Conference Transcript - SGP 2026-09-10

Yigal Nachamav, Analyst — Citi Group

So welcome again, everyone, to Citi's Biopharma Back to School, and we indeed are back to school, so no books open. I'm Yigal Nachamav, Senior Biotech Analyst at Citi Group. It's my great pleasure to have with me Senior Management at Spyglass Pharma. We recently launched coverage, or maybe not so recently, beginning of the year. So we have Patrick Mooney, CEO. Great to see you. Nice to be here. Gene Verre, CFO, joined, I believe, several months ago. Great to see you. And then James Denouel, COO, great to have you as well. Yeah, thanks for having us. So super interesting technology, no doubt. So just maybe just to start, you know, explain the technology, explain what's so interesting here in terms of the marriage of a product for solving the cataract problem as well as solving the glaucoma problem in one drug device combo. So let's go with that question, and then we can move along into everything you're doing.

Patrick Mooney, CEO

Yeah, thanks, Sigal. I appreciate the invite to be here today. Spyglass was originally founded to improve lives of patients suffering with chronic eye conditions. Two of the world's leading causes of preventable blindness, cataracts and cataract formation, which all of us will undergo at some point in our life, it's biology. And for some percentage of population, they also have the comorbidity of glaucoma. And so there's an intersection of patients with chronic glaucoma, which means they're on some type of medical therapy or laser therapy to manage that. And then as those patients make their way to the operating room for cataracts, why can't we really address in a meaningful way, in a simple way that serves the patients to meet both of those needs, improving their life from their glaucoma management, as well as restore their vision from cataracts. And so Spyglass's lead asset currently in phase three clinical trials is essentially addressing both. We're correcting the vision with an intraocular lens and attached to that intraocular lens is three years of payload of a very commonplace first-line therapy for glaucoma management, bimatoprost. That agent's been used commercially for over two decades, so we know the drug works very, very well, and so essentially with a simple one-step implantation of the intraocular lens and these drug pads attached, this is what cataract surgeons do in their normal workflow, and so it's easy for the surgeon to implement, and it's also a step for the patient because it's one trip to the operating room and we can solve and address both issues at one time.

Yigal Nachamav, Analyst — Citi Group

So let's, let's talk about just the market first, you know, who, what's the addressable population in the United States when you look at that, that intersection of, of those with the, you know, requiring the cataract as well as, as well as glaucoma solution?

Patrick Mooney, CEO

Yeah, great question. So, you know, cataract surgery is, you know, either number one or number two, you know, surgery in an outpatient setting in the United States every year. So annually today, there's about 5 million annual cataract procedures done in the United States. About 20% of those 5 million procedures are patients also with glaucoma. And so if you take the arithmetic, you have 1 million incident procedures annually every year, growing at around 3% of these patients with glaucoma and cataracts that are having surgery. So the market is clearly there. This is knowable. It's addressable. We don't have to create that market. We're just simply serving a very knowable, unmet need and addressing both conditions at the time when patients are already there.

Yigal Nachamav, Analyst — Citi Group

And I mean, to ask a basic but super important question, those a million today without, obviously, you're not approved yet. What are they doing?

Patrick Mooney, CEO

I mean, it's just, so what are the options for patients, you know, in the absence of your technology? one option is to do nothing which means they stay on their drops or some type of medical therapy two-thirds of the cataract surgeons in the united states are not doing surgical glaucoma type of procedures they're they're very skilled at their cataract procedures and so they routinely just perform cataract surgery and unaddress say the glaucoma portion of it and so about two-thirds of surgeons could definitely be engaged in this procedure and now meaningful help patients. About one-third of surgeons do perform glaucoma filtration surgeries, implantation of minimally invasive glaucoma surgical devices. So that's great. We love the fact that a third of surgeons are intervening and actively trying to manage that. But our aim is to not only engage the one-third, but all 10,000 cataract surgeons in a meaningful way, and we think spyglass technology does that because cataract surgery, regardless of whether you're a glaucoma specialist or a general surgeon, cataract surgery is your bread and butter procedure, and so our procedure is essentially adoptable immediately from all 10,000 surgeons.

