All right. Good morning, everyone. My name is Yatin Suneja. I am one of the biotech analysts here at Guggenheim. Welcome to our SMID Cap Biotech Conference. Our next presenting company is EyePoint. From the company, we have a few executives here. We have George Elston, who is the Chief Financial Officer, and we have Ramiro Ribeiro, who's the Chief Medical Officer. I'm going to hand it over to George, who'll make some opening comments. I do have a set of questions that I want to run through. Why don't you, George, make some opening comments, tell us a little bit about what's going on, how the enrollment is going. If you want, you can touch on the DME data that you presented yesterday, or we'll go into the Q&A. Sure. Thank you, Yatin. And thank you to Guggenheim for having us here today. We're really excited to give you an update on EyePoint. Just for a quick background, for those of you who are not familiar with our story, we are a company focused on developing therapeutics for delivery to the back of the eye, in particular retina. We use our proprietary Durasert E technology, which is a bioerodible formulation that allows us to deliver small molecule drugs ratably using zero order kinetic delivery over about six to nine months. And we can actually tailor that based on the drug and the indication. We are currently in two global Phase III trials with our lead program, which is called Duravyu. And Duravyu is the tyrosine kinase inhibitor, vorolanib, in our Durasert E technology. And on the heels of really robust Phase II data, in 2023, we've launched now in two global trials. And we can touch on that as we go forward. We're very excited about those programs. We updated at the beginning of January that the first trial, which is named Lugano, is about a third enrolled at the beginning of January in the Lucia trial, which started about five weeks after that. Both are exceeding our enrollment expectations through not just the end of last year, but even more robustly into 2025. So we're really excited about the program there. And then yesterday, we announced the 24-week data for our Verona trial in DME. And that's Duravyu in diabetic macular edema. We're very excited about that data. I think we, from EyePoint's perspective, that story was told when we announced the 16-week data. We saw immediate separation with Duravyu versus control. We saw both vision improvement and reduction in fluid, which was very exciting, and that was really maintained through week 24, and so we gave that update yesterday, and very excited about that program. Ramiro's going to talk about that in a little bit, but our goal is to go to FDA in the second quarter with both our data and our plans for Phase III, which we are hopeful will just be a single Phase III trial. Very good. Thank you. So first on Duravyu, I have three questions which I want you to address because we keep getting these questions all the time. How your molecule is different than the competition versus in terms of delivery, potency, et cetera. Can it be redosed? Does it have to be at a fixed interval? Yeah. So the beautiful part of Duravyu, which is the name for the program, which is previously EYP-1901. Let's start with our delivery technology, which is called Durasert. Durasert 's been in four FDA-approved products across tens of thousands of eyes, amazing safety profile. The Durasert E formulation, which is essentially the bioerodible formulation of Durasert, the main difference is we've removed a polyamide coating, essentially making that matrix fully bioerodible. And it's behaving exactly the same in all of the four trials that we've held so far with Duravyu. And so that technology is beautiful. Our inserts that are using in Phase III, and were also used in the Verona trial, are 94% drug, about 6% matrix, fully bioerodible. And we know that in animals that we measurably give zero order kinetic delivery for about nine months. So it's a great technology and a great molecule. vorolanib, in particular, which is our tyrosine kinase inhibitor, is a patent-protected molecule. It's actually not been approved in the United States, and so in addition to our IP, which we have composition of matter to 2037, we think we will also have that regulatory exclusivity as well, so we're really excited about that molecule. It's a very unique and novel molecule. We've studied it in an animal model of neuroprotection and shown that it demonstrates neuroprotection. We're hoping to see that as we advance it through the clinic, and it's got a remarkable safety profile. I think if you look at the space for sustained delivery, we stand at the top. Our safety profile is impeccable. We saw that again with Verona yesterday. No ocular or systemic SAEs associated with Duravyu or vorolanib for that matter. In fact, vorolanib was previously studied as an oral therapy in wet AMD across 150-plus patients with no ocular toxicity. We are very excited about the safety profile. I think as we all know, in retina, safety is first, second, and third. We think we've checked that box. We're feeling really good about safety. Got it. So can a patient see an insert? And at steady state, based on the dose that you're using, at least in wet AMD or other indication, which is 2.7, how many insert you'd expect in a steady state in an eye? So in the wet AMD trials, it's two inserts. Each insert is 1.34 milligrams. So it's about a 2.7 milligram dose. And as I mentioned earlier, those are 