Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 02, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | EVOK | |
Entity Registrant Name | Evoke Pharma Inc | |
Entity Central Index Key | 0001403708 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-36075 | |
Entity Tax Identification Number | 20-8447886 | |
Entity Address, Address Line One | 420 Stevens Avenue | |
Entity Address, Address Line Two | Suite 370 | |
Entity Address, City or Town | Solana Beach | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92075 | |
City Area Code | 858 | |
Local Phone Number | 345-1494 | |
Entity Incorporation, State or Country Code | DE | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,390,246 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Current Assets: | ||
Cash and cash equivalents | $ 6,280,656 | $ 5,663,833 |
Prepaid expenses | 336,432 | 581,706 |
Inventory | 86,145 | |
Other current assets | 11,551 | |
Total current assets | 6,714,784 | 6,245,539 |
Operating lease right-of-use asset | 36,115 | 138,538 |
Other assets | 11,551 | |
Total assets | 6,750,899 | 6,395,628 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 765,603 | 1,033,383 |
Accrued compensation | 715,423 | 843,162 |
Operating lease liability | 36,115 | 138,538 |
Paycheck protection program loan | 104,168 | |
Milestone payable | 5,000,000 | |
Total current liabilities | 6,621,309 | 2,015,083 |
Long-term Liabilities: | ||
Note payable | 2,000,000 | |
Accrued interest payable | 53,005 | |
Total long-term liabilities | 2,053,005 | |
Total liabilities | 8,674,314 | 2,015,083 |
Stockholders' equity: | ||
Common stock, $0.0001 par value; authorized shares - 50,000,000; issued and outstanding shares - 26,332,122 and 24,431,914 at September 30, 2020 and December 31, 2019, respectively | 2,633 | 2,443 |
Additional paid-in capital | 94,691,151 | 90,108,492 |
Accumulated deficit | (96,617,199) | (85,730,390) |
Total stockholders' (deficit) equity | (1,923,415) | 4,380,545 |
Total liabilities and stockholders' (deficit) equity | $ 6,750,899 | $ 6,395,628 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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 | 26,332,122 | 24,431,914 |
Common stock, shares outstanding | 26,332,122 | 24,431,914 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Operating expenses: | ||||
Research and development | $ 205,032 | $ 822,444 | $ 6,450,979 | $ 2,774,924 |
General and administrative | 1,874,578 | 814,218 | 4,387,284 | 2,955,371 |
Total operating expenses | 2,079,610 | 1,636,662 | 10,838,263 | 5,730,295 |
Loss from operations | (2,079,610) | (1,636,662) | (10,838,263) | (5,730,295) |
Other income (expense): | ||||
Interest income | 1,033 | 8,597 | 4,896 | 22,868 |
Interest expense | (50,528) | (53,442) | ||
Total other income (expense) | (49,495) | 8,597 | (48,546) | 22,868 |
Net loss | $ (2,129,105) | $ (1,628,065) | $ (10,886,809) | $ (5,707,427) |
Net loss per share of common stock, basic and diluted | $ (0.08) | $ (0.07) | $ (0.43) | $ (0.26) |
Weighted-average shares used to compute basic and diluted net loss per share | 26,146,220 | 24,128,060 | 25,191,359 | 21,623,648 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' (Deficit) Equity (Unaudited) - USD ($) | Total | At The Market Offering [Member] | Common Stock [Member] | Common Stock [Member]At The Market Offering [Member] | Additional Paid-In Capital [Member] | Additional Paid-In Capital [Member]At The Market Offering [Member] | Accumulated Deficit [Member] |
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 | ||||||
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 | ||||||
Net loss | (5,707,427) | ||||||
Ending Balance at Sep. 30, 2019 | 5,173,197 | $ 2,423 | 89,482,936 | (84,312,162) | |||
Ending Balance, Shares at Sep. 30, 2019 | 24,231,914 | ||||||
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 | ||||||
Stock-based compensation expense | 331,303 | 331,303 | |||||
Issuance of common stock, net | 123,813 | $ 12 | 123,801 | ||||
Issuance of common stock, shares net | 117,958 | ||||||
Net loss | (1,628,065) | (1,628,065) | |||||
Ending Balance at Sep. 30, 2019 | 5,173,197 | $ 2,423 | 89,482,936 | (84,312,162) | |||
Ending Balance, Shares at Sep. 30, 2019 | 24,231,914 | ||||||
Beginning Balance at Dec. 31, 2019 | $ 4,380,545 | $ 2,443 | 90,108,492 | (85,730,390) | |||
Beginning Balance, Shares at Dec. 31, 2019 | 24,431,914 | 24,431,914 | |||||
Stock-based compensation expense | $ 310,162 | 310,162 | |||||
Issuance of common stock from employee stock purchase plan | 21,250 | $ 3 | 21,247 | ||||
Issuance of common stock from employee stock purchase plan, shares | 25,000 | ||||||
Net loss | (1,790,309) | (1,790,309) | |||||
Ending Balance at Mar. 31, 2020 | 2,921,648 | $ 2,446 | 90,439,901 | (87,520,699) | |||
Ending Balance, Shares at Mar. 31, 2020 | 24,456,914 | ||||||
Beginning Balance at Dec. 31, 2019 | $ 4,380,545 | $ 2,443 | 90,108,492 | (85,730,390) | |||
Beginning Balance, Shares at Dec. 31, 2019 | 24,431,914 | 24,431,914 | |||||
Issuance of common stock from warrant exercise, shares | 381,625 | ||||||
Issuance of common stock from stock option exercise, shares | 4,237 | ||||||
