Tram Bui - The Ruth Group Dave Gonyer - CEO Matt D’Onofrio - Chief Business Officer.

Mitchell Kapoor - H.C. Wainwright Pat Gallagher - Laidlaw & Company.

Greetings and welcome to the Evoke Pharma Second Quarter 2017 Conference. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host Tram Bui of The Ruth Group..

Good afternoon and welcome to Evoke Pharma's second quarter 2017 earnings conference call and audio webcast. With me today are Dave Gonyer, Evok’s Chief Executive Officer; Matt D’Onofrio, Chief Business Officer; and Dr. Marilyn Carlson, Chief Medical Officer.

Earlier today Evoke issued a press release announcing financial results for the three months ended June 30, 2017. We encourage everyone to read today’s press releases as well as Evoke’s quarterly report on Form 10-Q, which is filed with the SEC.

The company’s quarterly report and press releases are also available on Evoke’s website at www.evokepharma.com. In addition, this conference call is being webcast through the company’s website and will be archived there for future reference.

Please note that certain of the information discussed on the call today is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Evoke’s management will be making forward-looking statements.

Actual results could differ materially from those stated or implied by these forward-looking statements due to risk and uncertainties associated with the company’s business.

These forward-looking statements are qualified by the cautionary statements contained in Evoke’s press releases and SEC filings including its annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 14, 2017.

Evoke undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that I would now like to turn the call over Dave Gonyer..

Thank you Tram and thank you all for joining us this afternoon. Well after spending the first half of the year working with key consultants and vendors and securing clinical trial material in preparation for the start of our comparative exposure PK study for Gimoti, we are very pleased to announce that we have begun dosing subjects in the trial.

This marks another important milestone for the company as we work to complete a 505(b)(2) NDA for Gimoti.

And in parallel with the initiation of the PK study with Spaulding Clinical Research, we've engaged Rho, CRO, to assist us with the development and submission of the NDA, which we plan to submit as quickly as possible following the completion of the PK trial.

With that let me highlight the details of the PK trial which we expect to complete by the end of the third quarter with results available in the fourth quarter, all within our previously announced timelines.

The trial is designed to demonstrate a dose of Gimoti that has a similar systemic exposure to that of the currently listed drug Reglan Tablets in a four way crossover study where approximately 100 healthy male and female volunteers will receive Reglan Tablets in three different doses of Gimoti.

Spalding, the company that previously conducted our successful thorough ECG study for Gimoti has a strong track record of success and we expect that their past experience with Gimoti will be beneficial as they conduct our current PK trial.

And additionally, we believe that the incorporated changes through FDA feedback that we received from FDA at our March Type A Meeting further validates the design of the comparative PK trial. As we await the completion and results of this trial, we're concurrently working with Rho to prepare an NDA submission package for Gimoti.

Rho is a well established CRO that has worked on NDA submissions for gastrointestinal products that resulted in FDA approval. We intend to leverage the depth and breadth of their knowledge to develop a successful NDA submission for Gimoti.

As we previously mentioned, FDA confirmed in December 2016 that the comparative PK trial is an acceptable pathway toward a 505 (b)(2) NDA submission and can serve as part of the submission package, which we expect to file by the end of this year or early 2018.

Now as we approach these final stages of our clinical development program, we want to make sure investors understand the recent history and expected steps to an NDA for Gimoti based on discussions with FDA.

Following the unexpected outcome from our Phase 3 trial last summer, we met with FDA on three different occasions to discuss topics related to our potential NDA submission. The positive August 2016 pre-NDA meeting covered topics related to CMC, pre-clinical and other regulatory items.

At the second pre-NDA meeting in December 2016, we described the efficacy results from the Phase 3 study showing statistically significant separation from placebo for patients with moderate to severe symptoms at baseline of which made up over half of the patient population in that study.

And we further discuss Gimoti’s favorable safety profile in comparison to placebo. Based on the data and further discussion, FDA agreed with our proposal to finalize clinical development with the PK trial to show similar exposure of Gimoti to the reference listed drug, Reglan Tablets.

Finally, we had a meeting with FDA again in March to review the planned PK trial protocol and a few other remaining items. We incorporated the FDA’s recommendations into the protocol and have used that to initiate the trial announced today. We’re focused on executing our strategy in completing the PK study in a timely and efficient matter.

Our confidence is reinforced by the support of our focused internal team and exceptional CROs, Spaulding and Rho as well as our investors who have continued to support the company as we have gone through the development of Gimoti.

In closing, let me just reiterate that we in combination with the FDA recognize that there is a need for an effective non-oral product to treat symptoms of diabetic gastroparesis.

We believe that Gimoti, our nasal spray formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis offers an important new treatment option that we look forward to the opportunity to bring it to market.

We remain very excited for the future of Evoke and Gimoti, and believe we have significant opportunity to help patients suffering from this debilitating disease. And with that I'll turn it over Matt to discuss the financials..

