Hey, good afternoon, everyone. Tom Stephan with Stifel. Really excited to have SpyGlass Pharma here with us at the Ophthalmology Forum today for the second straight year. Last year as a private company, this year as a public company. Here with me is CEO Patrick Mooney. Patrick, I'm going to dive right in. Wanted to ask about early execution. You've been public for less than six months, but already have accomplished a lot. If we reflect on the last six to 12 months, Patrick, to kick things off, talk about key examples of how the company has executed on its goals, and made progress operationally. Cool. Tom, thank you so much. Always great to talk to you and appreciate the time today. SpyGlass, as you know, for seven years has executed really well. The last 12 months, certainly no change in that. We've accomplished a lot. If I go back exactly 12 months ago, we closed our Series D crossover round. We then went on to initiate two large phase III pivotal trials for BIM IOL, exactly when we said we were going to. End of last year, we released three-year data in our First-in-Human trial, so that trial read out on time. Earlier this year, we released our one-year follow-up data from our phase II readout. On top of all of that, we took the company public, as you know, in February. That was a three-year mission. It's funny, when I went back and looked at the Series C investor decks, we actually had pegged Q1 of 2026 to take the company public. Short answer is this team knows how to execute. Last year was no different, and that's our mantra moving forward. This is all about getting our phase III trial enrolled and moving on to submission of that NDA. Got it. That's fantastic. We'll get to the BIM-IOL phase III and the milestones around data approval and commercialization. If we think prior to that, call it the next 12 to 18 months, Patrick, what would you say to investors are the most important catalysts for the company and by extension for the stock? Yeah, great question. It's cool. Every three to four months, we have something really meaningful to say. This year alone, second half of this year, we have two important catalysts. First and foremost, the initiation of our first-in-human trial with our secondary platform. This is the Bimatoprost Drug Ring System or BIM-DRS for short. That system's going to go into humans the second half of this year, and I'm excited about it because this is a system that could potentially provide up to seven years of drug elution for bimatoprost in glaucoma patients. Our vision all along was to be able to care for patients over their lifetime. BIM-IOL is certainly a cataract procedure. We can solve two problems at the same time when patients are already in the operating room. Correct their vision from cataracts, as well as give them years of medical therapy for their glaucoma. Years later, when patients need additional help, we know they will. Patients do progress and all options are available to them. This BIM-DRS platform is really our answer to be able to re-treat not only our own patients, but any pseudophakic patient that has previously had cataract surgery. Regardless of what lens they have in their intraocular or intracapsular bag, this is an option for us to be able to re-treat patients and care for them over their lifetime. That's coming this year. Later this year, we also have our four-year readout from our first-in-human BIM-IOL study. That is significant. Clearly, three years was monumental. We're in a category of our own with 95% of patients off all topicals at three years. Each year we go beyond that is showing proof of concept that we can, and our technology has the ability to continue to innovate here and reach new benchmarks of long-term drug delivery. I'm excited to release that later this year. Next year, we have all kinds of catalysts, a two-year readout on phase II, announcing full enrollment in our phase III, and ultimately top line readout Q4 2027 for our phase III trials, which as you know, lots of folks are looking forward to seeing. Got it. That's great. We'll explore a handful of those. Your comment on the four-year First-in-Human data readout, obviously an upcoming milestone. Patrick, to start, can you level set us a bit on that readout in terms of the differences we should be mindful of when comparing these four-year First-in-Human data and the version of the BIM-IOL being used in that study to the phase II and phase III? Maybe if you can level set us on some of the differences there, I think that'd be helpful. Sure. Happy to. The first-in-human trial that is now out three years and will collect and release the four-year data this year, does have seven years of drug payload. That form factor has a payload of seven years for all patients. When we started this program, we wanted multiple years of efficacy, not only in BIM-IOL, but also BIM-DRS. You can imagine as a small private biotech, the idea of initiating a seven to 10-year trial right out of the gates, it was a daunting task. Then you couple that with the market research with surgeons. We asked them, "What's the minimally viable product? How long do you need BIM-IOL to last?" They were very clear. 