Q4 2024 Clearside Biomedical Inc Earnings Call
Speaker Change: [music].
Greetings and welcome to the Coeur site biomedical fourth quarter 2024 financial results and corporate update call.
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A question and answer session will follow the formal presentation.
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I will now turn the conference over to your host.
Speaker Change: Andy Cohen of Investor Relations Ma'am the floor is yours.
Speaker Change: 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.
Speaker Change: 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 December 30 <unk>.
Speaker Change: 2024, and our other SEC filings available on our website.
Speaker Change: 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, 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.
Speaker Change: On today's call, we have George laid SK, our Chief Executive Officer, Dr. Victor Chung, our Chief Medical Officer, and head of research and development and Charlie Deignan, Our Chief Financial Officer. We also have accompanying slides that are available unclear sides website and the <unk>.
Speaker Change: Vince and presentations section after our formal remarks, we will open the call for your questions I would now like to turn the call over to George.
Speaker Change: Thank you Jenny and good afternoon, everyone.
George: Clear side is the proven leader in the delivery of drugs and drug candidates to the supercritical space.
George: Our SCS micro injector provides safe and reliable delivery with over 15000, Supercoil injections performed to date.
George: We continue to have increasing interest in my retinal specialist and leading pharmaceutical companies and applying our innovative delivery platform to treating serious retinal diseases.
George: We are pleased to announce that the positive results from our Odyssey phase to be wet AMD clinical trial led to a successful end of phase II meeting with the FDA regarding the planned phase III activities for CLS Ax.
George: Based on our interactions with the FDA, we are aligned on our pivotal phase III program that we believe is positioned for success and maximize the commercial potential for CLS ax in wet AMD Victor.
George: Victor will elaborate on these plans shortly.
Our commercial and development partners that made excellent progress over the last several months as they continued to validate the broad applicability of supercritical delivery in several indications.
George: Across our partners supercritical treatments being developed for delivery by our SCS micro injector and our proved into Asian territories under regulatory review in China and involved in two ongoing or planned phase III trials.
George: Our partner Arctic vision achieved several regulatory milestones in the Asia Pacific region, with our cadence or <unk> for the treatment of <unk> uveitis macular edema.
George: This year, they announced that a new drug application is currently under regulatory review in China and.
George: And that the product was approved in Australia and Singapore.
George: Importantly, Arctic vision also entered into a commercial collaboration with Santana pharmaceuticals for the marketing and distribution rights to Arcadis in China.
George: In addition, <unk> bile in collaboration with Abbvie.
George: Announced in January that our global Phase III clinical program in diabetic retinopathy for their gene therapy candidate <unk> 314, now referred to as <unk> is planned to start later this year using our SCS micro injector.
George: In addition, their phase II altitude Super Choroidal trial is currently enrolling a cohort of patients with center involved diabetic macular edema and their phase III Aviate supercritical trial is enrolling a cohort in wet AMD at dose level four.
George: Our oncology partner Aura Biosciences is enrolling its global Super Choroidal Phase III trial of Bell Saar for the first line treatment of patients with choroidal melanoma delivered using our SCS micro injector.
Ora has also initiated a phase II trial in metastasis to the court.
George: And finally, our partner Biocryst recently highlighted plans to initiate clinical testing in 2025 of Orlistat, It's plasma <unk> inhibitor using Supercoil administration for the potential treatment of Dnb.
George: With that I would now like to turn over the call to our Chief Medical Officer, and head of research and development, Dr. Victor jaw to up.
George: Outline the phase III plans for CLS Ax and other opportunities with our Super Choroidal pipeline Victor.
Victor Jaw: Thank you George and good afternoon, everyone.
Victor Jaw: As George described we are excited about the results of Odyssey that supports USAA is a phase III ready assets for the treatment of wet AMD.
Victor Jaw: Today, I would like to share stable aside outlining the phase III plans that we believe will position <unk>.
Victor Jaw: As a leading maintain and treatment for wet AMD if the results are positive.
