Hi everyone, I think we'll get started with our next fireside discussion. My name is Derek Archila. I'm one of the Wells Fargo Biotech Analysts. Very excited to have Kyverna Therapeutics and their CEO, Warner Biddle. Warner, thank you so much for joining us.
Thanks for inviting us, Derek, and thanks for hosting this. It's been great so far.
Awesome. Well.
I didn't know there was a Las Vegas casino in the middle of Boston.
Here you go.
I'm learning a lot.
Exactly. Well, thanks again for coming. And maybe just to kind of level set us in terms of Kyverna, maybe just give us a sense of kind of where you're at with your programs, KYV-101. You're kind of a pioneer in the CAR T space for autoimmune. So maybe just set the landscape and we can kind of get into the Q&A.
Sure. Well, we're really excited about all the progress that we're making, and I think you're hinting to that. Our lead indication, stiff person syndrome, is now fully enrolled in terms of its clinical trial, and we're looking to read out those results in the first half of next year, as well as file our BLA in the first half of next year as well. So that's really, really exciting for us. And then quickly on the heels of that, we're looking at our second indication, which is myasthenia gravis. And we just announced last week through our IR event the details around our pivotal clinical trial. So we're moving from our phase two and actually converting that trial into a phase three design that is again going to be registrational, and we're looking to start enroll patients in the latter part of this year as well.
Moving forward with two pivotal trials and registrational trials in two neuroimmunology diseases. We've chosen those two indications, as you and I have talked about before, specifically because of the synergies between those indications. It's allowing us to move really, really quickly, be first and fast. We believe it gives us a chance not just to launch in those two indications, but to be the first CAR T company to launch in the autoimmune space, period. With that, of course, we know we're going to be looking at future indications, and we've got some interesting data coming in the second part of this year, or second part of the fourth quarter, rather, in MS and RA.
There's interesting new data happening there with KYV-101 that we're really, really excited about, as well as, of course, our follow-on construct KYV-102, which should make this more streamlined for patients to access. We're looking at filing the IND in the second half of this year as well, too. A lot of things going on, a lot of progress, but we're really excited about what we're doing here.
Yeah. Maybe at a high level, can you just kind of tell us in terms of what we've started to see emerge from CAR T therapies in autoimmunity in general? And I guess there's a lot of folks working on this. I mean, where do you feel like you guys are positioned kind of with your construct and your program and the data set that you've already generated?
Yeah. Well, I think we've got some real advantages here that are really putting us into a leadership position. First of all, KYV-101, which is our lead construct, is, of course, a CD19, as a lot of them are being studied in the space. But we're the only CD28 co-stimulatory domain, fully human design. We believe this is important. We believe this provides advantages in terms of its ability to give this deep B cell reset and this chance at a long-term durable remission in patients that we're starting to see from these initial patients that are being treated, as well as it's been designed for safety. It's now been studied. We've now treated over 100 patients. We just announced that last week, which is great.
And then the compassionate use data set, which we've been studying and looking at in over 40 patients, we're seeing no high-grade CRS and ICANS in those patients. So we know there's something different here in terms of what this construct brings to the marketplace, both in terms of its efficacy profile as well as its safety. So that's the construct. But then as a company, I think we've touched on the fact that we've got this small and nimble company that we're able to pivot and be quite nimble in terms of how we're executing. The fact that we're being first with SPS and MG starting this neuroimmunology franchise gives us a real opportunity to be the first CAR T company to launch into the space, which is a huge advantage.
We believe there's a lot of synergies between these indications as well, which is going to allow us to move forward in a very capital-efficient way as well, which I think is going to be a huge advantage for us. And then, as you've probably seen, I've been really fleshing out the team around me with a lot of late-stage development experience, a lot of CAR T experience, a lot of manufacturing and commercialization experience that's going to allow us to advance the company to the next level. So I think all these things coming together really put us in a really prime position, a pole position, if you will, to be first and fast and really disrupt the space.
