Document and Entity Information - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Feb. 29, 2020 |
Jun. 30, 2019 |
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Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Evoke Pharma Inc | ||
Entity Central Index Key | 0001403708 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 13.2 | ||
Entity Common Stock, Shares Outstanding | 24,431,914 | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | EVOK | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-36075 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-8447886 | ||
Entity Address, Address Line One | 420 Stevens Avenue | ||
Entity Address, Address Line Two | Suite 370 | ||
Entity Address, City or Town | Solana Beach | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92075 | ||
City Area Code | 858 | ||
Local Phone Number | 345-1494 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A in connection with the registrant’s 2020 Annual Meeting of Stockholders, which will be filed subsequent to the date hereof, are incorporated by reference into Part III of this Form 10-K. Such proxy statement will be filed with the Securities and Exchange Commission not later than 120 days following the end of the registrant’s fiscal year ended December 31, 2019. |
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Balance Sheets (Parenthetical) - $ / shares |
Dec. 31, 2019 |
Dec. 31, 2018 |
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Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 24,431,914 | 17,427,533 |
Common stock, shares outstanding | 24,431,914 | 17,427,533 |
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Statements of Operations - USD ($) |
12 Months Ended | |
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Dec. 31, 2019 |
Dec. 31, 2018 |
|
Operating expenses: | ||
Research and development | $ 3,416,466 | $ 4,095,014 |
General and administrative | 3,737,987 | 3,919,671 |
Total operating expenses | 7,154,453 | 8,014,685 |
Loss from operations | (7,154,453) | (8,014,685) |
Other income: | ||
Interest income | 28,798 | 15,213 |
Gain from change in fair value of warrant liability | 433,392 | |
Total other income | 28,798 | 448,605 |
Net loss | $ (7,125,655) | $ (7,566,080) |
Net loss per share of common stock, basic and diluted | $ (0.32) | $ (0.46) |
Weighted-average shares used to compute basic and diluted net loss per share | 22,296,089 | 16,602,422 |
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Organization and Basis of Presentation |
12 Months Ended |
---|---|
Dec. 31, 2019 | |
Organization And Basis Of Presentation [Abstract] | |
Organization and Basis of Presentation |
1. Organization and Basis of Presentation Evoke Pharma, Inc. (the “Company”) was incorporated in the state of Delaware in January 2007. The Company is a specialty pharmaceutical company focused primarily on the development of drugs to treat gastroenterological disorders and disease. Since its inception, the Company has devoted substantially all of its efforts to developing its sole product candidate, Gimoti™, and has not realized revenues from its planned principal operations. The Company filed a 505(b)(2) New Drug Application (“NDA”) for Gimoti with the U.S. Food and Drug Administration (“FDA”) on June 1, 2018, and on April 1, 2019, the Company received a Complete Response Letter (“CRL”) from FDA for the NDA. The CRL stated that FDA has determined it cannot approve the NDA in its present form and provided recommendations to address the two remaining approvability issues in an NDA resubmission. The approvability issues are related to clinical pharmacology and product quality/device quality. FDA did not request any new clinical data and did not raise any safety concerns. On July 25, 2019, the Company completed a type A meeting with FDA to obtain FDA’s feedback and agreement on the Company’s plan to address deficiencies cited in the CRL in support of a resubmission of the Gimoti NDA. The focus of the discussion was on topics noted in the CRL, including the root cause analysis of low drug exposure in the comparative bioavailability study and additional product quality/device quality control testing. On December 19, 2019, based on FDA feedback received during the type A meeting, the Company resubmitted the Gimoti NDA to FDA. The resubmission provided the requested additional information intended to address the deficiencies cited in the CRL. To address the clinical pharmacology issues, the resubmission included an in-depth root cause analysis, as well as patient use and experience data from the Company’s clinical trials. To address product quality/device quality issues cited in the CRL, the resubmission included 3-month stability data from commercial scale registration batches that met all product specifications. We believe these data support the acceptance criteria for performance characteristics and device quality control we proposed in the Gimoti NDA. Additionally, as requested by FDA, the resubmission included data from an analysis of pump performance characteristics for the product used in the comparative bioavailability study and the product from commercial scale registration batches. The results of this testing showed all products performed within specifications. On January 17, 2020, the Company received a notice from FDA that it had accepted the Company’s NDA resubmission for review and set a target goal date for a decision under the Prescription Drug User Fee Act (“PDUFA”) of June 19, 2020. The Company does not anticipate realizing revenues until FDA approves the NDA and the Company begins commercializing Gimoti, which events may never occur. The Company’s activities are subject to the significant risks and uncertainties associated with any specialty pharmaceutical company that has substantial expenditures for research and development, including funding its operations. Going Concern The Company has incurred recurring losses and negative cash flows from operations since inception and expects to continue to incur net losses for the foreseeable future until such time, if ever, that it can generate significant revenues from the sale of Gimoti. Although the Company ended 2019 with approximately $5.7 million in cash and cash equivalents, the Company anticipates that it will continue to incur losses from operations due to pre-approval and pre-commercialization activities, including interactions with FDA on the Company’s NDA submission for Gimoti, responding to approvability issues raised in the CRL received from FDA, and potentially manufacturing commercial batches of Gimoti, and for general and administrative costs to support operations. As a result, the Company believes that there is substantial doubt about its ability to continue as a going concern for one year after the date these financial statements are issued. The financial statements do not include any adjustments that may result from the outcome of this uncertainty. The determination as to whether the Company can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. In its report on the Company’s financial statements for the year ended December 31, 2019, the Company’s independent registered public accounting firm included an explanatory paragraph expressing substantial doubt regarding the Company’s ability to continue as a going concern. The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. The Company believes, based on its current operating plan, that its existing cash and cash equivalents will be sufficient to fund its operations through the target goal date for a decision under PDUFA and into the third quarter of 2020. If Gimoti is approved by FDA, additional funds will become available from the revolving credit facility (the “Eversana Credit Facility”) with Eversana Life Sciences Services, LLC (“Eversana”), as disclosed in Note 8, which we believe, based on our current operating plan, will provide sufficient cash to fund the Company’s operations into 2021 excluding any potential future Gimoti product revenue. This period could be shortened if there are any significant increases in planned spending other than anticipated. Even with the Eversana Credit Facility, the Company will be required to raise additional funds through debt, equity or other forms of financing, such as potential collaboration arrangements, to fund future operations and continue as a going concern. There can be no assurance that additional financing will be available when needed or on acceptable terms. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, financial condition and future prospects. There can be no assurance that the Company will be able to further develop Gimoti, if required, and receive FDA approval of the Gimoti NDA. Because the Company’s business is entirely dependent on the success of Gimoti, if the Company is unable to secure additional financing or identify and execute on other development or strategic alternatives for Gimoti or the company, the Company will be required to curtail all of its activities and may be required to liquidate, dissolve or otherwise wind down its operations. Notice of Delisting On May 15, 2019, the Company received a letter from Nasdaq indicating that, for the last thirty consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market. In accordance with Nasdaq listing rules, the Company was provided an initial period of 180 calendar days, or until November 11, 2019, to regain compliance. The Nasdaq letter had no immediate effect on the listing or trading of the Company’s common stock and the common stock continued to trade on the Nasdaq Capital Market. The Company did not regain compliance with Nasdaq listing rules by November 11, 2019, but Nasdaq provided an additional 180 calendar day compliance period. On November 29, 2019, the Company received notification from Nasdaq that the Company regained compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. |
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- Definition Organization and basis of presentation. No definition available.
