Good morning, everyone. Welcome to Day 2 of TD Cowen's 45th Annual Healthcare Conference. My name is Tyler Van Buren, Senior Biotech Analyst here at TD Cowen. To kick things off with the sessions this morning, very pleased to have a hybrid presentation and Q&A with EyePoint, and it's my pleasure to introduce Jay Duker, CEO and President of EyePoint. Jay, it's a privilege to have you here. Thank you for joining me, and I'll go ahead and hand it over to you to kick off the presentation. Thanks, Tyler. It's really a pleasure to be here. I've always loved this meeting, even when I was on the other side of the table, but especially enjoy it now to be able to give the investment and analyst community some new information about EyePoint. We are a publicly traded company. If you'd like any more details about our disclaimers, you can certainly come to our website. We are the leader in sustained-release drug delivery to the back of the eye, and our lead asset is called DURAVYU. DURAVYU was formerly known as EYP-1901. It consists of vorolanib, which is a best-in-class, patent-protected tyrosine kinase inhibitor, that is in Duracert E, which is our bioerodible form of sustained delivery technology. Duracert has been in over tens of thousands of patients and across multiple indications, and it's shown really robust safety. We have done four trials so far with DURAVYU, and our phase II wet AMD trial, that's called the DAVIO 2 trial, really had compelling data. Based on that compelling data, we're able to rapidly enroll our two global phase III pivotal trials in wet AMD, and I'll be giving you a little specific detail about that shortly. Recently, we reported highly positive phase II data in diabetic macular edema for DURAVYU, and we have a strong balance sheet as of the end of 2024, $370 million in cash and cash equivalents, which gives us a cash runway into 2027. We hope well past phase III readout for wet AMD. Wet AMD and DME represent 80% of the VEGF market opportunity, so these really are the two by far largest opportunities that we expect to fill. This is our pipeline. As I mentioned, DURAVYU, EYP-1901, is now in two global pivotal trials that are well underway. We also recently reported very positive 24-week data for DME, and we have another pipeline asset called EYP-2301, which is razuprotafib in our sustained-release technology. Razuprotafib is a small molecule agonist of Tie2. By agonizing Tie2, you downregulate angiopoietin-2 and upregulate angiopoietin I, which leads to retinal vascular stability. DURAVYU, again, is vorolanib and Duracert E. Vorolanib is a patent-protected small molecule tyrosine kinase inhibitor. It blocks VEGF by blocking at the receptor level, and it blocks all receptors of VEGF, which means it inhibits all isoforms of VEGF, including VEGF C and D. In addition, it blocks PDGF, which should theoretically give an antifibrotic effect. At the doses we are using in humans, we do not block Tie2. You do not want to block Tie2. You want to agonize it. Again, if you block Tie2, you will destabilize the retinal vasculature. The features of Duracert E that make it advantageous, aside from I already mentioned how we have a very large safety database for Duracert, there's no delay in reaching the target tissue. We have immediate bioavailability. We feature what's called zero-order kinetics, which means there's essentially a microdosing that occurs every hour, every day, every week until the insert is really depleted. That lack of fluctuation allows for relatively small doses to be very effective. The way these inserts were designed is we designed them to have the drug delivery complete before the matrix is reabsorbed. In humans, we're confident that the drug should last at least six months, and in most eyes should be depleted by month nine. The remaining matrix, which in the current form is only 6% of the insert, should go away several months later. We do not have free-floating drug in the eye. Another unique feature for DURAVYU is you don't need to store it cold. It doesn't need to be in a refrigerator or freezer. It can be shipped and stored at ambient temperature. We've run four trials of DURAVYU. They're listed here: two wet AMD trials, DAVIO and DAVIO 2, a non-prophylactic diabetic retinopathy trial, and the VERONA trial, which was the DME trial. In over 190 patients, we've had no reported ocular or systemic SAEs. The safety has been quite good, and you can see some of the efficacy outcomes on the right side of this slide. In all trials, we were able to show activity of the drug. I'm going to briefly talk now about our phase III LUGANO and LUCIA pivotal trials in wet AMD. They are non-inferiority trials against a 2 mg aflibercept control. The outline and basic premise of the study was really empowered by our excellent data in DAVIO 2, which was our phase II wet AMD trial. This enrolled about 160 patients with previously treated wet AMD, randomized to either 2 mgs of our drug, 3 mgs of our drug, or an aflibercept 2 mg control arm. The results are listed here, and you can see we hit the top line, which is non-inferiority change in visual acuity. In fact, the difference between our two doses of drug and aflibercept was less than a half letter. Statistically, there was essentially no difference. The p-value for difference was 0.0009. No DURAVYU-related SAEs, I mentioned, and about an 80% reduction in treatment burden or more, depending