Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 31, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | EVOK | |
Entity Registrant Name | Evoke Pharma Inc | |
Entity Central Index Key | 0001403708 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 24,113,956 | |
Entity File Number | 001-36075 | |
Entity Tax Identification Number | 208447886 | |
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 |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and cash equivalents | $ 7,440,079 | $ 5,319,004 |
Prepaid expenses | 109,739 | 329,218 |
Other current assets | 11,551 | |
Total current assets | 7,561,369 | 5,648,222 |
Operating lease right-of-use asset | 69,795 | |
Other assets | 11,551 | |
Total assets | 7,631,164 | 5,659,773 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 407,517 | 476,202 |
Accrued compensation | 807,706 | 1,158,251 |
Operating lease liability | 69,795 | |
Total current liabilities | 1,285,018 | 1,634,453 |
Stockholders' equity: | ||
Common stock, $0.0001 par value; authorized shares - 50,000,000; issued and outstanding shares - 24,113,956 and 17,427,533 at June 30, 2019 and December 31, 2018, respectively | 2,411 | 1,743 |
Additional paid-in capital | 89,027,832 | 82,628,312 |
Accumulated deficit | (82,684,097) | (78,604,735) |
Total stockholders' equity | 6,346,146 | 4,025,320 |
Total liabilities and stockholders' equity | $ 7,631,164 | $ 5,659,773 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 24,113,956 | 17,427,533 |
Common stock, shares outstanding | 24,113,956 | 17,427,533 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating expenses: | ||||
Research and development | $ 1,205,599 | $ 1,388,791 | $ 1,952,481 | $ 2,774,157 |
General and administrative | 918,139 | 917,305 | 2,141,152 | 1,949,550 |
Total operating expenses | 2,123,738 | 2,306,096 | 4,093,633 | 4,723,707 |
Loss from operations | (2,123,738) | (2,306,096) | (4,093,633) | (4,723,707) |
Other income: | ||||
Interest income | 9,642 | 2,902 | 14,271 | 4,335 |
Gain from change in fair value of warrant liability | 433,392 | |||
Total other income | 9,642 | 2,902 | 14,271 | 437,727 |
Net loss | $ (2,114,096) | $ (2,303,194) | $ (4,079,362) | $ (4,285,980) |
Net loss per share of common stock, basic and diluted | $ (0.09) | $ (0.14) | $ (0.20) | $ (0.27) |
Weighted-average shares used to compute basic and diluted net loss per share | 23,258,567 | 16,425,468 | 20,371,442 | 15,926,253 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2017 | $ 2,165,749 | $ 1,541 | $ 73,202,863 | $ (71,038,655) |
Beginning Balance, Shares at Dec. 31, 2017 | 15,413,610 | |||
Stock-based compensation expense | 393,775 | 393,775 | ||
Issuance of common stock, net | 544,643 | $ 27 | 544,616 | |
Issuance of common stock, shares net | 268,870 | |||
Reclassification of warrant liability due to warrant amendment | 3,267,885 | 3,267,885 | ||
Net loss | (1,982,786) | (1,982,786) | ||
Ending Balance at Mar. 31, 2018 | 4,389,266 | $ 1,568 | 77,409,139 | (73,021,441) |
Ending Balance, Shares at Mar. 31, 2018 | 15,682,480 | |||
Beginning Balance at Dec. 31, 2017 | 2,165,749 | $ 1,541 | 73,202,863 | (71,038,655) |
Beginning Balance, Shares at Dec. 31, 2017 | 15,413,610 | |||
Net loss | (4,285,980) | |||
Ending Balance at Jun. 30, 2018 | 5,360,378 | $ 1,690 | 80,683,323 | (75,324,635) |
Ending Balance, Shares at Jun. 30, 2018 | 16,898,664 | |||
Beginning Balance at Mar. 31, 2018 | 4,389,266 | $ 1,568 | 77,409,139 | (73,021,441) |
Beginning Balance, Shares at Mar. 31, 2018 | 15,682,480 | |||
Stock-based compensation expense | 387,429 | 387,429 | ||
Issuance of common stock, net | 2,886,877 | $ 122 | 2,886,755 | |
Issuance of common stock, shares net | 1,216,184 | |||
Net loss | (2,303,194) | (2,303,194) | ||
Ending Balance at Jun. 30, 2018 | 5,360,378 | $ 1,690 | 80,683,323 | (75,324,635) |
Ending Balance, Shares at Jun. 30, 2018 | 16,898,664 | |||
Beginning Balance at Dec. 31, 2018 | $ 4,025,320 | $ 1,743 | 82,628,312 | (78,604,735) |
Beginning Balance, Shares at Dec. 31, 2018 | 17,427,533 | 17,427,533 | ||
Stock-based compensation expense | $ 378,959 | 378,959 | ||
Issuance of common stock, net | 636,432 | $ 45 | 636,387 | |
Issuance of common stock, shares net | 450,000 | |||
Net loss | (1,965,266) | (1,965,266) | ||
Ending Balance at Mar. 31, 2019 | 3,075,445 | $ 1,788 | 83,643,658 | (80,570,001) |
Ending Balance, Shares at Mar. 31, 2019 | 17,877,533 | |||
Beginning Balance at Dec. 31, 2018 | $ 4,025,320 | $ 1,743 | 82,628,312 | (78,604,735) |
Beginning Balance, Shares at Dec. 31, 2018 | 17,427,533 | 17,427,533 | ||
Net loss | $ (4,079,362) | |||
Ending Balance at Jun. 30, 2019 | $ 6,346,146 | $ 2,411 | 89,027,832 | (82,684,097) |
Ending Balance, Shares at Jun. 30, 2019 | 24,113,956 | 24,113,956 | ||
Beginning Balance at Mar. 31, 2019 | $ 3,075,445 | $ 1,788 | 83,643,658 | (80,570,001) |
Beginning Balance, Shares at Mar. 31, 2019 | 17,877,533 | |||
Stock-based compensation expense | 344,841 | 344,841 | ||
Issuance of common stock, net | 5,039,956 | $ 623 | 5,039,333 | |
Issuance of common stock, shares net | 6,236,423 | |||
Net loss | (2,114,096) | (2,114,096) | ||
