Good afternoon. I'm Serge Belanger, one of the healthcare analysts at Needham. I wanna welcome you to the 21st Annual Needham Healthcare Conference. We're happy to have for our next session, KalVista Pharmaceuticals, one of the pure play HAE story. They are seeking to address both the acute and prophylactic segment of the HAE space, both with oral products as well as new mechanisms of action. Today with us we have, T. Andrew Crockett, the CEO, Benjamin L. Palleiko, CFO, and Christopher M. Yea, the Chief Development Officer of the company. I'll hand it over to Andy to give us a brief overview of the company. Then we'll proceed to Q&A. For those listening online, there is an option to submit questions via the portal. I'll be checking that as we move to the Q&A portion of the presentation. Andy, please, take it away. Thanks, Serge, for having us. Happy to be here today. Just as an overview, we are focused in discovery and development of small molecule protease inhibitors. As Serge said, we're, you know, disease area of focus is primarily HAE, although we also have interest in diabetic macular edema as well. Our lead programs are in HAE, or KVD900, which is a small molecule plasma kallikrein inhibitor, for the treatment of on-demand attacks of HAE. That program recently started a phase III clinical study following a very successful phase II clinical study that we read out last year. KVD824, a distinct molecule, also a small molecule plasma kallikrein inhibitor, for the treatment of prophylactic treatment of HAE. That program is now in a phase II clinical study. The strategy of the company is to be able to provide kind of a full suite of oral therapies for HAE patients. These two plasma kallikrein inhibitors in the on-demand and prophylactic space respectively are the company's, you know, first entry into HAE. We look to commercialize those molecules as well in addition to getting them approved and various regulatory to commercialize those in the majors, certainly in the U.S. and Europe ourselves. In addition to our work with plasma kallikrein inhibitors, we're also discovering and bringing forward to development oral Factor XIIa inhibitors. We believe we're the first company in the world to do that. Also interested in pursuing indications in HAE with our Factor XIIa programs as well as potential additional indications that we may explore kind of down the road. That's a high-level summary of where we are. The molecules Serge we discussed here have all been discovered at KalVista. We have our own research and development groups here and we'll be looking to bring those forward just as quickly as we can in clinical development. I'm happy to chat through any questions you might have. Great. Maybe let's start with like a deep dive on the HAE market. I think with the new products and there's been some changes you know between the acute and prophylactic segment. If we can just talk about the overall number of patients in both the U.S. and outside the U.S. diagnosed and treated just so we get an idea of what kind of markets you're looking. You can address. Sure. The HAE market. HAE is obviously a very, you know, a very rare disease. It's about the estimates vary, but most people circle it around 1 in 50,000, some a little higher, some a little lower. That suggests you've got something in the order of 7,000 to 8,000 patients in the U.S. In Europe, similar. There's really no ethnic or racial or any other distinctions identified in terms of incidence rates. Generally worldwide, we believe that to be true. Again, those two markets add up to about 15,000 to 16,000 patients plus the rest of the world. It's usually more overall. I'm curious, out of those 8,000 patients, are the vast majority of them treated or diagnosed and treated, or there's still some out there that remain undiagnosed? The U.S. in general is very highly diagnosed. It's generally believed that most patients in the U.S. have been identified. Europe is somewhat less than that. Again, it probably becomes a little more geography dependent. But outside of those geographies, you've got large parts of the world where there's very low diagnosis rates. Japan is one example as a country where in theory there's a couple thousand patients just based on the population, but to date, the identification rates and treatment have been very low. The only thing that goes against that is to some degree there are even though it's familial and obviously it's monogenic, there are about 25% of patients are believed to be de novo. I mean, spontaneous mutations that come up. You do have a fair number of patients that come up on a de novo basis. Again, especially in the U.S., the treatment for those folks has dramatically improved over the last 10 years or so. A while ago, you'd hear these horrific stories of patients who went 10, 20 years, you know, sometimes longer trying to get a diagnosis and going through these terrible procedures and in some cases these just terrible surgeries as doctors try to understand what happened. You hear that less frequently now, again, in the U.S. Ex-U.S. it's very