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- Definition The entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Summary of Significant Accounting Policies |
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Summary of Significant Accounting Policies |
2. Summary of Significant Accounting Policies Use of Estimates The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment operating in the United States. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents include cash in readily available checking and savings accounts. Fair Value of Financial Instruments The carrying amounts of all financial instruments, including accounts payable and accrued expenses, and employee-related liabilities, are considered to be representative of their respective fair values because of the short-term nature of those instruments. Concentrations of Risk Financial instruments that potentially subject the Company to significant credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in a federally insured financial institution in excess of federally insured limits. The Company has established guidelines designed to maintain safety and liquidity, has not experienced any losses in such accounts and believes the exposure to significant risk to the cash balance is minimal. The Company relies on contract research organizations (“CROs”) and consultants to assist with ongoing regulatory discussions and submissions supporting the NDA. If the CROs and consultants are unable to continue their support, this could adversely affect FDA’s review of the NDA. In addition, the Company relies on third-party manufacturers for the production of Gimoti. If the third-party manufacturers are unable to continue manufacturing Gimoti, or if the Company loses one of its sole source suppliers used in its manufacturing processes, the Company may not be able to meet any development needs or commercial supply demand for Gimoti, if approved by FDA, and the development and/or commercialization of Gimoti could be materially and adversely affected. The Company also relies on third-party sales and marketing organizations for the management of the pre-commercial launch preparation for Gimoti, as well as for a dedicated sales team to sell Gimoti, if approved by FDA. If such third-party organizations are unable to continue managing the launch preparation, or serving as a dedicated sales team, the commercialization of Gimoti could be materially and adversely affected. Warrant Accounting In March 2018, the Company entered into warrant amendments (the “Warrant Amendments”) with each of the holders of the Company’s outstanding warrants to purchase common stock issued on July 25, 2016 and August 3, 2016 (the “Warrants”). As a result of the Warrant Amendments, the Warrants are no longer classified as a liability on the Company’s balance sheet, were adjusted to fair value as of the date of the Warrant Amendments, and were reclassified to additional paid-in capital, a component of stockholders’ equity. Prior to the Warrant Amendments, the Warrants were classified as warrant liability and recorded at fair value. These Warrants contained a feature that could have required the transfer of cash in the event a change of control occurred without the authorization of the Company’s board of directors, and therefore, were classified as a liability in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity. This warrant liability was subject to remeasurement at each reporting date and the Company recognized any change in the fair value of the warrant liability in the statement of operations. The Company continued to adjust the carrying value of the warrants for changes in the estimated fair value until the date of the Warrant Amendments. Stock-Based Compensation Stock-based compensation expense for stock option grants and employee stock purchases under the Company’s Employee Stock Purchase Plan (the “ESPP”) is recorded at the estimated fair value of the award as of the grant date and is recognized as expense on a straight-line basis over the employee’s requisite service period. The estimation of stock option and ESPP fair value requires management to make estimates and judgments about, among other things, employee exercise behavior, forfeiture rates and volatility of the Company’s common stock. The judgments directly affect the amount of compensation expense that will be recognized. The Company grants stock options to purchase common stock to employees and members of the board of directors with exercise prices equal to the Company’s closing market price on the date the stock options are granted. The risk-free interest rate assumption was based on the yield of an applicable rate for U.S. Treasury instruments with maturities similar to those of the expected term of the award being valued. The weighted average expected term of options and employee stock purchases was calculated using the simplified method as prescribed by accounting guidance for stock-based compensation. This decision was based on the lack of relevant historical data due to the Company’s limited historical experience. In addition, due to the Company’s limited historical data, the estimated volatility was calculated based upon the Company’s historical volatility, supplemented, as necessary, with historical volatility of comparable companies in the biotechnology industry whose share prices are publicly available for a sufficient period of time. The assumed dividend yield was based on the Company never paying cash dividends and having no expectation of paying cash dividends in the foreseeable future. Research and Development Expenses Research and development costs are expensed as incurred and primarily include compensation and related benefits, stock-based compensation expense and costs paid to third-party contractors for product development activities and drug product materials. The Company expenses costs relating to the purchase and production of pre-approval inventories as research and development expense in the period incurred until FDA approval is received. Service providers typically invoice the Company monthly in arrears for services performed. In accruing service fees, the Company estimates the time period over which services were performed and the level of effort expended in each period. If the Company does not identify costs that have begun to be incurred, or if the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ materially from estimates. To date, the Company has not experienced significant changes in estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, no assurance can be made that changes to the estimates will not be made in the future as the Company becomes aware of additional information about the status or conduct of clinical studies and other research activities. The Company does not own or operate manufacturing facilities for the production of Gimoti, nor does it plan to develop its own manufacturing operations in the foreseeable future. The Company currently depends on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its pre-commercial product development. The Company has agreements with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, and with Thermo Fisher Scientific Inc., who acquired Patheon UK Limited, for product development and manufacturing of Gimoti. The Company currently utilizes third-party consultants, which it engages on an as-needed, hourly basis, to manage product development and manufacturing contractors. Income Taxes The Company accounts for income taxes in accordance with ASC 740, Income Taxes. Under ASC 740, deferred tax assets and liabilities reflect the future tax consequences of the differences between the financial reporting and tax basis of assets and liabilities using current enacted tax rates. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company’s policy related to accounting for uncertainty in income taxes prescribes a recognition threshold and measurement attributed criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common stock outstanding for the period, without consideration for common stock equivalents and adjusted for the weighted-average number of common stock outstanding that are subject to repurchase. Since the Company’s repurchase right lapsed upon the filing of the NDA in June 2018, the Company no longer has any common stock subject to repurchase. As such, to account for the time the common stock was subject to repurchase, the Company excluded 18,791 shares from the weighted-average number of common stock outstanding for the year ended December 31, 2018. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of shares subject to repurchase, warrants to purchase common stock, options to purchase common stock under the Company’s equity incentive plans and potential shares to be purchased under the ESPP. For the 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 because to do so would be anti-dilutive:
Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842). 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. The Company adopted this standard effective January 1, 2019, as required. The Company determines if an arrangement is a finance lease, operating lease or short-term lease at inception. The Company elected the “package of practical expedients,” which permits the Company not to reassess prior conclusions about lease identifications, lease classification and initial direct costs. The Company also elected not to separate lease and non-lease components when certain conditions are met. As discussed in Note 3, the Company’s only significant lease is its facility lease, which expires on December 31, 2020, and is classified as an operating lease. |
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- References No definition available.
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- Definition The entire disclosure for all significant accounting policies of the reporting entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Commitments |
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Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments |
3. Commitments In December 2016, the Company entered into an operating lease for office space in Solana Beach, California. The lease commenced on January 1, 2017, was extended in September 2018 and December 2019, and has an expiration date of December 31, 2020. According to ASU No. 2016-02, the Company recognized an operating lease ROU asset and liability based on the present value of the future minimum lease payments over the lease term at the commencement date, using the Company’s assumed incremental borrowing rate, and then amortizes the ROU assets over the lease term. The Company applies a discount rate to the minimum lease payments within the lease agreement to determine the value of right-of-use assets and lease liabilities. Unless the rate implicit in the lease is determinable, ASU No. 2016-02 requires the use of the rate of interest that a lessee would have to pay to borrow on a collateralized basis over a similar term for a similar amount to the lease payments in a similar economic environment. The Company noted that the implicit rate in the lease was not determinable and calculated its incremental borrowing rate primarily based on the Company’s assumed borrowing rate of 12%. On January 1, 2019, the Company recorded an operating lease ROU asset and liability of approximately $136,000 based on the present value of the remaining minimum lease payments. During the year ended December 31, 2019, changes in operating lease ROU asset and payments of the lease liability were included in prepaid expenses and other assets and accounts payable and other current liabilities, respectively, on the statement of cash flows. Upon amendment and renewal of the term of the lease in December 2019, the Company updated the operating lease ROU asset and liability based on the present value of the future minimum lease payments over the lease term at the commencement date of the lease amendment and recorded an operating lease ROU asset and liability of approximately $139,000. Rent expense for the years ended December 31, 2019 and 2018 was approximately $145,000 and $139,000, respectively. The Company also pays pass through costs and utility costs, which are expensed as incurred. As of December 31, 2019, the Company has future minimum lease payments under its facility lease in 2020 of approximately $146,000.
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- References No definition available.
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- Definition The entire disclosure for significant arrangements with third parties, which includes operating lease arrangements and arrangements in which the entity has agreed to expend funds to procure goods or services, or has agreed to commit resources to supply goods or services, and operating lease arrangements. Descriptions may include identification of the specific goods and services, period of time covered, minimum quantities and amounts, and cancellation rights. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Technology Acquisition Agreement |
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Dec. 31, 2019 | |
Technology Acquisition Agreement [Abstract] | |
Technology Acquisition Agreement |
4. Technology Acquisition Agreement In June 2007, the Company acquired all worldwide rights, data, patents and other related assets associated with Gimoti from Questcor Pharmaceuticals, Inc. (“Questcor”) pursuant to an Asset Purchase Agreement. The Company paid Questcor $650,000 in the form of an upfront payment and $500,000 in May 2014 as a milestone payment based upon the initiation of the first patient dosing in the Company’s Phase 3 clinical trial for Gimoti. In August 2014, Mallinckrodt, plc (“Mallinckrodt”) acquired Questcor. As a result of that acquisition, Questcor transferred its rights included in the Asset Purchase Agreement with the Company to Mallinckrodt. In addition to the payments previously made to Questcor, the Company may also be required to make additional milestone payments totaling up to $52 million. In March 2018, the Company and Mallinckrodt amended the Asset Purchase Agreement to defer development and approval milestone payments, such that, rather than paying two milestone payments based on FDA acceptance for review of the NDA and final product marketing approval, the Company would be required to make a single $5 million payment on the one-year anniversary after the Company receives FDA approval to market Gimoti. The remaining $47 million in milestone payments depend on Gimoti’s commercial success and will only apply if Gimoti receives regulatory approval. In addition, the Company will be required to pay Mallinckrodt a low single digit royalty on net sales of Gimoti. The Company’s obligation to pay such royalties will terminate upon the expiration of the last patent right covering Gimoti, which is expected to occur in 2032, subject to possible extension should any additional, later expiring, licensed patents be granted.
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- Definition Technology acquisition agreement. No definition available.
