Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Feb. 28, 2018 | Jun. 30, 2017 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | IOVANCE BIOTHERAPEUTICS, INC. | ||
Entity Central Index Key | 1,425,205 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 363,066,000 | ||
Trading Symbol | IOVA | ||
Entity Common Stock, Shares Outstanding | 89,445,753 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current Assets | ||
Cash and cash equivalents | $ 145,373 | $ 106,717 |
Short-term investments | 0 | 59,753 |
Prepaid expenses and other current assets | 3,917 | 3,042 |
Total Current Assets | 149,290 | 169,512 |
Property and equipment, net | 2,450 | 2,374 |
Long-term assets | 3,633 | 0 |
Total Assets | 155,373 | 171,886 |
Current Liabilities | ||
Accounts payable | 1,232 | 863 |
Accrued expenses | 8,660 | 4,105 |
Total Current Liabilities | 9,892 | 4,968 |
Commitments and contingencies (Note 11) | ||
Stockholders' Equity | ||
Common stock, $0.000041666 par value; 150,000,000 shares authorized, 73,164,914 and 62,248,074 shares issued and outstanding as of December 31, 2017 and December 31, 2016, respectively | 3 | 3 |
Additional paid-in capital | 394,651 | 323,994 |
Accumulated other comprehensive income | 0 | 29 |
Accumulated deficit | (249,180) | (157,116) |
Total Stockholders’ Equity | 145,481 | 166,918 |
Total Liabilities and Stockholders’ Equity | 155,373 | 171,886 |
Series A Convertible Preferred stock [Member] | ||
Stockholders' Equity | ||
Preferred stock,Value | 0 | 0 |
Total Stockholders’ Equity | 0 | 0 |
Series B Convertible Preferred stock [Member] | ||
Stockholders' Equity | ||
Preferred stock,Value | 7 | 8 |
Total Stockholders’ Equity | $ 7 | $ 8 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Common Stock, Par or Stated Value Per Share | $ 0.000041666 | $ 0.000041666 |
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 |
Common Stock, Shares, Issued | 73,164,914 | 62,248,074 |
Common Stock, Shares, Outstanding | 73,164,914 | 62,248,074 |
Series A Convertible Preferred Stock [Member] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 17,000 | 17,000 |
Preferred Stock, Shares Issued | 1,694 | 1,694 |
Preferred Stock, Shares Outstanding | 1,694 | 1,694 |
Preferred Stock, Redemption Amount | $ 1,694 | $ 1,694 |
Series B Convertible Preferred Stock [Member] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 11,500,000 | 11,500,000 |
Preferred Stock, Shares Issued | 7,378,241 | 7,946,673 |
Preferred Stock, Shares Outstanding | 7,378,241 | 7,946,673 |
Preferred Stock, Redemption Amount | $ 35,047 | $ 35,047 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Revenues | $ 0 | $ 0 | $ 0 |
Costs and expenses | |||
Research and development | 71,615 | 26,941 | 15,470 |
General and administrative | 21,262 | 26,698 | 12,390 |
Total costs and expenses | 92,877 | 53,639 | 27,860 |
Loss from operations | (92,877) | (53,639) | (27,860) |
Other income | |||
Interest income | 813 | 745 | 200 |
Net Loss | (92,064) | (52,894) | (27,660) |
Deemed dividend related to beneficial conversion feature of convertible preferred stock | 0 | (49,454) | 0 |
Net Loss Attributable to Common Stockholders | $ (92,064) | $ (102,348) | $ (27,660) |
Net Loss Per Common Share, Basic and Diluted | $ (1.41) | $ (1.85) | $ (0.62) |
Weighted-Average Common Shares Outstanding, Basic and Diluted | 65,242 | 55,268 | 44,410 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Net Loss | $ (92,064) | $ (52,894) | $ (27,660) |
Other comprehensive income: | |||
Unrealized (loss) gain on short-term investments | (29) | (19) | 48 |
Comprehensive Loss | $ (92,093) | $ (52,913) | $ (27,612) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-InCapital [Member] | Accumulated other Comprehensive Income [Member] | Accumulated Deficit [Member] | Series A Convertible Preferred stock [Member] | Series B Convertible Preferred stock [Member] |
Beginning Balance at Dec. 31, 2014 | $ 44,845 | $ 2 | $ 121,405 | $ 0 | $ (76,562) | $ 0 | $ 0 |
Beginning Balance (in Shares) at Dec. 31, 2014 | 33,750,188 | 5,694 | 0 | ||||
Stock-based compensation expense | 6,752 | 6,752 | |||||
Common stock issued upon exercise of warrants | 9,705 | 9,705 | |||||
Common stock issued upon exercise of warrants (in Shares) | 3,880,210 | ||||||
Common stock issued upon exercise of stock options | 255 | 255 | |||||
Common stock issued upon exercise of stock options (in shares) | 42,387 | ||||||
Conversion of convertible preferred stock into common stock | 0 | ||||||
Conversion of convertible preferred stock into common stock (in Shares) | 2,000,000 | (4,000) | |||||
Common stock issued for services | 1,771 | 1,771 | |||||
Common stock issued for services (in shares) | 15,000 | ||||||
Common stock sold in public offering, net of offering costs | 68,307 | 68,307 | |||||
Common stock sold in public offering, net of offering costs (in shares) | 9,200,000 | ||||||
Cancellation of restricted shares | 0 | $ 0 | |||||
Cancellation of restricted shares (in Shares) | (340,065) | ||||||
Unrealized (loss) gain on short-term investments | 48 | 48 | |||||
Net loss | (27,660) | (27,660) | |||||
Ending Balance at Dec. 31, 2015 | 104,023 | $ 2 | 208,195 | 48 | (104,222) | $ 0 | $ 0 |
Ending Balance (in Shares) at Dec. 31, 2015 | 48,547,720 | 1,694 | 0 | ||||
Stock-based compensation expense | 18,904 | 18,904 | |||||
Tax payments related to shares witheld for vested restricted stock awards | (642) | (642) | |||||
Common stock issued upon exercise of warrants | 1,235 | $ 0 | 1,235 | ||||
Common stock issued upon exercise of warrants (in Shares) | 592,132 | ||||||
Common stock issued upon exercise of stock options | 626 | 626 | |||||
Common stock issued upon exercise of stock options (in shares) | 100,480 | ||||||
Conversion of convertible preferred stock into common stock | 0 | 3 | $ (3) | ||||
Conversion of convertible preferred stock into common stock (in Shares) | 3,421,960 | (3,421,960) | |||||
Common stock sold in private placement, net of offering costs | 44,009 | $ 1 | 44,008 | ||||
Common stock sold in private placement, net of offering costs (in shares) | 9,684,000 | ||||||
Preferred stock sold in private placement, net of offering costs | 51,676 | 51,665 | $ 11 | ||||
Preferred stock sold in private placement, net of offering costs (in shares) | 11,368,633 | ||||||
Cancellation of restricted shares | 0 | $ 0 | |||||
Cancellation of restricted shares (in Shares) | (98,218) | ||||||
Beneficial conversion feature of preferred stock | (49,454) | (49,454) | |||||
Deemed dividend on beneficial conversion feature of preferred stock | 49,454 | 49,454 | |||||
Unrealized (loss) gain on short-term investments | (19) | (19) | |||||
Net loss | (52,894) | (52,894) | |||||
Ending Balance at Dec. 31, 2016 | 166,918 | $ 3 | 323,994 | 29 | (157,116) | $ 0 | $ 8 |
Ending Balance (in Shares) at Dec. 31, 2016 | 62,248,074 | 1,694 | 7,946,673 | ||||
Stock-based compensation expense | 11,968 | 11,968 | |||||
Tax payments related to shares witheld for vested restricted stock awards | (1,252) | $ 0 | (1,252) | ||||
Common stock issued upon exercise of warrants | 662 | $ 0 | 662 | ||||
Common stock issued upon exercise of warrants (in Shares) | 265,000 | ||||||
Common stock issued upon exercise of stock options | 5,616 | $ 0 | 5,616 | ||||
Common stock issued upon exercise of stock options (in shares) | 1,011,284 | ||||||
Conversion of convertible preferred stock into common stock | 0 | 1 | $ (1) | ||||
Conversion of convertible preferred stock into common stock (in Shares) | 568,432 | (568,432) | |||||
Common stock sold in public offering, net of offering costs | 53,662 | $ 0 | 53,662 | ||||
Common stock sold in public offering, net of offering costs (in shares) | 8,846,154 | ||||||
Vesting of restricted shares issued for services | 0 | $ 0 | 0 | ||||
Vesting of restricted shares issued for services (in shares) | 225,970 | ||||||
Unrealized (loss) gain on short-term investments | (29) | (29) | |||||
Net loss | (92,064) | (92,064) | |||||
Ending Balance at Dec. 31, 2017 | $ 145,481 | $ 3 | $ 394,651 | $ 0 | $ (249,180) | $ 0 | $ 7 |
Ending Balance (in Shares) at Dec. 31, 2017 | 73,164,914 | 1,694 | 7,378,241 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash Flows From Operating Activities | |||
Net loss | $ (92,064) | $ (52,894) | $ (27,660) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 952 | 978 | 999 |
Amortization of discount (premium) on investments | 19 | (74) | 0 |
Stock-based compensation expense | 11,968 | 18,904 | 8,523 |
Changes in assets and liabilities: | |||
Prepaid expenses and other assets | (875) | (2,765) | (211) |
Accounts payable | 369 | (250) | (290) |
Accrued expenses | 4,555 | 3,433 | 258 |
Other assets | (3,633) | 0 | 0 |
Net cash used in operating activities | (78,709) | (32,668) | (18,381) |
Cash Flows From Investing Activities | |||
Purchase of short- term investments | 0 | (110,249) | (140,665) |
Maturities of short- term investments | 59,705 | 120,664 | 70,600 |
Purchase of property and equipment | (1,028) | (1,521) | (1,143) |
Net cash provided by (used in) investing activities | 58,677 | 8,894 | (71,208) |
Cash Flows From Financing Activities | |||
Tax payments related to shares withheld for vested restricted stock | (1,252) | (642) | 0 |
Proceeds from the issuance of common stock upon exercise of warrants | 662 | 1,235 | 9,705 |
Proceeds from the issuance of common stock upon exercise of options | 5,616 | 626 | 255 |
Proceeds from the issuance of preferred stock and common stock, net | 53,662 | 95,685 | 68,307 |
Net cash provided by financing activities | 58,688 | 96,904 | 78,267 |
Net increase (decrease) in cash and cash equivalents | 38,656 | 73,130 | (11,322) |
Cash and Cash Equivalents, Beginning of Period | 106,717 | 33,587 | 44,909 |
Cash and Cash Equivalents, End of Period | 145,373 | 106,717 | 33,587 |
Supplemental Disclosures of Cash Flow Information: | |||
Cash paid for income taxes | 0 | 0 | 0 |
Interest paid | 0 | 0 | 0 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Unrealized (loss) gain on short-term investments | (29) | (19) | 48 |
Acquisitions of property and equipment under accounts payable | 0 | 155 | 0 |
Deemed dividend related to a beneficial conversion feature | 0 | 49,454 | 0 |
Conversion of convertible preferred stock to common stock | $ 1 | $ 3 | $ 0 |
GENERAL ORGANIZATION, BUSINESS
GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY | NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY General Organization and Business Iovance Biotherapeutics, Inc. (the “Company”) is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. The Company’s lead program is an adoptive cell therapy (“ACT”) utilizing tumor-infiltrating lymphocytes (“TIL”), which are T cells derived from patients’ tumors, for the treatment of metastatic melanoma. The TIL are extracted from the tumor tissue, expanded in the Company’s manufacturing suites and then infused back into the patient to fight their cancer. On June 1, 2017, the Company reincorporated from Nevada to Delaware. On June 27, 2017, the Company changed its corporate name from Lion Biotechnologies, Inc. to Iovance Biotherapeutics, Inc. Liquidity The Company is currently engaged in the development of therapeutics to fight cancer, specifically solid tumors. The Company does not have any commercial products and has not yet generated any revenues from its business. The Company currently does not anticipate that it will generate any revenues during the 12 months from the date these financial statements are issued, from the sale or licensing of any of its product candidates. The Company has incurred a net loss of $ 92.1 78.7 145.4 15,000,000 11.50 1,956,521 172.5 161.7 The Company expects to further increase its research and development activities, which will increase the amount of cash used during 2018 and beyond. Specifically, the Company expects continued spending on clinical trials, continued and expansion of manufacturing activities, higher payroll expenses as the Company increases its professional and scientific staff and research and development activities. Based on the funds the Company has available as of the date these financial statements are issued, which includes the net proceeds of approximately $161.7 million raised in connection with the Company’s January 2018 public offering, the Company believes that it has sufficient capital to fund its anticipated operating expenses for at least 24 months from the date these financial statements are issued. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES All highly liquid investments with an original maturity date of three months or less when purchased that are readily convertible into cash and have an insignificant interest rate risk are considered to be cash equivalents. The Company's short-term investments are classified as “available-for-sale”. The Company includes these investments in current assets and carries them at fair value. Unrealized gains and losses on available-for-sale securities are included in accumulated other comprehensive income (loss). The amortized cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest income. Gains and losses on securities sold are recorded based on the specific identification method and are included in interest income in the statement of operations. The Company has not incurred any realized gains or losses from sales of securities to date. Management assesses whether declines in the fair value of short-term investments are other than temporary. If the decline is judged to be other than temporary, the cost basis of the individual security is written down to fair value and the amount of the write down is included in the statement of operations within other expense, net. In determining whether a decline is other than temporary, management considers various factors including the length of time and the extent to which the market value has been less than cost, the financial condition and near-term prospects of the issuer and the Company's intent and ability to retain its investment in the issuer for a period of time sufficient to allow for any anticipated recovery in market value. To date, the Company has not recorded any impairment charges on short-term investments related to other-than-temporary declines in market value. At December 31, 2017, the Company did not have any short-term investments. At December 31, 2016, the Company’s short-term investments were invested in short-term fixed income debt securities and notes of domestic and foreign high credit issuers and in money market funds. