Press Release
Evoke Pharma Reports Third Quarter 2014 Results
"Looking ahead, we anticipate top-line data to be reported in mid-2015 for our Phase 3 trial in female diabetic gastroparesis patients. We are excited by the potential to bring a novel non-oral treatment to market for female patients that suffer from this debilitating ailment."
Third Quarter 2014 Financial Review
For the third quarter of 2014, net loss was approximately
Research and development expenses in the third quarter of 2014 were approximately
For the third quarter of 2014, general and administrative expenses were approximately
Total operating expenses for the third quarter of 2014 were approximately
As of
Conference Call and Webcast
Evoke will hold a conference call on
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About
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 timing of top-line data 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, the timing of top-line data completion of the thorough ECG study and Evoke's current trials and
study serving as a basis for submission of a New Drug Application. 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, male companion trial and thorough ECG study, and Evoke cannot be certain that it will be able to obtain regulatory approval for, or successfully commercialize, EVK-001; 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 risk
that the results of the thorough ECG study may not replicate the cardiovascular safety profile observed in patients administered with metoclopramide to date; the inherent risks of clinical development of EVK-001, including potential delays in enrollment and completion of clinical trials and studies; Evoke will require substantial additional funding to complete the Phase 3 clinical trial of and potentially commercialize EVK-001 as well as to finance additional development requirements, and may be unable to raise capital when needed; the potential for adverse safety findings relating to EVK-001 to delay or prevent regulatory approval or commercialization; Evoke's reliance on outsourcing arrangements for many of its activities, including clinical development and supply of EVK-001; 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
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| Condensed Balance Sheets | ||
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2014 |
2013 |
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| (Unaudited) | ||
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 12,176,682 | $ 24,196,691 |
| Prepaid expenses | 1,131,685 | 234,262 |
| Total current assets | 13,308,367 | 24,430,953 |
| Other assets | 82,553 | 555,505 |
| Total assets | $ 13,390,920 | $ 24,986,458 |
| Liabilities and stockholders' equity | ||
| Current liabilities: | ||
| Accounts payable and accrued expenses | $ 1,049,369 | $ 284,915 |
| Accrued compensation | 636,098 | 557,399 |
| Current portion of long-term debt | — | 1,442,592 |
| Total current liabilities | 1,685,467 | 2,284,906 |
| Deferred rent expense | 14,714 | 6,830 |
| Long-term debt, net of current portion | — | 1,511,461 |
| Total liabilities | 1,700,181 | 3,803,197 |
| Stockholders' equity: | ||
| Common stock | 611 | 610 |
| Additional paid-in capital | 44,709,474 | 43,874,119 |
| Accumulated deficit | (33,019,346) | (22,691,468) |
| Total stockholders' equity | 11,690,739 | 21,183,261 |
| Total liabilities and stockholders' equity | $ 13,390,920 | $ 24,986,458 |
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| Condensed Statements of Operations and Comprehensive Loss | ||||
| (Unaudited) | ||||
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Three Months Ended |
Nine Months Ended |
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| 2014 | 2013 | 2014 | 2013 | |
| Operating expenses: | ||||
| Research and development | $ 3,088,373 | $ 78,731 | $ 7,815,466 | $ 320,558 |
| General and administrative | 732,800 | 406,862 | 2,420,167 | 700,489 |
| Total operating expenses | 3,821,173 | 485,593 | 10,235,633 | 1,021,047 |
| Loss from operations | (3,821,173) | (485,593) | (10,235,633) | (1,021,047) |
| Other income (expense): | ||||
| Interest income | 1,725 | 629 | 8,995 | 2,850 |
| Interest expense | (5,906) | (39,940) | (101,240) | (119,570) |
| Change in fair value of warrant liability | — | 39,000 | — | (82,000) |
| Total other income (expense) | (4,181) | (311) | (92,245) | (198,720) |
| Net loss and comprehensive loss | $ (3,825,354) | $ (485,904) | $ (10,327,878) | $ (1,219,767) |
| Net loss per common share, basic and diluted | $ (0.63) | $ (0.41) | $ (1.71) | $ (1.06) |
| Weighted-average shares used to compute basic and diluted net loss per share | 6,054,250 | 1,190,212 | 6,028,309 | 1,153,751 |
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