Thanks, Dave and once again, thank you all for joining us this afternoon. From a financial perspective, we believe we have been diligently managing our expenses and have a sufficient balance sheet that will allow us to complete the PK study and submit our NDA.

In the second quarter, we reported net loss of 1.6 million or $0.11 per basic share as compared to net loss of 3 million or $0.41 per share for the second quarter of 2016. The net loss from the second quarter of 2017 was partially offset by gain of approximately 1.3 million due to the change in fair value of the warrant liability.

Our research and development expenses in the second quarter were 2 million compared with 2.1 million in the second quarter of 2016. General and administrative expenses in the second quarter of 2017 were 872,000 compared with 803,000 for the six months ended June 30, 2016.

Total operating expenses for the second quarter of 2017 and 2016 were approximately 2.9 million. And finally, turning to our balance sheet, we ended the second quarter with cash and cash equivalents of 12.6 million.

We believe we have a sufficient runway, until at least February of 2018 and potentially longer, depending upon the commercialization spend ramp. That concludes our prepared remarks. Operator, we’d like to turn the call to questions..

[Operator Instructions] Our first question is from Ram Selvaraju of H.C. Wainwright. Please proceed with your question..

This is Mitchell on for Ram. Thank you for taking our questions.

My first question is how granularly will you describe the PK study data whenever you release it?.

This is Dave. It’s a good question.

We've been, debating that back and forth here at the company over the last couple of weeks, certainly we want to wait till we see the data which we expect in the fourth quarter, but likely we’ll identify a dose from that study and probably based upon some, what we believe and hope that there's some IP benefit to doing this trial that will likely identify the dose that we’ll take forward into the NDA..

And any thoughts on the potential Phase 2b data from Vanda Pharmaceuticals with Tradipitant?.

It was interesting. I don't want to comment too much because it was their top line data, but they study three different doses of 5, 15 and 30. They didn't see a dose effect with those three doses, but did see quite a few side effects at the higher doses.

They had efficacy at one dose, which is the lowest dose, but we're not sure how to interpret some of those data based upon the endpoint. Clearly, there is a guidance out there that came out in 2015 on how to do these clinical trials for gastroparesis and also to, how to design an endpoint as well.

It didn't seem that those endpoints were exactly what the FDA may be looking for, but I can't comment too much on that. But it is encouraging for patients with the disease. I mean, certainly, any new product in this marketplace would be beneficial for patients, since there's been nothing since the [indiscernible] in 1980.

We believe that our nasal spray delivery is the best way to deliver a product for this disease because you have a stomach that stopped working, food, drug can’t get through. By delivering a drug nasally instead of orally, you're bypassing the stomach and you have a much better chance of the drug working.

So I think patients are hopeful, we're all hopeful that we can help patients with this disease, but we've seen other products work in Phase 2 as well; in Phase 3, they haven't. So they got a long ways to go from what we can tell.

We’ll have two Phase 3 clinical trials and a pretty large safety database that they'll need to navigate through, so it'll be a few more years after we're on the market for sure..

Our next question is from Yale Jen of Laidlaw & Company..

It’s Pat Gallagher for Yale. And glad the PK Study is moving on a little bit, it’s terrific news.

Is there anything you can do pre-approval to really help raise awareness and get people prepared for potential PK data and then hopefully more news from the agency in the near term?.

So, of course we’ll be on the -- much like last year when we were leading up to the Phase 3 data, we're on the road quite a bit on the phone quite a bit with investors, at different meetings. So we're doing that again as we have done last year, we're doing that now.

So we're spending a lot of time talking to investors, getting them familiar with the pathway that we're taking, how we’re taking it, what -- how quick the study will be done and when we'll have results and then following the NDA.

So it’s going to take a grassroots effort of just being out there in front of folks and putting Evoke’s names back onto a watchlist. I think it drifted off with the news of last July and now we'll put it back on like we did last year.

I wasn't clear on your question about the agency and what expectations you were thinking?.

No. I know there's no expectations there, it can never happen, but I just was getting eyeballs on the story with folks and I think you’ve addressed that and I think that's terrific and it's good for current guys obviously and hopefully into new ones..

Yeah. We're extremely excited. I mean these PK trials, straightforward though you never, you can’t predict what happens, but we've done a PK trial in the past.

It’s in our current slide deck now where we talk about it and you can see in there where we study the 10 milligram and the 20 milligram nasal dose versus a 10 milligram oral dose and you can see we bracketed with those two doses and it looks pretty good.

So assuming we've picked the right dose, which we think we have, we should be in a pretty good spot..

Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the call back to Dave Gonyer for closing remarks..

All right. Well, great. Thank you everyone again for taking the time middle of summer and probably one of the last earnings call. But we appreciate you taking the time. We look forward to providing an update over the next several weeks and look for providing some good information here this fourth quarter and moving forward to an NDA.

So again thank you for participating..

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation..