Document and Entity Information - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Mar. 14, 2019 |
Sep. 21, 2018 |
|
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Y-mAbs Therapeutics, Inc. | ||
Entity Central Index Key | 0001722964 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 301.6 | ||
Entity Common Stock, Shares Outstanding | 34,193,666 |
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- Definition If the value is true, then the document is an amendment to previously-filed/accepted document. No definition available.
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- Definition End date of current fiscal year in the format --MM-DD. No definition available.
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- Definition This is focus fiscal period of the document report. For a first quarter 2006 quarterly report, which may also provide financial information from prior periods, the first fiscal quarter should be given as the fiscal period focus. Values: FY, Q1, Q2, Q3, Q4, H1, H2, M9, T1, T2, T3, M8, CY. No definition available.
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- Definition This is focus fiscal year of the document report in CCYY format. For a 2006 annual report, which may also provide financial information from prior periods, fiscal 2006 should be given as the fiscal year focus. Example: 2006. No definition available.
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- Definition The end date of the period reflected on the cover page if a periodic report. For all other reports and registration statements containing historical data, it is the date up through which that historical data is presented. If there is no historical data in the report, use the filing date. The format of the date is CCYY-MM-DD. No definition available.
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- Definition The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'. No definition available.
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- Definition A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Indicate number of shares or other units outstanding of each of registrant's classes of capital or common stock or other ownership interests, if and as stated on cover of related periodic report. Where multiple classes or units exist define each class/interest by adding class of stock items such as Common Class A [Member], Common Class B [Member] or Partnership Interest [Member] onto the Instrument [Domain] of the Entity Listings, Instrument. No definition available.
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- Definition Indicate 'Yes' or 'No' whether registrants (1) have filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that registrants were required to file such reports), and (2) have been subject to such filing requirements for the past 90 days. This information should be based on the registrant's current or most recent filing containing the related disclosure. No definition available.
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- Definition Indicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Indicate if registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Indicate whether the registrant is one of the following: (1) Large Accelerated Filer, (2) Accelerated Filer, (3) Non-accelerated Filer, (4) Smaller Reporting Company (Non-accelerated), (5) Smaller Reporting Accelerated Filer or (6) Smaller Reporting Company and Large Accelerated Filer. Definitions of these categories are stated in Rule 12b-2 of the Exchange Act. This information should be based on the registrant's current or most recent filing containing the related disclosure. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition State aggregate market value of voting and non-voting common equity held by non-affiliates computed by reference to price at which the common equity was last sold, or average bid and asked price of such common equity, as of the last business day of registrant's most recently completed second fiscal quarter. The public float should be reported on the cover page of the registrants form 10K. No definition available.
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- Definition The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Indicate if company meets the shell company criteria: a company with no or nominal operations, and with no or nominal assets or assets consisting solely of cash and cash equivalents. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Indicates that the company is a smaller reporting company with both a public float and revenues of less than $75 million. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Indicate 'Yes' or 'No' if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. No definition available.
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- Definition Indicate 'Yes' or 'No' if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Is used on Form Type: 10-K, 10-Q, 8-K, 20-F, 6-K, 10-K/A, 10-Q/A, 20-F/A, 6-K/A, N-CSR, N-Q, N-1A. No definition available.
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- References No definition available.
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- Definition Carrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Carrying value as of the balance sheet date of obligations incurred and payable, pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered. Examples include taxes, interest, rent and utilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Accumulated change in equity from transactions and other events and circumstances from non-owner sources, net of tax effect, at period end. Excludes Net Income (Loss), and accumulated changes in equity from transactions resulting from investments by owners and distributions to owners. Includes foreign currency translation items, certain pension adjustments, unrealized gains and losses on certain investments in debt and equity securities, other than temporary impairment (OTTI) losses related to factors other than credit losses on available-for-sale and held-to-maturity debt securities that an entity does not intend to sell and it is not more likely than not that the entity will be required to sell before recovery of the amortized cost basis, as well as changes in the fair value of derivatives related to the effective portion of a designated cash flow hedge. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Excess of issue price over par or stated value of the entity's capital stock and amounts received from other transactions involving the entity's stock or stockholders. Includes adjustments to additional paid in capital. Some examples of such adjustments include recording the issuance of debt with a beneficial conversion feature and certain tax consequences of equity instruments awarded to employees. Use this element for the aggregate amount of additional paid-in capital associated with common and preferred stock. For additional paid-in capital associated with only common stock, use the element additional paid in capital, common stock. For additional paid-in capital associated with only preferred stock, use the element additional paid in capital, preferred stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are recognized. Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are expected to be realized in cash, sold, or consumed within one year (or the normal operating cycle, if longer). Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Represents the caption on the face of the balance sheet to indicate that the entity has entered into (1) purchase or supply arrangements that will require expending a portion of its resources to meet the terms thereof, and (2) is exposed to potential losses or, less frequently, gains, arising from (a) possible claims against a company's resources due to future performance under contract terms, and (b) possible losses or likely gains from uncertainties that will ultimately be resolved when one or more future events that are deemed likely to occur do occur or fail to occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Aggregate par or stated value of issued nonredeemable common stock (or common stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable common shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Specific incremental costs directly attributable to a proposed or actual offering of securities which are deferred at the end of the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Sum of the carrying amounts as of the balance sheet date of all liabilities that are recognized. Liabilities are probable future sacrifices of economic benefits arising from present obligations of an entity to transfer assets or provide services to other entities in the future. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of liabilities and equity items, including the portion of equity attributable to noncontrolling interests, if any. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Total obligations incurred as part of normal operations that are expected to be paid during the following twelve months or within one business cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount of current assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of noncurrent assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of liabilities classified as other, due after one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Aggregate par or stated value of issued nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable preferred shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business to produce goods and services and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of cash restricted as to withdrawal or usage, classified as current. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The cumulative amount of the reporting entity's undistributed earnings or deficit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Carrying value as of the balance sheet date of obligations incurred through that date and due beyond one year (or beyond one operating cycle if longer) for milestone and royalty payments. No definition available.
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Consolidated Balance Sheets (parenthetical) - $ / shares |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized shares | 5,500,000 | 5,500,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized shares | 100,000,000 | 50,000,000 |
Common stock, shares issued | 34,193,666 | 26,749,666 |
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- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The maximum number of common shares permitted to be issued by an entity's charter and bylaws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Face amount or stated value per share of preferred stock nonredeemable or redeemable solely at the option of the issuer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The maximum number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) permitted to be issued by an entity's charter and bylaws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Total number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) issued to shareholders (includes related preferred shares that were issued, repurchased, and remain in the treasury). May be all or portion of the number of preferred shares authorized. Excludes preferred shares that are classified as debt. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
OPERATING EXPENSES | ||
Research and development | $ 34,269 | $ 14,307 |
General and administrative | 8,961 | 4,937 |
Total operating expenses | 43,230 | 19,244 |
Loss from operations | (43,230) | (19,244) |
OTHER INCOME/(EXPENSES) | ||
Interest and other income/(expenses) | (44) | 83 |
NET LOSS | (43,274) | (19,161) |
Other comprehensive income/(loss) | ||
Foreign currency translation | 175 | (199) |
COMPREHENSIVE LOSS | $ (43,099) | $ (19,360) |
Net loss per share attributable to common stockholders, basic and diluted | $ (1.50) | $ (0.99) |
Weighted average common shares outstanding, basic and diluted | 28,772,384 | 19,397,506 |
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- Definition Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or loss for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The aggregate total of expenses of managing and administering the affairs of an entity, including affiliates of the reporting entity, which are not directly or indirectly associated with the manufacture, sale or creation of a product or product line. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Generally recurring costs associated with normal operations except for the portion of these expenses which can be clearly related to production and included in cost of sales or services. Includes selling, general and administrative expense. No definition available.
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- References No definition available.
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- Definition The net result for the period of deducting operating expenses from operating revenues. No definition available.
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- Definition Amount after tax and reclassification adjustments of gain (loss) on foreign currency translation adjustments, foreign currency transactions designated and effective as economic hedges of a net investment in a foreign entity and intra-entity foreign currency transactions that are of a long-term-investment nature, attributable to parent entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount of income (expense) related to nonoperating activities, classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Average number of shares or units issued and outstanding that are used in calculating basic and diluted earnings per share (EPS). No definition available.
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- Definition Amount of increase to additional paid-in capital (APIC) from recognition of equity-based compensation for stock options. No definition available.
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- Definition Number of shares of common stock outstanding. Common stock represent the ownership interest in a corporation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. No definition available.
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount after tax and reclassification adjustments of gain (loss) on foreign currency translation adjustments, foreign currency transactions designated and effective as economic hedges of a net investment in a foreign entity and intra-entity foreign currency transactions that are of a long-term-investment nature. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Number of shares issued in lieu of cash for services contributed to the entity. Number of shares includes, but is not limited to, shares issued for services contributed by vendors and founders. No definition available.
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- Definition Number of new stock issued during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Equity impact of the value of new stock issued during the period. Includes shares issued in an initial public offering or a secondary public offering. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Represents the shares issued during period new issues to investors. No definition available.
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- Definition Represents the stock issued during period value new issues to investors. No definition available.
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- References No definition available.
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- Definition Amount of cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage. Excludes amount for disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) in cash, cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; including effect from exchange rate change. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The aggregate expense recognized in the current period that allocates the cost of tangible assets, intangible assets, or depleting assets to periods that benefit from use of the assets. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of increase (decrease) from effect of exchange rate changes on cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; held in foreign currencies. Excludes amounts for disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount before tax of foreign currency transaction realized and unrealized gain (loss) recognized in the income statement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The increase (decrease) during the reporting period in the aggregate amount of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount of increase (decrease) in current assets classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Amount of increase (decrease) in noncurrent assets classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Amount of cash inflow (outflow) from financing activities, including discontinued operations. Financing activity cash flows include obtaining resources from owners and providing them with a return on, and a return of, their investment; borrowing money and repaying amounts borrowed, or settling the obligation; and obtaining and paying for other resources obtained from creditors on long-term credit. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount of cash inflow (outflow) from investing activities, including discontinued operations. Investing activity cash flows include making and collecting loans and acquiring and disposing of debt or equity instruments and property, plant, and equipment and other productive assets. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount of cash inflow (outflow) from operating activities, including discontinued operations. Operating activity cash flows include transactions, adjustments, and changes in value not defined as investing or financing activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- References No definition available.
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- Definition The cash outflow for cost incurred directly with the issuance of an equity security. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash outflow associated with the acquisition of long-lived, physical assets that are used in the normal conduct of business to produce goods and services and not intended for resale; includes cash outflows to pay for construction of self-constructed assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cash inflow from the additional capital contribution to the entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The consolidated profit or loss for the period, net of income taxes, including the portion attributable to the noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The aggregate amount of noncash, equity-based employee remuneration. This may include the value of stock or unit options, amortization of restricted stock or units, and adjustment for officers' compensation. As noncash, this element is an add back when calculating net cash generated by operating activities using the indirect method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The increase (decrease) during the reporting period in the aggregate amount of expenses incurred but not yet paid and other liabilities. No definition available.
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- Definition The amount of common stock issuance costs that were incurred during a noncash or partial noncash transaction, included in accounts payable. No definition available.
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- Definition The amount of deferred offering costs that were incurred during a noncash or partial noncash transaction, included in other assets and accounts payable and accrued liabilities and other . No definition available.
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ORGANIZATION AND DESCRIPTION OF BUSINESS |
12 Months Ended |
---|---|
Dec. 31, 2018 | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | NOTE 1—ORGANIZATION AND DESCRIPTION OF BUSINESS Y‑mAbs Therapeutics, Inc. (“we,” “us,” “our,” the “Company,” or “Y‑mAbs”) is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel antibody-based therapeutic products for the treatment of cancer. We have entered into a worldwide license and research collaboration agreement (the “MSK License Agreement”) with Memorial Sloan‑Kettering Cancer Center (“MSK”) our strategic partner, under which we have obtained the exclusive rights to MSK’s rights to two clinical stage antibody‑based product development programs for the treatment of neuroblastoma and other oncology indications. The MSK License Agreement also includes a protein Multimerization Platform Technology—MULTI TAGTM, and an option to obtain the rights to certain chimeric antigen receptor T‑cell, or CAR‑T, technologies, as well as rights to next‑generation humanized, affinity matured bispecific antibodies. The Company is headquartered in New York and was incorporated on April 30, 2015 under the laws of the State of Delaware. |
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- Definition The entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition NA No definition available.
