Kyverna Therapeutics, Inc. (KYTX) September 2026 Conference Transcript

All right. Good afternoon, everyone, and thanks for joining us at the Morgan Stanley Global Health Care Conference. I'm Mike Oltz, one of the biotech analysts, and it's my pleasure to introduce Werner Beadle, CEO of Kyberna Therapeutics. And just as a quick reminder, the format for today is the Fireside Chat, so if anyone in the audience has a question, please raise your hand and we'll get it looped into our discussion here. But before we get started, I just need to read a quick disclosure. for important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com backslash research disclosures.

If you have any questions, please reach out to your Morgan Stanley sales representative.

And with that, I'll turn it over to Werner, and if you want to make some introductory comments, and then we can hop into the Q&A.

Sure, Mike. Thanks very much for hosting us. It's been a great day so far. And, yeah, I'd like to just start off by saying Kyverna's really excited about the tremendous progress we're making. We're leading the world in bringing cell therapy to autoimmune patients, starting with our first indication with stiff person syndrome. But we're on track to finish filing our BLA as of Q4 of this year, which would put us on track to be the first approved therapy in this terrible condition that has no approved therapies. But more importantly, it puts us on track to be the first cell therapy company anywhere in the world with an approved therapy in autoimmune diseases. So really excited about that tremendous progress there. but this really opens up the aperture for the rest of our neuroimmunology strategy and portfolio that we're building here and looking at additional indications with myasthenia gravis and progressive MS and other things that will continue to build and grow our company as we continue to navigate this space, but more importantly help these patients that desperately need something new in terms of a new therapy that can transform their lives.

Great, and thanks for that introduction, and I thought maybe we could start with a couple big-picture questions here, just, you know, maybe why autologous CAR-T cell therapy, you know, and specifically MIV cell has been so promising for autoimmune indications?

I think what's really important here is that MIV cell, unlike other CAR-T therapies, has been specifically designed for autoimmune diseases. This construct was in-licensed from the NIH as a next-generation construct for potency in these conditions, but more importantly, significantly improved safety. We're the only CD19 with a CD28 co-stimulatory domain in the autoimmune space with a fully human design as well and other changes to the car construct that provide this improved safety profile. And we're now seeing that bear out in the over 100 patients that we've now treated. We're seeing these remarkable clinical results, but at the same time, no high-grade CRS, no high-grade ICANs, no incidences or reported cases of IECHS. All these things are really important when you're looking at developing a construct that's going to help patients more broadly across these conditions.

So you're seeing very promising results, not only on efficacy, but safety across a lot of different indications and quite a few number of patients there. So maybe talk about the impact of the recent news from Novartis and BMS and kind of what that means for your program or doesn't mean, yeah, first of all, I think it's really unfortunate that these cases were announced and the impact that it has on these patients and these programs.

But I do think it really underscores what we're doing at Caverna is very different and very different on two important ways. First, the construct itself, and I touched on this a little bit in my opening, but MivCell has been uniquely designed for use in autoimmune patients, and it's been designed for significantly improved safety. And like I said, this has been bearing itself out in the clinical profile that we've now seen in over 100 patients treated. So again, no high-grade CRS, no high-grade ICANs, no cases of the IECHS, which some of these other constructs have been associated with. And I think that's critically important to keep in mind that we're dealing with a construct like MivCell that has this prominent safety profile, and proven safety profile. In addition, what's also really important is the manufacturing. We're not using a rapid manufacturing process. In fact, we're using a traditional, well-established, tried-and-true manufacturing process that has been, again, well-validated and established in the over 100 patients we've now treated. We see 98% manufacturing success rate, and we believe this combination of the construct and the manufacturing is what's contributing to the overall promising safety profile that we're now seeing.

And just on the manufacturing side, what do you think is contributing to the sort of risk around that, particularly in autoimmune disease?

Well, it's difficult to speculate about other manufacturing programs and other companies. Some would say you're introducing more naive T-cells, and that has a different clinical profile in patients and one that needs to be elucidated through their own development program. But again, coming back to Caverna, what is really critically important here is we know what we've got, and we've got a really well-established manufacturing process, been well-validated, and this is bearing itself out in the safety profile that we're seeing across all these patients.

Yep, makes sense. And if we focus on stiff person syndrome, you mentioned this in your prepared remarks. It's your sort of first-to-market strategy here. Maybe discuss the unmet need there and give us a sense of, you know, the potential market opportunity, patient numbers, et cetera.

