Good morning. Welcome to Needham's 23rd Annual Healthcare Conference. I'm Serge Belanger, one of the healthcare analysts at Needham. And for our next session, we're happy to have KalVista Pharmaceuticals, like an emerging HAE company, recently reported some very positive phase III results for their lead asset for on-demand treatment of HAE. So we have the company's CEO, Ben Palleiko, who's gonna be able to give us an overview, and then we'll proceed to questions.
So Ben, I'll hand it over to you, if you just wanna start with a brief overview of the company, and then we'll jump to questions. And I guess before I hand it over, for those listening online, you do have the option to submit questions via the portal you're watching the presentation on. Alternatively, you can also email me questions. I'll check email as the presentation goes on here. So Ben, I'll hand it over to you now.
Hey, Serge. Nice to see you. Thanks for having me today. Yeah, and actually, thrilled to, you know, to be here at the Needham Conference and talk about KalVista a little bit more. So, in summary, KalVista is a company that has been working in the HAE space for actually the last seven or eight years now. We're developing primarily an on-demand therapy for treatment of HAE, which is called sebetralstat. Sebetralstat, actually in February, we reported the data from a phase III study that we call KONFIDENT, which was actually an exceedingly positive data set. We have generated now the most robust and, you know, and I think positive data set ever done in hereditary angioedema, certainly in the on-demand side.
We've conducted the largest trial ever conducted in HAE as well, so we, you know, we think we're really well positioned, with regard to both what the efficacy and the safety data we've shown to date and with the market opportunity that exists. So, you know, we're really excited to be moving forward. We'll be filing an NDA this quarter in the U.S., and filings in Europe and Japan later on this year. And the plan here is to commercialize it as early as next year, based upon those approvals.
Great. Well, let's talk about the phase III trial. I think this was the first phase III trial for on-demand HAE treatment in over a decade. So maybe just talk about how, you know, the field had changed and how that impacted the design of the phase III trial.
Yeah, you're right. So the last approval in the on-demand space in the U.S. at least was back right around 2015 when RUCONEST, which is a, an intravenously-delivered C1 inhibitor, was approved in the U.S. for on-demand usage. And since then, really all, pretty much all the activity in the space has been really more on the prophylaxis side, and you know, we think that affects somehow how people actually view the market, 'cause all they've really heard about for ten years has been prophylaxis therapies. What's interesting, though, is despite the fact that you've had a number of these new therapies come along, and more are coming, and we'll talk about that later, the fact is, the on-demand space still remains you know, really important.
In the US, about a third of patients actually treat exclusively with on-demand therapy, even nowadays. Of the other two-thirds, the vast majority use both on-demand and prophylaxis to treat their disease. So it is still a very robust area, and you really don't see any declines in on-demand usage, despite the fact you've had these prophylaxis therapies come online. Now, to your specific question in terms of how the trial designs have changed, you're right, the world has really evolved. An important thing about our phase III study, and also our phase II study, the report back in 2021, is we designed these to really reflect the fact that treatment of hereditary angioedema has changed over the past few years, and the studies have to change, you know, commensurate with that.
A lot of the early studies that were done in the space, most importantly by Takeda, when they pursued approval for their drug that became FIRAZYR, used what's called VAS scale, which is a measurement essentially of swallowing in certain locations. And that was done. That was how they actually generated their primary endpoints to support approval. But what's happened over time is that these more patient-reported endpoints have become more subtle, and what you really start to focus is on things that tie better to clinical outcomes. And so RUCONEST, when they got their approval, actually used a treatment effect questionnaire they called the TEQ, which actually asked patients how they felt compared to when they took their drug initially, and that was their primary endpoint.
What we did was actually use a similar scale that got to the same question, which is, how do patients feel compared to when they first treated? And basically, the scale runs from much worse to much better. Turns out we did that based upon the fact that, well, first of all, that RUCONEST had gotten their approval on that. And second of all, we actually talked to a lot of patients and physicians along the way to make sure we understood what really clinically matters to patients and what is indicative of that, them actually feeling like an attack is improving. And far and away, that was the most common responses. They could understand the scale, and it actually tied to something that was clinically meaningful.
