Q1 2021 Otonomy Inc Earnings Call
Okay.
Good day, and thank you for each one and by welcome to the Q1 2021 Inc earnings Conference call.
And this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session.
Yeah. Good question your and your question you'll need to price.
And one on your telephone keypad and if you require any further assistance just price.
I will now turn the call over to your speaker today, Mr. Robert West with ICR you May begin your conference.
Good afternoon, and welcome to autonomy as first quarter 2021 financial results and business update conference call. Joining me on the call from autonomous <unk> 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 Autonomies 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.
<unk>, specifically disclaims any obligation to update any forward looking statements, except as required by law.
I'll now turn the call over to Dave Weber, President and CEO of autonomy.
Thank you Robert Good afternoon, everyone and thank you for joining us on this call to discuss Autonomies recent business updates as well as the financial results for the first quarter of 2021.
We are now fully focused on advancing our multiple programs for hearing loss and tinnitus.
As reflected by the following recent accomplishments and activities.
In March we announced initiation of the phase two clinical trial for OTO, 313, and tentative and patient enrollment is underway.
Set up activities continue and for an expansion of our OTO 413 phase one two trial and 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 and I'll highlight and this call.
We expect results from both of these trials and mid 2020 two.
In addition, we announced the upcoming presentation of exciting preclinical hearing recovery and data for our O to O 825 gene therapy program for congenital hearing loss.
Can't discuss specifics of these results before.
American Society of gene and cell therapy presentation on Thursday, but will provide a high level summary, based on the published abstract.
We're also continuing to progress our two other preclinical programs and <unk>.
10, and Ono fixed X X that respectively target Boto protection for cisplatin induced hearing loss and hair cell repair and regeneration for severe hearing loss.
Finally, we have completed our analysis and the activity next phase III trial results. While we continue to believe that steroids and provide a benefit to patients with many years disease proving this and a clinical trial setting and the cigna.
Second challenge, we do not see a path forward based on the existing clinical data for <unk> 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 and extends our cash runway into the second half of 2020 three.
We can then open up the lines for any questions.
And at this time, if you would like to ask any questions you all need to press star one and your telephone keypad.
All your question and pass it back.
Beginning with OTO 313, we announced initiation of the phase two trial at the end of March the design of this trial is based on the successful phase one two trial and demonstrated a higher proportion of responders and the other 313 group versus placebo based on the tinnitus functional index or T F I.
The phase two will enroll approximately 140 patients with persistent unilateral tinnitus or at least moderate severity based on the T F I.
And then the prior trial, where we observed a high correlation between the various metrics and responders. We will also attract tenants as loudness and annoyance and patient global impression of change.
To enrich the study population and the trial will exclude patients with severe hearing loss and we believe are less likely to respond to treatment and we are increasing the minimum minimum and severity of tentative 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 and 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 the durability of the treatment effect.
This is because patients responded to OTO 313, we're still improving at the end of the study.
We are excited to have this trial up and running to advance the effort to find and effective treatment for tinnitus, which negatively impact 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 and sadly reported and a recent case of a prominent post COVID-19 patient experiencing unrelenting tinnitus.
We have multiple centers enrolling patients and the U S and won't be adding investigators in Europe, as well and order to have topline results and.
Mid 2022.
Our next clinical stage program is OTO 413, and sustained exposure formulation of brain derived neurotrophic factor or bdnf that we are developing for hearing loss due to the cochlea snapped off that day.
A growing body of research and identified damage to synaptic connections as an important underlying pathology in noise and age related hearing loss. Furthermore, recent studies indicate that the loss and synapses actually occurs earlier and the loss of hair cells.
These findings are highly supportive of our total $4 13 program and the potential treatment for a broad set of hearing loss patients.
In December we announced positive topline results from our phase one two trial that provides clinical validation of this therapeutic approach.
Key endpoints and 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, and noise and digits and noise.