common. I mean, a 10-year journey for a patient to get to an HAE diagnosis if they don't come from a family with a known history is not an uncommon thing. Okay. The number of treated and non-treated patients, is it still kind of 70%-30%? Yep. That's fairly accepted. Again, it's a very small opportunity for us as you get outside the U.S. and major European countries. Yes, in U.S. that's definitely the case here. Patients that choose to go untreated, typically, is it mostly because they have kind of a milder disease or they have found a way to cope with it that they feel they don't need treatment? A little bit of both. Again, some of these are folks who really haven't chosen, they just haven't been diagnosed yet, going back to the novel population. Okay. Let's move. I know there's numerous prophylactic treatments as well as options for the treatment of acute attacks. Maybe just talk about how the overall therapeutic market has changed over the last couple of years. The primary change in the market in the last year or so has been the launch of Orladeyo, which is an oral drug, was approved in late 2020, I guess, and launched in early 2021. That's been the most significant one. Before that, the most recent launch of a drug was Takhzyro, which is a prophylactic injectable, that was approved and launched in 2018, I guess, 2019. Before that, it had been several years since you had another drug to come along. The market nowadays has got three major competitors in the prophylaxis space. You know, I've got Orladeyo in that group now, and then you've got Takhzyro and Haegarda, which is a CSL Behring drug that's been marketed for a while. Those are probably the primary ones in that world. In the acute space, Firazyr, generic icatibant is far and away the market leader there. It's probably got pushing 80% market share. You've got a number of smaller players. CSL has a lesser drug. Pharming has Ruconest, which is a lesser drug. You've got a few other options in the acute space. Okay. The therapeutic market is, I think, widely known to be about a $2 billion market, split maybe 60% towards prophylactic and 40% towards the acute segment. Most of the growth has been on the prophylactic side. Just what are your thoughts on the current segment, acute segment and its growth projections? The reason that acute sales have actually come down substantially has less to do with growth of prophylaxis case and more of the fact that icatibant went generic three years ago. The generic pricing, of course, is dramatically lower than the branded price. Generic icatibant is probably about 25% the price of branded Firazyr. The sales have really come down overall, even though if you look at the scripts, the scripts haven't really moved in three years. I mean, acute scripts have essentially been flat for three years. A lot of this sort of significant shift people talk about does relate at least to some extent to the fact that the pricing has come down so much in the space with the advent of the generics. We, you know, our view is that from a patient preference standpoint in the U.S., and I'm focusing on the U.S. here. And maybe Eli is moving this a little bit, although it is really not seeing that. By and large, it's fairly stable at this kind of 60/40 split between, you know, prophylaxis and on-demand. Again, there are large numbers of patients who choose to treat their disease on demand, almost unrelated to the frequency or severity of their attacks. Patients like the fact that they feel like they have more control if they treat attacks when they come on. Patients with lesser form disease may view it as a favorable dosing profile compared to giving yourself a couple injections of Takhzyro a month or a couple a week of Haegarda. Patients actually may view themselves as having to take fewer injections if they use on-demand therapy. The average HAE patient has about two attacks a month, and if you're taking two attacks a month of the MAb or you're taking two injections a month of Takhzyro or eight of Haegarda, that's a trade-off patients actually are going to think about that overwhelmed the question of whether or not, you know, generally well in some cases the severity of this disease questions. The point is we don't see any wholesale shift away from it. We think it's a very complicated dynamic with patients that can involve obviously the physical manifestations of disease, but also a lot of mental health impacts and other factors you see that come into play here. We know they're relatively stable, which is why the shares are relatively stable. Okay. From a payer reimbursement perspective, I know you don't have a commercial product out on the market right now, but from your interactions and research, have there been any changes here, especially as you know there's more and more treatment options. You now have a generic icatibant product. Do you expect the landscape to change, especially given that most products have you know have been able to price with an orphan premium level? Just curious how you're thinking about that going forward. We've done some early