Got it. And maybe discuss the stiff person syndrome opportunity. How did that even come about in terms of an opportunity that was kind of put on your radar? And as you think about kind of the pivotal trial data next year, what do we need to see in that or from that data set to really see uptake and kind of at least physician enthusiasm around that data?
Right. Well, Stiff Person Syndrome, obviously more of a rare disease, if you will, but probably one that's been underappreciated. In fact, we just announced at our investor relations day last week that we believe the market's been underappreciated in terms of the size of the market. So we think it's larger than initially anticipated. And there's a big reason for that. There hasn't been an approved therapy in this space forever. And if KYV-101 is approved, this will be the first approved therapy in this space. The course of this disease for patients is horrendous. The natural history of this disease over time, patients never get better. They just get progressively worse over time.
And because it's this autoimmune disease that really impacts the GABA system in the neuromuscular junction for patients, these patients start to get progressively stiff over time, that eventually they start to lose their lower limb and truncal dexterity. They have trouble walking. A lot of them end up in wheelchairs or even end up bedbound. So there's a huge unmet need for these patients, which is a big reason why we chose SPS as one of the initial indications because of the unmet need, but also because of the transformative impact that we were seeing from the early patients that were being studied. And you've seen some of this data. We've talked to you about it. The compassionate use patients that we saw get exposed to KYV-101 now, the first one's now approaching two years.
With just one therapy, seeing a significant reduction in the Timed 25-Foot Walk test, which was the primary endpoint that's being studied in our clinical trial, as well as significant impact in stiffness and other key clinical endpoints. This patient is now in a drug-free, disease-free remission now for almost two years without the need for other background therapy. Again, doing something very, very transformative for these autoimmune patients and doing it with a one-time therapy and in a space where there's no approved therapies for this kind of an indication, I think really pointed us this could be an optimal first indication for us because it would allow us to enroll in a clinical trial really quickly and allow us to get to market really, really quickly in a capital-efficient manner. That's what we've been focused on executing.
We're fully enrolled in the trial, as you know, and we're going to be reading out the results in the first half of next year. If we see results trending in the same direction that we saw from these initial patients, from compassionate use patients, we'll be really excited by that. I think the regulators are going to be excited by that. I think payers are going to be excited and patients too.
I guess, why do you think some of the other therapies that use an SPS, they don't really work well? Like again, Rituximab, what about CAR T really drives the efficacy here? And ultimately, I guess the second part of this question is going to be about durability. I mean, obviously, you've got two-year data with this one patient, but what's your expectation around that?
Yeah. Well, I think what's exciting about what KYV-101 is doing, I guess what CAR T therapy is doing versus other therapies being studied in this disease, is a lot of them stiff person syndrome, a lot of them are symptomatic. There's pain relievers, muscle relaxants, etc. And even IVIG and immunosuppressant isn't really addressing the underlying course of the disease, which is what makes KYV-101 very different. It works by having this complete and deep B cell depletion. And it's also able to target these pathogenic B cells in targeted tissues and have this complete B- cell depletion, which again gives patients a chance at this autoimmune reset. We're also seeing, and one of the professors, Ricardo, was presenting some of this data last week as well, showing it's not just this regeneration of naive B- cells that are non-pathogenic anymore.
It's this ability to reset the T- cells as well, as well as significantly reduce cytokine reduction, which is a primary inflammation driver in these patients. All these coming together is really indicative that we're really resetting the immune system here and doing something fundamentally different than other therapies in the space. It's not just with SPS. We're seeing this translate over into myasthenia gravis as well. I think this is why if you ask some of these physicians that are close to it and are seeing not just CAR T therapies, but other therapies being studied in the space, you ask them why we're seeing this with something like KYV-101, they're pointing to this underlying drive and what we're fundamentally doing on a translational basis to impact these patients.
And that gives us hope that this durable remission that we're starting to see emerge in these patients can be longer lasting. And to your second part of your question, I think is a really interesting one. I mean, it's a little early to tell, but we know from our market research that patients with these diseases, if you can get them out past a year being drug-free, disease-free from their condition, we already know that's transformational. So the fact that we're getting at two years or going past two years with myasthenia gravis, I think we're already showing that we're going to bring something very, very transformational for patients.
