Vaxcyte, Inc. (PCVX) Earnings Call Transcript & Summary

Good afternoon, everyone. Thank you for joining the 21st Annual Needham Healthcare Conference. My name is Joey Stringer, and I'm one of the biotech analysts at Needham & Company. It's my pleasure to introduce our next presenting company, Vaxcyte. Joining us today from Vaxcyte is CEO, Grant Pickering; and COO, Jim Wassil. [Operator Instructions] With that, we'll get started. I'll turn it over to Grant for some opening remarks, and then we'll start the chat.

Great. Thank you, Joey. Delighted to be participating in the Needham conference. We really appreciate you including us. And I guess I'll just start out by saying I'm expecting that we'll be making some forward-looking statements over the course of this conversation and would direct you to the sec.gov page for our filings so you can have a more complete and balanced perspective on our business. And would just like to say that 2022 is going to be a really big year for Vaxcyte. We have become known for broad-spectrum pneumococcal conjugate vaccines that we are developing. And we've been off to a really exciting start to the year. We filed our IND for our lead vaccine called VAX-24, a 24-valent pneumococcal conjugate vaccine. We filed that IND in December of 2021. And the FDA cleared that IND for initiation of clinical studies in January, and we just announced last week that we completed Phase I and have initiated dosing of the Phase II portion of the development program to develop VAX-24 for adults. So the Phase I, we were just looking at safety, and we cleared that bar based on our data monitoring committee and that allows us to initiate the Phase II portion, where we'll be enrolling 50- to 64-year-old subjects. We're enrolling 800 in total in that study. 600 will receive VAX-24 and 200 will receive Prevnar 20, and we will be able to enroll that study and obtain the serology so as to perform the antibody comparisons of VAX-24 to Prevnar 20, we'll have that study completed and the immunogenicity data read out before the end of this year. So it's going to be a very exciting year for the company, obviously led by that VAX-24 development progress. But we also have an exciting portfolio of vaccines beyond that. We have an even broader form of pneumococcal conjugate vaccine that we call VAX-XP along with 2 other named programs, one of which is a Group A Strep conjugate vaccine, called VAX-A1 and a periodontitis therapeutic vaccine called VAX-PG. So very excited about what we're doing here. Obviously, vaccines have probably never had as much notoriety and we hope to continue that with important new developments with these conjugate vaccines to prevent bacterial infections that are continuing to plague us over and above, obviously, the viral issues that we're all dealing with. So delighted to be here, Joey, and looking forward to a good conversation today.

Great. Thanks so much, Grant, for that overview. For those who are not as familiar with the pneumococcal vaccine market, it's huge. It's over $7 billion annually, but it's highly concentrated amongst a few players. Can you describe the market dynamics in this -- for a pneumococcal vaccines. And why has the Prevnar family vaccines dominated the market to date?

Yes. In a word, it's been a monopoly. The key market driver is coverage. And so for this particular bacteria, Joey, as you know, it's strep pneumonia. This is a commensal bacteria that lives in the upper respiratory tract. And when you're immunocompromised, it can traffic into the lower respiratory tract and cause pneumonia and blood-borne infections. This has been historically the biggest problem that we faced as a race. And Prevnar was the first form of this vaccine that came out in the conjugated form over 20 years ago. And despite having competitors try to emerge, what has kept that franchise in a monopoly position, at least here in the U.S., it's a little bit more complicated outside the U.S. is their coverage. So Prevnar's initial form was a 7-valent vaccine, had 7 different types of strep pneumonia bacteria included in it. There was a competitive race 10, 12 years ago, where GSK was developing a 10-valent form, but Pfizer was able to one up them with a 13-valent form of Prevnar, which persisted this monopoly position. So even though GSK was able to develop successfully a 10-valent vaccine, it wasn't even competitive enough to bring out in the United States because the 13-valent form would have obviously become a more protective vaccine. And in vaccines, there's a long history of broadest coverage wins. And naturally, with vaccines, you can't predict what strains could eventually infect someone. So if you have a broader spectrum form that you can start with, those always get chosen over lesser valent forms. So whoever delivers the broadest spectrum vaccine wins in this space, that's what makes our opportunity exciting. We think we can develop broader spectrum forms with our approach.

What are the main limitations of current pneumococcal conjugate vaccines or PCVs? And how would VAX-24 or your follow-on VAX-XP address the unmet need?

