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Evoke Pharma Reports Third Quarter 2019 Financial Results

Gimoti NDA resubmission on track for fourth quarter 2019

SOLANA BEACH, Calif., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced its financial results for the third quarter ended September 30, 2019.

“We made significant progress toward addressing the regulatory requests from the U.S. Food and Drug Administration (FDA) during the third quarter, and we continue to prepare for the  resubmission of our New Drug Application (NDA) for Gimoti during the fourth quarter,” said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma, Inc. “We successfully completed manufacturing of commercial scale batches of Gimoti, which allows us to collect Chemistry, Manufacturing and Controls data as well as undertaking the analysis of pump performance characteristics on the nasal spray devices that will be used to support the NDA and bring us one step closer to commercial readiness. In addition, we believe that we have sufficient capital to support our operations into the second quarter of 2020.”

Third Quarter 2019 Financial Review

For the third quarter of 2019, net loss was approximately $1.6 million, or $0.07 per share, compared to a net loss of approximately $1.5 million, or $0.09 per share for the third quarter of 2018.

Research and development expenses totaled approximately $0.8 million for the third quarter of 2019, compared to approximately $0.6 million for the third quarter of 2018. Research and development expenses were primarily related to responding to requests for additional information from FDA for the Gimoti NDA and manufacturing registration batches of Gimoti.

For the third quarter of 2019, general and administrative expenses were approximately $0.8 million compared to approximately $0.9 million for the third quarter of 2018.

Total operating expenses for the third quarter of 2019 were approximately $1.6 million, compared to total operating expenses of approximately $1.5 million for the third quarter of 2018.

As of September 30, 2019, the Company’s cash and cash equivalents were approximately $6.5 million.

About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat Gastrointestinal (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 for an NDA resubmission and the timing thereof and Evoke’s expected 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: Evoke’s resubmission of the NDA may be delayed and Evoke cannot be certain that FDA will accept or approve an NDA resubmission for Gimoti; Evoke may be unable to timely and successfully address the deficiencies raised in the CRL, including as a result of adverse findings from a root cause analysis or data from newly manufactured product batches; FDA may not agree with Evoke's conclusion of the root cause analysis or may require Evoke to conduct additional studies; the inherent risks of clinical development of Gimoti; Evoke’s dependence on third parties for the manufacture of Gimoti and analysis of the PK data; Evoke is entirely dependent on the success of Gimoti; Evoke will require substantial additional funding to continue its operations beyond the second quarter of 2020, 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; Evoke’s ability to maintain the continued listing of its common stock on the Nasdaq Capital Market; 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.

Condensed Balance Sheets

    September 30,
    December 31,
Current Assets:                
Cash and cash equivalents   $ 6,504,802     $ 5,319,004  
Prepaid expenses     775,607       329,218  
Other current assets     11,551      
Total current assets     7,291,960       5,648,222  
Operating lease right-of-use asset     35,398      
Other assets         11,551  
Total assets   $ 7,327,358     $ 5,659,773  
Liabilities and stockholders' equity                
Current Liabilities:                
Accounts payable and accrued expenses   $ 1,154,520     $ 476,202  
Accrued compensation     964,243       1,158,251  
Operating lease liability     35,398      
Total current liabilities     2,154,161       1,634,453  
Stockholders' equity:                
Common stock, $0.0001 par value; authorized shares - 50,000,000;
  issued and outstanding shares - 24,231,914 and 17,427,533
  at September 30, 2019 and December 31, 2018, respectively
    2,423       1,743  
Additional paid-in capital     89,482,936       82,628,312  
Accumulated deficit     (84,312,162 )     (78,604,735 )
Total stockholders' equity     5,173,197       4,025,320  
Total liabilities and stockholders' equity   $ 7,327,358     $ 5,659,773  

Evoke Pharma, Inc.

Condensed Statements of Operations


    Three Months Ended
September 30,
    Nine Months Ended
September 30,
    2019     2018     2019     2018  
Operating expenses:                                
Research and development   $ 822,444     $ 625,497     $ 2,774,924     $ 3,399,654  
General and administrative     814,218       897,060       2,955,371       2,846,611  
Total operating expenses     1,636,662       1,522,557       5,730,295       6,246,265  
Loss from operations     (1,636,662 )     (1,522,557 )     (5,730,295 )     (6,246,265 )
Other income:                                
  Interest income     8,597       3,089       22,868       7,425  
  Gain from change in fair value of warrant liability                 433,392  
Total other income     8,597       3,089       22,868       440,817  
Net loss   $ (1,628,065 )   $ (1,519,468 )   $ (5,707,427 )     (5,805,448 )
Net loss per share of common stock, basic and diluted   $ (0.07 )   $ (0.09 )   $ (0.26 )   $ (0.36 )
Weighted-average shares used to compute basic and diluted net loss per share     24,113,956       17,129,649       21,618,947       16,327,385  


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