evok-8k_20200312.htm

 

 

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):  March 12, 2020

 

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 March 12, 2020, Evoke Pharma, Inc. issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2019.  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 March 12, 2020.

 

 

 

 

 


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: March 12, 2020

 

 

 

By:

 

/s/ Matthew J. D’Onofrio

 

 

 

 

Name:

 

Matthew J. D’Onofrio

 

 

 

 

Title:

 

Executive Vice President,
Chief Business Officer and Secretary

 

 

evok-ex991_6.htm

Exhibit 99.1

 

 

Investor Contact:

The Ruth Group

Tram Bui

Tel: 646-536-7035

tbui@theruthgroup.com

 

 

 

 

 

Evoke Pharma Reports Fourth Quarter and Full Year 2019 Financial Results

 

Gimoti™ Prescription Drug User Fee Act (PDUFA) decision date set for June 19, 2020

 

SOLANA BEACH, CA. March 12, 2020 – Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2019.

 

“Over the course of 2019, we worked diligently to address the regulatory requests from the U.S. Food and Drug Administration (FDA) that culminated in the resubmission and acceptance for filing of our Gimoti NDA. We look forward to the June 19th PDUFA date and will continue to work with FDA throughout the review process,” said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. “During this FDA review process, we are actively working with our commercial partner, Eversana, to prepare for the potential commercialization of Gimoti. Our partnership allows us to leverage Eversana’s integrated suite of capabilities, including highly experienced personnel with proficiency in all key facets of pharmaceutical product commercialization including sales. This partnership has allowed us to continue to maximize our resources and we expect our current cash to support our operations into the third quarter of 2020, excluding the $5 million Eversana line of credit that becomes available if FDA approves the Gimoti NDA.”

 

Fourth Quarter and Full Year 2019 Financial Review

 

For the fourth quarter of 2019, the net loss was approximately $1.4 million, or $0.06 per share, compared to a net loss of approximately $1.8 million, or $0.10 per share for the fourth quarter of 2018. For the year ended December 31, 2019, the net loss was approximately $7.1 million, or $0.32 per share. This compares to a net loss of approximately $7.6 million, or $0.46 per share for the full year of 2018.

 

Research and development expenses totaled approximately $0.6 million for the fourth quarter of 2019 compared to approximately $0.7 million for the fourth quarter of 2018. For the full year of 2019, research and development expenses were approximately $3.4 million compared to approximately $4.1 million in the prior year.

 

For the fourth quarter of 2019, general and administrative expenses were approximately $0.8 million compared to approximately $1.1 million for the fourth quarter of 2018. For the year ended December 31, 2019, general and administrative expenses were approximately $3.7 million versus approximately $3.9 million for the full year of 2018.

 

Total operating expenses for the fourth quarter of 2019 were approximately $1.4 million compared to total operating expenses of approximately $1.8 million for the same period of 2018. For the year ended December 31, 2019, total operating expenses were approximately $7.2 million compared to approximately $8.0 million for the full year of 2018.

 

 


 

 

As of December 31, 2019, the Company’s cash and cash equivalents were approximately $5.7 million.

 

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 is developing Gimoti, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.

 

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 digestive system symptoms. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Metoclopramide is currently available only in oral and injectable formulations and is the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.

 

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 potential timing of FDA action on the NDA and potential approval and product launch for Gimoti; Evoke’s belief that it can leverage Eversana’s capabilities to prepare for potential commercialization of Gimoti; and Evoke’s projected cash runway. 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: the potential for the FDA to delay the PDUFA target goal date due to the FDA's internal resource constraints or other reasons; Evoke may be unable to timely and successfully address the deficiencies raised in the Complete Response Letter (CRL) regarding Gimoti, including as a result of adverse findings from a root cause analysis or data from the newly manufactured product batches not fully addressing issues raised by the FDA in the CRL and type A meeting; FDA may not agree with Evoke's conclusion of the results from the manufacturing testing or the root cause analysis, or may require Evoke to conduct additional studies; the inherent risks of clinical development and regulatory approval of Gimoti; Evoke’s dependence on third parties for the manufacture of Gimoti and analysis of the manufacturing data; Evoke’s depending on EVERSANA to prepare for commercialization and launch commercial sales of Gimoti, if approved; Evoke is entirely dependent on the success of Gimoti; Evoke will require substantial additional funding to continue its operations, and may be unable to raise capital or obtain funds when needed, including to fund ongoing operations; Evoke could face significant additional costs due to litigation or other events; 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 Pharma, Inc.

 

Balance Sheets

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

2019

 

 

2018

 

Assets

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

5,663,833

 

 

$

5,319,004

 

Prepaid expenses

 

 

581,706

 

 

 

329,218

 

Total current assets

 

 

6,245,539

 

 

 

5,648,222

 

Operating lease right-of-use asset

 

 

138,538

 

 

 

Other assets

 

 

11,551

 

 

 

11,551

 

Total assets

 

$

6,395,628

 

 

$

5,659,773

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

1,033,383

 

 

$

476,202

 

Accrued compensation

 

 

843,162

 

 

 

1,158,251

 

Operating lease liability

 

 

138,538

 

 

 

Total current liabilities

 

 

2,015,083

 

 

 

1,634,453

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

2,443

 

 

 

1,743

 

Additional paid-in capital

 

 

90,108,492

 

 

 

82,628,312

 

Accumulated deficit

 

 

(85,730,390

)

 

 

(78,604,735

)

Total stockholders' equity

 

 

4,380,545

 

 

 

4,025,320

 

Total liabilities and stockholders' equity

 

$

6,395,628

 

 

$

5,659,773

 

 

 

 

 

 

 

 

 

 

 


 


 

Evoke Pharma, Inc.

 

Statements of Operations

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2019

 

 

2018

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

$

3,416,466

 

 

$

4,095,014

 

General and administrative

 

 

3,737,987

 

 

 

3,919,671

 

Total operating expenses

 

 

7,154,453

 

 

 

8,014,685

 

Loss from operations

 

 

(7,154,453

)

 

 

(8,014,685

)

Other income:

 

 

 

 

 

 

 

 

       Interest income

 

 

28,798

 

 

 

15,213

 

       Gain from change in fair value of warrant liability

 

 

 

 

433,392

 

Total other income

 

 

28,798

 

 

 

448,605

 

Net loss

 

$

(7,125,655

)

 

$

(7,566,080

)

Net loss per share of common stock, basic and diluted

 

$

(0.32

)

 

$

(0.46

)

Weighted-average shares used to compute basic and

   diluted net loss per share

 

 

22,296,089

 

 

 

16,602,422