Q3 2024 Clearside Biomedical Inc Earnings Call
Thank you for watching!
Ladies and gentlemen, thank you for your patience.
This call will begin shortly. Once again, thank you for your patience and this call will begin shortly.
Speaker Change: Greetings and welcome to the CareSite Biomedical third quarter 2024 financial results and corporate update call.
Speaker Change: At this time, all participants are on a listen-only mode, and a question and answer session will follow the formal presentation.
Speaker Change: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.
Please note, this conference is being recorded.
Speaker Change: I will now turn the conference over to your host, Jenny Kobin, Investor Relations.
Mom, you may begin.
Thank you for watching!
Speaker Change: Good afternoon, everyone, and thank you for joining us on the call today.
Speaker Change: Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements.
Speaker Change: 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.
Speaker Change: In the risk factors section of our annual report on Form 10-K for the year ended December 31, 2023, that was filed on March
Speaker Change: 12, 2024, and our quarterly report on Form 10-Q for the quarter ended September 30, 2024, filed today, 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.
Speaker Change: 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.
Speaker 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 your questions. I would now like to turn the call over to George.
Thank you for watching!
George Lasezkay: Thank you, Jenny, and good afternoon, everyone. We continue to make outstanding progress advancing our differentiated supercorroidal delivery pipeline.
George Lasezkay: Last month, we reported the positive results from our ODYSSEY Phase IIb clinical trial in patients with wet AMD.
George Lasezkay: These data strongly support the potential efficacy, safety, and versatility of CLSAx to treat this chronic disease.
George Lasezkay: We believe CLSAx is now positioned for real-world success in the wet AMD market with its potential to provide physicians with an extended duration maintenance therapy combined with the option for flexible redosing.
George Lasezkay: These features may improve outcomes and reduce the treatment burden for patients and their caregivers. Importantly, ODYSSEY also demonstrated a positive safety profile with the ability to re-dose with our own drug as part of a maintenance treatment regimen.
George Lasezkay: We are the only TKI wet AMD program with repeat dosing data, giving us a competitive advantage as we advance CLSAx into Phase III.
Thank you for watching!
George Lasezkay: In addition to our WET-AMD program, our research team is currently evaluating certain specific small molecules through in vivo models for the potential treatment of geographic atrophy, a market size valued at over $20 billion in sales. Victor will expand on this opportunity in his remarks.
George Lasezkay: We are also working to expand the overall value of our supercorroidal platform. ClearSight is the proven leader in delivery of drugs to the supercorroidal space.
George Lasezkay: Our SCS microinjector continues to provide safe and reliable delivery with well over 10,000 injections performed to date.
George Lasezkay: We have successfully navigated the drug device regulatory pathway to obtain commercial approval for Xypyr, the first and only FDA-approved product for supracaroidal administration. And a permanent CPT code has been granted for supracaroidal injections as a result of Xypyr's U.S. approval.
George Lasezkay: A tremendous amount of work is also happening behind the scenes. We have solidified our formulation expertise in developing suspensions that can be delivered into the supracaroidal space and we have commercial scale microinjector manufacturing capability that includes ISO certification.
This industry-leading know-how continues to be recognized.
George Lasezkay: We are seeing significant interest among the retinal specialist community and from leading biopharmaceutical companies in applying our innovative approach to treating serious retinal diseases.
George Lasezkay: The last several months have seen continued advancement by our collaboration partners.
George Lasezkay: In the Asia-Pacific region, our partner, Arctic Vision, has made excellent progress advancing the development of Xipir, including regulatory reviews in Australia and Singapore, and a pending regulatory submission in China.
George Lasezkay: We were delighted by the announcement last week of the commercial collaboration between Arctic Vision and Santan Pharmaceuticals, a highly respected global ophthalmic company.
George Lasezkay: This collaboration leverages the capabilities of SANTAN to bring this potential important treatment to patients with uveotic macular edema in China.
George Lasezkay: Importantly, this partnership is tremendously gratifying as it provides additional strategic validation of our supercoroidal delivery platform by another global pharmaceutical company.
Speaker Change: Regenexx Bio has partnered with AbbVie to utilize our SCS microinjector to deliver their gene therapy ABBB-RGX314 for the treatment of wet AMD, diabetic retinopathy, and diabetic macular edema.