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. Property and equipment is stated at cost, net of accumulated depreciation and amortization. The cost of property and equipment is depreciated or amortized on the straight-line method over the following estimated useful lives: Computer equipment 2 years Office furniture and equipment 5 years Lab equipment 2-5 years Leasehold improvements Lesser of the remaining life of the asset or the lease-term Expenditures for maintenance and repairs are charged to operations as incurred while renewals and betterments are capitalized. Gains and losses on disposals are included within operating expenses in the statements of operations. Management assesses the carrying value of property and equipment whenever events or changes in circumstances indicate that the carrying value may not be recoverable. If there is indication of impairment, management prepares an estimate of future cash flows expected to result from the use of the asset and its eventual disposition. If these cash flows are less than the carrying amount of the asset, an impairment loss is recognized to write down the asset to its estimated fair value. For the years ended December 31, 2017, 2016 and 2015, the Company did not recognize any impairments for its property and equipment. Cash and cash equivalents and short-term investments are carried at fair value. As of December 31, 2017 and 2016, the Company had no liabilities measured at fair value. Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period increased to include the number of additional shares of common stock that would have been outstanding if the potentially dilutive securities had been issued. As of December 31, 2017 2016 2015 Stock options 6,072,368 6,233,150 2,693,237 Warrants 6,301,216 6,566,216 7,202,216 Series A Convertible Preferred* 847,000 847,000 847,000 Series B Convertible Preferred* 7,378,241 7,946,673 - Restricted stock awards - 7,084 321,252 Restricted stock units 114,582 550,000 - 20,713,407 22,150,123 11,063,705 * on an as-converted basis Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, fair value is defined as the price at which an asset could be exchanged, or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied. Assets and liabilities recorded at fair value in the Company’s financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows: Level 1Inputs are unadjusted, quoted prices in active markets for identical assets at the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2Are inputs, other than quoted prices included in Level 1, that are either directly or indirectly observable for the asset or liability through correlation with market data at the reporting date and for the duration of the instrument’s anticipated life. The fair valued assets the Company holds that are generally assessed under Level 2 are corporate bonds and commercial paper. The Company utilizes third party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. The Company uses quotes from external pricing service providers and other on-line quotation systems to verify the fair value of investments provided by its third-party pricing service providers. The Company reviews independent auditor’s reports from its third-party pricing service providers particularly regarding the controls over pricing and valuation of financial instruments and ensure that its internal controls address certain control deficiencies, if any, and complementary user entity controls are in place. Level 3Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities and which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the reporting date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. The Company does not have fair valued assets classified under Level 3. As of December 31, 2017, the Company had no financial assets measured at fair value on a recurring basis. Assets at Fair Value as of December 31, 2016 Level 1 Level 2 Level 3 Total Commercial paper $ - $ 29,178 $ - $ 29,178 Corporate debt securities - 26,578 - 26,578 US Government agency securities - 3,997 - 3,997 Total $ - $ 59,753 $ - $ 59,753 The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include valuation of short-term investments, the useful lives of property and equipment, accounting for potential liabilities, the valuation allowance associated with the Company’s deferred tax assets, and the assumptions made in valuing stock instruments issued for services. The accompanying consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiary, Iovance Biotherapeutics GmbH (formerly Lion Biotechnologies GmbH). All intercompany accounts and transactions have been eliminated. The U.S. dollar is the functional currency for all the Company's consolidated operations. The Company periodically grants stock options and warrants to employees and non-employees in non-capital raising transactions as compensation for services rendered. The Company accounts for stock option grants to employees based on the authoritative guidance provided by the FASB where the value of the award is measured on the date of grant and recognized over the vesting period. The Company accounts for stock option grants to non-employees in accordance with the authoritative guidance of the FASB where the value of the stock compensation is determined based upon the measurement date at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Non-employee stock-based compensation charges generally are amortized over the vesting period on a straight-line basis. In certain circumstances where there are no future performance requirements by the non-employee, option grants are immediately vested, and the total stock-based compensation charge is recorded in the period of the measurement date. The fair value of the Company's common stock option grants is estimated using a Black-Scholes option pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the common stock options, and future dividends. Compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model, and based on actual experience. The assumptions used in the Black-Scholes option pricing model could materially affect compensation expense recorded in future periods. During the years ended December 31, 2016 and 2015, the Company estimated forfeitures at the time of grant and revised those estimates in subsequent periods if actual forfeitures differed from those estimates. Effective January 1, 2017, the Company adopted ASU 2016-09 and elected to recognize forfeitures when they occur using a modified retrospective approach, which did not have a material impact on its consolidated financial statements. The Company has in the past issued restricted shares of its common stock for share-based compensation programs. The Company measures the compensation cost with respect to restricted shares issued to employees based upon the estimated fair value of the equity instruments at the date of the grant, which is recognized as an expense over the period during which an employee is required to provide services in exchange for the award. The fair value of restricted stock units is based on the closing price of the Company’s common stock on the grant date. Years Ended December 31, 2017 2016 2015 Research and development $ 5,270 $ 3,267 $ 2,248 General and administrative 6,698 15,637 6,275 Total stock-based compensation expense $ 11,968 $ 18,904 $ 8,523 Years Ended December 31, 2017 2016 2015 Stock option expense $ 10,862 $ 16,453 $ 6,752 Restricted stock award expense 34 989 1,771 Restricted stock unit expense 1,072 1,462 - Total stock-based compensation expense $ 11,968 $ 18,904 $ 8,523 Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services. Research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability. Clinical development costs are a significant component of research and development expenses. The Company has a history of contracting with third parties that perform various clinical trial activities on its behalf in connection with the ongoing development of its product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. The Company accrues and expenses costs for clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with contract research organizations and clinical trial sites. The Company determines its estimates through discussions with internal clinical personnel and outside service providers as to the progress or stage of completion of trials or services and the agreed upon fee to be paid for such services. General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, accounting, legal, investor relations, facilities, business development and human resources functions. Other significant costs include facility costs not otherwise included in research and development expenses, sublicense royalty expenses, legal fees relating to corporate matters, insurance, public company expenses relating to maintaining compliance with Nasdaq listing rules and Securities and Exchange Commission (“SEC”) requirements, insurance and investor relations costs, and fees for accounting and consulting services. General and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers, and adjusting its accruals as actual costs become known. The Company accounts for income taxes using the asset and liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. ASC Topic 740-10-30 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740-10-40 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company will classify as income tax expense any interest and penalties. The Company has no material uncertain tax positions for any of the reporting periods presented. Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents. The Company maintains cash balances at two financial institutions. At times, the amounts on deposit exceed the federally insured limits. Management believes that the financial institutions which hold the Company’s cash are financially sound and, accordingly, minimal credit risk exists. As of December 31, 2017 and 2016, respectively, the Company’s cash balances were in excess of insured limits maintained at the financial institutions. The Company applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity. The Company applies the accounting standards for derivatives and hedging and for distinguishing liabilities from equity when accounting for hybrid contracts that feature conversion options. The accounting standards require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (i) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. Conversion options that contain variable settlement features such as provisions to adjust the conversion price upon subsequent issuances of equity or equity linked securities at exercise prices more favorable than that featured in the hybrid contract generally result in their bifurcation from the host instrument. The Company also records, when necessary, deemed dividends for the intrinsic value of the conversion options embedded in preferred stock based upon the difference between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred stock. Recent Accounting Standards In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), The Company operates in one segment, focused on developing and commercializing ACT using autologous TIL for the treatment of metastatic melanoma and other solid cancers. Management evaluates events that have occurred after the balance sheet date but before the financial statements are issued. Based upon the review, management did not identify any recognized or non-recognized subsequent events which would have required an adjustment or disclosure in the financial statements, except as described in Note 15. Certain amounts within the balance sheets and statements of operations and stockholders’ equity for the prior periods have been reclassified to conform with the current period presentation. These reclassifications had no impact on the Company's previously reported financial position or cash flows for any of the periods presented. |
CASH AND CASH EQUIVALENTS, AND
CASH AND CASH EQUIVALENTS, AND SHORT-TERM INVESTMENTS | 12 Months Ended |
Dec. 31, 2017 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
CASH AND CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | NOTE 3. CASH AND CASH EQUIVALENTS, AND SHORT-TERM INVESTMENTS December 31, December 31, 2017 2016 Cash - Demand deposits $ 54,092 $ 76,071 Cash equivalents - Money market funds 91,281 30,646 Cash and cash equivalents total $ 145,373 $ 106,717 December 31, December 31, 2017 2016 Commercial paper $ - $ 29,178 Corporate debt securities - 26,578 US Government agency securities - 3,997 Short-term investments total $ - $ 59,753 Gross Gross Unrealized Unrealized As of December 31, 2017 Cost Gains Losses Fair Value Money market funds $ 91,281 $ - $ - $ 91,281 Gross Gross Unrealized Unrealized As of December 31, 2016 Cost Gains Losses Fair Value Money market funds $ 30,646 $ - $ - $ 30,646 Commercial paper 29,118 60 - 29,178 Corporate debt securities 26,606 1 (29) 26,578 US Government agency securities 4,000 - (3) 3,997 Total $ 90,370 $ 61 $ (32) $ 90,399 Unrealized gains and losses are included in accumulated other comprehensive income. |
BALANCE SHEET COMPONENTS
