EyePoint, Inc. (EYPT) Earnings Call Transcript & Summary

Welcome, everyone, to the 44th Annual JPMorgan Healthcare Conference. My name is Tessa Romero, and I'm one of the senior biotech analysts here at JPMorgan. Our next presenting company is EyePoint. And presenting on behalf of the company, we have President and CEO, Jay Duker. Jay, over to you.

Well, thanks, Tess, and good morning, everybody. I hope you've had your jolt of coffee this morning, but I expect this presentation and subsequent discussion will really wake you up. So as Tess said, I am President and CEO of EyePoint. These are our legal disclaimers, which if you'd like to read more, feel free to go to our website. EyePoint is the leader in sustained-release drug delivery for retinal disease. And the #1 reason for that is our lead product DURAVYU. DURAVYU is currently in Phase III trials for wet age-related macular degeneration. Both trials are fully enrolled, and we anticipate the top line data from both trials this year, starting midyear. In addition, DURAVYU is also in Phase III DME and the program is underway, and we are on target to dose the first patients in both trials this quarter. Durasert is our proprietary delivery system, and it has been in 4 FDA-approved products with a strong safety and efficacy record. We have a veteran leadership team, some of whom are next to me up here in the podium. And we have over 3 decades of experience, not just with clinical drug development, but equally importantly, with the successful commercialization and manufacture of drug. Speaking of commercial manufacturing, we built our own commercial manufacturing facility in Northbridge, Massachusetts. If you're looking for it on a map, it's right next to Uxbridge, Massachusetts, about 45 minutes west of our headquarters in Watertown, but obviously, that is still in the United States. That facility has been up and running for over a year. We now have about 60 employees there, and we are gearing up for pre-approval inspection as well as commercial success with manufacturer. Our financial situation is terrific. As of the end of the year, we had approximately $300 million in cash, which gives us a runway well past data into the end of 2027. This is our pipeline. Again, we are in the 2 largest markets for retinal disease, wet AMD and DME in Phase III in both. In addition, we have a pipeline drug that is moving forward, EYP-2301, which is a TIE-2 agonist, also sustained release. Following the history of anti-VEGFs in both wet AMD and DME, it's an interesting story of how relatively small gains in durability led to very successful multibillion-dollar products. And in fact, the most recent, of course, is Vabysmo, now almost a $4.5 billion product 3 years after the launch with, again, just relatively minor improvements in durability. So here we are in 2026. And if you ask the question, okay, what are the unmet needs in these VEGF-mediated disease. The first one still is longevity because in the long term, despite these excellent drugs we have, patients still lose vision. And the primary reason for that is they just can't keep up with the necessary visits and injections over years. The second unmet need is new mechanisms of action. And it's becoming increasingly clear that VEGF suppression is not the only story, but inflammation plays an important role in both these diseases, and we believe DURAVYU will be the solution for both of these problems. Vorolanib, which is the active ingredient in DURAVYU, is a small molecule tyrosine kinase inhibitor with multi-MOA. It addresses both the vascular leakage that is the result of elevated VEGF and PDGF levels. And it does it, of course, with a new MOA at the receptor level. In addition, vorolanib is able to block IL-6 signaling also at the receptor level. IL-6 is a potent pro-inflammatory protein. And by blocking it, we can reduce not only inflammation leakage, but also suppress VEGF. Our delivery system is called Durasert E. It's the next generation in sustained-release intravitreal drug delivery, and we have 3 decades of experience developing sustained release in the retina drug for drug delivery. Our technology, again, spans 4 FDA-approved products, including Vitrasert, Retisert, ILUVIEN and YUTIQ. DURAVYU is different in that it is fully bioerodible. The first iteration of DURAVYU had a payload of approximately 1 milligram of vorolanib, and our scientists were able to improve the insert so that the inserts now contain 1.34 milligrams of vorolanib. This represents a drug payload of 94% of the weight and volume of the insert. Most intraocular inserts are about 50% to 60% drug. So this is a really unique formulation to deliver vorolanib sustained release. There are multiple advantages of DURAVYU. I've already spoken briefly about the multi-MOA, which we uniquely provide. But Durasert allows for immediate and sustained therapeutic levels of drug. In animals, we can measure vorolanib within hours after injection, and we can sustain it in humans