And these tests the subject was presented with a set of phrases words, our number and bearing loudness and with a constant background noise level. Then it's typically set to the loudness of a normal conversation.
A significant advantage of speech and noise tests over conventional testing and quiet isn't they test overall speech intelligibility.
And making the real world setting for patients who complain that they can't hear it didnt noisy setting.
This is especially important because it had been well established that neither audiometry, nor word recognition and quiet predict hearing and a noisy setting.
The initial results were presented from the phase one two trial demonstrated a higher responder rate for OTO 413, compared to placebo across and 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 day 57, and 85 per each of the three tests individually.
This additional data shows the same result, a higher proportion of patients treated with <unk> 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 and you will see speech intelligibility curves and.
And that's fine and day 85 four per.
And for patients who are responders on the words and noise tests.
These curves demonstrate the improved ability of OTO 413 treated patients to hear words correctly and varying levels of wildness compared to the fixed background noise.
And at a minimum improvement and 20% across multiple signal levels, which other our general threshold for a clinically meaningful improvement.
Beginning this quarter, we plan to enroll hearing loss patients and and expansion trial to further demonstrate treatment benefit and a larger population.
Evaluate and refine the study protocol and to refine and power calculations or a more formal phase two study.
This phase II expansion cohort will randomize approximately 30 subjects to a single treatment with OTO 413, or placebo and evaluate a reduced number of endpoints focusing on the three speech and noise hearing tap.
Enrollment criteria will continue to target a broad hearing loss population to support the design of a phase two trial.
We expect results to be available in mid 2020 two.
Our third program and total eight to five and gene therapy targeting G. J B, two which is the most common cause of congenital hearing loss.
And as born with this mutation can have severe to profound deafness in both yours and theirs.
Identified and screening tests now performed routinely and newborns.
Together with our partner a G. T C. We presented preclinical data demonstrating that auto 825 provides excellent expression of connection and 26, the gene product of G. J B, two and the non sensory cells of the cocoa here, which are the relevant target cells for treating G. J b two deficiencies.
<unk> seen.
Furthermore, we have demonstrated consistent gene expression for at least 12 weeks and nonhuman primates. Following a single local administration.
Yeah.
We also recently announced the upcoming presentation and a F. G. P. T. This week and preclinical proof of concept results demonstrating successful recovery of hearing and cochlear morphology and two independent mouse models of G. J B two deficiency.
And these models, we knockout connection twenty-six expression, which results in hearing loss and structural changes of the cochlea that mimic the human condition.
These studies demonstrate and interim cochlear and administration of OTO 825 provides a marked improvement and hearing across multiple frequencies and greatly improve cochlear morphology.
We're very excited by these results and the advancement of OTO 825 into IND, enabling studies, which are now and process.
We look forward to discussing these proof of concept results in more detail as well as outlining our plans for the program and a couple of months.
Our remaining two programs, our OTO 510, and OTO protectant for patients at risk for cisplatin induced hearing loss and OTO sector X X, which targets per cell repair and regeneration and for patients with severe hearing loss.
Preclinical development continues on both of these programs.
Yeah.
In summary, we are focused on advancing our multiple programs and for treating hearing loss and tentative, which represent large untapped market opportunities with significant unmet medical need.
Positive clinical results for OTO 313, and OTO 413 provides validation for these programs and positions us and the only company and the narrow and <unk> field with clinical stage programs in both indications.
Additionally, we have the first and only company to present preclinical proof of concept results for a gene therapy targeting G. J P. Two deficiency, the largest congenital hearing loss patient population.
We're excited about our pipeline and appreciative of Investor and support and 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.
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 and the first quarter of 2021 and.
And non-GAAP operating expenses of $9 7 million.
The primary adjustment for non-GAAP expenses is exclusion of stock based compensation.
So this is the financial metric that best approximates our spending level.
For all of 2021 week.
We expect GAAP operating expenses will be and the range of $46 million to $48 million with non-GAAP operating expenses totaling $38 million 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.
