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Vertex Pharmaceuticals Diversification Strategy Update
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2023-09-13
2025-07-24
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# Vertex Pharmaceuticals Incorporated presents at Morgan Stanley 21st Annual Global Healthcare Conference 2023 Wednesday, September 13, 2023 11:30 AM # Event Participants Analysts 1 Terence Flynn Executives 2 Reshma Kewalramani, Charles Wagner # Terence Flynn Analyst Well, thanks, everybody, for joining us. I'm Terence Flynn from the U.S. biopharma analyst here at Morgan Stanley and we're very pleased to be hosting Vertex for this session. Today from the company, we have Reshma Kewalramani, who's President and CEO; and Charlie Wagner, who is CFO. Thank you both so much for being here. I appreciate the time today. Before we get started, please see the Morgan Stanley Research Disclosure website at [www.morganstanley.com/researchdisclosures](http://www.morganstanley.com/researchdisclosures). If you have any questions, please reach out to your Morgan Stanley sales representative. # Terence Flynn Analyst With out of the way, Reshma and I again, we had the opportunity to speak last...
# Vertex Pharmaceuticals Incorporated presents at Morgan Stanley 21st Annual Global Healthcare Conference 2023 Wednesday, September 13, 2023 11:30 AM # Event Participants Analysts 1 Terence Flynn Executives 2 Reshma Kewalramani, Charles Wagner # Terence Flynn Analyst Well, thanks, everybody, for joining us. I'm Terence Flynn from the U.S. biopharma analyst here at Morgan Stanley and we're very pleased to be hosting Vertex for this session. Today from the company, we have Reshma Kewalramani, who's President and CEO; and Charlie Wagner, who is CFO. Thank you both so much for being here. I appreciate the time today. Before we get started, please see the Morgan Stanley Research Disclosure website at [www.morganstanley.com/researchdisclosures](http://www.morganstanley.com/researchdisclosures). If you have any questions, please reach out to your Morgan Stanley sales representative. # Terence Flynn Analyst With out of the way, Reshma and I again, we had the opportunity to speak last night and again got a kind of a great overview of the company. And so I guess the question I wanted to start with was more one on strategy. Obviously, part of your mandate, the team's mandate has been the diversi!cation strategy here that's been well underway for a number of years now to position the company beyond cystic !brosis and we were just talking about the number of medical conferences that the team is attending now versus just going to the cystic !brosis conferences. So maybe just give us an update on kind of where we stand with the diversi!cation progress? And what are some of the next milestones that we should be focused on here over the next 12 months or so? Reshma Kewalramani Executive Certainly. Well, !rst of all, thank you for the invitation. It's nice to be in New York, and it's certainly very nice to be here live. We have been a CF company for 20-plus years in the commercialized sense since 2012 and the availability of KALYDECO, and we aim to be and we intend to always be a CF company. That is going nowhere. But going forward, we're going to be a CF plus company. And that plus starts with, and we've been talking for some time about the fact that we have been preparing for the day when we're going to have a CF franchise. And just as we transform CF, our aim is to transform multiple more diseases. The !rst next disease after cystic !brosis is going to be sickle cell disease and beta thalassemia with exa-cel and then there are a whole host of additional diseases that we are in terms of not only clinical stage, but in terms of post proof of concept like acute pain, like type 1 diabetes, like AMKD with VX-147. And so when you look at the company from 30,000, 40,000 foot view, we started this diversi!cation e"ort in full VL circa 2014, 2015. And the big goal was to be in multiple diseases, check multiple modalities. We're now in 8 modalities, depending on exactly how you count check. And we want to be in a place where we are the leaders in CF and in CF have line of sight to that last $1 0 % ,$ so the last 5,000 to 6,000 patients who can't bene!t from CFTR modulators because they simply don't make any protein. For the !rst time, I can say, check, we have the program with Moderna for those last patients. And so when you look at it, we said this is where we want it to be. This is where we were planning to be and this is where we are today. # Terence Flynn Analyst Okay. Great. And I know we're going to unpack a lot of these programs over the next 30 minutes or so. Maybe !rst, we'll just start on the CF franchise because again, it's been so integral to the company's growth here. As we look forward, obviously, you have the next-gen triple coming as well, which is going to be part of the strategy. But maybe what are the additional growth opportunities kind of -- on the kind of near to medium term before we have that next-gen triple? # Reshma Kewalramani Executive De!nitely, Charlie? # Charles Wagner Executive De!nitely, maybe been just ground that in the current year. So we recently increased our revenue guidance in CF to a range of $$ 9.7$ million to $$ 9.8$ million sets this up for another