This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk10: Greetings and welcome to the Clearsight Biomedical First Quarter Financial Results and Corporate Update Conference Call. As a reminder, this conference call is being recorded. I would now like to introduce your host, Ms. Jenny Cobin, Clearsight Investor Relations. Ma'am, please go ahead.
spk04: 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, 2020, and our other SEC filings available on our website. In addition, any forward-looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent date. 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 Lozeski, our Chief Executive Officer, Dr. Thomas Chula, our Chief Medical Officer and Chief Development Officer, and Charlie Degnan, 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.
spk07: Thank you, Jenny. Good afternoon, and thank you for joining us on the call today. We have made meaningful progress since we hosted our last earnings call in March. We resubmitted our Zypier new drug application to the U.S. Food and Drug Administration. Zypyr is our proprietary suspension of the corticosteroid triamcinolone. It's formulated for superchoroidal administration for the treatment of macular edema associated with uveitis, which is delivered by our patented SCS microinjector. This is an important milestone for our company and our shareholders for two reasons. First, Zypyr approval would represent ClearSight's first commercial product approval. Second, it would be the first drug approved for delivery into the supracoroidal space, which is behind the patient's visual field. This innovative approach to ophthalmic drug delivery could be a major breakthrough for the treatment of retinal diseases, as it demonstrates the potential for a reliable, non-surgical, office-based method to deliver a variety of therapeutic products for a broad range of back-of-the-eye diseases. Our team has worked tirelessly throughout this Zypher NDA resubmission process, and I'd like to publicly recognize their efforts. They successfully accomplished the technology transfer to our new manufacturing partner in an incredibly short period of time. The efficiency of this transfer process is a testament to the hard work, cooperation, and professionalism of both the ClearSight team and the team at our new contract manufacturer. The Zyper NDA resubmission is a full and complete response to all of the items identified in the complete response letter we received from the FDA in October 2019. We anticipate FDA acceptance of the resubmission of the NDA within approximately 30 days of its submission date, and we believe this application will be considered a Class 2 resubmission with a targeted six-month review timeline under the Prescription Drug User Fee Act. We will provide an update when we receive our assigned PDUFA date. The potential approval of Zypyr will further validate our superchoroidal injection platform and its utility in delivering small molecule suspensions into the superchoroidal space. For the commercialization of Zypyr, we have two outstanding global partners, Bausch & Lomb and Arctic Vision. Bausch Health and Bausch & Lomb, its leading global eye health business, has the exclusive license for commercialization and development of Zypyr in the United States and Canada, as well as exclusive options for the European Union, United Kingdom, and other territories. We have maintained an ongoing dialogue with Bausch Health and Bausch & Lomb as we prepared the Zypyr NDA resubmission, and they provided input and support in connection with the filings. Our medical affairs, supply chain, and clinical teams have also worked closely with Bausch Health and Bausch & Lomb as they prepare for the commercial launch of Zypyr in the U.S., once approved. In Asia, Arctic Vision has the exclusive license for the commercialization and development of Zypyr in Greater China and South Korea. They announced in December that they obtained approval from the Chinese Regulatory Authority for their investigational new drug application in uveitic macular edema. They currently expect to begin Phase III clinical trials in that indication later this year. The second small molecule suspension for supercoroid of delivery in our internal pipeline is CLS-AX, our proprietary suspension of the tyrosine kinase inhibitor Excedinib. We're excited about this program because we believe that CLS-AX may improve the treatment of neovascular age-related macular degeneration, commonly known as wet AMD. through potentially improved safety and efficacy, and by reducing the frequency of patient injections with its prolonged durability. CLSA-X is currently being evaluated in a U.S.-based Phase 1-2A clinical trial entitled OASIS. It is a multicenter, open-label study to evaluate safety and tolerability of escalating single doses of CLSA-X in wet AMD patients. We have completed patient dosing in Cohort 1, and we expect to announce Cohort 1 results by the end of June after the last patient visit and data analysis. I'll now turn over the call to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to elaborate on CLS-AX, our partnered programs, and recent data presentations. Tom?