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- Definition The entire disclosure for a business combination (or series of individually immaterial business combinations) completed during the period, including background, timing, and recognized assets and liabilities. The disclosure may include leverage buyout transactions (as applicable). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Preferred Stock, Common Stock and Stockholders' Equity |
5. Preferred Stock, Common Stock and Stockholders’ Equity Preferred Stock Under the Company’s amended and restated certificate of incorporation, the Company is authorized to issue 5,000,000 shares of preferred stock with a $0.0001 par value. No shares of preferred stock were outstanding as of December 31, 2019 or 2018. Common Stock As of December 31, 2019, there were 24,431,914 shares of common stock outstanding. Each share of common stock is entitled to one vote. The holders of the common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors of the Company. To date, no dividends have been declared. As of December 31, 2019, the holders of 1,509,789 shares of the Company’s common stock are entitled to reasonable best efforts registration rights with respect to the registration of their shares under the Securities Act of 1933, as amended (“Securities Act.”). Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares held by affiliates, as defined in Rule 144 under the Securities Act. At the Market Equity Offering Program In November 2017, the Company filed a shelf registration with the SEC on Form S-3. The shelf registration statement includes a prospectus for the at-the-market offering to sell up to an aggregate of $16.0 million of shares of the Company’s common stock through B. Riley FBR, Inc. (“FBR”) as a sales agent (the “FBR Sales Agreement”). During the year ended December 31, 2018, the Company sold 1,985,054 shares of common stock at a weighted-average price per share of $2.38 pursuant to the FBR Sales Agreement and received proceeds of approximately $4.6 million, net of commissions and fees. During the year ended December 31, 2019, the Company sold 7,004,381 shares of common stock at a weighted-average price per share of $0.89 pursuant to the FBR Sales Agreement and received proceeds of approximately $6.1 million, net of commissions and fees. From January 1, 2020 through February 29, 2020, the Company has not sold any shares of common stock pursuant to the FBR Sales Agreement. Future sales will depend on a variety of factors including, but not limited to, market conditions, the trading price of the Company’s common stock and the Company’s capital needs. There can be no assurance that FBR will be successful in consummating future sales based on prevailing market conditions or in the quantities or at the prices that the Company deems appropriate. In addition, the Company will not be able to make future sales of common stock pursuant to the FBR Sales Agreement unless certain conditions are met, which include the accuracy of representations and warranties made to FBR under the FBR Sales Agreement. Furthermore, FBR is permitted to terminate the FBR Sales Agreement in its sole discretion upon ten days’ notice, or at any time in certain circumstances, including the occurrence of an event that would be reasonably likely to have a material adverse effect on the Company’s assets, business, operations, earnings, properties, condition (financial or otherwise), prospects, stockholders’ equity or results of operations. The Company has no obligation to sell the remaining shares available for sale pursuant to the FBR Sales Agreement. Warrants The Company has issued warrants to purchase common stock to banks that have previously loaned funds to the Company, as well as to representatives of the underwriters of the Company’s public offerings and certain of their affiliates. In March 2018, the Company entered into the Warrant Amendments with each of the holders of the Company’s outstanding Warrants acquired as a part of the Company’s financings which closed in July and August 2016. As a result of the Warrant Amendments, all of the remaining Warrants to purchase 2,449,129 shares of the Company’s common stock were no longer required to be classified as liabilities. The value of the amended Warrants was adjusted to the fair value immediately prior to the Warrant Amendments, resulting in a net gain of approximately $433,000 in the statement of operations for 2018, and approximately $3.3 million was reclassified from warrant liability to additional paid-in capital. In September 2018, warrants to purchase 84,000 shares of the Company’s common stock, issued to representatives of the underwriters in connection with the Company’s initial public offering in September 2013, expired and have been cancelled. At December 31, 2019 and 2018, there were warrants outstanding to purchase 2,713,561 shares of the Company’s common stock with a weighted average exercise price of $2.91. At December 31, 2019, the weighted average remaining contractual term of the outstanding warrants is 2.04 years. Equity Incentive Award Plans The Company adopted the 2007 Equity Incentive Plan (the “2007 Plan”) in May 2007 under which 450,000 shares of common stock were reserved for issuance to employees, nonemployee directors and consultants of the Company. There are no options available for future grant under this plan. In August 2013, the Company adopted the 2013 Equity Incentive Award Plan (the “2013 Plan”) as a successor to the 2007 Plan. Under the 2013 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then employees, officers, non-employee directors or consultants of the Company. A total of 510,000 shares of common stock were initially reserved for issuance under the 2013 Plan. In addition, the number of shares of common stock available for issuance under the 2013 Plan will be annually increased on the first day of each fiscal year during the term of the 2013 Plan, beginning with the 2014 fiscal year, by an amount equal to the least of: (i) 300,000 shares; (ii) four percent of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. In April 2016, the Company’s stockholders approved an amendment and restatement of the 2013 Equity Plan to increase the number of shares of common stock reserved under the 2013 Plan by 500,000 shares, to an aggregate of 4,786,425 shares, and to extend the term of the 2013 Plan into 2026. In April 2018, the Company’s stockholders approved another amendment and restatement of the 2013 Plan (the “Restated Plan”) to increase the number of shares of common stock authorized for issuance under the 2013 Plan by 1,500,000 shares, to an aggregate of 6,286,425 shares, and to extend the term of the 2013 Plan to February 2028. In addition, beginning on January 1, 2019, the number of shares available for issuance will be annually increased on the first day of each fiscal year by that number of shares equal to the least of (a) four percent of the outstanding shares of common stock on the last day of the immediately preceding calendar year, and (b) such other amount determined by the Company’s board of directors. Notwithstanding the foregoing, the number of shares of common stock that may be issued or transferred pursuant to incentive stock options under the Restated Plan may not exceed an aggregate of 8,000,000 shares. In June 2019, the Company effected a one-time option exchange, wherein employees were offered the opportunity to exchange certain outstanding stock options for the grant of a lesser number of replacement stock options. The participants received three new stock options for every four stock options tendered for exchange. As a result, 2,456,999 stock options were exchanged for 1,842,746 replacement stock options. The replacement stock options have a four-year vesting schedule and an exercise price of $0.62 per share, which was the closing price of the Company’s common stock on the date of the option exchange. All other terms of the replacement stock options remain the same as the original stock options that were exchanged. As a result of this transaction, the Company will recognize approximately $84,000 of additional stock-based compensation expense over the four-year vesting term of the exchanged options. As a result of the annual increases since the 2013 Plan originated, and the increase of stock options reserved under the Restated Plan approved by the Company’s stockholders through April 2018, the Company has increased the number shares reserved for issuance under the 2013 Plan by 4,073,526 shares. As of December 31, 2019, 1,587,155 options remain available for future grant under the 2013 Plan. On January 1, 2020, the Company further increased the number of shares reserved for issuance under the 2013 Plan by 977,277 shares, making 2,564,432 options available for future grant under the 2013 Plan. Options granted under the 2007 Plan and 2013 Plan have ten-year terms from the date of grant and generally vest over a one to four year period. The Company granted options to purchase 829,500 and 886,000 shares of common stock in 2019 and 2018, respectively. The exercise price of all options granted during the years ended December 31, 2019 and 2018 was equal to the market value per share of the Company’s common stock on the date of grant. A summary of the Company’s stock option activity under the 2007 Plan and 2013 Plan is as follows:
The intrinsic values above represent the aggregate value of the total pre-tax intrinsic value based upon a common stock price of $1.62 and $2.48 at December 31, 2019 and 2018, respectively, and the contractual exercise price. The weighted average grant date fair value per share of employee stock options granted during the years ended December 31, 2019 and 2018, was $0.91 and $1.86, respectively. There were no options exercised in 2019 and 2018. The Company had the following nonvested options under the 2007 Plan and 2013 Plan:
Employee Stock Purchase Plan In June 2013, the Company’s board of directors adopted the ESPP, and the Company’s stockholders approved the ESPP on August 29, 2013. The ESPP became effective on the day prior to the effectiveness of the IPO. The ESPP permits participants to purchase the Company’s common stock at 85% of the fair market value through payroll deductions of up to 20% of their eligible compensation. A total of 30,000 shares of common stock were initially reserved for issuance under the ESPP. In addition, the number of shares of common stock available for issuance under the ESPP has been annually increased on the first day of each fiscal year during the term of the ESPP by an amount equal to the lesser of: (i) 30,000 shares; (ii) one percent of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. Payroll withholdings from the Company’s employees of approximately $47,000 resulted in the issuance of 28,869 shares of common stock through its ESPP during the year ended December 31, 2018. No shares of common stock were issued through the ESPP during 2019. Stock-Based Compensation Stock-based compensation expense includes charges related to employee stock purchases under the ESPP and stock option grants. The Company measures stock-based compensation expense based on the grant date fair value of any awards granted to its employees. Such expense is recognized over the period of time that employees provide service and earn rights to the awards. The estimated fair value of each stock option award granted was determined on the date of grant using the Black Scholes option-pricing valuation model with the following weighted-average assumptions for option grants during the years ended December 31, 2019 and 2018:
The estimated fair value of the shares to be acquired under the ESPP was determined on the initiation date of each six-month purchase period using the Black-Scholes option-pricing valuation model with the following weighted-average assumptions for ESPP shares to be purchased during the years ended December 31, 2019 and 2018 as follows:
The Company recognized non-cash stock-based compensation expense to employees and directors in its research and development and its general and administrative functions during the years ended December 31, 2019 and 2018 as follows:
As of December 31, 2019, there was approximately $2.1 million of unrecognized compensation costs related to outstanding employee and board of director options, which are expected to be recognized over a weighted-average period of 1.24 years. Common Stock Reserved for Future Issuance Common stock reserved for future issuance consists of the following at December 31, 2019 and 2018:
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- References No definition available.
