Good morning. Thanks for joining us for another session at the 44th JPMorgan Healthcare Conference. I'm Brian Cheng, one of the senior biotech analysts here at the firm. On stage, we have Intellia Therapeutics. I'll now pass the mic to their CEO, John Leonard, for a short presentation, followed by a live audience Q&A. John, the stage is yours.
Thank you, Brian. I appreciate the opportunity to give you a sense of where we are at Intellia Therapeutics as we begin the new year here. This is our forward-looking statement. It's available on the website. People want to examine it further. So Intellia has been a leader in the CRISPR medicine space since its outset, 2014. We've been leaders in many respects, but have emphasized work in the in vivo treatment of genetic diseases. From our outset in 2014, here we stand on the verge of completing trials that will lead to some of the first approved agents for in vivo use of CRISPR therapeutics. We have three phase three trials that are ongoing. We'll talk a little bit more about that in a minute. Across the board, from the outset, we've dosed over 600 total patients, and we're accumulating a, I think, very vast safety database.
We have extended follow-up on patients going all the way back to the beginning, where patients have now been followed for an excess of four years, and we've had five landmark publications. First one, with the very first report of humans edited with CRISPR for transthyretin amyloidosis. A second gene, which is KLKB1 for hereditary angioedema, the second report, and then two follow-up, or three follow-on articles showing the clinical consequences of those edits, whether in angioedema or the two different indications for transthyretin amyloidosis and cardiomyopathy and polyneuropathy, and something we're very proud of and hope to build on that legacy. As we look at the pipeline as it exists today, we're well into the clinical phase of the company. Two programs are late-stage clinical work, the wholly owned hereditary angioedema product Lombozi, and then our partnered program with Regeneron, Nexi for the treatment of transthyretin amyloidosis.
We're also partners with Regeneron for their work with hemophilia B. It's a program that they lead. And then we have a robust research effort that we're not going to talk about today, but will bring forward what we think will be, again, paradigm-breaking products in the not-so-distant future. So let's focus on where we are from a clinical point of view. As I said, we're in late-stage phase three work. Both of these programs have breakthrough profiles, and these are in large, important, and growing markets. We think that we compete very well within them. First product is Lombozi for the treatment of HAE, or hereditary angioedema. This is the first, and to our understanding, only product that at this point has the potential to be able to offer patients not only freedom from attacks, but freedom from any additional therapy, probably over the course of their life.
We have completed the enrollment of our phase 3 program called HAELO. We have several very favorable regulatory designations for the review following submission, and I want to point out that although the target enrollment figure was 60 for this trial, we over-enrolled it to 80 because of the vast and very quick interest that appeared, and we were able to accommodate those patients. We'll talk more about that in a moment. We have some important milestones coming up this year, which we'll talk about, and importantly, for the marketplace, which is currently in excess of $3 billion, we see that growing, doubling by the end of the decade. With respect to Nex-Z for the treatment of transthyretin amyloidosis, again, this is an agent that we think resets the paradigm for treatment in this disease.
It is the first agent to not only stabilize, but potentially reverse the clinical course of these patients following a single dose of the drug. We're well into our phase 3 programs, although they are in clinical hold. We'll talk a little bit more about that in a minute. And again, this is a large and growing market that we look forward to participating in. Here is the list of progress over 2025 and a look ahead to important milestones for this year. We were able to present extended follow-up from our phase 1-2 work in HAE, which we did towards the end of the year. As I said, we completed, in fact, over-enrolled the phase 3 Halo trial.
As we look ahead to 2026, we anticipate presenting top-line data by mid this year, submitting a BLA in the second half, and look forward to a commercial launch of the product in the first half of next year. With respect to the TTR program and Nexi, also, we presented long-term follow-up on patients for both indications of cardiomyopathy and polyneuropathy. We had very robust and rapid enrollment in our MAGNITUDE trial for CM with over 650 patients enrolled, and enrolled the preponderance of patients for the polyneuropathy indication and MAGNITUDE-2. The top priority for the year is getting off clinical hold and resuming the enrollment and hopefully regaining the momentum that we had coming into the end of the year. Let's talk a little bit more about Lombozi, as we call it, for the treatment of HAE. Many of you may know something about the disease.