pricing studies, and we haven't gotten any sensitivity from payers whatsoever to pricing the range of branded therapies. This is on the $900 space. You know, branded therapies are $12,000-$13,000 a dose. There's a couple therapies that are higher, there's a couple therapies which are lower, but in that ballpark. Our early work with payers has indicated no sensitivity at all. We obviously tested a range, and we actually got no sensitivity, even at higher prices. Because, again, the argument you come in with is we're providing better patients to better control their disease. They have better outcomes. They have better quality of life, right? All those measures sort of work for us. There's really been no specific payer pushback. I should point out, we did that in the presence of generics. Even there, generics obviously going to generic tier is kind of a fundamentally different thing. We don't anticipate any problems with having scripts written for KVD900 as a branded product and having to deal with the generics as part of that. The pricing is really not an issue. Payers are certainly starting to become a little more attentive to the orphan drug space generally and obviously HAE specifically. We, you know, are starting to have some early interactions with those folks. We're being careful about how the pricing structures work and how we actually interact with them to sort of help them, providing the outcomes measures on the real-world evidence that they need to support pricing decisions. We have no great concerns about that. We're utterly confident we'll get there and get you a reasonable price that works for everybody. Okay. Let's move to the KVD900 program. I think everybody's kind of familiar with the mechanism of action here. Plasma kallikrein inhibition is well established for HAE. An oral acute treatment is a very different change to the paradigm that has previously been used for any acute segment. Maybe just talk about what an oral product would offer in the acute segment and what would be the ideal product profile? Yeah, I mean, I think that when you think about an HAE patient and kind of the journey they've been through over the past decade or so as these treatments have evolved, we're at a place, as we just highlighted with the number of treatments. They're in a much better place now than they certainly used to be. But the reality is even patients that are well managed on prophylaxis have experienced quite often breakthrough attacks. Patients, whether they primarily manage their disease with acute or on-demand therapy or whether those therapies are a rescue therapy or breakthrough therapy, right, for their prophylactic, everybody is advised to have on-demand therapy with them, right? The challenges of injectable, whether that be IV or subcutaneous, on-demand therapy shouldn't be kind of underplayed, right? These are therapies that you have to have at kind of a moment's notice, which means you have to carry them with you. They have storage condition issues, right? The portability of those treatments are challenging, right? Those types of challenges have led to patients either not treating all their attacks or delaying their treatment. Okay? That functional delay leads to poor outcomes for patients, whether that is a completely untreated attack or whether symptoms get much more severe than they need to because of this delayed treatment. The concept behind oral on-demand therapy is that you kind of remove those barriers to treatment, and you encourage patients to treat at the earliest sign of attack, which is what the current guidelines in HAE are asking patients to do, right? Because we know that the earlier you treat, the better your outcomes will be. We think that, and this is the way that KVD900 was designed, was to be something that is obviously eminently portable, easy to take with you, and works very quickly. I think that's the other key aspect is the drug had to get on board very quickly and be effective very quickly. Perhaps that's one of the things that maybe is the most surprising about sebetralstat when we talk to people about the drug is how quickly even as an oral therapy that it works. We know that we get to effective concentration in minutes. Our PK/PD data will tell you that, and then our clinical data reinforce that. That's critical, right? That it tells patients that, yes, you know, the ease of taking this drug, right, combined with, you know, how quickly it works, you know, should remove those barriers to treatment they currently face with injectable therapy. The ideal therapy in the on-demand space is something that you can take very quickly, has no barriers, you can carry with you. That's what KVD900, we hope KVD900 will be in the fullness of time once it's approved. Okay. It was over a year ago now, you reported positive results from your proof of concept phase II data. Can you just highlight, you know, the efficacy that you saw there and how it compares to current available treatments? Yeah, I can talk to that. The primary outcome of that phase II was the time to use of conventional attack