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- Definition The entire disclosure for shareholders' equity and share-based payment arrangement. Includes, but is not limited to, disclosure of policy and terms of share-based payment arrangement, deferred compensation arrangement, and employee stock purchase plan (ESPP). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Fair Value Measurements |
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Fair Value Measurements |
6. Fair Value Measurements 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 on the measurement date. As noted in Notes 2 and 5, due to the Warrant Amendments in March 2018, the warrant liability was reclassified to additional paid-in capital. Prior to the Warrant Amendments, the Company utilized a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value. This hierarchy prioritized the inputs into three broad levels as follows: Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on the Company’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. The Company had no assets or liabilities classified as Level 1 or Level 2. The warrant liability, prior to the Warrant Amendments of the warrants, was classified as Level 3. The following table presents a reconciliation of the Company’s warrant liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the year ended December 31, 2018:
There were no transfers between Level 1 and Level 2 in any of the periods reported. |
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- References No definition available.
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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://www.xbrl.org/2003/role/disclosureRef
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Employee Benefit Plan |
12 Months Ended |
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Dec. 31, 2019 | |
Compensation And Retirement Disclosure [Abstract] | |
Employee Benefit Plan |
7. Employee Benefit Plan The Company has established a defined contribution 401(k) plan (the “Plan”) for all employees who are at least 21 years of age. Employees are eligible to participate in the Plan beginning on the date of employment. Under the terms of the Plan, employees may make voluntary contributions as a percentage of compensation. The Company’s contributions to the Plan are discretionary, and no contributions have been made by the Company to date. For the years ended December 31, 2019 and 2018, the Company adopted Safe Harbor 401(k) provisions. No contributions were required to be made to the accounts of employees for the years ended December 31, 2019 and 2018 in order to maintain the Plan’s compliance with Internal Revenue Service regulations. |
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- References No definition available.
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- Definition The entire disclosure for postemployment benefits, which may include supplemental unemployment benefits, obligations recognized for all types of benefits provided to former or inactive employees, their beneficiaries, and covered dependents after employment but before retirement. Disclosure may also include discussion that an obligation for postemployment benefits is not accrued in accordance with regulation only because the amount cannot be reasonably estimated. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Commercial Services and Loan Agreements with Eversana |
12 Months Ended |
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Dec. 31, 2019 | |
Commercial Services And Loan Agreements [Abstract] | |
Commercial Services and Loan Agreements with Eversana |
8. Commercial Services and Loan Agreements with Eversana On January 21, 2020, the Company entered into a commercial services agreement (the “Eversana Agreement”) with Eversana for the commercialization of Gimoti. Pursuant to the Eversana Agreement, Eversana will commercialize and distribute Gimoti in the United States, if approved by FDA. Eversana will manage the marketing of Gimoti to gastroenterologists and other targeted health care providers, as well as the sales and distribution of Gimoti to wholesalers, pharmacies and other customers within the United States. Under the terms of the Eversana Agreement, the Company maintains ownership of the Gimoti NDA, as well as legal, regulatory, and manufacturing responsibilities for Gimoti. Eversana will utilize its internal sales organization, along with other commercial functions, for market access, marketing, distribution and other related patient support services. The Company will record sales for Gimoti and retain more than 80% of net product profits once the parties’ costs are reimbursed. Eversana will receive reimbursement of its commercialization costs pursuant to an agreed upon budget and a percentage of product profits in the mid-to-high teens. Net product profits are the net sales (as defined in the Eversana Agreement) of Gimoti, less (i) reimbursed commercialization costs, (ii) manufacturing and administrative costs set at a fixed percentage of net sales, and (iii) third party royalties. During the term of the Eversana Agreement, Eversana agreed to not market, promote, or sell a competing product in the United States. The term of the Eversana Agreement is from January 21, 2020 until five years from the date, if any, that FDA approves the Gimoti NDA. Upon expiration or termination of the agreement, the Company will retain all profits from product sales and assume all corresponding commercialization responsibilities. Within 30 days after each of the first three annual anniversaries of commercial launch, either party may terminate the agreement if net sales of Gimoti do not meet certain annual thresholds. Either party may terminate the agreement: for the material breach of the other party, subject to a 60-day cure period; in the event an insolvency, petition of the other party is pending for more than 60 days; upon 30 days written notice to the other party if Gimoti is subject to a safety recall; the other party is in breach of certain regulatory compliance representations under the agreement; the Company discontinues the development or production of Gimoti; Gimoti is not commercially launched within nine months of FDA approval, if any, or the net profit is negative for any two consecutive calendar quarters beginning with the first full calendar quarter 24 months following commercial launch; or if there is a change in applicable laws that makes operation of the services as contemplated under the agreement illegal or commercially impractical. Either party may also terminate the Eversana Agreement upon a change of control of the Company’s ownership, subject, in the event that the Company initiates such termination, to a one-time payment equal to between two times and one times annualized service fees paid by the Company under the Eversana Agreement, with such amount based on which year after commercial launch the change of control occurs. Such payment amount would be reduced by the amount of previously reimbursed commercialization costs and profit split paid for the related prior twelve month period and any revenue which occurred prior to the termination yet to be collected. In addition, Eversana may terminate the Eversana Agreement if Gimoti is not approved by FDA by December 31, 2020 (provided Eversana gives the Company notice of such termination no later than March 1, 2021), or if the Company withdraws Gimoti from the market for more than 90 days. The Company may also terminate the agreement if the parties are unable to agree to a commercialization plan and budget within 75 days of the date of the Eversana Agreement. In addition, in connection with the Eversana Agreement, the Company and Eversana have entered into the Eversana Credit Facility, pursuant to which Eversana has agreed to provide a revolving Credit Facility of up to $5.0 million to the Company upon FDA approval of the Gimoti NDA, if any, as well as certain other customary conditions. The Eversana Credit Facility is secured by all of the Company’s personal property other than the Company’s intellectual property. Under the terms of the Eversana Credit Facility, the Company cannot grant an interest in the Company’s intellectual property to any other person. Each loan under the Eversana Credit Facility will bear interest at an annual rate equal to 10.0%. The Company may prepay any amounts borrowed under the Eversana Credit Facility at any time without penalty or premium. The maturity date of all amounts, including interest, borrowed under the Eversana Credit Facility will be 90 days after the expiration or earlier termination of the Eversana Agreement. The Eversana Credit Facility also includes events of default, the occurrence and continuation of which provide Eversana with the right to exercise remedies against the Company and the collateral securing the loans under the Eversana Credit Facility, including the Company’s cash. These events of default include, among other things, the Company’s failure to pay any amounts due under the Eversana Credit Facility, an uncured material breach of the representations, warranties and other obligations under the Eversana Credit Facility, the occurrence of insolvency events and the occurrence of a change in control. On January 23, 2020, the Company and Novos Growth, LLC mutually agreed to terminate, effective immediately, a commercialization agreement entered into in January 2019. |
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- Definition Commercial services and loan agreements. No definition available.
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- Definition Commercial services and loan agreements. No definition available.
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Income Taxes |
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Income Tax Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes |
9. Income Taxes The Company accounts for uncertain tax positions in accordance with ASC Topic 740, Income Taxes. The application of income tax law and regulations is inherently complex. Interpretations and guidance surrounding income tax laws and regulations change over time. As such, changes in the Company’s subjective assumptions and judgments can materially affect amounts recognized in its financial statements. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no accrual for interest and penalties on the balance sheet at December 31, 2019. The Company has an uncertain tax position of $2.0 million related to California net operating losses at December 31, 2019. The Company is subject to taxation in the United States and state jurisdictions, and the Company’s tax years beginning 2007 to date are subject to examination by taxing authorities. Deferred income taxes result from temporary differences between the tax basis of assets and liabilities and their reported amounts in the financial statements that will result in taxable or deductible amounts in future years. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in years in which those temporary differences are expected to be recovered or settled. As changes in tax laws or rates are enacted, deferred tax assets and liabilities are adjusted through income tax expense. A reconciliation of the federal statutory income tax rate and the effective income tax rate is as follows for the years ended December 31, 2019 and 2018:
Pursuant to Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has not completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and research and development credit carryforwards. Until this analysis has been completed, the Company has removed the deferred tax assets for net operating losses of approximately $19.0 million and a research and development credit of approximately $3.5 million generated through December 31, 2019 from its deferred tax asset schedule, and has recorded a corresponding decrease to its valuation allowance. When this analysis is finalized, the Company plans to update its unrecognized tax benefits accordingly. The Company does not expect this analysis to be completed within the next twelve months and, as a result, the Company does not expect that the unrecognized tax benefits will change within twelve months of this reporting date. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate. Significant components of the Company’s deferred tax assets at December 31, 2019 and 2018 are as follows:
At December 31, 2019, the Company has federal and California net operating loss carryforwards of approximately $74.5 million and $47.7 million, respectively. The federal and California net operating loss carryforwards begin to expire in 2027 and 2028, respectively, unless previously utilized. The portion of federal net operating losses created after 2017 of approximately $12.6 million do not expire and will carry forward indefinitely. The Company also has federal and California research tax credit carryforwards of approximately $2.3 million and $1.4 million, respectively. The federal research credit carryforwards will begin expiring in 2027 unless previously utilized. The California research credit will carry forward indefinitely. Furthermore, under U.S. tax legislation enacted in December 2017, although the treatment of tax losses generated before December 31, 2017 has generally not changed, tax losses generated in calendar year 2018 and beyond do not expire, but may only offset 80% of the Company’s taxable income. This change may require us to pay federal income taxes in future years despite generating a loss for federal income tax purposes in prior years. There were no changes to unrecognized tax benefits in 2019 and 2018. As such, the balance of unrecognized tax benefits (excluding interest and penalties) was approximately $2.0 million at December 31, 2019 and 2018. Due to the full valuation allowance that the Company has on the deferred tax assets, there are no unrecognized tax benefits that would impact the effective tax rate, if recognized. |
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- References No definition available.