94% drug. There are likely cases, and it's true of most injectables, where patients can see them when they're injected. But the beauty of Durasert, the inserts are heavier than water. They drop to the bottom of the vitreous, and they stay there. And that's consistent with the prior products using Durasert technology. Got it. And so maybe, Ramiro, do you want to add to that? Yeah. I think first, in terms of the mechanism of action of Duravyu, it is important that it brings a different mechanism of action. And I think the retina community is looking for something to add to their arsenal of treatment. So we are blocking intracellular receptors, not just A, but also B and C. I think we're very lucky that we have the most robust data in TKI for wet AMD. We have those more than 190 patients. And when we look at the visual symptoms, we haven't seen things like vision impairment because of the implant or vitreous floaters. The rates are similar to what we have seen before. All myodesopsia did not require removing the implant, for example. In terms of redosing, of course, we have all the preclinical data that the FDA has seen that supports us to redose in a Phase III study. So we're confident in terms of the safety profile of redosing those patients. Very good. Ramiro, can you review for us the DME data? What were some of the key takeaways for you from the data that you presented yesterday? And how conceptually you are thinking about a pivotal development? I know you have not talked to the FDA yet. So there's still that study needs to be negotiated. But just talk about how you're thinking about it and the key takeaways. Sure, so I think just to give a little bit more of the background, the purpose of Duravyu is to provide gain of vision while reducing the treatment burden that we have now with anti-VEGFs, so that's what we did for our wet AMD, diabetes study. That's what we're doing for our Phase III program. The Verona trial enrolled patients with active DME, so all patients had to have fluid above 325 and some vision loss because of DME. We dosed at day one patients three arms of aflibercept plus Duravyu high dose, a aflibercept plus Duravyu low dose, and then a aflibercept plus sham, so it was an open label study, but the patients were masked, so that's why we had that sham injection. Once they were dosed at day one, after that, patients were observed for a total of 24 weeks. In that period, they were assessed every four weeks for safety, for vision, but also for the need of supplemental injection. In this study, we had five criteria. Four of them are very common for other studies: vision loss, increase in fluid, the combination of the two of them, and then investigator discretion. Starting at week 12, because those patients, they came with edema, they got one dose at day one. The feedback we got from some KOLs was, if those patients don't see a reduction in their disease of 10% in CST, they should be redosed. It's hard for you to observe a patient for six months without dosing. So those were the supplemental criteria. And I think when we think about the study, we did a release with the week 16 data, where we show in that first part of the study, Duravyu gained vision about eight, nine letters. And then the aflibercept arm gained about three letters. And there was a rapid improvement in BCVA at week four that was mirrored on the CST. And for us, what is very important, it shows that the drug has immediate bioavailability in the vitreous, reaches therapeutic effect. And we're seeing this additional benefit of Duravyu at day one, week four. Starting at week 12 and 16, patients start to get supplemental. And what we show on the release yesterday is that week 24, patient Duravyu arm still gained seven letters, seven letters, compared to baseline. So they gained the vision, and that vision was maintained. And there was no difference at week 24 with the aflibercept, which again indicates for us that if we do a non-inferiority trial design, we should be OK because the patients on Duravyu arm received less supplemental injection, which was the primary endpoint for the study, of course. In terms of safety, we continue to see a very favorable safety profile, no inflammation, no vasculitis, no endophthalmitis, no SAE related to Duravyu. So we are very happy with the results we saw. And now we're going to be working on the Phase III program, start discussing with the retina specialists, with the agencies in preparation for our Phase III program. Got it, so I think some of the feedback that we got yesterday, and I think there was some confusion, is that this was supposed to be a superiority study, but I don't think that's true. You have always run non-inferiority study, whether it's in wet AMD or this. Is that true? Yeah. So again, the purpose of Duravyu is to maintain vision while reducing the treatment burden. We know anti-VEGFs are great drugs, but they have a certain frequency that they have to be given. So for us, of course, we were very happy about what we saw, the week 16 results. But in the end of the day, the way we're going to design the trial is going to be a non-inferiority trial. Got it. Yeah. So the other point I want to touch on a little bit is on the phase 3 study design. And I think some of the feedback that have been that if you are required to do a full dose, it could either make the study longer in duration. So I'm just trying to understand the strategy that you might have to