And 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 and 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.
Thank you Paul operator, we're now ready for questions.
And at this time, if you would like to ask any questions you all need to press star and one on your telephone keypad.
And then is that is sorry, one thing and telephone keypad and your.
Phosphate and momentum.
And you're asking.
And your first question comes from the line of Stacy.
<unk> Company your line is open.
Hi, good afternoon, and thanks for taking my questions.
Yeah, I'm so sorry.
Can you talk about the enrollment rate for 31, three and connect Tinnitus study and.
What level of demand and are you flow based on the large opportunity.
And then second question is on the hearing loss program. So.
Net of a different patient population, but given the recent news from competitor a company frequency wondering if you guys can maybe talk about the benefits and the cingal injection or maybe what you would think with EBITDA.
Dosing frequency.
And to preserve the hearing structures and also given the large placebo response observed and the competitor study, maybe remind us what kind of beef and Roman criteria free Air change, let's say, one slash 230 patient study.
What are you thinking about that and how you're working around any type of patient bias and when we talk about your channel. Thank.
Thank you.
Thank you Stacey.
Let me take those one other time here, so first with regards to enrollment rate for $3 13.
And we felt very confident about our middle of 'twenty 'twenty two a readout for topline results from the phase II trial, and which were rolled 140 patients.
And those patients will have a follow up of four months.
So two months for the efficacy and then and an additional two months and 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 and the past on the timing that we say I will say that theres tremendous demand and frankly, we've heard from many patients suffering from tenants who are interested and enrolling in the trial of course the trial.
Have very set criteria for enrollment.
And as most.
Clinical trials due and so many patients are unfortunately, not eligible at this stage, but we see tremendous outreach from patients who are interested and a therapy and it and it very much.
And it's consistent with what we know as being a very large and a market with unmet need.
So with regards to then moving towards the other questions.
In terms of let's just talk about single injection and our 413 program and hearing loss, but this applies to the $3 13, and intended to us and frankly anything being done and the year, obviously as as a company autonomy is really one of the oldest focussed 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 per protocol prolonged period by a single administration. So I think investors understand this is where we have a tremendous amount of intellectual property and knowhow with regards.
And to drug delivery to establish and effective pharmacokinetic profile from a single administration. So we believe that is incredibly important for efficacy.
And I think the recent data further support the both the 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 trying to do multiple administrations does of course are not efficient and and.
And our 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 debt 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, though repeated administrations because in our hands and of course, I think we've done more administrations and anyone in the world entered tympanic Lee we've not seen issues from tremendous amount of work from multiple administrations done in the year, that's not really been.
And the issue that we've observed.
With regards to placebo and the large per people respond to that and that was observed and a competitor study.
I think we can show through our data with $4 13, we did not observe that we saw a little to know plus.
Placebo effect, and our with our word and noise and speech and noise and tests that we conducted and I think you know is an important piece here is that there are tremendous differences and the nature of the clinical trials conducted I think one other things the competitor as noted is that theyre going to be doing lead in.
And do additional.
Additional testing upfront, while we do that routinely our studies both tinnitus and the 413 study include a lead in patients are undergoing testing.
Before they were ever randomized into the study and those are that testing is also done to ensure consistency of the patient's level of of deficit in terms of hearing.
So we think that that is creates a strong control on the placebo response.
And as well as then obviously that we're doing a single administration that we're not going repeatedly and for a single course of therapy.
And I hope that address did you did I answer your question or did you have one more there I missed.
Now that's incredibly helpful. Thank you so much thank you.
And your next question comes from the line of Chris Raymond from Piper Sandler Your line is open.
And I just wanted to drill down a little bit more on 313.
So I know you guys and the last question and sort of addressed.
The demand and the enrollment dynamics, but just maybe if you can fill and a little bit of color.
I think youre using a different inclusion criteria and the phase one two trial and patients with a higher tsi level.
