Otonomy (OTIC) Q4 2021 Earnings Call Transcript

Otonomy (OTIC)
Q4 2021 Earnings Call
Feb 28, 2022, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by and welcome to the Q4 2021 Otonomy, Inc. earnings conference call. [Operator instructions]. I would now like to hand the conference over to your speaker today, Mr.

Robert Uhl. Thank you. Please go ahead.

Robert Uhl -- Managing Director

Good afternoon and welcome to Otonomy's fourth quarter and full year 2021 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. 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. Otonomy specifically disclaims any obligation to update any forward-looking statements, except as required by law.

I will now turn the call over to Dave Weber, president, and CEO of Otonomy.

Dave Weber -- President and Chief Executive Officer

Thank you, Robert. Good afternoon, everyone. And thank you for joining us on this call to discuss Otonomy's recent business updates, as well as our financial results for the fourth quarter and full year. We have continued to execute well against our development goals, which has set up 2022 to be a year of multiple clinical readouts for two of the largest market opportunities in neurotology, each with significant unmet medical needs.

Key takeaways from this update are as follows; as we announced last week, we have completed patient enrollment in the OTO-313 Phase 2 trial in tinnitus ahead of schedule with top-line results for all time points expected in mid-2022. We also fully enrolled the OTO-413 Phase 2a cohort in hearing loss earlier than planned and moved up the timing for top-line results to early in the second quarter of 2022. Additionally, we have initiated clinical evaluation of higher dosing for OTO-413 and are initiating safety evaluation of higher and bilateral dosing for OTO-313. The data from this expansive set of clinical studies will support and inform our next steps for both programs.

We believe these include initiating a full dose-ranging Phase 2 efficacy trial for OTO-413 by the end of this year and initiating the Phase 3 program for OTO-313 in the first half of 2023. Regarding our OTO-825 gene therapy program, we continue to make good progress with ongoing IND enabling activities, and still expect to file an IND in the first half of 2023. We're also continuing to progress our two other pre-clinical programs, OTO-510 for auto protection and OTO-6XX for severe hearing loss. Finally, our balance sheet remains strong, and we continue to expect that our current cash will fund the company through these multiple clinical readouts and into the second half of 2023.

During this call, I'll provide a brief update on our programs, including plans for an investor R&D event in March, and then ask Paul to summarize the financial results. We can then open up the line for any questions. Beginning with OTO-313, we have completed enrollment in the Phase 2 trial ahead of schedule. We randomized 153 patients with persistent unilateral tinnitus of at least moderate severity, which was above our target enrollment of 140 patients.

Patients were randomized one-to-one to a single intratympanic injection of 0.32 milligram OTO-313, or placebo, and are being followed for four months. The primary endpoint is the same as reported for the successful Phase 1/2 trial. A responder analysis based on the proportion of patients who report. The clinically meaningful improvement in the Tinnitus Functional Index or TFI, from baseline to month 12 following treatment.To assess durability of the OTO 313 treatment effect, we extended the follow-up period out to four months.

Compliance for completion of the TFI and daily symptom diary remains high and we look forward to announcing top-line results for all time points in mid-2022. Additionally, we are close to initiating safety evaluations for bilateral as well as higher dosing of OTO-313. This effort is important for the program since bilateral patients comprised of approximately 50% of the tentatives population. Furthermore, at the higher dose, we're evaluating 0.64 milligrams.

Twice the dose used in the successful Phase 1/2 trial and ongoing Phase two, we expect results from this one-month safety evaluation in the second half of 2022, this data, together with the Phase 2 results, are expected to support and end up Phase 2 meeting with the FDA and inform the design of the Phase 3 clinical program plan to start in the first half of 2023. Our next clinical-stage program is OTO-413 for hearing loss. Following a successful ascending dose Phase 1/2 trial, we initiated a Phase 2a cohort that enrolled a total of 33 patients with speech and noise hearing loss, the most common reason that patients seek treatment for hearing loss. This is a randomized double-blind placebo-controlled study that randomize patients 2:1 for a single intratympanic injection of 0.3 milligrams, OTO-413, or placebo.

Patients are being followed for three months and evaluated using the same three clinically validated speech-in-noise hearing tests used in the prior cohorts, the Digits in Noise, Words in Noise, and American English Matrix phrase test. Enrollment of the Phase 2a was completed ahead of schedule, and we expect top-line results early in the second quarter of 2022. In addition to the Phase 2a, we have also initiated clinical evaluation of higher dosing for OTO-413. We expect to enroll approximately 12 hearing loss patients randomized 2:1 to OTO-413 or placebo, and at least one higher dose safety cohort beginning with 0.75 milligrams.