very strong year. That's growth of $9 %$ to $10 %$ even after a 150 basis point headwind from currency. So we've come into the year with a lot of momentum, continue to execute very well. The growth in '23 is really driven by the annualization of patients. We had a number of new reimbursements and launches last year. That carries into this year with great momentum. Additionally, we've had the approval in the 2 to 5 age group in the U.S. That launch has gone really well and we would expect to have approval in Europe in the 2 to 5 age group later this year. So this strategy of new reimbursement, younger age groups has been driving the growth. Looking ahead, obviously, we said we started the year with about 20,000 patients or so who are not yet on therapy, so we're making a dent in that this year. But importantly, the patient population continues to grow. We've now updated our estimate of a CF patient population a couple of times in the last few years. And the reality is with the availability of a medicine like TRIKAFTA, more people are coming forward, registries are getting better and patients are living longer. So I would expect that we will continue to update our estimate of the patient population in future years. And so with the continuation of that strategy, plus our work on an mRNA therapy for the 5,000 or 6,000 patients who don't produce the protein we see many years of further growth in CF from here. # Terence Flynn Analyst Okay. Great. Maybe just moving on to the vanzacaftor triple. We're going to see data early next year from the Phase III program. Maybe just help frame for us what's the successful outcome here as we think about that -- those 2 Phase III trials? # Reshma Kewalramani Executive Yes, absolutely. So if you're wondering what are we trying to accomplish? What are the big goals in CF? They're really threefold. First, get a medicine that can treat the $9 0 %$ of all CF patients who can respond to a CFTR modulator, and that goal was achieved by way of TRIKAFTA. Before that, we couldn't reach the FMF patients as they are called. The second big goal and that goes directly to Terence's question about vanzacaftor, the second big goal is for those $9 0 %$ of patients who can bene!t from CFTR modulators, get them to carrier levels of sweat chloride. Why? Because at carrier levels of sweat chloride to think about the parents who are carriers that have children with CF, they have virtually no manifestation of disease. So that's a big goal #2. And big goal #3 is get a therapy for those last $10 %$ of patients. So focusing on vanzacaftor. Vanzacaftor, let's call it, the next next-generation CFTR modulators. By way of our in vitro data in our HBE cells, which have been the workhorse assays that have not only qualitatively predicted what happens in the clinic, but quantitatively predicted it. The vanzacaptar triple looks to be even better and I know this is a tall order, but it looks to be even better than TRIKAFTA. In the clinic in Phase II, you have to do some cross-study comparisons, but the vanzacaftor triple looks to be even better than TRIKAFTA. And the additional bene!t is of once a day dosing. I do not think that's the be all end all our patients take many dozens of medicines a day. So I don't think that's the be all end all. But I think it can help with compliance. And so it's a positive and for the company, it has a lower royalty burden than the TRIKAFTA triple. So that's why I see there. And in terms of when are we going to see results. We have completed enrollment. And it's important to note that this is a study that's not only in 12 plus. This program is a 6-plus year old study and program. So the results that we're going to see, the studies have !nished enrollment. They're going to !nish dosing in the tail half of this year with results early next year. We're going to see that for the 12-plus year olds. We're going to see that for the 6-plus year olds and that's sort of what you should expect in the coming few months. # Terence Flynn Analyst Okay. Great. I know we've talked about this before, but just as we think about the lung function versus sweat chloride, those are the 2 metrics that everyone looks to lung function, patients perceive that. But again, to your point, getting to normal sweat chloride levels has been another part that maybe physicians are also focused on. So how do you think about the relative importance of those 2 e#cacy endpoints in these studies? # Reshma Kewalramani Executive Yes. It's an excellent question and it's been debated in the literature amongst physicians and the CF community. This idea of whether there is or is not a ceiling e"ect to the improvement in lung function, right? So patients generally speaking, enter the clinical trials with a ppFEV1 let's say, $6 0 %$ or so. So when you give the addition of $1 3 % .$ $1 4 % .$ , let's round to $1 5 % .