Victor Jaw: To begin I will highlight two subgroup analysis from Odyssey that helped inform the current phase III trial design.
Victor Jaw: These data were presented at angiogenesis and macro society last months, which provided an opportunity for us.
Victor Jaw: <unk>, if you get the feedback.
Victor Jaw: The first analysis provided the basis for the target patient population and supports enrolling children naive patients in phase III trial.
Victor Jaw: On this graph, we show that the discipline solely we dose <unk> at week 24, meaning that they did not receive any additional interventional treatment before or after the second mandate <unk> dose at week 24.
Victor Jaw: As you can see the subsequent analysis show, even more stable B E V. A P. S. T. In these type of participants to week 36, and we believe that by targeting children naive patients in a phase III trial, there may be an even greater percentage of patients reaching six months will stay.
Victor Jaw: The need for any intervention.
Victor Jaw: On the next slide effected scrutinize the support the time to phase III design that excluded the discipline, we've known Dcs related changes in visual acuity higher did randomization.
Victor Jaw: This chart exclude the data at which the visit with a patient and vision has a change of 10 or more or less from that previous gets it but didn't.
Victor Jaw: <unk> has a corresponding change in CST of at least 25 microns. What it means is that the patient did not see as well that day or the IHI.
Victor Jaw: That was deliberate in OTT changes.
Victor Jaw: Please tell us the CVA changed on that day may not be <unk> related.
Victor Jaw: May just be that the patient did not perform the test well on that day.
Victor Jaw: In running this analysis, we again saw compelling BCA result.
Victor Jaw: In the phase III trial by excluding patients who have a tendency to change just prior to randomization, we may reduce <unk> and related to wet AMD activities.
Victor Jaw: Now I'd like to walk you through the phase III plans and trial design discussed and agreed with the FDA and our recent annual phase II meeting.
Victor Jaw: The plan, we presented to the SBA is for two pivotal non inferiority trial.
Victor Jaw: Trial designed is similar to the most recent phase III trial in wet AMD that lead to the approval of IV, a high dose and low bit mode.
Victor Jaw: Designed to apply the re dosing criteria generally utilizing real world clinical practice will move features the ability to effectively dose <unk> and we believe the ability to re dose with CLSA exclusive rescuing patients who have anti VEGF product.
Victor Jaw: The important differentiator compared to other TPI programs currently in development.
Victor Jaw: Slide nine shows the current planned phase III program.
Victor Jaw: Signed it to potentially reduce directly to risks and maximize the commercial opportunity for <unk> in wet AMD.
Victor Jaw: I will walk through the key design aspect.
Victor Jaw: As I mentioned it previously.
Victor Jaw: Plan is to enroll treatment naive patients, which we believe can potentially expand the commercial valued or CNS AA with a broader patient population.
Victor Jaw: From a statistical perspective, we know it is important to reduce variability in <unk> study.
Victor Jaw: The plan is optimized our study population we need.
Victor Jaw: No. The <unk> study patients with poor vision and of thicker Retinas had high availability in the outcome. Therefore.
Victor Jaw: Therefore at screening participants will be required to have a D. C V. A reading between 2018 to 20 over 32.
Victor Jaw: In addition, <unk>.
Victor Jaw: As to your reading on the OCD must be elected <unk> Mitra.
Victor Jaw: This component designed to minimize enrolling enrollment of highly variable patients to potentially increase the probability of success of the trial.
Victor Jaw: Between the third and the fourth injection of <unk>, we do not normally see a change of vision or and that to me.
Victor Jaw: Therefore, the plan is to exclude participants who had more than a 10 lots of change or CST increase of more than 100 micron from their previous visit.
Victor Jaw: This criteria was strongly recommended by Kols on our scientific Advisory Board and are designed to increase the pool of data. This is SaaS by further reducing the ability.
Victor Jaw: On day, one the disciplines. We will then be ready Tonight, 1212, Crs H, one milligram <unk> two milligram.
Victor Jaw: But disciplined in a 3%.