Sure. Well, stiff person syndrome is really a really underappreciated disease. It is a rare condition. It has no approved therapies up to this point, and nothing that these patients are actually using actually works for them. So if you look at the natural history of stiff person syndrome, over 80% of these patients will progress throughout the course of their disease to significant disability, where they'll either need a walker, a wheelchair, or be bed-bound. Less than 20% of them will actually be employed four years after their initial diagnosis. So the impact on these patients and their families is horrendous, which puts into context what we're seeing with MIVCEL in the clinical pivotal program that we just announced earlier. this year, so remarkable, and what we're doing here is so remarkable, for the first time ever, not only seeing clinical improvements in these patients, but for the first time ever, actually seeing a reversal of disease and a reversal of disability. So patients that in the trial, we had 12 patients in the trial that required walking and assisted devices, over two-thirds of these patients actually didn't need those walking devices by the end of the trial. So you're able to reverse the course of disability in these patients and do so with the one-time therapy that also allows these patients to come off background therapies that they've been chronically burdened So high doses of steroids, high doses of IVIG, things that have their own safety impact on patients, these patients are able to come off of that and live this drug-free, disease-free remission, which is actually quite remarkable.

Yeah, quite dramatic effect there. I guess maybe just talk a little bit about how you identify these patients or diagnose them and kind of what percentage are currently diagnosed.

Well, we know in the U.S. there's 6,000 diagnosed patients, and we know this through epidemiological studies as well as through additional work that we've done on claims analysis. And patients are diagnosed in two ways. They need the clinical symptomology, So there's a battery of tests that these patients take with stiffness scores and mobility scores, and that plus a combination with their diagnostic testing. So they're also tested for antibodies like GAD-65 being the predominant one. And when patients have both of those, that becomes a confirmed diagnosis for an SPS patient. And as I said, there's 6,000 patients in the U.S. These are well-identified patients. And, in fact, we do know there's between 2,000 and 2,500 that are also refractory to existing therapies, and these are highly concentrated in a number of key academic centers. So this makes this a very important disease but also one that's easily identifiable and we can tackle here at Kyvern in terms of addressing.

Yep, makes sense. You talked a little bit about the data you've seen so far, and I think near-term you're going to have another update with some longer-term data out to 12 months, I believe, and later this quarter. so probably fairly soon here. I guess, you know, how should we think about durability of the effect? Is it something that's kind of, you know, can it continue to improve? Is it something that, you know, is kind of you have a nice impact early and you kind of stabilize it at the same place? So just maybe talk about what to expect there or how to think about that.

Well, if you look at the pivotal data readout that we announced earlier this year, the primary endpoint being the time 25-foot walk test, we saw a 46% improvement in patients, and this is highly statistically significant but also highly clinically relevant because a 20% improvement is considered clinically important. So we're seeing that from the primary endpoint, but we also saw high statistical significance across all the secondary and exploratory endpoints as well, which is quite remarkable. What we're looking for in the longer-term follow-up is can we see a majority of these patients continue to see a durability of effect? Can we actually see a majority of these patients also remain off their background IVIG and background immunosuppressants that they've been chronically burdened with? Again, if you put this in perspective with the natural history of the disease, again, these are patients that progressively get worse over time. Patients never get better. At best, they'll stay constant, but most will progress. And if we can actually continue to show that a majority of these patients can have this significant clinical improvement, And, again, with the one-time therapy that allows them to come off all these other background chronic therapies that they've been burdened with, we are truly introducing a paradigm shift here that will have never been seen before.

Can you talk about durability and what you've seen with the longest patient out there?

I think it might be the MG patient, but just generally what you've seen over the longer term after treatment. well prior to the initiation of our clinical studies here at Caverna we had done some work through it compassionate use in IIT programs and some of our first patients treated with both stiff person syndrome and myasenia gravis are now well past the two year mark and free of disease but also off their background in immunosuppressants and chronic therapy so the early patients are really giving us an indication of what the longer term durability of their cell can be and that's why we're so excited by the longer-term follow-up of the Stiff Person Syndrome Kaiza 8 trial, which we will provide an update here in the coming weeks, as well as a longer-term follow-up on our Kaiza 6, which is our MG Phase 2 study. And again, if we can continue to demonstrate a durability defect in a majority of these patients, we are truly doing something transformative here.