bring this product to the market fastest way possible in DME, but not extending the time. And what is your view on these loads that are required in the control arm? Yeah. I think when we are running a phase 3 program, we have to keep in mind that we have to meet the regulatory requirements for approval of that drug and also generate evidence for physicians to know how to use the drug. I think we have a few options. One option is, I think what you said and what we can mimic from the wet AMD study. Wet AMD study, we're doing three loading dose. We then give Duravyu. And then we follow those patients to week 16. For DME, that could be one option. Of course, it would be five loading dose and then Duravyu. Second option, similar to what we did for Verona, maybe day one, we give Duravyu plus an aflibercept, maybe some loading dose after that. That might reduce the duration of the study or something in the middle. But those are the good discussions that we have to have for preparation of the Phase III program. But most likely, it will be a non-inferiority study on the phase 3. Yes. It is going to be a non-inferiority study. Yeah, and I think keep in mind, depending on how we ultimately design the trial and we'll get alignment with FDA, is you can test for superiority in a non-inferiority trial, and that'll be part of our plan. That's part of the plan. OK. I think it's a pretty decent-sized market. DME, obviously, not as big as wet AMD. But just can you tell us how big that market is, DME? So from a market perspective, I think generally speaking, people see DME market about a third of the wet AMD market. In our discussions with KOLs, and I think coming back to yesterday, the difference between KOL reaction and investor reaction yesterday couldn't have been more opposite. KOLs are very excited about the data, about the opportunity for Duravyu and DME, even on just duration alone. And I think in that population in particular, the DME population, those patients don't have a great history of coming to the doctor on a regular basis. And I think what's beautiful about Duravyu and the options for physicians is they send them home with forced compliance. So you get a Duravyu insert. You're going home with six-plus months of drug delivery. And so there's a lot of excitement in the KOL community. We've had a number of calls with not just our phase 3 investigators, but our clinical and scientific advisory boards. Ramiro's getting emails last night about people wanting to be in the DME trial, which is not yet defined. I think there is potential, going back to the market question, if the data that we see in phase 2 holds to actually expand that DME market beyond where it sits today. Very good. Going to the wet AMD program now, just help me understand the difference between Lugano and LUCIA. What's driving this faster enrollment? I mean, a third of the study enrolled in a few months of study being started. What's driving that? I think when we think about enrollment rate, there are three things that are very important. First is the amount of data you have on your phase 2 study and how you communicate with the investigators. Second, you design a study that it's easy to be followed by the clinical sites and patients. So if you look at our study design from a patient perspective, they are either going to get standard of care with an aflibercept or a potential drug that is going to last long. So from a patient perspective, it's kind of an easy choice to be in a clinical study. And then third, I think operationally, we were very, very efficient. So trying to open as much sites as possible. And then now, as we move along, we're going to start to open sites ex-U.S., which also is going to help us with the enrollment. Yeah. And to your point, both trials are identical. They're both global phase 3 trials. And I think just to underscore what Ramiro said, we did a robust phase 2 trial. We had 70 sites in the U.S. for DAVIO 2. Many of those sites are now in the phase 3s. And we have, and this is not to be underestimated, having real data to go to the physicians with. And patients are going to get treatment on day one is resonating really well. What is the official guidance in terms of when these studies will complete enrollment and when they will read out both studies? Yeah. So our guidance is currently unchanged. So we expect completion of enrollment second half of this year in both trials with top line data 12-ish months after. So it is a 12-month endpoint. So sometime second half of 2026. How quickly you will be able to file a regulatory package? The NDA? Post NDA. Do you want to? Yeah. So we're going to be providing the top line results in end of 2026. We're going to be quickly trying to be as efficient as possible to write all the modules, submit to the FDA. Likely, this is going to be a priority review because that's kind of the path for wet AMD. It is our first submission. So I think as quick as possible, we're going to be submitting. OK. I think one of the unique things in this study is that there is a fixed-dose redosing. Could you maybe help us understand the comfort around this fixed? What risk does it introduce, if any? So from a safety perspective, again, we have sufficient data from preclinical studies that we redose those patients with much more payload, especially in those small animals with small eyes. So from a safety perspective, we have safety margin. And we're comfortable with the results. Of