Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 05, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
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 $0.0001 per share | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-36075 | |
Entity Tax Identification Number | 20-8447886 | |
Entity Address, Address Line One | 420 Stevens Avenue | |
Entity Address, Address Line Two | Suite 370 | |
Entity Address, City or Town | Solana Beach | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92075 | |
City Area Code | 858 | |
Local Phone Number | 345-1494 | |
Entity Incorporation, State or Country Code | DE | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 3,343,070 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 13,450,949 | $ 9,144,710 |
Accounts receivable, net | 365,643 | 295,193 |
Prepaid expenses | 307,919 | 923,746 |
Inventory, net | 268,334 | 185,534 |
Other current assets | 11,551 | 11,551 |
Total current assets | 14,404,396 | 10,560,734 |
Operating lease right-of-use asset | 12,428 | |
Total assets | 14,404,396 | 10,573,162 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 824,481 | 874,028 |
Accrued compensation | 528,665 | 519,317 |
Operating lease liability | 12,428 | |
Total current liabilities | 1,353,146 | 1,405,773 |
Long-term Liabilities: | ||
Note payable | 5,000,000 | 5,000,000 |
Accrued interest payable | 860,240 | 612,295 |
Total long-term liabilities | 5,860,240 | 5,612,295 |
Total liabilities | 7,213,386 | 7,018,068 |
Commitments and contingencies (Note 3) | ||
Stockholders' equity: | ||
Common stock, $0.0001 par value; authorized shares — 50,000,000 at June 30, 2022 and December 31, 2021; issued and outstanding shares — 3,343,070 and 2,721,373 at June 30, 2022 and December 31, 2021, respectively | 334 | 272 |
Additional paid-in capital | 119,020,734 | 110,977,835 |
Accumulated deficit | (111,830,058) | (107,423,013) |
Total stockholders' equity | 7,191,010 | 3,555,094 |
Total liabilities and stockholders' equity | $ 14,404,396 | $ 10,573,162 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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 | 3,343,070 | 2,721,373 |
Common stock, shares outstanding | 3,343,070 | 2,721,373 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Net product sales | $ 461,795 | $ 236,635 | $ 880,175 | $ 327,056 |
Operating expenses: | ||||
Cost of goods sold | $ 67,774 | $ 68,253 | $ 90,535 | $ 133,004 |
Cost, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 191,478 | $ 195,229 | $ 233,194 | $ 473,054 |
Selling, general and administrative | 2,315,175 | 2,142,149 | 4,720,251 | 4,480,443 |
Total operating expenses | 2,574,427 | 2,405,631 | 5,043,980 | 5,086,501 |
Loss from operations | (2,112,632) | (2,168,996) | (4,163,805) | (4,759,445) |
Other income (expense): | ||||
Forgiveness of paycheck protection loan and accrued interest | 105,130 | |||
Interest income | 3,910 | 3,011 | 4,705 | 6,174 |
Interest expense | (124,658) | (124,658) | (247,945) | (247,997) |
Total other income (expense) | (120,748) | (121,647) | (243,240) | (136,693) |
Net loss | $ (2,233,380) | $ (2,290,643) | $ (4,407,045) | $ (4,896,138) |
Net loss per share of common stock, basic | $ (0.71) | $ (0.85) | $ (1.50) | $ (1.85) |
Net loss per share of common stock, diluted | $ (0.71) | $ (0.85) | $ (1.50) | $ (1.85) |
Weighted-average shares used to compute basic net loss per share | 3,156,925 | 2,698,833 | 2,944,183 | 2,647,669 |
Weighted-average shares used to compute diluted net loss per share | 3,156,926 | 2,698,833 | 2,944,183 | 2,647,669 |
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, 2020 | $ (3,214,623) | $ 222 | $ 95,670,216 | $ (98,885,061) |
Beginning Balance, Shares at Dec. 31, 2020 | 2,218,496 | |||
Stock-based compensation expense | 561,348 | 561,348 | ||
Issuance of common stock, net | 13,070,154 | $ 48 | 13,070,106 | |
Issuance of common stock, shares net | 479,166 | |||
Net loss | (2,605,495) | (2,605,495) | ||
Ending Balance at Mar. 31, 2021 | 7,811,384 | $ 270 | 109,301,670 | (101,490,556) |
Ending Balance, Shares at Mar. 31, 2021 | 2,697,662 | |||
Beginning Balance at Dec. 31, 2020 | (3,214,623) | $ 222 | 95,670,216 | (98,885,061) |
Beginning Balance, Shares at Dec. 31, 2020 | 2,218,496 | |||
Net loss | (4,896,138) | |||
Ending Balance at Jun. 30, 2021 | 5,965,606 | $ 271 | 109,746,534 | (103,781,199) |
Ending Balance, Shares at Jun. 30, 2021 | 2,703,280 | |||
Beginning Balance at Mar. 31, 2021 | 7,811,384 | $ 270 | 109,301,670 | (101,490,556) |
Beginning Balance, Shares at Mar. 31, 2021 | 2,697,662 | |||
Stock-based compensation expense | 399,411 | 399,411 | ||
Issuance of common stock from stock option exercises | 45,454 | $ 1 | 45,453 | |
Issuance of common stock from stock option exercises, shares | 5,618 | |||
Net loss | (2,290,643) | (2,290,643) | ||
Ending Balance at Jun. 30, 2021 | 5,965,606 | $ 271 | 109,746,534 | (103,781,199) |
Ending Balance, Shares at Jun. 30, 2021 | 2,703,280 | |||
Beginning Balance at Dec. 31, 2021 | $ 3,555,094 | $ 272 | 110,977,835 | (107,423,013) |
Beginning Balance, Shares at Dec. 31, 2021 | 2,721,373 | 2,721,373 | ||
Stock-based compensation expense | $ 381,061 | 381,061 | ||
Issuance of common stock, net | 171,521 | $ 2 | 171,519 | |
Issuance of common stock, shares net | 21,783 | |||
Net loss | (2,173,665) | (2,173,665) | ||
Ending Balance at Mar. 31, 2022 | 1,934,011 | $ 274 | 111,530,415 | (109,596,678) |
Ending Balance, Shares at Mar. 31, 2022 | 2,743,156 | |||
Beginning Balance at Dec. 31, 2021 | $ 3,555,094 | $ 272 | 110,977,835 | (107,423,013) |