Victor Jaw: Who received treatment every eight weeks the standard dosing label up to the time the endpoint at week 52.
Victor Jaw: <unk> at week, 12, 16, and 20 participants will undergo assessments of D. C that <unk> determined that person I'd shipment integral op GTI.
Victor Jaw: Based on that P. D. I put this systems will be assigned to a treatment regimen of every 12 16 or 20 weeks.
Victor Jaw: One is to employ in also if OCC biomarker that will be determined using an AI tool to improve consistency in assessing the need for re dosing.
Victor Jaw: For those patients who did not meet the criteria at week 20, they will be assigned to a treatment regimen of every 24 weeks.
Victor Jaw: Once a dosing interval is established for each discipline during the peak period.
Victor Jaw: Discipline will stay at that interval until the primary endpoint at week 52.
Victor Jaw: This is the fixed dosing period.
Victor Jaw: For example, even if the citizens Matt <unk> at week 16, they will be given C. O S. H every 16 weeks in the fixed dosing period.
Victor Jaw: As at the primary end point is reached the trial will continue for another year as a safety follow up period people would use the data required by the SBA for a new drug application.
Speaker Change: M. A C S. A exxon the fixed dosing interval Lou Ann.
Speaker Change: But discipline good Dan continue and be treated with variable dosing. According to anatomical signed based on the PPI criteria.
Speaker Change: If you put that on pace.
Speaker Change: Patients will cross over to receive <unk> every 16 weeks, which will provide additional safety and efficacy data in an anti VEGF treatment experienced patient population. It will also provide experience in moving patients from makers that to see how SaaS as a maintenance therapy.
Speaker Change: Wet AMD is a chronic disease, requiring numerous injection to maintain vision and stabilize the disease.
Speaker Change: We are targeting C H.
Speaker Change: They maintained and treatment, which can put a majority of the wet AMD driven market, we know from clinical experience that patient required differing frequency of treatment to achieve stable vision.
Speaker Change: The only T T I in development with multi dosing data from our phase III <unk> trial, and only TPI in development with the ability to re dose before six months.
Speaker Change: Therefore, we expect minimal to no anti VEGF rescue in phase III.
Speaker Change: Which could reduce our regulatory risk and prove to be a clear and important differentiator.
Speaker Change: Oh, Yes, we believe this important feature of the phase III trial to support a strong well.
Speaker Change: Regulatory and commercial strategy for the success of <unk>.
On slide 17, we have lay out the competitive landscape related to dosing flexibility in the wet AMD market.
Speaker Change: The initially approved the anti Rev. Just dropped to treat wet AMD will well, but have lowered your ability and less flexibility in dosing regimen.
Speaker Change: The next generation have moderate durability, and a more flexible dosing regimen.
Speaker Change: We have heard from numerous physician that the dosing flexibility of one to four months, what's important to them.
Speaker Change: In contrast, the protocol for other TK I currently in development only allows with dosing at 24 weeks in the pool.
Speaker Change: And the discipline, we will need to be rescue if they cannot go that long.
We've durability up to six months and flexible dosing regimen, we believe <unk> will have a potential versus tile.
Speaker Change: And commercially appealing label and would be well positioned to compete in the wet AMD market, which represents over $12 billion in and new sales.
Charlie: Before I turn the call to Charlie I wanted to take a minute to review our pipeline opportunities.
Charlie: We continue to be excited about the broad potential for Super Colorado delivery with our SCS micro injector.
Charlie: Internally I see a great potential opportunity beyond wet AMD, we're delivering all the small molecules, we are super Colorado space committed a tremendous impact in the treatment of retinal disease.
Charlie: Our research team is currently evaluating two approach with certain specific small molecule <unk> in vivo models for the potential shippers, Colorado treatment of geographic atrophy.
Charlie: Our team is doing the necessary work.
Charlie: Potentially advancing one or both of these candidates toward an investigational new.
Charlie: New drug application.
Charlie: In G&A, we are currently evaluating two matters or action that could potentially be used as an add on to complement based therapy <unk>.
