Thomas Meyer - Chairman, Chief Executive Officer Sven Zimmermann - Chief Financial Officer Bettina Stubinski - Chief Medical Officer Anne Sabine Zoller - General Counsel.

Mike Schmidt - Leerink Partners.

Good day ladies and gentleman and welcome to the Auris, Third Quarter 2015 Financial Results and Business Update Conference Call. At this time I would like to turn the conference over to Anne Sabine Zoller, General Counsel. Please go ahead..

Thank you operator and thank you everyone on the call for joining. On behalf of Auris Medical, I would like to welcome everyone to our third quarter 2015 earnings call.

I am Anne Sabine Zoller, General Counsel and with me are Thomas Meyer, Chairman and Chief Executive Officer; Sven Zimmermann, Chief Financial Officer; and Bettina Stubinski, Chief Medical Officer. Earlier today we issued a press release available at auris.com with our results for the third quarter of 2015 and a business update.

We also filed this press release with the SEC earlier today. During today's call, we’ll 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 conditions 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, the prospectus dated May 14, 2015 relating to our Registration Statement on Form F-1 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 over to Thomas..

Thank you, Anne. Good morning to our listeners in the U.S. and good afternoon to our listeners in Europe. We are pleased to provide you today with a report on the third quarter 2015 and a general business update. I will begin with a presentation of some of Auris Medical's key developments over the past few months.

Our linked program with AM-101, the treatment of acute inner ear tinnitus continues to keep us busy over the past few months. We made further progress with our TACTT2 and TACTT3 trials, as well as the AMPACT open label follow-on trials. Bettina will discuss this further shortly.

In addition, we have been focusing on preparations for regulatory submissions, the up scaling of the manufacturing process and the development of AM-101 branding. We are very excited by AM-101’s potential to become the first in class treatment for acute inner ear tinnitus, following dramatic cochlear injury or otitis media.

For our AM-111 development program, in the treatment of acquit inner ear hearing loss we achieved significant progress with our preparations for the three clinical trials; HEALOS, ASSENT and REACH. In particular we are approaching the beginning of patient recruitment in HEALOS. Bettina will also provide you with a more detailed update here.

We are very pleased to see the considerable interest our hearing loss program is generating within the ENT community. Like tinnitus acute hearing loss represents a strong unmet medical need.

AM-111 has showed a broad therapeutic spectrum as otoprotectant in various types of acute insults to the inner year by inhabiting the JNK stress kinase, the [drop blocks] [ph]apoptosisof sensory cells and potentially damaging inflammatory responses inside the cochlear allowing for preservation of functional hearing.

With a single dose treatment and the ability to defuse rapidly into the cochlear and up to it’s most optical part that is the speech frequency region, AM-111 offers potentially unique benefits.

At the recent Annual meeting of the American Academy of Otolaryngology Head and Neck Surgery, the world’s largest ENT conference, we received a lot of positive feedback on AM-111. Importantly many ENT physicians inquired about participation as investigators in our forthcoming ASSENT trial.

We also hosted the Corporate Symposium at the Academy meeting, following last year’s successful Tinnitus Symposium, this year’s event was focused on the Pharmacotherapy for Acute Hearing Loss. The Symposium was Chaired by Professor Larry Lustig of Colombia University.

Four key opinion leaders presented the state of the art in hearing preservation following Acute Cochlear Stress Injury, Inner Ear Drug Delivery and Clinical Research in Acute Hearing Loss. The Symposium highlighted the lack of effective treatments and the significant unmet medical need in the treatment of Acute Hearing Loss.

Further, it laid out key considerations for the design of clinical trials. I will conclude my remarks with some comments on our second generation Tinnitus product candidate AM-102.

Together with some of our academic partners over the past few years, we have sort of gained additional insights into the generation and maintenance of Tinnitus in order to better understand how AM-101 works and to identify other possible therapeutic targets.

This research work led to the discovery of one particularly interesting target that is different from the NMDA receptor, which is the target for AM-101. This new target has since been validated and several compounds have been tested on it.

