Document and Entity Information - shares |
6 Months Ended | |
|---|---|---|
Jun. 30, 2019 |
Jul. 31, 2019 |
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| Document and Entity Information | ||
| Entity Registrant Name | AGILE THERAPEUTICS INC | |
| Document Type | 10-Q | |
| Document Period End Date | Jun. 30, 2019 | |
| 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 Common Stock, Shares Outstanding | 44,775,811 | |
| Entity Central Index Key | 0001261249 | |
| Current Fiscal Year End Date | --12-31 | |
| Document Fiscal Year Focus | 2019 | |
| Document Fiscal Period Focus | Q2 | |
| Amendment Flag | false |
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- References No definition available.
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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 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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| X | ||||||||||
- Definition Indicates that the company is a smaller reporting company with both a public float and revenues of less than $75 million. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Current assets: | ||
| Cash and cash equivalents | $ 10,586 | $ 7,851 |
| Prepaid expenses | 178 | 607 |
| Total current assets | 10,764 | 8,458 |
| Property and equipment, net | 13,906 | 13,916 |
| Right of use and other assets | 250 | 18 |
| Total assets | 24,920 | 22,392 |
| Current liabilities: | ||
| Accounts payable | 804 | 875 |
| Accrued expenses | 803 | 1,343 |
| Lease liability, current portion | 167 | |
| Total current liabilities | 1,774 | 2,218 |
| Lease liability, long-term | 82 | |
| Commitments and contingencies (Note 11) | ||
| Stockholders' equity | ||
| Common stock, $.0001 par value, 150,000,000 shares authorized, 44,632,329 and 34,377,329 issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 4 | 3 |
| Additional paid-in capital | 272,977 | 261,722 |
| Accumulated deficit | (249,917) | (241,551) |
| Total stockholders' equity | 23,064 | 20,174 |
| Total liabilities and stockholders' equity | $ 24,920 | $ 22,392 |
| X | ||||||||||
- 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 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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| X | ||||||||||
- 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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| X | ||||||||||
- 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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| 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
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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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| X | ||||||||||
- 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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| X | ||||||||||
- 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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| X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of asset related to consideration paid in advance for costs that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- 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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| X | ||||||||||
- 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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| X | ||||||||||
- 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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| X | ||||||||||
- References No definition available.
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Balance Sheets (Parenthetical) - $ / shares |
Jun. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Balance Sheets | ||
| Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
| Common stock, authorized (in shares) | 150,000,000 | 150,000,000 |
| Common stock, issued (in shares) | 44,632,329 | 34,377,329 |
| Common stock, outstanding (in shares) | 44,632,329 | 34,377,329 |
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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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| X | ||||||||||
- 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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- References No definition available.
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Statements of Operations - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
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| Operating expenses: | ||||
| Research and development | $ 1,779 | $ 2,413 | $ 4,660 | $ 6,372 |
| General and administrative | 1,768 | 2,318 | 3,594 | 5,404 |
| Restructuring Charges | 416 | 0 | 416 | |
| Total operating expenses | 3,547 | 5,147 | 8,254 | 12,192 |
| Loss from operations | (3,547) | (5,147) | (8,254) | (12,192) |
| Other income (expense) | ||||
| Interest income | 63 | 101 | 101 | 198 |
| Interest expense | (320) | (689) | ||
| Change in fair value of warrants | 22 | 29 | ||
| Total other income (expense), net | 63 | (197) | 101 | (462) |
| Loss before benefit from income taxes | (3,484) | (5,344) | (8,153) | (12,654) |
| Benefit from income taxes | 477 | |||
| Net loss | $ (3,484) | $ (5,344) | $ (8,153) | $ (12,177) |
| Net loss per share (basic and diluted) (in dollars per share) | $ (0.08) | $ (0.16) | $ (0.20) | $ (0.36) |
| Weighted-average common shares (basic and diluted) (in shares) | 43,776,549 | 34,277,601 | 40,560,259 | 34,253,515 |
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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 Amount of expense (income) related to adjustment to fair value of warrant liability. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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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 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
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- Definition Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of the cost of borrowed funds accounted for as interest expense. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount before accretion (amortization) of purchase discount (premium) of interest income on nonoperating securities. 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 The aggregate amount of income or expense from ancillary business-related activities (that is to say, excluding major activities considered part of the normal operations of the business). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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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 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 Amount of expenses associated with exit or disposal activities pursuant to an authorized plan. Excludes expenses related to a discontinued operation or an asset retirement obligation. 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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| X | ||||||||||
- Definition Amount of increase to additional paid-in capital (APIC) from recognition of equity-based compensation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of the cumulative effect on retained earnings net of related income tax effect. 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 Number of shares of stock issued as of the balance sheet date, including shares that had been issued and were previously outstanding but which are now held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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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 Number of shares (or other type of equity) issued during the period as a result of any equity-based compensation plan other than an employee stock ownership plan (ESOP), net of any shares forfeited. Shares issued could result from the issuance of restricted stock, the exercise of stock options, stock issued under employee stock purchase plans, and/or other employee benefit plans. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Number of share options (or share units) exercised during the current 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 Value of stock issued as a result of the exercise of stock options. 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 The cash outflow for principal payments of long-term debt. No definition available.
