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

Good afternoon, everyone. My name is Graig Suvannavejh. I cover European and U.S. Goldman Sachs. So welcome to the 3 p.m. session of Day 2 at the Goldman Sachs Global Healthcare Conference. I've got the pleasure of hosting a fireside chat today with Kodiak Sciences. From Kodiak, we're pleased to have 3 members of the senior management team, Victor Perlroth, who's the Chief Executive Officer; Jason Ehrlich, who is the company's Chief Medical Officer; and John Borgeson, who is the Chief Financial Officer. So I want to welcome 3 of you to your first Goldman Sachs Healthcare Conference. And certainly looking forward to you joining in years to come, and hopefully, we'll do this in person. For those who in the audience who might be newer to Kodiak, it's a name that kind of has been under the radar screen, I think, for a little bit of time, but certainly has come into its own. Maybe let's -- Victor, if you could just start off from a high level, telling us a little bit about Kodiak and what you're working on? And how you see it in terms of helps to differentiate you from other companies in the areas with which you focus?

Sure. Thanks, Graig, wonderful to be here, thank you very much. Kodiak Sciences, we were founded back in 2009, and we're focused on developing disruptive platforms, but importantly, products on top of those platforms, for the big diseases in ophthalmology and in retina, in particular. So our ABC Platform, which we developed, it's antibody biopolymer conjugate platform. It was developed in-house. And essentially, we make antibody conjugates, which are then injected into the eye, just to fuse the retina with the drug that will stick around for a very long time, and our conjugates are very large in size. So that translates into a very long durability of effect as it diffuses very slowly and that's well known in the field. But we went a different path than many others, where it's just not the size, right? It's not just the size and the mass of the drug but it's kind of the special nature of the biopolymer conjugates, using the special kind of biophysics of phosphorylcholine, okay, which forms the external surface of all the cells in our body. So the biophysics of our antibody conjugates built on this phosphorylcholine bring a higher potency, a higher tissue bioavailability to the retina and the choroid. Those are the tissues of action for these high-prevalence retinal indications. And then we're applying our ABC Platform to monospecific drugs with one mechanism of action. Also, that's our lead asset, KSI-301 that we'll talk more about. But also to buy specific drugs where we have 2 mechanisms of action as conjugates are KSI-501 that's in our pipeline. And then also more recently now to build triplet therapies on top of the EDC platform, where we have 3 mechanisms of action. For example, our KSI-601 pipeline program, really allowing us to broaden and expand our depth and focus in ophthalmology and retina to the adjacent retinal diseases of dry AMD and even glaucoma as they relate to the retina. So a company, Kodiak, that's very much focused in ophthalmology, in retina, with platforms and products and targeting diseases and indications with tens of millions, if not more, subjects, who are at risk, who are going blind or at risk of going blind, and we're working to prevent and treat blindness with strong science and products and platforms on a global basis.

It's a great high-level introduction of the company. The focus for many investors, if not most, is KSI-301. It's your lead asset. It's being developed, as you mentioned, for chronic degenerative eye diseases, like wet AMD. You talked a little bit about the technology platform, but in a space that, wet AMD that is, that seems to be a bit crowded in terms of those assets that have been on the market for some time and with other competitors that are working on future products as well that may join the competitive landscape in a couple of years or so. Maybe let's drill down into what makes KSI-301 so unique? And especially, maybe we can also talk about some of the data that's already been generated?

