Tram Bui – Investor Relations, The Ruth Group Dave Gonyer – Chief Executive Officer Matt D’Onofrio – Chief Business Officer Marilyn Carlson – Chief Medical Officer.

David Buck – B. Riley FBR Mitchell Kapoor – Rodman & Renshaw Pat Gallagher – Laidlaw & Company.

Greetings and welcome to the Evoke Pharma Third Quarter 2017 Earnings Conference Call. At this time all participants are in a listen-only mode. An interactive 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 Ms. Tram Bui of The Ruth Group. Thank you. You may begin..

Good afternoon and welcome to Evoke Pharma’s third 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 September 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 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 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, November 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. We continue to make great progress these past few months as we work toward the submission of our 505(b)(2) New Drug Application or NDA for Gimoti to the U.S. Food and Drug Administration next quarter.

At the end of October, we announced positive top line data from our comparative exposure of pharmacokinetic or PK trial, which marked completion of what we believe is the final clinical milestone in the development path for Gimoti prior to the NDA filing.

The topline results which we discussed in more detail on a conference call on October 31, we’re in line with our expectations but more importantly, they were in line with our previous communications with FDA.

As we work with our regulatory consulting a contract research organization to complete our NDA submission package for Gimoti, we’ve concurrently reevaluated our financial structure and capital needs heading into 2018, which will mainly be focused on pre-commercialization activities.

And we now estimate that our current cash balance of $10.4 million will be sufficient to fund our operations through June 2018. To provide some further details on the latest updates to our cash runway pre-commercialization activity and third quarter results – financial results, I have the call over to Matt..

Thanks, Dave. Once again, thank you all for joining us this afternoon. As Dave just mentioned, we have made an adjustment to our projected cash runway, we plan and budget for 2018. The company has historically been a lean organization, while prudently managing our cash expenses.

We routinely evaluate our capital structure and cash needs and this extension of our cash runway was primarily driven by our ability to better manage our pre-commercialization activities for next year. We now estimating that our current balance sheet will be sufficient through June 2018.

The completion of the comparative exposure PK clinical trial for Gimoti, we’ve stepped up our activities with our marketing and manufacturing partners, which include inVentiv health, we initially partnered with in 2015 to help build our commercial infrastructure and the Patheon division of Thermo Fisher Scientific with whom we recently signed a commercial manufacturing agreement.

There are early discussions with these partners to map our immediate next steps. We believe that we can effectively work with these organizations to remain on track to execute on a commercial strategy pending FDA approval of the Gimoti NDA.

On the commercial side inVentiv is a leader in providing the necessary support and infrastructure to help commercialize new products. And we have full confidence that they will help us successfully bring Gimoti to the market following potential approval.

Importantly, their experts had rapidly buildings sales organizations to appropriately launch newly approved products. As a reminder, under our agreement with inVentiv, they can provide overall commercial management services such as sales representatives, marketing, account management and distribution support.

By utilizing their infrastructure Evoke remain focused on overall strategy, which we believe is much more efficient financial approach. Currently there are nearly 4 million prescriptions for oral metoclopramide in each year.

The only approved outpatient treatment for diabetic gastroparesis, this provides Gimoti with a significant market opportunity to offer an alternative to oral metoclopramide for patients who are suffering from erratic stomach emptying and unpredictable absorption of oral medications including Reglan Tablets.

Physicians and patients have reported broad interest in non-oral treatment route of administration. And based on various pricing scenarios, we don’t anticipate, they’ll be significant impediment to reimbursement.

On the manufacturing side, the Patheon division of Thermo Fisher Scientific, which is a leading global contract development and manufacturing organization or CDMO will be responsible for manufacturing batches of Gimoti in accordance with FDA standards for chemistry, manufacturing, and control, CMC.

With Thermo Fisher recent acquisition of Patheon, a company we have worked closely with since 2008. We believe that the addition of Patheon is extensive experience in the preparation, fill and finish of nasal spray products has only supplemented Thermo’s already specialized capabilities.

Our five-year agreement represents another critical component of the Company’s potential commercial success. Additionally, before I go into our financials of the third quarter, I like to discuss the registration statement on Form S-3 which accompany at our 10-Q filing today with SEC.

Shelf registration and the amendment to our at the market agreement, ATM are only replacements of what we currently have in place which are set to expire on November 23 of this year.

As filing as typical company similar to ours and will continue to afford us the flexibility to opportunistically raise capital on an expedited basis should market opportunities arise. ATM has been in place for several years and the inclusion of this agreement with FBR is to maintain that option.

On note, that we have not used this ATM in over a year and continue to carefully consider its utility. We will continue to evaluate all financing options, including non-diluted financing such as debt, relative financing and other partnerships. Before I hand the call back to Dave, I’ll run through the third quarter finals results.