For this initial phase of drug discovery we worked together with the Wolfson Centre for Age-Related Diseases at King's College, London. Now for a second stage of drug discovery the collaboration has been expanded to also include the Institute of Pharmaceutical Science at King’s.

Another collaboration, King’s will develop an optimize range of specific small molecules for the AM-102 project. We expect to select by the end of next year a lead compound for the pre-clinical and subsequent clinical development.

We are very excited about AM-102’s potential to become a powerful second generation Tinnitus Treatment and the opportunity to further strengthen our leadership in Tinnitus research. Bettina will now provide you with an update on our clinical programs. Sven will conclude the presentation by walking you through the financial results.

With that, let me pass over the call to Bettina..

Thank you, Thomas. For this last quarter we’ve seen substantial progress on the clinical side. First, we have further advanced with recruitment in the AM-101 Phase 3 program.

For both TACTT2 and TACTT3 we are now beyond two-thirds of our enrolment targets and we expect to have top line results for the first study to complete at the end of Q2, 2016 and it is likely that TACTT2 will complete ahead of the European TACTT3 study, which has the largest sample size due to the additional exploratory Stratum B in the post-acute tinnitus.

Based on current rollover rates in our open label follow-on studies AMPACT1 and AMPACT2, we are confident is our ability to meet the FDA’s request for safety data from chronic intermittent use of AM-101.

So as a reminder all TACTT patients completing a trial have the option to rollover into the corresponding AMPACT trail and receive at their choice, up to three additional treatment cycles. It means that patients can receive up to a maximum of four treatment cycles with AM-101 over a total of 12 months.

The FDA has asked us to provide safety data from 300 patients treated over six months and from 100 patients treated over 12 months. Moving on to AM-111, I am very pleased to report that we also made tremendous progress in advancing this important program.

As a reminder, the Phase 3 program comprises two placebo control studies with AM-111 evaluating 0.4 mg/mL and 0.8 mg/mL in a single injection given within 72 hours of onset in patients with unilateral idiopathic sudden sensorineural hearing loss, that is severe or profound.

These patients have a hearing threshold that is 60 decibels or higher at the average of the three most effective testing frequencies, which means that in the best case they cannot hear a normal conversation across the table in one ear and at the worst case are completely deaf in that ear.

This can be a very frightening experience and could result in permanent hearing loss and substantial negative impact on communicative capabilities and quality of life. The HEALOS study is being conducted in Europe and Asia and we are excited to have the first few sites now initiated with enrolment expected to begin shortly.

Readout of HEALOS is expected in Q3, 2017. The ASSENT study will be a primarily North American study very similar in design to HEALOS, expect that here we are allowing to background oral corticosteroids therapy, which is the defect of standard treatment for these patients in North American.

We have an open IND and subject to final consultation with the FDA on the protocol, this study is expected to initiate in the first half of 2016 with readout two years later. Finally, we have also progressed with the REACH trial.

This is a Phase 2 proof of concept study designed to assess the potential of AM-111 through its anti-apoptotic and anti inflammatory mode of action to protect against hearing loss induced by cochlear implantations. The drug is applied intraoperatively during surgery for cochlear electrode insertion.

Since the announcement of our plans for REACH, we have seen a high level of interest in the ENT community. We are also very pleased to have Cochlear Corporation onboard as an ideal partner for the preparation and conduct of the study.

The REACH protocol was finalized following feedback from the FDA and a grant application was recently submitted to NIH. Our intention is to begin the study in Q3, 2016 contingent on securing grant funding. Overall, we are extremely enthused on the clinical side by now having not just AM-101, but also AM-111 well underway in Phase 3 development.

With that, let me pass the call onto Sven for his financial update..

Thank you, Bettina. So with regards to the financials, as you know this financial information has been prepared using the same accounting policies and methods of computation as compared with the most recent annual financial statements.

The financial statements are presented in Swiss francs, the company’s functional and presentation currency and all amounts are in Swiss francs unless otherwise specified. Let me start with slide number 10.

Our research and development expenses increased from CHF13 million in the nine months ended September 30, 2014 to CHF20.9 million in the nine months ended September 30, 2015.