Ending Balance at Jun. 30, 2019 | $ 6,346,146 | $ 2,411 | $ 89,027,832 | $ (82,684,097) |
Ending Balance, Shares at Jun. 30, 2019 | 24,113,956 | 24,113,956 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Operating activities | ||
Net loss | $ (4,079,362) | $ (4,285,980) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 723,800 | 781,204 |
Change in fair value of warrant liability | (433,392) | |
Change in operating assets and liabilities: | ||
Prepaid expenses and other assets | 285,496 | 167,364 |
Accounts payable and other current liabilities | (485,247) | (808,904) |
Net cash used in operating activities | (3,555,313) | (4,579,708) |
Financing activities | ||
Proceeds from issuance of common stock, net | 5,676,388 | 3,431,520 |
Net cash provided by financing activities | 5,676,388 | 3,431,520 |
Net increase (decrease) in cash and cash equivalents | 2,121,075 | (1,148,188) |
Cash and cash equivalents at beginning of period | 5,319,004 | 7,679,267 |
Cash and cash equivalents at end of period | $ 7,440,079 | 6,531,079 |
Non-cash financing activities | ||
Reclassification of warrant liability to equity due to amendment of warrants | $ 3,267,885 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 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. Based on FDA feedback and the meeting minutes, the Company will include its root cause analysis and previously collected patient use and experience information in its resubmission package. The Company also agreed to provide an analysis of pump performance characteristics on the nasal spray devices used in the comparative bioavailability study and 3-month stability data from commercial scale batches of Gimoti which the Company initiated manufacturing in June 2019. No additional human clinical trials were requested by FDA and the Company plans to resubmit the Gimoti NDA in the fourth quarter of 2019. 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 the second quarter of 2019 with approximately $7.4 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, manufacturing of registration, and potentially commercial batches of Gimoti, and 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 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, 2018, 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 into the second quarter of 2020. If Gimoti is approved by FDA, additional funds will become available from the Novos Growth, LLC (“NGP”) Working Capital Loan and the NGP Credit Agreement, as disclosed in Note 6. Under either situation, 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 resubmit 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 our 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 has been provided an initial period of 180 calendar days, or until November 11, 2019, to regain compliance. The letter states that Nasdaq will provide written notification that the Company has achieved compliance with its rules if at any time before November 11, 2019, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of ten consecutive business days. The Nasdaq letter has no immediate effect on the listing or trading of the Company’s common stock and the common stock will continue to trade on The Nasdaq Capital Market. The Company intends to monitor the bid price of its common stock and consider available options if its common stock does not trade at a level likely to result in the Company regaining compliance with Nasdaq’s minimum bid price rule by November 11, 2019. If the Company does not regain compliance with Nasdaq listing rules by November 11, 2019, the Company may be eligible for an additional 180 calendar day compliance period. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to Nasdaq that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq would notify the Company that its securities would be subject to delisting. In the event of such a notification, the Company may appeal Nasdaq’s determination to delist its securities, but there can be no assurance Nasdaq would grant the Company’s request for continued listing. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The accompanying condensed balance sheet as of December 31, 2018, which has been derived from audited financial statements, and the unaudited interim condensed financial statements, have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and follow the requirements of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In management’s opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position and its results of operations and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the year ended December 31, 2018, which are contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 6, 2019. The results for interim periods are not necessarily indicative of the results expected for the full fiscal year or any other interim period. