Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit ~~and post~~ such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer, ” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange ~~Age.~~Act. ☒☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November ~~3, 2017,~~2, 2020, the registrant had ~~15,413,610~~26,390,246 shares of common stock outstanding.

	September 30, 2017			December 31, 2016			September 30, 2020			December 31, 2019
	(Unaudited)						(Unaudited)
Assets
Current Assets:
Cash and cash equivalents	$	10,412,968		$	9,007,071		$	6,280,656		$	5,663,833
Prepaid expenses		334,728			267,711			336,432			581,706
Inventory								86,145		—
Other current assets	—				7,997			11,551		—
Total current assets		10,747,696			9,282,779			6,714,784			6,245,539
Operating lease right-of-use asset								36,115			138,538
Other assets		11,551			11,551		—				11,551
Total assets	$	10,759,247		$	9,294,330		$	6,750,899		$	6,395,628

Liabilities and stockholders' equity
Current Liabilities:
Accounts payable and accrued expenses	$	1,720,816		$	478,223		$	765,603		$	1,033,383
Accrued compensation		927,843			933,450			715,423			843,162
Operating lease liability								36,115			138,538
Paycheck protection program loan								104,168		—
Milestone payable								5,000,000		—
Total current liabilities		2,648,659			1,411,673			6,621,309			2,015,083
Warrant liability		6,050,901			4,095,019

Long-term Liabilities:
Note payable								2,000,000		—
Accrued interest payable								53,005		—
Total long-term liabilities								2,053,005		—

Total liabilities		8,699,560			5,506,692			8,674,314			2,015,083


Stockholders' equity:
Common stock, $0.0001 par value; authorized shares - 50,000,000; issued and outstanding shares - 15,413,610 and 12,350,360 at September 30, 2017 and December 31, 2016, respectively		1,541			1,235
Common stock, $0.0001 par value; authorized shares - 50,000,000; issued and outstanding shares - 26,332,122 and 24,431,914 at September 30, 2020 and December 31, 2019, respectively								2,633			2,443
Additional paid-in capital		72,788,358			62,595,546			94,691,151			90,108,492
Accumulated deficit		(70,730,212	)		(58,809,143	)		(96,617,199	)		(85,730,390	)
Total stockholders' equity		2,059,687			3,787,638
Total liabilities and stockholders' equity	$	10,759,247		$	9,294,330
Total stockholders' (deficit) equity								(1,923,415	)		4,380,545
Total liabilities and stockholders' (deficit) equity							$	6,750,899		$	6,395,628

Three Months Ended
September 30,

Nine Months Ended
September 30,

2017

2016

2017

2016

Operating expenses:

Research and development

$
2,717,698

$
1,339,343

$
5,505,953

$
5,449,568

General and administrative

984,047

830,092

3,065,595

2,770,500

Total operating expenses

3,701,745

2,169,435

8,571,548

8,220,068

Loss from operations

(3,701,745
)

(2,169,435
)

(8,571,548
)

(8,220,068
)
Other income (expense):

   Interest income (expense), net

2,822

(123,209
)

5,452

(268,483
)
   Financing costs related to warrant liability

—

(533,692
)

—

(533,692
)
   Change in fair value of warrant liability

(1,544,138
)

(198,945
)

(3,354,973
)

(198,945
)
Total other expense, net

(1,541,316
)

(855,846
)

(3,349,521
)

(1,001,120
)
Net loss

$
(5,243,061
)

$
(3,025,281
)

$
(11,921,069
)

$
(9,221,188
)

Net loss per share of common stock, basic

$
(0.34
)

$
(0.29
)

$
(0.81
)

$
(1.11
)

Net loss per share of common stock, diluted

$
(0.34
)

$
(0.29
)

$
(0.89
)

$
(1.11
)
Weighted-average shares used to compute basic
net loss per share

15,351,295

10,614,692

14,740,977

8,341,750

Weighted-average shares used to compute diluted net loss per share

15,351,295

10,614,692

14,766,853

8,341,750

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Operating expenses:
Research and development	$	205,032		$	822,444		$	6,450,979		$	2,774,924
General and administrative		1,874,578			814,218			4,387,284			2,955,371
Total operating expenses		2,079,610			1,636,662			10,838,263			5,730,295
Loss from operations		(2,079,610	)		(1,636,662	)		(10,838,263	)		(5,730,295	)
Other income (expense):
Interest income		1,033			8,597			4,896			22,868
Interest expense		(50,528	)	—				(53,442	)	—
Total other income (expense)		(49,495	)		8,597			(48,546	)		22,868
Net loss	$	(2,129,105	)	$	(1,628,065	)	$	(10,886,809	)	$	(5,707,427	)

Net loss per share of common stock, basic and diluted	$	(0.08	)	$	(0.07	)	$	(0.43	)	$	(0.26	)

Weighted-average shares used to compute basic and diluted net loss per share		26,146,220			24,128,060			25,191,359			21,623,648


					Additional						Total
	Common Stock				Paid-In			Accumulated			Stockholders'
	Shares		Amount		Capital			Deficit			(Deficit) Equity
Balance at January 1, 2020		24,431,914	$	2,443	$	90,108,492		$	(85,730,390	)	$	4,380,545
Stock-based compensation expense		—		—		310,162			—			310,162
Issuance of common stock from employee stock purchase plan		25,000		3		21,247			—			21,250
Net loss		—		—		—			(1,790,309	)		(1,790,309	)
Balance at March 31, 2020		24,456,914		2,446		90,439,901			(87,520,699	)		2,921,648
Stock-based compensation expense		—		—		362,955			—			362,955
Issuance of common stock from At-The-Market offering, net		1,395,855		140		3,308,976			—			3,309,116
Issuance of common stock from warrant exercises		158,494		15		(15	)		—			—
Net loss		—		—		—			(6,967,395	)		(6,967,395	)
Balance at June 30, 2020		26,011,263		2,601		94,111,817			(94,488,094	)		(373,676	)
Stock-based compensation expense	—		—			478,574		—				478,574
Issuance of common stock from employee stock purchase plan		93,491		9		98,156		—				98,165
Issuance of common stock from warrant exercises		223,131		22		(22	)	—			—
Issuance of common stock from stock option exercise		4,237		1		2,626		—				2,627
Net loss	—		—		—				(2,129,105	)		(2,129,105	)
Balance at September 30, 2020		26,332,122	$	2,633	$	94,691,151		$	(96,617,199	)	$	(1,923,415	)


					Additional						Total
	Common Stock				Paid-In			Accumulated			Stockholders'
	Shares		Amount		Capital			Deficit			Equity
Balance at January 1, 2019		17,427,533	$	1,743	$	82,628,312		$	(78,604,735	)	$	4,025,320
Stock-based compensation expense		—		—		378,959			—			378,959
Issuance of common stock, net		450,000		45		636,387			—			636,432
Net loss		—		—		—			(1,965,266	)		(1,965,266	)
Balance at March 31, 2019		17,877,533		1,788		83,643,658			(80,570,001	)		3,075,445
Stock-based compensation expense		—		—		344,841			—			344,841
Issuance of common stock, net		6,236,423		623		5,039,333			—			5,039,956
Net loss		—		—		—			(2,114,096	)		(2,114,096	)
Balance at June 30, 2019		24,113,956		2,411		89,027,832			(82,684,097	)		6,346,146
Stock-based compensation expense		—		—		331,303			—			331,303
Issuance of common stock, net		117,958		12		123,801			—			123,813
Net loss		—		—		—			(1,628,065	)		(1,628,065	)
Balance at September 30, 2019		24,231,914	$	2,423	$	89,482,936		$	(84,312,162	)	$	5,173,197

	Nine Months Ended September 30,
	2017			2016
							Nine Months Ended September 30,
							2020			2019
Operating activities
Net loss	$	(11,921,069	)	$	(9,221,188	)	$	(10,886,809	)	$	(5,707,427	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		1,404,926			1,298,279			1,151,691			1,055,103
Non-cash interest	—				120,889
Financing costs allocated to warrant liability	—				533,692
Change in fair value of warrant liability		3,354,973			198,945
Milestone expense								5,000,000		—
Accrued interest								53,442		—
Change in operating assets and liabilities:
Prepaid expenses and other assets		(59,020	)		408,030			261,552			(345,975	)
Accounts payable and accrued expenses		1,236,986			(676,745	)
Accounts payable and other current liabilities								(498,379	)		383,896
Net cash used in operating activities		(5,983,204	)		(7,338,098	)		(4,918,503	)		(4,614,403	)

Financing activities
Payment of bank loan	—				(4,500,000	)
Proceeds from issuance of common stock, net		7,389,101			358,023			3,309,116			5,800,201
Proceeds from issuance of common stock and warrants, net	—				13,168,802
Proceeds from issuance of common stock from employee stock purchase plan								119,415		—
Proceeds from issuance of common stock from stock option exercised								2,627		—
Proceeds from paycheck protection program								104,168		—
Proceeds from Eversana line of credit								2,000,000		—
Net cash provided by financing activities		7,389,101			9,026,825			5,535,326			5,800,201
Net increase in cash and cash equivalents		1,405,897			1,688,727			616,823			1,185,798
Cash and cash equivalents at beginning of period		9,007,071			8,691,155			5,663,833			5,319,004
Cash and cash equivalents at end of period	$	10,412,968		$	10,379,882		$	6,280,656		$	6,504,802

Supplemental disclosure of cash flow information
Interest paid	—			$	169,813

Non-cash financing activities
Fair value of warrants issued to placement agent	—			$	369,863

Evoke Pharma, Inc. (the “Company”) was incorporated in the state of Delaware in January 2007. The Company is a ~~publicly-held~~ 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 ~~substantially all of~~ its efforts to developing its sole product, ~~development, raising capital~~Gimoti™ (metoclopramide) nasal spray, the first and ~~building infrastructure,~~only nasally-administered product indicated for the relief of symptoms in adults with acute and ~~has not realized revenues~~recurrent diabetic gastroparesis. On June 19, 2020, the Company received approval from the U.S. Food and Drug Administration (“FDA”) for its ~~planned principal operations.~~505(b)(2) New Drug Application (“NDA”) for Gimoti. The Company ~~does not anticipate realizing revenues for the foreseeable future.~~ 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 ~~substantial expenditures~~launched its first commercial product, including market acceptance of the product and the potential need to obtain additional funding for ~~research and development, including funding~~ its operations.

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 ~~its sole product, Gimoti™. The~~Gimoti. Although the Company ~~ended the third quarter of 2017 with~~had approximately ~~$10.4~~$6.3 million in cash and cash equivalents ~~and~~at September 30, 2020, the Company anticipates that it will continue to incur losses from operations due to its plans to fund additional clinical development, including the analysis of data from the comparative exposure pharmacokinetic (“PK”) clinical trial, completion of a planned new drug application (“NDA”) submission for Gimoti, pre-approval and pre-commercializationcommercialization activities, including ~~marketing and~~ manufacturing commercial batches of Gimoti, and ~~support its~~ 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 financial statements are issued.~~

The determination as to whether the Company can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. ~~In its report on~~As a result, the ~~Company’s financial statements for the year ended December 31, 2016, the Company’s independent registered public accounting firm included an explanatory paragraph expressing~~Company believes that there is substantial doubt ~~regarding the Company’s~~about its ability to continue as a going concern ~~which contemplates~~for one year after the ~~realization~~date these financial statements are issued. The financial statements do not include any adjustments that may result from the outcome of ~~assets and the satisfaction of liabilities in the normal course of business.~~ 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 ~~current~~existing cash and cash equivalents will be sufficient to ~~meet estimated working capital requirements~~fund its operations into the second quarter of 2021, excluding any potential additional borrowings from the revolving credit facility with Eversana (the “Eversana Credit Facility”), as discussed in Note 5, and ~~fund operations through at least June 2018. The~~future Gimoti product revenue. This period could be shortened if there are any unanticipated increases in planned spending. Even with the remaining amount available under the Eversana Credit Facility and future Gimoti product revenue, the Company ~~will need~~may be required to raise additional funds through debt, equity or ~~equity~~other forms of financing, such as potential collaboration arrangements, to fund future ~~operations.~~ operations and continue as a going concern.