on how you measured it. Secondary outcome, again, two-thirds of the eyes were rescue-free up to six months, and the anatomic control was quite good. This is the outline of the phase III pivotal trials, LUGANO and LUCIA. We're using one dose of our drug, 2.7 mgs, and this is the higher payload insert. This is the same insert that we first tested in the VERONA trial. This insert contains approximately 1.34 mgs of drug. Each insert is one five-thousandths of the vitreous cavity, and the matrix is only 6% in this design insert. Patients get randomized to one of two arms, 2.7 mg DURAVYU or controlled 2 mg Eylea. Patients are either previously treated, approximately 25%, or newly diagnosed, approximately 75%, and they are randomized on day one. All patients then get loaded with 2 mg Eylea. They get an Eylea shot at day one, week four, and week eight. Thirty minutes later at week eight, they either get their 2.7 mg DURAVYU or they get a sham. Patients are then followed monthly for two years. At each visit, they're evaluated for supplement criteria, and the supplement investigator is masked, so the Eylea arm can theoretically be supplemented as well. Every two months, the Eylea arm gets another Eylea. The DURAVYU arm gets a sham for masking. Every six months, the DURAVYU arm will get another dose of DURAVYU. We are going for a label of every six months, and that repeat dosing will continue through two years. We expect full enrollment for both of these trials in the second half of this year. This is a timeline of the trials so far. June of 2024, we had the final protocol. First patient dosed in LUGANO in the end of October. First patient dosed in LUCIA in January, I'm sorry, in December. As of yesterday, we were well over 50% enrolled in LUGANO, and we are now approaching 60% enrollment in LUGANO. This, again, was way beyond our expectations and way beyond what has been historically reported for wet AMD trials. These trials are enrolling very rapidly. LUCIA is enrolling above our expectations as well. We are confident that full enrollment will occur in both trials by the second half of this year. This gives us top-line data a little over a year later in 2026. Also very proud of the fact that we opened up our own manufacturing facility in Northbridge, Massachusetts, which is about an hour directly west of here, right next to Uxbridge, if you're looking for it on a map. 41,000 sq ft manufacturing facility, state-of-the-art CGMP, ready for both USA and Europe manufacturing. This is where we will do the remainder of our phase III production of DURAVYU and commercial. There are eight cleanrooms here. When it's fully up and running, we should be able to make over 1 million inserts per year, enough to service both the United States and global market. Their registration batches are in the works to support the future NDA filing. Once again, we are planning for success in making sure that this technology stays within our company, and certainly the control of COGS is really important to us as well. Let's talk about DME now. The Verona trial was a 24-week open-label trial in patients with previously treated DME. DME is another potentially billion-dollar market. In 2030, there is estimated to be over 50 million diabetics in the United States alone, of which about a quarter will get diabetic macular edema. In another five years, it is estimated it will be about a $4 billion global market. Delayed and missed visits matter. Just like in wet AMD, if patients cannot come in for the required injections, they will not gain the required vision. In fact, can lose vision permanently, and studies have suggested that even the loss of one injection scheduled can lose a line of vision. This is not just an individual problem. This is an economic problem for the United States. The vision loss related to diabetic retinopathy is estimated to cost the U.S. $500 million by 2050. There is a great unmet need, not only as individuals, but in our society as well. This is what we hope to accomplish. What you can see here at the top is label for Eylea and Eylea HD in DME, what the injection frequency is in the first two years, Lucentis and Vabysmo below that, and what we hope to accomplish using DURAVYU every six months in DME. The VERONA trial, the structure is shown here on the slide. This is the first trial we re-enrolled all patients with active disease. In our prior wet AMD trials, patients could be active or inactive. We really did not make a distinction at the beginning of the trial. All these patients had to have fluid and decreased vision with active DME, and in fact, there was an eight-week washout period of the previous treatment before they could be enrolled to ensure that. This was also open label, and some of you may be aware that we released interim 16-week very positive data and recently released the 24-week data. The primary endpoint of the study, however, was a little different. It wasn't change in visual acuity, even though obviously the visual acuity is what we're concerned with, what patients are concerned with, and what the FDA is concerned with. The primary endpoint of the study was time to first rescue, again, to show that we had more durability than standard of care. On day one, all patients got a single aflibercept injection. There was not a full load in this trial. Thirty minutes later, they either got a sham or they got 1.3 mg of DURAVYU or 2.7 mg of