Been a private company for seven years, we just took the company public in February of this year, which is funding our phase III execution of our enrollment as well as advancing prep for commercialization in time. Thrilled to share the story. These are our standard disclaimers. We will be sharing some forward-looking statements today. SpyGlass is essentially addressing two of the world's leading causes of preventable blindness, cataracts and glaucoma, and we're doing this in combination in a single procedure. We're delivering years of long-term intraocular pressure lowering medicine, and we're attaching that securely to the intraocular lens that's being implanted during routine procedure. One surgery, two birds, one stone. We are addressing a $13 billion market. This is the 1 million incident procedures that are happening annually in the U.S., cataract surgeries underway for glaucoma patients. We're going to triple the available surgeon pool that can address both glaucoma and cataract. We'll talk about that. We're out three years with our longest study, post-implantation, 95% of patients off of all topical therapy, and 37% mean IOP reduction. Topically, we expect these medicines to work about 20%-30% reduction. We're seeing great safety and efficacy, not just with our first-in-human, but also a multicenter randomized controlled clinical trial in phase II. We're replicating that same design in phase III. Clear paths to regulatory approval and reimbursement. We'll talk about that today. A focused pipeline. Our lead asset is this bimatoprost implant system or BIM-IOL for short. Registrable under a single new drug application, 505(b)(2) pathway. Focused pipeline on our BIM-IOL and then our secondary platform. Since our lead asset is targeting three years of elution with bimatoprost, we're developing a secondary system, BIM-DRS or BIM Drug Ring System, to be implanted years later when patients need additional help. Not just our own patients, but any pseudophakic patient who has previously undergone cataract surgery, regardless of intraocular lens in the bag, we can also address those patients as well. That system we can likely load with seven years of drug. Potentially 10 years of therapy between two surgeries. Strong IP throughout the world on the U.S. market, but protecting the IP globally. $151 million in cash and cash equivalents through quarter one of this year. Here's the rest of our team. What, in short, you'll hear from us is this is a team with deep expertise in ophthalmology. My background is all commercialization, Alcon and Novartis for 25+ years. Our two co-founders, Malik Kahook and Glenn Sussman. Malik is a talented serial entrepreneur, clinician, surgeon, scientist at the University of Colorado. You can see several devices under his picture in market today. These are marketable products for surgical glaucoma, this is yet another iteration from his lab. Glenn Sussman, our co-founder, brilliant engineer, years and decades at Allergan, Alcon, designing medical devices. He and Malik teamed up to form ClarVista, which was an intraocular lens company they sold to Alcon in 2017. James is here, a skilled operator with deep experience in ophthalmology as well. Chetan Pujara came to us from Allergan, Abbott, and AbbVie, I should say. Key products in market today, drug device combinations that he worked on personally, DURYSTA, OZURDEX. He knows drug device combinations from development all the way through commercialization. Jon, a skilled CFO with years of public company commercial experience to round out our team. What are we solving for? First, there are millions of patients around the world struggling with glaucoma. It's a plumbing problem. Essentially, pressure inside of the eye continues to build as the fluid, aqueous humor, is produced at a constant rate, 2.5 nanograms per hour. That pressure continues to build and essentially the drain gets plugged. In glaucoma, the entire management mainly is treated by reducing the pressure, and we typically do that through topical drops. Some lower aqueous humor production, some increase outflow, but all designed to meet the physiologic target that most of us need every day, which is somewhere between 12 and 22 millimeters of mercury. The drops work very well. Sadly, they don't work when patients don't take them. We've known this for decades. Adherence is a huge problem. All the published studies suggest somewhere between 70% and 90% of patients don't take their medicine. The refill data shows it alone. 