Q1 2024 Clearside Biomedical Inc Earnings Call
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Operator: Ladies and gentlemen, please remain on the line. Your conference call will begin momentarily. Once again, please remain on the line. Your conference call will begin shortly.
Ladies and gentlemen, please remain on the line to your conference call will begin momentarily.
Operator: Again, please remain on the line your conference call will begin shortly.
Operator: [music].
Remy Bernard: Greetings and welcome to the clear side biomedical first quarter 'twenty 'twenty four financial results and corporate update conference call. As a reminder, this conference call is being recorded I would now like to introduce your host Remy Bernarda clear sight Investor Relations. Please go ahead.
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Operator: Greetings and welcome to the Clearside Biomedical First Quarter 2024 Financial Results and Corporate Update Conference Call. As a reminder, this conference call is being recorded. I would now like to introduce your host, Remy Bernarda, Clearside Investor Relations. Please go ahead.
Remy Bernarda: 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 December 31, 2023, that was filed March 12, 2024, and our other SEC filings available on our website.
Remy Bernarda: 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.
Remy Bernarda: 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 today's call, we have George Lasezkay, our Chief Executive Officer, Dr. Victor Chong, our Chief Medical Officer, and Charlie Deignan, our Chief Financial Officer. After our formal remarks, we will open the call for questions. I would now like to turn the call over to George.
Speaker Change: Various remarks that we make during this call about the company's future expectations plans and prospects.
Remy Bernarda: Institute forward looking statements for purposes of the private Securities Litigation Reform Act of 1995.
Remy Bernarda: 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.
Remy Bernarda: Our annual report on Form 10-K for the year ended December 31, 2023 that was filed March 12, 2024, and our other SEC filings are available on our website.
Remy Bernarda: 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.
Remy Bernarda: We may elect to update these forward looking statements in the future.
George M. Lasezkay: Specifically disclaim any obligation to do so even if our views change on today's call. We have George Lewis SK, Our Chief Executive Officer, Dr. Victor Chung, our Chief Medical Officer, and Charlie <unk>, Our Chief Financial Officer after ours.
George M. Lasezkay: Formal remarks, we will open the call for questions.
George M. Lasezkay: I would now like to turn the call over to George.
George M. Lasezkay: Thank you, Remy, and good afternoon, everyone. As we near the midpoint of 2024, I'm excited with the progress we have made to date, which positions Clearside for an important year. Recently, we added two key positions to our team who are having an immediate and meaningful impact on our organization. In March, we welcomed Dr. Victor Chong as our chief medical officer. Victor is a well-respected board-certified retinal specialist with more than 25 years of experience advancing drug candidates through all stages of development, including the development of ranamizavab and aflibrizeb for wet AMD.
George M. Lasezkay: Thank you Rami and good afternoon, everyone as we near the midpoint of 2024 I'm excited with the progress we have made to date, which is position clear side for an important year Reese.
George M. Lasezkay: Most recently, Victor served as Global Head of Retina at Johnson & Johnson, and prior to that, he was Global Head of Medicine in Retinal Health at Boringer England. His extensive experience is extremely valuable as he spearheads our product development activities led by the upcoming Odyssey Data Analysis and the planning for our CLSAx Phase III program. Victor will be discussing these shortly.
George M. Lasezkay: Recently, we added two key positions to our team who are having an immediate and meaningful impact on our organization and.
George M. Lasezkay: In March we welcomed Dr. Victor Jong as our Chief Medical Officer, Victor is a well respected board certified retinal specialist with more than 25 years of experience advancing drug candidates through all stages of development, including the development of random Isabella and a flipper set for wet AMD.
George M. Lasezkay: Most recently Victor served as global head of Retina, Johnson, and Johnson and prior to that he was global head of medicine, and retinal health at Boehringer Ingelheim.
George M. Lasezkay: Victor has extensive experience is extremely valuable as he spearheaded our product development activities led by the upcoming Odyssey data analysis and the planning for our CLS Ax Phase III program.