And you began your rolling submission for Stiff Person earlier this year. You expect to complete that, I think, by the end of this year. So maybe just talk about what's been submitted so far and what kind of remains to be submitted to sort of complete that process.

Well, through the RMAT designation that we have for stiff person syndrome, we've had some very positive dialogues with the FDA and started our rolling BLA submission earlier this year after our pre-BLA meeting. And we're on track. We've announced this earlier, but we're reiterating our guidance to finish this BLA submission in Q4 of this year. We have submitted all of the modules except for the clinical module. So the CMC module we just announced in our Q2 earnings has been submitted, and as I think everybody knows, this is a critical module for cell and gene therapies to have completed and gives us a lot of confidence that we're de-risking the rest of the file. And in terms of the clinical package itself, we are finishing the completion of that documentation, including adding in the one-year follow-up data, which we just mentioned a few minutes ago, as well as some additional analyses on the natural history study, which will provide some context as to what we're seeing in the Kaiser 8 study. And these things are coming together, and we're well on track. So, as I said, we're going to be on track to finish filing in Q4.

Yep. Great. Can you talk about interactions that you've had with the FDA? You know, is this sort of the same team you've been working with for a while for this stiff person syndrome? And there's been some, obviously, changes. Leadership, has that had any impact at all in your interactions?

At this point, no. We've had no, you know, major deviations at all from the conversations we've been having with the FDA. In fact, throughout the whole development process, and again, tapping into the RMAT designation that we do have with the FDA, we've had constant conversations with them, and they've been highly supportive of what we're doing here at Caverna, and highly supportive of this program with the recognition that, again, there's no approved therapies, and what we're doing here is highly transformative with the clinical results that we're generating.

And just given the profile and the dramatic impact you've had in stiff person, is it fair to assume you'll request a priority review for an accelerated timeline?

Definitely. The high unmet need here, the transformative results that we have, the RMAT designation, all these things will allow us to request a priority review, and we think there's a high probability that the FDA will grant that.

And considering you're sort of, I think I've mentioned, and you're in the process of preparing for the launch and kind of being ready by the end of this year, maybe just talk a little bit about, you know, what you've done so far and what remains and maybe early thoughts on strategy.

Yeah, stiff person syndrome is an excellent first launch for us at Caverna. It allows us to be really focused in terms of our strategy and generate some really valuable opportunity commercially. And we've been working behind the scenes on a number of fronts to prepare for launch. First, in terms of manufacturing, we're working with our manufacturing suppliers, continue to prepare for scaling, for commercialization, and we're well on track and feel confident that we're doing the right things there. In addition, site activation becomes critically important, and we're targeting 10 centers to start because of the concentrated nature of these patients and where they are actually seeking and accessing treatments up to this point, and we're working with these centers now to prepare them for commercialization, including getting the necessary contracts and processes in place to deliver MivCell on time and consistently for them in a commercial setting. In addition, we're doing a lot of work with payers, spending time with them, working through the value proposition. We've now got the data set from our pivotal readout. We'll have some longer-term follow-up here in a few weeks. We're sharing that with payers, and we have a very, very strong value proposition in support of MivCell and a strong payer position, which has been positively moving forward well. In addition, we're spending a lot of time working with patient advocacy groups. This is a very tight-knit community. These patients are well aware of their own personal diagnosis, but also by looking at their peers and their friends, they know what the prognosis of this disease will happen to them over time. And so there's a lot of anxiousness and hope in the community right now with what we're doing here at Caverna and a lot of support for helping us bring this to patients more broadly.

Can you talk about maybe some of the market research you've done so far and kind of the level of enthusiasm among maybe the physicians and patients as well?

Well, physicians and patients are waiting. We've seen clearly from the market research that over 90% of physicians are strongly supportive of the TPP that we have and the value proposition that MIV-Cell can bring for patients. And we know that 85% of physicians would use MIV-Cell consistently in their moderate to severe patient population. So that's a very, very strong initial market research read, and we believe that will only improve as we get closer to launch. If we can continue to show a durability of impact, if we continue to show that a majority of patients can remain drug-free, disease-free, rather, post-miv-cell treatment, we believe the adoption rate and the willingness to try and use miv-cell will only go up over time.