spk02: Thank you, George. Our clinical and development teams are extremely excited about the milestone we achieved with the resubmission of our Zypyr NDA. We look forward to our first potential product approval and further validation of the benefits of our supracordial injection platform. We are also pleased with the progress we have made with CLSA-X, our lead development asset. As George mentioned, the CLSA-X Phase 1-2 OASIS clinical trial is a US-based single-dose escalation clinical trial consisting of three cohorts. The primary endpoint for the trial will assess the safety and tolerability of CLSA-X for three months following its administration. Secondary endpoints will evaluate the pharmacokinetics, visual function, ocular anatomy, and the need for additional treatment with intravascular liver set. As we reported in March, we completed enrollment of cohort one on schedule. Our primary objective for cohort one is to establish a floor for safety in this first in-human trial using a low dose of 0.03 milligrams of COSAX as we are committed to proceeding prudently in developing a safe and well-tolerated treatment. We expect to announce data from cohort one by the end of June. Following that announcement, we then expect to begin recruiting patients in cohort two. Late last year, as part of our overall regulatory strategy, We submitted a plan to the FDA to study a broader range of doses in OASIS. Based on our preclinical data, the FDA and our institutional review board recently accepted this approach. Consequently, we plan to increase our CLSAx cohort two dosing from 0.06 milligrams to 0.1 milligram, which was our originally planned cohort three dose. Overall, we are pleased with the trajectory of this trial to date, and we believe CLSA-X will be attractively differentiated, combining the potential benefits of pan-VEGF inhibition with the compartmentalized safety of supracordial administration. Ultimately, we believe that CLSA-X may improve the overall patient experience with a more durable treatment and a favorable tolerability profile. With respect to our preclinical initiatives, we continue to advance our integrin inhibitor program with a focus on diabetic macular edema and macular degeneration, where specific integrins have been implicated in these diseases. Similar to what we have demonstrated with our other small molecule suspensions, Exitinib and Trine Cinalone, we believe our supercoital delivery approach of an integrin inhibitor could provide targeting, compartmentalization, and durability advantages over other delivery approaches. We are currently running preclinical studies with our intricate inhibitor suspension, and we expect to conclude these studies later this year. Our clinical development partners also continue to advance their programs utilizing our SCS microinjector to deliver their agents. Regenexx Bio is currently conducting two phase two clinical trials evaluating the efficacy, safety, and tolerability of supracordial delivery of their gene therapy agent, RGX314. The first trial, entitled 88, is targeting the treatment of patients with severe wet AMD who are responsive to anti-VEGF treatment. On their Q1 earnings call, Regenexx Bio reported meaningful advancements on this trial and provided three key updates regarding supracordial delivery of gene therapy. First, they expect to report interim data from Cohort 1 in the third quarter of this year. they have completed dosing of patients in cohort two and expect to report interim data in the second half of 2021. And third, they have expanded the patient population for AV8 and have begun dosing a third cohort in patients who are positive for neutralizing antibodies. As a reminder, based on the protocol, patients are not receiving corticosteroids before or after administration of RGX314. Thus, the continued progress in this trial without immune suppressive therapy is very encouraging. The second RGX314 clinical trial is a phase two trial for the treatment of diabetic retinopathy entitled Alpha-2. Regenexx Bio continues to enroll patients in cohort one and expect to report initial data later this year. These Regenexx Bio programs highlight the opportunity for an in-office super quarterly administered gene therapy. We're also excited about the recent new data from our oncology partner, Oro Biosciences. They are currently running a phase two clinical trial, evaluating their lead asset, AU011, delivered via our SCS microinjector into the supracordial space. AU011 is a first in class virus-like drug conjugate therapy in development for the first line treatment of choroidal melanoma, a rare and aggressive form of eye cancer that is the most common interocular cancer in adults. Recently, ORA has published promising preclinical data on AU011. In April, data was published in the peer-reviewed medical journal Cancer Immunology Research, a journal of the American Association for Cancer Research, reinforcing the therapeutic advantage of their virus-like blood conjugate in treating cancer compared to other available treatments. In addition, at the recent ARVO conference, or presented