for at least 6 months, and we believe virtually everybody. The release is also controlled, and this is important. We designed these inserts so the matrix holds the drug until the drug is completely eluded. So we control drug release until the end. Therefore, no free floating drug particles in the eye. One of the unique aspect of this, which I think will really help us in commercial success is the convenience. DURAVYU can be shipped and stored at room temperature. All the other approved drugs, and I believe all the others that are in investigation now are either refrigerated or frozen. From a safety perspective, our inserts contain no PEG and contain no PLGA. I think this slide summarizes very well why we are so confident that DURAVYU will be a market leader. You can see the important things that retina specialists are looking for in treating these VEGF-mediated diseases. Of course, you have to have VEGF inhibition. But DURAVYU also has IL-6 inhibition. In addition, we block PDGF, which should be helpful as fibrosis is another reason that eyes lose vision in the long term. We have at least 6-month durability, and we can redose, and we are testing it as every 6-month redosing. Also, ours obviously can be administered in the office through a standard intravitreal procedure. And as you look at the single approved sustained release device, that's the port delivery system and all the other competitors in the space that are being developed, we are uniquely positioned here. We've performed 4 trials and completed them successfully, including a Phase I called the DAVIO trial, which was previously treated wet AMD patients. And we are almost at the 5-year anniversary of the first patient dosed in that Phase I trial. And I do like to point out what great execution we've had over those 5 years. So we've gone in 5 years performing 1 Phase I, 3 Phase IIs, and we're now in 4 Phase III trials. The other Phase II were the DAVIO 2 trial, again, a large trial enrolling previously treated wet AMD patients, the PAVIA trial, which enrolled NPDR and the VERONA trial, which is our Phase II DME trial. All of these trials showed efficacy and all showed safety. With regard to safety, as I'm sure you know, this is a really important topic in the retinal space. And I'm delighted that these 4 trials, there have been no reported ocular systemic SAEs due to the review of vorolanib, and we've had no safety signals. In addition, in the ongoing Phase III LUGANO and LUCIA trials for wet AMD, we're monitoring the masked safety, and we have seen similar safety as we have seen in these previous trials. Nothing new, nothing unremarkable. And I would like to add in the timing of the trials that all the patients who have enrolled in these Phase III, approximately 450 likely have received our drug. All of them have received the first dose. And by now, about 50% of them have got their second dose and the safety persists. So let's talk a little bit about the wet AMD program. We believe we're in the position to be first to market among all these investigational sustained delivery, and we believe we will have the best-in-class profile. The key elements of the Phase III design is, first of all, we did a large Phase II, and we learned a lot from the Phase II about our drug, about how it works, about who it works in and how to conduct large wet AMD trials successfully. The trial was developed in align with both FDA and EMA. And in fact, we had European sites enrolled patients in the LUCIA trial. The primary endpoint is noninferior change in visual acuity versus an on-label Eylea control. This is the same trial design that the last 5 anti-VEGFs that have been approved successfully used. And we believe and have evidence, of course, that we will be the first pivotal program that's evaluating redosing of sustained release in both trials throughout the entire trial. Both of these trials are fully enrolled, and they enrolled in record time. Each trial enrolled over 400 patients in about 7 months. Typically, wet AMD trials take about a year to enroll. And I think this is a testament, first of all, to how accepted our drug profile is in both the retina community and for patients. I think this speaks very well for our potential commercial success. The top line dates are a week 52, week 56 combined. And again, the first trial, the Lugano trial, we expect the top line data sometime in the middle of the year with LUCIA data to follow. This slide shows the schematic of the pivotal trial design. Again, noninferiority regulatory pathway, which is the tried and true. We are testing a single dose of our drug, 2.7 milligrams of DURAVYU against the aflibercept 2-milligram control. And again, the FDA insists that if you're doing a non-inferiority trial, you have to use on-label either Lucentis or 2-milligram EYLEA, and you have to randomize the patients on day 1, and we're doing that. All patients get loaded with 2 milligrams EYLEA over the first 3 visits. And on the third visit, they either get