Makes sense. I don't know how much you can say about this, but just in terms of your current thinking on pricing, I know you mentioned you're doing a lot of work with payers there to try and figure that out, but any thoughts on, you know, how we should think about pricing? Are there good sort of analogs out there or just, you know, any thoughts you can share?

Well, we come back to the value proposition that MibCell is bringing for these patients and looking specifically at these diseases. In the case of both stiff person syndrome and myasthenia gravis, which would be our second indication, there's a high cost to managing these patients. In stiff person syndrome alone, the cost of IVIG costs the system and patients hundreds of thousands of dollars a year. And then you layer on top of that caregiver costs, lost time from work. There's a lot of emergency costs because these patients, unfortunately, have these stiffness attacks where they freeze up and fall and have significant injuries. There's a psychological burden as well with these diseases. But overall, it costs the system and the patients hundreds of thousands of dollars a year to manage. So we believe there's a strong value proposition for MivCell if you can come and treat these patients once and not only have this transformative clinical impact, but also get these patients off the background chronic therapies and chronic burden on the health care system that these patients have been enduring. So we're actually targeting, if you take a look at the cost of CAR-T therapies now, which is roughly $500,000 to $600,000 for a CAR-T treatment, We're targeting a significant premium to that for no cell, and we believe it's justified given the high-value proposition that we're bringing for these patients in both of these initial indications.

Yeah, makes sense. So a lot to look forward in stiff-person syndrome, but you also have myasthenia gravis studies ongoing, the Kaiser VI, the phase II study maybe highlight some of the key takeaways from that data that you've shared so far.

Well, again, MivCell is setting a new standard for myosthenia gravis patients. No one is doing what we're doing in terms of the clinical impact. We're seeing dramatic reductions in MG-ADL scores and QMG, which are the primary endpoints that are used in a number of these trials. Again, no one is delivering reductions of 8.5 for MG-ADL and 11.3 reduction in QMG. Any of the other current therapies or ones that are being studied? So we're doing something dramatically different from a clinical perspective. But in addition, we're also allowing more patients to get to MSC, which is minimal symptom expression. If you ask patients and physicians what they ultimately want, they want to feel like they're free of their disease. And MSC is an attribution to that. And we're getting a majority of our patients in the early data to an MSC level, which is remarkable. And again, we're doing with a one-time therapy that also allows them to come off their background FCRNs and complement inhibitors, which are usually layered on top of high-dose steroids or other immunosuppressants that these patients are burdened with, which you take a look at the burden of therapy for these MG patients and the fact that it's not always working for them, it really opens up the door for why MivCell is so remarkable and what we're doing here is so transformational.

And you mentioned this earlier, but you'll also be sharing longer-term update from that study as well. And I guess maybe a similar question, Is it possible for those responses to deepen over time with longer treatment, or how should we think about that?

Well, between the initial top-line readout and additional follow-up from the MG patients, we did see some of the deepening of effects. So we'll be looking for that in the readout of this data. But, again, we're talking about seven patients. At this longer-term follow-up, we'll have all seven patients at the 24-week primary endpoint time frame, as well as five patients that will be at one year or beyond. So, again, we're going to be seeing if there's a continued effect in the majority of these patients, and can we also continue to see a positive safety profile in these patients? And, again, this will be part of the overall readout.

Yep, got it. Also, maybe, you know, MG is a pretty competitive space right now. Maybe talk about where you think MivCell could fit in, you know, and what the market opportunity might be there.

Well, there's a significant space for MivCell in this disease. If you take a look at MG patients, and again, there's a lot of treatment options for these patients, but none of these treatments are doing what MivCell is doing. Again, not just in terms of the clinical responses, but this ability to provide this deep B-cell depletion and give an autoimmune reset in these patients, which gives them a chance at a drug-free, disease-free remission. We haven't had to redose any of our patients with MivCell. in myasthenia gravis. This includes the patients in the compassionate use program as well as in the clinical trial, which gives us a lot of hope that we are actually seeing a durable remission in patients that is highly differentiating versus existing therapies. So if you take a look at the overall market for MG, here in the U.S., there's roughly 80,000 patients with generalized myasthenia gravis. We know there's at least 12,000 that are already refractory to existing therapies. This will be an initial target for us with MivCell, where we know we can provide immediately improved value because these patients aren't getting full clinical relief from the existing therapies that they're taking. But we also know from market research that patients are looking for therapies that also simplify their treatment. And only MivCell allows these patients to come off their other background therapies and do so with a one-time dose. So we believe the opportunity for MIV-Cell is even greater than this initial 12,000 patients.

Yeah, do you think initial use may be sort of later line patients, you know, that have been on all these other treatments first, and then over time you think you move upstream just given the profile?

I think there's going to be a broad adoption for MIV-Cell, not only in patients that are refractory to existing therapies, but we even know from our clinical trial we are getting patients approaching our physicians wanting to be in the clinical trial that are at earlier stages of their disease and simply because they don't want to be taking chronic FCRNs and complement inhibitors that just don't work for them. And so I think there's going to be a large opportunity for MivCell beyond just refractory patients.

Yeah, makes sense. Maybe since you'll be launching stiff person syndrome first and MG technically second, I would assume, but can you leverage the sales force? Can you leverage the infrastructure? when you kind of get the MG, or how do you think about that, or how much build-out is needed?

This is why we chose the strategy we did and why we're starting with stiff-person syndrome. This allows us to go to market in a commercialization setting in a very focused way and start with a very valuable opportunity like stiff-person syndrome, which is going to provide a valuable revenue opportunity for us as a company. But then we can continue to build on that. So there's a lot of synergy between the physicians and the academic centers that are treating stiff person syndrome, that those are also treating myasthenia gravis. And if you even look ahead to other neuroimmunology conditions that we're generating early data in, like progressive MS, all these things fit together really nicely in terms of a portfolio that we can leverage and synergize together as we continue to advance our commercialization strategies.

Yeah, you mentioned PMS, right? So maybe you could talk a little bit about that. You know, what are the early findings there and what additional data might you share later this year?

We've been very encouraged by the results that we've seen in progressive MS, and we're treating patients in an IIT setting right now. But these initial patients that we've treated, again, it's progressive MS, So there's not a lot of treatment options for these patients. And we're seeing for the first time ever in a disease that naturally just progresses over time, we're seeing for the first time ever stabilization of EDSS in all of the patients that we've treated. And in a majority of the patients, we're seeing a significant improvement in EDSS, which is, again, something that's never been seen before. So this has generated a lot of excitement with us. has generated a lot of excitement with the KOL community. And as a result, we've submitted this data and had really positive dialogue with the FDA. In fact, we were just granted our third RMAT designation, and we now have three RMATs.

And this is going to allow us to have a real positive dialogue with the FDA on the next steps of what that development program will look like for progressive MS. Can you maybe talk about why progressive MS versus maybe some, I know you were looking at other indications too, I believe, but maybe talk about the why.

Well, progressive MS has some high unmet needs. In fact, the RMAT designation is specifically in the non-active secondary progressive MS. This is the largest proportion of that patient population and one where there are no approved therapies and one where anti-CD20 therapies just simply don't work. And again, we're seeing these remarkable clinical results, which then gives us a really important window into how we can accelerate and bring this to patients really, really quickly. And maybe one point I'd add here is in addition to the clinical results that we're seeing, this dovetails very nicely with the mechanism of action and how MivCell actually works because MivCell actually has this ability because of its mechanism of action to actually cross the CSF, get past the blood-brain barrier. So we know we're having this deep and broader B-cell depletion in targeted tissues. And these pathogenic B-cells, which a number of the opinion leaders are saying are responsible for the fundamental clinical involvement that these patients are experiencing, MIRCELL has a way of attacking those and attacking those at the source, which is probably why we're seeing these clinical results that we're seeing in such a transformative way.

Can you talk a little bit about just manufacturing scalability? your strategy makes a lot of sense you start with stiff person syndrome kind of smaller and then keep going much larger over time so maybe just talk about the ability to scale later down the road when you get there it seems like there's lots of opportunity and places to go and treat a lot of patients so how do you make sure that you can scale this and kind of get it to the patients that need it well we're taking advantage of high-quality CDMOs that are able to support not only our clinical program right now, but our path to commercialization.

We're working with two, Elevate Bio out of Boston and Minaris Advanced Therapeutics out of Philadelphia, and this allows us to, as you indicated, scale and support our commercial program as well as our clinical development program. In fact, with Elevate, we just signed our commercial contract with them. We now have a pathway to support not only the SPS launch, but the initial launches of Myasthenia Gravis as well. And we won't stand pat with this. We're continuing to evaluate our manufacturing processes to look for improvements in automation, improvements of how we can bring innovations like whole blood that make it easier for patients to access these cell therapies. And we're going to continue to look at alternative manufacturing platforms that will allow us to scale, because as we continue to move from stiff person syndrome to Myasthenia Gravis, and other larger indications like progressive MS, we're going to continue to tap into the technologies that continues to evolve.