DURAVYU. Again, this was the first time that we tested the new higher payload injection. We also key secondary endpoints, obviously safety, change in visual acuity, and anatomy as measured on OCT. We had supplement criteria, and here is the first four supplement criteria. These supplement criteria are essentially the same thing we used for wet AMD. I would say they are standard for phase II or phase I trials. In addition, however, we had a fifth supplement criteria for this study. The fifth supplement criteria was, as of week 12 or beyond, if the patient's OCT had not dried by 10%, they should be supplemented. That is a supplement criteria that was unique for this study, and the reason we put it in is that all of these patients had active disease. If they had active disease, we did not think it was fair to watch a patient who was not improving throughout the whole study, that the patient should have the opportunity to get better. That is why this was put in. As it turns out, 80% of the supplements in this trial were due to this fifth criteria. I can assure you, in our pivotal trial, we are not going to be using this criteria since it certainly was not needed in this trial. In the real world, it is not something that doctors use at all. Top line, we met the primary and all the key secondary endpoints. Not only did we show a superior dosing interval to what is typically done for Eylea, but we also had significant improvement in both vision and anatomy. The unique thing about this, as you'll see from the subsequent slides, the vision and the anatomy were really tied together, and that's not always the case. Sometimes you will see better anatomy and the vision will lag, but our drug showed immediate at four-week improvement in both vision and anatomy. Best corrected visual acuity in the high dose, 2.7 mgs, which is what we're going forward with in the pivotal trials and what we'll commercialize, was a little over seven letters. We had early and sustained CST improvement of about 76 microns. Once again, really clean safety profile, really nothing at all. In this trial, there were only four TEAEs, one of which was elevated pressure in the Eylea arm. The other three, one of them was subconjunctival hemorrhage, which is from the injection. Really, really clean safety here. Here are the results. First of all, for primary endpoint, remember it was time to first rescue. This slide shows rescue-free rates, including each visit. At the end of the study, 64% of the 2.7 mg arm were rescue-free and half of the Eylea arm were rescue-free. This was the primary endpoint, which was positive. I want to highlight the supplement-free rates up to week 24. This is the standard way that these are discussed in these sustained release trials. Just to remind you, for example, Vabysmo talks about approximately 45% could make it up to four months, which meant 45% did not meet the criteria at three months. The other way to think about it is in a pivotal trial, and if we get a label for six months at 24 weeks, that is when the patients will get another DURAVYU. You can't get supplemented if you're getting a mandated injection. The other way of thinking of this supplement-free data is who was supplement-free up to 24 weeks, and the number was 74% at 2.7 mgs. What we would expect in a pivotal trial would be to do at least that well. Of course, if you take away that fifth criteria, we think the supplement-free rate in this population would be even better in a pivotal. 2.7 mgs had a reduction in treatment burden by over two-thirds. Mean change in best corrected visual acuity, that's what we really care about. I've cut the slide off at week 12, and the reason is there were no supplements up to week 12. There's no confusion here about how these eyes are doing. These eyes are based on purely DURAVYU with an Eylea versus Eylea alone. You can see there's a significant difference in the 2.7 mg arm unsupplemented up to week 12. I like to highlight the week four result because once again, this is very unique. At week four, there was a significant improvement in visual acuity in both the DURAVYU arms. This, again, could certainly be explainable by our differentiated mechanism of action. It may be explainable by the fact that we block C and D. DME is an inflammatory disease, and there's an anti-inflammatory component to blocking all the VEGF receptors. That may be altogether the reasons we've seen such a fast and robust effect on vision. At the end, all three arms had virtually the same vision, which we, again, when we look at doing a non-inferiority type trial for pivotal for approval, we have great confidence that our drug would be non-inferior to Eylea. One of the things I want to mention, though, is there was an outlier in this trial. You notice how the 2.7 mg takes a dip between week 20 and week 24 of the visual acuity. That was based on one patient who came in late for their week 20 visit, and their week 20 visit became the week 24 visit. They got rescued. They improved. If you look at the data without that patient, taking that one patient out, there's quite a difference between our drug and control. Now, the interesting thing about this is look at the visual acuity improvement. By week eight, it maximizes in our arm, minus that one patient, and the visual acuity doesn't waver. There were a few other rescues given, but notice the rescues didn't seem to make a difference. As I said, that