50% of patients discontinue their topical therapy after the first six months, regardless of class of medicine. It's pretty sad. They need these medicines to preserve what vision they have left. Glaucoma is a lifelong disease, and they need these therapies to maintain the vision. SpyGlass can address this directly and more efficiently. The patient journey starts the same. Upon initial diagnosis, most glaucoma patients are diagnosed in their 60s. By the time they get to cataract surgery, typically in the 70s, they've been on medical therapy for a decade, struggling to maintain their adherence and preserve their vision. In a SpyGlass world, all of us in this room will eventually need cataract surgery. It's biology. Good news, when BIM-IOL is in market, the surgeon can address two problems at the same time when the patient's already coming in for cataract surgery. You don't have to convince patients to come in to correct their vision. They need it. While we're there, BIM-IOL can likely get the patients off their topical therapy for the glaucoma as well. Patients can live a daily life without the burden of taking topical medication. For years of therapy when the BIM-IOL is done eluting product, BIM-DRS is our secondary system, which is going into humans later this year. Our lead asset, the bimatoprost intraocular lens system, is targeting three years of bimatoprost therapy for patients with glaucoma or ocular hypertension. We're combining a known drug with a known device, an intraocular lens, and a known procedure, cataract surgery. The elegance is surgeons do what they do. We're not disrupting their workflow. We're not introducing new technical skills or instrumentation. This fits directly into 100% of cataract surgeons' workflow. A little bit about our product. This is an animation, but before I play it, I just want you to notice the haptic-optic junction here. You'll see some specific geometry. The center optic, this is a monofocal lens. 90% of glaucoma patients receive a basic monofocal lens today. We can do this with other optics, more advanced optics, but we're starting in glaucoma, therefore, we're meeting the market where they are and starting with the monofocal lens. We have future development pipeline plans for a toric lens for patients with astigmatism, which gets you closer to 100% of the pie for glaucoma. You'll notice we've modified the haptic-optic junction here. That's intentional to receive two non-bioerodible drug-eluting pads at that junction. Takes less than a minute in the operating room to assemble the pads, and from that point forward, it's routine cataract surgery. We're using an off-the-shelf intraocular lens injector. The surgeon implants through the standard cataract incision size they've already made. In this case, the cataract is already out. The lens and drug pads attached are implanted into the capsular bag. Same procedure, same technique they use today implanting any lens without the drug pads. Those drug pads remain far in the periphery as to not impact vision, and those drug pads, again, are non-bioerodible, so they do not change in size, shape, or volume, and that's intentional because we want that lens to maintain in its effective lens position to continue giving the patient excellent vision for years. When the drug pads are empty, essentially they become part of the lens. You don't go back into that part of the anatomy. We want to maintain the good vision that the patients have. BIM IOL is a pure cataract procedure. BIM DRS, our secondary platform, allows us to be able to re-treat patients years later when they need help. Back to the market. We know there are 5 million annual cataract procedures done in the U.S. every year. 20% of them, or one in five, are done in patients with glaucoma or ocular hypertension. There are 1 million incident procedures happening every year, glaucoma, undergoing cataracts, growing at 3% annually just in the U.S. Another 5 million procedures worldwide. The U.S. TAM alone, these 1 million procedures times a reference price, Glaukos is in market today at $14,000 for their iDose TR. You just do the arithmetic, 1 million procedures time $14,000, that's where we come up with the TAM. Sadly, only 1/3 of cataract surgeons today are trying to address glaucoma at the time of routine cataract surgery. These are minimally invasive glaucoma devices, usually stents or shunts. Additional skill to implant these MIGS devices, takes additional time, come with more significant AEs. This is the reason why only 1/3 of cataract surgeons are trying to implant these other MIGS devices. Two-thirds of cataract surgeons are simply doing the cataract procedure and not addressing the glaucoma. The good news is that 100% of surgeons can implant SpyGlass. All of them, since their second year of residency, their bread and butter procedure is cataract surgery, implanting IOLs in the capsular bag. Right off the bat, SpyGlass is accessible to 3 times as many surgeons with an excellent profile for delivering safety and efficacy for decades. Excuse me, years. Someday we'll get to decades. Competitive landscape. Cataract procedure is the point of competition. We're going to engage the 2/3 of surgeons who are sitting on the sidelines of MIGS, and they now can address both cataracts and glaucoma. The MIGS surgeons, they'll like SpyGlass as well because there are procedure codes on the books today, category one codes, that allow you to do a combined MIGS cataract procedure. They will do that. They'll put SpyGlass in the capsular bag, they'll put whatever shunt they want in the angle, and they'll bill them both. SpyGlass fits into all surgeons' workflow. From a registration standpoint, this is a 505(b)(2) pathway. The FDA has been very clear with that on that point for seven years. No change. One approval pathway, new