There can be no assurance that additional financing will be available when needed or on acceptable terms. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, and/or suspend or curtail ~~planned programs.~~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.

The Company relies on contract research organizations (“CROs”) and consultants to assist with ongoing regulatory discussions and submissions to FDA. If these CROs and consultants are unable to continue their support, this could adversely affect the operations of the Company.

In addition, the Company relies on third-party suppliers and manufacturer for the production of Gimoti. If the third-party manufacturers are unable to continue manufacturing Gimoti, or if the Company loses one of its sole source suppliers used in its manufacturing processes, the Company may not be able to meet commercial supply demand for Gimoti and the commercialization of Gimoti could be materially and adversely affected.

The Company also relies on Eversana for the management of the commercialization of Gimoti, distribution services and a dedicated sales team to sell Gimoti. If Eversana is unable to continue serving as a dedicated sales team or distributing Gimoti, the commercialization of Gimoti could be materially and adversely affected.

To date, the Company has not experienced material disruptions to its financial condition or operations from the novel coronavirus disease (“COVID-19”) pandemic. The Company has begun its commercial activities, including commercial manufacturing, and with Eversana, the commercial sales of Gimoti. However, there can be no assurance that the Company or Eversana will not be impacted by the COVID-19 pandemic. For example, Eversana’s commercialization efforts may be adversely affected by operational restrictions imposed on its sales force from quarantines, travel restrictions and bans and other governmental restrictions related to COVID-19. As a result of these restrictions, their sales force may not be able to conduct in-person interactions with physicians and customers and may be restricted to conducting educational and promotional activities for Gimoti virtually, which may impact Eversana’s ability to market Gimoti. In addition, the COVID-19 pandemic may disrupt the operations of the Company’s third-party suppliers and manufacturers and delay the Company’s manufacturing timelines of Gimoti, which may negatively impact the Company’s ability to successfully commercialize Gimoti and generate product sales. Further, 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 business and financial condition, including impairing its ability to raise capital when needed. In April 2020, the Company applied for and was approved for a Small Business Administration (“SBA”) loan under the Paycheck Protection Program (“PPP”), established by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. On May 1, 2020, the Company received the loan proceeds of approximately $104,000. Processes are being developed for companies to submit for loan forgiveness and the Company plans to submit for loan forgiveness when such processes are finalized.

The accompanying condensed balance sheet as of December 31, ~~2016,~~2019, which has been derived from audited financial statements, and the unaudited interim condensed financial statements, have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and follow the requirements of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In management’s opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position and its results of operations and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the year ended December 31, ~~2016,~~2019, which are contained in the Company’s Annual Report on Form 10-K filed with the SEC on March ~~15, 2017.~~12, 2020. The results for interim periods are not necessarily indicative of the results expected for the full fiscal year or any other interim period.

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.

~~The Company also relies on contract research organizations (“CROs”)~~Inventory

Subsequent to ~~manage the analysis~~FDA approval of data from the comparative exposure PK trial and the preparation of the planned NDA. If these CROs are unable to continue with this analysis and the management of the NDA preparation, the delays could adversely affect the completion and the timing of the filing of the NDA with FDA.

~~In addition,~~Gimoti in June 2020, the Company ~~relies on third-party manufacturers~~began a manufacturing process for the production of ~~its drug candidate. If~~Gimoti for sale and began capitalizing inventory. As the ~~third-party manufacturers are unable to continue~~ manufacturing process was not completed until October 2020, the ~~Company’s drug candidate, or if~~inventory was classified as work-in-process at September 30, 2020. Following the ~~Company loses one of its sole source suppliers used in its manufacturing processes, the Company may not be able to meet commercial supply demand for its product candidate, if approved by the FDA,~~completion and ~~the development~~release of the product ~~candidate could be materially and adversely affected.~~

~~Certain of the warrants to purchase shares of~~by the Company’s ~~common stock, issued as~~manufacturer in October 2020, inventory is being stated at the lower of cost or net realizable value and recognized on a part of the at-the-market registered direct offerings in July and August 2016, are classified as warrant liability and recorded at fair value. These warrants contain a feature that could require the transfer of cash in the event a change of control occurs without the authorization of our Board of Directors, and therefore, are classified as a liability in accordancefirst-in, first-out method. Prior to FDA approval, expenses associated with the ~~Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480.~~ manufacturing of Gimoti were recorded as research and development expense.

The fair value of each warrant is estimated on the date of issuance, and each subsequent balance sheet date, using the Black-Scholes valuation model using the appropriate risk-free interest rate, expected term and volatility assumptions. The expected life of the warrant was calculated using the remaining life of the warrant. Due to the Company’s limited historical data as a public company, the estimated volatility is 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 risk-free rate is based upon U.S. Treasury securities with remaining terms similar to the expected term of the stock award being valued.

~~This warrant liability is subject to remeasurement at each balance sheet date and the Company recognizes any change in the fair value of the warrant liability in the statement of operations.~~ The Company will ~~continue~~analyze its inventory levels on a periodic basis to ~~adjust the carrying value~~determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments will be recognized through cost of ~~the warrants for changes~~sales in the estimated fair value until the earlier of the modification, exercise or expiration of the warrants. At that time, the liabilities will be reclassified to additional paid-in capital, a component of stockholders’ equity. We anticipate that the value of the warrants could fluctuate from quarter to quarter and that such fluctuation could have a material impact on our financial statements.period in which they are incurred.

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.~~period, except awards with a performance condition. Awards with performance conditions commence vesting when the satisfaction of the performance condition is probable. The estimation of stock option and ESPP fair value requires management to make estimates and judgments about, among other things, employee exercise behavior, forfeiture rates and volatility of the Company’s common stock. The judgments directly affect the amount of compensation expense that will be recognized.

The Company grants stock options to purchase common stock to employees and members of the board of directors with exercise prices equal to the Company’s closing market price on the date the stock options are granted. The risk-free interest rate assumption was based

on the yield of an applicable rate for U.S. Treasury instruments with maturities similar to those of the expected term of the award being valued. The ~~weighted average~~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 costs are expensed as incurred and primarily include compensation and related benefits, stock-based compensation expense, ~~and~~ costs paid to third-party contractors ~~to perform research, conduct clinical trials~~for product development activities and ~~develop~~ drug product materials and ~~delivery devices.~~technology acquisition milestones. The Company ~~expenses~~has expensed costs relating to the purchase and production of pre-approval inventories as research and development expense in the period incurred ~~until~~prior to FDA approval ~~is received.~~

~~The Company bases its expense accruals related to clinical studies on estimates of the services~~ received ~~and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical studies on its behalf. The financial terms~~

of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors, such as the successful enrollment of patients, site initiation and the completion of clinical study milestones. Service providers typically invoice the Company monthly in arrears for services performed. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the Company does not identify costs that have begun to be incurred, or if the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ materially from estimates. To date, the Company has not experienced significant changes in estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, no assurance can be made that changes to the estimates will not be made in the future as the Company becomes aware of additional information about the status or conduct of clinical studies and other research activities.

Included in research and development expenses for the three and nine months ended September 30, 2017 were costs of approximately $8,000 and $19,000, respectively, for clinical trial services incurred by a related party of one of the Company’s officers. There were no related party costs incurred during the nine months ended September 30, 2016.June 19, 2020.

The Company does not own or operate manufacturing facilities for the production of Gimoti, nor does it plan to develop its own manufacturing operations in the foreseeable future. The Company ~~currently depends~~depended on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its ~~preclinical research,~~pre-commercial product development, and ~~clinical trials.~~will continue to depend on such third-party manufacturers for its commercial manufacturing. The Company has agreements with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, and with Thermo Fisher Scientific Inc., ~~who recently acquired~~through its subsidiary Patheon UK Limited, for ~~product development and~~the manufacturing of Gimoti. The Company currently utilizes a third-party ~~consultant,~~consultants, which it engages on an as-needed, hourly basis, to manage product development and manufacturing contractors.

Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common stock outstanding for the period, without consideration for common stock equivalents and adjusted for the weighted-average number of common stock outstanding that are subject to repurchase. The Company has excluded 45,000 shares of common stock subject to repurchase from the weighted-average number of common stock outstanding for the three and nine months ended September 30, 2017 and 2016.equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common ~~stock~~share equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of ~~shares subject~~warrants to ~~repurchase, warrants for the~~ purchase of common stock, options ~~outstanding~~to purchase common stock under the Company’s equity incentive plans and potential shares to be purchased under the ESPP. For the periods presented, the following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive:

	Three Months Ended September 30,				Nine Months Ended September 30,				Three Months Ended September 30,				Nine Months Ended September 30,
	2017		2016		2017		2016		2020		2019		2020		2019
Common stock subject to repurchase		45,000		45,000		45,000		45,000
Warrants to purchase common stock		2,797,561		3,323,876		2,771,685		3,323,876		1,841,879		2,713,561		1,841,879		2,713,561
Common stock options		2,131,624		1,275,624		2,131,624		1,275,624		4,273,065		3,114,371		4,273,065		3,114,371
Employee stock purchase plan		7,064		10,938		7,064		10,938		4,716		7,294		4,716		7,294
Total excluded securities		4,981,249		4,655,438		4,955,373		4,655,438		6,119,660		5,835,226		6,119,660		5,835,226

For the three and nine months ended September 30, 2017, dilutive shares of 0 and 25,876, respectively, related to the outstanding warrants were included in the diluted net loss per share of common stock calculation.

~~In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02,~~ ~~Leases~~. The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact of its pending adoption of the new standard on the Company’s financial statements.

~~In March 2016, the FASB issued ASU No. 2016-09~~ ~~Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting~~. This guidance changes the accounting for certain aspects of share-based payments to employees. The guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid-in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting. In addition, the guidance allows for a policy election to account for forfeitures as they occur rather than on an estimated basis. The adoption of this guidance on January 1, 2017 did not have a material impact on the Company’s financial statements.

On August 4, 2016, the Company repaid in full the entire $4.5 million of outstanding principal and interest under the Loan and Security Agreement (the “Loan Agreement”) between the Company and Square 1 Bank (“Square 1”). In connection with such repayment, the Loan Agreement was terminated, and all security, liens or other encumbrances on assets of the Company were released.

The Company incurred $82,685 of loan origination costs related to this credit facility. The remaining unamortized costs of approximately $38,000 were charged to interest expense upon the payment of the loan in August 2016.

In connection with the funding of the term loan, the Company issued to Square 1 a warrant to purchase 22,881 shares of the Company’s common stock at an exercise price of $5.90 per share, the closing price of the Company’s common stock on the day of funding of the credit facility. During July 2016, Square 1 converted its warrant by a “cashless” conversion and received 9,887 shares of the Company’s common stock. The value determined for the warrant at the time of the grant of $108,122 was recorded as a debt discount, as well as to stockholders’ equity. The remaining unamortized debt discount associated with the warrant of approximately $59,000 was charged to interest expense upon the payment of the loan in August 2016.

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 ~~$51.5~~$52 million. ~~These milestones include up~~In March 2018, the Company and Mallinckrodt amended the Asset Purchase Agreement to ~~$4.5 million in~~defer development and approval milestone payments, ~~if Gimoti achieves the following development targets:~~

The remaining $47 million in milestone payments depend on Gimoti’s commercial ~~success and will only apply if Gimoti receives regulatory approval. In addition, the~~success. The Company will be required to pay to 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.~~2032, subject to possible extension should any additional, later expiring, patents be granted.

On July 25, 2016, the Company completed a registered direct offering of 1,804,512 shares of common stock at a purchase price of $2.49375 per share (the “July 2016 Financing”). Concurrently in a private placement, for each share of common stock purchased by an investor, such investor received from the Company an unregistered warrant to purchase three-quarters of a share of common stock, for a total of 1,353,384 shares (the “July Warrants”). The July Warrants have an exercise price of $2.41 per share, are immediately exercisable and will expire on January 25, 2022. The aggregate gross proceeds from the sale of the common stock and warrants were $4.5 million, and the net proceeds after deduction of commissions and fees were $4.0 million.