Sure. There is tremendous unmet need in retina, the areas of LUCENTIS and EYLEA as products, and also Avastin, being used to treat retinal vascular diseases. So wet AMD, macular degeneration of the wet form, also in diabetic eye disease. So diabetic macular edema, a very important area for these medicines and also retinal vein occlusion. So the anti-VEGF mechanism of action is very powerful. LUCENTIS and EYLEA, in particular, are anti-VEGF medicines that are injected into the eye. The issue is that if you treat patients on the label with those medicines, say, monthly, once a month with LUCENTIS or after 3 loading doses, for example, with EYLEA and then every other month, you can take a treatment-naive patient who has serious disease with wet AMD or DME, for example, and you treat them on label for many months and perhaps even many years to data show, 10 years in many cases, you can see an early boost in vision and you can maintain that vision over many years. The reality, though, in the real world, though, is that patients are told by the physician, look, there's going to be kind of intensive therapy for the first year. But after that, you'll be able to come in less frequently. And we'll be able to kind of get that early boost and vision and maintain that. In reality, patients come into the doctor's office, the retina's office, say about 5.5 times a year on average. And when you do that, the data is very clear, really, on a global basis. But you get maybe an early boost in vision of, say, not a full benefit over the first couple of months. And then basically, you begin seeing deterioration of that early benefit right away, such that even in the United States, whether you're on LUCENTIS or EYLEA, in general, patients are back to their starting visual acuity pretreatment by 12 months. And so the full power of the anti-VEGF mechanism and of the anti-VEGF drugs of LUCENTIS and EYLEA, for example, is not being realized in patients, in the United States nor in Europe nor on a global basis. So we can't force patients to come in more frequently, and we can't force the physicians to make room in their practices to give injections into all these patients on label. It's kind of like putting a square peg in a round hole. We can't blame the system or the patients. We need new science and new medicines that can be dosed much less frequently in the first year and in subsequent years so that you can treat the patient on, say, a 2, 3, 4 times a year profile and keep the drug around. So there's no drug holiday in between doses because it's during these drug holidays that you get disease reactivation and long-term photoreceptor damage leading to vision loss and eventually blindness. So although we have great medicines today, with LUCENTIS or EYLEA in sort of an acute zone, in the realistic zone, they are not working for patients. And so there's been a lot of work on exotic solutions and exotic medicines over -- since, let's say, over the last 20 years, and those have not really delivered actually. And so what Kodiak has done with our platform is, we bring new science into the design of our antibody conjugates with the special phosphorylcholine kind of special sauce. And we're a biologic-based medicine, like LUCENTIS or an EYLEA, that's dosed and injected in the same way, bought and sold and delivered and distributed in the same manner as LUCENTIS or an EYLEA. But where the science is really in the design of the medicine, we call it the same where it matters, right, and different where it counts. So a biologic with the same paradigms and the same types of safety as EYLEA and LUCENTIS, yet can stick around and create durable effects with many, many fewer doses in those core indications of wet AMD, DME and RVO. And we are generating really phenomenal data in a multiple dose, sort of what we call a Phase Ib study, which is fundamentally a Phase II equivalent, where we're dosing 120 treatment-naive patients with wet AMD, DME and RVO. And we're giving 3 loading doses and then we're monitoring the patients out for 3 years. And we're giving reasonable data updates over time. Initially, it was give 3 loading doses and see whether we have a nice power of improving vision in all of these treatment-naive patient populations of wet AMD, DME and RVO, and we did. And then it was, well how long after the loading phase does it take for you to have to begin retreating the patients, when does the disease reactivate? And we're seeing phenomenal durability through that first retreatment zone. We can talk about that. And then now, the question is really shifting to what we call the durability of the durability as we take patients to 9 months, 12 months, 18 months, and whether or not that early really phenomenal durability that we've seen, in many cases, taking the majority of patients to, say, 6 months or longer before they need retreatment in those indications, in particular, wet AMD and DME. And then now, we'll have our next data update at the ASRs meeting in July, where we'll really be able to showcase that durability of the durability. But as we've publicly disclosed, internally, we're very pleased with the progression of this open-label data that we're generating in the Phase Ib study, and we're using this data to design our pivotal studies and then to have a high probability of success, I would say, of achieving the endpoints in the pivotal studies in terms of the primary endpoint of vision retention but versus EYLEA, but also really looking at fundamentally disruptive durability groupings. So we're very pleased with the progression of the data, the performance of the molecule from a safety, efficacy and durability standpoint. And I think we're in a very strong or optimistic position anyway, based on the data we've seen to date, that we expect to have a really differentiated profile and a disruptive profile, in fact, in each one of these 3 major retinal vascular diseases. And then together, as part of our clinical plan, which we can talk about filing a BLA on target and on track for that in 2022, which would include wet AMD, DME and RVO together, such that we could enter the market with individually disruptive profiles in each indications, and together, a fundamentally disruptive profile, hoping to really fight for being the first-line agent for all of these next-generation anti-VEGF agents. To really try and solve the problem fundamentally for patients, which is vision retention over the long term, with a medicine that doesn't bring a lot of new exotic risks, but is, as I said, the same where it matters, as a biologic yet differentiated and different work counts in terms of durability and the ability of patients really to seek treatment appropriately. So a fairly long answer, but I hope it helps to bring the room together a little bit for what we're trying to do with KSI-301 for patients.