The increase is primarily due to higher clinical expenses due to the progression of our AM-101 Phase 3 clinical program, as well as for the preparation as we’ve just heard from Bettina for the AM-111 late stage program.

General and administrative expenses decreased from CHF3.6 million in the nine months ended September 30, 2014 to CHF3.2 million in the nine months ended September 30, 2015.

The decrease was primarily related to higher legal and auditing expenses in relation to the IPO preparation in Q1 2014, partially offset by the expenses related to our follow-on offering in May this year and higher public listing expenses.

With regards to our net financial income and expenses, we have decided to provide additional detail on the respective financial line items and going forward we will be differentiating between interest income, interest expense and by far the most important contributor, net foreign currency exchange gains or losses.

During the first nine months of 2015 we recorded unrealized foreign exchange losses of CHF0.14 million whereas we had recorded a gain of CHF2.4 million in the same period in 2014. As you know, since the majority of our cash and cash equivalents are held in U.S. dollars, in the first nine months of 2015 the net depreciation of the U.S.

dollar against the Swiss franc had a negative impact, whereas the appreciation of the U.S. dollars against the Swiss franc resulted in a gain in the first nine months of 2014. In the third quarter of 2015 as well as in the third quarter of 2014 the U.S.

dollar actually appreciated against the Swiss franc and we therefore recorded an unrealized foreign exchange gain of CHF2 million and CHF2.3 million for the respective periods.

The reported net loss for the first nine months of 2015 was CHF24.2 million, compared with CHF14.2 million in the same period in 2014, corresponding to a net loss per share of CHF0.76 versus CHF0.68 Swiss francs.

The reported net loss for the third quarter of 2015 was CHF5.2 million compared with CHF3.4 million in the same period in 2014, corresponding to a net loss per share of CHF0.15 versus CHF0.14.

We remain on track to meet our previously issued operating loss guidance for the full year of CHF30 million to CHF35 million Swiss francs including the Phase 3 related costs for AM-111. Our cash and cash equivalents as of September 30, 2015 was CHF55.4 million compared to CHF56.9 million at the end of December 31, 2014.

The slight decrease in cash is essentially the net result of the cash inflow from our follow-on offering in May 2015 in one end and operating expenses inured during the first nine months of 2015 on the other. Our cash or our current cash position should allow us to finance operations until at least the fall of 2017.

With that, I would now like to turn the call over to the operator who will be opening the line for question. Thank you..

Thank you. [Operator Instructions] Now we have an opening question from Joe Schwartz of Leerink Partners. Please go ahead. Your line is open..

Thank you very much. This is Mike dialing in for Joe. Congrats on all the progress this quarter. I just have three follow-up questions. Maybe you mentioned it and I missed that during the call. Have you given in addition the completion of enrollment for both TACTT2 and TACTT3 trials separately? I believe TACTT3 is bigger. It has a Stratum B.

Soany guidance in that would be helpful. And on the HEALOS Study did you say that there was an intelligent analysis inbuilt. If its not we’ll just look at the full data in 2017 and then maybe then one or two we are really intrigued about this new target that we are working on as next generation to Tinnitus.

Can you maybe highlight the lab which you are working with at King's College, so that we can just understand how your thinking about where and what; how in the treatment paradigm would that fit in with 101. Thanks..

Okay, so I think I’ll take the first two questions and then I’ll hand over to Thomas for the last question. So in terms of the TACTT2 and TACTT3 study read out as I was mentioning earlier, it does look like TACTT2 will be the first study to read out at the end of the first half of 2016.

TACTT3 being a larger study, because as you rightly stated, it has the exploratory Stratum B which is in post-acute Tinnitus, sop patients with Tinnitus is over than three months and up to six months, whereas Stratum A in patients with Tinnitus is up to three months prior. So Stratum B requires 330 patients. Stratum A requires 300 patients.

That makes it a total of 630 patients that we need in TACTT3. So we expect this study to read out a few weeks or a few months after TACTT2. Regarding the HEALOS Study, no we do not have an interim analysis planned in this study. We have one planned in the ASSENT study. So that’s one of the differences also between HEALOS and ASSENT.