medication. Patients had access to their usual acute medication at all times during the study. After taking the investigational drug, if they felt their symptoms demanded to use their conventional attack medication or rescue medication, if you will. KVD900 significantly extended that time to use of rescue medication versus placebo. Both if you took that within a 12-hour period and then that efficacy was maintained after 24 hours. I think really importantly though, KVD900 also met the vast majority, if not all the secondary endpoints and the majority of the exploratory endpoints. In the secondary endpoints, we have more, if you will, patient-reported outcome. The, you know, the patients reporting how their attack was progressing or otherwise. One of those was something we called a Patient Global Impression of Change, which is where we ask the patient at regular intervals, "How are your symptoms right now compared to when you first took your investigational medication?" That was a seven-point scale from much worse up to much better. This was actually an outcome that was used essentially the identical outcome for the approval of Ruconest, which was a study that was run seven or eight years ago. Really importantly that showed a really good treatment effect of KVD900 versus placebo. That will be the primary outcome in our phase III study, and we've agreed that primary endpoint with FDA. But I think the other nice thing was all of the other endpoints which use separate instruments. How do you rate your symptoms at this time from none to severe, and also using Visual Analog Scale, all repeated that pretty strong efficacy signal, KVD900 versus just placebo. Okay. Then I think as Andy said in his opening comments, the phase III trial, I think it's called KONFIDENT, recently got underway. Maybe let's just talk about the design of it and how similar it is to the phase II trial and maybe some of the difference besides the endpoint, the primary endpoint that you just mentioned. Yeah. It is very similar to the phase II study stage. The phase II study was a 600-mg dose of KVD900 versus placebo. In that study, patients treated two attacks, one with KVD900, one with placebo in a randomized blinded sequence. That is to say, you know, some treated with KVD900 first, some treated with placebo first. The phase III study is a very similar crossover study design. One difference is we're looking at a second dose level of KVD900. We're looking at 600 mg as per the phase II. We're also looking at dose level of 300 mg and then placebo. It will be a blinded three-way crossover, so patients will treat three attacks in that study. It's essentially the same study design as the phase II. We'll be looking to recruit a very similar patient population, although in this study, we will be also recruiting some adolescents to help support a broader label for treatment down to 12 years of age. We'll also be treating patients who are already on prophylaxis therapy. I think Ben was talking about, you know, patients treated on prophylaxis who get breakthrough attacks. Those attacks need to be treated, so we will be treating those attacks in the phase III study as well. We'll also be including laryngeal attacks which weren't eligible in the phase II study because, of course, we didn't have proven efficacy at that time, and they can be life-threatening. We'll be including those attacks. I think it's fair to say, you know, generally the study design and the study outcomes that we expect to see will be similar between phase III and phase II. Same, as you say, the change in the endpoint, it's just a promotion of an endpoint. It was a secondary endpoint, an a priori secondary endpoint in the phase II will be promoted to the primary outcome, or the primary endpoint I should say, actually. Did you find this new primary endpoint is more reflective of what the FDA is looking for or it's even as important to patients and physicians who treat these patients? Absolutely, yeah. The primary endpoint for the phase II, it is a very much a new treatment paradigm. It's early intervention. While patients were already being told, "You should treat all of your attacks and you should treat them as early as possible," none of the clinical trials had actually been run under that paradigm. The older clinical trials were the attack had to actually escalate to moderate, to severe, to moderate severity at least before it's treated, so it was more of a resolution. However, patients were told to treat their attacks as soon as possible. We were trying to do that and replicate that for the treatment guidelines in our phase II. Because of that, of course, there was very little data out there to help guide us other than one previous study in which Takhzyro had shown this positive impact on the use of rescue medication. We used that primarily as a pragmatic approach. It's something that we could power a phase II to reach. To your point, and you're absolutely right, this outcome of how do you rate your symptoms now compared to when you first took your attack medication actually is really meaningful to