And so there's a lot of other endpoints that have been thrown about, and there's some secondaries that we did, and there's some other endpoints people have used and are going to use. But far and away, the one that seems to really resonate the most with patients and physicians, and we think with the FDA, is this what we call the PGIC, Patient Global Impression of Change endpoint.
Great. And as you mentioned earlier, it's a very positive study. I think you met all the primary endpoints with a solid P value at both doses you evaluated. Maybe just talk about on the primary endpoint, you mentioned RUCONEST use the same one. So, obviously important to hit the P value a good P value, but also to be within the range of RUCONEST was also kind of an important,
Yeah
... aspect of the data.
Yeah. Yeah, going back to the, to before we even had the phase II data, there was this common question we'd get, which was: How could we possibly—how can oral therapy possibly be as efficacious as quickly as an, as an IV injectable or, or a subcutaneous injection like FIRAZYR? And the good news is that the study results actually proved conclusively that that's the case. If you look at the primary endpoints from our phase II and our phase III compared to RUCONEST, RUCONEST showed time to initial symptom relief, which is that primary endpoint of right around 1.5 hours in their phase III. We showed it to be, in our phase III, right around 1.6 hours. So you're, you know, talking within 5 minutes of their timeframe.
Again, theirs is an IV infusion. Other people have looked at some of the FIRAZYR data from their study and kind of recut in a different way, and what they've found is that the FIRAZYR time to initial symptom relief is probably something closer to 2.4 hours, so actually meaningfully longer than ours. And again, that does cause a lot of questions, and people think inherently, if you're injecting something into your skin, it's gonna be faster acting. But it really goes to the fact that those drugs don't get in the bloodstream immediately, and also the fact that sebetralstat really dissolves quickly as soon as it's taken. We see patients getting to efficacious concentration levels within 15 minutes.
And we have a Tmax that's you know many many times higher than IC50 within an hour. So it's a really fast absorbed drug, and that's what leads to its efficacy and what's, which allows us to show that data that is so robust compared to the other therapies out there, even if they're delivered, you know, through these alternate mechanisms.
How do physicians look at the, some of your key secondary endpoints, time to reduction of severity and time to complete resolution? How do they look at those relative to the primary endpoint?
Yeah. They, they really fall pretty far down in terms of importance to anybody. I mean, again, far and away, you know, the, the primary endpoint's the most important, because what... People with HA understand that when they have an attack, and when it's, and when it's gotten to a certain point, it just takes, it does take some time to resolve. It, you know, this, the, if you, if you got a little bit of swelling, it's a biological process. It's going to take time for that to get out of the system. So people can understand that, that attacks don't just kinda magically disappear as soon as, as soon as the therapy is taken.
But what really matters to people, and again, this came through with all the interviews we conducted, is the fact that what they really wanna know is that they're starting to improve, and that which tells them that their attack is past the peak that they've felt, and that it's going to resolve over time. And that becomes essentially the all clear for them to go back and start to reconsider how they're gonna get back to their daily activities. So starting to feel that initial symptom relief is the most important thing because, again, it just shows that your attack is now transitioned into something that's going to resolve itself over time.
Reduction in severity is important, don't get me wrong, and it, and obviously, the more severe your attack, the more severe an attack is, the more that you wanna feel that severity go down. But again, a lot of attacks are mild, and so those, you know, those are that's far less of a critical element for patients when they're suffering less than severe attacks. Interestingly, what we showed in our study is actually the more severe the attack, the actually the faster the response was for patients. So to this for...