Beginning Balance, Shares at Dec. 31, 2021 | 2,721,373 | 2,721,373 | ||
Net loss | $ (4,407,045) | |||
Ending Balance at Jun. 30, 2022 | $ 7,191,010 | $ 334 | 119,020,734 | (111,830,058) |
Ending Balance, Shares at Jun. 30, 2022 | 3,343,070 | 3,343,070 | ||
Beginning Balance at Mar. 31, 2022 | $ 1,934,011 | $ 274 | 111,530,415 | (109,596,678) |
Beginning Balance, Shares at Mar. 31, 2022 | 2,743,156 | |||
Stock-based compensation expense | 366,924 | 366,924 | ||
Issuance of common stock, net | 7,123,455 | $ 60 | 7,123,395 | |
Issuance of common stock, shares net | 599,914 | |||
Net loss | (2,233,380) | (2,233,380) | ||
Ending Balance at Jun. 30, 2022 | $ 7,191,010 | $ 334 | $ 119,020,734 | $ (111,830,058) |
Ending Balance, Shares at Jun. 30, 2022 | 3,343,070 | 3,343,070 |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Statement Of Stockholders Equity [Abstract] | |||||
Stock Issuance Cost | $ 145,445 | $ 3,548 | $ 1,304,846 | $ 148,993 | $ 1,304,846 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities | ||||||
Net loss | $ (2,233,380) | $ (2,173,665) | $ (2,290,643) | $ (2,605,495) | $ (4,407,045) | $ (4,896,138) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Forgiveness of paycheck protection loan and accrued interest | (105,130) | |||||
Stock-based compensation expense | 366,924 | 399,411 | 747,985 | 960,759 | ||
Change in operating assets and liabilities: | ||||||
Accounts receivable, net | (70,450) | (175,100) | ||||
Prepaid expenses, inventory and other assets | 545,455 | 703,867 | ||||
Accounts payable and other current liabilities | (61,975) | (805,318) | ||||
Accrued compensation | 9,348 | (394,756) | ||||
Accrued interest expense | 247,945 | 248,208 | ||||
Net cash used in operating activities | (2,988,737) | (4,463,608) | ||||
Financing activities | ||||||
Proceeds from issuance of common stock | 7,443,969 | 14,375,000 | ||||
Payment of common stock offering costs | (145,445) | (3,548) | (1,304,846) | (148,993) | (1,304,846) | |
Proceeds from issuance of common stock from exercise of stock options | 45,454 | |||||
Net cash provided by financing activities | 7,294,976 | 13,115,608 | ||||
Net increase in cash and cash equivalents | 4,306,239 | 8,652,000 | ||||
Cash and cash equivalents at beginning of period | $ 9,144,710 | $ 8,068,939 | 9,144,710 | 8,068,939 | ||
Cash and cash equivalents at end of period | $ 13,450,949 | $ 16,720,939 | $ 13,450,949 | 16,720,939 | ||
Non-cash financing activities | ||||||
Forgiveness of paycheck protection loan and accrued interest | $ 105,130 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
Organization And Basis Of Presentation [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Evoke Pharma, Inc. (the “Company”) was incorporated under the laws of 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 financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. 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. As of June 30, 2022, the Company had approximately $13.5 million in cash and cash equivalents. The Company anticipates that it will continue to incur losses from operations due to commercialization activities, including manufacturing Gimoti, conducting the post-marketing commitment single-dose pharmacokinetics (“PK”) clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti, and for other general and administrative costs to support the Company’s operations. As a result, the Company believes that there is substantial doubt about its ability to continue as a going concern for one year after the date these financial statements are issued. The financial statements do not include any adjustments that may result from the outcome of this uncertainty. The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. The Company anticipates that it 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 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, the Company will be required to curtail all of its activities and may be required to liquidate, dissolve or otherwise wind down its operations. Impact of COVID-19 The Company began its commercial sales of Gimoti with Eversana in October 2020. Due to the COVID-19 pandemic, the Company experienced disruptions to its sales activities, including its efforts to reach physicians and customers. For example, Eversana’s commercialization efforts at the time the Company launched Gimoti were 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, Eversana’s sales force was restricted from conducting in-person interactions with certain physicians and customers and was restricted to conducting Gimoti educational and promotional activities virtually in certain circumstances, which impacted Eversana’s ability to more actively market Gimoti. Starting in the fourth quarter of 2021, certain physician offices began to allow more frequent in-person interactions, which has helped to increase the educational and promotional activities of the sales force. The Company anticipates that it and Eversana will continue to be impacted by the COVID-19 pandemic to some extent. The COVID-19 pandemic has not significantly disrupted the operations of the Company’s third-party suppliers and manufacturers or delayed the Company’s manufacturing timelines of Gimoti, but may negatively impact the Company’s ability to successfully commercialize Gimoti and generate product sales in the future. Further, t he COVID-19 pandemic and related mitigation measures have also had an adverse impact on global economic conditions which could have an adverse effect on the Company’s future business and financial condition, including impairing its ability