Net loss | $ (10,886,809) | ||||||
Ending Balance at Sep. 30, 2020 | $ (1,923,415) | $ 2,633 | 94,691,151 | (96,617,199) | |||
Ending Balance, Shares at Sep. 30, 2020 | 26,332,122 | 26,332,122 | |||||
Beginning Balance at Mar. 31, 2020 | $ 2,921,648 | $ 2,446 | 90,439,901 | (87,520,699) | |||
Beginning Balance, Shares at Mar. 31, 2020 | 24,456,914 | ||||||
Stock-based compensation expense | 362,955 | 362,955 | |||||
Issuance of common stock, net | $ 3,309,116 | $ 140 | $ 3,308,976 | ||||
Issuance of common stock, shares net | 1,395,855 | ||||||
Issuance of common stock from warrant exercises | $ 15 | (15) | |||||
Issuance of common stock from warrant exercise, shares | 158,494 | ||||||
Net loss | (6,967,395) | (6,967,395) | |||||
Ending Balance at Jun. 30, 2020 | (373,676) | $ 2,601 | 94,111,817 | (94,488,094) | |||
Ending Balance, Shares at Jun. 30, 2020 | 26,011,263 | ||||||
Stock-based compensation expense | 478,574 | 478,574 | |||||
Issuance of common stock from employee stock purchase plan | 98,165 | $ 9 | 98,156 | ||||
Issuance of common stock from employee stock purchase plan, shares | 93,491 | ||||||
Issuance of common stock from warrant exercises | $ 22 | (22) | |||||
Issuance of common stock from warrant exercise, shares | 223,131 | ||||||
Issuance of common stock from stock option exercise | 2,627 | $ 1 | 2,626 | ||||
Issuance of common stock from stock option exercise, shares | 4,237 | ||||||
Net loss | (2,129,105) | (2,129,105) | |||||
Ending Balance at Sep. 30, 2020 | $ (1,923,415) | $ 2,633 | $ 94,691,151 | $ (96,617,199) | |||
Ending Balance, Shares at Sep. 30, 2020 | 26,332,122 | 26,332,122 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Operating activities | ||
Net loss | $ (10,886,809) | $ (5,707,427) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 1,151,691 | 1,055,103 |
Milestone expense | 5,000,000 | |
Accrued interest | 53,442 | |
Change in operating assets and liabilities: | ||
Prepaid expenses and other assets | 261,552 | (345,975) |
Accounts payable and other current liabilities | (498,379) | 383,896 |
Net cash used in operating activities | (4,918,503) | (4,614,403) |
Financing activities | ||
Proceeds from issuance of common stock, net | 3,309,116 | 5,800,201 |
Proceeds from issuance of common stock from employee stock purchase plan | 119,415 | |
Proceeds from issuance of common stock from stock option exercised | 2,627 | |
Proceeds from paycheck protection program | 104,168 | |
Proceeds from Eversana line of credit | 2,000,000 | |
Net cash provided by financing activities | 5,535,326 | 5,800,201 |
Net increase in cash and cash equivalents | 616,823 | 1,185,798 |
Cash and cash equivalents at beginning of period | 5,663,833 | 5,319,004 |
Cash and cash equivalents at end of period | $ 6,280,656 | $ 6,504,802 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended |
Sep. 30, 2020 | |
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 and commercialization of drugs to treat gastroenterological disorders and disease. Since its inception, the Company has devoted its efforts to developing its sole product, Gimoti™ (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. On June 19, 2020, the Company received approval from the U.S. Food and Drug Administration (“FDA”) for its 505(b)(2) New Drug Application (“NDA”) for Gimoti. The Company launched U.S. commercial sales of Gimoti in October 2020 through its commercial partner Eversana Life Science Services, LLC (“Eversana”). The Company’s activities are subject to the significant risks and uncertainties associated with any specialty pharmaceutical company that has launched its first commercial product, including market acceptance of the product and the potential need to obtain additional funding for 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 had approximately $6.3 million in cash and cash equivalents at September 30, 2020, the Company anticipates that it will continue to incur losses from operations due to commercialization activities, including manufacturing commercial batches of Gimoti, and general and administrative costs to support operations. 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. 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 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 2021, excluding any potential additional borrowings from the revolving credit facility with Eversana (the “Eversana Credit Facility”), as discussed in Note 5, and future Gimoti product revenue. This period could be shortened if there are any unanticipated increases in planned spending. Even with the remaining amount available under the Eversana Credit Facility and future Gimoti product revenue, the Company may 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 commercialization activities. 