It's a genetic illness typically diagnosed when patients are younger, oftentimes in adolescence or in the 20s. Patients suffer lifelong attacks related to the missing protein that leads to bradycardia and angioedema throughout different parts of their body. That can be life-threatening when it occurs in the larynx, and many patients have experienced that over the course of their disease. There are treatments available, and certainly progress has been made over the last several years, but in fact, most patients achieve only partial control, and they make all kinds of modifications in their lives to adapt to not only their disease, but the therapies necessary to treat it. We think that that, along with some of the high costs of these agents and the difficulty accessing them with insurance, represents a major opportunity for us and Lombozi.
So with respect to the market, again, despite the fact that there are agents approved, we believe it's absolutely ripe for disruptive innovation. We'll show you some of the clinical results that we think mirror that. We expect this marketplace to get to the point of about $6 billion by the end of the decade. In the United States, there are about 7,000 or so patients actively treated, many of them currently on prophylaxis, and the U.S. represents the lion's share of the marketplace. Now, with respect to treatment that exists today and what patients actually experience despite on-demand therapy, despite various forms of long-term prophylaxis, if you actually go and ask patients how you're doing and what level of attacks you've experienced, fully 80% of them have experienced attacks in the last 12 months. In other words, only 20% would say that they're actually attack-free with their disease control.
And the majority of those patients, about 90% of them, are actually taking long-term prophylaxis. That contrasts with the data that we've been accumulating in our phase one and two work, and I'll show you some of the pooled analysis that we presented recently that shows fully 76% of the patients that we've had who have been followed for at least 12 months remain attack-free and also long-term prophylaxis-free. And that's a very significant difference in the lives of these patients that we think represents a major opportunity. That is a set of patients that we will continue to expand and extend the follow-up and increase the number of patients who will pass that 12-month follow-up period, which we think will continue to support and perhaps even improve on these statistics.
What you're looking at here is a pooled analysis that was presented at the college meeting in the fourth quarter last year, November, and what this represents is any patient from a phase one or two program who's received a 50-milligram dose of the drug. 50 milligrams is the phase three dose. What you see in the upper portion are patients who have been attack-free for at least a six-month period, and in fact, of the 24 patients there, many of them have been attack-free for at least seven months all the way out to the 12 months that I talked about. What you see is attacks cease, and they don't come back in these patients. That middle group with the seven patients there are patients who have less than six months follow-up since their last attack.
The blue shows an attack-free, prophylaxis-free interval for those patients, and we expect that several of those patients may move up to that upper category. Of the 32 patients on this chart, there's only one patient who has not achieved attack-free status following a single dose of the drug. That's that patient on the bottom who, despite that, still had a 60% reduction in attacks from his baseline on prior therapy, which is a significant improvement. And as we're learning, as we follow that patient, he certainly has HAE, but there's good reason to believe there's another condition contributing to what's actually leading to his swelling attacks, and we'll present more on that later this year. With the safety profile of the product and the combined efficacy that we talked about, it remains a very attractive profile.
What you're seeing here is that the primary adverse experience that patients have will be an infusion reaction typically at the time of infusion. And other than that, there are nuisance sorts of things that patients experience around the time of infusion. From the point of view of chemical abnormalities, it's a very clean profile with literally a single case of grade two transaminases elevation in this patient population. I would point out that there's interest in the TTR program. As we look across phase one, phase two, and our phase three program, the entire Halo study, there's no incidences of grade three or grade four transaminitis.
If you ask patients, "What do you want?" Given that low incidence of attack-free status, fully 99% of patients, when confronted with a Lombozi phase 2 profile, emphasizing the fact that it's a gene-editing product, will be likely, extremely likely, or very likely to want to take the drug if it's offered to them, and of that group, fully two-thirds are extremely or very likely to take the product. We think that is indicative of what the demand is at the patient level, again, despite the fact that existing therapy is available to them, and if you look across the board and look at what those patients were taking, it really doesn't matter which agent that they're on. That interest in taking therapy in the form of Lombozi is across the board.
You can ask the same sort of a question to a group of physicians here in work that was completed just the last two months, again, with the Lombozi phase 2 profile and a gene-editing product. Of the 151 surveyed physicians, when asked, "Can they identify a patient in their practice that they would prescribe the drug to?" Fully 92% of them say, "Yes, I can identify a patient." And when you ask them, "How many patients do you manage in total? And how many patients do you think would benefit the drug that you would be willing to prescribe to?" About 2,200 of the over 4,000 patients that they care for, they think would be appropriate to treat. And you see some of their commentary there, whether it's a game changer, how highly they would prioritize its use.