George M. Lasezkay: Victor will be discussing these shortly.
George M. Lasezkay: Last month, we also added seasoned biotech executive Tony Gibney to our board of directors. Tony has a deep understanding of the biotechnology business and combined it with recent and relevant ophthalmology experience at Iveric Bio, where he was chief business and strategy officer. Tony has broad expertise in collaborations, finance, and M&A that will help guide our strategic and business development initiatives as we explore future value-creating opportunities at Clearside. These personnel additions are important as we continue to build on our leadership position in super coroidal delivery.
George M. Lasezkay: Last month, we also added seasoned biotech executive Tony give me to our board of directors Tony.
George M. Lasezkay: Tony has a deep understanding of the biotechnology business and combined with recent and relevant ophthalmology experience as I buried bio where he was chief business and strategy officer.
George M. Lasezkay: Tony has broad expertise and collaborations finance and M&A that will help guide our strategic and business development initiatives as we explore future value creating opportunities in clear sight.
George M. Lasezkay: These personnel additions are important as we continue to build on our leadership position in Supercoil delivery. Our SCS Microinjection technology has been used in thousands of injections in the clinic and continues to demonstrate a strong safety record that includes no cases of end up remind us to date.
George M. Lasezkay: Our SES micro injector technology has been used in thousands of injections in the clinic and continues to demonstrate a strong safety record that includes no cases of end ophthalmitis to date. As the pioneers in delivery to the supracarotid space, we are proud of the breadth and depth of our pipeline, which includes our internally developed assets as well as those from our collaborators in a broad range of retinal diseases. With that, I'd like to now introduce our new chief medical officer, Victor Chong, who will provide his perspective on joining Clearside and our programs.
Victor Chong: As the pioneers and delivery to the Super Choroidal space, we are proud of the breadth and depth of our pipeline that includes our internally developed assets as well as those from our collaborators and a broad range of retinal diseases.
Victor Chong: With that I'd like to now introduce our new Chief Medical Officer, Victor jaw, who will provide his perspectives on joining clear side and our programs Victor.
Victor Chong: Thank you, George, and good afternoon, everyone. Let me begin by saying it is a pleasure to speak with all of you today as a member of the PSI team. I have been on board for almost two months now, and I'm extremely excited by the prospect of our drug device technology, as well as our border pipeline. I wanted to share some of the reasons I chose to join Clearside from J&J.
Victor Chong: Thank you George and good.
Victor Chong: Afternoon, everyone. Let me begin by saying it is a pleasure to speak with all of you today as a member of the GSI team.
Victor Chong: I've been on board for almost two months now and I am extremely excited by the possibility dropped.
Victor Chong: Device technology as well as a boarder pipeline.
Victor Chong: Wanted to shed some of the reason I chose to join with Tsi from J&J.
Victor Chong: First, I believe the suprachoroidal platform is an important but undervalued approach to treat retinal disease. QSR is leading the way in suprachoroidal delivery by a very big margin, including having the only FDA-approved product for suprachoroidal use. With my background as a physician scientist, combined with almost ten years in large pharma, I look forward to leading our team as we approach our Odyssey data readout and begin planning our phase 3 program for CLSAA.
Victor Chong: I believe it's Super Corrado platform is an important but undervalued approach to treat retinal diseases.
Victor Chong: Keith is leading the way initiative, Colorado affiliates revise or a big margin, including having the only FDA approved products plus the right issues.
Victor Chong: With my background as a decision sciences combined with almost a decade in large pharma.
Victor Chong: Look forward to eating out team as we approach our oldest these data will be out and begin planning a phase III program for C. O S. A H.
Victor Chong: And finally, I can utilize my translational expertise in advising new molecules into the clinic. I see many opportunities to use our company's device and formulation platform to potentially expand our pipeline into areas such as geographic atrophy. Today, I want to focus on CLSA-X, the standard differentiators for the drug, and the Odyssey clinical trial. The current wet AMD market is driving more than $12 billion annually in sales.