If you look at the impact of CAR T therapies and maybe the hematological side, what was really interesting there, and I worked in that side of the CAR T business in a prior life, but what was really interesting is we saw patients once they got past the three-year mark, and if they had this durable remission, there was a high likelihood that that durable remission will continue. It's too early to say whether this will be translatable to the autoimmune space as well. We're already seeing as we can get these patients at two years and beyond a durable remission. I think that gives us hope that we can actually make this even longer lasting for patients, which would be incredible.
Gotcha. And then in terms of the SPS opportunity from a revenue perspective, I guess, how do you think about that? And also, are you prepared or preparing for kind of commercial activities post-data? What does a launch in SPS look like?
Right. Well, we believe there is a significant commercial opportunity. It's, I think, been underappreciated, but there's a prevalent pool of patients that are waiting that are just basically rotating through a number of different symptomatic therapies and IVIG. Again, all of them are progressing over time. So there's a significant unmet need for something that's going to clearly come in and disrupt the space. Again, I think if you take a look at the cost of managing these therapies or managing these patients in Stiff Person Syndrome, it's not insignificant. $100s of 1000s a year. And again, it's chronic therapy, and they're still living with the disease.
So again, I think there's a real value argument from a payer perspective of what we can bring to the market with KYV-101 and really justify a significant price here that would still drive value for these patients from a health economic perspective. So all those things are going to come into place in terms of us setting the pricing and market access strategy around this. But we believe there's a significant market size opportunity here in terms of the number of patients that can be readily addressable. And by us being first and fast, I think that puts us in a real pole position that we'd be the ones to take advantage of that prevalent pool of patients.
Gotcha. I mean, are there SPS communities? Are they very aware of this therapy and development? Is that something that you've already kind of looked to kind of generate enthusiasm around? And also, obviously, you had a couple of KOLs on your webcast last week, but just trying to understand, are there true centers of excellence that are out there that exist for SPS that you can kind of target early in the launch?
For sure. There are centers of excellence. I think that was why we were able to effectively recruit our trial as quickly as we did. We did that in under seven months. I don't think anybody really expected we were able to do that. We were able to tap into these centers of excellence, but obviously, there's a huge unmet need as well, and patients talk. There's the Stiff Person Syndrome Research Foundation. In fact, they just had a symposium a few weeks ago which we attended as a company.
And just to feel the energy in the room and to see these patients actually show up for this meeting and talk about their disease, talk about the impact that it has on not just their physical symptoms, but actually there's new scientific evidence showing that Stiff Person Syndrome actually attacks the brainstem as well and has an impact in terms of their psychology and their anxiety levels as well. So there's a huge impact from a psychological level to these patients that has a huge impact in terms of their quality of life. We were witnessing that firsthand in the room. And really, the thing that came up a lot from in the room and the presentations that were happening as well as the hallway conversations was, "Keep going with your clinical trial. We need something new.
We need something that's going to address this disease." So I think there's going to be a lot of excitement from the patient perspective and from the patient advocacy perspective as we get closer to launch.
How many of those things on quality of life are you measuring in your trial? Is that something that you're going to have data on that you can actually report in terms of, I don't know, anxiety levels or any of that sort of stuff?
We'll be looking at that as a totality of quality of life scores. Of course, there's the Timed 25-Foot Walk test, which is the primary endpoint that we'll be measuring in the study, and then there's other things like the Stiffness Index and the Hauser index and stuff that are also validated endpoints in Stiff Person Syndrome. All of those things together, along with our safety profile, will be part of the data package and the data readout that we'll be submitting.