95% of them said six to 12 months is our MVP. We thought, okay, that's interesting. How about two years? Of course, they all said, "Yes, that's even better." Then when we asked about three years, they said, "Yes, of course, it's even better, but is that really possible?" They started to not believe whether three years was even doable, and we said, "No, no, we can." I share that story with you because it's a very simple story to say, how did we land on three years? Our phase II product as well as our phase III product, and ultimately our first commercial product will be a three-year product because that was 3X what surgeons were looking for, significant value for patients, and we felt really good about that in terms of our company and our ability to run a trial for that length. Beyond that, now that we're public, obviously more resources. We can pour those resources into BIM-DRS and potentially other portfolio plays to get even longer. I think it's important that the 4-year data signifies that we can do this. Our technology is capable of going beyond 3 years, and I think that's exciting for both platforms, BIM-IOL and BIM-DRS. Got it. You answered my follow-up question, but importance and relevance of the four-year First-in-Human data when we see that hit. If positive, if a general continuation of what we've seen through 36 months, is that main takeaway that there is proof of concept here that you're able to provide sustained release therapy for three, four plus years? Maybe if you can talk a bit more about that, Patrick. Yeah, I think it shows we're leveraging the form factor, the release kinetics, all of our technical know-how. It took us years to figure out how to finally tune that release kinetics. What the four-year data and beyond, because we're going to collect five-year, six-year, we've extended all of those patients out to a seven-year trial. Our intent, quite honestly, is to continue to follow these patients. I think what it says is that this system is very capable for longer durations of payload, and I think that's directly applicable to our confidence and what investors should take as confidence to be able to do this with BIM-DRS. Got it. Perfect. The BIM-DRS helps inform what BIM-DRS and how long you want that to last and the level of payload. It's going to be informative in that sense. Yes. Fantastic. Okay, great. Appreciate that, Patrick. Maybe the pivot to the BIM-IOL phase III to move back to that. Patrick, I'll kick things off, just a sort of a progress question, but talk about how enrollment is progressing early on, the pace, and it'd be great if you can maybe give us a sense for surgeon feedback that you're hearing now that a lot of sites are up and running. Great. I'm very happy to tell you we are right on track with where we thought we would be. We literally had it planned down to the exact number of randomizations, and we hit that exact number through April. May is another strong month for us, and so I'm really pleased to be able to talk with you today and say we are right on track where we thought we would be, where we thought we should be. That's really important for us to be able to stay on that pathway to achieve our enrollment at our target zone to be able to deliver that phase III top line readout Q4 2027. That also empowers the NDA submission in 2028, and as we've previously guided, intended approval and launch in 2029. We are right on track, so that's a very positive thing to say, and I'm going to be saying that a lot because I think a lot of companies struggle in the early phase. We've done really well there, and I think it's a testament to our team's ability to continue to execute. The second part of your question, what do surgeons have to say? They really like our system. I'm amazed at how many phase II sites wanted to also be in our phase III trials. That's a testament to the technology that they know how to use it. They see the benefits that their patients are benefiting from, and they wanted to be in our phase III trial. We've made some really cool updates to the assembly device that attaches the drug-eluting pads to the IOL. Really positive feedback from surgeons that experienced our phase II trial as well as our phase III. All in all, very positive updates from an enrollment standpoint and really positive surgeon feedback. Got it. That's great. Maybe last one on the phase III. You talked about kind of 4Q27 target for the data readout. At that time, what will we see? What will be disclosed? Is that just the three-month efficacy across all patients? Maybe if you can give us a sense for in that press release in the fourth quarter, if that's the avenue, what we should expect the company to disclose. Yeah. First and foremost, the FDA has told us we see you as a drug first. CDER is leading our review. CDRH is clearly there as well because we are a drug and device combination product. Primary mechanism of action is intraocular pressure lowering. What you're going to see from us in that top line readout is all patients through three months IOP lowering, non-inferior to timolol, weeks two, six, and 12. Same standard that all prostaglandins topically or sustained release have been asked to prove compared to topical timolol in our case. You're going to see all patients through three months from a pressure lowering standpoint. I also expect that we'll have a good sense. We won't have all patients through one year for vision or safety. Those come later, but that's also been discussed with FDA, and so we have that built into the timelines that we've stated and feel really good about those as well. Okay. that's built into the timelines around. Yes. 2028 NDA submission and launch in 2029 is the vision and the safety at one year following that three-month efficacy readout. That's correct. Essentially, we know all along that we're combining drug and device, proving