Cindy McGee - Head, IR and Corporate Communications Thomas Meyer - Chairman and CEO Thomas Jung - Chief Development Officer Hernan Levett - CFO.

Serge Belanger - Needham & Company.

Thank you, operator, and thanks to everyone on the call for joining. I am Cindy McGee, Head of Investor Relations and Corporate Communications at Auris Medical. With me are Thomas Meyer, Auris Medical’s Chairman and Chief Executive Officer; Thomas Jung, Chief Development Officer; and Hernan Levett, Chief Financial Officer.

Earlier today, we provided a business update and announced our financial results for the full-year 2016. The news release is available on our website at aurismedical.com and has been filed 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 decisions 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 our regulatory filings and approvals, 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’ll hand the call over to Thomas..

Thank you, Cindy. Good morning to our listeners in the U.S. and good afternoon to our listeners in Europe. On today’s call, we are pleased to provide a business update and discuss our full year 2016 financial results. I will begin with the brief overview of our recent highlights with the focus on our expanded pipeline of product candidates.

We are excited to now cover all of the big three inner ear disorders, hearing loss, tinnitus, and vertigo as we aim to continue to lead the way in this category of significant medical need. First, we continue to progress with AM-111 our cell-penetrating peptide for the treatment of acute inner hearing loss.

Building on the AM-111 orphan drug designation, we are pleased to have received fast track designation from the FDA in February. This development highlights the unmet medical need and seriousness of the condition.

Acute in inner ear hearing loss can have a significant impact on day-to-day functioning; it may develop irreversible, chronic hearing loss with debilitating consequences. And as of today, there is no therapy available for acute inner ear hearing loss that has shown clear evidence of therapeutic benefit.

We consider AM-111 to offer several interesting product features. It is administered as a single dose treatment, provides for rapid recovery of hearing and reduces the tinnitus that frequently accompanies acute hearing loss. Now, turning to Keyzilen, our small molecule NMDA receptor antagonist for the treatment of acute inner ear tinnitus.

Here, we have resumed enrollment in the Phase 3 TACTT3 trial. This came after amending the protocol to incorporate key learnings from the TACTT2 trial. We believe the protocol amendment increases the probability for a positive outcome even if the treatment shows similar effect as in TACTT2.

Another recent highlight is addition of AM-125, which represents a third clinical stage program in our pipeline and expands our work into vestibular disorders. For the AM-125 program, we are developing betahistine in a spray formulation for the intranasal treatment of Meniere’s disease and vestibular vertigo.

Oral betahistine is approved and marketed in more than 80 countries worldwide with the U.S. being one of the notable exceptions. The clinical data from an initial Phase 1 trial with intranasal betahistine suggests that this administration route allows for a significantly higher bioavailability than reported for oral betahistine administration.

I’m pleased to say that our recent announcement of the AM-125 project was met with great interest from the ENT community, highlighting the significant need for better treatment options for vestibular disorders. These conditions occur quite frequently.

For example, in the U.S., there are almost 4 million visits per year to the emergency department for problems of dizziness of vertigo and they can be highly debilitating. Thomas Jung, our Chief Development Officer will now provide a further update on our development programs.

And Hernan Levett, our Chief Financial Officer will continue the presentation by reviewing the financial results. With that, let me pass over the call to Thomas..

Thanks, Thomas. Today, I will provide an overview of our two Phase 3 assets, the recent addition to our clinical development pipeline and the extension of our research collaboration with King’s College. AM-111 is now our most advanced program from the data readout perspective.

This compound has the potential to become the first therapeutic indicated specifically for the treatment of acute inner ear hearing loss. As Thomas highlighted in his opening remarks, there is a high unmet medical need for an otoprotective treatment.

In the randomized placebo controlled Phase 2 trial in patients with the severe to profound hearing loss, AM-111 showed compelling otoprotective efficacy. Two Phase 3 trials evaluating AM-111 are currently ongoing. We are enrolling patients with severe to profound sudden deafness who received one single dose of AM-111.

HEALOS is the first of our two pivotal trials and is being conducted in Europe and Asia. We are on track to complete enrollment of approximately 255 patients in the second quarter this year. For the three months follow-up period, we plan to announce top-line results toward the end of the third quarter.

