Otonomy, Inc. (OTIC) CEO David Weber on Q3 2020 Results - Earnings Call Transcript
Otonomy, Inc. (NASDAQ:OTIC) Q3 2020 Earnings Conference Call November 4, 2020 4:30 PM ET
Company Participants
Robert Uhl - Westwicke Partners, LLC
David Weber - President, CEO & Director
Paul Cayer - Chief Financial & Business Officer
Conference Call Participants
Tara Bancroft - Piper Sandler & Co.
Georgi Yordanov - Cowen and Company
Oren Livnat - H.C. Wainwright
Francois Brisebois - Oppenheimer
Operator
Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Q3 2020 Otonomy, Incorporated Earnings Conference Call. [Operator Instructions] As a reminder, this conference call maybe recorded.
I would now like to hand the conference over to your speaker today, Mr. Robert Uhl from Westwicke Partners. Please go ahead, sir.
Robert Uhl
Thank you, operator. Good afternoon, and welcome to Otonomy's third quarter 2020 financial results and business update conference call. Joining me on the call from Otonomy are Dr. David Weber, President and Chief Executive Officer; and Paul Cayer, Chief Financial and Business Officer.
Before I turn the call over to Dr. Weber, I would like to remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from expected results.
Such statements include, but are not limited to, statements relating to the timing of results, activity for and conduct of ongoing clinical trials; statements relating to the updated statistical analysis plan for the ongoing Phase 3 clinical trial of OTIVIDEX; expectations regarding the Negative Binomial model; and statements regarding plans to submit a New Drug Application; expectations regarding advancement of clinical trials; expectations regarding preclinical programs, including potential benefits and development activities; statements relating to the potential benefits and opportunities of, and activities under the collaboration agreement between Otonomy and AGTC, the co-promotion agreement between Otonomy and ALK-Abelló and the license agreement between Otonomy and Kyorin; expectations regarding Otonomy's business plans and the outcomes, market opportunity and value potential of Otonomy's clinical and preclinical programs; and expectations regarding operating expenses for 2020, cash runway and Otonomy's ability and resources to support its product pipeline and development activities. Please refer to Otonomy's filings with the SEC, which are available from the SEC or on the Otonomy website, for information concerning the risk factors that could affect the company.
I will now turn the call over to Dave Weber, President and CEO of Otonomy.
David Weber
Thank you, Robert. Good afternoon, everyone, and thank you for joining us [technical difficulty] call to discuss Otonomy's business updates as well as financial results for the third quarter of 2020. We continue to execute on our business plan during the third quarter, including achievement of the following milestones. We completed patient enrollment in the Phase 3 trial of OTIVIDEX in Ménière's disease and are on track for announcing results in the first quarter of 2021.
We announced positive Phase I/2 clinical results for our OTO-313 program in tinnitus, and are now moving into full Phase 2 development. We completed patient enrollment in our OTO-413 Phase 1/2 two trial in hearing loss and expect to announce results by the end of year. We also advanced our multiple preclinical programs that extend our efforts across additional hearing loss pathologies and patient populations.
And we completed a successful financing that attracted new, top tier biotech investors to the company, and significantly extended our cash runway to support continued advancement of our product pipeline, the broadest and most advanced in the neurotology field. In short, we are doing the things we need to do to drive value creation. And I am very excited about the OTIVIDEX and OTO-413 clinical catalyst we have coming up.
During this call, I'll provide a brief update on our programs and highlight the financial results from the quarter. We can then open up the line for any questions. Beginning with the OTIVIDEX Phase 3 trial Ménière’s disease, we completed patient enrollment at the beginning of October and expect results in the first quarter of 2021.
We enrolled a total of 149 patients in the United States and Europe, exceeding our target of 142 patients. We appreciate the continued effort by investigators in support of our study completion activities, as well as by the final randomized patients working through their 3 months observation period, following treatment.
In July, we provided an update on the statistical analysis plan for this trial. In response to questions received from the FDA regarding use of the generalized Poisson model to analyze the daily vertigo count data reported by patients, we submitted a revised statistical analysis plan that uses a statistical method called the negative binomial model for the primary analysis.
After an extensive review, we selected the negative binomial model because we believe it provides the best fit of the OTIVIDEX clinical data based on the Phase 2b trial, the successful AVERTS-2 trial and the integrated data set from both trials, assuming positive results from this additional Phase 3 trial, we plan to submit a new drug application to the FDA in the third quarter of 2021.