a sham 30 minutes after the EYLEA or they get their dose of drug. Patients are then followed monthly. A masked observer determines whether or not the patient meets what we refer to as supplement criteria. So if the patients had recurrent fluid from best on study of 75 microns or drop in vision of 5 letters from best on study, then the eye will receive a supplemental EYLEA injection. Notice that we're redosing every 6 months. Primary endpoint is 52, 56 weeks combined, which is derisking and also at the request of the FDA, this is a 2-year trial. The second year is for safety. We will be able to submit the NDA after 1 year. This slide summarizes the results from our DAVIO 2 trial. It was both doses, 2 milligram and 3 milligram that were tested in the DAVIO 2 trial were statistically non-inferior to the EYLEA control. And you can see the absolute change in vision was less than 1 letter. Now remember, when you're reading the eye chart of the doctors, that line is 5 letters. So there was less than half a letter difference. And so statistically identical to on-label EYLEA. All the other secondary endpoints were met, including a significant reduction in treatment burden between 75% and 90%, depending how you measure it. About 2/3 of the patients were able to go up to 6 months without reinjection. And we only injected these patients once with DURAVYU in this trial. And the trial went out to 12 months. 50% of the eyes did not need supplement injection at the end of the year. So while we are going for an every 6-month label, we believe some of the patients can go longer with this injection. The only difference, and you can see it on this chart is that the higher dose of 3 milligrams had slightly better anatomic control on OCT. OCT is a measure of permeability. Normal thickness in the retina is about 300 microns. When you get above 325 microns thick, that usually means there's excess fluid. So when you're looking at differences of 5 or 10 microns, that's less than the standard deviation on the test. The other thing I want to point out, and this is important, is while these were previously treated patients, both groups had an improvement in vision in this trial. So our drug was able to improve the vision, albeit slightly. We went back and did multiple subgroup analyses from the DAVIO 2 trial. But one of the subgroup analyses that we did is we wanted to look at the patients who were in DAVIO 2 who would have been eligible for the pivotal trials. So some of the eligibility criteria was changed. And therefore, we wanted to see how the Phase III eligibility criteria would have affected the results from the Phase II. And the answer is it didn't. The results were robust for the patients who would have met Phase III criteria. You can see the visual acuities were between approximately 1.5 letters and 2 letters, and there was no statistical difference. The bottom graph is the OCT, which is the anatomic results of these same patients and notice again at the end of the study, very good anatomic control in all 3 arms. This gives us increasing confidence for the Phase III result. About 1/3 of the patients were supplemented in the Phase II at the primary endpoint. However, we have changed the supplement criteria for Phase III. Ramiro Ribeiro, our CMO, who's at my left, his group did some important work to look at the supplements and answer the question, which supplements made a difference? In other words, if you had a supplement criteria, the patient received a supplement, but the vision didn't improve in a sense, you wasted a supplement and you didn't help the patient. So we then went back to DAVIO 2 and said, let's apply the supplement criteria that we're now using in pivotal to the DAVIO 2 patients. And say, how many would have been supplemented. So the bars on the left were the numbers of supplements from DAVIO 2 and on the right were the ones who met criteria for Phase III. You may remember, and if not, I'll remind you that about 20% of the supplements in DAVIO 2 were at the physician discretion and met none of the criteria for supplementation. So you can see across all 3 arms, there would have been a significant reduction in the supplement rate by anywhere between 1/3 and 50%. And you can see in the higher dose, the 3-milligram dose, only about 13% of the eyes met the criteria, again, giving us confidence in the Phase III result. These pictures show you our new commercial facility in Northbridge, Massachusetts, 41,000 square feet, built completely from the ground up to our specifications by our landlord, and our landlord gave us a terrific deal. We didn't start paying rent until it was fully occupied less than a year ago. And so this facility was built to FDA and EMA standards, and we are currently completing registration batches for stability for our NDA. And again, we are amidst in preparing for not only the pre-approval inspection, but also for commercial success and the ability to scale and makes hundreds of thousands of inserts a year at