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spk08: Welcome to the Q1 2021 Autonomy, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone keypad. And if you require any further assistance, just press star 0. I will now turn the call over to your speaker today, Mr. Robert Ohl with the Westwick ICR Community Beginner Conference, sir.
spk01: Good afternoon, and welcome to Autonomy's first quarter 2021 financial results and business update conference call. Joining me on the call from Autonomy are Dr. David Weber, President and Chief Executive Officer, and Paul Koehr, 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 Autonomy's filings with the SEC, which are available from the SEC or on the Autonomy website, for information concerning the risk factors that could affect the company. Autonomy 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 Autonomy.
spk04: Thank you, Robert. Good afternoon, everyone, and thank you for joining us on this call to discuss Autonomy's recent business updates as well as financial results for the first quarter of 2021. We are now fully focused on advancing our multiple programs for hearing loss and tinnitus. This is reflected by the following recent accomplishments and activities. In March, we announced initiation of the Phase II clinical trial for OTO 313 in tinnitus, and patient enrollment is underway. Setup activities continue for an expansion of our OTO 413 Phase 1-2 trial in hearing loss patients, and we are on track to initiate the study this quarter. We also have additional details from the proof of concept cohort that I'll highlight in this call. We expect results from both of these trials in mid-2022. In addition, we announced the upcoming presentation of exciting preclinical hearing recovery data for our OTO-825 gene therapy program for congenital hearing loss. I can't discuss specifics of these results before the American Society of Gene and Cell Therapy presentation on Thursday, but we'll provide a high-level summary based on the published abstract. We're also continuing to progress our two other preclinical programs, OTO-510 and OTO-6XX, that respectively target otoprotection for cisplatin-induced hearing loss and hair cell repair and regeneration for severe hearing loss. Finally, we have completed our analysis of the Otividex Phase III trial results. While we continue to believe that steroids provide a benefit to patients with Meniere's disease, Proving this in a clinical trial setting is a significant challenge. We do not see a path forward based on the existing clinical data for Otividex and have decided to not pursue additional development of the product candidate. During this call, I'll provide a brief update on our programs and then ask Paul to summarize the financial results including our recently completed financing that extends our cash runway into the second half of 2023. We can then open up the lines for any questions.
spk08: And at this time, if you would like to ask any questions, you will need to press star 1 on your telephone keypad. To withdraw your questions, press the found key.
spk04: Beginning with OTO 313, we announced initiation of the Phase 2 trial at the end of March. The design of this trial is based on the successful Phase I-II trial that demonstrated a higher proportion of responders in the OTO313 group versus placebo based on the Tentative Functional Index, or TFI. The Phase II will enroll approximately 140 patients with persistent unilateral tinnitus of at least moderate severity based on the TFI. As in the prior trial, where we observed a high correlation between the various metrics and responders, we will also track tinnitus loudness, annoyance, and patient global impression of change. To enrich the study population, the trial will exclude patients with severe hearing loss who we believe are less likely to respond to treatment, and we are increasing the minimum severity of tinnitus required for entry. We will also expand the patient population eligible for enrollment by increasing the time from onset, tinnitus onset, from six months to one year. Finally, while we will continue to use response at both months one and two, following a single treatment for primary efficacy, we will also extend the total observation period out to 12 months to assess durability of the treatment effect. This is because patients who responded to OTO313 were still improving at the end of the study. We are excited to have this trial up and running to advance the effort to find an effective treatment for tinnitus, which negatively impacts millions of people by disrupting their ability to sleep, concentrate at work, and enjoy leisure activities. This often leads to anxiety and depression that can be quite severe, as sadly reported in a recent case of a prominent post-COVID patient experiencing unrelenting tinnitus. We have multiple centers enrolling patients in the U.S., and we'll be adding investigators in Europe as well in order to have top-line results in mid-2022. Our next clinical stage program is OTO 413, a sustained exposure formulation of brain-derived neurotrophic factor, or BDNF, that we are developing for hearing loss due to cochlear synaptopathy. A growing body of research has identified damage to synaptic connections as an important underlying pathology in noise and age-related hearing loss. Furthermore, recent studies indicate that the loss of synapses actually occurs earlier than the loss of hair cells. These findings are highly supportive of our OTO 413 program as a potential treatment for a broad set of hearing loss patients. In December, we announced positive top line results from a Phase 1-2 trial that provides clinical validation of this therapeutic approach. The key endpoints in this proof of concept trial and for the program going forward are hearing tests conducted in a noisy background. In particular, we are using three speech and noise tests, the American English Matrix, words in noise, and digits in noise. In these tests, the subject is presented with a set of phrases, words, or numbers