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- Definition The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Subsequent Events |
12 Months Ended |
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Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events |
10. Subsequent Events For the purposes of the financial statements as of December 31, 2019 and the year then ended, the Company has evaluated subsequent events through the date the audited annual financial statements were issued. The Company has concluded that no subsequent event has occurred that required disclosure in the financial statements other than what has been disclosed. |
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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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Summarized Quarterly Data (Unaudited) |
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Summarized Quarterly Data (Unaudited) |
11. Summarized Quarterly Data (Unaudited) The following financial information reflects all adjustments, which include only normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the financial results of the interim periods. Summarized quarterly data for the years ended December 31, 2019 and 2018 are as follows:
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- References No definition available.
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- Definition The entire disclosure for quarterly financial data. Includes, but is not limited to, tabular presentation of financial information for fiscal quarters, effect of year-end adjustments, and an explanation of matters or transactions that affect comparability of the information. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Summary of Significant Accounting Policies (Policies) |
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Use of Estimates |
Use of Estimates The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. |
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Segment Reporting |
Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment operating in the United States. |
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Cash and Cash Equivalents |
Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents include cash in readily available checking and savings accounts. |
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Fair Value of Financial Instruments |
Fair Value of Financial Instruments The carrying amounts of all financial instruments, including accounts payable and accrued expenses, and employee-related liabilities, are considered to be representative of their respective fair values because of the short-term nature of those instruments. |
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Concentrations of Risk |
Concentrations of Risk Financial instruments that potentially subject the Company to significant credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in a federally insured financial institution in excess of federally insured limits. The Company has established guidelines designed to maintain safety and liquidity, has not experienced any losses in such accounts and believes the exposure to significant risk to the cash balance is minimal. The Company relies on contract research organizations (“CROs”) and consultants to assist with ongoing regulatory discussions and submissions supporting the NDA. If the CROs and consultants are unable to continue their support, this could adversely affect FDA’s review of the NDA. In addition, the Company relies on third-party manufacturers for the production of Gimoti. If the third-party manufacturers are unable to continue manufacturing Gimoti, or if the Company loses one of its sole source suppliers used in its manufacturing processes, the Company may not be able to meet any development needs or commercial supply demand for Gimoti, if approved by FDA, and the development and/or commercialization of Gimoti could be materially and adversely affected. The Company also relies on third-party sales and marketing organizations for the management of the pre-commercial launch preparation for Gimoti, as well as for a dedicated sales team to sell Gimoti, if approved by FDA. If such third-party organizations are unable to continue managing the launch preparation, or serving as a dedicated sales team, the commercialization of Gimoti could be materially and adversely affected. |
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Warrant Accounting |
Warrant Accounting In March 2018, the Company entered into warrant amendments (the “Warrant Amendments”) with each of the holders of the Company’s outstanding warrants to purchase common stock issued on July 25, 2016 and August 3, 2016 (the “Warrants”). As a result of the Warrant Amendments, the Warrants are no longer classified as a liability on the Company’s balance sheet, were adjusted to fair value as of the date of the Warrant Amendments, and were reclassified to additional paid-in capital, a component of stockholders’ equity. Prior to the Warrant Amendments, the Warrants were classified as warrant liability and recorded at fair value. These Warrants contained a feature that could have required the transfer of cash in the event a change of control occurred without the authorization of the Company’s board of directors, and therefore, were classified as a liability in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity. This warrant liability was subject to remeasurement at each reporting date and the Company recognized any change in the fair value of the warrant liability in the statement of operations. The Company continued to adjust the carrying value of the warrants for changes in the estimated fair value until the date of the Warrant Amendments. |
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Stock-Based Compensation |
Stock-Based Compensation Stock-based compensation expense for stock option grants and employee stock purchases under the Company’s Employee Stock Purchase Plan (the “ESPP”) is recorded at the estimated fair value of the award as of the grant date and is recognized as expense on a straight-line basis over the employee’s requisite service period. The estimation of stock option and ESPP fair value requires management to make estimates and judgments about, among other things, employee exercise behavior, forfeiture rates and volatility of the Company’s common stock. The judgments directly affect the amount of compensation expense that will be recognized. The Company grants stock options to purchase common stock to employees and members of the board of directors with exercise prices equal to the Company’s closing market price on the date the stock options are granted. The risk-free interest rate assumption was based on the yield of an applicable rate for U.S. Treasury instruments with maturities similar to those of the expected term of the award being valued. The weighted average expected term of options and employee stock purchases was calculated using the simplified method as prescribed by accounting guidance for stock-based compensation. This decision was based on the lack of relevant historical data due to the Company’s limited historical experience. In addition, due to the Company’s limited historical data, the estimated volatility was calculated based upon the Company’s historical volatility, supplemented, as necessary, with historical volatility of comparable companies in the biotechnology industry whose share prices are publicly available for a sufficient period of time. The assumed dividend yield was based on the Company never paying cash dividends and having no expectation of paying cash dividends in the foreseeable future. |
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Research and Development Expenses |
Research and Development Expenses Research and development costs are expensed as incurred and primarily include compensation and related benefits, stock-based compensation expense and costs paid to third-party contractors for product development activities and drug product materials. The Company expenses costs relating to the purchase and production of pre-approval inventories as research and development expense in the period incurred until FDA approval is received. Service providers typically invoice the Company monthly in arrears for services performed. In accruing service fees, the Company estimates the time period over which services were performed and the level of effort expended in each period. If the Company does not identify costs that have begun to be incurred, or if the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ materially from estimates. To date, the Company has not experienced significant changes in estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, no assurance can be made that changes to the estimates will not be made in the future as the Company becomes aware of additional information about the status or conduct of clinical studies and other research activities. The Company does not own or operate manufacturing facilities for the production of Gimoti, nor does it plan to develop its own manufacturing operations in the foreseeable future. The Company currently depends on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its pre-commercial product development. The Company has agreements with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, and with Thermo Fisher Scientific Inc., who acquired Patheon UK Limited, for product development and manufacturing of Gimoti. The Company currently utilizes third-party consultants, which it engages on an as-needed, hourly basis, to manage product development and manufacturing contractors. |
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Income Taxes |
Income Taxes The Company accounts for income taxes in accordance with ASC 740, Income Taxes. Under ASC 740, deferred tax assets and liabilities reflect the future tax consequences of the differences between the financial reporting and tax basis of assets and liabilities using current enacted tax rates. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company’s policy related to accounting for uncertainty in income taxes prescribes a recognition threshold and measurement attributed criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. |
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Net Loss Per Share |
Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common stock outstanding for the period, without consideration for common stock equivalents and adjusted for the weighted-average number of common stock outstanding that are subject to repurchase. Since the Company’s repurchase right lapsed upon the filing of the NDA in June 2018, the Company no longer has any common stock subject to repurchase. As such, to account for the time the common stock was subject to repurchase, the Company excluded 18,791 shares from the weighted-average number of common stock outstanding for the year ended December 31, 2018. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of shares subject to repurchase, warrants to purchase common stock, options to purchase common stock under the Company’s equity incentive plans and potential shares to be purchased under the ESPP. For the 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 because to do so would be anti-dilutive:
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Recent Accounting Pronouncements |
Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842). 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. The Company adopted this standard effective January 1, 2019, as required. The Company determines if an arrangement is a finance lease, operating lease or short-term lease at inception. The Company elected the “package of practical expedients,” which permits the Company not to reassess prior conclusions about lease identifications, lease classification and initial direct costs. The Company also elected not to separate lease and non-lease components when certain conditions are met. As discussed in Note 3, the Company’s only significant lease is its facility lease, which expires on December 31, 2020, and is classified as an operating lease. |
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- References No definition available.
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- Definition Disclosure of accounting policy for cash and cash equivalents, including the policy for determining which items are treated as cash equivalents. Other information that may be disclosed includes (1) the nature of any restrictions on the entity's use of its cash and cash equivalents, (2) whether the entity's cash and cash equivalents are insured or expose the entity to credit risk, (3) the classification of any negative balance accounts (overdrafts), and (4) the carrying basis of cash equivalents (for example, at cost) and whether the carrying amount of cash equivalents approximates fair value. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for credit risk. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy for its derivative instruments and hedging activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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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 income taxes, which may include its accounting policies for recognizing and measuring deferred tax assets and liabilities and related valuation allowances, recognizing investment tax credits, operating loss carryforwards, tax credit carryforwards, and other carryforwards, methodologies for determining its effective income tax rate and the characterization of interest and penalties in the financial statements. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Disclosure of accounting policy pertaining to new accounting pronouncements that may impact the entity's financial reporting. Includes, but is not limited to, quantification of the expected or actual impact. No definition available.