Yigal Nachamav, Analyst — Citi Group

Okay. Now, when I first heard about it, you know, it's a very elegant and simple solution, but there was obviously a lot of technical challenges along the way to, to, to achieve what you've achieved. So just maybe just describe the technology in a little bit more detail and, you know, the, the, the very small additional steps that the cataract surgeon needs to implement to, you know, to, to, to hook in the drug pads, just, just kind of go through it a little more detail what you've, what you've done.

Patrick Mooney, CEO

Sure. Well, our, our system is primarily two component parts. First, the intraocular lens, And the second component part is the non-bioerodible drug-eluting paths that attach to the intraocular lens. We spent years getting the intraocular lens right first. What you see commonly in drug development or long-lasting drug delivery systems, oftentimes it's a really interesting, innovative polymer, and then it's baked and trying to secure it or attach it to something else. And Spyglass actually did the inverse. We started with the intraocular lens, get that right first. We know surgeons rely on their refractive outcomes, they trust the products that they use today, and they have a lot of confidence when they predict to the patient, I can correct your vision, and we don't want to change that. And so really, it was important for us to make sure that the lens quality and really the quality of vision that one can achieve with the spyglass lens is uncompromised, unparalleled to what they achieve today with their standard of care lenses. So we did that first, and then we figured out how to securely attach our drug delivery system in a way that doesn't impede vision. And we spent years fine-tuning how do we get the exact illusion profile 24-7 for years. And so it's really that special know-how and really our special sauce, if you think about how to get the vision right and constantly deliver the amount of drug consistently per day that you need. That's essentially the know-how within Spyglass. And we're starting in glaucoma, but it's also transferable to other chronic conditions and even acute conditions in ophthalmology with other drugs and APIs that are commonly used to treat patients.

Yigal Nachamav, Analyst — Citi Group

So that's an important point, which everyone listening shouldn't overlook, is that it's your proprietary lens that you've, and you didn't, you know, would have not been possible to start with like an off the shelf lens that wouldn't work that way because you wouldn't be able to adapt the technology to have the, you know, the hooks and the haptic arms for the drug pads.

Patrick Mooney, CEO

I'd say the technical aspect, essentially spyglass technology is applicable and agnostic to any of the existing optics or lens material out there today so we could essentially take our design and put it on any base platform today but the technical know-how it's it's it's purely milling changes uh to be able to implement our design on any of the lens platforms today but the you're right it is a our proprietary lens but the lens material that we're using is already fda approved and it's been millions of eyes and it's proven technology. So we're essentially taking known proven monomers trusted in restoring vision for cataract patients. And we're changing or adapting the design of the edge of the material, if you will. And that's, that's agnostic to anyone's material.

Yigal Nachamav, Analyst — Citi Group

All right. Well, let's talk about, you know, obviously we'll get to the phase threes you're in, you're in phase threes, but tell us, tell us a little bit more about, you know, the data that you've generated to date because you have to show two things you obviously have to show the vision which should be straightforward as you point out it's you know a known known solution you're just recreating it and then the bromatoposte which it's also a known solution but it's coming into the eye in a slightly different way so yeah just kind of tell us what data you've generated so far great yeah james okay yeah happy to so we started on this journey over four years ago now clinically with our first in human study.