Victor Chong: And finally I can utilize my translational expertise in advancing new more again to take let me I see many opportunities to see our company's device and formulation.
Victor Chong: Could potentially expand our pipeline in the area such as geographic atrophy.
Victor Chong: To date I wanted to focus on C. O S. A eight standard differentiator for the drug and the Odyssey clinical trial.
Victor Chong: In the wet AMD market is driving more than $12 million annually and Vera.
Victor Chong: While the existing approved therapies are effective, including fluorescent map and high-dose FibroSAM, they are delivered individually and only last up to four months in some patients. We believe CLS-AX may extend the time between doses for up to six months for most patients, which could meaningfully reduce the treatment burden for patients, caregivers, and payers. I find the ODYSSEY trial to be a compelling design that is differentiated from many of the other mixed phase wet AMD studies.
Victor Chong: While the existing approved therapies effective including tourism at an idle.
Victor Chong: They are deliver into virtually and only lost up to four months in some patients.
Victor Chong: We believe C O S. A H may extend the time between doses for up to six months, so most patients which could meaningfully reduce it shouldn't burden for patients caregivers and payers.
Victor Chong: I find the Odyssey trial to be a compelling design that is differentiated from many of the auto mix phase wet AMD study.
Victor Chong: First, the trial was designed to allow retreatment with our own drug candidate if needed prior to six months, which is similar to the anti-VEGF currently on the market. In addition, the protocol mandates participants in the CLS-AX arm to be re-dosed at month six, if not previously re-treated. William B is a chronic disease, and retrieval is essential.
Victor Chong: Third the trial was designed to allow re treatment with our own drug candidate if needed piety six months.
Victor Chong: Which is similar to the antibody.
Victor Chong: Currently on the market.
Victor Chong: In addition, the protocol mandates participant either C. A S E T.
Victor Chong: You read those at month six if not P was seem to be treated.
Victor Chong: What AMD is a chronic disease and retrieval and disease Enzo.
Victor Chong: This multi-dosing data will help inform our CLF-AX Phase III development program. Second, the trial duration of 36 weeks will allow us to follow patients beyond six months. This is close to the duration required for the primary endpoint by the FDA for phase 3 trials in wet AMD, and it allows us to translate our CLS-AX Phase IIb results to the design of phase III trials more easily. And finally... ODYSSEY is treating patients with confirmed active disease. So we will have a data set on patients who definitely need re-treatment.
Victor Chong: These multi dosing data will help inform our E L F a space fee development.
Victor Chong: Matt.
Victor Chong: Second the charter duration of 36 week allow us to follow patients beyond six months.
Victor Chong: This is close to the duration required for <unk> by the FDA for Phase III trial in wet AMD, you would allow us to translate our C. O S 88 day too deep resolve two phase III trial design more easily.
Victor Chong: And finally.
Victor Chong: To see is treating pain chamber consent at T. S. D. C is so we will have a data set on patients who are definitely need re treatment.
Victor Chong: I'm pleased to report that AUDACY is progressing as planned, and we expect to have top-line results at the end of the third quarter of this year. Our target profile for CLF-A8 is to maintain research acuity without the need for retreatment for potentially up to six months. We expect that the final Phase 2B data will provide important insights to create a robust Phase 3 development program for CLSAA. I am looking forward to this journey at TSI and will now turn the call over to our CFO, Charlie Dickens, to provide a financial update. Thank you, Victor.
Victor Chong: I'm pleased to report that Odyssey is progressing as planned and we expect to have top line results at the end of the third quarter of this year.
Charles A. Deignan: Tactical Fabulous SaaS is to maintain vishay acuity was delta needful recruitment, but potentially up to six months.
Charles A. Deignan: Sad that define the phase II b data will provide important insights to create a robust phase III Berlin program for C. O S a eggs.
