Kodiak Sciences Inc. (KOD) Earnings Call Transcript & Summary

Thanks, everyone, for joining us for the last session of the third day of our conference. I'm pleased to be joined by Victor Perlroth, CEO of Kodiak Sciences. Thank you so much, Victor.

Thanks a lot, Andrea. Can you hear me?

Yes. So maybe we can start. We're at an exciting time for Kodiak. We're sitting in front of 4 Phase III trials that are coming, starting in July. Maybe help frame -- maybe let's take a step back actually. Let's talk about your antibody platform, and how is it uniquely positioned to address this idea of durability?

Right. Well, that's a good question because we start with the science of the design and then what we do with it. Durability is complex, and it's an integration of a number of different properties. So in our case, our ABC medicines, our antibody conjugates, as you mentioned, and what we conjugate is a branched phosphorylcholine polymer. So phosphorylcholine is the primary component of our cell membrane. So it's recognized as native in the body. And more importantly, it's biophysically what's known as zwitterion, which means it has a permanent positive and a permanent negative charge like a balance. And what that means in biology is it binds water at the core, like, of the balance. So -- and that water is permanently attached, so to say, to the polymer and that forms a bit of what we call a water force field around the antibody, once it's conjugated. So that's quite interesting scientifically. So for durability, you need the drug after the injection into the eye to stick around a long time physically. It's half life or its residence time, you needed not to degrade so you have to have very good stability. And remember, an eyeball at 37 degrees, for many months, that's actually a very high bar for a naked protein. And you need your drug not to get kind of grouped up onto other molecules that are sitting around there through miscellaneous, like, hydrophilic contacts as the drugs is bouncing around. That's what's called preventing nonspecific biological background. And then you need the drug to be potent and to remain potent. So for all of these items, our ABC platform has really a close to ideal set of properties, 3 to 4x the half-life of other biologics, so you're not just dosing in more drug, but you're flattening the exit curve in a unique way. We have very strong 4-degree, 25-degree and 37-degree stability, really unparalleled for protein, I would think. And we also have tremendous protection from nonspecific binding through that watery force field, and we have a picomolar potency in line with other agents. So it's a very attractive set of integrated properties that led us to design these medicines and then to begin testing them and to learn more clinically. So of course, you have to be able to manufacture the medicine, and we have our commercial facility now online to be able to really efficiently manufacture these for the large scale. So there's a long -- a strong underlying rationale around the durability. And therefore, we designed the Phase III pivotal program to really test that, to showcase that, right, with the BEACON RVO study we read out last year at 2x the interval of dosing versus the comparator and then the GLEAM, GLIMMER and GLOW studies this summer, we'll be looking at 6-month dosing in those 3 studies in diabetes. And then wet AMD, approval and the mix, right, with more than a majority of the patients having done very well on the longest interval tested for durability even though, unfortunately, in that IIb study, we didn't meet the endpoint.

Maybe let's talk about the properties of tarcocimab that you saw -- or that you've seen in your studies. And remind us what you saw in the Phase I study.