And you just sort of talk to if you can and I know you've maintained the guidance in terms of having data in mid 'twenty 'twenty two but I'm. Just if you can what are you guys doing to sort of counteract that enrollment criteria difference is it does it matter given now you have the higher demand.
Maybe walk through that that dynamic if you would and.
And I know you mentioned six Xx and your prepared comments, but and I Wonder if you could maybe tell us when you'd be willing to.
And maybe Phil and a few more blanks on on this program as well. Thanks Yep. Thank you Christopher.
So with regards to $3 13, and the enrollment you are correct and that we did.
Make additional criteria around that enrollment to to further hum homogenize the population, we're no longer allowing patients with it.
With severe hearing loss as well as we increase the minimum minimum level of the tinnitus functional index score that is required.
And both of those obviously would then mean debt and.
Fewer patients may qualify for the study the way we address that was actually and the number of clinical sites and we won't be enrolling and importantly, we will be enrolling. This study both in the U S and Europe. The phase one two 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 and.
And the clinical study that was done really for two reasons one is.
Obviously, not understanding how things will proceed with COVID-19, but hopefully with the vaccination and things will be much smoother, but 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 from cleared for the number of clinical sites involved so there's tremendous and Oh.
Larger number of clinical sites, approximately 40 clinical centers that will be involved.
And enrolling this trial of 140 patients. So we think with that we're very confident and the middle of 2020 two and that's based on also looking at the phase one two and understanding how those patients came in and that would now meet our criteria and.
And and understanding what we needed to do to enroll it like I said theres been great enthusiasm for this trial and <unk>.
And the amount of outreach makes it.
And I will say a little bit easier for clinicians because patients are actively seeking treatment and they're the largest challenge. They have is to really be able to screen patients.
Prior to having them coming and for any of screening for the study.
With regards to <unk>. So I think that is something we'll be looking to do a little bit later this year clearly we're focused right now and the eight to five and the data there and we do look forward to talking more about that and the middle of 'twenty two.
This year and 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 six effects with additional update there I do want to say you know the other areas that we plan to do it.
Outreach with investors to further talk about both tentative, but also for our sin cochlear snapped off Potheen 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 and take them through the endpoints that we have so we look forward to doing that through the year.
Great. Thanks, a lot.
Okay.
And your next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open.
Hi, Charles.
Yeah.
Hello, Hi.
And you hear me Hi, Ken Hi, Charles.
Okay, sorry about that thanks for taking our questions David and Paul.
A follow up to Chris's question Tinnitus and particular.
You know patient phenotypes and I guess I'm wondering in terms of enrollment criteria are you keeping track of any initiating event or.
Day time since onset or do you think that tsi does a good job of.
Much and icing or reducing debt heterogeneity and that's in the sample.
Oh.
Good question, Charles So you're exactly right and in addition to the <unk> criteria and and hearing loss.
And not being severe hearing loss.
We do have other criteria, we are carefully tracking what is the origin of the tenant. So it is actually a point of which we asked patients for the nature of origin. We are looking at.
Ill turn it just that it is due to cochlea origin, which means the patients have to be able to point to a given place and time and situation and which the tinnitus onset occurred. So we are tracking that.
And that also then goes hand in hand with the time since onset.
And this study we will look at all and set 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 and addition to the <unk> level.
Okay. That's helpful. And then when you think about the <unk>.
Geographic dispersion.
I guess 40 sites 140 patients and then and then the very few number of patients you know call it three and.
Patients per site.
On average debt will be enrolled how do you feel about being able to track the quality of patients as you conduct this.
And I think well I mean.
First let me say that you know not all sites enroll and thank all of US have been worked and clinical trials know that you do and frequently have a fairly significant number of sites that don't actually enroll pay.
Patients and part of what we're doing here is as I mentioned managing.
Managing risk on the other geographical side and with with with COVID-19.
The other part is obviously, we 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 too.
