Sam Martin - Investor Relations, Vice President of The Ruth Group David Gonyer - Chief Executive Officer, Founder, Director Matt D'Onofrio - Executive Vice President, Chief Business Officer Treasurer, Secretary.

Irina Koffler - Cantor Fitzgerald Ken Trbovich - MLV Yale Jen - Laidlaw.

Greetings. Welcome to the Evoke Pharma first quarter 2015 earnings call. At this time, all participants are in a listen-only mode. a brief 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 Sam Martin of The Ruth Group.

Thank you, Mr. Martin. You may now begin..

Good afternoon and welcome to Evoke Pharma's first quarter 2015 financial results conference call and audio webcast. With me today are Dave Gonyer, Chief Executive Officer and Matt D'Onofrio, Chief Business Officer of Evoke Pharma. Earlier today, Evoke issued a press release announcing financial results for the three months ended March 31, 2015.

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 today. The company's annual report and press releases 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. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 14, 2015.

Evoke undertakes no obligation to revise or update any forward-looking statement 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?.

Thanks, Sam and thank you all for joining us this afternoon for our call to review our financial results for the first quarter of 2015, provide a business over review and an update on recent accomplishment as well as our outlook for the company.

As we get closer to the end of the development process for EVK-001, our patented formulation metoclopramide nasal spray, we are expected to begin shifting our focus towards commercialization. We believe the execution of our strategy over the years has positioned Evoke for success.

Throughout the development of EVK-001, we have been diligent and deliberate in our strategic planning. First, we have been very focused on the indications for use of EVK-001 when designing our clinical studies and very selective in our choice of eligible patients.

Second, we have developed the business infrastructure that is efficient and cost-effective. And finally, we will continue to take the proper steps in order to bring EVK-001 to the market in a timely manner. Starting with our Phase 2b study. We were careful in designing the trial protocol and selecting our prespecified study endpoint.

This included the analysis of efficacy by gender, which led to the discovery that intranasal metoclopramide works for women but not for men. In addition, with FDA input we targeted a sizable and significant study population and enrolled 287 patients.

This is the largest metoclopramide study to-date and possibly the largest well-controlled study in patients with gastroparesis. The thorough planning and execution of our Phase 2b study allowed us to focus on confirming the results in our current Phase 3 trial in women with diabetic gastroparesis.

According to literature, women make up approximately 80% of the population. This is important for two reasons. First, we are confident that we have clearly identified the subset of gastroparesis patients to best utilize our intranasal formulation of metoclopramide to control the symptoms of the disease.

And second, the Phase 2b eligibility criteria identified the type of patients that responded well to EVK 001. This gives us confidence in generating positive data from our current Phase 3 study. While we have screened hundreds of patients, we have enrolled only those that meet the prespecified eligibility criteria.

This ensures that the Phase 3 study population closely matches those subjects that achieved a benefit from EVK-001 in our Phase 2b study. We have recently ramped up our efforts on the publication enrollment front to increase awareness of the Phase 3 study and help drive patients to the clinical site.

We have begun to see the benefits from this enhanced outreach and believe we are in target for enrollment be completed in the fourth quarter. We have confidence that our focus on patients with our selectivity is in the best interest of the company and will provide the most comprehensive and impactfull data for our new drug application or NDA.

Most important for Evoke at this point are the steps we have taken and continue to take to ensure the long-term commercial success of the company and bring EVK-001 to the market as soon as possible.

There is an immediate need for a better option for this underserved market and we believe EVK-001 can have a positive impact on patient health as well as capture a significant market share of the currently 4 million oral metoclopramide prescriptions written each year.

In line with this commercial focus, we recently demonstrated our ability to manufacture commercial scale quantities in accordance with the FDA standards for chemistry, manufacturing and controls or CMC.

In addition to data from this recent program, Evoke has a three-year registration stability data package from previous manufacturing, which have all met proposed specifications. These CMC datasets will be used as part of our NDA. We have continued to effectively execute on our business in a cost-efficient manner.

We also understand the importance of being a well-capitalized company and will continue to assess the market and address any additional capital requirements as needed, especially as we move toward an NDA filing and potential commercialization. We have confidence that this will continue to benefit our shareholders over the long run.

Overall we are excited be in the position we are today and believe there is a tremendous amount of value in Evoke. I would say, in summary, we have focused our clinical study design to support our EVK-001 indication in women with gastroparesis. We are selective in our patient enrollment.

We run our business efficiently and cost-effectively and we continue to execute on all fronts in order to prepare for the commercial launch of EVK-001, following a potential FDA approval. These reasons, we believe, are well positioned as we move forward completing our Phase 3 trial.

