Cindy McGee - Head, IR and Corporate Communications Thomas Meyer - Chairman and CEO Sven Zimmermann - CFO Bettina Stubinski - CMO.

Joseph Schwartz - Leerink Partners Serge Belanger - Needham & Company Chris Howerton - Jefferies.

Thank you, Operator and thank you to everyone on the call for joining. On behalf of Auris Medical, I would like to welcome everyone to our first quarter 2016 financial results conference call. I am Cindy McGee, Head of Investor Relations and Corporate Communications at Auris Medical.

I am joined by Thomas Meyer, Auris Medical’s Chairman and Chief Executive Officer; Sven Zimmermann, Chief Financial Officer; and Bettina Stubinski, Chief Medical Officer. Earlier today we issued a press release with a business update in our first quarter financial results. The release is available on our website aurismedical.com.

We also filed this press release with the SEC. During today's call, we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements that address future operating, financial or business performance or our strategies or expectations.

Forward-looking statements are based on management's current expectations and beliefs, and involve significant risks and uncertainties that could cause actual results, developments and business decision to differ materially from those contemplated by these statements.

These risks and uncertainties include, but are not limited to the timing and conduct of our clinical trials, the clinical utility of our product candidates, the timing or likelihood of regulatory filings and approval, our intellectual property position and our financial position, as well as those described in the Risk Factors section in our Annual Report on Form 20-F and future filings with the Securities and Exchange Commission.

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change.

With that, I hand the call over to Thomas..

Thank you, Cindy. Good morning to our listeners in the US and good afternoon to our listeners in Europe. On today's call we are pleased to provide a business update and discuss our first quarter 2016 financial results.

As we move through the year, we are focused on executing with regards to our two phase 3 development programs in AM-101 in acute inner ear tinnitus and AM-111 for acute inner ear hearing loss. Our lead program AM-101 which could be the first approved therapy for tinnitus have made significant progress.

The TACTT2 trials fully enrolled and we plan to announce top line results in August. In addition, recruitment for our TACTT3 trial has been strong recently and we now feel comfortable providing guidance for the completion of enrollment by the end of June. Based on this timing, we plan to announce top line results in the first quarter of this year.

With regards AM-111, we initiated the first phase 3 trial HEALOS last November and we expect to initiate the second phase 3 trial called ASSENT in the upcoming months. I’m very excited about the potential of AM-101 and AM-111, and look forward to delivering the therapies to patients as soon as possible.

Last month, one of our covering analysts hosted a conference call with the American Tinnitus Association to discuss market dynamics and access the opportunity for AM-101. On the call, the ATA highlighted that tinnitus sufferer are engaged with [well-informed] therapy seeking patient population with the lack of effective treatments.

We believe that AM-101 has the potential to be an important an important advance for patients with acute tinnitus and represent approximately [$750,000] million in US market potential.

To build on this effort and prepare for the upcoming phase 3 data readouts, we will host a key opinion leader breakfast focused on the phase 3 program and market opportunity of AM-101 and the treatment of acute inner ear tinnitus.

The event is scheduled to take place on June 14 at 8:00 in the morning in New York City, and feature a keynote presentation by [Dr. Hendricks Stacker] who is a principal investigator in the TACTT2 trial. We look forward to your participation in this event. I would now like to report on a few developments with regards to our leadership team.

At our recent annual general meeting, each member of our Board of Directors was reelected, and Armando Anido was elected as a new member of our Board and as Chairman of our compensation committee.

With more than 35 years of experience in the pharmaceutical industry, Armando has built an excellent track record as an executive with strong operational and commercial expertise in therapeutic areas that share many similarities with the quality fields. As we progress towards commercialization of AM-101, we believe Mr.

Anido’s input is extremely valuable and we’re pleased to welcome him to our team. In addition we are pleased to welcome Andrea Braun as our Head of Regulatory Quality Affairs and member of our executive management committee. In this newly created position Andrea is leading our regulatory affairs, quality and pharmacy-vigilance activities.

We will benefit from Andreas outstanding experience in global regulatory affairs, including 15 years spent at Roche and look to her expertise as we navigate the regulatory review processes for marketing authorization.

Furthermore, it is with great regret that I inform you that Sven Zimmermann will be leaving Auris Medical for personal reasons this summer. Sven has been our Chief Financial Officer and a key member of our management team since 2014. He also played a major in our IPO. We respect Sven’s decision and wish him the best of luck with his new projects.

A search for Sven’s replacement has been initiated. I will now turn the call over to Bettina, who will provide a further update of our clinical programs. Sven will then continue the presentation by reviewing the financial results.