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- Definition The aggregate amount of recurring noncash expense charged against earnings in the period to allocate the cost of assets over their estimated remaining economic lives. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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| X | ||||||||||
- Definition Amount of amortization expense attributable to debt discount (premium) and debt issuance costs. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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| X | ||||||||||
- 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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| X | ||||||||||
- 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 amount of expense recognized in the current period that reflects the allocation of the cost of tangible assets over the assets' useful lives. Includes production and non-production related depreciation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of expense (income) related to adjustment to fair value of warrant liability. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The increase (decrease) during the reporting period in the amounts payable to vendors for goods and services received and the amount of obligations and expenses incurred but not paid. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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| X | ||||||||||
- Definition Amount of increase (decrease) in prepaid expenses, and assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of cash paid for interest, excluding capitalized interest, classified as operating activity. Includes, but is not limited to, payment to settle zero-coupon bond for accreted interest of debt discount and debt instrument with insignificant coupon interest rate in relation to effective interest rate of borrowing attributable to accreted interest of debt discount. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- 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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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- 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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| X | ||||||||||
- 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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| X | ||||||||||
- Definition Amount of cash outflow from operating lease, excluding payments to bring another asset to condition and location necessary for its intended use. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- 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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| X | ||||||||||
- 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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| X | ||||||||||
- Definition The cash inflow associated with the amount received from entity's raising of capital via private rather than public placement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of cash inflow from exercise of stock options granted under share-based compensation arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- 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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| X | ||||||||||
- 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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| X | ||||||||||
- References No definition available.
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Organization and Description of Business |
6 Months Ended |
|---|---|
Jun. 30, 2019 | |
| Organization and Description of Business | |
| Organization and Description of Business | 1. Organization and Description of Business
Nature of Operations
Agile Therapeutics, Inc. ("Agile" or the "Company") was incorporated in Delaware on December 22, 1997. Agile is a women's healthcare company dedicated to fulfilling the unmet health needs of today's women. The Company's activities since inception have consisted principally of raising capital and performing research and development, including development of the Company’s lead product candidate, Twirla®, also known as AG200-15. The Company is headquartered in Princeton, New Jersey.
The Company's lead product candidate, Twirla is a once-weekly prescription contraceptive patch that is at the end of Phase 3 clinical development. The Company is seeking approval by the U.S. Food and Drug Administration (the "FDA") of the new drug application, (the "NDA") for Twirla, which was resubmitted in May 2019. The NDA has been assigned a Prescription Drug User Fee Act ("PDUFA") goal date of November 16, 2019. Substantially all of the Company's resources are currently dedicated to developing and seeking regulatory approval for Twirla in the United States. The Company has not generated product revenue to date and is subject to a number of risks similar to those of other early stage companies, including, but not limited to, dependence on key individuals, the difficulties and uncertainties inherent in the development of commercially usable products, market acceptance of products, protection of proprietary technology, the potential need to obtain additional capital necessary to fund the development of its products, competition from larger companies and compliance with FDA and other government regulations. If the Company does not successfully commercialize any product candidates, it will be unable to generate recurring product revenue or achieve profitability. The Company has incurred operating losses and negative cash flows from operating activities each year since inception. As of June 30, 2019, the Company had an accumulated deficit of approximately $249.9 million. The Company expects to continue to incur net losses into the foreseeable future.
The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 8), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding.
Going Concern
On December 21, 2017, the Company received a complete response letter (the "2017 CRL") from the FDA citing deficiencies related to the manufacturing process for Twirla and raising questions on the in vivo adhesion properties of Twirla and their potential relationship to the Company's Phase 3 clinical trial results. The Company's ability to commercialize Twirla, and the timing of Twirla commercialization, is dependent on the FDA's review of the Company's response to the 2017 CRL and its NDA for Twirla, and other items such as timely and successful completion of the validation of equipment for commercial manufacturing, ultimate FDA approval, and the Company’s ability to secure additional capital. In January 2018, following the Company's receipt of the 2017 CRL, the Company significantly scaled back its preparations for commercialization of Twirla, including commercial pre-launch and manufacturing validation activities, pending its ability to address the 2017 CRL and receive approval of Twirla. In April 2018, the Company met with the FDA in a Type A meeting to discuss the deficiencies in the Twirla NDA and the regulatory path for approval of Twirla, and the Company announced the content of the official minutes from the meeting in May 2018.
In June 2018, the Company announced it had submitted a formal dispute resolution request (“FDRR”) with the FDA for Twirla. The dispute pertained to the determination from the FDA’s reviewing Division of Bone, Reproductive and Urologic Products (“DBRUP”) that concerns surrounding the in vivo adhesion properties of Twirla prevent the approval and could not be addressed through the Company’s proposed patient compliance programs. The initial FDRR was submitted in June 2018 and was reviewed by the Office of Drug Evaluation III, which denied the Company’s appeal on July 20, 2018. The Company then escalated its appeal to the Office of New Drugs (“OND”).
In October 2018, the OND formally denied the Company’s appeal and provided a path forward that may not require that the Company reformulate Twirla or conduct a bioequivalence study between formulations, as previously suggested by DBRUP. Specifically, OND suggested that the Company conduct a wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane®, the generic version of the previously marketed Ortho Evra® contraceptive patch, a product the FDA considers to have acceptable adhesion. If this result is demonstrated, OND stated that the study would support the conclusion of adequate Twirla adhesion. DBRUP later agreed that Twirla would show adequate adhesion if it demonstrated statistical non-inferiority to Xulane by a margin of less than +0.15. On February 11, 2019, the Company announced the top-line results of the comparative wear study, which demonstrated that Twirla was statistically non-inferior to Xulane. The wear study suggested by OND to address adhesion provides a path forward but is not intended to address efficacy. Twirla’s safety and efficacy, including the Pearl Index that FDA noted is substantially higher than other previously approved combined hormonal contraceptives, will need to be reviewed by FDA after the Company resubmits the NDA for Twirla. The FDA has notified the Company that they plan to convene a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee, or BRUDAC, which is the advisory committee for contraceptive products, on October 30, 2019 to discuss the Twirla NDA.
The Company believes that its cash and cash equivalents as of June 30, 2019 will be sufficient to meet its operating requirements through the end of 2019. The Company will require additional capital to fund operating needs for 2020 and beyond including, the resumption and completion of its commercialization plan for Twirla, which primarily includes the validation of the Company’s commercial manufacturing process and the commercial launch of Twirla, if approved, and advancing the development of its other potential product candidates. The Company cannot assure you that the FDA will approve Twirla, or that the Company along with Corium International, Inc. ("Corium"), its third-party manufacturer, will be able to complete validation of the Company's commercial manufacturing successfully and in a timely manner.
