Thomas Meyer – Chairman and Chief Executive Officer Bettina Stubinski – Chief Medical Officer Sven Zimmermann – Chief Financial Officer.

Joseph Schwartz – Leerink Partners Serge Belanger – Needham and Company.

Good day and welcome to Auris First Quarter 2015 Financial Results and Business Update. At this time, I would like to turn the conference over to [indiscernible] Senior Leader Council of Auris Medical. Please, go ahead..

Thank you, Alice [ph] and thank you, everyone for joining the call for joining. On behalf of Auris, I would like to welcome everyone to our first quarter 2015 earnings call. I’m Senior Leader Council of the company.

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 aurismedical.com with our results for the first quarter 2015 and business update. We also filed this press release with the SEC earlier today.

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, beliefs and involve significant risks and uncertainties that could cause actual results, development, 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 regulatory filings and approval for our intellectual property and our financial position, as well as those described in the risk factors section of our Annual Report on 20-F and some declines with the SEC.

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 would like to hand over to Thomas..

Thank you [indiscernible]. Good morning to our listeners in the U.S. and good afternoon to our listeners in Europe. Together with Bettina and Sven, I am very pleased to provide you today with a report on the first quarter of 2015 and a general business update. Let me begin with the brief overview and some highlights.

We continued to make strong progress in the first months of 2015 enrollment into the AM-101 Phase 3 trials in the treatment of acute inner ear tinnitus continue to advance well.

We refined and strengthened our development program for AM-111 in the treatment of acute sensorineural hearing loss based on further discussions was clinicians and also feedback that we obtain from regulatory agencies.

Resulting in a clear and in comprehensive roadmap and through our recent equity raise we laid the financial groundwork for moving forward with our AM-111 projects.

The treatment of acute inner ear hearing loss with AM-111 addresses an important unmet medical need as evidenced by the orphan drug designation by the FDA and DMA and represents a substantial commercial opportunity for our company.

Importantly, Auris Medical is now evolving into a company with two ongoing late stage clinical development programs with both of them being based on rational pharmacotherapy with solid animal model structure based clinical proof-of-concept in Phase 2 extensive interactions with regulatory agencies and clear end points.

Bettina will provide you with an update on our clinical development programs and talk in particular about our late stage AM-111 projects. 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. So today, I would like to start with our second clinical development program. AM-111 is provided in a biocompatible gel formulation similar to that of AM-101 and also via intratympanic injection.

It contains a synthetic peptides D-JNK inhibitor 1 the come form protects sensorineural structures in the inner ear from stress-induced damage by acting on the JNK cell death signaling cascade. As Thomas mentioned, AM-111 is being developed for the treatment of acute sensorineural hearing loss or acute inner ear hearing loss.

There are currently no approved treatments for this patient population and AM-111 has been granted orphan drug status by both the European Medicines Agency as well as the FDA. From market research, we have found that idiopathic sensorineural hearing loss or ISSNHL represents the most frequent form of ASNHL.

The acute stage of hearing loss represents a window of time in which the inner ear can be protected from permanent hearing loss. AM-111 attenuates inflammation and protect cells from apoptosis helping to prevent or minimize permanent damage or clinic hearing loss.

They also protect the effects of AM-111 has been demonstrated in various animal models of cochlear stress including acute acoustic trauma, acute labyrinthitis, which is inflammation draw those toxicity due to aminoglycoside, bacterial infection, cochlear ischemia and cochlear implantation trauma.

As you can see on this slide, we have a solid late stage clinical development program for AM-111, which comprises two Phase 3 studies in ISSNHL and one Phase 2 study in surgery-induced hearing loss. We already completed a Phase 2 study in ISSNHL which hasn’t formed our Phase 3.

As far as our two Phase 3 studies are concerned these will have a similar design with both HEALOS and ASSENT randomizing patients to receive a single injection of either 0.4 milligrams per mL, 0.8 milligrams per mL of placebo.

The previous Phase 2 study show the statistically significant that clinically meaningful improvement for the primary as well as the co-primary end points in patients with severe-to-profound acute sensorineural hearing loss treated with 0.4 milligrams per mL compared to placebo.

In the Phase 3, we’re therefore enrolling severe-to-profound patients, the difference between the two Phase 3 studies that we are conducting now is that ASSENT also allows for what in the U.S. in particular is the factor of standard of care even if not labeled for this indication i.e., oral corticosteroids as background therapy.