Turning to OTO-313 for tinnitus, we announced positive results from a Phase 1/2 trial in July. The exploratory efficacy cohort of this trial included 31 evaluable patients with persistent tinnitus of at least moderate severity based on the Tinnitus Functional Index, or TFI, a clinically validated instrument. Patients also reported the loudness and annoyance of their tinnitus using daily phone diaries and completed the Patient Global Impression of Change, or PGIC.
Following a 2 week lead in period subject to randomized to a single intratympanic injection of OTO-313 or placebo in a 1:1 randomization and then followed for 8 weeks. This trial achieved its objectives by demonstrating a positive clinical signal for OTO-313 using a TFI responder analysis, good correlation with other endpoint metrics and a favorable safety profile versus placebo. In particular, 43% of OTO-313 patients were responders at both day 29 and day 57 compared to only 13% of placebo patients with statistical significance at p-value of less than 0.05.
Furthermore, OTO-313 patients who were TFI responders reported improvements in tinnitus loudness and annoyance levels based on the daily diaries as well as improvement in the PGIC with a high correlation coefficient between these various measures. Finally, the trial demonstrated that a single intratympanic injection of OTO-313 was well tolerated and the incidence of ear related adverse events was lower than in the placebo group. Based on these results, we are advancing OTO-313 into full Phase 2 development and have submitted a Type C meeting request to review aspects of the Phase 2 clinical plan with the FDA.
Our third clinical stage program is OTO-413, a sustained exposure formulation of brain-derived neurotrophic factor, or BDNF, that we are developing for the repair of cochlear synaptopathy. Recent research has identified damage to synaptic connections as the underlying pathology in noise and age-related hearing loss that manifests speech and noise hearing deficit. Neurotrophic factors, including BDNF, have potential therapeutic effects in the cochlea by promoting the survival of spiral ganglion neurons, increasing neurite outgrowth and reconnecting neurons with cochlear hair cells after damage.
During the third quarter, we completed enrollment in a Phase 1/2 ascending dose safety and exploratory efficacy study of OTO-413 that enrolled 39 patients with speech and noise hearing deficit, including 15 patients in the high dose cohort. Each dose cohort was randomized 3:1 for a single intratympanic injection of OTO-413 or placebo, and then followed for 3 months.
As this is the first clinical evaluation of BDNF delivered to the ear, the primary objective is the assessment of safety and tolerability with multiple assessments of hearing function conducted at baseline and during follow-up to evaluate signs of clinical activity. We expect to announce topline results by end of this year for this trial.
A brief update now about our preclinical programs that are focused on different hearing loss pathologies and patient populations. The first of these is our gene therapy collaboration with AGTC that targets GJB2, the most common cause of congenital hearing loss. Patients born with this mutation can have severe to profound deafness in both ears that is identified in screening tests now performed routinely in newborns.
We presented preclinical results at conferences earlier this year, demonstrating that a gene of interest can be expressed in support cells of the cochlea, which are the relevant target cells for treating GJB2 deficiency, using novel and proprietary AAV capsids. Also, consistent gene-expression was observed for at least 12 weeks following a single local administration. These results supported selection of the product candidate for further development. We are very excited about this program and we'll provide additional information about the timeline in the coming months.
We also presented data earlier this year related to our OTO-510 program targeting otoprotection for patients at risk for cisplatin-induced hearing loss or CIHL. Cisplatin is a potent chemotherapeutic agent that is widely used to treat a variety of cancers in adults and children. Unfortunately, it is also commonly associated with severe adverse effects, including cisplatin-induced hearing loss that is progressive, bilateral and irreversible.
We have identified a novel class of agents that potently bind to cisplatin and provide greater otoprotection in preclinical models than known antioxidant and anti-apoptotic molecules and increased potency relative to other cisplatin-binding molecules currently in clinical development. These results highlight the therapeutic potential of our locally delivered OTO-510 product candidate to provide superior otoprotection without tumor protection.
Our third preclinical program, OTO-6XX, targets hair cell regeneration as an approach to treating patients with severe hearing loss. It is well-established that damage to cochlea hair cells through aging, excessive noise, or exposure to ototoxic chemical leads to hearing loss and that these cells do not regenerate naturally.