In addition, our second pivotal trial ASSENT, which has a very similar design was initiated in summer 2016 and is ramping up. Now, moving onto Keyzilen. As already announced, we implemented three key modifications to the TACTT3 protocol. First, the tinnitus functional index was elevated from a key secondary endpoint to an alternate primary endpoint.

Second, the subgroups of patients with tinnitus following otitis media or with a severe or extreme tinnitus were included in confirmatory testing.

And third, 60 additional patients are being enrolled in each of Stratum A which includes patients with tinnitus onset within three months and Stratum B which includes patients with tinnitus onset within three to six months.

In fall, we submitted the protocol amendment to regulatory agencies and other committees in the countries where we are continuing the trial. Following regulatory approval, we re-initiated patient enrollment in January. We expect to complete enrollment in the third quarter of this year and announce top-line results in early 2018.

In addition, our two open label extension studies AMPACT-1 and 2 are evaluating the long-term safety of Keyzilen. All patients in the TACTT2 and TACTT 3 trials have the option to receive up to three additional cycles of active treatment. We have now completed enrollment into these studies and expect to announce the results in the upcoming month.

Moving beyond AM-111 and Keyzilen, we’re committed to expanding our portfolio to address additional unmet medical needs associated with inner ear disorders. As part of this effort, we are pursuing another administration route of betahistine for the treatment of Meniere’s disease other vertigo conditions.

As we recently announced, through an agreement with Otifex Therapeutics, we have added another development program called AM-125 to our pipeline. To build on Otifex Phase 1 results, we plan to initiate a second Phase 1 trial this year.

We believe that intranasal administration of betahistine instead of oral would substantially increase platinum [ph] levels of betahistine, a key element for improving the efficacy profile of this compound. We are preparing for regulatory discussions including a pre-IND meeting and assembling an advisory board of experts in this space.

And lastly, our collaboration with King’s College in London has provided new insights for our second generation tinnitus program called AM-102. Consequently, we will continue the collaboration this year, aiming to identify and characterize our lead compound with high potential to treat acute tinnitus.

I will now turn the call over to Hernan for a financial update..

Thank you, Thomas. Before reviewing our financial results for the full year 2016, I would like to note that the financial statements are presented in Swiss francs. The net loss for the full year 2016 was CHF 30.7 million or CHF 0.89 per share compared to CHF 29.7 million or CHF 0.92 per share for the full year 2015.

Our research and development expenses decreased from CHF 26.5 million in the full year of 2015 to CHF 24.8 million in the full year of 2016. The reduction in research and development expenses is mainly driven by the completion of TACTT2 and progress with the AMPACT studies, partially offset by the full year effect of our AM-111 programs.

General and administrative expenses increased from CHF 4.3 million in the full year of 2015 to CHF 5.4 million for the full year 2016. The increase was due to higher employee and administration expenses.

In addition to our operating expenses, the net loss for the full year 2016 included interest expenses of CHF 800,000 and a net unrealized foreign currency exchange loss of CHF 100,000. Our cash and cash equivalents as of 31 December 2016 were CHF 32.4 million.

This cash balance did not include the $9.1 million received from the public offering we completed last month. As previously announced, we expect our operating expenses for the full year 2017 will be in the range of CHF 28 million to CHF 32 million.

With the proceeds from the recent offering, our cash runway has now been extended into the first quarter of 2018. I will now turn the call back to Thomas..

Thank you, Hernan. Before concluding, I want to inform you about our annual general meeting, which will take place in Zug, Switzerland on April 13th. The agenda for the meeting as well as the financial statements for the 2016 financial year are available on our website in the Investors section.

At the meeting, we will propose the re-election of our current members of the Board of Directors with the exception of Professor Wolfgang Arnold and Jim Healy. We would like to thank Wolfgang who is retiring due to the statutory term limitation and Jim for a great contribution to our Board of Directors since 2008 and 2013 respectively.

We are delighted to propose the election of Mats Blom as a new Board member. Mats is Senior Vice President and CFO of Zealand Pharma. Prior to joining Zealand, he served as CFO of Swedish Orphan International, Active Biotech and Anoto Group.