In HEALOS on the other hand there will be no corticosteroids allowed except for optional reserve oral corticosteroids therapy after a week only in case of insufficient hearing recovery. So in both studies the primary efficacy variable will be the change in hearing threshold which is an objective outcome measure determined by an audiologist.

Based on assumptions following data from the Phase 2 results we have positive studies so its have a very good margin of error. HEALOS study setup is well underway with regulatory submissions ongoing and we expect first study sized to be approved end of August and start enrolling by September.

Readout of the data is expected Q3 2017 for HEALOS with ASSENT readout in Q1 2018. This does me to the Phase 2 study REACH, which we are planning in surgery-induced trauma following cochlear implantation research conducted at the University of Miami by Dr.

Adrien Eshraghi has provided very compelling data that showing a high degree of protection against surgery-induced hearing loss following cochlear implant electrode insertion in guinea pig, cochlear implantation is a very, invasive surgical procedure closing acute trauma and that causes a risk of losing residual hearing.

This side effect is preventing the more wide spread use of cochlear implants in adults. Reach is expected to start in Q3 2016, and we are seeking NIH funding for the study.

For AM-101 on the other hand I'm happy to say that our studies are progressing nicely TACTT2 which are the target of 330 patients is nearly at half mark where is the TACTT3 with the target of 300 patients we have now recruited 55% of the patients.

As such the AM-101 program is on track and we already talked previously extensively about the exploratory cohort in post acute tinnitus is our last webcast and in this stratum B enrollment continues in patients with tinnitus is between three and six months old. So that we will also have data and patients with a slightly later onset of tinnitus.

As we are progressing with the AM-101 studies we are also continuing with the activities and that raising the awareness of our products in the medical community to very recent publications in peer-reviewed journals released additional pre-clinical and clinical data on AM-101.

One of the articles presented experimental data from an animal model of noise-induced tinnitus in which the author showed a significant reduction in the loss of inner hair cell ribbon and superior preservation of the amplitudes of centrally generated auditory brainstem response waves in rough treated with AM-101 compared to controls.

The second article, published in an Audiology & Neurotology, presented the results of the Phase 2 TACTT1 trial with AM-101 and further more detailed how the most appropriate dose regimen for the Phase 3 program was determined based on the outcomes of the two Phase 2 studies we conducted. You can access all the references on our website.

We’ve also organized symposium for some of the ENT conferences taken place in the Europe this spring. Scientific and clinical data from the AM-101 program was presented in a very well attended corporate symposium at the annual congress of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery in Berlin.

We will be holding another symposium in a couple of weeks in Prague at the European ENT conference. With that, let me pass over the call to Sven..

Thank you, Bettina. So with regard to our financials, the 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 currencies, and all amounts are in Swiss francs, unless otherwise specified. Please note that for the convenience of our U.S. based investors we have provided a pro forma P&L and balance sheet in U.S. dollars in our news release.

Our cash and cash equivalents as of March 31, 2015 with CHF47.9 million compared to CHF66.9 million at the end of December 31, 2014. The declining cash is due to our operating expenses during the first quarter 2015.

Our research and development expenses increased from CHF4.1 million in the three months ended March 31, 2014, to CHF6.2 million in the three months ended March 31, 2015. The increase is mainly due to higher clinical expenses due to the good progression of our AM-101 Phase 3 clinical development program.

In addition, as we referred we continue to care our late stage AM-111 clinical program. General and administrative expenses decreased CHF1.7 million in the three months ended March 31, 2014, to CHF0.9 million in the three months ended March 31, 2015.

The decrease was primarily related to higher legal and auditing expenses in relation to the IPO preparations in Q1, 2014. Partially offset by the expenses related to our May 2015 following offering during in which we incurred expense in Q1 2015.

Net financial income decreased to CHF0.9 million in the first three months of 2015, as we recorded higher unrealized foreign exchange losses. Since majority of our cash and cash equivalents are held in U.S.

dollars, ends to a lesser extend of some euros, a short depreciation of the Swiss francs in the first three months of 2015 had a negative impact here. The reported net loss for the first three months of 2015 was CHF8 million, compared with CHF5.9 million in the same period in 2014, corresponding to a net loss per share of CHF28 versus CHF32.

From today’s perspective, we expect operating expenses for the entire 2015 financial year to reach between CHF30 million and CHF35 million. This includes the cost for starting the HEALOS Phase 3 trial with AM-111 and also includes cost for the preparation of the ASSENT trial.