Speaker Change: Last week, they reported on their programs administering 314 via our SES microinjector.
Speaker Change: Based on the positive interim results from Phase 2 altitude trial in diabetic retinopathy, AbbVie and Regenexx have accelerated a planned end-of-Phase 2 meeting with the FDA that they now expect to have this quarter.
Speaker Change: Regenexx Bio expects to initiate the first global pivotal trial in diabetic retinopathy in the first half of 2025. In addition, Altitude is enrolling a new cohort of patients with center-involved diabetic macular edema.
Speaker Change: And finally, in WET-AMD, the Phase II AVA trial is enrolling a new cohort based on a favorable safety profile and to evaluate dose levels for a planned pivotal program.
Speaker Change: At the Retina Society annual meeting in September, our ocular oncology partner, Ora Biosciences, presented positive phase 2 end-of-study results evaluating Belsar for the first-line treatment of early-stage choroidal melanoma.
Speaker Change: Laura continues to enroll their Global Phase III trial in Coroidal Melanoma.
Speaker Change: We have been working closely with our partner Biocryst Pharmaceuticals on the formulation of their plasma calocrine inhibitor aborlistat.
Speaker Change: In 2025, Biochrist plans to advance aborlistat into a clinical trial of patients with diabetic macular edema.
Speaker Change: Biochrist believes that a vorlistat delivered to the supracaroidal space as a depot formulation utilizing our SCS microinjector can potentially provide high drug levels to the retinal vessels with long-lasting exposure.
Speaker Change: With that, I would now like to hand the call over to our Chief Medical Officer, Dr. Victor Chong, to provide additional perspectives on our ODYSSEY results, the current plans for our phase three program, and exciting new opportunity to expand our supracarotidal pipeline. Victor.
Speaker Change: Thank you George and good afternoon everyone. We are extremely pleased with the ODYSSEY trial results which we reported last month, which exceeded our expectations for the data needed to advance CRS-AX into phase 3 development.
Speaker Change: There were three key objectives we were looking for from the ODYSSEY trial.
First, safety.
Speaker Change: We showed that the CL-SAAx was well tolerated and maintained a positive safety profile with repeat dosing of the drug.
Speaker Change: This was especially important as almost all of the patients were administered at least two doses of CLSA-X. Importantly, our Phase 2B trial had no treatment-related serious adverse events, including no endophthalmitis and no retinal vasculitis.
Second, efficacy.
Speaker Change: We saw stable measurement of best corrected visual acuity and central subfield thickness. We were able to maintain vision over 36 weeks.
Speaker Change: will be CBA within two letters from baseline at both week 24 and week 36.
Speaker Change: We were also able to demonstrate that CLS-AX reduced CST fluctuations and provides stable anatomical control over 36 weeks, as confirmed by the Independent Reading Center.
and third, duration and reduction of treatment burden.
Speaker Change: We were able to show an 84% reduction in the frequency of injection after the initial dose of CRSAA.
Speaker Change: with approximately 90% of CRSAA participants not require any additional treatment up to four months, 81% up to five months, and 67% up to six months.
Speaker Change: Wet AMD is a chronic disease. Over the patient's lifetime, they will be given numerous injections to maintain vision and stabilize the disease.
Speaker Change: We are developing CL-SAA as a maintenance treatment, and the fact that we demonstrate the ability to administer multiple doses of CL-SAA was a critical component of the ODYSSEY trial.
Speaker Change: We want CLSAEs to be easily adopted into current physician practice.
Speaker Change: Based on the input we have received from numerous clinicians, in order to be meaningful, a new therapy entered the wet AMD market needs to have the option of flexible dosing.
Speaker Change: Any new agent that can only be dosed every six months will be a challenge for physicians to utilize.
Speaker Change: The frequency of treatment differs from patient to patient. In fact, even from eye to eye in the same patient, the frequency might differ.
Speaker Change: Physicians need the flexibility to deliver a treatment that will accommodate the varying needs and schedules for each eye of the patient at different times of the treatment journey.
Speaker Change: We continue to evaluate data from the ODYSSEY trial to help refine our Phase 3 plans.
Speaker Change: We are focused on designing a phase 3 drug program that will produce data supportive of a label with flexible dosing between 3 to 6 months.