It does. Thank you very much. You've reported early data. And again, you've mentioned that you will have an update on what you saw in the initial study, but for those who are really interested in like the nuggets and the details of what you saw, can you perhaps -- or maybe is a good segue for Jason to chime in just on what were the exact data that you saw at the various time intervals before you saw retreatment that kind of gave you confidence that perhaps you can achieve a profile where the frequency of dosing is more on a more infrequent side than frequent side?

Right. Jason, would you like to kind of weigh in a little bit on that, thinking a little bit about the time to first retreatment at 6 months across wet AMD and DME and what we may be looking towards, as we look to the durability of that durability?

Yes. Right. Thanks, Graig. So I think if you think back to the data that we started to present last year at AGM and then at this year's Angiogenesis. For instance, you can see how -- in our DAZZLE wet AMD pivotal study that's ongoing, we have dosing with KSI-301 at every 3, 4 or 5 months. And based on the Phase Ib data, it's clear that the majority of patients should be on 4- or 5-month dosing based on the data that we've observed to date, where actually many patients were able to go 6 months, right? But it's a -- DAZZLE, for instance, our pivotal studies are all noninferiority head-to-head studies against EYLEA on its frequent labeled regimen, so we tighten up the criteria a little bit. And so in DAZZLE, we do 3- to 5-month dosing. But it's clear, from the data that we've seen so far, that the -- well as of the Angiogenesis data cut, for instance, 75% of the patients would be on 5-month dosing based on applying the DAZZLE regrouping criteria to the Phase Ib clinical patients that we've seen so far. So that's the type of data that we use. I think for -- likewise, for RVO, where we're going to do a Phase III study with every 8-week dosing for KSI-301 versus monthly dosing for EYLEA, which is what it's labeled for in that sort of high-VEGF load disease, it's clear from the Phase Ib data that actually, many patients can go 3 months or longer with RVO on KSI-301 with the vast majority 2 months or longer. So that seems like a smart approach. In DME, where our Phase III plan is for every 2 to 6-month dosing, and really, I think the DME data that we've seen and presented back in February, same sort of approach. It's -- the majority of patients are pushed far to the right on that sort of histogram of injection need. And what we really want to do, I think, we realized that with each of these diseases, there's a distribution of how often people need dosing. There are some people like with EYLEA who need dosing every month or even more often. There are some people who need it every other month. There are some people who can go every 10 to 12 weeks. So we want in our Phase III studies to essentially allow people to get individualized dosing that is empirically determined to be the best for them, which will result in the best outcomes for patients and Phase Ib data, I'd say, pretty strongly support the idea that we're able to move that distribution or histogram far to the right. And so we're designing the studies based on those data as we continue to see them.

Okay. That's really helpful just on the efficacy side that you saw. I think I'd like to ask about any safety signals that may have come up, and I think this is a particularly hot topic given the recent approval of the drug by Novartis that does offer the profile of the more extended dosing relative to EYLEA and LUCENTIS, but yet had some inflammation and oculitis and toxicity that was seen. And so if I could ask how -- what are you seeing on the safety side for KSI-301?

