Toronto-Dominion Bank Q4 2024 Earnings Call Transcript

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Provided by Quartr
March 27, 2025

There are 9 speakers on the call.

Operator

and welcome to the Clearside Biomedical Fourth Quarter twenty twenty four Financial Results and Corporate Update Call. At this time, all participants are in a listen only mode and a question and answer session will follow the formal presentation. Please note, this conference is being recorded. I will now turn the conference over to your host, Jenny Cobin of Investor Relations. Ma'am, the floor is yours.

Speaker 1

Good afternoon, everyone, and thank you for joining us on the call today. Before we begin, I would like to remind you that during today's call, we will be making certain forward looking statements. Various remarks that we make during this call about the company's future expectations, plans and prospects constitute forward looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the Risk Factors section of our annual report on Form 10 K for the year ended 12/31/2024, and our other SEC filings available on our website. In addition, any forward looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent date.

Speaker 1

While we may elect to update these forward looking statements in the future, we specifically disclaim any obligation to do so even if our views change. On today's call, we have George Lizeske, our Chief Executive Officer Doctor. Victor Chong, our Chief Medical Officer and Head of Research and Development and Charlie Degnan, our Chief Financial Officer. We also have accompanying slides that are available on ClearSite's website in the Events and Presentations section. After our formal remarks, we will open the call for your questions.

Speaker 1

I would now like to turn the call over to George.

Speaker 2

Thank you, Jenny, and good afternoon, everyone. ClearSight is the proven leader in the delivery of drugs and drug candidates to the suprachoroidal space. Our SES microinjector provides safe and reliable delivery with over 15,000 suprachoroidal injections performed to date. We continue to have increasing interest among retinal specialist and leading pharmaceutical companies in applying our innovative delivery platform to treating serious retinal diseases. We are pleased to announce that the positive results from our Odysee Phase 2b wet AND deep clinical trial led to a successful end of Phase two meeting with the FDA regarding the planned Phase three activities for CLSAX.

Speaker 2

Based on our interactions with the FDA, we are aligned on a pivotal Phase three program that we believe is positioned for success and maximizes the commercial potential for CLSAX in wet AMD. Victor will elaborate on these plans shortly. Our commercial and development partners have made excellent progress over the last several months as they continue to validate the broad applicability of suprachoroidal delivery in several indications. Across our partners, suprachoroidal treatments being developed for delivery by our SCS micro injector are now approved in two Asian territories under regulatory review in China and involved in two ongoing or planned Phase III trials. Our partner Arctic Vision achieved several regulatory milestones in the Asia Pacific region with Arcadis or XIPERE for the treatment of uveitic macular edema.

Speaker 2

This year, they announced that a new drug application is currently under regulatory review in China and that the product was approved in Australia and Singapore. Importantly, Arctic Vision also entered into a commercial collaboration with Santan Pharmaceuticals for the marketing and distribution rights to Arcadis in China. In addition, REGENXBIO in collaboration with AbbVie announced in January that a global Phase III clinical program in diabetic retinopathy fourteen now referred to as CIRUVEC is planned to start later this year using our SCS microinjector. In addition, their Phase II ALPTUTUDE suprachoroidal trial is currently enrolling a cohort of patients with center involved diabetic macular edema and their Phase III AAV8 suprachoroidal trial is enrolling a cohort in wet AMD at dose level four. Our oncology partner, Ora Biosciences is enrolling its global suprachoroidal Phase III trial of BELLSAR for the first line treatment of patients with choroidal melanoma delivered using our SCS microinjector.

Speaker 2

Oura has also initiated a Phase II trial in metastases to the choroid. And finally, our partner BioCryst recently highlighted plans to initiate clinical testing in 2025 of oborlistat, its plasmacallochrone inhibitor using suprachoroidal administration for the potential treatment of DME. With that, I would now like to turn over the call to our Chief Medical Officer and Head of Research and Development, Doctor. Victor Chong, to outline the Phase III plans for CLS A X and other opportunities with our suprachoroidal pipeline. Victor?

Speaker 3

Thank you, George, and good afternoon, everyone. As George described, we are excited about the result of Audezeit that supports CLSAX as a Phase III ready asset for the treatment of wet AMD. Today, I would like to share several slides outlining the Phase III plans that we believe will position CISA as a leading maintenance treatment for wet AMD if the results are positive. To begin, I will highlight two subgroup analysis from Olessee that helped inform the current Phase III trial design. Some of these data were presented at Angiogenesis and MacSociety last month, which provide an opportunity for us to continue to gather KOL feedback.