I just wanted to flip back to progressive MS and kind of next steps and how you're thinking about it. I know you're kind of working on a development plan with the FDA, and you're going to maybe share it sometime next year, but just what are the things you need to sort of iron out kind of in the development plan from here?

Well, I mean, we just received the RMAT designation, so this will be part of the dialogue that we have with the FDA. But if I can put it to you a different way, when you look at other therapies that have been studied in MS for many years now, many of them actually had an explicit goal of just trying to slow the progression. And if we're coming to the market with a potential opportunity to not just slow progression, but stabilize EDSS or even improve EDSS in the majority of patients, that changed the mindset of how you think about designing a clinical study, how you think about the size of that what that clinical study would be and we believe we might have an opportunity here at kyverna to really accelerate and bring that to patients faster so more to come um we've got again a real positive dialogue with the fda on a number of fronts and this will be another one and we'll share the details of this coming up in 2027. okay very exciting um maybe in the last few minutes we can flip to some of these survey questions on on key themes in the space um we're

We're asking all the biotech teams, asking all our companies on these themes. So I'll start with the first one here. It's, you know, how has the rise of China origin innovation sort of changing your competitive positioning and your R&D versus sort of BD playbook?

Yeah. Well, overall, I think the innovation that's being developed in China right now is exciting. It's exciting for patients, and it's exciting for the entire field because I think it's accelerating and making us all more competitive and stronger. In fact, I think back to looking here at the U.S. I'm hoping that it continues to accelerate the dialogue here on how we can continue to improve innovation, things on the advances in the discussions around how to accelerate first in human studies, the work that's being done at NIH now to translate that and bring that to patients faster, or the work that's being done with key academic centers to accelerate these early trials. I think all of that is really, really positive, and Kyvern is taking advantage of that, and all of us will be taking advantage of that in this space. But overall, if you look at what's going on in China, I think we've got to keep in mind here is that Kyvern is leading the world. We're leading the world in bringing MIV cell and V-cell therapies to autoimmune diseases, and we're really excited about the progress, and I think we'll be setting a bar for any company, whether they're from China or from the U.S. in terms of what great looks like in terms of bringing these therapies to patients. Makes sense.

Second question, this is a hot topic that seems to be getting hotter by the day. I guess in terms of implementing AI adoption, you know, where has it, I guess, where are you implementing it? Where has it already changed the decision or timelines or cost or probability of success? And, you know, what measurable evidence should we expect over the next, say, two years or something like that?

Well, I think two years is even too long with how quickly everything's moving. Obviously, like every company, we're assessing AI and how we can apply it into our own development programs. We are looking specifically and using it to enhance our manufacturing program and the processes of how we can continue to streamline that, reduce deviations and improve the turnaround time and success rate for patients. So that's one key area. We're also leveraging AI for patient identification in clinical trials, and also from a competitive intelligence perspective, it's becoming extremely valuable to monitor what's going on out there. But I think there's more to come. I think this is just the tip of the iceberg, and I think it's going to impact in a very meaningful way many aspects of how we do business here and develop drugs.

Okay, great. And maybe third and last question here, just which policy variable, whether it's FDA, Medicare negotiations, MFN tariffs, or global pricing matters the most to your economics? And what have you changed, if anything, because of it?

Well, I think just given where we are in our life cycle, on our journey, it's the FDA is probably the thing that's front and center for us. And, you know, as I commented on earlier, the dialogue with the FDA has been very, very positive and constructive. In fact, the review team has been very, very consistent as well, as we talked about earlier. So we're really confident with the progress that we're making and the group that we're working with with the FDA. In addition, I think some of the policies that the FDA has publicly announced that will help improve access for rare diseases and rare disease medicines as well as accelerating those development programs I think are going to become really extremely important. And I'm encouraged by some of the positive dialogue because it will help improve our ability at Caverna to bring these therapies to patients but help the class overall.

Okay, great. Looks like we're just about out of time, so why don't we end it there. Werner, thanks so much for your time. We appreciate it.

Really appreciate it, Mike. Thanks for hosting us.