Kyverna Therapeutics, Inc. (KYTX)
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Morgan Stanley 24th Annual Global Healthcare Conference

Sep 14, 2026

Summary

Cell therapy for autoimmune diseases is advancing rapidly, with miv-cel showing strong efficacy and safety in stiff person syndrome and myasthenia gravis. Regulatory progress, robust clinical data, and a focused commercialization strategy position the therapy for near-term launch and broader pipeline expansion.

Mike Ault
Biotech Analyst, Morgan Stanley

All right. Good afternoon, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Mike Ault, one of the biotech analysts, and it's my pleasure to introduce Warner Biddle, CEO of Kyverna Therapeutics. Just as a quick reminder, the format for today is a fireside chat. If anyone in the audience has a question, please raise your hand and we'll get it looped into our discussion here. 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/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that, I'll turn it over to Warner, if you want to make some introductory comments, then we can hop into the Q&A.

Warner Biddle
CEO, Kyverna Therapeutics

Sure. Mike, thanks very much for hosting us. It's been a great day so far. 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. 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. 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.

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. More importantly, help these patients that desperately need something new in terms of a new therapy that can transform their lives.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah. Great, and thanks for that introduction. I thought maybe we could start with a couple big picture questions here. Just maybe why autologous CAR T-cell therapy, and specifically miv-cel, has been so promising for autoimmune indications.

Warner Biddle
CEO, Kyverna Therapeutics

I think what's really important here is that miv-cel, 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.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah.

Warner Biddle
CEO, Kyverna Therapeutics

We're the only CD19 with a CD28 costimulatory 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. 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 ICANS. 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.

Mike Ault
Biotech Analyst, Morgan Stanley

Yep. 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. Maybe talk about the impact of the recent news from Novartis and BMS and what that means for your program or doesn't mean.

Warner Biddle
CEO, Kyverna Therapeutics

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 Kyverna 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 miv-cel's been uniquely designed for use in autoimmune patients, and it's been designed for significantly improved safety. Like I said, this has been bearing itself out in the clinical profile that we've now seen in over 100 patients treated. Again, no high-grade CRS, no high-grade ICANS, no cases of the ICANS, which some of these other constructs have been associated with.

I think that's critically important to keep in mind that we're dealing with a construct like miv-cel that has this prominent safety profile and proven safety profile.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah.

Warner Biddle
CEO, Kyverna Therapeutics

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 rates.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah.

Warner Biddle
CEO, Kyverna Therapeutics

We believe this combination of the construct and the manufacturing is what's contributing to the overall promising safety profile that we're announcing.

Mike Ault
Biotech Analyst, Morgan Stanley

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

Warner Biddle
CEO, Kyverna Therapeutics

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. Coming back to Kyverna, what is really critically important here is we know what we've got, and we've got a really well-established manufacturing process that's been well-validated, and this is bearing itself out in the safety profile that we're seeing across all these patients.

Mike Ault
Biotech Analyst, Morgan Stanley

Yep. Makes sense. 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 the potential market opportunity, patient numbers, et cetera.

Warner Biddle
CEO, Kyverna Therapeutics

Sure. Well, stiff person syndrome is 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. 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 miv-cel 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. 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 a one-time therapy that also allows these patients to come off background therapies that they've been chronically burdened with. 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.

Mike Ault
Biotech Analyst, Morgan Stanley

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

Warner Biddle
CEO, Kyverna Therapeutics

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. 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 GAD65 being the predominant one. When patients have both of those, that becomes a confirmed diagnosis for an SPS patient. As I said, there's 6,000 patients in the U.S. These are well-identified patients. 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.

This makes this a very important disease, but also one that's easily identifiable and we can tackle here at Kyverna in terms of addressing.

Mike Ault
Biotech Analyst, Morgan Stanley

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, how should we think about durability of the effect? Is it something that can it continue to improve? Is it something that you have a nice impact early and you stabilize it at the same place? Just maybe talk about what to expect there or how to think about that.