the facility. So now I'd like to talk about DME, diabetic macular edema, and we are the only TKI development at this point for DME and Phase III program underway. We had a very positive Phase II VERONA trial for patients with previously treated DME who are active. Again, this is aligned with both FDA and EMA. And we're using the same clinical trial infrastructure that we used for wet AMD, giving us confidence that we can enroll both of these trials rapidly. We are doing 2 trials in DME for global approval, but we are able to leverage the safety data from the wet AMD trial. So each of these trials will only have to enroll approximately 240 patients. This is the schematic of the Phase III DME program. We call the trials COMO and CAPRI. They're identical. And just small difference from the wet AMD trial is we're dosing DURAVYU on day 1, not at week 8. But again, it's non-inferiority change in visual acuity against EYLEA on label. EYLEA on label has a load of 5 injections monthly before it goes to every other month. We're only doing 3 injection load in the DURAVYU arm. Secondary endpoints, of course, similar safety, resolution of fluid, percent of the eyes that are supplement free at the 1-year endpoint. This graph is from the high dose in the control group in the VERONA trial. All of these patients had active DME, they have fluid and decreased vision. On day 1, they either got an EYLEA injection or they got EYLEA and 30 minutes later, they got 2.7 milligrams of DURAVYU. The red boxes show you what happened at week 4. Notice the DURAVYU eyes at week 4 were already 4 to 5 letters better, and they were 50, 60 microns thinner. That to us did not represent solely a VEGF response, an anti-VEGF response. EYLEA is a great anti-VEGF. This represented something additional, and this is what set us out to discover that vorolanib was also a potent JAK1 inhibitor. And therefore, through that, we block IL-6. At the end of the trial, we were identical to EYLEA in this trial. And if we, of course, do a non-inferiority trial in the Phase III, so if we end up identical to EYLEA, obviously, we're going to be non-inferior and likely approved. But if we can show the same effect at week 4, we show better vision in dry retinas versus EYLEA. I think that will lead to great commercial adoption and success of our drug because what patient wouldn't want to see better faster. Now one of the patients in this high dose missed some visits. And you can see between week 20 and week 24, there was a drop in the vision overall from 10 letters to 7 letters. If you actually remove that patient, the rest of the group had a 10-letter improvement. So we have increasing data, both preclinically and clinically that IL-6 makes a difference. I'm going to show you a study that Genentech did called the BARDENAS trial, which was a trial of diabetic macular edema patients who received either Lucentis on label or Vamikibart, which is an IL-6 biologic monthly. This is the improvement in vision if you give them Lucentis alone. When they received Vamikibart on top of the Lucentis, notice at week 4, there is a substantial improvement in vision over anti-VEGF alone, which was sustained. On top of that, I've now shown you what happened with our 2.7 milligram eyes that were not supplemented, that they received an EYLEA on day 1, they received 2.7 milligrams DURAVYU on day 1, and they received nothing else for 6 months. And you can see it overlaps the IL-6 plus anti-VEGF blockage. What's the difference? We accomplished this in 2 injections. They required 12 injections to get that result. Some additional evidence from Verona. This is a measurement of vascular leakage, and that's a biomarker for vascular integrity. And you can see in a dose response, our drug reduced vascular leakage significantly more than EYLEA. And finally, a case, as you're probably aware, Vabysmo is really the treatment of choice for most doctors now in DME. This is a patient on the top right, you can see before the trial was getting Vabysmo monthly, suggesting that the retina specialists didn't feel that the response was enough to allow Vabysmo to be extended. And in the top left OCT, you can see there's fluid. And by the time the patient got enrolled in the trial, the fluid had actually increased. They received 2.7 milligrams with one shot of EYLEA and received nothing else through week 24. And notice at week 24, this eye was 8 letters better than they were with Vabysmo and [ dryer ]. Now you can imagine if we can do this with a significant group of Vabysmo patients, how commercially successful we will be. So in summary, only DURAVYU in the sustained release field shows a novel multi-MOA with 6-month durability. We have robust data from both Phase I and Phase II efficacy, both wet AMD and DME, favorable safety so far, including the mass safety data from our ongoing Phase III trials and the top line data is coming in approximately 7 months. The DME program will have first patient in shortly. Thank you very much.