This is more than twice the dose used in the successful Phase 1/2 trial, which is an important expansion of the clinical data set to support next steps for this program. Based on results from the Phase 2a and higher dose evaluation, we expect to initiate a full dose-ranging Phase 2 efficacy trial in hearing loss patients by the end of 2022. Our third development program is OTO-825, a gene therapy targeting GJB2, which is 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.

Pre-clinical proof-of-concept results for OTO-825 demonstrate that a single administration of OTO-825 rescues hearing loss and cochlear damage in two pre-clinical models representing a range of hearing loss severity caused by GJB2 deficiency. We have completed a pre-IND meeting with the FDA that provided guidance regarding nonclinical study design, manufacturing requirements, and clinical trial considerations and have incorporated this feedback into our IND enabling program. These activities are ongoing and we expect to file an IND in the first half of 2023. Our remaining two programs are OTO-510, an otoprotectant for patients at risk for cisplatin-induced hearing loss, and OTO-6XX, which targets hair cell repair or regeneration for patients with severe hearing loss.

Pre-clinical development continues on both programs. In summary, we are making good progress in advancing our multiple programs for treating hearing loss in tentatives, which represent large untapped markets with significant unmet medical needs. In fact, we believe that the early completion of enrollment for both the OTO-313 Phase 2 and OTO-413 Phase 2a trials demonstrate the interest in new therapeutic options for these conditions. To help prepare investors for our upcoming clinical readouts, we will be hosting an Investor R&D event on March 22nd.

This event will include presentations by multiple key opinion leaders who will provide background information on tentative and hearing loss, and review the Phase 1, 2 trial results for OTO-313 and OTO-413. Additionally, members of our senior management team will provide an update on the ongoing trials and outline next steps for these programs. We hope that you are able to join us for this informative session, which is open for registration via the events page on our website. With that, I'll turn the call over to Paul Cayer, our chief financial and business officer, who will provide a summary of our financial results and plan.

Paul Cayer -- Chief Financial and Business Officer

Thank you, Dave, and good afternoon, everyone. Overall, our expenses for 2021 were slightly above our financial guidance for the year due primarily to the faster than expected enrollment in the OTO-313 Phase 2 trial which is obviously a favorable situation. Our balance sheet remains strong and our cash gets us significantly beyond the multiple clinical readouts that Dave has mentioned. Now let me briefly recap the financial results that are more fully described in today's earnings release and 10-K filing.

In the fourth quarter of 2021, we reported total non-GAAP operating expenses of $11.3 million with GAAP operating expenses totaling $13.2 million. The primary adjustment for non-GAAP expenses is the exclusion of stock-based compensation. So this is the financial metric that best approximates our spending level. For the full-year 2021, total non-GAAP operating expenses were $42 million with GAAP operating expenses totaling $49.4 million.

As mentioned, these expense levels slightly exceeded our financial guidance due to timing differences for the OTO-313 clinical trial expenses. Going forward, we expect non-GAAP expenses for 2022 to total $42 million to $44 million, and GAAP expenses to be in the range of $52 million to $54 million. From a cash perspective, we finished the year with a cash balance including cash, cash equivalents, and short-term investments of $77.4 million. And we continue to expect that this cash balance will fund the company into the second half of 2023.

With that, I'll turn the call back over to Dave.

Dave Weber -- President and Chief Executive Officer

Thank you, Paul. Operator, we are now ready for questions.

Questions & Answers:

Operator

Understood. [Operator instructions]. We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Stacy Ku from Cowen and Company.

Your line is open.

Stacy Ku -- Cowen and Company -- Analyst

Hi, all. Thanks for taking our questions and congratulations with the progress. So we have a few. The first question is, as we await the 413 results, can you remind us how to think about the profile of patients enrolled with speech and noise hearing loss, what are the different parameters in place to maintain consistency of hearing loss? In addition, can you help us understand the potential path forward for retreatment? Then next, wondering if you could help narrow some expectations for the Tinnitus results in mid-2022.

David, I believe you stated we should expect all the time points for 313 results. Given your update for completed enrollment last week and secondary endpoints at week 16, our math suggests that we should expect results in roughly, let's say July, to give some legal room for data analysis. So any thoughts there would be appreciated. And then third, in designing additional trials for bilateral treatment of Tinnitus, can you speak to some of the different considerations and recommendations from your experts? Thank you.