BALANCE SHEET COMPONENTS | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BALANCE SHEET COMPONENTS | NOTE 4. BALANCE SHEET COMPONENTS December 31, December 31, 2017 2016 Lab equipment $ 3,207 $ 2,405 Leasehold improvements 1,726 1,381 Computer equipment 349 245 Office furniture and equipment 188 148 Construction in progress 13 276 Total Property and equipment, cost 5,483 4,455 Less: Accumulated depreciation and amortization (3,033) (2,081) Property and equipment, net $ 2,450 $ 2,374 Depreciation expense for the years ended December 31, 2017, 2016 and 2015 was $ 1.0 1.0 1.0 December 31, December 31, 2017 2016 Accrued payroll and employee related expenses $ 2,613 $ 1,581 Legal and related services 935 927 Clinical related 3,310 614 Manufacturing related 876 437 Deferred rent 430 422 Accrued other 496 124 $ 8,660 $ 4,105 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2017 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 5. STOCKHOLDERS’ EQUITY Preferred stock The Company’s certificate of incorporation authorizes the issuance of up to 50,000,000 17,000 11,500,000 Series A Convertible Preferred Stock A total of 17,000 1,000 2.00 The Series A Preferred Stock may, at the option of each investor, be converted into fully paid and non-assessable shares of the Company’s common stock. The holders of shares of Series A Preferred Stock do not have the right to vote on matters that come before the Company’s stockholders. In the event of any dissolution or winding up of the Company, proceeds shall be paid pari passu among the holders of the Company’s common stock and preferred stock, pro rata based on the number of shares held by each holder. The Company may not declare, pay or set aside any dividends on shares of capital stock of the Company (other than dividends on shares of common stock payable in shares of common stock) unless the holders of the Series A Preferred Stock shall first receive an equal dividend on each outstanding share of Series A Preferred Stock. During the year ended December 31, 2017, no shares of Series A Preferred Stock were converted into shares of common stock. During the years ended December 31, 2016 and 2015, 4,000 11,306 2,000,000 5,653,000 500 Series B Preferred Stock A total of 11,500,000 4.75 4.75 Holders of Series B Preferred Stock are entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of the Series A Preferred Stock or the Company’s common stock. So long as any Series B Preferred Stock remains outstanding, the Company may not redeem, purchase or otherwise acquire any material amount of the Series A Preferred Stock or any securities junior to the Series B Preferred Stock. During the year ended December 31, 2017 568,432 568,432 3,421,960 3,421,960 7,378,241 2016 Private Placement On June 2, 2016, the Company entered into a securities purchase agreement with various institutional and individual accredited investors to raise gross proceeds of $ 100 9,684,000 11,368,633 4.75 4.75 The Company has also evaluated its convertible preferred stock in accordance with the provisions of ASC 815, Derivatives and Hedging, including consideration of embedded derivatives requiring bifurcation. The issuance of the convertible preferred stock could generate a beneficial conversion feature (“BCF”), which arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor or in the money at inception because the conversion option has an effective strike price that is less than the market price of the underlying stock at the commitment date. The Company recognized the BCF by allocating the intrinsic value of the conversion option, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, to additional paid-in capital, resulting in a discount on the convertible preferred stock. As the convertible preferred stock may be converted immediately, the Company recognized a BCF of $ 49.5 The Company received net proceeds of approximately $ 95.7 Public Offering On September 25, 2017, the Company sold 8,846,154 6.50 53.7 Warrants Weighted Weighted Average Aggregate Shares Average Remaining Intrinsic Under Exercise Contractual Value Warrants Price Life (in thousands) Outstanding at January 1, 2015 11,084,426 $ 2.51 Issued - - Exercised (3,882,210) 2.50 Expired/Cancelled - - Outstanding at December 31, 2015 7,202,216 $ 2.51 Issued - - Exercised (592,132) 2.50 Expired/Cancelled (43,868) 2.50 Outstanding at December 31, 2016 6,566,216 $ 2.51 Issued - - Exercised (265,000) 2.50 Expired/Cancelled - - Outstanding at December 31, 2017 6,301,216 $ 2.51 0.8 years $ 34,651 |
STOCK BASED COMPENSATION
STOCK BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
STOCK BASED COMPENSATION | NOTE 6. STOCK BASED COMPENSATION Stock Plans As of October 14, 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). Employees, directors, consultants and advisors of the Company are eligible to participate in the 2011 Plan. The 2011 Plan initially had 180,000 1,700,000 an amendment to increase the number options or other awards that can be granted to any one person during a twelve (12) month period from 50,000 shares to 300,000 shares 1,900,000 725,267 On September 19, 2014, the Company’s Board of Directors (the “Board”) adopted the Iovance Biotherapeutics, Inc. 2014 Equity Incentive Plan (the “2014 Plan”). The 2014 Plan was approved by the Company’s stockholders at the Company’s 2014 Annual Meeting of Stockholders held in November 2014. The 2014 Plan, as approved by the stockholders, authorized the issuance up to an aggregate of 2,350,000 4,000,000 On August 16, 2016, the Company’s stockholders approved an increase in the total number of shares that can be issued under the 2014 Plan to 9,000,000 2,516,992 Restricted Stock Units On June 1, 2016, the Company entered into a restricted stock unit agreement with the Company’s new Chief Executive Officer, Maria Fardis, Ph.D., pursuant to which the Company granted Dr. Fardis 550,000 5.87 137,500 275,000 137,500 36 Stock-based compensation expense for restricted stock units (“RSUs”) is measured based on the closing fair market value of the Company's common stock on the date of grant. As of December 31, 2017, $ 0.7 During the years ended December 31, 2017 and 2016, the Company recognized $ 1.1 1.5 Stock Options Weighted Weighted Average Aggregate Number Average Remaining Intrinsic of Exercise Contractual Value Options Price Life (in thousands) Outstanding at January 1, 2015 1,857,877 $ 7.31 Granted 1,171,984 8.12 Exercised (42,387) - Expired/Forfeited (294,237) 2.88 Outstanding at December 31, 2015 2,693,237 $ 8.12 Granted 4,407,983 6.86 Exercised (100,480) 6.23 Expired/Forfeited (767,590) 8.12 Outstanding at December 31, 2016 6,233,150 $ 7.24 Granted 2,188,800 6.68 Exercised (1,011,284) 5.55 Expired/Forfeited (1,338,298) 6.79 Outstanding at December 31, 2017 6,072,368 $ 7.42 7.9 years $ 6,199 Exercisable at December 31, 2017 2,769,205 $ 7.96 6.4 years $ 2,457 Exercisable at December 31, 2016 2,496,695 $ 7.35 4.1 years $ 1,839 The total pre-tax intrinsic value of stock options exercised during the year ended December 31, 2017, 2016 and 2015 was $ 2.6 0.2 0.0 The weighted average grant date fair value for employee options granted under the Company's stock option plans during the year ended December 31, 2017, 2016 and 2015 was $ 6.58 6.78 8.77 As of December 31, 2017, $ 19.5 1.9 Years Ended December 31, 2017 2016 2015 Expected dividend yield 0% 0% 0% Risk-free interest rate 2.34 % - 1.72% 2.16 % - 1.18% 1.56% Expected term (in years) 6.50 - 5.13 6.50 - 5.07 6.00 Expected volatility 209.69% - 190.46% 213.60% - 189.40% 218.00% - 207.00% Expected Dividend Yield Risk-Free Interest Rate Expected Term Expected Volatility Forfeiture Rate Each of the inputs discussed above is subjective and generally requires significant management judgment. During the years ended December 31, 2017, 2016 and 2015, the Company recorded compensation costs of $ 10.9 16.5 6.8 Options Outstanding Exercisable Range of Exercise Prices Number of Weighted Average Weighted Average Aggregate Number of Weighted Average Weighted Average Aggregate $5.05 - $5.86 959,200 8.16 $ 5.32 $ 390,000 6.31 $ 5.43 $5.87 - $6.58 932,550 7.90 6.02 421,712 6.77 6.08 $6.59 - $7.43 897,500 7.51 6.99 323,790 4.25 6.94 $7.44 - $7.57 1,358,166 8.91 7.52 434,370 8.67 7.54 $7.58 - $9.00 864,286 7.37 7.83 401,273 5.50 7.81 $9.01 - $117 1,060,666 6.90 10.46 798,060 6.33 10.90 6,072,368 7.86 $ 7.42 $ 6,199 2,769,205 6.40 $ 7.96 $ 2,457 Restricted Common Stock Awards Weighted Average Number Grant Date of Shares Fair Value Non-vested shares, January 1, 2015 782,500 $ 7.04 Granted 15,000 8.44 Vested (284,748) 4.31 Forfeited (191,500) 6.81 Non-vested shares, December 31, 2015 321,252 $ 6.96 Granted - - Vested (274,167) 6.90 Forfeited (40,001) 7.02 Non-vested shares, December 31, 2016 7,084 $ 6.48 Granted - - Vested (7,084) (6.48) Forfeited - - Non-vested shares, December 31, 2017 - $ - During the years ended December 31, 2017, 2016 and 2015, the Company recorded compensation costs of $ 0.0 1.0 1.8 |
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2017 | |
Compensation and Retirement Disclosure [Abstract] | |
Compensation and Employee Benefit Plans | NOTE.7 EMPLOYEE BENEFIT PLAN The Company maintains a defined contribution plan covering substantially all U.S. employees under Section 401(k) of the Internal Revenue Code of 1986, as amended (the “IRC”). The Company's matching contribution to the plan was $ 0.3 0.1 0.0 |
SEPARATION AGREEMENTS
SEPARATION AGREEMENTS | 12 Months Ended |
Dec. 31, 2017 | |
Restructuring and Related Activities [Abstract] | |
Separation Agreements Disclosure | NOTE 8. SEPARATION AGREEMENTS In June 2016, the Company entered into a separation agreement with Dr. Elma Hawkins, its former Chief Executive Officer. Under the terms of the agreement, Dr. Hawkins vesting was accelerated on certain outstanding options and she was entitled to receive a severance payment of approximately $ 0.5 5.0 In July 2016, Molly Henderson, the former Chief Financial Officer provided the Board with written notice under her Employment Agreement, dated June 5, 2015, that she would terminate her employment with the Company for “good reason” effective August 16, 2016. In connection with this event all unvested options were accelerated and she received a severance payment of approximately $ 0.4 4.5 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 9. INCOME TAXES As of December 31, 2017 2016 Deferred income tax asset: Net operating loss carry forward $ 33,300 $ 23,912 Stock-based compensation 4,568 9,562 Tax credit carryforwards 9,323 8,167 Reserves and accruals 733 139 Deferred tax asssets before valuation allowance 47,924 41,780 Less: valuation allowance (47,849) (41,402) Net deferred income tax assets 75 378 Deferred tax liabilities: Depreciation and amortization (75) (378) Net deferred tax assets (liabilities) $ - $ - Years ended December 31, 2017 2016 2015 Federal statutory tax rate (34) % (34) % (34) % Orphan Drug &; Research credits 0 (8) (12) Permanent and other differences 4 4 10 Tax rate change 23 - - State tax, net of federal benefit - (4) (5) (7) % (42) % (41) % Valuation allowance 7 % 42 % 41 % Effective tax rate - % - % - % Years ended December 31, 2017 2016 2015 Federal: Current $ - $ - $ - Deferred (7,391) (19,050) (9,724) State and Local Current - - - Deferred 944 (3,007) (1,887) Change in Valuation Allowance 6,447 22,057 11,611 Total income tax expense (benefit) $ - $ - $ - The Company had net operating loss carryovers (“NOLs”) for federal and state income tax purposes of approximately $143.3 million and $66.3 million, respectively, as of December 31, 2017. The federal NOLs will expire beginning in 2027 through 2037. The state NOLs will expire if unused in years 2030 through 2037 The Company’s utilization of NOLs is subject to an annual limitation due to ownership changes that have occurred previously or that could occur in the future as provided in Section 382 of the IRC (“Section 382”), as well as similar state provisions. Section 382 limits the utilization of NOLs when there is a greater than 50% change of ownership as determined under the regulations. Since its formation, the Company has raised capital through the issuance of capital stock and various convertible instruments which, combined with the purchasing shareholders’ subsequent disposition of these shares, has resulted in an ownership change as defined by Section 382, and could result in an ownership change in the future upon subsequent disposition. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (“Tax Act”) was signed into law making significant changes to the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 35% to 21% effective for tax years beginning after December 31, 2017, the transition of U.S international taxation from a worldwide tax system to a territorial system, and a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings as of December 31, 2017. The Company has calculated its 2017 year-end income tax provision with its best estimate of the impact of the Act in accordance with its understanding of the Act and guidance available as of the date of this filing. The tax rate decrease resulted in a reduction of $20.8 million in the Company’s deferred tax assets, and a corresponding decrease of the same amount in the valuation allowance against these deferred tax assets. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon future generation for taxable income during the periods in which temporary differences representing net future deductible amounts become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. After consideration of all the information available, management believes that significant uncertainty exists with respect to future realization of the deferred tax assets and has therefore established a full valuation allowance. For the years ended December 31, 2017, 2016 and 2015, the change in the valuation allowance was approximately $6.4 million, $22.1 million and $11.6 million, respectively. The Company evaluated the provisions of ASC 740 related to the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements. ASC 740 prescribes a comprehensive model for how a company should recognize, present, and disclose uncertain positions that the company has taken or expects to take in its tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. Differences between tax positions taken or expected to be taken in a tax return and the net benefit recognized and measured pursuant to the interpretation are referred to as “unrecognized benefits.” A liability is recognized (or amount of net operating loss carry forward or amount of tax refundable is reduced) for unrecognized tax benefit because it represents an enterprise’s potential future obligation to the taxing authority for a tax position that was not recognized as a result of applying the provisions of ASC 740. If applicable, interest costs related to the unrecognized tax benefits are required to be calculated and would be classified as “Other Income (Expense)” in the consolidated statement of operations. Penalties would be recognized as a component of “General and Administrative Expenses” in the consolidated statement of operations. A reconciliation of the beginning and ending balances of the unrecognized tax benefits during the years ended December 31, 2017, 2016 and 2015 is as follows (in thousands): Years ended December 31, 2017 2016 2015 Unrecognized benefitbeginning of period $ - $ - $ - Gross decreasesprior period tax positions 2,780 - - Gross increasescurrent period tax positions 1,331 - - Unrecognized benefitend of period $ 4,111 $ - $ - No interest or penalties on unpaid tax were recorded during the years ended December 31, 2017, 2016 and 2015, respectively. The Company does not anticipate any significant changes within 12 months of this reporting date of its uncertain tax positions. The Company files tax returns in the U.S. federal and state jurisdictions. The tax years beginning with the year ended December 31, 2007 remain open to examination by tax authorities to the extent of the utilization of net operating losses and credit carryovers. The Company is not currently under examination by income tax authorities in federal, state or other foreign jurisdictions. |