vision is achievable in the same quality and state-of-the-art lenses from all the big strategics. We knew that was going to be important for the product. We essentially have to prove both. We have to prove that we can provide best-corrected distance visual acuity, 20/40 or better. You've seen us do that and well beyond in our FIH trial, as well as our phase II. It's not necessarily something that I think concerns us. It's just something that we must deliver, and we feel really confident that we're going to be able to deliver that same endpoint as all other monofocal IOLs. Got it. Perfect. That's great. Thanks for that, Patrick. I want to pivot a lot. I usually say a little bit, but somewhat a lot. Last week we obviously saw LCDs for iDose TR come through. A material update for the sustained-release drug delivery category, which obviously in glaucoma, SpyGlass is playing deeply in. Patrick, I'll just kick things off here. What are your thoughts on the read-throughs of those LCDs to SpyGlass and BIM-IOL System, if any? Yeah. I think from a SpyGlass perspective, it's important that we talk about the way we set this product in motion. From day one, we wanted to be efficient in the operating room for not only the surgeon and the facility, but also efficient in the way we decided to build this product. The LCDs announced last week, I can see some probably short-term challenges for others in market today, but these are proposed. We'll see what the final rule ends up being. I think there's a lot of good discussion that should come to be able to figure that out. LCDs typically are usually used to scrutinize multiple procedures being done in a single surgery. We are not that. We have always tried to be efficient to say, look, we're not asking for a separate standalone procedure code. Our procedure is cataract surgery. We're studying it in conjunction with cataract surgery. Our label, ultimately, someday, will say to be used at the time of cataract surgery. All of our clinical data is combining that same single surgery, cataract surgery. There's really nothing to try and squash from a SpyGlass standpoint, because we haven't propped up additional codes that I think MACs struggle with to be able to figure out how many of these procedures should be done or considered at one time. Our story is very simple. It's cataract surgery. Our add-on CPT code that we just got issued a couple of weeks ago, I think is a testament to say, look, this company's thinking about it the right way. We want to be efficient, not only with the surgeon time and the operating room time, but we also want to be efficient with the procedure payment. Since we're not asking for another facility fee, I think that's actually welcomed by CMS. I think our technology will be invited and welcomed into that discussion because it's a much more efficient procedure to pay for, if you think about it from their point of view. Our main mechanism for reimbursement is a J-code. LCDs are typically not deployed to govern use of J-codes. They're usually deployed to limit stacking of multiple procedures to make sure that it's medically necessary for the patient or what have you. I think we are nowhere near that discussion. I think this is actually tailwinds for SpyGlass should some of these proposed changes actually hit, because our story is much simpler and I look forward to that discussion with CMS based on the way we've designed this procedure. Got it. That makes sense. Something we've had in mind or thought would be, and I've heard from surgeons, is something that they would gravitate towards, would be combining BIM-IOL with something like an iStent or some sort of mixed procedure. What would be your level of confidence the MACs wouldn't also scrutinize BIM-IOL plus MIGS in the same way per the LCDs they're disallowing iDose TR plus MIGS? Maybe I'll start there and then just have a quick follow-up question to that. Yeah, I think it's way too early to think about SpyGlass in combination with other MIGS procedures. I know MIGS surgeons like to use multiple technologies. I think they're all additive and beneficial for patients. In our case, this is still cataract surgery. You have Category 1 codes on the books today, 66991, for example. It is cataract surgery and you could put some kind of stent in the angle, and that's a given Category 1 code. Even with SpyGlass, it's still 66991. There is no additional facility fee being mandated by the use of SpyGlass technology. The J-code for the drug, usually these are immune from LCDs, and I haven't seen an example in 30 years where LCDs actually govern use of J-codes. It's typically used when you're stacking multiple procedure codes. That's not us. It's going to be a much cleaner procedure and I can say, I feel really confident 66984 or any of the cataract codes, including 66991. We're still cataract surgery, and this is with a little bit of medicine lasting three years and a J-code reimbursement. Yep. Got it. Okay. Super helpful. Maybe in the last five, six minutes or so, wanted to ask about the add-on code, another great update to see from the company recently. Patrick, can you just begin by providing your thoughts on the importance of this and what type of impact it can have once we get to commercialization, hopefully, come 2029? Yeah. I think it does two things. Well, one, this team has been really thoughtful. We've launched collectively multiple Medicare Part B buy-and-bill products in ophthalmology. Part of getting ready for a smooth launch and a launch