$ the acute improvement brings you to a lung function of $7 5 %$ . And what we've shown in the real-world trials of TRIKAFTA, which is now 4 years in the market, is not only is there no decrement in lung function. It's actually the !rst time that's ever been shown even amongst the other CFTR modulators in our portfolio. So you maintain that improvement that you derive from the acute bene!t but we markedly reduce hospitalizations, pulmonary exacerbations. And at the European CF meeting earlier this year, a Swiss physician was telling us that in the country of Switzerland, there were no lung transplants in CF patients. So there are these tremendous bene!ts that we're looking at. So if you ask me what is the direct readout of an improved CFTR modulator in our hands and that I think will help patients. I think the most direct readout, the most direct PD readout is indeed on sweat chloride. And so we have measured that. It's part and parcel of the Phase III program. The main comparison, the primary endpoint is non-inferiority on ppFEV1. Why? Because that's the regulatory enabling end point. You must do that. And we're certainly going to look at sweat chloride. And that's where I think there is opportunity just like there was in Phase II. # Terence Flynn Analyst Yes. And I guess the related question is just obviously, it depends on the e#cacy data. But as you think about like analogs for potential conversion of the market, I think that's something else that investors are trying to understand is, obviously, it ties back to the data, but maybe just anything to think through as we think about what that could look like over the back half of the decade? # Reshma Kewalramani Executive Absolutely. I'll ask Charlie to comment on if the pro!le is what we think it is, how is that going to work in the marketplace. And Charlie, probably also comment on some patients who are not on TRIKAFTA, who we think will come on to vanza? # Charles Wagner Executive Sure. Yes. Obviously, again, it will depend on the pro!le, but there are about 6,000 patients who were previously on CFTR modulators who discontinued for one reason or another. That's a relatively small number of the total number of patients. But with any medicine, there's some discontinuation. We think that there's an opportunity for those folks who come back on and what we have seen when new medicines are introduced, the number of patients are inclined to come back and try again. So really excited about this as an opportunity for those who have discontinued. # Terence Flynn Analyst Okay. # Reshma Kewalramani Executive I'll add just Terence, this is a disease that is obviously a genetic disease. It runs in families, children have this. The patient community is acutely aware of drug development and want to avail themselves of the best medicine out there. We saw that when TRIKAFTA. came and I think we're going to see the same. If the vanza program has a better bene!t risk if it has more e#cacy, I think, the same thing is going to happen here. # Terence Flynn Analyst Okay. Great. The other program you mentioned in your opening remarks is VX-522, the RNA program, which would target those CF therapy for those patients that don't make any protein. So again, I know the company has been working at this for a long time. So maybe just remind us of the current trial, when we might see some data and then where your con!dence is coming because I know it's been a very hard problem to solve for a number of reasons, including delivery? # Reshma Kewalramani Executive Yes, yes. So this program, VX-522, is also in CF. This is that last $1 0 %$ , so 5,000 or 6,000 people. We have a partnership with Moderna and our approach involves an LNP with an mRNA. For these last 5,000, 6,000 patients, some nucleic acid therapy is going to be required because they simply don't make any protein that we can correct. We've been working on this with Moderna for many years. And actually, the RNA construct, we've solved that for 2-plus years. The real challenge in the last mile on this 1 has been delivery. And that's what we've cracked in the last 18 months or so, which has led to the program, which is the VX-522 program in patients already in the clinic. There is a single ascending dose component. That's where we are today. After we complete that, we'll be in the multiple ascending dose component. And I do think that it's going to take multiple dosing to evaluate e#cacy. Everyone asked me when are we going to be able to do some results. Never say never, and our CF programs have surprised us in the past. But I do think to see e#cacy, it's going to take more than 1 dose. I think it's a 24 event. Where do we get the con!dence from? Will we go back to our HBE workhorse cells. We've been able to look at the mRNA construct in exactly those cells, which we have done, I think, 6 programs now, including 2 that we didn't advance the Phase III because we had 2 better ones. But we have trained this model and seen this model over years, over 6 molecule. The mRNA construct performed extremely well in our HBE assay. We've also looked at this with the LNP and delivered to small animals and large, we get to the appropriate cells with the appropriate expression. And so when we think forward about the possibility of this program, I have great enthusiasm for it and my con!dence comes from those preclinical experiments, particularly the HBE assay. # Terence Flynn Analyst Okay. Perfect. Maybe now we'll pivot to the -- some of the other non-CF programs that's part of the longer-term strategy here. Pain has been front and center, I think, for a number of investors given you've been working on this for a long time, but we're approaching the Phase III data now late this year, early next year. And so maybe just, again, give us a recap of the Phase II data. Those are recently published in