Evoke Pharma Reports First Quarter 2019 Financial Results
Projected cash runway extended to first quarter 2020
“We remain diligent in the preparation of our resubmission of the Gimoti™ (metoclopramide nasal spray) new drug application (NDA) to address the approvability issues raised in the complete response letter from
“Furthermore, as we continue to effectively manage our cash position, we have extended our cash runway into the first quarter of 2020, which we believe will be sufficient to see us through the NDA resubmission,” concluded Mr. Gonyer.
First Quarter 2019 Financial Review
For the first quarter of 2019, net loss was approximately
Research and development expenses totaled approximately
For the first quarter of 2019, general and administrative expenses were approximately
Total operating expenses for the first quarter of 2019 were approximately
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
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 Evoke’s resubmission of the Gimoti NDA; the timing and volume of Evoke’s manufacturing run with
(Financial Statements to Follow)
|Evoke Pharma, Inc.
|Cash and cash equivalents||$||4,028,550||$||5,319,004|
|Other current assets||11,551||—|
|Total current assets||4,259,580||5,648,222|
|Operating lease right-of-use asset||103,252||—|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||491,831||$||476,202|
|Operating lease liability||103,252||—|
|Total current liabilities||1,287,387||1,634,453|
|Additional paid-in capital||83,643,658||82,628,312|
|Total stockholders' equity||3,075,445||4,025,320|
|Total liabilities and stockholders' equity||$||4,362,832||$||5,659,773|
|Evoke Pharma, Inc.
Statements of Operations
|Three Months Ended
|Research and development||$||746,882||$||1,385,366|
|General and administrative||1,223,013||1,032,245|
|Total operating expenses||1,969,895||2,417,611|
|Loss from operations||(1,969,895||)||(2,417,611||)|
|Gain from change in fair value of warrant liability||—||433,392|
|Total other income||4,629||434,825|
|Net loss per share of common stock, basic and diluted||$||(0.11||)||$||(0.13||)|
|Weighted-average shares used to compute basic and diluted net loss per share||17,484,318||15,427,037|
Source: Evoke Pharma, Inc.