Speaker 3

The first analysis provided the basis for the targeted patient population and supports enrolling TRU1N90 patient in Phase III trial. On this graph, we showed that participants solely redose with CRS ax dose at week twenty four. As you can see, the subgroup analysis show even more stable BCVA and CST in this participants to week thirty six. And we believe that by targeting proven naive patients in a Phase III trial, there may be an even greater percentage of patients reaching six months without the need for any intervention. On the next slide, a second subgroup analysis support the planned Phase III design that exclude the participant with non disease related changes in visual acuity prior to randomization.

Speaker 3

This chart excludes the data at which the visit where the patient vision have a change of 10 or more lesser from their previous visit, but did not have a corresponding change in CSC of at least 25 What it means is that the patient did not see as well that date on the eye chart, but without significant OCT changes. This tells us the BCVA change on that day may not be disease related. It may just be that the patient did not perform the test well on that day. In running this analysis, we again saw compelling BCA result. In the Phase III trial, by excluding patients who have a 10 letter change just prior to randomization, we may reduce BCVA variability related to wet AMD activities.

Speaker 3

Now I'd like to walk you through the Phase III plans and trial design discussed and agreed with the FDA at our recent annual Phase II meeting. The plan we presented to the FDA is for two pivotal non inferiority trial. The trial design is similar to the most recent Phase III trial in wellAMD that lead to the approval of IDEA high dose and Vebismo. The design applies the redosing criteria generally utilized in real world clinical practice, we will feature the ability to flexibly dose CLFAX. And we believe the ability to redose with CLFAX versus rescue in patient with anti VEGF product is an important differentiator compared to other TKI programs currently in development.

Speaker 3

Slide nine shows the current Slide nine shows the current planned Phase III program designed to potentially reduce regulatory risk and maximize the commercial opportunity for CF8 in wet AMD. I will walk through these key design aspects. As I mentioned previously, the plan is to enroll TRUMA9EV patients, which we believe can potentially expand the commercial value of CIFAA with a broader patient population. From a statistical perspective, we know it is important to reduce variability in a non inferiority study. The plan is optimize our study population.

Speaker 3

We know from previous studies, patients with poor vision and or thicker retinas have higher variability in the outcome. Therefore, at screening, participants will be required to have a BCVA reading between 2,080 to twentythirty two. In addition, the CST reading on the OCT must be less than 500 microns. These components are designed to minimize enrollment of highly variable patients to potentially increase the probability of success of the trial. Between the third and the fourth injection of Libercept, we do not normally see a change of vision or anatomy.

Speaker 3

Therefore, the plan is to exclude participants who had more than a 10 letter change or a CST increase of more than 100 micron from their previous visit. This criteria was strongly recommended by KOLs on our Scientific Advisory Board and are designed to increase the probability of success by further reducing variability. On day one, participants will then be randomized one to one to CRSAX one milligram or Aflacep two milligram. Participants in the a-three percent arm will receive treatment every eight weeks for standard dosing label up to the primary endpoint at week fifty two. In a CLSA exam in week twelve, sixteen and twenty, participants will undergo an assessment for disease activity to determine the personalized treatment interval or PTI.

Speaker 3

Based on their PTI, participants will be assigned to a treatment regimen of every twelve, sixteen or twenty weeks. The plan is to employ in office OCT biomarker that will be determined using an AI tool to improve consistency in assessing the need for redosing. For those patients who did not meet the criteria at week twenty, they will be assigned to a treatment regimen of every twenty four weeks. Once a dosing interval is established for each participant during the PTI period, the participant will stay at that interval until the primary endpoint at week fifty two. This is the fixed dosing period.

Speaker 3

For example, if the participant met their PTI criteria at week sixteen, they will be given CLS A X every sixteen weeks in a fixed dosing period. After the primary endpoint is reached, the trial will continue for another year as a safety follow-up period to produce the data required by the FDA for a new drug application. In a CRSA exam, the fixed dosing interval will end. The participant will then continue and be treated with variable dosing according to anatomical sign based on the PTI criteria. In the efibrocep arm, patient will cross over to receive CRSaX every sixteen weeks, which will provide additional safety and efficacy data in an NT VEGF treatment experienced patient population.