Bettina?.

Thank you Thomas. So since our last call in March we have announced that we completed enrollment of more than 330 patients with acute tinnitus in to the phase 3 TACTT2 trial. The TACTT2 trial is been conducted primarily in North American under the special protocol assessment with the FDA.

The primary end points on this trial are the improvement in tinnitus loudness from baseline to day 84 and the improvement in tinnitus impact as measured by the tinnitus functional index. We look forward to top line results from this trial which we expect to announce in August.

In parallel, we’re progressing towards completion of enrollment of approximately 630 patients with acute and post-acute tinnitus. In the phase 3 TACTT3 trial, which is being conducted in Europe, the TACTT3 trial consists of two strata, A and B.

Stratum A, which is expect to enroll approximately 300 patients is a confirmatory trial, evaluating efficacy in patients who are within three months from tinnitus onset.

Stratum B which is expected to enroll approximately 330 patients is an exploratory trial evaluating efficacy beyond the three months acute time window focusing on patients who are three to six months from onset.

The primary endpoint in the TACTT3 trial is the improvement in tinnitus loudness from baseline to day 84 and in this study, the tinnitus functional index is the main secondary end point. We expect to complete enrollment next month and announce topline results in the fourth quarter of 2016.

With the upcoming results of these studies, we are continuing with the preparation of regulatory submissions for the marketing authorization of AM-101 in the US and Europe, as well as pre-commercial activities in preparation for the planned future launches of AM-101.

Moving on to our second program, AM-111 for acute inner ear hearing loss, we have advanced enrollment in to the phase 3 HEALOS trial. HEALOS is being conducted in several European and Asian countries and began recruiting last November.

The trial aims to enroll approximately 255 patients with severe to profound idiopathic sudden sensorineural hearing loss, and the primary end point of HEALOS is the improvement in hearing threshold to day 28. We’re also moving towards initiation of the second phase 3 trial ASSENT.

This trial will be conducted in the US, Canada and South Korea and is scheduled to initiate in the upcoming months.

The trial is set to enroll approximately 300 patients with sever to profound idiopathic sudden sensorineural hearing loss with the same inclusion criteria as the HEALOS study and the primary endpoint of ASSENT is the improvement in hearing threshold to day 91.

As a reminder, AM-111 has been granted Orphan drug designation from both the EMA and the FDA for the treatment of acute sensorineural hearing loss. With that let me pass the call on to Sven for the financial update. .

Thank you Bettina. So reviewing our financial results for the first quarter, I would like to note as always that this information has been prepared using the same accounting policies and masses of computation as compared with the most recent annual financial statement.

Financial statements are presented in Swiss franc the company’s financial and presentation currency, all amounts are in Swiss Franc unless otherwise specified. So research and development expenses were about 6.1 million and were comparable in the three months ended March 31, 2016 and in the three months March 31, 2015.

In the three months ended March 31, 2016, we incurred lower clinical expenses than in the three months ended March 31, 2015, primarily due to lower service and milestone costs in connection with the phase 3 AM-101 clinical trial program, which reflects mainly the completion of enrollment in TACTT2.

This decrease in AM-101 related cost was partially offset by higher cost in the first quarter of 2016 related to preparations for the AM-111 phase 3 ASSENT trial.

General and Administrative expenses was 1.2 million in the three months ended March 31, 2016 compared to 0.9 million in the three months ended March 31, 2015 mainly as a result of high administration costs as well as the higher headcount.

With regard to our net financial income and expenses, in the three months ended March 31, 2016 we recorded a net largely unrealized foreign loss of 1.5 million whereas we had recorded a smaller loss of 0.9 million in the same period last year.

The higher loss in 2016 is mainly due to the strong appreciation of the Swiss Franc against the US dollar compared to the period in 2015. Reported net loss for the first three months of 2016 was 8.9 million compared to 8 million in the same period of 2015. This corresponds to a net loss per share of 0.26 versus 0.28.

However, keep in mind that those figures include the results from the unrealized foreign exchange gains or losses. We continue to expect that our operating expenses for the full year 2016 will be in the range of 33 million to 38 million essentially as guided earlier in the year.

Our cash and cash equivalents as of March 31, 2016 were 41.4 million compared to 50.2 million at the end of December 2015. The decrease in cash is essentially the net result of the cash outflow from operating expenses during the first three months of the year.

Our current cash position should allow us to finance operations until the fall of 2017 also as previously communicated. With that, I would now like to turn the call back to Thomas, who will conclude our presentation and then open the line of questions. .