James Dennewell, COO

This was a single site down in Honduras. And this is where we had 21 patients now read out to three years and the results were amazing. I mean, exactly what we want to see at three years, 95% of patients aren't taking any additional therapy, 37% mean IOP reduction, which is on par with some of the more invasive glaucoma surgical procedures. And again, like Patrick said, this is all in a procedure that all cataract surgeons can do. It just fits up that with our phase 1-2 study, where we now expanded to 22 sites, 104 patients. And this was an interesting one because now we have a control. And that control group was cataract surgery with state-of-the-art IOLs. And we told surgeons, pick your favorite IOL, Alcon, J&J, or Vaush, whatever you use every day. And that's in our control arm. And those patients would get dosed with topical timolol twice a day. Our test group has the spyglass IOL, which was everything that Patrick described with the bimatoprost pads, and they would get placebo drops twice a day as well. And so in that study, we showed two things. One, we replicated the IOP lowering in the patients off meds. So we had 12-month data come out earlier this year. 98% of patients in our 78-microgram dose, which is that dose we're taking into phase 3 and intend to commercialize, off of topical therapy at one year. and then 34% mean IOP reduction and on the IOL side some of the data that was really exciting because we had the same question early on from surgeons which was you know prove to me that your IOL works just as well as the IOL I use every day and then I would offer this to all of my glaucoma patients and we showed that in our phase one too with that same 78 microgram dose at a year patients saw on average 87 letters and which was exactly what they saw with the control arm right So it just shows, as Patrick mentioned, we have a state-of-the-art IOL material. Monofocal optics designs are standard, right? They haven't really changed in 30-plus years. And so it's everything that we wanted to see in our phase two. And we'll do this again in our phase three. So our control group, very similar in phase three. And we'll compare it just to that 78 microgram arm.

Yigal Nachamav, Analyst — Citi Group

So what you just referenced was the larger study, but there was an earlier first in humans study too, yes? And you have, that's gotten quite a lot of follow-up and you had the three-year, I believe you're going to have some additional follow-up. So talk to us about that.

James Dennewell, COO

So the last patient came in for their four-year visit just recently. And so by the end of the year, we'll release our four-year data from that first in human And we really are forging new ground here, right? No one's had a four-year drug delivery study before for glaucoma. And when we look at potential read-throughs from the three-year data, we just expect to see more of the same, but honestly anything close to what we saw at year three is awesome for patients. I mean, the idea of patients being able to be four years out from cataract surgery and the vast majority of them not needing to take drops, it's amazing.

Yigal Nachamav, Analyst — Citi Group

So at three years, you just remind everyone what was shown at three years and the design of the product was what was the target profile was to get to, I think around three years, but you didn't kind of know how much further you'd be able to go, right?

James Dennewell, COO

Yeah, there is a key distinction between the product in our first in human and our phase one, two, and phase three studies. And so our first in human studies, they're actually loaded with seven years of amatoprost. And so we are following those patients all the way out to seven years. And the great thing about amatoprost is, you know, we have 25 years of data that already exists from topical amatoprost. And so you know that patients can take the same dose for years and expect to see similar levels of efficacy. And And that's exactly what we expect to see there as well.

Yigal Nachamav, Analyst — Citi Group

And by the way, in the randomized study, there must be a good reason why you used Timolol in the control. Because I've gotten that. I got that question, too, when I was first covering, as opposed to Bermatoprost.

James Dennewell, COO

So Timolol has been the standard control for glaucoma studies for over a few years.

Yigal Nachamav, Analyst — Citi Group

So no controversy there. All right. Um, you want to talk a bit about, um, the phase, the phase three, uh, design. And I mean, those are obviously underway. So can we talk about how they're similar and different, perhaps slightly from what you've already done?

James Dennewell, COO

So as you'd expect, the phase three is too much larger studies. So we're looking two studies, 400 patients in each, so 800 patients total. And so we'll do that across more sites. We're now over 90 sites in our phase three study. and we took just that 78 microgram dose from our phase one, two into the phase three and some key changes on the inclusion exclusion criteria just to reduce variability. So we reduce the maximum number of drops from three to two and the maximum intraocular pressure for patients coming in from 36 millimeters of mercury to 33. And that's not that the product doesn't work great on those patients that have more severe disease. It's just that they add a lot of variability in a phase three. And so you try to take that out so you could really compare the control group to the test arm. The other key change with the primary endpoint was we added best corrected distance visual acuity as a co-primary endpoint. And that's just to show the FDA that our IOL performed just as you would expect from a monofocal IOL.

Yigal Nachamav, Analyst — Citi Group

Okay. And then timelines briefly? Yeah.