Speaker 3

It will also provide experience in moving patients from acliptocept to CLSAX as a maintenance therapy. Wet AMD is a chronic disease requiring numerous injection to maintain vision and stabilize the disease. We are targeting clinical experience that patients require differing frequency of treatment to achieve stable vision. We are the only TKI in development with multi dosing data from our Phase 2b trial and the only TKI in development with the ability to redose before six months. Therefore, we expect minimal to no anti VEGF rescue in Phase three, which could reduce our regulatory risk and prove to be a clear and important differentiator.

Speaker 3

All in, we believe this important feature of the Phase three trial support a strong regulatory and commercial strategy for the success of CLFAX. On Slide 17, we have laid out the competitive landscape related to dosing flexibility in the wet AMD market. The initially approved anti wet drug to treat wet AMD worked well, but have lower durability and less flexibility in dosing regimen. The next generation have moderate durability and a more flexible dosing regimen. We have heard from numerous physicians that the dosing flexibility of one to four months was important to them.

Speaker 3

In contrast, the protocol for other TKI currently in development only allow for dosing at twenty four weeks interval and participants will need to be rescued if they cannot go that long. With durability up to six months and flexible dosing regimen, we believe CIF A8 will have a potential versatile and commercially appealing label and would be well positioned to compete in the wet AMD market, which represent over $12,000,000,000 in annual sales. Before I turn the call to Charlie, I want to take a minute to review our pipeline opportunities. We continue to be excited about the Board's potential for supercaroidal delivery with our SCS microinjector. Internally, I see a great potential opportunity beyond wet AMD where delivering of a small molecule via the suprachoroidal space could make a tremendous impact in the treatment of retinal disease.

Speaker 3

Our research team is currently evaluating two approach with certain specific small molecule full in vivo models for the potential suprachoroidal treatment of geographic atrophy. Our team is doing the necessary work to potentially advancing one or both of these candidate for an investigational new drug application. In GA, we are currently evaluating two methods of action that could potentially be used as an add on to complement base therapy. Administrate suprachoroidal, this smaller molecule suspension can treat both sides of the Bruch's membrane, including the retina, RPE and the choroid. And with chupro choroidal administration of the agents, we expect it achieve higher concentration of drug in the choroid.

Speaker 3

As a result, we believe this molecule will improve choroidal perfusion to improve retinal function directly and slow progression. And moderating post inflammatory cell can reduce the root cause of complement activation. With that, I will turn the call over to our CFO, Charlie Bennett, to provide a financial update.

Speaker 4

Thank you, Victor, and good afternoon, everyone. Our financial results for the fourth quarter and year ended 2024 were published earlier in our press release and are available on our website. Therefore, I will just provide a summary of our financial status on today's call. As of 12/31/2024, our cash and cash equivalents totaled approximately $20,000,000

Speaker 3

We believe

Speaker 4

we have sufficient resources to fund our planned operations into the fourth quarter of twenty twenty five. We are actively pursuing options to fund the CLS AX Phase III program, including potentially partnering with one or more third parties. We look forward to participating in the Needham Virtual Healthcare Conference and the Jones Trading Conference next month. I will now turn the call back to George for his closing remarks.

Speaker 2

Thank you, Charlie. We remain focused on our small molecule suprachoroidal pipeline led by CLSAX for the treatment of wet AMD. We have seen increasing interest among retinal specialists and leading pharmaceutical companies in applying the suprachoroidal delivery approach to treat serious retinal diseases. Our broad formulation, development and regulatory expertise and the delivery of agents to the suprachoroidal space makes us well positioned in the overall treatment landscape for retinal diseases. We are grateful for the hard work and dedication of our ClearSight team and the ongoing support from our stakeholders as we continue to advance our suprachoroidal delivery pipeline.

Speaker 2

I would now like to ask the operator to open the call up for questions.

Operator

Thank you. At this time, we'll be conducting our question and answer session. Thank you. Our first question is coming from John Wallobin with Citibank. Your line is live.

Speaker 5

Hey, good afternoon and thanks for taking the questions.

Speaker 2

Hi, Joe.

Speaker 5

Hi, Joe. Hi, Joe. The subpopulation and the amendments you're making to the planned Phase three, I'm wondering if you could give any context about how you think that might improve the results from what you saw Phase two? Victor there?

Speaker 3

Sure. Great. Can you hear me? You're there, Victor. Okay.

Speaker 3

Can you hear me? Yes. I can. Yes. So, can you so I think that from our plan to Phase three that we try to exclude the patient with higher wearability.