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BASIS OF PRESENTATION |
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BASIS OF PRESENTATION | |
BASIS OF PRESENTATION | NOTE 2—BASIS OF PRESENTATION The Company has not generated any revenue and has incurred losses since inception. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of drug candidate development; technological uncertainty; uncertainty regarding patents and proprietary rights; uncertainty in obtaining FDA approval in the United States and regulatory approval in other jurisdictions; marketing or sales capability or experience; uncertainty in getting adequate payer coverage and reimbursement; and dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Drug candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance‑reporting capabilities. The Company’s drug candidates are in the development stage. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. The Company has experienced negative cash flows and had an accumulated deficit of $84.8 million as of December 31, 2018 and $41.6 million as of December 31, 2017. Through December 31, 2018, the Company has funded its operations through proceeds from sales of shares of its common stock, including its initial public offering, or IPO, in September 2018. As of December 31, 2018, the Company had cash and cash equivalents of $147.8 million, and as of December 31, 2017 the Company had cash and cash equivalents of $90.5 million. As of the issuance date of the annual financial statements for the year ended December 31, 2018, the Company expects that its cash and cash equivalents at December 31, 2018 will be sufficient to fund its operating expenses and capital expenditure requirements through at least the next twelve months. The future viability of the Company, until such time that the Company has commercialized any of its products, is dependent on its ability to raise additional capital to finance its operations. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The accompanying consolidated financial statements reflect the accounts of the Company and its wholly‑owned subsidiary and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). All intercompany balances and transactions have been eliminated. |
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- Definition The entire disclosure for the basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition NA No definition available.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the accrual for research and development expenses, the accrual of milestone and royalty payments, the valuation of shares of common stock and stock options. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly‑liquid investments with maturities of three months or less from date of purchase to be cash equivalents. The Company primarily maintains its cash balances with financial institutions in federally insured accounts and cash held in an unrestricted escrow account. The Company has cash in financial institutions in excess of FDIC insurance limits. Restricted cash represents a bank account with funds to cover the Company’s corporate credit card availability. Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight‑line method over the estimated useful life of each asset as follows:
Depreciation and amortization expense on property and equipment was $29,000 and $0 for the years ended December 31, 2018 and 2017, respectively. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. Impairment of Long‑Lived Assets ASC 360, Property, Plant and Equipment, addresses the financial accounting and reporting for impairment or disposal of long‑lived assets. The Company reviews the recorded values of long‑lived assets for impairment whenever events or changes in business circumstance indicate that the carrying amount of an asset or group of assets may not be fully recoverable. Deferred Offering Costs The Company capitalizes certain legal, professional accounting and other third‑party fees that are directly associated with in‑process equity financings as deferred offering costs within other assets until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of proceeds generated as a result of the offering. Should the planned equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statement of comprehensive loss. The Company did not record any deferred offering costs as of December 31, 2018. The Company recorded deferred offering costs of $0.8 million as of December 31, 2017. Accounts payable and accrued liabilities at December 31, 2017 included $0.2 million of deferred offering costs. These deferred operating costs were reclassified to shareholders’ equity upon the successful completion of the IPO during the year ended December 31, 2018. Income Taxes The Company accounts for income taxes under the asset and liability approach for the financial accounting and reporting of income taxes. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to net operating loss carry forwards and temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. These assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which the temporary differences are expected to reverse. A valuation allowance is established when management determines that it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company prepares and files tax returns based on its interpretation of tax laws and regulations. In the normal course of business, the Company’s tax returns are subject to examination by various taxing authorities. Such examinations may result in future tax and interest assessments by these taxing authorities. In determining the Company’s tax provision for financial reporting purposes, the Company establishes a reserve for uncertain tax positions unless such positions are determined to be more likely than not of being sustained upon examination based on their technical merits. The Company considers many factors when evaluating and estimating its tax positions and tax benefits, which may require periodic adjustments and which may not accurately anticipate actual outcomes. Accordingly, the Company will report a liability for unrecognized tax benefits resulting from any uncertain tax positions taken or expected to be taken on a tax return. The Company’s policy is to recognize, when applicable, interest and penalties on uncertain tax positions as part of income tax expense. In accordance with guidance issued by Financial Accounting Standards Board (“FASB”), companies should make and disclose a policy election as to whether they will recognize deferred taxes for basis differences expected to reverse as Global Intangible Low‑Taxed Income (“GILTI”) or whether they will account for GILTI as period costs if and when incurred. The Company has elected to recognize the resulting tax with respect to the GILTI provision as a period cost. No costs were incurred by the Company through December 31, 2018 as a result of GILTI. Research and Development Costs Research and development costs are charged to operations when incurred and are included in operating expenses. Research and development costs consist principally of compensation cost for our employees and consultants that perform our research activities, the fees paid to maintain our licenses, the payments to third parties for manufacturing and clinical research organizations and additional product development, and consumables and other materials used in research and development. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Actual results could differ from the Company’s estimates. The Company is obligated to make certain milestone and royalty payments in accordance with the contractual terms of its license agreement with MSK based upon the resolution of certain contingencies. The Company records the milestone and royalty payment when the achievement of the milestone or payment of the milestone or royalty is probable and the amount of the payment is reasonably estimable. Research and development costs were $34.3 million and $14.3 million for the years ended December 31, 2018 and 2017, respectively. Patent Costs The Company expenses the costs of obtaining and maintaining patents as general and administrative expenses. Stock‑Based Compensation The Company measures stock options granted to employees and directors based on the fair value on the date of the grant and recognizes compensation expense of those awards, over the requisite service period, which is the vesting period of the respective award. Forfeitures are accounted for as they occur. The Company issues stock options with only service‑based vesting conditions and records the expense for these awards using the straight‑line method over the requisite service period. For share‑based awards granted to non‑employees, compensation expense is recognized over the period during which services are rendered by such non‑employees until completed. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then‑current fair value of the Company’s common shares and updated assumption inputs in the Black‑Scholes option‑pricing model. The fair value of each stock option grant is estimated on the date of grant using the Black‑Scholes option pricing model. The Company historically has been a private company and lacks company‑specific historical and implied volatility information for its shares. Therefore, it estimates its expected share price volatility based on the historical volatility of a group of publicly‑traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards as the Company has limited historical data to support the expected term assumption. The expected term of stock options granted to non‑employees is equal to the contractual term of the option award. The risk‑free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield is based on the fact that the Company has never paid cash dividends on common shares and does not expect to pay any cash dividends in the foreseeable future. Segment Information The Company is engaged solely in the discovery and development of novel antibody therapeutic products to treat cancer. Accordingly, the Company has determined that it operates in one operating segment. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with shareholders. The difference between net loss and comprehensive loss for the period presented in the accompanying financial statements was due to foreign currency translation. Foreign Currency The financial statements of our Danish subsidiary with a functional currency other than the U.S. dollar are translated into U.S. dollars using period‑end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income (loss), net of tax, in stockholders’ equity. Foreign currency transaction gains and losses are included in the results of operations in other income and expense, and totaled $(97,000) and $63,000 for the years ended December 31, 2018 and 2017, respectively.
Recently Issued Accounting Pronouncements - Adopted In March 2018, the FASB issued Accounting Standards Update No. 2018-05 (“ASU 2018-05”), Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin (SAB) No. 118. The ASU adds seven paragraphs to ASC 740, Income Taxes, that contain SEC guidance related to SAB 118 (codified as SEC SAB Topic 5.EE, “Income Tax Accounting Implications of the Tax Cuts and Jobs Act”), which provides guidance for companies that are not able to complete their accounting for the income tax effects of the Tax Cuts and Jobs Act in the period of enactment which is the period that includes December 22, 2017. The measurement period should not extend beyond one year from the enactment date. The Company completed its accounting for the income tax effects for the year ended December 31, 2018. See Note 10 for a discussion of the impact of the guidance on the Company’s consolidated financial statements. In May 2017, the FASB issued Accounting Standards Update No. 2017‑09 (“ASU 2017‑09”), Compensation—Stock Compensation (Topic 718)—Scope of Modification Accounting. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award changes as a result of the change in terms or conditions. The guidance is effective prospectively for annual periods beginning on or after December 15, 2017 with early adoption permitted. The Company adopted ASU 2017‑09 on January 1, 2018 and will account for any modifications in accordance with ASU 2017‑09 subsequent to the effective date. The adoption of this standard on January 1, 2018 did not have a material impact on our consolidated financial statements and related disclosures. In November 2016, the FASB issued Accounting Standards Update No. 2016‑18 (“ASU 2016‑18”), Statement of Cash Flows (Topic 230)—Restricted Cash. Under the new guidance, it changes the presentation of restricted cash and cash equivalents on the statement of cash flows. Restricted cash and restricted cash equivalents will be included with cash and cash equivalents when reconciling the beginning‑of‑period and end‑of‑period total amounts shown on the statement of cash flows. This amendment is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. The adoption of this standard on January 1, 2018 did not have a material impact on our consolidated financial statements and related disclosures. In October 2016, the FASB issued Accounting Standards Update No. 2016-16 (“ASU 2016-16”), Intra-Entity Transfers of Assets Other than Inventory, as part of its simplification initiative. Under the new guidance, an entity should recognize the income tax consequences of an intra-entity transfer of an asset other than inventory when the transfer occurs. Consequently, the amendments in this Update eliminate the exception for an intraentity transfer of an asset other than inventory. ASU 2016-16 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The adoption of this standard on January 1, 2018 did not have a material impact on our consolidated financial statements and related disclosures. In August 2016, the FASB issued Accounting Standards Update No. 2016‑15 (“ASU 2016‑15”), Classification of Certain Cash Receipts and Cash Payments. ASU 2016‑15 clarifies how certain cash receipts and payments should be presented in the statement of cash flows. The guidance is effective in 2018 with early adoption permitted. The adoption of this standard on January 1, 2018 did not have a material impact on our consolidated financial statements and related disclosures. In March 2016, the FASB issued Accounting Standards Update No. 2016-09 (“ASU 2016-09”), Compensation-Stock Compensation (Topic 718), as part of its simplification initiative. The areas for simplification in ASU 2016-09 involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for periods beginning after December 15, 2016 with early adoption permitted. The adoption of this standard on January 1, 2017 did not have a material impact on our consolidated financial statements and related disclosures. In November 2015, the FASB issued Accounting Standards Update No. 2015‑17 (“ASU 2015‑17”), Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. ASU 2015‑17 simplifies current guidance and requires companies to classify all deferred tax assets and liabilities as noncurrent on the balance sheet. ASU 2015‑17 can be applied either prospectively or retrospectively and is effective for periods beginning after December 15, 2016, with early adoption permitted. The adoption of this standard on January 1, 2017 did not have a material impact on our consolidated financial statements and related disclosures.