LICENSES AND AGREEMENTS
LICENSES AND AGREEMENTS | 12 Months Ended |
Dec. 31, 2017 | |
Licenses And Agreements [Abstract] | |
LICENSES AND AGREEMENTS | NOTE 10. LICENSES AND AGREEMENTS National Institutes of Health (NIH) and the National Cancer Institute (NCI) Cooperative Research and Development Agreement (CRADA) In August 2011, the Company signed a five-year Cooperative Research and Development Agreement (“CRADA”) with the National Cancer Institute (NCI”) to work with Dr. Steven Rosenberg on developing adoptive cell immunotherapies that are designed to destroy metastatic melanoma cells using a patient’s tumor infiltrating lymphocytes. In January 2015, the Company executed an amendment to the CRADA (the “Amendment”) to include four new indications. As amended, in addition to metastatic melanoma, the CRADA included the development of TIL therapy for the treatment of patients with bladder, lung, triple-negative breast, and Human Papilloma Virus (“HPV”)-associated cancers. In August 2016, the NCI and the Company entered into a second amendment to the CRADA (the “Second Amendment”). The principal changes effected by the Second Amendment included (i) extending the term of the CRADA by another five years to August 2021, and (ii) modifying the focus on the development of unmodified TIL as a stand-alone therapy or in combination with U.S. Food and Drug Administration (“FDA”) licensed products and commercially available reagents routinely used for adoptive cell therapy. The parties will continue the development of improved methods for the generation and selection of TIL with anti-tumor reactivity in metastatic melanoma, bladder, lung, breast, and HPV-associated cancers. Pursuant to the terms of the CRADA, the Company is currently required to make quarterly payments of $ 0.5 2.0 1.8 2.0 Patent License Agreement Related to the Development and Manufacture of TIL Effective October 5, 2011, the Company entered into a patent license agreement (the “Patent License Agreement”) with the National Institutes of Health, an agency of the United States Public Health Service within the Department of Health and Human Services (“NIH”), which was subsequently amended on February 9, 2015 and October 2, 2015. Pursuant to the Patent License Agreement, as amended, the NIH granted the Company licenses, including exclusive, co-exclusive, and non-exclusive licenses, to certain technologies relating to autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma, lung, breast, bladder and HPV-positive cancers. The Patent License Agreement requires the Company to pay royalties based on a percentage of net sales (which percentage is in the mid-single digits), a percentage of revenues from sublicensing arrangements, and lump sum benchmark royalty payments on the achievement of certain clinical and regulatory milestones for each of the various indications and other direct costs incurred by the NIH pursuant to the agreement. Exclusive Patent License Agreement Related to TIL Selection On February 10, 2015, the Company entered into an exclusive patent license agreement (the “Exclusive Patent License Agreement”) with the NIH under which the Company received an exclusive license to the NIH’s rights to patent-pending technologies related to methods for improving adoptive cell therapy through more potent and efficient production of TIL from melanoma tumors by selecting for T-cell populations that express various inhibitory receptors. Unless terminated sooner, the license shall remain in effect until the last licensed patent right expires. In consideration for the exclusive rights granted under the Exclusive Patent License Agreement, the Company paid the NIH a non-refundable upfront licensing fee in the amount of $ 0.8 During the year ended December 31, 2017, the costs associated with the NIH patent licenses were immaterial. During the years ended December 31, 2016 and 2015, the Company recorded $ 0.4 0.4 H. Lee Moffitt Cancer Center Research Collaboration and Clinical Grant Agreements with Moffitt In September 2014, the Company entered into a research collaboration agreement with the H. Lee Moffitt Cancer Center (“Moffitt”) to jointly engage in translational research and development of adoptive tumor-infiltrating lymphocyte cell therapy with improved anti-tumor properties and process. In December 2016, the Company entered into a new three-year Sponsored Research Agreement with Moffitt (the “Moffitt SRA”). At the same time, the Company entered into a clinical grant agreement with Moffitt to support an ongoing clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with metastatic melanoma. In June 2017, the Company entered into a second clinical grant agreement with Moffitt to support a new clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with non-small cell lung cancer. In the years ended December 31, 2017, 2016 and 2015, the Company recorded research and development costs of $ 1.2 0.7 0.7 Exclusive License Agreement with Moffitt The Company entered into a license agreement with Moffitt (the “Moffitt License”), effective as of June 28, 2014, under which the Company received a world-wide license to Moffitt’s rights to patent-pending technologies related to methods for improving TIL for adoptive cell therapy. Unless earlier terminated, the term of the license extends until the earlier of the expiration of the last issued patent related to the licensed technology or 20 Pursuant to the Moffitt License, the Company paid an upfront licensing fee in the amount of $ 0.1 PolyBioCept and Karolinska University Hospital PolyBioCept Exclusive and Co-Exclusive License Agreement On September 14, 2016, the Company entered into an exclusive and co-exclusive license agreement (the “PolyBioCept Agreement”) with PolyBioCept AB, a corporation organized under the laws of Sweden (“PolyBioCept”). PolyBioCept has filed two patent applications with claims related to a cytokine cocktail for use in expansion of lymphocytes, one of which has been abandoned. Under the PolyBioCept Agreement, the Company received the exclusive right and license to PolyBioCept’s intellectual property to develop, manufacture, market and genetically engineer TIL produced by expansion, selection and enrichment using a proprietary cytokine cocktail. The Company also received a co-exclusive license (with PolyBioCept) to develop, manufacture and market genetically engineered TIL under the same intellectual property. The licenses are for the use in all cancers and are worldwide in scope, with the exception that the uses in melanoma are not included for certain countries of the former Soviet Union. The Company paid PolyBioCept a total of $ 2.5 If all of the foregoing product development, regulatory approval and sales milestone payments are met, the Company will have to pay PolyBioCept an additional $ 8.7 2,219,376 0.2 0.1 0.2 30 0.2 2.7 2.5 Karolinska University Hospital and Karolinska Institute Agreements In connection with the execution of the PolyBioCept Agreement, the Company also (i) entered into a clinical trials agreement with the Karolinska University Hospital to conduct clinical trials in glioblastoma and pancreatic cancer at the Karolinska University Hospital, and (ii) agreed to enter into a sponsored research agreement with the Karolinska Institute for the research of the cytokine cocktail in additional indications. The Company agreed to enter into the sponsored research agreement within 90 days after the date of the PolyBioCept Agreement, which date has been extended by amendments to the PolyBioCept Agreement. Failure to enter into the sponsored research agreement or further amend the PolyBioCept Agreement will give PolyBioCept the right to terminate the PolyBioCept Agreement, while the Company will have the right to recoup $ 2.2 2.6 1.6 1.6 0.3 0.1 M.D. Anderson Cancer Center Strategic Alliance Agreement On April 17, 2017, the Company entered into a Strategic Alliance Agreement (the “SAA”) with M.D. Anderson Cancer Center (“M.D. Anderson”) under which the Company and M.D. Anderson agreed to conduct clinical and preclinical research studies. The Company agreed in the SAA to provide total funding not to exceed approximately $ 14.2 1.4 MedImmune In December 2015, the Company entered into a collaboration agreement (the “MedImmune Agreement”) with MedImmune, the global biologics research and development arm of AstraZeneca (“MedImmune”), to conduct clinical and preclinical research immuno-oncology. Under the MedImmune Agreement, the Company will fund and conduct at least one clinical trial combining MedImmune's PD-L1 inhibitor, durvalumab, with TIL for the treatment of patients. MedImmune will supply durvalumab for the clinical trials. The purpose of the studies is to establish a dosing regimen for this combination therapy and assess its safety and efficacy. WuXi Apptech, Inc. (“WuXi”) In November 2016, the Company entered into that a three-year manufacturing and services agreement with WuXi pursuant to which WuXi agreed to provide manufacturing and other services. Under the agreement, the Company entered into two statements of work for two cGMP manufacturing suites to be established and operated by WuXi for Lion, one of which is expected to be capable of being used for the commercial manufacture of our products. The fee payable under the first statement of work for the use of one of the manufacturing suites during the first year of the agreement, including the fees for the necessary personnel, is $ 2.5 5.85 13.9 2.4 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 11. COMMITMENTS AND CONTINGENCIES Facilities Leases Tampa Lease In December 2014, the Company commenced a five-year non-cancellable operating lease with the University of South Florida Research Foundation for a 5,115 In April 2015, the Company amended the original lease agreement to increase the rentable space to 6,043 8,673 20,000 San Carlos Lease On August 4, 2016, the Company entered into an agreement to lease 8,733 54 38,000 On April 28, 2017, the Company entered into a sublease agreement with Teradata US, Inc., pursuant to which the Company agreed to sublease certain office space located adjacent to the Company's headquarters for approximately $ 26,000 11,449 New York Lease The Company leased office space in New York for a monthly rental of approximately $ 18,000 9,000 The Company recognizes rental expense on the facilities on a straight-line basis over the lease term. Differences between the straight-line rent expense and rent payments are classified as deferred rent liability on the balance sheet. As of December 31, 2017, the Company's future minimum lease payments under non-cancelable operating leases are as follows (in thousands): Year Operating 2018 $ 1,023 2019 700 2020 495 2021 169 $ 2,387 Rent expense for the years ended December 31, 2017, 2016 and 2015 was $ 1.0 0.7 0.3 |
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS | 12 Months Ended |
Dec. 31, 2017 | |
Loss Contingency [Abstract] | |
LEGAL PROCEEDINGS | NOTE 12. LEGAL PROCEEDINGS Class Action Lawsuit and Derivative Lawsuit In the Matter of Certain Stock Promotion Leonard DeSilvio v. Lion Biotechnologies, Inc., et al., case no: 3:17cv2086 (Amra Kuc vs. Lion Biotechnologies, Inc., et al., case no: 3:17cv2086 In the Matter of Certain Stock Promotions Kuc Kuc Jay Rabkin v. Lion Biotechnologies, Inc., et al., In the Matter of Certain Stock Promotions On December 15, 2017, a purported shareholder derivative complaint, Kevin Fong v. Manish Singh, et al. In the Matter of Certain Stock Promotions The Company intends to vigorously defend against the foregoing complaints. Based on the very early stage of the litigation, it is not possible to estimate the amount or range of possible loss that might result from an adverse judgment or a settlement of these matters. Solomon Capital LLC. Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Lion Biotechnologies, Inc. 0.1 0.2 0.2 111,425 1.5 On June 3, 2016, the Company filed an answer and counterclaims in the lawsuit. In its counterclaims, the Company alleges that the plaintiffs misrepresented their qualifications to assist it in fundraising and that they failed to disclose that they were under investigation for securities laws violations. The Company is seeking damages in an amount exceeding $ 0.5 On April 19, 2017, the Court granted plaintiffs’ counsel’s motion to withdraw from the case. On May 25, 2017, the plaintiffs filed a notice that they had hired new counsel. On June 7, 2017, the judge presiding over the case recused herself because of a conflict of interest arising from her relationship with plaintiffs’ new attorneys. The case has been assigned to a new judge, and briefing on a motion to dismiss has occurred, with oral argument on the motion to dismiss scheduled for April 20, 2018. The Company intends to vigorously defend the complaint and pursue its counterclaims. Litigation Involving Dr. Steven Fischkoff Steven Fischkoff v. Lion Biotechnologies, Inc. and Maria Fardis 0.3 150,000 The Company intends to vigorously defend against Dr. Fischkoff’s lawsuit and pursue the Company’s counterclaims. Based on the very early stage of the litigation, it is not possible to estimate the amount or range of (i) a possible loss that might result from an adverse judgment or settlement of this action, or (ii) the potential recovery that might result from a favorable judgment or a settlement of this action. Other Matters. 128,500 128,500 128,500 The Company may be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. The Company accrues amounts, to the extent they can be reasonably estimated, that it believes are adequate to address any liabilities related to legal proceedings and other loss contingencies that the Company believes will result in a probable loss. While there can be no assurances as to the ultimate outcome of any legal proceeding or other loss contingency involving the Company, management does not believe any pending matter will be resolved in a manner that would have a material adverse effect on the Company’s financial position, results of operations or cash flows. Regardless of outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. |
QUARTERLY UNAUDITED RESULTS
QUARTERLY UNAUDITED RESULTS | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