I think the most important part about that secondary endpoint is the fact that we showed that across all the spectrum of severity, patients did well, and patients who were experiencing more severe attacks actually technically did even better because their severity came down faster. And then, you know, the final endpoint, which is time to complete symptom relief, it's, you know, it's not all that interesting. Again, these. You know, this is a biological process. Swelling takes time to resolve. It's going to go on for a little while for patients. I think the most important part of our study, though, you know, and when people make these trial study comparisons to realize is that we designed that as a really hard endpoint to meet.
Because what we're actually saying is, we want, we want to know the time when patients have no symptoms at all, like their, their, you know, their attack was fully resolved. No one's ever done that before in this space. All the other studies, including another, you know, phase III that's about to commence from Pharvaris, actually looked at time to near complete symptom relief, which is a much different measure, and especially when you're using a VAS scale. The last bits of an attack are the hardest to resolve in terms of getting patients to go from symptoms being mild to symptoms being none. And you can understand that. I mean, psychologically, it makes a lot of sense. If you're thinking about your attack, there's always a temptation to feel, you know, to feel it isn't perfectly resolved yet.
So that's why most people go with this near complete relief because they appreciate the fact that the line goes essentially asymptotic at the end. We again set a very high bar for ourselves, and so I think we were thrilled with that data, that data set, even if it was again a much higher bar to reach than anyone else has ever tried to do before.
Yeah. And then maybe just if you can discuss the way the study protocol was set up, which allowed usage of a second dose after a set time. And, you know, I know you've provided additional data showing that second dose probably didn't have much of an impact, but maybe you can just talk about that.
Yeah, what we... Again, this study was designed to a large extent to mimic real-world use, right? We treated all attack severities, all attack locations, and the protocol was actually written to allow patients to take a second dose. And that was because in the real world, we found out that they actually often do. I mean, redose rates for FIRAZYR are as high as 30%-40%, according to some studies. And so it's not unusual for patients to wanna take a dose. And it's not necessarily because they need it, it's just, it's effectively, to some extent, an insurance policy. Because, again, they're looking to get back to their routine activities, and they want to be comfortable that their attack's not gonna rebound.
So, redosing is just very common in this space. And also, like, you know, and there are probably some attacks that do require more than one dose. And again, so this, again, FIRAZYR is instructive. In the real world, you see a fair amount of FIRAZYR reuse. We wrote the protocol to design it, said the patients were allowed to take up to 2 doses in the study. We did ask them to wait 3 hours before they would redose, and so there was. It wasn't that they could just immediately do it. What we found in the study was, again, that the time to initial symptom relief in the 300 mg dosage, which is what. We did 2 doses.
It was 1.6 hours in the 300, then 1.8 hours in the 600. Those are both those times from initial symptom relief are obviously meaningfully less than 3 hours. So, and what the statistics show is that right around 94% of the patients that got to that endpoint actually got there without taking a second dose. So effectively, everybody got to the endpoint on a single dose of the drug. It was not important for the efficacy endpoint, is the critical point. And so, again, what we found is, so then why did they take it? Again, they took it because the protocol said they could, and patients followed the protocol.
And they took it because we think in the real world, it's not an uncommon phenomenon to do that. And again, that's... And last but not least, I guess it's important to remember they took it 'cause it's oral. That the redosing with FIRAZYR is, you know, painful obviously by definition. Redosing with a tablet is very low burden. And so for all those reasons, you know, the redose rate was where it was. And again, we view it as a positive thing, not as anything detrimental, and it certainly doesn't imply there's any challenges with the data.
Okay. And then, I think in phase III you have a, you had a much broader patient population than you had initially evaluated in the phase II, including some patients on prophy. Maybe if you can just talk about how consistent the data was across those different subgroups.
Yeah. Yeah, again, this is the biggest and most broad-ranging trial ever conducted in HAE. To your point, we included all attack types, all severities, we included patients on long-term prophylaxis. We also included adolescents, and you know, one of the things that's really important to understand is that the unmet need in this space generally, we believe is very high, in adolescents, it's even higher. FIRAZYR was never approved for under age 18. The only things that are approved actually for adolescents in the on-demand space are these intravenously delivered C1 inhibitor therapies. So the burden of an adolescent with HAE is really high. Either they're using off-label FIRAZYR, or they're having to get IVs whenever they have an attack come on.