Of course, they respond to what is the compelling set of clinical results that we presented. What you see here is the schematic for the phase three program that we call Halo. This is a program where patients wash out of whatever therapy they may be taking. So they are essentially, we say, naked with respect to prophylaxis. On-demand therapies are made available to them, randomized two to one that's drug to placebo. And then over a 28-week interval, we count the number of attacks. Primary endpoint is HAE attack rate reduction. And then among the various other endpoints that we look at will be the attack-free rate along the lines of what I presented in that pooled analysis. This is data that we expect to share by mid this year. And again, I would emphasize that we enrolled 80 patients. The target number for this trial was 60.
There was great interest, and given the long washout period, we had to think very carefully about what the screen failure rate, which turned out to be very low, and so we got this very high number of patients, but I think it's indicative of the interest in the product, and I would point out that in a single month, 42 patients presented themselves to be screened, most of those patients in the United States, so where are we with commercializing the product? We've made a lot of headway with our team and our thinking. We've got the core team in place. We are out in the field with our RSDs actively engaging with KOLs. We've been talking to payers and understanding that marketplace.
And we think we have a good idea of where we want to go and how we want to do it and have been building the necessary relationships, as you would expect in a rare disease group that's highly connected. The to-do list for this year is on the right: scaling our field team, finalizing contracting models, distribution, and pricing. So all of that is well in hand, and we're very excited about where we are and where we're going. So let's turn to Nexi for the treatment of TTR cardiomyopathy and polyneuropathy, the two standard indications for TTR amyloidosis. This is also a disease that has very significant morbidity and mortality associated with it. Patients with the cardiomyopathic form experience symptoms of heart failure, which can be quite severe. And of course, there's a mortality associated with it that is quite significant. There is a large patient population worldwide.
What's very interesting about the cardiomyopathic form of the disease is that most of these patients have the wild type gene in contrast with polyneuropathy, which is primarily the heritable form, which suggests that the cardiomyopathic form is primarily a disease of aging. When you think about patients over time, I would expect that in addition to the higher recognition of the condition, the actual number of patients that have the underlying condition is only going to expand. With respect to therapy that's currently available for these patients, it certainly improved the prognosis of patients with the underlying disease, but what we see is that it only slows progression. The end point for these patients, the end stage, is unchanged, except for the rate at which they get there.
And if you look at the actual rate of failure, even in the first year after beginning therapy, it's quite significant. And given the recurring nature of these therapies, it's subject to issues with adherence, all of which we think we can address with a one-time dose. The marketplace, as I said in my opening comments, is large and growing. You see that doubling to in excess of $16 billion by the end of the decade. I would draw your attention to the orange segment of that, which is the knockdown category in which Nexi would participate. That is where most of the growth is taking place. And again, when you talk to patients in terms of what they're looking for, patients with a mortal illness want a cure if they can find one.
They want something that's convenient to take and something that they will deal with permanently when they realize that this is a condition that comes from within, so to speak. We believe that the drug, if it is approved, is not only an important opportunity for the care of patients. I think it would be very helpful in the care that physicians are offering, but importantly, it'll be resource-sparing for the healthcare system when we consider the high expense of other agents in this category. What is the basis of the excitement, and what is the basis of the clinical data that we'll see here in a moment? It is the profound, rapid, deep, and durable reduction in TTR. TTR is the pathogenic protein. It's been demonstrated in a variety of different analyses that the level of TTR reduction correlates with clinical progression or the absence thereof.
What you're looking at are patients here in both the CM on the left or the PN indication on the right. And what you see is that very rapid and deep and sustained, essentially unchanging level of TTR. These are not percentage reductions. These are absolute values. And what patients reach is typically on the order of 17-19 micrograms per milliliter of blood, which are the lowest levels that have been reported in patients and significantly superior to what we've seen with other agents that are approved. This is 36 months of data. We do not have a single instance of a patient losing that effect over time. And as far as we can tell, it should be permanent, at least for many, many years and potentially lifelong. This is the important data that was presented at the American Heart Association last November.