Charlie: A ministry shipper, Colorado. This small molecule suspension can treat both sides of the Brooks membrane, including the retina RP in the core right.
Charlie: And we should book Corrado administration of the agents, we expected to achieve a higher concentration of drug in the Colorado.
Charlie: As a result, we believe this molecule it will improve Colorado perfusion to improve breath, a little function directly and slow progression.
Charlie: And mortgage rates April inflammatory cell kill.
Charlie: <unk> reduced the root cause of complement activation.
David: With that I will turn the call over to our CFO Chinese David to provide a financial update.
David Chinese: 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.
David Chinese: Before I will just provide a summary of our financial status on today's call.
David Chinese: As of December 31, 2024, our cash and cash equivalents totaled approximately $20 million. We believe we have sufficient resources to fund our planned operations into the fourth quarter of 2025.
David Chinese: We are actively pursuing options to fund the CLS Ax phase III program, including potentially partnering with one or more third parties.
David Chinese: We look forward to participating in the Needham Virtual health care Conference and the Jones trading conference next month.
David Chinese: I will now turn the call back to George for his closing remarks.
George: Thank you Charlie.
Speaker Change: We remain focused on our small molecule Super Choroidal pipeline led by CLSA X for the treatment of wet AMD, we have seen increasing interest among retinal specialist and leading pharmaceutical companies and applying the supercritical delivery approach to treat serious retinal diseases.
Speaker Change: Our broad formulation development and regulatory expertise and the delivery of agents to the Super Coital space makes us well positioned in the overall treatment landscape for retinal diseases.
Speaker Change: We are grateful for the hard work and dedication of our clear side team and the ongoing support from our stakeholders as we continue to advance our supercritical delivery pipeline.
Speaker Change: I would now like to ask the operator to open the call up for questions.
Speaker Change: Thank you.
Speaker Change: At this time, we will be conducting our question and answer session.
Speaker Change: If you'd like to ask a question. Please press star one on your telephone keypad.
Speaker Change: A confirmation tone will indicate your line is in the question queue.
Speaker Change: And you May press Star two if you would like to remove your question from the queue.
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Speaker Change: One moment, please while we poll for questions.
Speaker Change: Thank you.
Speaker Change: Our first question is coming from John Wall oven with citizens. Your line is live.
Speaker Change: Hey, good afternoon, and thanks for taking the questions.
Speaker Change: I'm wondering if.
Speaker Change: Right.
Speaker Change: The subpopulation in 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 there.
Speaker Change: Two.
Speaker Change: Okay.
Speaker Change: Victor there Joe Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes, okay.
Speaker Change: Yes.
Speaker Change: Yeah. So.
Speaker Change: Can you so I think that.
Speaker Change: Some in our plan.
Speaker Change: Condensates free.
Speaker Change: We try to exclude patients with higher greatly.
Speaker Change: I think that one two things about that space tool with delivering selecting the patients who offer to talk with a tree.
Speaker Change: And we do need to move into a more general population reward half back the results.
Speaker Change: And one of the sub group analysis. The first one that we mentioned, but those who actually it doesn't need any extra.
Speaker Change: Treatment and so one of the concern was that could be under treated.
Speaker Change: In fact, they were not they were actually doing extremely well. So we believe that when we move to the general population.
Speaker Change: Sackman the only every six month injection will be actually a higher a little bit if that's what you're referring to.
Speaker Change: The second sub grandma's it changed the corporation slightly in a different way.
Speaker Change: It's sort of helpful. I'm wondering.
Speaker Change: Difficult question to answer, but maybe moving on to two other ones. How long do you think a good place to enroll.
Speaker Change: How long do you think it would take to enroll the treatment naive population.
Speaker Change: And then last one for me did the FDA say you need a certain number of patients in each of these.
Speaker Change: Treatment intervals.
Speaker Change: Sufficient size.
Speaker Change: Michelle efficacy safety.
Speaker Change: Or will you or.