In May 2015, we completed a follow on offering placing 5.275 million shares at US$475 raising gross proceeds of about US$25 million and net proceeds after underwriting discounts and offering expenses of approximately $22.9 million.

These proceeds together with our existing cash on hand, allow us to finance operations, including the AM-111 Phase 3 trial program, at least until the fall of 2017. With that, I would now like to turn the call back to the operator who will open the line for questions..

Thank you, [Operator Instructions]. We’ll take our first question today from Joseph Schwartz, of Leerink Partners. Please go ahead, your line is open..

Great, thanks very much for taking the question.

First of all on AM-111, it sort of relates to the competitors program which is not even in this indication, but I was wondering is there any read through in your mind about as far as anything that autonomy recently saw when they reported data in Meniere's disease, in terms of things like the variability or the placebo response in some of the PROs that are used in these hearing disorders as it relates to either of your lead indications?.

Okay. Hi, Joe, thank you for attending this conference call. With regards to these outcomes in acute hearing loss we have a very comfortable situation since here we are dealing with well established outcomes.

So when you look at the primary end point that is the improvements recovering in hearing thresholds, so this is an objective measure performed by an audiologist, so this is not a patient reported outcome. We also have additional outcomes like each discrimination.

So here this is well established and therefore we expected to see here clearly less variability and also I have seen in the past trials here that these outcomes, they performed quite nicely.

When it comes to tinnitus here obviously we’re dealing with patient reported outcomes, however I think here it’s very specific when you look at Meniere's there you are counting vertigo episodes of vertigo attacks. So that’s a number of events and that is relatively a rough measure.

I would say whereas with tinnitus here its relatively straightforward measure of tinnitus loudness that is for patients straightforward. It has been around for very long time and we had also the agreements with the agencies in the past.

Here also I think its important to note that placebo effects that we have been seeing in tinnitus, they were definitely much lower than what has been observed in Meniere's trials and I’m not only referring to the autonomy trials, but Meniere's in general, Meniere's is a relatively challenging disorder.

And here we are dealing with something that is I would say quite different..

Okay, thank you for that color. Also I was wondering how – can you walk us through a little bit more details on the utility analysis that you took when this determining whether or not it was appropriate to enroll more patients in stratum B with the later onset tinnitus..

Yes, it’s Bettina. So we’ve performed a facility analysis which was a pre-planned analysis for protocol. And we clear the facility threshold that which meant that as for protocol, we would have been able to continue enrolling those patients with tinnitus was between 3 and 12 months old.

We also had an independent data monitoring committee reviewing the data in order to assess whether there was any particular focus we should be putting on the type of patients continue enrolling.

And in fact this committee recommended that we focused on those patients tinnitus with between three and six months, although we could have continued with the whole 3 to 12-month population. The reason was they saw slightly higher activity in that group and recommended that we enrich this particular population in our stratum B.

So that we could been have a sizable number of patients at the end of the study to be able to have some results that might be able to provide us with data to work and also with the regulatory agencies once we submit our package. So we are continuing recruitment in stratum B in the three to six months category..

Okay, its sounds like good work. Can I just ask one on AM-111 before turn it over to someone else, I was wondering, can you talk a little bit about the decision to include oral corticosteroids in the ASSENT study.

And what does a literature suggest is the response rate in terms of hearing threshold for them?.

So the reason we’ve included cortico so you see that we have conducting the ASSENT study in the U.S. So REACH I’m sorry, the HEALOS study is the first study we designed and is ready to start enrolling in Q3. That HEALOS study is being conducted in Europe and Asia because it is not feasible in the U.S.

if you do not allow for that background oral corticosteroid therapy. For the reason I mentioned the four which is that oral corticosteroids de facto even its not approved for this indication. They are the de facto standard of care in the U.S. So that is the reason we are conducting now study in the U.S. to address the U.S.

population in particular for FDA requirements, which therefore have to in order to be feasible have to include corticosteroid background therapy..

With regards to the efficacy of steroids, I would like to refer to a fairly recent study which was conducted in Sweden, which was a well-designed double blind randomized placebo controlled study where actually the outcome was that the active treatment was prednisolone was not significantly different from placebo.

We also see from our own previous data with placebo and other published data that there is definitely no, let’s see absolutely no proof or evidence that these corticosteroids in customary concentrations and doses would have an effect here or a material effect on acute hearing loss.

So therefore, we expect to see from these corticosteroids therapy very little if no effect at all. However, we will take this into considerations we have some room for effects also in the design of our ASSENT study..

