David Burke - The Ruth Group Dave Gonyer - CEO Matt D'Onofrio - Chief Business Officer.

Analysts:.

Greetings and welcome to the Evoke Pharma Third Quarter 2016 Conference 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, the conference is being recorded. It is now my pleasure to introduce your host, Mr.

David Burke of The Ruth Group. Thank you. You may begin..

Good afternoon and welcome to Evoke Pharma's third quarter 2016 quarterly 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.

Earlier today, Evoke issued a press release announcing financial results for the three months ended September 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'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 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, November 9, 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. And thank you all for joining us this afternoon to discuss the third quarter 2016, our progress with the FDA and the overall view of our current efforts towards identifying a potential approval path for our product candidate Gimoti.

Following my remarks, our Chief Business Officer, Matt D'Onofrio, will discuss Evoke's financial results before we open the call for questions.

Since we announced results from our Phase 2 trial of Gimoti, we've been extremely busy on several fronts as we work towards our ultimate goal of gaining FDA approval to Gimoti for the release of symptoms associated with acute and recurrent diabetic gastroparesis in women.

Today I'd like to discuss some of the recent events and provide insight into our plans as much as possible. First, I want to reiterate three key messages.

One, we are still actively preparing, working to prepare for another meeting with the FDA to discuss a potential path towards approval and continue to prepare for a potential new drug application submission.

Two, when looking at the totality of clinical efficacy and safety data for Gimoti and metoclopramide in general, we believe we have the largest database complied for this molecule. And three, gastroparesis is a very large and very underserved market with real patient needs.

We announced in September that we have meet with the FDA in the first of at least two meetings to discuss Evoke's proposed content format of the regulatory CMC and non-clinical sections of the NDA for Gimoti.

This was an opportunity to have a face-to-face conversation with the FDA and to gain better understanding of the FDAs expectations for our NDA submission. We were extremely pleased with the outcome of that meeting. For example, no new studies for preclinical or CMC were requested at this time.

During the meeting, we also discussed the human factors analysis based on the new FDA guidance published in February of this year and applies to products like Gimoti. Following the FDA meeting, Evoke completed and submitted this analysis to the agency for their commentary.

We don't foresee other requirements beyond what is typical for CMC and commercial manufacturing based on what was discussed at the meeting and included in the official meeting minutes.

Again, we are very pleased that the agency had agreed to meet with us separately to discuss the regulatory CMC and non-clinical items prior to meeting to discuss the clinical section of the proposed NDA.

We can now focus our next meeting exclusively on the clinical data to be included in the NDA of which we expect to have additional clarity from the FDA by late December or early 2017. To that end, we've conducted extensive analysis of the efficacy PK and safety data from the Phase 3 trial.

All the work done in their development program nearly 10 years and supplemental data from studies conducted under the same IND by previous sponsors over more than 20 years. As a result of this process, we have identified areas of supportive efficacy and safety and important pharmacokinetics data that we intend to present to the FDA.

When we bring our clinical package for Gimoti to the FDA, it is important to remember that we are seeking marketing approval throughout a 505(b)(2) NDA pathway with Reglan tablets as the listed drug.

This regulatory pathway enables us to reference information news in the original Reglan NDA approval, data from 35 years of uses in improved therapy to treat gastroparesis and the published literature.

In total, there is a tremendous amount of data that shows metoclopramide is an effective treatment and is safe for patients with diabetic gastroparesis. And there are nasal delivery of metoclopramide provides patients with consistent blood levels. Having reviewed this data, we believe there is a rational for submission of an NDA for Gimoti.

Just recently, we received results from the companion trial of men with diabetic gastroparesis that was conducted in parallel with the Phase 3 trial of women with a stopping rule for futility. The study has been requested by the FDA to confirm Phase 2b results and to collect additional safety data in men.

And as anticipated, a futility analysis and additional preliminary results confirm what was observed in men in the Phase 2b trial. According to the statistical analysis, if the study had fully enrolled, the study would have likely not shown up to see in men as we have been in Phase 2.

Now also seen in Phase 2, the safety profile was favorable for Gimoti compared to placebo. For example, all the SAE were in subjects on placebo and more than twice as many adverse events were also in placebo arm. The safety data will be included in the NDA.

Lastly, the FDA understands the significant need that these patients have for an effective treatment. Gastroparesis, specifically in diabetic patients has a negative impact on glucose control, nutrition and their overall well-being.

To late [indiscernible] not only affects their diabetic management and control, it can also negatively impact successful treatment of concurrent medical conditions when oral medications are not being absorbed on a consistent basis.