Issued Accounting Pronouncements – Not Yet Adopted In August 2018, the Securities Exchange Commission (“SEC”) adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statement. Under the amendments, an analysis of changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. The Company anticipates its first presentation of changes in stockholders’ equity as required under the new SEC guidance will be included in its Form 10-Q for the three-month period ended March 31, 2019. In August 2018, the FASB issued Accounting Standards Update No. 2018-15 (“ASU 2018-15”), Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. ASU 2018-15 clarifies certain aspects of ASU 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement, which was issued in April 2015. Specifically, ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal use software (and hosting arrangements that include an internal-use software license). ASU 2018-15 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the impact its adoption may have on its consolidated financial statements. In July 2018, the FASB issued Accounting Standards Update No. 2018-09 (“ASU 2018-09”), Codification Improvements, which clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2018-09 are not expected to have a significant effect on current accounting practices. Some of the amendments in this update do not require transition guidance and will be effective upon this update. However, many of the updates do have transition guidance with effective dates for periods beginning after December 15, 2018. The Company does not expect this ASU to have a significant impact on its consolidated financial statements. In June 2018, the FASB issued Accounting Standards Update No. 2018‑07, (“ASU 2018-07”), Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share‑Based Payment Accounting. ASU 2018‑07 is intended to simplify aspects of share‑based compensation issued to non‑employees by making the guidance consistent with the accounting for employee share‑based compensation. ASU 2018‑07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of ASU 2018‑07 will have on its consolidated financial statements. In February 2018, the FASB issued Accounting Standards Update No. 2018‑02, (“ASU 2018-02”), Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. ASU 2018‑02 allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. ASU 2018‑07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company does not expect this ASU to have a significant impact on its consolidated financial statements. In February 2016, the FASB issued Accounting Standards Update No. 2016‑02 (“ASU 2016‑02”), Leases, which is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018 with early adoption permitted. Under ASU 2016‑02, lessees will be required to recognize for all leases, at the commencement date of the lease, a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and a right‑to‑use asset, which is an asset that represents the lessee’s right to use or control the use of a specified asset for the lease term. Topic 842 was subsequently amended by ASU 2017-13, Revenue and Leases: Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments; ASU 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; ASU No. 2018-11, Targeted Improvements and ASU No. 2018-20, Narrow Scope Improvements for Lessors. ASU 2016-02 is effective for the Company on January 1, 2019. The Company expects to adopt the new standard on its effective date. A modified retrospective transition approach is required, applying the new standard to all leases existing on the date of initial application. An entity may choose to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the financial statements as its date of initial application. The Company expects to adopt the new standard on January 1, 2019 and use the effective date as our date of initial application. Consequently, financial information will not be updated and the disclosures required under the new standard will not be provided for dates and periods before January 1, 2019. The new standard also provides a number of optional practical expedients in transition. The Company expects to elect the package of practical expedients, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. The Company is currently evaluating the effect that the new guidance will have on its financial statements and related disclosures and currently believe the most significant effects of the adoption relate to (1) the recognition of new ROU asset and lease liabilities on our balance sheet for our real estate operating leases and (2) providing significant new disclosures for our leasing activities. ASU 2016-02 also provides practical expedients and certain exemptions for an entity’s ongoing accounting post implementation. The Company currently expects to elect the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize ROU assets or liabilities, and this includes not recognizing ROU assets or liabilities for existing short-term leases of those assets in transition. We also currently expect to elect the practical expedient to not separate lease and non-lease components for all of our leases.We expect to complete our assessment of the full financial impact of ASC 842 during the first quarter of 2019. |
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- Definition The entire disclosure for all significant accounting policies of the reporting entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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LOSS PER SHARE |
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Earnings Per Share [Text Block] | NOTE 4—LOSS PER SHARE Basic loss per share (“EPS”) is calculated by dividing net loss attributable to common stockholders by the weighted average common stock outstanding. Diluted EPS is calculated by adjusting weighted average common shares outstanding for the dilutive effect of common stock options and warrants. In periods in which a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be antidilutive. Securities that could potentially dilute basic EPS in the future were not included in the computation of diluted EPS because to do so would have been antidilutive. The calculations of basic and diluted net loss per share are as follows:
Potentially dilutive securities outstanding as of December 31, 2018 and 2017 relate to stock options outstanding of 3,357,873 and 2,219,000 shares, respectively. |
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- Definition The entire disclosure for earnings per share. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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ACCRUED LIABILITIES | NOTE 5—ACCRUED LIABILITIES Accrued short‑term liabilities are as follows:
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- Definition The entire disclosure for accounts payable and accrued liabilities at the end of the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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LICENSE AGREEMENTS AND COMMITMENTS |
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LICENSE AGREEMENTS AND COMMITMENTS | NOTE 6—LICENSE AGREEMENTS AND COMMITMENTS The Company has entered into two license agreements and certain other agreements with MSK. The license agreements are further described below as the MSK License Agreement and the CD33 License Agreement. These license agreements with MSK grant the Company certain patent rights and intellectual property rights. In consideration of obtaining the patent rights and intellectual property rights, the Company agreed to make certain payments and issue shares of the Company’s common stock to MSK. Certain of the payments are contingent milestone and royalty payments, the terms of which are further described below. Amounts disclosed in footnote 5 for accrued milestone and royalty payments are inclusive of obligations under the MSK License Agreement and CD33 License Agreement, collectively. MSK License Agreement On August 20, 2015, we entered into the MSK License Agreement that grants us a worldwide, sublicensable license to MSK’s rights to certain patent rights and intellectual property rights related to certain know‑how to develop, make, and commercialize licensed products and to perform services for all therapeutic and diagnostic uses in the field of cancer diagnostics and cancer treatments. The patents and patent applications covered by this agreement are directed, in part, to naxitamab, an anti GD2 antibody, and omburtamab, which is an anti B3‑H7 antibody, as well as affinity matured versions of certain antibodies and certain single chain variable fragments (Fv) constructs, and their use for immunotherapy, targeting the treatment of neuroblastoma and other oncology indications. Upon entering into the MSK License Agreement in 2015 and in exchange for the licenses, we paid MSK an upfront payment, issued 1,428,500 shares of our common stock to MSK and agreed to provide certain anti‑dilution rights to MSK. In addition, we are required to pay to MSK certain royalty and milestone payments. We expensed the upfront payment and the issuance of shares to MSK in 2015. We also recorded expense related to common stock issued related to certain anti‑dilution rights held by MSK. See further description in note 7, Stockholders’ Equity. The MSK License Agreement requires us to pay to MSK mid to high single digit royalties based on annual net sales of licensed products or the performance of licensed services by us and our affiliates and sublicensees. We are obligated to pay annual minimum royalties of $80,000 over the royalty term, commencing on the fifth anniversary of the license agreement. These amounts are non‑refundable but are creditable against royalty payments otherwise due under the MSK License Agreement. Total expensed minimum royalty payments in 2016 under the MSK License Agreement were $1,200,000, upon determination that the payment of such minimum royalties was probable and the amount was estimable in 2016. The accrued minimum royalties were recorded as long‑term accrued liabilities as of December 31, 2018 and 2017. We are also obligated to pay MSK certain clinical, regulatory and sales‑based milestone payments under the MSK License Agreement. Certain of the clinical and regulatory milestone payments become due at the earlier of completion of the related milestone activity or the date indicated in the MSK License Agreement. Total clinical and regulatory milestones potentially due under the MSK License Agreement are $2,450,000 and $9,000,000, respectively. There are also sales‑based milestones that become due should the Company achieve certain amounts of sales of licensed products resulting from the license arrangement with MSK, with total sales‑based milestones potentially due of $20,000,000. The Company records milestones in the period in which the contingent liability is probable and the amount is reasonably estimable. In addition, to the extent we enter into sublicense arrangements, we are obligated to pay to MSK a percentage of certain payments that we receive from sublicensees of the rights licensed to us by MSK, which percentage will be based upon the achievement of certain clinical milestones. The Company has not entered into any sublicenses related to the MSK License Agreement. Failure by the Company to meet certain conditions under the arrangement could cause the related license to such licensed product to be canceled and could result in termination of the entire arrangement with MSK. In addition, the Company may terminate the MSK License Agreement with prior written notice to MSK. No milestones were expensed in the twelve months ended December 31, 2018. The Company expensed $150,000 in milestones in the twelve months ended December 31, 2017. As of both December 31, 2018, and December 31, 2017, $875,000 of accrued milestone obligations were recorded in accrued short‑term liabilities and $300,000 was recorded within accrued long‑term liabilities. These milestone-related charges were recorded as research and development expense upon determination that payment of these clinical milestone obligations was probable after satisfying the financing requirements described herein. Research and development is inherently uncertain and as described above, should such research and development fail, the MSK License Agreement is cancelable at the Company’s option. The Company also considered the development risk and each party’s termination rights under the agreement when considering whether any regulatory‑based milestone payments, certain of which also contain time‑based payment requirements, were probable. Given the uncertainty associated with research and development and the Company’s ability to cancel the MSK License Agreement, such regulatory‑based obligations were determined not to be probable as of December 31, 2018 and 2017, and therefore have not been accrued. CD33 License Agreement On November 13, 2017, we entered into an exclusive license agreement for certain MSK rights in connection with certain CD33 antibodies, which we refer to as the CD33 License Agreement. The CD33 License Agreement obligates us to pay to MSK mid to high single digit royalties based on annual net sales of licensed products or the performance of licensed services by us and our affiliates and sublicensees. We are obligated to pay annual minimum royalties of $40,000 over the royalty term, increasing to $60,000 once a patent within the licensed rights is issued, and commencing on the tenth anniversary of the CD33 License Agreement. These amounts are non‑refundable but are creditable against royalty payments otherwise due under the CD33 License Agreement. We are also obligated to pay MSK certain fees under a sponsored research agreement under the CD33 License Agreement. In addition, milestone payments become due upon achievement of the related clinical, regulatory or sales‑based milestone defined in the CD33 License Agreement. Certain of the clinical and regulatory milestone payments become due at the earlier of completion of the related milestone activity or the date indicated in the CD33 License Agreement. Total potential clinical and regulatory milestones potentially due under the CD33 License Agreement are $550,000 and $500,000, respectively. There are also sales‑based milestones that become due should the Company achieve certain amounts of sales of licensed products resulting from the CD33 License Agreement with MSK, with total sales‑based milestones potentially due of $7,500,000. Failure by the Company to meet certain conditions under the CD33 License Agreement could cause the related license to such licensed product to be canceled and could result in termination of the arrangement with MSK. In addition, the Company may terminate the CD33 License Agreement with prior written notice to MSK. The Company records milestones in the period in which the contingent liability is probable and the amount is reasonably estimable. In addition, to the extent we enter into sublicense arrangements, we are obligated to pay to MSK a percentage of certain payments that we receive from sublicensees of the rights licensed to us by MSK, which percentage will be based upon the achievement of certain clinical milestones. The Company has not entered into any sublicenses related to the CD33 License Agreement. In 2017, the total milestone obligations expensed under the CD33 License Agreement with MSK was $550,000, all of which related to clinical milestones. Such clinical milestone obligations become due either based upon the passage of time or achievement of the related milestone activities. None of these clinical milestone obligations were paid in 2017 or 2018, and the total amount of $550,000 was recorded as accrued long‑term liabilities as of December 31, 2018 and December 31, 2017. These milestone‑related charges were recorded as research and development expense in 2017. Research and development is inherently uncertain and as described above, should such research and development fail, the CD33 License Agreement is cancelable at the Company’s option. The Company considered risks as well as each party’s termination rights under the CD33 License Agreement when considering whether any regulatory‑based milestone payments and minimum royalty payments, certain of which also contain time‑based payment requirements, were probable. Given the uncertainty associated with research and development and the Company’s ability to cancel the CD33 License Agreement, such obligations were determined not to be probable as of December 31, 2018 and December 31, 2017 and therefore have not been accrued. MabVax sublicense agreement On June 27, 2018, we entered into a sublicense agreement with MabVax Therapeutics Holding, Inc (“MabVax”) pursuant to which MabVax has sublicensed to the Company certain of MabVax’s patent rights and know‑how for development and commercialization of products for the prevention or treatment of neuroblastoma by means of administering a bi‑valent ganglioside vaccine, granted to MabVax pursuant to an exclusive license agreement between MabVax and MSK. Under the sublicense agreement, the Company has paid a license fee of $700,000 to MabVax and will pay an additional $600,000 at the first anniversary of the sublicense agreement. The initial license fee of $700,000 was expensed and paid upon execution of the agreement and the continuation fee of $600,000 was accrued in 2018. The Company has agreed to become solely responsible for future amounts payable to MSK and to handle other of MabVax’ obligations applicable to the licensed indication towards MSK. This includes the obligation to pay development milestones totaling $1,400,000 and mid single‑digit royalty payments to MSK. Research and development is inherently uncertain and as described above, should such research and development fail, the MabVax sublicense agreement is cancelable at the Company’s option. The Company considered risks as well as each party’s termination rights under the MabVax sublicense agreement when considering whether any milestone payments and minimum royalty payments were probable. Given the uncertainty associated with research and development and the Company’s ability to cancel the MabVax sublicense agreement, such obligations were determined not to be probable as of December 31, 2018 and therefore have not been accrued. Other agreements On November 5, 2015, we entered into a sponsored research agreement, which we refer to as the SRA, with MSK pursuant to which we agreed to pay MSK to provide research services over a period of five years related to the intellectual property licensed under the MSK License Agreement. During 2018 and 2017, we incurred research and development expenses of $1,192,000 and $1,160,000, respectively, under the SRA. On September 20, 2016, we entered into a master data services agreement, which we refer to as the MDSA, with MSK pursuant to which we committed to provide make certain payments in exchange for services provided by approximately two full time employees at MSK, who are engaged in transferring clinical data, databases, regulatory files and other know‑how included in the MSK License Agreement to the Company. On October 11, 2017 the MDSA was amended to increase the resources to approximately three full time employees. During 2018 and 2017, we incurred expenses of $396,000 and $357,000, respectively, under the MDSA. On June 21, 2017, we entered into a master clinical trial agreement, which we refer to as the CTA, with MSK pursuant to which we committed to fund certain clinical trials at MSK. Under the MSK License Agreement, the funding of clinical activities is limited to a five year period. During 2018 and 2017, we incurred research and development expenses of $3,043,000 and $725,000, respectively, under the CTA. On June 27, 2017, we entered into two separate core facility service agreements, which we refer to as the CFSAs, with MSK pursuant to which we committed to obtaining certain laboratory services from MSK. During 2018 and 2017, we incurred research and development expenses of $325,000 and $195,000, respectively, under the CFSAs. On November 13, 2017, we entered into a CD33‑sponsored research agreement, which we refer to as the CD33‑SRA, with MSK pursuant to which we agreed to pay MSK to provide research services over a period of two years related to the intellectual property licensed under the CD33 License Agreement. During the second half of 2017, we incurred research and development expenses of $88,000 under the CD33‑SRA. During 2018 and 2017, we incurred research and development expenses of $670,000 and $88,000, respectively, under the CD33-SRA. Lease Agreements In January 2018, the Company entered into a lease agreement in connection with its corporate headquarters in New York. The term of the lease is five years from the date the Company begins to occupy the premises. Fixed rent payable under the lease is approximately $384,000 per annum and is payable in equal monthly installments of approximately $32,000, which are recognized on a straight‑line basis. Additionally, the Company entered a three‑year lease agreement for the lease of certain office space in Denmark in February 2018, as amended in November 2018 and February 2019. The lease is payable in monthly installments of approximately $19,000, which are recognized on a straight‑line basis. Until the end of March 2018, the Company, has maintained a lease for certain office space in Denmark as further described in footnote 9, Related Party Transactions. |