Right. Well thanks, Graig. We agree that our drug KSI-301 needs to have a very clean safety profile, together with the phenomenal efficacy and durability that we're seeing. I think we're very, very pleased with the safety profile that we're seeing with the medicine. Importantly, looking at the Phase Ia/Ib study, which is still ongoing, and then also the current pivotal study, the DAZZLE wet AMD pivotal, which is also ongoing, and we're planning, I think as we've mentioned, to initiate 3 to 4 additional pivotal studies this year, 2 in DME, 1 in RVO. So we can look to the totality of the safety data generated thus far in the Phase Ia/Ib and also through database review across the masked DAZZLE pivotal study. So we've treated with KSI-301 up to 250 subjects through May. Of those, 130 were in the Phase Ia/Ib and beyond that reflects the one-to-one randomization in the DAZZLE study. And we've had only across all of those patients dosed, with, I think, close to, well, north of 750 injections of drug and a close to 150 patient years of exposure of drug KSI-301 in patients across the Phase Ia/Ib and across DAZZLE. Only 2 very mild cases of inflammation noted. So it depends how you want to do your math or your accounting, but that's a sub-1% level of inflammation in terms of patients, and perhaps 0.3% in terms of actual injections. That compares extremely favorably to the levels of inflammation that one would expect to see for EYLEA and LUCENTIS. For example, EYLEA in the 2% to 4% category from the view studies and LUCENTIS also in similar studies in the 3% to 4% range. So we're looking at a fairly attractive exposure level to date up close to 150 patient years in treatment-naive populations, right, for wet AMD, DME and RVO and seeing really de minimis levels of inflammation, that are at or below the levels seen with LUCENTIS or EYLEA. So we believe that to date, we're in a very favorable profile for safety with our medicine.

That's great to provide that color. You mentioned you're looking at the opportunity with 301 beyond wet AMD and into other indications as well. And you've kind of come to a very novel innovative regulatory path around that. And there was a recent update on how you're thinking about that clinical development pathway. So can you tell us how you came up with this innovative strategy as how it fits to your 2022 vision? And also provide us the update and the changes you recently made?

Right. Well historically, the company is developing these anti-VEGF biologic medicines have developed them for one indication initially, wet AMD. And then after the approval there, they've driven the approval in DME and, say, RVO as subsequent indications. We're able to piggyback somewhat in looking at their development plan and the approval, of course, of these anti-VEGF biologics across all of these different retinal vascular disease indications, and to take a look at their clinical development and regulatory plans, the sizes of their studies, the designs and outcomes of their studies and sit on top of that and pick and choose somewhat and cherrypick the best clinical study designs. And in addition, it was our intention to run all of these pivotal studies in parallel and to package them together into a single BLA filing which makes sense today given the significant experience, right, with anti-VEGF biologics in these diseases rather than stretching these studies out in series. And we're fortunate enough to be well capitalized and with a strong set of long-term investors in the company that we can also raise the capital that we need to finance such an in-parallel plan, right, rather than a plan done in series. And at the same time, we were planning to move forward with -- we're running our DAZZLE wet AMD pivotal study, of course, right now, and in addition, we were looking at DME and RVO pivotal studies as well. In the course of the COVID-19 pandemic, we were able to pause for a short period and to evaluate our clinical plan, and we, I think, did that and were quite thoughtful. And although we had originally planned to run 2 pivotal studies in RVO as an initial indication set, and one study in DME and one study in wet AMD. I think in this context of pausing and being a bit more thoughtful about the complexity of global clinical trial execution and also looking a little bit at some of the enrollment rates for other DME pivotal studies, which have been enrolling fairly well. We made the swap to decide to run 2 DME pivotals as that lead indication and 1 pivotal study in RVO. So not to get too complex, but our integrated clinical plan is to run 2 DME pivotals, 1 wet AMD pivotal and 1 RVO pivotal to package those together, as I mentioned, into our single BLA. We like putting the good amount of money into diabetic eye disease, into DME. RVO is a lower prevalence component, right, disease and would probably have made more complex, our clinical development plan into more clinical sites in more countries, which isn't really the best idea right now given the COVID-19 pandemic. So we're able to take the opportunity to simplify and slim down the clinical plan to fewer countries and fewer sites, which increases the overall predictability of our execution and the timing for our BLA submission, while also putting more of the capital into development in DME and diabetic eye disease, where we see a significant unmet need and even opportunities for further market expansion based on the phenomenal data that we're generating in DME. So again, a slightly long answer to your question, but we believe we're on track to submitting a fairly innovative regulatory package for the BLA for approval and licensure of KSI-301 in 2022 with commercialization in 2023.

