8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  August 10, 2022

EVOKE PHARMA, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-36075	20-8447886
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
420 Stevens Avenue, Suite 370 Solana Beach, California		92075
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (858) 345-1494

(Former Name or Former Address, if Changed Since Last Report.)

Securities registered pursuant to Section 12(b) of the Exchange Act
Title of each class	Trading symbol	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	EVOK	The Nasdaq Capital Market

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

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 Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On August 10, 2022, Evoke Pharma, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2022.  A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release issued on August 10, 2022
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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 hereunto duly authorized.

	EVOKE PHARMA, INC.
Date: August 10, 2022	By:	/s/ Matthew J. D’Onofrio
	Name:	Matthew J. D’Onofrio
	Title:	Executive Vice President, Chief Business Officer and Secretary

EX-99.1

1

99.1

EvokePharmaReportsSecond Quarter 2022FinancialResults

Total new inbound prescriptions over 500 for first time, 24% increase over Q1; New cumulative prescribers up 23%; Net revenue increased by 11%.

SOLANA BEACH, Calif., August 10, 2022 (GLOBE NEWSWIRE) – Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases, today announced its financial results for the second quarter ended June 30, 2022, and recent corporate developments.

“Evoke delivered a solid second quarter based on several key metrics and developments,” David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. “Net product sales during the second quarter of 2022 were approximately $462,000, up 11% compared with first quarter of 2022. Patient prescriptions had the largest number of quarterly enrollments to date and posted an increase of 24%, compared with the first quarter. In addition, the cumulative number of new GIMOTI® prescribers increased by approximately 23%, through June 30, 2022 compared to March 31, 2022. Although filled prescriptions were up modestly in the second quarter, we believe the increased patient enrollments in our vitaCare Prescription Services and EvokeAssist reimbursement programs during Q2 will convert to higher new prescriptions in the second half of the year. Finally, we substantially bolstered our cash reserves in Q2 and extended our operational runway. We believe the additional capital positions us to sustain and increase GIMOTI sales and to capitalize on future market opportunities and provide more patients with access to our novel GIMOTI treatment option.”

SecondQuarter2022DevelopmentsandRecentProgress:

GIMOTI received Medicaid approvals in Texas and Florida

• Market access improves with approximately 10 million lives in the Texas and Florida Medicaid patient networks combined.

▪ Adds to the list of other state Medicaid approvals, including New York, which was announced in the 1^st quarter of 2022.

Evoke improves exclusivity around Gimoti with FDA and patent allowances

▪ Evoke currently has exclusive marketing rights from the U.S. FDA for three (3) years from the original approval date under the Hatch-Waxman Act to protect GIMOTI from generic drug competition.

▪ Awarded Canadian patent covering the method of use for GIMOTI in July with an expiry in 2029. The new patent adds to two other U.S. Food and Drug Administration (FDA) Orange Book-listed patents under the same title that expire in 2029 and 2030, respectively.

▪ Patient Experience Survey Reported Positive Findings for GIMOTI.

First patient centric survey conducted by Evoke and Eversana indicates increasing patient awareness, trial, and product usage of GIMOTI.

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▪ Essential findings: 100% of current GIMOTI users report seeing at least some symptom improvement, particularly diminished nausea.

▪ Company presented real-world data analyses demonstrating a lower risk of tardive dyskinesia (TD) associated with metoclopramide usage compared to previous reports.

▪ Evoke poster at Digestive Disease Week (DDW) 2022 in May showed a 98.8 per 100,000 (0.1%) incidence of TD among gastroparesis patients treated with metoclopramide.

▪ Supports safety profile of only approved molecule in US to treat symptoms of acute and recurrent diabetic gastroparesis.

▪ Evoke continues to expand GIMOTI access expansion/sales channel partnerships

▪ Percentage of inbound prescriptions increased with the start of a pilot program with vitaCare Prescription Services, a wholly owned subsidiary of GoodRx, that began in February 2022.

▪ vitaCare helps patients understand coverage and identify available savings opportunities and facilitates communications between providers and payors.

▪ Company improved cash position.

▪ Company utilized its “at-the-market” (ATM) program to raise proceeds of approximately $7.1 million, net of commissions and fees.

▪ Cash extends the Company’s cash runway into the second quarter of 2023.

Second Quarter 2022FinancialReview

For the second quarter of 2022, net product sales were approximately $462,000 compared with $237,000 during the second quarter of 2021, andthenetlosswasapproximately$2.2million, or $0.71cents per share, compared with$2.3million, or $0.85 per share, forthesecondquarterof2021. The increase in net sales was due to a higher number of GIMOTI prescriptions.

Researchanddevelopmentexpensestotaledapproximately$191,000forthesecondquarterof2022comparedwith approximately $195,000forthesecondquarterof 2021.