So that population is one that we were really happy to include in the study because we think, we think the benefit for them is even, is even greater probably than for, for people in general. In terms of the consistency of effect across all these subgroups, I mean, again, the, the larger the... The more you cut these subgroups up, the less robust the statistics become, just 'cause your, your populations are so much smaller. But, but across the board, you, you- we saw, you know, virtually, virtually identical results. Patients on, patients on long-term prophylaxis, we actually disproved a, a couple of myths here. You know, one thing we showed is that actually the severity range of their attacks is almost identical to patients on on-demand only.
So there's been this, you know, belief in the space generally, that patients on LTP don't really have severe attacks, and we conclusively disproved that. We showed that their attack, like I said, their attack severities looked almost identical. Their response rates were almost identical to the patients on on-demand only. Adolescents responded similarly. All attack locations responded similarly. Laryngeal attacks, we didn't have many of them in the phase III. We have more of them in the open label, but, you know, they've responded similarly. So really what we showed is that the drug is efficacious in all these subpopulations to almost and the same degrees as, you know, anywhere else.
Okay. So you still have an open label extension study that's ongoing. I imagine most of the patients that completed KONFIDENT, significant amount moved over. How are they... I guess, what's the protocol in that trial? How are they using the drug, and when could we see data from the open label study?
Yeah. Yeah, the open label extension, right, it's a fair number of rollovers. We also allowed de novo patients into it, so we do have some new entrants who were in the phase three studies. You know, I described the phase three study as kind of fairly close to real world, and to a greater or less degree, that's true. But certainly in the open label extension, it's much more similar to open, to, you know, to real world. For one reason, they don't have a one in three chance of having placebo. They always know they're getting active.
To the extent the data set in the open label, we've talked about, I think we've said that, you know, at a minimum, it looks just as good as the phase III, and in some places, it looks really even more interesting. Time to dosing is a really interesting topic in the space, and one of the significant reasons that patients don't do as well nowadays is because they end up waiting so long to take their on-demand therapies when they have an attack. And we've shown, and there's been multiple sets, data sets have shown, patients wait on average between 3 and 5 hours before they treat nowadays when they have an attack come on, and that's just entirely too long.
In the phase III, we showed that patients treated within 41 minutes of the attack onset. In the open label extension, so far, the most recent data I saw, patients are treating within 9 minutes of attack onset. First quartile is 2 minutes. So what we're showing in the open label is that to the extent the data is different, it's actually even more meaningfully, you know, improved. Patients should be treating very early in the attack progression because that's how they halt the attack, and you avoid suffering all the sort of challenges that come as it increases. And so getting patients to dose that early is just tremendous from their standpoint. And so-...
You know, that's one place where, again, I think getting even closer to real-world experience is just really showing how good a drug sebetralstat actually can be in this population. In terms of where we'll show the data set, we do have to do a data cut that supports the NDA filing, and I expect that we'll have a presentation in the EAACI of incremental KONFIDENT data and also some of this open label data we've talked about.
Okay. And I think you mentioned at the top of our session here that NDA filing is still expected in the H1 of-
Yep
... of this year, so-
Yep
... that's coming fairly soon. You still plan on seeking approval of both 300 and 600 mg doses at this time?
The data sets overlay almost perfectly, and so our plan is going to be to file for the 300.
Okay. And anything in the label you'll be seeking, obviously, you conducted, as we spoke earlier, in a broad patient population, so clearly all the way down to 12 years old and encompassing all types of attacks is kind of the goal for the label?
We have shown efficacy and safety in essentially every element of this population. And again, I think in a very robust fashion, you should expect we'll pursue a big, broad label to match.