at varying loudness with a constant background noise level that is typically set to the loudness of a normal conversation. A significant advantage of speech and noise tests over conventional testing in quiet is that they test overall speech intelligibility. mimicking the real-world setting for patients who complain that they can't hear in a noisy setting. This is especially important because it has been well established that neither audiometry nor word recognition and quiet predict hearing in a noisy setting. The initial results we presented from the Phase 1-2 trial demonstrated a higher responder rate for OTO413 compared to placebo across the three speech and noise tests combined. We have updated the corporate slide deck available on our website to also include the patient response rates at days 57 and 85 for each of the three tests individually. This additional data shows the same result. A higher proportion of patients treated with OTO413 demonstrated a clinically meaningful improvement from baseline compared to placebo for each of the speech and noise tests. We also thought it might be helpful to highlight some patient case studies, so you will see speech intelligibility curves at baseline and day 85 for patients who are responders on the words and noise test. These curves demonstrate the improved ability of OTO413-treated patients to hear words correctly at varying levels of loudness compared to the fixed background noise. At a minimum, the improvement is 20% across multiple signal levels, which is our general threshold for clinically meaningful improvement. Beginning this quarter, we plan to enroll hearing loss patients in an expansion trial to further demonstrate treatment benefit in a larger population, evaluate a refined study protocol, and to refine power calculations for a more formal phase two study. This Phase II-like expansion cohort will randomize approximately 30 subjects to a single treatment with OTO413 or placebo and evaluate a reduced number of endpoints, focusing on the three speech and noise hearing tests. Enrollment criteria will continue to target a broad hearing loss population to support the design of a Phase II trial. We expect results to be available in mid-2022. Our third program is OTO825, 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. Together with our partner, AGTC, We have presented preclinical data demonstrating that OTO825 provides excellent expression of connection 26, the gene product of GJB2, in the non-sensory cells of the cochlear, which are the relevant target cells for treating GJB2 deficiency. Furthermore, we have demonstrated consistent gene expression for at least 12 weeks in non-human primates following a single local administration. We also recently announced the upcoming presentation at ASGCT this week of preclinical proof of concept results demonstrating successful recovery of hearing and cochlear morphology in two independent mouse models of GJB2 deficiency. In these models, we knock out connection 26 expression, which results in hearing loss and structural changes of the cochlea that mimic the human condition. These studies demonstrate that intercochlear administration of OTO825 provides a marked improvement in hearing across multiple frequencies and greatly improves cochlear morphology. We're very excited by these results and the advancement of OTO825 into IND-enabling studies, which are now in process. We look forward to discussing these proof-of-concept results in more detail, as well as outlining our plans for the program in a couple of months. 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 and regeneration for patients with severe hearing loss. Preclinical development continues on both of these programs. In summary, we are focused on advancing our multiple programs for treating hearing loss and tinnitus, which represent large, untapped market opportunities with significant unmet medical need. Our positive clinical results for OTO 313 and OTO 413 provide validation for these programs and positions us as the only company in the neuro-otology field with clinical stage programs in both indications. Additionally, we are the first and only company to present preclinical proof-of-concept results for a gene therapy targeting GJB2 deficiency, the largest congenital hearing loss patient population. We're excited about our pipeline and appreciative of investor support in our recent financing to support these development activities. With that, I'll turn the call over to Paul Kerr, our Chief Financial and Business Officer, who will provide a summary of our financial results and plan.
spk03: Paul Kerr Thank you, Dave, and good afternoon, everyone. With our development plan now defined, we have finalized our spending level for 2021 and also have improved visibility on our cash runway following our financing in April. I'll review both of these for you, but first, let me recap the financial results from the first quarter. We reported total GAAP operating expenses totaling $11.7 million in the first quarter of 2021 and non-GAAP operating expenses of $9.7 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 all of 2021, we expect GAAP operating expenses will be in the range of $46 to $48 million, with non-GAAP operating expenses totaling $38 to $40 million. A detailed reconciliation of GAAP to non-GAAP numbers can be found at the end of today's press release posted on the investor relations page of our website. From a cash perspective, we finished the first quarter with a cash balance including cash, cash equivalents, and short-term investments of $73.8 million. In April, we completed an underwritten public offering that raised gross proceeds totaling $34.7 million. Following this financing, we believe that our current cash balance will be sufficient to fund company operations into the second half of 2023. This gives us plenty of runway beyond our clinical milestones in mid-2022 and continue advancing our preclinical programs, including our exciting gene therapy program. With that, I'll turn the call back over to Dave.