Speaker Change: Will it be.
Speaker Change: Purely on the individual assessment of the response.
Speaker Change: Well.
Speaker Change: Yes, I think the first question.
Speaker Change: How long do we expect that to enroll and used related to tango trial will be around 12 months or slightly under 12 months and indeed that we see.
Speaker Change: The reason trial.
Speaker Change: All the phase III are doing pretty well, so we would expecting bag will be.
Speaker Change: <unk> on the 12 months.
Speaker Change: In terms of the agency that they think its the type of and the US is very very similar to what the tool recent approval with IV high bills.
Speaker Change: Tourism that.
Speaker Change: So we do not expect that they would be separating it.
Speaker Change: The adverse event rate in disciplined.
Speaker Change: Group on different frequency and he's really good.
Speaker Change: As the overall and then just a similar expectation that we are using the drug.
Speaker Change: When we get to market.
Speaker Change: Would be different in Google.
Speaker Change: So I would not expect.
Speaker Change: I think the agency was quite clear.
Speaker Change: So that's one.
Speaker Change: So the whole.
Speaker Change: I'll work event assessment will be most of the data and I think that's very similar Marta.
Speaker Change: Modality that they use a variety of high growth of a bespoke.
Speaker Change: Okay got it all right thanks for taking the questions.
Speaker Change: Thank you.
Serge Belanger: Our next question is coming from Serge Belanger with Needham Your line is live.
Speaker Change: Hi, good afternoon.
Speaker Change: My first question now that the phase III trial plan has been finalized.
Speaker Change: Can you give us an estimate.
Speaker Change: The overall cost of such a program.
Speaker Change: And and.
Speaker Change: And I guess is it feasible you know we're talking about 900 patients total here.
Speaker Change: Or for clarified too to run such a large program. Thanks.
Andre: Hello Andre.
Speaker Change: Second part.
Speaker Change: Hum.
Speaker Change: Charlie to answer the first part and yes, we would using a cocoa Seattle.
Speaker Change: So we believe that it's something that we would be able to manage.
Speaker Change: Although it's a relatively large trial, but at the same time that.
Speaker Change: Wet AMD trial is relatively straightforward.
Speaker Change: From the both the end point.
Speaker Change: Vaccination needs it and I'll, let Kelly.
Speaker Change: Palo Verde costs.
Speaker Change: Yeah sure.
Speaker Change: So just to remind you.
Speaker Change: <unk>.
Speaker Change: We ran two phase III concurrent RVO studies.
Speaker Change: Years ago so.
Speaker Change: We know how to run the phase III trials here.
Speaker Change: In terms of costs, we're not giving specifics.
Speaker Change: On the cost.
Speaker Change: Some of the other phase III as I think I've seen they're around $55 $60 million for Ya study.
Speaker Change: Yes.
Speaker Change: We haven't given out a estimate for prime members.
Speaker Change: Trials.
Speaker Change: Okay. Thanks, and then I guess one for Victor.
Speaker Change: Just curious.
Speaker Change: As you set up the design of the phase III and whether you considered.
Speaker Change: Emulating whenever a potential competitor in running a superiority trial.
Speaker Change: And why.
Speaker Change: What were the pros and cons and why you decided to.
Speaker Change: Go forward with two non inferiority studies.
Speaker Change: So the two non inferiority study it was true in politics.
Speaker Change: The agency.
Speaker Change: Have reflected that multiple times.
Speaker Change: And this is a lot more risky he got tools how is not the same.
Speaker Change: And I can't comment on our competitors why they decided to do something differently.
Speaker Change: Yeah.
Speaker Change: That makes sense.
Speaker Change: But I think from our point of view and also the outlook.
Speaker Change: Interaction with the agency.
Speaker Change: Two non inferiority trial.
Speaker Change: Is proven and tested in virtually if not every single.
Speaker Change: Retinal drug was the pools.
Speaker Change: Based on the two non inferiority trial other than obviously the first one lucentis was a superiority trial.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Our next question is coming from Devin Jonna Chatterji with Jones trading your line is live.