patients. Because of that, it's meaningful to the FDA. Obviously we took our phase II data to FDA. We also took the feedback from patients and from doctors regarding that endpoint. I have to say, when you speak to a patient, the patients you spoke of, it's very interesting. What they were most concerned about when they take their medication is they want to feel their medication starting to work, and they want to feel that as quickly as possible. Once they feel that, then they're dealt with their attack and they can go on, get on with their day, if you will. Rather than perhaps a longer monitoring the severity. That was. Of course they want the severity to reduce, and they want the attack to resolve. It was this very early indication that the medication's starting to work, which is probably the thing that was most important to patients. In terms of a successful outcome, obviously for the FDA, beating out placebo is the main goal. I guess for more marketing aspect, since this is a time-related primary endpoint, do you need to be better or on par to existing treatments like icatibant? It's tough to make those comparisons. One of the comparisons we can make is that Ruconest trial that I referred to earlier, where they used essentially the same endpoint as we used. Bearing in mind the study design differences and severity of attacks at the time of administration, take out the caveat, Ruconest actually met that same endpoint as our primary endpoint in phase III at 1.5 hours. In the phase II, KVD 900 delivered that endpoint in 1.6 hours. What that says is, remember, Ruconest is intravenous infusion, so it's about as quickly as you can deliver a drug, clearly. If you've taken that at the same time, KVD 900 works as quickly as an intravenous drug. Remember, of course, as Andy alluded to, patients are delaying using their injectables. We know that with icatibant as well. There's some, you know, real-life data with icatibant that says, you know, generally it's kind of 1.5-2 hours before patients use their icatibant injection. Not only you can take them at the same time, it works as quickly. However, our expectation, of course, is that KVD900 will be dosed, you know, significantly quicker. In the phase II study, we know the mean time to administration after the patients reported onset of the attack is 30 minutes. Bearing in mind, in that 30 minutes, they also have to contact their doctor to confirm the eligibility of the attack. We think in a real-life setting, you know, KVD900 will be administered much earlier. As we do know for sebetralstat and all the other products, the earlier you intervene, the better the treatment outcome. I think, you know, there's a good body of evidence that we work very quickly. The PK/PD supports that. The clinical efficacy data I think we've just got that supports that. Of course, we'll go on to show that patients actually administer their KVD900 much quicker than they do their current therapies. Broadening the patient population a little bit in the phase III with adolescents as well as laryngeal attacks, just curious if you know, is the drug expected to have a different PK/PD profile in younger patients, and are these laryngeal attacks harder to treat than other kinds of attacks of HAE attacks? Apart from PK/PD, our expectation in adolescents is that it will be the same. We've done some obviously, based on our population PK modeling, there's nothing in that modeling to suggest that adolescents will show any different PK/PD profile to adults. There will be a limited number of adolescents in the study as well. As far as laryngeal attacks go, there are very few. I mean, patients don't thankfully experience that many laryngeal attacks, so I think it will be a small number in the study. There's no evidence from any of the other treatments. Kalbitor works just as well on laryngeal attacks. lanadelumab in a prophylactic setting certainly, you know, you're gonna get more laryngeal breakthroughs than you do other types of attacks. You know, on this, there's no mechanistic rationale to think that Takhzyro would be just as effective on laryngeal attacks as it would on any other attack location. Okay. As Andy said earlier, the KONFIDENT trial, just since we got it underway, if there's any feedback yet on how enrollment is going. You know, as COVID restrictions lessen here, are you seeing better enrollment than what you saw in the phase II trial? Yeah. I mean, we've got nothing publicly to say about enrollment. Safe to say, certainly the enthusiasm from the site is very high for KVD900. I think you mentioned earlier that, you know, KVD900 is a real paradigm shift in the on-demand treatment area. We know generally patients' demand for oral therapy is extremely high in this indication. This being the first opportunity that patients have to treat their attack on demand with an oral therapy really is, I think, exciting for them. It's also exciting for the investigators to be able to provide that opportunity to their patients. You know, the general feedback we get is very positive to this trial. You know, to date, recruitment