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 successfully commercialize Gimoti. Because the Company’s business is entirely dependent on the success of Gimoti, if the Company is unable to secure additional financing, successfully commercialize Gimoti or identify and execute on 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. Contract Research Organizations and Consultants The Company relies on contract research organizations (“CROs”) and consultants to assist with ongoing regulatory discussions and submissions to FDA. If these CROs and consultants are unable to continue their support, this could adversely affect the operations of the Company. In addition, the Company relies on third-party suppliers and manufacturer 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 commercial supply demand for Gimoti and the commercialization of Gimoti could be materially and adversely affected. The Company also relies on Eversana for the management of the commercialization of Gimoti, distribution services and a dedicated sales team to sell Gimoti. If Eversana is unable to continue serving as a dedicated sales team or distributing Gimoti, the commercialization of Gimoti could be materially and adversely affected. Impact of COVID-19 To date, the Company has not experienced material disruptions to its financial condition or operations from the novel coronavirus disease (“COVID-19”) pandemic. The Company has begun its commercial activities, including commercial manufacturing, and with Eversana, the commercial sales of Gimoti. However, there can be no assurance that the Company or Eversana will not be impacted by the COVID-19 pandemic. For example, Eversana’s commercialization efforts may be adversely affected by operational restrictions imposed on its sales force from quarantines, travel restrictions and bans and other governmental restrictions related to COVID-19. As a result of these restrictions, their sales force may not be able to conduct in-person interactions with physicians and customers and may be restricted to conducting educational and promotional activities for Gimoti virtually, which may impact Eversana’s ability to market Gimoti. In addition, the COVID-19 pandemic may disrupt the operations of the Company’s third-party suppliers and manufacturers and delay the Company’s manufacturing timelines of Gimoti, which may negatively impact the Company’s ability to successfully commercialize Gimoti and generate product sales. Further, t he COVID-19 pandemic and mitigation measures have also had an adverse impact on global economic conditions which could have an adverse effect on the Company’s business and financial condition, including impairing its ability to raise capital when needed. In April 2020, the Company applied for and was approved for a Small Business Administration (“SBA”) loan under the Paycheck Protection Program (“PPP”), established by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. On May 1, 2020, the Company received the loan proceeds of approximately $104,000. Processes are being developed for companies to submit for loan forgiveness and the Company plans to submit for loan forgiveness when such processes are finalized. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The accompanying condensed balance sheet as of December 31, 2019, 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, 2019, which are contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 12, 2020. 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. Inventory Subsequent to FDA approval of Gimoti in June 2020, the Company began a manufacturing process for the production of Gimoti for sale and began capitalizing inventory. As the manufacturing process was not completed until October 2020, the inventory was classified as work-in-process at September 30, 2020. Following the completion and release of the product by the Company’s manufacturer in October 2020, inventory is being stated at the lower of cost or net realizable value and recognized on a first-in, first-out method. Prior to FDA approval, expenses associated with the manufacturing of Gimoti were recorded as research and development expense. The Company will analyze its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments will be recognized through cost of sales in the period in which they are incurred. 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, except awards with a performance condition. Awards with performance conditions commence vesting when the satisfaction of the performance condition is probable. 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. The Company accounts for forfeitures as the forfeitures occur. Research and Development Expenses Research and development costs are expensed as incurred and primarily include compensation and related benefits, stock-based compensation expense, costs paid to third-party contractors for product development activities and drug product materials and technology acquisition milestones. The Company has expensed costs relating to the purchase and production of pre-approval inventories as research and development expense in the period incurred prior to FDA approval received June 19, 2020. 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 depended on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its pre-commercial product development, and will continue to depend on such third-party manufacturers for its commercial manufacturing. The Company has agreements with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, and with Thermo Fisher Scientific Inc., through its subsidiary Patheon UK Limited, for the 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. 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 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: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Warrants to purchase common stock 1,841,879 2,713,561 1,841,879 2,713,561 Common stock options 4,273,065 3,114,371 4,273,065 3,114,371 Employee stock purchase plan 4,716 7,294 4,716 7,294 Total excluded securities 6,119,660 5,835,226 6,119,660 5,835,226 |