Right. Well, in the Phase Ib study that we ran, it was a nice study design because we enrolled treatment-naive patients into 3 major indications in retinal vascular disease, wet AMD, DME and RVO. And then in that study, we had certain -- after the loading phase of 3 doses, I believe we had certain criteria that deficiency physicians could use to decide whether the patient should be dosed. I think really importantly, in the Ib, we allowed the physicians the opportunity to dose the patient every month if they wanted to. And so in some way, I like to think that the Phase Ib data represent how our drug would actually most likely be used in the real world by physicians. And in that study, in those 3 diseases we showed that 66% or more of the patients could be on the 6-month or longer interval across those diseases. So part of that is the challenge of drug development, where you generate that kind of data in a Phase I/II type study and then how very quickly you translate that into running larger studies, because we didn't have an active comparator in this study. And so it didn't really help us to calibrate the different behavior of the medicine, say, infant diseases. For example, how it behaves in wet AMD versus how it may behave in RVO or DME. And then in terms of our design of our pivotal studies, where we deviated somewhat from the norm because in the first study, the Phase IIb, the DAZZLE study, we didn't allow a rescue group that would be dosed at the same interval as our comparator. EYLEA Q8 week. And that was really the critical element in the design of the study that led, I believe, to the failure of the study to meet the primary endpoint. However, we did show, again, a strong durability signal with 60% of the patients doing well at 5 months. Now people also, I think, rightfully made the argument from the Phase IIb study that the loading phase is weak versus the aflibercept comparator. And really what does that mean? And why is that? And what does it mean for the profile of tarcocimab as a medicine. Now that's a powerful criticism. Part of it is we didn't have the active comparator in the Phase I study. So we didn't have that visibility to help us better design the study. That's the first thing. The second thing to understand is really we saw that weakness in what I call 1/3 of 1/3 of the patients. So 2/3 did well on the long interval dosing, the same as the comparator of that other 1/3 in our corporate presentation, you can see that the OCT drawing continues to drive through the loading phase in those patients. But as soon as we withhold therapy, we made everybody go to 1/4, those patients jumped back dramatically. And then that 1/3 of 1/3 of patients lost a lot of vision. And we couldn't make up with the majority for the amount of vision that 1/3 of the 1/3 plus some number of patients who were discontinued from the study. So in those early translational studies, the Phase IIb, we didn't have all the insights. I think we don't believe from the data that we've seen that the early weakness that we see in the wet AMD translates into RVO, where we were equally potent at the week 1 in BEACON. Or that we don't believe we're going to see that type of early weakness in the DME studies. So you have the learning. And what's important is that we're running a wet AMD monthly study, which was originally started not to basically supplement the DAZZLE study for approval but rather to bring monthly dosing into the label across all of the diseases. But now actually, it's a great experiment because it will show to the community of physicians and say investors, what does happen when you dose patients monthly in wet AMD, not just through the loading phase where, let's say, our expectation is that we may similarly be weak compared to we were in the DAZZLE. But what's most important because physicians called us after the Phase IIb after DAZZLE. They said, well, I was a participant in your study. I know that a number of my patients were on long interval dosing with tarcocimab and DAZZLE on the longest interval allowed and they did extremely well. And so I'm disappointed in the results, okay? And they said, I'm not surprised because really dragging the highest need patients to every 3 months, those patients can lose a lot of vision. But what they said is that in the real world, where tarcocimab approved, they believe that, that long interval durability is that really special thing. And so many of them said they would want to dose the patients at the beginning, watching them carefully to see what are they part of that 1/3 of 1/3 or whatever. Or are they part of that vast majority that actually do very well on the medicine and can get out to, say, 5- and 6-month dosing, which is quite special. So that's part of what our broad pivotal program is designed to explore is sort of the boundaries, okay? And also from the science of the design and then the pivotal program this summer with rate 3 out of the 4 studies in diabetes and those 3 studies long 6-month dosing, I think will provide a lot of information for all of us to better understand what is the place, yes or no for tarcocimab in the community, right? And if the data meet our hopes and dreams and reasonable objectives, there's a special place in the market, I think, for the drug.

Maybe let's dig in there on durability, and that is at the core of what Kodiak's platform is really looking to address. How significant is that to KOLs as they think about taking their patients who are potentially on EYLEA, brolucizumab other anti-VEG-F therapies and switching them on to tarcocimab?

Right. Well, I like to say there's no unmet need for a drug retina for the vascular diseases that's dosed monthly really or every other month. There's plenty of agents. But even I was at the clinical trial was at the Summit, retina meeting this past weekend, which was a very nice well attended retina meeting with a number of KOLs and there was a lot of good discussion. I think what I was actually surprised myself at was the level of the overwhelming agreement amongst the physicians, still that durability remains the key unmet need, okay? And what physicians called true durability. For example, one of the KOLs, Dr. [ Hire ] is very well respected and has been part of the drug development for LUCENTIS and EYLEA since the beginning. And he said he would sacrifice vision actually for true durability. So then there is the discussion of, well, how to get there. And there was a lot of discussion around futuristic systems such as gene therapy and port delivery systems that were discussed. But in some way, both of those systems are further behind now than they were several years ago, actually. So what I would say, there are still more unknowns than knowns on those categories. So what's very simple about Kodiak and about our platform, about tarcocimab, we're a biologic, right, like Roche or Regeneron. It's just that our biologics are uniquely designed for durability. So the long -- and we're testing in our pivotal program, right, the longest dosing interval, 6 months of any intravitreal biologic that we know about anyway. And so our hope is to show that we can bring a majority of the patients to 5- and 6-month dosing in our clinical studies and still be non-inferior to intensive labeled comparator regimen of aflibercept. And then in the real world, we can imagine that translating to the majority of patients being on twice a year dosing, and that's the durability that matters, right? That's a true durability in our view. So I think a way to think about it, because you're asking, well, what does the community think. If physicians want to schedule the patients, let's say, every 3 to 4 months, maybe to see the patient. Life gets in the way and often the patient will come in, say, every 5 to 6 months. I mean, that's just the reality. And the right agent for the patient then would be tarcocimab where we have clinical evidence, right, that we hold the disease at bay out to that 6-month point. Nobody else will have that. So in the context of good data, that's really a powerful differentiation. And I'd like to say like physicians went into medicines because they have a bit of anxiety and didn't want to go into some other field. But a drug like tarcocimab sort of helps to quell the anxiety because in many cases, patients actually don't come back properly for the next visit. So we kind of solve that problem.