is going as we would anticipate. You know, as you say, we're just starting this study. We're excited and confident that this is a study which really should pull patients in very effectively. Can you remind me again, have you given timelines on when a potential readout would be, or it's too early at this point to talk about that? We've guided second half of next year for results. Okay, great. I'm gonna ask you to look in your crystal ball here, like I said earlier, this would be a significant change to the treatment paradigm of acute HAE treatment. Do you expect an oral product would garner market share from current injectables or bring back some of the prophylactic treated patients to treat individual attacks with an acute oral treatment? Hope so. You know, our expectation is, again based on the data we've seen to date, that this should meet all patients' desires. It's designed to be a very patient-friendly, right, easy, easily portable, easy to take, easy to deal in all directions, the therapy that can be taken at the first signs of an impending attack. We think it's going to have a very high degree of this acceptability in the patient population. It has been, in all respects, designed and executed to date to meet the needs we've heard from patients in the marketplace. Absolutely, we fully expect this to capture a, you know, a very large share of the existing on-demand marketplace. We think it becomes an obvious place to go for patients in the breakthrough space. We think there's a fair number of patients who maybe don't nowadays treat as many attacks, and we think treatment rates should actually go up because patients now... I mean, again, a substantial number of attacks really aren't treated or are treated too late. This can solve all those problems. We think increased usage should result from this. Certainly to your point, we based upon what we've seen and what we've heard so far, I think we're beginning to believe that we have the opportunity to take some of these patients who may have transferred over to prophylaxis because they want an oral therapy and now Orladeyo is available to them. Just because, again, from an attack basis, they see better, sort of essentially less injections by using prophylaxis as opposed on-demand. We think a lot of those patients would actually be very seriously interested in KVD900 and in fact, you said moving back to an on-demand from that. So We think the opportunity is, to your point, not as certainly in the market share gain is very high. In terms of just market growth opportunity that comes are primarily also as a result of that, we think it's dramatically underestimated in the outlook. KVD-824, the prophylactic HAE program. I think the development path in the prophylactic area is a little more established and well-known given the recent approvals of other products. Maybe just talk about the goals you're looking to achieve with KVD-824 as a product profile. Yeah. I mean, Derek said, you know, very similar to what we want to achieve with KVD900, which is providing oral therapy to patients and not have to then sacrifice efficacy, right? That, that's kind of the whole idea behind the development. Our research with patients, our interaction with patients has said, you know, patients want really two things out of their HAE therapies. One of them, obviously they need their therapy to be effective. You know, with these really effective therapies on the market, you know, patients, we don't see them over a long-term basis going backwards in efficacy, right? You know, these therapies have really improved their lives and, efficacy is paramount. Then also the other clear, you know, desire from patients is oral therapy. With KVD824, what we're looking to do is provide patients with that prophylaxis, that same kind of level of efficacy they've come to expect with oral therapy. Very similar to what we're trying to achieve with KVD900 but in the prophylaxis space. KONFIDENT trial is underway, or got underway last year. I know you don't give enrollment updates, but what is the potential timeline for a readout with this trial? We expect data sometime around the middle of next year. Okay. Assuming this is positive, the next step would be a single pivotal phase II trial similar to what we've seen with Orladeyo. Yeah. Other precedents we've set, I think Orladeyo and Takhzyro have been tracking. Okay. All right. Lastly, your Factor XIIa program, I think that's one. It's a new mechanism of action, definitely less known than plasma kallikrein inhibition. Can you just give us an overview of where it sits on the cascade that leads to HAE attacks and, you know, where the Factor XIIa inhibitor product could, you know, what kind of role it could play in the treatment paradigm? Yeah, good question. Factor XIIa actually sits at the top of the cascade that ultimately leads to these HAE attacks. You know, for a long time I think everybody in this space has thought this would be a very interesting place to intervene. Actually, you know, CSL has an antibody, garadacimab, which is a Factor XIIa antibody. It's now