In connection with the July 2016 Financing, the Company issued to its placement agent, Rodman & Renshaw, a unit of H.C. Wainwright & Co. LLC (“Wainwright”), and its designees unregistered warrants to purchase an aggregate of 90,226 shares of the Company’s common stock (the “July Wainwright Warrants”). The July Wainwright Warrants have substantially the same terms as the July Warrants, except that the July Wainwright Warrants will expire on July 21, 2021 and have an exercise price equal to $3.1172 per share of common stock.

On August 3, 2016, the Company completed a registered direct offering of 3,244,120 shares of common stock at a purchase price of $3.0825 per share (the “August 2016 Financing”) and together with the July 2016 Financing (the “2016 Financings”). Concurrently in a private placement, for each share of common stock purchased by an investor, such investor received from the Company an unregistered warrant to purchase one half of a share of common stock, for a total of 1,622,060 shares (the “August Warrants”). The August Warrants have an exercise price of $3.03 per share, are immediately exercisable and will expire on February 3, 2022. The aggregate gross proceeds from the sale of the common stock and warrants were $10 million, and the net proceeds after deduction of commissions and fees was approximately $9.2 million.

In connection with the August 2016 financing, the Company issued to its placement agent, Wainwright, and its designees unregistered warrants to purchase an aggregate of 162,206 shares of the Company’s common stock (the “August Wainwright Warrants”). The August Wainwright Warrants have substantially the same terms as the August Warrants, except that the August Wainwright Warrants will expire on July 29, 2021 and have an exercise price equal to $3.853125 per share of common stock.

The warrants issued in connection with the 2016 Financings had a total initial fair value of $4,899,459 on their respective closing dates as determined using the Black Scholes pricing model and such value was recorded as the initial carrying value of the warrant liability. The fair value of the warrants is remeasured at each financial reporting period with any change in fair value recognized as a change in fair value of the warrant liability in the Statement of Operations.

On December 15, 2016, the Company entered into amendments (the “Warrant Amendments”) with certain of the holders (the “Holders”) of the Company’s outstanding warrants to purchase common stock issued on July 25, 2016 and August 3, 2016. Pursuant to the Warrant Amendments, the Holders’ right to require the Company to purchase the outstanding warrants upon the occurrence of certain fundamental transactions will not apply if the fundamental transaction is a result of a transaction that has not been approved by the Company’s board of directors. As a result of this amendment, warrants to purchase 252,432 shares of the Company’s common stock were no longer required to be classified as liabilities. The value of amended warrants were adjusted to their fair value immediately prior to the amendment and approximately $207,000 was reclassified from warrant liability to Additional Paid-in Capital.

On February 16, 2017, an institutional investor from the Company’s financing which closed in July 2016 converted its warrant to purchase 526,315 shares of our common stock by a “cashless” exercise and received 211,860 shares of the Company’s common stock. The warrant had an exercise price of $2.41 per share. The shares were issued, and the warrants were sold, in reliance upon the registration exemption set forth in Section 4(a)(2) of the Securities Act of 1933, as amended. The value of the exercised warrants were adjusted to their fair value immediately prior to the exercise and approximately $1.4 million was reclassified from warrant liability to Additional Paid-in Capital. Subsequent to this transaction, warrants to purchase 2,449,129 shares of the Company’s common stock remain classified as a liability.

In February and March 2017, the Company completed the sale of 2,775,861 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 $2.90 per share resulting in gross proceeds to the Company of approximately $8.0 million. After deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, the net proceeds to the Company from this offering was approximately $7.3 million.

On April 15, 2016, the Company terminated its At Market Sales Agreement with MLV & Co. LLC and entered into a new At Market Issuance Sales Agreement with B. Riley FBR, Inc. (as successor by merger to FBR Capital Markets & Co., “FBR”) (“FBR Sales Agreement”), and filed a prospectus supplement, pursuant to which the Company may sell from time to time, at its option, up to an aggregate of 649,074 shares of the Company’s common stock through FBR as the sales agent. The sales of shares made through this equity program are made in “at-the-market” offerings as defined in Rule 415 of the Securities Act. Through December 31, 2016, the Company sold 56,000 shares of common stock at a weighted average price per share of $5.45 and received proceeds of approximately $296,000, net of commissions and fees.

~~On March 10,~~In November 2017, the Company filed a ~~prospectus supplement, which replaced~~shelf registration with the ~~prospectus supplement filed on April 15, 2016, permitting the Company to sell up to an aggregate of $20.0 million of shares of its common stock through FBR as a sales agent. Under current~~ SEC ~~regulations, if at the time the Company files its Annual Report~~ on Form 10-K, or Form 10-K, the Company’s public float is less than $75 million, and for so long as its public float remains less than $75 million, the amount the Company can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of the Company’s public float, which is referred to as the baby shelf rules. As of November 3, 2017, the Company’s public float was approximately $49.9 million, based on 12,858,418 shares of outstanding common stock held by non-affiliates and at a price of $3.88 per share, which was the last reported sale price of the Company’s common stock onS-3. The ~~Nasdaq~~

Capital Market on October 11, 2017. As a result of the Company’s public float being below $75 million, the Company will be limited by the baby shelf rules until such time as the Company’s public float exceeds $75 million, which means the Company only has the capacity to sell shares up to one-third of its public float under shelf registration statements in any twelve-month period. The Company had no sales of common stock under the baby shelf rules in the twelve-month period ended November 3, 2017. ~~If the Company’s public float decreases, the amount of securities we may sell under our Form S-3 shelf registration statement will also decrease.~~ ~~The Company has not sold any shares of common stock through the FBR Sales Agreement during 2017.~~

The Company’s current Form S-3 shelf registration statement expires on November 25, 2017. Concurrently with filing this Quarterly Report on Form 10-Q, the Company is filing a new shelf registration statement on Form S-3 which extends the effectiveness of the current shelf registration statement until the earlier of the date the SEC declares the new shelf registration statement effective or 6 months from the expiration date of the current shelf registration statement. The new shelf registration statement includes a prospectus for the at-the-market offering to sell up to an aggregate of $16.0 million of shares of the Company’s common stock through B. Riley FBR, Inc. (“FBR”) as a sales ~~agent. The~~agent (the “FBR Sales Agreement”). During the nine months ended September 30, 2019, the Company ~~remains subject~~sold 6,804,381 shares of common stock at a weighted-average price per share of $0.87 pursuant to the ~~limitations~~FBR Sales Agreement and received proceeds of approximately $5.8 million, net of commissions and fees. During the ~~baby shelf rules described above.~~nine months ended September 30, 2020, the Company sold 1,395,855 shares of common stock at a weighted-average price per share of $2.42 pursuant to the FBR Sales Agreement and received proceeds of approximately $3.3 million, net of commissions and fees.

Future sales will depend on a variety of factors including, but not limited to, market conditions, the trading price of the Company’s common stock and the Company’s capital needs. There can be no assurance that FBR will be successful in consummating future sales based on prevailing market conditions or in the quantities or at the prices that the Company deems appropriate.

In addition, the Company will not be able to make future sales of common stock pursuant to the FBR Sales Agreement unless certain conditions are met, which include the accuracy of representations and warranties made to FBR under the FBR Sales Agreement. Furthermore, FBR is permitted to terminate the FBR Sales Agreement in its sole discretion upon ten days’ notice, or at any time in certain circumstances, including the occurrence of an event that would be reasonably likely to have a material adverse effect on the Company’s assets, business, operations, earnings, properties, condition (financial or otherwise), prospects, stockholders’ equity or results of operations. The Company has no obligation to sell the remaining shares available for sale pursuant to the FBR Sales Agreement.

As a result of payroll withholdings from the Company’s employees of approximately $135,000 and $99,000, the Company sold 75,529 and 34,067 shares of common stock through its Employee Stock Purchase Plan (“ESPP”) duringDuring the nine months ended September 30, ~~2017 and 2016, respectively.~~

~~On May 3, 2017, the Company’s stockholders approved an amendment and restatement~~2020, certain holders of warrants exercised their warrants to purchase 871,682 shares of the Company’s ~~ESPP to increase the number of~~common stock by a “cashless” exercise and received 381,625 shares of the Company’s common ~~stock reserved under~~stock. The warrants had exercise prices ranging from $2.41 to $3.12 per share. The shares were issued, and the ~~ESPP by 100,000 shares (to an aggregate of 1,250,000 shares), to increase~~warrants were originally sold, in reliance upon the ~~annual evergreen provision from 30,000 shares to 100,000 shares, and to extend the term~~registration exemption set forth in Section 4(a)(2) of the ~~ESPP into 2027.~~Securities Act of 1933.

During the nine months ended September 30, 2020, certain holders of stock options exercised their stock options to purchase 4,237 shares of the Company’s common stock. The stock options had exercise prices of $0.62 per share.

Stock-based compensation expense includes charges related to ~~stock option grants under the Company’s 2016 Equity Incentive Award Plan and~~ employee stock purchases under the ~~ESPP.~~ESPP and stock option grants. The Company measures stock-based compensation expense based on the grant date fair value of any awards granted to its employees. Such expense is recognized over the period of time that employees provide service and earn rights to the awards.

During the nine months ended September 30, 2020, the Company granted stock options to purchase 1,172,000 shares of the Company’s common stock. Of such options, 437,500 did not begin vesting until the date that FDA approved the Gimoti NDA. The estimated fair value of each stock option award granted was determined on the date of grant using the Black Scholes option-pricing valuation model with the following weighted-average assumptions for option grants during the ~~three and~~ nine months ended September 30, ~~2017~~2020 and ~~2016:~~2019:

~~There were no stock options granted during the three months ended September 30, 2017 and 2016.~~

The estimated fair value of ~~each~~the shares to be acquired under the ESPP ~~award~~ was determined on the initiation date of ~~grant~~each six-month purchase period using the ~~Black Scholes~~Black-Scholes option-pricing valuation model with the following weighted-average assumptions for ~~option grants~~ESPP shares to be purchased during the three and nine months ended September 30, ~~2017~~2020 and ~~2016:~~2019:

The Company recognized non-cash stock-based compensation expense to employees and directors in its research and development and its general and administrative functions during the three and nine months ended September 30, 2020 and 2019 as follows:

As of September 30, ~~2017,~~2020, there ~~were~~was approximately ~~$2.1~~$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~~weighted-average period of ~~1.2~~1.13 years.

~~6. Fair Value Measurements~~5. Commercial Services and Loan Agreements with Eversana

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

~~As noted in Note 5, during the third quarter of 2016~~On January 21, 2020, the Company entered into ~~the 2016 Financings~~a commercial services agreement (the “Eversana Agreement”) with ~~an institutional investor providing~~Eversana for the ~~issuance~~commercialization of Gimoti. Pursuant to the Eversana Agreement, Eversana will commercialize and ~~sale~~distribute Gimoti in the United States. Eversana will manage the marketing of Gimoti to targeted health care providers, as well as the sales and distribution of Gimoti within the United States.

Under the terms of the Eversana Agreement, the Company maintains ownership of the Gimoti NDA, as well as legal, regulatory, and manufacturing responsibilities for Gimoti. Eversana will utilize its internal sales organization, along with other commercial functions, for market access, marketing, distribution and other related patient support services. The Company will record sales for Gimoti and retain more than 80% of net product profits once the parties’ costs are reimbursed. Eversana will receive reimbursement of its commercialization costs pursuant to an agreed upon budget and a percentage of product profits in the mid-to-high teens. Net product profits are the net sales (as defined in the Eversana Agreement) of Gimoti, less (i) reimbursed commercialization costs, (ii) manufacturing and administrative costs set at a fixed percentage of net sales, and (iii) third party royalties. During the term of the Eversana Agreement, Eversana agreed to not market, promote, or sell a competing product in the United States.

