David Burke - The Ruth Group Dave Gonyer - CEO Matt D’Onofrio - Chief Business Officer Marilyn Carlson - Chief Medical Officer.

Yale Jen - Laidlaw and Company Vernon Bernardino - FBR Capital Markets.

Greetings and welcome to the Evoke Pharma Second Quarter 2016 Conference Call. 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, the conference is being recorded.

I would now like to turn the conference over to your host, David Burke of The Ruth Group. Please go ahead..

Thank you. Good afternoon and welcome to Evoke Pharma’s second quarter 2016 financial results conference call and audio webcast. With me today are Dave Gonyer, Chief Executive Officer; Matt D’Onofrio, Chief Business Officer, Dr. Marilyn Carlson, Chief Medical Officer of Evoke Pharma.

After the close today, Evoke issued a press release announcing financial results for the three months ended June 30, 2016. We encourage everyone to read today's press release as well as Evoke’s quarterly report on Form 10-Q, which is filed with the SEC.

The Company’s quarterly report and press release are 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 provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Evoke management will be making forward-looking statements.

Actual results could differ materially from those stated or implied by these forward-looking statements due to risks 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 15, 2016.

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

Dave?.

Thank you, David. And thank you all for joining us this afternoon to discuss the second quarter of 2016, our recent Phase 3 clinical trial results and the future for Evoke and our product candidate Gimoti, which was previously referred to as EVK-001. We're pleased that we recently received the FDA's conditional approval the proprietary name.

This action further demonstrates our belief that there is value in pursuing their approval of our product candidate for the treatment of diabetic gastroparesis in women. Following my remarks, our Chief Business Officer, Matt D’Onofrio, will discuss Evoke’s financial results before we open the call up to questions.

I would like to take this opportunity on this call to speak with the investors, analysts and stakeholders of Evoke, following the recent release of our Phase 3 study results to provide a general overview of what Evoke has been working toward over the past few weeks and to discuss the strategy going forward.

Most importantly, I want to provide assurance that we're continuing to work toward approval and commercialization of Gimoti for the symptomatic treatment of women with diabetic gastroparesis. While I am unable at this time to provide the specifics on the particular aspects of the data, I will provide comments on our ongoing review and next steps.

As I am sure you're all aware, our Phase 3 trial did not achieve the primary end point of having a statistically significant improvement of symptoms over placebo and needless to say, we're quite surprised by these results.

As we discussed in the press release of the 41 sites that enrolled in the trial, patients reported a positive response to drug at 28 of the sites and at 13 of the sites, placebo improved patient symptoms over active according to the patient reported outcome scores.

We find this confounding in light of the positive results for Phase 2B trial and what Gimoti did provide us statistically significant improvement in female patients with gastroparesis. We're continuing to review and analyze the data to better understand the results of the trial.

At this point and as data continues to come in, it would be premature to comment on our findings to date. We can say that we have spent time confirming and to our knowledge there are no systemic issues in how the trial was conducted, how the data was collected and how the analysis was performed.

Of course, these are not the only reasons for which unexpected results can occur, but it was important that we -- that they be investigated and ruled out.

We've also ruled out study drug assignment errors, based on PK data there are metoclopramide blood levels in patients randomized active study drug and the absence of metoclopramide blood levels in patients randomized to placebo.

I want to reiterate that analysis of our data continues and it's been ongoing since we announced topline data results just four weeks ago. Those of you who are familiar with clinical trials and data analysis, understand that this is a very arduous process, especially when results conflict with what was learnt in earlier studies.

This can take a considerable amount of time as we not only are reviewing possible rational and subgroup analysis within the Phase 3 trial, but are also comparing the data to our Phase 2b trial. When we are fully confident that we have definitive answers we'll provide them.

While conducting our review, we're 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 both oral and IV dose forms, is the only drug approved by the FDA to treat symptoms associated with diabetic gastroparesis.

In previous clinical trials, we've demonstrated that dosing with metoclopramide nasal spray achieves comparable blood levels in both healthy volunteers and patients with diabetic gastroparesis.

Additionally, in the Phase 2b study, a female patient with diabetic gastroparesis Gimoti provided statistically significant improvement in the symptoms of the disease. We currently believe there are potential opportunities for Gimoti and we will continue to explore all possible routes to approval and commercialization.

This will require discussions with the FDA, which we anticipate to take place in the near term. Throughout this clinical development process, the agency has been very supportive of our efforts. In order to move forward with the exploration of potential regulatory pathways to an NDA and marketing approval we strengthened our balance sheet.

We raised gross proceeds of approximately $14.5 million since the announcement of the Phase 3 results. With these financings, we were able to repay our outstanding debt and enhance our financial flexibility. This is also significant as we believe it demonstrates investor confidence in Evoke and provides validation of our efforts to move forward.

With all this said, we are in the process of developing long-term strategy that will create value for the company and its shareholders.