Okay. And maybe just as we're talking about COVID-19, as you see -- like, COVID-19 pandemic perhaps, receding into the background or maybe it's not, I guess time will tell. Can you just remind us, and I think it's been weaved into various comments you made earlier before, but how are you currently thinking about how COVID-19 has impacted either significantly or not the timing of clinical trials and the new expected existing trials to continue at the pace that you had originally planned? And also about new expected trials, how -- or where is Kodiak today in terms of thinking about how COVID-19 has impacted your clinical development plan?

Right. It's always difficult to project forward into the future because we don't know exactly the future of the pandemic. I think just based on today's fact pattern and the experience we had over the last quarter, where we were able to continue actually to enroll patients in our pivotal study DAZZLE and had very low single-digit missed visit rates, very low patient discontinuations in our clinical studies, and we continue to enroll. So these are serious diseases. Patients need to go to the doctor or they're going to lose vision. Physicians want to and need to see their patients. So in the United States, we were able to succeed very well with a lot of effort. In our existing studies, we took the opportunity, as I mentioned, to upgrade our overall plan to make it more doable in a post-COVID-19 world, and we feel very good about our ability to execute on plan. Even in the context of COVID, we've now activated Europe and are enrolling patients in Europe for the DAZZLE pivotal, and as I mentioned, are looking for first patient in, targeting September, across the 3 additional pivotals required for DME and RVO. So we are glad that we're working in serious disease with the medicine that, I think, that the community feels is important for the field and also for patients. And we're looking forward to accelerating in this next level of momentum right towards our 2022 vision plan.

Okay. Let's, like, jump ahead. Let's look forward a couple of years when we get to that 2023 time frame where you are, hopefully, on the market with KSI-301. This question is really more for those of us who have to model the opportunity. But when you think about -- where the patients will come from with 301, can you talk about how we should be thinking about whether this is truly a switch model and how easy it is for patients to switch, driven by trying to get new patients on? And obviously, there are a lot of patients with these chronic degenerative eye diseases. How should we be thinking about that dynamic on where KSI-301 will initially appeal?

Well, we're not the ones pushing a narrative on a community that a new drug is needed. It's the community pulling the narrative. That new, better, longer-acting drugs, hopefully, with a similar or better safety profile are critically needed for patients, based on the fact that undertreatment is driving, let's say, an epidemic of preventable blindness. So a new medicine has the potential, perhaps, as a winner-take-all opportunity, in the United States and outside of the United States. So we believe that also with our clinical plan to have very broad labels for KSI, not just across the indications, but inside of each indication, in a single submission, we believe should allow KSI to be seen as a first-line agent, and therefore, to be able to rapidly and aggressively grab the market share. Remember, there were 25 million-plus intravitreal injections, I think that was in 2018, of which half were Avastin, and there's quite a lot of growth even of the branded agents. So I believe there's market share to be had from LUCENTIS, market share to be had from EYLEA. And perhaps physicians have even said, "Wouldn't it be unethical to be forced to use Avastin monthly when a drug like KSI on a 3-, 4-, 5- or 6-month basis is available and can deliver real benefit to patients over time?" So there are many opportunities for this agent. I think retina is a phenomenally interesting, highly technical area for drug development. So a lot of tricks for young players that are trying to kind of get in. I think I consider Kodiak at this point a little bit more part of an older guard, in terms of our ability to really manufacture product for retina that's clean, with low inflammation, and that really drives benefit and to distribute that, at least, in our clinical studies on a global basis. So there are going to be new biosimilars in the market, but I think, say, LUCENTIS biosimilar will eat LUCENTIS market share. And EYLEA biosimilar, when it would become available in the U.S. anyway, it will generally eat EYLEA market share. But KSI coming in as an agent that really solves the problem, retina docs can make money on the drug and really provide a service to their patients. And it's already a predicated kind of opportunity where EYLEA came in, and even in their first year, really exceeded their projections in terms of market penetration. And we're hopeful as well that if we can come in with a strong supply of drug product, which is our investment to do that and to commit to that, that similarly KSI can also be aggressive and grab market share as well.