What you see are the matching of this phase one cohort that was in the cardiomyopathic slide that you just looked at, matched with a group of patients from the same site who are contemporaneous, who are not receiving silencers or stabilizers, with a high degree of match and then look for mortality over the three-month, I'm sorry, three-year observation period. That's represented here. In blue, you're seeing incidents of mortality in patients who have received Nexi, and that contrasts with the 1,800 patients that were followed, again, on a match basis at the National Amyloidosis Center in the U.K., which you're looking at essentially a 70% reduction in mortality in this analysis. Again, it's not a prospective randomized study, but nonetheless, I think it's indicative of what the level of TTR reduction may promise as we carry out our phase three work.
I would point out that that incidence of mortality, when thought about in terms of numbers needed to treat, would be about a number as low as four in this particular analysis to save a life over three years of observation, which is, I think, an outstanding number. With respect to the safety profile in that set of patients, you see that here, most of the adverse events are related to the disease that they have, the underlying cardiac failure. There is an incidence of infusion-related reactions and a low level of transaminase elevations. I would point out in the Magnitude study, this is again phase 1 carried out. In the Magnitude study where we have the over 650 patients enrolled, we've had transaminase elevations. That study is currently on clinical hold. On Friday of last week, we presented additional information on the one patient that triggered that clinical hold.
That patient who had elevated transaminases and bilirubin that triggered the hold ultimately succumbed to septicemia due to a perforated duodenal ulcer that the patient developed over approximately 10 days that the patient was in the hospital. If you look across the phase 3 study, the incidence of grade 4 transaminases is less than 1% across that entire study. And at this point, we're working through the clinical hold with the FDA, and we're actively engaged in that process with them. So as we look at where we are on hold, I said that we've enrolled over 650 patients. The target number is 1,200. Last year, before we went on hold, we had a very rapid and robust and actually increasing enrollment. And this 650 patients was our target for the end of the year. We achieved that by the end of October.
Again, indicative of the high level of interest of the physicians and the patients that are participating in the trial. And if you look at Magnitude-2, the phase 3 trial for polyneuropathy, fully 47 of the intended 50 patients were enrolled at the time that we went on clinical hold. The study continues as we speak. We're not accruing new patients, but we're collecting data on all the patients, those 650 patients. They contribute endpoints, safety information, etc. All of that's being collected as time passes here. So wrapping up, we like where we are. We're very excited about the prospects for Lombozi. We think that this has the potential for just revolutionizing the HAE marketplace. And as I said, it not only deals with the underlying disease, but should be able to obviate ongoing therapy for the vast majority of patients over time.
And with Nexi, we're excited about the benefit that we think there's very strong signals of in the work that I just went through with you. And it's a matter of getting back on clinical hold. As I said, we're very back off of clinical hold. And as I said, we're actively engaged with the FDA as we speak. From a capital point of view, we're in a strong position, and we're able to fund operations into mid-2027 at this point. So Brian, I'm happy to take some questions. And I think Ed, our CFO, is going to join us as well.
Great. Well, thank you so much for joining us. So let's kick off the Q&A. For those who are in the audience, if you have any questions, please feel free to raise your hand. We have a runner on the floor. And for those of you who are joining us virtually, you can also submit questions on the portal. John, maybe just kick off with some questions on Lombozi. As we think about the Halo trial reading out sometime later this year, how should we think of a win scenario? What do you want to see from the trial? In your slide, you pointed out there are endpoints of interest. One is attack rate and the other one is attack-free rates. So can you kind of frame what a win scenario looks like relative to those endpoints that you pointed out?
Yeah, no, it's an important question. The way that these products are evaluated at the level of the FDA is an attack rate reduction, and that's how these studies are set up to run. We would anticipate an attack rate reduction that's highly competitive with any of the agents that have been reported, probably well into the 80% or so from baseline. I think that that, in the real-world scenario, may even underestimate what actually happens as we went through in that pooled analysis. All those patients are not blinded, but ultimately know that they've been treated. I think the real driver in the marketplace and what patients are ultimately looking for is not just an attack rate reduction, but an attack-free life in which they're able to abandon long-term prophylaxis, and we would expect that we will have a very high percentage of that.
When we compare ourselves, what we've seen already to what's currently out there, the best in class is on the order of 60%. Takhzyro, the leader in the marketplace, is down in the 40s% somewhere. We would expect that we should be able to handily beat that. I don't know if Ed, you want to add some color to that? Any other thoughts?