to raise capital when needed. In March 2020, the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act In April 2020, the Company applied for and was approved for a Small Business Administration (“SBA”) loan under the Paycheck Protection Program, established by the CARES Act. On May 1, 2020, the Company received the loan proceeds of approximately $104,000. In January 2021, the Company received notice that its loan and accrued interest were forgiven by the SBA. Notice of Delisting and Reverse Stock Split On December 29, 2021, the Company received a letter from Nasdaq indicating that, for the last thirty consecutive business days, the bid price for our common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market. In accordance with Nasdaq listing rules, the Company was provided an initial period of 180 calendar days, or until June 27, 2022, to regain compliance. The letter stated that Nasdaq will provide written notification that the Company has achieved compliance with its rules if at any time before June 27, 2022 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 had no immediate effect on the listing or trading of the Company’s common stock and the common stock continued to trade on The Nasdaq Capital Market. On April 27, 2022, the Company’s stockholders granted the board of directors the authority to effect a reverse stock split of the Company’s outstanding common stock. On May 23, 2022 the Company effected a 1-for-12 reverse stock split of the shares of the Company’s common stock (the “Reverse Stock Split”). The par value and the authorized shares of the common stock were not adjusted as a result of the Reverse Stock Split. All of the Company’s issued and outstanding common stock, warrants to purchase common stock, and options to purchase common stock have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented. On June 7, 2022, the Company received notice from Nasdaq stating that the closing price of the Company’s common stock had been at $1.00 per share or greater for the prior ten consecutive business days and that the Company had regained compliance with the minimum $1.00 per share requirement. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The accompanying condensed balance sheet as of December 31, 2021, 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 statement 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, 2021, which are contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2022. 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 revenues and 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 activities. If the CROs and consultants are unable to continue their support, this could adversely affect the Company’s operations. 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, and the development and/or commercialization of Gimoti could be materially and adversely affected. The Company also relies on a dedicated third-party sales team to sell Gimoti. If such third-party organization is unable to continue serving as a dedicated sales team, the commercialization of Gimoti could be materially and adversely affected. Accounts Receivable Accounts receivable are recorded net of allowance for doubtful accounts. Estimates for allowances for doubtful accounts are determined based on existing contractual obligations and historical payment patterns. The allowance for doubtful accounts was zero at June 30, 2022 and December 31, 2021 and no bad debt expense was recorded for the six months ended June 30, 2022 and 2021. Inventory 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 depends on third-party contract manufacturers for all of its required raw materials, drug substance and finished product 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 the manufacturing contractors. Subsequent to FDA approval, the Company began manufacturing Gimoti for commercialization and began capitalizing inventory at that time. The Company’s inventory consisted of approximately $169,000 of raw materials at June 30, 2022 and $150,000 at December 31, 2021, and approximately $100,000 and $35,000 of finished goods inventory at June 30, 2022 and December 31, 2021, respectively. Inventories are stated at the lower of cost (first-in first-out basis) or net realizable value. Inventory at December 31, 2021 was written down by $30,000 due to establishing a reserve for obsoletion. The new cost basis and its value is not to be subsequently increased based upon changes in underlying facts and circumstances. The Company’s raw materials inventory is held at its third-party suppliers and its work-in-process and finished goods inventory is held at its manufacturer and at Eversana. The Company records such inventory as consigned inventory. Revenue Recognition The Company’s ability to generate revenue and become profitable depends on its ability to successfully commercialize Gimoti, which was launched in the United States through prescription in October 2020 through the Company’s commercial partner Eversana. If the Company or Eversana fail to successfully grow and maintain sales of Gimoti, the Company may never generate significant revenues and its results of operations and financial position will be adversely affected. In accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers Product sales are recorded at the transaction price, which may include variable considerations for co-payment assistance to commercially insured patients meeting certain eligibility requirements, as well as to uninsured patients. Co-payment assistance is recorded as an offset to gross revenue at the time revenue from the product sale is recognized based on expected and actual program participation. Co-pay liabilities are estimated using prescribing data available from customers. Actual amounts of consideration ultimately received may materially differ from the Company’s estimates. If actual results in the future vary from estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance of approximately $49,000 and $44,000 at June 30, 2022 and December 31, 2021, respectively, are classified as accounts payable and accrued expenses in the balance sheets. 