in phase III. That's some fantastic phase II clinical results. Just validating, I think, what scientifically we believed all along, this is an appropriate place to intervene. We've actually been working on this target for a number of years now, and from a small molecule, you know, oral drug hunting perspective, from medicinal chemistry perspective, it's been a really challenging target. One of those reasons is because no one's ever done it before. It becomes, you know, a challenge because there's nowhere to start. You're doing it all by yourself. You know, the great thing for us now is that also now becomes a huge competitive advantage for us because we've done the work. We now have selective oral potent molecules from multiple series moving towards the clinic. You know, we're looking to file an IND next year. Where this fits in, I think, you know, remains to be seen, right? We think that, you know, what we wanna do, as I've said now multiple times, is become a, you know, one provider of really effective oral therapies in HAE, be that on-demand prophylaxis with a plasma kallikrein inhibitor, Factor XIIa inhibitor, right? The nuances and differences of how Factor XIIa may or may not be better than plasma kallikrein is yet to be seen, right? Certainly sits at the top of the cascade. It certainly gives us opportunity. If you were to dose twice daily perhaps that gives us opportunity to get to a once daily really effective therapy. We'll see. We think from an R&D company like ourselves, though, you know, what we wanna do is bring forward more therapies to try to fill what the patients really need in the space. Factor XIIa also, we don't have much time to talk about it today, but it also gives the opportunity to move beyond HAE and to some other potential indications that, as a company, we're looking at more closely and we'll provide more information as we move in that direction. I think you're planning an IND for next year for this program? Yeah. Yes. Do we know at this point if it's gonna be an oral treatment and whether you're targeting acute or prophylactic? Oral treatment for sure. Right now I think our focus would be prophylaxis. You know, we'll see how the molecules pan out. Okay. Is there any reason to believe that since this is a new mechanism of action, that you wouldn't be able to follow the same path that KVD824 is taking right now as a prophylactic treatment in development? I don't think so. Again, I mentioned this garadacimab is following a very similar type of paradigm that we've seen with the other approved therapies in prophylaxis. You know, no reason to think that would be different. You've mentioned a couple times today that there could be a potential role for Factor XIIa inhibitor outside of HAE. Is that something you plan on evaluating as a company or- Sure. remain an HAE focused player? HAE is an important focus of the company, right? As we have opportunities beyond HAE, we'll explore them. You know, as I mentioned, you know, as we move those things forward, as we get more information, we'll share that. Certainly we're interested in where else this might take us. Okay. I think we only have a few minutes left, so maybe I'll ask Ben to give us a kind of financial overview of cash balances and operational runway. Sure. We report on April 30th for the year. The last quarter we reported publicly was ending January 31st. At that point, we had $195 million in the balance sheet. Good guide that carries us into at least early 2024. We're very comfortable with our financial position. Okay. In terms, obviously in the U.S., I think you can take on the development of both 900 and 824. Outside the U.S., is that something you're willing to do on your own or you're starting to look at potential partnering opportunities? We have always said that our plan is to commercialize this in both the U.S. and major European countries. It's the perfect disease for a biotech company to market in. I mean, it's addressable with just a few dozen sales reps in each geography. The cost is eminently doable. This is by no means an extreme toll for a company of our size. Given the market price, you can get how the patients roll out and how attacks. That said, we've also always said that we're like more likely than not to partner in most of the rest of the world. We do on a routine basis get expressions of interest from parties. Those have obviously picked up a little bit more as we've moved into phase III. We intend to be thoughtful in what we do. We are considering a variety of different structures philosophically. As we move forward and we make some decisions on that, we'll talk to people about it. For all the reasons we talked about earlier, this is a very attractive therapy worldwide and you know, the interest to date reflects that. Great. Well, I think we've reached the end of our time, so I'll have to wrap it up. I want to thank you for taking some time with us today. I know it's late in the U.K. So I'm sure you're happy that it's your day's almost over. But thanks for the overview, and we'll look forward to seeing some data next year.