The Eversana Agreement terminates on June 19, 2025, unless terminated earlier pursuant to its terms. Upon expiration or termination of the agreement, the Company will retain all profits from product sales and assume all corresponding commercialization responsibilities. Within 30 days after each of the first three annual anniversaries of commercial launch, either party may terminate the agreement if net sales of Gimoti do not meet certain annual thresholds. Either party may terminate the agreement: for the material breach of the other party, subject to a 60-day cure period; in the event an insolvency, petition of the other party is pending for more than 60 days; upon 30 days written notice to the other party if Gimoti is subject to a safety recall; if the other party is in breach of certain regulatory compliance representations under the agreement; if the Company discontinues the development or production of Gimoti; if the net profit is negative for any two consecutive calendar quarters beginning with the first full calendar quarter 24 months following commercial launch; or if there is a change in applicable laws that makes operation of the services as contemplated under the agreement illegal or commercially impractical. Either party may also terminate the Eversana Agreement upon a change of control of the Company’s ownership, subject, in the event that the Company initiates such termination, to a one-time payment equal to between two times and one times annualized service fees paid by the Company under the Eversana Agreement, with such amount based on which year after commercial launch the change of ~~5,048,632 shares~~control occurs. Such payment amount would be reduced by the amount of previously reimbursed commercialization costs and profit split paid for the related prior twelve-month period and any revenue which occurred prior to the termination yet to be collected. In addition, Eversana may terminate the Eversana Agreement if the Company withdraws Gimoti from the market for more than 90 days.

In connection with the Eversana Agreement, the Company and Eversana also entered into the Eversana Credit Facility, pursuant to which Eversana agreed to provide a revolving Credit Facility of up to $5 million to the Company upon FDA approval of the Gimoti NDA, as well as certain other customary conditions. The Eversana Credit Facility terminates on June 19, 2025, unless terminated

earlier pursuant to its terms. The Eversana Credit Facility is secured by all of the Company’s ~~common stock and warrants to purchase up to 2,975,444 shares~~personal property other than its intellectual property. Under the terms of the ~~Company’s common stock for aggregate gross proceeds of $14.5 million. In addition, as partial payment for services,~~Eversana Credit Facility, the Company ~~issued~~cannot grant an interest in its intellectual property to any other person. Each loan under the ~~underwriters warrants~~Eversana Credit Facility will bear interest at an annual rate equal to ~~purchase up to 252,432 shares~~10.0%, with such interest due at the end of the ~~Company’s common stock.~~loan term. In June 2020, the Company borrowed $2 million from the Eversana Credit Facility.

The Company ~~utilizes a valuation hierarchy for disclosure~~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 ~~inputs~~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 ~~valuations used~~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 ~~measure fair value. This hierarchy prioritizes~~pay any amounts due under the inputs into three broad levels as follows: Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full termEversana Credit Facility, an uncured material breach of the ~~financial instrument. Level 3 inputs are unobservable inputs based on~~representations, warranties and other obligations under the ~~Company’s own assumptions used to measure assets~~Eversana Credit Facility, the occurrence of insolvency events and ~~liabilities at fair value. A financial asset or liability’s classification within~~ the ~~hierarchy is determined based on the lowest level input that is significant to the fair value measurement.~~

~~The Company had no assets or liabilities classified as Level 1 or Level 2. The warrant liability is classified as Level 3.~~occurrence of a change in control.

The Company has classified the warrants as a liability and has remeasured the liability to estimated fair value at September 30, 2017 and December 31, 2016, using the Black Scholes option pricing model with the following assumptions:

The following fair value hierarchy table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2017 and December 31, 2016:

The following table presents a reconciliation of the Company’s liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the nine months ended September 30, 2017:

~~There were no transfers between Level 1 and Level 2 in any of the periods reported.~~

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the audited financial statements and accompanying notes thereto for the fiscal year ended December 31, ~~2016~~2019 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March ~~15, 2017.~~12, 2020. Past operating results are not necessarily indicative of results that may occur in future periods.

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, ~~prospective products, product approvals,~~commercial activities to be conducted by Eversana Life Science Services, LLC, or Eversana, the pricing and reimbursement for Gimoti, future regulatory developments, research and development costs, the timing and likelihood of success, plans and objectives of management for future operations, ~~and~~ future results of current and anticipated products and the expected impact of the novel coronavirus, or COVID-19 pandemic, on us or on third parties on whom we rely, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statement. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. Although we believe the expectations reflected in these forward-looking statements are reasonable, such statements are inherently subject to risk and we can give no assurances that our expectations will prove to be correct. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form 10-Q completely. As a result of many factors, including without limitation those set forth under “Risk Factors” under Item 1A of Part II below, and elsewhere in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements. Except as required by applicable law, we undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes. For all forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

We use our registered trademark, EVOKE PHARMA, and our trademarked product name, ~~Gimoti,~~GIMOTI, in this Quarterly Report on Form 10-Q. This Quarterly Report on Form 10-Q also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this Quarterly Report on Form 10-Q appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and tradenames.

Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Evoke,” “we,” “us” and “our” refer to Evoke Pharma, Inc.

WeWe are a specialty pharmaceutical company focused primarily on the development and commercialization of drugs to treat gastrointestinal, or GI, disorders and diseases. ~~We are~~Since our inception, we have devoted our efforts to developing our sole product, Gimoti ~~an investigational metoclopramide~~(metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms ~~associated~~in adults with acute and recurrent diabetic gastroparesis. On June 19, 2020, we received approval from the U.S. Food and Drug Administration, or FDA for our 505(b)(2) New Drug Application, or NDA, for Gimoti. We launched U.S. commercial sales of Gimoti in October 2020 through our commercial partner Eversana.

Diabetic gastroparesis is a ~~gastrointestinal~~GI disorder ~~afflicting~~affecting millions of ~~people~~patients worldwide, ~~and~~in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other system complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Gimoti is ~~characterized by slow or delayed gastric emptying and evidence of gastric retention in the absence of mechanical obstruction and can cause various~~ ~~serious digestive system symptoms and other complications. Metoclopramide tablets and injection are~~ the only ~~products~~nasally-administered drug currently approved in the United States to treat the symptoms ~~associated~~in adults with acute and recurrent diabetic gastroparesis. ~~Gimoti is a novel nasal spray formulation of metoclopramide and designed to provide systemic delivery of~~

On January 21, 2020, we entered into an agreement with Eversana for the ~~molecule through the nasal mucosa.~~

~~In July 2016, we announced results from a Phase 3 clinical trial~~commercialization of Gimoti, or the Eversana Agreement. Pursuant to the Eversana Agreement, Eversana commercializes and distributes Gimoti in female subjects with symptoms associated with acute and recurrent diabetic gastroparesis. The trial was a multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial to evaluate the ~~efficacy, safety and population pharmacokinetics, or PK,~~United States. Eversana also manages the marketing of Gimoti ~~in adult female subjects with diabetic gastroparesis. Subjects received either~~to targeted health care providers, as well as the sales and distribution of Gimoti within the United States.

Eversana also provided a $5 million revolving credit facility, or ~~placebo four times daily for 28 days. The primary endpoint was~~Eversana Credit Facility, which became available upon FDA approval of Gimoti. In June 2020, we borrowed $2 million under the change in symptoms from the baseline period to Week 4 as measured using a proprietary Patient Reported Outcome, or PRO, instrument. On a daily basis, subjects reported the frequency and severity of their gastroparesis signs and symptoms using a telephone diary. The subjects’ daily symptom scores were the basis for calculating their weekly scores using the PRO instrument. A total of 205 subjects were randomized in this trial. Preliminary results of the trial showed that Gimoti did not achieve its primary endpoint of symptom improvement at Week 4 in the intent to treat, or ITT, population.

Although the Phase 3 trial failed to reach its primary endpoint, Gimoti demonstrated efficacy in patients with moderate to severe symptoms at baseline, which included 105 of the 205 patients (51%) enrolled in the study. In these patients with higher symptom severity, statistically significant benefits were demonstrated for those treated with Gimoti versus those receiving placebo. These statistically significant benefits were observed at Weeks 1, 2 and 3 in the ITT population and at all four weeks in the per protocol population. There were also clinically and statistically significant improvements in nausea and upper abdominal pain, two of the more severe and debilitating symptoms of gastroparesis, at all four weeks.

In December 2016, we announced we had completed a second pre-new drug application, or NDA, meeting with FDA, in which FDA agreed that a comparative exposure PK trial was acceptable as a basis for submission of a Gimoti NDA. The comparative exposure PK trial will serve as a portion of the 505(b)(2) NDA submission that will include prior efficacy and safety data developed by us along with FDA’s prior findings of safety and efficacy for the Listed Drug, Reglan Tablets. In March 2017, we met with FDA to discuss the design of the comparative exposure PK trial and certain other chemistry, manufacturing and controls related items associated with the proposed NDA submission.Eversana Credit Facility.

On October 23, 2017, we announced positive topline results from the comparative exposure PK trial. The objective of the trial was to determine the bioequivalent dose of Gimoti compared to the Reglan Tablets after nasal and oral administration to healthy volunteers under fasted conditions. Based on these results, we expect to submit the Gimoti NDA to FDA in the first quarter of 2018.

The comparative exposure PK trial was an open label, 4-way crossover and enrolled 108 male and female healthy volunteers who were each to receive one Reglan Tablet dose and three different doses of Gimoti in a random sequence. Following discussions at pre-NDA meetings with FDA, we planned to select a Gimoti dose based on criteria that includes a 90% confidence interval for the ratio of area under the plasma concentration curve, or AUC, falling within the bioequivalence range of 80-125% of Reglan Tablets. Though only one dose was needed to meet the dose selection criteria, the comparative exposure PK trial was designed to test three different strengths of Gimoti. Based on results of the study, two of the three doses tested met the dose selection criteria. The maximum observed plasma concentration, or C_max_,for Gimoti was slightly lower than the bioequivalence range, but in line with expectations that had been previously discussed with FDA as a likely outcome given the different route of administration and prior Gimoti PK trial results. Additionally, data showed the AUC and C_max increased in a dose related manner across all three strengths tested. Relative to safety, all Gimoti doses were well tolerated with no clinically significant adverse events reported following any of the doses.

~~We have no products approved for sale, and we have not generated any revenue from product sales or other arrangements.~~ We have primarily funded our operations through the sale of our convertible preferred stock prior to our initial public offering in September 2013, borrowings under our bank loans and the sale of shares of our common stock on the ~~NASDAQ~~Nasdaq Capital Market. We have

incurred losses in each year since our inception. ~~Substantially all of our~~These operating losses resulted from expenses incurred in connection with advancing Gimoti through development activities and general and administrative costs associated with our operations. We expect to continue to incur ~~significant expenses and increasing~~ operating losses ~~for at least the next several years.~~until revenues from sales of Gimoti, which we launched in October 2020, exceed our expenses, if ever. We may never become profitable, or if we do, we may not be able to sustain profitability on a recurring basis.

As of September 30, ~~2017~~2020, we had cash and cash equivalents of approximately ~~$10.4~~$6.3 million. Current cash on hand is intended to fund commercialization activities for Gimoti, including manufacturing commercial batches of Gimoti, and general and administrative costs to support operations. Our operations have consumed substantial amounts of cash since inception. We believe, based on our current operating plan, that our existing cash and cash equivalents will be sufficient to fund our operations ~~through at least June 2018. Current~~into the second quarter of 2021, excluding any potential additional borrowings from the Eversana Credit Facility and future Gimoti product revenue. This period could be shortened if there are any unanticipated increases in planned spending, including as a result of the COVID-19 pandemic. Even with the remaining amount available under the Eversana Credit Facility, and Gimoti product revenue, we may be required to raise additional funds in order to continue as a going concern. Because our business is entirely dependent on ~~hand~~the success of Gimoti, if we are ~~intended~~unable to ~~fund clinical development, pre-approval~~secure additional financing, successfully commercialize Gimoti or identify and ~~pre-commercialization~~execute other strategic alternatives for Gimoti or our company, we will be required to curtail all of our activities and may be required to liquidate, dissolve or otherwise wind down our operations. Any of these events could result in a complete loss of your investment in our securities.