James Dennewell, COO

So we're still right on track. We projected any enrollment in 2027 and we're on track to do that in the coming months we'll refine that a little bit further as we get further along and then once we finish enrollment it'll be just a few months after that as we crunch the data and then report out top line results and we'll follow that up with an nda submission in 2028 and a launch in 2029 so the top line data i guess early 20 early 28 there's something in that there there's a window the window yeah but but the two studies so are they going to read out uh you know conjunction or is there some there are they starting are they kind of going rolling in parallel so they're running in parallel whether they read out in

Yigal Nachamav, Analyst — Citi Group

conjunction will be to be determined okay okay so it could be all together and or slight separation yeah okay um so that's that's uh very good um let's talk a little bit about the pharmacoeconomic model because you had some important updates um recently which you know may seem you know very in the weeds, but certainly super important, specifically this, you know, determination from CMS regarding one of the procedure codes. So there's a lot to unpack there, but can you go through why that's so, why that was so important?

Patrick Mooney, CEO

Yes, you're right. And we appreciate you being in the weeds, by the way, because this is an important topic. You know, for years, we've been asked, will surgeons be paid at a different rate? And will there be an additional professional fee associated with spyglass. And we always believe that there should be because there is a bit of additional surgeon work inside of their normal 20-minute case. The surgeon's just busier for longer. And we presented that case to the AMA and explained our procedure and they agreed, which is what you saw issued July 1st, a add-on category three CPT code. So the fact that we were granted that signals that there is additional work that should be paid to the professional, not to the facility, just for the surgeon themselves. And we think that's important. The answer is a key question. Is there additional economic incentive for the surgeon to consider spyglass? And yes, that's true. This is something that would be priced at launch. And this is something that will work with the max to price that out appropriately. One thing we're doing to help with that objectively in our phase three studies, we're quantifying all of this surgeon work at each of the different stages of the procedure. And so we'll be able to go back with 400 patients in your typical standard of care case. Here's the work versus spyglass. And that difference is incremental workflow and additional time and payment for the surgeon. And so that's a really important piece for us. I think that speaks to the surgeon fee. And then from a facility standpoint, we always want it to be simple in terms of not adding incremental expenses to the facility for an incremental procedure. Spyglass is still one single procedure, cataract surgery. And we have very knowable category one CPT codes on the books that are not debated. They get paid well with very minimal pushback. And so spyglass is still cataract surgery. We're going to use the existing codes will have an on-label use to be implanted at the time of cataract surgery. So that simplifies, you know, the MAC discussion of, is this an additional procedure code? No, we're trying to be very simple and straight ahead. Yes, a little additional payment for the physician, but pales in comparison to an additional procedure fee. So instantly we're more efficient. We think Medicare and the MACs will like that. And then from a procedural reimbursement, it's really the drug reimbursement. And so ASP plus 6%, this is a physician-administered drug, so there's additional margin that can be made 6% on top of this price. That goes back to the facilities, which, as you know, reimbursement continues to get cut. And most of the cataract procedures are performed in ambulatory surgery centers owned by physicians or private equity.

Yigal Nachamav, Analyst — Citi Group

So you mentioned ASPs plus 6%, So that obviously raises the pricing question. Can you discuss, you know, your initial thoughts on how you would price this product at this Or is it something that, you know, pending the phase three data, you would make that determination?

Patrick Mooney, CEO

No pricing decisions have been made at this point. We get asked a lot about what are our thoughts. And, you know, our view is you've got two reference products in market today, Eidos being one of them and Dorista being another. And if you look at the cost of those products over a 36-month period, there's a well-established price point.