Speaker Change: Hi, Thanks for taking my question I was wondering if you could provide any additional color on the.
Speaker Change: Financing strategy for the fees and do what they think and how should we think about the timeline of the steadiness Asia and I know you were planning.
Speaker Change: In addition in the second half is that still in the plan.
George: Well George I.
Speaker Change: Im going to take us.
Speaker Change: Go ahead, Charlie that's one.
Speaker Change: Yeah. So we're we're still.
Speaker Change: In terms of study, where we're gearing up.
Speaker Change: To continue to 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.
Speaker Change:
Speaker Change: As we said were pursuing our options.
Speaker Change: To get the study clothing, including potentially partnering with one or more third parties. So that's about all the information I gave you at this point and as soon as we have.
Speaker Change: Some clarity, we'll let everybody know.
Speaker Change: That's all we can say right now.
Speaker Change: Thanks for that I have a quick follow up so if I may.
Speaker Change: I think correctly this Sean in the study is it being administered monthly and I was just curious as to the design of why that's why we don't choose that instead of like every two weeks is that to kind of market without P. T I D.
Speaker Change:
Speaker Change: So the way that we wanted to do this study is in every single visit.
Speaker Change: The patients will be taken.
Speaker Change: A assessment and then after that assessment procedure.
Speaker Change: That would be how that we agreed with the agency.
Speaker Change: Mass gaming.
That's the study so that the patient would not know which there would be.
Speaker Change: So from a patient perspective, they will have that assessment and then they would then have a procedure and the procedure could be a simple, colorado injection could be a sham and could be a good perfect injection and again, depending on the P. T I that 19 area.
Speaker Change: Or if they have met the rescue criteria. So throughout the study back there will be a patient that had except for <unk> injection, sometimes it could be just in the beginning.
Speaker Change: Only just in the beginning of the XR and then.
Speaker Change: The patients.
Speaker Change: <unk> would halfway injection in the group is that so we have discussed that in detail with the agency and the agency that would be.
Adequate masking offline in the way that some other.
Speaker Change: Probably the area.
Speaker Change: So that is how do we think that was the right thing to do I'm not sure about the two weeks that you mentioned.
Speaker Change: This is going to be some error free months actually visit and other than somebody says that.
Speaker Change: That would be no procedure needed.
Speaker Change: Okay. Thank you so much.
Speaker Change: Thank you.
Speaker Change: Our next question is coming from E. Chen.
Speaker Change: H C. Wainwright your line is live.
E. Chen: Thank you for taking my questions My first questions.
Speaker Change: What are the potential.
Speaker Change: Factors that could contribute to UCB changeover 10 later.
Speaker Change: Yes.
Speaker Change: Yeah, So what we have known it.
Speaker Change: In the clinic in fact that a lot of conviction don't even believe that vision.
Speaker Change: In the clinic, because it's just that at such a high variability even slightly more reliable and in fact that the agency also always probably 15 like that is the only 15 latter is real.
Speaker Change: So I think that understanding that you know a lot of our patient uptake the elderly and then you could have in the back Bay.
Speaker Change: That they couldnt really be better at that day or the tax they just couldn't deal with it and that's just something that we know in routine clinical practice in a clinical trial that some of these data points affecting our data.
Speaker Change: So what we have done in the supply of nurses that I show is that.
Speaker Change: The OTT and lastly, we have not changed at all and normally that you know the new lifting cost was the OTT will get what I'll call widespread.
Speaker Change: And if I may call. It just a kind of a way to think that way you have not you got 25, micron chains, which is a very small change.
Speaker Change: And then your vision may not be reliable and so we can see that this was the pool Hall analysis. So we took that out but it's just that's not the whole patient obviously that will take a lot of a decline, but just that one data point and then as you can see on the on the chart that make it even better.
Speaker Change: All I would say it's already good anyway.
Speaker Change: Looking even better.
Speaker Change: Training for some time that some patients just don't do it while it could be a problem.