And maybe in those discussions you're having with physicians, how are they thinking about the proportion of patients they would want to see being able to achieve that every 5 months, every 6 months dosing to feel comfortable, maybe to your point, being able to let their patients go that long?

Right. Well, I think a lot of it depends on the physicians that actually know how to do their job. And the thing about these diseases is patients are quite variable. So what they want to do is to try to establish what the level of need is of the particular patient and then to try to see the patients on some useful interval. That's good for the practice and also achievable for the patient, right? And then maybe to have a little bit of overage, so that the anxiety is kind of minimized. And that's where I think tarcocimab could be just the Goldilocks type thing that the field is looking for. And that's why I think there could be a really nice spot for it in the complex commercial landscape that exists today.

Maybe to put some numbers on that, and I know you've marked it to the majority, so over 50%. Is that generally in line with what you're hearing?

Yes, absolutely, I think, because nobody else is testing at that level. So it's really kind of a virgin territory. And so we want to put our footprint out there in a unique manner. And then we'll be excited to get the drug out there, so physicians can actually use it and see how some of these unique design characteristics give them a new and different agent in the mix of agents, but as one of the majors. That's what we want to achieve. And from where we are today at Kodiak, that would be amazing.

Maybe jumping to GLEAM and GLIMMER, your 2 studies in DME that are reading out in July. Maybe walk us through the trial design here. Just remind us how -- maybe how the patients are treated within this design.

Right. So first, the patients, they're all treatment-naive patients, first of all, which is a bit of a difference from the other majors with faricimab, they had in the range of 20% previously treated. And then the recent high dose studies had, I think, north of 40%, maybe previously treated. But we've stayed true to the treatment-naive patient at 100%. So they come in and they're randomized either to KSI-301 tarcocimab or aflibercept. In both cases, initially, they'll have 3 doses once a month. And then the EYLEA will continue on its 5 loading doses Q8 week through the endpoint. And the tarcocimab patients, all the patients come in, so they're dosed at 0.48. They come in at week 12, and they have sort of a sham kind of injection. And then starting at week 16, which is 8 weeks after the loading phase, they'll be assessed for these disease activity assessments, okay? And then they'll go out to week 32, and that's a 6 months of evaluation. And the goal there is to establish their base treatment interval according to the criteria. So if they never meet the criteria, they'll go out to 32 weeks, which is 6 months, and then they'll be dosed and their base interval is 6 months. Alternatively, they'll be dosed prior to that because they'll meet the activity criteria, and then their interval would be set at, say, every 8 weeks, every 12, 16, 20 or 24. And then through the study and the endpoint is the average of the vision, the average of week 60 and 64. So it's a bit of a long 1-year study. But we like that because it allows the patient to have 2 6-month doses, which we think is nice from a regulatory standpoint and also to really drive a little bit of that stronger support again around it being really a true 6-month true durability agent. But along the way, the patients will be evaluated monthly and then their base treatment interval can either be reduced, kept the same or lengthened according to slightly different criteria. And we like this approach because the criteria, they're not entirely anatomic-based but largely, okay? One of the important changes we made versus the Phase IIb DAZZLE study and the wet AMD is those disease activity assessments, which we had in some manner, a similar, they referred back in that case to a fixed week 12, which assumed the patient was at its best at week 12. That turned out not to be the case. A lot of patients were their best later and the algorithm didn't adapt and that led a number of patients to be undertreated. That was not good. So in the GLEAM and GLIMMER studies, we always refer the disease activity assessment to the patient's best, okay? So that will -- the goal is to get the patient to their best and then to basically maintain them at their best so that we're optimizing for the vision, which is the non-inferior endpoint. Because if you think about it, if we're going to bring a majority of patients to 6 months or 5 plus 6, we're significantly treating less than aflibercept because those patients are getting basically jammed every week. So you don't want to have too much separation. So our criteria that we're using to shorten, maintain or to lengthen the treatment intervals are fairly tight. And so we think the physician community will like that. And we also think because they're tight, we're driving the patients to their best division, and so that optimizes the chance of really showing a nice non-inferiority endpoint. But I think the key -- some key elements of the design are thoughtful and are really optimizing and maximizing our chance of achieving the endpoint while showing nice durability. And of course, it will be a nice way to show safety as well.