Yigal Nachamav, Analyst — Citi Group

So today's value on both of those products, the floor price is $14,000 for three years of drug delivery in this space. so for for someone that's say doing you know what you just referenced the the idos the darista plus uh a lens replacement you know help how would you position when you when you're when your sales people are positioning bim iol the the argument for the switch or to adopt bim iol just walk us through the you know the logic it's it's a time saver it's a it's a simplicity saver right um what are the other aspects so you know the average cataract surgeon are not

Patrick Mooney, CEO

using these minimally invasive glaucoma procedures they could and we think that's great if they like to implement those tools patients need more options and we need to to service all of the 1 million today about half the market is completely locked one third of surgeons are doing about 50 percent of the total volume of opportunity. And so the other 500 million, excuse me, 500,000 procedures, we think we will unlock. And then surgeons that are using, you know, these minimally invasive glaucoma procedures, they will have a choice to make. Does spyglass make sense to be put in the bag after cataract surgery, or does something else in the angle make sense? And those are good options for patients as well. Our case is very straightforward. This is still cataract surgery. It's one procedure. And all cataract surgeons know how to put in a foldable intraocular lens in the capsular bag. They do it every single day. So our workflow is very streamlined and in sync with what they already do. When you start adding additional surgical glaucoma procedures, that's a timeout in the OR. There's a shift of the patient. There's a shift of the microphone. It's extra tools. It's extra skill that everyone could learn. But the reality is most surgeons today are not taking those options. They prefer to do fast, efficient, convenient surgery, and they'll just do more cases versus adding on some of these additional tools. This is why spyglass is attractive. Patient's already there, solving and addressing two problems with one procedure they're already doing.

Yigal Nachamav, Analyst — Citi Group

Okay. So let's swift a little bit to some of the pipeline work because you have you know you're thinking ahead as as as as you should obviously um and uh uh so there's another product which um bim drs which is a sort of a next generation i guess i think of it as like a recharger or something like that but tell tell us tell us what it is and what what the potential there is for you know even longer duration sure you know in any of our platforms um we've known that roughly seven years of payload is possible.

Patrick Mooney, CEO

As James talked about earlier, our very first in-human trial with our drug pads with BIM-IOL, we did load that with seven years of product. We scaled back to three years as we came into phase one, two, and phase three. Doctors wanted one year of efficacy. That was their MVP. And the FDA said, hey, as long as you've got drug eluding, you're going to have to study and follow these patients. So the idea of a small private company doing their first trials seven to 10 years was untenable. And so three years as a starting point was a great midpoint where surgeons saw extreme value to the patient. Let's get that to market. And then later systems could be explored with longer payloads. So one of the common questions we get today is, hey, three years is fantastic. We've never really seen that reliably with such high rates of patients that are medication But what happens after three years? And so this is an important question that we will answer, and this will happen soon as we move into our first in human trial. It's a clear signal to the market that not only is BIM-IOL going to service this, you know, one million procedures well, but what about the millions of patients that are post-cataract surgery, whether they had BIM-IOL or not? if there's a million incident procedures annually and we're addressing many of them, but what about the others each year that are being unaddressed from a glaucoma perspective? It doesn't matter what IOL they had implanted at the time of cataract surgery. There's still millions of patients that need help. And so the BIMDRS or brimatoprost drug ring system is not an intraocular lens. It's more of a ring, if you will. It's essentially leveraging our same core technology with our drug core, our release profile, and all of our know-how. And that system, we're about to go into humans with our first in human trial. And we're going to experiment with both a three-year drug load and a seven-year drug load. So it's a clear signal to the market that we know we can get to seven years technically, and we're about to go into humans and prove that in our data.

Yigal Nachamav, Analyst — Citi Group

So that's going to be in patients that have an existing lens or that are also, you're going to, you know, take new patients that are the first cataract surgery? What's going to go into that study?

Patrick Mooney, CEO

We're going to explore both. So phagic patients that are coming in at the time of cataract surgery, as well as pseudophagic patients, meaning they had previously had cataract, regardless of what lens they have in their eye. So you're going to see us experiment with pseudophagics and phagics, as well as a three and a seven year drug load.

Yigal Nachamav, Analyst — Citi Group

But it's the so the BIM DRS has the it can click on to one of the standard lenses from, you know, one of the big manufacturers but it also the geometry can click it onto your proprietary lens or the or there's are there differences to depending on whether it's a you know an external lens or your lens or yeah so bim drs is not a lens it doesn't clip onto the prior lens it's actually implanted anterior to the capsular bag in the existing lens system oh oh okay it's so it's planted in the ciliary sulcus oh i thought it okay got it all right so this is the same space Star ICL, for example.