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- Definition Disclosure of accounting policy for costs it has incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for segment reporting. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Disclosure of accounting policy for award under share-based payment arrangement. Includes, but is not limited to, methodology and assumption used in measuring cost. 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) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | For the 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 because to do so would be anti-dilutive:
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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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Preferred Stock, Common Stock and Stockholders' Equity (Tables) |
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Equity [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Stock Option Activity |
A summary of the Company’s stock option activity under the 2007 Plan and 2013 Plan is as follows:
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Summary of Nonvested Options Activity |
The Company had the following nonvested options under the 2007 Plan and 2013 Plan:
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Summary of Estimated Fair Value of Stock Option Award |
The estimated fair value of each stock option award granted was determined on the date of grant using the Black Scholes option-pricing valuation model with the following weighted-average assumptions for option grants during the years ended December 31, 2019 and 2018:
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Summary of Estimated Fair Value of Shares to be Acquired under Employee Stock Purchase Plan |
The estimated fair value of the shares to be acquired under the ESPP was determined on the initiation date of each six-month purchase period using the Black-Scholes option-pricing valuation model with the following weighted-average assumptions for ESPP shares to be purchased during the years ended December 31, 2019 and 2018 as follows:
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Summary of Recognized Non-Cash Stock-Based Compensation Expense |
The Company recognized non-cash stock-based compensation expense to employees and directors in its research and development and its general and administrative functions during the years ended December 31, 2019 and 2018 as follows:
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Summary of Common Stock Reserved for Future Issuance |
Common stock reserved for future issuance consists of the following at December 31, 2019 and 2018:
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- Definition Schedule of common stock reserved for future issuance. No definition available.
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- References No definition available.
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- Definition Tabular disclosure of allocation of amount expensed and capitalized for award under share-based payment arrangement to statement of income or comprehensive income and statement of financial position. Includes, but is not limited to, corresponding line item in financial statement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of the changes in outstanding nonvested shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure for stock option plans. Includes, but is not limited to, outstanding awards at beginning and end of year, grants, exercises, forfeitures, and weighted-average grant date fair value. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of the significant assumptions used during the year to estimate the fair value of employee stock purchase plans, including, but not limited to: (a) expected term, (b) expected volatility of the entity's shares, (c) expected dividends, (d) risk-free rate(s), and (e) discount for post-vesting restrictions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of the significant assumptions used during the year to estimate the fair value of stock options, including, but not limited to: (a) expected term of share options and similar instruments, (b) expected volatility of the entity's shares, (c) expected dividends, (d) risk-free rate(s), and (e) discount for post-vesting restrictions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Fair Value Measurements (Tables) |
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||
Summary of Reconciliation of Warrant Liability Measured at Fair Value on Recurring Basis Using Significant Unobservable Inputs |
The following table presents a reconciliation of the Company’s warrant liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the year ended December 31, 2018:
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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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Income Taxes (Tables) |
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Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reconciliation of Federal Statutory Income Tax Rate and Effective Income Tax Rate |
A reconciliation of the federal statutory income tax rate and the effective income tax rate is as follows for the years ended December 31, 2019 and 2018:
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Summary of Significant Components of Deferred Tax Assets |
Significant components of the Company’s deferred tax assets at December 31, 2019 and 2018 are as follows:
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- References No definition available.
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- Definition Tabular disclosure of the components of net deferred tax asset or liability recognized in an entity's statement of financial position, including the following: the total of all deferred tax liabilities, the total of all deferred tax assets, the total valuation allowance recognized for deferred tax assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of the reconciliation using percentage or dollar amounts of the reported amount of income tax expense attributable to continuing operations for the year to the amount of income tax expense that would result from applying domestic federal statutory tax rates to pretax income from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Summarized Quarterly Data (Unaudited) (Tables) |
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Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summarized Quarterly Data | Summarized quarterly data for the years ended December 31, 2019 and 2018 are as follows:
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- References No definition available.
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- Definition Tabular disclosure of quarterly financial data. Includes, but is not limited to, financial information for fiscal quarters, cumulative effect of a change in accounting principle and earnings per share data. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Organization and Basis of Presentation - Additional Information (Detail) - USD ($) |
12 Months Ended | |||
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May 15, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
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Organization And Basis Of Presentation [Abstract] | ||||
Month and year of incorporation | 2007-01 | |||
Cash and cash equivalents | $ 5,663,833 | $ 5,319,004 | $ 7,679,267 | |
Minimum common stock closing bid price | $ 1.00 | |||
Initial period to regain compliance | 180 days | |||
Closing bid price description | On May 15, 2019, the Company received a letter from Nasdaq indicating that, for the last thirty consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market. In accordance with Nasdaq listing rules, the Company was provided an initial period of 180 calendar days, or until November 11, 2019, to regain compliance. The Nasdaq letter had no immediate effect on the listing or trading of the Company’s common stock and the common stock continued to trade on the Nasdaq Capital Market. |
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- Definition Closing bid price description. No definition available.
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- Definition Entity incorporation month and year of incorporation. No definition available.
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- Definition Initial period to regain compliance. No definition available.
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- Definition The minimum closing bid price per share of the common stock. No definition available.
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- Definition Organization and basis of presentation. No definition available.
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- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Summary of Significant Accounting Policies - Additional Information (Detail) |
12 Months Ended | |
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Dec. 31, 2019
Segment
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Dec. 31, 2018
shares
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Accounting Policies [Abstract] | ||
Number of operating segment | Segment | 1 | |
Shares of common stock subject to repurchase excluded from the weighted-average number of common stock outstanding | shares | 18,791 |
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- References No definition available.
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- Definition Number of operating segments. An operating segment is a component of an enterprise: (a) that engages in business activities from which it may earn revenues and incur expenses (including revenues and expenses relating to transactions with other components of the same enterprise), (b) whose operating results are regularly reviewed by the enterprise's chief operating decision maker to make decisions about resources to be allocated to the segment and assess its performance, and (c) for which discrete financial information is available. An operating segment may engage in business activities for which it has yet to earn revenues, for example, start-up operations may be operating segments before earning revenues. No definition available.
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- Definition Number of shares of common stock subject to repurchase or cancellation determined by relating the portion of time within a reporting period that these shares have been outstanding to the total time in that period. Common stock subject to repurchase are outstanding common shares that are contingently returnable (that is, subject to recall). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- 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
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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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- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
|
Commitments - Additional Information (Detail) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Jan. 01, 2019 |
|
Disclosure - Commitments - Additional Information (Detail) [Line Items] | |||
Lease commencement date | Jan. 01, 2017 | ||
Lease expiry date | Dec. 31, 2020 | ||
Operating lease incremental borrowing rate | 12.00% | ||
Operating lease ROU | $ 138,538 | $ 136,000 | |
Operating lease liability | 138,538 | 136,000 | |
Rent expense | 145,000 | $ 139,000 | |
Future minimum facility lease payments due in 2020 | 146,000 | ||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||
Operating lease ROU | 138,538 | 136,000 | |
Operating lease liability | 138,538 | $ 136,000 | |
Accounting Standards Update 2016-02 | |||
Disclosure - Commitments - Additional Information (Detail) [Line Items] | |||
Operating lease ROU | 139,000 | ||
Operating lease liability | 139,000 | ||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||
Operating lease ROU | 139,000 | ||
Operating lease liability | $ 139,000 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Lease commencement date. No definition available.
|
X | ||||||||||
- Definition Operating lease incremental borrowing rate. No definition available.
|
X | ||||||||||
- Definition Amount of minimum lease payments for capital leases due in the next fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|
X | ||||||||||
- Definition Amount of rent expense incurred for leased assets, including but not limited to, furniture and equipment, that is not directly or indirectly associated with the manufacture, sale or creation of a product or product line. No definition available.
|
X | ||||||||||
- Definition Date which lease or group of leases is set to expire, in CCYY-MM-DD format. 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 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
|
X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition Estimated year of patent expiration. No definition available.
|
X | ||||||||||
- Definition Milestone payment. No definition available.
|
X | ||||||||||
- Definition Milestone payments contingent amount. No definition available.
|
X | ||||||||||
- Definition The number of milestone payments. No definition available.
|
X | ||||||||||
- Definition Description of material contingencies of the registrant unless separately disclosed in the consolidated statements. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
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 amount of purchased research and development assets that are acquired in a business combination have no alternative future use and are therefore written off in the period of acquisition. No definition available.