Great. We've got about 2 minutes left in our fireside chat. I do want to get your sense of how KSI-301 -- how to contextualize the profile of that? You're developing for the product against other products that are in mid- or late-stage development? And certainly, we just had some recent positive top-of-the-line Phase III data for delivery system from Roche. People who are knowledgeable in the space are very aware that there are at least 2 efforts looking at gene therapy using an anti-VEGF approach. Maybe this question is for Jason. Can you provide some context as to those who might be a little bit more, I don't want to say skeptical, but trying to figure out where does KSI fit when you've got different approaches like a port delivery or a gene therapy? Where do you see KSI being able to still effectively compete?

Victor, do you want me to take that or you want to take that?

Sure. Jason. Go right ahead.

Yes, sure. Thanks. So yes, Graig, I think a few points to consider. I think, first, of course, it goes without saying, it's a big market, and it's fundamentally good for patients and doctors to have different options for different types of patients, right? So I think with that sort of as the base. I think nonsurgical approaches to me are going to be preferred over surgical approaches for a number of different reasons. Obviously, the perioperative and midterm and long-term safety profile, the durability of long-acting intravitreal approaches, the long-term safety of a permanently implanted indwelling device like the port delivery system. And I did a lot of work on that project when I was at Roche. So I think it will have an important role in a segment of patients, but there's a lot of complexities to the port when you think again about the safety, but all sort of the economics of it between the economics of the surgical center, where it's implanted and the physician and the co-pays for surgery versus co-pays for routine care and drugs. Of course, we haven't seen the data. We just know that top line data are positive. I think with KSI-301, the more patients that we get out to 4- 5-, even 6-month dosing, say, within AMD and DME, the more we encroach on the potential benefits of the Port delivery system, where some people who've received that even if it's every 6-month refills also need rescue therapy at month 4 or 5 or even before them. So I think as we continue to exceed even our own internal expectations, I think that, that's beneficial for the intravitreal approach. And gene therapies, again, I think, we've certainly seen progress there from a number of companies taking different approaches, right? Surgical approach, subretinal surgery, for instance, as well as intravitreal. And I think really, some of the critical questions around the gene therapies for common disease as opposed to Mendelian rare disease are, "What's the long-term safety profile look like of things that you can't necessarily turn off or control the expression of?" You're taking cells in the retina or in the eye, of which there are not that many of those cells. And they have underlying disease and you're transforming them into protein factories. So what does that do to those cells over time over a couple of year period? We've seen inflammation of different types of persistent inflammation with the intravitreal vectors that have been used. What's the underlying etiology of that? And what's the mid- to long-term safety of either the persistent inflammation or the steroid treatments for that? So that's a lot of different points there, but I think really -- I think the key thing is that when you look at the safety profile of intravitreally delivered biologics, it's clear that to me at least that's going to be the backbone core therapy for a long period of time. And so that's a tremendous opportunity for us at Kodiak and the platform technology, we can build, the additional medicines in the future on the platform for new targets. So I see intravitreal as the core for many years to come. And so I think that, that leads us very well positioned as the future agent of choice. And then these other segments of the population could be served by things like the port and gene therapy with a medicine like KSI fundamentally at the core. Victor, anything to add?

No. I think subretinal gene therapy is not a major approach that's going to be relevant. And then the intravitreal gene therapy, I think, is really in a time frame that's pushed well beyond based on existing fact patterns. That's not so relevant for the next 5 years certainly and perhaps longer even. And we're in a phase of acceleration in driving towards the BLA in the market. We're not sort of in an early platform exploration phase.

Great. Thanks so much for that perspective. We've got maybe less than 3 minutes left, and the time is just flown by. I'd be remised if I didn't at least have you put an award on your assets beyond 301. So maybe if you could just briefly talk about 501 and 601?

