Clearside Biomedical, Inc.

Good day, everyone, and thank you for standing by. Welcome to the ClearSight Biomedical Second Quarter of 2021 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. And please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Ms. Janie Coben, ClearSight Investor Relations. Please go ahead.

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 will 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 Lizeski, 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 up for your questions. During our call today, Dr. Chula will discuss the key results from cohort one of our phase 1-2A clinical trial for CLSAX that we announced last month. Slides related to this data are available on our website as supporting materials for this earnings call webcast. Now, I'd like to turn the call over to George. Thank you, Jenny.

Thank you, Jenny. Good afternoon, everyone, and thank you for joining us on the call today. We continue to demonstrate our position as the leader in the superchoroidal space with multiple clinical trials in several different ophthalmic indications, a new drug application for Zypyr currently under FDA review, and a recent positive results from our CLS-AX wet AMD clinical trial. We are the first company to develop a clinically tested, non-surgical, repeatable microinjection technology designed to unlock the potential clinical benefits of administering drugs into the superchoroidal space. We have over 85 global patents to protect our platform technology, which includes patents covering our proprietary SES microinjector, as well as the delivery of therapeutic agents into the superchoroidal space. Internally, our research team has proven our capabilities to transform existing small-molecule drugs into proprietary suspensions for delivery into the supracoroidal space to target back-of-the-eye diseases. Our first product candidate, Zypyr, is a proprietary suspension of trimicinolodacinidine for the potential treatment of patients with macular edema associated with uveitis. If approved, Excuse me. Zypyr is now under review by the U.S. FDA with a PDUFA action date of October 30, 2021. If approved, Zypyr will be our first commercial product, the first therapy approved for macular edema associated with uveitis, and the first product ever approved for suprachoroidal administration. Zypyr will be sold in the U.S. and Canada by our partner Bausch Health and Bausch & Lomb, its leading global eye health business. In addition, Arctic Vision, our partner in Greater China and South Korea, is planning a confirmatory Phase III clinical trial in macular edema associated with uveitis to begin in China later this year with the ultimate goal of commercializing Zypyr in that region. The lead clinical development candidate in our pipeline is CLSAX, which combines our proprietary suspension of the tyrosine kinase inhibitor Exidinib for suprachoroidal delivery with our SCS microinjector. As Tom will discuss in detail, we achieved our safety and tolerability objectives in cohort one of our phase 1-2a OASIS trial in patients with wet AMD. We are now enrolling cohort two and expect to complete recruitment this month with data by the end of this year. With the PanVEGF attributes of Excedinib delivered to the suprachoroidal space, we have the opportunity to improve the treatment of patients with wet AMD as we believe CLS-AX may offer improved safety and efficacy, as well as prolonged durability by reducing the frequency of patient injections. The clinical experience with our SCS microinjector is unparalleled. At Clearside, we have tested it in over 1,200 suprachoroidal injections in multiple global clinical trials in a variety of retinal disorders. The safety profile of our suprachoroidal injections is comparable to intravitreal injections with no procedure-related serious adverse events to date. In addition, we have published data that indicates the superchoroidal injection procedure utilizing our SCS microinjector is well accepted by physician investigators and could readily be adopted in clinical practice by retinal specialists. Further, our technology is currently being used in three separate clinical trials being conducted by our two clinical development partners, Regenexx Bio and Oro Biosciences. Regenexx Bio is delivering its AAV-based gene therapy with our SCS microinjector in two ongoing Phase II clinical trials in wet AMD and diabetic retinopathy, potentially transforming gene therapy delivery into an office-based, non-surgical treatment option. As Tom will discuss shortly, Regenexx Bio continues to make meaningful progress on both of these programs, and Ora Biosciences is delivering their viral-like drug conjugates into the superchoroidal space to treat choroidal melanoma, again, using our SCS microinjector. We are excited about the progress to date with our partners and look forward to future results from these trials. As such, we believe we are the leader in developing small molecule superchoroidal products and the partner of choice for the delivery of a variety of other therapeutic agents into the superchoroidal space. I will now turn the call over to Dr. Tom Chula, our Chief Medical Officer and Chief Development Officer, to delve into our CLSAx data and review our partners' programs. Tom?