The Company anticipates it will continue to incur net losses for the foreseeable future and the Company's ability to continue operations for 2020 and beyond will depend on its ability to obtain additional funding, as to which no assurances can be given. There can be no assurance that any financing by the Company can be realized by the Company, or if realized, what the terms of any such financing may be, or that any amount that the Company is able to raise will be adequate. Based upon the foregoing, management has concluded that there is substantial doubt about the Company's ability to continue as a going concern.
As of June 30, 2019, the Company had cash and cash equivalents of $10.6 million. The Company continues to analyze various alternatives, including strategic and refinancing alternatives, asset sales and mergers and acquisitions. The Company's future success depends on its ability to raise additional capital and/or implement the various strategic alternatives discussed above. The Company cannot be certain that these initiatives or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company's current stockholders will experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company then may be unable to complete the development of Twirla, and may also be required to further cut operating costs, forego future development and other opportunities and may need to seek bankruptcy protection.
The unaudited financial statements as of June 30, 2019 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company's ability to continue as a going concern is dependent upon its uncertain ability to obtain additional equity and/or debt financing and reduce expenditures. The accompanying financial statements as of June 30, 2019 do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements.
Basis of Presentation
The accompanying unaudited interim financial statements have been prepared by the Company, without audit, in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. These interim financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s annual report on Form 10-K for the year ended December 31, 2018 filed with the SEC.
In the opinion of management, the unaudited interim financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods have been made. The results of operations for the three and six months ended June 30, 2019 are not necessarily indicative of the operating results for the full fiscal year or any future period. |
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Summary of Significant Accounting Policies |
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| Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies
The Company’s complete listing of significant accounting policies is described in Note 2 to the Company’s audited financial statements as of December 31, 2018 included in its annual report on Form 10-K filed with the SEC.
Use of Estimates
The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for common stock warrants, stock-based compensation, income taxes, and accounting for research and development costs. Actual results could differ from those estimates.
Fair Value of Financial Instruments
In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents are carried at fair value (see Note 3).
Other financial instruments, including accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.
Long-Lived Assets
In accordance with ASC 360, Property, Plant and Equipment, the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of June 30, 2019.
Warrants
The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity. ASC 480 requires that a financial instrument, other than an outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer’s equity shares, regardless of the timing or the probability of the redemption feature and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using the Black-Scholes option-pricing model with changes in fair value recognized as increases or reductions to other income (expense) in the statement of operations.
In connection with the completion of the Company’s initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. Prior to January 1, 2019, warrants with non-standard anti-dilution provisions (referred to as down round protection) were classified as liabilities and re-measured each reporting period. On January 1, 2019, the Company adopted the provisions of Accounting Standards Update (“ASU”) 2017-11 Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part 1) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception, which indicates that a down round feature no longer precludes equity classification when assessing whether an investment is indexed to an entity’s own stock. The Company used a modified retrospective approach to adoption, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to additional paid-in capital. As of June 30, 2019, there were outstanding 62,505 warrants to purchase common stock at $6.00 per share. These warrants expire on December 14, 2019.
The warrants issued in connection with the Company’s debt financing completed in February 2015 (see Note 7) are classified as a component of stockholders’ equity. The value of such warrants was determined using the Black-Scholes option-pricing model. As of June 30, 2019, there were outstanding 180,274 warrants to purchase common stock at $5.89 per share related to this debt financing. These warrants expire on February 24, 2020.
Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to or, in some cases, above the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital.
The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Cost associated with performance-based restricted stock units with a performance condition, which affects the vesting is recognized only if the performance condition is probable of being satisfied.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented.
The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2019 and 2018, respectively, because to do so would be anti-dilutive (in common equivalent shares):
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. The recent accounting pronouncements did not have a material impact of the financial statements unless otherwise disclosed, and the Company does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.
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Fair Value Measurements |
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| Fair Value Measurements | 3. Fair Value Measurements
ASC 820, Fair Value Measurements and Disclosures, describes the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value.
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
The Company is required to mark the value of its warrant liability to market and recognize the change in valuation in its statements of operations each reporting period.
The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of June 30, 2019 and December 31, 2018.
As indicated in Note 2, on January 1, 2019, the Company adopted the provisions of ASU 2017-11 to account for the down round feature of its warrants issued in connection with its initial public offering in May 2014. As a result of the adoption of ASU 2017-11, effective January 1, 2019, the Company no longer measures these warrants at fair value.
The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of December 31, 2018 include (i) volatility (70.0%), (ii) risk free interest rate of 2.57% (estimated using treasury bonds with a 1-year life), (iii) strike price ($6.00) for the common stock warrants, (iv) fair value of common stock ($0.58) and (v) expected life (1 year).
The following is a rollforward of the fair value of Level 3 warrants:
There were no transfers between Level 1, 2 or 3 during 2019 or 2018. If the Company’s estimates regarding the fair value of its warrants are inaccurate, a future adjustment to these estimated fair values may be required. Additionally, these estimated fair values could change significantly. |
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- Definition The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| Prepaid Expenses | 4. Prepaid Expenses
Prepaid expenses consist of the following:
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Accrued Liabilities |
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| Accrued Liabilities | 5. Accrued Liabilities
Accrued liabilities consist of the following:
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Leases |
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| Leases | 6. Leases
In February 2016, the FASB issued ASU No. 2016-02, Leases. The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the statement of operations. The Company adopted ASU No. 2016-02 on January 1, 2019. The Company recorded a lease asset and lease liability of approximately $0.3 million on its balance sheet as of January 1, 2019, with no material impact on its statement of operations. The Company has no finance leases and one operating lease for office space in Princeton, NJ. Operating lease expense was $48 and $97 for the three and six months ended June 30, 2019, respectively. Operating cash flows used for operating leases during the three and six months ended June 30, 2019 were $35 and $75, respectively. As of June 30, 2019, the weighted-average remaining lease term was 1.4 years and the weighted-average discount rate was 21.2%. Future minimum lease payments under non-cancellable leases as of June 30, 2019 were as follows:
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Loan and Security Agreement |
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| Loan and Security Agreement | 7. Loan and Security Agreement
Hercules Capital, Inc.