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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- Details
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X | ||||||||||
- Details
|
Preferred Stock, Common Stock and Stockholders' Equity - Preferred Stock - Additional Information (Detail) - $ / shares |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Equity [Abstract] | ||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares outstanding | 0 | 0 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Face amount or stated value per share of preferred stock nonredeemable or redeemable solely at the option of the issuer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The maximum number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) permitted to be issued by an entity's charter and bylaws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Aggregate share number for all nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer) held by stockholders. Does not include preferred shares that have been repurchased. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Common stock shares to be issued, value. No definition available.
|
X | ||||||||||
- Definition Common stock weighted average price per share. No definition available.
|
X | ||||||||||
- Definition Sale of stock. No definition available.
|
X | ||||||||||
- Definition Shares of common stock subject to registration rights. No definition available.
|
X | ||||||||||
- Definition Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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
|
X | ||||||||||
- Definition Description of voting rights of common stock. Includes eligibility to vote and votes per share owned. Include also, if any, unusual voting rights. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of paid and unpaid common stock dividends declared with the form of settlement in cash. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The cash inflow from the additional capital contribution to the entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
|
Preferred Stock, Common Stock and Stockholders' Equity - Warrants - Additional Information (Detail) - USD ($) |
1 Months Ended | 3 Months Ended | 12 Months Ended | |
---|---|---|---|---|
Sep. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Sale Of Stock [Line Items] | ||||
Change in fair value of warrant liability | $ 433,392 | $ 433,392 | ||
Warrants outstanding to purchase common stock | 2,713,561 | 2,713,561 | ||
Weighted average exercise price of warrants | $ 2.91 | $ 2.91 | ||
Weighted average remaining contractual term of outstanding warrants | 2 years 14 days | 2 years 14 days | ||
Warrant Amendments [Member] | ||||
Sale Of Stock [Line Items] | ||||
Unregistered warrants to purchase of common stock | 2,449,129 | |||
Change in fair value of warrant liability | $ 433,000 | |||
Reclassification of warrant liability to Additional Paid-in Capital | $ 3,300,000 | |||
Amendment date | 2018-03 | |||
Underwriters [Member] | ||||
Sale Of Stock [Line Items] | ||||
Unregistered warrants to purchase of common stock expired | 84,000 |
X | ||||||||||
- Definition Amendment agreement month and year. No definition available.
|
X | ||||||||||
- Definition Class of warrant or right number of securities called by warrants or rights expired. No definition available.
|
X | ||||||||||
- Definition Class of warrant or right outstanding weighted average remaining contractual term. No definition available.
|
X | ||||||||||
- Definition Reclassification of warrant liability to additional paid-in capital. No definition available.
|
X | ||||||||||
- Definition Sale of stock. No definition available.
|
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 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 Number of warrants or rights outstanding. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of expense (income) related to adjustment to fair value of warrant liability. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition Additional number of common stock capital shares reserved for future issuance. No definition available.
|
X | ||||||||||
- Definition Increase in number of shares of common stock reserved for issuance. No definition available.
|
X | ||||||||||
- Definition Sale of stock. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement by share based payment award expiration month and year. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement by share based payment award expiration year. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement increase in number of shares reserved for issuance percentage under plan. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangements by share based payment award options outstanding date intrinsic value. No definition available.
|
X | ||||||||||
- Definition Amount of expense for award under share-based payment arrangement. Excludes amount capitalized. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Aggregate number of common shares reserved for future issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The number of shares converted in a noncash (or part noncash) transaction. Noncash is defined as transactions during a period that do not result in cash receipts or cash payments in the period. "Part noncash" refers to that portion of the transaction not resulting in cash receipts or cash payments in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The number of new shares issued in the conversion of stock in a noncash (or part noncash) transaction. Noncash is defined as transactions during a period that do not result in cash receipts or cash payments in the period. "Part noncash" refers to that portion of the transaction not resulting in cash receipts or cash payments in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Estimated period over which an employee is required to provide service in exchange for the equity-based payment award, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Period over which grantee's right to exercise award under share-based payment arrangement is no longer contingent on satisfaction of service or performance condition, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Includes, but is not limited to, combination of market, performance or service condition. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Agreed-upon price for the exchange of the underlying asset relating to the share-based payment award. No definition available.
|
X | ||||||||||
- Definition The difference between the maximum number of shares (or other type of equity) authorized for issuance under the plan (including the effects of amendments and adjustments), and the sum of: 1) the number of shares (or other type of equity) already issued upon exercise of options or other equity-based awards under the plan; and 2) shares (or other type of equity) reserved for issuance on granting of outstanding awards, net of cancellations and forfeitures, if applicable. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
X | ||||||||||
- Definition The weighted average grant-date fair value of options granted during the reporting period as calculated by applying the disclosed option pricing methodology. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Description of terms of award under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Ratio applied to the conversion of stock split, for example but not limited to, one share converted to two or two shares converted to one. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition Share based compensation arrangement by share based payment award options outstanding aggregate intrinsic value. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement by share based payment award options outstanding weighted average remaining contractual term 2 expired or forfeited or exchanged. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement by share based payment award options outstanding weighted average remaining contractual term 2 granted. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement by share based payment award options outstanding weighted average remaining contractual term. No definition available.
|
X | ||||||||||
- Definition The number of shares into which fully or partially vested stock options outstanding as of the balance sheet date can be currently converted under the option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The weighted-average price as of the balance sheet date at which grantees can acquire the shares reserved for issuance on vested portions of options outstanding and currently exercisable under the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average price of options that were either forfeited or expired. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The number of shares under options that were cancelled during the reporting period as a result of occurrence of a terminating event specified in contractual agreements pertaining to the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
X | ||||||||||
- Definition Amount by which the current fair value of the underlying stock exceeds the exercise price of options outstanding. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of options outstanding, including both vested and non-vested options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. No definition available.
|
X | ||||||||||
- Definition Weighted average price at which grantees can acquire the shares reserved for issuance under the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount by which current fair value of underlying stock exceeds exercise price of fully vested and expected to vest options outstanding. Includes, but is not limited to, unvested options for which requisite service period has not been rendered but that are expected to vest based on achievement of performance condition, if forfeitures are recognized when they occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of fully vested and expected to vest options outstanding that can be converted into shares under option plan. Includes, but is not limited to, unvested options for which requisite service period has not been rendered but that are expected to vest based on achievement of performance condition, if forfeitures are recognized when they occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted-average exercise price, at which grantee can acquire shares reserved for issuance, for fully vested and expected to vest options outstanding. Includes, but is not limited to, unvested options for which requisite service period has not been rendered but that are expected to vest based on achievement of performance condition, if forfeitures are recognized when they occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average per share amount at which grantees can acquire shares of common stock by exercise of options. No definition available.
|
X | ||||||||||
- Definition Amount of difference between fair value of the underlying shares reserved for issuance and exercise price of vested portions of options outstanding and currently exercisable. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average remaining contractual term for vested portions of options outstanding and currently exercisable or convertible, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average remaining contractual term for option awards outstanding, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average remaining contractual term for fully vested and expected to vest options outstanding, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Includes, but is not limited to, unvested options for which requisite service period has not been rendered but that are expected to vest based on achievement of performance condition, if forfeitures are recognized when they occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
X | ||||||||||
- Definition The weighted average grant-date fair value of options granted during the reporting period as calculated by applying the disclosed option pricing methodology. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of non-vested options outstanding. No definition available.
|
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 Number of non-vested options forfeited. No definition available.
|
X | ||||||||||
- Definition Weighted average grant-date fair value of non-vested options outstanding. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Number of options vested. No definition available.
|
X | ||||||||||
- Definition Weighted average grant-date fair value of options vested. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition Increase in number of shares of common stock reserved for issuance. No definition available.
|
X | ||||||||||
- Definition Number of shares increased annually to common stock shares reserved for issuance. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement by share based payment award approval date. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement by share based payment award expiration year. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement by share based payment award number of shares authorized for employee stock purchase plan. No definition available.
|
X | ||||||||||
- Definition Share based compensation arrangement increase in number of shares reserved for issuance percentage under plan. No definition available.
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred and payable for statutory payroll taxes incurred through that date and withheld from employees pertaining to services received from them, including entity's matching share of the employees FICA taxes and contributions to the state and federal unemployment insurance programs. 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 Aggregate number of common shares reserved for future issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of cost not yet recognized for nonvested award under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted-average period over which cost not yet recognized is expected to be recognized for award under share-based payment arrangement, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
X | ||||||||||
- Definition The highest percentage of annual salary that an employee is permitted to utilize with respect to the plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Description of terms of award under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Purchase price of common stock expressed as a percentage of its fair value. No definition available.
|
X | ||||||||||
- Definition Number of shares issued during the period as a result of an employee stock purchase plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The increase (decrease) during the period in the number of shares issued. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
Preferred Stock, Common Stock and Stockholders' Equity - Summary of Estimated Fair Value of Stock Option Award (Detail) - Common stock options [Member] |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free interest rate | 1.80% | 2.66% |
Expected option term | 4 years 3 months 7 days | 5 years 6 months |
Expected volatility of common stock | 90.34% | 90.15% |
Maximum [Member] | ||
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free interest rate | 2.55% | 2.85% |
Expected option term | 6 years | 6 years |
Expected volatility of common stock | 112.58% | 92.30% |
X | ||||||||||
- Definition The estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the option's term. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The estimated measure of the percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The risk-free interest rate assumption that is used in valuing an option on its own shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition 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 Expected term of award under share-based payment arrangement, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
Preferred Stock, Common Stock and Stockholders' Equity - Summary of Estimated Fair Value of Employee Stock Purchase Plan Award (Detail) - Employee stock purchase plan [Member] |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 6 months | 6 months |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free interest rate | 1.89% | 1.85% |
Expected volatility of common stock | 130.36% | 45.24% |
Maximum [Member] | ||
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free interest rate | 2.52% | 2.29% |
Expected volatility of common stock | 170.68% | 58.76% |
X | ||||||||||
- Definition The estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the option's term. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The estimated measure of the percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The risk-free interest rate assumption that is used in valuing an option on its own shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition 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 Expected term of award under share-based payment arrangement, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- Details
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Preferred Stock, Common Stock and Stockholders' Equity - Summary of Recognized Non-Cash Stock-Based Compensation Expense (Detail) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 1,373,958 | $ 1,539,469 |
Research and development [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 710,155 | 673,525 |
General and administrative [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 663,803 | $ 865,944 |
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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 Amount of noncash expense for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Preferred Stock, Common Stock and Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Detail) - shares |
Dec. 31, 2019 |
Dec. 31, 2018 |
Apr. 26, 2018 |
---|---|---|---|
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Stock options issued and outstanding | 3,114,371 | 3,017,624 | |
Authorized for future option grants | 1,587,155 | 986,801 | |
Warrants to purchase common stock | 2,713,561 | 2,713,561 | |
Authorized for employee stock purchase plan | 263,065 | 163,065 | |
Total common stock reserved for future issuance | 7,678,152 | 6,881,051 | 6,286,425 |
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- Definition Share based compensation arrangement by share based payment award number of shares authorized for employee stock purchase plan. No definition available.