Thank you Sven. In summary, I’m very pleased to say that we have achieved significant progress with our development programs, bringing us closer to the completion of the pivotal AM-101 tinnitus trials in advancing the late stage AM-111 hearing loss program.

As we move through a productive 2016, we look forward to the following upcoming milestones; completed enrollment of the AM-101 TACTT3 trial next month, initiation of the AM-111 ASSENT trial in the middle of this year, topline results from the TACTT2 trial in August, and topline results from the TACTT3 trial in the fourth quarter.

With that let me turn to one point here about the upcoming presentations. So we hope to connect with you at one of the following presentations.

So we will participate in the Jefferies Healthcare Conference Scheduled for June 7 to June 10, our AM-101 key opinion leader meeting scheduled for June 14 for the JMP Securities Life Sciences Conference scheduled for June 21, and 22.

In closing, we look forward to the upcoming results of our phase 3 AM-101 program, initiating the second of our phase 3 AM-111 trials and obtaining further progress towards our ultimate goal of providing effective and safe inner ear therapeutics for patients.

With the, I would now like to turn the call back to the operator, who will open the line for questions. .

[Operator Instructions] We will now take our first question from Joseph Schwartz from Leerink Partners. Please go ahead sir your line is open. .

It would be helpful if you could explain to use a little bit more about how the statistical analysis plan will be working for the TACTT2 trial for AM-101. I heard you mention a couple primary endpoints there.

So, is the case where you just need to show less than P close to 0.05 on both of those, is there any hierarchal treatment, are they co-primary in any way. .

Absolutely. Yes, as you pointed out these are co-primary endpoints and we do need to hit that P value on both of these endpoints. So both end points need to be met for the study to be a positive study. .

So then you 0.05 of alpha for each, you don’t share any alpha..

Correct. So that means that both of these primary endpoints they are co-primary end points. .

And then maybe I could just ask, since you’re enrolling a subset of the patients that you’ve studied before in particular those with otitis media and acute acoustic trauma, and I know you’ve done a lot of basic science work in animals’ etcetera.

Can you explain to us what the biologic rationale is if there is any for AM-101 working more in these patients than patients that have other etiologies behind their tinnitus?.

Hello Joseph I will take this one. Well, the development program for AM-101 started with an acute noise trauma model and that’s pretty well defined, well characterized animal model for generating tinnitus and also for measuring our behavioral collates or other collates of tinnitus.

There are unfortunately not that many other tinnitus animal models available. For example there is none for otitis media or other triggers. We tested AM-101 in humans with tinnitus, after otitis media there we have very good results which led us to continue with this.

As you know, we also passed it in idiopathic conditions and there we had mixed results or inconclusive results. So we stopped that. So in essence this is really testing it on humans, because you have clear limitations in what you can test in animals.

But from the mechanism of action and the biology actually there are a number of potential triggers that actually share the same pathway.

So as you know also in our program we included not only noise trauma but also [bara] trauma or surgery trauma through traumatic incidence that’s clearly one important entity otitis media there you have simply the proinflammatory cytokines migrating from the infected middle ear in to the inner ear and producing a similar effect glutamate excitotoxicity that will lead to tinnitus.

I hope this answers your question. .

Our next question comes from Serge Belanger from Needham & Company. Please go ahead, your line is open. .

Just a couple questions, first on the 101 tinnitus program, just to clarify, you mentioned the TACTT3 results are expected in the fourth quarter, will that be results for both Stratum A and Stratum B, and then do you describe the Stratum B as exploratory.

Do you expect that data to be part of a final product label or it will be subject to additional clinical evaluation down the road?.

I’ll take this question. The stratum A and stratum B are both close to enrolling, completing enrollment and so they read out for these two will be both towards the end of the fourth quarter.

Now, Stratum B is exploratory, it is the first time we are testing patients with tinnitus onset beyond three months, and this will obviously be a question of the robustness of the results of this stratum as to how much save and contribute to the regulatory package and will be a matter of review, so we cannot at this stage specular further.

Of course it will be our intention to discuss this with the agencies. .

And then on 111, I think in the past you’ve provided enrollment updates, I don’t know if you’re still doing that or I may have missed it.

And then are you also planning to initiate the REACH study later this year?.

So in terms of enrollment, HEALOS is well underway with enrollment, and we’re focusing right now on the AM-101 program. We will be providing updates probably at later stage in the next calls, but at this stage what we can say is that it is well underway and the ASSENT study is going to start soon mid-year, and your second question was? Sorry. .

It was about the REACH study and whether you (inaudible) this year. .

For the REACH study currently we are not progressing at this stage with the REACH study, we will re-access this later this year. .