It'll take additional time to review and accurately analyze all of the results in order to develop the complete understanding of the sites, patients and end points to make an informed and confident decision regarding our next steps.

As we receive information that is material for the company and important for shareholders' awareness, we'll communicate the information. We appreciate the continued support of our shareholders and remain very excited about the market opportunity for Gimoti and the potential to serve an unmet need for female diabetic gastroparesis patients.

And with that, I'd like to turn it over to Matt to discuss the company's financial results for the quarter..

Thanks Dave. Once again thank you all for joining us this afternoon. For the second quarter of 2016, the net loss was approximately $3 million, or $0.41 per share, compared to a net loss of about $3.2 million or $0.52 per share for the three-month period ended June 30, 2015.

The year-over-year decrease is primarily attributable to the completion of our Phase 3 clinical trial and a switch to focus and data collection. Research and development expenses totaled approximately $2.1 million for the three months ended June 30, compared to $2.2 million for the same period of 2015.

The decrease was due to the completion of our clinical trial as previously noted. For the second quarter of 2016, general and administrative expenses were approximately $800,000 compared with approximately $976,000 for the second quarter of 2015.

And the total operating expenses for the quarter were approximately $2.9 million, compared to total operating expenses of approximately $3.2 million for the three months ended June 30. More recently, during the current quarter, we utilized our access to the capital markets to strengthen our balance sheet.

In total as Dave previously noted, we raised approximately $14.5 million in gross proceeds through two separate registered direct offerings, both of which were priced at the market.

In the first transaction, we raised approximately $4.5 million in gross proceeds with the issuance of approximately 1.8 million shares, purchased shareholders received a warrant to purchase three quarters of the share common stock.

In a second transaction we raised approximately an additional $10 million in gross proceeds, issuing approximately 3.2 million shares with shareholders receiving a warrant to purchase one half of a share of common stock for each share purchased in the offering.

With this capital, we were able to repay our outstanding debt facility of $4.5 million, which elevates us of any financial covenants associated with the debt and eliminates approximately $0.25 million in interest expense on an annual basis.

We believe these investments and debt extinguish put the company in a good footing to address the Phase 3 results and possible regulatory interactions in the near term.

We've stated our resources will support the company at least until the end of 2016, but I want to reiterate, the company remains very streamlined with only seven full time employees and a Phase 3 trial as it wraps up, that creates limited ongoing expenses.

At the next quarterly conference call we'll plan to update our expected cash runway to better determine our clinical and regulatory strategy and financial implications of those activities.

Finally as Dave said earlier, we believe the recent investments made by firms that have recently filed 13G forms show continued interest and support of the company and its further development of Gimoti and the opportunity to help those with diabetic gastroparesis.

That concludes our prepared remarks and we can turn it back over to the operator for questions.

Operator?.

Thank you, sir. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question today comes from Ram Selvaraju of Rodman & Renshaw. Please go ahead. [Operator Instructions] Mr. Selvaraju from Rodman & Renshaw. Your line is open. Please proceed with your questions..

We'll move to next question then come back to Ram..

Yes sir. The next question comes from Yale Jen of Laidlaw and Company. Please go ahead..

Good afternoon and thanks for taking the questions. I have two may be you can help us what, the first is that you've mentioned that there is two third of side or two third of patient that have a positive result from drug treatment where the remaining one-third has totally opposite outcomes.

I know you guys do try to figure the things out, but do you have any theory or hypothesis at this point to try to sort of pass or approve to see what happens because -- is this a little bit off that in a way that if there are certain sides that was positive, where the other side could be -- may be even instead of between the treatment and placebo group in this case actually they actually perform better.

So, could you elaborate more on this situation?.

Yeah, thanks for the question, this is Dave. Right now we’re not going to terrorize, we’re getting through each site, each patient level piece of data as well. So, I think it would be best if we wait till we have all our data together to verify specifically what may or may not have happened at those individual sites..

Okay. That’s good. Also you mentioned [already] in the prepared remarks that you are exploring the strategy for commercialization.

Was there a way that was there additional clinical study that can be done or were there any precedence for that or is something in a different venue of thinking you're exploring?.

Well, I will say, as I said earlier metoclopramide has been available for 35 years. It's well characterized in the marketplace as an IV and oral. It is indicated for this disease. So it's well characterized. So, as we explore all options, we use the history of the product being on the market, as kind of our marker.

Now I’m sure there is specific examples of other products that have gone down past that have led them to a regulatory approval based upon past data, but until we get to meet with the FDA, we don't know exactly what would transpire..

Okay. That’s helpful. And then maybe I just sneak in a last question here, which is that the Phase 3 study was using 10 mg of metoclopramide, my question is that that seems to be the starting dose of the oral drug and frequently patient has -- the physician may be up-titrating the dose if patient is not adequately treated.