Warner Biddle
CEO, Kyverna Therapeutics

Well, if you look at the pivotal data readout that we announced earlier this year, the primary endpoint being the timed 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. We are 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 are 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 have 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 will 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, again, with a one-time therapy that allows them to come off all these other background chronic therapies that they have been burdened with, we are truly introducing a paradigm shift here that will have never been seen before.

Mike Ault
Biotech Analyst, Morgan Stanley

Yep. Can you talk about durability and what you have seen with the longest patient out there? I think it might be the MG patient, but just generally what you have seen over the longer term after treatment.

Warner Biddle
CEO, Kyverna Therapeutics

Well, prior to the initiation of our clinical studies here at Kyverna, we had done some work through a compassionate use in IIT programs, and some of our first patients treated with both stiff person syndrome and myasthenia gravis are now well past the 2-year mark and free of disease, but also off their background immunosuppressants and chronic therapy. So the early patients are really giving us an indication of what the longer-term durability of cell can be, and that is why we are so excited by the longer-term follow-up of the stiff person syndrome, KYSA-8 trial, which we will provide an update here in the coming weeks, as well as a longer-term follow-up on our KYSA-6, which is our MG phase II study. Again, if we can continue to demonstrate a durability of effect in a majority of these patients, we are truly doing something transformative here.

Mike Ault
Biotech Analyst, Morgan Stanley

Yep, great. You began your rolling submission for stiff person earlier this year. You expect to complete that, I think, by the end of this year. Maybe just talk about what's been submitted so far and what remains to be submitted to complete that process.

Warner Biddle
CEO, Kyverna Therapeutics

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. 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. 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.

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 KYSA-8 study, and these things are coming together and we're well on track. As I said, we're going to be on track to finish filing in Q4.

Mike Ault
Biotech Analyst, Morgan Stanley

Yep, great. Can you talk about interactions that you've had with the FDA? Is this sort of the same team you've been working with for a while for this stiff person syndrome? There's been some obviously changes of leadership. Has that had any impact at all on your interactions?

Warner Biddle
CEO, Kyverna Therapeutics

At this point, no. We've had no major deviations at all from the conversations we've been having with the FDA. In fact, throughout the whole development process, 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 Kyverna 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.

Mike Ault
Biotech Analyst, Morgan Stanley

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

Warner Biddle
CEO, Kyverna Therapeutics

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.

Mike Ault
Biotech Analyst, Morgan Stanley

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

Warner Biddle
CEO, Kyverna Therapeutics

Yeah. Stiff person syndrome is an excellent first launch for us at Kyverna. It allows us to be really focused in terms of our strategy and generate some really valuable opportunity commercially. We have been working behind the scenes on a number of fronts to prepare for launch. First, in terms of manufacturing, we are working with our manufacturing suppliers, continue to prepare for scaling for commercialization, and we are well on track and feel confident that we are doing the right things there. In addition, site activation becomes critically important, and we are 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.

We are working with these centers now to prepare them for commercialization, including getting the necessary contracts and processes in place to deliver miv-cel on time and consistently for them in a commercial setting.

In addition, we are doing a lot of work with payers.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah.

Warner Biddle
CEO, Kyverna Therapeutics

Spending time with them, working through the value proposition. We have now got the dataset from our pivotal retail. We will have some longer-term follow-up here in a few weeks. We are sharing that with payers, and we have a very, very strong value proposition in support of miv-cel and a strong payer position, which has been positively moving forward well. In addition, we are 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, so there is a lot of anxiousness and hope in the community right now with what we are doing here at Kyverna and a lot of support for helping us bring this to patients more broadly.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah. 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?