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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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STOCKHOLDERS' EQUITY |
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STOCKHOLDERS’ EQUITY | NOTE 7—STOCKHOLDERS’ EQUITY Authorized Stock As of December 31, 2018, the Company has authorized a total of 105,500,000 shares, 100,000,000 of which are to be common stock, par value $0.0001 per stock, and 5,500,000 of which are to preferred stock, par value $0.0001 per share. As of December 31, 2017, the Company has authorized a total of 55,500,000 shares, 50,000,000 of which are to be common stock, par value $0.0001 per stock, and 5,500,000 of which are to preferred stock, par value $0.0001 per share. Common Stock Each share of common stock is entitled to one vote. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to preferential dividend rights of the preferred stock, none of which have been issued. The Company has issued 34,193,666 shares of its common stock as of December 31, 2018 and 26,749,666 shares of its common stock as of December 31, 2017. Preferred Stock Preferred stock may be issued from time to time in one or more series with such designations, preferences and relative participating, optional or other special rights and qualifications, limitations or restrictions as approved by the Company’s Board of Directors. No preferred stock has been issued as of December 31, 2018 or December 31, 2017. Issuances of common stock for MSK License Agreement In connection with the MSK License Agreement, in August 2015 we issued to MSK 1,428,500 shares of our common stock. We also agreed to provide certain anti‑dilution rights to MSK. If at any time after such issuance, the Company issued any shares of its common stock, the Company was required to issue sufficient shares of common stock to MSK such that at all times prior to the Company obtaining equity financing equal to or greater than $25,000,000 in the aggregate, MSK shall hold shares of the Common Stock of the Company equal to 12.5% of the issued and outstanding shares of common stock. In 2016, our aggregate equity financing reached $25,000,000 since inception, and we issued to MSK an additional 999,929 shares of our common stock in order to maintain MSK’s 12.5% ownership of the Company. The additional shares were issued at the estimated fair market value of such shares at the time of issuance of $4.38 per share, and the total value of $4,380,000 was charged to expense in the period when the anti‑dilution rights were triggered, with $2,280,000 recognized in 2016. Subsequent to the issuance of such shares and upon achievement of the financing requirement, there are no further anti‑dilution rights due to MSK. Stock grant agreements with non‑employees In August 2015, we entered into certain stock grant agreements with non‑employees of the Company. We agreed to issue a total of 2,800,000 shares to two non‑employee physicians who were involved in the development of technology licensed from MSK in consideration for their prior service. These two physicians were employees of MSK on the date of grant. The shares are released according to a vesting schedule. A total of 560,000 shares were issued in 2015, with a total of 448,000 shares issued in each of 2016 and 2017. In 2018 a total of 448,000 shares were issued to the two researchers, and upon completion of the IPO we issued an additional 96,000 shares such that one of the two grants was fully issued. The issuance was made pursuant to a stock grant agreement and did not result in proceeds to the Company. A total of 400,000 shares are to be issued in each of 2019 and 2020 to one non-employee physician, subject to certain conditions, such that the total grant will have been issued. The total award was expensed at its estimated fair value in 2015, as no future service was required to continue to vest in and receive the shares of common stock. In August 2016, the Company repurchased and retired a total of 83,600 shares from the two non‑employees of the Company at an amount equal to the estimated fair value of $4.38 per share. The transaction reduced the Company’s shareholders’ equity by $366,000. In April 2018, the Company granted 72,373 common stock options to a non‑employee physician employed by MSK under our 2015 Equity Incentive Plan (the 2015 Plan). The options become exercisable over a four‑year period, with the first twenty‑five percent (25%) exercisable twelve (months) from the date of grant and the remainder becoming exercisable ratably each month over the three years thereafter. The contractual term of the option award is 10 years from the date of grant. The total award was expensed at its estimated fair value in April 2018, as no future service was required by the non‑employee to continue to vest in the option grant. The shares will become immediately exercisable upon the occurrence of a change in control, as defined in the 2015 Plan as further described in footnote 8, Stock Options. Issuance of common stock In September 2018, we completed an initial public offering and issued 6,900,000 shares of Common Stock at a purchase price of $16.00 per share for an aggregate consideration of $99,507,000, net of issuance costs. In November 2017, we issued 3,208,552 shares of Common Stock at a purchase price of $9.35 per share for an aggregate consideration of $28,887,000, net of issuance costs. In October 2017, we issued 5,347,568 shares of Common Stock at a purchase price of $9.35 per share for an aggregate consideration of $49,812,000, net of issuance costs. In January and February 2017, we issued 1,192,662 shares of Common Stock at a purchase price of $8.50 per share for an aggregate consideration of $10,137,000, net of issuance costs.
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- Definition The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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STOCK OPTIONS |
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STOCK OPTIONS | NOTE 8—STOCK OPTIONS 2015 Equity Incentive Plan Our board of directors and stockholders have approved and adopted the 2015 Plan, which provides for the grant of incentive stock options, within the meaning of Section 422 of the Code (the Internal Revenue Code), to our employees and any parent and subsidiary corporations’ employees, and for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock and restricted stock units to our employees, directors and consultants and our parent and subsidiary corporations’ employees and consultants. A total of 4,500,000 shares of our common stock are reserved for issuance pursuant to the 2015 Plan. In addition, the number of shares available for issuance under the 2015 Plan will also include an annual increase on the first day of each fiscal year beginning in 2016, equal to 6% of the outstanding shares of common stock as of the last day of our immediately preceding fiscal year. The exercise price of options granted under the plans must at least be equal to the fair market value of our common stock on the date of grant. The term of an incentive stock option may not exceed 10 years, except that with respect to any participant who owns more than 10% of the voting power of all classes of our outstanding stock, the term must not exceed five years and the exercise price must equal at least 110% of the fair market value on the grant date. The administrator will determine the methods of payment of the exercise price of an option, which may include cash, shares or other property acceptable to the administrator, as well as other types of consideration permitted by applicable law. Options granted under the 2015 Plan vest according to the schedule specified in the grant agreements, which is generally over a four year period and generally become immediately exercisable upon the occurrence of a change in control, as defined. Upon the adoption of the 2018 Equity Incentive Plan in September 2018, no further grants are allowed under the 2015 Equity Incentive Plan. 2018 Equity Incentive Plan Our board of directors and stockholders approved and adopted the 2018 Plan, which became effective upon the Company’s initial public offering in September 2018 and which provides for the grant of incentive stock options, within the meaning of Section 422 of the Code (the Internal Revenue Code), to our employees and any parent and subsidiary corporations’ employees, and for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock and restricted stock units to our employees, directors and consultants and our parent and subsidiary corporations’ employees and consultants. A total of 5,500,000 shares of our common stock, inclusive of the awards previously granted under the 2015 Equity Incentive Plan, are reserved for issuance pursuant to the 2018 Plan. In addition, the number of shares available for issuance under the 2018 Plan will also include an annual increase on the first day of each fiscal year beginning in 2019, equal to 4% of the outstanding shares of common stock as of the last day of our immediately preceding fiscal year. The exercise price of options granted under the plans must at least be equal to the fair market value of our common stock on the date of grant. The term of an incentive stock option may not exceed 10 years, except that with respect to any participant who owns more than 10% of the voting power of all classes of our outstanding stock, the term must not exceed five years and the exercise price must equal at least 110% of the fair market value on the grant date. The administrator will determine the methods of payment of the exercise price of an option, which may include cash, shares or other property acceptable to the administrator, as well as other types of consideration permitted by applicable law. Options granted under the 2018 Plan vest according to the schedule specified in the grant agreements, which is generally over a four year period and generally become immediately exercisable upon the occurrence of a change in control, as defined.
Stock Option Valuation During the years ended December 31, 2018 and 2017, stock‑based compensation expenses for stock option grants were $1,381,000 and $609,000, respectively, for options granted to employees. During 2018 the expenses were recorded as $276,000 in research and development expense and $1,105,000 in general and administrative expense. During 2017 the expenses were recorded as $167,000 in research and development expense and $442,000 in general and administrative expense. During the year ended December 31, 2018, stock-based compensation for stock option grants was $585,000 in research and development expense for options granted to non-employees. The Company did not grant any options to non‑employees during the year ended December 31, 2017. The assumptions that the Company used to determine the fair value of the stock options granted to employees and directors were as follows, presented on a weighted average basis:
The assumptions that the Company used to determine the fair value of the stock options granted to non‑employees were as follows, presented on a weighted average basis:
The Company recognizes compensation expense for only the portion of awards that vest. The following table summarizes common stock options issued and outstanding:
The weighted average grant‑date fair value of stock options granted during the years ended December 31, 2018 and 2017 was $9.58 and $5.59 per share, respectively. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. As of December 31, 2018, we had $10,848,000 of unrecognized compensation related to employee stock options that are expected to vest over a period of 2.82 years. |
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- Definition The entire disclosure for compensation-related costs for equity-based compensation, which may include disclosure of policies, compensation plan details, allocation of equity compensation, incentive distributions, equity-based arrangements to obtain goods and services, deferred compensation arrangements, employee stock ownership plan details and employee stock purchase plan details. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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RELATED PARTY TRANSACTIONS |
12 Months Ended |
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Dec. 31, 2018 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 9—RELATED PARTY TRANSACTIONS MSK is a shareholder of the Company and under the MSK License Agreement, the CD33 License Agreement, CTA, CFAs, SRA and MDSA, we have expensed costs in the total amount of $5,761,000 and $3,730,000 in the years ended December 31, 2018 and 2017, respectively, for milestones, minimum royalties, research and development costs and patent activities. Please refer to footnote 6 for additional details on our various agreements with MSK. As of December 31, 2018 and 2017, we had a total of $4,475,000 and $4,587,000, respectively, recorded as accounts payable and accrued liabilities related to amounts due to MSK. In July 2016, the Company entered into an agreement of lease with a shareholder of the Company, Weco Group, in connection with the subsidiary in Denmark. The lease payable thereunder is approximately $4,000 per month and, as the lease can be terminated with three months’ notice, any future rent commitment thereunder will amount to approximately $12,000. The lease terminated in March 2018, when the Company moved to a new third‑party lease. In addition, the Company has reimbursed Weco Group for certain administrative expenses. The total expenses, including rent, equaled $44,000 and $88,000 during 2018 and 2017, respectively. |
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- References No definition available.
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- Definition The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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INCOME TAXES |
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INCOME TAXES | NOTE 10—INCOME TAXES Domestic and foreign loss before income taxes are as follows:
The Company provided no current and deferred income taxes on net losses of $(43,274,000) and $(19,161,000) for years ended December 31, 2018 and 2017, respectively. The Tax Cuts and Jobs Act (TCJA) was enacted on December 22, 2017. The TCJA contains significant changes to corporate taxation, including but not limited to, a reduction in the U.S. federal corporate tax rate from a top marginal rate of 35% to 21%, a one‑time mandatory transition tax on accumulated foreign earnings, limitation of the deduction for net operating losses to 80% of annual taxable income while providing that the net operating loss carryovers for years after 2017 will not expire, limitation on the amount of research and development expenses deductible per year beginning in years after 2021 and reduction of the Orphan Drug Credit from 50% to 25% of qualified clinical testing expenditures for years after 2017. The TCJA also made changes to the U.S. federal taxation of foreign earnings and to the timing of recognition of certain revenue and expenses and the deductibility of certain business expenses. In response to the TCJA, the staff of the Securities and Exchange Commission issued Staff Accounting Bulletin No. 118, (“SAB 118”) to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the TCJA. As a result of the TCJA being signed into law, the Company recognized a provisional charge of $4,394,000 in the fourth quarter of 2017 related to the re‑measurement of its U.S. deferred tax assets at the lower enacted corporate tax rate. Due to the history of net operating losses, the Company is in a full valuation allowance position. As a result, the additional tax expense due to the TCJA was offset by an equal reduction to the valuation allowance, resulting in no net tax impact from the TCJA to the overall financial condition and results of operations of the Company. The Company was allowed a measurement period of up to one year after the enactment date of the TCJA to finalize the recording of the related tax accounting effects. As of December 31, 2018, the Company had completed its accounting for the effects of the TCJA and no adjustments were recorded to the provisional amount. The difference between income taxes expected at the U.S. federal statutory income tax rate of 21% and 34% for tax years ended December 31, 2018 and December 31, 2017, respectively, and income taxes provided are set forth below:
For the year ended December 31, 2017, as a result of the enactment of the Tax Cuts and Jobs Act, there was no impact to our financial position or results associated with a write‑off of deferred tax assets due to the rate change from 34% to 21% and their associated valuation allowance, and a one‑time mandatory transition tax. Significant components of the Company’s net deferred tax assets/(liabilities) are as follows:
The Company recognizes income tax benefits for tax positions determined more likely than not to be sustained upon examination, based on the technical merits of the positions. As of December 31, 2018, and 2017, the Company has determined that there were no uncertain tax positions. The Company’s tax returns for years 2017, 2016 and 2015 are open for tax examination by U.S. federal and state, and the Danish tax authorities. The Company maintains a full valuation allowance on its U.S. and foreign deferred tax assets. The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more‑likely‑than‑not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In its evaluation, the Company considered its cumulative loss in recent years and its forecasted losses in the near‑term as significant negative evidence. Based upon review of available positive and negative evidence, the Company determined that the negative evidence outweighed the positive evidence and a full valuation allowance on its U.S. and foreign deferred tax assets will be maintained. The Company will continue to assess the realizability of its deferred tax assets and will adjust the valuation allowance as needed. As of December 31, 2018, the Company had U.S. federal and state and local net operating loss (“NOL”) carryforwards of approximately $72,323,000, which are available to reduce future taxable income. The Company also had U.S. federal tax credits of $2,789,000 as of December 31, 2018, which may be used to offset future tax liabilities. The NOL and tax credit carryforwards will begin to expire in 2035. The NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986 (“IRC”). The Company has performed an analysis of its Section 382 ownership changes through December 31, 2018. Due to the large annual limitation, the Company believes that it is more likely than not that none of the net operating loss carryforwards will expire as a result of the limitation from the ownership change under Section 382. The Company also has Danish NOL carryforwards of $1,154,000, which have an indefinite carryforward period. |
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- References No definition available.