So my question is, was 10 mg so far you think do appropriate or you may consider maybe that's some sort of up-titration or were not in terms of changing the dosing at a same time contemplate the possibility not to hitting too much on the potential to have touching on the black box label of concerns and thanks for answering this..

Yes, good question Yale. In terms of the 10 milligram dose, is chosen based upon the results that we have from our Phase 2b trial where the 10 and a 14 had very marginal differences in terms of their ability to lower symptoms of these patients.

And also we have our Phase 2a studies that we purchased from course when we got the product that show that a 10 milligram and 20 milligram dose worked better than the oral medication and those were pretty similar in terms of results as well. So we feel pretty confident with the 10 milligram dose that we had in Phase 3..

Okay. Great. Thanks a lot. I appreciate it..

Thanks, Yale..

[Operator Instructions] Our next question comes from Vernon Bernardino of FBR Capital Markets. Please go ahead..

Hi guys, thanks for taking my questions. Regarding the number of patients as far as the study is concerned, now you had mentioned like Yale had also mentioned, 28 sites and then 13 sites.

Do you know how many patients obviously hopefully now by now the number of patients were in those 28 sites versus the 13 sites?.

There is roughly two thirds, one third. We do know the number Vernon. We don't have it in front of us right now, but it's about two thirds one third..

Two thirds, one third, okay. And then obviously you would want to just go to the FDA with these results, if you can find the lining of the results that show that it was positive and determine registration strategy.

Have you thought that you might require conducting another Phase 3 study?.

Well again, we’ll look at all the options that are before us and also it’ll be determined by the FDA I would suspect. So you're exactly right. We're looking for the lining of the data.

And as we do that and perform a strategy to go to the FDA, so it will be up to them to let us know what they'll want to see obviously, but that's exactly what we're doing now..

Okay.

And then two last questions if I may, which percentage of metoclopramide usage are diabetic gastroparesis patients?.

Right. It's one of the more common causes depending -- this is Marilyn Carlson, hi..

Hi Marilyn..

Depending on the reference you use, it's one of the more common causes; however idiopathic depending on the series that someone looks at may also factor in that are relatively equivalent number of patients and then there is this other basket, so idiopathic meaning we don't know, but not diabetic.

And then there's another group that are post-surgical and other kinds of causes, and so I would say somewhere between a third and a half would be diabetic gastroparesis..

Terrific and what percent of current gastroparesis patients using metoclopramide pills are dissatisfied with the pill and could perhaps prefer the spray?.

Yeah Vernon, this is Matt D’Onofrio. Based on them -- hello, thanks for the questions, we've done a fair amount of market research and thankfully and partly because there are so few treatments or really just the one that's approved, it makes for a pretty straightforward series of questions to physicians to understand how they do treat these patients.

Right now since the only approved product is oral metoclopramide on outpatient basis, that's the one that's used the most often. However, even in that regard, we find anywhere between 50% to 80% of diabetic gastroparesis patients or gastroparesis patients in general are actually taking metoclopramide.

The others are likely either using diet modification where they change their diet to much smaller meals, more frequent meals, more liquid meals, different fat content that sometimes can have a very minor helpful effect and there maybe some other patients who are taking Erythromycin, which is used occasionally off label to help these patients, but again most physicians don't like to do that because it's an antibiotic and so there is issues with giving a patient any infectives long term without actually having an infection and it's known to be transient in effect meaning the patient tends to be compensating effect where it only lasts where it only lasts for a few days and then it tends to go away.

So we do believe that even the four million prescriptions that are currently being written of oral metoclopramide still only represents a relatively small portion of the overall opportunity and there is much more on the outset that's likely available for new help out with along with those patients that are currently unsatisfied with the oral version as it is..

Great. And one more question before I get back in the queue. Now you have confirmed that the spray device for this trial was the same as the one used in the Phase 2 trial with the men and women. Was the vehicle the same, and was there any difference as far as the taste is concerned between the EVK-001 fluid sprayed versus the placebo sprayed..

No it is exactly the same, same spraying device, same formulation as in Phase 2..

Okay.

And there was no taste?.

No it’s the same, exactly the same..

Okay. Thanks for taking my question, appreciate it..

Hey Vernon your first question I'd like answer too, we were able to get the specific numbers, you asked the questions of how many patients were in the 28 sites and how many in 13? You can imagine we're looking at so many different numbers over the last four weeks that that was an easy one, I also didn't know.

It was 130 in the 28 sites 75 patients in the 13 sites..

Okay. Terrific.

Now if you combine the study, then the P value was not statistically significant?.

That's correct..

Just want to confirm the math..

Yes..

Okay. Thank you very much..

Thanks for your question..

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

Great. Thank you everyone for participating in the call today. We appreciate your time and we look forward to keeping everyone up to date on our progress and developments over the next several weeks and months. Thank you..

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