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Fireside chat has started here, guys. Again, welcome. So we're shifting from gene therapy to wet AMD. And I'm proud to be joined by Dr. Praveen Dougal, Executive Chairman, President, and CEO of Ocular Therapeutics. In February, Ocular reported SOL1, the first trial in which a novel agent and be an approved anti-VEGF on a superiority endpoint, wet AMD. The company has since cleared both a type C and pre-NDA meeting with FDA and is targeting an NDA submission this quarter. Plenty to cover. Praveen, thank you for joining us. So for the generalists in the room, for those who aren't familiar, give us the two-minute version of SOL1. What did X-Paxly show, and why does it matter for how retina specialists will actually use it? So Andres, first of all, thank you for having me here. It's an honor to talk with you and thank you all for being here. I think you first start out with the need. We've had a very, very effective and safe class of drugs, the anti-VEGFs, now for almost four decades. But yet, in this country alone, in the first year, there's a 40% dropout rate. And that's not just tragic, it's intolerable, really. And all of these patients who drop out, almost half of them end up going blind. So there's a great need for sustainability of treatment so that the dropout rate decreases. We know that's the case historically. And the other part of this is also that because of the pulsatile nature of injections, even in those patients who are able to stay through the therapy, the majority of them after two to five years end up losing vision because of atrophy and fibrosis. So, what we're trying to do is to solve both of those problems. We have a tunable hydrogel with a TKI called X-Paxly. We have shown superiority. We have hit a superiority endpoint versus an anti-VEGF for the first time ever. We're very proud of the results. We think the results are terrific, and we've got a single trial approval pathway formalized with the FDA. Fantastic. And as everyone knows, we write these scripts ahead of time, and then things happen where we have to modify. So I'm bouncing around on the script here, and I think it's actually important that we do so, given some news that came yesterday. So iPoint missed its non-inferiority primary endpoint in its second straight phase 3 trial. Is that a TKI-class signal or product-specific, and how do you position X-PAX against the review, high-dose, cephalopreceptin-first amount? That's a great question. You know, look, I think it goes without saying to this audience that we're in a very, very tough field. You know 9 out of 10 drugs fail, and it has an impact on everything, including a lot of employees and families and everything else. So that's the first thing to be said. There's no joy in seeing somebody else fail. The way that I look at this is, there are lessons to be learned here, and we'll talk about that in detail, and these are really important, so I'll take a little bit of time. But in terms of the overview, we had one competitor in our field, which is that we have a maintenance drug. We don't have a bolus injection. Everything else that you hear about, which are non-inferiority studies, are in a morass of bolus injections. There are really, as far as we're concerned, two drugs competing for maintenance. One is us and one is iPoint, and now it's only us. And I think there's a clear path forward for us without any kind of competition whatsoever. But now let me get to this really important topic. And this really applies to anybody who's an analyst, who's investor looking at chronic retinal diseases. And one thing that is absolutely misunderstood, in my humble opinion, outside of the retina community, is the variability of our diseases. Let's look at macular degeneration, but quite honestly, it's true for diabetic macular vima, for RVO, for diabetic retinopathy, all of those things. The bottom line is that we are at least 75 years behind oncology and rheumatology and immunology. We have absolutely no idea about disease stratification. If I were to come to you, Andreas, and say, look, I have a drug for colon cancer, you just kind of look at me like I was from Mars. You know, you'd say, well, what kind of colon? What stage? What grade? I come toyou and say look, there's a drugfor wet macular degeneration, diabetic macular edema, and nobody pays mine. You go, okay, that's great. But we know there's an enormous amount of variability. We know that even with the regular Lucentis, there are patients that require treatment every two weeks. There are patientsthat require treatmentevery six months. So the selection of patients and clinical trial design is absolutely key. And we're not doing 2,000, 3,000 patient large studies anymore that would negate this perhaps or mitigate this at least, you know, like Genentech and Roche and others did. We're doing smaller studies. And great attention has to be paid for patient selection because we don't have any biomarkers of disease. We don't Have any genetic markers of disease, And what we have done is very, very thoughtfully gone through patient de-risking in a bespoke manner for each of our studies. It's an entirely different patient population and an appropriate one that we have selected for SOL1 versus the stable patient population for SOL-R. And this is why we're so confident in succeeding with SOL-RR. It has nothing to do with retreatment criteria. It's got everything to do with clinical trial design and proper patient selection. And I think now iPoint themselves are actually admitting to that now following the failure. I think you saw some of that news this morning and yesterday. We emphasize that, and I think the reason for their failure is not only what we said earlier on, which is that we believe it's a weaker TKI, but one of the very, very big reasons is the patient selection, Now, it's easy to select patients, easy to enroll trials when you allow everybody to come in, as they did. They mixed previously treated patients with treatment-naive patients. They randomized, and then they loaded. We're doing the opposite. We're only using treatment- naive patients who are making sure that we load first, and the loading for us is not necessarily biologic. It's to select the right patient population, and only then are we randomizing. So that is the key to why we are so confident in the success and why this is different than what happened with Lugano and Luchia. Yeah, that was great. Maybe we'll keep it on the competitor side of things. Talk about Kodiak