However, we believe it is possible to regenerate new functional hair cells with drug treatment. In July, we entered an exclusive license agreement with Kyorin Pharmaceutical Company, providing us with worldwide rights to develop and commercialize a novel Kyorin compound for the treatment of sensorineural hearing loss. This is a very interesting program, which is complementary to our OTO-413 program targeting cochlear synaptopathy.
One final program update related to our co-promotion partnership with ALK-Abelló that supports the sales and marketing of OTIPRIO. We initiated this collaboration in June focused on acute otitis externa and recently expanded the effort to include use of OTIPRIO during ear tube surgery. We will continue to record all product revenues and pay ALK-Abelló a share of proceeds from sales. During the multiyear deal, Otonomy will also receive co-promotion fees and reimbursement for proportion of product support costs.
Now, Switching gears, let me now provide a brief summary of the financial results for the third quarter. And please refer to our earnings release and 10-Q for the details. The key takeaways are that we are on track with our spending guidance for the year, which is for non-GAAP expenses of $35 million to $38 million and GAAP expenses of $45 million to $48 million.
Importantly, we finished the quarter with $94.5 million in cash, cash equivalents and short-term investments. Thanks to our continued careful spending and the financing we completed in July that raised gross proceeds of approximately $69 million. This cash balance will fund the company for at least 2 years and enable us to achieve important milestones for our programs.
In closing, we are continuing to execute on our business plan that is focused on the advancement of the broadest pipeline in neurotology. We have clinical stage programs targeting the largest patient populations and market opportunities in the field, including hearing loss, tinnitus and balance disorders. We look forward to the completion of our OTIVIDEX Phase 3 trial in Ménière’s disease next quarter, and are ready to move to an NDA filing in the third quarter of 2021, following a successful result.
In tinnitus, we are building up the positive Phase 1/2 results for OTO-313, and advancing the program into full Phase 2 development. And in hearing loss, we are finishing a Phase 1/2 trial for OTO-413, the first of our several programs to address multiple hearing loss pathologies and patient populations. I am very excited about the transformational opportunity, our clinical catalysts provide for the company over the next few months and look forward to keeping you updated on our progress.
Operator, we are now ready for questions.
Question-and-Answer Session
Operator
[Operator Instructions] We have a question from the line of Tara Bancroft from Piper Sandler. Your line is open.
Tara Bancroft
Hi, guys. Thanks for taking the question. So for the OTO-413 data that's coming this quarter, can we talk about what we can expect to see both for the global impression range and the electrophysiology measurements, and what KOL believe are meaningful changes for these patients?
David Weber
Hi Tara. Yes. Thanks for the question. For the 413 data, there is numerous auditory measures that are being done for safety, since it is first and foremost, the safety study. In addition, we will be looking at those to determine if there are any measures with regards to changes in hearing loss, but given that these patients would typically be expected to have almost normal hearing in terms of standard audiometric tests, like for example, the pure tone average. What we're really focused on to look for signs of activity are the speech and noise hearing deficit tests. So these are the ones that are word recognition or number recognition in the background of sound, because that's the real pathology for these patients is the inability to hear in the background of noise. So we believe these word and noise tests are really going to be the primary focus for looking for signals of activity as composed to the more safety related audiometric measures.
Tara Bancroft
Thank you.
David Weber
Obviously, you also asked about the patient global impression of change, sorry. The PGIC is obviously one that also just give from a patient perspective, do they observe and feel that they have made changes in basically the impression of their hearing ability. And there what we really look for is exactly like what we saw with 313, whether with a very high consistency between the patient global impression of change and actual improvements as measured by in that case for tinnitus, the Tinnitus Functional Index. Obviously, we'd be looking here more again to the word and recognition tests where the noise recognition tests connected with those PGIC outcomes.
Tara Bancroft
Perfect. Thank you so much.
David Weber
Thank you.
Operator
Thank you. We do have another question from the line of Georgi Yordanov from Cowen and Company. Your line is open. Please ask your question.
Georgi Yordanov
Hey, guys. Thank you so much for taking my question and congratulations on all the progress. So just a couple from us. So first on OTIVIDEX. With the enrollment into trial exceeding your initial target of 142 patients, could you remind us of your powering assumptions? And where would this get you in terms of statistical power? Do you have any early sense of patient compliance and dropout rates? And then I'll have one more follow-up.