In February 2015, the Company entered into a loan and security agreement (the "Hercules Loan Agreement") with Hercules Capital, Inc. ("Hercules") for a term loan of up to $25.0 million (the "Term Loan"). In August 2016, the Company entered into the First Amendment to Loan and Security Agreement (the "First Amendment") with Hercules, which amended certain terms of the Hercules Loan Agreement. In May 2017, the Company entered into the Second Amendment to Loan and Security Agreement (the "Second Amendment") with Hercules, which further amended certain terms of the Hercules Loan Agreement. A first tranche of $16.5 million was funded upon execution of the Hercules Loan Agreement, approximately $15.5 million of which was used to repay the Company’s existing term loan with Oxford Finance LLC.
The First Amendment revised the Term Loan's maturity date to be on December 1, 2018. In connection with the execution of the First Amendment, the Company paid Hercules a facility fee of $165. The facility fee represented a debt issue cost, which was reflected as a reduction to the carrying amount of the loan payable in accordance with ASU 2015-03. Such issue costs were amortized to interest expense over the life of the Term Loan using the effective interest method.
The Term Loan accrued interest at a rate of the greater of 9.0% or 9.0% plus Prime minus 4.25% and was payable monthly. Principal was due in 23 consecutive monthly installments beginning on February 1, 2017 and ending on December 1, 2018. In addition to the outstanding principal balance, the Company was required to make a final payment of approximately $611 on the maturity date of the Term Loan (December 1, 2018). The amount of the end of term final payment was accrued over the loan term as interest expense.
In connection with the Hercules Loan Agreement, the Company issued Hercules a warrant to purchase 180,274 shares of the Company’s common stock at an exercise price of $5.89 per share, which expires on February 24, 2020 and granted Hercules the right to participate in future equity financings in an amount up to $2.0 million while the loan and warrant are outstanding.
The Company allocated the proceeds of $16.5 million in accordance with ASC 470 based on the relative fair values. The relative fair value of the warrants of approximately $1.2 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in preparing the option pricing model for valuing the Company’s warrant issued to Hercules include (i) volatility (75.0%), (ii) risk free interest rate of 1.22% (estimated using treasury bonds with a 4-year life), (iii) strike price ($5.89) for the common stock warrant, (iv) fair value of common stock ($9.82) and (v) expected life (4 years). The discount on the debt was amortized to interest expense over the term of the debt.
Interest expense on the Hercules Loan Agreement including the accretion of the value of the related warrants, accrual of term loan back-end fee and amortization of the deferred financing costs was $0 for the three and six months ended June 30, 2019 and was approximately $320 and $689 for the three and six months ended June 30, 2018, respectively. |
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- Definition The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| Stockholders' Equity | 8. Stockholders’ Equity
Shelf Registration Statement
On November 2, 2018, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $100.0 million (the "2018 Shelf Registration Statement"). On November 14, 2018, the 2018 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2018 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.
Private Placement
In March 2019, the Company completed a private placement of 8,426,750 shares of common stock at $0.93 per share. Proceeds from the Company’s private placement, net of offering costs were approximately $7.8 million.
ATM Sales Agreement
In January 2019, the Company entered into a common stock sales agreement (the “Sales Agreement”) under which the Company may sell up to an aggregate of $10.0 million in gross proceeds through the sale of shares of common stock from time to time in "at-the-market" equity offerings (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended). The Company agreed to pay a commission of 3% of the gross proceeds of any common stock sold under the Sales Agreement. For the three months ended June 30, 2019, the Company sold 992,072 shares of common stock under the ATM agreement, resulting in net proceeds of approximately $1.4 million. For the six months ended June 30, 2019, the Company sold 1,658,046 shares of common stock under the Sales Agreement, resulting in net proceeds of approximately $2.2 million.
Stock-Based Compensation Expense
Stock-based compensation expense was allocated as follows:
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- Definition The entire disclosure for accounts comprising shareholders' equity, comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income, and compensation-related costs for equity-based compensation. Includes, but is not limited to, disclosure of policies, compensation plan details, equity-based arrangements to obtain goods and services, deferred compensation arrangements, 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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Income Taxes |
6 Months Ended |
|---|---|
Jun. 30, 2019 | |
| Income Taxes | |
| Income Taxes | 9. Income Taxes
Sale of New Jersey Net Operating Losses
In January 2018, the Company received net proceeds of approximately $0.5 million in non-dilutive financing through the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”). The Program enables approved biotechnology companies to sell their unused Net Operating Loss Carryovers and unused Research and Development Tax Credits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The New Jersey Economic Development Authority and the New Jersey Department of the Treasury’s Division of Taxation administer the Program. The Company used the proceeds from the sale for working capital purposes. The Company has now reached the maximum lifetime benefit of $15.0 million under the Program and will no longer be eligible to participate in the Program. |
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- References No definition available.
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| X | ||||||||||
- 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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Restructuring Costs |
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| Restructuring Costs | 10. Restructuring Costs
In June 2018, the Company announced a reduction in its workforce, which resulted in the termination of several employees primarily from the Company’s commercial and clinical teams, representing approximately thirty percent of its employees. This workforce reduction, along with other reductions in planned operating expenses is designed to preserve cash while the Company pursued formal dispute resolution with the FDA for Twirla and determines a regulatory path forward for the resubmission of the Company’s NDA for Twirla.
In June 2018, the Company also announced that it had adopted a retention plan (the “Retention Plan”) to provide (i) cash retention payments to all remaining employees in order to induce such employees to remain employed by the Company through December 31, 2018 and (ii) stock option grants to all remaining employees in order to induce such employees to remain employed by the Company through December 31, 2019.