Charles A. Deignan: I'm looking forward to this journey of Ksi Anvil now turn the call over to our CFO Chinese data to provide a financial update.
Charles A. Deignan: Thank you, Victor, and good afternoon, everyone. Our financial results for the first quarter of 2024 were published earlier in our press release, and they are available on our website. Therefore, I will just provide a summary of our financial status on today's call. As of March 31st, 2024, our cash and cash equivalents totaled approximately $35 million. We believe we have sufficient resources to fund our planned operations into the third quarter of 2025. This takes us through the anticipated data readout for the ODYSSEY trial this year and supports planning our CLSA Act Phase 3 program.
Charles A. Deignan: Thank you Victor and good afternoon, everyone. Our financial results for the first quarter 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.
Charles A. Deignan: As of March 31, 2024, our cash and cash equivalents totaled approximately $35 million. We believe we have sufficient resources to fund our planned operations into the third quarter of 2025.
Charles A. Deignan: This takes us through the anticipated data readout for the Odyssey trial this year and supports planning our CLSA ex phase III program.
Charles A. Deignan: We will be participating in the Citizens J&P Securities Life Sciences Conference next week, and we look forward to keeping you updated on our progress. I will now turn the call over to George for his closing remarks.
Charles A. Deignan: We will be participating in the citizens JMP Securities Life Sciences Conference next week, and we look forward to keeping you updated on our progress I will now turn the call over to George for his closing remarks.
George: Thank you Charlie.
George M. Lasezkay: We expect 2024 to be a transformative year for Clearside. We are committed to maintaining our leadership role in the supracaroidal space as we and our partners generate additional clinical data demonstrating the potential benefits of drug delivery with our SCS microinjection. We believe that the data readout from ODYSSEY later this year will demonstrate that CLSA-X could be a valuable addition to the treatment regimen in the multi-billion dollar wet AMD market. Our efforts in developing suprachoroidal drug delivery have the potential to change the treatment paradigm for serious retinal diseases and provide a lasting positive impact for patients, physicians, and our shareholders. I would now like to ask the operator to open the call up for questions.
George: We expect 2024 will be a transformative year for clear side.
George M. Lasezkay: We're committed to maintaining our leadership role in the Super Choroidal space as we and our partners generate additional clinical data demonstrating the potential benefits of drug delivery with our SCS microinjection.
George M. Lasezkay: We believe that the data readout from Odyssey later this year will demonstrate that C. L. S. A X could be a valuable addition to the treatment regimen in the multibillion dollar wet AMD market.
George M. Lasezkay: Our efforts in developing Supercoil drug delivery has the potential to change the treatment paradigm for serious retinal diseases and provide a lasting positive impact for patients physicians and our shareholders.
George M. Lasezkay: I would now like to ask the operator to open the call up for questions.
Operator: At this time, we will conduct the question and answer session. If you have a question at this time, please press star and then the number one on your telephone keypad, and you will be placed in the queue in the order received. Once again, to ask a question, please press star, then the number one on your telephone keypad now. Your first question comes from John Wolleben with JMP Securities. Your line is open.
Speaker Change: At this time, we will conduct a question and answer session.
Operator: If you have a question at this time. Please press Star then the number one on your telephone keypad and you will be placed in the queue in the order received once again to ask a question. Please press Star then the number one on your telephone keypad now.
Operator: Your first question comes from John Weldon with J M. P Securities. Your line is open.
Jonathan Patrick Wolleben: Hey, good afternoon, and thanks for taking the questions. Hey, John. Hey, George.
Jonathan Patrick Wolleben: Hey, good afternoon, and thanks for taking the questions.
George: Hi, John.
Jonathan Patrick Wolleben: I was hoping to just get a reminder of what constitutes active disease as the inclusion criteria prior to seeing how that differs from other mid-stage wet A&E trials.