Technology Acquisition Agreemen
Technology Acquisition Agreement | 9 Months Ended |
Sep. 30, 2020 | |
Technology Acquisition Agreement [Abstract] | |
Technology Acquisition Agreement | 3. 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. At the time of the Gimoti NDA approval by FDA, the Company recorded the $5 million payable owed to Mallinckrodt with a due date of June 19, 2021, along with a $5 million research and development expense. The remaining $47 million in milestone payments depend on Gimoti’s commercial success. 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, patents be granted. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2020 | |
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 nine months ended September 30, 2019, the Company sold 6,804,381 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 $5.8 million, net of commissions and fees. During the nine months ended September 30, 2020, the Company sold 1,395,855 shares of common stock at a weighted-average price per share of $2.42 pursuant to the FBR Sales Agreement and received proceeds of approximately $3.3 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. Warrant Exercises During the nine months ended September 30, 2020, certain holders of warrants exercised their warrants to purchase 871,682 shares of the Company’s common stock by a “cashless” exercise and received 381,625 shares of the Company’s common stock. The warrants had exercise prices ranging from $2.41 to $3.12 per share. The shares were issued, and the warrants were originally sold, in reliance upon the registration exemption set forth in Section 4(a)(2) of the Securities Act of 1933. Stock Option Exercises During the nine months ended September 30, 2020, certain holders of stock options exercised their stock options to purchase 4,237 shares of the Company’s common stock. The stock options had exercise prices of $0.62 per share. 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. During the nine months ended September 30, 2020, the Company granted stock options to purchase 1,172,000 shares of the Company’s common stock. Of such options, 437,500 did not begin vesting until the date that FDA approved the Gimoti NDA. 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 nine months ended September 30, 2020 and 2019: Nine Months Ended September 30, 2020 2019 Common Stock Options Risk free interest rate 0.39% - 0.96% 1.80% - 2.55% Expected option term 5.5 - 6.0 years 4.27 - 6.0 years Expected volatility of common stock 99.73% - 103.99% 90.34% - 112.58% Expected dividend yield 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 three and nine months ended September 30, 2020 and 2019: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Employee Stock Purchase Plan Risk free interest rate 0.13% 1.89% 0.13% - 1.11% 1.89% - 2.52% Expected term 0.5 years 0.5 years 0.5 years 0.5 years Expected volatility of common stock 111.98% 170.68% 69.72% - 111.98% 130.36% - 170.68% Expected dividend yield 0.0% 0.0% 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 during the three and nine months ended September 30, 2020 and 2019 as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development $ 31,186 $ 179,227 $ 286,148 $ 533,518 General and administrative 447,388 152,076 865,543 521,585 Total stock-based compensation expense $ 478,574 $ 331,303 $ 1,151,691 $ 1,055,103 As of September 30, 2020, there was approximately $2.5 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 1.13 years. |
Commercial Services and Loan Ag
Commercial Services and Loan Agreements with Eversana | 9 Months Ended |
Sep. 30, 2020 | |
Commercial Services And Loan Agreements [Abstract] | |
Commercial Services and Loan Agreements with Eversana | 5. 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. Eversana will manage the marketing of Gimoti to targeted health care providers, as well as the sales and distribution of Gimoti 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 Eversana Agreement terminates on June 19, 2025, unless terminated earlier pursuant to its terms. 