Warner Biddle
CEO, Kyverna Therapeutics

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-cel can bring for patients. We know that 85% of physicians would use miv-cel consistently in their moderate to severe patient population. 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 a miv-cel treatment. We believe the adoption rate and the willingness to try and use miv-cel will only go up over time.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah. 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 how we should think about pricing? Are there good sort of analogs out there, or just any thoughts you can share?

Warner Biddle
CEO, Kyverna Therapeutics

Well, we come back to the value proposition that miv-cel 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 USD 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. Overall, it costs the system and the patients hundreds of thousands of USD a year to manage.

We believe there's a strong value proposition for miv-cel 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 healthcare system that these patients have been enduring. We're actually targeting, if you take a look at the cost of CAR T therapies now, which is roughly $500,000-$600,000 for a CAR T treatment, we're targeting a significant premium to that for miv-cel, and we believe it's justified given the high-value proposition that we're bringing for these patients in both of these initial indications.

Mike Ault
Biotech Analyst, Morgan Stanley

Yep, makes sense. A lot to look forward in stiff person syndrome, but you also have myasthenia gravis studies ongoing, the KYSA-6, the phase II study. Maybe highlight some of the key takeaways from that data that you've shared so far.

Warner Biddle
CEO, Kyverna Therapeutics

Well, again, miv-cel is setting a new standard

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah.

Warner Biddle
CEO, Kyverna Therapeutics

for myasthenia 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. We're doing something dramatically different from a clinical perspective. But in addition, we're also allowing more patients to get to MSE, 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 the MSE is an attribution to that, and we getting a majority of our patients in the early data to an MSE level, which is remarkable.

We are 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. You take a look at the burden of therapy for these MG patients and the fact that it is not always working for them, it really opens up the door for why miv-cel is so remarkable and what we are doing here is so transformational.

Mike Ault
Biotech Analyst, Morgan Stanley

Yep. You mentioned this earlier, but you will also be sharing longer term update from that study as well. 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?

Warner Biddle
CEO, Kyverna Therapeutics

Well, between the initial top-line readout, and the additional follow-up from the MG patients, we did see some of the deepening of effects. We will be looking for that in the readout of this data. Again, we are talking about seven patients. At this longer-term follow-up, we will have all seven patients at the 24-week primary endpoint timeframe, as well as five patients that will be at one year or beyond.

Mike Ault
Biotech Analyst, Morgan Stanley

Okay.

Warner Biddle
CEO, Kyverna Therapeutics

Again, we are going to be seeing if there is a continued effect in the majority of these patients and can we also continue to see a positive safety profile in these patients. Again, this will be part of the overall readout.

Mike Ault
Biotech Analyst, Morgan Stanley

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

Warner Biddle
CEO, Kyverna Therapeutics

Well, there's a significant space for miv-cel in this disease. If you take a look at MG patients, there's a lot of treatment options for these patients, but none of these treatments are doing what miv-cel 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

Mike Ault
Biotech Analyst, Morgan Stanley

Right.

Warner Biddle
CEO, Kyverna Therapeutics

with miv-cel 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. 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 miv-cel, 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 burden.

Only miv-cel 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-cel is even greater than this initial 12,000 patients.

Mike Ault
Biotech Analyst, Morgan Stanley

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

Warner Biddle
CEO, Kyverna Therapeutics

I think there's going to be a broad adoption for miv-cel, not only in patients that are refractory to the 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

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah, right.

Warner Biddle
CEO, Kyverna Therapeutics

chronic FcRNs and complement inhibitors that just don't work for them. I think there's going to be a large opportunity for miv-cel beyond just refractory patients.

Mike Ault
Biotech Analyst, Morgan Stanley

Yep. Makes sense. Maybe since you will be launching stiff person syndrome first, and MG technically second, I would assume, can you leverage the sales force? Can you leverage the infrastructure when you get to MG or how do you think about that, or how much build-out is needed?