ASSENT plan has an interim analysis plan, because we are also providing for background corticosteroids therapy. So the interim analysis will be halfway through – well, at the midpoint of recruitment and it is only for sample size adjustment and there will not be any stopping growth. So I’ll pass on to Thomas for the last question..

Yes, well thank you for the question about AM-102. So I’d love to share with you and the public some details about this program. However after having worked on this very hard for several years, I mean we are not at a point where we wish to disclose the target. I just have to ask for your patience.

I mean what I can say is while its different from NMDA receptors and it has shown so far in pre-clinical studies better or even much better efficacy or effects. So this is very promising. We are in a process here of optimizing the molecules, small molecules, while we are building our IP on these discoveries. So please have some patience on that one..

Great, thanks Tom and if I may follow-up on Bettina’s color on the data readout, is there anything that you’re saying on finishing the patient enrollment in particular. I understand the data readout, but can you comment maybe on the enrollment expectation, when that is completing..

Well that is in line with the readouts. If you calculate back from readouts of patients; once they enroll they have 84 days, so roughly three months. So the patient enrollment is expected to complete just over three months ahead of readout..

Perfect. Thank you for the clarification..

[Operator Instructions] Our next question comes from Serge Belanger of Needham & Company. Please go ahead. Your line is open..

Hi, this is Nicole dialing in for Serge. I have a couple of quick questions for you.

So I just wanted to know how far enrolled the AM-101 Phase 3 studies are?.

Yes, absolutely. So as I mentioned, I think I mentioned on the last slide, so we’re just over two-thirds of enrollment actually. TACTT2 slightly more or less around three quarters enrolled. So we’re now at the stage of enrolling our last third or last quarter of patients..

Okay. And how far is the AM-102 program from entering the clinic and should we expect any additional collaborations beyond the one with King’s College and anything new to report with the other pre-clinical program AM-123..

Well, the AM-102 program, I think at this point is probably 2 to 2.5 years away from the clinic. So we will fine tune this as we move forward. So currently the expectation is that we will have the lead compound selected before year end 2016. Now with regards to other collaborations, well we have had several collaborations here.

I mean on the science side I think we are well covered and we have all what is required and necessary, so there maybe some additional collaborations, but at this point we have nothing concrete here, so we have all the knowhow, skills and experience to take this forward ourselves.

The question about AM-123, while we have had their collaboration for several years, so with the research institutes in the U.S., we are currently adding to our internal resources to move forward to advance more aggressively on this program. I mean, this is relating to a renology [ph] indication, a large renology indication.

We have identified a number of compounds that have shown very promising results. Again, we prefer not to disclose too many details at this point and we will provide further updates as we progress..

Okay, great. And just one more question.

Is the pace of enrollment in the AM-111 hearing loss trials expected to be similar to what we’re seeing with the AM-111 Tinnitus study?.

Regarding the acute hearing loss studies, so here the patient population is rather different. First of all, they will not have triggering events such as acute acoustic trauma or otitis media or barotraumas like patients with tinnitus.

So here it’s an idiopathic onset with no apparent cause and we will recruit patients within 72 hours of onset as opposed to the three months of sensitivity patients. So we can’t really compare these populations in quite the same way.

We will target similar sites potentially to enroll patients and of course we will be capitalizing on the experience with enrollment that we’ve had in and with the investigators that we’ve had with the Tinnitus program. We aim at having 60 to 80 sites in HEALOS.

So we have spread and we’ve done an in-depth feasibility across the various countries that you’ve seen listed. So we believe to have selected the most appropriate and best site with the best potential..

Okay, great. Thank you so much..

[Operator Instructions] As we have no further questions, I would like to turn the call back to the speakers for any additional or closing remarks. .

Thank you very much operator and thanks to everyone for joining the call today and your continued interest in Auris Medical. I wish you a great day and please remember to take care of your ears. Thanks. Bye-bye..

Thank you. That will conclude today's conference call. Thank you for your participation ladies and gentlemen. You may now disconnect..