Gotcha. Maybe to shift gears to MG, I mean, obviously, you provided a very interesting update. The one major takeaway that we took from kind of the design of the pivotal trial is that you're going to enroll patients that are biologically naive. So seemingly, I think the overall assumption was that CAR T would be late line, basically after everything was exhausted. This opens up the opportunity, not necessarily to maybe front line, but certainly somewhere in the middle or early line. So I guess, what do you think that means from the FDA perspective? Do you think that they're more amenable to CAR T being used earlier? And I guess, does that carry forward to potentially other indications in the future?
Yeah. I mean, it's a great question and very multi-layered question, obviously. But just coming back to the design, I think we're really excited by this design. We think it's really bold. We think it really addresses the unmet needs that are in the space right now with myasthenia gravis because although there's a lot of treatments out there right now, none of them are getting, as we talked about with Stiff Person Syndrome, it's very analogous. They're not getting at the underlying cause of the disease and giving patients a chance at really changing all of that, which we think is really, really exciting. The design is looking at patients who have moderate to severe disease. We're looking at MG-ADL scores of greater than six, QMG scores greater than 11.
These patients largely cycle through a lot of different types of therapies, including immunosuppressants, but also FcRns and complements. We thought when we were designing this study, it was really important that we found a way to include a lot of them because a lot of these patients are being managed heterogeneously, and I think the way we've designed this study allows a lot of flexibility in terms of what patients are on from a background perspective. As long as they fulfill those criteria, they'll be candidates for the clinical trial, and I think that's going to your first part of your question, you're going to really allow us to stratify and take a look at results with patients that have had prior exposure to biologics, patients that have not had prior exposure to biologics.
And I think really paint a clinical picture for us that will provide a lot of, I think a lot of interesting data, not just for regulators, but I think for payers as well in terms of how these get positioned in the marketplace. Again, I think given the fact that we're doing something fundamentally different here and we're doing something that can change the course of the disease at a very basic level and give patients a chance at a drug-free, disease-free remission, separates us from everything else in the space. And I think if we're able to successfully read out this trial the way the compassionate use patients are reading out or something trending in that direction, I think we're going to be bringing something to market that's going to be, again, transformative.
Gotcha. I mean, I guess one of the questions is in terms of what can be in that standard of care bucket in the control arm, I guess, how are you thinking about it? I know you guys talked about some of the powering, so maybe you can kind of reiterate that. But I guess, yeah, how do you think that will perform in this trial based on the population that you're enrolling there?
Yeah. Well, I think what makes the design really unique is we're allowing, again, patients with various different treatment backgrounds to be enrolled in the trial. And then we've got a standard of care arm that's an active control arm, which again, I think is very bold, but I think it speaks to the large effect size that we're seeing with KYV-101 and this ability to have this significant reduction in MG-ADL scores, as well as an ability to bring patients down to an MSE or an MG-ADL score of zero, which again is something very, very transformative that we're not seeing consistently in all these other therapies. But patients will be allowed to, after the washout in apheresis, be able to go back on a standard of care therapy.
This will include a choice of immunosuppressants, and they'll also be allowed to use complement inhibitors as well, so I think mimicking a lot of what patients are seeing and using in a real-life setting, and then the fact that these patients get normalized on this in terms of their run-in really sets up a baseline then that as we give them the KYV-101 therapy, we're going to have something that we can compare to. Again, if we see this transformative effect size that we're seeing in some of these early patients also translated into this clinical study, this is why the study has been designed the way it is, and in conversations with the FDA, we really believe it's been effectively powered as well with the trial size that we have in order to achieve the outcomes we've got.
Gotcha. And maybe different from SPS, I mean, how do you think about the benefit risk, particularly around preconditioning in MG? Obviously, that population slants more female in terms of just an interest in the trial. So obviously, SPS enrolled very quickly. Do you expect the same for MG, but also in terms of the commercial opportunity vs weighing CAR T vs maybe just like an FcRn or other types of therapies?
Yeah. I mean, it's a really important question. I think this lymphodepletion thing is being talked about a lot in various settings. And I think it's really important to note that this is, first of all, it's a low-dose lymphodepleting regimen, a low-dose Flu rather that these patients are being exposed to. And in all the clinical trials we've had, including discussions with patients themselves, this is not something that's holding back patients from being enrolled in the study. And patients are able to successfully manage it in many cases on an outpatient basis in terms of the.