David Weber
Yes. Thank you, Georgi. Thank you for participating here. Yes, for the OTIVIDEX trial, 142 was our target and that 142 was based on a powering of well over 90%. So with the 149, we obviously feel very, very good about our powering. We would expect to have a few dropouts, it's just natural in the course of these types of studies with long -- longer follow-up. But that said, this is well within -- even the 142 incorporated our assumptions with regards to any patient drop off, which again is usually low in these studies. We’ve always seen very high compliance and high participation with minimal dropout. So the 149 really gives us a very strong number as it's well above the 142. The other part in terms of powering, so that basically would tell us that we're well into the 90% plus power range.
In terms of compliance, I'm very happy and very delighted with the efforts of the patients, the investigators and our staff, and CRO with regard to patient compliance throughout the -- not only the trial, but obviously the more recently this year, the COVID pandemic, and compliance has remained extremely high. Again, very consistent with what we've seen in prior studies with Ménière’s. These patients are highly motivated given the lack of any therapy, and therefore are highly compliant. And that's exactly what we've continued to see even despite COVID.
Georgi Yordanov
Thank you. And on 313, I was just wondering have you received a response regarding the timing of the type -- of the Type C meeting for the Phase 2 trial from the FDA? Do you have any idea for the initiation of the Phase 2 program? And I guess, just if you could, talk about the option to pursue a higher dose or a slightly changed the clinical trial enrollment criteria. If you could just talk about your -- I guess, decision-making process in this, and what would you be expecting from the FDA?
David Weber
Yes, thank you there. So once we submitted the Type C meeting requests, the FDA has 75 days in which to respond to the -- for that meeting request. So we do have a date that will be coming up, but we have not reached that yet. So we have not heard a response from them. The primary purpose of that Type C meeting request was with the question of dose. As you know, the 313 results that we observed, we saw very strong safety for OTO-313. In fact, there were fewer AEs, including specifically ear related adverse events with the treatment group relative to the placebo.
And as a result of that plus, and coupled with the strong clinical efficacy signals that we saw both in the TFI and the loudness and annoyance and patient global impression of change measures, it really made sense to us to try a higher dose, given that good safety profile. So that's the primary question that we've asked for the agency to respond to. We think it still is -- meets our levels that we observed in the preclinical animals. So we're still well within a good safety margin there, and we do expect to have a favorable outcome in response to the option to go to a higher dose.
Now, I will say Georgi, that importantly we will continue to look at the current dose as well. The current dose is clearly showing very good activity. And so as we look at our clinical trial design for Phase 2, we will definitely include the current dose. It will just be a matter of adding an additional dose at a higher level.
With regards to initiation and more details in terms of the inclusion exclusion criteria, we're going to be talking about that more in the coming months. We are trying, as soon as we hear from the agency that we would be -- we are working very quickly to be ready to initiate a trial in the early part of 2021. And as part of that, we're currently going through a very rigorous analysis, both with our statisticians, as well as with KOLs to talk about potential changes to our inclusion exclusion criteria, basically refinements based on the data that we have.
I think there will be a number that we will be looking at such things, for example, as the level of disease, entering into the study, what level of TFI would we require as well as the duration of the tinnitus is something that we want to look at and expanding out the duration from within 6 months of onset, probably to 9 months, possibly up to 1 year. So we'll be looking at those things and talking about them more in the months to come here shortly.
Georgi Yordanov
This is great. Thank you so much.
David Weber
Thank you, Georgi.
Operator
Thank you. Our next question is from the line of Oren Livnat from H.C. Wainwright. Your line is open. Please ask your question.
Oren Livnat
Thanks. I have a couple of questions. Just quickly regarding the 413 program, can -- I'm sorry, if I already mentioned it, can you just remind us, is it just primarily the higher dose in 15 patients that you're focused on for the upcoming efficacy readouts? And just do you have any more color on the efficacy end points using in terms of what sort of variability one would tend to even see across these? How robust a result do you think you'll get out of this small sample? And do you think the FDA has a view already in this field as to what the right sort of tests are in this area? And I have a follow-up. Thanks.
David Weber
Okay. Thanks, Oren. Yes, we can take this and then tackle your next question. So with regard to the 413 program, really we're looking at all the cohorts. Clearly, we started off very low for safety reasons. We started off at a very low exposure, but we will be looking and contrasting all the different cohorts to look for the activity, given that it is a dose ranging both for safety, but we are going to higher doses. So I think we would expect potentially to see some changes as we go through the dose levels. With regards to the variability, that's exactly one of the things that we are looking at. I mean, to be fair, and I think this is where it's different than the tinnitus 313 program, where we had a very established clinically valid -- validated clinical instrument with the TFI that was clearly our primary.