Primary endpoint being non-inferiority, but there will be a focus on that proportion of patients capable of making it to the 5 or 6 months. How do you think about what is more meaningful in terms of a data set when you think about the proportion of patients capable of making it to that time frame at the end of study versus at any point over that 60-plus weeks?

Right. Well, actually, I think this is a bit unknown territory because, like I said, no other biologic that we're aware of is exploring it to this level of depth. And so many of those different metrics, I think, will be important and an important part of the messaging for Kodiak, for example, coming out of the loading phase, right, how many patients get to 6 months immediately, right? Or another one, how many patients do 2 complete 6-month intervals, right? Or how many patients have a 6-month interval at any point in the study, how many patients are on 6 months as the processing through the endpoint? So there are many different metrics. Because nobody has really done this before, we have the opportunity to look broadly and to try and work with the physician community. And the idea that we have 2 of them, I think, can be quite strong. So there's a lot of ways to win, I think.

How much read-through is there from the RVO study from BEACON?

Yes. Well, BEACON met the endpoint, and it did so where we didn't have a rescue group matched to the comparator, which, as I said, is not the standard way to do things, where both Roche and Regeneron had to match the rescue to their comparator. So we didn't have that in the IIb and then BEACON was very close to the readout, so we couldn't add that. It would have been a good idea to have it and nobody in the community would have held that against us. I think having met the endpoint without having that gives a stronger view into the power and the durability, but it's also a liability. I think what was really nice in BEACON was to see the really strong match potency coming out the gates on the OCT and vision, okay? Because it really shows a distinction from the earlier DAZZLE, the Phase IIb study, where we saw a separation from the beginning, okay? We don't see that and we didn't see it in BEACON. And we don't expect that we're going to see much deviation in DME either. Now we don't say we have to match the comparator in terms of its immediacy because our core element is that true durability. But I also think what's important for the community is that they shouldn't have a feeling that the drug is weak at the beginning. And we believe that from the Phase Ib data that we saw, that we don't believe we're going to be weak in DME of the gates. So I think the read-through from BEACON is we've designed GLEAM and GLIMMER more thoughtfully. We had more time to do that. We have that matched rescue. We have very tight disease activity assessment criteria. We've lengthened the endpoint to allow those 2 -- those kind of 2, 6 months. And we think at the beginning, we don't feel like we need to be right on like high dose was basically not any better than regular aflibercept. I think they would have hoped they would have been a little better. I think, well, if we're a little bit worse, I mean, I think that's quite successful, actually.

Got it. Maybe as we jump over to DAYLIGHT, which is the monthly dosing in my AMD I guess maybe help us understand, do you still see a path for tarcocimab in wet AMD on the back of the DAZZLE results?