rescue criteria that we added did not really show any improvement. There may be a ceiling effect we are seeing in this arm. In fact, plus 10 letters, when you look at the approved drugs, how much did Eylea get better in their phase III trial? It was about eight letters. This arm, minus that one patient, looks like it is doing even better. CST follows. Immediate reduction in both DURAVYU arms in CST, much greater than a single shot of Eylea. Even if we end up the same, which they did not, we had a much better, much more robust improvement. The idea of improving rapidly in this disease is important, especially if you have got durability. Patients and doctors will be confident in that early improvement that this will stay and that this will be stable. Again, very little wavering in the OCTs in the 2.7 mg group. I now want to show you a subgroup analysis. This is the subgroup for patients who were supplement-free. Taking away all the supplement-free, I'm sorry, they're all supplemented patients, supplement-free patients alone, you can see that the 2.7 mg arm did great. Well over 10 letters improvement, much better than the control group, which is only three letters improvement. Once again, look at the stability of the visual acuity. It's not as if these patients in the real world would have been supplemented. They're not slipping a vision, nor are they slipping in anatomy. The supplement-free eyes did really, really well. This slide reflects that also. At the end of the study for the supplement-free eyes, about half of the DURAVYU patients no longer had DME. None of the supplement-free Eylea eyes had no DME. They still had it. Therefore, in the real world, would have continued to be treated. A couple of cases that I think will highlight this. First of all, this is a patient in the 2.7 mg arm never got supplemented. Last treated before the trial, they got a shot of Vabysmo about six months before the screening visit. Notice the vision, 50 letters. Notice they had fluid. Six months after Vabysmo, you could say maybe it's worn off. A couple of weeks later, when they actually entered the trial on day one, they had slipped vision, had a lot more fluid. Four weeks, fluid gone, vision improved, and that lasted through six months. Now, if you look at the bottom and look at, this is obviously just DURAVYU alone because the Eylea had washed out. Six months after DURAVYU versus six months after Vabysmo, we look better. This is an even more compelling case. This patient was getting Vabysmo almost monthly leading into the trial. The top picture, the last time they had gotten a Vabysmo was about two months, 72 letters, still had fluid. Once again, by screening, that fluid had increased. At month one, the fluid was slightly better, the vision was slightly better, but look what happens. Month four, even better improvement. Month six, patient is dry and the vision is significantly better. In this patient, our drug did better than Vabysmo with no supplements. Again, safety, no issues. Talked about this already. No sign of insert migration. We've not had a case of endophthalmitis from our injection yet, and we did not see any IOI in this study. We met all the primary key secondary endpoints, immediate improvement, immediate bioavailability, meaningful reduction in treatment burden, and these results were really driven by our drug with favorable safety. We are on track for continued execution. We are well funded through the key milestones. We have got an end of phase II meeting. We are expecting to discuss DME next quarter. Stay tuned for full enrollment second half of this year. Thank you very much. Great. Jay, thank you very much for that presentation. Included some exciting updates there, but you ended with DME, so I am going to start with that. We had our ophthalmology panel yesterday morning where the KOLs or expert panelists said that you guys probably have about an 80% probability of success in phase III with DME given your data. They actually said that more DME patients could potentially be treated with a therapy like this as opposed to wet AMD given the need for longer duration and control in this patient population. With the new analysis that you provided, the ceiling effect is very interesting. Where you remove that one patient, can you just elaborate on why it makes sense to potentially remove that one patient from the analysis? When you say, "Does it make sense?" It is what it is. We showed you the whole data set, but if you frame-shifted that patient left and their 24-week had been a 20-week visit when they were supposed to come in, our eyes would have done a couple of letters better at the end. I think it's a fair analysis. I think, again, when you have this is a small N trial. When you have a larger N, eyes like that, that might be outliers, you expect to be randomized equally across both arms. Remember, in a non-inferiority trial, we do not have to do better than Eylea. There is quite a bit of evidence here. We might be better than Eylea, but we do not have to be. In fact, I like to remind everybody, high-dose Eylea was 1.4 letters worse than 2 mg Eylea, yet it was non-inferior approved and is being used. Yep. I think Pavblu was even like a letter worse than 2 mg, and KOLs were saying it could take 50% of the market from 2 mg by the end of the year. Because one letter to a patient in a KOL is imperceptible. That is why. What about eight letters like