Jonathan Patrick Wolleben: Hey, George I was hoping to just get a reminder, on what constitutes active disease as the inclusion criteria you're proud of seeing how fast.
Jonathan Patrick Wolleben: Problems.
Jonathan Patrick Wolleben: Other exchange, whether it'd be trial.
George M. Lasezkay: Okay, I think Victor, I think that's a great question for you. So why don't you, why don't you take that one?
Jonathan Patrick Wolleben: Okay, I think Victor I think that's a great question for you. So why don't you.
Victor Chong: Once you take that one.
Victor Chong: Yeah, John, how are you? On the protocol that we would require patients that still have subretinal fluid, or intrarectal fluid, or the fluid in antithrombosis. So that is what we would define as still having active disease because some patients would have been treated, and then they were already dry, and might not be further treated.
Victor Chong: Yeah, John how are you.
Victor Chong: Well on the protocol that we would require that patients that still had a retinal fluid correct. So correct all the fluid natural gas gauge. So that is what we would be fine.
Victor Chong: You remain active.
Victor Chong: Some patients would have been treated and then they've already dry and might not need further treatment.
Victor Chong: Okay. And can you talk a little bit about how you think about TLS-AX in comparison to the other TKIs in development? And then also, what is the, you know, we talk a lot about durability, but how do you feel about the data package you'll provide, and what is most important for investors to keep in mind as they're interpreting the readout in 3Q?
Victor Chong: Okay.
Speaker Change: And could you talk a little bit about how you think about scale.
Victor Chong: In.
Victor Chong: Parison together to CASM development, and then also what else.
Victor Chong: We talk a lot about durability, but how do you feel about the data package Youll provided what is most important for investors.
Victor Chong: Keep in mind as they are interpreting the readout in third Q.
Speaker Change: Yeah. So.
Victor Chong: When you think about comparing different companies, there are two TTIs in play; Existineb is the one that we have shared with Opera Therapeutic, and then iPorn has another TTI. And in terms of that, we believe that anti-badger is most important, and among the anti-badgers at the IC50, it's a little bit lower in Existineb. In terms of, I'm sorry, I missed the second question. Can you just quickly repeat that?
Victor Chong: When do you think comparing different company to Teekay I.
Victor Chong: Isn't that the walking dead.
Victor Chong: We have sharing with vault there P J.
Victor Chong: Happening out there.
Victor Chong: And in terms, so that we believe that iPad yet.
Victor Chong: Important.
Speaker Change: And I bet you do.
Victor Chong: T E.
Victor Chong: No.
Victor Chong: And there would be a much more potent.
Victor Chong: In terms of.
Victor Chong: Yeah.
Speaker Change: Sorry, I missed the second question can you just quickly.
Victor Chong: We talk about durability as a key thing to look at in these late-stage trials, but should we worry more about BCDA, burden of treatment? If you had to think about the endpoints you'd be giving us, what should we focus on? Yeah, so I think that, you know, that's a very good question.
Victor Chong: We talk about durability is a key thing to look at it. This way if these trials makes sure we've worried more about B C. J.
Victor Chong: Yeah burden of treatment.
Victor Chong: If you had to think about the endpoints you'll be given us what should we focus on.
Victor Chong: But I think that at the moment, we are still waiting for our phase two results. At the same time, that would help us to inform our phase three design. But I think that, as I mentioned in my webcast discussion earlier, at least we have data that shows the treatment works. So, every patient in Odyssey will be at least retreated once, even if they have been doing okay up until six months.
Speaker Change: Yeah. So I think that that's a very good question, but I think that at the moment.
Victor Chong: <unk> philosophy is to resolve at the same time that would help us form.
Victor Chong: <unk>.
Victor Chong: But I think that as I mentioned in my.
Victor Chong: In my work.
Victor Chong: Discussion earlier already at least that we have data that had the treatment of agitation.