New England Journal of Medicine. And why you are con!dent moving into a broad Phase III program where you're conducting 3 Phase III trials in the acute setting? # Reshma Kewalramani Executive Yes, yes, yes. So we just spent the last 10 minutes or so talking about cystic !brosis. We've been working on that for 20 years in the San Diego site. It turns out that the San Diego site is the exact same site and it's actually the same group of researchers who've been working on our pain program, and they've been working on paying longer than we've been working on cystic !brosis. So it is a tough nut to crack. But it's also that target NaV1.8, which is what we're talking about for the VX-548 program and its counterpart NaV1.7, they are considered the holy grail of pain. And they are considered the holy grail of pain because they are found in C-!bers. They're responsible for the activation and the propagation of the action potential, which carries pain signals from the periphery to the center. And the reason it's really seen as this holy grail is you can, hopefully and what we've already shown in Phase II trial, you can decrease pain in the periphery. This is not a centrally acting drug. There are no known NaV1.8 receptors in the brain. And therefore, you could have pain relief without the addictive potential or the other side e"ects of opioids, for example. We've been very excited about this program. It is an exceptionally large population, whether you look at acute pain or neuropathic pain, the 2 indications that we're very focused on. And for that reason, it's not only important to have excellent pain relief, it's important to have a drug that has great manufacturability, great drug-drug interaction pro!le, ability to take with food or without food because obviously, acute pain patients may be coming out of surgery. And so while our predecessor molecule, 150, showed very good e#cacy and safety, we did not advance that preferring to wait for what I used to call the perfect molecule, and that's what we see VX-548 out. Phase 2 is complete, the data where the results were presented in the New England recently. Phase III will complete all 3 studies, a study in bunionectomy, a study in abdominoplasty and a study in single arm, let's call it, an all-comer study tail end of this year with results either end of this year or early next. And where does my con!dence enthusiasm come from? 3 lines of evidence. First, the target is a genetically validated target and it's pharmacologically validated by VX-150. Second, we did the exact same studies that we're doing in Phase III , just Phase III is bigger, but it's the exact same study, one in bunionectomy, one in abdominoplasty, and we've already demonstrated that it works in both of those conditions. And the third is the predicate of 150 itself. Usually, people ask me then about the acute pain studies and neuropathic pain and how do you feel about them? I'm equally con!dent, equally enthusiastic about both of those because of those predicate points. # Terence Flynn Analyst Yes. Perfect. And again, the other -- in the New England Journal, there's this editorial, and I wanted to give you guys an opportunity to address some of the points raised. There's a question about rescue medication, onset of action and need for combination. So again, I know combination, you're working on NaV1.7 , as you mentioned, seems pretty straightforward. And maybe those other 2 points, just anything to add in terms of how you'd respond to that editorial? # Reshma Kewalramani Executive Yes. I think it's a testament to the program to the target and to the data that the New England Journal published it. And if you look at the data, I think they speak for themselves. You always can !nd something to ask a question about, provide a critique on. But the bottom line is we have a raging opioid epidemic in the country. We have the desire to use non-opioid medicines. We have no non-opioid medicines. So I think the big news here is we have potentially the !rst new class of pain medicines in 3 decades that look to have a very good e#cacy pro!le, very good bene!t risk pro!le and there are always things we can do better. # Terence Flynn Analyst And that's maybe one commercial question is just the pro!le. So maybe just remind us of what you're helping in Phase III because the question we get a lot is do you need to actually beat opioids to make this a commercially successful opportunity? Or is just showing equivalent e#cacy enough? So maybe help us think through the commercial implications of the data when we see it. # Reshma Kewalramani Executive Sure. Let me ask Charlie to outline the acute pain market !rst, and I'll come back and tell you a little bit about what we're expecting from the study. # Charles Wagner Executive Yes. Part of the enthusiasm, obviously, for the program is we see that as a signi!cant opportunity. The acute pain market today is we estimate is north of $$ 4$ billion, and that's at generic pricing. So the opportunity for a medicine with a superior pro!le, we think, is very signi!cant. We've further drilled down and looked at the dynamics of the market where prescribing happens. Again, north of $$ 1$ billion, $$ 1.5$ billion treatment days in the U.S., 2/3 of that in$uenced either in a hospital or a surgical center or at time of discharge, which gives us comfort in the