spk04: Thank you, Paul. Operator, we are now ready for questions.
spk08: And at this time, if you would like to ask any questions, you will need to press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. We will pause for just a moment to compile the Q&A roster. And your first question comes from the line of Stacy Koo. From Colin and Company, your line is open.
spk07: Hi, good afternoon. Thanks for taking my questions. I have a few. So first, can you talk about the enrollment rate for the 313 tinnitus study? What level of demand are you seeing based on this large opportunity? And then second question is on the hearing loss program. It's a bit of a different patient population, but given the recent news from a competitor company frequency, wondering if you guys can maybe talk about the benefits of a single injection or maybe what you would think would be the best dosing frequency to preserve the hearing structures. Also, given the large placebo response observed in the competitor study, maybe remind us what kind of baseline enrollment criteria for your phase, let's say, 1-2-30 patient study. What are you thinking about that, and how are you working around any type of patient bias? And can we talk about your experiences there? Thank you.
spk04: Thank you, Stacey. Let me take those one at a time here. So first, with regards to enrollment rate for 3-13, we feel very confident about our middle of 2022 readout for top-line results from the Phase 2 trial. in which we'll enroll 140 patients. And those patients will have a follow-up of four months. So two months for the efficacy and then an additional two months of follow-up. I think we feel very, very good about that timing. I think it's important to note that we've been very effective in terms of enrolling our trials in the past on the timing that we say. I will say that there's tremendous demand. Frankly, we've heard from many patients suffering from tinnitus who are interested in enrolling in the trial. Of course, the trial has very set criteria for enrollment, as most clinical trials do, and so many patients are unfortunately not eligible at this stage. But we see tremendous outreach from patients who are interested in a therapy, and it very much is consistent with what we know as being a very large market with unmet need. So with regards to then moving toward the other questions, I think in terms of let's just talk about single injection in our 413 program and hearing loss, but this applies to 313 and tinnitus and, frankly, anything being done in the ear. Obviously, as a company, autonomy is really one of the oldest focused on the ear, and our focus has been driven by the fact of how do you develop effective treatment for inner ear disease by getting drug to the inner ear and keeping it there for a prolonged period by a single administration. So I think investors understand this is where we have a tremendous amount of intellectual property and know-how with regards to drug delivery to establish an effective pharmacokinetic profile from a single administration. So we believe that is incredibly important for efficacy. And I think the recent data further support both the value of what we've developed and the need for what we've developed to really provide effective therapy. We've seen many companies try to do multiple administrations. Those, of course, are not efficient and are very painstaking for clinicians and patients, but even more so, obviously, I think the important part is that you can drive greater effectiveness by being sure that you get uniform distribution through the cochlea that you can only do through sustained delivery, and that is what our IP and know-how focuses on. So I think that's very key. I'm not going to talk to the idea of repeated administrations because in our hands, and of course I think we've done more administrations than anyone in the world intratimpanically, we've not seen issues from tremendous amounts of work from multiple administrations done in the year. That's not really been the issue that we've observed. With regards to placebo and the large placebo response that was observed in a competitor study, I think we can show through our data with 413, we did not observe that. We saw little to no placebo effect with our word and noise and speech and noise tests that we conducted. And I think an important piece here is that there are tremendous differences in the nature of the clinical trials conducted. I think one of the things the competitor has noted is that they're going to be doing lead-in and do additional testing up front. Well, we do that routinely. Our studies, both TENETIS and the 413 study, include a lead-in. Patients are undergoing testing before they're ever randomized into the study, and that testing is also done done to ensure consistency of the patient's level of deficit in terms of hearing. So we think that that creates a strong control on the placebo response, as well as then obviously that we're doing a single administration, that we're not going repeatedly in for a single course of therapy. I hope that addressed. Did I answer your question, or did you have one more there I missed?
spk07: No, that's incredibly helpful. Thank you so much.
spk04: Thank you.
spk08: And your next question comes from the line of Chris Raymond from Piper Sandler. Your line is open.