Speaker 3

I think the one to think about is on the Phase two, we're delivering selecting the patient who are very difficult to treat and we believe they're moving to a more general population, we would have better results. And one of the subgroup analysis, the first one that we mentioned, that those who actually doesn't need any extra treatment. And so one of the concern was that could be under treated, but in fact they will not. They will actually do extremely well. So we believe that when we move to general population, that segment that only every six months injection will be actually higher.

Speaker 3

I don't know whether that is what you're referring to because the second sub granular changed the population slightly in a different way.

Speaker 5

Sort of helpful. I'm wondering, yes, maybe it's a difficult question to answer, but maybe moving on to two other ones. How long do you think it could take to enroll how long do you think it would take to enroll the treatment naive population? And then last one for me, did FDA say you need a certain number of patients in each of these treatment intervals to have a sufficient size to show efficacy and safety? Or will it be purely on the individual assessment of the response in 12?

Speaker 3

Yes. I think the first question first is how long do we expect it to enroll? And usually this kind of trial will be around twelve months or slightly under twelve months. And indeed, we see the recent trial in other Phase III are doing pretty well. So we would expecting that will be probably just under twelve months.

Speaker 3

In terms of the agency that this is the type of analysis very, very similar to what the two recent approval with IDH and florizumab. So we do not expect that they would be separating the adverse event rates in different group on different frequency and it's really the drug as an overall. And it's just a similar expectation that we're using the drug when we get to market would be on different interval. So we will not expect that. I think the agency was quite clear that it would be considered as one arm.

Speaker 3

So the whole awards event assessment will be merged together. And I think that's a very similar modality that they use for IDH high dose and abysmal.

Speaker 5

Okay, got it. All right. Thanks for taking the questions.

Operator

Thank you. Our next question is coming from Serge Belanger with Needham. Your line is live.

Speaker 6

Hi, good afternoon. I guess my first question now that the Phase III trial plan has been finalized. Can you give us an estimate of the overall cost of such a program? And I guess is it feasible, we're talking about 900 patients total here for ClearSign to run such a large program? Thanks.

Speaker 3

So I'll answer the second part and I'll let Charlie to answer the first part. And yes, we would using a global CRO. And so we believe that it's something that we would be able to manage. And although it's a relatively large trial, but at the same time that well AMD trial is relatively straightforward from the both the endpoint and the investigation needed. And I'll let Charlie to answer the first part about the cost.

Speaker 4

Yes. And Serge, I'll also just remind you, back, we ran two Phase three concurrent RVO studies years ago. So we know how to run Phase three trials here. In terms of costs, we're not giving specifics on the cost, but I think some of the other Phase III's I think I've seen, they're around $55,000,000 60 million dollars for each study. But we haven't given out an estimate for our numbers for our trials.

Speaker 6

Okay, thanks. And then I guess one for Victor. I'm just curious as you set up the design of the Phase III, whether you considered emulating one of your potential competitor in running a superiority trial and why what were the pros and cons and why you decided to go forward with two non inferiority studies? Thanks.

Speaker 3

The two non inferiority study was true and tested and the agency have reflected that multiple times. And this is a lot more risky, the HER2 trial is not the same. And I can't comment on our competitor why they decided to do something different and that is their decision. But I think from our point of view and also our interaction with the agency, the two non inferiority trial is test and is proven tested in virtually, if not, every single retinal drug was approved based on the two non inferiority trial other than oversee the first one, LUCENTIS was a superior trial.

Speaker 6

Thank you.

Operator

Thank you. Our next question is coming from Debenjanath Chatterjee with Jones Trading. Your line is live.

Speaker 7

Hi. Thanks for taking my question. I was wondering if you could provide any additional color on the your financing strategy for the Phase two sorry, Phase three and how should we think about the timeline of the study initiation? I know you were planning initiation in the second half. Is that still the plan?

Speaker 3

Well, let me take this. Yes, go

Speaker 2

ahead, Charlie. That's fine.

Speaker 4

Yes. So we're still in terms of study, we're gearing up to continue to be ready to start the study in the second half of the year. Obviously, we need to fund the clinical part of the study. As we said, we're pursuing our options to get the study funded, including potentially partnering with one or more third parties. So that's about all the information I give you at this point.

Speaker 4

And as soon as we have some clarity, we'll let everybody know. But that's all we could say right now.