I do. I think it will be -- first of all, DAZZLE has -- or DAYLIGHT as a study has 3 jobs, okay, as I like to say. The first job is we want it to meet the endpoint, so we can get monthly dosing into our label broadly across all the diseases, okay? That's really important, and that was its original job. The second is that we're dosing monthly, so it's an intensive regimen with a lot of exposure over 1 year. And so the safety in IOI in particular, is of high interest to the community that will help to assuage or provide confidence to the community around the safety of tarcocimab on its maximal regimen, which really, let's say, fewer than 10% of patients would likely ever get. And the third is to get approval of the medicine in wet AMD. So then the point is, okay, well, what does it mean to be approved and wet AMD on top of the fact that in the IIb, we didn't meet the end point? I think, like I said, 60% of the patients did really well in the DAZZLE study and now long interval dosing. So physicians said, how do I get the patient to that kind of promised land? DAYLIGHT will not only give the ability for physicians to use the medicine in wet AMD, but it will also provide a lot of information kind of about what the curves look like. And we're also very curious to see. We don't expect, like I said, the loading phase to really be that different. But I think what will be really interesting is to look at months 3 to 6 and 6 to 9 and 9 to 12. But I think irrespective of all of that, I do think like the Phase Ib data, like a lot of patients are going to do really well. And a lot of the most potent responses in all the studies that we've unmasked so far, like in the BEACON and even in the DAZZLE. A number of the most potent responses are actually tarcocimab patients, whether it's minus 600 or 700 or 800 on the OCT or a strong vision gainer. So the complexity of some of the biology of the disease biology is not that the drug is impotent. And in the vast majority of patients, it's really an amazing medicine. And so from a an investor standpoint or maybe an analyst or a market standpoint, I don't think somebody needs to believe that tarcocimab is going to be a major player in wet AMD. You could even model that there's an expectation of 0 sales because within the diabetes side, it's such a large opportunity. But I do think that DAYLIGHT will create a lot of data, that there is an interest by the community. And I think physicians will try it. And then meanwhile, Kodiak can decide, do we want to run some other study that went, say, Q4 to Q24 to really showcase where we do have a pop in the right kind of patients based on the right kind of knowledge. But I don't think we need to make that decision today.

You touched on the safety profile and monitoring the rates of IOI. Remind us what you saw in DAZZLE and how much risk is there that as you go to the more frequent dosing, you will get that step up in the tox profile -- tolerability profile?

Yes. Well, obviously, when you talk about IOI, everybody thinks, well, 0 is like the best number, but that's not really very credible. So that's highly unusual. I think in BEACON, we were in the 1%, and that's really great. I think faricimab, let's say, is in the 2s, okay? I think DAZZLE, the IIb was in the 3s. And then people worry, well, what does that mean? I think people don't worry about the 3s, I don't think, for its own sake. I think -- but what you don't want is to go into DAYLIGHT and say, well, we're dosing at 2x the amount and then therefore, we're popping into the 4s, 5s and 6s, okay? I don't think we want to go there. I think we want to look at the DAYLIGHT data. By and large, and we now have many thousands of patient years of exposure, okay? IOI rates appear to be very low. So that's very good. You do want to get to the next level of the discussion. But when you get there, you don't want to say, well, I'm hiding my head from what that absolute value is in terms of percent IOI, okay? That's an important thing that the community sort of focuses on. But in reality, you want to look at, well, what kind of IOI is it. And in many cases, let's say, you have trace IOI. And in all cases, you could have IOI that's responsive to topical steroids. And not blinding IOI, et cetera. So there's many different levels, but I do think we want to be competing on what's that top line percent IOI and we hope that the numbers are in the 0, 1s and 2s, but we would tolerate the 3s. Beyond that, you get into a different discussion. That's a lot more hand waving and we hope not to be there.

Remind us where you stand with the injector, the needle gauge that you're using. Is this your final iteration that will be used in a potentially commercial setting? And how much of an impact can that have ultimately on this IOI rate?

Yes. Well, that's really an important point. It does seem highly unfair that were held to this 0 standard when actually a number of the pieces of what we're doing are moving, right? On the other hand, that's a standard that people hold you to, and you have to try and compete for that, but it's not really very fair. There are a number of things. For example, we're currently using a 27-gauge needle, which is larger than I would like. And commercially, our objective is to be in the 29. So that will be a lot better because when we're talking about trace IOI, very small things matter. Also, when we think about the types of syringes that are using for dosing and you think about what kind of siliconization are there and you have bubbles and there's a lot of people thinking that there's a relationship between those kinds of things with low levels of inflammation, which we -- I think we generally agree with that. Also, we continue to do a lot of work on our prefilled syringe, and I think we're in a pretty good situation, whether we could file with that or whether as a stretch goal or whether we would do that later. But I think you have with our product that is a little bit more viscous than, say, a LUCENTIS or EYLEA, there's more handling that you have to do, and it does take a little bit longer to dose and the patient's eye is moving. So we're at a disadvantage in that regard for the studies. But those are things that are being fixed in the context of like our commercial drug. And so actually, the fact that we're doing quite well even with all of these other elements, actually, I think speaks really well of the medicine. But it's a good question and also like a number of the different scale-up elements as you move to commercial, we're making a number of small changes that are important whereas you're being compared against an active comparator that's running, I don't know, how many 10 or 20 or more commercial batches each year in the same facilities with the same operators. Whereas we have a lot of small things that are moving, and that's just what every sponsor has to do to get their drug approved.