You're already doing the preconditioning lightly in these trials.
We're already doing the preconditioning light. But I think the other thing to keep in mind here is the patients that we're targeting, these moderate to severe myasthenia gravis patients, think about the burden of disease that they're actually under right now. Even if they're on an FcRn and being successfully treated, many of them are also on background immunosuppressants, background steroids chronically for years. And they're still living with the course of their disease. So they're probably still having an underlying MG-ADL score of two, three, four in many cases. So you've got to look at the chronic burden of managing these patients, not just in terms of the treatment burden, but the chronic burden of immunosuppressants and background steroids on patients also has a total cumulative effect on patients over time as well.
The fact we can go in with a low-dose lymphodepleting regimen and then a one-time therapy like KYV-101, potentially give these patients a long-term disease-free, drug-free remission, I think is setting a new standard here. It's something I think we've got to keep in mind when we look at the risk-benefit of what these patients are being exposed to chronically over the course of their disease.
Gotcha. And how would you frame this opportunity? Obviously, SPS, quite small, MG, a lot more patient numbers. But I guess as you kind of hone in on where the opportunity really lies for KYV-101 or just CAR T in general, where do you think that will reside in terms of the overall opportunity?
First, I think Stiff Person Syndrome in and of itself is an attractive commercial opportunity. We believe, again, there's a significant prevalent pool of patients that really desire something new, and I think we're going to be first to market, and we're going to be able to offer that to them, and we'll create a significant commercial market there, and this will be a great springboard, if you will, into the second indication with myasthenia gravis. There's a lot of, we didn't talk about this a lot, but there's a lot of synergies between these two indications, both in terms of the call points, the synergies from a manufacturing and commercialization perspective.
The same neuroimmunology, neuromuscular centers that are treating Stiff Person Syndrome will also be the same centers that treat myasthenia gravis, which again, from a young company's perspective, as we grow and build our commercial footprint, it's going to allow us to be very efficient in terms of how we actually navigate and make that happen. But there is a significant commercial opportunity for stiff person syndrome on itself. And then I think that, to your point, bridges to an even larger one with myasthenia gravis. And even if you look at patients that are refractory to either two lines of an immunosuppressant or an immunosuppressant + IVIG, the kinds of patients that we're enrolling in our clinical trial, there's 1000s of patients out there in the U.S. alone that are looking for an alternative therapy.
And even if you take a look at what some of the other analysts and physicians are talking about, even patients that, again, are well-controlled or seemingly well-controlled on FcRns and complement inhibitors, a lot of them have breakthrough myasthenia crises. A lot of them are on background immunosuppressants and other therapies. A lot of them are still having a huge burden on the healthcare system. So we believe there's going to be a significant number of patients who can benefit from KYV-101.
Gotcha. I also want to talk about you've got some data coming up from the RA as well as multiple sclerosis, right? So maybe you can kind of just frame up for us what we should be paying attention to for those. And ultimately, these are much larger indications. So this brings up a lot of questions about partnering and manufacturing scale. So maybe help us with all those questions.
Another multi-layered question, Derek. Yeah. Well, first of all, just on the data itself, I mean, when I joined the company about a year ago, there was a lot of interest in the use of KYV-101 in multiple sclerosis, but the data was very immature at that stage. And I think what's surprised me and probably a lot of people, even as we're sort of moving out just a few months after the first patients are being treated, how interesting and how motivating it is to see the impact from these first patients being treated with KYV-101 and MS. I don't think any of us would have expected some of the results that Jeff Dunn now presented from Stanford in terms of the early impact that we're seeing with the disease. So I think that's creating a lot of momentum for us.