Okay. And you expect any language around second dose or just kind of reporting what, what occurred in the study? Or you plan on marketing the product with the second dose? I, I don't know how you with the goal-
I wanna keep a few cards up our sleeve.
Sure.
But I guess I would say that we view the safety and efficacy support, first of all, the fact that a first dose should work for pretty much all patients. I mean, you know, a single dose should be adequate for almost everybody. But obviously, attacks have different severities, and patients have different responses, and so flexibility of dosing is valuable to them. And so we would certainly want to enable patients to treat the disease as they see fit, to get the, to get the kind of relief that they need.
And given the, you know, remarkably robust safety profile, right? I mean, this has shown just a tremendous level of tolerability. We... There's really no downsides we could foresee to patients being able to take incremental doses. So again, we think this drug deserves flexibility of patient choice, and we intend to enable that.
Okay. And we've spoken before, this is the first on-demand treatment in over a decade. I think it offers a real change in treatment paradigm. I think that would support a Priority Review. I assume that is your view, but how are you looking at that potential, and is there also a potential for an AdCom?
We think the unmet need is high, we think the safety profile is outstanding, we think the efficacy data is superior to anything else out there. You know, that all adds up to, I think, a very good case for Priority Review. We think we would have a very, very strong argument. That said, the FDA is very busy, Priority Reviews are hard to come by, and so, you know, I don't know that at a baseline I'd wanna set expectation for that. I think we'll make as good a case as anybody has made for a Priority Review. But again, really, it really doesn't boil down to us, it boils down to, I think, factors outside of our control, that will influence that.
So I wouldn't want to overly set expectations for that. We don't expect... But that said, we certainly don't expect an AdCom. There's never been one in the space. The data is, again, the data is great. The safety profile is really good. I don't see any reason for that anybody would want change, you know, from past practice and have an AdCom here.
Okay. So let's talk about the market opportunity for sebetralstat. You mentioned earlier, you know, most of the action has been around prophy over the last decade, and we've seen the market move over to prophy. You know, where does a product like sebetralstat fit, and how it can change the movements we've seen over the last decade or so?
Yeah. So again, we'll talk about the US exclusively here, right? I mean, and once you get outside the US, the rest of the world is almost entirely on demand. I mean, the next highest... The country with the next highest level of prophylaxis use after the US is probably Germany, and that's about one-third prophylaxis. And that's an interesting point because what Germany does that the US doesn't really do is really has much higher and more tightly enforced requirements for attack rates to get on prophylaxis. And so, at some level, I'd argue that, you know, a third prophylaxis is probably the natural rate, 'cause that's probably the people who have the more severe disease and who really would most benefit from a prophylaxis therapy.
In the US, to your point, prophylaxis has gotten a lot of attention in the last 10 years. There's really been no one else talking about anything but prophylaxis the last 10 years, and certainly for the last 5 years since TAKHZYRO came out. It's basically gotten all the mind share. You know, prophylaxis on a dollar basis in the US is about two-thirds of the market, about one-third of the sales are on demand. Of that prophylaxis market, about half of that is TAKHZYRO alone. So, you know, TAKHZYRO is a $1.2 billion drug or something of that sort.
Despite that, what you really see is, though, if you look at, if you look at scripts, and we've talked about this, you know, multiple times in the past, script numbers haven't actually budged in the last five years. Assuming on demand and actually even in prophylaxis, you really, you really don't, you really don't see a lot of, a lot of shift across. And, and people wonder why that is, and, and the answer is 'cause really, at some level, the market breaks down into three, three different segments. Again, I said about a third of those pa- about a third of the patients are, are treated their disease only with on-demand. And, and, and, and they're happy with that, and they don't see any real reason to switch over to a prophylaxis.