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 a performance condition 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 will expense the clinical, regulatory and manufacturing costs related to the post-marketing commitment to conduct a single dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti, as well as other costs that may occur for any additional clinical trials the Company may pursue to expand the indication of Gimoti. 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 stock and common stock equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of warrants to purchase common stock, and options to purchase common stock under the Company’s equity incentive plan. 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 for the three and six months ended June 30, 2022 and 2021: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Warrants to purchase common stock — 153,490 — 153,490 Common stock options 491,851 460,642 491,851 460,642 Total excluded securities 491,851 614,132 491,851 614,132 Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, (“FASB”) issued ASU 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options, Derivatives and Hedging—Contracts in Entity’s Own Equity, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, The Company’s early adoption of this accounting standard on January 1, 2022 did not have a material impact on the Company’s financial statements and related disclosures. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 3. Commitments and Contingencies Leases The Company’s current operating lease for office space in Solana Beach, California was extended in February 2022 and has an expiration date of October 31, 2022, subject to the landlord’s option to cancel upon 30 days written notice. As of June 30, 2022, the Company has future minimum lease payments under its existing facility lease of approximately $50,000 payable in 2022. Legal Proceedings On February 25, 2022, the Company received a letter notifying us that Teva Pharmaceuticals, Inc. (“Teva”) submitted to FDA an abbreviated new drug application, or ANDA, for a generic version of Gimoti (metoclopramide hydrochloride) nasal spray eq. 15 mg base/spray that contains Paragraph IV certifications with respect to two of our patents covering Gimoti, U.S. Patent Nos. 8,334,281, expiration date May 16, 2030; and 11,02,0361, expiration date December 22, 2029. These patents are listed in FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, for Gimoti. The certifications allege these patents are invalid or will not be infringed by the manufacture, use or sale of Teva’s metoclopramide hydrochloride nasal spray eq. 15 mg base/spray. In April 2022, the Company initiated litigation in the United States District Court for the District of New Jersey, alleging that Teva infringes the patents covering Gimoti. Teva has denied all material allegations and asserted counterclaims of non-infringement and invalidity. The Company has not recorded any loss in connection with this matter because it believes that a loss is neither probable nor estimable at this time. |
Technology Acquisition Agreemen
Technology Acquisition Agreement | 6 Months Ended |
Jun. 30, 2022 | |
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 The remaining $47 million in milestone payments depend on Gimoti’s commercial success. The Company is required to pay Mallinckrodt a low single digit royalty percentage on net sales of Gimoti. As of June 30, 2022, the Company has paid Mallinckrodt approximately $82,000 in royalties 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 2030, subject to possible extension should any additional, later expiring, licensed patents be granted. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity | 5. Stockholders’ Equity Sale of Common Stock in Public Offering In January 2021, the Company completed the sale of 479,166 shares of its common stock in an underwritten public offering led by Laidlaw & Company (UK) Ltd. The price to the public in this offering was $30.00 per share resulting in gross proceeds to the Company of approximately $14.4 million. After deducting underwriting discounts and commissions and offering expenses paid by the Company, the net proceeds to the Company raised from this offering were approximately $13.1 million. 