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- Definition The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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OTHER BENEFITS |
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Dec. 31, 2018 | |
OTHER BENEFITS | |
OTHER BENEFITS | NOTE 11—OTHER BENEFITS The Company has established a retirement program for employees of our Danish subsidiary pursuant to which all such employees can contribute an amount at their election from their base compensation and may receive contributions from our Danish subsidiary. Contributions from our Danish subsidiary were immaterial during the years ended December 31, 2018 and 2017. In addition, health insurance benefits for our Danish employees are fully paid for by such employees. Our Danish subsidiary does not incur any costs for these health insurance benefits.
On October 1, 2018, the Company adopted a defined contribution 401(k) savings plan (the 401(k) plan) covering all U.S. employees of the Company. Participants may elect to defer a percentage of their pretax or after-tax compensation to the 401(k) plan, subject to defined limitations. The plan allows for a discretionary match by the Company. The Company made no matching contributions to the plan during the years ended December 31, 2018 and December 31, 2017. |
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- References No definition available.
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- Definition The entire disclosure for other benefits including retirement benefits and health insurance benefits. No definition available.
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SUBSEQUENT EVENTS |
12 Months Ended |
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Dec. 31, 2018 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 12—SUBSEQUENT EVENTS In February 2019, the Company entered a three year lease for a 4,500 square feet laboratory lease in Nutley, New Jersey. Monthly lease payments are approximately $12,000 per month during the lease term. |
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- References No definition available.
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- Definition The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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QUARTERLY CONSOLIDATED FINANCIAL DATA (unaudited) |
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QUARTERLY CONSOLIDATED FINANCIAL DATA (unaudited) | NOTE 13—QUARTERLY CONSOLIDATED FINANCIAL DATA (unaudited)
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- References No definition available.
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- Definition The entire disclosure for quarterly financial data. Includes, but is not limited to, tabular presentation of financial information for fiscal quarters, effect of year-end adjustments, and an explanation of matters or transactions that affect comparability of the information. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) |
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||||||||
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the accrual for research and development expenses, the accrual of milestone and royalty payments, the valuation of shares of common stock and stock options. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. |
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Cash, Cash Equivalents, and Restricted Cash | Cash and Cash Equivalents The Company considers all highly‑liquid investments with maturities of three months or less from date of purchase to be cash equivalents. The Company primarily maintains its cash balances with financial institutions in federally insured accounts and cash held in an unrestricted escrow account. The Company has cash in financial institutions in excess of FDIC insurance limits. Restricted cash represents a bank account with funds to cover the Company’s corporate credit card availability. |
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Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight‑line method over the estimated useful life of each asset as follows:
Depreciation and amortization expense on property and equipment was $29,000 and $0 for the years ended December 31, 2018 and 2017, respectively. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. |
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Impairment of Long-Lived Assets | Impairment of Long‑Lived Assets ASC 360, Property, Plant and Equipment, addresses the financial accounting and reporting for impairment or disposal of long‑lived assets. The Company reviews the recorded values of long‑lived assets for impairment whenever events or changes in business circumstance indicate that the carrying amount of an asset or group of assets may not be fully recoverable. |
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Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, professional accounting and other third‑party fees that are directly associated with in‑process equity financings as deferred offering costs within other assets until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of proceeds generated as a result of the offering. Should the planned equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statement of comprehensive loss. The Company did not record any deferred offering costs as of December 31, 2018. The Company recorded deferred offering costs of $0.8 million as of December 31, 2017. Accounts payable and accrued liabilities at December 31, 2017 included $0.2 million of deferred offering costs. These deferred operating costs were reclassified to shareholders’ equity upon the successful completion of the IPO during the year ended December 31, 2018. |
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Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability approach for the financial accounting and reporting of income taxes. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to net operating loss carry forwards and temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. These assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which the temporary differences are expected to reverse. A valuation allowance is established when management determines that it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company prepares and files tax returns based on its interpretation of tax laws and regulations. In the normal course of business, the Company’s tax returns are subject to examination by various taxing authorities. Such examinations may result in future tax and interest assessments by these taxing authorities. In determining the Company’s tax provision for financial reporting purposes, the Company establishes a reserve for uncertain tax positions unless such positions are determined to be more likely than not of being sustained upon examination based on their technical merits. The Company considers many factors when evaluating and estimating its tax positions and tax benefits, which may require periodic adjustments and which may not accurately anticipate actual outcomes. Accordingly, the Company will report a liability for unrecognized tax benefits resulting from any uncertain tax positions taken or expected to be taken on a tax return. The Company’s policy is to recognize, when applicable, interest and penalties on uncertain tax positions as part of income tax expense. In accordance with guidance issued by Financial Accounting Standards Board (“FASB”), companies should make and disclose a policy election as to whether they will recognize deferred taxes for basis differences expected to reverse as Global Intangible Low‑Taxed Income (“GILTI”) or whether they will account for GILTI as period costs if and when incurred. The Company has elected to recognize the resulting tax with respect to the GILTI provision as a period cost. No costs were incurred by the Company through December 31, 2018 as a result of GILTI. |
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Research and Development Costs | Research and Development Costs Research and development costs are charged to operations when incurred and are included in operating expenses. Research and development costs consist principally of compensation cost for our employees and consultants that perform our research activities, the fees paid to maintain our licenses, the payments to third parties for manufacturing and clinical research organizations and additional product development, and consumables and other materials used in research and development. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Actual results could differ from the Company’s estimates. The Company is obligated to make certain milestone and royalty payments in accordance with the contractual terms of its license agreement with MSK based upon the resolution of certain contingencies. The Company records the milestone and royalty payment when the achievement of the milestone or payment of the milestone or royalty is probable and the amount of the payment is reasonably estimable. Research and development costs were $34.3 million and $14.3 million for the years ended December 31, 2018 and 2017, respectively. |
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Patent Costs | Patent Costs The Company expenses the costs of obtaining and maintaining patents as general and administrative expenses. |
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Stock-Based Compensation | Stock‑Based Compensation The Company measures stock options granted to employees and directors based on the fair value on the date of the grant and recognizes compensation expense of those awards, over the requisite service period, which is the vesting period of the respective award. Forfeitures are accounted for as they occur. The Company issues stock options with only service‑based vesting conditions and records the expense for these awards using the straight‑line method over the requisite service period. For share‑based awards granted to non‑employees, compensation expense is recognized over the period during which services are rendered by such non‑employees until completed. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then‑current fair value of the Company’s common shares and updated assumption inputs in the Black‑Scholes option‑pricing model. The fair value of each stock option grant is estimated on the date of grant using the Black‑Scholes option pricing model. The Company historically has been a private company and lacks company‑specific historical and implied volatility information for its shares. Therefore, it estimates its expected share price volatility based on the historical volatility of a group of publicly‑traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards as the Company has limited historical data to support the expected term assumption. The expected term of stock options granted to non‑employees is equal to the contractual term of the option award. The risk‑free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield is based on the fact that the Company has never paid cash dividends on common shares and does not expect to pay any cash dividends in the foreseeable future. |
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Segment Information | Segment Information The Company is engaged solely in the discovery and development of novel antibody therapeutic products to treat cancer. Accordingly, the Company has determined that it operates in one operating segment. |
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Comprehensive Loss | Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with shareholders. The difference between net loss and comprehensive loss for the period presented in the accompanying financial statements was due to foreign currency translation. |
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Foreign Currency | Foreign Currency The financial statements of our Danish subsidiary with a functional currency other than the U.S. dollar are translated into U.S. dollars using period‑end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income (loss), net of tax, in stockholders’ equity. Foreign currency transaction gains and losses are included in the results of operations in other income and expense, and totaled $(97,000) and $63,000 for the years ended December 31, 2018 and 2017, respectively. |
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Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements - Adopted In March 2018, the FASB issued Accounting Standards Update No. 2018-05 (“ASU 2018-05”), Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin (SAB) No. 118. The ASU adds seven paragraphs to ASC 740, Income Taxes, that contain SEC guidance related to SAB 118 (codified as SEC SAB Topic 5.EE, “Income Tax Accounting Implications of the Tax Cuts and Jobs Act”), which provides guidance for companies that are not able to complete their accounting for the income tax effects of the Tax Cuts and Jobs Act in the period of enactment which is the period that includes December 22, 2017. The measurement period should not extend beyond one year from the enactment date. The Company completed its accounting for the income tax effects for the year ended December 31, 2018. See Note 10 for a discussion of the impact of the guidance on the Company’s consolidated financial statements. In May 2017, the FASB issued Accounting Standards Update No. 2017‑09 (“ASU 2017‑09”), Compensation—Stock Compensation (Topic 718)—Scope of Modification Accounting. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award changes as a result of the change in terms or conditions. The guidance is effective prospectively for annual periods beginning on or after December 15, 2017 with early adoption permitted. The Company adopted ASU 2017‑09 on January 1, 2018 and will account for any modifications in accordance with ASU 2017‑09 subsequent to the effective date. The adoption of this standard on January 1, 2018 did not have a material impact on our consolidated financial statements and related disclosures. In November 2016, the FASB issued Accounting Standards Update No. 2016‑18 (“ASU 2016‑18”), Statement of Cash Flows (Topic 230)—Restricted Cash. Under the new guidance, it changes the presentation of restricted cash and cash equivalents on the statement of cash flows. Restricted cash and restricted cash equivalents will be included with cash and cash equivalents when reconciling the beginning‑of‑period and end‑of‑period total amounts shown on the statement of cash flows. This amendment is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. The adoption of this standard on January 1, 2018 did not have a material impact on our consolidated financial statements and related disclosures. In October 2016, the FASB issued Accounting Standards Update No. 2016-16 (“ASU 2016-16”), Intra-Entity Transfers of Assets Other than Inventory, as part of its simplification initiative. Under the new guidance, an entity should recognize the income tax consequences of an intra-entity transfer of an asset other than inventory when the transfer occurs. Consequently, the amendments in this Update eliminate the exception for an intraentity transfer of an asset other than inventory. ASU 2016-16 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The adoption of this standard on January 1, 2018 did not have a material impact on our consolidated financial statements and related disclosures. In August 2016, the FASB issued Accounting Standards Update No. 2016‑15 (“ASU 2016‑15”), Classification of Certain Cash Receipts and Cash Payments. ASU 2016‑15 clarifies how certain cash receipts and payments should be presented in the statement of cash flows. The guidance is effective in 2018 with early adoption permitted. The adoption of this standard on January 1, 2018 did not have a material impact on our consolidated financial statements and related disclosures. In March 2016, the FASB issued Accounting Standards Update No. 2016-09 (“ASU 2016-09”), Compensation-Stock Compensation (Topic 718), as part of its simplification initiative. The areas for simplification in ASU 2016-09 involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for periods beginning after December 15, 2016 with early adoption permitted. The adoption of this standard on January 1, 2017 did not have a material impact on our consolidated financial statements and related disclosures. In November 2015, the FASB issued Accounting Standards Update No. 2015‑17 (“ASU 2015‑17”), Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. ASU 2015‑17 simplifies current guidance and requires companies to classify all deferred tax assets and liabilities as noncurrent on the balance sheet. ASU 2015‑17 can be applied either prospectively or retrospectively and is effective for periods beginning after December 15, 2016, with early adoption permitted. The adoption of this standard on January 1, 2017 did not have a material impact on our consolidated financial statements and related disclosures.
