Tram Bui - The Ruth Group David Gonyer - Chief Executive Officer Matthew D’Onofrio - Chief Business Officer Marilyn Carlson - Chief Medical Officer.

Ram Selvaraju - Rodman & Renshaw Yale Jen - Laidlaw & Company.

Greetings and welcome to the Evoke Pharma First Quarter 2017 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] I would now like to turn the conference to your host today, Mr. Tram Bui or the Ruth Group. Please proceed..

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

Earlier this afternoon, Evoke issued a press release announcing financial results for the 3months ended March 31, 2017. 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 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 included in 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, May 15, 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 for Evoke Pharma’s first quarter 2017 earnings conference call. Well, we started the year off with some very positive developments which are bringing us closer and with our planned timeline to following our NDA or New Drug Application for Gimoti.

We believe that our FDA meetings and the agreements reached with the agency have provided us with a clear path forward. The positive developments include FDA’s agreement that a comparative exposure of Pharmacokinetic or PK Study of Gimoti in healthy volunteers can serve as the basis for a 505(b)(2) NDA submission.

Earlier this year the FDA agreed that we do not need to conduct a Human Factors validation study and most recently confirmed the acceptability of the design for the planned PK Study of Gimoti. With that all of us at Evoke are keenly focused on completing these remaining requirements to finish the data package needed for the NDA submission.

Working closely with FDA on this late stage development program, we believe that FDA recognized the unmet medical need for an effective treatment for gastroparesis that has a favorable safety profile. We had two very positive face to face PRE-NDA meetings with FDA in the second half of 2016 and a third meeting by teleconference in March of this year.

At our second PRE-NDA meeting this past December, we presented data from our Phase 3 study of Gimoti, which demonstrated efficacy benefits that were clinically and statistically significant in women with moderate to severe diabetic gastroparesis symptoms at study entry.

As a result of these discussions, FDA has agreed that a healthy volunteer comparative exposure PK Study can serve as the portion of our NDA submission for Gimoti and that additional clinical trials will not be required.

As of February 2016, drug products classified as a drug, device combinations such as Gimoti must undergo evaluation that may require Human Factor validation study as described in the new guidance. Earlier this year, FDA agreed that we do not need to conduct a Human Factors validation study for Gimoti.

The exemption was based on our Human Factors validation repost submitted to the FDA last year. Our assessment use the risk analysis known as a failure mode in the sex analysis taking into account the various factors associated with the use of Gimoti. We’re pleased that FDA agreed with the conclusion of our report.

This eliminated us of the test or requirements that would have cost additional time and capital and allows us to focus on initiating the PK Study. Since December, we’ve been working to prepare for the launch of our PK study.

The official minutes from our March Type A Meeting, acceptability of the protocol design of our study and agreement and chemistry, manufacturing and controls items associated with our proposed NDA was established. We’re now in the final planning stages for the study, which would be conducted by Spaulding Clinical Research.

We’ve worked with Spaulding in the past when they successfully completed our Thorough ECG or Thorough QT trial on time and on budget in 2014. The team at Spaulding has experience with conducting studies using nasal spray formulation which gives us added confidence in their ability to conduct a successful study.

The PK Study will be conducted in approximately 100 healthy volunteers and is designed to establish comparative exposure of Gimoti with the listed drugs Reglan Tablets currently the standard of a care for gastroparesis.

We look forward to initiating and completing the PK Study in the second half of this year, which we will believe will conclude the clinical development work for Gimoti. We then expect to finalize the NDA by the end of this year or early 2018. Before I conclude and hand the call off to Matt, let me like our strong financial position.

As of March 31, we had $14.7 million on the balance sheet after a successful $8 million capital raise in February, which netted us a little over $7 million.

Our balance sheet now gives us runway into early next year, at least to February 2018 depending upon our commercialization ramp and allows us to focus on completing the PK Study and finalizing the NDA for Gimoti.

We continue to be supported by a group of long-term investors who reaffirm their confidence in Evoke by participating in the latest financing round. We’ve continued to make progress on our outlined objectives for 2017 and believe that we’re on track to take Gimoti through a successful PK Study, NDA submission and eventually to market.

Our constructive dialog with FDA gives us confidence that with our updated development plans or path for Gimoti, the agency recognizes the need for an effective treatment for diabetic gastroparesis. We look forward to keeping you informed over the coming months as we launch our PK Study and gear up for the NDA.

And now I’ll let Matt discuss the financials..

Thanks, Dave and once again, thank you all for joining us this afternoon.

From a financial position, to reiterate what Dave said, we had a great start to 2017 with our successful public offering of 2.8 million shares at $2.90 per share, which brought in about $8 million in gross proceeds investor validation of our strategy, allows us to be in a stronger cash position as we advance our PK Study and NDA filings.

We appreciate the new investor support and understanding of our long-term opportunity.

In the first quarter we reported a net loss of 5 million or $0.37 per share based on weighted average shares outstanding of approximately 13.5 million shares as compared to a net loss of 3.2 million or $0.45 per share based on approximately 7.2 million weighted average shares outstanding for the first quarter of 2016.

Our research and development expenses for the first quarter were 770,000, down from 2 million in the fourth quarter 2016. General and administrative expenses in the first quarter of 2017 were 1.2 million compared with 1.1 million for the three months ended March 31, 2016.

Total operating expenses for the first quarter were approximately 2 million compared to total operating expenses of 3.2 million in the first quarter 2016. Included in the net loss for the first quarter of 2017 was a reduction of net loss due to the change in the fair value of the warrant liability of approximately 3.1 million.

The warrant liability is subject to re-measurement at each reporting period and we recognize any change in the fair value of the warrant liability in the statement of operations.