Thank you, George, and good afternoon, everyone. Today I'm going to focus primarily on our CLSAx clinical program and the positive safety results we reported last month from Cohort 1 of our OASIS Phase 1-2A clinical trial in patients with blood AMD. As Jenny mentioned at the outset of the call, slides related to this data are available on our website at supporting materials for this webcast. CLSA-X is our proprietary suspension of excitinib delivered via our SCS microinjector into the suprachordal space. In this program, we are marrying a very highly potent tyrosine kinase inhibitor with the potential benefits of suprachordal delivery. Importantly, excitinib is designed to inhibit all of the VEGF receptors as opposed to the currently improved agents that bind only to VEGF-A. And with our proprietary SCS microinjector, we were able to specifically target the affected core retinal tissues rapidly, and we can compartmentalize that therapy away from unaffected tissues for potential safety benefits. We've seen the benefits of supracordial delivery with our first product candidate, Zypyr, and now some preliminary signs of benefit in our first data set with CLS-AX. As a reminder, the design of our Phase 1-2A clinical trial is an open-label study to establish the safety and tolerability of escalating doses of CLSAX in patients suffering from wet AMD. The study involves three cohorts of approximately five patients each, and we started cohort one at a very low dose in order to establish a floor of safety. Now, I'd like to walk you through the details of the patient journey in our trial. Patients have a diagnosis of wet AMD, for which they've received a minimum of two prior anti-VEGF injections. Patients have active disease with suboptimally controlled choroidal neovascularization, despite multiple doses of anti-VEGF therapy. Once deemed potentially eligible for our trial, patients are screened, which includes standard visual acuity testing and imaging that is ultimately assessed by an independent mass reading center. The patient receives a single dose of Aflibircep, and the reading center confirms eligibility. One month later, the patient returns, undergoes the same assessments, then receives a supracordial dose of CLS-AX. Patients are then monitored monthly for three months. What I like about this trial design is that it allows us to assess the patients in a crossover fashion. We are first able to assess how patients perform one month after treatment with the FlibberCept, and then compare how the same patients perform one month after treatment with CLS-AX. In cohort one, the patient's average age was 82, and each was highly treatment experienced. On average, patients had 26 prior anti-ZIGEF injections and received nine injections on average in the year prior to screening. Let me walk you through the summary of the data for each of the most important components we monitor in the trial. Starting with safety, we're pleased to report that no study suspension or stopping rules were met. There were no serious adverse events, and importantly, there were no signs of inflammation, vitreous haze, interocular pressure safety signals, vasculitis, or individual dispersion of CLSAX. There were two treatment emergent adverse events that were assessed as unrelated to CLSAX, one with atrial fibrillation and one with subconjunctival hemorrhage assessed to be related to the subconjunctival lidocaine anesthetic injection. Moving now to the outcomes related to best corrective visual acuity. At baseline, prior to CLSI-X administration, the mean best-corrected visual acuity score was 59 letters with a range of 29 to 74. In cohort one, we observed important changes in best-corrected visual acuity. One month after receiving a Flibercept, three patients worsened and three improved, all within three letters. Therefore, on average, they worsened by 0.2 letters, indicating that there was no mean change in best-corrected visual acuity for patients treated with a Flibercept. In contrast, one month after receiving a CLSAX dose, five of six patients improved by four or more letters, with the mean improvement for the entire body of six patients of 4.7 letters. This was statistically significant on post-hoc analysis with a p-value of 0.029. Regarding central subfield thickness of the macula, patients had a mean CST of 231 microns just prior to receiving CLSAX. I would like to highlight here that this is essentially