0001564590-21-026996 | 10-Q | XBRL Viewer

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Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2021	Apr. 30, 2021
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2021
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q1
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		32,371,954
Document Quarterly Report	true
Document Transition Report	false

Condensed Balance Sheets (Unaudited) - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Current Assets:
Cash and cash equivalents	$ 18,185,974	$ 8,068,939
Accounts receivable, net	127,795	23,311
Prepaid expenses	614,508	921,762
Inventory	236,044	236,480
Other current assets	11,703	30,300
Total current assets	19,176,024	9,280,792
Operating lease right-of-use asset	119,926	141,705
Other assets		11,551
Total assets	19,295,950	9,434,048
Current Liabilities:
Accounts payable and accrued expenses	691,225	1,273,572
Accrued compensation	428,794	1,016,232
Operating lease liability	119,926	141,705
Paycheck protection program loan		104,168
Milestone payable	5,000,000	5,000,000
Other current liabilities	9,038
Total current liabilities	6,248,983	7,535,677
Long-term liabilities
Note payable	5,000,000	5,000,000
Accrued interest payable	235,583	112,994
Total long-term liabilities	5,235,583	5,112,994
Total liabilities	11,484,566	12,648,671
Stockholders' (deficit) equity:
Common stock, $0.0001 par value; authorized shares - 50,000,000; issued and outstanding shares - 32,371,954 and 26,621,954 at March 31, 2021 and December 31, 2020, respectively	3,237	2,662
Additional paid-in capital	109,298,703	95,667,776
Accumulated deficit	(101,490,556)	(98,885,061)
Total stockholders' (deficit) equity	7,811,384	(3,214,623)
Total liabilities and stockholders' (deficit) equity	$ 19,295,950	$ 9,434,048

Condensed Balance Sheets (Parenthetical) (Unaudited) - $ / shares	Mar. 31, 2021	Dec. 31, 2020
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	32,371,954	26,621,954
Common stock, shares outstanding	32,371,954	26,621,954

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Income Statement [Abstract]
Net product sales	$ 90,421
Operating expenses:
Cost of goods sold	$ 64,751
Type Of Cost Good Or Service Extensible List	us-gaap:ProductMember	us-gaap:ProductMember
Research and development	$ 277,825	$ 463,853
Selling, general and administrative	2,338,295	1,329,834
Total operating expenses	2,680,871	1,793,687
Loss from operations	(2,590,450)	(1,793,687)
Other income (expense):
Forgiveness of paycheck protection loan and accrued interest	105,130
Interest income	3,164	3,378
Interest expense	(123,339)
Total other income (expense)	(15,045)	3,378
Net loss	$ (2,605,495)	$ (1,790,309)
Net loss per share of common stock, basic and diluted	$ (0.08)	$ (0.07)
Weighted-average shares used to compute basic and diluted net loss per share	31,158,065	24,439,881

Condensed Statements of Stockholders' (Deficit) Equity (Unaudited) - USD ($)	Total	Common Stock [Member]	Additional Paid-In Capital [Member]	Accumulated Deficit [Member]
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
Stock-based compensation expense	310,162		310,162
Issuance of common stock, net	21,250	$ 3	21,247
Issuance of common stock, shares net		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, 2020	$ (3,214,623)	$ 2,662	95,667,776	(98,885,061)
Beginning Balance, Shares at Dec. 31, 2020	26,621,954	26,621,954
Stock-based compensation expense	$ 561,348		561,348
Issuance of common stock, net	13,070,154	$ 575	13,069,579
Issuance of common stock, shares net		5,750,000
Net loss	(2,605,495)			(2,605,495)
Ending Balance at Mar. 31, 2021	$ 7,811,384	$ 3,237	$ 109,298,703	$ (101,490,556)
Ending Balance, Shares at Mar. 31, 2021	32,371,954	32,371,954

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

+ References + Details

Condensed Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Operating activities
Net loss	$ (2,605,495)	$ (1,790,309)
Adjustments to reconcile net loss to net cash used in operating activities:
Forgiveness of paycheck protection loan and accrued interest	(104,168)
Stock-based compensation expense	561,348	310,162
Change in operating assets and liabilities:
Accounts receivable, net	(104,484)
Prepaid expenses, inventory and other assets	359,617	227,089
Accounts payable and other current liabilities	(604,126)	(140,941)
Accrued compensation	(587,438)	(157,896)
Accrued interest expense	122,589
Deferred rent expense	9,038
Net cash used in operating activities	(2,953,119)	(1,551,895)
Financing activities
Proceeds from issuance of common stock, net of cost of $1,304,846	13,070,154
Proceeds from issuance of common stock from employee stock purchase plan		21,250
Net cash provided by financing activities	13,070,154	21,250
Net increase (decrease) in cash and cash equivalents	10,117,035	(1,530,645)
Cash and cash equivalents at beginning of period	8,068,939	5,663,833
Cash and cash equivalents at end of period	18,185,974	$ 4,133,188
Non-cash financing activities
Forgiveness of paycheck protection loan and accrued interest	$ 104,168