Yes. So the situation is this type of vaccine is extremely effective and it's so effective that when the 7-valent form of Prevnar first came out, and we universally vaccinated infants, those 7 strains were effectively taken out of circulation. The problem is that there are actually around 100 different serotypes of strep pneumonia. The good news is only about 25 or 30 of those strains circulate in ways that create disease. But when those 7 were taken out of the equation, an incremental half dozen or so started to circulate much more aggressively. And as I hinted at a moment ago, that's what drove this race between GSK and Pfizer to develop broader spectrums of PCVs beyond those original 7. And so that led to the next gen, which were 13 versus 10 but then in the intervening decade since then, Joey, bacteria don't morph like viruses do. Viruses have a much higher immunogenicity rate and bacteria more gradually shift as the original strains are vacated, it creates a void for which these other strains start to circulate more aggressively. So back 10 years ago, most of the disease started to come from these incremental half dozen strains that then got incorporated into Prevnar 13. Now once again, we're at a point where a decade in, we have another half dozen or more strains that are causing the majority of the disease. And so that's led to a next-gen kind of approach between, again, now Pfizer, but now Merck, trying to compete to cover those incremental strains. So Pfizer has now got a 20-valent form of the vaccine. And Merck has a 15-valent vaccine they've been developing. They're all using the exact same technology, which is just where it gets a little complicated. We'll try not to get into all the detail in this forum. But when they make this type of vaccine, Joey, you take a common diphtheria toxin backbone and you attach these different serotype sugar strains to the protein toxin and you make individual forms of the vaccine. So Prevnar 13 has 13 different conjugates, Prevnar 20 has 20 different conjugates. And the problem starts to arise that as you add more and more conjugates with the same diphtheria toxin protein that accumulation of the diphtheria toxin starts to hijack the immune response away from the targeted antibodies to the bacteria sugars and starts to create responses against the diphtheria toxin. And so that's the problem that the original technology faces as you need to incorporate broader and broader forms of the vaccine, that hijacking becomes more and more pronounced. And so the net effect of that is the overall antibody responses start to get lower and lower with these broader spectrum form vaccines. And so what we have an opportunity to do is to leverage a next-generation chemistry that allows us to use less of the diphtheria toxin in each of the conjugates without sacrificing immunogenicity, and that allows us to add more conjugates to create broader spectrum forms of this type of vaccine that we believe will side step this hijacking feature. And so that's the idea behind our 24-valent, VAX-24 vaccine and then this even more broad-spectrum form called VAX-XP that has 31 strains of the vaccine. So we're trying to honor what has been a really effective type of vaccine, Joey, but put these vaccines together in a way that we can create broader spectrum, more protective forms that don't lose the immunogenicity that you need to create a protective response.

Got it. So more of the old technology is more of a random conjugation attachment and your approach is to sort of pinpoint precise placement of the serotypes to kind of avoid the issues of the suppression -- carrier suppression?

Yes, that's exactly right. So we've just got a novel form of chemistry that allows us to do one better than the convention. But critically, we're still able to deliver the same type of vaccine that is recognized by the immune system in a really robust way. So yes, it's next generation without inviting what we think is significant incremental biological risk.

And can you -- circling back to serotypes here, can you explain how these circulating serotypes are monitored throughout the U.S. and the relative abundance of each can change on kind of a time scale. Is it weeks or months or years?

Yes. I kind of hinted at that earlier. So with viruses, obviously, we've been seeing this play out how quickly they can morph and circulate. But with bacteria, it's different. They are really just starting to gradually fill in the void when you vaccinate against a certain cohort of serotypes. So the way that we monitor that in the U.S. is the centers for disease control have a cohort of hospitals for which when people present with infections and this type of disease is characterized as invasive pneumococcal disease. So this is when bacteria enters a compartment of your body where it doesn't usually reside. And so you can actually get a sample of that and specifically track which serotypes are circulating. And it's that accumulated data from, I think, 5 different hospitals in the U.S. that are regionally located for which they amalgamate into what are the circulating strains on any given period of time. And so it's that surveillance that guides us to what would really be the most relevant vaccine composition. But this isn't something where you're making these choices and these changes year-over-year. It's really more like once every decade or so, you really need to deliver something more broadly protective, and we're in that zone right now.

Now given the large market opportunity and the few approved vaccines, there's relatively little competitive programs, relatively a little competitive programs in the clinic. What are your thoughts on the reasons for this?