Here this is really the first kind of study of its kind, using these word recognition measures, which we have multiples to in order to, to answer those very questions, which kind of variability would we expect to see in clinical trials and what kind of changes could we detect. So that -- the important part about this trial, it will also allow us to not only understand the variability of the measures, but also be able to compare them and understand how they relate to one another. So I think these will be very important as we continue to move on, not only for this program, but for hearing loss programs in general, because word recognition is another important measure of hearing function.
With regard to the FDA, I don't think the FDA at this point is really familiar with these different measures. Again, this is the first study of its kind. And there's other work going on in the field as well that's very early stage. And so the FDA has not to our knowledge, really seen this kind of data. And that is one of the things of why we're doing the work we're doing, that we can also share with them, our learnings and show the data that support what we're viewing as being important measures to understand both cochlear synaptopathy as well as overall hearing loss changes.
Oren Livnat
Okay. And I guess you had kind of segued into my next question. I'm sure you don't want to comment too much about anyone else's program. But you did mention there are some other work going on out there and it's not [indiscernible], there's another public company with $800 million market cap in a early stage, maybe Phase 2a hearing loss program with a mechanism not totally unlike one of yours. And I'm just wondering that's Frequency Therapeutics. I'm just wondering if you can comment just to what extent your knowledge is there anything different that you're doing? Is there any difference in the end points or thresholds that you've studied to date and are looking at going forward that you think will differentiate your program and based on what the data you've seen to date from theirs? Thanks.
David Weber
Yes, I mean, I think from the -- from what I know obviously of their program publicly, I mean, I think one of the things that we can say is we have an extensive amount of testing going on here, both for classic audiometric type tests as well as word and noise hearing tests. We have multiple, as I've talked about, multiple word and noise study testing that we're doing here, which I think others are more focused on a very narrow set. So I think, we -- that'll obviously be a very important learnings that we will have, understanding how these different measures compare. I think one of the things that's important to remember is our drug delivery technology, which we've now shown not only with OTIVIDEX, previously with OTIPRIO, but now even with OTO-313, a single administration, that's improving tinnitus in those patients, 43% of patients at the high dose for 8 weeks.
That delivery technology and the ability to deliver high concentrations of drug for an extended period, the hallmark of that, why that is so important to us is the ability to drive efficacy that you're getting enough drug in. And I think this is one of the things you're seeing about our program that compares differently to other companies in the field. And I mean, multiple companies that have been working in the otology space, the need to retreat and undergo multiple re-treatments as opposed to our practice of doing a single intratympanic injection to cover a broad patch of time is inherent to our technology and strong IP position around drug delivery to the ear. And that really we believe drives efficacy. So while it's very convenient for the physician and for the patient and will aid in the commercialization of a product, importantly, we think it's an important determinant of efficacy, and so I think that's probably the most important.
And then I think the final comparison obviously of us to others in the field is our broad pipeline. We have a program addressing every aspect that is currently away -- in work amongst any other company in hearing loss. But in addition to hearing loss, we have tinnitus [indiscernible] as well. So I think the extensive, both clinical and preclinical program, obviously sets us apart from others.
Oren Livnat
All right. Thanks. I appreciate the color.
David Weber
Thank you, Oren.
Operator
Thank you, sir. [Operator Instructions] We do have another question from the line of Francois Brisebois from Oppenheimer. Your line is open. Please ask your question.
Francois Brisebois
Hi. Thanks for taking the question. Just quickly here, in terms of the Type C meeting you talked about upping the dose, talked about maybe the duration that patients that maybe up to 9 months that have had tinnitus. But I was wondering anything in terms of repeat dose and also in terms of the end point on the TFI, which seems to be very clear that 13 point is a responder. Is the FDA okay with -- do you expect them to be okay, in terms of primary end point with responders only, or is this all patients put together that they might want to see?
David Weber
Yes. Thanks, Francois. With regard to the Type C, in addition to the upper dose and the duration, we did consider -- we really -- our approach on repeat dosing is more from a safety aspect of, if patients need to be retreated. I think that is still something we're trying to understand in this condition with tinnitus, because if you look at the patients who improve the 43% of patients, they were still improving at the end of this eight week study. So one of the things that we will be looking at in our Phase 2 program is extending the observation period out. We keep the 8 weeks as primary.