Condensed Statements of Cash Flows (Unaudited)(Parenthetical)	3 Months Ended
	Mar. 31, 2021 USD ($)
Statement Of Cash Flows [Abstract]
Total costs incurred from issuance of common stock	$ 1,304,846

Organization and Basis of Presentation

3 Months Ended

Mar. 31, 2021

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. As discussed in Note 5, 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 March 31, 2021, the Company had approximately $18.2 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, and selling, general and administrative costs to support operations. As a result, the Company believes that there is substantial doubt about its ability to continue as a going concern for one year after the date these financial statements are issued. The financial statements do not include any adjustments that may result from the outcome of this uncertainty.

The 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 cash and cash equivalents as of March 31, 2021 will be sufficient to fund its operations into the first quarter of 2022, less than one year after the date these financial statements are issued, excluding any future Gimoti revenue. This period could be shortened if there are any significant increases in planned spending other than anticipated. 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 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.

Impact of COVID-19

Despite the COVID-19 pandemic, the Company began its commercial sales of Gimoti with Eversana in October 2020. The Company has experienced various disruptions to its sales activities, but has continued its efforts to reach physicians and customers. For example, Eversana’s commercialization efforts have been 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 has been restricted from conducting in-person interactions with certain physicians and customers and has been restricted to conducting Gimoti educational and promotional activities virtually in certain circumstances, which has impacted Eversana’s ability to more actively market Gimoti. Third-party research stated that as a result of COVID-19, fewer patients are visiting physician offices resulting in lower patient volumes than normal. The Company anticipates that it and Eversana will continue to be impacted by the COVID-19 pandemic.

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, the 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 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 was enacted in response to the COVID-19 pandemic. 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.

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2021

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

The accompanying condensed balance sheet as of December 31, 2020, 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, 2020, which are contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 11, 2021. The results for interim periods are not necessarily indicative of the results expected for the full fiscal year or any other interim period.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates.

Contract Research Organizations and Consultants

The Company relies on contract research organizations (“CROs”) and consultants to assist with ongoing regulatory 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 is 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 March 31, 2021 and December 31, 2020 and no bad debt expense was recorded for the three months ended March 31, 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.

Prior to FDA approval of Gimoti in June 2020, the cost of materials and expenses associated with the manufacturing of Gimoti were recorded as research and development expense. Subsequent to FDA approval, the Company began manufacturing Gimoti for commercialization and began capitalizing inventory. The Company’s inventory consisted of approximately $151,000 of raw materials and approximately $85,000 of finished goods at March 31, 2021 and December 31, 2020. Inventories are stated at the lower of cost (first-in first-out basis) or net realizable value. Inventory when written down to net realizable value establishes a new cost basis and its value is not 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 finished goods inventory is held at its contract 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 launch Gimoti and grow and maintain sales, 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, the Company recognizes revenue when a customer obtains control of promised goods in an amount that reflects the consideration the Company expects to receive in exchange for the goods provided. Customer control is determined upon the customer’s physical receipt of the product. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: identify the contracts with the customer; identify the performance obligations in the contract; determine the transaction price; allocate the transaction price to the performance obligations in the contract; and recognize revenue when (or as) it satisfies a performance obligation. At contract inception, the Company assesses the goods promised within each contract and determines those that are performance obligations and assesses whether each promised good is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the customer obtains control of the product.

Product sales are recorded at the transaction price, which includes 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 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 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 on June 19, 2020. The Company will expense the clinical, regulatory and manufacturing costs related to the post-marketing commitment to conduct a single dose pharmacokinetics (“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 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 March 31,
	2021		2020
Warrants to purchase common stock		1,841,879		2,713,561
Common stock options		5,392,259		3,989,371
Employee stock purchase plan	—			24,714
Total excluded securities		7,234,138		6,727,646

Technology Acquisition Agreement

3 Months Ended

Mar. 31, 2021

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 2030, subject to possible extension should any additional, later expiring, licensed patents be granted.

Stockholders' Equity

3 Months Ended

Mar. 31, 2021

Equity [Abstract]

Stockholders' Equity

4. Stockholders’ Equity

Sale of Common Stock in Public Offering

In January 2021, the Company completed the sale of 5,750,000 shares of its common stock in an underwritten public offering. The price to the public in this offering was $2.50 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 statement 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”). During the three months ended March 31, 2021 and 2020, there were no shares sold under the FBR Sales Agreement. Effective January 6, 2021, the Company terminated the FBR Sales Agreement.