Well, I think the -- it's a complicated answer to that question. These are very complex vaccines to produce. And what we've seen is the original technology that Pfizer uses to make Prevnar, it's the same technology that now Sanofi and Merck are trying to create some products that can get into the same zone as what they have with Prevnar but to leapfrog over that, you need new technology, and that's what we think we have with our novel form of chemistry. But nonetheless, we have to make -- basically, what we're doing is making 24 vaccines in 1. So this is incredibly complicated and to be able to do this in a way that you can make it of the sufficient quality, you really need to make a profound investment, which is what we've done is recognize that this is an already very well established clear market, this is a $7 billion a year market where we're spending this money yet still only protecting against less than half of the circulating disease. So there's a big need but to get a vaccine of sufficient quality and quantity, it's a really profound undertaking. So that's why we have chosen to go with best-in-class contract manufacturing with Lonza, so as to minimize the sort of execution risk that it will take to ultimately be competitive. And to be competitive, you need to be able to make these vaccines in ways that can be broadly administered. So the capacity and scale is going to be really critical to ultimately be successful. And we've really taken a long-term perspective as we build this company is to create something where we can actually have a vaccine that could be used in the same sort of way that Prevnar is now, which is basically every child and now almost every adult get this vaccine.

Yes. And you alluded to it earlier, Grant, around the differences between Vaxcyte's approach here and that more traditional vaccine approaches, can you drill down a little bit more specifically on the differences between your site-specific technology versus the random conjugation approaches, including those from Merck and Pfizer? And then kind of as a follow-up question, why hasn't big pharma invested or switch to this more precise type of technology that you are taking?

Yes, yes, yes. So I kind of hinted at the type of vaccine we're talking about. These are conjugate vaccines where you take the polysaccharide sugar, and the sugar is what forms the outer coat of this type of bacteria. It kind of serves as cloaking device to the immune system. And so if you just use that sugar antigen, it doesn't result in a really durable immune response. So you have to get something more immunogenic. And so what they use to make Prevnar is this diphtheria toxin that I hinted at. The reason they use that diphtheria toxin is that toxin has T-cell epitopes on it, that the human immune system recognizes and it allows when those 2 immunogens are presented together, this response that's directed to the polysaccharide sugar. So it's there for those T-cell epitopes. The problem with their old chemistry, Joey, as you hinted at, is they can't control where the sugars connect to the protein. And it can just as easily superimpose the polysaccharide sugars over those T-cell epitopes as not. And so when that happens, you've got a situation where if the T-cell epitopes aren't presented, you get this very immunogenic response to the diphtheria toxin without the benefit of those T-cell epitopes being exposed. And so our chemistry allows us to take those same 2 components, but precisely conjugate the sugars to the protein in ways that lead those T-cell epitopes exposed every single time. And so the on-target effect from the diphtheria toxin is highlighted. And so what we decided to do was use a less of the diphtheria toxin in each conjugate because we were confident that we have enough T-cell epitopes exposed in ways that over a 24-valent vaccine, we wouldn't have more diphtheria toxin than is used in the 13 valent form of Prevnar. And so that was the approach that we used to recognize that if we can get the right antibody responses, that would be adequate. But if we can create a more broad spectrum vaccine, that would create a best-in-class type of profile. And so the reason why pharma hasn't done that is they just don't have access to that technology. So this is a novel approach. It was invented at Stanford, and it's a way to make this type of protein in a way that you can create it with these homing mechanisms on the protein itself that allow us to put the polysaccharide exactly where we'd like it. And there have been some other site-specific conjugation technologies that have come along, but none of them have allowed you to have multiple sites of conjugation on the protein. And if you don't have multiple sites, you can't create a conjugate vaccine that takes the ultimate shape of a pneumococcal conjugate. And so our technology allows multiple conjugation sites which are fundamental to getting the right sort of immunogenic presentation to the immune system. And so even though there have been some other types of this conjugation come along, they can't perform what's necessary to actually create the right sort of structure that we think drives the immune responses in the way that we've seen historically.

Okay. A few more market regulatory questions, and then we'll jump into VAX-24 -- the VAX-24 program. Can you describe the role that ACIP plays in which vaccines have strong uptake? And what drives adoption?

Yes. Great. Now we have to pull in my colleague, Jim. Give a chance to hear some other folks from the company. Jim, do you want to talk about the ACIP?