For the second quarter of 2022, selling, general and administrative expenses were approximately$2.3 million compared with$2.1 million for the second quarter of 2021. We continue to expect that selling, general and administrative expenses will increase in the future as we continue to progress with the commercialization of GIMOTI and we reimburse Eversana from the net profits attained from the sales of GIMOTI.

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Total operating expenses for the second quarter of 2022 were approximately $2.6 million compared with $2.4 million for the same period of 2021.

As of June 30, 2022, cash and cash equivalents were approximately $13.5 million. Evoke believes, based on its current operating plan, that its existingcashandcashequivalents,aswellasfuturecashflowsfromnetproductsalesofGIMOTI,willbesufficienttofundoperationsintothesecond quarter of 2023.

   Conference Call Information

Management will host a conference call on Wednesday, August 10, 2022, at 4:30 p.m. ET to discuss the results. The dial-in numbers for the conference call are (800) 343-4849 and (203) 518-9848 for international callers. The conference ID number is EVOKQ222

AboutEvokePharma,Inc.

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed,commercializedandmarketsGIMOTI,anasalsprayformulationofmetoclopramide,forthereliefofsymptomsassociatedwithacuteand recurrent diabetic gastroparesis in adults.

DiabeticgastroparesisisaGIdisorderaffectingmillionsofpatientsworldwide,inwhichthestomachtakestoolongtoemptyitscontentsresultingin serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visitwww.EvokePharma.comformore information.

FollowGIMOTIonFacebook:https://www.facebook.com/GIMOTI-metoclopramide-nasal-spray-104672345100289Follow Evoke Pharma on Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724

FollowEvokePharmaonLinkedIn:https://www.linkedin.com/company/evoke-pharma/

About EVERSANA

EVERSANA™ is a leading provider of global services to the life science industry.Thecompany’sintegratedsolutionsarerootedinthepatient experienceandspanallstagesoftheproductlifecycletodeliverlong-term,sustainablevalueforpatients,prescribers,channelpartnersandpayers. Thecompanyservesmorethan500organizations,includinginnovativestart-upsandestablishedpharmaceuticalcompaniestoadvancelifescience solutionsforahealthierworld.TolearnmoreaboutEVERSANA,visitwww.eversana.comorconnectthroughLinkedInandTwitter.

AboutGIMOTI®(metoclopramide)nasalspray

GIMOTIisindicatedforthereliefofsymptomsinadultswithacuteandrecurrentdiabeticgastroparesis. Important Safety Information

WARNING:TARDIVEDYSKINESIA

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• Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.

• Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.

• Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.

GIMOTIisnotrecommendedforuse in:

• Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.

• Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions.

GIMOTIiscontraindicated:

• Inpatientswithahistoryoftardivedyskinesia(TD)oradystonicreactiontometoclopramide.

• Whenstimulationofgastrointestinalmotilitymightbedangerous(e.g.,inthepresenceofgastrointestinalhemorrhage, mechanicalobstruction,orperforation).

• In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.

• Inpatientswithepilepsy.Metoclopramidemayincreasethefrequencyandseverityofseizures.

• In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.

Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia,effectsontheabilitytodriveandoperatemachinery.Mostcommonadversereactions(≥5%)forGIMOTIare:dysgeusia, headache,andfatigue.ThesearenotallofthepossiblesideeffectsofGIMOTI.Callyourdoctorformedicaladviceaboutwhetheryoushouldtake GIMOTIandthepossibleriskfactorsandsideeffects.YouareencouragedtoreportnegativesideeffectsofprescriptiondrugstotheFDA.

Visitwww.fda.gov/medwatchorcall1-800-FDA-1088.

SafeHarborStatement

Evokecautionsyouthatstatementsincludedinthispressreleasethatarenotadescriptionofhistoricalfactsareforward-lookingstatements.Insome cases, you can identify forward-looking statements by terms such as “may,”“will,”

