Evoke Pharma (NASDAQ: EVOK) reported Q1 EPS of ($0.13), $0.06 better than the analyst estimate of ($0.19).

Dave Gonyer, R.Ph., President and CEO, stated, “After successfully completing our comparative exposure pharmacokinetic (PK) trial late last year, we entered 2018 with a discovery of sex-based PK differences for Gimoti. With this significant finding and additional direction from the U.S. Food and Drug Administration (FDA), we are in the process of finalizing our 505(b)(2) New Drug Application (NDA) for Gimoti. The proposed indication for Gimoti is the relief of symptoms of acute and recurrent diabetic gastroparesis in adult women, which comprise an estimated 80% of the patients suffering from the disease. In line with prior guidance, we plan to submit the NDA in the second quarter.”

Mr. Gonyer continued, “We have continued to efficiently manage our cash resources and have benefited from the waiver of the Prescription Drug User Fee Act (PDUFA) NDA submission fee and Mallinckrodt’s agreement to defer near term milestone payments until one year after approval of Gimoti. We believe our current cash will now extend until April 2019. We look forward to holding a conference call later this quarter once the NDA is submitted to FDA.”

First Quarter 2018 Financial Review

• For the first quarter of 2018, net loss was approximately $2.0 million, or $(0.13) per share, compared to a net loss of approximately $5.1 million, or $(0.37) per share, for the three-month period ended March 31, 2017.
• Research and development expenses totaled approximately $1.4 million for the three months ended March 31, 2018, compared to approximately $0.8 million for the three months ended March 31, 2017. For the first quarter of 2018, general and administrative expenses were approximately $1.0 million, compared to approximately $1.2 million for the first quarter of 2017.
• Total operating expenses for the three months ended March 31, 2018 were approximately $2.4 million, compared to approximately $2.0 million for the same period in 2017.
• Included in net loss for the first quarter of 2018 was a gain of approximately $433,000 due to the change in the fair value of the warrant liability. The warrant liability was subject to remeasurement at each reporting period until the time the warrants were amended in March 2018. We recognized any change in the fair value of the warrant liability in the statement of operations. Following the amendment of the warrants, the warrants were reclassified to equity and no longer require remeasurement on a quarterly basis.
• As of March 31, 2018, our cash and cash equivalents were approximately $5.4 million.

For earnings history and earnings-related data on Evoke Pharma (EVOK) click here.