Issued Accounting Pronouncements – Not Yet Adopted In August 2018, the Securities Exchange Commission (“SEC”) adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statement. Under the amendments, an analysis of changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. The Company anticipates its first presentation of changes in stockholders’ equity as required under the new SEC guidance will be included in its Form 10-Q for the three-month period ended March 31, 2019. In August 2018, the FASB issued Accounting Standards Update No. 2018-15 (“ASU 2018-15”), Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. ASU 2018-15 clarifies certain aspects of ASU 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement, which was issued in April 2015. Specifically, ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal use software (and hosting arrangements that include an internal-use software license). ASU 2018-15 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the impact its adoption may have on its consolidated financial statements. In July 2018, the FASB issued Accounting Standards Update No. 2018-09 (“ASU 2018-09”), Codification Improvements, which clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2018-09 are not expected to have a significant effect on current accounting practices. Some of the amendments in this update do not require transition guidance and will be effective upon this update. However, many of the updates do have transition guidance with effective dates for periods beginning after December 15, 2018. The Company does not expect this ASU to have a significant impact on its consolidated financial statements. In June 2018, the FASB issued Accounting Standards Update No. 2018‑07, (“ASU 2018-07”), Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share‑Based Payment Accounting. ASU 2018‑07 is intended to simplify aspects of share‑based compensation issued to non‑employees by making the guidance consistent with the accounting for employee share‑based compensation. ASU 2018‑07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of ASU 2018‑07 will have on its consolidated financial statements. In February 2018, the FASB issued Accounting Standards Update No. 2018‑02, (“ASU 2018-02”), Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. ASU 2018‑02 allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. ASU 2018‑07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company does not expect this ASU to have a significant impact on its consolidated financial statements. In February 2016, the FASB issued Accounting Standards Update No. 2016‑02 (“ASU 2016‑02”), Leases, which is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018 with early adoption permitted. Under ASU 2016‑02, lessees will be required to recognize for all leases, at the commencement date of the lease, a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and a right‑to‑use asset, which is an asset that represents the lessee’s right to use or control the use of a specified asset for the lease term. Topic 842 was subsequently amended by ASU 2017-13, Revenue and Leases: Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments; ASU 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; ASU No. 2018-11, Targeted Improvements and ASU No. 2018-20, Narrow Scope Improvements for Lessors. ASU 2016-02 is effective for the Company on January 1, 2019. The Company expects to adopt the new standard on its effective date. A modified retrospective transition approach is required, applying the new standard to all leases existing on the date of initial application. An entity may choose to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the financial statements as its date of initial application. The Company expects to adopt the new standard on January 1, 2019 and use the effective date as our date of initial application. Consequently, financial information will not be updated and the disclosures required under the new standard will not be provided for dates and periods before January 1, 2019. The new standard also provides a number of optional practical expedients in transition. The Company expects to elect the package of practical expedients, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. The Company is currently evaluating the effect that the new guidance will have on its financial statements and related disclosures and currently believe the most significant effects of the adoption relate to (1) the recognition of new ROU asset and lease liabilities on our balance sheet for our real estate operating leases and (2) providing significant new disclosures for our leasing activities. ASU 2016-02 also provides practical expedients and certain exemptions for an entity’s ongoing accounting post implementation. The Company currently expects to elect the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize ROU assets or liabilities, and this includes not recognizing ROU assets or liabilities for existing short-term leases of those assets in transition. We also currently expect to elect the practical expedient to not separate lease and non-lease components for all of our leases.We expect to complete our assessment of the full financial impact of ASC 842 during the first quarter of 2019. |
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- References No definition available.
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- Definition Entity's cash and cash equivalents accounting policy with respect to restricted balances. Restrictions may include legally restricted deposits held as compensating balances against short-term borrowing arrangements, contracts entered into with others, or company statements of intention with regard to particular deposits; however, time deposits and short-term certificates of deposit are not generally included in legally restricted deposits. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for comprehensive income. No definition available.
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- Definition Disclosure of accounting policy for deferral and amortization of significant deferred charges. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for (1) transactions denominated in a currency other than the reporting enterprise's functional currency, (2) translating foreign currency financial statements that are incorporated into the financial statements of the reporting enterprise by consolidation, combination, or the equity method of accounting, and (3) remeasurement of the financial statements of a foreign reporting enterprise in a hyperinflationary economy. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for recognizing and measuring the impairment of long-lived assets. An entity also may disclose its accounting policy for long-lived assets to be sold. This policy excludes goodwill and intangible assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for income taxes, which may include its accounting policies for recognizing and measuring deferred tax assets and liabilities and related valuation allowances, recognizing investment tax credits, operating loss carryforwards, tax credit carryforwards, and other carryforwards, methodologies for determining its effective income tax rate and the characterization of interest and penalties in the financial statements. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy pertaining to new accounting pronouncements that may impact the entity's financial reporting. Includes, but is not limited to, quantification of the expected or actual impact. No definition available.
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- Definition Disclosure of accounting policy for long-lived, physical assets used in the normal conduct of business and not intended for resale. Includes, but is not limited to, basis of assets, depreciation and depletion methods used, including composite deprecation, estimated useful lives, capitalization policy, accounting treatment for costs incurred for repairs and maintenance, capitalized interest and the method it is calculated, disposals and impairments. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for costs it has incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for segment reporting. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for stock option and stock incentive plans. This disclosure may include (1) the types of stock option or incentive plans sponsored by the entity (2) the groups that participate in (or are covered by) each plan (3) significant plan provisions and (4) how stock compensation is measured, and the methodologies and significant assumptions used to determine that measurement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for the use of estimates in the preparation of financial statements in conformity with generally accepted accounting principles. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy for patent costs. No definition available.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) |
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Schedule of property and equipment |
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- Definition Tabular disclosure of physical assets used in the normal conduct of business and not intended for resale. Includes, but is not limited to, balances by class of assets, depreciation and depletion expense and method used, including composite depreciation, and accumulated deprecation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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LOSS PER SHARE (Tables) |
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Schedule of basic and diluted net loss per share |
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- Definition Tabular disclosure of an entity's basic and diluted earnings per share calculations, including a reconciliation of numerators and denominators of the basic and diluted per-share computations for income from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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ACCRUED LIABILITIES (Tables) |
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- Definition Tabular disclosure of the components of accrued liabilities. No definition available.
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STOCK OPTIONS (Tables) |
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Schedule of common stock options issued and outstanding |
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Schedule of assumptions that Company used to determine the fair value of the stock options granted |
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Schedule of assumptions that Company used to determine the fair value of the stock options granted |
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- Definition Tabular disclosure for stock option plans. Includes, but is not limited to, outstanding awards at beginning and end of year, grants, exercises, forfeitures, and weighted-average grant date fair value. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Tabular disclosure of the significant assumptions used during the year to estimate the fair value of stock options, including, but not limited to: (a) expected term of share options and similar instruments, (b) expected volatility of the entity's shares, (c) expected dividends, (d) risk-free rate(s), and (e) discount for post-vesting restrictions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
INCOME TAXES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INCOME TAXES | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of domestic and foreign loss before income taxes |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of difference between incomes taxes expected at U.S. federal statutory income tax rate and income taxes |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of significant components of net deferred tax assets/(liabilities) |
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of the components of net deferred tax asset or liability recognized in an entity's statement of financial position, including the following: the total of all deferred tax liabilities, the total of all deferred tax assets, the total valuation allowance recognized for deferred tax assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Tabular disclosure of the reconciliation using percentage or dollar amounts of the reported amount of income tax expense attributable to continuing operations for the year to the amount of income tax expense that would result from applying domestic federal statutory tax rates to pretax income from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Tabular disclosure of income before income tax between domestic and foreign jurisdictions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
QUARTERLY CONSOLIDATED FINANCIAL DATA (unaudited) (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
QUARTERLY CONSOLIDATED FINANCIAL DATA (unaudited) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of quarterly consolidated financial data |
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of quarterly financial data. Includes, but is not limited to, financial information for fiscal quarters, cumulative effect of a change in accounting principle and earnings per share data. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
ORGANIZATION AND DESCRIPTION OF BUSINESS (Details) |
12 Months Ended |
---|---|
Dec. 31, 2018
agreement
| |
ORGANIZATION AND DESCRIPTION OF BUSINESS | |
Number of product development programs for which entity has obtained exclusive rights | 2 |
X | ||||||||||
- Definition Number of product development programs for which entity has obtained exclusive rights. No definition available.
|
X | ||||||||||
- Definition NA No definition available.
|
BASIS OF PRESENTATION (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
BASIS OF PRESENTATION | ||
Accumulated deficit | $ 84,835 | $ 41,561 |
Cash and cash equivalents | $ 147,840 | $ 90,483 |
X | ||||||||||
- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The cumulative amount of the reporting entity's undistributed earnings or deficit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition NA No definition available.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Property and Equipment | ||
Depreciation and amortization expense | $ 29,000 | $ 0 |
Furniture and fixtures | ||
Property and Equipment | ||
Estimated Useful Life | 5 years | |
Leasehold improvements | Maximum | ||
Property and Equipment | ||
Estimated Useful Life | 15 years |
X | ||||||||||
- Definition The current period expense charged against earnings on long-lived, physical assets not used in production, and which are not intended for resale, to allocate or recognize the cost of such assets over their useful lives; or to record the reduction in book value of an intangible asset over the benefit period of such asset; or to reflect consumption during the period of an asset that is not used in production. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Useful life of long lived, physical assets used in the normal conduct of business and not intended for resale, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Examples include, but not limited to, land, buildings, machinery and equipment, office equipment, furniture and fixtures, and computer equipment. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Other (Details) |
12 Months Ended | |
---|---|---|
Dec. 31, 2018
USD ($)
segment
|
Dec. 31, 2017
USD ($)
|
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Deferred offering costs | $ 772,000 | |
Deferred offering costs included in accounts payable and accrued liabilities | 200,000 | |
Research and development | $ 34,269,000 | 14,307,000 |
Number of operating segments | segment | 1 | |
Foreign currency transaction gains and losses | $ (97,000) | $ 63,000 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Specific incremental costs directly attributable to a proposed or actual offering of securities which are deferred at the end of the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount before tax of foreign currency transaction realized and unrealized gain (loss) recognized in the income statement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of operating segments. An operating segment is a component of an enterprise: (a) that engages in business activities from which it may earn revenues and incur expenses (including revenues and expenses relating to transactions with other components of the same enterprise), (b) whose operating results are regularly reviewed by the enterprise's chief operating decision maker to make decisions about resources to be allocated to the segment and assess its performance, and (c) for which discrete financial information is available. An operating segment may engage in business activities for which it has yet to earn revenues, for example, start-up operations may be operating segments before earning revenues. No definition available.
|
X | ||||||||||
- Definition The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of deferred offering costs included in accounts payable and accrued liabilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
|
LOSS PER SHARE - Basic and diluted (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 12 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2017 |
Sep. 30, 2017 |
Jun. 30, 2017 |
Mar. 31, 2017 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
LOSS PER SHARE | ||||||||||
Net loss (numerator) | $ (14,060) | $ (11,426) | $ (10,305) | $ (7,483) | $ (9,253) | $ (3,827) | $ (3,191) | $ (2,890) | $ (43,274) | $ (19,161) |
Weighted average common shares outstanding, basic and diluted (denominator) | 28,772,384 | 19,397,506 | ||||||||
Basic and diluted net loss per share (in dollars per share) | $ (0.42) | $ (0.42) | $ (0.38) | $ (0.28) | $ (0.44) | $ (0.21) | $ (0.18) | $ (0.16) | $ (1.50) | $ (0.99) |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or loss for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Average number of shares or units issued and outstanding that are used in calculating basic and diluted earnings per share (EPS). No definition available.
|
LOSS PER SHARE - Anti-dilutive securities (Details) - shares |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Stock options | ||
LOSS PER SHARE | ||
Potentially dilutive securities outstanding | 3,357,873 | 2,219,000 |
X | ||||||||||
- Definition Securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Details
|
ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Accrued short term liabilities | ||
Accrued milestone payments | $ 1,475 | $ 875 |
Accrued clinical costs | 63 | 212 |
Accrued compensation and board fees | 1,144 | 810 |
Accrued rent | 44 | |
Other | 525 | 119 |
Total | $ 3,251 | $ 2,016 |
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred and payable, pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered. Examples include taxes, interest, rent and utilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for contractual rent under lease arrangements. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of expenses incurred but not yet paid classified as other, due within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for clinical costs. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for compensation and board fees. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for milestone payments. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
|
LICENSE AGREEMENTS AND COMMITMENTS (Details) |
Dec. 31, 2018
agreement
|
---|---|
LICENSE AGREEMENTS AND COMMITMENTS | |
Number of license agreements | 2 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Represents the number of license agreements. No definition available.
|
LICENSE AGREEMENTS AND COMMITMENTS - MSK License Agreement (Details) - USD ($) |
1 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|
Aug. 20, 2015 |
Aug. 31, 2015 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Agreements | |||||
Accrued milestone payments, current | $ 1,475,000 | $ 875,000 | |||
MSK License Agreement | |||||
Agreements | |||||
Issuance of common stock to strategic partner (in shares) | 1,428,500 | 1,428,500 | 999,929 | ||
Annual minimum royalties payable from fifth anniversary | $ 80,000 | ||||
Expensed minimum royalty payments | $ 1,200,000 | ||||
Clinical milestones potentially due | 2,450,000 | ||||
Regulatory milestones potentially due | 9,000,000 | ||||
Sales-based milestones potentially due | $ 20,000,000 | ||||
Clinical milestone expense | 0 | 150,000 | |||
MSK License Agreement | Accrued short-term liabilities | |||||
Agreements | |||||
Accrued milestone payments, current | 875,000 | 875,000 | |||
MSK License Agreement | Accrued long-term liabilities | |||||
Agreements | |||||
Accrued milestone payments, noncurrent | $ 300,000 | $ 300,000 |
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Amount of expense related to royalty payments under a contractual arrangement such as payment for mineral and drilling rights and use of technology or intellectual property. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for milestone payments. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and due after one year (or beyond the operating cycle if longer) for milestone payments. No definition available.