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 included 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”). Effective January 6, 2021, the Company terminated the FBR Sales Agreement. As a result, there were no shares sold under the FBR Sales Agreement during 2021. In December 2020, the Company filed a new shelf registration statement with the SEC on Form S-3, or the replacement shelf registration statement. The replacement shelf registration statement replaced the registration statement on Form S-3 the Company originally filed with the SEC in November 2017, which registration statement expired in December 2020. The replacement shelf registration was declared effective by the SEC on January 6, 2021. In December 2020, the Company also entered into a new At Market Issuance Sales Agreement (the “ATM Sales Agreement”), with FBR and H.C. Wainwright & Co. (together with FBR, the “Sales Agents”), pursuant to which the Company may sell from time to time, at its option, up to an aggregate of $30 million worth of shares of the Company’s common stock through the Sales Agents. The ATM Sales Agreement provides, among other things, that sales under the ATM Sales Agreement will be made pursuant to the registration statement, including the base prospectus filed as part of such registration statement. During the third quarter of 2021, the Company sold 18,091 shares of common stock at a weighted-average price per share of $17.64 pursuant to the ATM Sales Agreement and received proceeds of approximately $313,000, net of commissions and fees. During the three months ended March 31, 2022, the Company sold 21,783 shares of common stock at a weighted-average price per share of $ pursuant to the ATM Sales Agreement and received proceeds of approximately $ 172,000 , net of commissions and fees. During the three months ended June 30 , 2022, the Company sold shares of common stock at a weighted-average price per share of $ pursuant to the ATM Sales Agreement and received proceeds of approximately $ 7.1 million, net of commissions and fees . Future sales under the ATM Sales Agreement 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 the Sales Agents 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 ATM Sales Agreement unless certain conditions are met, which include the accuracy of representations and warranties made to the Sales Agents under the ATM Sales Agreement. Furthermore, each of the Sales Agents is permitted to terminate the ATM Sales Agreement with respect to itself 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 shares available for sale pursuant to the ATM Sales Agreement. Warrants The Company has issued warrants to purchase common stock to banks that have previously loaned funds to the Company, as well as to representatives of the underwriters of the Company’s public offerings and certain of their affiliates. During 2021, there were no warrants exercised and warrants to purchase 13,517 shares of common stock expired. During the six months ended June 30, 2022, there were no warrants exercised and warrants to purchase 139,972 shares of common stock expired. At June 30, 2022, there were no warrants outstanding to purchase shares of common stock. At December 31, 2021, there were warrants outstanding to purchase 139,972 shares of common stock with a weighted average exercise price of $34.80. 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 six months ended June 30, 2022 and 2021, the Company granted stock options to purchase 78,247 and 140,167 shares of the Company’s common stock, respectively. Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Common Stock Options Risk free interest rate 2.82% - 3.55% 0.91% - 1.08% 1.67% - 3.55% 0.57% - 1.08% Expected option term 5.5 - 6.0 years 5.5 - 6.0 years 5.5 - 6.0 years 5.5 - 6.0 years Expected volatility of common stock 97.04% - 113.23% 105.93%-107.53% 97.04% - 113.23% 103.45%-107.53% 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 assumptions for ESPP shares to be purchased during the three and six months ended June 30, 2022 and 2021: Three and Six Months Ended June 30, 2022 Three and Six Months Ended June 30, 2021 Employee Stock Purchase Plan Risk free interest rate — 0.13% Expected term — 0.5 years Expected volatility of common stock — 111.98% Expected dividend yield — 0.0% There were no employee withholdings to purchase shares during the six-month purchase period beginning September 1, 2021 and March 1, 2022. The Company recognized stock-based compensation expense to employees and directors in its research and development and its selling, general and administrative functions during the three and six months ended June 30, 2022 and 2021 as follows: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 3,752 $ 23,820 $ 5,608 $ 92,200 Selling, general and administrative 363,172 375,591 742,377 868,559 Total stock-based compensation expense $ 366,924 $ 399,411 $ 747,985 $ 960,759 As of June 30, 2022, 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 1.17 years. |
Commercial Services and Loan Ag
Commercial Services and Loan Agreements with Eversana | 6 Months Ended |
Jun. 30, 2022 | |
Commercial Services And Loan Agreements [Abstract] | |
Commercial Services and Loan Agreements with Eversana | 6. Commercial Services and Loan Agreements with Eversana In January 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 commercializes and distributes Gimoti in the United States. Eversana also manages the marketing of Gimoti to targeted health care providers, as well as the sales and distribution of Gimoti in 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. For the three months ended June 30, 2022 and 2021, approximately $368,000 and $192,100 of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. For the six months ended June 30, 2022 and 2021, approximately $716,000 and $268,000 of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. As of June 30, 2022, unreimbursed commercialization costs to Eversana were approximately $38.4 million. Such costs will generally be payable only as net product profits are recognized. 