velocity that everyone is proud of is getting a lot of the sand out of the gears well before you launch. This is an example of our team using what we have in terms of our knowhow. We obviously applied for an add-on CPT code, and the AMA agreed that, yes, there's extra work here for SpyGlass. Clearly, we have to add our drug-eluting pads onto the IOL. There's an aspect of loading, implantation, positioning, viscoelastic removal. All of that is a function of surgeon work. They clearly saw it as, yes, there's additional surgeon work here, and it should have its own add-on Category III procedure code. I'm really encouraged by it. We thought that they would obviously see it our way, and they clearly did. We didn't have to do this now, but we chose to, and for a couple of reasons. One, I think one of the questions we've received over the years is, "Hey, will surgeons get paid for their work with SpyGlass?" The answer is yes. This add-on CPT code answers that question. Just like others will have to go and obviously meet with MACs and negotiate MAC by MAC, but this is a much different level of ask. This is a position procedure fee on top of the existing fee, different rates, different types of expectations. This is not an additional $2,000 facility fee, for example. It's a much cleaner and simpler conversation with the MACs. More importantly, I think MACs need and rely on clinical evidence to weigh into their decision-making. In our phase III pivotal trials, we're collecting all of that additional work as a function of the component of time at each phase. So we're going to be able to go back to Medicare with objective data. Here's the amount of work with a standard of care case in your typical cataract versus the SpyGlass case and show that level of work. So objectively, we'll be able to make the case in our phase III registration trials. We'll have a label to support to be used at the time of cataract surgery. We'll have all the clinical evidence as well as objective data to make that case, and I feel confident we're going to be able to definitely motivate surgeons to consider SpyGlass. Super exciting, super compelling. Patrick, you mentioned you're doing work in the phase III to help quantify the additional work that's necessary relative to standard cataract surgery. How should investors, I guess with that in mind, think about the range of outcomes for the dollar amount that may be attached to the add-on code? Is there a base low downside, upside type of scenario? Maybe if you can ground us on the dollar amount that you think could be attached to that add-on code and why. Yeah, I think it's probably too early to peg an exact number. I think you published ranges last week that I'm very comfortable with, but we can talk about that. I've seen a number of cases myself, and I know there's additional work, not new skill. This is skill that all cataract surgeons have, but it's just a function of their particular time and effort in the OR to assemble, to implant, to position all of that stuff. If cataract surgery reimburses X and a surgeon has 2X that total amount of time, well, that's worth something. Last week in our discussion, you said, "Hey, on the low end is $100 reasonable?" I think that's absolutely fair on the low end. Anything over 0 is a positive for SpyGlass. Surgeons told us all along, "Hey, I really like your tech." We know two-thirds of surgeons don't do MIGS, and if you're not doing MIGS today, you're probably not going to do a lot of MIGS in the future. All cataract surgeons have glaucoma patients, and they see SpyGlass as something that they can do. They said, "Look, I like your tech enough that I would use it anyway, and if you get something for an extra add-on code, even better." That's kind of like cherry on top of the cake, so to speak. I think I'm going to use all of our data, and I think this will inform a really healthy discussion. We won't know until it's all said and done. Once I have the data, I think a base case is definitely higher than that low end, and we'll see how high that can be with the objective data in our hands. Got it. That's great. Last minute or so, if I can squeeze one more in. Public, again, for less than six months, investor conversations, I'm sure have ramped up pretty materially, and certainly in the IPO process, there were a lot of investor discussions. Patrick, what do you think when it comes to the SpyGlass story is still most underappreciated by investors? Underappreciated? I think the fact that this team has successfully launched multiple products in buy-and-bill. I think there's always a question about, hey, what do you think? What's the policy going to be like there? We've thought through a streamlined approach for surgeons. We've thought through a streamlined approach for payer policies. I think once we are commercial, and if approved, obviously, our message is going to be a welcomed breath of fresh air when you go and talk to the payers that have to make some tough decisions as to what they're going to pay for. We're offering years of medical therapy. We're not trying to create new procedure codes that I think they struggle with. I think the simplicity of our design, the success of our technology, make it a really welcomed conversation, and I really look forward to that in time. Got it. Looking forward to that as well. Great note to end on, Patrick. Great to speak as always. Thanks again for participating this year, and looking forward to catching up again soon. Thanks, Tom. All right. Take care. Bye.