spk02: Thank you. I just wanted to drill down a little bit more on 313. So I know you guys in the last question sort of addressed the demand and the enrollment dynamics, but just maybe if you can fill in a little bit of color. I think you're using a different inclusion criteria than the phase 1-2 trial at patients with a higher TFI level. You know, just sort of talk to, if you can, I know you've maintained the guidance in terms of having data in mid-2022, but just, if you can, what are you guys doing to sort of counteract, you know, that enrollment criteria difference? Does it matter, you know, given now you have the higher demand? Maybe walk through that dynamic, if you would. And then I know you mentioned 6XX in your prepared comments, but I wonder if you could maybe tell us when you'd be willing to maybe fill in a few more blanks on this program as well. Thanks.
spk04: Yeah, thank you, Christopher. So with regards to 313 and the enrollment, you are correct in that we did make additional criteria around that enrollment to further improve homogenize the population. We're no longer allowing patients with severe hearing loss, as well as we increase the minimum level of the tentative functional index score that is required. And both of those obviously would then mean that fewer patients may qualify for the study. The way we addressed that was actually in the number of clinical sites that we will be enrolling. And importantly, we will be enrolling the study both in the U.S. and Europe. The Phase 1-2 was conducted only in the U.S. And what we are doing is both increasing the number of clinical sites, and that includes including Europe in the clinical study. That was done really for two reasons. One is obviously not understanding how things will proceed with COVID, but hopefully with the vaccination things will be much smoother. basically to be prepared, but we wanted to be able to not be dependent on any one country. And so we felt that was important to kind of spread geographical risk at this point. But also for the number of clinical sites involved. So there's a larger number of clinical sites, approximately 40 clinical centers that will be involved in enrolling this trial of 140 patients. So we think With that, we're very confident in the middle of 2022, and that's based on also looking at the Phase 1-2 and understanding how those patients came in that would now meet our criteria. and understanding what we needed to do to enroll it. Like I said, there's been great enthusiasm for this trial. The amount of outreach makes it, I will say, a little bit easier for clinicians because patients are actively seeking treatment. And the largest challenge they have is to really be able to screen patients prior to having them coming in for any screening for the study. With regards to 6XX, I think that is something we'll be looking to do a little bit later this year. Clearly, we're focused right now on the 825 and the data there, and we do look forward to talking more about that in the middle of this year, middle of 2021, to really take people through the rescue data that we're seeing and the excitement that we have for that program. And I think what you can expect from us is to follow up then a little bit later in the year, both with 510 as well as 6XX with additional updates there. I do want to say, you know, the other areas that we plan to do is outreach with investors to further talk about both tinnitus, but also for our cochlear synaptopathy program. We understand that there's a lot of information and a very complex amount of testing that is done for these indications, and it's something we understand that we need to help educate investors and take them through the endpoints that we have. So we look forward to doing that through the year.
spk02: Great. Thanks a lot.
spk04: Thank you.
spk08: And your next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open.
spk04: Hi, Charles.
spk06: Hello? Hi there. Can you hear me? Yes, I can. Hi, Charles. Okay, sorry about that. Thanks for taking our questions, David and Paul. I had a follow-up to Chris's question on tinnitus. In particular, you know, patient phenotypes, I guess I'm wondering, in terms of enrollment criteria, are you keeping track of any initiating events or, say, time sense onset, or do you think that TFI does a good job of homogenizing or reducing the heterogeneity in the sample?
spk04: Good question, Charles. You're exactly right. In addition to the TFI criteria and hearing loss not being severe hearing loss, we do have other criteria. We are carefully tracking what is the origin of the tinnitus. So it is actually a point of which we ask patients for the nature of origin. We are looking at tinnitus that is due to cochlear origin, which means the patients have to be able to point to a given place in time and situation in which the tinnitus onset occurred. So we are tracking that. That also then goes hand-in-hand with the time since onset. In this study, we will look at onset up to 12 months. So we do want to be able to point back to that initiating event, and so that is a very key part of our criteria in addition to the TFI level.
spk06: Okay, that's helpful. And then when you think about the geographic dispersion of the, I guess, 40 sites, 140 patients, and then the very few number of patients, you know, call it, three and a half patients per site on average that will be enrolled. How do you feel about being able to track the quality of patients as you conduct this?