Each employee who participated in the Retention Plan (the “Retention Plan Participants”) and (i) remained continuously employed by the Company through December 31, 2018 or (ii) had been terminated by the Company other than for cause (as defined in an applicable employment agreement, or, if no employment agreement existed, as determined by the Company in good faith) prior to December 31, 2018, were paid a lump-sum cash payment in an amount determined by the compensation committee (the “Compensation Committee”) of the Company’s board of directors at the time of the adoption of the Retention Plan. The total amount of the cash portion of the Retention Plan was approximately $0.6 million and was paid out to the Retention Plan Participants in January 2019.
In addition, each Retention Plan Participant was granted a stock option to purchase the number of shares of common stock as approved by the Compensation Committee, with a per share exercise price of $0.58, representing the closing price of the Company’s common stock as reported by Nasdaq on the date the Retention Plan was approved by the Compensation Committee. Each option vests in four equal 25% installments on the following dates: (i) June 20, 2018, (ii) December 31, 2018, (iii) June 30, 2019 and (iv) December 31, 2019.
A summary of accrued restructuring costs, included as a component of accrued liabilities on the Company’s unaudited June 30, 2019 balance sheet is as follows:
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- References No definition available.
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- Definition The entire disclosure for restructuring and related activities. Description of restructuring activities such as exit and disposal activities, include facts and circumstances leading to the plan, the expected plan completion date, the major types of costs associated with the plan activities, total expected costs, the accrual balance at the end of the period, and the periods over which the remaining accrual will be settled. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Commitments and Contingencies |
6 Months Ended |
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Jun. 30, 2019 | |
| Commitments and Contingencies | |
| Commitments and Contingencies | 11. Commitments and Contingencies
The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. An unfavorable outcome to any legal matter, if material, could have an adverse effect on the Company’s operations or its financial position. As of June 30, 2019, the Company has not recorded a provision for any contingent losses. |
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- References No definition available.
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| X | ||||||||||
- Definition The entire disclosure for commitments and contingencies. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Subsequent Events |
6 Months Ended |
|---|---|
Jun. 30, 2019 | |
| Subsequent Events | |
| Subsequent Events | 12. Subsequent Events
In July 2019, the Compensation Committee adopted a retention plan (the “2019 Retention Plan”) for all employees (with the exception of the Chairman and Chief Executive Officer) in order to induce such employees to remain employed by the Company through the approval of the NDA for Twirla by the FDA (the “Approval”), which has a PDUFA goal date of November 16, 2019.
Each employee who participates in the 2019 Retention Plan and remains continuously employed by the Company through the Approval shall be paid a lump-sum cash payment in an amount determined for each eligible employee by the Compensation Committee at the time of the adoption of the 2019 Retention Plan. If an eligible employee terminates employment prior to the Approval for any reason, no such retention payment shall be made to the eligible employee. The total amount of the cash portion of the 2019 Retention Plan is approximately $0.3 million.
All employees (with the exception of the Chairman and Chief Executive Officer) who were employed by the Company as of July 3, 2019 were also granted a stock option to purchase the number of shares of common stock as approved by the Compensation Committee, with a per share exercise price of $1.48, representing the closing price of the Company’s common stock as reported by Nasdaq on the date of grant. Each option will vest in two equal 50% installments on the following dates (i) July 3, 2020 and (ii) December 31, 2020.
In addition, the vesting for the stock options granted in January 2019 have been amended for all employees holding such options who were employed on July 3, 2019 as follows: 50% of the option will vest on January 29, 2020, 25% on June 30, 2020 and the remaining 25% on December 31, 2020. The accelerated vesting will result in an increase to non-cash stock based compensation beginning in July 2019.
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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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Summary of Significant Accounting Policies (Policies) |
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| Summary of Significant Accounting Policies | ||||||||||||||||||||||||||||||||||||
| Use of Estimates | Use of Estimates
The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for common stock warrants, stock-based compensation, income taxes, and accounting for research and development costs. Actual results could differ from those estimates.
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| Fair Value of Financial Instruments | Fair Value of Financial Instruments
In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents are carried at fair value (see Note 3).
Other financial instruments, including accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.
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| Long-Lived Assets | Long-Lived Assets
In accordance with ASC 360, Property, Plant and Equipment, the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of June 30, 2019.
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| Warrants | Warrants
The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity. ASC 480 requires that a financial instrument, other than an outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer’s equity shares, regardless of the timing or the probability of the redemption feature and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using the Black-Scholes option-pricing model with changes in fair value recognized as increases or reductions to other income (expense) in the statement of operations.
In connection with the completion of the Company’s initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. Prior to January 1, 2019, warrants with non-standard anti-dilution provisions (referred to as down round protection) were classified as liabilities and re-measured each reporting period. On January 1, 2019, the Company adopted the provisions of Accounting Standards Update (“ASU”) 2017-11 Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part 1) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception, which indicates that a down round feature no longer precludes equity classification when assessing whether an investment is indexed to an entity’s own stock. The Company used a modified retrospective approach to adoption, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to additional paid-in capital. As of June 30, 2019, there were outstanding 62,505 warrants to purchase common stock at $6.00 per share. These warrants expire on December 14, 2019.
The warrants issued in connection with the Company’s debt financing completed in February 2015 (see Note 7) are classified as a component of stockholders’ equity. The value of such warrants was determined using the Black-Scholes option-pricing model. As of June 30, 2019, there were outstanding 180,274 warrants to purchase common stock at $5.89 per share related to this debt financing. These warrants expire on February 24, 2020.
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| Stock-Based Compensation | Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to or, in some cases, above the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital.
The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Cost associated with performance-based restricted stock units with a performance condition, which affects the vesting is recognized only if the performance condition is probable of being satisfied.
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| Net Loss Per Share | Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented.
The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2019 and 2018, respectively, because to do so would be anti-dilutive (in common equivalent shares):
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| Recent Accounting Pronouncements | Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. The recent accounting pronouncements did not have a material impact of the financial statements unless otherwise disclosed, and the Company does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations. |
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- Definition Represents disclosure of accounting policy for warrants or rights that give the holder the right to purchase securities (usually equity) from the issuer at a specific price within a certain time frame. No definition available.