promising data comparing the ocular distribution and exposure of AU011 with both intravitreal and suprachoroidal administration in a rabbit model of human uveal melanoma. After suprachoroidal administration, negligible levels of AU011 were observed in the vitreous, while there were high exposure levels in the tumor and choroid retina. In addition, when comparing suprachoroidal to intravitreal administration, the exposure of AU011 in the tumor was approximately five times higher when AU011 was injected suprachoroidally. These data suggest that suprachoroidal administration may have certain advantages compared to intravitreal administration, including superior tumor distribution, higher tumor bioavailability, and less unintended exposure in the vitreous and other key ocular structures. We are extremely encouraged by this preclinical data and look forward to the continued progress from ORA on their Phase II clinical trial. We've also been active among the retina physician community. We are pleased to have ClearSight featured in several recent key industry events. At the WET-AMD and DME Drug Development Summit, we participated in panel discussions entitled Ending the Burden of Monthly Treatments and Making Strides Forward in Drug Delivery and Dosing. We also presented supercritical drug delivery of CLSAX as a potential solution for treatment burden in patients with WET-AMD. During the Investing in Cures Summit 2021, organized by the Foundation Fighting Blindness and its RD Fund, we were honored to have the opportunity to present our corporate profile. At the recent ARVO 2021 Annual Meeting, we had multiple posters and presentations. These presentations highlighted the benefits of supercritical delivery in multiple settings and diseases. There are several key posters I'd like to mention from these data presentations. Dr. Alan Ho presented a multimodal imaging study on supracordial injections across species. This project compared supracordial injections to individual injections using diagnostic imaging and demonstrated the uniquely differentiating compartmentalization and targeting of supracordial drug delivery. Dr. Sumit Sharma presented on safety results of the supracordial injection procedure across three retinal disorders in our clinical trial programs. This poster demonstrated that In humans, the safety profile of supracoital injections is broadly comparable to individual injections. Our team also presented a poster on the ongoing supracoital injection procedure training we've been running with physicians during COVID-19. This training program is becoming increasingly important as we advance our CLSA-X trials and prepare for the potential US approval of Zypure. Importantly, physicians who completed virtual or in-person training felt highly confident in their ability to perform the procedure in patients in the future. In addition, Dr. Viral Kansara presented a poster where he showed that suprachoroidally delivered DNA nanoparticles containing the human MYO7 transgene produced durable levels of human MYO7A protein in the RPE and choroid. These data demonstrate that suprachoroidal delivery has potential as an office-based repeatable therapy for retinal disorders caused by defects in genes too large to fit into an AAV vector approach. Links to these publications and presentations are available on our website in the science section. In closing, we've had a productive start to 2021, and we look forward to continued progress as we advance our clinical and preclinical development programs. I will now turn the call over to our CFO, Charlie Degnan, to review our financial results. Charlie?
spk03: Thank you, Tom. Our financial results for the first quarter were published this afternoon in our press release and are available on our website. Therefore, I will summarize our current financial stats. Our cash and cash equivalents as of March 31st, 2021, totaled approximately $26 million. This includes approximately $14.4 million in aggregate net proceeds from our registered direct offering and use of our ATM facilities in January. Our quarterly cash burn is primarily due to work on the activities related to getting ZIPER approved in our CLS AX program. Investments in our pipeline are also incorporated into our operating plans. Based on our current funding and plan spending, we expect to have sufficient resources to fund our operations into the first quarter of 2022. Importantly, this estimate does not include milestone payments we may receive under our current partnership agreement. If Zypera is approved, we expect to receive up to $15 million from Bausch & Lomb in approval and pre-launch milestones. In addition, we would receive a milestone payment from Arctic Vision of $4 million. Thus, we are on track to receive nearly $20 million of non-diluted funding before the end of this year. We appreciate the interest and support from our shareholders and the broader investment community and we look forward to participating in the upcoming J&P and Raymond James investor conferences next month. I will now turn the call back over to George for his closing remarks.
