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

Yale Jen - Laidlaw and Company Ram Selvaraju - Rodman & Renshaw Nathan Cali - Noble Financial Difei Yang - Brean Capital Ben Hayner - Felton and Company.

Greetings and welcome to the Evoke Pharma First Quarter 2016 Earnings 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. It is now my pleasure to introduce your host, David Burke of The Ruth Group.

Please go ahead..

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

Earlier today, Evoke issued a press release announcing financial results for the three months ended March 31, 2016. We encourage everyone to read today’s press release as well as Evoke’s quarterly report on Form 10-Q which was 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 filing. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 11, 2016.

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 to Dave Gonyer.

Dave?.

Thank you, David. Thank you all for joining us this afternoon to discuss Evoke’s financial results for the first quarter of 2016, and a brief update on our outlook for the business over the next several months.

Following my remarks, our Chief Business Officer, Matt D’Onofrio, will discuss Evoke’s financial results before we open the call up for questions. Let me just start by saying the last couple of weeks have been very eventful for Evoke as we hit an important milestone for the company.

We are now in the midst of a pivotal and very exciting time and we anticipate continued excitement over the coming weeks and months. We recently announced that Evoke had completed enrolment of our Phase 3 study with EVK-001, our last study before submitting a new drug application of which we expect results early next quarter.

For those patients currently suffering from gastroparesis and for participants in our clinical trials with [Indiscernible] has to get EVK-00l to help with their daily struggle. We are hopeful that the results of the trial will open the door for an NDA submission, potential FDA market approval and commercialization.

As we approach results on the Phase 3 study, we have several reasons to be confident in the future results in EVK-001 our novel, nasal, delivery formulation of metoclopramide for the treatment of gastroparesis in diabetic women.

First, metoclopramide is the only molecule specifically approved by the FDA for gastroparesis, however the oral formulation currently used for treatment outside the hospital may not be appropriate for all patients, as the disease itself can inhibit absorption of oral medications due to delayed gastric tempting or even in nausea and vomiting associated with gastroparesis.

Consequently, this unpredictable absorption may prevent consistent relief as symptoms for patients. The alternative delivery provided by EVK-001 may help us relieve some of these issues by avoiding a dysfunctional GI tract.

Nasal delivery allows the drug to directly enter the blood stream and potentially provide a more predictable or reliable dosage of the drug than the oral formulation. And according to market research the physicians who treat the disease, this is a very important clinical benefit in helping patients with gastroparesis.

Second, we have had success in previous studies showing clinical benefits in patients, specifically our large Phase 2b study, and we hope to see similar results in our Phase 3 study as it was designed to be comparable with the successful Phase 2 trial in women.

Third, we’ve begun planning and preparing for a potential submission of a new drug application with the expectations to meeting the applications to the FDA as soon as possible after final study results are achieved. And lastly, the gastroparesis market represents a large, growing and underserved opportunity.

We estimate the total prescription market for EVK-001 to be approximately $3 billion to $4 billion with only $2 million to $3 million of an estimated 12 million to 16 million patients currently receiving treatment each year.

EVK-001 has the potential to provide much needed relief to the millions of patients that suffer from the debilitating and life changing condition by providing a more predictable delivery of metoclopramide. And because of this large untapped market opportunity, we’ve begun taking steps towards the potential commercialization of EVK-001.

Before I turn it over to Matt to discuss financials and an update on the competitive landscape for gastroparesis, let me just say again, this is a pivotal time for Evoke and we are well prepared as an organization. We believe we have positioned the company for future success from a clinical, regulatory and commercial perspective.

And with Phase 3 data expected to be just a few months away, we are extremely excited about where we are headed and what the rest of the year will bring.

Matt?.

Thanks David. And once again thank you guys for calling in on today’s quarterly conference call. For the first quarter of 2016, net loss was approximately $3.2 million, or $0.45 per share, compared to a net loss of approximately $3.5 million, or $0.58 per share, for the three-month period ended March 31, 2016.

The year-over-year decrease is primarily attributable to our ongoing clinical trials for which expenses decreased as we approached the end of enrolment and began moving toward data.