Sure. So Joey, the ACIP, it stands for Advisory Committee on Immunization Practices. So I think the title is pretty self-evident. It advises the CDC on what vaccines to give in the U.S. and when. And the way that it works in the ACIP by law if the ACIP recommends it, then you get federal and private health care reimbursement. So obviously, these recommendations really play a strong role in the uptake and adoption of vaccines, and they're religiously followed by health care practitioners. Now when you talk about preferential recommendations, ACIP doesn't always give preferential recommendations when there are multiple vaccines out there. Historically, differences in safety or even immunogenicity may not lead to these preferential recommendations. But what does lead to preferential recommendations historically has been broader coverage. So a 3 versus 4 of the quadrivalent flu, for instance, gets a preferential over a trivalent or when Gardasil came out versus Cervarix, Gardasil for cervical cancer had 4 strains and GSK Cervarix had 2, and it led eventually to Gardasil getting a preferential recommendation. So we think that from our approach with having broader coverage that we also have the opportunity to get that preferential recommendation.

Got it. And there have been some regulatory updates in this space over the past several months. Two new vaccines have been approved within the last year and some important updates from ACIP and HHS and the CDC. Just can you summarize these recent regulatory developments. What does this mean for the overall pneumococcal vaccine market? And how does it affect your strategy going forward?

So last year, I guess, Merck got their 15-valent pneumococcal vaccine approved in adults and Pfizer got their 20-valent approved. And because of that, the ACIP met in October to revise their recommendations for what should be given in adults and -- now there were a couple of things. There were 2 changes, I think both were favorable for Vaxcyte. And then there was a discussion about a third change that I think also could [ sell ] additional market size for everybody. Essentially, what they did was they recommended for the first time that PCVs be used in 18 to 64 year olds that are at risk of pneumococcal disease. When you think about at risk, typically people think about those with severe immuno-compromising conditions, chemotherapy, asplenics, things of that sort. But this is really a much broader group. It includes diabetics, it includes smoking, includes COPD, chronic lung, chronic liver disease. So when you add it all up, it's between 50 and 64, almost 1/3 of the population qualifies as at risk for pneumococcal disease. So that really expanded the market. The second thing they did was they recommended that PCV20 be given alone or if you want to give PCV15, you give PCV15 followed by Pneumovax 23. So what you see there is a differentiation that broader gets a little bit better recommendation, you don't need to have 2 doses, you only need one. But what you also see is they're not ready to give up Pneumovax 23 in the breadth of that coverage. So our interpretation is that once we have 24 different serotypes, you can retire Pneumovax and you can get a preferential recommendation. And then the third thing I'll bring up is there was a lot of discussion over potentially moving the age down to 50 years of age, which would mean that you still need another dose at 65, so that could double the size of the market. And there were 4 ACIP members that were strongly in favor of this, and we need 8 of them to get a vote to pass. And the reluctance was that Pneumovax, if it's still being given, could create hypo-responsiveness, which is it doesn't get as great of a boost response. So if you're going to move it to 50, you're going to have that boost at 65. So we think, again, there, if you can retire Pneumovax that there's a strong opportunity that the age moves down to 50 as well.

And switching to manufacturing here. What are the manufacturing requirements for Vaxcyte's conjugation technology? Can you compare and contrast that to the relative cost and margins of, say, the big pharma approach of the random conjugation?

Yes. I would say at the 10,000-foot view, it's more similar than dissimilar We have to make the polysaccharide sugars, which is nothing unique, you just grow up the bacteria and you strip off the sugar for each the serotypes you use in the vaccine. Then we have to make our protein carrier just like they have to make their protein carriers. The difference there is there is a 2-step process to making our protein carrier. We have to make this extract that allows us to create the site specific aspects of our protein. So we do have an extra step on the protein carrier front than they do. But then we make up for it in the next step, which is that conjugation where you combine the polysaccharide sugar with the protein. Our chemistry is a lot more facile and efficient than the older chemistry, it takes much less time to perform the reaction and has a much higher efficiency rate. So we make up the difference in the conjugation step and then you have to create the drug product, mix them all together, et cetera. So it's a little too early to say where we'll net out on a cost of goods perspective, Joey. But this market is one where this type of vaccine has such a profound positive impact societally that the price that Pfizer is able to command for Prevnar because of its impact is quite high relative to the cost of goods. So the Prevnar 24, as Jim had mentioned, which is just coming out cost over $200 a dose. And historically, if you look -- you kind of read between the lines, it's cost you in the kind of less than $10 a dose to make this type of vaccine. So it has really extremely high margins. And so for a new entrant, obviously, we'll have to get to the right capacity to have competitive cost of goods with them. But with the sort of prices that these vaccines command, we don't expect this to be a disadvantage for us as we move to build our business.