No, you said it well. I think the attack-free status, the fact that it comes with no additional therapy, is also of significant importance, and so John did a good job outlining the data that we've seen from our patient surveys and market research, and what you see is the vast majority of patients still have a high unmet need. The vast majority are still having attacks, and so to the extent that we can have a one-time therapy, very easy to administer with an attack-free status, also accompanied by the absence of additional therapeutic intervention like long-term prophylaxis, that's a profile that we think not only speaks to patients, but we're finding physicians resonate with that as well, and we haven't talked about it much today, but payers are responding favorably to that profile.
Just in terms of the top line, have you decided on what we could see at the time of the top line and what could investors expect?
Yeah, I would anticipate at this point that we would share the primary endpoint, attack rate reduction, probably some insights into that attack-free, drug-free interval that we've been talking about here, as well as some top-line safety data, whatever we think is particularly relevant. And that would be the base case.
Okay. Just kind of stepping back into the competitive landscape, right? There are acute treatments. There are prophylactic options. How do you think about Lombozi? How do you think about the opportunity itself?
We think the market, as I said in my comments, is ripe for disruption. I mean, it's clear that we've made advances, but I'm talking about the field in general, in terms of treating the disease. And that's a wonderful thing. But I think we hold in our hands something that is tantamount to a functional cure for these patients, for many of them. And when I think about what patients are looking for, when you just ask them, they want to be free of their disease. And it's not just being free of attacks. They want to be free of the medicines that they take to do that. And I think it's important to understand that the disease is more than an attack.
It's how you order and organize your life to avoid things that stimulate that, to put yourself in positions where you may not be able to take your medicine. And importantly, these medications are extremely expensive that require insurance authorization on an ongoing annual and sometimes even semiannual basis. And that leads to a behavior with respect to how they treat their workplace, their jobs. And if you think about their lives as how fully it might be lived, in fact, these are lives that shrink in terms of what patients would like to do. So when given the opportunity to potentially abandon all of that, that's what the market is looking for. And we think that represents a very significant opportunity for Intellia.
Ed, I think you noted some feedback from payer. You must have done some research on that front. How should we think about just the payer access side of things as you start to prepare yourself towards the commercial launch?
Yeah, I mean, we're not going to talk too much about that. As we get closer to launch in the first half of 2027, we may say more. I'll just build on what John said and some of what has already been presented. We see a large growing market opportunity. Of the 7,000 or more patients in the U.S. that are already being treated on therapy, you're seeing a trend toward long-term prophylaxis use. So we think that's a tailwind for us as well. In a prevalent pool of patients like HAE, which is a genetic disorder, the ability to switch patients is really important. When you have new therapies being introduced, some of which have been in the last several months, you can see that desire to switch for new therapies that add incremental benefit.
So when we look at that backdrop, we're very encouraged by what we see with a one-time therapy. And so when you layer in now this prospect of becoming drug-free and attack-free, it's a very strong value proposition. As we talk to payers, it's not lost on them that drug therapy is very expensive today, right? Some of these IV therapies are well in excess of $650,000. So that's already part of the treatment paradigm. And for what is otherwise a relatively young and healthy patient population, this ongoing annual process of prior authorizations, continuing to take therapy, they are a patient for life. A payer also looks at that and looks at the amount of resources that are required to manage this patient population.
So they see a lot of benefit in reduction of healthcare resource utilization from a one-time therapy that admittedly will be a premium price, but one that we think delivers value to patients, to physicians, and actually to payers substantially so.
As we think about your plan towards filing later this year, are there any gating factors toward the filing, assuming Halo is positive?
We're really in a good position at this point. I mean, the basic thing that we need to do is complete the data collection of these patients that are being observed in the Halo study. And as I said, they've all been dosed, so we're just collecting the event rates here. As you might imagine, all the preclinical work is done. It's been written up. We've templated a lot of the material that will come from the clinical program. But probably most importantly, on the CMC side, which sometimes is a bugaboo for programs, that work is completed. What we're using in the phase three work is essentially the commercial form of the product. So we should be in a very good position to rapidly turn this around and go to the FDA. As I said, we have several regulatory designations that are very favorable as well.
Great. Any questions from the audience?
Can you talk about the steps or the engagement with the agency with respect to the clinical hold and maybe outline what information or any statutory timelines for that process? And then maybe just in concert, just comment on the overall status of your partnership with Regeneron.