Let me add just two points here; so as previously indicated, we plan to provide updates on important interim or final enrollments statuses, so 50% and completion of enrollment so there will be no quarterly updates. This was communicated on one of our previous calls. With regards to REACH, as you know, we have clearance actually to do the study.

We will do the study if we have additional funding from a third party. So as this has not been secured yet, this is just on hold. But basically the study design and the protocol and everything will be ready. But while we would later, we’d need to see the full funding here assumed or secured. .

Our next question comes from Chris Howerton from Jefferies. Please go ahead, your line is open. .

I think majority of my questions were answered. I was just curious for Stratum B on the TACTT3 trial. Do you have any sense in terms of what the onset is, in terms of those patients is it skewed more towards the early side or towards three months or is it more towards six months.

Just trying to get a sense in terms of what kind of range of patients you might be seeing in that stratum. .

Well as you know the - or I’m not sure if you will recall that we originally recruited patients up to 12 months. Following an interim analysis we then focused on the three to six months’ time period in order to enrich this population, and the distribution is relatively well balanced across these three months, from months three to six. .

And in terms of your expectations for reporting the topline results, what do you foresee is going to be constituted within that topline results release. .

Well in terms of topline results, we’re going to be presenting the results of the primary end point for sure, so we’re talking about TACTT2 reading out in and communicated in August; we will be presenting the results of the co-primary endpoints.

That is what constitutes topline results and depending on outcome of any other interesting end points we may communicate. As such you should expect communication really on the primary end point. .

Our next question comes from Liisa Bayko from JMP Securities. Please go ahead, your line is open. .

This is John for Liisa just two quick questions.

Regarding TACTT2 what are kind of the biggest factors of concern that you see that could swing the results one way or another?.

Well I will take this one. Hello John, well the biggest concerns for any phase 3 trial where you have additional countries coming in, additional sites, I mean we have more than 60 sites involved in each of this trials. Now many of them were already on previous trials and so we have already experienced this.

That’s the usual game that you have here with phase 3 where you go much broadly in terms of geography and in terms of a number of sites. I think what has changed otherwise from phase 2, we already disclosed this earlier.

We have here a daily rating of tinnitus loudness and annoyance with an e-diary that is part which we did not have in the phase 2 for example. We have the tinnitus functional index that we are using which did not exist in its final forum during phase 2. We feel very comfortable about the tinnitus functional index.

We believe it’s very well designed questionnaire and it has shown in quite a few other studies already good reliability and especially also responsiveness. So these are the kind of things here that we are dealing with. Overall, we feel confident about this.

We have shown in three clinical trials randomized placebo controlled trials before phase 3 that we have consistent outcomes here with regards to several patient reported outcomes.

We do have the same study population that unchanged from our phase 2 and therefore while we think we have a good position here actually to confirm the earlier positive results from phase 2 trials. .

My question we touched Stratum B as far as your regulatory process.

Looking down the road, how important do you see that commercially for AM-101?.

Yes. Well the potential extension from up to three months, to up to six months should have a pretty substantial impact. Based on available data we estimate that the market potential would increase by probably around 50%.

We clearly see that more patients are actually seeking treatment within the first three months then within the following three months. We especially in some countries where you have also gatekeepers, general practitioners and referral systems that take some time that this could be quite important there. So all-in-all I think it will be a big plus.

And just as a reminder, the three months definition, it is kind of arbitrary lines drawn in the sand so there is now strict scientific rationale why this is defined at three months.

So something we are quite convinced that the therapeutic times when those are actually extending beyond the three months based on the phase 2 analysis that we did, where we did not see a decrease in the drugs activity towards the three months.

So the interim analysis also pointed in that direction such as suggesting that the drug is still active beyond the three months also at a decreasing level I think that makes a lot of sense. In the end nobody can tell for certain how far you can go.

This is also probably differing from patient to patient, when it comes to potential centralization of the tinnitus. So clearly, we believe that three months that’s the target right now, but one way or the other we expect here to see an extension possible for the post-acute patients as well..

And just one follow-up, you mentioned earlier you’ve been tentative of the $750 million opportunity in the US, does that include the Stratum B or is that just Stratum A?.

That is just the Stratum A for the target indication. .

There are no further questions in the queue at this time. I would now like to hand the call back to our speaker for any additional or closing remarks. .

Thank you and operator and thanks to everyone for joining the call today, and your continued interest in Auris Medical. Have a great day and as always please remember, take care of you ears. Thank you and good bye. .

Thank you for your participation ladies and gentlemen, that will conclude todays’ conference call, you may now disconnect..