Gimoti through nasal administration bypasses the dysfunctional stomach to deliver medical from directly to the systemic circulation. With Gimoti, treatment of nausea can decrease episodes of vomiting and improved gastric motility.

So in wrapping up, with our fund raising in Q3, we have financial runway until at least June of 2017 to allow us to determine an agreeable submission strategy for Gimoti.

Matt will provide additional comment to this financial forecast but given that our spending has dramatically curtailed with the end of the clinical trials, we're on a solid position to press forward with our goals.

We believe very strongly in the delivery of metoclopramide through nasal administration and that Gimoti is the candidate to be able to accomplish this safely and effectively for patients.

This is what drives the determination to get approval for this drug and bring our product to the market that has the ability to dramatically change the lives of patients who suffer from gastroparesis.

We have a strong balance sheet as we forward to this process and are in good position to determine the path forward without the need of any additional capital. And we look forward to the coming months and keeping our shareholders upto speed on our NDA process in discussions with FDA.

Matt?.

Thanks, Dave. From a financial standpoint we're well positioned following the two successful capital raises in July and August with growth proceeds totaling approximately $14.5 million.

Importantly, with the completion of our Phase 3 clinical trials, we expect to see a reduction at our cost, at least for short-term until we gain additional regulatory insight.

And as we've said and Dave touched on his comments, we still have one more meeting with the FDA to discuss clinical package and based on that time we will be able to refine our cash projections further.

We're also debt-free after paying down our credit facility during the quarter further strengthening our balance sheet and providing additional financial flexibility. Now let me briefly run through the financials before we open the call for questions.

For the third quarter of 2016, net loss was approximately $3 million, or $0.29 per share compared to a net loss of approximately $2.7 million or $0.42 per share for the three-month's period ended September 30, 2015.

The per share results are based on shares outstanding of approximately $10.6 million in the recent quarter and $6.5 million in the previous year period. Research and development expenses totaled approximately $1.3 million for the three months ended September 30, 2016 compared to $1.8 million for the three month ended September 30, 2015.

With the clinical trials now complete, we anticipate our continued reduction in our R&D expenses. For the third quarter of 2016, general and administrative expenses were approximately $830,000 compared to approximately $820,000 for the third quarter of 2015.

Total operating expenses for the three-months ended September 30, 2016 were approximately $2.2 million compared to total operating expenses of approximately $2.6 million for the three months ended September 30, 2015. The decrease in expenses is largely attributed to the completion of clinical trial activities.

As of September 30, 2016, the company's cash and cash equivalents were approximately $10.4 million. We know that our cash runway takes us to at least June of 2017, and noting that our quarterly cash levels as we just reported. Along with that, last month our burn rate for the month I dropped just under $500,000 for the month.

So at this pen rate our cash would last considerable long than the nine months to June. However, we planning for additional regulatory direction and being able to ramp up spend with that input. Again, further refinement of the forecast will be undertaken as regulatory input is received.

Finally, I just want to note; the warrant liability on our balance sheet, current accounting rules require us to treat these warrants issued in our recent financing as a liability that's to revalued at each quarter.

As this value is modified in large part by changes in stock price, it's very possible that large non-cash income or expenses can arrive each quarter depending upon this external factor. Please take this into consideration reviewing or projecting our quarterly income and loss results.

We'd like now to open up the call for any questions that you might have.

Operator?.

Thank you. [Operator Instructions] Our first question comes from the line of Yale Jen from Laidlaw. Please go ahead..

Good afternoon. This is Olivia [ph] covering for Yale.

So I have one question for moving Gimoti forward, do you anticipate or have explored any potential partnership opportunities?.

Thanks, Olivia. I'll let Matt discuss that. We are always talking to companies as you might imagine, nothing that we've given our specifically but I'll let Matt touch on that..

Yes, I don't think there was much more to discuss. We know all the different players in the GI space. There is a large interest in gastroparesis in general.

There are not really many products that are available or late-stage; in fact, just to that aspect noting the [indiscernible] data that just was announced, the fact that that transaction occurred with our gain was what I'm just comes, it's pretty surprising.

So there is even for -- for that situation I had a failed trial, large opportunity for potential transactions..

Okay, great. Thank you so much..

Thank you. [Operator Instructions] Ladies and gentlemen, we have no further questions in queue at this time. I would like to turn the floor back to management for closing comments..

Great, thank you. We thank everybody for joining today. We look forward to providing more updates by the end of the year, early in 2017 and appreciate your time. Thank you..

Thank you, ladies and gentlemen. This does conclude the teleconference for today. You may now disconnect your lines at this time. Thank you for your participation, and have a wonderful day..