Victor Chong: So, that recruitment data will get us to nine months and longer. And also, I'll try those for nine months. So, again, that's closer to the FDA requirement for the primary end point, which is, at the end of the day, most important. And I think that would be something that we were focusing on how we can measure the activity that will require that will meet the requirements of FDA as well as other agencies around the world.
Victor Chong: He will be able to get to be treated.
Victor Chong: Even if they had been doing okay up in Q six months, so that human data will get us to a nine month long there and also outside those are nine months. So again, that's closer to the FDA required by the time he had point.
Victor Chong: Alex indicate QE end of the day is most important.
Victor Chong: That would be something that we would focus in on how do we can measure that.
Victor Chong: We should see a key states will require that we will need to face.
Victor Chong: We'll meet those requirements.
Victor Chong: On the agency around the world.
Speaker Change: Okay. That's helpful. Thanks, Thanks again for taking the questions.
Victor Chong: Okay, that's helpful. Thanks, thanks again for taking the time to answer the question.
Speaker Change: Thank you Scott.
Operator: Once again, to ask a question at this time, please press star, then the number one on your telephone keypad. Your next question comes from Jay Abnum on Stiefel. Your line is open.
Victor Chong: Once again to ask a question at this time. Please press Star then the number one on your telephone keypad.
Jay Abnum: Your next question comes from Jay a moment with Stifel. Your line is open.
Jay Abnum: Hi, thanks. This is Jayat. I'm calling in for Annabel. I have two questions for you. First question, realizing that you're still in phase two trials with CLS-AX, have you given any further thought to the phase 3 design in light of some of your competitors funding superiority trials to signers of care?
Operator: Hi, Thanks, This is Diana I'm, calling in for Annabel.
Jay Abnum: Alright.
Jay Abnum: Sure.
Jay Abnum: First question.
Jay Abnum: The thing that you're still in phase III trials with CLS Ax.
Jay Abnum: You give it any further thought to the phase III design.
Jay Abnum: Some of your competitors funding superiority trial.
Jay Abnum: Sure.
Jay Abnum: Yeah.
George M. Lasezkay: Well, let me say first that what we're doing now while we're waiting for our face data to come in is we are undergoing internal planning for phase three, depending on how the data comes out. So we're already looking at that. We're discussing phase three trial designs with our consultants. And that's all under evaluation at this time. Victor, do you want to add anything to that?
Speaker Change: Well, let me say first that.
Victor Chong: What we're doing now while we're waiting for a face to be data that come in as we are undergoing.
Victor Chong: Internal planning for phase III, depending on how the data comes out so we're already looking at that we're discussing.
Victor Chong: Discussing phase III trial designs with us consultants.
Victor Chong: And that's.
George M. Lasezkay: That's all under evaluation as times, but Victor do you want to add anything to that.
Victor Chong: Yes, I think that, as I mentioned earlier, we are still working on it, and there are a number of options that we are considering. But at the end of the day, the key difference for us is that we can retreatment based on our own drugs. So that could be a major difference in the study design that some other TBI companies might not be able to do. So again, surrounding that is something that we can maximize our advantage at the same time providing future veterinary specialists in the future to use our drug more easily.
Victor Chong: Yeah, So I think that.
Victor Chong: As I mentioned earlier that we.
Victor Chong: Working on it.
Victor Chong: And the number of auction day.
Terry: Hey, Terry.
Victor Chong: End of the day that.
Victor Chong: The key for us to some work that we can be true but.
Victor Chong: Based on our own.
Victor Chong: So that could be a major is different and you need it but did you find that some of the tbi company might not be able to do so again surrounding that.
Victor Chong: We will see how we can maximize our advantage at the same time, providing future ratner retro pressure, especially in the future.
Victor Chong: You as Alan Graf and more easily.
Jay Abnum: Great, thank you for that. You had a second question? Yeah, I did. Thank you. The second question was, "In regards to the FDA, have they come any closer to establishing new clinical trial guidelines based on the shifting treatment paradigm, namely the Weisnell?