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. On February 1, 2022, the Eversana Agreement was amended (the “Amended Eversana Agreement”) to extend the term from June 19, 2025 (five years from the date the Food & Drug Administration approved the Gimoti new drug application) to December 31, 2026, 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; 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; if the cumulative net product profits fail to reach certain thresholds in the first three years following 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 Amended Eversana Agreement upon a change of control of the Company’s ownership. In the event that the Company initiates such termination, the Company shall pay to Eversana a one-time payment equal to all of Eversana’s unreimbursed cost plus a portion of Eversana’s commercialization costs incurred in the 12 months prior to termination. 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. If Eversana terminates the agreement due to an uncured material breach by the Company, or if the Company terminates the Eversana Agreement in certain circumstances, the Company has agreed to reimburse Eversana for its unreimbursed commercialization costs for the prior twelve-month period and certain other costs. 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 have entered into the Eversana Credit Facility, pursuant to which Eversana has agreed to provide a revolving Credit Facility of up to $5 million to the Company upon FDA approval of the Gimoti NDA under certain customary conditions. The Eversana Credit Facility terminates on June 25, 2025, unless terminated earlier pursuant to its terms. The Eversana Credit Facility is secured by all of the Company’s personal property other than the Company’s intellectual property. Under the terms of the Eversana Credit Facility, the Company cannot grant an interest in the Company’s intellectual property to any other person. Each loan under the Eversana Credit Facility will bear interest at an annual rate equal to 10.0%, with such interest due at the end of the loan term. In 2020 the Company borrowed $5 million under 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) | 6 Months Ended |
Jun. 30, 2022 | |
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 revenues and 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 activities. If the CROs and consultants are unable to continue their support, this could adversely affect the Company’s operations. 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, and the development and/or commercialization of Gimoti could be materially and adversely affected. The Company also relies on a dedicated third-party sales team to sell Gimoti. If such third-party organization is unable to continue serving as a dedicated sales team, the commercialization of Gimoti could be materially and adversely affected. |
Accounts Receivable | Accounts Receivable Accounts receivable are recorded net of allowance for doubtful accounts. Estimates for allowances for doubtful accounts are determined based on existing contractual obligations and historical payment patterns. The allowance for doubtful accounts was zero at June 30, 2022 and December 31, 2021 and no bad debt expense was recorded for the six months ended June 30, 2022 and 2021. |
Inventory | Inventory 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 depends on third-party contract manufacturers for all of its required raw materials, drug substance and finished product 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 the manufacturing contractors. Subsequent to FDA approval, the Company began manufacturing Gimoti for commercialization and began capitalizing inventory at that time. The Company’s inventory consisted of approximately $169,000 of raw materials at June 30, 2022 and $150,000 at December 31, 2021, and approximately $100,000 and $35,000 of finished goods inventory at June 30, 2022 and December 31, 2021, respectively. Inventories are stated at the lower of cost (first-in first-out basis) or net realizable value. Inventory at December 31, 2021 was written down by $30,000 due to establishing a reserve for obsoletion. The new cost basis and its value is not to be subsequently increased based upon changes in underlying facts and circumstances. The Company’s raw materials inventory is held at its third-party suppliers and its work-in-process and finished goods inventory is held at its manufacturer and at Eversana. The Company records such inventory as consigned inventory. |
Revenue Recognition | Revenue Recognition The Company’s ability to generate revenue and become profitable depends on its ability to successfully commercialize Gimoti, which was launched in the United States through prescription in October 2020 through the Company’s commercial partner Eversana. If the Company or Eversana fail to successfully grow and maintain sales of Gimoti, the Company may never generate significant revenues and its results of operations and financial position will be adversely affected. In accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers Product sales are recorded at the transaction price, which may include variable considerations for co-payment assistance to commercially insured patients meeting certain eligibility requirements, as well as to uninsured patients. Co-payment assistance is recorded as an offset to gross revenue at the time revenue from the product sale is recognized based on expected and actual program participation. Co-pay liabilities are estimated using prescribing data available from customers. Actual amounts of consideration ultimately received may materially differ from the Company’s estimates. If actual results in the future vary from estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance of approximately $49,000 and $44,000 at June 30, 2022 and December 31, 2021, respectively, are classified as accounts payable and accrued expenses in the balance sheets. |