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“should,”“expect,”“plan,”“anticipate,”“could,”“intend,”“target,”“project,”“contemplates,”“believes,”“estimates,”“predicts,”“potential”or“continue”orthenegativesofthesetermsorothersimilarexpressions. Thesestatementsarebasedonthecompany’scurrentbeliefsandexpectations.Theseforward-lookingstatementsincludestatementsregarding: potentialfutureprescribingtrendsforGIMOTIbasedonEvoke’sorEVERSANA’smarketingefforts and enrollments in vitaCare andEvokeAssist;Evoke’scommercializationplans,includingitsplans to increase awareness of and access to GIMOTI; and Evoke’s future capital requirements. The inclusion of forward-looking statements should notberegardedasarepresentationbyEvokethatanyofitsplanswillbeachieved.Actualresultsmaydifferfromthosesetforthinthispressrelease duetotherisksanduncertaintiesinherentinEvoke’sbusiness,including,withoutlimitation:Evoke’sandEVERSANA’sabilitytosuccessfullydrive marketdemandforGIMOTI;theCOVID-19pandemicmaycontinue todisruptEvoke’sandEVERSANA’sbusinessoperationsimpairingtheabilitytocommercializeGIMOTIandEvoke’sabilitytogenerateproduct revenue;Evoke’sdependenceonthirdpartiesforthemanufactureofGIMOTI;EvokeisentirelydependentonthesuccessofGIMOTI;Evoke’sability to fund its operating plans with our current capital resources and abilitytoobtainadditionalfinancingasneededtosupportitsoperations;inadequate efficacyorunexpectedadversesideeffectsrelatingtoGIMOTIthatcouldresultinrecallsorproductliabilityclaims;Evoke’sabilitytomaintain intellectualpropertyprotectionforGIMOTI;andotherrisksanduncertaintiesdetailedinEvoke’spriorpressreleasesandintheperiodicreportsitfiles withtheSecuritiesandExchangeCommission.Youarecautionednottoplaceunduerelianceontheseforward-lookingstatements,whichspeakonly asofthedatehereof,andEvokeundertakesnoobligationtoreviseorupdatethispressreleasetoreflecteventsorcircumstancesafterthedate hereof.Allforward-lookingstatementsarequalifiedintheirentiretybythiscautionarystatement.Thiscautionismadeunderthesafeharborprovisions of the Private Securities Litigation Reform Act of 1995.

Investor & Media Contact:

Daniel Kontoh-Boateng

DKB Partners

Tel: 862-213-1398

dboateng@dkbpartners.net

Source:EvokePharma,Inc.

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Evoke Pharma, Inc. Balance Sheet
	June 30, 2022			December 31, 2021
	(Unaudited)
Assets
Current Assets:
Cash and cash equivalents	$	13,450,949		$	9,144,710
Accounts receivable, net		365,643			295,193
Prepaid expenses		307,919			923,746
Inventory		268,334			185,534
Other current assets		11,551			11,551
Total current assets		14,404,396			10,560,734
Operating lease right-of-use asset	—				12,428
Total assets	$	14,404,396		$	10,573,162
Liabilities and stockholders' equity
Current Liabilities:
Accounts payable and accrued expenses	$	824,481		$	874,028
Accrued compensation		528,665			519,317
Operating lease liability	—				12,428
Total current liabilities		1,353,146			1,405,773
Long-term liabilities
Note payable		5,000,000			5,000,000
Accrued interest payable		860,240			612,295
Total long-term liabilities		5,860,240			5,612,295
Total liabilities		7,213,386			7,018,068
Stockholders' equity:
Common stock		334			3,266
Additional paid-in capital		119,020,734			110,974,841
Accumulated deficit		(111,830,058	)		(107,423,013	)
Total stockholders' equity		7,191,010			3,555,094
Total liabilities and stockholders' (deficit) equity	$	14,404,396		$	10,573,162

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	Three Months Ended June 30,						Six Months Ended June 30,
	2022			2021			2022			2021
Net product sales	$	461,795		$	236,635		$	880,175		$	327,056
Operating expenses:
Cost of goods sold		67,774			68,253			90,535			133,004
Research and development		191,478			195,229			233,194			473,054
Selling, general and administrative		2,315,175			2,142,149			4,720,251			4,480,443
Total operating expenses		2,574,427			2,405,631			5,043,980			5,086,501
Loss from operations		(2,112,632	)		(2,168,996	)		(4,163,805	)		(4,759,445	)
Other income (expense):
Forgiveness of paycheck protection loan and accrued          interest		—			—			—			105,130
Interest income		3,910			3,011			4,705			6,174
Interest expense		(124,658	)		(124,658	)		(247,945	)		(247,997	)
Total other income (expense)		(120,748	)		(121,647	)		(243,240	)		(136,693	)
Net loss	$	(2,233,380	)	$	(2,290,643	)	$	(4,407,045	)	$	(4,896,138	)
Net loss per share of common stock, basic and diluted	$	(0.71	)	$	(0.85	)	$	(1.50	)	$	(1.85	)
Weighted-average shares used to compute basic and      diluted net loss per share		3,156,925			2,698,833			2,944,183			2,647,669

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XML

Document and Entity Information	Aug. 10, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 10, 2022
Entity Registrant Name	EVOKE PHARMA, INC.
Entity Central Index Key	0001403708
Entity Emerging Growth Company	false
Entity File Number	001-36075
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	20-8447886
Entity Address, Address Line One	420 Stevens Avenue
Entity Address, Address Line Two	Suite 370
Entity Address, City or Town	Solana Beach
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92075
City Area Code	(858)
Local Phone Number	345-1494
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock,par value $0.0001 per share
Trading Symbol	EVOK
Security Exchange Name	NASDAQ