To date, we have not experienced material disruptions to our financial condition or operations from the novel coronavirus disease, or COVID-19 pandemic. We have begun our commercial activities, including commercial manufacturing, and with Eversana commercial sales of Gimoti. However, there can be no assurance that we or Eversana will not be impacted by the COVID-19 pandemic. For example, Eversana’s commercialization efforts may be adversely affected by operational restrictions imposed on its sales force from quarantines, travel restrictions and bans and other governmental restrictions related to COVID-19. As a result of these restrictions, their sales force may not be able to conduct in-person interactions with physicians and customers and may be restricted to conducting educational and promotional activities for Gimoti virtually, which may impact Eversana’s ability to market Gimoti. In addition, the COVID-19 pandemic may disrupt the operations of our third-party suppliers and manufacturers and delay our manufacturing timelines of Gimoti, which may negatively impact our ability to successfully commercialize Gimoti and generate product sales. 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 our business and financial condition, including impairing our ability to raise capital when needed. In April 2020, we applied for and were approved for a Small Business Administration, or SBA, loan under the ~~analysis~~Paycheck Protection Program, or PPP, established by the Coronavirus Aid, Relief, And Economic Security, or CARES Act. On May 1, 2020, we received loan proceeds of ~~data from~~approximately $104,000. Based on the ~~comparative exposure PK trial,~~SBA guidelines, we believe that the ~~planned NDA submission,~~balance of the loan and accrued interest will be forgiven in accordance with the terms of the PPP loan. Processes are being developed for ~~working capital~~companies to submit for loan forgiveness and ~~general corporate purposes.~~ we plan to submit for loan forgiveness when such processes are finalized.

In June 2007, we acquired all worldwide rights, data, patents and other related assets associated with Gimoti from Questcor Pharmaceuticals, Inc., or Questcor, pursuant to an asset purchase agreement. We 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 our Phase 3 clinical trial for Gimoti. In August 2014, Mallinckrodt, plc, or Mallinckrodt, acquired Questcor. As a result of that acquisition, Questcor transferred its rights included in the asset purchase agreement with us to Mallinckrodt. In addition to the payments wepreviously made to Questcor, we may ~~also~~ be required to make additional milestone payments ~~to Mallinckrodt~~ totaling up to ~~$51.5~~$52 million. ~~These milestones include up~~In March 2018, we amended the asset purchase agreement with Mallinckrodt to ~~$4.5 million in~~defer development and approval milestone payments, ~~if Gimoti achieves the following development targets:~~

The remaining $47 million in milestone payments depend on Gimoti’s commercial ~~success and will only apply if Gimoti receives regulatory approval. In addition, we~~success. We will be required to pay to Mallinckrodt a low single digit royalty on net sales of Gimoti. Our obligation to pay such royalties will terminate upon the expiration of the last patent right covering Gimoti, which is expected to occur in ~~2030.~~ 2032, subject to possible extension should any additional, later expiring, patents be granted.

Our ability to generate revenue and become profitable depends on our ability to successfully commercialize Gimoti, which we launched in October 2020 through our commercial partner Eversana. If we or Eversana fail to successfully launch Gimoti and grow and maintain sales, we may never generate significant revenues and our results of operations and financial position will be adversely affected.

We expense all research and development expenses as they are incurred. Research and development expenses primarily include:

All of our research and development expenses to date have been incurred in connection with the development of Gimoti. ~~For~~With the ~~remainder~~FDA approval of ~~2017~~Gimoti, we expect research and development costs ~~related~~ to ~~our clinical development, including the analysis~~decrease and shift to commercialization and selling costs. However, we expect to begin planning for an FDA post-marketing commitment pharmacokinetics trial of ~~data from the comparative exposure PK~~Gimoti. This trial, ~~and pre-approval and pre-commercialization activities, including marketing and manufacturing~~which we expect to begin in 2021, will characterize dose proportionality of a lower dosage strength of Gimoti ~~and completion of a planned NDA submission,~~ to ~~continue. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming.~~accommodate patients that may require further dosage adjustments. We are unable to estimate with any certainty the costs we will incur inrelated to this trial, or the ~~continued development~~regulatory review of ~~Gimoti.~~such lower dosage of Gimoti, though such costs may be significant. Clinical development timelines, the probability of success and development costs can differ materially from expectations. ~~We may never succeed in achieving marketing approval for our product candidate.~~

The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:

General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation. Other general and administrative expenses include professional fees for accounting, tax, patent costs, legal services, insurance, facility costs and costs associated with being a publicly-traded company, including fees associated with investor relations and directors and officers liability insurance premiums. We expect that general and administrative expenses will increase in the future as we ~~expand our operating activities, prepare for the growth needs associated with commercialization and~~ continue to ~~incur additional costs associated~~progress with ~~being a publicly-traded company~~the commercialization of Gimoti and maintaining compliance with exchange listing and Securities and Exchange Commission requirements. These increases will likely include higher consulting costs, legal fees, accounting fees, directors’ and officers’ liability insurance premiums and fees associated with investor relations.

~~Other income (expense) consists~~we reimburse Eversana from the net profits attained from sales of changes in the fair value of the warrant liability, which represents the change in the fair value of common stock warrants from reporting period to reporting period. The warrant liability relates to the warrants issued in the July 2016 Financing and August 2016 Financing, or collectively the 2016 Financings, and will be revalued each reporting period until the

~~liability is settled. We use the Black Scholes pricing model to value the related warrant liability. Other expense in 2016 also included interest expense incurred on our former outstanding debt.~~ Gimoti.

~~Our~~Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported ~~revenues and~~ expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ materially from these estimates under different assumptions or conditions.

The critical accounting policies and estimates underlying the accompanying unaudited financial statements are those set forth in Part II, Item 7 included in our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2016,~~2019, which was filed with the SEC on March ~~15, 2017.~~12, 2020.

On April 5, 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board, regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth company” until the earliest of (a) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more, (b) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering, or IPO, (c) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years or (d) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

The following table summarizes the results of our operations for the three months ended September 30, ~~2017~~2020 and ~~2016:~~

Research and Development Expenses. Research and development expenses for the three months ended September 30, ~~2017~~2020 compared to the three months ended September 30, ~~2016 increased~~2019 decreased by approximately ~~$1.4 million due primarily to our comparative exposure PK trial being conducted~~$617,000. The decrease during the ~~third quarter of 2017. Our Phase 3 clinical trial was completed during the second quarter of 2016 and the analysis of the trial data occurred during the second half of 2016, so~~three months ended September 30, 2020 is primarily due to a decrease in research and development ~~costs were lower during~~activity following the ~~quarter~~Gimoti NDA approval by FDA in June 2020. During the three months ended September 30, ~~2016. Costs~~2020, we incurred ~~in 2017 include~~costs of approximately ~~$1.8 million~~$158,000 related primarily to continued stability testing of ~~clinical trial costs,~~batches of Gimoti manufactured prior to FDA approval and approximately ~~$601,000~~$36,000 for wages, taxes and employee insurance, including approximately ~~$201,000~~$31,000 of stock-based compensation ~~expense,~~expense. Following FDA approval of Gimoti, and ~~approximately $337,000~~until we begin our post-marketing commitment pharmacokinetics trial, which is expected to begin in 2021, we expect future research and development expenses to remain consistent with the current quarter as we have shifted our focus to commercialization and selling activities, but we will continue to test the stability of Gimoti manufactured prior to approval.

In 2019, we incurred expenses primarily related to ~~costs associated with~~responding to requests for additional information from FDA for the ~~preparation~~Gimoti NDA and manufacturing registration batches of ~~an NDA.~~Gimoti as required by FDA. Costs incurred in ~~2016 include~~2019 included approximately ~~$650,000 related~~

~~to the Phase 3 clinical trial for Gimoti, approximately $489,000~~$493,000 for wages, taxes and employee insurance, including approximately ~~$178,000~~$179,000 of stock-based compensation expense, approximately $248,000 related to manufacturing, and approximately ~~$193,000~~$75,000 related to ~~costs associated with~~responding to FDA information requests on the ~~preparation of an NDA.~~NDA and preparing for the NDA resubmission.

General and Administrative Expenses. General and administrative expenses for the three months ended September 30, ~~2017~~2020 compared to the three months ended September 30, ~~2016~~2019 increased by approximately ~~$154,000.~~$1.1 million as we have shifted our focus to selling activities. Costs incurred in ~~2017~~2020 primarily included approximately ~~$542,000~~$1.1 million for wages, taxes and employee insurance, including approximately ~~$275,000~~$447,000 of stock-based compensation expense, and approximately ~~$309,000~~$654,000 for legal, accounting, directors and officers liability insurance and other costs associated with being a public company. Of the general and administrative expenses incurred during the three months ended September 30, 2020, approximately $745,000 related to commercialization activities. Costs incurred in ~~2016~~2019 primarily included approximately ~~$446,000~~$423,000 for wages, taxes and employee insurance, including approximately ~~$274,000~~$152,000 of stock-based compensation expense, and approximately ~~$319,000~~$326,000 for legal, accounting, directors and officers liability insurance and other costs associated with being a public company.

~~Other Expenses, net.~~ ~~Other expenses for the three months ended September 30, 2017 compared~~ General and administration costs are expected to the three months ended September 30, 2016 increased by approximately $685,000 due primarily to the increase of approximately $1.5 million in the fair value of the warrant liability, which resulted in a corresponding increase in ~~other expense. Other expenses for~~future periods as we continue to progress with the ~~three months ended September 30, 2016 included approximately $534,000~~commercialization of costs related to the 2016 Financings, an increase of approximately $199,000 in the fair value of the warrant liability, and approximately $123,000 of interest expense incurred on our former outstanding debt with Square 1 Bank, or Square 1.Gimoti.

The following table summarizes the results of our operations for the nine months ended September 30, ~~2017~~2020 and ~~2016:~~2019:

Research and Development Expenses. Research and development expenses for the nine months ended September 30, ~~2017~~2020 compared to the nine months ended September 30, ~~2016~~2019 increased by approximately ~~$56,000.~~$3.7 million. The increase during the nine months ended September 30, 2020 is primarily due to recording a $5 million expense in June 2020 upon achieving a technology acquisition milestone related to FDA’s approval of Gimoti. Although the expense was recorded when incurred, the payment is not due to Mallinckrodt until June 19, 2021. During the ~~first~~ nine months ~~of 2017,~~ended September 30,2020, we ~~were~~also incurred expenses responding to requests for additional information from FDA related to the NDA and preparing for future manufacturing and ~~conducting~~the commercial launch of Gimoti. Excluding the Mallinckrodt milestone expense, research and development expenses decreased during 2020 as we have shifted our ~~comparative exposure PK trial, including product development activities~~focus to commercialization and ~~manufacturing Gimoti for such trial. In addition, we also were incurring costs associated with the preparation of an NDA.~~selling activities. Costs incurred in ~~2017 include~~2020 included approximately ~~$2.1 million~~$784,000 for wages, taxes and employee insurance, including approximately $286,000 of ~~clinical trial costs,~~stock-based compensation expense, and approximately ~~$1.9~~$581,000 related to acquiring raw material prior to obtaining FDA approval of Gimoti and to continued testing of Gimoti batches that were manufactured prior to FDA approval.

In 2019, we incurred expenses primarily related to responding to requests for additional information from FDA and manufacturing registration batches of Gimoti as required by FDA. Costs incurred in 2019 included approximately $1.8 million for wages, taxes and employee insurance, including approximately ~~$627,000~~$534,000 of stock-based compensation expense, approximately ~~$958,000~~$787,000 related to manufacturing, ~~costs~~ and approximately ~~$561,000~~$150,000 related to ~~costs associated with~~responding to FDA information requests regarding the ~~preparation of~~NDA and preparing for the NDA. Costs incurred in 2016 include approximately $3.1 million related to the Phase 3 clinical trial for Gimoti, approximately $1.5 million for wages, taxes and employee insurance, including approximately $488,000 of stock-based compensation expense, and approximately $740,000 related to costs associated with the preparation of an NDA.NDA resubmission.