Speaker Change: As I mentioned, this will align with the current wet AMD treatment approach desired by most retinal specialists and enable easy adoption in the physician practice.
Go to Beadaholique.com for all of your beading supply needs!
Speaker Change: keeping in mind that our phase 3 plans remain in development and are subject to change.
Speaker Change: We are currently planning to run two phase 3 trials with a Fibicep 2mg as a comparator.
Speaker Change: We are likely to conduct the study in truly naive patients with a flexible dosing component, consistent with the Phase III trial design for recently-approved efibizep high-dose and forizumab.
Speaker Change: We expect to conduct an end-of-Phase II meeting with the FDA in early 2025 to present and finalize our plans.
Speaker Change: One of the main reasons I joined Clearsight was to further explore the potential for supercoroidal delivery with our SCS microinjector.
Speaker Change: Over the course of my career, I have had a great deal of translational experience in advancing new molecules into the clinic, and I see many opportunities to utilize our device and formulation platform to potentially expand our pipeline.
Speaker Change: Beyond Well-AMD, we are targeting Geographic Atrophy, a preferent disease with a market size valued at over $20 billion in sales.
We believe that geographic atrophy is primarily a coronary disease.
Speaker Change: Several of my colleagues in the academic world have demonstrated that endothelial cells in the cholerae are damaged even well before any significant change occurs in the retinal pigment epithelium, or RPE.
Speaker Change: The vascular density is also significantly lower in the eye of patients with geographic atrophy.
supporting the hypothesis that geographic atrophy is a choroidal disease.
Speaker Change: Therefore, drugs that directly target the choroid are important for GA as well as for wet AMD. And our superchoroidal delivery platform does just that.
Speaker Change: Delivering small of small molecule via the super coroidal injection and it enables comprehensive drug coverage of both the retina and choroid.
while also potentially minimizing systemic and anterior segment side effects.
Speaker Change: I am pleased to report that our research team has made great progress in evaluating certain specific small molecules through in vivo models for the potential treatment of GA.
We are currently focused on two approaches.
Speaker Change: One may improve choroidal perfusion, and the other may moderate polyinflammatory cells.
Speaker Change: Our team is doing the necessary work to potentially advance one or both of these candidates toward an investigational new drug application.
Speaker Change: As George described, our partners continue to make extensive progress with their respective supercoroidal delivery programs, utilizing our SES microinjectors.
Speaker Change: This advancement, combined with our positive CRS-AX results, showed that our innovative suprachoroidal delivery platform could have a tremendous impact in the treatment of retinal diseases.
Speaker Change: I'm excited by what the future holds for PSI and supercolloidal drug administration.
Speaker Change: With that, I'll now turn the call to our CFO, Charlie Zipman, to provide a financial update.
Charlie Zipman: Thank you, Victor, and good afternoon everyone. Our financial results for the third 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.
Charlie Zipman: As of September 30, 2024, our cash and cash equivalents totaled approximately $23.6 million.
Charlie Zipman: We believe we have sufficient resources to fund our planned operations into the third quarter of 2025. This supports planning for our CLSAx Phase III program and research work to expand our pipeline into geographic atrophy.
Speaker Change: We look forward to participating in the Steeple Healthcare Conference next week, and we will continue to update you on our progress. I will now turn the call over to George for his closing remarks.
George Lasezkay: Thank You Charlie. Earlier this month we made a couple of key personnel changes to further advance our mission.
George Lasezkay: Tony Gibney was appointed to serve as Chair of our Board of Directors, bringing many years of relevant ophthalmic business development and strategic experience, most recently serving as the Executive Vice President, Chief Business and Strategy Officer of IbericBio.
George Lasezkay: During his time as a director for ClearSci, Tony has been a very active contributor, working closely with management and providing valuable strategic and financial guidance.
Speaker Change: I'd like to thank Clay Thorpe, our outgoing chairman, for his support and significant contributions during his tenure. Clay will remain as a valued member of our Board of Directors.
Speaker Change: In addition, Victor Chong has assumed a broader set of management responsibilities to utilize his extensive expertise in advancing drugs from preclinical through clinical development to commercialization.
Speaker Change: in his expanded role as Chief Medical Officer and Executive Vice President, Head of Research and Development.