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- References No definition available.
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- Definition Disclosure of accounting policy for computing basic and diluted earnings or loss per share for each class of common stock and participating security. Addresses all significant policy factors, including any antidilutive items that have been excluded from the computation and takes into account stock dividends, splits and reverse splits that occur after the balance sheet date of the latest reporting period but before the issuance of the financial statements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for determining the fair value of financial instruments. 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 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 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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Summary of Significant Accounting Policies (Tables) |
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| Schedule of outstanding potentially dilutive securities excluded from calculation of diluted net loss per share | The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2019 and 2018, respectively, because to do so would be anti-dilutive (in common equivalent shares):
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- References No definition available.
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- Definition Tabular disclosure of securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) in the future that were not included in the computation of diluted EPS because to do so would increase EPS amounts or decrease loss per share amounts for the period presented, by antidilutive securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Fair Value Measurements (Tables) |
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| Schedule of financial instruments measured at fair value by level within the fair value hierarchy |
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| Schedule of rollforward of the fair value of Level 3 warrants |
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- References No definition available.
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- Definition Tabular disclosure of the fair value measurement of liabilities using significant unobservable inputs (Level 3), a reconciliation of the beginning and ending balances, separately presenting changes attributable to the following: (1) total gains or losses for the period (realized and unrealized), segregating those gains or losses included in earnings (or changes in net assets), and gains or losses recognized in other comprehensive income (loss) and a description of where those gains or losses included in earnings (or changes in net assets) are reported in the statement of income (or activities); (2) purchases, sales, issues, and settlements (each type disclosed separately); and (3) transfers in and transfers out of Level 3 (for example, transfers due to changes in the observability of significant inputs) by class of liability. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of assets and liabilities, including [financial] instruments measured at fair value that are classified in stockholders' equity, if any, that are measured at fair value on a recurring basis. The disclosures contemplated herein include the fair value measurements at the reporting date by the level within the fair value hierarchy in which the fair value measurements in their entirety fall, segregating fair value measurements using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Prepaid Expenses (Tables) |
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| Schedule of prepaid expenses |
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- Definition Tabular disclosure of the amounts paid in advance for capitalized costs that will be expensed with the passage of time or the occurrence of a triggering event. This disclosure includes current and noncurrent prepaid expenses. No definition available.
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- References No definition available.
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Accrued Liabilities (Tables) |
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| Schedule of accrued liabilities |
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- References No definition available.
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- Definition Tabular disclosure of the components of accrued liabilities. No definition available.
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Leases (Tables) |
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| Maturity of lease liabilities | Future minimum lease payments under non-cancellable leases as of June 30, 2019 were as follows:
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- References No definition available.
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| X | ||||||||||
- Definition Tabular disclosure of undiscounted cash flows of lessee's operating lease liability. Includes, but is not limited to, reconciliation of undiscounted cash flows to operating lease liability recognized in statement of financial position. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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Stockholders' Equity (Tables) |
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| Stockholders' Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of allocation of stock-based compensation expense |
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- Definition Tabular disclosure of the allocation of equity-based compensation costs to a given line item on the balance sheet and income statement for the period. This may include the reporting line for the costs and the amount capitalized and expensed. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Restructuring Costs (Tables) |
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| Summary of accrued restructuring costs, included as a component of accrued liabilities |
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- References No definition available.
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| X | ||||||||||
- Definition Tabular disclosure of an entity's restructuring reserve that occurred during the period associated with the exit from or disposal of business activities or restructurings for each major type of cost. This element may also include a description of any reversal and other adjustment made during the period to the amount of an accrued liability for restructuring activities. This element may be used to encapsulate the roll forward presentations of an entity's restructuring reserve by type of cost and in total, and explanation of changes that occurred in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Organization and Description of Business (Details) - USD ($) $ in Thousands |
6 Months Ended | |
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Jun. 30, 2019 |
Dec. 31, 2018 |
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| Organization and Description of Business | ||
| Product revenue | $ 0 | |
| Accumulated deficit | (249,917) | $ (241,551) |
| Cash and cash equivalents | $ 10,586 | $ 7,851 |
| 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
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| X | ||||||||||
- References No definition available.
|
| 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 Amount, including tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value-added and excise. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Summary of Significant Accounting Policies - Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |||
|---|---|---|---|---|
Jan. 01, 2019 |
Mar. 31, 2019 |
Jun. 30, 2019 |
Feb. 28, 2015 |
|
| Common stock warrants | Oxford Finance LLC | ||||
| Warrants | ||||
| Common stock that can be purchased with warrants (in shares) | 62,505 | |||
| Exercise price of warrants (in dollars per share) | $ 6.00 | |||
| Additional Paid-in Capital | ||||
| Warrants | ||||
| Cumulative effect adjustment | $ 213 | |||
| Accumulated Deficit | ||||
| Warrants | ||||
| Cumulative effect adjustment | $ (213) | |||
| Warrants | Common stock warrants | Hercules Capital, Inc. | ||||
| Warrants | ||||
| Common stock that can be purchased with warrants (in shares) | 180,274 | 180,274 | ||
| Exercise price of warrants (in dollars per share) | $ 5.89 | $ 5.89 | ||
| ASU 2017-11 | Additional Paid-in Capital | ||||
| Warrants | ||||
| Cumulative effect adjustment | $ 213 | |||
| ASU 2017-11 | Accumulated Deficit | ||||
| Warrants | ||||
| Cumulative effect adjustment | $ (213) |
| X | ||||||||||
- Definition Exercise price per share or per unit of warrants or rights outstanding. 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 Number of securities into which the class of warrant or right may be converted. For example, but not limited to, 500,000 warrants may be converted into 1,000,000 shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of the cumulative effect on retained earnings net of related income tax effect. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
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| X | ||||||||||
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- Details
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| X | ||||||||||
- Details
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Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares |
6 Months Ended | |
|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
|
| Anti-dilutive securities | ||
| Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 7,769,599 | 6,093,309 |
| Common stock warrants | ||
| Anti-dilutive securities | ||
| Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 242,779 | 242,779 |
| Restricted Stock Units | ||
| Anti-dilutive securities | ||
| Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 147,554 | |
| Common stock options | ||
| Anti-dilutive securities | ||
| Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 7,526,820 | 5,702,976 |
| 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
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
|
Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - Level 1 - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Assets: | ||
| Cash and cash equivalents | $ 10,512 | $ 7,776 |
| Total assets at fair value | $ 10,512 | $ 7,776 |
| X | ||||||||||
- Definition Fair value portion of 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
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Fair value portion 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. No definition available.