General and Administrative Expenses. General and administrative expenses for the nine months ended September 30, ~~2017~~2020 compared to the nine months ended September 30, ~~2016~~2019 increased by approximately ~~$295,000.~~$1.4 million. Costs incurred in ~~2017~~2020 primarily included approximately ~~$1.6~~$2.3 million for wages, taxes and employee insurance, including approximately ~~$778,000~~$866,000 of stock-based compensation expense, and approximately $1.8 million for legal, accounting, directors and officers liability insurance and other costs associated with being a public company. Of the general and administrative expenses incurred during the nine months ended September 30, 2020, approximately $1.2 million related to pre-commercialization and commercialization activities. Costs incurred in 2019 primarily included approximately $1.4 million for wages, taxes and employee insurance, including approximately $522,000 of stock-based compensation expense, approximately $1.2 million for legal, accounting, directors and officers liability insurance and other costs associated with being a public ~~company. Costs incurred in 2016 primarily included~~company, approximately ~~$1.5 million~~$116,000 for ~~wages, taxes and employee insurance, including approximately $811,000 of stock-based compensation expense,~~outside consultants and approximately ~~$1.1 million~~$68,000 for ~~legal, accounting, directors and officers liability insurance and other costs associated with being a public company.~~pre-commercialization costs.

~~Other Expenses.~~ Other expenses for the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016 increased by approximately $2.3 million due primarily to the increase of approximately $3.4 million in the fair value of the warrant liability, which resulted in a corresponding increase in other expense. Other expenses for the nine months ended September 30, 2016 included approximately $534,000 of costs related to the 2016 Financings, an increase of approximately $199,000 in the fair value of the warrant liability and approximately $268,000 of interest expense incurred on our former outstanding debt with Square 1.

In November 2014, we entered into a sales agreement with MLV & Co., LLC, or the MLV Sales Agreement, which was subsequently acquired by FBR Capital Markets & Co., or FBR, pursuant to which we were able to sell from time to time, at our option, up to an aggregate of $6.6 million worth of shares of common stock through MLV, as sales agent. The sales of shares of our common stock made through this equity program were made in “at-the-market” offerings as defined in Rule 415 of the Securities Act. During the year ended December 31, 2015, we sold 1,048,507 shares of common stock at a weighted average price per share of $4.78 pursuant to the MLV Sales Agreement and received proceeds of approximately $4.9 million, net of commissions and fees. We did not sell any shares of common stock through the MLV Sales Agreement during 2016.

On April 15, 2016, we terminated the MLV Sales Agreement and entered into a new At Market Issuance Sales Agreement with FBR, or the FBR Sales Agreement, and filed a prospectus supplement, pursuant to which we may sell from time to time, at our option up to an aggregate of 649,074 shares of our common stock through FBR as the sales agent. Through December 31, 2016, we sold 56,000 shares of common stock and received net proceeds of approximately $296,000 under the FBR Sales Agreement. On March 10, 2017, we filed a prospectus supplement, which replaced the prospectus supplement filed on April 15, 2016, permitting us to sell up to an aggregate of $20.0 million of shares of our common stock through FBR as the sales agent. FBR was subsequently acquired by B. Riley Financial, Inc., or B. Riley. See Item 5 for additional details regarding FBR Sales Agreement.

~~Our current Form S-3~~ shelf registration ~~statement expires on November 25, 2017. Concurrently~~ with ~~filing this Quarterly Report~~the SEC on Form 10-Q, we are filing a new shelf registration statement on Form S-3 which extends the effectiveness of the current shelf registration statement until the earlier of the date the SEC declares the new shelf registration statement effective or 6 months from the expiration date of the current shelf registration statement.S-3. The ~~new~~ shelf registration statement includes a prospectus for the at-the-market offering to sell up to an aggregate of $16.0 million of shares of our common stock through B. Riley ~~(as successor by merger to FBR)~~FBR, Inc., or FBR, as a sales ~~agent. We remain subject~~agent, or FBR Sales Agreement. During the nine months ended September 30, 2019, we sold 6,804,381 shares of common stock at a weighted-average price per share of $0.87 pursuant to the ~~limitations~~FBR Sales Agreement and received proceeds of approximately $5.8 million, net of commissions and fees. During the ~~baby shelf rules described below.~~nine months ended September 30, 2020, we sold 1,395,855 shares of common stock at a weighted-average price per share of $2.42 pursuant to the FBR Sales Agreement and received proceeds of approximately $3.3 million, net of commissions and fees.

As of October 31, 2020, we had the capacity to issue up to approximately $1.7 million of additional shares of common stock pursuant to the FBR Sales Agreement. Future sales under the FBR Sales Agreement will depend on a variety of factors including, but not limited to, market conditions, the trading price of our common stock and our capital needs. There can be no assurance that FBR will be successful in consummating future sales based on prevailing market conditions or in the quantities or at the prices that we deem appropriate.

Under current SEC regulations, if at the time we file our Annual Report on Form 10-K, and our public float is less than $75 million, and for so long as our public float remains less than $75 million, the amount we can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of our public float, which is referred to as the baby shelf rules. During June 2020, our public float exceeded $75 million, thereby allowing us to conduct primary offerings without being constrained by the baby shelf rules. We will remain unconstrained by the baby shelf rules under our Form S-3 shelf registration statement until the date we file a new registration statement or our Form 10-K for the fiscal year ending December 31, 2020, at which time if our public float is less than $75 million, the amount of securities we may sell under a Form S-3 registration statement will again be limited by the baby shelf rules.

In addition, we will not be able to make future sales of ~~our~~ common stock pursuant to the FBR Sales Agreement unless certain conditions are met, which include the accuracy of representations and warranties made to FBR under the FBR Sales Agreement. Furthermore, FBR is permitted to terminate the FBR Sales Agreement in its sole discretion upon ten days’ notice, or at any time in certain circumstances, including the occurrence of an event that would be reasonably likely to have a material adverse effect on our assets, business, operations, earnings, properties, condition (financial or otherwise), prospects, stockholders’ equity or results of operations. We have no obligation to sell the remaining shares available for sale pursuant to the FBR Sales Agreement. ~~However, u~~nder current SEC regulations, at any time during which the aggregate market value of our common stock held by non-affiliates, or public float, is less than $75 million, the amount we can raise through primary public offerings of securities in any twelve-month period using shelf registration statements, including sales under the FBR Sales Agreement, is limited to an aggregate of one-third of our public float. As of November 3, 2017, our public float was approximately $49.9 million, which means we may only sell shares up to one-third of our public float using shelf registration statements in any twelve-month period. We had no sales of common stock under the baby shelf rules in the twelve-month period ended November 3, 2017. If our public float decreases, the amount of securities we may sell under our Form S-3 shelf registration statements will also decrease.

In July 2016, we completed an at-the-market offering of 1,804,512 shares of common stock at a purchase price of $2.49375 per share, or the July 2016 Financing. Concurrently in a private placement, for each share of common stock purchased by an investor, such investor received an unregistered warrant to purchase three-quarters of a share of our common stock, for a total of 1,353,384 shares, or the July Warrants. The July Warrants have an exercise price of $2.41 per share, are immediately exercisable and will expire on January 25, 2022. The aggregate gross proceeds from the sale of the common stock and warrants were $4.5 million, and the net proceeds after deduction of commissions and fees were approximately $4.0 million.

In connection with the ~~July 2016 Financing,~~Eversana Agreement, we ~~issued~~entered into the Eversana Credit Facility, pursuant to which Eversana agreed to provide a revolving Credit Facility of up to $5 million to us upon FDA approval of the Gimoti NDA, as well as certain other customary conditions. The Eversana Credit Facility terminates on June 19, 2025, unless terminated earlier pursuant to its terms. The Eversana Credit Facility is secured by all of the Company’s personal property other than its intellectual property. Under the terms of the Eversana Credit Facility, we cannot grant an interest in our ~~placement agent, Rodman & Renshaw, a unit of H.C. Wainwright & Co. LLC, or Wainwright, and its designees unregistered warrants~~intellectual property to ~~purchase~~any other person. Each loan under the Eversana Credit Facility will bear interest at an aggregate of 90,226 share of our common stock, or the July Wainwright Warrants. The July Wainwright Warrants have substantially the same terms as the July Warrants, except that the July Wainwright Warrants will expire on July 21, 2021 and have an exercise priceannual rate equal to ~~$3.1172 per share of common stock.~~

In August 2016, we completed an at-the-market offering of 3,244,120 shares of common stock at a purchase price of $3.0825 per share, the August 2016 Financing. Concurrently in a private placement, for each share of common stock purchased by an investor, such investor received from an unregistered warrant to purchase one half of a share of our common stock, for a total of 1,622,060 shares, or August Warrants. The August Warrants have an exercise price of $3.03 per share, are immediately exercisable and will

expire on February 3, 2022. The aggregate gross proceeds from the sale of the common stock and warrants were $10.0 million, and the net proceeds after deduction of commissions and fees were approximately $9.2 million.

In connection with the August 2016 Financing, we issued to our placement agent, Wainwright, and its designees unregistered warrants to purchase an aggregate of 162,206 shares of our common stock, or the August Wainwright Warrants. The August Wainwright Warrants have substantially the same terms as the August Warrants, except that the August Wainwright Warrants will expire on July 29, 2021 and have an exercise price equal to $3.853125 per share of common stock.

On February 16, 2017, an institutional investor from our financing which closed in July 2016 converted its warrant to purchase 526,315 shares of our common stock by a “cashless” exercise and received 211,860 shares of the our common stock. The warrant had an exercise price of $2.41 per share. The shares were issued, and the warrants were sold, in reliance upon the registration exemption set forth in Section 4(a)(2) of the Securities Act of 1933, as amended. The value of the exercised warrants were adjusted to their fair value immediately prior to the exercise and approximately $1.4 million was reclassified from warrant liability to Additional Paid-in Capital. Subsequent to this transaction, warrants to purchase 2,449,129 shares of our common stock remain classified as a liability.

In February and March 2017, we completed the sale of 2,775,861 shares of our common stock in an underwritten public offering led by Laidlaw & Company (UK) Ltd. The price to the public in this offering was $2.90 per share resulting in gross proceeds to us of approximately $8.0 million. After deducting underwriting discounts and commissions and estimated offering expenses payable by us, the net proceeds to us from this offering was approximately $7.3 million.

On August 4, 2016, we repaid in full the entire $4.5 million of outstanding principal and interest under the Loan and Security Agreement, or the Loan Agreement, between us and Square 1. In connection10.0%, with such ~~repayment,~~interest due at the ~~Loan Agreement was terminated, and all security, liens or other encumbrances on assets of ours were released.~~

~~We incurred $82,685 of loan origination costs related to this credit facility. The remaining unamortized costs of approximately $38,000 were charged to interest expense upon the payment~~end of the loan ~~in August 2016.~~term. In June 2020, we borrowed $2 million from the Eversana Credit Facility.

In connection with the funding of the term loan, we issued to Square 1 a warrant to purchase 22,881 shares of our common stock at an exercise price of $5.90 per share, the closing price of our common stock on the day of funding of the credit facility. During July 2016, Square 1 converted its warrant by a “cashless” conversion and received 9,887 shares of our common stock. The value determined for the warrant at the time of the grant of $108,122 was recorded as a debt discount, as well as to stockholders’ equity. The remaining unamortized debt discount associated with the warrant of approximately $59,000 was charged to interest expense upon the payment of the loan in August 2016.

~~Our independent registered public accounting firm included an explanatory paragraph in their report on our financial statements as of and for the year ended December 31, 2016 with respect to~~Management concluded that there is substantial doubt about our ability to continue as a going concern. This doubt about our ability to continue as a going concern ~~opinion~~for at least twelve months from the date of the financial statements could materially limit our ability to raise additional funds through the issuance of new debt or equity securities or otherwise. Future reports on our financial statements may also include an explanatory paragraph with respect to our ability to continue as a going concern. We have incurred significant losses since our inception and have never been profitable, and it is possible we will never achieve profitability. As of September 30, 2020, we had cash and cash equivalents of approximately $6.3 million. We ~~have devoted~~believe, based on our ~~resources to developing Gimoti, but it cannot~~current operating plan, that our

existing cash and cash equivalents will be ~~marketed until regulatory approvals have been obtained. Based upon our currently expected level of operating expenditures, we expect to be able~~sufficient to fund our operations ~~through at least June 2018.~~into the second quarter of 2021, excluding any potential additional borrowings from the Eversana Credit Facility and future Gimoti product revenue. This period could be shortened if there are unanticipated increases in planned spending, including as a result of the COVID-19 pandemic. Even with the Eversana Credit Facility and Gimoti product revenue, we may be required to raise additional funds through debt, equity or other forms of financing, such as potential collaboration arrangements, to fund future operations and continue as a going concern. Because our business is entirely dependent on the success of Gimoti, if we are unable to secure additional financing, successfully commercialize Gimoti, or identify and execute other strategic alternatives for Gimoti or our company, we will be required to curtail all of our activities and may be required to liquidate, dissolve or otherwise wind down our operations. Any of these events could result in a complete loss of your investment in our securities.

