Evoke Pharma (EVOK) Tops Q2 EPS by 2c

August 15, 2016 4:35 PM EDT
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Evoke Pharma (NASDAQ: EVOK) reported Q2 EPS of ($0.41), $0.02 better than the analyst estimate of ($0.43).

As of June 30, 2016, the Company's cash and cash equivalents were approximately $4.1 million.

Dave Gonyer, R.Ph., President and CEO, stated, “Following the results of our recently concluded Phase 3 study of Gimoti™, our nasally delivered metoclopramide product for the treatment of diabetic gastroparesis in women, we continue to analyze the incoming data to further understand the trial outcome. While conducting our review, we are also developing potential regulatory submission strategies based on our findings.

“Although this trial with Gimoti did not demonstrate a statistically significant improvement over placebo for the primary endpoint, it is important to remember that metoclopramide, in oral and IV dose forms, is the only drug approved by the FDA to treat symptoms associated with diabetic gastroparesis. In previous pharmacokinetic and placebo controlled clinical trials, we have demonstrated that dosing with metoclopramide nasal spray achieves comparable blood levels in both healthy volunteers and diabetic gastroparesis patients. Additionally, in our Phase 2b study, Gimoti provided statistically significant improvement in the symptoms of gastroparesis in female subjects, and we will continue to work with the FDA to pursue a path to approval of Gimoti.

“Importantly, we recently completed financings for $14.5 million in gross proceeds to support the continued review and development of potential clinical and regulatory strategies for Gimoti. This represents a significant investment in Evoke, which we believe demonstrates investor confidence in Gimoti’s potential to benefit patients suffering from gastroparesis and helps position us to explore potential options as we work to get Gimoti to market. We appreciate the support of our shareholders and continue to believe nasal delivery of metoclopramide is a clinically‑important alternative to oral and injectable formulations in this symptomatic population of diabetic gastroparesis patients.”

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

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