And I think a lot of interest around the industry that CAR T therapy may not just be for some of these nicher, smaller indications, but could be something that could impact larger autoimmune diseases like MS. So more of that data to come. We're going to have an update on the IIT data coming later this year at ECTRIMS, as well as the RA data, which is just something we started. We had an interest through another IIT program, and we're going to see some of those results come out at ACR this year. Again, I think showing some early, again, very transformative results in rheumatoid arthritis, which again is a well-studied disease. There's a lot of therapies in the space, as everyone knows. But again, there's a segment of the population that doesn't respond well to these therapies, even after chronic or multiple switches of therapy.
So we believe there's a significant market opportunity in RA as well. So it's early to project the exact steps for us from a commercialization perspective. All I can say is I think you nailed it, is that there's a huge unmet needs here. These are significantly large markets. And I think as this data reads out, we're going to continue to evolve our commercial strategy and how we're going to think about that as a company, including potential for partnership with other companies. And we've had some inbound inquiries just based on these early data and a lot of excitement about working with us. And this is something we're continuing to assess.
Gotcha. I mean, one of the big questions that we always get just kind of for the space in general is around manufacturing. And I guess where do you think we are in terms of generating enough scale for an indication, even just for a myasthenia gravis? Do you think we're already there? Is this something that you do internally? You outsource? Or what has to happen? Because I think that kind of, I feel like, holds back some of the folks who want to be bullish on the space because the data is excellent, right? I think we can really dispute what we've seen. But it's really like, how do we make this a business going forward beyond just small indications like maybe like SPS or some other niche things?
Yeah. Well, I think there's been a lot from us as a company, but us as an entire class in an industry. So much has evolved over the last five, six, seven years in terms of manufacturing effectiveness. I know for ourselves, we've had a manufacturing success rate at more than 95%, which I think has boded well in terms of our ability to enroll in the clinical trials. And then as we announced last year, we're bringing on board a second manufacturing partner with Elevate, which is actually based here in Boston, which is great. And they've been very, very effective in terms of expanding our overall capacity. And we feel very comfortable about not just our ability to meet the demand for our clinical trial programs, but also the ability to meet that early demand for Stiff Person Syndrome as well as myasthenia gravis.
And then we're going to continue to evaluate other options as we continue to grow as a company. We know that we're going to need to probably expand the footprint even further as we look at larger indications, but there's a lot of options out there in terms of how we can tackle that. And then if we look at KYV-102, for example, and really the opportunity for us to come with this whole blood rapid manufacturing construct, I think that really, again, will set another bar in terms of our manufacturing effectiveness. Because it's a more rapid manufacturing, it should reduce the cost of goods even further, which will allow us to put us in a better, even better position, I think, to commercialize for some of these larger indications that will demand that flexibility and access for patients.
Gotcha. I guess as you think about kind of the overall CAR T landscape, so now you've got obviously 101, you've got 102, there's ALLO there's in vivo, there's all these. So I guess where do you think we kind of net out? I mean, obviously, with autologous CAR T, we have excellent data. What's kind of maybe your prediction on how this evolves over the next couple of years?
Yeah. Well, I think you touched on it at the very end, how we feel about it. We really believe in the power of autologous CAR T therapy. And with KYV-101 and Kyverna being in this leadership position, we really think we've got an opportunity here to reshape this market, particularly when you're talking about these prevalent patients that, if you can treat them once with this therapy and have this huge impact over time, I think will completely change the epidemiology and prevalence of these diseases over time. So I think we're all in on autologous because of the transformative impact we're seeing with patients. And then to your point, I think the manufacturing is getting easier. I think the safety profiles that we're seeing with KYV-101, for example, are making these therapies even easier to administer. The CRS profiles are very predictable and transient and well-managed.
So we believe that these will translate to an outpatient setting once we get to a commercialization, once we get this to a commercialization stage, which will, again, make it easier to use the existing capacity within the market. In addition, we're seeing a lot of the key academic centers and secondary ones as well starting to invest in capacity in their systems. They're not viewing themselves as hematological CAR T centers only. They're expanding that into the autoimmune space. We're seeing a lot of interest from community centers as well that are looking to expand and move into CAR T, particularly as CAR Ts become easier and easier to manage. So all of these things, I think, are boding really well for the marketplace that's being set up here to treat these patients with autologous CAR T therapies.