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- Definition Number of warrants or rights outstanding. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Aggregate number of common shares reserved for future issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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X | ||||||||||
- Definition The difference between the maximum number of shares (or other type of equity) authorized for issuance under the plan (including the effects of amendments and adjustments), and the sum of: 1) the number of shares (or other type of equity) already issued upon exercise of options or other equity-based awards under the plan; and 2) shares (or other type of equity) reserved for issuance on granting of outstanding awards, net of cancellations and forfeitures, if applicable. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Number of options outstanding, including both vested and non-vested options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- 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
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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 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
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- 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
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- 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
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- 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
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- Definition Fair value of financial and nonfinancial obligations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Fair Value Measurements - Summary of Reconciliation of Warrant Liability Measured at Fair Value on Recurring Basis Using Significant Unobservable Inputs (Detail) - Fair Value Measurement, Recurring [Member] - Warrant Liability [Member] |
12 Months Ended |
---|---|
Dec. 31, 2018
USD ($)
| |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Beginning balance | $ 3,701,277 |
Change in fair value upon re-measurement | (433,392) |
Reclassification to Additional Paid-in Capital due to warrant amendment | $ (3,267,885) |
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- Definition Fair value measurement with unobservable inputs reconciliation recurring basis liability reclassification to additional paid in capital due to warrant amendment. No definition available.
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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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- Definition Amount of gain (loss) recognized in income from liability measured at fair value on recurring basis using unobservable input (level 3). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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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
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Employee Benefit Plan - Additional Information (Detail) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Postemployment Benefits [Abstract] | ||
Eligible age for employees for participating in the plan | 21 years | |
Company's contributions to employee benefit plan | $ 0 | $ 0 |
X | ||||||||||
- Definition Minimum age of employee to participate in defined benefit plan. No definition available.
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X | ||||||||||
- Definition Amount of discretionary contributions made by an employer to a defined contribution plan. No definition available.
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- References No definition available.
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Commercial Services and Loan Agreements with Eversana - Additional Information (Detail) - Eversana Agreement [Member] |
Jan. 21, 2020
USD ($)
|
---|---|
Commercial Services And Loan Agreements [Line Items] | |
Term of agreement | 5 years |
Agreement termination fee description | The Company may also terminate the agreement if the parties are unable to agree to a commercialization plan and budget within 75 days of the date of the Eversana Agreement. |
Subsequent Event [Member] | Revolving Credit Facility [Member] | |
Commercial Services And Loan Agreements [Line Items] | |
Line of credit | $ 5,000,000 |
Line of credit facility, Interest rate | 10.00% |
Gimoti [Member] | Minimum [Member] | Subsequent Event [Member] | |
Commercial Services And Loan Agreements [Line Items] | |
Percentage Of Product Profits | 80.00% |
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- Definition Agreement termination fee description. No definition available.
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- Definition Commercial services and loan agreements. No definition available.
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- Definition Percentage of product profits. No definition available.
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- Definition Term of agreement. No definition available.
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- Definition The effective interest rate during the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- 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
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- Definition Cumulative change in ownership period. No definition available.
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- Definition Cumulative minimum change in ownership percentage for limitation on utilization of net operating loss carry forwards. No definition available.
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- Definition Percentage of taxable income offset by tax losses. No definition available.
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- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible operating loss carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible operating loss carryforwards that are not subject to expiration dates. No definition available.
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- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible research tax credit carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The amount of estimated penalties and interest accrued as of the balance sheet date arising from income tax examinations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tax year being audited in the income tax examination, in CCYY format. No definition available.
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- Definition Amount of operating loss carryforward, before tax effects, available to reduce future taxable income under enacted tax laws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Expiration date of each operating loss carryforward included in operating loss carryforward, in CCYY-MM-DD format. 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 The amount of the tax credit carryforward, before tax effects, available to reduce future taxable income under enacted tax laws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of unrecognized tax benefits. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of increase (decrease) in unrecognized tax benefits attributable to uncertain tax positions taken in tax returns. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The total amount of unrecognized tax benefits that, if recognized, would affect the effective tax rate. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Income Taxes - Reconciliation of Federal Statutory Income Tax Rate and Effective Income Tax Rate (Detail) |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21.00% | 21.00% |
Change in valuation allowance | (4.00%) | (1.00%) |
State income taxes, net of federal effect | 7.00% | |
Warrant liability FMV adjustment | 1.00% | |
Research and development credits | 3.00% | 4.00% |
Removal of net operating losses and other credits | (27.00%) | (22.00%) |
Impact of state tax rate change | 4.00% | |
Stock compensation and other permanent items | (4.00%) | (3.00%) |
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- Definition Effective income tax rate reconciliation deductible expense share based compensation and other permanent items. No definition available.
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- Definition Effective income tax rate reconciliation fair market value of warrant liability adjustment. No definition available.
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- Definition Effective income tax rate reconciliation operating loss and tax credits other. No definition available.
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- Definition Effective income tax rate reconciliation tax credits research and development. No definition available.
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- Definition Percentage of domestic federal statutory tax rate applicable to pretax income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to changes in the valuation allowance for deferred tax assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to changes in the income tax rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations applicable to state and local income tax expense (benefit), net of federal tax expense (benefit). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
|
Income Taxes - Summary of Significant Components of Deferred Tax Assets (Detail) - USD ($) |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Deferred tax assets: | ||
Acquired technology | $ 80,000 | $ 81,000 |
Stock compensation expense | 846,000 | 574,000 |
Lease liability | 39,000 | |
Accruals and other | 237,000 | 244,000 |
Total deferred tax assets | 1,202,000 | 899,000 |
Deferred tax liabilities: | ||
Right of use asset | (39,000) | |
Total deferred tax liabilities | (39,000) | |
Less valuation allowance | $ (1,163,000) | $ (899,000) |
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- Definition Deferred tax assets lease liability. No definition available.
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- Definition Deferred tax assets, tax accruals and other. No definition available.
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- Definition Deferred Tax Liabilities, Right Of Use Asset No definition available.
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- Definition Amount of deferred tax liability attributable to taxable temporary differences. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from intangible assets including goodwill. No definition available.
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- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences and carryforwards. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from share-based compensation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of deferred tax assets for which it is more likely than not that a tax benefit will not be realized. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
|
Summarized Quarterly Data (Unaudited) - Summarized Quarterly Data (Detail) - USD ($) |
3 Months Ended | 12 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 |
Sep. 30, 2019 |
Jun. 30, 2019 |
Mar. 31, 2019 |
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Quarterly Financial Information Disclosure [Abstract] | ||||||||||
Research and development expense | $ 641,541 | $ 822,444 | $ 1,205,599 | $ 746,882 | $ 695,360 | $ 625,497 | $ 1,388,791 | $ 1,385,366 | $ 3,416,466 | $ 4,095,014 |
General and administrative expense | 782,617 | 814,218 | 918,139 | 1,223,013 | 1,073,061 | 897,060 | 917,305 | 1,032,245 | 3,737,987 | 3,919,671 |
Gain from change in fair value of warrant liability | 433,392 | 433,392 | ||||||||
Net loss | $ (1,418,228) | $ (1,628,065) | $ (2,114,096) | $ (1,965,266) | $ (1,760,633) | $ (1,519,468) | $ (2,303,193) | $ (1,982,786) | $ (7,125,655) | $ (7,566,080) |
Net loss per share of common stock, basic and diluted | $ (0.06) | $ (0.07) | $ (0.09) | $ (0.11) | $ (0.10) | $ (0.09) | $ (0.14) | $ (0.13) | $ (0.32) | $ (0.46) |
Weighted average shares outstanding, basic and diluted | 24,313,411 | 24,128,060 | 23,258,567 | 17,484,318 | 17,427,533 | 17,129,649 | 16,425,468 | 15,427,037 | 22,296,089 | 16,602,422 |
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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 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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- References No definition available.
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- Definition The costs incurred 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 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, excluding in-process research and development acquired in a business combination consummated during the period. Excludes software research and development, which has a separate concept. 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.
|