Research and development expenses totaled approximately $2 million for the three months ended March 31, 2016, compared to approximately $2.4 million for the same period in 2015.

The change was due to the advancement of our clinical trials as previously noted and for the first quarter of 2016 general administrative expenses were approximately $1.1 million compared with approximately $1 million for the first quarter of 2015.

Total operating expenses for the quarter were approximately $3.2 million, compared to total operating expenses of approximately $3.4 million for the three months ended March 31, 2015. As of March 31, 2016, the Company's cash and cash equivalents were approximately $6.1 million.

As previously stated, we expect our cash position will provide us vision [ph] capital to complete our Phase 3 clinical trial and provide data which is expected early in the third quarter.

As Dave mentioned earlier, Evoke has begun preparations for the potential commercialization of EVK-001 given the entire patient need and only a single product currently approved to treat the symptoms of gastroparesis here in the U.S.

Unfortunately for patients, other competitor development programs are significantly behind EVK-001 and the development process. More importantly, we are unaware of any other development program that has prospectively shown patient report and symptom efficacy in a gastroparesis patient in the recent past.

This is most recently demonstrated with the termination of Ironwood’s IW-9179 program just a few weeks ago. Although this is clearly not good news for those suffering from gastroparesis it highlights pure competitive products entering the commercial market in the future.

Additionally, we note that GSK962040 from Glaxo has reported in clinical trials outcome that their trial completed in August of last year and have thus far not reported any results and our opinion given the drag guidance 58 [ph] provided for endpoint development and the time required to run clinical trials for new chemical entities if approved Evoke may have several years headstart commercializing an optimized version of the only approved product before any possible other product would enter the market.

That concludes our prepared remarks. We appreciate your attendance and are excited in the near future for Evoke. At this time, we will turn it over to the operator for questions..

Thank you. At this time, we will be conduction a question-and-answer session. [Operator Instructions] The first question is from Yale Jen of Laidlaw and Company. Please go ahead..

Good afternoon and thanks for the update and congrats on the progress and we are encouraged [ph] to see what happened in earlier months instead of a longer period of time.

My first question is that should the data be positive and do you guys have guided before that when you presented at some medical conference possibly in the second half of this year given that you are already approaching that time -- that data topline released have you [Indiscernible] focus or giving a better sense of what medical meeting might possibly to present this and possible timeline on that?.

Thanks, Yale. We are excited to as you can tell to have data in the next few months and early in the third quarter. It is exciting so we are looking forward to that. Unfortunately or fortunately, we are missing DDW in terms of being able to announce any results. That’s coming up in two weeks. We are however, Dr.

Carlson is presenting a poster on our therapeutic [ph] results there which was accepted, it’s fantastic. But in the second half for GI meetings there is nothing that we would deem appropriate to put the message out on the results.

We will announce obviously through a press release and likely a conference call as well to have a discussion on the results with investors..

Okay, great.

Another follow up question here, second question is that, I know you guys are already started the process of preparing the mission and their relevant work, could you give a little more color in terms of how things has progressed at this point, any details or regarding a specific data at this stage you should do and maybe other things to follow half the reported data, reporting of the data?.

Sure. So we’ve hired a firm, a regulatory consultants firm who has filed a number of NDAs. They are helping us, while we have a team probably got a very strong team, folks that we’ve worked with in the past who have gone to the FDA with us, they know our program very well.

The team here has been collecting all the appropriate information that we’ll need for a 505(b)(2) NDA which we have much of it I’d say. The last piece will be this Phase 3 study to drop in.

So we are trying to get as much done now as we wait for data and then of course with a pre NDA meeting that we’ll have with the FDA at some point which will guide us as well. But we have not given a specific timeline when we’ll have an NDA prepared, but we hope to in the near future..

Okay, the last question, my last question is that is there any other CMC issues you need to deal with or already in preparation for potential submission. And thanks for taking the questions..

Thanks Yale. No nothing specific that I can say on that. It’s been -- we’ve had a number of years to work on the CMC section.

We’ve had meetings with the FDA in the past with the end of Phase 2 meetings and everything we presented to them there was acceptable and we also just to remind everybody we do have three years registration stability on the molecule and also I think we announced this year, this year that we are able to scale up on a commercial scale level.