We believe, again, we're going to be in the leading position in order to take advantage of that. I do think to your second part of your question, things will evolve. KYV-102, for example, like we just talked about with this whole blood rapid manufacturing, in a sense, gets us to a lot of the benefits that people were hoping to see from allogeneic CAR T therapies, but I don't think have really borne themselves out so far. They were looking for things that are easier to manufacture, easier for patients to use, maybe lower the cost of goods. We're doing all of that with KYV-102, while still keeping the fundamental background of KYV-101 and the power of autologous therapy.
So I think in a lot of respects, the next generation construct that we're bringing is already providing a lot of those advantages that people are already hoping for. And then we're going to continue to assess, as I think a lot of companies are, what the next generation therapy would be after that. But I think I want to stress, I think there's going to be a lot of short-term opportunity and medium-term opportunity for a company like Kyverna to take advantage of the autologous CAR T space, particularly as it gets easier to use and the capacity of the system continues to increase.
What do you think in terms of the development plan for 102 vs 101? And will that be different, or will you kind of just ride on its coattails? How do you think about that as you kind of get that into clinic?
We're working on that right now. We're working on the non-clinical and the CMC package work that will allow us to file the IND. We're going through an assessment right now of which indications we want to prioritize with this therapy. Again, because it's the ease of use for patients, the reduced cost of goods, we believe this is going to have a lot of opportunity for us, particularly when we think about some of these larger autoimmune conditions that get treated out in the community more readily. We think this is going to have a huge advantage for them. We'll come back with more specifics around the development plan and how we're thinking about that. We're really excited about it too because I think it's going to provide a lot of opportunity for us.
Gotcha. And then maybe just to wrap up here, just in terms of beyond other CAR Ts, and obviously, there's a lot of competition in these autoimmune spaces. And there's a lot of, I guess, angst created around bispecific T-cell engagers and whatnot. I mean, I guess, has that kind of calmed down as more people have come to realize kind of the differing efficacy profiles here? I'm just kind of curious your view on, I guess, now the dozen that are in development for all these indications, but again, how you kind of see those fitting kind of in the treatment paradigm as well in a lot of these competing indications.
Yeah. I mean, you've kind of touched on the answer a little bit in your question. I mean, first of all, it's great for patients that the science is there and that there's a lot of options being studied because I think patients do need options for sure. But again, I think the way you think about our data and how we're continuing to deliver, not just on this short-term efficacy and short-term clinical impact, but these long-term durable effects that we're seeing in patients that seem to be now happening consistently, not just across SPS, but now we're seeing across MG as well. Again, I think we're doing something here transformatively different that other therapies are going to have to prove that they're able to do that.
And if we continue to improve manufacturing, as your earlier question, if we continue to work on how we manage these from an AE perspective, make it easier for use, bring these closer to the patients in terms of access and expanding and taking advantage of the existing capacity and growing capacity in the system, we think all of those things coming together are going to make this really a gold standard or really set the standard for what therapy of these autoimmune diseases should be.
Got it. So maybe just before we end here, recap what we're looking for for the next six to 12 months in terms of updates and milestones.
I mean, from a Kyverna perspective, we're excited about all these near-term catalysts. Later this year, as we talked about reading out some of these initial data for MS and RA, which we're really excited about, we're initiating enrollment in our pivotal phase 3 study for myasthenia gravis, which we're obviously very excited about. We'll also be reading out interim phase 2 results from myasthenia gravis in the fourth quarter of this year as well. A lot of catalysts happening in the second half of this year. Of course, we are very excited about the readout of Stiff Person Syndrome, which is our first indication in the filing of the BLA in the first half of next year, which I think is really going to propel our company into the next phase of growth.
Got it. All right. Well, Warner, we'll leave it there. Thank you so much.