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities 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. Contract Research Organizations and Consultants The Company relies on contract research organizations (“CROs”) and consultants to assist with ongoing regulatory discussions and submissions supporting the NDA. If these 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 our board of directors, and therefore, were classified as a liability in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification 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 and, if necessary, supplemented 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. 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. 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. The Company excluded 30,165 and 37,582 shares of common stock subject to repurchase from the weighted-average number of common stock outstanding for the three and six months ended June 30, 2018, respectively. 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. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of common stock 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 their inclusion would be anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Common stock subject to repurchase — 30,165 — 37,582 Warrants to purchase common stock 2,713,561 2,797,561 2,713,561 2,797,561 Common stock options 3,232,871 3,017,624 3,232,871 3,017,624 Employee stock purchase plan — 19,144 — 26,047 Total excluded securities 5,946,432 5,864,494 5,946,432 5,878,814 Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases |
Commitments
Commitments | 6 Months Ended |
Jun. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | 3. Commitments Facility Lease 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 has an expiration date of December 31, 2019. 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 and liabilities 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 six months ended June 30, 2019, operating lease ROU asset and liability were included in prepaid expenses and other assets and accounts payable and other current liabilities, respectively, on the statement of cash flows. Rent expense for the three months ended June 30, 2019 and 2018 was approximately $36,000 and $35,000, respectively. Rent expense for the six months ended June 30, 2019 and 2018 was approximately $74,000 and $69,000, respectively. The Company also pays pass through costs and utility costs, which are expensed as incurred. |
Technology Acquisition Agreemen
Technology Acquisition Agreement | 6 Months Ended |
Jun. 30, 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 one year 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. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | 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 six months ended June 30, 2018, the Company sold 1,485,054 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 $3.4 million, net of commissions and fees. During the six months ended June 30, 2019, the Company sold 6,686,423 shares of common stock at a weighted-average price per share of $0.87 pursuant to the FBR Sales Agreement and received proceeds of approximately $5.7 million, net of commissions and fees. 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 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 are 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, 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 were cancelled. 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. 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. 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 three and six months ended June 30, 2019 and 2018: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Common Stock Options Risk free interest rate 1.80%-2.36% 2.85% 1.80%-2.55% 2.66%-2.85% Expected option term 4.27-5.77 years 5.5 years 4.27-6.0 years 5.5-6.0 years Expected volatility of common stock 101.46%-112.58% 92.30% 90.34%-112.58% 90.15%-92.30% Expected dividend yield 0.0% 0.0% 0.0% 0.0% 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 six months ended June 30, 2019 and 2018: Six Months Ended June 30, 2019 2018 Employee Stock Purchase Plan Risk free interest rate 2.52% 1.85% Expected term 0.5 years 0.5 years Expected volatility of common stock 130.36% 58.76% Expected dividend yield 0.0% 0.0% The Company recognized non-cash stock-based compensation expense to employees and directors in its research and development and its general and administrative functions as follows: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Research and development $ 202,117 $ 168,733 $ 354,291 $ 357,510 General and administrative 142,724 218,696 369,509 423,694 Total stock-based compensation expense $ 344,841 $ 387,429 $ 723,800 $ 781,204 As of June 30, 2019, there were approximately $2.7 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 1.4 years. |
Commercial Services Agreement
Commercial Services Agreement | 6 Months Ended |
Jun. 30, 2019 | |
Commercial Services Agreement [Abstract] | |