Dave Weber -- President and Chief Executive Officer

Thank you, Stacey, in terms of the 413 results and the profile of the patients with regard to hearing loss, we do exclude patients with profound hearing loss based on standard audiometry. But we are requiring that patients all show a speech and noise hearing loss that's determined by one of the three speech and noise tests that we administer, but we do allow it to be open in terms of the audiological performance up to, as I mentioned, the profound hearing loss. What that means and what we've seen in the prior work that we've presented is that the majority of these patients have moderate to severe hearing loss on normal audiograms, as well as in the speech and noise hearing loss And so that is the patient population that we are investigating. In terms of ensuring the consistency of these patients, that's really done by requiring that the patients complete a lead-in period in which they are also showing consistency of their hearing loss, including the speech and noise hearing loss.

And so this is something that, of course, is modeled in all of our clinical trials, including the tentatives. We believe that doing lead-ins, that'll make the patient -- allow us to evaluate the disease of the patient at, both initial screening, as well as then a visit prior to randomization really ensures that we have consistency both in terms of the disease level and with that patient and the reporting of the patient. So that is something that we're doing here as well, and we believe gives us good consistency for the patients. Turning to the expectations for the 313 Phase 2 trial, you're correct in that because now that we've enrolled ahead of time, we are going to include the results for all time points, including week 16, that will be both the primary and secondary endpoints.

And as far as getting more specifics of time, I'll just say middle of 2022. Clearly, we are conducting this trial to potentially be -- it is a Phase 2 trial, but if successful and with discussions with the FDA, we would look potentially to include that as part of our registration package. And so for that reason, we are taking great care in doing the final visits of patients, as well as then going through database -- the normal cleanup in the database lock that you would go through. We're obviously going to take a great care in that process.

But in mid-2022, we can definitely say that we will have all results for that program. Additionally, then for the bilateral, the question on bilateral tentatives and our plans there. Importantly, with bilateral tentatives, it does represent about half the patient population. I think it's then obviously great to see the enrollment of the unilateral patients, it's very clear that they represent approximately 50% of the population given how fast we were able to enroll.

But with the bilateral patients, our approach for them, obviously, pending our discussions with the FDA in the end of Phase 2a meeting that we plan to have before the end of the year based on successful Phase 2 data, our plan would be to actually evaluate the bilateral patients in the safety studies and not in efficacy studies. We believe that doing efficacy and bilateral condition may be difficult because there may be different responses between the two years and patients may struggle really identifying and separating their perceptions based on the ears. And for that reason, the reason that we're doing the bilateral in our Phase 1 safety is to build up the initial data that we would then need to support, including bilateral patients in the safety program for OTO-313 that would run in parallel to the efficacy studies. And so that is something, of course, that we'll talk with the FDA at the end of Phase 2 meeting, but we think represents a good approach to address those patients as well.

Stacy Ku -- Cowen and Company -- Analyst

Thanks so much for the details. Appreciated.

Dave Weber -- President and Chief Executive Officer

Sure. Thank you, Stacy.

Operator

Your next question comes from the line of Chris Raymond from Piper Sandler. Your line is open.

Nicole Gabreski -- Piper Sandler -- Analyst

Good afternoon. This is Nicole Gabreski on for Chris. Thanks for taking the question. So maybe one just around the Phase 2 Tinnitus study, I guess.

Beyond the primary analysis, can you maybe just remind us or help us understand what the longer-term follow-up will tell us about potential redosing frequency and how it will inform on Phase 3 design. And then maybe a second, a little bit more naive question. I guess, looking back at some of the previous data for 313, we were interested in the placebo effect on TFI, from your analysis, is that truly a placebo effect or is there some kind of potential short-term benefit to doing intratympanic injection in general? Thanks.

Dave Weber -- President and Chief Executive Officer

Thanks, Nicole. With regard to the Phase 2 Tinnitus beyond the primary outcome, what we're looking at beyond week eight, and looking at months three and four, is really to understand how patients continue to respond in their Tinnitus. As you may recall, in the Phase 1, 2 trial, we saw patients at week eight continuing to improve; and so the question that we have is, do these same patients then continue to improve over month three and four? The other thing that we want to observe is of course, with those patients, if that is the case, where would the optimum redosing period be for those patients, as well as perhaps the patients who don't respond initially. And so by looking at month three and four, we believe that will inform us of what we would want to do in the safety studies to support the safety of redosing, whether that would be month two, month three, or month four; any of which we think are very viable from a clinician and patient standpoint.