drug application. Why? Because, yes, we are a drug and a device. The FDA sees us as a drug first. The value creation that we see as well is in the drug elution, not the $100 IOL. Good news for us, because we understand the approval pathway. prostaglandin analogs, which is the class of bimatoprost belongs to, has been well established, and we have over two decades of experience registering these drugs in a very similar fashion. From a reimbursement side, this is important. The primary mechanism of reimbursement is Medicare Part B. This is a physician-administered drug. Only the surgeon can attach an implant. From a J-code standpoint, you can appreciate this is an average selling price plus 6%. The facility's going to buy and hold, and they'll, if we price parity to reference product in market today, using iDose as an example, at $14,000 plus 6%, that's adding another $800 on that ASP plus 6% back to the facility. You take a $200 U.S., now taking a procedure from $1,200 to roughly $2,000 for a procedure that's happening anyway. From a surgeon standpoint, last month we were issued a category three add-on CPT code by AMA. That's important. For a couple of years now, we've been asked, will the surgeon make additional revenue for the professional with SpyGlass? The answer now is definitively yes. This code is not priced today. It's issued as a, "Yes, AMA agrees there's additional surgeon work. It should have its own standalone code," and that code will be priced at the time of commercialization. Stay tuned on that. Definitively, yes, there will be additional revenue for the surgeon as well. How do we know it works? Well, this is the fun part. This is our secret sauce. I don't think you see too many elution in vitro release curves for other products in our space today, but we're very proud of this, and we publish it. We cut the graph off after three years just to prove that we can control, finally, the daily elution profile of bimatoprost. Year one looks just like year two, which looks just like year three. Definitively, we know in a laboratory, yes, we know we can do this for at least three years and likely up to seven. What matters is how does this translate into humans? Four years ago, we initiated a first-in-human feasibility trial down in Central America. We went down there because this is the site that most ophthalmic strategics use for their early work. We wanted everyone to be confident in the data because it's coming from a reputable site. We took 23 subjects with real glaucoma, real cataracts, and we sequentially assigned them to three different dose strengths of our system, 75 mic, 150 mic, and 300 mic. These are two dose escalations. We knew from the DURYSTA published data, we did not expect to see a dose response effect in this. We were just curious to see would there be a dose response effect, and is there any difference in safety profile? Our hypothesis was no. That's exactly what we found. All three doses work. Right off the bat, you don't need the high dose. You'll see as we go into further trials, we actually took lower doses. These are patients on medicine. You wash them out, and then you do the surgery. 37% mean IOP reduction, 95 medication. Outstanding. No new adverse events. SpyGlass is cataract surgery. What you see in typical adverse event profile with cataract, you see also with SpyGlass. No significant AEs. Vision, 100% of our patients 20/30 or better. By the way, the FDA benchmark for approvability is 88% at 20/40. We are a whole line vision better than that right out of the gates. Our lens works very, very well. The procedure is effective and safe. Phase II. We moved into a phase II trial a couple of years ago. We're out one year now with that follow-up data. Next year, you'll see us release two-year follow-up. This was a multicenter randomized controlled clinical, 104 evaluable subjects. We've always liked the 78 mic dose. You see a 2:1:1 randomization, but we took the 78, a lower dose 39 mic, and a control group. In the control group, interestingly, this was, again, cataract glaucoma patients. We told surgeons use whichever monofocal lens you prefer from Alcon, J&J, or Bausch + Lomb. You pick. We didn't care. We went up head to head against state-of-the-art monofocal IOLs from the biggest strategics. The primary endpoint was IOP lowering at weeks two, six, and 12, and this is consistent with how all prostaglandin analogs have been studied and compared in clinical trials. We also had secondary endpoints. Obviously, we're going to follow these patients out to three years and visual performance when we need to see how our lens performs against the best of the best. Here are the data we released earlier this year in March. You can see the data pretty much replicates what we saw in our first in-human trial. 