Commercial Services Agreement | 6. Commercial Services Agreement On January 5, 2019, the Company entered into a commercial services agreement with NGP (the “NGP Agreement”) for the commercialization of Gimoti. Pursuant to the NGP Agreement, NGP will manage the commercial operations for a dedicated sales team to market Gimoti, if approved by FDA, to gastroenterologists and other targeted health care providers. Under the terms of the NGP Agreement, the Company maintains ownership of the Gimoti NDA, as well as legal, regulatory, and manufacturing responsibilities for Gimoti. The Company will also retain a contract sales organization, which would be managed by NGP. The Company will record sales for Gimoti and retain more than 80% of product profits. NGP will receive a percentage of product profits in the mid-to-high teens as a service fee (such product profit amount, the “Contribution Profits”). Pursuant to the NGP Agreement, upon any Gimoti NDA approval, NGP has agreed to finance the Company’s working capital requirements for specified commercialization costs in an amount by which Contribution Profits are expected to fall (or do actually fall) below zero (as projected by sales forecasts and a commercialization budget) to be drawn by the Company on a monthly basis, as needed (“NGP Working Capital Loan”), pursuant to a credit agreement to be negotiated in good faith between the Company and NGP (“NGP Credit Agreement”). The NGP Working Capital Loan will be repaid by the Company, if at all, only out of positive Contribution Profits, unless the NGP Agreement is terminated (a) by NGP due to a material breach by the Company, or (b) by the Company other than due to the gross negligence or intentional misconduct of NGP. Termination of the NGP Agreement by NGP for any other reason (including, without limitation, minimum net sales thresholds and negative Contribution Profits, as described below) will cause the NGP Working Capital Loan to be forgiven in full. The interest rate and other terms of the NGP Working Capital Loan will be set forth in the NGP Credit Agreement. In addition, under the NGP Agreement, NGP has agreed to provide a line of credit of up to $5.0 million to the Company following NDA approval of Gimoti, if any, and for a period of up to nine months thereafter. The line of credit will be extended pursuant to a credit agreement between the parties. NGP will receive a low single digit percentage on net sales of Gimoti in lieu of any interest on the line of credit (the “NGP Credit Fee”); provided that in no event shall the cumulative NGP Credit Fee exceed twice the amount of the principal borrowed by the Company. The line of credit will mature on the earlier of 30 days following the date the NGP Credit Fee is twice the amount of the borrowed principal and the two-year anniversary of the date the principal is borrowed by the Company. In the event the Company secures financing from a third-party wholesale distributor for the purchase of Gimoti for launch in excess of $2.5 million dollars, NGP will no longer be required to offer the line of credit. The term of the NGP Agreement is five years from the date of commercial launch of Gimoti, if any, after which the Company will recapture 100% of product sales and assume all corresponding responsibilities. Within 30 days after each one-year anniversary of the NGP Agreement, either party may terminate the NGP Agreement if net sales of Gimoti do not meet certain annual thresholds. Either party may terminate the NGP Agreement for the material breach of the other party, subject to a 60-day cure period, or in the event an insolvency petition of the other party is pending for more than 60 days. Either party may also terminate the NGP Agreement upon |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities 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. |
Contract Research Organizations and Consultants | Contract Research Organizations and Consultants The Company relies on contract research organizations (“CROs”) and consultants to assist with ongoing regulatory discussions and submissions supporting the NDA. If these 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 | 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 our board of directors, and therefore, were classified as a liability in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification 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 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 and, if necessary, supplemented 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 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. 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. |
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. The Company excluded 30,165 and 37,582 shares of common stock subject to repurchase from the weighted-average number of common stock outstanding for the three and six months ended June 30, 2018, respectively. 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. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of common stock 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 their inclusion would be anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Common stock subject to repurchase — 30,165 — 37,582 Warrants to purchase common stock 2,713,561 2,797,561 2,713,561 2,797,561 Common stock options 3,232,871 3,017,624 3,232,871 3,017,624 Employee stock purchase plan — 19,144 — 26,047 Total excluded securities 5,946,432 5,864,494 5,946,432 5,878,814 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 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 their inclusion would be anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Common stock subject to repurchase — 30,165 — 37,582 Warrants to purchase common stock 2,713,561 2,797,561 2,713,561 2,797,561 Common stock options 3,232,871 3,017,624 3,232,871 3,017,624 Employee stock purchase plan — 19,144 — 26,047 Total excluded securities 5,946,432 5,864,494 5,946,432 5,878,814 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