Patrick Mooney, CEO

It's a space that's now usable once you remove your natural lens, which is much thicker and artificial lenses are much thinner. And so there's room essentially anatomically to be able to access the sulcus. And so this is the same space and skill set that cataract surgeons have today. And so we're going to leverage that know-how with our secondary platform. And this BIM DRS is designed to be removable and replaceable for the lifetime of the patient.

Yigal Nachamav, Analyst — Citi Group

And this is probably getting further ahead, but like the procedure code for that, does that still fall under cataract? That would be a brand new standalone procedure with different economics. I would think so. Okay. Makes sense. And then you mentioned, you know, some further opportunities going beyond glaucoma. Can you, I mean, with sustained drug delivery, you could think of, you know, wet AMD, you could think of GA, you could think of DME, a lot of things. So where do those opportunities stand? Are those all sort of in discovery mode now or what?

Patrick Mooney, CEO

Those are of interest to us as well. Yes, they're in discovery pipeline. We've experimented with several different drugs that are relevant in chronic diseases, like you mentioned, AMD, for example. There's a lot of interest in our space, small molecules for AMD or even GA. We know our system can elute these products. We know we can control the elution rate. the big question is can you get products from say anterior segment to the posterior segment for retinal conditions and so essentially we've done a lot of work on the bench to prove viability of our illusion profile with multiple drugs both chronic and acute phases and those are essentially neatly on a shelf all of our focus is primarily in BIM-IOL and BIM-DRS because we don't want to get too diffuse we believe BIM-IOL alone is a blockbuster by itself and so getting that product to market as fast as possible. And then once we have more bandwidth and clear lines of sight, we can advance some of our pipeline work and bring additional systems to market that are relevant for patients.

Yigal Nachamav, Analyst — Citi Group

Okay. And maybe we can bring Jane into the conversation. Tell us just a little bit about the P&L management and the cash utilization and what the runway is, obviously um and then either for gene or for for you patrick you know just talk about your your how you're prepping for for launch i mean it's not that far away right it will it'll be there before you know it uh so talk us through you know how you're building a commercial team and um you know the the strategy there well thank you eagle i'll start with your last question but i'll let patrick answer about the commercial team clearly we've started to do some pre-commercial activity we get two senior executives on board when doing market research or talking to uh kols

Jean Varey, CFO

or talking to uh eventually physicians will be using our product so that's already using some of our cash today we at the end of june we had over slightly over 234 million cash position which will take us through 2028 therefore into 2029 and that will do two principal things one complete the BIM IOL trials, phase three trials. So enrollment, readout, submission to the FDA. And the second thing is it also cover the BIM DRS first in human trial. And lastly, provided that we have positive data, we will continue to ramp, you know, our commercial activities right before launch. So in terms of PNL, I think you have to think about it. you know we'll have expenses increase through 2026 it will level off during 2027 why because all the upfront activities are happening now for the phase three trial and they'll make room therefore for the bim drs first in human trial and pre-commercial activities and then we'll continue to have an increase in expenses until launching 2020 29 okay i'll just add a couple comments on the commercial prep.

Patrick Mooney, CEO

You're exactly right. Three years to launch. This is exactly how we think about it as well. Our team came from big drug launches and big pharma and three years is your kind of launch readiness timing when you start all of these things. We've already begun that planning. We have a launch readiness cadence with our team, thinking through strategic imperatives, both commercially as well as medically and advancing and putting effort on those things. So you've seen us bring in a couple of folks with big buy-and-bill ophthalmology drug launches that have been successful in the past. And so I would say at this point, we're early in that process, but we've begun. And we started thinking through carefully the systems of care, the things that we need to build to make sure that we're building reimbursement confidence well in advance of launch, not after launch. These are really important things. We call them sand in the gears. And we need to get those things right well before launch. And that can be done in parallel as we move through our clinical trials. And so you're going to see us bring additional folks to the team that help both with those medical and commercial imperatives.