quickly. They reported a daybreak date on what AMD. Tarkosamab was non-inferior to Aflibricev, 54% of patients on six-month dosing. Wall Street reacted very favorably. Any thoughts on the results? our Tarkosam and we compete with Xpaxi, both are approved? Well, look, I wish them well. I don't see them as our competitor for reasons that I mentioned earlier on, which is that they're a bolus injection. I think it's important to separate bolus injections from maintenance drugs. We're a maintenance drug, as I said earlier on. Our competitor was iPoint, and now it's only us. Whatever bolus injecting one uses, if one feels the need to use that prior to using a maintenance drugs, it really doesn't matter to us. It could be Avastin, it could be Vibismo, it could be Lucentis, it could be the Kodiak drug if it makes it that far. But it's the maintenance drug category that we're in. So it's not the same thing. It's important to separate, and we don't consider them competitors at all. Having said that, I think there are a lot of questions to be answered. You know, who were the patients that actually lasted six months? Where were they? Were they after, you know, six bolus injections? Were they in the beginning? Did they have to be treated? How many injections did they actually get? We haven't seen the total number of injections. These are just really basic questions. It's a PRN arm versus an on-label arm. I don't know what the regulatory pathway is for a PRNarm. As far as AEs are concerned, I think we at best may have seen 25% of the AEs. I think there's a lot more to be seen. So look, I wish them well. You know, there's a lot of data that we'd still like to see from a clinical trialist point of view. I'm sure that'll be forthcoming I hope that'll be forth coming but again we don't consider them our competitors they're competing with the Lucentis' Avast and the Biobismos as a bolus injection we're a maintenance injection I have to say I do appreciate how not just how specific and thorough you are but how quick you are because I know this clock keeps running yeah I'm looking at it we'll move right along here and if we have to go over a little bit that's fine Just a couple minutes. So you plan a Q4 NDA under a 505B2 based on one adequate and well-controlled trial plus confirmatory evidence, and both the May Type C and September pre-NDA meetings went your way. What remains before submission, and what are the residual risks, whether CMC, size of safety database, or potential advisory committee? Yeah, let's talk about the regulatory path. Look, this is not something that we just thought of. This is not Something that we said after a failed study and said, look, how about one study? And this is something that has to be planned out for years in advance, and the entire trial has to be planned Out that way for a single trial submission. We're in constant contact with the FDA. The FDA has been very collaborative, very supportive, and we've checked all the boxes. All the evidentiary standards have been checked. Remember, we have a robust trial. Their definition of robustness is a p-value less than 0.001. Ours is less than0.0006. We've hit a superiority endpoint for the first time in the history of the planet. We said that we would have a pre-NDA meeting in the third quarter. We did. We've got the minutes back. We are very, very happy with the FDA minutes. We're absolutely in lockstep with them. and we've said that we would submit the full package in the fourth quarter, and we're certainly on schedule for that. So we're very pleased with our interaction with the FDA. We couldn't be more grateful to them, and we'RE absolutely on schedule FOR a single trial submission. I was trying to catch all that. Did you mention anything about a potential advisory committee? Again, it's a little early to be talking about that at this point, but there should be no, in my opinion, and this is just my opinion. There should be NO reason for that that's usually reserved for something. That's a brand new mechanism, a brand-new treatment, and this is not. We're suppressing VEGF, which is what anti-VEGFs have done for 40 years, and we don't see any reason for an adcom at all. You amended SOLAR to add a key secondary of superiority versus a filibuster 8 milligrams at week 96 and extended masking, which moved top line from Q127 to Q128. Critics say you're pushing the trial that tests repeat dosing against the on-label control past the potential approval? Or was the right trade? Well, look, it's an absolutely correct strategic decision because what we didn't want was we didn'T want a major amendment in the middle of a review. And a card turn of any kind would have been a major amendment because who wouldn't want to see the card turn? Who wouldn't? Of course, everybody would. And as soon as you get a major amendment, you lose the time advantage that you've had. We're in an accelerated path, right? We've got a 505B2, so we're in absolutely accelerated path. Our goal is to go ahead and get this approved as quickly as possible and as cleanly as possible. And there's no reason to go ahead and be off track by having a major amendment, which would then turn back the clock and start all over again. So from that point of view, we think that it was the right strategy. Fantastic. I'm going to ask one financial question we'll be close to time um so cash was almost 600 million uh at june 30th with runaway into 2028 but guidance explicitly excludes the full cost of commercializing xpaxly um how much incremental capital does a u.s launch require what is the preferred funding the equity debt royalty or ex-us partner look our goal is to go ahead and launch this product we're absolutely on track to do that we've got the right team we've scaled up to be able to do that we're more confident than ever and being able to do that very very well uh we're uh you know by retina for retina uh that's all we know and and we know how to do that extremely well so having said all of that yet our our guidance has not changed we're well capitalized into 2028 we haven't guided you as to what is needed for the launch but as you can imagine as we get closer if if if that is necessary there are all kinds of flexible ways that one can go ahead and get capital without being. Fantastic. Thank you, Praveen. That was a quick one, guys. That was very efficient. So I appreciate that again. Everyone, please stay seated. Opus Genetics joins us right now. We're behind a little bit, but we'll make it work. Thanks, everyone. Thank Thank you very much.