34% mean IOP reduction. You can see as the patient heals, the error bars get tighter and tighter. The primary endpoint is really three months, and the FDA wants to see weeks two, six, and 12 in terms of onset of action, with the primary endpoint being three months. Again, very exciting. Our intended commercial dose, 98% of subjects off of all topical IOP lowering in our group. Again, high confidence that these patients can be well controlled off of medicine in a safe procedure. My favorite slide, how do we compare to the best ophthalmic lenses from the big strategics? The dark blue bar is our intended commercial dose. Number of letters read, 87 with our system, and this is an amalgam, 87 letters read between the Alcon, J&J, and Bausch lenses. This is what will enable us to go to surgeons and say, "We can deliver with high confidence the same high-quality vision that you expect from your best-of-the-best monofocals today." We're meeting them where they are, which opens the door for them to be able to think about offering this to patients. No serious ocular adverse events observed. What you see with SpyGlass is what you see with cataract surgery. All comers, anything noted in the chart, adverse events similar across all three doses. With high confidence, we moved into randomized phase III clinical trials. There are two parallel identical protocols, each with 400 patients, so a total of 800 patients between the two studies. We took a single dose, again, our 78 mic dose against a control. These patients receive a commercial IOL, and they're on topical masked timolol BID. Phase III protocol, very, very similar. Primary efficacy endpoint, IOP at weeks two, six, and 12. Per FDA, because we are also an intraocular lens, they asked us to move up the visual endpoint from a key secondary to a co-primary. Yes, we have to show that both were reducing pressure and delivering that bar of 20/40 or better from a vision standpoint. We have high confidence we've done that in every trial, a whole line better than the FDA benchmark. No issues or concerns from our standpoint making that a co-primary. From a pipeline standpoint, most of our energy are in those top two lines. BIM IOL is a blockbuster by itself. Our aim is to get that to market as soon as we can and initiate our secondary platform, which is the follow-up procedure, not only for our own patients, but for any pseudophakic patient with glaucoma. You see discovery pipeline. We've experimented with small molecules for AMD, steroids and NSAIDs for either acute or chronic diseases that are relevant in ophthalmology. All of these drugs are able to be eluted within our present system. We can relute them, we can control the elution rate, and these are essentially on the shelf ready to go should we want to advance any of these projects. As a small company, you can imagine we don't want to be too diffused. I would say 90% of our energy is in those top two lines. Getting BIM IOL to market ASAP is priority one. Our road ahead, the good news is we have lots of catalysts. Every three to four months, we have something meaningful to say. It's usually an endpoint or a readout for a trial that's already underway on a set cadence. For the remainder of this year, there are two significant readouts, a four-year readout from our initial BIM IOL patients, as well as moving into humans in our secondary system, the BIM DRS. Next year you see a five-year readout, a two-year readout on phase II, completion of phase III enrollment, top-line readout is what everyone's looking forward to seeing, and that's primary efficacy endpoint of intraocular pressure lowering. Also a 12-month follow-up on our secondary system, BIM DRS. With phase III completed in 2027, Q4 2027 top-line readout, that enables an NDA submission in 2028 with FDA approval, hopefully in 2029. In summary, multi-billion dollar market opportunity. We're creating a brand new vertical in ophthalmology with a commodity product today. Better serving patients. Patients win because they get better control of both their glaucoma as well as their cataract result. Surgeons win because they're going to get paid incremental revenue to perform our procedure, facilities win as well because there's now drug revenue tied to a procedure that's already happening. Clear regulatory and reimbursement pathways, focused pipeline, strong IP, a strong cash position. We are well suited to bring this product to market ourselves and we look forward to your questions today. Thank you for your time and attention. Great. Thanks, Patrick. I guess maybe just thinking through the first human data you've had so far, the phase I/II, obviously very strong, very consistent. Any thoughts about read-through to the phase III trials you have ongoing? You had mentioned obviously the change in terms of the secondary endpoint to the primary endpoint, any other changes you've made relative to the phase I/II design? Yeah, good question. James, you want to take that? Yeah. I've got me on mute, right? We're good. Come on up. Thank you. Yeah. We've known for 25 years that bimatoprost works well in patients, right? We're not really learning anything new there, and you've seen the consistency between our FIH and phase II. That's fully what we expect for phase III. We have made little tweaks to the protocol just to reduce the variability. We lowered the maximum IOP from 36 millimeters of mercury down to 33, and reduced the maximum number of topical drops from three to two, and all of that's just to make sure that we don't have