In the third quarter of 2017, we reported a net loss of $5.2 million or $0.34 per basic share, compared to a net loss of $3 million or $0.29 per share for the third quarter of 2016. The net loss for the third quarter of 2017 was increased by an additional loss of approximately $1.5 million due to the change in the fair value of the warrant liability.

Our research and development expenses in the third quarter were $2.7 million, compared to $1.3 million in the third quarter of 2016. General and administrative expenses in the third quarter of 2017 were 984,000 compared to 830,000 for the three months ended September 30, 2016.

Total operating expenses for the third quarter of 2017 and 2016 were approximately $3.7 million, compared to approximately $2.2 million for the same period of 2016. We’ve said in the past the warrant liability continues to be very volatile and can often dramatically alter the quarterly net loss.

Net loss for the quarter of 2017 included an increase of a net loss of approximately $1.5 million due to the change in the fair value of the warrant liability. Given our cash burn it was $2.2 million you can see how this accounting rule can complicate the actual financial picture.

Finally, turning to our balance sheet, as was mentioned previously, we ended the quarter with cash and cash equivalents of $10.4 million. Looking into the next few quarters, we see meaningful decrease in development expenses as the clinical trial activities wind down and the NDA submission is completed. And now let me hand the call back to Dave..

Thanks, Matt. As we discussed at our investors conference call a couple weeks ago, we’re very excited about the success of the comparative exposure PK trial for Gimoti. Our goal was identify at least one dose of Gimoti that was suitable for submission in our NDA.

Specifically, we’re looking for dose that match the area under the plasma concentration curve or AUC of the reference listed drugs which is Reglan Tablets. To set the stage, let me briefly review our discussions with FDA that have guided us to this point.

For the past year or so, we’ve had three meetings with the agency and each meeting has helped to clarify and confirm our 505(b)(2) NDA submission pathway for Gimoti. At the first pre-NDA meeting with FDA in August 2016, we focused on the regulatory, CMC, and non-clinical sections of the plans NDA for Gimoti.

During the second pre-NDA meeting in December of last year, we presented our additional data analysis for our Phase 3 clinical trial of Gimoti, which indicated clinically and statistically significant efficacy benefit in moderate to severe diabetic gastroparesis patients.

During that meeting, we reached agreement with FDA the demonstration of a similar systemic exposure to the reference list of drugs in a healthy volunteer PK study could be used as a portion of our 505(b)(2) NDA for Gimoti.

We also proposed in this meeting that since Gimoti a nasal spray uses a different route of administration compared to the reference drug which is oral, we should – we would select the dose of Gimoti based on the extent of exposure or AUC of the active ingredient falling within a comparable range of the tablet.

We received risk feedback from the agency that it agrees this proposal was reasonable. During a type A meeting in March of this year, we finalized design of the PK trial and agreed with and incorporated the agencies comment on study design.

At this meeting, we also discussed the different route of administration and the rate of absorption, which is measured by the maximum observed plasma concentration or Cmax. And then it would likely be outside the 80% to 125% interval in comparison to the reference list of drug.

And as noticed in Title 21 of the Code of Federal Regulations Section 320.23 for an innovator product, such as Gimoti, which is intended for use four times per day or up to four weeks. We believe the rate of absorption is not clinically – not considered clinically essential.

These three meetings confirmed our 505(b)(2) pathway and the PK trial, which we launched in August. From an analysis of our top line results, we are pleased to have identified not just one, but two doses of Gimoti that met the necessary criteria and we intend to select one of these doses for our NDA package.

We also observe that AUC and Cmax increase in a dose related manner across three different Gimoti strengths tested providing insurance, but the study drugs performed as expected. So Gimoti is successfully met the criteria for the expense of exposure measured by the AUC and we believe it is acceptable for a submission as a 505 (b)(2) NDA.

PK study achieved exactly what we set out to accomplish, while also being in line with our expectations in our previous discussions with FDA. Our full attention is now on the completion of the NDA, which remains on track for submission next quarter.

Finally, we’ve learned a lot these past ten years developing Gimoti and our focus has always been on providing a new treatment for patients to remain underserved by existing treatment option.

Gimoti represents the first paradigm shift in the treatment of gastroparesis and we’re encouraged and excited about the possibility of helping patients with this debilitating disease. That concludes our prepared remarks. Operator, we would now like to open the call to questions..

Thank you. At this time, we’ll be conducting a question-and-answer session. [Operator Instructions] And our first question comes from David Buck from B. Riley FBR. Please go ahead..

Yes. Thanks for taking the questions. Just a couple of quick ones, maybe for Dave, can you talk about with Patheon whether you –nowherewill be manufactured and is there anything in terms of FDA compliance or we should know about for the manufacturing site, either warning letters or 43sin the last 12 months.