Speaker Change: So translating to athletes redesign albertsons or we can do this in the real study.
Speaker Change: Because it is a poll analysis.
Speaker Change: <unk>.
Speaker Change: And what we decided that you know as I mentioned in the coal between the third and the calls injection and again, we have a lot of historic data that during those those two victory position doesn't change normally so again.
Speaker Change: It changed that means that that patient is unreliable patient and so we believe that by removing those patient be full randomization will help us to reducing the variability.
Speaker Change: Okay.
Speaker Change: By implementing these criteria before randomization.
Speaker Change: I expect to have any negative impact on enrollment speed or.
Speaker Change: Future market adoption.
Speaker Change: The suezmax eventually reaches the market.
Speaker Change: Yeah. So I didn't think that you would.
Speaker Change: Affecting the label in a meaningful way and again, obviously that is something that we can really discussing detail now we have seen that in other accruals that Pablo.
Speaker Change: They have particular inclusion exclusion criteria, but Dan the label.
Speaker Change: Sam as wet AMD.
Speaker Change: On the Alaska AMD, we discuss with the agency and agency didn't really.
Speaker Change: Any concern on the way.
Speaker Change: We wanted to do the study.
Speaker Change: And in fact that you know I think that reducing variability truly show with a drop welcome not you know scientifically.
Speaker Change: Scientifically justified so so I think from the from that point of view the label discussion yet too early to talk about it but we believe from past experience that should not be a key problem.
Speaker Change: In terms of you.
Speaker Change: You know the recruitment and other thing we actually did some analysis on the data set that I have access to market and time.
Speaker Change: The number of patients that get rejected.
Speaker Change: Between the third and the fault injection.
Speaker Change: Should be less than 10%.
Speaker Change: So you won't be a major impact, but we believe that 10% can create a lot of variability and so by removing that will give us a better and more consistent results and again the agency agreed to that.
Speaker Change: Okay. Thank you very much.
Speaker Change: Thank you.
Speaker Change: Our next question is coming from Andreas <unk> with Oppenheimer. Your line is life.
Speaker Change: Hi, Thanks for taking our questions. This is <unk> on for Andrea.
Speaker Change: Can you talk about the powering assumption.
Speaker Change: <unk> Ah trial and all.
Speaker Change: So if you would share do you have any insights on how payers think about like a rain birth meant for a potential three to six months flexible dosing label for CLS Ax.
Speaker Change: Compared to competitors. Thank you.
Speaker Change: So I go to the second question first you might be ahead of all your question, but I think the first question Republic quite technical.
Speaker Change: The second part is like we have do some.
Speaker Change: Payer research and that pay us at the payer research that support.
Speaker Change: No.
Speaker Change: And then how do we can potentially.
Speaker Change: For the commercial value to it.
Speaker Change: They can get a simplistic way to think about it is that it.
Speaker Change: Some of our competitors would.
Speaker Change: Would do something different to us actually on the other hand, it from our point of view he had the effect of both dosing. So we believe that we will quite likely to Bordeaux from the flexible dosing drugs, such as IV a high dose arm of this MAU and then.
Speaker Change: One way to think about it if that could cause.
Speaker Change: You have a small molecule.
Speaker Change: The devices make by our own.
Speaker Change: Our own device and so our cost of goods will be fairly low and so yeah.
Speaker Change: It will be actually Lola.
Speaker Change: And then the biologic so again that we can be potentially pricing competitively. So I think that is something that will sort of down the road, but we have EXPAREL on the payer research at what will be the best way to get into the market.
Speaker Change: And then the third question I would reaffirm that phase III kind of sums.
Speaker Change: Samsung that we took some of the assumption that very similar tobacco smoke.
Speaker Change: Tanking to potentially around 14 Leicester.
Speaker Change: And we believe that our equity of a little bit lower however that we were.
We're looking at effective molecular baseball type of.
Speaker Change: <unk> number.