You know, they look actually demographically and all, you know, maybe a little bit older than the general population with HAE, but by and large, they look the same. They just have a preference, and their preference is to treat on-demand. And they seem very stable. So they're, you know, they're kind of an easy existing group. Now, the other two-thirds of the market, about half—which is the prophylaxis space, about half of those patients break up into two really interesting subgroups. One of which is patients who are, you know, probably pretty well-controlled on prophylaxis. They have very low breakthrough attack rates. They're maybe having, you know, 0.5-6 attacks a year on breakthrough or something. They're the ones you hear about constantly or who are attack-free.
When you hear about attack-free rates, this is the population you're talking about. Maybe half or so of patients on prophylaxis across the board are more or less attack-free for some reasonable duration, and that's this group. So they don't use a lot of on-demand therapy, but they really haven't, and ever. But the other half is really interesting, 'cause they... What you find in this other half of the prophylaxis market is you find patients with really high attack rates, such that the blended rate of the prophylaxis patients, actually, their attack rate based upon claims data we've looked at, actually suggests that the overall the attack rate of patients on prophylaxis is higher than it is for patients just using on-demand. And so these patients actually still use a fair amount of on-demand on a routine basis.
And so that's why the on-demand space hasn't really changed, 'cause you've got these two end segments that are stable. They've, they both use on-demand routinely. And this intermediate space, which doesn't use a lot of on-demand, really never used a lot of on-demand. But they're the ones you hear about all the time. And so, you know, our view of how the market is going from here is in the on-demand space, I mean, I think we'll come in as the clear leader. Again, you know, we feel very comfortable that in the on-demand segment, which comprises both the on-demand-only users and the breakthrough attack users, you know, we'll be a really attractive, you know, proposition for those people.
We think we should have fairly high transition rates fairly quickly. We also note that a lot of attacks in the space nowadays aren't treated at all. You know, we've talked for a bit about how the ones are generally treated too late, but only about maybe two-thirds are actually probably less of attacks are actually treated nowadays. So the other thing that happens, we think, over time, is that the treatment rates go up in the on-demand space, and that accrues to our benefit, probably exclusively. The final thing is, let's come back to this middle third of patients that I talked about a minute ago. You know, their attack rates aren't that high. They're not using a lot of on-demand nowadays, but they're still using prophylaxis, which is generally an injectable prophylaxis.
We think, you know, we think sebetralstat may actually become, over time, a fairly attractive option for those folks. If you're having a couple attacks a month and you're taking, you know, two attacks, our injections a month, or 30 tablets a month, or... And you're, you know, you may really look at this and think, "you know, for two attacks a month, if I can take two tablets a month, that's, you know, that really reduces my burden of treatment." And so we do believe that a third option here is, over time, some of those patients may naturally find that we can offer them a better alternative to manage their disease, and they'll come over there.
So our view on the on-demand space is we think, we think we're in the sweet spot. We think the market, baseline market is stable. We think the treatment rates are gonna go up. We think we're gonna be an attractive option for a number of these prophylaxis patients nowadays that maybe don't really, you know, have the really high requirement for prophylaxis. And the prophylaxis space, you know, is gonna increasingly get crowded. There's a lot of people coming after that, and I think there's a lot of marginally differentiated products that I, you know, I think are gonna be splitting up a market that probably doesn't have a lot of growth attached to it.
Yeah. So I think on the prophylactic side, ORLADEYO has kind of become the de facto initial treatment.
Yeah.
And then some, some patients stay on, some move on.
Yeah.
Do you think it makes sense that sebetralstat could take over that role, and so for patients to try, and then they could decide at that point to move to prophy or remain on on-demand?
Yeah. I think at a minimum, we're complementary to ORLADEYO. I mean, if patients need a prophylaxis and they want an oral prophylaxis, obviously, that's the only option now and for the foreseeable future. But if they're having breakthrough attacks, obviously, the burden of those breakthrough attacks. 'Cause now all you've gotta do is you know, nowadays, you have a breakthrough attack on ORLADEYO, you've gotta go for your IV or injection and deal with all the things you're trying to avoid by going ORLADEYO in the first place. In the future, if you have a breakthrough attack, you can have sebetralstat and use that. And it maybe becomes your primary therapy. I think that would be terrific.