spk07: Thanks, Charlie. We are optimistic as we look forward to reporting data next month from our OASIS trial and to the potential Zyper US marketing approval later this year. There are currently four ongoing clinical trials with three novel product candidates administered into the supracoroidal space using our proprietary SCS microinjector. Our extensive clinical experience with more than 1,200 injections reinforces our belief that the SCS microinjector has the potential to be a reliable, non-surgical, office-based method to access the supracoroidal space for the treatment of a broad range of back of the eye diseases. We at ClearSight remain dedicated to making a difference for people suffering from potentially blinding diseases, and we look forward to keeping you updated on our progress as the year unfolds. I would now like to ask the operator to open the call up for questions.
spk10: Ladies and gentlemen, if you have a question at this time, please press star, standard number one on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question is from Dr. Segbe Jelang from Roche Hospital of Perkins. Your line is open.
spk01: Hi, guys. Thanks for taking my question. Just have a couple quick ones here. I think the first one is just about the upcoming Phase 1-2 study. Just wanted to clarify the patients that have been enrolled, are they anti-VEGF responders or non-responders? And I know, you know, the focus is safety, but just wanted to get a sense of the patient.
spk07: Tom, you want to take that question?
spk02: Sure. So patients to be eligible in the trial had to have been treatment experienced. They had to have had two prior injections within the four months preceding screening. They received a Flibercept injectant on screening and then a CLSAX injection a month later. They have to have active exudation based on a masked reading center assessment. So I would categorize these patients as VEGF dependent.
spk01: Okay. Okay. Perfect. And then just to follow up here, I know at ARVA you presented some information, your virtual training procedures and just kind of wanted to get some more details on that and then to get a sense of how you expect that to perhaps influence your ability to actually train more physicians for future studies.
spk02: That's a great question. We have a very robust training program. Our medical science liaisons are biomedical engineers who have helped with the validation of the original injector. And They, in conjunction with the medical affairs team, have designed a very robust training program. We have an artificial eye where physicians can practice. And during COVID-19, obviously with travel restricted, we actually developed a virtual training program. It's a very clever program where we will ship out this artificial eye to the physician. and able to actually do live training over the internet. We then, as part of this project with Senator Arvo, looked at some metrics with respect to the training, and physicians were overall quite pleased with both the virtual and in-person training, and both the virtual and in-person training felt quite well trained in order to be able to deliver investigational products super quarterly in the future.
spk01: Thanks, Tom. Looking forward to more updates on the program, including the data coming up. And congrats to the team on the NDA for Zype here.
spk07: Thanks, Zypa.
spk10: Appreciate it. Your next question is from Annabelle Samimi from Stable. Your line is open.
spk05: Hi, guys. Thanks for taking my questions and congratulations on the progress. I had a couple questions. I guess first on OASIS, I just wanted to understand, are you skipping an actual dose and going straight into the one milligram for that second cohort? Are there going to be any additional cohort, dosing cohorts after that? So are you looking to go higher? And then are you, beyond the three months, are you looking for durability data beyond I'm just trying to understand what your intention is of this dose escalation trial. And then I'll have another follow-up. Thanks.
spk07: Okay. Tom, you want to go ahead?
spk02: Sure. Let me talk a little bit about the dosing and the changes we've made. As I mentioned in the prepared remarks, we approached the FDA and the IRBs ultimately because we wanted a broader range of dosing and more flexibility. So cohort one was unaffected. It's the 0.03 milligram dose. Cohort two is now the 0.1 milligram dose, which was our originally proposed cohort three. And then for cohort three, we plan to go to 0.3 milligrams.
spk05: You're going to which one?
spk02: To 0.3. So the dosing will range from 0.03 to 0.3, so a potential tenfold escalation, that's right. And of course, this will all be contingent on cohort two results and review by the safety monitoring committee, but that's the current plan. So in essence, we are skipping over the point, So instead of going from a two-fold increase over cohort one, we're going to a three-fold increase over cohort one.