that Vabysmo to DURAVYU patient? Eight letters. Everybody agrees that eight letters is significant. Patients notice when you get past four to five letters. Remember, there's always a fluctuation. Many of these patients, at least in wet AMD, are elderly. They may come in one day and they're 20, 30 minus two letters, and the next day they're 20, 25 plus two letters. Nothing changed except that there's a certain variability. You can imagine yourself at the eye doctor squinting to see that one last letter. Whether you get it or not doesn't really matter. Makes sense. I thought the bar chart showing half of the patients with no DME was pretty striking versus 0%. Maybe you could just elaborate on how you define no DME. For that, it was 325 microns or less. That was a pre-specified. What it tells you is that in the real world, at least half of the DURAVYU eyes would not be treated. Probably more because we will tolerate a little bit of fluid in DME, provided the vision is good. Whereas you would argue, and I will state it, the Eylea arm was relatively undertreated because half of them still had DME in that those eyes in the real world would have received more treatment. Okay. Given this data, how do you think about your path forward in DME? Obviously, you have the wet AMD program ongoing that we'll talk about in a second. How are you balancing the focus on that pivotal program with DME, and what should we expect for the next updates? Great question. Balancing the focus is easy. We are totally focused on wet AMD. That is our value. That is what we believe will be a winning study and a winning drug for us. We are conserving capital at this point to make sure that we have enough cash beyond the readout of wet AMD to suit us well. That really, when you say balancing, we're not actually balancing right now. We will talk to the FDA. We will discuss potential pathways forward in the pivotal trials. At this point, we are not going to put the wet AMD program at any risk. Okay. Sounds great, especially in this ongoing environment in biotech. Wet AMD, so a third enrolled in LUGANO in January, and a month later, over 50%, approaching 60%. That's a pretty striking jump. Yeah. Why did that occur? Maybe you could elaborate on what happened in the beginning of the year. First of all, I have to acknowledge our CMO, who's here in the room, Ramero Ribeiro. It's his doing and his people. I will say also, doing a phase II is important for a lot of reasons. It's de-risking. We learned a lot of lessons about how to enroll wet AMD trials from our phase II. There were things that we could have done better, and we took those things and we're changing them in the pivotal. I think our protocol is easy for doctors to understand. Everybody gets treated. We're not withholding treatment at all. We're protecting the patients in both arms with sufficient rescue. Again, the doctors understand it, the patients understand it. We have a very good safety track record also, which makes doctors more comfortable. There are a lot of factors and external factors that are ongoing in the world right now that, frankly, are probably helping everybody enroll wet AMD trials. The last two months in LUGANO have truly been record-setting, almost double what anyone else has ever recorded for enrollment. Now, can I guarantee it's going to continue? No, but we're getting there. I mean, we are enrolling very rapidly, and doctors and patients so far are very happy with the trial. Maybe you could elaborate on what's going on in the world right now that also has some influence on your enrollment. Yeah. A couple of things. Obviously, there's this macroeconomic things that are affecting individuals as they're worried about losing insurance and things like that, which makes a trial attractive. Number two is there is currently a shortage of Avastin, and therefore, patients are really left with a branded drug when they're newly diagnosed. There was a not-for-profit called Good Days, I believe, that was set up by some of the major companies in this area. What they were doing is they were helping to fund the 20% or the copay that patients who didn't have insurance for the branded drugs. That was not funded this year. So far, since January, the combination of the shortage of Avastin and the lack of Good Days has, I think, incentivized patients to think about a clinical trial when they might not have. Very interesting. We're up on time, unfortunately, but I figured I'd wrap up the conversation asking you what you believe is the most underappreciated aspect of the EyePoint story by investors right now. I would say the whole story. I mean, we have great phase II data. We have two rapidly enrolling pivotal trials. I don't think anybody argues that if we get approval with a Q6 month interval, we're going to be a multi-billion dollar product. We're almost there. The enrollment is getting there. I think that each day that passes, our risk is less. We have a second potential multi-billion dollar program now as well. I would say what's being missed is we are grossly undervalued now. We think our probability of success is quite high right now. Great. Yeah. Survey data on the panel said 33%-50% of the wet AMD market, which is obviously $15 billion and growing. Pretty large opportunity. With that, we'll go ahead and wrap. Jay, thank you very much. Thank you, Tyler. Thanks, everybody, for being here. That's great. Thank you.