Criteria that we have and being very careful about.
And it's meeting the criteria.
With regards to enrollment criteria, yeah. The enrollment criteria. So I think those are key parts of that are managing that.
Did you weather and other parts of your question I didn't address.
No sorry.
Sorry for talking only.
I think you got it with regard to 313 I did have a question on point 13, unless you wanted to add on <unk>.
That's right.
Okay regarding the.
Expansion trial I guess.
It's a twist to what I answered.
<unk> and I guess I'm wondering if you could give us a little bit of.
For additional color and if you will.
And the observations you want to make out of that extension trial and bedroom Forum.
The design and <unk>.
And the phase two and and would you would you anticipate being able to come up with that design by the end of 'twenty two for the four and 13 trial.
Yeah, Great question, and I think it is probably a little confusing and what we've done here, but let me explain.
For all intents and purposes, what we're actually doing is a phase two trial if you will.
Its not atypical to go from a phase one two initial safety study and initial proof of concept into a phase two study and what share of enrolled 30 40 patients for example to further refine your criteria you may call that a phase iia or are such what we've done here is really kind of take.
<unk> of what we see happening and oncology, whereas as you know we have many we have clinical centers for these for this study who are highly specialized centers in terms of being able to do the audio logical testing and.
And as a result of that we wanted 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 two study and enroll 30 patients. What we're literally doing here is just keeping the study open and and adding an additional cohort.
So you can think about it as an efficiency play, we're doing that on and less cost and 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 III study. We're just doing it for reasons of those efficiencies and and I think the reason, we're going and it will be 30 patients 20 on drug and 10 on placebo and part of what we're trying to do is further learn about these speech and noise tests the reason.
And we're doing three test is because we're still trying to understand those tests for the first and the world to have done this kind of of work on looking at a therapeutic product drug product through these different speech and noise tests and so not.
And the only or are we trying to demonstrate the benefit of $4 13, the activity and safety of <unk>, but also then to try and 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.
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 the day as you know we had a lot of different testing, we did and the phase one two in addition to the speech and noise tests that were based on input from key opinion leaders things like electrophysiology coal middle ear muscle reflects things that they thought might be.
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 are either due to poor repeat ability or.
What we'd call a lack of sensitivity and that is where that's free speech and noise has clearly show their benefit and obviously are are the real world test for these patients.
In terms of improving there.
Their deficits and hearing and what we now need to do is really defined 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 are in addition to the data and we've already shown will be quite compelling for the efficacy of OTO 413.
And Oh.
But that would be kind of a.
And I joke Oh.
Thanks for that goofy sensitive here and my last question and then.
<unk>.
Any.
And any further update on I know the tax or is this is this just a program that we should forget about at this point.
Yeah. So I think as we have said, where we're pivoting to the other programs, we will not conduct any additional development work on <unk> X I think I would 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 and are looking for help and our day to continue to support.
And and in fact that we see both at month, two and my three numerically greater improvement with placebo a or.
I'm, sorry for <unk> Xa and placebo. The challenge is conducting the regulatory type of study you need in this patient population to separate separate the treatment from placebo and it's just extremely difficult clinical setting and so I think you know we we we definitely want to ensure that that people do not and.
Misinterpret that this means that the drug may not and that steroids may not be a benefit we do believe they are but obviously that's the difference there between that and what clinicians can provide their patients and what we can successfully develop.
For regulatory approval.
Okay. That's helpful. I appreciate you've taken all of our questions.
Good luck with the upcoming price.
Yes.
Thank you Charles.
And again if he has any question you will need to press star one on your telephone keypad.
And your next question comes from the line of from this law from open your.
Your line is open.
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 to discuss too much more on <unk>, but just you know the placebo response is so important in this field.
Anything and is very few patients debt.
And kind of move the needle here on the trial readout anything from the specific patients that you can share or door now.
No. We we have done extensive analysis, Frank and thanks for your question and extensive analysis of this now and spent considerable.