With regards to then our approach, it would be taking that information into the FDA and in the Phase 2 meeting, and discussing with them the approach that we would take for the safety program with regards to the redosing frequency that would then support approval of the product. So we do not expect at this point in time that we would be running redosing on efficacy, it would only be safety. And that's very consistent with prior discussions that we've had with the agency on other programs, as well as what previous Tinnitus programs that have been conducted in the field. With regards to the placebo and any short-term benefit, we've never seen in our programs that there was a benefit to intratympanic injection of placebo.

Of course, that would be very difficult to separate from a placebo response if you will, but there is no basis from any of our animal work or from human work that would just suggest to us that the intratympanic injection itself has any short-term benefit. I think with the -- with regards to the placebo response that we saw in the earlier study, it was very small. Really essentially one patient who had the placebo response, and I think that really is attributed to what we're doing in terms of having the responder analysis where we really require the patients to be clinically meaningfully improved at two consecutive time points, month one and at month two. And I think that really then takes away that variability that you get that may just be due to a placebo effect.

So that's our approach, and we obviously will be interested at looking at it with the Phase 2 trial results.

Nicole Gabreski -- Piper Sandler -- Analyst

Great. Thanks so much.

Dave Weber -- President and Chief Executive Officer

Thank you, Nicole.

Operator

Your next question comes from the line of Francois Brisebois from Oppenheimer. Your line is open.

Francois Brisebois -- Oppenheimer and Company -- Analyst

Thanks for taking my questions, and congrats on the progress nearly enrollment completion. Just a couple here. In terms of 413, just the field being so novel in terms of endpoints and what not, can you just help us maybe set expectations for what you would consider a successful trial. And then just when you're going up to a dose that's twice as big as the one used in previous trials, can you just talk about maybe the rationale for why higher dose might be OK on the safety side and maybe help in terms of efficacy?

Dave Weber -- President and Chief Executive Officer

OK. Thanks. Thanks, Francois. Great to talk with you.

With regards to our 413 and the endpoints, it is true to say that the FDA has never really evaluated a program with speech and noise endpoints. And this is why frankly, we are conducting our program with three endpoints at this time. In addition to evaluating the safety and obviously the activity of 413, what we are trying to establish as well is which of the three speech and noise tests would be the best test to carry forward in registration future trials As well as potential registration trials. We believe that gathering that data is the best way to be informed as well as having productive conversations with the FDA.

Importantly, I think people need to recognize that these tests have never been used to support the approval of a drug. And so. As they've been developed, they've been developed by audiologists to really help them understand and assess patients. In the current modalities that they can treat those patients, such as hearing aids.

So that is why we think it's very important that we're doing the work we're doing. And obviously, we will allow us to understand not only such things statistically of test-retest types of parameters for future statistical considerations. But also allows us to compare the three different tests because they are quite different tests that may have certain advantages and disadvantages in registration tripe trials. So that's what we're trying to figure out.

In regards to what would a successful trial look like, at this stage with the Phase 2a, what we're really looking to do is to confirm the observations that we've had demonstrating activity of 413, and that would then support going into larger trials, it also would, of course, give us the data that we want to see if we can select a specific speech and noise test, or at this point could narrow down to two because every test we do obviously requires additional time. So those are the kinds of things that we would consider to be successful is that it confirms what our observations are of 413 activity in terms of improving the speech and noise hearing function of patients, and allow us then to design a full Phase 2 trial. That's connected to your second question, of course, with regards to the higher dose and this is really true of both of our programs is with 413 with the good safety profile there there was very clear opportunity to go up and dose. Clearly, the current dose showed us strong efficacy that we're looking to confirm in the Phase 2a.

But as a developer, you always want to see what you could do with a higher dose, particularly if you have a good safety profile, which we do. BDNF, I remind people is endogenous. We express BDNF during development embryonically, so it is something our body is used to and then has a very good safety profile from what we've seen, so obviously for that going up in dose makes sense. With regards to 313, it was a little bit more involved because gacyclidine is a very potent molecule, but our results from the Phase 1/2 showed very good safety.

In fact, the safety of patients on the drug actually showed a better safety profile with fewer adverse events that were irrelated than the placebo. And so as a result of that, we decided to go back in and do additional GLP tox work, that would allow us to then go up to this higher level that we're now approaching. And that was really a matter of that in initial tox work what you tend to do very broadbands if you will, of your safety analysis. We were able to go and then based on the clinical data, and be more narrow and get data that we took to the FDA in a type C meeting, that then supported going to this higher dose that we're evaluating.