a normal value and creates a floor effect with CST. In other words, if patients start on average with normal values, they are unlikely to improve. Importantly, the mean CST was stable one month post-CLSAX. Durability is an important component of our treatment plan, and we were encouraged by the preliminary signs of potential durability that we saw in Cohort 1 in these highly treatment-experienced patients, especially given the low starting dose of CLSAX. We have three criteria to determine if patients need additional therapy. These include a loss of 10 or more letters from best measured visual acuity at any point in the trial, an increase in CST by greater than 75 microns, and or a vision-threatening macular hemorrhage. With the best corrective visual acuity measurement, I'd like to emphasize that we are assessing from the patient's best vision at any point in the trial, including after receiving a flibrocept or a CLSAX. As a result, patients are more likely to be retreated in our trial, which is focused on safety. Importantly, in cohort one, after receiving CLS-EX, at one month, no patients required additional treatment. At two months, four patients required retreating with the Flivercept. At three months, two patients, or 33% of the patients, did not require additional treatment. In these two patients, their vision actually improved one by five letters and one by seven letters. With these results from cohort one, we have now advanced to cohort two at a dose of 0.1 milligram. This is a 3.3-fold increase compared to the cohort one data. And ultimately, we expect a cohort three dose of 0.3 milligrams, which is a 10-fold increase over the cohort one dose. In cohorts two and three, we're also adding a three-month extension study to follow patients over a longer period of time. As George mentioned, we're very pleased with the progress in enrollment for cohort two and expect to complete recruitment this month. We expect to report data from cohort two by the end of the year. With respect to partner programs, as George mentioned, Regenexx Bio continues to advance their programs utilizing our STS microinjector in both of their phase two clinical trials, evaluating the efficacy, safety, and tolerability of supracordial delivery of their gene therapy agent, RGX314. The first trial entitled Aviate is targeting the treatment of patients with severe wet AMD who are responsive to anti-VEGF treatment. In their second quarter earnings announcement yesterday, they reported on all three of their cohorts in the trial. For cohort one, they will report interim data at the Retina Society scientific meeting that will take place from September 29th to October 2nd of this year. For cohort two, they expect to report interim data in the fourth quarter of 2021. And for cohort three, They have completed dosing in patients who are positive for neutralizing antibodies. The second RGX314 clinical trial is a phase two trial for the treatment of diabetic retinopathy entitled Altitude. For this trial, Regenexx Bio has completed enrollment of diabetic retinopathy patients in cohort one and expects to report initial data in the fourth quarter of 2021. Regenexx Bio has also reported that enrollment of patients in cohort two has begun. They have also announced plans to enroll diabetic retinopathy patients in a third cohort of altitude, which will evaluate RGX314 in patients who are positive for neutralizing antibodies. As in previous cohorts, patients will not receive prophylactic immune-suppressive corticosterotherapy before or after administration of RGX314. The continued progress by Regenexx Bio is very encouraging, and we look forward to their data presentations later this year. In addition, we're very excited about the status of our clinical development programs and the progress from our partners. We will remain active within the retina physician community over the second half of the year as we plan to have presentations at the Retina Society meeting, the meeting of the American Society of Retina Specialists, and the American Academy of Ophthalmology medical meeting, as well as participation in other ophthalmic industry events. Ultimately, we believe that CLSA-X may improve the overall patient experience with a more durable treatment and a favorable tolerability profile, and we look forward to keeping you updated. I will now turn the call over to our CFO, Charlie Degnan, to review our financial results.