QUARTERLY UNAUDITED RESULTS | NOTE 13. QUARTERLY UNAUDITED RESULTS 2017 2016 (in thousands, except per share information) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Revenue $ - $ - $ - $ - $ - $ - $ - $ - Net loss attributable to common stockholders $ (20,684) $ (23,377) $ (22,149) $ (25,854) $ (6,884) $ (11,563) $ (68,212) $ (15,689) Net loss per share, basic and diluted $ (0.33) $ (0.37) $ (0.35) $ (0.36) $ (0.14) $ (0.23) $ (1.15) $ (0.25) Weighted average shares used in computing net loss per share, basic and diluted 62,286 62,457 63,332 72,794 48,548 51,082 59,113 62,130 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 14. RELATED PARTY TRANSACTIONS Sanford J. Hillsberg, one of the Company’s directors, is an attorney at TroyGould PC. TroyGould PC rendered and continues to render legal services to the Company. The Company paid TroyGould PC $ 0.7 0.8 0.7 0.1 0.1 On September 14, 2017, the Company entered into a three-year consulting agreement with Iain Dukes, D. Phil, the Chairman of the Board. As compensation for his consulting services, the Company granted Dr. Dukes a stock option to purchase up to 150,000 7.30 The granted stock options vest in 12 quarterly installments (with 1/12th of the option shares having vested on the date of grant). 0.2 |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 15. SUBSEQUENT EVENT In January 2018, the Company announced the closing of its underwritten public offering of 15,000,000 shares of the Company’s common stock at a public offering price of $11.50 per share, before underwriting discounts, which included 1,956,521 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by the Company, are $172.5 million, with estimated net proceeds to the Company of approximately $161.7 million. |
SUMMARY OF SIGNIFICANT ACCOUN23
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Cash and Cash Equivalents | Cash and Cash Equivalents All highly liquid investments with an original maturity date of three months or less when purchased that are readily convertible into cash and have an insignificant interest rate risk are considered to be cash equivalents. |
Short-term Investments | Short-term Investments The Company's short-term investments are classified as “available-for-sale”. The Company includes these investments in current assets and carries them at fair value. Unrealized gains and losses on available-for-sale securities are included in accumulated other comprehensive income (loss). The amortized cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest income. Gains and losses on securities sold are recorded based on the specific identification method and are included in interest income in the statement of operations. The Company has not incurred any realized gains or losses from sales of securities to date. Management assesses whether declines in the fair value of short-term investments are other than temporary. If the decline is judged to be other than temporary, the cost basis of the individual security is written down to fair value and the amount of the write down is included in the statement of operations within other expense, net. In determining whether a decline is other than temporary, management considers various factors including the length of time and the extent to which the market value has been less than cost, the financial condition and near-term prospects of the issuer and the Company's intent and ability to retain its investment in the issuer for a period of time sufficient to allow for any anticipated recovery in market value. To date, the Company has not recorded any impairment charges on short-term investments related to other-than-temporary declines in market value. At December 31, 2017, the Company did not have any short-term investments. At December 31, 2016, the Company’s short-term investments were invested in short-term fixed income debt securities and notes of domestic and foreign high credit issuers and in money market funds. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. |
Property and Equipment, net | Property and Equipment, net Property and equipment is stated at cost, net of accumulated depreciation and amortization. The cost of property and equipment is depreciated or amortized on the straight-line method over the following estimated useful lives: Computer equipment 2 years Office furniture and equipment 5 years Lab equipment 2-5 years Leasehold improvements Lesser of the remaining life of the asset or the lease-term Expenditures for maintenance and repairs are charged to operations as incurred while renewals and betterments are capitalized. Gains and losses on disposals are included within operating expenses in the statements of operations. Management assesses the carrying value of property and equipment whenever events or changes in circumstances indicate that the carrying value may not be recoverable. If there is indication of impairment, management prepares an estimate of future cash flows expected to result from the use of the asset and its eventual disposition. If these cash flows are less than the carrying amount of the asset, an impairment loss is recognized to write down the asset to its estimated fair value. For the years ended December 31, 2017, 2016 and 2015, the Company did not recognize any impairments for its property and equipment. |
Fair value of financial instruments | Fair value of financial instruments Cash and cash equivalents and short-term investments are carried at fair value. As of December 31, 2017 and 2016, the Company had no liabilities measured at fair value. |
Loss per Share | Loss per Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period increased to include the number of additional shares of common stock that would have been outstanding if the potentially dilutive securities had been issued. As of December 31, 2017 2016 2015 Stock options 6,072,368 6,233,150 2,693,237 Warrants 6,301,216 6,566,216 7,202,216 Series A Convertible Preferred* 847,000 847,000 847,000 Series B Convertible Preferred* 7,378,241 7,946,673 - Restricted stock awards - 7,084 321,252 Restricted stock units 114,582 550,000 - 20,713,407 22,150,123 11,063,705 * on an as-converted basis |
Fair Value Measurements | Fair Value Measurements Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, fair value is defined as the price at which an asset could be exchanged, or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied. Assets and liabilities recorded at fair value in the Company’s financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows: Level 1Inputs are unadjusted, quoted prices in active markets for identical assets at the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2Are inputs, other than quoted prices included in Level 1, that are either directly or indirectly observable for the asset or liability through correlation with market data at the reporting date and for the duration of the instrument’s anticipated life. The fair valued assets the Company holds that are generally assessed under Level 2 are corporate bonds and commercial paper. The Company utilizes third party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. The Company uses quotes from external pricing service providers and other on-line quotation systems to verify the fair value of investments provided by its third-party pricing service providers. The Company reviews independent auditor’s reports from its third-party pricing service providers particularly regarding the controls over pricing and valuation of financial instruments and ensure that its internal controls address certain control deficiencies, if any, and complementary user entity controls are in place. Level 3Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities and which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the reporting date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. The Company does not have fair valued assets classified under Level 3. As of December 31, 2017, the Company had no financial assets measured at fair value on a recurring basis. Assets at Fair Value as of December 31, 2016 Level 1 Level 2 Level 3 Total Commercial paper $ - $ 29,178 $ - $ 29,178 Corporate debt securities - 26,578 - 26,578 US Government agency securities - 3,997 - 3,997 Total $ - $ 59,753 $ - $ 59,753 |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include valuation of short-term investments, the useful lives of property and equipment, accounting for potential liabilities, the valuation allowance associated with the Company’s deferred tax assets, and the assumptions made in valuing stock instruments issued for services. |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiary, Iovance Biotherapeutics GmbH (formerly Lion Biotechnologies GmbH). All intercompany accounts and transactions have been eliminated. The U.S. dollar is the functional currency for all the Company's consolidated operations. |
Stock-Based Compensation | Stock-Based Compensation The Company periodically grants stock options and warrants to employees and non-employees in non-capital raising transactions as compensation for services rendered. The Company accounts for stock option grants to employees based on the authoritative guidance provided by the FASB where the value of the award is measured on the date of grant and recognized over the vesting period. The Company accounts for stock option grants to non-employees in accordance with the authoritative guidance of the FASB where the value of the stock compensation is determined based upon the measurement date at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Non-employee stock-based compensation charges generally are amortized over the vesting period on a straight-line basis. In certain circumstances where there are no future performance requirements by the non-employee, option grants are immediately vested, and the total stock-based compensation charge is recorded in the period of the measurement date. The fair value of the Company's common stock option grants is estimated using a Black-Scholes option pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the common stock options, and future dividends. Compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model, and based on actual experience. The assumptions used in the Black-Scholes option pricing model could materially affect compensation expense recorded in future periods. During the years ended December 31, 2016 and 2015, the Company estimated forfeitures at the time of grant and revised those estimates in subsequent periods if actual forfeitures differed from those estimates. Effective January 1, 2017, the Company adopted ASU 2016-09 and elected to recognize forfeitures when they occur using a modified retrospective approach, which did not have a material impact on its consolidated financial statements. The Company has in the past issued restricted shares of its common stock for share-based compensation programs. The Company measures the compensation cost with respect to restricted shares issued to employees based upon the estimated fair value of the equity instruments at the date of the grant, which is recognized as an expense over the period during which an employee is required to provide services in exchange for the award. The fair value of restricted stock units is based on the closing price of the Company’s common stock on the grant date. Years Ended December 31, 2017 2016 2015 Research and development $ 5,270 $ 3,267 $ 2,248 General and administrative 6,698 15,637 6,275 Total stock-based compensation expense $ 11,968 $ 18,904 $ 8,523 Years Ended December 31, 2017 2016 2015 Stock option expense $ 10,862 $ 16,453 $ 6,752 Restricted stock award expense 34 989 1,771 Restricted stock unit expense 1,072 1,462 - Total stock-based compensation expense $ 11,968 $ 18,904 $ 8,523 |
Research and Development Expenses | Research and Development Expenses Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services. Research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability. Clinical development costs are a significant component of research and development expenses. The Company has a history of contracting with third parties that perform various clinical trial activities on its behalf in connection with the ongoing development of its product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. The Company accrues and expenses costs for clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with contract research organizations and clinical trial sites. The Company determines its estimates through discussions with internal clinical personnel and outside service providers as to the progress or stage of completion of trials or services and the agreed upon fee to be paid for such services. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, accounting, legal, investor relations, facilities, business development and human resources functions. Other significant costs include facility costs not otherwise included in research and development expenses, sublicense royalty expenses, legal fees relating to corporate matters, insurance, public company expenses relating to maintaining compliance with Nasdaq listing rules and Securities and Exchange Commission (“SEC”) requirements, insurance and investor relations costs, and fees for accounting and consulting services. General and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers, and adjusting its accruals as actual costs become known. |
Income taxes | Income taxes The Company accounts for income taxes using the asset and liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. ASC Topic 740-10-30 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740-10-40 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company will classify as income tax expense any interest and penalties. The Company has no material uncertain tax positions for any of the reporting periods presented. |
Concentrations | Concentrations Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents. The Company maintains cash balances at two financial institutions. At times, the amounts on deposit exceed the federally insured limits. Management believes that the financial institutions which hold the Company’s cash are financially sound and, accordingly, minimal credit risk exists. As of December 31, 2017 and 2016, respectively, the Company’s cash balances were in excess of insured limits maintained at the financial institutions. |
Preferred Stock | Preferred Stock The Company applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity. |