Speaker Change: Great. Thank you and I just wanted you had a second question.
Speaker Change: Thank you.
Speaker Change: Second question was.
Speaker Change: In regards to the SBA they come any closer to establishing a new clinical trial guidelines based on the shifting treatment paradigm lately, but.
Jay Abnum: No.
Jay Abnum: You mean, have they seen, have they started to finalize, come close to finalizing their draft guidance, their previous draft guidance that was like over a year ago for what AMD trials? Victor, you might be more up-to-date on where you think the FDA is based on our recent conversation.
Jay Abnum: You mean the seat as they started to finally come close to finalizing their draft guidance.
Jay Abnum: The previous draft guidance that looks like over a year ago for wet AMD is that what youre talking about.
Victor Chong: So you might be more up to date on where you think the F. D. A is based on our recent conversation.
Victor Chong: Yeah, I think that when guidelines are more than a year old and they are still not finalized, and obviously, the community has some potential concerns. But yes, that is not unusual for FDA to have a draft guideline for a long time as well. So, it's hard to predict, but that suggested that some of the points on the guidelines were inconsistent with practice. So, so again, that is something that I think everyone is discussing at multiple different conferences, on multiple different platforms.
Jay Abnum: Yeah.
Victor Chong: I think that when the guideline.
Victor Chong: More than yeah, Oh do not finalized.
Victor Chong: And the commitment you have some potential clients, there and but yet it's not unusual for a having a.
Victor Chong: Dropped out for a long time as well so.
Victor Chong: So it's hard to predict.
Victor Chong: That's what Jeff said that some of the.
Victor Chong: Corn on the guideline was inconsistent.
Victor Chong: Every practice.
Victor Chong: So again it sounds like there's something bad I think everyone.
Victor Chong: When you have multiple different content.
Victor Chong: But again, exactly when that's right, when it will become finalized or even or moving to interim. You feel difficult to be sure and, especially as you know, that there's a recent need to change as well, whether that might be late things as well.
Victor Chong: But again exactly when that guy that trough Brian.
Victor Chong:
Victor Chong: Finalize or even all hoping to interrupt you.
Victor Chong: You.
Victor Chong: Okay.
Speaker Change: To be sure.
Victor Chong: Actually you know that we need.
Victor Chong: We need to see change.
Victor Chong: Well that might be listening as well.
George M. Lasezkay: And obviously, as we go forward, before we announce any Phase 3 plans, we will have been engaged, at least once, if not multiple times, with the agency to discuss phase three trial design. So we'll get the most up-to-date information from the agency and our conversations with them as our planning continues.
Victor Chong: And obviously as we are as we go forward before we announce any phase III plans, we will evolve it.
George M. Lasezkay: Been engaged.
George M. Lasezkay: At least once if that multiple times with the agency to discuss phase III trial design. So we will get the most up to date reading from the agency and our conversations with them is they're planning continues.
Jay Abnum: Got it. Thank you. Thank you for your thoughtful answers.
Speaker Change: Got it thank you and thank you for your thoughtful answers.
Jay Abnum: Okay.
George M. Lasezkay: I would now like to turn the call back to George Lasezkay for any further remarks.
Jay Abnum: I would now like to turn the call back to George Lai is SK for any further remarks.
George M. Lasezkay: Well, I want to thank everybody for being on the call today. We look forward to keeping you apprised of our progress.
George M. Lasezkay: Well I want to thank everybody for being on the call today.
Operator: And with that, I would say that the operator can end the call. This concludes today's Clearside Biomedical first quarter 2024 financial results and corporate update call. Thank you for attending, and have a wonderful rest of your day.
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Music: We look forward to keeping you apprised of our progress and with that I would say that the the operator, you can and nickel.
Music: This concludes today's clear side biomedical first quarter 'twenty 'twenty four financial results and corporate update call. Thank you for attending and have a wonderful rest of your day.
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