Thanks so much, Jay. So I thought I would start our conversation here just taking a little bit of a step back and before we get into some of the details of DURAVYU and the emerging product profile, can you talk a little bit more about what you are seeing in terms of what physicians are reaching for in the market to try and extend the treatment interval for wet AMD?

Yes. So I think, again, with the data around the acceptance of Vabysmo shows it's now over a $4 billion product. High-dose EYLEA is approved as well, and I believe just recently got a label for every month dosing, and that's important to retina specialists. About 20% of eyes, no matter what you give them, have to be treated monthly. And if you look at the Vabysmo study, about 50% of the eyes could not be extended beyond 8 weeks. So despite these 2 innovative drugs, we still have a great need for more durable therapies. I suspect, and again, as a very, very part-time practicing retina specialists that these 2 will compete until a better sustained release option comes out.

And how has the feedback from the physicians and institutions evolved over time about DURAVYU? What is the level of awareness that you think is around the emerging TKI class in DURAVYU specifically?

Yes. So it's interesting because our commercial team talks about an A to B shift, meaning, A, is the way you do things now and B is the way we hope you do things in the future. And physicians are used to this paradigm of the next anti-VEGF saying, don't use the old one, use us because we are better, we last longer. We're not another anti-VEGF. We do things that they can't. We last 6 months and should be in virtually all patients. We block PDGF, we block IL-6. So we have other things to offer their patients. And in addition, it's not an either/or. I notice in our patient -- in our studies, all the patients are getting loaded with EYLEA and some get supplemented with EYLEA. So the idea of using 2 mechanism of action, I mean, what chronic disease nowadays isn't treated with more than one mechanism of action, including glaucoma. Our ophthalmologists are used to that. And I think that will be likely a paradigm that's going to be used.

Okay. And just a couple of housekeeping questions before we get into some scenarios around the data. Should we expect 2 top line announcements from EyePoint or do you think they're going to be together?

So the plan right now is they're likely to be separate. One never knows, but our plan is to when we have locked the data on the first trial and are confident in the result, we will release it.

Okay. And if I did my math right, maybe I didn't, but it seems like there will be one more DSMC meeting before the top lines.

Ramiro, do you want to comment on that?

Yes.

And maybe what you've seen to date might be helpful, too.

That's right. So we, as a company, we provide oversight of the safety of the studies on an ongoing basis. So we review that data on a masked fashion, of course, on an ongoing basis. And then we have an independent DMC that reviews the masked data every 6 months. So we had so far 2 meetings, the last one in November. We're going to have another one in May. So this is before the top line results. They're going to be reviewing the data. So far, both the mask assessment tell us that the safety profile overall is very similar to what we have seen before in our Phase I, Phase II studies. So everything as we expected. And very importantly, the DMC reviewed the mask data and told us that there is no need to change the protocol or the conduct of the study.

Okay. And what -- can we talk a little bit more about what you think represents positive data here for each of these studies? And what relevant detail do you plan to provide at the time of your top line?

Sure. So I think...

Sorry. And Jay, just in that context, just I know we talked a little bit about your primary endpoint, but what are you specifically looking for around your secondary endpoints of reduction in treatment burden and percentage of eyes free of supplemental EYLEA injections?

So I do believe it's going to be pretty straightforward. We need to be statistically noninferior to 2 milligram EYLEA. The actual numerical difference will probably not matter unless we're superior. And frankly, while that's not our expectation of superiority, we have some data to suggest that we could be numerically superior, including the DME data without that outlier, we were 3 letters better. And the wet AMD data, if you looked at our DAVIO 2 trial and you just looked at the unsupplemented eyes, the DURAVYU arms did slightly better visually than the EYLEA did. But we need to be obviously to hit the primary endpoint. And I do like to remind everybody that retina specialists, if we're a letter or so worse, probably doesn't matter. High-dose EYLEA was 1.4 letters worse than 2-milligram EYLEA, but it hasn't stopped my colleagues from using the drug. Obviously, safety that goes hand-in-hand with efficacy here. And you just heard from Ramiro that we now have given our drug to approximately 650 patients and really aren't seeing anything at this point, which would suggest an issue. Obviously, the study is not done yet there. And the third thing we need to do is in the secondary endpoint is be statistically superior to 2-milligram EYLEA in reduction in treatment burden. And I have to say when you actually do the stats on that, that should be an easy bar to hit. The percentage of eyes that are rescue-free, I think, will help us from a commercial perspective, but not sure it's actually as relevant to the FDA. Just like the OCT data, important to retina specialists, but probably not as relevant to regulatory. So again, there's 3 things we need to hit. I like to hit them in both trials. Both trials are essentially identical. And so we have quite a bit of confidence based on the data that I've talked about already today that we will be able to achieve that.

Okay. So in that context, what keeps you guys up at night?

Did the time change? No. I have to say, I've been in this role about 2.5 years, and I've learned a lot in a very short period of time. And one of the things I've learned is we have a really, really good team of people. And for those of you who do drug development, you know every day is a new challenge. But when you see how your team fights through the challenges, some easy and some hard, you get very confident in their ability to tackle anything. And I do want to point out, again, Ramiro's clinical team, we did faster and I hope better recruitment to those Phase III trials than all of the big companies, Roche Genentech, Regeneron, we did better. So what keeps you awake at night is we have a daunting task. I think we have a great drug that has a lot of advantages over the ligand blockers, but we're going to have two 10,000 pound gorillas out there, Roche Genentech and Regeneron that we'll be going up against. But we have enough differentiation that if approved, I think we will carve out a very, very good market share.

Okay. And assuming positive data here, how quickly do you think you can file in the U.S. and Europe?

Ramiro, do you want to take that one?