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 three and six months ended June 30, 2019 and 2018: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Common Stock Options Risk free interest rate 1.80%-2.36% 2.85% 1.80%-2.55% 2.66%-2.85% Expected option term 4.27-5.77 years 5.5 years 4.27-6.0 years 5.5-6.0 years Expected volatility of common stock 101.46%-112.58% 92.30% 90.34%-112.58% 90.15%-92.30% Expected dividend yield 0.0% 0.0% 0.0% 0.0% |
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 six months ended June 30, 2019 and 2018: Six Months Ended June 30, 2019 2018 Employee Stock Purchase Plan Risk free interest rate 2.52% 1.85% Expected term 0.5 years 0.5 years Expected volatility of common stock 130.36% 58.76% Expected dividend yield 0.0% 0.0% |
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 as follows: Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Research and development $ 202,117 $ 168,733 $ 354,291 $ 357,510 General and administrative 142,724 218,696 369,509 423,694 Total stock-based compensation expense $ 344,841 $ 387,429 $ 723,800 $ 781,204 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Detail) | May 15, 2019d$ / shares | Jun. 30, 2019USD ($) | Dec. 31, 2018USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2017USD ($) |
Organization And Basis Of Presentation [Abstract] | |||||
Month and year of incorporation | 2007-01 | ||||
Cash and cash equivalents | $ | $ 7,440,079 | $ 5,319,004 | $ 6,531,079 | $ 7,679,267 | |
Minimum common stock closing bid price | $ / shares | $ 1 | ||||
Initial period to regain compliance | 180 days | ||||
Number of minimum consecutive business days | d | 10 | ||||
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 has been provided an initial period of 180 calendar days, or until November 11, 2019, to regain compliance. The letter states that Nasdaq will provide written notification that the Company has achieved compliance with its rules if at any time before November 11, 2019, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of ten consecutive business days. The Nasdaq letter has no immediate effect on the listing or trading of the Company’s common stock and the common stock will continue to trade on The Nasdaq Capital Market. |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - shares | 3 Months Ended | 6 Months Ended |
Jun. 30, 2018 | Jun. 30, 2018 | |
Accounting Policies [Abstract] | ||
Shares of common stock subject to repurchase excluded from the weighted-average number of common stock outstanding | 30,165 | 37,582 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 5,946,432 | 5,864,494 | 5,946,432 | 5,878,814 |
Common stock subject to repurchase [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 30,165 | 37,582 | ||
Warrants to purchase common stock [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 2,713,561 | 2,797,561 | 2,713,561 | 2,797,561 |
Common stock options [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 3,232,871 | 3,017,624 | 3,232,871 | 3,017,624 |
Employee stock purchase plan [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 19,144 | 26,047 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jan. 01, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |||||
Lease commencement date | Jan. 1, 2017 | ||||
Lease expiry date | Dec. 31, 2019 | ||||
Rent expense | $ 36,000 | $ 35,000 | $ 74,000 | $ 69,000 | |
Operating lease incremental borrowing rate | 12.00% | ||||
Operating lease ROU | $ 69,795 | $ 69,795 | $ 136,000 | ||
Operating lease liability | $ 136,000 |
Technology Acquisition Agreem_2
Technology Acquisition Agreement - Additional Information (Detail) | 1 Months Ended | 6 Months Ended | |
May 31, 2014USD ($) | Jun. 30, 2007USD ($) | Jun. 30, 2019USD ($)Milestone | |
Technology Acquisition Agreement [Line Items] | |||
Payment expensed as in-process research and development | $ 650,000 | ||
Mallinckrodt Plc [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Milestone payments contingent amount | $ 5,000,000 | ||
Number of milestone payments | Milestone | 1 | ||
Mallinckrodt Plc [Member] | Rights and Patents Acquired from Questcor Pharmaceuticals Inc [Member] | Maximum [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Milestone payments contingent amount | $ 52,000,000 | ||
Development Target One [Member] | Rights and Patents Acquired from Questcor Pharmaceuticals Inc [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Milestone payment | $ 500,000 | ||
Development targets description | Upon the initiation of the first patient dosing in the Company's Phase 3 clinical trial for Gimoti. | ||
