Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  November 10, 2020



(Exact Name of Registrant as Specified in its Charter)








(State or Other Jurisdiction

of Incorporation)



File Number)


(IRS Employer

Identification No.)



420 Stevens Avenue, Suite 370

Solana Beach, California



(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


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 November 10, 2020, Evoke Pharma, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2020.  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.





Press Release issued on November 10, 2020.








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.











Date: November 10, 2020






/s/ Matthew J. D’Onofrio







Matthew J. D’Onofrio







Executive Vice President,
Chief Business Officer and Secretary




Exhibit 99.1


Investor Contact:

The Ruth Group

Jan Medina, CFA

Tel: 646-536-7035



Media Contact:

The Ruth Group

Kirsten Thomas

Tel: 508-280-6592






Evoke Pharma Reports Third Quarter 2020 Financial Results


Gimoticommercial launch underway


SOLANA BEACH, CA, November 10, 2020 – Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced its financial results for the third quarter ended September 30, 2020 and recent corporate developments.


“The third quarter was marked by preparation for the commercial launch of GIMOTI, which we successfully implemented in early fourth quarter. The launch of GIMOTI to treat symptoms of acute and recurrent diabetic gastroparesis with our commercial partner EVERSANA marked a pivotal event for the Company,” said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. “As a nasally delivered product, GIMOTI has distinct differences over oral formulations of metoclopramide. It is the only outpatient non-oral treatment option to help improve the quality of life for patients suffering with diabetic gastroparesis. Initial prescriptions of GIMOTI have already been filled at the EVERSANA specialty pharmacy through our patient support team at EvokeAssistTM. We believe this vital support program will aid both physicians and patients through enrollment, reimbursement, and delivery of GIMOTI directly to the patient. Given the milestones achieved for commercial preparedness, we believe we are in a strong position as we launch GIMOTI and address a significant unmet medical need for millions of patients suffering from diabetic gastroparesis.”


Third Quarter 2020 Developments and Recent Progress:



Launched GIMOTI with commercial partner, EVERSANA, in line with prior guidance


Implemented EvokeAssist, an integrated patient support program


Appointed Chris Quesenberry as Chief Commercial Officer for GIMOTI through our Commercial partner, EVERSANA


Built an entire commercial team, including field sales and call center


Completed manufacturing of the first commercial lot of GIMOTI



Third Quarter 2020 Financial Review


For the third quarter of 2020, net loss was approximately $2.1 million, or $0.08 per share, compared to a net loss of approximately $1.6 million, or $0.07 per share, for the third quarter of 2019.


Research and development expenses totaled approximately $0.2 million for the third quarter of 2020, compared to approximately $0.8 million for the third quarter of 2019. The decrease during the three months ended September 30, 2020 was primarily due to the decrease in research and development activity following the GIMOTI NDA approval in June 2020.


For the third quarter of 2020, general and administrative expenses were approximately $1.9 million compared to approximately $0.8 million for the third quarter of 2019. The increase during the three months ended September 30, 2020 was primarily due to increased costs associated with our commercialization and selling activities. Of the costs incurred during the third quarter of 2020, approximately $745,000 were related to commercialization activities.


Total operating expenses for the third quarter of 2020 were approximately $2.1 million, compared to total operating expenses of approximately $1.6 million for the third quarter of 2019.


As of September 30, 2020, the Company’s cash and cash equivalents were approximately $6.3 million. The Company expects that its current cash balance will be sufficient to support operations into the second quarter of 2021, without consideration of potential future GIMOTI revenue.


About Evoke Pharma, Inc.


Evoke is a specialty pharmaceutical company focused primarily on the commercialization and development of drugs to treat GI disorders and diseases. The Company developed GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. GIMOTI is available by prescription through the EvokeAssist™ patient support center. Visit www.GimotiRx.com for more information.


Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. GIMOTI is absorbed in the nasal cavity and bypasses the erratic gastric absorption often seen in gastroparesis patients. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations. It remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.



About Gimoti™ (metoclopramide) nasal spray


GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.


Important Safety Information





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.


GIMOTI is not recommended for use 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.


GIMOTI is contraindicated:



In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.


When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).


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.


In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.


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, effects on the ability to drive and operate machinery.

Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. 



These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.



Safe Harbor Statement


Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. 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 negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: the size of the gastroparesis market and the potential of GIMOTI to provide an important new alternative to current treatment options. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations, including through the EVERSANA line of credit which is subject to certain customary conditions; the COVID-19 pandemic may disrupt Evoke’s and EVERSANA’s business operations impairing the ability to commercialize GIMOTI and Evoke’s ability to generate any product revenue; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to obtain and maintain intellectual property protection for GIMOTI; and other risks detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.



(Financial Statements to Follow)




Evoke Pharm, Inc.


Balance Sheets






September 30,




December 31,




















Current Assets:









Cash and cash equivalents









Prepaid expenses
















Other current assets







Total current assets









Operating lease right-of-use asset









Other assets







Total assets


















Liabilities and stockholders' equity









Current Liabilities:









Accounts payable and accrued expenses









Accrued compensation









Operating lease liability









Paycheck protection program loan







Milestone payable







Total current liabilities


















Long-term Liabilities:









      Note payable







      Accrued interest payable







Total long-term liabilities
















Total liabilities


















Stockholders' equity:









Common stock









Additional paid-in capital









Accumulated deficit









Total stockholders' (deficit) equity









Total liabilities and stockholders' (deficit) equity




























Evoke Pharma, Inc.


Statement of Operations








Three Months Ended

September 30,



Nine Months Ended

September 30,















Operating expenses:

















Research and development

















General and administrative

















Total operating expenses

















Loss from operations

















Other income (expense):

















Interest income

















Interest expense













Total other income
    (expense), net

















Net loss


































Net loss per share of common stock, basic and diluted


































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