (included in Other current liabilities) | 1,823 | 1,687 | 0 |
Lease liabilities, non-current (included in Other liabilities) | 4,002 | $ 4,946 | $ 0 |
Total lease liabilities | $ 5,825 |
Leases - Maturities of Operatin
Leases - Maturities of Operating Lease Liabilities (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Leases [Abstract] | |
2019 | $ 1,207 |
2020 | 2,443 |
2021 | 2,437 |
2022 | 820 |
Total lease payments | 6,907 |
Less imputed interest | (1,082) |
Total lease liabilities | $ 5,825 |
Leases - Supplemental Informati
Leases - Supplemental Information Relating to Operating Leases (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Leases [Abstract] | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 1,185 | |
Right-of-use assets obtained in exchange for operating lease liabilities | $ 4,208 | $ 0 |
Weighted-average remaining lease term of operating leases (years) | 2 years 9 months 18 days | |
Weighted-average discount rate of operating leases | 12.40% |
Termination of Equity Offerin_2
Termination of Equity Offering Program (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
Nov. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Class of Stock [Line Items] | ||||
Write-off of deferred financing costs | $ 213 | $ 0 | ||
Common Stock | ||||
Class of Stock [Line Items] | ||||
Shares issued issued (in shares) | 23,012,000 | |||
Common Stock | Cowen And Company, LLC | ||||
Class of Stock [Line Items] | ||||
Proceeds from common stock offering | $ 50,000 | |||
Period of notice to counterparty to terminate agreement | 5 days | |||
Period of notice to company to terminate agreement | 5 days | |||
Write-off of deferred financing costs | $ 200 | |||
Shares issued issued (in shares) | 0 |
Termination of Servier Agreem_2
Termination of Servier Agreement (Details) € in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Feb. 28, 2019EUR (€) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2018EUR (€) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
License and contract revenues | $ | $ 416 | $ 613 | $ 1,056 | $ 11,459 | ||
Collaborative Arrangement, Product | Servier | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Reimbursement of costs incurred | € 620 | |||||
Receivable required upon counterparty entering asset purchase agreement | 2,000 | |||||
Extends Beyond May 31, 2019, Monthly Amount | Collaborative Arrangement, Product | Servier | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Reimbursement of costs incurred | 50 | |||||
Extends Beyond May 31, 2019 | Collaborative Arrangement, Product | Servier | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Reimbursement of costs incurred | € 200 | |||||
License and contract revenue | Collaborative Arrangement, Product | Servier | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
License and contract revenues | $ 200 | $ 600 | € 65 |
Restructuring Activities (Detai
Restructuring Activities (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2018USD ($)position | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | |
Restructuring and Related Activities [Abstract] | |||||
Number of positions impacted | position | 21 | ||||
Restructuring expense incurred to date | $ 1,500 | $ 1,500 | |||
Restructuring expense incurred during period | 800 | ||||
Restructuring Reserve [Roll Forward] | |||||
Restructuring expenses | 0 | $ 0 | 794 | $ 0 | |
Employee Separation Costs | |||||
Restructuring Reserve [Roll Forward] | |||||
Restructuring accruals - December 31, 2018 | 660 | ||||
Restructuring expenses | 794 | ||||
Cash payments | (1,268) | ||||
Restructuring accruals - June 30, 2019 | $ 660 | $ 186 | $ 186 |
Share-based Compensation Expe_3
Share-based Compensation Expense - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense | $ 1,361 | $ 1,040 | $ 2,618 | $ 2,376 |
Research and development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense | 223 | 164 | 252 | 543 |
Selling, general and administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense | $ 1,138 | $ 876 | $ 2,366 | $ 1,833 |
Share-based Compensation Expe_4
Share-based Compensation Expense - Share-based Compensation Expense by Types of Awards (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 1,361 | $ 1,040 | $ 2,618 | $ 2,376 |
Restricted stock | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | 1 | (60) | (15) | 109 |
Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 1,360 | $ 1,100 | $ 2,633 | $ 2,267 |
Other Comprehensive Loss (Detai
Other Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||||||
Beginning balance | $ (10,643) | $ (10,643) | ||||
Current period other comprehensive income (loss) | $ 12 | 9 | $ (3,094) | $ (532) | 21 | $ (3,626) |
Ending balance | (10,622) | (10,622) | ||||
Net Unrealized (Loss) Gain on Available-For- Sale Securities | ||||||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||||||
Beginning balance | (14) | (14) | ||||
Current period other comprehensive income (loss) | 34 | |||||
Ending balance | 20 | 20 | ||||
Foreign Currency Translation Adjustments | ||||||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||||||
Beginning balance | (9,672) | (9,672) | ||||
Current period other comprehensive income (loss) | 238 | |||||
Ending balance | (9,434) | (9,434) | ||||
Unrealized Foreign Exchange Loss on Intercompany Balance | ||||||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||||||
Beginning balance | $ (957) | (957) | ||||
Current period other comprehensive income (loss) | (251) | |||||
Ending balance | $ (1,208) | $ (1,208) |
Contingencies (Details)
Contingencies (Details) € in Millions, $ in Millions | Jun. 30, 2019EUR (€) | Jun. 30, 2019USD ($) | Dec. 31, 2007EUR (€) | Dec. 31, 2006EUR (€) | Dec. 31, 2003EUR (€) |
Loss Contingencies [Line Items] | |||||
Range of possible loss | € 0.9 | € 2.7 | € 0.6 | ||
VAT Assessments | |||||
Loss Contingencies [Line Items] | |||||
Range of possible loss | € 4.2 | $ 4.8 |
Uncategorized Items - ctic-2019
Label | Element | Value |
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 1,196,000 |
Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | 1,203,000 |
Additional Paid-in Capital [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ (7,000) |