spk04: I mean, first let me say that, you know, not all sites enroll. I mean, I think all of us have worked in clinical trials know that you do frequently have a fairly significant number of sites that don't actually enroll patients. And part of what we're doing here is, as I mentioned, managing risk on the geographical side with COVID. The other part is, obviously, we've started in the U.S. and we'll be expanding into Europe. So part of that will be based on what we feel we need to do to drive the enrollment. So I think we can handle quality through careful consideration of what sites we open up, as well as obviously tracking to the criteria that we have and being very careful about the patients meeting the criteria. With regards to the enrollment criteria. So I think those are key parts of managing that. Was there another part to your question I didn't address?
spk06: No, sorry for talking over you. No, I think you got it with regard to 313. I did have a question on 413, unless you wanted to add on 313. No, that's fine. Okay, regarding the expansion trial, I guess it's a twist to what I had anticipated. I guess I'm wondering... if you could give us a little bit of additional color, if you will, on the observations you want to make out of that expansion trial to better inform the design and conduct of the Phase II. And would you anticipate being able to come up with that design by the end of 22 for the 413 trial?
spk04: Yeah, great question. I think it is probably a little confusing of what we've done here, but let me explain. For all intents and purposes, what we are actually doing is a Phase II trial, if you will. It's not atypical to go from a Phase I to initial safety study and initial proof of concept into a Phase II study in which you're enrolled 30, 40 patients, for example, to further refine your criteria. You may call that a Phase IIa or such. What we've done here is really kind of take advantage of what we see happening in oncology. As you know, we have clinical centers for this study who are highly specialized centers in terms of being able to do the audiological testing. And as a result of that, we want to keep those centers, and those centers are already up and functioning. So the idea here is to leverage that. And so rather than just stop the study and go to a separate Phase II study and enroll 30 patients, what we're literally doing here is just keeping the study open and adding an additional cohort. So you can think about it as an efficiency play. We're doing that on less cost and speed. with centers that are already up and available. And so, you know, I call it a phase two-like expansion because it's literally could be a separate phase two study. We're just doing it for reasons of those efficiencies. And I think the reason we're going, you know, will be 30 patients, 20 on drug, 10 on placebo. Part of what we're trying to do is further learn about these speech and noise tests. The reason we're doing three tests is because we're still trying to understand those tests. We're the first in the world to have done this kind of work on looking at a therapeutic product, a drug product, through these different speech and noise tests. And not only are we trying to demonstrate the benefit of 413, the activity and safety of 413, but also then to try to decide what do we want to use as we advance further into clinical development. And that is part of what we're learning is a lot about these tests and which ones of those we think may be the best as we continue to move forward. If you will, we've already done that through what we've done to date. As you know, we had a lot of different testing we did in the Phase I to Phase in addition to the speech and noise test, that were based on input from key opinion leaders, things like electrophysiological, middle ear muscle reflex, things that they thought might be able to be used in a clinical setting to evaluate treatment effect. What we found through doing that work was that those were not beneficial, either due to poor repeatability or what we call a lack of sensitivity. And that is where the three speech and noise tests clearly show their benefit and obviously are the real-world test for these patients in terms of improving their deficits in hearing. And what we now need to do is really define further which of those tests look to be the best to extend forward, as well as, of course, I think people seeing data on 30 patients in addition to the data we've already shown will be quite compelling for the efficacy of OTO 413.
spk06: I could add a what, but that would be kind of a joke. So I apologize for that goofy sense of humor. Last question, Otividex and Meniere's. Any further update on Otividex? Is this just a program that we should forget about at this point?
spk04: Yes, I think as we have said, we're pivoting to the other programs. We will not conduct any additional development work on Atividex. I think, you know, I do want to say very clearly we still believe, as I've said, that steroids do provide a benefit to these patients. We think it's important to say that because these patients are looking for treatment, are looking for help, and our data continue to support that. and in fact that we see both at month two and month three numerically greater improvement with placebo, sorry, for Atividex than placebo, the challenge is conducting the regulatory type of study you need in this patient population to separate the treatment from placebo. And it's just extremely difficult clinical setting. And so I think we definitely want to ensure that that people do not misinterpret that this means that the drug may not, that steroids may not be a benefit. We do believe they are, but obviously there's a difference there between that and what clinicians can provide their patients and what we can successfully develop for regulatory approval.
spk06: Okay, that's helpful. Appreciate you taking all our questions, and good luck with the upcoming progress. Thank you, Charles.
spk08: And again, if you have any questions, you will need to press star 1 on your telephone keypad. And your next question comes from the line of Fran Qua-Brisbois from Oppenheimer. Your line is open.