Mats holds a BA in Business Administration and Economics from the University of Lund and an MBA from IESE University in Barcelona.

He has built a great track record in key roles with several innovative European biotech and pharmaceutical companies and will provide great support as we advance our clinical stage programs and move towards commercialization.

Furthermore, it is with great regret that I inform you that Anne Sabine Zoller will be leaving Auris Medical in the coming months. Anne has served as our General Counsel since 2016. We respect Anne’s decision and wish her the best as she pursues a new career opportunity with another company.

Moving ahead, we look forward to productive 2017 with the following upcoming milestones. In the second quarter, we expect to complete enrollment in the HEALOS trial and announce results from the AMPACT open label trials. In the third quarter, we expect to complete enrollment of the TACTT3 trial and announce top-line results for HEALOS.

In addition, we plan to initiate a second Phase 1 trial with AM-125 in the second half of this year. In summary, we have implemented important changes to increase the probability of success with our Phase 3 Keyzilen program in tinnitus and we have extended our cash runway to cover the readout from the TACTT3 trial.

Further, we are progressing towards important beta readouts for our Phase 3 AM-111 program. And last but not least, we have added AM-125 a third clinical stage development program with great potential. With that, I would now like to turn the call back to the operator who will open the line for questions..

Thank you, sir. [Operator Instructions] We will take our first question from Serge Belanger from Needham & Company. Please go ahead, sir..

Hi. Good morning. Just a couple of questions for me.

First on AM-125, can you talk a little bit about the details of the second Phase 1 study you’re looking to initiate in the second half of this year? It sounds like the data of this Phase 1 will be important for your upcoming regulatory discussions?.

Good morning. Yes, the data will be important. However, as you know, we already can draw on data from the first Phase 1 study. Actually, we are planning to meet with regulatory agencies prior to initiating the second Phase 1 to have a discussion here on the scope and some elements of the design.

And to give you a broad overview of what we’re planning with AM-125, I quickly pass the call over to Thomas Jung, our Chief Development Officer, who can give you a brief outline of this.

Thomas?.

Yes, sure, of course, my pleasure. So, Auris Phase 1 trial has the volunteers and we titrated upto a concentration with which they have not reached the maximum tolerated dose. Now, we believe this is an important aspect of our program to understand to which extent the drug is well tolerated from nasal perspective so to speak.

So, we want to actually increase the dose and want to go to higher doses. The second element of what we wanted to do in our trial which was not addressed in the recent Otifex trial is the aspect of multiple dosing.

So, we assume based upon the short time, half life of the drug that we actually need to administer the drug similar to oral dosing, three times a day. Now, a nasal spray three times a day or even more, again, this requires a certain level of confidence building in the local tolerability issue. These are the major elements we want to investigate.

So, a local tolerability, multiple dosing under high doses and finally we want to introduce some modeling and simulation work into the PK parameters in order to get a better understanding or a better dose rational for the subsequent proof of concept study..

Okay..

Okay, Thomas. Let me just add here that we do have preclinical data with repeated dosing in locks [ph] which very well supports the repeated dosing of betahistine, actually at fairly high concentration with the intranasal right..

Okay. Just a question on your collaboration with King’s College, you mentioned for the discovery of second generation small molecule tinnitus treatment.

Are these second generation to Keyzilen meaning the same mechanism of actions or are they other -- or are you looking at different mechanism of actions for this collaboration?.

Okay. I will take this question right away. Now the AM-102 has a different target than Keyzilen. So, this is not an NMDA receptor antagonist. The target has been tested and validated here with a number of compounds in number of assays already including in vivo.

So, here, the objective is really to obtain through medicinal chemistry compound that has desired properties, so we already that it works. The goal here is really to get to a small molecule that has the desired properties here to take this into development. So, we are very confident that this can be achieved.

We have a great team that King’s College that is working on these programs..

[Operator Instructions] It appears there are no further questions at this time. Mr. Meyer, I’d like to turn the conference back to you for any additional or closing remarks..

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

Ladies and gentlemen, this concludes today’s call. Thank you for your participation. You may now disconnect..