Development Target Four [Member] | Mallinckrodt Plc [Member] | Patented Technology [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Development targets description | Depend on Gimoti's commercial success and will only apply if Gimoti receives regulatory approval. In addition, the Company will be required to pay to Mallinckrodt a low single digit royalty on net sales of Gimoti. | ||
Milestone payments contingent amount | $ 47,000,000 | ||
Expected expiration of patent right | 2032 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock - Additional Information (Detail) - USD ($) | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Nov. 30, 2017 | |
Sale Of Stock [Line Items] | ||||
Common stock, shares issued | 24,113,956 | 17,427,533 | ||
Proceeds from issuance of common stock, net | $ 5,676,388 | $ 3,431,520 | ||
FBR Sales Agreement [Member] | ||||
Sale Of Stock [Line Items] | ||||
Common stock, shares issued | 6,686,423 | 1,485,054 | ||
Common stock , weighted average price per share | $ 0.87 | $ 2.38 | ||
Proceeds from issuance of common stock, net | $ 5,700,000 | $ 3,400,000 | ||
FBR Sales Agreement [Member] | Maximum [Member] | ||||
Sale Of Stock [Line Items] | ||||
Common stock, value of shares issuable | $ 16,000,000 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended |
Sep. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2018 | |
Sale Of Stock [Line Items] | |||
Change in fair value of warrant liability | $ 433,392 | ||
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 |
Stockholders' Equity - Stock-Ba
Stockholders' Equity - Stock-Based Compensation - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2019USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stockholders' equity, stock split, conversion ratio | 0.75 |
Stock options exchanged | shares | 2,456,999 |
Stock options issued | shares | 1,842,746 |
Exercise price | $ / shares | $ 0.62 |
Share-based compensation expense | $ | $ 84,000 |
Share-based compensation arrangement, vesting period | 4 years |
Unrecognized compensation costs | $ | $ 2,700,000 |
Weighted average period | 1 year 4 months 24 days |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Estimated Fair Value of Stock Option Award (Detail) - Common stock options [Member] | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk free interest rate | 2.85% | |||
Expected option term | 5 years 6 months | |||
Expected volatility of common stock | 92.30% | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Minimum [Member] | ||||
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk free interest rate | 1.80% | 1.80% | 2.66% | |
Expected option term | 4 years 3 months 7 days | 4 years 3 months 7 days | 5 years 6 months | |
Expected volatility of common stock | 101.46% | 90.34% | 90.15% | |
Maximum [Member] | ||||
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk free interest rate | 2.36% | 2.55% | 2.85% | |
Expected option term | 5 years 9 months 7 days | 6 years | 6 years | |
Expected volatility of common stock | 112.58% | 112.58% | 92.30% |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Estimated Fair Value of Shares to be Acquired Under Employee Stock Purchase Plan (Detail) - Employee stock purchase plan [Member] | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free interest rate | 2.52% | 1.85% |
Expected term | 6 months | 6 months |
Expected volatility of common stock | 130.36% | 58.76% |
Expected dividend yield | 0.00% | 0.00% |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Recognized Non-Cash Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 344,841 | $ 387,429 | $ 723,800 | $ 781,204 |
Research and development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 202,117 | 168,733 | 354,291 | 357,510 |
General and administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 142,724 | $ 218,696 | $ 369,509 | $ 423,694 |
Commercial Services Agreement -
Commercial Services Agreement - Additional Information (Detail) | Jan. 05, 2019USD ($) |
NGP Credit Agreement [Member] | |
Commercial Services Agreement [Line Items] | |
Line of credit | $ 5,000,000 |
Third-Party Wholesale Distributor [Member] | NGP Credit Agreement [Member] | |
Commercial Services Agreement [Line Items] | |
Minimum financing arrangements from purchase order not to avail line of credit. | $ 2,500,000 |
NGP Agreement [Member] | |
Commercial Services Agreement [Line Items] | |
Term of agreement | 5 years |
Recapture percentage of product sales after agreement term | 100.00% |
Minimum termination fee | $ 5,000,000 |
Agreement termination fee description | The Company may terminate the NGP Agreement upon a change of control of the Company, subject to a one-time payment equal to between four times and one times annualized service fees paid by the Company under the NGP Agreement, with such amount based on which year (between one and five years) after commercial launch the change of control occurs, provided if the change of control occurs within one year of commercial launch, such amount will be the greater of the specified annualized service fee amount and $5 million. |
NGP Agreement [Member] | Gimoti [Member] | Minimum [Member] | |
Commercial Services Agreement [Line Items] | |
Percentage of product profits | 80.00% |