But again, there are patients who need to be on prophylaxis and who wanna be on prophylaxis, and I think even for them, if you will, this kind of lowers the, not, you know, not financial cost, but kind of like treatment cost of-
Yeah
... of being on ORLADEYO. And so, you know, so no matter what, we win.
Yeah. And you mentioned a lot of attacks aren't treated. I think you guys have done a lot of work on that front.
Yeah.
How would that change the acute on-demand market if you, if you count those attacks? I mean, how many of them remain untreated?
... again, you know, 65, if 60 or what, let's say it's 65% of attacks are treated, you know, you move—I mean, you know, you don't have to make heroic assumptions. You're never gonna treat 100% of attacks. But, you know, but if you move that up a fair bit, you know, that's all incremental value, and all of which is, again, gonna really accrue to us. 'Cause the only reason they're gonna be treating more attacks is 'cause there's sebetralstat available.
Okay. I'm sure you started discussions with payers and about coverage and pricing. This is typically an area that usually has favorable coverage.
Right.
I know their FIRAZYR has gone generic. Just curious if you think that that kind of limits the pricing level and potential coverage of the, of a sebetralstat?
Yeah. No, the answer is no. I mean, there's a lot of examples of branded drugs that have launched in the marketplaces where there's generics. I mean, an easy one is the migraine space, where the triptans went generic a long time ago, and you still have branded products launched, and doing exceedingly well. So the point is, we don't really expect any pricing challenges because of generic icatibant. We expect a price on par with the branded therapies and maybe even, you know, if we demonstrate proper value. You know, I think there's even an argument to be made for pricing at the higher end of those branded therapies.
So I'm not saying we would do any of that, but I am saying, I do think the pharmacoeconomics of the thing make a lot of sense, and we can offer a lot of value to patients, and I think we'll be recognized in the marketplace. In terms of other, you know, limits, I mean, step edits aren't really too much of a thing in the space. We don't really expect any significant impact from that. Everybody has a prior authorization requirement in this space. I mean, that's effectively 100%, and everyone deals with it nowadays, but that's why you have patient support services hubs. You just have to work through that process. And so there's really no significant barriers, I think, to adoption here, on the payer side.
I mean, again, we're gonna offer a product that's gonna improve patient, you know, quality of life, that's gonna, you know, give better outcomes, that's gonna, I think, from an economic standpoint, really show advantages to everybody. And so, you know, this is, this is not something that, that I think is gonna be something that's gonna be a lot of attention, that people are gonna feel like they have to actually obstruct in some way. This is something that patients are gonna want, and doctors are gonna wanna give it to them, and payers, I think, are gonna wanna support that.
Yeah. And then in terms of your go-to-market launch strategy, maybe how you're currently thinking about it? I know we're probably a year or so away from there, but clearly this is when you have to start thinking about it.
Yeah, we've been thinking about it for two years before this. So, you know, we're doing all the important setup work. We've had a commercial team on board now. We've had a commercial and medical teams on board now for, you know, for actually coming on three years. So it's—we've had the key people in place for a while. We've got a terrific Chief Medical Officer and a terrific Chief Commercial Officer, you know, both of whom has joined us in the last three years, and have got a great breadth of experience in this space. Our Chief Commercial Officer in particular launched TAKHZYRO at Takeda, and actually was involved in the FIRAZYR launch before that.
So we've got experience in HAE. We've got a full medical team already put in place. We've got MSLs that cover the U.S. and Europe, and we've even got a you know, a little bit of a presence in Japan. So we're really well established on that side. On the commercial side, again, we've built out all the key senior roles. We've hired a fair number of people with HAE experience, so we know this world well, through multiple different avenues. And you know, we've already done. Again, we've done an enormous amount of patient advisory boards, and we've done physician advisory boards, and we've done, you know, all the appropriate and standard things that a company would do at this stage.