These estimates of cash runway could be shortened if there are any significant increases in planned spending on ~~our Gimoti development program,~~commercialization activities, including ~~the analysis of data from our completed comparative exposure PK trial, pre-approval and pre-commercialization activities, including~~for marketing and manufacturing of Gimoti, ~~completion of a planned NDA submission, including whether or not FDA grants our request to waive the user fees that would otherwise become due upon our filing of an NDA with FDA,~~ and our general and administrative costs to support operations. There is no assurance that other financing will be available when needed to allow us to continue as a going concern. The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.

We expect to continue to incur expenses ~~and increase operating losses for at least the next several years. In the near-term, we anticipate incurring costs~~ as we:

Operating Activities. The primary use of our cash has been to fund our clinical research, prepare our NDA, manufacture Gimoti, and other general operations. The cash used in operating activities ~~decreased~~during the nine months ended September 30, 2020 was primarily related to ongoing communication with FDA related to the resubmitted NDA, pre-approval and commercialization activities and other ongoing costs of operating the business. The cash used in ~~2017 as we have been preparing for~~operating activities during the nine months ended September 30, 2019 was primarily related to ongoing communication with FDA related to the NDA and ~~conducting our comparative exposure PK clinical trial and the~~to manufacturing registration batches of ~~Gimoti for such trial.~~Gimoti. We expect that cash used in operating activities will increase ~~throughout the remainder~~due to commercialization activities, including manufacturing of ~~2017 as those projects, as well as the preparation of the NDA and pre-approval and pre-commercialization activities, continue.~~Gimoti.

Financing Activities. During the nine months ended September 30, ~~2017,~~2020, we received net proceeds of approximately ~~$7.3~~$3.3 million from the sale of 2,775,861 shares of common stock in an underwritten public offering. In addition, we received proceeds of approximately $135,000 from the sale of 75,529 shares of common stock through our employee stock purchase plan, or ESPP. During the nine months ended September 30, 2016, we received net proceeds of approximately $13.2 million through the 2016 Financings from the sale of 5,048,632 shares of common stock and 2,975,444 warrants to purchase our common stock. In addition, we received net proceeds of approximately $358,000 from the sale of 56,0001,395,855 shares of common stock pursuant to the FBR Sales Agreement, $2 million from borrowings under the Eversana Credit Facility, approximately $104,000 from the PPP loan, and approximately $119,000 from the sale of ~~34,067~~118,491 shares of common stock ~~through~~pursuant to our ESPP.

~~We believe that our existing cash and cash equivalents as of~~ During the nine months ended September 30, ~~2017, together with interest thereon, will be sufficient~~2019, we received net proceeds of approximately $5.8 million from the sale of 6,804,381 shares of common stock pursuant to ~~meet our anticipated cash requirements through at least June 2018. However, our forecast of~~ the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. FBR Sales Agreement.

The amount and timing of our future funding requirements will depend on many factors, including but not limited to:

Through September 30, ~~2017,~~2020, we have not entered into and did not have any relationships with unconsolidated entities or financial collaborations, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purpose.

~~In December 2016, we entered into an operating lease~~There were no material changes outside the ordinary course of our business during the nine months ended September 30, 2020 to the information regarding our contractual obligations that was disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for ~~office space in Solana Beach, California. The lease commenced on January 1, 2017 with an expiration date of~~the year ended December 31, ~~2018. We also~~2019, filed with the SEC on March 12, 2020, except for the $2 million borrowing from Eversana as discussed in Note 5 in our Notes to Condensed Financial Statements. In addition, with the approval of the Gimoti NDA, we are now committed to pay ~~pass through costs and utility costs, which are expensed~~Mallinckrodt $5 million as ~~incurred.~~discussed in Note 3 in our Notes to Condensed Financial Statements.

As of September 30, ~~2017,~~2020, there have been no material changes in our market risk from that described in “Item 7 – Management’s Discussion and Analysis of Financial Condition and Results of Operations – Quantitative and Qualitative Disclosures about Market Risk” in our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2016.~~2019, filed with the SEC on March 12, 2020.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the timelines specified in the ~~Securities and Exchange Commission’s~~SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Business Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

As required by ~~Securities and Exchange Commission~~SEC Rule 13a-15(b), as of September 30, 2020 we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Business Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as of the end of the period covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Business Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, ~~2017.~~2020.

There ~~have been~~were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during ~~our most recent fiscal~~the quarter ended September 30, 2020 that ~~have~~ materially ~~affected,~~affect, or are reasonably likely to materially affect, our internal control over financial reporting.

There have been no material changes to the risk factors included in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2016,~~2019, filed with the SEC on March 12, 2020, or the 2019 annual report, other than ~~those~~as set forth ~~below, which should be read in conjunction with~~below:

Risks Related to our Business, including the ~~risk factors disclosed therein.~~Regulatory Compliance and Commercialization of our Product, Gimoti

Our business is entirely dependent on the success of Gimoti, which ~~failed~~may never generate sufficient sales to achieve the primary endpoint of symptom improvement in a Phase 3 clinical trial in female patients with symptoms associated with diabetic gastroparesis. While we are continuing to pursue regulatory approval based on the results of our completed comparative exposure PK trial, we cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, Gimoti. become profitable.

To date, we have devoted all of our research, development and clinical efforts and financial resources toward the development of ~~Gimoti, our patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. Gimoti is~~ our only product, candidate. In July 2016, we announced topline results from our Phase 3 clinical trial that evaluated the efficacy and safety of Gimoti in women with symptoms associated with diabetic gastroparesis. In this study, Gimoti did not achieve its primary endpoint of symptom improvement in the Intent-to-Treat (ITT) group at Week 4.Gimoti.

In December 2016, we announced the completion of a second pre-NDA meeting with FDA, in which FDA agreed that a comparative exposure PK trial was acceptable as a basis for submission of a Gimoti NDA. The comparative exposure PK trial will serve as a portion of the full 505(b)(2) data package to include prior efficacy and safety data developed by us and the FDA’s prior findings of safety and efficacy for the Listed Drug, Reglan Tablets. On October 23, 2017, we announced positive topline results from the comparative exposure PK trial and plan to submit the Gimoti NDA during the first quarter of 2018. Although we believe the PK trial establishes bioequivalence, FDA may later determine to require the conduct of additional efficacy or safety trials, and we may be unable to submit an NDA on this timeframe, or potentially at all.

Because our business is entirely dependent on the success of Gimoti, if we are unable to successfully ~~complete development of and receive regulatory approval of~~commercialize this product, ~~candidate,~~ we will be required to curtail all of our activities and may be required to liquidate, dissolve or otherwise wind down our operations. Any of these events could result in the complete loss of an investment in our securities.

In addition to the ~~above~~other factors included in “Item 1A. Risk Factors” in our 2019 annual report, the future ~~regulatory and~~ commercial success of Gimoti is subject to a number of additional risks, including the following:

We ~~will~~may require substantial additional funding and may be unable to raise capital when needed, which would force us to liquidate, dissolve or otherwise wind down our operations.

Our operations have consumed substantial amounts of cash since inception. We believe, based on our current operating plan, that our existing cash and cash equivalents will be sufficient to fund our operations ~~through at least June 2018, although~~into the second quarter of 2021, excluding the $3.0 million remaining amount available under the Eversana Credit Facility and future Gimoti product revenue. This period could be shortened if there ~~can be no assurance~~are any significant increases in ~~that regard. We~~planned spending other than anticipated. Even with the remaining amount available under the Eversana Credit Facility and Gimoti product revenue, we will likely be required to raise additional funds ~~in order~~through debt, equity or other forms of financing, such as potential collaboration arrangements, to fund future operations and continue as a going ~~concern beyond~~concern. There can be no assurance that ~~time.~~we will be able to raise additional funds on acceptable terms, or at all. Because our business is entirely dependent on the success of Gimoti, if we are unable to secure additional financing, successfully commercialize Gimoti or identify and execute on other commercialization or strategic alternatives for Gimoti or our company, we will be required to curtail all of our activities and may be required to liquidate, dissolve or otherwise wind down our operations. Any of these events could result in a complete loss of your investment in our securities.

Our estimates of the amount of cash necessary to fund our activities may prove to be wrong and we could spend our available financial resources much faster than we currently expect. Our future funding requirements will depend on many factors, including, but not limited to:

Additional funding may not be available to us on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders. Furthermore, the issuance of additional shares or other securities by us, or the possibility of such issuance, may cause the market price of our shares to decline and dilute the holdings of our existing stockholders. If we raise additional funds by incurring debt, the terms of the debt may involve significant cash payment obligations, as well as covenants and specific financial ratios that may restrict our ability to operate our business. We cannot provide any assurance that our existing capital resources will be sufficient to enable us to identify or execute a viable plan for continued clinical development of Gimoti or to otherwise survive as a going concern.

~~Topline data may not accurately reflect~~Any termination or suspension of, or delays in the ~~complete results~~completion of, the post-marketing pharmacokinetics trial of Gimoti or any other future clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.

In connection with FDA’s approval of Gimoti, we committed to conduct a pharmacokinetics trial to characterize dose proportionality of a ~~particular study~~lower dose strength compared to the current 15 mg dose strength. We expect to initiate this trial in 2021. We do not know whether any trials will produce data on schedule, if at all. The commencement and completion of clinical trials can be delayed for a number of reasons, including delays related to:

In addition, disruptions caused by the COVID-19 pandemic may increase the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing clinical trials. Product development costs will increase if we need to perform more or larger clinical trials than planned. Additionally, changes in regulatory requirements and policies may occur and we may need to amend clinical trial. protocols to reflect these changes. Amendments may require us to resubmit our clinical trial protocols to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial. If we experience delays in completion of or if we, FDA or other regulatory authorities, the IRB, or other reviewing entities, or any of our clinical trial sites suspend or terminate any of our clinical trials, the commercial prospects for our product candidate may be harmed and our ability to generate product revenues will be delayed. In addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.

Delays in the completion of any clinical trials and studies we may conduct for Gimoti could be harmful to our business and cause us to require additional funding.

Use of Gimoti or any future product candidates we may develop could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of the approved labeling, or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.

If we or others identify undesirable side effects, or other previously unknown problems, with Gimoti, a number of potentially significant negative consequences could result, including:

Moreover, if any future product candidates we may develop are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial prospects for the product candidate, if approved. Undesirable side effects could cause us or regulatory authorities to interrupt, delay or halt clinical trials, result in a more restrictive label than proposed, or delay or cause the denial of regulatory approvals by FDA or comparable foreign regulatory authorities. The drug-related side effects could also affect patient recruitment for our clinical trials, or the ability of enrolled patients to complete the trials, or result in potential product liability claims. We may ~~publicly disclose topline or interim data from time~~also be required to ~~time, which is~~modify our plans for future studies based on ~~a preliminary analysis~~findings in our ongoing clinical trials. Many compounds that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of ~~then-available data~~the compound. In addition, regulatory authorities may draw different conclusions or require additional testing to confirm these determinations. Any of these occurrences may harm our business, financial condition and prospects significantly.

Undesirable side effects or other previously unknown problems could prevent us from achieving or maintaining market acceptance of Gimoti, or our future product candidates, if approved, and could substantially increase the costs of commercializing and developing such products or product candidates.

Our business may be impacted by epidemic diseases such as the ~~topline results~~recent global outbreak of the COVID-19 coronavirus.