Speaker Change: Victor will lead our preclinical, clinical, and medical affairs teams, providing an efficient structure as we prepare for the CLSAx end-of-Phase II meeting, plan for Phase III, and advance our preclinical supracaroidal programs.
Speaker Change: In summary, we are very excited that our innovative drug delivery platform is now being used in commercial products and promising clinical development programs by Baoxian Long, Eugenics Bio and AbbVie, Arctic Vision and Santan, Ora Biosciences, and Biochrist Pharmaceuticals.
Speaker Change: We remain motivated by the progress made internally and with our partners to expand the use of our differentiated supracaroidal delivery pipeline to treat patients with numerous retinal diseases.
Speaker Change: I would now like to ask the operator to open the call up for questions.
and Remy Bernarda. Thank you.
Speaker Change: Thank you. At this time we will be conducting our question and answer session. If you would like to ask a question please press star 1 on your telephone keypad.
Speaker Change: A confirmation tone will indicate your line is in the question queue.
Speaker Change: If you wish to remove your question, you may press star 2.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for questions.
Speaker Change: Thank you. Our first question is coming from Annabel Samimi with Stiefel. Your line is live.
Annabel Samimi: Hi all, thanks for taking my questions. So I had a few, I guess.
Annabel Samimi: You know, you just presented your data at AAO. I was just wondering if you can give us some feedback on what you heard, and I'm specifically interested.
Annabel Samimi: and what they thought of the study design that incorporated re-treatment rather than supplemental rescue with the FlibriSep.
Annabel Samimi: And also, what's the feedback on the three to six-month flexibility that you're looking for on your label relative to some of the competitors that might be looking for longer duration flexibility? So, I guess that's the first question.
Speaker Change: All right, thanks Annabelle and George. I appreciate that. Let me just say I'll make a comment or two, then I'll turn it over to Victor who can spend more, go into the details more.
Victor Chong: We had a very good AAO meeting. I think people were very happy with the data that we presented. They thought it was very strong data.
It was...
Victor Chong: very favorably received by the KOLs we talked to. We had a scientific advisory board. I think everybody looked at the data and felt it was very positive and clearly it was a product that should advance on to phase three. As to the specific questions that you asked I'll let Victor address some of those. Victor?
Thank you, George. Thank you, Annabelle.
Victor Chong: I think you know that our message is getting through and there is a key differentiation about the flexibility.
Victor Chong: I think before that, there was still some confusion about the priority and the suggestion and the argument between different companies.
Victor Chong: I think that now that it's become very clear that we are the only one who are offering a variability. And actually that variability is actually what physicians are really very keen on. And I think that's really supporting our notion on the commercial side.
Thank you. Thank you.
Speaker Change: Sorry, I apologize, other than that part, what was the other part of the question?
Speaker Change: Well, the flexibility was one, and then what were their thoughts about the re-treatment rather than the traditional supplemental liver sept?
All right. Thank you.
Speaker Change: Yeah, yeah, so I think that was like, you know, in the beginning that people not totally understanding the sets of differences in academy that we have multiple presentation, people are starting to understand that differences.
Speaker Change: and our phase two design able for us to read those already. And again, allow people to understand that it's already possible in our phase two.
Speaker Change: So I think all those are positive to show a differentiation in the marketplace and potentially also show a preference of KOL and physician that how they can thinking about that in the future to incorporate in their practice.
Speaker Change: And as I mentioned earlier, the flexible-do thing is critical for them.
Okay, got it and then
You know some questions regarding
Speaker Change: of CLS-AX at the second Aflivercept dose rather than the third. Were there any, I guess, concerns or inability to tease out the effect of Aflivercept rather than that of CLS-AX?
Speaker Change: CLS-AX at 12 weeks and do you have any details on who might have been rescued rather than retreated in a less than 12 week
timeframe.
Speaker Change: I think that wasn't really discussed by most people, certainly no one really questioned that.
Speaker Change: just to confirm that every patient there when the first intervention would be on re-dosing without drugs. So I think I appreciate that that has a little bit of confusion about the concept of intervention.
Speaker Change: So, in our 3-2-B study, every first intervention will be on our drug, so they will never be on using a Frippizat.
And second,
If that is... Umm...
Thank you. Bye.
Thank you. Thank you. Thank you.