So I believe we are in a pretty good spot there..

Okay, thanks a lot. I appreciate that. And congrats..

Thanks Yale..

The next question is from Ram Selvaraju of Rodman & Renshaw. Please go ahead..

Hi, thanks very much for taking my questions and congratulations again on all the progress you’ve made. Its’ obviously very exciting to see you get so close to the finish line now.

I wanted to specifically drill down on what you think are likely to be the total expenditures associated with the actual preparation and filing of the NDA assuming obviously that the Phase 3 data are positive.

Secondly, I wanted to see whether you have any additional updated information on the market research side concerning how the product could potentially be positioned from a reimbursement and the market access standpoint.

And then finally, if you could perhaps provide us with some additional commentary regarding how your strategic thinking is evolving with respect to whether or not you would look for a distribution arrangement for the product potentially seek to prepare to launch it independently, and if you were to consider the possibility of launching it independently if you do that it be a proprietary or a rented sales force? Thank you..

Ram, this is Matt D’Onofrio. Thanks so much for the question; we always appreciate your time on these calls. In terms of specific expenditures for the NDA we haven’t put out any specific estimates around that. The only thing I can say is I wouldn’t expect it to be outside of sort of the industry norms.

In that regard, things are progressing reasonably and as I think you’ve understood we have always approached our financial expectations rather frugally, so if you just take those concepts in mind that’s probably the most specifically could be about that at this time.

But we’ve remained shall we say very aware and believe that we’ll be able to in a very appropriate and approval fashion..

But just to clarify Matt if I may the expenses associated with the DeNovo NDA are obviously much higher that would be for a 505(b)(2) NDA which is what this is, correct?.

I’m really -- yes, and you are correct in that this is for a 505(b)(2) it tends to be less expensive and we would believe that it would be able to meet those sort of industry norms in that regard or better..

Okay, that’s helpful.

Any other questions please?.

Yes certainly.

In a rush to reimbursement, we haven’t put out any new additional information regarding market research around reimbursement structures, the current information that we have already listed with our corporate presentation that’s on our website is still the most up to date information and again that just to reaffirm that message to the investment public, what that really says is that overall the different groups that we have tested with on two different occasions through different market research firms, the 30 or so different insurance organizations have all basically described a very wide flexibility and ability for us to get reasonable premium branded reimbursement and that is based upon several factors, one of the most important thing that there is almost no available treatment for this particular disease.

I personally believe that this would be a very different discussion if there were 8 or 10 different substitutable products to help treat gastroparesis but because it is, as limited as it is down to the one oral medication that it provides a lot of flexibility.

The second thing that we’ve heard from those groups around reimbursement is that generally speaking, prescriptions or prescription a month is underneath about $600 per prescription. It doesn’t hit any of the major red flags or barriers for these insurance companies.

Underneath that, it tends to fall into more traditional tier 1, tier 2, tier 3 cost structure for patients. And so given that the only other product that is available out there is generic and it’s a clear tier-1, like almost all other branded products and GI or otherwise.

We expect EVK-001 to be a tier-3 product and have very wide flexibility in terms of open ability to have reimbursement added tier-3 status. So, we don’t know exactly what the price will be. We haven’t made any specific projections on that.

But that kind of structure in terms of less than $600 a month as the typical tier link [ph] to atleast give you a framework to think around..

Hey, Ram. I might add is that, understanding the landscape where pricing is changing and with the election year it may change more. But the work that we had done is just last year about this time last year we had performed the research Matt described..

Okay. Great. Thank you..

Certainly, Ram. The last question you had was around strategic thinking distribution or otherwise and go to learn or otherwise. We always consider what our strategic options are and we stated this in the past that there is a lot of communication with various companies, the firms and the industry. That hasn’t changed.

The GI industry itself has had a lot of transactions, combinations and otherwise. We are fully prepared and preparing to move forward and commercialize our own, should something else occur between here and then. We would obviously review that opportunity with the Board but we make no specific plans to do so otherwise.

And then given that since we are planning to move forward on our own for the time being, we are evaluating different structures to which, yes, the sort of sales force for hire or commercialization partnership process given there are companies like Quintiles and inVentiv and others like that out there.