|
X | ||||||||||
- Definition Represents the annual minimum royalties payable from fifth anniversary under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Amount charged for clinical milestone expense during the period under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the clinical milestone payments potentially due under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the regulatory milestone payments potentially due under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the sales based milestones payments potentially due under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Number of new stock issued to the strategic partner during the period. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
LICENSE AGREEMENTS AND COMMITMENTS - CD33 License Agreement (Details) - CD33 License Agreement - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Nov. 13, 2017 |
|
Agreements | |||
Annual minimum royalties payable | $ 40,000 | ||
Annual minimum royalties payable from tenth anniversary | 60,000 | ||
Clinical milestones potentially due | 550,000 | ||
Regulatory milestones potentially due | 500,000 | ||
Sales-based milestones potentially due | $ 7,500,000 | ||
Clinical milestone expense | $ 550,000 | ||
Clinical milestone payment | $ 0 | 0 | |
Accrued long-term liabilities | |||
Agreements | |||
Accrued milestone payments, noncurrent | $ 550,000 | $ 550,000 |
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and due after one year (or beyond the operating cycle if longer) for milestone payments. No definition available.
|
X | ||||||||||
- Definition Represents the annual minimum royalties payable under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the annual minimum royalties payable from tenth anniversary under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Amount charged for clinical milestone expense during the period under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Amount paid during the period for clinical milestones under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the clinical milestone payments potentially due under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the regulatory milestone payments potentially due under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the sales based milestones payments potentially due under collaborative arrangement. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
LICENSE AGREEMENTS AND COMMITMENTS - MabVax sublicense agreement (Details) - MabVax sublicense agreement - USD ($) |
12 Months Ended | |
---|---|---|
Jun. 27, 2018 |
Dec. 31, 2018 |
|
Agreements | ||
License fee paid | $ 700,000 | |
Additional license fee payable at first anniversary | 600,000 | |
License fee expense | $ 700,000 | |
Continuation fee | $ 600,000 | |
Development milestone payments due | $ 1,400,000 |
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Amount of continuation fee expense under the terms of the agreement. No definition available.
|
X | ||||||||||
- Definition Represents the additional license fee payable at first anniversary under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the development milestone payments due under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Amount charged for license fee expense during the period under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the payment of license fee under collaborative arrangement. No definition available.
|
X | ||||||||||
- Details
|
LICENSE AGREEMENTS AND COMMITMENTS - Other agreements (Details) |
6 Months Ended | 12 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|---|
Nov. 13, 2017 |
Oct. 11, 2017
employee
|
Jun. 27, 2017
agreement
|
Jun. 21, 2017 |
Sep. 20, 2016
employee
|
Nov. 05, 2015 |
Dec. 31, 2017
USD ($)
|
Dec. 31, 2018
USD ($)
|
Dec. 31, 2017
USD ($)
|
|
Agreements | |||||||||
Research and development | $ 34,269,000 | $ 14,307,000 | |||||||
SRA | |||||||||
Agreements | |||||||||
Research service period | 5 years | ||||||||
Research and development | 1,192,000 | 1,160,000 | |||||||
MDSA | |||||||||
Agreements | |||||||||
Research and development | 396,000 | 357,000 | |||||||
Number of full-time employees | employee | 3 | 2 | |||||||
CTA | |||||||||
Agreements | |||||||||
Research service period | 5 years | ||||||||
Research and development | 3,043,000 | 725,000 | |||||||
CFAs | |||||||||
Agreements | |||||||||
Number of core facility service agreements | agreement | 2 | ||||||||
Research and development | 325,000 | 195,000 | |||||||
CD33-SRA | |||||||||
Agreements | |||||||||
Research service period | 2 years | ||||||||
Research and development | $ 88,000 | $ 670,000 | $ 88,000 |
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Represents the number of full-time employees under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the research service period under collaborative arrangement. No definition available.
|
X | ||||||||||
- Definition Represents the number of core facility service agreements. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
LICENSE AGREEMENTS AND COMMITMENTS - Lease agreements (Details) - USD ($) |
Feb. 28, 2018 |
Jan. 31, 2018 |
---|---|---|
Corporate headquarters, New York | ||
Agreements | ||
Lease term | 5 years | |
Fixed rent payable per annum | $ 384,000 | |
Lease payable per month | $ 32,000 | |
Office space, Denmark | ||
Agreements | ||
Lease term | 3 years | |
Lease payable per month | $ 19,000 |
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Term of lessee's operating lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Amount of fixed rent payable per annum under the terms of the lease agreement. No definition available.
|
X | ||||||||||
- Definition Represents the amount of lease payable per month. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
STOCKHOLDERS' EQUITY - Authorized, Common and Preferred Stock (Details) |
12 Months Ended | |
---|---|---|
Dec. 31, 2018
Vote
$ / shares
shares
|
Dec. 31, 2017
$ / shares
shares
|
|
STOCKHOLDERS’ EQUITY | ||
Total shares authorized | 105,500,000 | 55,500,000 |
Common stock, authorized shares | 100,000,000 | 50,000,000 |
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized shares | 5,500,000 | 5,500,000 |
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Number of votes per common share | Vote | 1 | |
Common stock, shares issued | 34,193,666 | 26,749,666 |
Preferred stock, shares issued | 0 | 0 |
X | ||||||||||
- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition The maximum number of common shares permitted to be issued by an entity's charter and bylaws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Face amount or stated value per share of preferred stock nonredeemable or redeemable solely at the option of the issuer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The maximum number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) permitted to be issued by an entity's charter and bylaws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Total number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) issued to shareholders (includes related preferred shares that were issued, repurchased, and remain in the treasury). May be all or portion of the number of preferred shares authorized. Excludes preferred shares that are classified as debt. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of votes per common share. No definition available.
|
X | ||||||||||
- Definition The maximum number of common and preferred shares permitted to be issued by an entity's charter and bylaws. No definition available.
|
STOCKHOLDERS' EQUITY - MSK License Agreement (Details) - MSK License Agreement - USD ($) |
1 Months Ended | 12 Months Ended | |
---|---|---|---|
Aug. 20, 2015 |
Aug. 31, 2015 |
Dec. 31, 2016 |
|
Agreements | |||
Issuance of common stock to strategic partner (in shares) | 1,428,500 | 1,428,500 | 999,929 |
Maximum amount of equity financing for anti-dilution rights | $ 25,000,000 | $ 25,000,000 | |
Ownership percentage of the issued and outstanding shares of common stock to be held prior to entity reaching equity financing threshold | 12.50% | 12.50% | |
Share price (in dollars per share) | $ 4.38 | ||
Share issuance charged to expenses | $ 4,380,000 | ||
Non-cash expense in connection with equity issuance to strategic partner | $ 2,280,000 |
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Per share or per unit amount of equity securities issued. No definition available.
|
X | ||||||||||
- Definition The maximum amount of equity financing for anti-dilution rights under the terms of the agreement. No definition available.
|
X | ||||||||||
- Definition Ownership percentage of the issued and outstanding shares of common stock to be held prior to entity reaching equity financing threshold under the terms of the agreement. No definition available.
|
X | ||||||||||
- Definition The value of share issuance charged to expenses under the license agreement. No definition available.
|
X | ||||||||||
- Definition Amount of expense related to the stock issuance in connection with the strategic partner. No definition available.
|
X | ||||||||||
- Definition Number of new stock issued to the strategic partner during the period. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Number of shares issued in lieu of cash for services contributed to the entity. Number of shares includes, but is not limited to, shares issued for services contributed by vendors and founders. No definition available.
|
X | ||||||||||
- Definition Number of shares that have been repurchased and retired during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Equity impact of the value of stock that has been repurchased and retired during the period. The excess of the purchase price over par value can be charged against retained earnings (once the excess is fully allocated to additional paid in capital). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Represents the estimated fair value of shares repurchased and retired, in dollars per share. No definition available.
|
X | ||||||||||
- Definition Number of non-employee physicians with whom the entity entered into stock grant agreement and are employees of strategic partner. No definition available.
|
X | ||||||||||
- Definition Represents number of stock grants. No definition available.
|
X | ||||||||||
- Definition Represents number of stock grants fully issued. No definition available.
|
X | ||||||||||
- Definition The total number of shares agreed to be issued to non-employees under the stock grant agreements. No definition available.
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
|
STOCKHOLDERS' EQUITY - Stock options (Details) - shares |
1 Months Ended | 12 Months Ended |
---|---|---|
Apr. 30, 2018 |
Dec. 31, 2018 |
|
Stock Options | ||
Granted (in shares) | 1,138,873 | |
2015 Equity Incentive Plan | Nonemployees | ||
Stock Options | ||
Granted (in shares) | 72,373 | |
Vesting period | 4 years | |
Term of award | 10 years | |
2015 Equity Incentive Plan | Nonemployees | Tranche one | ||
Stock Options | ||
Vesting period | 12 months | |
Vesting (as a percent) | 25.00% | |
2015 Equity Incentive Plan | Nonemployees | Tranche two | ||
Stock Options | ||
Vesting period | 3 years |
X | ||||||||||
- Definition Period which an employee's right to exercise an award is no longer contingent on satisfaction of either a service condition, market condition or a performance condition, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
X | ||||||||||
- Definition Percentage of vesting of share-based compensation awards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Period from grant date that an equity-based award expires, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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STOCKHOLDERS' EQUITY - Issuance of common stock (Details) - USD ($) |
1 Months Ended | 2 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|---|
Sep. 30, 2018 |
Nov. 30, 2017 |
Oct. 31, 2017 |
Feb. 28, 2017 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Issuance of common stock | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 99,765,000 | $ 89,844,000 | ||||
IPO | ||||||
Issuance of common stock | ||||||
Shares issued | 6,900,000 | |||||
Share price (in dollars per share) | $ 16.00 | |||||
Proceeds from issuance of common stock, net of issuance costs | $ 99,507,000 | |||||
Investors | ||||||
Issuance of common stock | ||||||
Shares issued | 3,208,552 | 5,347,568 | 1,192,662 | |||
Share price (in dollars per share) | $ 9.35 | $ 9.35 | $ 8.50 | |||
Proceeds from issuance of common stock, net of issuance costs | $ 28,887,000 | $ 49,812,000 | $ 10,137,000 |
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition The cash inflow from the additional capital contribution to the entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Per share or per unit amount of equity securities issued. No definition available.
|
X | ||||||||||
- Definition Number of new stock issued during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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STOCK OPTIONS - Equity Incentive Plan (Details) - 2015 Equity Incentive Plan |
8 Months Ended |
---|---|
Aug. 31, 2018
shares
| |
Stock Options | |
Shares reserved for issuance pursuant to the plan | 4,500,000 |
Annual increase on share reserve (as a percent) | 6.00% |
Stock options | Employees and nonemployees owning less than 10% of voting power | |
Stock Options | |
Term of award | 10 years |
Vesting period | 4 years |
Stock options | Employee owning more than 10% of voting power | Minimum | |
Stock Options | |
Ownership (as a percent) | 10.00% |
Option price as percentage of fair market value of common stock on the date of grant | 110.00% |
Stock options | Participants owning more than 10% of voting power | |
Stock Options | |
Term of award | 5 years |
X | ||||||||||
- Definition Aggregate number of common shares reserved for future issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Period which an employee's right to exercise an award is no longer contingent on satisfaction of either a service condition, market condition or a performance condition, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Maximum number of shares that may be issued in accordance with the plan as a proportion of outstanding capital stock. No definition available.
|
X | ||||||||||
- Definition Period from grant date that an equity-based award expires, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Represents the option price as percentage of fair market value of common stock on the date of grant. No definition available.
|
X | ||||||||||
- Definition Ownership of the entity as a percentage of voting power. No definition available.
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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STOCK OPTIONS - 2018 Equity Incentive Plan (Details) - 2018 Equity Incentive Plan |
1 Months Ended |
---|---|
Sep. 30, 2018
shares
| |
Stock Options | |
Shares reserved for issuance pursuant to the plan | 5,500,000 |
Annual increase on share reserve (as a percent) | 4.00% |
Stock options | Employees and nonemployees owning less than 10% of voting power | |
Stock Options | |
Term of award | 10 years |
Vesting period | 4 years |
Stock options | Participants owning more than 10% of voting power | |
Stock Options | |
Term of award | 5 years |
Stock options | Employee owning more than 10% of voting power | Minimum | |
Stock Options | |
Ownership (as a percent) | 10.00% |
Option price as percentage of fair market value of common stock on the date of grant | 110.00% |
X | ||||||||||
- Definition Aggregate number of common shares reserved for future issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Period which an employee's right to exercise an award is no longer contingent on satisfaction of either a service condition, market condition or a performance condition, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Maximum number of shares that may be issued in accordance with the plan as a proportion of outstanding capital stock. No definition available.
|
X | ||||||||||
- Definition Period from grant date that an equity-based award expires, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Represents the option price as percentage of fair market value of common stock on the date of grant. No definition available.
|
X | ||||||||||
- Definition Ownership of the entity as a percentage of voting power. No definition available.