|
| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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Fair Value Measurements - Warrant Valuation Assumptions (Details) - Liabilities - Common stock warrants - Option pricing model |
Dec. 31, 2018
Y
item
|
|---|---|
| Significant assumptions used in valuation of the Company's warrants | |
| Life of treasury bonds | 1 year |
| Volatility | |
| Significant assumptions used in valuation of the Company's warrants | |
| Warrants, Measurement Input | 0.700 |
| Risk free interest rate | |
| Significant assumptions used in valuation of the Company's warrants | |
| Warrants, Measurement Input | 0.0257 |
| Strike price | |
| Significant assumptions used in valuation of the Company's warrants | |
| Warrants, Measurement Input | 6.00 |
| Share price | |
| Significant assumptions used in valuation of the Company's warrants | |
| Warrants, Measurement Input | 0.58 |
| Expected life | |
| Significant assumptions used in valuation of the Company's warrants | |
| Warrants, Measurement Input | Y | 1 |
| X | ||||||||||
- Definition Period between issuance and maturity of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), 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 | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Value of input used to measure outstanding warrant and right embodying unconditional obligation requiring redemption by transferring asset at specified or determinable date or upon event certain to occur. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Details
|
Fair Value Measurements - Rollforward of Fair Value of Level 3 Warrants and Transfers Between Levels (Details) - USD ($) |
6 Months Ended | 12 Months Ended | |
|---|---|---|---|
Jun. 30, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
| Fair value measurements | |||
| Asset transfers out of Level 1 into Level 2 | $ 0 | $ 0 | |
| Asset transfers out of Level 2 into Level 1 | 0 | 0 | |
| Asset transfers into (out of) Level 3 | 0 | 0 | |
| Liability transfers out of Level 1 into Level 2 | 0 | 0 | |
| Liability transfers out of Level 2 into Level 1 | 0 | 0 | |
| Liability transfers into (out of) Level 3 | 0 | 0 | |
| Common stock warrants | Liabilities | |||
| Rollforward of the fair value of Level 3 warrants: | |||
| Beginning balance | $ 0 | 29,000 | $ 172,000 |
| Change in fair value | (29,000) | (143,000) | |
| Ending balance | $ 0 | $ 29,000 | |
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of transfers of assets measured on a recurring basis out of Level 1 of the fair value hierarchy into Level 2. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of transfers of assets measured on a recurring basis out of Level 2 of the fair value hierarchy into Level 1. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of transfers of liabilities measured on a recurring basis out of Level 1 of the fair value hierarchy into Level 2. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of transfers of liabilities measured on a recurring basis out of Level 2 of the fair value hierarchy into Level 1. 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 Amount of transfer of financial instrument classified as an asset into (out of) level 3 of the fair value hierarchy. No definition available.
|
| X | ||||||||||
- Definition Amount of gain (loss) recognized on the income statement for financial instrument classified as a liability measured using unobservable inputs that reflect the entity's own assumption about the assumptions market participants would use in pricing. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of transfers of financial instrument classified as a liability into (out of) level 3 of the fair value hierarchy. No definition available.
|
| X | ||||||||||
- Definition Fair value of financial instrument classified as a liability measured using unobservable inputs that reflect the entity's own assumption about the assumptions market participants would use in pricing. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
|
| X | ||||||||||
- Details
|
Prepaid Expenses (Details) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Prepaid Expenses | ||
| Prepaid insurance | $ 102 | $ 484 |
| Other | 76 | 123 |
| Total prepaid expenses | $ 178 | $ 607 |
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for other costs that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for costs that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for insurance that provides economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Accrued Liabilities (Details) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Accrued Liabilities | ||
| Employee bonuses | $ 540 | $ 621 |
| Accrued retention bonus | 638 | |
| Accrued professional fees and other | 263 | 84 |
| Total accrued liabilities | $ 803 | $ 1,343 |
| X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable related to the retention bonus. 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 and payable for incentive compensation awarded to employees and directors or earned by them based on the terms of one or more relevant 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 | ||||||||||
- References No definition available.
|
| 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 | ||||||||||
- 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
|
Leases - Summary (Details) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
|
Jun. 30, 2019
USD ($)
lease
|
Jun. 30, 2019
USD ($)
lease
|
Jan. 01, 2019
USD ($)
|
Dec. 31, 2018
USD ($)
|
|
| Leases | ||||
| Lease assets | $ 250 | $ 250 | $ 18 | |
| Lease liability | $ 249 | $ 249 | ||
| Number of finance leases | lease | 0 | 0 | ||
| Number of operating leases | lease | 1 | 1 | ||
| Operating lease expense | $ 48 | $ 97 | ||
| Operating lease expense information: | ||||
| Cash paid for amounts included in measurement of lease liabilities | $ 35 | $ 75 | ||
| Weighted-average remaining lease term (years) | 1 year 4 months 24 days | 1 year 4 months 24 days | ||
| Weighted-average discount rate | 21.20% | 21.20% | ||
| ASU 2016-02 | ||||
| Leases | ||||
| Lease assets | $ 300 | |||
| Lease liability | $ 300 |
| X | ||||||||||
- Definition The number of finance leases. No definition available.
|
| X | ||||||||||
- Definition The number of operating leases. No definition available.