With that, I will hand the call over to Matt to provide an overview of the financials for the quarter..

Thanks, Dave and thanks everyone for joining today. In the first quarter 2015, we reported a net loss of $3.5 million or about $0.58 per share. This compares with a net loss of $3 million or $0.49 per share for the first quarter of 2014.

The net loss increased primarily due to our ongoing clinical trial for EVK-001 being further advanced as compared to last year when we were preparing for the initiation of the trial. R&D expenses in the first quarter of 2015 were $2.4 million, up from $1.9 million in the first quarter of 2014.

The year-over-year increase in research and development expenses was primarily related to our ongoing clinical trials for EVK-001 being further advanced as compared to the prior year. General and administrative expenses for the first quarter 2015 were approximately $1 million compared with approximately $1.1 million for the first quarter 2014.

Total operating expenses in the first quarter of 2015 were $3.4 million, up from $2.9 million in the first quarter of 2014. Looking at our balance sheet. As of March 31, 2015 we had cash and cash equivalents of $11.7 million.

For April 2015, we have sold approximately 133,000 shares of our common stock through our aftermarket common stock sale where we raised approximately $936,000 in net proceeds. We will continue to monitor the market for prudent financial management opportunity.

However given our current cash burn and efficient corporate structure, we feel comfortable that we are suitably financed to accomplish our immediate goal. And with that, that concludes our prepared remarks. We would like to turn this over to the operator to open up the call for some questions..

[Operator Instructions]. Our first question is coming from the line of Irina Koffler with Cantor Fitzgerald. Please proceed with your question..

Hi. Good afternoon. I wanted to check a little bit more on enrollment timelines and data reporting.

So when you say that you can have enrollment completed in the fourth quarter, the way I read that is, that your last patient may have their first visit in end of December, which would still meet the cutoff and then that person will need to be followed for at least another four weeks in your study.

So would that imply readout in first quarter? That's the first question..

In that scenario, yes, it would, Irina. Hello, by the way..

Hi..

We continue to monitor the enrollment on a daily basis, obviously. So we will continue to provide you updates as we move forward..

And then can you just remind us about, besides the $11.7 million that you have on the balance sheet, it looks like you are burning through about $3 million a quarter, a little bit more than that. So by my math, I think you will be completely out of cash in first quarter of next year, if that happens.

So what other sources of cash do you have?.

Sure, Irina. This is Matt. We still have the active market facility in place, should we choose to utilize any of that. The remainder on the baby shelf rules would allow us about another $6 million or $7 million over the course of 2015, if we were so interested in doing so.

However, you are generally correct in the sense that, we have put it in our most recently release that we believe we have cash through the March 31, 2016. So that is further data than what has previously been described. That being said, once the trial winds down, the expenses of course wind down pretty considerably as well.

So I actually don't believe we would have a similar burn rate in the first quarter of 2016 under that scenario. It would probably be lower..

Okay. Thank you..

Sure..

Thank you. Our next question is coming from the line of Ken Trbovich with MLV. Please go ahead with your question..

Good afternoon, gentlemen. I appreciate you taking the time. I had a chance to meet with a few companies in the last couple of weeks and I was reminded that the most difficult process of running a clinical trial is having centers where there is only one patient.

Can you give us a sense as to, without obviously talking about specifics on numbers, can you give us a sense as to how the centers look like representation might be across the study? Are you seeing any geographic uniqueness in terms of some centers being faster than others, perhaps simply because of concentrations of [indiscernible], things of that nature?.

Hi, Ken. Generally, it's the enrollment for diabetic gastroparesis studies, the Southeast, South corridor, generally is more diabetes, it seems to be. So we see a lot of our enrollment happening there.

That said and to your point about enrolling one patient, we are constantly reviewing that, making sure that we do have a right size that are screening a number of patients to avoid those type of situations.

And we will consider if sites haven't enrolled this late in the trial, we would consider closing the sites so that they don't enroll one patient..

Got it. So to prevent all of the headaches of that and to audit and do all of those things for a single patient at a single site..

Exactly..

Got it. And I know you mentioned early commercial preparation, I just happened to notice something when I was looking at some executives at firms that are no longer independent that they are some senior management talent in the sales and marketing, GI side that are available.

Is there a reason or thought around perhaps starting to look to build those in the latter part of this year or what's the timing you would be looking at possibly doing that?.

We haven't definitely have any timing for it. We are looking at preparations that maybe are above hiring folks, more market research related, pricing research related, those type of items that take time and need to be started now in order to prepare for a commercial launch at some point.