In March 2020, the World Health Organization declared the outbreak of COVID-19, which has spread across the United States and worldwide, to be a pandemic. A pandemic, including COVID-19 or other public health epidemics, poses the risk that we ~~reported~~or our employees, or our third-party suppliers and manufacturers may be prevented from conducting business activities for an indefinite period of time, including due to spread of the ~~comparative exposure PK trial,~~disease within these groups or due to shutdowns that may be requested or mandated by governmental authorities. To date, we have not experienced material disruptions to our financial condition or operations from COVID-19. However, there can be no assurance that we or Eversana will not be impacted in the future by the COVID-19 pandemic. The continued spread of COVID-19 and the measures taken by the governments of countries affected could disrupt the raw material supply chain and the manufacture or shipment of Gimoti for commercial sale or cause us and Eversana to delay or materially modify our commercial plans, which could increase costs or decrease potential Gimoti revenues and have a material adverse effect on our business, financial condition and results of operations. For example, Eversana’s commercialization efforts may be adversely affected by operational restrictions imposed on its sales force from quarantines, travel restrictions and ~~related findings~~bans and ~~conclusions are subject to change following a more comprehensive review of the data~~ other governmental restrictions

related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data.COVID-19. As a result ~~the topline results that we report may differ from future results~~ of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially

~~different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available.~~

~~Further, others, including regulatory agencies,~~these restrictions, their sales force may not ~~accept or agree~~be able to conduct in-person interactions with physicians and customers and may be restricted to conducting educational and promotional activities for Gimoti virtually, which may impact Eversana’s ability to market Gimoti. In addition, the COVID-19 pandemic may disrupt the operations of our ~~assumptions, estimations, calculations, conclusions or analyses or~~third-party suppliers and manufacturers and delay our manufacturing timelines of Gimoti, which may ~~interpret or weigh the importance of data differently, which could~~negatively impact our ability to successfully commercialize Gimoti and generate product sales. COVID-19 may also impact the ~~value of the particular program, the approvability or commercialization of the particular product candidate or product~~costs and our company in general. For example, while we believe that the AUC measurement is the most clinically relevant PK parameter for this comparative exposure PK trial based on discussions with FDA at previous pre-NDA meetings, the FDA may change their view regarding C_max ~~falling below the bioequivalence range of Reglan Tablets as it relates to selecting our dose and more generally in the FDA’s review~~timing of our planned ~~NDA submission. In addition,~~post-marketing commitment pharmacokinetics trial of Gimoti. Moreover, to the ~~information we may publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information,~~extent any of these risks and ~~you or others may not agree with what we determine is~~uncertainties adversely impact us in the ~~material~~ways described above or otherwise, ~~appropriate information to include~~they may also have the effect of heightening many of the other risks set forth in our ~~disclosure,~~2019 annual report. The COVID-19 pandemic and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug, drug candidate ormitigation measures have also had an adverse impact on global economic conditions which could have an adverse effect on our ~~business. If the topline data that we report differ from actual results, or if others,~~business and financial condition, including ~~regulatory authorities, disagree with the conclusions reached,~~impairing our ability to ~~obtain approval for,~~raise capital when needed. The extent to which the COVID-19 pandemic impacts our manufacturing capabilities and ~~commercialize, our product candidates~~commercial plans and other results will depend on future developments that are highly uncertain and cannot be predicted, including new information that may ~~be harmed,~~emerge concerning the actions to contain its impact and treat the disease.

Disruptions at FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could ~~harm~~negatively impact our ~~business, operating results, prospects~~business.

The ability of FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect FDA’s ability to perform routine functions. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at FDA and other agencies may also slow the time necessary for new drugs or ~~financial condition. Further, although we~~modifications to approved drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as FDA, have ~~reported positive topline data for~~had to furlough critical FDA employees and stop critical activities.

Separately, in response to the ~~PK trial,~~COVID-19 pandemic, on March 10, 2020 FDA announced its intention to postpone most foreign inspections of manufacturing facilities and products through April 2020, and subsequently, on March 18, 2020, FDA announced its intention to temporarily postpone routine surveillance inspections of domestic manufacturing facilities. Regulatory authorities outside the United States may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic. If a prolonged government shutdown occurs, or if global health concerns continue to prevent FDA ~~may still require~~or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ~~conduct~~ability of ~~additional efficacy~~FDA or ~~safety trials prior~~other regulatory authorities to timely review and process our ~~planned NDA submission.~~regulatory submissions, which could have a material adverse effect on our business.

On November 14, 2017, substantially concurrently with this Current Report on Form 10-Q, we will file a shelf registration statement on Form S-3, or the replacement shelf registration statement, with the SEC, which has not yet been declared effective. The replacement registration statement is replacing the registration statement on Form S-3 we originally filed with the SEC on November 13, 2014, which registration statement is set to expire on November 25, 2017. On November 14, 2017, we entered into an amendment, or the Amendment, to the FBR Sales Agreement, pursuant to which sales agreement we may sell from time to time, at our option, shares of common stock through FBR, as sales agent. The Amendment provides, among other things, that sales under the FBR Sales Agreement will be made pursuant to the replacement registration statement, including the base prospectus filed as part of such registration statement, as of and effective upon the SEC declaring such replacement registration statement effective. Sales under the FBR Sales Agreement will continue to be made, if any, pursuant to the original registration statement until the earlier of the effectiveness of the replacement registration statement or 180 days following the expiration of the original registration statement. The Amendment will be effective concurrently with the effectiveness of the replacement shelf registration statement. The foregoing description of the Amendment is not complete and is qualified in its entirety by reference to the Amendment, a copy of which will be filed as Exhibit 1.2 to the replacement shelf registration statement and is incorporated herein by reference. Please refer to the description of the FBR Sales Agreement in the Liquidity and Capital Resources section contained in Item 2 above. Additional information with respect to the FBR Sales Agreement is available in the current report on Form 8-K filed by us with the SEC on April 15, 2016, and is hereby incorporated by reference. The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the FBR Sales Agreement, a copy of which is filed as Exhibit 1.1 to the current report on Form 8-K filed with the SEC on April 15, 2016.None.

~~A list of exhibits is set forth below and is incorporated herein by reference.~~

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Delaware		20-8447886
(State or other jurisdiction of incorporation)		(IRS Employer Identification No.)

420 Stevens Avenue, Suite 370, Solana Beach, CA		92075
(Address of principal executive offices)		(Zip Code)

PART I. FINANCIAL INFORMATION	1
Item 1. Financial Statements	1
Condensed Balance Sheets as of September 30, ~~2017~~2020 (Unaudited) and December 31, ~~2016~~2019	1
Condensed Statements of Operations for the three and nine months ended September ~~2017~~30, 2020 and ~~2016~~2019 (Unaudited)	2
Condensed Statements of Stockholders’ (Deficit) Equity for the three and nine months ended September 30, 2020 and 2019 (Unaudited)	3
Condensed Statements of Cash Flows for the nine months ended September 30, ~~2017~~2020 and ~~2016~~2019 (Unaudited)	34
Notes to Condensed Financial Statements (Unaudited)	45
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	1211
Item 3. Quantitative and Qualitative Disclosures about Market Risk	2017
Item 4. Controls and Procedures	2117
PART II. OTHER INFORMATION	2218
Item 1. Legal Proceedings	2218
Item 1A. Risk Factors	2218
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	2421
Item 3. Defaults Upon Senior Securities	2421
Item 4. Mine Safety Disclosure	2421
Item 5. Other Information	2421
Item 6. Exhibits	2522
SIGNATURES	2624

	Three and Nine Months Ended September 30,				Nine Months Ended September 30,
	2017		2016		2020	2019
Common Stock Options
Risk free interest rate	1.93% - 2.16%		1.25% - 1.58%		0.39% - 0.96%	1.80% - 2.55%
Expected option term	5.5 - 6.0 years		5.3 - 6.0 years		5.5 - 6.0 years	4.27 - 6.0 years
Expected volatility of common stock	94.05% - 98.25%		74.44% - 75.91%		99.73% - 103.99%	90.34% - 112.58%
Expected dividend yield		0.0%		0.0%	0.0%	0.0%

	Three Months Ended September 30,		Nine Months Ended September 30,
	2020	2019	2020	2019
Employee Stock Purchase Plan
Risk free interest rate	0.13%	1.89%	0.13% - 1.11%	1.89% - 2.52%
Expected term	0.5 years	0.5 years	0.5 years	0.5 years
Expected volatility of common stock	111.98%	170.68%	69.72% - 111.98%	130.36% - 170.68%
Expected dividend yield	0.0%	0.0%	0.0%	0.0%

	September 30, 2017		December 31, 2016
Risk-free interest rate		1.77%		1.93%
Expected volatility		100.41%		94.19%
Expected term	4.33 years		5.08 years
Expected dividend yield		0.0%		0.0%

	Level 1		Level 2		Level 3		Total
Warrant liability
Balance at September 30, 2017	$	-	$	-	$	6,050,901	$	6,050,901

Balance at December 31, 2016	$	-	$	-	$	4,095,019	$	4,095,019

	Warrant Liability
Balance at December 31, 2016	$	4,095,019
Issuance of warrants	—
Change in fair value upon re-measurement		3,354,973
Reclassification to Additional Paid-in Capital due to warrant exercise		(1,399,091	)
Balance at September 30, 2017	$	6,050,901

	Three Months Ended September 30,				Increase/ (Decrease)		Three Months Ended September 30,				Increase/
	2017		2016				2020		2019		(Decrease)
Research and development expenses	$	2,717,698	$	1,339,343	$	1,378,355	$	205,032	$	822,444	$	(617,412	)
General and administrative expenses	$	984,047	$	830,092	$	153,955	$	1,874,578	$	814,218	$	1,060,360
Other expenses	$	1,541,316	$	855,846	$	685,470

	Nine Months Ended September 30,				Increase/ Decrease		Nine Months Ended September 30,					Increase/
	2017		2016		Increase/ Decrease		2020		2019			(Decrease)
Research and development expenses	$	5,505,953	$	5,449,568	$	56,385	$	6,450,979	$	2,774,924		$	3,676,055
General and administrative expenses	$	3,065,595	$	2,770,500	$	295,095	$	4,387,284	$	2,955,371		$	1,431,913
Other expenses	$	3,349,521	$	1,001,120	$	2,348,401
Other (income) expense, net							$	48,546	$	(22,868	)	$	(71,414	)

Exhibit Number		Description of Exhibit

3.1 (1)		Amended and Restated Certificate of Incorporation of the Company

3.2 (1)		Amended and Restated Bylaws of the Company

4.1 (2)		Form of the Company’s Common Stock Certificate

4.2 (3)		Investor Rights Agreement dated as of June 1, 2007

4.3 (3)		Warrant dated June 1, 2012 issued by the Company to Silicon Valley Bank

4.4 ~~(2)~~		Form of Warrant Agreement dated September 30, 2013 issued by the Company to the representative of the underwriters and certain of its affiliates in connection with the closing of the Company’s initial public offering

~~4.5~~ (4)		Form of Warrant issued by the Company to certain investors under the Securities Purchase Agreement between the Company and such investors dated July ~~20,~~25, 2016

~~4.6~~4.5 (5)		Form of Warrant issued by the Company to certain investors under the Securities Purchase Agreement between the Company and such investors dated ~~July 29,~~August 3, 2016

4.6 (6)		Form of Amendment to Common Stock Purchase Warrant, amending certain of the warrants dated July 25, 2016 and August 3, 2016

4.7 (7)		Form of Amendment to Common Stock Purchase Warrant, amending certain of the warrants dated July 25, 2016 and August 3, 2016

4.8 (8)		Form of Amendment to Common Stock Purchase Warrant, amending certain of the warrants dated July 25, 2016 and August 3, 2016

4.9 (9)		Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934

10.1†		3PL Agreement between the Company and Eversana Life Science Services, Inc. dated August 27, 2020

31.1*		Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934

31.2*		Certification of Chief Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934

32.1*		Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2*		Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS		XBRL Instance Document

101.SCH		XBRL Taxonomy Extension Schema Document

101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		XBRL Taxonomy Extension Label Linkbase Document

101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document

	Evoke Pharma, Inc.

Date: November ~~14, 2017~~10, 2020	By:	/s/ David A. Gonyer
		David A. Gonyer President and Chief Executive Officer (Principal Executive Officer)

Date: November ~~14, 2017~~10, 2020	By:	/s/ Matthew J. D’Onofrio
		Matthew J. D’Onofrio Executive Vice President, Chief Business Officer, Treasurer and Secretary (Principal Financial and Accounting Officer)