Thanks, Tom. Our financial results for the second quarter were published this afternoon in our press release and are available on our website. Therefore, I will summarize our current financial status. Our cash and cash equivalents as of June 30th, 2021 total approximately $26 million. This includes approximately $7 million and aggregate net proceeds from the use of our ATM facility in the quarter, providing an additional quarter of cash runway. Our quarterly cash burn is primarily due to the work on the activities related to our CLSAX program and obtaining approval for Zypere. Investments in our broader research pipeline are also incorporated into our operating plans. Based on our current funding and planned spends, we expect to have sufficient resources to fund our operations into the second quarter of 2022. Importantly, this estimate does not include additional milestone payments we may receive under our current partnership agreements. As Zypera is approved, we expect to receive up to $15 million from Bausch & Lomb in approval and pre-launch milestones. Additionally, we will receive a milestone payment from Arctic Vision of $4 million. Thus, we may receive nearly $20 million of non-dilutive 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 investor events this month. The Webb Bush Pack Healthcare Conference tomorrow, and the AC Wainwright Ophthalmology Conference next week. I will now turn the call back over to George for his closing remarks.

Thanks, Charlie. We believe ClearSight is well-positioned for future growth, with the potential approval of Zypere, recent positive data from our OASIS study targeting large wet AMD market, and multiple clinical and commercial partnerships with top companies in their respective field. Our innovative platform makes us the clear leader in the delivery of drugs into the supercoroidal space with a reliable, non-surgical, office-based treatment approach. We continue to make meaningful progress as we execute on our internal corporate milestones, work closely with our partners, and look forward to making a difference for patients suffering from a broad range of potentially blinding diseases. I would now like to ask the operator to open the call up for questions.

Thank you. That's our CEO, George Seske. Well, at this point, as a reminder to all the participants, to ask a question, please press the star 1. And to begin with, our first question is coming from, excuse me, I mispronounced the name, Zigby Jala from Roth Capital Partners. Please ask your question.

Thanks for taking my question. Just have a couple here. The first one, just wondering if Tom can just clarify his statement around the studies being more likely to have patients retreated.

Tom, you want to take that? Sure. Thank you for your question. So the question is about our retreatment criteria. And as I mentioned in my prepared remarks, we have three criteria, one of which is, a loss of 10 letters. And we measure the loss of 10 letters from best measured within the trial. Some other companies are measuring loss of 10 letters from baseline. So in our trial where we had patients improve at the one-month visit post-excitinib, that sets a higher bar from where we start our measurement of loss of letters. So theoretically, in this example, patients could gain numerous letters after receiving Exitinib. For example, they could gain, let's say, nine letters, and then they could, on the next visit, lose 11 letters, and they would qualify for re-treatment. But in essence, they'd only be a couple letters worse than baseline. So in other trials, they would not have been treated. And in fact, we've mentioned that four patients were re-treated at month two after Exitinib, Actually, one of those four patients would not have been treated if we used criteria of loss of 10 or more letters from baseline.

Thanks, Tom. And then the other one here is, can you just describe the details of the extension period in cohort two and cohort three, and what can we possibly glean from that?

Yes, thank you for your questions. The questions about the extension study that we plan to add to both cohorts two and three, Essentially, we'll be following patients for an additional three months to have the total follow-up after Exitinib be for six months post-dosing.

Thank you. And then the last one here is just about expectations for the readout by the end of the year. I know you mentioned the data that we did see was really encouraging in terms of efficacy, but I think the only thing was durability, so I was just wondering What kind of gives you confidence that this 3.3-fold increase could result in greater durability and how you plan to leverage that data in terms of designing future studies?

Yeah, great question. The question about expected durability. So we're basing that on our preclinical studies. And in our current corporate deck, we have some slides that address this. One of the slides is from a paper we just published in Translational Vision Science and Technology. This is one of the official ARVO journals, the Association for Research in Vision and Ophthalmology. It's a peer-reviewed MEDLINE indexed paper. But in that journal article and also in our corporate deck, we showed data in our rabbit PK model where we have levels, several orders of magnitude greater than the IC50 for the VEGF2 receptor going out to six months. So I always caution when I get this question that we know the rabbit model is not directly translatable to humans, but it's directionally important. It gives us a lot of confidence that we can get multiple months of durability once we achieve the correct dose.

Thanks, Tom. Congrats to the team on all the progress, and looking forward to the data from Regenexx Bio.

Thank you for your interest. And our next question is from Annabelle Samimi. Please go ahead.

Hi. Thanks for taking my question. You touched on this in just the last question in terms of what level of durability can you expect with the higher doses. What are you actually aiming for? I guess in other words, is there a sweet spot, whether it be six months or 12 months, for patients when you think about this drug commercially, what ophthalmologists might want in terms of foot traffic and monitoring of patients? What durability do you think is ideal?

Tom, do you want to discuss that? I mean, we've talked about this internally, and I think you can answer that question or at least give some directional guidance.