And will you expect your NDA to require pre-approval inspection. And some of the answers you got for thatand then just for Matt maybe you can give us a sense of what the fourth quarter cash burn should be. Thanks..

Thanks, David. Just for clarification, in terms of the Patheon manufacturing, you trying to understand where which facility they would manufacturing..

Correct, yes..

Okay, I don’t think we’ve specifically or publicly announced, where that would be done, but it will be in a site that works with nasal delivery products in the past, we’ll continue. And the answer to your question, yes, they are likely will be a pre-approval inspection at that site..

So and the next question in regards to burn, probably be a bit elevated this quarter, just as we have been wrapping up the PK trial expenditures and running through some of the NDA related processes and consulting expenses. So it’ll be a little bit elevated for the fourth quarter..

Thanks. And just a final one maybe for Dave, will you expect to announce the submission of the NDA and then with the press release and then announce the exceptions as well..

Yes, definitely..

Okay, thanks..

Few very important next step milestones growth..

Sure..

Our next question comes from Ram Selvaraju from Rodman & Renshaw. Please go ahead..

Hi, there. This is Mitchell on for Ram. Thank you for taking our questions. The first one is what commercialization preparations do you intend to have completed by the time that NDA is filed..

This is Matt. In relationship to completion, I guess maybe a simple response. There’s no such thing as really ever being completed, I mean we’ve been conducting market research in the past. You’re always looking to update those pieces of information.

Thankfully, because the market hasn’t really changed, which is unfortunate for the patient, but there haven’t been any new entrance into the markets. So lot of our prior market research is still very valid, but we’ll continue to look at some of the information associated with that.

And of course, along with just marketing related activities, the distribution aspect of it is something we’re actively doing currently. So looking at the wholesaler process, pharmacy, the different networks of many different facets associated with how you probably distribute the product.

So we don’t believe any of that will be done until literally as you’re approaching the product launch, but we are currently working on those and continued through most of 2018 that..

Lowest distribution to state licensure that needs to be completed as well, so some of those things, we’re actively doing now and we talk to have that done before commercialization or before approval..

Okay, great. And what kinds of sales representative, do you intend to use launch of Gimoti, and is any contract sales force likely to be involve..

You asked the best one..

So inVentiv in – if I guess by definition is a contract sales force. And they’ve been very successful at launching a number of other products.

It’s particularly a propel, we believe for this particular product, because we’re able to enter a market, where there are no active competitors, there’s no active counter detailing from a sales force that is trying to persuade physicians to look at alternative treatments.

And also the selling messaging of itself, this is not necessarily about receptors and a lot of very, very fancy science might get another scenario, this is really much more straightforward in terms of the benefit to the patient.

So we’ve – in terms of our market testing, it seems very appropriate that we can use a contracted sales force like inVentiv to rapidly efficiently get the word out to physicians that this is an alternative that’s available to their patient..

Okay, great. Thank you, guys. That really makes sense..

Sure..

[Operator Instructions] And our next question is from Yale Jen of Laidlaw & Company. Please go ahead..

Hey, gentlemen. It’s actually Pat Gallagher here to step up for a moment. I know you have made a ton of progress over last quarter. Just wondering is there major parts of the pre-filing packaging needs to be worked on.

I know that you’ve been spending a lot of time on a fortunate data, you can recent CMC relationship, it feel like that’s probably in pretty good shape. But, is there any other major parts they should be thinking about or is it largely under control..

Okay. Pat, this is Marilyn Carlson. I would say all of the sections are moving forward in parallel some have been lot and are ready to be published. So there are no huge – I don’t know this is left to be done. So we’re feeling very confident that everything’s on track..

That’s great. Thank you..

You’re welcome..

And we do have a follow-up question from David Buck from B. Riley. Please go ahead..

Yes, thanks. For Dave, just a quick clarification on the Patheon relationship, I know you’re not disclosing what specifics site you mentioned it’s one that has nasal spray manufacturing. But can you just confirm that there haven’t been any form 43s or warning letters at that specific site that’s going to be manufacturing Gimoti..

There everybody that we are aware of FDA has been a site – at that site, our European regulatory groups have been at it as well and we’re not aware of any 43 there..

Okay, great. Thank you..

Thank you. This does conclude the question-and-answer session. I’d like to turn the floor back over to management for any closing comments..

Great, thank you. Thank you everybody for joining today, we’re looking forward to getting an NDA and as Marilyn said, it’s tracking as we expected. And we look forward to summiting that next quarter. And as David asked, we will be letting everyone know when that does go in. So we’re looking forward to that milestone occurring next quarter.

Thank you very much..

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