spk05: Okay. And are you looking for greater durability data than just the three-fold?
spk02: Sure. Yeah. So with respect to the second question, as we've said before, the cohort one dose, is really to establish a floor of safety. It's a low dose and we want to proceed prudently in escalating these doses. So we don't expect robust signs of biologic efficacy from cohort one. And ultimately, as we escalate, we plan to establish an extension study where we follow the patients for an additional three months beyond the originally planned three months. So we'll be looking for durability as we escalate the dose.
spk05: Okay. And then I have one other question on the, I guess, the regenerative bio, and I'm thinking more conceptually. I guess historically there have been some serious immune responses to delivery of viral Zuckers for gene therapy is outside of being surgery sparing, like delivering to the SCS space. Are there benefits to delivering the gene therapy super quietly in terms of an immune response? Is there anything you can help us understand about that? Thanks.
spk02: That's a great question. So it's really a two-part question. So number one, What are the potential benefits of supracoital delivery over subretinal surgical delivery of gene therapy? And as you mentioned, obviously, we avoid the surgical risks of the tracheotomy in general. We also avoid the risk of creating a retinotomy or a hole in the retina through which the gene therapy is injected. And we also avoid the risks of creating a bleb or subretinal during the subretinal injection, you're literally creating a small retinal detachment, which of course can cause harm to the photoreceptors. So we avoid the risks of surgery. Also, the distribution of supracordial delivery may be quite attractive for gene therapy because we're able to potentially expose the retina and the choroid circumferentially and peripherally, which may be a very attractive way to treat inherited retinal diseases, which often start in the retinal periphery. So those are the potential advantages of suprachordal delivery. And then for the second part of your question with the immune response, and that's really an important key question, you know, that's still being worked out. There's an increasing body of literature suggesting that it is well tolerated and that the immune response is not insurmountable, that it's overall a fairly favorable immune response. And I think the fact that Regenexx Bio is starting Cohort 3, these are patients who actually have neutralizing antibodies, is a very positive sign for supracordial gene therapy. And I just want to remind everybody that they're doing this without any protocol-mandated corticosteroid immunosuppressive therapy. So I think we're still learning a lot about suprachoroidal gene therapy administration, but I think so far so good, especially with respect to some of the news coming from Regenexx Bio.
spk05: Great. Thank you.
spk10: Your next question is from Andreas Arduites from RedBush Securities. Your line is open.
spk08: Good afternoon. Thanks for taking our question. This is Andreas on Feliana Musatos. Congrats, guys, also on the progress during the quarter. For Zypure, can you provide an update on the status of the pre-approval manufacturing inspections? And then I have a follow-up after that. Thanks. Sure.
spk07: I'll take that. This is George. We're not sure how the FDA is going to approach this. We've made our resubmission. We've Two things that we've done in the resubmission, actually it was a full NDA resubmission that was responsive to all of the items in the CRL, as I mentioned in the prepared remarks. The most important thing that we had to provide to them was stability data, three-month stability data on our registration batches, and we've done that. Secondly, and more to your question, we had to demonstrate that the procedure by which we make the drug product was substantially the same as the previous CMO. And we've done that as well. So it's really up to the FDA at this point in time. It's hard to predict how they're going to do any kind of inspection of our new contract manufacturer. They may decide to do an on-site inspection and they may not because of some COVID backup in their shop. They may take a different approach, but I'm sure they'll let us know once we're engaged in the conversations with the FDA regarding the NDA resubmission. So right now that's up to them, and we don't know exactly what they're going to do in terms of a pre-approval inspection.
spk08: Would that be included in the six-month timeline, or do you think if they were to do an inspection that could, push it out?
spk07: Well, they're going to do it. If they do an onsite inspection, it's going to be on whatever schedule they have available, how they can fit it into their schedule. But we would anticipate that any inspection, including an onsite inspection would be within that six month timeframe.
spk08: I appreciate that. Thanks. This is probably one for Tom. So for, for CLSAX, Um, anatomic benefit remains the biggest driver of, of positive outcomes. Um, when do you think you guys will provide imaging of fluid levels at what point? Thanks.