Convertible Instruments | Convertible Instruments The Company applies the accounting standards for derivatives and hedging and for distinguishing liabilities from equity when accounting for hybrid contracts that feature conversion options. The accounting standards require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (i) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. Conversion options that contain variable settlement features such as provisions to adjust the conversion price upon subsequent issuances of equity or equity linked securities at exercise prices more favorable than that featured in the hybrid contract generally result in their bifurcation from the host instrument. The Company also records, when necessary, deemed dividends for the intrinsic value of the conversion options embedded in preferred stock based upon the difference between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred stock. |
Recent Accounting Standards | Recent Accounting Standards In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), |
Segment reporting | Segment reporting The Company operates in one segment, focused on developing and commercializing ACT using autologous TIL for the treatment of metastatic melanoma and other solid cancers. |
Subsequent Events | Subsequent Events Management evaluates events that have occurred after the balance sheet date but before the financial statements are issued. Based upon the review, management did not identify any recognized or non-recognized subsequent events which would have required an adjustment or disclosure in the financial statements, except as described in Note 15. |
Reclassifications | Reclassifications Certain amounts within the balance sheets and statements of operations and stockholders’ equity for the prior periods have been reclassified to conform with the current period presentation. These reclassifications had no impact on the Company's previously reported financial position or cash flows for any of the periods presented. |
SUMMARY OF SIGNIFICANT ACCOUN24
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | At December 31, 2017, 2016 and 2015, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive. As of December 31, 2017 2016 2015 Stock options 6,072,368 6,233,150 2,693,237 Warrants 6,301,216 6,566,216 7,202,216 Series A Convertible Preferred* 847,000 847,000 847,000 Series B Convertible Preferred* 7,378,241 7,946,673 - Restricted stock awards - 7,084 321,252 Restricted stock units 114,582 550,000 - 20,713,407 22,150,123 11,063,705 * on an as-converted basis |
Schedule of Assets Measured at Fair Value | As of December 31, 2016, financial assets measured at fair value on a recurring basis are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands): Assets at Fair Value as of December 31, 2016 Level 1 Level 2 Level 3 Total Commercial paper $ - $ 29,178 $ - $ 29,178 Corporate debt securities - 26,578 - 26,578 US Government agency securities - 3,997 - 3,997 Total $ - $ 59,753 $ - $ 59,753 |
Schedule of Stock-Based Compensation | Total stock-based compensation expense related to all of the Company’s stock-based awards was recorded on the statements of operations as follows (in thousands): Years Ended December 31, 2017 2016 2015 Research and development $ 5,270 $ 3,267 $ 2,248 General and administrative 6,698 15,637 6,275 Total stock-based compensation expense $ 11,968 $ 18,904 $ 8,523 |
Schedule of Compensation Cost for Share-based Payment Arrangements, Allocation of Share-based Compensation Costs by Plan | Total stock-based compensation broken down based on each individual instrument was as follows (in thousands): Years Ended December 31, 2017 2016 2015 Stock option expense $ 10,862 $ 16,453 $ 6,752 Restricted stock award expense 34 989 1,771 Restricted stock unit expense 1,072 1,462 - Total stock-based compensation expense $ 11,968 $ 18,904 $ 8,523 |
CASH AND CASH EQUIVALENTS, AN25
CASH AND CASH EQUIVALENTS, AND SHORT-TERM INVESTMENTS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Schedule of Cash, Money Market Funds and Short-Term Investments | Cash and cash equivalents, and short-term investments consist of the following (in thousands): December 31, December 31, 2017 2016 Cash - Demand deposits $ 54,092 $ 76,071 Cash equivalents - Money market funds 91,281 30,646 Cash and cash equivalents total $ 145,373 $ 106,717 December 31, December 31, 2017 2016 Commercial paper $ - $ 29,178 Corporate debt securities - 26,578 US Government agency securities - 3,997 Short-term investments total $ - $ 59,753 |
Schedule of Unrealized Gains and Losses | Money market funds and short-term investments include the following securities with gross unrealized gains and losses (in thousands): Gross Gross Unrealized Unrealized As of December 31, 2017 Cost Gains Losses Fair Value Money market funds $ 91,281 $ - $ - $ 91,281 Gross Gross Unrealized Unrealized As of December 31, 2016 Cost Gains Losses Fair Value Money market funds $ 30,646 $ - $ - $ 30,646 Commercial paper 29,118 60 - 29,178 Corporate debt securities 26,606 1 (29) 26,578 US Government agency securities 4,000 - (3) 3,997 Total $ 90,370 $ 61 $ (32) $ 90,399 |
BALANCE SHEET COMPONENTS (Table
BALANCE SHEET COMPONENTS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property and equipment, net consists of the following (in thousands): December 31, December 31, 2017 2016 Lab equipment $ 3,207 $ 2,405 Leasehold improvements 1,726 1,381 Computer equipment 349 245 Office furniture and equipment 188 148 Construction in progress 13 276 Total Property and equipment, cost 5,483 4,455 Less: Accumulated depreciation and amortization (3,033) (2,081) Property and equipment, net $ 2,450 $ 2,374 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): December 31, December 31, 2017 2016 Accrued payroll and employee related expenses $ 2,613 $ 1,581 Legal and related services 935 927 Clinical related 3,310 614 Manufacturing related 876 437 Deferred rent 430 422 Accrued other 496 124 $ 8,660 $ 4,105 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | A summary of the status of stock warrants at December 31, 2017, and the changes during the three years then ended, is presented in the following table: Weighted Weighted Average Aggregate Shares Average Remaining Intrinsic Under Exercise Contractual Value Warrants Price Life (in thousands) Outstanding at January 1, 2015 11,084,426 $ 2.51 Issued - - Exercised (3,882,210) 2.50 Expired/Cancelled - - Outstanding at December 31, 2015 7,202,216 $ 2.51 Issued - - Exercised (592,132) 2.50 Expired/Cancelled (43,868) 2.50 Outstanding at December 31, 2016 6,566,216 $ 2.51 Issued - - Exercised (265,000) 2.50 Expired/Cancelled - - Outstanding at December 31, 2017 6,301,216 $ 2.51 0.8 years $ 34,651 |
STOCK BASED COMPENSATION (Table
STOCK BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Status of Stock Options | A summary of the status of stock options at December 31, 2017, and the changes during the three years then ended, is presented in the following table: Weighted Weighted Average Aggregate Number Average Remaining Intrinsic of Exercise Contractual Value Options Price Life (in thousands) Outstanding at January 1, 2015 1,857,877 $ 7.31 Granted 1,171,984 8.12 Exercised (42,387) - Expired/Forfeited (294,237) 2.88 Outstanding at December 31, 2015 2,693,237 $ 8.12 Granted 4,407,983 6.86 Exercised (100,480) 6.23 Expired/Forfeited (767,590) 8.12 Outstanding at December 31, 2016 6,233,150 $ 7.24 Granted 2,188,800 6.68 Exercised (1,011,284) 5.55 Expired/Forfeited (1,338,298) 6.79 Outstanding at December 31, 2017 6,072,368 $ 7.42 7.9 years $ 6,199 Exercisable at December 31, 2017 2,769,205 $ 7.96 6.4 years $ 2,457 Exercisable at December 31, 2016 2,496,695 $ 7.35 4.1 years $ 1,839 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The following table summarizes the assumptions relating to options granted pursuant to the Company’s equity incentive plans for the years ended December 31, 2017, 2016 and 2015: Years Ended December 31, 2017 2016 2015 Expected dividend yield 0% 0% 0% Risk-free interest rate 2.34 % - 1.72% 2.16 % - 1.18% 1.56% Expected term (in years) 6.50 - 5.13 6.50 - 5.07 6.00 Expected volatility 209.69% - 190.46% 213.60% - 189.40% 218.00% - 207.00% |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding and Exercisable | A summary of outstanding, exercisable and vested stock options as of December 31, 2017 is as follows (in thousands, except per share amounts): Options Outstanding Exercisable Range of Exercise Prices Number of Weighted Average Weighted Average Aggregate Number of Weighted Average Weighted Average Aggregate $5.05 - $5.86 959,200 8.16 $ 5.32 $ 390,000 6.31 $ 5.43 $5.87 - $6.58 932,550 7.90 6.02 421,712 6.77 6.08 $6.59 - $7.43 897,500 7.51 6.99 323,790 4.25 6.94 $7.44 - $7.57 1,358,166 8.91 7.52 434,370 8.67 7.54 $7.58 - $9.00 864,286 7.37 7.83 401,273 5.50 7.81 $9.01 - $117 1,060,666 6.90 10.46 798,060 6.33 10.90 6,072,368 7.86 $ 7.42 $ 6,199 2,769,205 6.40 $ 7.96 $ 2,457 |
Schedule of Nonvested Restricted Stock Units Activity | The following table summarizes restricted common stock awards activity: Weighted Average Number Grant Date of Shares Fair Value Non-vested shares, January 1, 2015 782,500 $ 7.04 Granted 15,000 8.44 Vested (284,748) 4.31 Forfeited (191,500) 6.81 Non-vested shares, December 31, 2015 321,252 $ 6.96 Granted - - Vested (274,167) 6.90 Forfeited (40,001) 7.02 Non-vested shares, December 31, 2016 7,084 $ 6.48 Granted - - Vested (7,084) (6.48) Forfeited - - Non-vested shares, December 31, 2017 - $ - |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | As of December 31, 2017 2016 Deferred income tax asset: Net operating loss carry forward $ 33,300 $ 23,912 Stock-based compensation 4,568 9,562 Tax credit carryforwards 9,323 8,167 Reserves and accruals 733 139 Deferred tax asssets before valuation allowance 47,924 41,780 Less: valuation allowance (47,849) (41,402) Net deferred income tax assets 75 378 Deferred tax liabilities: Depreciation and amortization (75) (378) Net deferred tax assets (liabilities) $ - $ - |
Schedule of Effective Income Tax Rate Reconciliation | Years ended December 31, 2017 2016 2015 Federal statutory tax rate (34) % (34) % (34) % Orphan Drug &; Research credits 0 (8) (12) Permanent and other differences 4 4 10 Tax rate change 23 - - State tax, net of federal benefit - (4) (5) (7) % (42) % (41) % Valuation allowance 7 % 42 % 41 % Effective tax rate - % - % - % |
Schedule of Components of Income Tax Expense (Benefit) | Years ended December 31, 2017 2016 2015 Federal: Current $ - $ - $ - Deferred (7,391) (19,050) (9,724) State and Local Current - - - Deferred 944 (3,007) (1,887) Change in Valuation Allowance 6,447 22,057 11,611 Total income tax expense (benefit) $ - $ - $ - |
Schedule of Unrecognized Tax Benefits | A reconciliation of the beginning and ending balances of the unrecognized tax benefits during the years ended December 31, 2017, 2016 and 2015 is as follows (in thousands): Years ended December 31, 2017 2016 2015 Unrecognized benefitbeginning of period $ - $ - $ - Gross decreasesprior period tax positions 2,780 - - Gross increasescurrent period tax positions 1,331 - - Unrecognized benefitend of period $ 4,111 $ - $ - |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | As of December 31, 2017, the Company's future minimum lease payments under non-cancelable operating leases are as follows (in thousands): Year Operating 2018 $ 1,023 2019 700 2020 495 2021 169 $ 2,387 |
QUARTERLY UNAUDITED RESULTS (Ta
QUARTERLY UNAUDITED RESULTS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information | The results of operations by quarter for the years ended December 31, 2017 and 2016 are as follow: 2017 2016 (in thousands, except per share information) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Revenue $ - $ - $ - $ - $ - $ - $ - $ - Net loss attributable to common stockholders $ (20,684) $ (23,377) $ (22,149) $ (25,854) $ (6,884) $ (11,563) $ (68,212) $ (15,689) Net loss per share, basic and diluted $ (0.33) $ (0.37) $ (0.35) $ (0.36) $ (0.14) $ (0.23) $ (1.15) $ (0.25) Weighted average shares used in computing net loss per share, basic and diluted 62,286 62,457 63,332 72,794 48,548 51,082 59,113 62,130 |
GENERAL ORGANIZATION, BUSINES32
GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||
Jan. 31, 2018 | Sep. 25, 2017 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Net Income (Loss) Attributable to Parent, Total | $ (25,854) | $ (22,149) | $ (23,377) | $ (20,684) | $ (15,689) | $ (68,212) | $ (11,563) | $ (6,884) | $ (92,064) | $ (52,894) | $ (27,660) | |||
Cash and Cash Equivalents, at Carrying Value | $ 145,373 | $ 106,717 | 145,373 | 106,717 | 33,587 | $ 44,909 | ||||||||
Stock Issued During Period, Shares, New Issues | 8,846,154 | |||||||||||||
Proceeds from Issuance of Common Stock | $ 53,700 | 53,662 | 95,685 | 68,307 | ||||||||||
Shares Issued, Price Per Share | $ 6.50 | |||||||||||||
Stock Issued During Period, Value, New Issues | 53,662 | 68,307 | ||||||||||||
Net Cash Provided by (Used in) Operating Activities | $ (78,709) | $ (32,668) | $ (18,381) | |||||||||||
IPO [Member] | Subsequent Event [Member] | Underwriting Options [Member] | ||||||||||||||
Stock Issued During Period, Shares, New Issues | 15,000,000 | |||||||||||||
Proceeds from Issuance of Common Stock | $ 161,700 | |||||||||||||
Shares Issued, Price Per Share | $ 11.50 | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 1,956,521 | |||||||||||||
Stock Issued During Period, Value, New Issues | $ 172,500 |
SUMMARY OF SIGNIFICANT ACCOUN33
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES (Details) - shares | 12 Months Ended | |||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 20,713,407 | 22,150,123 | 11,063,705 | |
Employee Stock Option [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 6,072,368 | 6,233,150 | 2,693,237 | |
Warrant [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 6,301,216 | 6,566,216 | 7,202,216 | |
Restricted Stock Awards [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 0 | 7,084 | 321,252 | |
Restricted Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 114,582 | 550,000 | 0 | |
Series A Preferred Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | [1] | 847,000 | 847,000 | 847,000 |
Series B Preferred Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | [1] | 7,378,241 | 7,946,673 | 0 |
[1] | on an as-converted basis |
SUMMARY OF SIGNIFICANT ACCOUN34
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES (Details 1) $ in Thousands | Dec. 31, 2016USD ($) |
Assets, Fair Value Disclosure, Total | $ 59,753 |
Corporate Debt Securities [Member] | |