Great. On the VAX-24, we've made into there. I know it's an exciting time for you guys, first in-human clinical trial well underway. Can you provide a broad overview of the initial trial design here and any assumptions around powering or statistical assumptions?

So I'll take that. I am overseeing the clinical trial. So I'll just give a brief description here. And so the trial -- this trial is designed first in the Phase I assessed the safety of 3 different doses of VAX-24 and compare it to PCV20 in 64 healthy adults between 18 and 49 years of age. And I'll say while we remain blinded, as Grant mentioned, Data Safety Monitoring Committee assesses the safety. So they looked at the safety and decided if we could proceed to the Phase II portion of the study. And we heard -- we recently announced that we're now dosing subjects in the Phase II. The Phase II is very similar to the Phase I and that we plan to assess 3 different doses of VAX-24 and compare it to PCV20. This time, though, we're in a little bit older adults, we're in the 50- to 64-year-old age group, and we'll be assessing now both safety and immunogenicity where the Phase I was safety only, and we'll be doing it in 800 subjects now instead of 64. So that leads you to the -- your question about powering assumptions. Obviously, when you're dealing with a new vaccine, there are some uncertainties. But we've been fortunate in this space where there's been other examples, including Prevnar that have published data in clinical trials. So we took the variability of their immunogenicity that has been seen in PCV13 in terms of clinical trials and use that as a surrogate to power our study. And based on this, with 200 subjects per arm, we believe we have at least an 85% probability of being able to demonstrate the non-inferiority based on what the FDA is giving regulatory guidance for what their definition of non-inferiority will be.

And in terms of the output here, obviously, safety and you'll look at immunogenicity, sorry, can you -- for those that are maybe not familiar with the OPA and the IgG titers? Can you explain the difference between those and the importance of each of those from a regulatory perspective?

Jim, maybe highlight the criticality of these immune endpoints and how they're -- the basis for approval?

Yes. Exactly. So IgG is an antibody measure. The OPA or opsonophagocytic activity assay measures what is called functional antibody that you have to be able to neutralize the pneumococci. So one, just is an antibody response and the other is measuring functional antibodies. And from a regulatory perspective, for infants, IgG is acceptable. That's because infants are what we say is naive. They have not been pre-exposed to carrying pneumococci before. So they haven't developed an immune response. So you can use IgG as a good surrogate for achieving a certain level of immunogenicity correlates well with protection. And that's been demonstrated with Prevnar 7 and Prevnar 13 already. For the OPA, which is a functional antibody, that's what is required for assessment in adults. And the reason is as we go through life, pneumococci are commensal, we carry them in our throats and we develop an immune response over time. So just IgG is not sufficient to show protection because we all have IgG, but yet as adults and especially as older adults, we get pneumonia and we get invasive pneumococcal disease. And so from that perspective, we're measuring both, obviously, in both subjects, but we're a lot more focused in the OPAs in the adults, and we're much more focused in the IgG in infants.

And in terms of the immune response that the readout here, when do you expect results from the Phase II portion? And would you need to see kind of the non-inferiority across the matching 20 serotypes relative to Prevnar 20 both OPA and IgG? And then what about the remaining 4 serotypes. Can you kind of walk us through that?

Yes. So the readout we expect by the end of this year, we've been guiding towards the year-end. From a perspective of what's required for licensure, I mean, obviously, the FDA has discretion. They define the non-inferiority, not as a statistical non-inferior, it's actually a twofold non-inferior. So it's a much wider target for us, meaning that for -- on a serotype or strain basis, if we get roughly half the response that Prevnar does, that should be able to meet the non-inferiority requirement. So one is that it's not statistical, it's roughly getting half as much. That said, in the past, when Pfizer went from 7 to 13 and even when they went from 13 to 20, they missed on some serotypes in terms of the non-inferior criteria. They missed on 3 -- from 7 to 13, so that's 3 out of the original 7, and they still got an approval. And the reason they got the approval is the FDA then looks and says, okay, you're broadening the coverage. You're preventing incremental disease in these additional serotypes, even though you have a reduced immunogenicity. So if we miss on a few or if somebody misses on a few, there is precedent to say that you could still get licensure. But obviously, our goal is to meet the non-inferior criteria across all the serotypes. You mentioned then the 4 incremental.