Speaker Change: I guess I'm curious if there was any data prior to 12 weeks on who might have been rescued rather than retreated. I think you're saying every intervention was on.
Speaker Change: All right, so there will be no intervention needed at all, you know, I think that that was I appreciate that. Yeah, what?
Speaker Change: So when we were sharing that there was no intervention at all up to week 12, so that was absolutely no intervention, not just said no re-dosing because no one needed it.
Thank you. Thank you.
Speaker Change: Okay, got it. And I guess it's too early to talk about non-inferiority margins for Phase 3. Would it be the standard that FDA typically looks for, or could it be, you know, smaller, larger? What are your thoughts around what non-inferiority is going to mean for Phase 3?
are going to be defined as in phase three.
Speaker Change: Yeah, I think the draft guideline has suggested that four and a half letter and I think that the agency that still holding that is the expected, you know, margin is four and a half letter.
Okay, great, thank you.
Speaker Change: Just to be clear, Annabelle, we have not gone, we don't have our end of phase two meeting until maybe.
sometime early in 2025.
Speaker Change: and all that, it will end up being worked out and be clear by then exactly the specifications of the phase 3 trials. Okay, great. Yeah, no, I appreciate that. Thank you.
Okay.
Thank you.
Speaker Change: Thank you. Our next question is coming from Andreas Argaridis with Oppenheimer. Your line is live.
Andreas Argaridis: Thank you for taking our questions. Two for us here, and I know it's early and you haven't had time to phase two, but
Andreas Argaridis: I think it is helpful to kind of maybe get a little bit of sense of.
of the Phase III trial design.
Andreas Argaridis: Maybe, to some extent, you made comments in the past about sizing.
Andreas Argaridis: and kind of maybe patient criteria. Maybe, I mean, to whatever, you know, to what you can kind of provide a little bit more data after having thought about it and talk to KOLs.
Speaker Change: at AAO and the like in digesting the data, how you're thinking about this and positioning essentially CLS-AX
Speaker Change: in the best position versus the competition as well in the TKI space. And then just looking into 25, could you give us some additional color on the expansion of the geographic attribution program?
Speaker Change: and what we may be able to get in terms of early data. That'd be helpful. Thanks, guys.
Thank you.
All right, Victor.
Victor Chong: Yes, I think we have previously shared that we are targeting to have the End of Phase II meeting with the agency early in 2025. And as we said earlier, that will finalize the data, finalize the design then.
Victor Chong: Currently, as we also shared earlier, that our Phase III design will be taught similar to the 80% high-dose and Flurizumab design.
Victor Chong: So basically, it's a non-inferiority design with flexible dosing, and compared it with a 2.7 mg on label.
Victor Chong: and at the moment that our position is toward a tumor-naïve patient and whether there are further details that we will share as time goes along.
Victor Chong: In reference to geographic atrophy, I think that was the second question.
Victor Chong: We have like like what I like what we shared earlier that you know, we
Victor Chong: have looking at several molecules. There are small molecules that can utilize things.
Au.
Victor Chong: suspension platform which is proven and then to see whether that we can delivering those molecules.
Victor Chong: And in particularly, there are two areas that are of particular interest to us. One is improving choroidal perfusion.
Victor Chong: And the other one is to moderate a polyinflammatory cell. And those two pathways are...
potentially important pathway from that perspective.
Victor Chong: And that is what we are working on at this stage.
Speaker Change: Okay, this is one last follow-up. You know, just looking at the 25 and the phase 2, when do you think you might start the phase 3 trial?
Thank you very much.
Speaker Change: So at the moment, our target is to start the phase 3 trial in the second half of 2025.
Speaker Change: Fantastic. Thanks for the color there and congrats on all the progress this course. Thanks.
Thank you.
Speaker Change: Thank you. Our next question is coming from Dubinjana Chatterjee with Jones Trading. Your line is live.
Speaker Change: Hi, thanks for taking my question. So, I wanted to ask if you will be sharing any additional data analysis from Odyssey, and if so, when can we expect it and what data points will you report on?
Speaker Change: So we're going to share more data in the upcoming medical conferences, including the sharing in Singapore in the Asia-Pacific Visual Recognition Society meeting, the APVRS meeting.