Okay, great. Thanks for taking my questions..

Thank you..

Thank you. We will now move to our next question today. This is from Serge Belanger of Needham and Company. Please go ahead..

Hi, good afternoon or good morning. It’s a question first on AM-101 now that you’ve reach the 50% enrollments. I just wanted to know if you provide more color on the timing for results beyond just early 2016..

Yes, absolutely. So as you’ve seen, we actually got the half mark for TACTT3. So we’re definitely well on our way to concluding enrollments before the end of the year. So that Q1 readout in 2016 is still very much on track..

Okay..

TACTT2 as you know is as I mentioned earlier it has target of 330 patients. So a few more patients on TACTT3 as such we still expect to be on target but there maybe a couple of weeks windows play with that..

Okay.

And then on AM-111 what additional work needs to be done prior to initiating both the REACH and ASSENT studies?.

Well, for the ASSENT study, what we’re doing now is we’re at the beginning of making sure that the feasibility is in place. So we’ve been do increase feasibility. We’re going to finalize that feasibility soon. So that we then reach out and just tied on with – on the CRO to involve in this study.

And then enroll starts on the packages, the registration submissions to initiate those sites. For REACH as I mentioned we’re also seeking NIH funding and so for that we need to make sure that we have well be the submission timeline is actually a submission timeline of beginning of October this year for that.

And that’s really the rate-limiting step here now suppose ASSENT and REACH we’re going to make sure we have a final FDA feedback as well on our design. We do not anticipate any major changes to ASSENT, because it is very similar to HEALOS and we already have the FDA include on HEALOS. And so we’re well set, I believe with the design as well..

Okay. And at this point, you believe with by completing the HEALOS and ASSENT studies you will be in a position to file in NDA and with the FDA as well as file with the EMEA for approval in hearing loss or will additional studies also do required..

No, you are correct. We will be in very well placed in fact with the two Phase 2 studies for ISSNHL to submit our registration package. In fact, we have orphan drug phases here. We would even be able to submit with just one Phase 3 study with to make sure we cover also the FDA the full extent with including U.S.

patients we’ve decided to conduct the second ASSENT study and thus far we have that very solid registration package in place. We do not leave REACH for our submission. This is a separate study we’re doing and for a proof-of-concept for the surgery-induced trauma..

I would like to add to that the orphan drug designation that we have for AM-111 relates to what we call an umbrella term that is acute sensorineural hearing loss and of which the ISSNHL is the largest subgroup, now by having two pivotal trials in ISSNHL, we will make sure that we did here two trials for this particular specific type of ASNHL.

Now given that the mechanism is actually the same, so we are dealing with JNK activation due to stress apoptosis and inflammatory responses on behalf plenty of preclinical data showing that this sharing in common pathway.

This was the bases for the orphan drug designation for the umbrella term and we would seek obviously to get obtained a label that is for ASNHL overall.

However in there can be no assurance that will obtain it, we will do this REACH trial to generate some additional data, but clearly let’s say at a minimum we would have two pivotal trials covering the most important type ISSNHL and then generate additional data..

Thanks for the additional color, one more I guess related to autonomy, earlier this month they announced their trial the suggestion of interference with U.S.

patent office related to one of their patent applications that was related to or as in others patent, just wanted to see, if you wanted to comment on that and maybe provide some color?.

Well, to-date we have not received any communication from the USPTO, in that matter we could just access some of their publically available sources, and what we learned from that is, that autonomies action is related to our patents where we just receives the recently notice of allowance and that is about treating of certain ear disorders of which fluoroquinolone in a Poloxamer formulation and from what it seems from what we can see from this public sources is that, autonomy has a filing that is also targeting this type of claims and there is a question about priority.

But again this is only what we can say at this point from public sources, I mean the facts are that we filed in 2005, patent application which discloses the use of Auris polymers with various active substances for the treatment of inner or middle ear of disease and we – well recently announced this notice of allowance.

So we do not really know much more about this and what we will see what will come out of this but so far we have not had any communication from the USPTO..

All right. Thank you. Thanks for taking the questions..

Thank you. [Operator Instructions] there are currently no further telephone questions in the queue. So I would like to hand the call back to our speakers today for any additional or closing remarks. Thank you..

Okay, thank you very much operator. And thanks to everyone for joining the call today. And your interest in Auris Medical, have a great and successful day and don’t forget to take care of your ears. Thank you..

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