spk02: I'm sorry. You broke up in the last part of that.
spk08: Yeah. Apologies. So at what point do you think you would show any type of imaging of fluid levels that would give indication of the effectiveness of drying, et cetera? Thanks.
spk02: Sure. Um, As I mentioned, the first cohort is really geared towards safety, so we don't expect robust signs of efficacy from this first cohort. In fact, the primary endpoint is really to look at the safety and tolerability. But, of course, the secondary endpoints will include best corrective visual acuity and some of the anatomic features from OCT and angiography. Once the final patient visits are completed and we review the data, we plan to report data from the first cohort And we expect that will be in the next month. And that will, you know, that will include the safety parameters as well as some of the, you know, obviously signs of biologic activity like visual acuity and some of the OCT anatomic parameters.
spk08: Okay.
spk10: Thanks for taking my questions.
spk08: And congrats again.
spk10: Your next question is from Serge Belanger from eDerm and Company. Your line is open.
spk09: Hey, good afternoon. Thanks for taking my questions. First one on Zype here. So from a ClearSight standpoint, what remains outstanding with regards to this collaboration now that you submitted the NDA?
spk07: The collaboration? Are you referring to the collaboration with Bausch Health?
spk09: Yes, yes.
spk07: Yeah. Well, we'll be working with them during the review period to plan on success, and they'll be working up their – hopefully their launch plans, anticipating that. We'll also – our medical affairs team, our supply chain people are working with their people to – make sure the training is all buttoned up and ready to go. They have a very aggressive training program that they're contemplating. We'll be talking to them about supply chain issues. We're just working on those with them very cooperatively. And we'll deal with any issues that may come up or any questions that came up with the FDA collaboratively. So, Once the IPR NDA is approved, there will be a transfer of the NDA to Bausch & Lomb. So that's why we've been very cooperative with them. They've been great to work with, and we've worked very cooperatively on the resubmission package, and we'll continue to do so through the entire review process.
spk09: Okay. Okay. And then on the licensing option for Europe and the UK, is there any timelines associated with them on when Bosch needs to get back to you on the decision there or something that you haven't disclosed?
spk07: Yes, there is a timeline. It will be the end of this summer, the end of August, unless for some reason the ZYCR is approved quicker than that. But the decision will have to be made before the end of August, and we'll be talking with Bausch about that decision. beginning or rather shortly we'll start having those conversations with them now that the NDA has been resubmitted. So, again, we anticipate that they're going to be very good partners, but we'll have to talk to them about their plans outside of North America. But that will be ongoing over the next couple of months. Okay.
spk09: And then on, I guess, a question for Tom on CLSAX. As you increase the dosing levels here, you talked about durability. What kind of durability do you think is possible? Can we see something as long as four to six months here? I guess just based on your preclinical models, is that something that's possible?
spk02: Thanks for the question. Great question. So we feel that supracordially administered CLSAX is really attractively differentiated for several reasons, not just durability, but first of all, for safety, because we're compartmentalizing the drug in the supracordial space. So we don't expect to have particle migration into the vitreous or into the visual axis. So we think there's a potential safety benefit. Number two, we think the pan-VEGF inhibition aspect of this further differentiates it from other long-acting therapies that are really focused on VEGF-A. This has potential to be more efficacious than current anti-VEGF-A therapies and even long-acting anti-VEGF-A therapies because both preclinical and early clinical studies suggest that pan-VEGF inhibition may be more efficacious with respect to visual acuity and or drying. And then third, with respect to durability, We know from our preclinical models that we can have levels in the posterior segment for many months, many months above the IC50 for the VEGF2 receptor, which controls antigenesis and leakage. So to answer your question, you know, yes, we think that we can have, there's good potential to have beyond three to four months of durability, but we also may have a very nice safety profile and also potential for enhanced efficacy being a pan-VEGF inhibitor.
spk09: Okay. Well, thanks. Look forward to seeing the data next month.