Speaker 7

Thanks for that. I have a quick follow-up. So if I understood correctly, the TAM in the study, is it being administered monthly? And I was just curious as to the design of why the like why would you choose that instead of like every two weeks? Is that to kind of merge it with the PCI phase?

Speaker 3

So the way that we want to do the study is in every single visit, the patient will be given an assessment and then after that assessment, then they will have a procedure. So that will be how that we agree with the agency of masking the study so that the patient will not know which arm they would be in. So from a patient perspective, they will have an assessment and then they would then have a procedure. And the procedure could be a suprachoroidal injection, could be a sham and could be a hypocept injection. And again, that is depending on the PTI that I mentioned earlier or if they have met the rescue criteria.

Speaker 3

So throughout the study that there will be a patient that have a triple step injection, sometimes it could be just in the beginning and only just in the beginning for the ax arm and then the patients would have the injection in the threeprazemap. So we have discussed that in detail with the agency and the agency felt that will be an adequate masking or blind in the way that some other therapeutic area use. So that's how do we think that was the right thing to do. I'm not sure about the two weeks that you mentioned, but this is going to be done every month every visit and other than some visit that there will be no procedure needed.

Speaker 7

Okay. Thank you so much.

Operator

Thank you. Our next question is coming from Yi Chen with H. C. Wainwright. Your line is live.

Speaker 8

Thank you for taking my questions. My first question is,

Speaker 5

what are the

Speaker 8

potential factors that could contribute to a BCBA change over 10 letter sound of the CST change?

Speaker 3

Yes. So what we have known in the clinic, in fact that a lot of clinicians don't even believe the vision in the clinic because it's just that it's such a high variability. PCV is slightly more reliable and in fact that the agency also always talk about this 15 letter, it's only 15 letter is real. And so I think that this understanding that a lot of our patients are pretty elderly and then you could have in a bad day that they couldn't really see better that day or the test, they just couldn't deal with it. And that's just something that we know in routine clinical practice.

Speaker 3

In a clinical trial, there's some of these data points affecting our data. So what we have done in the support analysis that I show is that, well, the OCT anatomy have not changed at all and normally that you your vision got worse, your OCT will get worse or vice versa. And the 25 micron, you just say kind of a way to think that, well, if you have not did a 25 micron change, which is a very small change, and then your vision might not be reliable. And so we could see that this was a cohort analysis. So we took that out, but just that not the whole patient, obviously that would take out a lot of data points.

Speaker 3

But just that one data point and then as you can see on the chart, that make it even better, although all our results are already good anyway, but this is just making it even better explaining that sometimes that some patients just don't do it well could be a problem. So translating to our Phase III design, obviously, we can't do this in a real study because it's a post hoc analysis to understand. And what we decided that as I mentioned in the call, between the third and the fourth injection and again, we have a lot of historic data that during those two visits, the vision doesn't change normally. So again, if they did change, that means that that patient is unreliable patient. And so we believe that by removing those patients before randomization will help us to reducing the variability.

Speaker 8

Okay. And by implementing these criteria before randomization, do you expect to have any negative impact on enrollment speed or future market adoption when the CLSX eventually reaches the market? Thank

Speaker 3

you. Yes. So I don't think that you were affecting the label in a meaningful way. And again, over see that is something that we can't really discuss in detail now. We have seen that in other approved product that they have particular inclusion exclusion criteria, but then the label is still the same as well AMD or Neovasta AMD.

Speaker 3

We discussed with the agency and the agency didn't really raise any concern on the way that we want to do the study. And in fact that I think that reducing variability to truly show whether the drug work or not are scientifically justified. So I think from that point of view, the label discussion is too early to talk about it, but we believe from past experience that should not be a key problem. In terms of the recruitment and other things, we actually did some analysis on the dataset that I have access to during academic time. The number of patients that would get rejected between the third and the fourth injection should be less than ten percent.

Speaker 3

And so it won't be a major impact, but we believe that ten percent can create a lot of variability. And so by removing them will give us a better, more consistent result. And again, the agency agreed to that.

Speaker 8

Okay. Thank you very much.

Operator

Thank you. Our next question is coming from Andreas Agarides with Oppenheimer. Your line is live.

Speaker 7

Hi. Thanks for taking our questions. This is Erika on for Andreas. Can you talk about the powering assumption and the Phase three trial? And also, if you would share, do you have any insights on how payers think about reimbursement for a potential three to six months flexible dosing label for CLSAX compared to competitors?