Assets, Fair Value Disclosure, Total | 26,578 |
US Government agency securities [Member] | |
Assets, Fair Value Disclosure, Total | 3,997 |
Fair Value, Inputs, Level 1 [Member] | |
Assets, Fair Value Disclosure, Total | 0 |
Fair Value, Inputs, Level 1 [Member] | Corporate Debt Securities [Member] | |
Assets, Fair Value Disclosure, Total | 0 |
Fair Value, Inputs, Level 1 [Member] | US Government agency securities [Member] | |
Assets, Fair Value Disclosure, Total | 0 |
Fair Value, Inputs, Level 2 [Member] | |
Assets, Fair Value Disclosure, Total | 59,753 |
Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member] | |
Assets, Fair Value Disclosure, Total | 26,578 |
Fair Value, Inputs, Level 2 [Member] | US Government agency securities [Member] | |
Assets, Fair Value Disclosure, Total | 3,997 |
Fair Value, Inputs, Level 3 [Member] | |
Assets, Fair Value Disclosure, Total | 0 |
Fair Value, Inputs, Level 3 [Member] | Corporate Debt Securities [Member] | |
Assets, Fair Value Disclosure, Total | 0 |
Fair Value, Inputs, Level 3 [Member] | US Government agency securities [Member] | |
Assets, Fair Value Disclosure, Total | 0 |
Commercial paper [Member] | |
Assets, Fair Value Disclosure, Total | 29,178 |
Commercial paper [Member] | Fair Value, Inputs, Level 1 [Member] | |
Assets, Fair Value Disclosure, Total | 0 |
Commercial paper [Member] | Fair Value, Inputs, Level 2 [Member] | |
Assets, Fair Value Disclosure, Total | 29,178 |
Commercial paper [Member] | Fair Value, Inputs, Level 3 [Member] | |
Assets, Fair Value Disclosure, Total | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN35
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES (Details 2) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | $ 11,968 | $ 18,904 | $ 8,523 |
Research and Development Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | 5,270 | 3,267 | 2,248 |
General and Administrative Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | $ 6,698 | $ 15,637 | $ 6,275 |
SUMMARY OF SIGNIFICANT ACCOUN36
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES (Details 3) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | $ 11,968 | $ 18,904 | $ 8,523 |
Employee Stock Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | 10,862 | 16,453 | 6,752 |
Restricted Stock Awards [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | 34 | 989 | 1,771 |
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | $ 1,072 | $ 1,462 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN37
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES (Details Textual) | 12 Months Ended |
Dec. 31, 2017 | |
Computer Equipment [Member] | |
Property, Plant and Equipment, Useful Life | 2 years |
Office Furniture and Equipment [Member] | |
Property, Plant and Equipment, Useful Life | 5 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment, Estimated Useful Lives | Lesser of the remaining life of the asset or the lease-term |
Maximum [Member] | Lab Equipment [Member] | |
Property, Plant and Equipment, Useful Life | 5 years |
Minimum [Member] | Lab Equipment [Member] | |
Property, Plant and Equipment, Useful Life | 2 years |
CASH AND CASH EQUIVALENTS, AN38
CASH AND CASH EQUIVALENTS, AND SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Cash and Cash Equivalents, at Carrying Value | $ 145,373 | $ 106,717 | $ 33,587 | $ 44,909 |
Available-for-sale Securities | 0 | 59,753 | ||
Commercial Paper [Member] | ||||
Available-for-sale Securities | 0 | 29,178 | ||
Corporate Debt Securities [Member] | ||||
Available-for-sale Securities | 0 | 26,578 | ||
US Government Debt Securities [Member] | ||||
Available-for-sale Securities | 0 | 3,997 | ||
Demand Deposits [Member] | ||||
Cash and Cash Equivalents, at Carrying Value | 54,092 | 76,071 | ||
Money Market Funds [Member] | ||||
Cash and Cash Equivalents, at Carrying Value | $ 91,281 | $ 30,646 |
CASH AND CASH EQUIVALENTS, AN39
CASH AND CASH EQUIVALENTS, AND SHORT-TERM INVESTMENTS (Details 1) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Amortized Cost | $ 90,370 | |
Gross Unrealized Gains | 61 | |
Gross Unrealized Losses | (32) | |
Fair Value | 90,399 | |
Corporate Debt Securities [Member] | ||
Amortized Cost | 26,606 | |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (29) | |
Fair Value | 26,578 | |
Commercial Paper [Member] | ||
Amortized Cost | 29,118 | |
Gross Unrealized Gains | 60 | |
Gross Unrealized Losses | 0 | |
Fair Value | 29,178 | |
US Government Debt Securities [Member] | ||
Amortized Cost | 4,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (3) | |
Fair Value | 3,997 | |
Money Market Funds [Member] | ||
Amortized Cost | $ 91,281 | 30,646 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 91,281 | $ 30,646 |
BALANCE SHEET COMPONENTS (Detai
BALANCE SHEET COMPONENTS (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Total Property and equipment, cost | $ 5,483 | $ 4,455 |
Less: Accumulated depreciation and amortization | (3,033) | (2,081) |
Property and equipment, net | 2,450 | 2,374 |
Lab Equipment [Member] | ||
Total Property and equipment, cost | 3,207 | 2,405 |
Computer Equipment [Member] | ||
Total Property and equipment, cost | 349 | 245 |
Office Furniture and Equipment [Member] | ||
Total Property and equipment, cost | 188 | 148 |
Leasehold Improvements [Member] | ||
Total Property and equipment, cost | 1,726 | 1,381 |
Construction in Progress [Member] | ||
Total Property and equipment, cost | $ 13 | $ 276 |
BALANCE SHEET COMPONENTS (Det41
BALANCE SHEET COMPONENTS (Details 1) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Accrued payroll and employee related expenses | $ 2,613 | $ 1,581 |
Legal and related services | 935 | 927 |
Clinical related | 3,310 | 614 |
Manufacturing related | 876 | 437 |
Deferred rent | 430 | 422 |
Accrued other | 496 | 124 |
Accrued liabilities | $ 8,660 | $ 4,105 |
BALANCE SHEET COMPONENTS (Det42
BALANCE SHEET COMPONENTS (Details Textual) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Depreciation, Total | $ 1 | $ 1 | $ 1 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Shares Under Warrants | |||
Outstanding, beginning balance | |||
Outstanding, ending balance | 6,072,368 | ||
Weighted Average Exercise Price | |||
Outstanding, beginning balance | |||
Outstanding, ending balance | $ 7.42 | ||
Weighted Average Remaining Contractual Life | |||
Outstanding | 7 years 10 months 10 days | ||
Aggregate Intrinsic Value | |||
Outstanding, ending balance | $ 6,199 | ||
Warrant [Member] | |||
Shares Under Warrants | |||
Outstanding, beginning balance | 6,566,216 | 7,202,216 | 11,084,426 |
Issued | 0 | 0 | 0 |
Exercised | (265,000) | (592,132) | (3,882,210) |
Expired/Cancelled | 0 | (43,868) | 0 |
Outstanding, ending balance | 6,301,216 | 6,566,216 | 7,202,216 |
Weighted Average Exercise Price | |||
Outstanding, beginning balance | $ 2.51 | $ 2.51 | $ 2.51 |
Granted | 0 | 0 | 0 |
Exercised | 2.5 | 2.50 | 2.50 |
Expired/Cancelled | 0 | 2.50 | 0 |
Outstanding, ending balance | $ 2.51 | $ 2.51 | $ 2.51 |
Weighted Average Remaining Contractual Life | |||
Outstanding | 9 months 18 days | ||
Aggregate Intrinsic Value | |||
Outstanding, ending balance | $ 34,651 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Jun. 07, 2016 | Sep. 25, 2017 | Jun. 30, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Class of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 8,846,154 | |||||
Proceeds from Issuance of Common Stock | $ 53,700 | $ 53,662 | $ 95,685 | $ 68,307 | ||
Shares Issued, Price Per Share | $ 6.50 | |||||
Other Preferred Stock Dividends and Adjustments | $ 0 | $ 49,454 | $ 0 | |||
Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 8,846,154 | 9,200,000 | ||||
Conversion of Stock, Shares Converted | 568,432 | 3,421,960 | ||||
Common Stock [Member] | Issuance Of Common Stock Upon Conversion Of Preferred Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Conversion of Stock, Shares Issued | 0 | 4,000 | 11,306 | |||
Conversion of Stock, Shares Converted | 0 | 2,000,000 | 5,653,000 | |||
2016 Private Placement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 9,684,000 | |||||
Proceeds from Issuance of Private Placement | $ 100,000 | |||||
Proceeds from Issuance or Sale of Equity | $ 95,700 | |||||
Series A Convertible Preferred Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Conversion of Stock, Shares Issued | 500 | |||||
Preferred Stock, Shares Authorized | 17,000 | |||||
Series A Convertible Preferred Stock [Member] | Private Placement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 17,000 | |||||
Sale of Stock, Price Per Share | $ 2 | |||||
Preferred Stock, Par or Stated Value Per Share | $ 1,000 | |||||
Series B Preferred Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Conversion of Stock, Shares Converted | 568,432 | 3,421,960 | ||||
Preferred Stock, Shares Authorized | 11,500,000 | 11,500,000 | ||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | ||||
Convertible Price Per Shares | $ 4.75 | |||||
Preferred Stock, Shares Outstanding | 7,378,241 | 7,946,673 | ||||
Series B Preferred Stock [Member] | 2016 Private Placement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Convertible Price Per Shares | $ 4.75 | |||||
Sock Issued During Period Preferred Stock Shares | 11,368,633 | |||||
Shares Issued, Price Per Share | $ 4.75 | |||||
Other Preferred Stock Dividends and Adjustments | $ 49,500 | |||||
Series B Convertible Preferred Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Preferred Stock, Shares Authorized | 11,500,000 | |||||
Blank Check [Member] | ||||||
Class of Stock [Line Items] | ||||||
Preferred Stock, Shares Authorized | 50,000,000 |
STOCK BASED COMPENSATION (Detai
STOCK BASED COMPENSATION (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Number of Options | ||||
Outstanding, beginning balance | 6,072,368 | |||
Outstanding, ending balance | 6,072,368 | |||
Exercisable | 2,769,205 | |||
Weighted Average Exercise Price | ||||
Outstanding, beginning balance | $ 7.42 | |||
Outstanding, ending balance | $ 7.42 | |||
Exercisable | $ 7.96 | |||
Weighted Average Remaining Contractual Life | ||||
Outstanding | 7 years 10 months 10 days | |||
Exercisable | 6 years 4 months 24 days | |||
Aggregate Intrinsic Value | ||||
Outstanding, beginning balance | $ 6,199 | |||
Exercisable | $ 2,457 | |||
Employee Stock Option [Member] | ||||
Number of Options | ||||
Outstanding, beginning balance | 6,072,368 | 6,233,150 | 2,693,237 | 1,857,877 |
Granted | 2,188,800 | 4,407,983 | 1,171,984 | |
Exercised | (1,011,284) | (100,480) | (42,387) | |
Expired/Forfeited | (1,338,298) | (767,590) | (294,237) | |
Outstanding, ending balance | 6,072,368 | 6,233,150 | 2,693,237 | |
Exercisable | 2,769,205 | 2,496,695 | ||
Weighted Average Exercise Price | ||||
Outstanding, beginning balance | $ 7.42 | $ 7.24 | $ 8.12 | $ 7.31 |
Granted | 6.68 | 6.86 | 8.12 | |
Exercised | 5.55 | 6.23 | 0 | |
Expired/Forfeited | 6.79 | 8.12 | 2.88 | |
Outstanding, ending balance | 7.42 | 7.24 | $ 8.12 | |
Exercisable | $ 7.96 | $ 7.35 | ||
Weighted Average Remaining Contractual Life | ||||
Outstanding | 7 years 10 months 24 days | |||
Exercisable | 6 years 4 months 24 days | 4 years 1 month 6 days | ||
Aggregate Intrinsic Value | ||||
Outstanding, beginning balance | $ 6,199 | |||
Exercisable | $ 2,457 | $ 1,839 |
STOCK BASED COMPENSATION (Det46
STOCK BASED COMPENSATION (Details 1) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Risk-free interest rate | 1.56% | ||
Expected term (in years) | 6 years | ||
Maximum [Member] | |||
Risk-free interest rate | 2.34% | 2.16% | |
Expected term (in years) | 6 years 6 months | 6 years 6 months | |
Expected volatility | 209.69% | 213.60% | 218.00% |
Minimum [Member] | |||
Risk-free interest rate | 1.72% | 1.18% | |
Expected term (in years) | 5 years 1 month 17 days | 5 years 25 days | |
Expected volatility | 190.46% | 189.40% | 207.00% |
STOCK BASED COMPENSATION (Det47
STOCK BASED COMPENSATION (Details 2) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2017USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | shares | 6,072,368 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 10 months 10 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 7.42 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Aggregate Intrinsic Value | $ | $ 6,199 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | shares | 2,769,205 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 4 months 24 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ / shares | $ 7.96 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Aggregate Intrinsic Value | $ | $ 2,457 |
Range Of Exercise Prices $5.05 - $5.86 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | shares | 959,200 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 1 month 28 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 5.32 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | shares | 390,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 3 months 22 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ / shares | $ 5.43 |
Range Of Exercise Prices $5.87 - $6.58 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | shares | 932,550 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 10 months 24 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 6.02 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | shares | 421,712 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 9 months 7 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ / shares | $ 6.08 |
Range Of Exercise Prices $6.59 - $7.43 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | shares | 897,500 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 6 months 4 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 6.99 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | shares | 323,790 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 4 years 3 months |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ / shares | $ 6.94 |
Range Of Exercise Prices $7.44 - $7.57 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | shares | 1,358,166 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 10 months 28 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 7.52 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | shares | 434,370 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 8 years 8 months 1 day |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ / shares | $ 7.54 |