Sure. So the question is about desired durability. And, you know, the simple answer is you want the most possible. But, you know, it's much more complicated than that. I think, first of all, there are no approved agents that have very significant durability. And, you know, anything better than several months will be better than what we have currently. So I think the bar right now is rather low. And then the other aspect to realize is that right now the model involves, the retina practice model involves patients returning to the physician for examination, assessment, and possible retreatment. So, to go from the current system to say you're going to have, you know, one and done is really disruptive of the current system and it may not be, you know, it may not be completely realistic for all patients. So, I think anything more than three to four months would be very meaningful in this current setting and, you know, certainly, somewhere between three to six months, what I think would be the sweet spot where you could decrease the treatment burden, but also patients will be coming back to the doctor anyway for reassessment. And I think it's less disruptive to the current retina practice model. The other aspect about our therapy is that it is a panVEGF inhibitor. And there's some evidence preclinically and also clinically that panVEGF inhibition may have potential efficacy benefits over current focused VEGFA inhibition. So we're obviously, you know, targeting multi-month durability, but we also have potential for better efficacy outcomes in current therapy with what seems so far to be a favorable safety profile.

Okay, great. And also, you know, as far as... you know, the program going forward, how are you thinking about future trial design? Obviously, it seems like you're going to be able to find an appropriate dose with this phase 1-2 trial. But when you think about the next trials, are you looking again at treatment experience patients, naive patients in combination with an active control with a placebo? How are you thinking about this trial? And I guess Following to that and your last comment, how high is the bar? Are you going to be looking for superiority or non-inferiority?

Well, before Tom says anything on that, I would just say that those are discussions we're having. Those are ongoing discussions in the company. We haven't really worked out our final plan on that, but I'm sure that Tom can give you some color around some of the issues, at least, that are related to that trial design in the Phase 2B.

You stole my thunder. It's very data-dependent. You know, we only have data from our lowest dose, Cohort 1, and obviously we're going to be looking at Cohorts 2 and 3. We'll have a better idea about the durability, you know, the potential treatment effect, And that will inform the next trial. So as George mentioned, you know, we're having those discussions now. And ultimately, it'll be data dependent.

Okay. Great. Thank you.

And our next question is from Andreas Argerides of WebBoost Securities. Please ask your question.

Thank you, Operator. Good afternoon, everyone. Thanks for taking our questions. This is . Just a quick one here. When it comes to cohort one and the patient baseline characteristics, how did those help inform cohort twos, the enrollment of cohort two, the patients in cohort two? Could you provide a little bit of color on that? Thanks.

Thanks for the question. We didn't change any of the criteria for enrollment in Cohort 2. Generally, in clinical trials, it's best not to change patient populations, you know, as this is being explored. So, we kept our criteria very consistent. very strict in terms of BCDA, patients requiring, patients have to have prior treatment, have to have persistent activity based on a reading center. And we essentially didn't change any of the criteria as we went into cohort two.

So let me rephrase the question just so I ask it correctly from my perspective. Were the results from cohort one, were you able to enrich the patient selection for cohort two based on some of the results maybe that you saw, let's say patient subjects number two and six who were responders that had durable responses? Not changing the criteria, but were you able to enrich that response?

Well, you know, we didn't change criteria, and I'm not sure what you mean by enriching, but we really kept the criteria the same. The clinical trial sites are the same. We tried to keep everything pretty much the same except for the dosing.

Okay. I appreciate that. Thank you, guys. I'll jump back to you, too. Thanks.

And our next question is from Yi Chen, HC Wainwright. Please go ahead.

Thank you for taking my question. I don't know if you can comment on Bosch House commercial preference for the potential launch of Zypia once approved and how quickly they can access formularies of various insurance payers.

Um, yeah, thanks for the question, but, uh, that's really a question better directed to, to the Bausch team. Um, we have not had, and we've worked very closely with them on the preparation of the NDA, uh, dealing with the FDA, um, their med affairs team in terms of, uh, injection training and all that, but we have not, uh, uh, really gotten into, um, We know a little bit about what they think they're going to do with the product, but the kind of questions you're asking, especially accessing formularies and reimbursement-related questions, are really best addressed to a voucher that's not something that we're really dealing with, as this product, once approved, will be their product to move forward and to deal with all of those issues. So I think that's a voucher question that's directed to them.

Got it. Has Bosch indicated that they would pursue other indications for dipyr once approved? And how long do they still have the option to do so?

If you're speaking about indications, there's been discussions about additional indications. No decisions have been made there, but we've had exchange of information on additional indications. They can pursue an indication under the contract that we have with them, the license agreement we have with them, at any time. So there's no timing restrictions on their – no reasonable timing restrictions. restrictions on them in terms of when or if they would pursue additional indications. They have the right to do that, but not an obligation to do that.

