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Aug 09, 2018

Evoke Pharma Reports Second Quarter 2018 Results and Recent Highlights

Gimoti NDA submitted to FDA on June 1st; awaiting 74-Day FDA filing communication letter

Gender-specific patents granted for Gimoti in the European Union and Mexico

SOLANA BEACH, Calif., Aug. 09, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced its financial results for the second quarter ended June 30, 2018.

Dave Gonyer, R.Ph., President and CEO, stated, “The June 1st submission of our 505(b)(2) New Drug Application (NDA) for Gimoti, our novel nasal delivery of metoclopramide for the treatment of symptoms associated with gastroparesis, represents another significant milestone for the Company and the opportunity to help women suffering from this debilitating disease. We anticipate receipt of the 74-Day FDA filing communication letter in mid-August and assignment of the Prescription Drug User Fee Act (PDUFA) goal date.” Mr. Gonyer continued, “The recently granted patents in the European Union and Mexico expand our intellectual property portfolio and further validate our novel discovery of sex-based differences in the treatment of gastroparesis in women.”

Second Quarter 2018 Financial Review

For the second quarter of 2018, net loss was approximately $2.3 million, or $(0.14) per share, compared to a net loss of approximately $1.6 million, or $(0.11) per share, for the three-month period ended June 30, 2017.

Research and development expenses totaled approximately $1.4 million for the three months ended June 30, 2018, compared to approximately $2.0 million for the same period in 2017. For the second quarter of 2018, general and administrative expenses were approximately $0.9 million, compared to approximately $0.9 million for the second quarter of 2017.

Total operating expenses for the three months ended June 30, 2018 were approximately $2.3 million, compared to approximately $2.9 million for the same period in 2017.

As of June 30, 2018, our 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 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 the 74-Day FDA letter for the NDA for Gimoti and the potential of Gimoti to significantly improve the quality of life for women suffering from gastroparesis. 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 issues raised with the NDA in the 74-Day letter; the FDA may disagree that the existing safety and efficacy data is sufficient to allow approval of the NDA, including risks associated with Cmax falling below the bioequivalence range in the comparative exposure PK trial and the proposed duration of use for Gimoti being shorter as compared to the maximum approved dosing duration for the referenced listed drug, Reglan Tablets, and the available safety database supporting such duration; the FDA may not agree with Evoke's interpretation of the results of clinical trials of Gimoti; later developments with the FDA that may be inconsistent with the already completed pre-NDA meetings; the inherent risks of clinical development of Gimoti; Evoke is entirely dependent on the success of Gimoti, and Evoke cannot be certain that FDA will approve the NDA for Gimoti or that Evoke will successfully commercialize Gimoti; Evoke will require substantial additional funding to conduct any new trials required by the FDA, and to conduct pre-commercialization activities and to commercialize Gimoti, if approved, and may be unable to raise capital when needed, including to fund ongoing operations; Evoke may not be able to obtain, maintain and enforce intellectual property rights; 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 Sheet
 
                 
                 
    June 30,
2018
    December 31,
2017
 
    (Unaudited)          
Assets                
Current Assets:                
Cash and cash equivalents   $ 6,531,079     $ 7,679,267  
Prepaid expenses     83,682       251,046  
Other current assets     11,551      
Total current assets     6,626,312       7,930,313  
Other assets         11,551  
Total assets   $ 6,626,312     $ 7,941,864  
                 
Liabilities and stockholders' equity                
Current Liabilities:                
Accounts payable and accrued expenses   $ 441,085     $ 1,048,927  
Accrued compensation     824,849       1,025,911  
Total current liabilities     1,265,934       2,074,838  
Warrant liability         3,701,277  
Total liabilities     1,265,934       5,776,115  
                 
                 
Stockholders' equity:                
Common stock     1,690       1,541  
Additional paid-in capital     80,683,323       73,202,863  
Accumulated deficit     (75,324,635 )     (71,038,655 )
Total stockholders' equity     5,360,378       2,165,749  
Total liabilities and stockholders' equity   $ 6,626,312     $ 7,941,864  
                 


Evoke Pharma, Inc.
Statements of Operations
 
                                 
                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
    2018     2017     2018     2017  
Operating expenses:                                
Research and development   $ 1,388,791     $ 2,017,569     $ 2,774,157     $ 2,788,255  
General and administrative     917,305       871,979       1,949,550       2,081,549  
Total operating expenses     2,306,096       2,889,548       4,723,707       4,869,804  
Loss from operations     (2,306,096 )     (2,889,548 )     (4,723,707 )     (4,869,804 )
Other income (expense):                                
Interest income     2,903       1,667       4,335       2,631  
Change in fair value of warrant liability         1,261,912       433,392       (1,810,835 )
Total other income (expense)     2,903       1,263,579       437,727       (1,808,204 )
Net loss   $ (2,303,193 )   $ (1,625,969 )   $ (4,285,980 )   $ (6,678,008 )
                                 
Net loss per share of common stock, basic   $ (0.14 )   $ (0.11 )   $ (0.27 )   $ (0.46 )
                                 
Net loss per share of common stock, diluted   $ (0.14 )   $ (0.13 )   $ (0.27 )   $ (0.49 )
Weighted-average shares used to compute
   basic net loss per share
    16,425,468       15,343,325       15,926,253       14,435,818  
Weighted-average shares used to compute
  diluted net loss per share
    16,425,468       15,420,954       15,926,253       14,474,633  
                                 

Investor Contact:
The Ruth Group
Tram Bui
Tel: 646-536-7035
tbui@theruthgroup.com

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Source: Evoke Pharma, Inc.