Yigal Nachamav, Analyst — Citi Group

So in those early conversations with providers like this, you know, we talked about this add-on code. Have you sort of socialized that concept with some of the practitioners to get a feeling for it's, you know, how receptive they'd be to that? Is that, or does that come later? We don't bring it up. you don't bring it up yet but they bring it up they noticed and it matters and they said that's great and so one of the questions we get a lot is why did you do it now and our answer is the same because we can yeah well i had the same question um okay we didn't talk about uh manufacturing and and supply it's a lot of patients a million patients you need a lot of product um can you just comment briefly on you know where is the product made how yeah just to the extent you can comment on that yeah so we manufacture all of our finished products in the u.s and one of the things that spyglass did really early in our development was bring process development in house so even

James Dennewell, COO

though we don't do any gmp manufacturing house ourselves we own the process so we can we have all the equipment we have all the engineers and so that allows us to scale because now we can take it to any contract manufacturer or even eventually build out our own manufacturing and drop the process in place to make drug pads. IOLs, on the other hand, IOLs are a very mature industry, right? There's dozens of IOL manufacturers globally that you could use, and we utilize one that manufactures IOLs for global strategics. And so plenty of capacity on both fronts to target our patients.

Yigal Nachamav, Analyst — Citi Group

Okay. And then just to finalize here, so just can you maybe just recap the catalyst path over the next, you know, 12 to 24 months? And then we also are asking everyone about AI. You know, how much are you using AI internally at the company to speed analysis or crunch data or begin to prep the ELA filing?

Patrick Mooney, CEO

It's great. I'll address the catalyst and James's nickname is Claude, so we'll have him address that one. Lots of catalysts. Honestly, we've guided publicly to, we've got some pretty important catalysts coming up here just before the end of the year. And we've got a four-year readout from our first in human study, as you mentioned. Why that's relevant, it's showing proof of concept. We know we have seven years of drug in that system. And showing a four-year readout will be the first time any system has proven reliably that you can get the vast majority of patients still off of medicine. It's also relevant for propping up our second generation system, which is about to go into humans. And so we are very much on track to deliver both of those catalysts, but moving into humans with BIMDRS before the end of the year sends a clear signal that we are starting. And our aim is to be able to bring BIM-IOL to market in 2029, continue BIM-DRS development three years after BIM-IOL is launched, we want to be ready with our secondary offering BIM-DRS. And so both of these upcoming catalysts support each other in terms of our aim, our vision, as well as the proof of concept to be able to do it reliably. Beyond that, we've got a two-year readout next year with phase two. We've got a five-year readout on FIH. We've got a 12-month readout on BIMDRS, and probably the biggest catalyst next year is announcing that we have completed enrollment because the data will be shortly thereafter in terms of top-line readout.

James Dennewell, COO

Sounds good, and I'll take the AI question. What's interesting is I'm now over seven years into the journey with Spyglass Pharma, and we've always been excited about the potential of the company well before anyone was logging into ChatGPT and getting answers the questions, but at this point, you can't really avoid AI. So I would describe Spyglass's approach to AI as deliberate and making sure that there's value and security in the application of it, right? So we are using it across, you know, on the clinical team, everyone on the Spyglass team has access to an AI model if they want it. And just when it comes to specific applications, you know, we would rather be error on the side of safety versus efficiency, right and so that's just that's overall how we've approached it and we know we could be successful even if we didn't use ai so given your nickname does that mean either spyglass only uses claude or you use some of the other platforms too now we we have a number of platforms out there my my preferred platform today is claude but uh whenever patrick asks a question i don't know the answer that's what login is like well i won't take credit for it i'll say claude says this.

Yigal Nachamav, Analyst — Citi Group

All right. Great. Well, thank you very much. We're going to update our catalyst calendar for the five-year data. I think we didn't put that in yet, so we'll do that and look forward to a lot of developments over the next few quarters. Thank you. Thank you. Thanks. Thank you, Eagle.