It does make a more financially efficient opportunity in many ways for us, not having to raise nearly as many dollars to have products commercialized. And it does also leave a number of risks associated with building that kind of infrastructure around that. So, we are evaluating all of those different certain aspects.

We do believe that many sample meet appropriate and efficient and effective method for commercializing our product but really has a relatively simple message for a GI community such as EBKs or one who will present..

Okay. I just had one very quick follow-up and that was relative to response to the question one of my peers asked earlier.

So, Dave, I think if I heard you correctly, you guys don’t see an appropriate venue later this year for the formal presentation of the topline data for EVK-001 safety study and I was wondering why you wouldn’t think that ECG would be an appropriate venue.

And even that event is coming up in October; I would assume that if you meet the deadline or the timeline that’s laid out for to meet the topline. The early part of the third quarter but you might to at least qualify as a late breaker effect.

So, I just wanted to know why ECG would be an appropriate venue to present this data, assuming its obviously [Indiscernible]?.

Yeah. Certainly is positive. Assuming that will have all of the appropriate data and be able to submit it, yes, we could consider it. We have a number of different items that we are discussing now.

I don’t -- Marilyn, do you have a comment?.

I think it’s going to be important that we have the opportunity to share the results first with the FDA and at this point that’s going to be a key customer for us.

And we will be focusing our attention on packaging and presenting and ranging for a successful FDA meeting and this meeting should allow us to put together an abstract and qualify for late breaker. We wouldn’t exclude the possibility but I’m sure you will understand our focus is going to be on our FDA filing..

Completely understand.

And just one last thing if I may, can you clarify if your current capital resources would be sufficient to provide you with a run rate up to the point where what the project might be timing of a pre-NDA meeting or not?.

Yes. Ram, this is Matt. So, at this point we haven't put out the timing on the NDA – pre-NDA meeting. So, it's been possible for me to state that. Right now we have final through the end of Q3, so depending upon when the pre-NDA meeting, if that's before after that, I don't know, it’s been determined yet..

Okay. Thank you..

Thanks Ram..

[Operator Instructions] The next question is from Nathan Cali of Noble Financial. Please go ahead..

Hey, guys, good afternoon. Thanks for taking the questions..

Thanks, Nathan..

Just a couple of follow-up questions, some of them been answered. So, we've seen the FDA in some of these situations especially 05(b) (2) provide a little guidance on a particular P value threshold.

Has the FDA provided any guidance for you guys as far as what they are looking as far as the P value that you would need to be well below that?.

Not a specific number, but we would expect if we hit to significant given -- this molecule well known, it’s been available for 30 plus years being use for this disease both in oral and IV will be in a very good spot, but at this point they haven't given a specific number..

Okay, great. Thanks. And then on the commercial scale side of things I know you guys have completed full commercial scale batches.

In your ongoing studies, is that the job that you're using, is that done on a full commercial scale for those one-time batches?.

Yes, exactly. We have used the same formulation. I think that's what you are asking. We have used the same formulation through our Phase 1 and Phase 2 and Phase 3 design along with the commercial scale up..

Okay. All right. Great. Thanks a lot..

Thanks Nathan..

We have a follow-up question from Yale Jen of Laidlaw & Company. Please go ahead..

Thanks for taking the follow-up question. This is a little follow-up with the previous question being post here, which is that the rightly speaking it’s still positioning this drugs, in other words, given there is a generic oral version available.

Would you, I mean, your market research suggest that whether the oral will be use first and the subsequently if not working or not work enough and we'll come to your drug, that they inhale drug or this could potentially be let’s use the word first line if an reimbursement is not an major issue there, any comment or colors on that regard?.

Yes, absolutely. This is Matt. And thanks for the question in that regards.

It depends, we definitely believe that this could be first line for a large portion of the patients, we know from market research that physician respond very favourably to that and they understand that for a number of patients the oral does not have the efficacy that they are seeking.

They also recognize that because the disease is erratic it comes on in sort of unexpectedly different times and it's different for each patient that they don't always understand why that occurs.