too much noise in those weeks two, six, and 12. As you can see from the charts that Patrick presented, as you get to month three and even beyond, the data gets tighter, and this is where we really create that value for patients. That's exactly what we expect to see in our phase III. Got it. Makes sense. I guess as you think about enrollment timelines, I think the slide had 2027, but within terms of 2027 or just thinking about factors that affect enrollment, can you speak through that, how that might impact timing? Yeah. The great story here is it's just like our commercial story. What we look for is high-volume cataract centers, right? It doesn't matter, glaucoma specialists, corneal specialists, cataract specialists, as long as they have cataract volume, they can get enough patients in, and then one in five of those patients who typically also have glaucoma or ocular hypertension. Those are the ones that will really drive our study. Luckily now we're 10 months into the study, everything's going right on plan, key to success here is just continuing to execute, and we'll deliver those catalysts going forward. Got it. Makes sense. Maybe just kind of talking through and defer to this question or who should answer quite this question, but around just the commercial launch strategy, kind of taking a look at iDose, their launch. Obviously, you have the Category 3 add-on CPT code approved. What's some strategies you'll take on to really maximize adoption and minimize the reimbursement hurdles? Yeah. I think right off the bat, years ago, we started with a strategy that this is cataract surgery. It's a single procedure. It's a single surgery. We made the conscious effort and choice to say we're not trying to create a new standalone procedure code that'll ultimately be something for Max to consider. Are they wanting to pay for this? An efficient strategy right off the top is that SpyGlass is still cataract surgery, and we have well-established Category 1 codes to perform that procedure. Our primary mechanism of reimbursement is J-code revenue. That's also a very well-defined and understood pathway to reimbursement. I think as it relates to establishing success in this type of market, this is Med B buy and bill. These facilities are buying product ahead of time and they're carrying the inventory, and that costs obviously money up front. This whole success was really proven out in terms of medical retina modeling. Anti-VEGFs also had the same hurdle to overcome. If you follow that path, we understand this area very well. This is about establishing reimbursement confidence even before launch. That means you have all of the wraparound services and systems in place to conduct appropriate patient benefit investigations and verifications. Surgeons, facilities want to know exactly how they're going to get paid and reimbursed before that procedure happens. There's a very knowable model and pathway to build that out years ahead of launch. Fine-tune it. At launch, it's more about making sure that that confidence remains high. You'll see us essentially prop that field team up, both field sales and, more importantly, field reimbursement, because these accounts want to know that they have high confidence going into utilization. You're going to see us do that. Our whole team has launched several products in Med B buy and bill in ophthalmology. We have that expertise, and we're thinking about this carefully and planning for it years ahead of launch. Great. Maybe one final question, just maybe talking about safety. Obviously, you've seen a pretty good safety profile to date. That being said, some of the other kind of prior bimatoprost implants, we've seen a little bit of maybe history of endothelial cell loss. Just kind of curious what you're hoping to see as you think about your phase III or even the longer-dated data from both first-in-human and to the phase I-II. Yeah, I think you'll see additional data come from us later this year. AAO is what we're targeting for a more full release of our, excuse me, one-year data on phase II. Right off the bat, as you noted and as I said today, we have high confidence going into this, whether it's endothelial cell loss or any of the AEs that we've seen to date. This is consistent with routine cataract surgery. As you notice, our system is implanted safely in the capsular bag. It's tethered, it's not going anywhere. Free-floating implants that are not tethered or things right in the angle, right underneath the corneal endothelium, those are products that come with more risk, if you will, because they're right next to that tissue that's so sensitive. I like to say we're down in the basement and other products are up on the roof right next to the shingles. Very simple analogy, but it's the fundamental reason mechanically and mechanistically why our product isn't necessarily creating that contact friction with the very tissue that people are worried about. Of course, we're going to continue to study this. When the data are released later this year, I think it'll give people high confidence that our system is synonymous with cataract surgery. Great. Thank you very much. Thank you.