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 replacement shelf registration statement, including the base prospectus filed as part of such registration statement. During the three months ended March 31, 2021, there were no shares sold under the ATM Sales Agreement.

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.

Stock-Based Compensation

During the three months ended March 31, 2021 and 2020, the Company granted stock options to purchase 1,315,000 and 875,000 shares of the Company’s common stock, respectively. Of the options granted in 2020, 50% did not begin vesting until June 19, 2020, 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 three months ended March 31, 2021 and 2020:

	Three Months Ended March 31,
	2021	2020
Common Stock Options
Risk free interest rate	0.57%	0.96%
Expected option term	6.0 years	6.0 years
Expected volatility of common stock	103.45%	99.73%
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 months ended March 31, 2020:

		Three Months Ended March 31,
		2020
Employee Stock Purchase Plan
Risk free interest rate		1.11%
Expected term		6.0 months
Expected volatility of common stock		69.72%
Expected dividend yield		0.0%

There were no employee withholdings to purchase shares during the six-month purchase period beginning March 1, 2021.

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 months ended March 31, 2021 and 2020 as follows:

	Three Months Ended March 31,
	2021		2020
Research and development	$	68,380	$	120,562
Selling, general and administrative		492,968		189,600
Total stock-based compensation expense	$	561,348	$	310,162

As of March 31, 2021, there was approximately $4.3 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 1.59 years.

Commercial Services and Loan Agreements with Eversana

3 Months Ended

Mar. 31, 2021

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 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. As of March 31, 2021, unreimbursed commercialization costs to Eversana were approximately $13.1 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.

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; if the cumulative net product profits fail to reach certain thresholds in the first three years 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. 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 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 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 June 2020 the Company borrowed $2 million and in December 2020 it borrowed the remaining $3 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 Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2021

Accounting Policies [Abstract]

Use of Estimates

Contract Research Organizations and Consultants

Accounts Receivable

Inventory

Revenue Recognition

Liabilities for co-pay assistance are classified as accounts payable and accrued expenses in the balance sheets.

Stock-Based Compensation

Research and Development Expenses

Net Loss Per Share

	Three Months Ended March 31,
	2021		2020
Warrants to purchase common stock		1,841,879		2,713,561
Common stock options		5,392,259		3,989,371
Employee stock purchase plan	—			24,714
Total excluded securities		7,234,138		6,727,646

- Definition

Disclosure of inventory accounting policy for inventory classes, including, but not limited to, basis for determining inventory amounts, methods by which amounts are added and removed from inventory classes, loss recognition on impairment of inventories, and situations in which inventories are stated above cost.

+ References + Details

Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2021

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 March 31,
	2021		2020
Warrants to purchase common stock		1,841,879		2,713,561
Common stock options		5,392,259		3,989,371
Employee stock purchase plan	—			24,714
Total excluded securities		7,234,138		6,727,646

Stockholders' Equity (Tables)

3 Months Ended

Mar. 31, 2021

Equity [Abstract]

Summary of Estimated Fair Value of Stock Option Award

	Three Months Ended March 31,
	2021	2020
Common Stock Options
Risk free interest rate	0.57%	0.96%
Expected option term	6.0 years	6.0 years
Expected volatility of common stock	103.45%	99.73%
Expected dividend yield	0.0%	0.0%

Summary of Estimated Fair Value of Shares to be Acquired under Employee Stock Purchase Plan

		Three Months Ended March 31,
		2020
Employee Stock Purchase Plan
Risk free interest rate		1.11%
Expected term		6.0 months
Expected volatility of common stock		69.72%
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 March 1, 2021.

	Three Months Ended March 31,
	2021		2020
Research and development	$	68,380	$	120,562
Selling, general and administrative		492,968		189,600
Total stock-based compensation expense	$	561,348	$	310,162

Organization and Basis of Presentation - Additional Information (Detail) - USD ($)		3 Months Ended
	May 01, 2020	Mar. 31, 2021	Dec. 31, 2020	Mar. 31, 2020	Dec. 31, 2019
Organization And Basis Of Presentation [Line Items]
Month and year of incorporation		2007-01
Cash and cash equivalents		$ 18,185,974	$ 8,068,939	$ 4,133,188	$ 5,663,833
Paycheck Protection Program [Member] \| COVID-19 [Member]
Organization And Basis Of Presentation [Line Items]
Proceeds from loan	$ 104,000

Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2021	Dec. 31, 2020
Accounting Policies [Abstract]
Allowance for doubtful accounts receivable	$ 0	$ 0
Bad debt expense	0
Inventory raw materials	151,000	151,000
Inventory finished goods	$ 85,000	$ 85,000

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
	Mar. 31, 2021	Mar. 31, 2020
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Anti-dilutive securities excluded from the calculation of diluted net loss per share	7,234,138	6,727,646
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
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	5,392,259	3,989,371
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		24,714

Technology Acquisition Agreement - Additional Information (Detail)	1 Months Ended		3 Months Ended
	May 31, 2014 USD ($)	Jun. 30, 2007 USD ($)	Mar. 31, 2021 USD ($) Milestone
Technology Acquisition Agreement [Line Items]
Payment expensed as in-process research and development		$ 650,000
Mallinckrodt Plc [Member]
Technology Acquisition Agreement [Line Items]
Milestone payments contingent amount			$ 5,000,000
Number of milestone payments \| Milestone			1
Mallinckrodt Plc [Member] \| Rights and Patents Acquired from Questcor Pharmaceuticals Inc [Member] \| Maximum [Member]
Technology Acquisition Agreement [Line Items]
Milestone payments contingent amount			$ 52,000,000
Gimoti [Member] \| Mallinckrodt Plc [Member]
Technology Acquisition Agreement [Line Items]
Borrowing due date			Jun. 19, 2021
Research and development expense payable			$ 5,000,000
Amount payable to Mallinckro dt			$ 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 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			2030

Stockholders' Equity - Common Stock - Additional Information (Detail) - USD ($)	1 Months Ended	3 Months Ended		12 Months Ended
	Jan. 31, 2021	Mar. 31, 2021	Mar. 31, 2020	Dec. 31, 2020	Nov. 30, 2017
Sale Of Common Stock [Line Items]
Common stock, shares issued		32,371,954		26,621,954
Proceeds from issuance of common stock, net of cost of $1,304,846		$ 13,070,154
Common stock, value of shares issuable					$ 16,000,000
Proceeds from issuance of common stock, net		$ 13,070,154
Options Granted [Member]
Sale Of Common Stock [Line Items]
Number of stock options granted		1,315,000	875,000
Options Granted [Member] \| Gimoti [Member]
Sale Of Common Stock [Line Items]
Percentage of options began vesting			50.00%
Public Offering [Member]
Sale Of Common Stock [Line Items]
Common stock, shares issued	5,750,000
Shares issued, price per share	$ 2.50
Proceeds from issuance of common stock, net of cost of $1,304,846	$ 14,400,000
Proceeds from issuance of common stock net of underwriting discounts and commissions and offering expenses	13,100,000
Proceeds from issuance of common stock, net	$ 14,400,000
FBR Sales Agreement [Member]
Sale Of Common Stock [Line Items]
Common stock, shares issued			0
FBR Sales Agreement [Member] \| Maximum [Member]
Sale Of Common Stock [Line Items]
Proceeds from issuance of common stock, net of cost of $1,304,846				$ 30,000,000
Proceeds from issuance of common stock, net				$ 30,000,000
At The Market Offerings
Sale Of Common Stock [Line Items]
Common stock, shares issued		0

Stockholders' Equity - Summary of Estimated Fair Value of Stock Option Award (Detail) - Common stock options [Member]	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Risk free interest rate	0.57%	0.96%
Expected option term	6 years	6 years
Expected volatility of common stock	103.45%	99.73%
Expected dividend yield	0.00%	0.00%

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
	Mar. 31, 2020
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Risk free interest rate	1.11%
Expected term	6 months
Expected volatility of common stock	69.72%
Expected dividend yield	0.00%

Stockholders' Equity - Summary of Recognized Stock-Based Compensation Expense (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	$ 561,348	$ 310,162
Research and development [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	68,380	120,562
Selling, general and administrative [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	$ 492,968	$ 189,600

Stockholders' Equity - Stock-Based Compensation - Additional Information (Detail) $ in Millions	3 Months Ended
	Mar. 31, 2021 USD ($)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Unrecognized compensation costs	$ 4.3
Weighted average period	1 year 7 months 2 days

Commercial Services and Loan Agreements with Eversana - Additional Information (Detail) - Eversana Agreement [Member] - USD ($)	Jan. 21, 2020	Mar. 31, 2021	Dec. 31, 2020	Jun. 30, 2020
Commercial Services And Loan Agreements [Line Items]
Unreimbursed commercialization cost		$ 13,100,000
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			$ 3,000,000	$ 2,000,000
Gimoti [Member] \| Minimum [Member]
Commercial Services And Loan Agreements [Line Items]
Percentage Of Product Profits	80.00%