spk05: Thanks for taking the questions. And a lot's been hit here. I think a lot of people are just checking on the enrollment. But not to discuss too much more on Otividex, but just, you know, the placebo response is so important in this field. Was there anything, and there's very few patients that kind of moved the needle here on the trial readout. Anything from the specific patients that you can share or no? No.
spk04: We have done extensive analysis, Frank, and thanks for your question, extensive analysis of this now, and spent considerable time both from a statistical standpoint as well as clinical standpoint looking at the data. And, you know, what I can say is that there's no, other than the fact that the intent to treat was obviously missed, the protocol was statistically significant. As we look at this, there's no clear pattern that emerges that provides the basis to make any kind of statement. You know, it really is a matter of that those particular patients just, with what they experienced, drove that outcome on the per protocol and that was not observed in the intent to treat. So really no clear pattern there. I think it is important to understand that this is incredibly different than the other conditions that we're studying like tinnitus and hearing loss. And I think you can see that in the placebo response that you see. And that's really driven by the fact that I think both these patients have the waxing and waning that's occurring You know, you look at hearing loss, you look at tinnitus, these are persistent conditions. In fact, we require them to be persistent. And additionally, patients are reporting their vertigo, which, of course, is just really kind of a yes, no, and then the duration of it. There's obviously much more extensive testing going on in these other areas, both for tinnitus with the Tinnitus Functional Index, That is 25 different questions as well as loudness and annoyance that we conduct. And then, of course, with the 413 for cochlear synaptopathy, you have these highly developed tests that are speech and noise tests that these patients go through. So very different on a placebo basis. in those conditions, and that's, you know, consistent with what we've seen in the Meniere's, and just being very difficult because of that waxing and waning and patient experiences that we think cause a lot of changes there.
spk05: Okay. Now, understanding the placebo effect between different diseases is extremely helpful. Thank you. And then, you know, you mentioned COVID. I think it was a pretty high-profile case here of kind of a symptom, I guess, was tinnitus. Uh, and I was just wondering, is this something, you know, who knows how long COVID will still be around? This is a yearly thing or whatnot, but have you done any research, you know, could it help enrollment, um, that this is, uh, potentially a side effect or symptom of, of the coronavirus?
spk04: We've not done a research. We carefully follow that obviously. And we're watching, uh, the literature and, and, and people that are looking at sequela associated with COVID. Obviously, there are reports such as this where there's worsening of existing, preexisting conditions in the presence of COVID, and it is something we will continue to follow. You know, that also goes for hearing loss. There's reports of hearing loss being worsened with COVID. So I think all of these things are worth us continuing to follow. Obviously, I don't think they're at a point yet in terms of development to say whether or not those would be additional populations we would go after.
spk05: Okay, great. And just lastly, any developments in terms of maybe your thought process through bilateral versus unilateral tinnitus and maybe seeing the bilateral population as well?
spk04: Yeah, I mean, first of all, I think, you know, we're obviously focused on the best way to develop. And as we work with KOLs, while, you know, half the population is unilateral, about half is bilateral, Unilateral is pretty direct in that you can point to the origin. Typically, patients are, here we require that they can point to a source of origin and what that event was so that we can pinpoint both time and causation and localize that to the cochlea. With bilateral, that's not always the case. The other part with bilateral is on the testing. You are asking general questions. You're asking the questions of the TFI. You're asking about loudness and annoyance. And can patients really do that on the basis of one single ear versus both ears at the same time? So as you can imagine, that sets up a totally another understanding you've got to have, if you will, in terms of how do your endpoints work in that patient population. We don't believe, and our KOLs don't believe, it's probably the same for unilateral as it is bilateral in terms of what changes they can detect. And so for that reason, we're focusing on the unilateral for now so that we can build additional data, and that doesn't even mean treatment data, really data to understand how bilateral patients respond to these endpoints is going to be important, and whether or not they have the ability to discern which ear is getting better or not is one of the questions that we have. So we think it's important to do this stepwise. Obviously, we're the first in many of these conditions that we're doing this kind of research, and we really need to understand the endpoints and the testing tools as much as we do just demonstrating the efficacy of our products and safety of them.
spk05: Great. Okay. Well, thank you very much. That's it for me.
spk08: And I'm showing no further questions at this time. I would now turn the conference back to Dr. David Weber, President and CEO, for closing remarks.
spk04: Well, thank you, everyone, for participating in our call today. Have a good evening. Thank you.
spk08: And this concludes today's conference call. Thank you for participating. You may now disconnect your lines.
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