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; if the other party is in breach of certain regulatory compliance representations under the agreement; if the Company discontinues the development or production of Gimoti; if 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 the Company withdraws Gimoti from the market for more than 90 days. In connection with the Eversana Agreement, the Company and Eversana also entered into the Eversana Credit Facility, pursuant to which Eversana agreed to provide a revolving Credit Facility of up to $5 million to the Company upon FDA approval of the Gimoti NDA, as well as certain other customary conditions. The Eversana Credit Facility terminates on June 19, 2025, unless terminated earlier pursuant to its terms. The Eversana Credit Facility is secured by all of the Company’s personal property other than its intellectual property. Under the terms of the Eversana Credit Facility, the Company cannot grant an interest in its intellectual property to any other person. Each loan under the Eversana Credit Facility will bear interest at an annual rate equal to 10.0%, with such interest due at the end of the loan term. In June 2020, the Company borrowed $2 million from the Eversana Credit Facility. 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
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. |
Inventory | Inventory Subsequent to FDA approval of Gimoti in June 2020, the Company began a manufacturing process for the production of Gimoti for sale and began capitalizing inventory. As the manufacturing process was not completed until October 2020, the inventory was classified as work-in-process at September 30, 2020. Following the completion and release of the product by the Company’s manufacturer in October 2020, inventory is being stated at the lower of cost or net realizable value and recognized on a first-in, first-out method. Prior to FDA approval, expenses associated with the manufacturing of Gimoti were recorded as research and development expense. The Company will analyze its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments will be recognized through cost of sales in the period in which they are incurred. |
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, except awards with a performance condition. Awards with performance conditions commence vesting when the satisfaction of the performance condition is probable. 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. The Company accounts for forfeitures as the forfeitures occur. |
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, costs paid to third-party contractors for product development activities and drug product materials and technology acquisition milestones. The Company has expensed costs relating to the purchase and production of pre-approval inventories as research and development expense in the period incurred prior to FDA approval received June 19, 2020. 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 depended on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its pre-commercial product development, and will continue to depend on such third-party manufacturers for its commercial manufacturing. The Company has agreements with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, and with Thermo Fisher Scientific Inc., through its subsidiary Patheon UK Limited, for the 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. 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 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: |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Warrants to purchase common stock 1,841,879 2,713,561 1,841,879 2,713,561 Common stock options 4,273,065 3,114,371 4,273,065 3,114,371 Employee stock purchase plan 4,716 7,294 4,716 7,294 Total excluded securities 6,119,660 5,835,226 6,119,660 5,835,226 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Summary of Estimated Fair Value of Stock Option Award | During the nine months ended September 30, 2020, the Company granted stock options to purchase 1,172,000 shares of the Company’s common stock. Of such options, 437,500 did not begin vesting until the date that FDA approved the Gimoti NDA. 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 nine months ended September 30, 2020 and 2019: Nine Months Ended September 30, 2020 2019 Common Stock Options Risk free interest rate 0.39% - 0.96% 1.80% - 2.55% Expected option term 5.5 - 6.0 years 4.27 - 6.0 years Expected volatility of common stock 99.73% - 103.99% 90.34% - 112.58% Expected dividend yield 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 three and nine months ended September 30, 2020 and 2019: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Employee Stock Purchase Plan Risk free interest rate 0.13% 1.89% 0.13% - 1.11% 1.89% - 2.52% Expected term 0.5 years 0.5 years 0.5 years 0.5 years Expected volatility of common stock 111.98% 170.68% 69.72% - 111.98% 130.36% - 170.68% Expected dividend yield 0.0% 0.0% 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 during the three and nine months ended September 30, 2020 and 2019 as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development $ 31,186 $ 179,227 $ 286,148 $ 533,518 General and administrative 447,388 152,076 865,543 521,585 Total stock-based compensation expense $ 478,574 $ 331,303 $ 1,151,691 $ 1,055,103 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) | May 01, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Organization And Basis Of Presentation [Line Items] | |||||
Month and year of incorporation | 2007-01 | ||||
