Press Release
Evoke Pharma Reports First Quarter 2015 Results
First Quarter 2015 Financial Review
For the first quarter of 2015, net loss was approximately
Research and development expenses totaled approximately
For the first quarter of 2015, general and administrative expenses were approximately
Total operating expenses for the three months ended
As of
Conference Call and Webcast
Evoke will hold a conference call on
After the live webcast, the event will remain archived on Evoke's website for one year. In addition, a telephonic replay of the call will be available until
About
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product 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 enrollment completion of Evoke's ongoing Phase 3 clinical trial of EVK-001, the potential approval and commercialization of EVK-001 as a new and effective treatment for gastroparesis and Evoke's completed and ongoing trials and studies serving as a basis for submission of an NDA. 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 risk and uncertainties inherent in Evoke's business, including, without limitation: Evoke is entirely dependent on the success of EVK-001, for which it has commenced a Phase 3 clinical trial and male companion trial, and Evoke cannot be certain that it will be able to obtain regulatory approval for, or successfully commercialize, EVK-001; risks that issues with future manufacturing production will arise, whether as a result of noncompliance with CMC requirements or otherwise; Evoke's reliance on outsourcing arrangements for many of its activities, including clinical development, manufacturing and supply of EVK-001, and Evoke's current lack of long-term commercial manufacturing agreements;
the results observed in female patients with symptoms associated with acute and recurrent diabetic gastroparesis in Evoke's Phase 2b clinical trial of EVK-001 may not be predictive of the safety and efficacy results in the Phase 3 clinical trial; the inherent risks of clinical development of EVK-001, including continued delays in enrollment and completion of the Phase 3 trial as well as potential delays in any other clinical trials and studies; Evoke will require substantial additional funding to complete the Phase 3 clinical trial and potentially commercialize EVK-001 as well as to finance additional development requirements, and may be unable to raise capital when needed, including to fund ongoing operations; the potential for adverse safety findings relating to EVK-001 to delay or prevent regulatory approval or commercialization; the ability of Evoke to obtain, maintain and
successfully enforce adequate patent and other intellectual property protection of its product candidate and the ability to operate its business without infringing the intellectual property rights of others; competition from other pharmaceutical or biotechnology companies; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the
(Financial Statements to follow)
|
|
||
| Condensed Balance Sheets | ||
|
|
|
|
| 2015 | 2014 | |
| (Unaudited) | ||
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 11,692,360 | $ 14,155,809 |
| Prepaid expenses | 858,128 | 931,461 |
| Other current assets | 23,624 | 161,436 |
| Total current assets | 12,574,112 | 15,248,706 |
| Other assets | 47,117 | 53,023 |
| Total assets | $ 12,621,229 | $ 15,301,729 |
| Liabilities and stockholders' equity | ||
| Current liabilities: | ||
| Accounts payable and accrued expenses | $ 1,353,147 | $ 1,011,629 |
| Accrued compensation | 424,597 | 697,245 |
| Other current liabilities | 9,015 | 12,313 |
| Current portion of long-term debt | 712,930 | 150,430 |
| Total current liabilities | 2,499,689 | 1,871,617 |
| Long-term debt, net of current portion | 3,688,216 | 4,241,448 |
| Total liabilities | 6,187,905 | 6,113,065 |
| Stockholders' equity: | ||
| Common stock | 620 | 611 |
| Additional paid-in capital | 45,892,601 | 45,127,202 |
| Accumulated deficit | (39,459,897) | (35,939,149) |
| Total stockholders' equity | 6,433,324 | 9,188,664 |
| Total liabilities and stockholders' equity | $ 12,621,229 | $ 15,301,729 |
|
|
||
| Condensed Statements of Operations | ||
| (Unaudited) | ||
| Three Months Ended | ||
|
|
||
| 2015 | 2014 | |
| Operating expenses: | ||
| Research and development | $ 2,419,961 | $ 1,852,116 |
| General and administrative | 1,025,261 | 1,070,479 |
| Total operating expenses | 3,445,222 | 2,922,595 |
| Loss from operations | (3,445,222) | (2,922,595) |
| Other income (expense): | ||
| Interest income | 1,522 | 4,055 |
| Interest expense | (77,048) | (36,944) |
| Total other income (expense) | (75,526) | (32,889) |
| Net loss and comprehensive loss | $ (3,520,748) | $ (2,955,484) |
| Net loss per common share, basic and diluted | $ (0.58) | $ (0.49) |
| Weighted-average shares used to compute basic and diluted net loss per share | 6,103,783 | 6,002,936 |
CONTACT: Investor Contact:
The Ruth Group
David Burke
Tel: 646-536-7009
dburke@theruthgroup.com
Media Contact:
The Ruth Group
Kirsten Thomas
Tel: 646-536-7014
kthomas@theruthgroup.com
Source: News Provided by Acquire Media