course, it's going to be the first time that we're going to be redosing patients. But we are confident from a safety perspective. Got it. Yeah. And just as a reminder, so the way the trials are designed is we're going to be doing redosing every six months. And so we will be submitting to FDA 12-month safety and efficacy. But the trial for year two will continue for safety only. And so the treated arms will get a total of four Duravyu. We want that on the label. Redosing is very important. And we'll submit year two when that data is available. Got it. Do you guys have any view on Vabysmo and high-dose Eylea? By the time you come to the market, they probably will be a little bit more entrenched. What commercial impact, if any, do you expect on your programs or on the TKI class in general once they're a little bit more entrenched? Yeah. So I think it's important to differentiate, so we are not another ligand-blocking anti-VEGF. We bring a new MOA. We have sustained delivery. We last six months or longer. Biologics just can't do that, and historically, if you look at the way wet AMD has been treated, each new entrant lasts a little bit longer than the prior one. Vabysmo being the most recent example, it's turned into a blockbuster drug, and there was an RCA paper last summer that basically said it lasts on average about eight days longer, and so we see that as a great pathway for us, but it's not an either/or discussion. Based on our data and based on how we see this product ultimately getting adopted, it's not either/or. It's with and used in conjunction with. Again, what's really interesting about wet AMD is it's the only major or one of the only major diseases that's been treated by a single MOA for about 15 years. And so what we like about Duravyu and vorolanib is that we're going to bring that second MOA. We're attacking the cell internally with the receptor binding. And as Ramiro mentioned earlier, we're also blocking VEGF, C, and D, which the ligand blockers do not. And so we see them being used together. Got it. What is the plan outside U.S.? What feedback you have gotten? And then obviously, you own the asset. How are you thinking about just opportunities in Europe? So regulatory or business development? Both. So when you talk about the regulatory approach. Yeah. So we got feedback from EMA. They are aligned with our study. Hopefully, we're going to be opening sites later this year in Europe, also other parts of the world. And then in terms of commercial. Yeah. So we've been very public. So EyePoint's a small company. We see OUS opportunity as a partner. And we are open to that. I think where we sit today, we've got time and capital. So we're not in a hurry. But clearly, commercialization OUS, we would bring in a partner for that. And for the US market, obviously, that's the big market. And while we are planning to launch ourselves, I mean, obviously, a big partner would be helpful. But if they want US exclusively, that's a different discussion. Got it. Got it. With regard to the enrollment in these two studies, should we expect periodic sort of update from you when you've reached certain threshold? Yeah. So we haven't really determined what that cadence will be. But obviously, it comes up in every investor meeting. So I expect updates at certain thresholds. What they are today, we're not sure. Our last update was beginning of the year where LUGANO in roughly 2 and 1/2 months with 1/3 enrolled. And I think as we hit key thresholds, we'll come back to the street in a month. How many sites in both studies and how many are already up and running? Globally, we have selected about 300 sites globally. Each? For both. For both studies. For both studies. How many are up and running? So we have this study up and running in the U.S. And we have for both studies about 80-100 sites active. Wow. With just these 80 or 100 sites, you got to a third. That's pretty fast. Yeah. And I think what's unique about our trial design, and there have been some very rapid enrollers. And kudos to Ramiro's team. There are scenarios where some of these sites will hit a cap on number of patients enrolled. And they'd be eligible to move over to the second trial. Very good. So it'll allow us to continue to move quickly. So in the last two minutes, just one question on the pipeline, the Tie-2 program, and then obviously then the financials. Yeah. So obviously, the team is laser-focused on Phase III. Getting those trials enrolled this year is key for us and our investors. And so that is the bulk of our organizational focus, along with planning for the Phase III opportunity for DME. But the R&D team continues to move EYP-2301, which is Razuprotafib. It's a Tie-2 agonist. We see that as a real potential next program for improvement in vision and retinal diseases. We expect some IND-enabling tox work to be done this year going into next year. And it's been put on. We've aligned resources to make sure that wet AMD and DME work first. But that's going to come in more likely as a 2026 event. And then financials, we are in great shape. Just to remind everyone, we have no debt. We ended year 2024 with about $370 million of cash. Our cash guidance is into 2027, which is about a year on the other side of the Wet AMD readout. And we have been very good shepherds of cash. And we'll continue to do that. Very good. That's all I had for you, gentlemen. Thank you so much. Thank you, Yatin. Thank you, Carol. Thank you.