Speaker Change: And we use the foreign Hottelet margin as suggested by the agency and then detecting the Nike brand X.
Speaker Change: You would expect on the phase III study.
Speaker Change: Thank you.
Speaker Change: Thank you. Our next question is coming from Daniel Guardiola with Shanghai. Your line is live.
Speaker Change: Hey, guys. Thank you for taking my question.
Speaker Change: Victor I have one for you.
Speaker Change: Can you just can you. Please elaborate on re dosing criteria, which as I understand it relies on OCC Biomarkers and how these interplay with the rest of your criteria.
Speaker Change: The severity of loss on the fluid gain.
Speaker Change: And also where the physician's discretion come in and re dosing decision because I think theres always some.
Speaker Change: Liability et cetera. Thank you.
Speaker Change: Yeah. Thank you for that question and allow me to spend time to explain that so to say.
Speaker Change: Re dosing and rescue is two different things in our position.
Speaker Change: So re dosing is similar to what we have seen with Eylea high those and.
Speaker Change: Baseball they have a sudden the criteria and the two company has different criteria and I'm not going to go into detail there criteria, but again neither of those are really used in clinical practice.
Speaker Change: And we have spent quite a lot of time talking to a lot of kols and including myself that we consider that just the thickness is not really back reliable and in fact, that's something what we call intra retinal fluid means that fluid inside the retina to sub retinal fluid which either.
Speaker Change: The fluids.
Speaker Change: Underneath the retina, but not in the retina.
Speaker Change: And again over the year to reload.
Speaker Change: They're eating a retinal fluid the rest of Florida because of insider retina, they cause more damage and at one level expected and also Cosmo visual loss.
Speaker Change: And so but sub retinal for it in fact, it's actually not as much harm and debate, even some sub retinal hopefully good for you. So so what we have decided is that because now we can really map out not just a singular and but we got to map out the inter retinal fluid as the rest.
Speaker Change: Alright, and then exactly he really had not openly share yet, but we can share is that.
Speaker Change: We have interest in those poorly returning.
Speaker Change: But it would.
Speaker Change: The use to re dosing the patients earlier and both the retinal for it we will allow a little bit more so but that is similar to as I mentioned earlier hydro them a bit mode. They have recent criteria and they have so called the FTE increased criteria.
Speaker Change: But we're just doing it a little bit more time can you take 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 that we now have AI tools.
Speaker Change: Can you give us that.
Speaker Change: The second part about rescue at the parent just like Eylea Heico's number please.
Speaker Change: Very rare that they have rescue and in fact that.
Speaker Change: We have agreed with the agency the criteria for rescue and different days something that you know the patient not lose English and and <unk> and ex Wow inactivate getting worse and again. This is something that we have agreed with the agency.
Speaker Change: Different and even different publicly.
Speaker Change: Some of our competitors trial.
Speaker Change: So obviously at ease that a physician can always so called rescue of patients.
When they wanted to.
Speaker Change: We can we can control that and on the other hand, there. What we believe is a seamless eylea hydro batesville and in fact, if anything I'll read those thing criteria.
Speaker Change: Title in other words, yes.
So we believe that you know.
Speaker Change: Because of that we will have no rescue very similar to what they spent all the high dose and again, obviously that is what we believe and we believe that.
Speaker Change: That design.
Speaker Change: Particularly useful is because that would be cool thing by other drop already.
Speaker Change: And so if I do.
Speaker Change: During that and by eliminating rescue we believed that we can also reduce our regulatory risk and improve our pasta predict success.
Speaker Change: Thank you.
S. K.: As we have no further questions in the queue at this time I would like to hand, the call back over to Mr. S. K for any closing remarks.
S. K.: I want to thank everyone for joining us on the call. This afternoon. We greatly appreciate your continued interest in our company clear side and we look forward to updating you on our progress operator, you may now disconnect the call.
Speaker Change: Thank you, Sir ladies and gentlemen, this does conclude today's call you may disconnect your lines at this time.
S. K.: And have a wonderful day, we thank you for your participation.