Yes. The 4 incremental, there you don't have a direct comparison to Prevnar 20. How will you assess the immune response there?

So there were 2 ways that this has been done based on the precedent. Pfizer did it based upon looking at non-inferior to Pneumovax 23, which is a non-conjugate vaccine. Merck, however, looked at fourfold rise. And as long as there was a statistically higher fourfold rise for the incremental 4 serotypes, fourfold rise is what you would -- a lot of -- the FDA considers a establishment of a robust immune response. So fourfold rise, meaning you increased your antibody titers by fourfold. So we are following the Merck approach. And with those 4 incremental serotypes, we're going to be monitoring and seeing if we can achieve a fourfold rise in those incremental serotypes.

Okay. And last question on VAX-24 because I wanted to touch on your other programs here. What would the next clinical development steps look like for VAX-24 if the Phase II readout is sufficiently positive?

Yes. So what we've mentioned is that we're doing the 50 to 64. Once we've finished the enrollment of the 50 to 64, we plan to do a 65-plus enrollment so that we have information from a Phase II portion of the study there as well. We expect that readout to be in the first half of 2023. When we get to the year-end top line results from our Phase II adults, our plan is obviously that we're going to start to move down into infants and toddlers, a significant portion of the market is obviously in infants. So once we've demonstrated safety and immunogenicity in adults, we'll move into infants as well as then once the studies have completed and realized while we have top line results by the end of the year, we still have to do a 6-month safety monitoring before we get our CSR. But once we have all that, obviously, we'll have discussions with the FDA in the Phase II meeting eventually and see how we can get into Phase III as well.

And you mentioned VAX-XP, which is a second-generation vaccine, briefly described this and what are the time lines for clinical development?

Yes. We haven't gotten specifics about -- into specifics about timing for VAX-XP yet. We do expect to get there in the not-too-distant future. But yes, I think just as we segue from VAX-24 to the balance of the pipeline, Joey, I think it would be helpful to just kind of put things in perspective. So I think what you're going to see and should expect from Vaxcyte is a cascade of what we think will hopefully be value creation drivers. So with VAX-24, we're starting in the adult market, having completed Phase I. We're now triggering incremental development. So we've already started the Phase II in 50- to 64-year olds. We're now triggering the study in 65 and older participants, so a second Phase II study. And then on the heels of this readout in adults later this year, we'll be triggering the pediatric development program for VAX-24. So that's one of the interesting things about this vaccine class is -- you have a very large adult market, which is only getting bigger as Jim hinted out based on some of the decisions that are being taken at the ACIP, but then you have the infant market that follows. So you have this succession is the indications can expand in the pneumococcal conjugate vaccine space. But then as you say -- we do have an even broader spectrum form of PCV called VAX-XP, which includes the original 24 that are in VAX-24 but there are an incremental half dozen or so strains that we're already starting to see circulate. So we have a life cycle management strategy with this even broader spectrum vaccine that we see coming after VAX-24. And so we are already hard at work on that successor vaccine because the original 24, we already made incremental material as we made VAX-24 that will roll into VAX-XP. So now we're hard at work on the incremental strains that go into VAX-XP that we'll be guiding to IND filing in the not-too-distant future as we think about that as a longer-term play. So we're very excited about this PCV franchise that we have in development. And then we have 2 other really important vaccines that we're working on. The next one is a Group A Strep conjugate vaccine. And what is similar is that Group A Strep is a problematic bacteria that circulates in children and in adults, but what's different is we have a proprietary polysaccharide sugar that we think can provide broad protection even against an array of different serotypes of this bacteria that can allow us to make a singular conjugate vaccine that can be broadly protective. And there are no vaccines available for this particular bacteria that circulates, Joey. So this is a white space opportunity. There really isn't competition, and we're very excited about the prospects for that vaccine, and we'll be guiding to an IND filing timing later this year. And then we've got a really cool therapeutic vaccine to address periodontitis, which is, again, an opportunity for which there are not any competitors. So we think that there's a lot more exciting developments to come for the company. Obviously, the data coming out of Phase II is going to be the headliner for us this year, but we think there's a lot more coming down the pike.

Great. Thank you both, Grant and Jim and the rest of the Vaxcyte team for your participation. Thanks, everyone, for joining us on the webcast. Have a good rest of your day.

Thanks, Joey.