And now we're starting to build out the market access activities and all the other elements that come next. So we're on track. I mean, we are, we've got a really good core team in place. I think they're really setting up for, you know, for a really aggressive launch. If we're able to get a Priority Review, trust me, we'll be ready to go then, too. But, but you know, we're no matter what, we have a good plan we're executing on, and, you know, we really expect to hit the ground running here, presumably we get an FDA approval.
Sales force here would be typical with the other players in the space, the 40-50-
Yeah
... or so?
It's not even that big. I think most people are closer to 30. You know, like in 30, you know, 30, low 30s, maybe. It's a really tight sales call. You know, it's way under 1,000 docs you have to call on here in the States. So again, it's the perfect indication for a biotech company to launch, and-
Yeah
... the resource requirements are very, very limited, and you can really, you know, cover the market in an appropriate fashion.
How are you thinking about ex-U.S., Europe, and Japan?
We are, we're working on NDA filings in both those locations ourselves. We've built small teams in both those locations ourselves. Japan's a market that's really interesting, and we've had tremendous support from PMDA to date in Japan. I mean, they moved us through in record time to allow us to get some patients into the phase III study. So we actually included, you know, Japanese patients in the phase III. We've got 'em in the open-label extension. So in both those locations, we think we're in a really good position to file for approval and commercialize ourselves. You know, we'll obviously, we're gonna keep moving in that direction.
We'll also talk to partner, potential partners along the way, primarily in other geographies. But as we go forward, we'll, you know, engage with the, you know, people who we think make good strategic sense. And we'll make decisions about who and when to partner and where as we move along.
I think we only have a few minutes left. You just wanna touch on, maybe financials-
Sure
... cash balance and runway?
Mm-hmm. So, again, the last quarter reported we had right around $240 million in the balance sheet. That's taking into account pro forma for the financing we did in February that Needham supported us on, so thank you for that. We have guided that we're funded into 2026. So we're, you know, we're past the launch. Again, the launch expenses aren't extraordinary, that's why we're able to do it on, you know, on that kind of a cash balance. And to the extent we wanna put in place additional financing to support more activities or, you know, other things we may do.
The great thing about being a company that's moving toward the commercial stage is you have options that earlier-stage companies don't. And so I've talked about collaborations, partnerships, that sort of thing. Obviously, there's different financing mechanisms that one can look into that, you know, can generate capital and maybe be less dilutive. So going forward, we will always finance thoughtfully. We've tried to make sure we do it at the right times, and we'll continue to do that in the future.
Okay. And maybe just to wrap it up, any facet of the KalVista story that you think remains underappreciated or, or misunderstood by investors?
It's always dangerous to say that investors don't understand something or that, you know, that they... But I think the challenge a lot of people have is really the HAE market is really, really busy, and it's really, really kind of, kind of opaque. And all that's been talked about, we touched on this a few minutes ago, is prophylaxis. And there are so many people coming into prophylaxis. I think there's, like, six other companies working on potential prophylaxis therapies, and so all of them only talk about prophylaxis as well.
So I think a little bit we feel like we're the only company talking about where we think the ball is actually going, which is in the on-demand space, and where we're the only player in town, and we're years ahead of the next potential at all. What we spend a lot of time trying to explain is our view on the market and how it's where it is and how it's evolving, which is, you know, unquestionably somewhat different than what everyone else says. And so I don't know if I'd say it's misunderstood.
I just think it just requires us to continue to tell the story, which we think is based on fundamentals and analytically constructed, and really shows that there's a tremendous opportunity here that maybe isn't, I guess I'm gonna use your word, kind of fully appreciated.
Yeah. Okay, well, guess we'll have to end it here. We're out of time, so thanks a lot for spending time with us this morning. But it was a great overview of KalVista and the potential of sebetralstat in HAE, so.
Thanks for inviting us. Nice to see you.