Cash and cash equivalents | $ 6,280,656 | $ 5,663,833 | $ 6,504,802 | $ 5,319,004 | |
Paycheck Protection Program [Member] | COVID-19 [Member] | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Proceeds from loan | $ 104,000 |
Summary of Significant Accoun_4
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 | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 6,119,660 | 5,835,226 | 6,119,660 | 5,835,226 |
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 | 1,841,879 | 2,713,561 | 1,841,879 | 2,713,561 |
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 | 4,273,065 | 3,114,371 | 4,273,065 | 3,114,371 |
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 | 4,716 | 7,294 | 4,716 | 7,294 |
Technology Acquisition Agreem_2
Technology Acquisition Agreement - Additional Information (Detail) | 1 Months Ended | 9 Months Ended | ||
May 31, 2014USD ($) | Jun. 30, 2007USD ($) | Sep. 30, 2020USD ($)Milestone | Jun. 30, 2016USD ($) | |
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] | Gimoti [Member] | ||||
Technology Acquisition Agreement [Line Items] | ||||
Amount payable to Mallinckro dt | $ 5,000,000 | |||
Borrowing due date | Jun. 19, 2021 | |||
Research and development expense payable | $ 5,000,000 | |||
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 ($) | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Nov. 30, 2017 | |
Options Granted [Line Items] | ||||
Common stock, shares issued | 26,332,122 | 24,431,914 | ||
Proceeds from issuance of common stock, net | $ 3,309,116 | $ 5,800,201 | ||
Warrants converted to purchase of common stock | 871,682 | |||
Issuance of common stock from warrant exercise | 381,625 | |||
Issuance of common stock from stock option exercise, shares | 4,237 | |||
Exercise Price | $ 0.62 | |||
Options Granted [Member] | ||||
Options Granted [Line Items] | ||||
Number of stock options granted | 1,172,000 | |||
Options Granted [Member] | Gimoti [Member] | ||||
Options Granted [Line Items] | ||||
Number of stock options not begin vesting | 437,500 | |||
Maximum [Member] | ||||
Options Granted [Line Items] | ||||
Weighted average exercise price of warrants | $ 3.12 | |||
Minimum [Member] | ||||
Options Granted [Line Items] | ||||
Weighted average exercise price of warrants | $ 2.41 | |||
FBR Sales Agreement [Member] | ||||
Options Granted [Line Items] | ||||
Common stock, shares issued | 1,395,855 | 6,804,381 | ||
Common stock, weighted average price per share | $ 2.42 | $ 0.87 | ||
Proceeds from issuance of common stock, net | $ 3,300,000 | $ 5,800,000 | ||
FBR Sales Agreement [Member] | Maximum [Member] | ||||
Options Granted [Line Items] | ||||
Common stock, value of shares issuable | $ 16,000,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Estimated Fair Value of Stock Option Award (Detail) - Common stock options [Member] | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk free interest rate | 0.39% | 1.80% |
Expected option term | 5 years 6 months | 4 years 3 months 7 days |
Expected volatility of common stock | 99.73% | 90.34% |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk free interest rate | 0.96% | 2.55% |
Expected option term | 6 years | 6 years |
Expected volatility of common stock | 103.99% | 112.58% |
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] | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk free interest rate | 0.13% | 1.89% | ||
Expected term | 6 months | 6 months | 6 months | 6 months |
Expected volatility of common stock | 111.98% | 170.68% | ||
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected option term | 6 months | 6 months | 6 months | 6 months |
Minimum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk free interest rate | 0.13% | 1.89% | ||
Expected volatility of common stock | 69.72% | 130.36% | ||
Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk free interest rate | 1.11% | 2.52% | ||
Expected volatility of common stock | 111.98% | 170.68% |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Recognized Non-Cash Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 478,574 | $ 331,303 | $ 1,151,691 | $ 1,055,103 |
Research and development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 31,186 | 179,227 | 286,148 | 533,518 |
General and administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 447,388 | $ 152,076 | $ 865,543 | $ 521,585 |
Stockholders' Equity - Stock-Ba
Stockholders' Equity - Stock-Based Compensation - Additional Information (Detail) $ in Millions | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Unrecognized compensation costs | $ 2.5 |
Weighted average period | 1 year 1 month 17 days |
Commercial Services and Loan _2
Commercial Services and Loan Agreements with Eversana - Additional Information (Detail) - Eversana Agreement [Member] - USD ($) | Jan. 21, 2020 | Jun. 30, 2020 |
Commercial Services And Loan Agreements [Line Items] | ||
Agreement termination date | Jun. 19, 2025 | |
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% | |
Borrowings | $ 2,000,000 | |
Gimoti [Member] | Minimum [Member] | ||
Commercial Services And Loan Agreements [Line Items] | ||
Percentage Of Product Profits | 80.00% |