ability to serve that market with our specialty commercial model. We think, with the number of hospitals and the number of IDNs a sales force in the range of 100 to 200 people is going to be su#cient to serve that market in the U.S. So that makes it very Vertexian and a great !t for our approach overall. In terms of the pro!le? # Reshma Kewalramani Executive In shorthand, if we see what we saw in Phase II, it's a home run. # Terence Flynn Analyst Okay. Great. What -- I guess one question always with CNS type studies, the companies run multiple studies because sometimes there could be placebo e"ects, et cetera. So what's the -- what's kind of like the minimum number of those 3 trials that you need to secure an approval? # Reshma Kewalramani Executive Yes. It's a really good point. When you're working in depression or in pain, even in schizophrenia, the placebo e"ect is real and it's something that you have to be very careful about when you're designing your studies. For our program, we are looking for a positive result. And when I say positive, the primary endpoint in the abdominoplasty and bunionectomy studies is the high dose from Phase II, the VX-548 high dose versus placebo on pain relief, this measure called SPID48. So we're looking for those primary endpoints. And the single arm safety and e"ectiveness studies there because in our conversations with the FDA, our goal in the label we seek is a broad moderate-to-severe acute pain label. We're not seeking a label that's post bunionectomy or post abdominoplasty or post surgery or anything like that. It's a broad, moderate to severe acute pain label, and that's what that single-arm study is therefore, let's call it, an all-comer study, if you have a fracture, if you have a sprain whatever pain condition you have, that's what's there for. # Terence Flynn Analyst Okay. Understood. The -- you're also running the Phase II neuropathic pain study. So maybe a similar question just timing of that data set? And then what's the successful outcome look like in that setting because it's a little bit di"erent from acute? # Reshma Kewalramani Executive De!nitely. I'll ask Charlie to give you a market opportunity, and I'll come back and tell you about expectations. # Charles Wagner Executive Yes. It's again, similar to the enthusiasm in acute, the opportunity in neuropathic pain is quite large, again, multibillion-dollar opportunity there. Again, one that we feel, given the concentration of prescriptions with specialists, one that we feel that we can serve with our specialty model. # Reshma Kewalramani Executive In terms of the neuropathic pain program, we did a neuropathic pain Phase II study with the predecessor molecule, VX-150 and it was positive. So going into this study, we have enthusiasm and excitement because of that and also because of the genetic and pharmacologic validation of NaV1.8. Where are we today? We are well underway in the Phase II program. I expect the study to complete towards the tail end of this year and I expect results to be available tail end of this year or beginning of next. In terms of success, the Phase II study is designed as a change from baseline study. There is a pregabalin arm and what we're looking to do is to assess the magnitude of the treatment e"ect, so we can appropriately design and power our Phase III study. So that's really what we're looking for. # Terence Flynn Analyst Okay. Okay. Perfect. And what is the idea to kind of bundle all this data together because it's all related in a sense and it's all around the same time? Or is it something that's going to be like sequenced out? # Reshma Kewalramani Executive Yes. Good question. So in terms of disclosure, what you should expect is the 3 studies that make up the acute pain VX-548 program. We're going to share all of those results altogether. And the reason for that is that, that whole package is what determines and drives the label that we seek. So that acute pain package will be altogether those 3 studies. It just turns out to be the case. It just happens to be the case that the time line for the neuropathic pain study is very, very similar. But that disclosure is a separate entity. We are going to do all 3 acute pain studies together. # Terence Flynn Analyst Okay. Understood. That's helpful. I guess moving on through the pipeline, exa-cel, another one we were talking about earlier today. You have an FDA AdCom coming up. So maybe just any insight in terms of kind of some of the key topics there that might be discussed? And then, Charlie, maybe you could update us in terms of the launch breadth that the company has been focused on because I know this is a very unique market opportunity and market launch, but you guys have a lot of expertise from the cystic !brosis data that you can leverage, obviously? # Reshma Kewalramani Executive Yes. Yes. In terms of the exact next steps, you know that in the U.S., it's 2 !lings. It's a separate !ling for sickle cell disease, PDUFA date, December 8, and it's a separate !ling for thalassemia and that's a March 24. Outside the U.S., in the U.K. and in the EU, it's a singular !ling for both sickle cell disease and beta thalassemia. Coming back into the U.S. then, we know that we're going to have an AdCom. This is not at all surprising because it is a new mechanism of action. And we also know the date of our