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 a performance condition 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 will expense the clinical, regulatory and manufacturing costs related to the post-marketing commitment to conduct a single dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti, as well as other costs that may occur for any additional clinical trials the Company may pursue to expand the indication of Gimoti. |
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 stock and common stock equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of warrants to purchase common stock, and options to purchase common stock under the Company’s equity incentive plan. 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 for the three and six months ended June 30, 2022 and 2021: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Warrants to purchase common stock — 153,490 — 153,490 Common stock options 491,851 460,642 491,851 460,642 Total excluded securities 491,851 614,132 491,851 614,132 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, (“FASB”) issued ASU 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options, Derivatives and Hedging—Contracts in Entity’s Own Equity, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, The Company’s early adoption of this accounting standard on January 1, 2022 did not have a material impact on the Company’s financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive for the three and six months ended June 30, 2022 and 2021: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Warrants to purchase common stock — 153,490 — 153,490 Common stock options 491,851 460,642 491,851 460,642 Total excluded securities 491,851 614,132 491,851 614,132 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 assumptions for option grants during the three and six months ended June 30, 2022 and 2021: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Common Stock Options Risk free interest rate 2.82% - 3.55% 0.91% - 1.08% 1.67% - 3.55% 0.57% - 1.08% Expected option term 5.5 - 6.0 years 5.5 - 6.0 years 5.5 - 6.0 years 5.5 - 6.0 years Expected volatility of common stock 97.04% - 113.23% 105.93%-107.53% 97.04% - 113.23% 103.45%-107.53% 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 assumptions for ESPP shares to be purchased during the three and six months ended June 30, 2022 and 2021: Three and Six Months Ended June 30, 2022 Three and Six Months Ended June 30, 2021 Employee Stock Purchase Plan Risk free interest rate — 0.13% Expected term — 0.5 years Expected volatility of common stock — 111.98% Expected dividend yield — 0.0% |
Summary of Recognized Stock-Based Compensation Expense | There were no employee withholdings to purchase shares during the six-month purchase period beginning September 1, 2021 and March 1, 2022. The Company recognized stock-based compensation expense to employees and directors in its research and development and its selling, general and administrative functions during the three and six months ended June 30, 2022 and 2021 as follows: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 3,752 $ 23,820 $ 5,608 $ 92,200 Selling, general and administrative 363,172 375,591 742,377 868,559 Total stock-based compensation expense $ 366,924 $ 399,411 $ 747,985 $ 960,759 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) | 6 Months Ended | ||||||
May 23, 2022 | May 01, 2020 | Jun. 30, 2022 | Jun. 26, 2022 | Jun. 07, 2022 | Dec. 31, 2021 | Dec. 29, 2021 | |
Organization And Basis Of Presentation [Line Items] | |||||||
Month and year of incorporation | 2007-01 | ||||||
Cash and cash equivalents | $ 13,450,949 | $ 9,144,710 | |||||
Common stock, par value | $ 0.0001 | $ 1 | $ 1 | $ 0.0001 | |||
Reverse stock split description | 1-for-12 reverse stock split | ||||||
Minimum [Member] | |||||||
Organization And Basis Of Presentation [Line Items] | |||||||
Common stock, par value | $ 1 | $ 1 | |||||
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 - Additional Information (Detail) - USD ($) | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Significant Accounting Policies [Line Items] | |||
Allowance for doubtful accounts receivable | $ 0 | $ 0 | |
Bad debt expense | 0 | $ 0 | |
Inventory raw materials | 169,000 | 150,000 | |
Inventory finished goods | 100,000 | 35,000 | |
Accounts Payable and Accrued Expenses [Member] | |||
Significant Accounting Policies [Line Items] | |||
Liabilities for co-pay assistance | $ 49,000 | $ 44,000 |
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, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 491,851 | 614,132 | 491,851 | 614,132 |
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 | 153,490 | 153,490 | ||
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 | 491,851 | 460,642 | 491,851 | 460,642 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |
Lease expiry date | Oct. 31, 2022 |
Future minimum facility lease payments due in 2022 | $ 50,000 |
Technology Acquisition Agreem_2
Technology Acquisition Agreement - Additional Information (Detail) | 1 Months Ended | 6 Months Ended | |||
Jul. 31, 2021 USD ($) | May 31, 2014 USD ($) | Jun. 30, 2007 USD ($) | Jun. 30, 2022 USD ($) Milestone | Jun. 30, 2021 USD ($) | |
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 | ||||
Gimoti [Member] | Mallinckrodt Plc [Member] | |||||
Technology Acquisition Agreement [Line Items] | |||||