Got it. Thank you.

And before I call the next questionnaire, as a reminder to all the participants, to ask a question, please press the star one. And now let's continue. Next is John Wallaban of J&P Securities. Please go ahead.

Hey, congrats on the progress and thanks for taking the question. One maybe for Tom on the CLSAx data. I'm just wondering when we're looking at the BCBA change, when these patients have come in with pretty dry eyes and we're not seeing a decrease in fluid, would you expect to see increases like this in BCBA or is this perhaps a function of being open label or some patient motivation or Just wondering if you could comment what might be going on mechanistically here to give the visual benefits.

That's a great question, John. I'm glad you asked it. You know, it's well known among retina clinical trialists that central subfield thickness correlates really poorly with visual acuity, especially in wet AMD. And so I think it may suggest disease activity, but doesn't really correlate with visual acuity. And so it's not too surprising, especially because we're up against a floor effect that we really didn't see much change in the CST. And, you know, that is a function of the fact that we are recruiting patients who are highly treatment experienced. So I wouldn't have expected them to have, you know, very thick maculas. The best corrective visual acuity, on the other hand, averaged 59 letters at study entry. So that's, you know, roughly in the 2060 range. So there's room for improvement there. And even though there may be, one can argue there's a little bit of a floor effect, there's still room for improvement there. So I think that explains a little bit of this, and obviously we need more patients and more data to corroborate it.

Got it. That's helpful. And can you talk about when you're able to start dosing the third cohort? Do you have to wait to see the second cohort data, or is that something that can happen sooner?

Well, as you know, essentially the trial is a four-month trial. Um, we've been discussing the fact that, you know, we plan to, uh, have data by the end of the year. Um, we run that through our safety monitoring committee, um, and then, you know, hope to start the third cohort, um, at the beginning of next year. And if you just march out the study timelines, um, you could, you could readily, um, you know, guess when we would should be done with cohort three.

Okay. And, uh, one last one, if I may. I think Charlie mentioned the potential payments on the ZIPER approval. Can you remind us of the development milestones that you're eligible for from Regenexx and maybe within the context of what you've already received and what triggered those? Appreciate it, guys.

Charlie, as to the Regenexx milestones, I don't know that we've done anything other than disclose the total milestones that might be available.

That's right. There's $34 million in additional development milestones and then about $102 million in sales milestones. But that's all the detail we can give out on that.

Okay. Thanks again.

And our next question is from Serge Bellinger from Needham & Company. Please go ahead.

Hey, good afternoon, and thanks for taking my questions. First one for Tom, just a follow-up on the prior questions related to the CST. How important is it for CLS-AX to show the ability to have an impact on CST? And it sounds like you're not tweaking the patient entry criteria, so do you expect you'll be able to show some differences in the next couple cohorts here.

Well, thanks for the question, Serge. It's a great follow-up question. You know, obviously, we're looking at multiple anatomic parameters. We're looking at angiographic parameters as well. And, you know, traditionally in wet AMD trials, you know, we've looked at lesion area, CNV area, leakage area. in addition to CST, and there's other parameters as well that we'll have in the reading. So we'll have a really comprehensive battery of anatomic assessments. CST is nice because it's quick, it's non-invasive, it's convenient, you know, it's quite precise, but it really doesn't, you know, tell the whole picture with respect to best corrected visual acuity.

Okay. I guess the next one for George, to get the start of your prepared comments, you mentioned that Arctic Vision was starting a phase three trial in China. Just curious if there's any milestone payment associated with that advancement of clinical development.

There is, but there is not. It's nothing that we've disclosed due to the nature of the agreement. But that's a phase three currently set to start this year in macular edema associated with uveitis. There is a milestone associated with that, but not one that we've been able to disclose the amount.

Okay. Thank you.

And that concludes the question and answer session. At this point, I would like to turn it over to our CEO, Sir George Wysoski.

Thank you, and thank you all for joining us on the call this afternoon. We appreciate your continued interest in our company, Clearside, and we look forward to updating you on our progress in the future. Operator, you may now disconnect the call. Thank you all.

Thank you. And this concludes today's conference call with Clearside. Thank you, everyone, for participation. You may now all disconnect.