Advisory Committee it's October 31 of this year. We don't yet have the FDA's brie!ng book or their questions. It will certainly come in the coming days and weeks. I expect the AdCom to be fairly standard is likely to be about e#cacy, safety, bene!t risk because that's what AdComs tend to be about and that's what I think. But to be fair, we don't have the questions or they're brie!ng book yet. Charlie? # Charles Wagner Executive Yes, in terms of launch, we are, I would say, palpably excited and very ready. So we have done all the work that we need to do in terms of hiring salespeople, medical liaisons, patient support specialists, supply chain is ready. We have done everything we can do to be ready there. We are working with our authorized treatment centers. We said we would target around $5 0 %$ in the U.S., $2 5 %$ in Europe. Those conversations are ongoing, and we will have centers ready at the time of approval. And then lastly, we've been advancing our discussions around access and reimbursement, great success there. We've talked with private payers in the U.S., of course, representing more than $8 0 %$ of covered lives. We've had conversations with all of the relevant Medicare -- state Medicare organizations, and we see a clear pathway for reimbursement for the procedure. So we're going to be ready. I think the only other point we would make is that with the launch, we're going to be ready. And then there's a patient journey that happens at that point. It's a multi-month process for a patient to go through selection, screening, cell collection, the editing process, ultimately the reinfusion. And so while there will be a lot of activity on day 1, it will take a little bit of time for patients to go through the process. And so we look at 2024 as really an important and foundational year as we treat patients and build towards a multibillion-dollar opportunity. # Terence Flynn Analyst Okay. And just remind us, geographically, again, I'm assuming it's more of a U.S. versus ex U.S. opportunity? # Reshma Kewalramani Executive Yes. So if you look at the total population in the U.S., let's call it, North America, we'll include Canada. In North America and the EU, total would be about 150,000. That's not what we're targeting with this exa-cel plus busulfan conditioning regimen. We're targeting 32,000 patients with sickle cell disease and beta thalassemia. Of that, the overwhelming majority of the opportunity is in sickle cell disease. And of that, the overwhelming number of patients are right here in the U.S., exactly right. And of that, 80-plus percent of the patients are in 20 states and an equivalent statement can be made about $8 0 %$ of the patients in Europe are in 4 countries. # Terence Flynn Analyst Great. Just in the last minute type 1 diabetes, obviously, another potentially transformative program that the company has been working on for some time here. I know we're going to get an update at EASD in October next month. Maybe just very quickly, what should we be focused on with that update? # Reshma Kewalramani Executive Yes. The type 1 diabetes program is one of the most exciting programs in our portfolio, largely because it can help so many patients along with pain. Pain is like tens of millions of patients. The type 1 diabetes program is 2.5 million patients in North America and Europe. And it's particularly exciting because it's another one of the programs in our portfolio that o"ers curative potential like exa-cel, the potential for one and done therapeutic. So what are we doing in this program? We know from 20-plus years of research that cadaveric islet cells or whole pancreas can provide a long-term durable or curative therapy. The problem is quality and quantity of cells or organs. So what we've done, when I say \[indiscernible\] and it's the SEMA group that we acquired, they determined a way to take stem cells and copes them into di"erentiating into fully di"erentiated insulin-producing islet cells. And what we're doing is 3 programs within the umbrella of type 1 diabetes. The !rst program, which is the program that we've already reported out on and the !rst person in that program, who was a 40-year diabetic taking 40 units of insulin takes no insulin, and we've already shared that data. That !rst program, let's call it the naked cell program. We require immunosuppressive o"-the-shelf immunosuppressives for that. We think that, that program could be useful for about 60,000 people, brittle diabetics and those who have already undergone a kidney transplant for their type 1 diabetes. Program number 2 is those exact same cells that we already know work encapsulated into a device, no immunosuppression needed. And the third program, that second program is also already in the clinic, and we've shared that we've dosed the !rst patient. The third program is those exact same cells that have certain gene edits to evade the immune system. That is still in preclinical development. I'm sorry, it took more than the 53 seconds. # Terence Flynn Analyst Well, I think we're going to break for lunch anyway. It's good that we run over. But thank you so much, Reshma, Charlie. Really a pleasure. Charles Wagner Executive Thanks, Terence. Thank you. Reshma Kewalramani Executive So good to see you. Terence Flynn Analyst Thank you. You too.
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