We anticipate that the value of the warrants could fluctuate from quarter-to-quarter and that any fluctuation could have a material impact on our financial statements from quarter-to-quarter and year-to-year. Finally, turning to our balance sheet, we ended the first quarter with cash and cash equivalents of 14.7 million.

We believe this will sufficiently fund as through the release of our data from our PK Study and until at least February 2018 depending upon the commercialization spend ramp. That concludes our remarks and we’d like to now open the call to questions..

Thank you. At this time we’ll conduct a question-answer-session. [Operator Instructions] Our first question comes from Ram Selvaraju with Rodman & Renshaw. Please proceed with your question..

Hi, thanks very much for taking my questions, just a couple of quick ones.

Firstly, could you just indicate to us whether there has been any significant changes in your thinking regarding design of the PK Study, in particular with respect to the number of doses you expect to test as well as the total of number of subjects who’re likely to be enrolled in the PK Study? Secondly, could you verify for me whether you expect the existing cash resources to be sufficient to fund operations through the submission of the 505(b)(2) NDA or only through the completion of the PK Study? And then finally, if you could just verify whether or not you anticipate reporting the PK study as follows, namely press releasing when the first patient is in, when the first patient is out and reporting the data or if you’re going to report the progression of the PK Study in some of other way, please.

Thank you..

Hey, Ram. This is Dave. Thanks for the questions. I’ll have the first one and third one, Matt in jump in for the cash question. But yeah, for any significant changes in design or number of doses and number of patients, no, we have a - when we met with FDA, we had a very nice dialog, the acceptability of the protocol was pretty ideal from our standpoint.

So we feel that what we submitted to the agency was sufficient and they accepted it. So that piece of it was very good.

And maybe I’ll jump to number three as well, in terms of reporting, we’re still working through what’s going to be the best strategy of reporting, but will likely let everyone know when we do start the study, so everybody is up to speed exactly when the study started.

And that will make some determination, what would be the best route to continue providing that information.

Did that answer your questions or you want any follow up?.

Yeah, I mean that’s reasonably straight forward. Obviously, I think that has much additional color that you can provide ahead of the start of the study regarding how you will report the study would be very helpful. Thank you and the last question please..

Sure, this is Matt. Hey, Ram. We’ll definitely have cash out to submission of NDA keeping on the timeline we described..

Thank you..

Thanks Ram..

Our next question comes from the line of Yale Jen with Laidlaw & Company. Please proceed with your question..

Good afternoon and thanks for taking the questions. First question is that, we get a little bit color in terms of when you plan to the start study, given the second of half of this year and you anticipate to have the data probably toward - also in the second half of this year.

So would that be fair to think that the trial is more likely to start in the third quarter?.

Hey, Yale. It’s Dave. So maybe I’ll start with kind of discussing our plan for with the NDA. We’re looking to file the NDA at the end of this year. So obviously need some time before - or early 2018, obviously need some time to have the study has been completed in order to put that into NDA.

So we’re pushing very hard to get it started just as soon as possible. So without giving a specific date and time, with the end goal in mind, you can probably work back from there..

Okay, that’s very helpful. That’s almost guided and tell me all of the details already, I appreciate that.

Second question is that you guys already have enough material, not only for this study, but potentially prepared for commercialization or something you need to prepare going forward?.

Yeah, it’s good question. So we’re preparing clinical trial material as we speak. As you might imagine, when we had met with the FDA in mid December, we didn’t know where we would walk out, what - walk out with that meeting.

So fortunately with the very successful meeting allowed us to path forward with this comparative exposure trial that we’ll move forward with. With that we had a ramp up and we were prepared to make clinical trial material at that time. As we didn’t think we would be going forward with a study like this. So that’s being done now.

We’ve acquired and cumulated all the appropriate pieces of the pump et cetera, API, in order to manufacture enough drugs moving forwarded to the trail..

Okay, great and the last question is probably for Matt, it’s a housekeeping question, that we look at the P&L, on the operating side there’s a decrease in R&D and too much increase in SG&A, just for modeling purpose, should we consider - I guess I probably anticipate increased R&D expenditures, but do we also anticipate a more spread SG&A expenditure for remaining of the year? Thanks..

Sure, Yale. It’s Matt.

Yeah, we don’t anticipate a significant ramp up in terms of SG&A, we kept that pretty down flat over the course of the last few year as it is, but - and you’re also correct in that while a lot of our prior research ahead has come to a close for the Phase 3 and otherwise, we’ll be ramping up to an certain extent in terms of manufacturing for the trial and then also running the PK trial itself here in the near term.

So I think you probably have a pretty good handle as to where we’re going to be out with that. The NDA also, we’ll be spending some additional funds there in putting all that together..

Do you - last one attached to it that - is there maybe one 1 million or 2 million expenditure needed for NDA or does one way you can wait [ph] from that?.

Are you referring to waver of the fees associated with that with the FDA itself or are you talking about internal process?.

Yeah, ways that these be needed to send to FDA to for the filing?.

So we will have internal cost in terms of consultancy to help piece together the overall package and that usually is like anywhere from 1 million to 2 million, typically out of the industry and you can the result that will still be in that range..

Okay, great. Thanks a lot and again, congrats on the progress..

Thank you..

Thanks Yale..

[Operator Instructions] At this time I’d like to turn the conference back over to management for closing remarks..

Great, thank you everyone joining. As I said earlier, we’re keenly focused on moving this process forward with the PK initiation. The team is working fantastically well with the groups outside the company as well to get this completed.

We’ll update investors and keep you informed over the coming months and as we launch the PK Study and we gear up for the NDA. Again we appreciate your time today..

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time and thank you for your participation..