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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STOCK OPTIONS - Expense (Details) - USD ($) |
1 Months Ended | 12 Months Ended | |
---|---|---|---|
Apr. 30, 2018 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Stock Options | |||
Options granted (in shares) | 1,138,873 | ||
Employees | Research and development expense | |||
Stock Options | |||
Stock-based compensation expenses | $ 276,000 | $ 167,000 | |
Employees | General and administrative expense | |||
Stock Options | |||
Stock-based compensation expenses | 1,105,000 | 442,000 | |
Nonemployees | Research and development expense | |||
Stock Options | |||
Stock-based compensation expenses | 585,000 | ||
Stock options | Employees | |||
Stock Options | |||
Stock-based compensation expenses | $ 1,381,000 | $ 609,000 | |
2015 Equity Incentive Plan | Nonemployees | |||
Stock Options | |||
Options granted (in shares) | 72,373 |
X | ||||||||||
- Definition Represents the expense recognized during the period arising from equity-based compensation arrangements (for example, shares of stock, unit, stock options or other equity instruments) with employees, directors and certain consultants qualifying for treatment as employees. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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STOCK OPTIONS - Stock Option Valuation (Details) - Stock options |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Employees | ||
Stock Option Valuation | ||
Risk-free interest rate | 2.89% | 2.10% |
Expected term (in years) | 6 years 3 months 18 days | 7 years |
Expected volatility | 57.80% | 58.90% |
Nonemployees | ||
Stock Option Valuation | ||
Risk-free interest rate | 3.00% | |
Expected term (in years) | 10 years | |
Expected volatility | 62.70% |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The estimated measure of the percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The risk-free interest rate assumption that is used in valuing an option on its own shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Expected term of share-based compensation awards, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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STOCK OPTIONS - Common stock options issued and outstanding (Details) - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Options | ||
Outstanding at beginning of period (in shares) | 2,219,000 | |
Granted (in shares) | 1,138,873 | |
Outstanding at end of period (in shares) | 3,357,873 | 2,219,000 |
Exercisable at end of period (in shares) | 1,690,153 | |
Weighted average exercise price | ||
Outstanding at beginning of period (in dollars per share) | $ 3.21 | |
Granted (in dollars per share) | 16.56 | |
Outstanding at end of period (in dollars per share) | 7.74 | $ 3.21 |
Exercisable at end of period (in dollars per share) | $ 3.00 | |
Aggregate intrinsic value and Weighted average remaining contractual life (years) | ||
Outstanding (in dollars) | $ 43,224 | $ 13,626 |
Exercisable (in dollars) | $ 29,303 | |
Outstanding (in years) | 7 years 10 months 24 days | 8 years |
Exercisable (in years) | 6 years 10 months 21 days | |
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 9.58 | $ 5.59 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The number of shares into which fully or partially vested stock options outstanding as of the balance sheet date can be currently converted under the option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The weighted-average price as of the balance sheet date at which grantees can acquire the shares reserved for issuance on vested portions of options outstanding and currently exercisable under the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
X | ||||||||||
- Definition The weighted average grant-date fair value of options granted during the reporting period as calculated by applying the disclosed option pricing methodology. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount by which the current fair value of the underlying stock exceeds the exercise price of options outstanding. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of options outstanding, including both vested and non-vested options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. No definition available.
|
X | ||||||||||
- Definition Weighted average price at which grantees can acquire the shares reserved for issuance under the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Weighted average per share amount at which grantees can acquire shares of common stock by exercise of options. No definition available.
|
X | ||||||||||
- Definition Amount of difference between fair value of the underlying shares reserved for issuance and exercise price of vested portions of options outstanding and currently exercisable. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average remaining contractual term for vested portions of options outstanding and currently exercisable or convertible, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average remaining contractual term for option awards outstanding, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
STOCK OPTIONS - Unrecognized compensation (Details) - Stock options - Employees |
12 Months Ended |
---|---|
Dec. 31, 2018
USD ($)
| |
Unrecognized compensation related to employee stock options | |
Unrecognized compensation | $ 10,848,000 |
Expected to vest over period | 2 years 9 months 26 days |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Weighted average period over which unrecognized compensation is expected to be recognized for equity-based compensation plans, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Unrecognized cost of unvested options awarded to employees as compensation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
|
RELATED PARTY TRANSACTIONS (Details) - USD ($) |
1 Months Ended | 12 Months Ended | |
---|---|---|---|
Jul. 31, 2016 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
MSK | MSK License Agreement, the CD33 License Agreement, CTA, CFAs, SRA and MDSA | |||
Related party transactions | |||
Expenses | $ 5,761,000 | $ 3,730,000 | |
Due to related parties | 4,475,000 | 4,587,000 | |
Weco Group | Lease Agreement | |||
Related party transactions | |||
Expenses | $ 44,000 | $ 88,000 | |
Lease payable per month | $ 4,000 | ||
Notice period to terminate lease | 3 months | ||
Future rent commitment | $ 12,000 |
X | ||||||||||
- Definition Carrying amount as of the balance sheet date of obligations due all related parties. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Expenses recognized resulting from transactions (excluding transactions that are eliminated in consolidated or combined financial statements) with related party. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition Represents the amount of lease payable per month. No definition available.
|
X | ||||||||||
- Definition Represents the notice period to terminate lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. No definition available.
|
X | ||||||||||
- Definition Amount of required rental payments for leases upon notice of termination. No definition available.
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
|
INCOME TAXES - Income (Loss) Before Income Taxes (Details) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Domestic and foreign loss before income taxes: | ||
United States | $ (42,456,000) | $ (18,975,000) |
Foreign | (818,000) | (186,000) |
Total losses before taxes | (43,274,000) | (19,161,000) |
Income tax expense | ||
Current income taxes | 0 | 0 |
Deferred income taxes | $ 0 | $ 0 |
X | ||||||||||
- Definition Amount of current income tax expense (benefit) pertaining to taxable income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of deferred income tax expense (benefit) pertaining to income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The portion of earnings or loss from continuing operations before income taxes that is attributable to domestic operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The portion of earnings or loss from continuing operations before income taxes that is attributable to foreign operations, which is defined as Income or Loss generated from operations located outside the entity's country of domicile. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- References No definition available.
|
INCOME TAXES - Tax Cuts and Jobs Act (TCJA) (Details) - USD ($) |
3 Months Ended | 12 Months Ended | |
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
U.S. federal corporate tax rate (as a percent) | 21.00% | 34.00% | |
Limitation of deduction for net operating losses as percentage of annual taxable income | 80.00% | ||
Orphan Drug Credit (as a percent) | 25.00% | 50.00% | |
Provisional charge | $ 4,394,000 | ||
Maximum | |||
U.S. federal corporate tax rate (as a percent) | 35.00% |
X | ||||||||||
- Definition Percentage of domestic federal statutory tax rate applicable to pretax income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Represents the limitation of deduction for net operating losses as percentage of annual taxable income. No definition available.
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X | ||||||||||
- Definition Represents the percentage of Orphan Drug Credit. No definition available.
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X | ||||||||||
- Definition Amount of reasonable estimate for income tax expense for remeasurement of deferred tax asset from change in tax rate pursuant to Tax Cuts and Jobs Act of 2017 for which accounting for tax effect is incomplete. No definition available.
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X | ||||||||||
- Details
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INCOME TAXES - Reconciliation of Income Taxes (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Difference between income taxes expected at U.S. federal statutory income tax rate and income taxes provided: | ||
Taxes on income at U.S. federal statutory rate | $ (9,127) | $ (6,515) |
State and local taxes, net of federal tax effects | (5,778) | (2,152) |
Effect of rate change | (9) | 4,394 |
Foreign tax rate differential | (8) | 22 |
Valuation allowance | 16,376 | 5,196 |
Tax credits | (1,431) | (958) |
Other | $ (23) | $ 13 |
U.S. federal corporate tax rate (as a percent) | 21.00% | 34.00% |
X | ||||||||||
- Definition Percentage of domestic federal statutory tax rate applicable to pretax income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Amount of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to increase (decrease) in the valuation allowance for deferred tax assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations, attributable to increase (decrease) in the income tax rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to foreign income tax expense (benefit). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition The amount of income tax expense or benefit for the period computed by applying the domestic federal statutory tax rates to pretax income from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to other adjustments. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to state and local income tax expense (benefit). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to tax credits. Including, but not limited to, research credit, foreign tax credit, investment tax credit, and other tax credits. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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INCOME TAXES - Components of Deferred Tax Assets/(Liabilities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Deferred tax assets/(liabilities):: | ||
Acquired Intangibles | $ 2,682 | $ 2,381 |
Accrued bonus | 200 | |
Unrealized foreign exchange (gain) | (163) | |
Unrealized foreign exchange loss | 187 | |
Accrued royalty | 415 | 414 |
Stock based compensation | 981 | 300 |
Net operating loss carryforwards | 25,285 | 10,847 |
Tax credit carryforwards | 2,789 | 1,358 |
Other | 78 | |
Total deferred tax assets/(liabilities) | 32,067 | 15,687 |
Valuation allowance | $ (32,067) | $ (15,687) |
X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from intangible assets including goodwill. No definition available.
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X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible operating loss carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount, before allocation of a valuation allowances, of deferred tax assets attributable to deductible tax credit carryforwards including, but not limited to, research, foreign, general business, alternative minimum tax, and other deductible tax credit carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from employee bonuses. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount, before allocation of valuation allowance, of deferred tax asset attributable to deductible temporary differences from compensation and benefits, classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from share-based compensation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from unrealized losses on foreign currency transactions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of deferred tax assets for which it is more likely than not that a tax benefit will not be realized. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of deferred tax liability attributable to taxable temporary differences from unrealized gains on foreign currency transactions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from accrued royalty. No definition available.
|
X | ||||||||||
- Definition Amount, after deferred tax liability and before allocation of valuation allowances, of deferred tax asset attributable to deductible differences and carryforwards, without jurisdictional netting. No definition available.
|
INCOME TAXES - Uncertain tax positions (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
INCOME TAXES | ||
Uncertain tax position | $ 0 | $ 0 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of unrecognized tax benefits. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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INCOME TAXES - Net Operating Loss Carryforwards (Details) |
Dec. 31, 2018
USD ($)
|
---|---|
U.S. federal and state and local | |
Operating Loss Carryforwards | |
Net operating loss carryforwards | $ 72,323,000 |
Danish | |
Operating Loss Carryforwards | |
Net operating loss carryforwards | $ 1,154,000 |
X | ||||||||||
- Definition Amount of operating loss carryforward, before tax effects, available to reduce future taxable income under enacted tax laws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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INCOME TAXES - Tax Credit Carryforwards (Details) |
Dec. 31, 2018
USD ($)
|
---|---|
U.S. federal | |
Tax Credit Carryforward [Line Items] | |
Tax credit | $ 2,789,000 |
X | ||||||||||
- Definition The amount of the tax credit carryforward, before tax effects, available to reduce future taxable income under enacted tax laws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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X | ||||||||||
- Details
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OTHER BENEFITS (Details) |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
OTHER BENEFITS | ||
Employer matching contribution to defined contribution plan (as a percent) | 0.00% | 0.00% |
X | ||||||||||
- Definition Percentage of employees' gross pay for which the employer contributes a matching contribution to a defined contribution plan. No definition available.
|
X | ||||||||||
- References No definition available.
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SUBSEQUENT EVENTS (Details) - Subsequent Event |
Feb. 28, 2019
USD ($)
ft²
|
---|---|
Subsequent Events | |
Lease term | 3 years |
Leased area (in square feet) | ft² | 4,500 |
Lease payable per month | $ | $ 12,000 |
X | ||||||||||
- Definition Area of a real estate property. No definition available.
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X | ||||||||||
- Definition Term of lessee's operating lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Detail information of subsequent event by type. User is expected to use existing line items from elsewhere in the taxonomy as the primary line items for this disclosure, which is further associated with dimension and member elements pertaining to a subsequent event. No definition available.
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X | ||||||||||
- Definition Represents the amount of lease payable per month. No definition available.
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X | ||||||||||
- Details
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QUARTERLY CONSOLIDATED FINANCIAL DATA (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 12 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2017 |
Sep. 30, 2017 |
Jun. 30, 2017 |
Mar. 31, 2017 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
QUARTERLY CONSOLIDATED FINANCIAL DATA (unaudited) | ||||||||||
Loss from operations | $ (14,078) | $ (11,415) | $ (10,258) | $ (7,479) | $ (9,275) | $ (3,842) | $ (3,230) | $ (2,897) | $ (43,230) | $ (19,244) |
Net loss | $ (14,060) | $ (11,426) | $ (10,305) | $ (7,483) | $ (9,253) | $ (3,827) | $ (3,191) | $ (2,890) | $ (43,274) | $ (19,161) |
Basic and diluted net loss per share (in dollars per share) | $ (0.42) | $ (0.42) | $ (0.38) | $ (0.28) | $ (0.44) | $ (0.21) | $ (0.18) | $ (0.16) | $ (1.50) | $ (0.99) |
X | ||||||||||
- Definition The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or loss for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition The net result for the period of deducting operating expenses from operating revenues. No definition available.
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X | ||||||||||
- References No definition available.
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