I think importantly there it's the same thing. One of the things that not only are we --would expect that a higher dose may provide even more efficacy that we expect to confirm with the current Phase 2 of that dose. So maybe even more efficacy. I think the other thing to keep in mind is our delivery technology, and of course, this is unique to Otonomy.

We have sustained delivery technology as part of our strong, intellectual property position. And it allows us to do a single administration, yet provide very prolonged exposure to drug, something we do talk about that other people do not have. And one of the important parts of that is that higher dose actually also translates into longer duration of exposure. So we're not just looking at a higher dose in terms of temporary plasma, or I should say, target tissue levels being higher, but also an extension of the exposure.

So clearly, what we'd be interested therein would be, would patients who perhaps, maybe not respond to 313 in our initial Phase 1/2 trial, whether there might be now those patients might respond because of that, not only higher level, but sustained level four even a longer period. So clearly, that's why we're interested in going to higher drug levels, and we think there's a very clear and easy path in which to incorporate additional drug dosing in the future work, whether that would be by doing two doses in a Phase 3 trial, for example, with 313 versus only a single-dose. We think that's very doable. And I think most people would agree given that we've been able to enroll the present trial ahead of schedule.

Francois Brisebois -- Oppenheimer and Company -- Analyst

Thanks, David. That's extremely helpful. And just maybe if I could sneak in this last one here, as you're getting more knowledgeable in tentatives, is it proven the fact that maybe if you've had tenatives for too long that it turns into central problems and it's almost too late to solve, or is this more of just a thought that some might have?

Dave Weber -- President and Chief Executive Officer

Yeah. It's not proven, so there is no definitive scientific evidence that there is the switch from peripheral to central. It is a belief in the field, many KOLs do believe that there may be a point at which there's a central involvement, but of course without -- with the absence of an actual therapeutic, it's difficult to really evaluate that. It is one of the reasons why we added additional patients into our study of looking up to one year.

Most KOLs who think there maybe that type of central involvement or conversion believe it's beyond a one-year period, maybe even two or three, no one has a set time period, but I think it is a question that remains in the field. And so our approach on this on the development side is to focus on the near-term patients which are clearly out there given our enrollment timing because it really helps us to identify tentative that is due to cochlear origin events as opposed to, for example, may be an event that was not associated with the cochlea or damage to the cochlea. People can recall something more recently. However, we would be interested in then looking at longer-term patients.

And so we do expect that in our clinical program, we would step-wise look at longer-term patients to see if there is benefit there. But clearly, we want to get our Phase 2 results, evaluate those patients that now are up to one year, and that will help inform us for those next steps.

Francois Brisebois -- Oppenheimer and Company -- Analyst

OK. Great. Thank you.

Dave Weber -- President and Chief Executive Officer

Thank you.

Operator

[Operator instructions]. Your next question comes from the line of Oren Livnat from H.C Wainwright. Your line is open.

Oren Livnat -- H.C. Wainwright -- Analyst

Hi, guys. Thanks for taking the questions. I have a few quickies. On 313.

I just want to clarify something you said earlier when you talked about taking your time to make sure you do everything right on this study so that it could be, I guess, registration quality as maybe how I interpreted that. I don't want to read too much into that statement, but are you potentially implying that if this looks really robust, that this could theoretically serve as a pivotal and you'd only have to do one Phase 3 after that or am I putting words in your mouth. And I have a couple of follow-ups.

Dave Weber -- President and Chief Executive Officer

Yeah. Oren, great to talk with you. So when we're doing a Phase 2 trial of this type, it is essentially, in many ways a Phase 3 trial. It's multinational, we have all the controls that we would run in a Phase 3.

And so while the study itself has been sized as of Phase 2, and I think that's important to stress, our sizing was based on a small Phase 1/2 trial, so we have to be cognizant of that. We size it, empower it as a Phase 2, that means not at 90% power. It's more powered toward what you would typically look for Phase 2, which is really to show the efficacy or the activity, I should say that would then allow us to design the Phase 3, and power that accordingly. But of course, we never know.

I mean, if we saw results like what we've seen in the current trial, the Phase 1/2 trial, obviously very strong, we may be -- we may see even a very strong outcome here. And so we wanted to be prepared for that. We are taking the steps to make sure that if the study was highly -- had a very strong outcome, as well as the FDA would agree because we've obviously not had an end of Phase 2 meeting with the FDA. We would expect to be able to take that into that end of Phase 2 meeting and have a discussion with them to see if that trial could apply as one of the two potential registration trials.