Maybe jumping to GLOW, which is the fourth study that they'll be reading out this year. Maybe help us understand why other agents are not necessarily used in this area and what is tarcocimab's value proposition?

Well, I think it's a nice discussion because I do think it focuses the mind on the concept of true long interval durability, like what we're exploring can be a game changer because LUCENTIS and EYLEA are both approved in earlier diabetes treatment and prevention, but they're not used. And actually, so our study is against sham because they're not the standard of care. But a twice a year agent can set a new standard of care, and that's what we're exploring. So we think it's really exciting.

Maybe digging in there just on the trial design and help frame expectations here.

Yes. Well, we enroll patients that have a certain level of diabetic retinopathy, that's, I would say, I think it's moderate to severe so that they have the ability to improve. And then we dose them randomized 1:1 sham versus tarcocimab. And on tarcocimab, they get a dose day 0, and they come in 2 months later and they get a dose and they come in 3 months later, they get a dose. And then for the remainder of the study, they're on 6-month dosing. And so that means they're dosed at week 44. And then the primary endpoint is at week 48. And it's using the photographs and looking at the severity of the diabetic retinopathy. So it's a pretty nice study design that has several initiating doses, but not very many, and then it pops out directly to 6-month dosing.

One interesting point, as you think about this market and these -- maybe the role of diabetes in these markets. And there's this prevalence now if you think GLP-1s, more screening of these patients, what does that ultimately mean as you think about these retinal diseases that you're going after?

Right. Well, I do think the intense interest both from a pharmaceutical company standpoint and also from a physician standpoint and clearly from a consumer standpoint, for diabetes, prediabetes, obesity, is really raising a lot of awareness. Obviously, going blind is the most feared complication of diabetes. And like we talked about, these patients really are not being treated, even though many of them have moderate to severe disease that could benefit. So the new awareness and also in many cases now, we understand that physicians are beginning to do a diabetic retinopathy screening before the drug -- before the GLP-1s are actually being initiated. And so that could be driving a number of these patients to the retina doctors. But today, they don't really have much to do. So it just uses up time in the clinic. So for tarcocimab to meet the endpoint and to more broadly achieve our hopes and dreams in our pivotal program would then give them a medicine that they could talk to the patients and actually prescribe and actually open up something really special for them and also surf the wave of this renewed interest in this whole new class. So -- and also we haven't partnered our medicine and we have a lot of ability to think commercially, right? How could we work together with some of these companies that have those agents for the systemic side. And then on the ocular side, Kodiak could become part of something kind of special like on formulary or whatever to help us buttress our battle against the majors within retina.

Maybe speak briefly on the work that you've done to understand the different stakeholders and what they're looking for here with respect to payers and the commercial adoption of tarcocimab.

Yes. Well, I do think within the diabetes area, it is -- it represents about 35% of the current anti-VEGF market today. And it represents, however, more than, say, 40% of the expected growth of the market. So it's a really nice growth area. And it's also a nice area for durability because many of the people that have diabetes have a sort of different payer structure than the typical wet AMD payers. So it's more of a commercial payer system. These people are younger. They're often working. They have jobs. They rely on their vision. So we believe that there are going to be a number of opportunities to try and work like in a more creative manner commercially to build on the concept of diabetes, but at the same time, to have the RVO and the wet AMD and to kind of build those, we have to learn more. I mean, our main focus right now is reading on the pivotals. But we think there's a lot of opportunity to think creatively there to battle it out.

And then if you think longer term, in the evolution of the competitive landscape, you mentioned gene therapies that might be under development. How much of a disruptive nature are those therapies? And what does that mean for tarcocimab?

Well, people always look for something new, but sometimes they forget to look at kind of what they have, so we'll have many thousands of patient years of exposure, and it's taken a number of years to really build the design and the program and the commercial manufacturing capability. And our objective really will be immediately to service that and then to deliver a biologic that is really eating away in some way, like what's supposed to be special about the sort of higher-risk other approaches. So many times, you can like incrementally improve and be disruptive from where you are rather than hoping that there's going to be some new thing out there. I mean, they may come, but it seems like it may not be in the time frame that's necessary where Kodiak can really thrive.

Perfect, Victor. Thank you so much. We're looking forward to the data.

Cool. Thanks a lot, Andrea.

Thank you.