There are, with all the collapsing of GI companies, the combinations, there are good folks out there that we definitely would consider brining them about once we have a clear understanding of the results of our trial..

Got it.

Any of those folks, people you are already working with on a consulting basis? Or is that maybe the first step to establishing a longer term relationship?.

No. Not at this point..

Okay.

And then last question, just on the European side, I know obviously you guys made the announcement about the patent, I am just kind of curious what the next steps, if any, are as it relates to ex-U.S.?.

Yes. So Ken, this is Matt. For the most part, as you know pricing is a very different process for many of the European countries and they have different kinds of hurdles associated with proving pricing.

There are some different strategies that we have been considering whether or not we need to consider additional clinical trials which would occur after we potentially get approval and have some revenue here in the U.S.

or other more creative ways we can approach the EMEA seeing approval with pricing appropriately without having to do some of those trials given they have a relatively similar scenario where they are very, very few alternatives to treat patients. So we are still evaluating what the right strategy is, but in our view, the U.S.

is the first and foremost process to penetrate and from there leverage that to oUS..

Got it.

But no specific plans to go out and try to engage somebody at this point in those types of discussions?.

No, not just yet. We are really focused on the U.S. That's the lion's share of the opportunity as it stands today and its the closest route to profitability..

Okay. Thanks for taking my questions..

Thanks, Ken..

Thank you. [Operator Instructions]. The next question is coming from the line of Yale Jen with Laidlaw. Please proceed with your question..

Good afternoon and thanks for taking the questions. Just expand a little bit on the patient recruitment situation. I remember, last time you updated investors in the last earnings quarters say that you have got at least two-third of sites have already recruited at least one patient.

Should I assume that number has improved or changed? Or can you give a little more color in that regard?.

Yes. I don't have that data directly in front of me now, Yale, but it has improved. I know that over the last three months, many of the sites have begun doing much more enrolling, especially the ones that have not done a lot in the past.

So we have instituted a number of programs to help the sites with some of that recruiting and we feel those are benefiting those sites now. But I don't have the specific numbers..

I remember you mention you have added measures on efforts including some social media and others and the UCBs have started to show results.

Is that right?.

Yes. Definitely..

And so a little bit also the confidence you have that you should be able to complete patient enrollment by the fourth quarter of this year. My understanding is often times, in these study is that in the last portion of the study, the patient enrollment naturally increases much quickly.

Have you seen this sort of change in pace to give you guys the confidence that that such situation is happening?.

Yes. Again, as I said to Irina earlier, we monitor those on a daily basis on these patient screening, which is the key, have to screen to enroll. Now, you are right, in terms of studies at the end when they figure out the study is coming to an end, they all seem to find patients that want to enroll quite a bit.

We had that happen in our Phase 2b trial the same thing as we got near the end and people started feeling that the study is closing, there was a rush to get the patients in. I will say, even with that rush and I said in our discussions, we are very selective in our patient.

Our CMO, Chief Medical Officer, allows no protocol waivers for patients to get in. So we still have that very strict control on that enrollment process..

Great. And the last question is on housekeeping that for the first quarter of this year as well as the last year, June and May seems a little bit high.

Should I anticipate in the remaining of the year, probably by quarter, that number will at least come down a little bit and maybe just have some nominal growth?.

This is Matt. Thanks for the time. We wouldn't expect SG&A to change much. We have had a little bit lower cost this year in terms of legal and accounting just because of our, let's call it, becoming more efficient with the public process and the filings associated with that compared to last year, especially.

But overall, we wouldn't expect there would be much of a change because our headcount is remaining the same and most of our related expenses are basically the same. The only thing that's changing is really towards the clinical trial activity..

Okay.

So we probably can use the first quarter SG&A number sort of flat out for the remaining of the year?.

Probably not too bad..

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

Thank you..

Our next question is a follow-up from the line of Irina Koffler with Cantor Fitzgerald. Please go ahead with your question..

Hi. So if we assume the enrollment and data come in first quarter 2016. Can you tell us how long it will take you to file an NDA once you get the data? Thanks..

Yes. Irina, that's a great question. We are taking action now as part of this commercialization process that we describe. We are taking preparations for the NDA now. We have begun that process, looking into it, collecting all of our data, trying to get in to the appropriate files that are needed for a filing.

I don't have a specific timeline but I can tell we will push very hard to get it done quickly..

Thank you..

Thank you. At this time, we have reached the end of our Q&A session. I will turn the floor back to management for closing comments..

Great. Thank you. Thank you everyone for taking the time and we look forward to keeping you up-to-date on our developments with EVK-001..

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