Speaker 7

Thank you.

Speaker 3

So I go to second question first. You might be a little bit easier question. I think the first question is probably quite technical. And the second part is like we have did some payer research and the payer have give the payer research have support our assessment, how that we can potentially put a commercial value to it. And I think that a simplistic way to think about it is that is some of our competitors would do something different to us potentially.

Speaker 3

On the other hand, from our point of view, if you have the flexible dosing, so we believe that we're quite likely to model from the flexible dosing drugs such as IDEAHY dose and RABISMO. And then one way to think about it is that because we have a small molecule and the device is made by our own device and so our cost of goods will be very low and it will be actually lower than the biologics. So again, that will we can be potentially pricing it very competitively. So I think that is something that for further down the road where we have explore on the payer research and what will be the best way to get into the market. And then the first question is really a standard Phase III, the kind of the assumption that we took some of the assumption that are very similar to abysmal.

Speaker 3

We were changing to potentially around a 14 letter variability and we believe that our probability is probably lower. However, that we were looking at a very similar to abysmal type of number. And we used a 4.5 letter margin as suggested by the agency and then to get to the 90% as you would expect on the Phase three study. Thank you.

Operator

Thank you. Our next question is coming from Daniel Gautauqua with Shada. Your line is live.

Speaker 8

Hey guys, thank you for taking my question. Victor, I have one for you. Can you please elaborate on redosing criteria, which as I understand, relies on OCT biomarkers and how these interplay with the rescue criteria of the BCVA loss and the fluid gain. And also where does the physicians discretion come in in redosing decision because I think that's always a big variability factor? Thank you.

Speaker 3

Yes. Thank you for that question and allow me to spend time to explain that. So redosing and Redscale is two different things in our position. So redosing is similar to what we have seen with IDeA high dose and with Bismol, they have a certain criteria and the two companies have different criteria. And I'm not going to go into detail of their criteria, but again neither of those are really used in clinical practice.

Speaker 3

And we have spent quite a lot of time talking to a lot of KOL and including myself that we consider that just the thickness is not really that reliable. And in fact, that's something what we call intra retinal fluid means the fluid is actually inside the retina to retinal fluid, which is the fluid just underneath the retina, so not in the retina. And again, over the years that we learned that intra retinal fluid, the rest of the fluid inside the retina, they cause more damage and as one of us expected and also cause more visual loss. And so but sub retinal fluid in fact is actually not as much harm and some debate that even some sub retinal fluid is good for you. So what we have decided is that because now that we can really map out not just the thickness, but we can actually map out the intrasinal fluid and subresinal fluid.

Speaker 3

And the exact criteria we have not openly shared yet, but we can share is that if we have interectinal fluid returning that would be used to redosing the patient earlier. And both of retinal fluid, we will allow a little bit more. So but that is similar to, as I mentioned, Alejandro and Vabismol, they have vision criteria and they have so called DST increased criteria, but we're just doing it a little bit more scientific, a little more technical. So I think that is what we would plan to do and that's what we're referring to. And luckily, we now have AI tools that can do that.

Speaker 3

The second part about rescue rescue is again just like Alea High dose and Vibrasil, they were very, very rare that they have rescue. And in fact that we have agreed with the agency the criteria for rescue and that is different. That is something that the patient are losing vision and as well as an estimate is getting worse. And again, this is something that we have agreed the agency. That is very different and even different probably in some of our competitive trial.

Speaker 3

So obviously, as you said, a physician can always so called rescue a patient when they wanted to. We can't control that. And on the other hand, what we believe is similar to IV hydro and Rhoprisol. And in fact, if anything, our redosing criteria are tighter, in other words, easier. And so we believe that because of that, we will have no rescue, very similar to what is when I did high dose.

Speaker 3

And again, obviously, that is what we believe and we believe that that design are particularly useful is because that is being proven by other drugs already. And so by doing that and by eliminating rescue, we believe that we can also reduce our regulatory risk and improve our possibility of success.

Operator

Thank you. As we have no further questions in the queue at this time, I would like to hand the call back over to Mr. Lizeski for any closing remarks.

Speaker 2

I want to thank everyone for joining us on the call this afternoon. We greatly appreciate your continued interest in our company, ClearSide, and we look forward to updating you on our progress. Operator, you may now disconnect the call.

Operator

Thank you, sir. Ladies and gentlemen, this does conclude today's call. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation.

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Toronto-Dominion Bank Q4 2024
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