Range Of Exercise Prices $7.58 - $9.00 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | shares | 864,286 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 4 months 13 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 7.83 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | shares | 401,273 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 5 years 6 months |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ / shares | $ 7.81 |
Range Of Exercise Prices $9.01 - $117 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | shares | 1,060,666 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 10 months 24 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 10.46 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | shares | 798,060 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 3 months 29 days |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ / shares | $ 10.90 |
STOCK BASED COMPENSATION (Det48
STOCK BASED COMPENSATION (Details 3) - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Number of Shares | |||
Non-vested shares, Beginning Balance | 7,084 | 321,252 | 782,500 |
Granted | 0 | 0 | 15,000 |
Vested | (7,084) | (274,167) | (284,748) |
Forfeited | 0 | (40,001) | (191,500) |
Non-vested shares, Ending balance | 0 | 7,084 | 321,252 |
Weighted Average Grant Date Fair Value | |||
Weighted Average Grant Date Fair Value, Beginning Balance | $ 6.48 | $ 6.96 | $ 7.04 |
Granted | 0 | 0 | 8.44 |
Vested | (6.48) | 6.90 | 4.31 |
Forfeited | 0 | 7.02 | 6.81 |
Weighted Average Grant Date Fair Value, Ending balance | $ 0 | $ 6.48 | $ 6.96 |
STOCK BASED COMPENSATION (Det49
STOCK BASED COMPENSATION (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Apr. 10, 2015 | Jun. 30, 2016 | Mar. 31, 2013 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Aug. 16, 2016 | Nov. 30, 2014 | Aug. 20, 2014 | Aug. 31, 2013 | Oct. 14, 2011 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Allocated Share-based Compensation Expense | $ 0 | $ 1 | $ 1.8 | ||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Total | $ 19.5 | ||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 10 months 24 days | ||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 10.9 | 16.5 | 6.8 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 2.6 | $ 0.2 | $ 0 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 0 | 0 | 15,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 0 | $ 0 | $ 8.44 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | 7,084 | 274,167 | 284,748 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 6.58 | $ 6.78 | $ 8.77 | ||||||||
Restricted Common Stock [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 36 months | ||||||||||
Restricted Stock [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Allocated Share-based Compensation Expense | $ 1.1 | $ 1.5 | |||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Total | $ 0.7 | ||||||||||
Restricted Stock [Member] | Chief Executive Officer [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 550,000 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 5.87 | ||||||||||
First Anniversary [Member] | Restricted Stock [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | 137,500 | ||||||||||
Satisfaction Of Clinical Trial Milestones [Member] | Restricted Stock [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | 275,000 | ||||||||||
2011 Equity Incentive Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 725,267 | ||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 1,900,000 | 1,700,000 | 180,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | an amendment to increase the number options or other awards that can be granted to any one person during a twelve (12) month period from 50,000 shares to 300,000 shares | ||||||||||
2014 Equity Incentive Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 9,000,000 | 2,350,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 4,000,000 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 2,516,992 |
EMPLOYEE BENEFIT PLAN (Details
EMPLOYEE BENEFIT PLAN (Details Textual) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Defined Contribution Plan, Cost Recognized | $ 0.3 | $ 0.1 | $ 0 |
SEPARATION AGREEMENTS (Details
SEPARATION AGREEMENTS (Details Textual) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2016 | |
Dr. Elma Hawkins [Member] | ||
Severance Costs | $ 0.5 | |
Share-based Compensation Arrangement by Share-based Payment Award Accelerated Compensation Cost | $ 5 | |
Molly Henderson [Member] | ||
Severance Costs | $ 0.4 | |
Share-based Compensation Arrangement by Share-based Payment Award Accelerated Compensation Cost | $ 4.5 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred income tax asset: | ||
Net operating loss carry forward | $ 33,300 | $ 23,912 |
Stock-based compensation | 4,568 | 9,562 |
Tax credit carryforwards | 9,323 | 8,167 |
Reserves and accruals | 733 | 139 |
Deferred tax assets before valuation allowance | 47,924 | 41,780 |
Less: valuation allowance | (47,849) | (41,402) |
Net deferred income tax assets | 75 | 378 |
Deferred tax liabilities: | ||
Depreciation and amortization | (75) | (378) |
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Federal statutory tax rate | (34.00%) | (34.00%) | (34.00%) |
Orphan Drug & Research credits | 0.00% | (8.00%) | (12.00%) |
Permanent and other differences | 4.00% | 4.00% | 10.00% |
Tax rate change | 23.00% | 0.00% | 0.00% |
State tax, net of federal benefit | 0.00% | (4.00%) | (5.00%) |
Effective Income Tax Rate Reconciliation Expected Rate Total | (7.00%) | (42.00%) | (41.00%) |
Valuation allowance | 7.00% | 42.00% | 41.00% |
Effective tax rate | 0.00% | 0.00% | 0.00% |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Federal: | |||
Current | $ 0 | $ 0 | $ 0 |
Deferred | (7,391) | (19,050) | (9,724) |
State and Local | |||
Current | 0 | 0 | 0 |
Deferred | 944 | (3,007) | (1,887) |
Change in Valuation Allowance | 6,447 | 22,057 | 11,611 |
Total income tax expense (benefit) | $ 0 | $ 0 | $ 0 |
INCOME TAXES (Details 3)
INCOME TAXES (Details 3) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Unrecognized benefit-beginning of period | $ 0 | $ 0 | $ 0 |
Gross decreases-prior period tax positions | 2,780 | 0 | 0 |
Gross increases-current period tax positions | 1,331 | 0 | 0 |
Unrecognized benefit-end of period | $ 4,111 | $ 0 | $ 0 |
INCOME TAXES (Details Textual)
INCOME TAXES (Details Textual) - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Contingency [Line Items] | ||||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 6.4 | $ 22.1 | $ 11.6 | |
Increase (Decrease) in Deferred Income Taxes | $ 20.8 | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 34.00% | 34.00% | 34.00% | |
Scenario, Plan [Member] | ||||
Income Tax Contingency [Line Items] | ||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | |||
Domestic Tax Authority [Member] | ||||
Income Tax Contingency [Line Items] | ||||
Operating Loss Carryforwards | $ 143.3 | |||
Operating Loss Carryforwards, Commencement Year | 2,027 | |||
Operating Loss Carryforwards, Expiration Year | 2,037 | |||
State and Local Jurisdiction [Member] | ||||
Income Tax Contingency [Line Items] | ||||
Operating Loss Carryforwards | $ 66.3 | |||
Operating Loss Carryforwards, Commencement Year | 2,030 | |||
Operating Loss Carryforwards, Expiration Year | 2,037 |
LICENSES AND AGREEMENTS (Detail
LICENSES AND AGREEMENTS (Details Textual) - USD ($) $ in Thousands | Sep. 14, 2016 | Apr. 17, 2017 | Nov. 30, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Research and Development Expense | $ 71,615 | $ 26,941 | $ 15,470 | |||
Research and Development Arrangement [Member] | ||||||
Prepaid Expense, Current | 1,400 | |||||
Maximum [Member] | Research and Development Arrangement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross | $ 14,200 | |||||
KarolinskaUniversityHospital [Member] | ||||||
Research and Development Expense | 300 | 100 | ||||
Payments For Clinical Trials Agreement | 1,600 | 1,600 | ||||
Repayments To Be Made For Termination Of Licence Agreement | $ 2,200 | |||||
Payments To Be Made For Other Related Agreements | 2,600 | |||||
National Cancer Institute [Member] | ||||||
Research and Development Expense | 500 | |||||
Exclusive Patent License Agreement [Member] | ||||||
Research and Development Expense | 400 | 400 | ||||
Payments For Upfront Licensing Fee | 800 | |||||
Moffitt License Agreement [Member] | ||||||
Payments For Upfront Licensing Fee | $ 100 | |||||
Agreement Term | 20 years | |||||
Cooperative Research and Development Agreement [Member] | ||||||
Research and Development Expense | $ 2,000 | 1,800 | 2,000 | |||
Agreement Term | 5 years | |||||
PolyBioCept, AB - Exclusive and Co-Exclusive License Agreement [Member] | ||||||
Research and Development Expense | $ 200 | 2,700 | ||||
Payments For Upfront Licensing Fee | 2,500 | 2,500 | ||||
Additional Milestone Payable | $ 8,700 | |||||
Number Of Unregistered Common Stock To Be Issued | 2,219,376 | |||||
Reimbursement In Relation To Transfer Of Knowhow | $ 200 | |||||
Clinical Trials Management Fees Payable | 100 | |||||
Consulting Fees Receivable | $ 200 | |||||
Initial Term Of Licence Agreement | 30 years | |||||
WuXi Apptech, Inc - Manufacturing and Services Agreement [Member] | ||||||
Research and Development Expense | 13,900 | 2,400 | ||||
Agreement Term | 3 years | |||||
WuXi Apptech, Inc - Manufacturing and Services Agreement [Member] | Manufacturing Suites [Member] | ||||||
Manufacturing and Services Agreement, Amount Payable | $ 2,500 | |||||
WuXi Apptech, Inc - Manufacturing and Services Agreement [Member] | Commercial Manufacturing cGMP Suite [Member] | ||||||
Manufacturing and Services Agreement, Amount Payable | $ 5,850 | |||||
Research Collaboration and Clinical Grant Agreements with Moffitt [Member] | ||||||
Research and Development Expense | $ 1,200 | $ 700 | $ 700 |
COMMITMENTS AND CONTINGENCIES58
COMMITMENTS AND CONTINGENCIES (Details) $ in Thousands | Dec. 31, 2017USD ($) |
2,018 | $ 1,023 |
2,019 | 700 |
2,020 | 495 |
2,021 | 169 |
Total | $ 2,387 |
COMMITMENTS AND CONTINGENCIES59
COMMITMENTS AND CONTINGENCIES (Details Textual) | Aug. 04, 2016USD ($)ft² | Apr. 28, 2017USD ($)ft² | Sep. 30, 2016USD ($)ft² | Apr. 30, 2015USD ($)ft² | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Jun. 05, 2017USD ($) | Dec. 31, 2014a |
License And Commitments [Line Items] | |||||||||
Operating Leases, Rent Expense | $ 1,000,000 | $ 700,000 | $ 300,000 | ||||||
Operating Leases, Future Minimum Payments Due | 2,387,000 | ||||||||
Tampa Lease [Member] | |||||||||
License And Commitments [Line Items] | |||||||||
Area of Land | 8,673 | 6,043 | 5,115 | ||||||
Operating Leases, Rent Expense, Minimum Rentals | $ 20,000 | $ 20,000 | |||||||
New York Lease [Member] | |||||||||
License And Commitments [Line Items] | |||||||||
Operating Leases, Future Minimum Payments Due | $ 9,000 | ||||||||
Operating Leases, Rent Expense, Minimum Rentals | $ 18,000 | ||||||||
San Carlos Lease [Member] | |||||||||
License And Commitments [Line Items] | |||||||||
Area of Land | ft² | 8,733 | ||||||||
Lease Expiration Term | 54 months | ||||||||
Operating Leases, Future Minimum Payments Due | $ 38,000 | ||||||||
Operating Leases, Rent Expense, Sublease Rentals | $ 26,000 | ||||||||
Teradata US, Inc [Member] | |||||||||
License And Commitments [Line Items] | |||||||||
Area of Land | ft² | 11,449 |
LEGAL PROCEEDINGS (Details Text
LEGAL PROCEEDINGS (Details Textual) $ in Millions | Jun. 13, 2017USD ($)shares | Jun. 03, 2016USD ($) | Nov. 30, 2012USD ($) | Jun. 30, 2012USD ($) | Sep. 30, 2016shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016shares | Dec. 31, 2015shares | Apr. 08, 2016USD ($) |
Loss Contingency, Damages Sought, Value | $ | $ 0.5 | ||||||||
Common Stock Registered For Resale | shares | 128,500 | ||||||||
Number of share options or share units exercised during the current period. | shares | 128,500 | ||||||||
Dr. Steven Fischkoff [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 150,000 | ||||||||
Severance Pay And Retention Bonus | $ | $ 0.3 | ||||||||
Warrant [Member] | |||||||||
Shares Sold Under Ineffective Registration | shares | 128,500 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 0 | 0 | 0 | ||||||
Minimum [Member] | |||||||||
Loss Contingency, Estimate of Possible Loss | $ | $ 1.5 | ||||||||
Solomon Capital, LLC [Member] | |||||||||
Proceeds from Related Party Debt | $ | $ 0.2 | $ 0.1 | |||||||
Debt Instrument, Convertible, Number of Equity Instruments | 111,425 | ||||||||
Solomon Capital, LLC [Member] | Commercial Paper [Member] | |||||||||
Debt Instrument, Face Amount | $ | $ 0.2 |
QUARTERLY UNAUDITED RESULTS (De
QUARTERLY UNAUDITED RESULTS (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Revenue | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
Net loss attributable to common stockholders | $ (25,854) | $ (22,149) | $ (23,377) | $ (20,684) | $ (15,689) | $ (68,212) | $ (11,563) | $ (6,884) | $ (92,064) | $ (52,894) | $ (27,660) |
Net loss per share, basic and diluted | $ (0.36) | $ (0.35) | $ (0.37) | $ (0.33) | $ (0.25) | $ (1.15) | $ (0.23) | $ (0.14) | $ (1.41) | $ (1.85) | $ (0.62) |
Weighted average shares used in computing net loss per share, basic and diluted | 72,794 | 63,332 | 62,457 | 62,286 | 62,130 | 59,113 | 51,082 | 48,548 | 65,242 | 55,268 | 44,410 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Sep. 14, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Payments for Legal Services | $ 0.7 | $ 0.8 | $ 0.7 | |
Due to Related Parties, Current | $ 0.1 | $ 0.1 | ||
Board of Directors Chairman [Member] | ||||
Consulting Agreement,Term | 3 years | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 150,000 | |||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 7.30 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Terms of Award | The granted stock options vest in 12 quarterly installments (with 1/12th of the option shares having vested on the date of grant). |
SUBSEQUENT EVENT (Details Textu
SUBSEQUENT EVENT (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2018 | Sep. 25, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Stock Issued During Period, Value, New Issues | $ 53,662 | $ 68,307 | |||
Shares Issued, Price Per Share | $ 6.50 | ||||
Stock Issued During Period, Shares, New Issues | 8,846,154 | ||||
Proceeds from Issuance of Common Stock | $ 53,700 | $ 53,662 | $ 95,685 | $ 68,307 | |
Subsequent Event [Member] | Underwriting Options [Member] | IPO [Member] | |||||
Stock Issued During Period, Value, New Issues | $ 172,500 | ||||
Shares Issued, Price Per Share | $ 11.50 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 1,956,521 | ||||
Stock Issued During Period, Shares, New Issues | 15,000,000 | ||||
Proceeds from Issuance of Common Stock | $ 161,700 |