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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):  May 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. ☐

 

 

 

 

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Item 2.02 Results of Operations and Financial Condition.

On May 10, 2022, Evoke Pharma, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 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 May 10, 2022
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

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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: May 10, 2022				By:		/s/ Matthew J. D’Onofrio
				Name:		Matthew J. D’Onofrio
				Title:		Executive Vice President, Chief Business Officer and Secretary

 

Exhibit 99.1

 

Evoke Pharma Reports First Quarter 2022 Financial Results

 

Several sales growth indicators increased over Q4, 2021: New Prescribers up 41%; Product delivered to patients up 39%; Net Revenue increased by 16%; Prescriptions written up 22%

 

SOLANA BEACH, Calif., May 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 first quarter ended March 31, 2022, and recent corporate developments.

“We are encouraged by the incremental improvement in net GIMOTI sales and prescriptions and continue to receive positive feedback from patients and physicians. Working closely with our strategic commercial partner, Eversana, we continue to implement and execute strategies as we seek continued improvement in the quarters ahead,” said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. “We have achieved four consecutive quarters of increased revenue with an additional 16% this quarter, to $418,000. In addition, the number of GIMOTI prescribers increased by approximately 41%, to 538 cumulative new healthcare providers (HCPs) through March 31, 2022. Finally, prescriptions received into our specialty pharmacies increased by 22% in the first quarter. More patients than ever – as well as their healthcare providers – are experiencing the benefits of GIMOTI’s novel nasal solution for diabetic gastroparesis.”

First Quarter 2022 Developments and Recent Progress:

 

        GIMOTI was added to two state Medicaid Programs

New York Medicaid;  Coverage allows for more rapid utility of GIMOTI

       New drug product exclusivity granted by the FDA for GIMOTI nasal spray

Company now has Hatch-Waxman Act exclusive marketing rights for three years from approval date

      

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Piloted strategic collaboration with vitaCare (subsidiary of GoodRx.com)

 

       Abstract on association between tardive dyskinesia (TD) and potential risk factors accepted as poster of distinction at Digestive Disease Week (DDW) on May 21, 2022 in San Diego

 

Extends cash runway into Q2, 2023

 

 

First Quarter 2022 Financial Review

 

For the first quarter of 2022, net product sales were approximately $418,000 compared to approximately $90,000 during the first quarter of 2021, and the net loss was approximately $2.2 million, or $0.07 cents per share compared with $2.6 million, or $0.08 per share, for the first quarter of 2021. The increase in net sales was primarily driven by increased educational and promotional activities of the Eversana sales force.

For the first quarter of 2022, selling, general and administrative expenses were approximately $2.4 million compared with $2.3 million for the first quarter of 2021. We expect that selling, general and administrative expenses may 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.

Total operating expenses for the first quarter of 2022 were approximately $2.5 million compared with $2.7 million for the same period of 2021.

As of March 31, 2022, cash and cash equivalents were approximately $7.7 million. We also received net proceeds of approximately $7.1 million from sales under our ATM program after March 31, 2022.  We believe, based on our current operating plan, that our existing cash and cash equivalents, as well as future cash flows from net product sales of GIMOTI, will be sufficient to fund our operations into the second quarter of 2023.

About Evoke Pharma, Inc.

 

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray

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formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.

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. 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. Visit www.EvokePharma.com for more information.

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

Follow Evoke Pharma on LinkedIn: https://www.linkedin.com/company/evoke-pharma/

About Gimoti® (metoclopramide) nasal spray

 

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

 

Important Safety Information

 

WARNING: TARDIVE DYSKINESIA

GIMOTI is not recommended for use in:

GIMOTI is contraindicated:

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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: potential future prescribing trends and sales for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, including its plans to increase awareness of and access to GIMOTI; and Evoke’s future capital requirements. 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; the COVID-19 pandemic may continue to disrupt Evoke’s and EVERSANA’s business operations impairing the ability to commercialize GIMOTI and Evoke’s ability to generate 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 maintain intellectual property protection for GIMOTI; and other risks and uncertainties 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)

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Exhibit 99.1

Source: Evoke Pharma, Inc.

 

 

 

 

 

 

 

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