Speaker Change: We are also looking at presenting some data in Furetuna, in Florence, in
Speaker Change: in December in Europe. And at the same time that we were also presenting potentially more data in the Hawaiian art meeting as well as the endogenesis meeting in the U.S. in January and early February.
and Remy Bernarda. Thank you.
Speaker Change: Yeah, so I think that, you know, we, you know, we are
Speaker Change: The type of data that we are sharing is to clarify some of the areas that we
might have some real confusion in the top nine results.
Speaker Change: and also some of the additional analysis that we are putting together.
Okay, thank you so much.
Thank you.
Speaker Change: Our next question is coming from Yi Chen with HC Wainwright. Your line is live.
Thank you.
Speaker Change: Hi, this is Eduardo Anferyi. I guess to start off, if you anticipate any apprehension for the FDA that would make them not want to recommend the re-dosing with the TKA, TKI within six months?
Speaker Change: I'm sorry I might have missed the question, if I just make sure that I answer the question.
Speaker Change: I think what he's asking is, is there any reason to believe the FDA may not...
Speaker Change: look kindly on us re-dosing with CLSAx less than every six months.
Oh, you mean the agency? The agency, yes.
Speaker Change: yeah so you know on our phase two study we've already done that I think that we are really more comfortable than anyone else if anything
Speaker Change: that, you know, because that we have data to support that we've already be able to read those on phase two.
And, in addition to that, as we have previously shared,
Speaker Change: that if a small number of patients even have three doses of CLA within the 36 weeks, they are a minority.
Speaker Change: also providing even additional safety data to supporting multiple redosing is certainly possible.
[inaudible]
Speaker Change: Got it, got it. And in regards to the Phase 3 program for...
Speaker Change: Do you have an estimated cost for what that would be?
and Remy Bernarda.
Speaker Change: That's something that we're still working on that as we put together the final trial design. That will come into focus.
Speaker Change: So, right now, I think it's premature to talk about that, but we'll have those kind of details will certainly be available as we finalize that phase 3 design and have our end of phase 2 meeting. We're working very hard on that right now.
Speaker Change: Understood, understood. And then in the geographic atrophy studies that you were doing, I was hoping to get, you mentioned a few comments on the endothelial cells and why you considered a choroidal disease versus a retinal one. Could you elaborate a little bit on that and the mechanism there?
and Remy Bernarda.
Speaker Change: Yeah, so I think that, you know, when we talk about geographic accuracy, because the FDA approval anatomical endpoint is on RPE cell death.
Speaker Change: And I think a lot of people somewhat automatically assume that LPE cell death was the primary problem.
Speaker Change: and indeed that what we have seen a lot of data shown that there was a lot of choroidal damage.
Speaker Change: occur way before RPA cell death and in fact the RPA cell death is almost like a terminal effect.
Speaker Change: And so, we believe that treating the cause, rather than just the last bit of preventing the LPSL death, would be able to provide additional efficacy.
Speaker Change: And at the moment, the current approval of the therapy that they probably wouldn't necessarily get to the choroid because they are quite big.
Speaker Change: that we think that the relatively limited efficacy for the current GGA treatment related to that, that they are only treating the LPE side. So I think that was something that we think that.
Speaker Change: are using suprachoroidal and small molecule that we can get a comprehensive drug delivery to both the choroidal side as well as the retinal side and obviously the LPSL in the retinal side.
Thank you.
Speaker Change: Got it. And do you have a timeline for IND submission? I know you guys are kind of still in the exploratory phase and you're in vivo models, but any color there would be helpful.
Speaker Change: Yeah, we stated too early to say exactly when, but it is, it's a little, so we are working on, we are working on that.
Speaker Change: And I think it's, you know, we are already moving toward.
Speaker Change: It's a more specific candidate to move forward, so it's not just a building model but we have candidates.
Got it. Thank you.
Thank you
Speaker Change: As we have no further questions on the lines at this time, I would like to turn it back over to Mr. Lasezkay for any closing remarks.
Speaker Change: Thank you, Ali. Thank you all for joining us on the call this afternoon.
George Lasezkay: We appreciate your continued interest in ClearSide, and we look forward to updating you on our progress.
Operator, you may not disconnect the call. Thanks again.
Speaker Change: Thank you sir. Ladies and gentlemen this concludes today's call and you may disconnect your lines at this time. We thank you for your participation.