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Amount of operating lease expense. Excludes sublease income. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
| X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of cash outflow from operating lease, excluding payments to bring another asset to condition and location necessary for its intended use. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Weighted average discount rate for operating lease calculated at point in time. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Weighted average remaining lease term for 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/2003/role/exampleRef
|
| X | ||||||||||
- Details
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Leases - Maturity of lease liabilities (Details) $ in Thousands |
Jun. 30, 2019
USD ($)
|
|---|---|
| Operating Leases | |
| Remainder of 2019 | $ 100 |
| 2020 | 191 |
| Total | 291 |
| Less: Interest | (42) |
| Present value of lease liability | $ 249 |
| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in second fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease having an initial or remaining lease term in excess of one year due in remainder of fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments in excess of discounted obligation for lease payments for operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Number of the required periodic payments applied to principal. No definition available.
|
| X | ||||||||||
- Definition Percentage points adjustment to the variable rate of the debt instrument. No definition available.
|
| X | ||||||||||
- Definition Amount of increase in additional paid in capital (APIC) resulting from the issuance of warrants. Includes allocation of proceeds of debt securities issued with detachable stock purchase warrants. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Exercise price per share or per unit of warrants or rights outstanding. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of securities into which the class of warrant or right may be converted. For example, but not limited to, 500,000 warrants may be converted into 1,000,000 shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Percentage points added to the reference rate to compute the variable rate on the debt instrument. No definition available.
|
| X | ||||||||||
- Definition The reference rate for the variable rate of the debt instrument, such as LIBOR or the US Treasury rate and the maturity of the reference rate used, such as three months or six months LIBOR. No definition available.
|
| X | ||||||||||
- Definition Amount of the fee that accompanies borrowing money under the debt instrument. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Contractual interest rate for funds borrowed, under the debt agreement. 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 Amount of payment greater than the preceding installment payments to be paid at final maturity date of debt. No definition available.
|
| X | ||||||||||
- Definition Amount, after accumulated amortization, of debt discount. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Period between issuance and maturity of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), 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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- References No definition available.
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Amount of the cost of borrowed funds accounted for as interest expense for debt. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Maximum borrowing capacity under the credit facility without consideration of any current restrictions on the amount that could be borrowed or the amounts currently outstanding under the facility. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition The cash inflow from a debt initially having maturity due after one year or beyond the operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The cash inflow from the issuance of common stock, preferred stock, treasury stock, stock options, and other types of equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The cash outflow for debt initially having maturity due after one year or beyond the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Value of input used to measure outstanding warrant and right embodying unconditional obligation requiring redemption by transferring asset at specified or determinable date or upon event certain to occur. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition The value authorized to issue and sell shares of its common stock from time to time. No definition available.
|
| X | ||||||||||
- Definition The percentage of commission payable on the sale of common stock. No definition available.
|
| X | ||||||||||
- Definition Aggregate amount of securities issuable under a universal shelf registration statement. 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
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| X | ||||||||||
- Definition The cash inflow associated with the amount received from entity's raising of capital via private rather than public placement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| 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
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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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Stockholders' Equity - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
| Stock-Based Compensation Expense | ||||
| Total stock-based compensation expense | $ 479 | $ 987 | $ 969 | $ 2,106 |
| Research and development | ||||
| Stock-Based Compensation Expense | ||||
| Total stock-based compensation expense | 159 | 338 | 310 | 689 |
| General and administrative | ||||
| Stock-Based Compensation Expense | ||||
| Total stock-based compensation expense | $ 320 | $ 649 | $ 659 | $ 1,417 |
| 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
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- 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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Income Taxes (Details) - State - New Jersey - Sale of unused NOLs and research and development credits $ in Millions |
1 Months Ended |
|---|---|
|
Jan. 31, 2018
USD ($)
| |
| Sale of New Jersey Net Operating Losses | |
| Proceeds from the issuance of common stock, net | $ 0.5 |
| Maximum lifetime benefit under the Program | $ 15.0 |
| Minimum | |
| Sale of New Jersey Net Operating Losses | |
| Allowable sale of unused tax benefits as a percentage of total value | 80.00% |
| X | ||||||||||
- Definition The maximum lifetime benefit under the State of New Jersey's Technology Business Tax Certificate Transfer Program. No definition available.
|
| X | ||||||||||
- Definition The sale of unused net operating loss carryovers and unused research and development tax credits for percentage of the value of the tax benefits to unaffiliated. No definition available.
|
| 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 disposal of asset without physical form usually arising from contractual or other legal rights, excluding goodwill. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Details
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| X | ||||||||||
- Definition The total amount of the cash portion of the Retention Plan. No definition available.
|
| X | ||||||||||
- Definition Represents the number of installments. No definition available.
|
| X | ||||||||||
- Definition Amount of cash payments made as the result of exit or disposal activities. Excludes payments associated with a discontinued operation or an asset retirement obligation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
| X | ||||||||||
- Definition The number of positions eliminated during the period as a percentage of total positions eliminated during the period in connection with the restructuring plan(s). No definition available.
|
| X | ||||||||||
- Definition Amount of expenses associated with exit or disposal activities pursuant to an authorized plan. Excludes expenses related to a discontinued operation or an asset retirement obligation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- 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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- Definition Carrying amount (including both current and noncurrent portions of the accrual) as of the balance sheet date pertaining to a specified type of cost associated with exit from or disposal of business activities or restructuring pursuant to a duly authorized plan. 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 Weighted average per share amount at which grantees can acquire shares of common stock by exercise of options. No definition available.
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- Definition Percentage of vesting of share-based compensation awards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The total amount of the cash portion of the Retention Plan. No definition available.
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- Definition Represents the number of installments. No definition available.
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- Definition Weighted average per share amount at which grantees can acquire shares of common stock by exercise of options. No definition available.
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- Definition Percentage of vesting of share-based compensation awards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- 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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