Yes. So I think the same efficient work that we have done with the enrollment, we're going to be looking to do that for the database lock as well as the submission. The beauty of our program is that the 2 studies are identical, and we're going to get Lugano first. So we're going to get that data. We're going to start to write the CSR, the modules. And then we get the LUCIA data which, again, because this says are very similar, the write-up of those documents should be quite quick. If you look at industry standard, submission is about 6 months after a database lock. We believe we can do better than that for the U.S. and then after that for EMA.

Okay. Great. And how are you thinking -- I think there were some comments in your presentation here, but just to maybe elaborate a little bit more. How are you thinking about the TAM for wet AMD? And what is the reasonable penetration of the market for an extended-release TKI like DURAVYU? And what -- are there any potential challenges that you envision from an adoption standpoint?

So let me take the last one first. From an adoption perspective, again, doctors are used to doing things in a certain way. And so one nice thing about being in retina is we're at heart surgeons. And so we don't always follow labels or directions all that well. And we're not afraid to try new things. So I think that's going to help with our adoption. And when you talk to some of the younger retina specialists, they are just overwhelmed with injections, and they really want the ability to take at least some of their patients out longer so that they can actually not be working until 8 o'clock at night seeing 100 patients in the day. I'm sorry, I took the last one first. So could you -- what were the other 2 you asked?

I don't know. Is it only Tuesday? No. Just talking through any challenges and just how you think about TAM, but you kind of covered it, I think.

Yes. The challenges, again, are really educational is to educate the physicians on quite simply who to use the drug in and how to integrate it into your practice. And the whole concept of it's not an either/or. You don't have to give up your favorite anti-VEGF. And if you want to use 2 MOAs, feel free. We can dose products that are approved once every 28 days. And so alternating a ligand blocker with a sustained-release TKI can make sense.

And I just wanted to ask kind of a quick question here. Just we know there's a competitor out there that has a study reading out shortly, the Phase III [ SOL-1 ] study. Can you maybe talk through, Jay, really what I'm interested in is what the read-throughs are for your program from those data from your perspective?

So sure. So at a high level, I think we already know this. TKIs work. There's been, to my knowledge now, 8 TKI trials with various delivery systems, intravitreal, orally suprachoroidal and wet AMD, and they've all been positive. And so I do expect the study to show a positive benefit of TKIs. Beyond that, however, the study design, again, is very, very different than what we're doing. And given that retinal physicians don't typically watch patients lose 15 letters, it's hard to know how applicable that result will be in the real world. But again, I go back to our trial design. We're going up against 2-milligram EYLEA on label. I believe physicians, if we're positive and approved, they will know exactly how to use us because they know what other products do against 2-milligram EYLEA because that's been the standard.

So maybe a couple of quick hits to round us out here. Just turning now to DME. How derisked do you think your Phase III trials are here? Like any nuances to be thinking about from like an opportunities and challenges point of view?

So I think we're very derisked in DME. Again, we had a very good result in the Phase II, and we block IL-6. And if you look at some of the data on that, for example, there's a study that was done where they were doing vitrectomy on eyes in the eyes that had diabetic macular edema had significantly higher IL-6 levels than normals or diabetics without diabetic macular edema. We know that high IL-6 levels result in poor response to anti-VEGF. And again, we showed you some of the combo data for anti-VEGF and anti-IL-6. So we believe that's going to be a significant advantage not only in the trial, but in the real world. Once again, who wouldn't like to see better faster with less injections. So I think the DME results, I'm very confident in them given the positioning and given the study design, I -- we are quite confident in the results.

Last question for me to round out the conversation here is maybe you could just remind us of your cash on hand and what milestones that allows you to complete to bring you in, George?

Go ahead, George.

Yes. So as part of the presentation, we ended 2025 with just over $300 million of cash, puts us our cash guidance remains unchanged into Q4 '27 that funds all of the ongoing Phase IIIs, including the 2 DME trials, which we expect to read out sometime in Q4 of '27. And so when we read out the wet AMD trials later this year, we'll have well over a year of cash. So we're feeling great about our balance sheet, no debt.

Okay. And any considerations just around commercial supply build-out?

Yes. So that's included in our projections as well. As Jay pointed out, our Northbridge facility is up and running. We've had remarkable activity there, and we're gearing up to meet that CMC section and registration batches, and that will also continue to support some of the initial commercial build.

Great. Thank you so much to the entire EyePoint team for being here, and appreciate all the listeners for joining as well. Thank you.