But we are going -- we are planning to extend out for a longer period of time to look to understand whether those patients continue to improve. Some of them have actually improved to the point that they are now a very mild tinnitus. And so the question is, do they even need another administration? And so that's something that may vary by patient and where they start off in tinnitus. And that's something we'd be able to look at in our Phase 2, as we will ultimately show with the design of the trial and these additional observation period.
So I think the question really with repeat, it's really how we tried to handle it in Ménière’s disease, which is a chronic condition where patients wax and wane in terms of the vertigo episodes is to look at repeat dosing more from a safety aspect than a therapeutic need. And so that is possible. We will be looking at here with tinnitus. But again, I think what we need to do is look at the longer observation period, see how these patients do and whether there is any need to do any long duration of treatment. But I can't tell that yet based on the great results we had from the Phase 1/2 trial here where every one of those patients was better at the end of the study and was their best outcomes. So clearly it's suggesting that at least in those patients, that they are continuing to improve over the full duration.
In regard to the TFI and the 13 point responder, we have had discussions. It's one of the reasons we chose the TFI as preliminary discussions with the agency, both in the pre -IND for 313, but also in connection with our Ménière’s program, because tinnitus is a symptom of Ménière’s. And as a result of that, we feel good about the TFI. Clearly, again, this is the -- really the -- some of the most data the FDA will have seen as they look at our TFI data. And so it is something that as we're conducting our Phase 2 trial, part of what we're doing is collecting data that I think we can even see in our Phase 1/2 trial that support the TFI as an outcome. And that is really looking at those correlations to other endpoints like loudness and annoyance, as well as the patient global impression of change. And I think that's what really, for me, is very important is that correlation really helps establish the TFI as a very practical and effective measure of not only the hearing function for these patients, but their overall quality of life changes and impression of change. And so I think that's a very important piece that will be very helpful with us as we ultimately talk to the FDA in the end of Phase 2 meeting.
Francois Brisebois
Understood. Just in terms of responders, because that 43% versus 13% that you saw with the p-value lower than 0.05 was for just the responders. But I'm wondering any discussions -- is that a primary end point just responders that you think you can go forward within the next trials, or are they going to be looking at all patients?
David Weber
We've not had those discussions since this is not a registration trial at this point, and we do not have the [indiscernible] meeting. We haven't had a full discussion about statistical analysis plans and what would be the ultimate primary endpoint. I will say that as our statisticians and KOLs and regulatory people look at potential endpoints, this is one that we think could be a potential end point based on looking at other programs and other areas that have been approved based on a responder type analysis. So that is something that we will look at. I think importantly, as you know, from the data we've more recently shown from that study is we were actually seeing overall changes in the population as well. So at the 8 week time patients, the overall population treated with OTO-313 was almost achieved that 13 point change, even on that small subset of small set of patients. So I think from the standpoint of is it very possible for us to do a full patient analysis? Yes, we could. From what I've seen of this data, we could definitely size for that, but I think the responder analysis is very powerful here and it is something that we would end up talking with the FDA.
Francois Brisebois
Great. Thank you for clarifying that. And I think, yes, that was the two new slides in the deck. Very helpful to get a feel for that. And it was trending the same way. And then just lastly, there's so much data in that 313, that I'm sure you're going through. And I think the daily diaries is extremely interesting to see every day, because it does seem like it's working more and more as time goes on. But for the data we've talked about in the past conferences aren't quite at the level in neurotology as they might be in ophthalmology. Is there any thoughts about getting all this data and the extensive --and to what extent would you show details of this potentially at a conference upcoming? Or is that still just a lot of work to be done before that?
David Weber
No, we have plans to present. We have submitted for potential presentation in upcoming meetings. Unfortunately as you know, many of those are virtual at this time and some of them have even been planned and then subsequently canceled. But we do have plans to present this data in upcoming meetings. And hopefully we'll be doing that in the early part of next year.
Francois Brisebois
Excellent. That's it for me. Thank you and congrats on the progress.
David Weber
Thank you, Francois.
Operator
Thank you, sir. There are no further questions at this time. I will now turn back the call to Mr. David Weber, President and CEO of Otonomy. Sir?
David Weber
Thank you everyone for participating in our call today. We will be attending the Piper Sandler and the Evercore ISI Virtual Health care Conferences in December and hope to speak with many of you then. Have a good evening, everyone. Thank you.
Operator
Ladies and gentlemen, this concludes today's conference call. You may now disconnect. Thank you for participating.