So that's what I meant by that statement, we would expect that the FDA will require two registration trials. And we just want to make sure that if the trial was highly successful, that there would be the opportunity to potentially have that be one of the two.

Oren Livnat -- H.C. Wainwright -- Analyst

Got it. And following up on 313, I want to make sure I'm not misunderstanding what you're doing with this higher dose and I'm not sure if you mentioned the timing of that and I could have missed it. That 0.64 milligram, is that -- I thought you were just looking at safety there, but are you in fact looking at efficacy measures on the same TFI endpoints, if the former, does that give you much new information for Phase 3 other than safety, and I guess you did mention earlier you could directly just take two doses in a Phase 3, is that right? If you wanted to?

Dave Weber -- President and Chief Executive Officer

That's correct, yeah. So it is just safety. We will get some readout of it, obviously, but we're not -- we don't have the criteria around the patients like we do in the efficacy trials. So I think it's important to understand they are safety trials that we're running here for 313.

Looking at both single-dose at 0.65 unilaterally, as well as bilaterally. And so those are really to support only safety. And the idea would be that it would support going into Phase 3 with potentially two doses of 0.3 to the current dose as well as 0.64, as well as in doing safety in bilateral patients at those doses, which we'd probably just do the highest dose at that point, but that's part of what we'll be looking at based on the results, but the idea is that it really supports moving into the Phase 3 program potentially with two doses and efficacy.

Oren Livnat -- H.C. Wainwright -- Analyst

OK. Speaking of higher dose is on for 13, you said you were doing at least one higher dose cohort. I think the tall patients, starting 0.7 something. When might you go, you plan or expect to go higher than that to?

Dave Weber -- President and Chief Executive Officer

Correct. We'll go to at least one higher dose. What we do is a -- once a specified number of patients complete a period following the randomization and dosing, we then evaluate. We actually have an independent panel that evaluates for safety.

And if they deem that there's good safety, then we would escalate to a higher dose.

Oren Livnat -- H.C. Wainwright -- Analyst

OK. And lastly -- I apologize. For this March 22 event, clearly, we're going to get some clinical perspectives here. Should we look forward to also maybe getting some more robust commercial outlook for one or both of these products from you guys? I don't know if you have a chance to dig much more into that or will we have to wait for the data before you can even begin to really evaluate the opportunity there.

Dave Weber -- President and Chief Executive Officer

Yeah. Oren, why don't -- I let Paul address that question.

Oren Livnat -- H.C. Wainwright -- Analyst

Thanks.

Paul Cayer -- Chief Financial and Business Officer

Hi, Oren. The intent of the R&D event is really to focus on the conditions themselves, background on the disease burden, the pathophysiology, mechanisms that make sense from a treatment standpoint, and then review of the Phase 1/2 trial results. All by key opinion leaders. So since key opinion leaders really aren't the experts when it comes to commercialization, I think where the plan or in Insta defer that discussion until a follow-on opportunity.

This is really meant to be a really good primer for investors on both tinnitus and hearing loss from a clinical perspective and then put the clinical results in the context of that. So we understand that while these markets are big and lots of unmet medical need because no approved drug therapeutics for other tinnitus or hearing loss. We do understand that that's some additional understanding about the target patient populations and commercial opportunity is something that we'll be doing, but not at this session.

Oren Livnat -- H.C. Wainwright -- Analyst

Fair enough. Thank you. Good luck.

Dave Weber -- President and Chief Executive Officer

Thank you, Oren.

Paul Cayer -- Chief Financial and Business Officer

Thanks, Oren.

Operator

There are no further questions at this time. Turning the call back to Dr. Dave Weber.

Dave Weber -- President and Chief Executive Officer

Thank you, everyone, for participating in our call today. We look forward to meeting with many of you at the upcoming Cowen and Oppenheimer virtual healthcare conferences. And also hope that you will join us for our R&D event on March 22nd. Have a good evening, everyone.

Operator

[Operator signoff]

Duration: 41 minutes

Call participants:

Robert Uhl -- Managing Director

Dave Weber -- President and Chief Executive Officer

Paul Cayer -- Chief Financial and Business Officer

Stacy Ku -- Cowen and Company -- Analyst

Nicole Gabreski -- Piper Sandler -- Analyst

Francois Brisebois -- Oppenheimer and Company -- Analyst

Oren Livnat -- H.C. Wainwright -- Analyst

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