spk10: Again, if you have a question at this time, please press star, then the number one on your telephone keypad. Your next question is from John Wallaban from JMP Securities. Your line is open.
spk06: Hey, thanks for taking the question, and congrats on the progress. Just a couple for me. First, with CLSAX, with the sign-off on going ahead to this 0.1 milligram dose, I'm wondering what else is left before you start dosing the patient. I think you said you're going to wait until July to start dosing. I'm wondering if that could happen any sooner and when we could see data from that second cohort.
spk02: Well, thanks for the question. So, as I mentioned, once the final patient visits are completed and and we review the data, have it reviewed by the Safety Monitoring Committee. We planned to report data from the first cohort. We expect that to be in June. And then after that, we plan to start enrollment. So we potentially could have a readout for the second cohort six months after that. So I think the investigators have been very eager to recruit Operationally, the study has gone extremely well. And I also want to remind everybody, we started this trial during the pandemic, during the holiday season, and we recruited very robustly. So, as I mentioned, the investigators are very enthusiastic about the program and about recruiting. So, we hope to have that data read out from the first cohort in June. And again, it's mostly going to be geared towards safety in the first cohort. but we expect to begin recruitment shortly thereafter for cohort two.
spk06: That's helpful. And then with the integrin inhibitors, you mentioned, I think, that you'd be completing preclinical work this year, but I'm just wondering when you might be publicly discussing those in more detail with any data and then if you've characterized which integrins you're going after. And then how do you think about the opportunity there in, I think you said DME or DR, versus expanding CLSAX into those indications?
spk02: I'll take the latter two questions and let George discuss disclosure. But we've adopted this integrin inhibitor that targets integrins alpha V, beta 3, alpha V, beta 5, and alpha-5-data-1. And these are the key integrins that have been implicated in diabetic macular edema, diabetic retinopathy, and AMD. As you know, there's been preclinical and early clinical data suggesting a role for integrin inhibitors in these large disorders. So we're currently formulating our integrin inhibitor as a small molecule suspension. We're doing further preclinical testing to assess the ocular tolerability, distribution, and pharmacokinetics. And we hope to share that sometime this year. In terms of portfolio planning, I'll defer that to George in terms of how it fits in with COSX.
spk07: Well, John, I think... you know, you never can have enough shots on goal. And so, you know, we, we think that we have an opportunity with integrin to have another shot on major retinal diseases. I take your point that you could be, you could consider something like a CLSA X to go after some of those similar diseases, but we're, we're looking at different, we're trying to diversify our pipeline based on mechanism of action as well as anything else. And we just think it makes perfect sense to us to be able to formulate integrin as a small molecule. It's our sweet spot in research and development, our small molecule suspensions of molecules that are relatively insoluble. And so it's another opportunity for us. And it... When we're talking about these kind of indications now, that doesn't mean that's where we're going to end up. Tom and I have constant discussions about other potential applications for both of these products, both CLSAX and Integra. This is where we're initially looking, but it may not be where we end up. We have some pretty robust discussions about that in the company. And as Tom mentioned, in terms of the preclinical data, we're hoping to have some preclinical data to be able to disclose before year-end on the integrated.
spk06: Perfect. Looking forward to it. Thanks again for taking the questions. Sure. Thank you.
spk10: I'm showing no further questions at this time. I would like to turn the conference back to CEO, Mr. George Lasesky, for closing remarks.
spk07: Thanks. Well, thank all of you for joining us on the call this afternoon. We really appreciate your continued interest in ClearSight and what we're doing, and we look forward to updating you on our progress throughout the rest of the year. Operator, now you may disconnect the call. And thanks again for everybody participating.
spk10: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and have a wonderful day. Thank you. Thank you. Thank you. Thank you. Music playing Thank you. Thank you. Thank you. Thank you. you you Thank you. you Greetings and welcome to the Clearside Biomedical First Quarter Financial Results and Corporate Update Conference Call. As a reminder, this conference call is being recorded. I would now like to introduce your host, Ms. Jenny Cobin,
Disclaimer