Tie and both from a statistical standpoint, as well as clinical standpoint, looking at the data and.
And you know what I can say is that there's no other than the fact that the the intent to treat what's obviously missed the per protocol was statistically significant and as we look at this there is no clear pattern that emerges.
And that provides a basis to make any kind of statement you know it.
It really is a matter of that those particular patients just with what they experienced.
<unk> drove that outcome on the per protocol and and that was not observed and the intent to treat so really no clear pattern. There I think it is important to understand that this is an incredibly different than the other you know other conditions that we're studying like tinnitus and hearing loss and I think you can see that in the placebo arm.
Sponsors that you see and that's really driven by the fact day.
Both these patients have the waxing and waning that's occurring.
And you look at hearing loss and you look at tentative.
Assistant conditions and in fact, we require them to be persistent.
And additionally patients are reporting their vertigo, which of course is just a really kind of a yes, no and and then the duration of it there is obviously much more extensive testing going on and these other areas both for tentative with the tenants and functional index that is 25 different question.
And as well as loudness and annoyance that we conduct and then of course with the 413 for cochlear and Fanapt apathy you have these highly developed.
Tests that are speech and noise tests that these patients go through so very different on a placebo basis.
And those conditions and Thats and.
Consistent with what we've seen in the many years.
And just being very difficult because of that that waxing and waning and and patient.
Experiences that we think caused a lot of changes there.
Okay now understanding the placebo effect between different is extremely helpful. Thank you and then.
You mentioned the COVID-19 I think it was pretty high profile case here and have a symptom I guess was the tinnitus.
And I was just wondering is this something you know who knows how long COVID-19 and will still be around this is a yearly thing or whatnot, but have you done any research could it help enrollment.
That this is potentially a satisfactory symptom of of the Corona virus.
We've not done a research we carefully follow that obviously and we're watching are the literature and and and people that are looking at sequela associated with COVID-19. Obviously, there are reports such as this where there was worsening of existing preexisting conditions and and the presence of COVID-19 and it is something we.
We'll continue to follow.
You know that also goes for hearing loss, there's reports of hearing loss being worsened.
And with with COVID-19 and so I think all of these things are worth continuing to follow I'm. Obviously I don't think they are at a point yet in terms of development to to say whether or not those would be additional populations. We would go after.
Okay, Great and then just lastly, any developments in terms of maybe your thought process through a bilateral.
Bilateral vs unilateral tinnitus, and and maybe seeing the you know.
Bilateral population as well.
Yeah, I mean first of all I think.
We're obviously focused on on the on the best way to develop and and yes, we were.
Work with Kols and.
And you know half the population is unilateral about half as bilateral.
Yeah, you know unilateral is pretty direct and that you can point to the origin. Typically patients are you know here, we require that they can point to other sorts of origin and what that event was so that we can pinpoint both time and causation and localize that to the cochlea are with <unk>.
Lateral that's not always the case the other part with bilateral is on the testing you know you are asking general questions Youre asking the questions of the TFR, you're asking about loudness and annoyance and can patients really do that on the basis of.
One single ear versus both years 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 and that patient population, we don't believe and our Kols don't believe is 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.
And treatment data really data to understand high and how bilateral patients respond to these end points is going to be important and whether they are not they have the ability to discern which ear is getting better or not is one other questions that we have so we think it's important to do this.
Step wise, obviously, where you know the first and many of these conditions that we're doing this kind of research and we really need to understand the endpoints and the and the testing tools as much as we do just demonstrating the efficacy of our products and safety of them.
Great. Okay. Thank you very much that's it for me.
And I'm showing no further questions at this time I will now turn the conference back to dealt with EBIT and I think president and CEO for closing remarks.
Yeah, well. Thank you everyone for participating on our call today have a good evening.
Yes.
And this concludes today's conference call. Thank you for participating you may now disconnect your lines.
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