Is it because the stomach has stopped functioning appropriately and therefore medication not getting through, so to help alleviate some that , that concerning question in the eyes of physician we deliver a good portion of those patients are going to beyond the cases of [Indiscernible] first line treatment.

We also recognize and it was described in some of our market research that some will clearly try the oral first and in some patients that maybe okay. So, it will depend on the patient's specific scenario but we do believe that a large portion of them well beyond a first line..

So it is possible for instance for patients who need re-treatment or subsequent incident that they could be beneficial – it could be beneficial for them to try this one out at that setting instead of retreated with oral drug and to see whether that is sufficient or not..

Yes, absolutely. I think could clearly try this.

And just anecdotally we speak to physicians and we understand when they say we have patients, we believe they are actually ingesting their oral, but we don't if it’s getting into the blood stream, that they'll be those questions that happen often enough because this disease is defined by the lack of motility of the stomach and the inability of absorb medication that are number of these patient are very appropriate to be on the nasal delivery EVK-001 as first line treatment..

Okay, great. Thanks a lot..

The next question is from Difei Yang of Brean Capital. Please go ahead..

Hi, good afternoon. And thanks for taking my question. Just a quick one, would you walk us through from the time when Phase 3 results will be available to the time when NDA will be file – can be filed.

What are the different steps that you have to go through, major steps?.

Sure. I'll let Marilyn discuss that..

Hi, Difei. Nice hearing from you again..

Hi. Nice talking to you..

So the first thing that we will do is we'll analyze our results and we will finalize the request to meet with FDA and the background package that will need to be submitted. We will propose to the FDA what is included in our NDA and then we will come away from that meeting and execute on that plan to prepare the NDA.

There are multiple components of the NDA and I'm sure you know that it is everything from the literature to all the studies we've conducted as well as the manufacturing data that's been discussed here today.

And we will then summarize that and package it up and provide it to the FDA and there will be also address label that we will later negotiate before the product is finally available on the market.

Is that enough detail or were there other questions that you had?.

I was wondering if – yes, that was very helpful first of all.

And I was wondering from this initial package to the FDA, so you along with that package you'll be requesting a meeting and is FDA obligated to you provide a response right away or is there timeframe they required to act?.

Most of this is very well laid out in guidance provided by FDA. So the type of meeting it is to determine how quickly the FDA will respond. Typically the meeting request goes in. The meeting is requested within 60 days of their request.

The background package has to go in at 30 days before the actual meeting and we should hear within the first two weeks or four weeks after we request the meeting whether or not it was granted and the date that the FDA would be available.

I have not seen a request for meeting for a pre-NDA, not accepted and usual it comes down when the sponsor and FDA both have availability to come together for this discussion..

Thank you so much Marilyn and this is very helpful. And look forward to the Phase 3 result. Thanks..

Thank you..

The next question is from Ben Hayner of Felton and Company. Please go ahead..

Good afternoon gentlemen and Marilyn. Congrats on finishing up the study. I was just wondering being that you have the worldwide rates to the drug, do you have any plans once you finish up the NDA assuming the data is good, everything is closure and it gets approved.

Do you any plans to take advantage of markets outside the U.S.?.

Ben this is Matt. Thanks for the question. Yes we absolutely are evaluating opportunities outside the U.S. and we do believe that they are definitely those available. It depends on different issues associated with approvals pricing and other factors that we're taking into consideration. Of course we do look at the U.S.

market as being a key and first market for us to be able to get approval and so we will be actively engaging in those strategic [shows the] internal debates after we see the Phase 3 data and they are able to move forward at least to a certain degree here.

So we are considering that both in terms of relationships, strategic relationships and otherwise are following the data..

Perfect. That’s all I had everyone. So thank you very much..

Thanks Ben..

There are no more questions at this time. I would like to hand the conference back over to Mr. Dave Gonyer. Please go ahead..

Okay. Great. Thank you everyone for your time today. Stay tuned over the next several weeks, the early third quarter especially as we get close to the results and we’ll be providing probably some more updates over the next several weeks. So we look forward to some exciting times here. Thank you..

This concludes today’s conference call. You may now disconnect your lines. Thank you for participating and have a pleasant day..