Warner Biddle
CEO, Kyverna Therapeutics

This is why we chose the strategy we did and why we are 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. There is a lot of synergy between the physicians and the academic centers that are treating stiff person syndrome, that those are also treating myasthenia gravis. If you even look ahead to other neuroimmunology conditions that we are 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.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah. You mentioned PMS.

Warner Biddle
CEO, Kyverna Therapeutics

Right.

Mike Ault
Biotech Analyst, Morgan Stanley

Maybe you could talk a little bit about that. What are the early findings there, and what additional data might you share later this year?

Warner Biddle
CEO, Kyverna Therapeutics

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. These initial patients that we've treated, again, it's progressive MS, so there's not a lot of treatment options for these patients. 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. In a majority of the patients, we're seeing a significant improvement in EDSS, which is, again, something that's never been seen before. This has generated a lot of excitement with us.

It's 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. 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.

Mike Ault
Biotech Analyst, Morgan Stanley

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.

Warner Biddle
CEO, Kyverna Therapeutics

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. 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.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah.

Warner Biddle
CEO, Kyverna Therapeutics

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 miv-cel actually works. Because miv-cel actually has this ability because of its mechanism of action to actually cross the CSF, to get it 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. Miv-cel 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.

Mike Ault
Biotech Analyst, Morgan Stanley

Yep. 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?

Warner Biddle
CEO, Kyverna Therapeutics

Yeah. 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, ElevateBio out of Boston and Minaris Advanced Therapies out of Philadelphia. 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. We won't stand pat with this. We're continuing to evaluate our manufacturing processes to look for improvements in automation, improvements in how we can bring innovations like whole blood that make it easier for patients to access these cell therapies.

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.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah. 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?

Warner Biddle
CEO, Kyverna Therapeutics

Well, we've 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.

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 what that clinical study would be. We believe we might have an opportunity here at Kyverna to really accelerate and bring that to patients faster.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah.

Warner Biddle
CEO, Kyverna Therapeutics

More to come. We've got, again, a real positive dialogue with the FDA on a number of fronts, and this will be another one. We'll share the details of this coming up in 2027.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah. Okay. Very exciting. Maybe in the last few minutes, we can flip to some of these survey questions on key themes in the space. We're asking all the biotech teams, asking all our companies on these themes. I'll start with the first one here. How has the rise of China origin innovation sort of changing your competitive positioning and your R&D versus sort of DD playbook?

Warner Biddle
CEO, Kyverna Therapeutics

Yeah. 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 and 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, 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 Kyverna is taking advantage of that, and all of us will be taking advantage of that in the space.

Overall, if you look at what's going on in China, I think we've got to keep in mind here is that Kyverna is leading the world. We're leading the world in bringing miv-cel and B 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.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah. 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, where are you implementing it? Where has it already changed the decision or timelines or cost or probability of success, and what measurable evidence should we expect over the next, say, two years or something like that?

Warner Biddle
CEO, Kyverna Therapeutics

Well, I think two years is even too long to predict with how quickly everything's moving.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah.

Warner Biddle
CEO, Kyverna Therapeutics

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. 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.

Mike Ault
Biotech Analyst, Morgan Stanley

Yeah. Okay, great. 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?

Warner Biddle
CEO, Kyverna Therapeutics

Well, I think just given where we are in our life cycle on our journey, the FDA is probably the thing that's front and center for us. As I commented on earlier, the dialogue with the FDA has been very positive and constructive. In fact, the review team has been 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 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.

I'm encouraged by some of the positive dialogue because it'll help improve our ability at Kyverna to bring these therapies to patients, but help the class overall.

Mike Ault
Biotech Analyst, Morgan Stanley

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

Warner Biddle
CEO, Kyverna Therapeutics

Really appreciate it, Mike. Thanks for hosting us.

Mike Ault
Biotech Analyst, Morgan Stanley

Great.

Warner Biddle
CEO, Kyverna Therapeutics

Thank you.

Mike Ault
Biotech Analyst, Morgan Stanley

Thank you.