Milestone payment | $ 5,000,000 | ||||
Research and development expense payable | $ 5,000,000 | ||||
Amount payable to Mallinckrodt | $ 5,000,000 | ||||
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. The Company is required to pay Mallinckrodt a low single digit royalty percentage on net sales of Gimoti. | ||||
Milestone payments contingent amount | $ 47,000,000 | ||||
Royalties on net sales | $ 82,000 | ||||
Expected expiration of patent right | 2030 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Jan. 31, 2021 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2021 | Nov. 30, 2017 | |
Sale Of Common Stock [Line Items] | |||||||||
Common stock, shares issued | 3,343,070 | 3,343,070 | 2,721,373 | ||||||
Proceeds from issuance of common stock | $ 7,443,969 | $ 14,375,000 | |||||||
Common stock, value of shares issuable | $ 16,000,000 | ||||||||
Options Granted [Member] | |||||||||
Sale Of Common Stock [Line Items] | |||||||||
Number of stock options granted | 78,247 | 140,167 | |||||||
Public Offering [Member] | |||||||||
Sale Of Common Stock [Line Items] | |||||||||
Common stock, shares issued | 479,166 | ||||||||
Shares issued, price per share | $ 30 | ||||||||
Proceeds from issuance of common stock | $ 14,400,000 | ||||||||
Proceeds from issuance of common stock net of underwriting discounts and commissions and offering expenses | $ 13,100,000 | ||||||||
FBR Sales Agreement [Member] | |||||||||
Sale Of Common Stock [Line Items] | |||||||||
Common stock, shares issued | 0 | ||||||||
ATM Sales Agreement [Member] | |||||||||
Sale Of Common Stock [Line Items] | |||||||||
Common stock, shares issued | 599,914 | 21,783 | 18,091 | 599,914 | |||||
Proceeds from issuance of common stock | $ 7,100,000 | $ 313,000 | |||||||
Proceeds from issuance of common stock from ATM, net | $ 172,000 | ||||||||
Common stock , weighted average price per share | $ 12.12 | $ 8.04 | $ 17.64 | $ 12.12 | |||||
ATM Sales Agreement [Member] | Maximum [Member] | |||||||||
Sale Of Common Stock [Line Items] | |||||||||
Potential proceeds from issuance of common stock, net | $ 30,000,000 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants - Additional Information (Detail) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Issuance of common stock from warrant exercise | 0 | 0 |
Warrants to purchase shares of common stock expired | 139,972 | 13,517 |
Warrants outstanding to purchase common stock | 0 | 139,972 |
Weighted average exercise price of warrants outstanding | $ 34.80 |
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, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected dividend yield | 0% | 0% | 0% | 0% |
Minimum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk free interest rate | 2.82% | 0.91% | 1.67% | 0.57% |
Expected option term | 5 years 6 months | 5 years 6 months | 5 years 6 months | 5 years 6 months |
Expected volatility of common stock | 97.04% | 105.93% | 97.04% | 103.45% |
Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk free interest rate | 3.55% | 1.08% | 3.55% | 1.08% |
Expected option term | 6 years | 6 years | 6 years | 6 years |
Expected volatility of common stock | 113.23% | 107.53% | 113.23% | 107.53% |
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 | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk free interest rate | 0.13% | 0.13% |
Expected option term | 6 months | 6 months |
Expected volatility of common stock | 111.98% | 111.98% |
Expected dividend yield | 0% | 0% |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Recognized Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 366,924 | $ 399,411 | $ 747,985 | $ 960,759 |
Research and development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 3,752 | 23,820 | 5,608 | 92,200 |
Selling, general and administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 363,172 | $ 375,591 | $ 742,377 | $ 868,559 |
Stockholders' Equity - Stock-Ba
Stockholders' Equity - Stock-Based Compensation - Additional Information (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized compensation costs | $ 2.5 |
Weighted average period | 1 year 2 months 1 day |
Commercial Services and Loan _2
Commercial Services and Loan Agreements with Eversana - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Feb. 01, 2022 | Jan. 21, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jan. 31, 2020 | |
Commercial Services And Loan Agreements [Line Items] | |||||||
Selling, general and administrative | $ 2,315,175 | $ 2,142,149 | $ 4,720,251 | $ 4,480,443 | |||
Eversana Agreement [Member] | |||||||
Commercial Services And Loan Agreements [Line Items] | |||||||
Unreimbursed commercialization cost | 38,400,000 | $ 38,400,000 | |||||
Agreement expiration date | Dec. 31, 2026 | ||||||
Agreement term | On February 1, 2022, the Eversana Agreement was amended (the “Amended Eversana Agreement”) to extend the term from June 19, 2025 (five years from the date the Food & Drug Administration approved the Gimoti new drug application) to December 31, 2026, unless terminated earlier pursuant to its terms. | ||||||
Selling, general and administrative | $ 368,000 | $ 192,100 | $ 716,000 | $ 268,000 | |||
Eversana Agreement [Member] | Revolving Credit Facility [Member] | |||||||
Commercial Services And Loan Agreements [Line Items] | |||||||
Line of credit | $ 5,000,000 | ||||||
Line of credit facility, Interest rate | 10% | ||||||
Borrowings | $ 5,000,000 | ||||||
Eversana Agreement [Member] | Gimoti [Member] | Minimum [Member] | |||||||
Commercial Services And Loan Agreements [Line Items] | |||||||
Percentage Of Product Profits | 80% |