That's a TTR Nexi question. Just to make that clear for the audience, we're actively engaged with the FDA. They submitted a variety of questions to us, many of which we anticipated. I think they're questions that any person or group running a clinical trial would expect to analyze. We've been doing that. That data has been presented with them. It's an ongoing discussion. There is not a mandated time to which people go off clinical hold. It's a decision that's made by the agency. We're providing them with everything that they've asked for and are happy to do that as efficiently as possible.
So in terms of just clinical holds in general, if you look at it from a historical point of view, on the order of three months or so would be a very, very fast turnaround for most companies that have been in clinical hold. And the bulk of them fall within three to nine months historically. With respect to Regeneron, they are our partners, as I said. They're involved in the process. They're partners that see all the data. We rely on each other, and we draw on their expertise and have been actively doing that.
I think there's another question in the front.
John, what are your thoughts on international commercialization?
Maybe Ed, you want to address?
Are you asking it generally or for a particular product?
Sorry, for Lombozi.
Yeah. Yeah, I'd say as a company, we're committed to getting outside the U.S. But as a small biotech building the infrastructure for the first time, not surprisingly, we've been focused on the U.S. So we have foundational leadership in place, a lot of the enabling activities that you would expect ahead of commercial launch. We've had that plan for quite some time, and we're executing very well. That, of course, continues in 2026. We are running our studies outside the U.S. We want to make sure that we gain broad access to the therapy and the profile that we're very excited about. We could do that in a number of ways. We could decide to build it at some point, not currently in the kind of short to mid-range plan, but we're also pro-collaboration. Just had a question on Regeneron.
That would be an obvious place to look, and so we're looking for a partner that's like-minded, has the capabilities to help us extend the reach beyond the U.S. We haven't made that determination yet, but it's definitely in our thinking for the next couple of years.
So in the deck, you presented additional color on the Grade 4 case. So any sense of the cause of the liver tox here based on the work that you have done in the past couple of weeks? Was it related to sepsis? Any additional color that you can give today?
Yeah, I mean, the patient, I mean, I could tell you the clinical course, which I think is helpful to understand. This is a patient who was in the study, 82-year-old man, received drug a little over three weeks later, reported abdominal pain to his treating physician. His physician said, "Go to the emergency room and they'll take a look at you." While he was there, he was observed to have an elevated transaminase. He was admitted to the hospital for observation. Over the course of the time that he was in the hospital, which took excellent care of him, as far as we can tell, his caregivers provided him with some steroids. About a week into his stay, he deteriorated, was evaluated, was found to have air in his abdomen.
He went to surgery and was found to have a two-inch perforation of his duodenum tied to a duodenal ulcer that was also found. The patient never really recovered from that. He had a very rocky course thereafter, had episodes of hypoperfusion, septicemia, and ultimately the family withdrew support. So that's what happened to him. He did not die of liver failure, which I think has been misunderstood by some observers here. It's very unlikely in our judgment that what the patient experienced in terms of liver injury as manifested by the transaminase elevation was attributable to that other underlying process. But the death was attributed ultimately to the sepsis resulting from the perforated ulcer.
Got it. Since the clinical hold, can you just talk to us about the level of engagement you have seen from investigators and clinical sites? How confident that enrollment will pick back up? How do you think about the pace as well after the clinical hold?
Yeah, it's an important question. I mean, as I said in my comments, the study is continuing. I mean, we're collecting data on the patients who are in the study. They contribute endpoints, safety information, and all of that is ongoing. The part that's not proceeding until we get off of clinical hold is the accrual of additional patients. The investigators remain fully engaged. As you might imagine, we have a very active outreach to them and have tried to keep them fully aware of where we are to the extent that we can, and that's also true of patients. I would point out that at the end of last year, the enrollment was only accelerating. I mean, we were really very pleased to see the rate at which patients were coming in.
And we had changed our guidance because it was very clear we were going to exceed what we anticipated at the beginning of the year. It will be a process, assuming we get off clinical hold. Studies done under the IND, it really comes down to starting with the FDA. And then depending on IRBs and any changes that may be necessary to the protocol, it's playing that out. It will not go immediately back to what it was, but we would expect that given the enthusiasm we've seen, that we would be able to continue enrolling the study and finish it.
Great. Well, thank you so much for your time. That's all the time we have. Thank you.