Well, yes, we're really excited about Kodiak as really a retina science, both in terms of the platform but also the biologies, the mechanism, the action and the pipeline. So KSI-501 is a bispecific antibody conjugate with our platform, the ABC Platform, so it inhibits VEGF as well as interleukin 6. So many of these high-prevalence diseases in the retina are driven through decades of inflammation in the eye. And there have been some very interesting data generated over the years, suggesting that interleukin 6 plays a key role in the inflammation and perhaps may even be important for driving resistance to patients to anti-VEGF therapy having a full response. So our bispecific is in response to that. It's a very unique agent. We're excited about it. It's very potent on both biologies and as a conjugate, can have very long durability. So that's in GMP manufacturing. We were able to pull that forward somewhat in the context of GMP manufacturing slots, actually, even in context of the pandemic. So that will be entering the clinic on our plan in 2021. And so we're very excited about KSI-501 as an important medicine for subsegments and subgroups of patients within these retinal diseases. And 601 is also a phenomenally interesting program. It brings a bispecific, so 2 biologic mechanisms of action, but then builds into our biopolymer, the phosphorylcholine, small molecule, many hundreds of them as coupled to the biopolymer. So it's a 3 mechanism of action-type drug platform, and we're building the initial triplets for dry AMD. And really in dry AMD and geographic atrophy, other companies developing single-agent inhibitors are really showing no-to-nominal benefits. And our idea in bringing 3 mechanisms of action, combining 2 biologic MOAs as well as an intracellular small molecule, will be to really bring what nominally is sort of a statistical kind of benefit for dry AMD and to bring that to a real strong, more obvious benefit into a disease where the prevalence is 10x higher actually than wet AMD and where there is really no good therapy. So our concept is to bring triplet therapies on our platform and to have multiple shots on goal with different triple therapies dry AMD and then to apply the same platform and product design potential to the retinal components of glaucoma. So really to service, broadly speaking, retinal diseases as intravitreal biologics, with our monospecific, bispecific and then triplet platforms with a long-term focus in retina. So we're very pleased with the progress of the pipeline as well.

Great. With the last minute or so that we have left, maybe I'll ask just about financially from a cash position, where you are in a way of financing late last year. Where you're on cash? And then lastly, if you could piggyback that with kind of the next upcoming catalysts?

Sure. Well, thanks, Graig. We're in a strong cash position from the royalty deal and also the follow-on equity offering that we closed in December of last year. We have upwards of $400 million cash, I think, upwards of $420 million. And then we'll drive towards the milestone for the second tranche of the royalty financing, which will bring in another $125 million, which is fundamentally operational driven in terms of enrolling in our pivotal program. So access to well north of $500 million, which is an important amount of money to drive the company certainly into 2022 in light of top line data from the pivotal programs towards the BLA filing, so in a strong position for the manufacturing and clinical standpoint. In terms of upcoming milestones and catalysts, we're looking forward to the ASRS data update in July, which will allow us, as I said, from the 1b study to look to the durability of the durability, and more importantly, for people to really look at the Phase Ib data in that treatment-naive population in each of the 3 indications. And then to project forward into our pivotal studies and pivotal study designs to really have a view into the probability of success of the molecule in each pivotal and looking broadly around what the profile is likely to be to really build the confidence, right, that KSI can, in fact, be a first-line agent. So we think the data from the ASRS update can help us build that confidence. And of course, then the next key operational milestone will be first patient in the 2 DME and RVO studies, such that all 4 major pivotals will be enrolling and then we'll be sort of on an operational build right towards top line data from DAZZLE and then from the 2 DME and RVO studies. So an exciting set of activities happening in Kodiak as we grow the company towards our 2022 vision.

Great. Well, with that said, that was a fantastic session that we just did. Great update. Looking forward to a lot of excitement in terms of the programs. Victor, Jason and John, thank you so much for joining us today. And thank you to the audience who dialed in. So thank you very much. Have a great rest of your day.

You bet. Thanks a lot, Graig.

Thanks. Have a great day.

Thanks. Bye.