Q4 2022 Vaxcyte Inc Earnings Call

Speaker 2: I would like to welcome everyone to the fact site fourth quarter and four year 2022 financial results conference call. All lines have been placed on mute to present any background noise. After the speakers remarks there will be a question and answer session.

Speaker 2: If you would like to ask a question during this time, simply press star 1 1 on your telephone keypad. If you would like to withdraw your question, please press star 1 1 again. I now would like to turn the call over to Andrew Guggenheim, President and Chief Financial Officer of AXSAT. Please go ahead, sir.

Speaker 3: and our VP of Research, Jeff Fairman.

Speaker 3: Earlier this afternoon, we issued a news release announcing our results. Copies of this and our other news releases, latest corporate presentation, and SEC filings can be found in the investors and media section of our website.

Speaker 3: Before we begin, I'd like to remind you that during this call, we'll be making certain forward-looking statements about back-sights, which are subject to various risks, uncertainties, and other factors that could cause actual results to differ materially from those referred to in any forward-looking statement.

Speaker 3: For discussion of the risks and uncertainties associated with these statements. Please see our press release issued today as well as our most recent filings with the. Including the risk factors set forth in our Form 10-K . For the year ended December 31 2022. And any subsequent reports filed with the. With that, I'll turn the call over to grant Pickering. Grant.

Speaker 3: Thanks, Andrew, and to all of you on the call on webcast, thanks for joining us today. 2022 is a landmark year for VaxSight. We reported positive and unprecedented proof of concept top-line clinical data for Vax24, our lead pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease in adults. These remarkable data validate our PCB franchise and our carrier-sparing approach for broad-spectrum PCBs, as well as our cell-free platform. They also represent the culmination of nearly a decade of thoughtful and methodical research and development by the entire VaxSight team and their partners.

Speaker 3: The findings of the large phase 2 study in adults 18 to 64 years of age indicate a potential best in class profile for Vax 24 and demonstrate how a novel self-free technology platform has the capability to overcome the limitations of other conventional approaches. These results and the foundation we have carefully created have as well positioned to advance our PTV franchise to potentially disrupt what has consistently been a crucial vaccine class, societally and financially. I'm incredibly proud of the progress this past year and I'm optimistic about our ability to execute and further scale our business in 2023 and beyond. As we look ahead we remain focused on advancing both of our PTV franchise programs.

Speaker 3: Vax24 and Vax31, which we previously referred to as VaxXP, with several upcoming milestones. Vax24, our lead PCV candidate, was recently granted breakthrough therapy designation for adults, adding to its fast track designation, and we remain on track to deliver top line safety, tolerability, and immunogenicity results in subjects 65 and older in the second quarter of this year. As we've discussed with many of you, for this pending readout, our focus from an immunogenicity perspective is almost exclusively on the point estimates for the EOPA geometric mean ratios for GMRs and their comparability to the prior results in our much larger phase two study in younger adults.

Speaker 3: Given the smaller size of this older adult trial at 50 subjects per cohort, these points estimate GMRs are the most important focal points and not the lower bounds of the confidence intervals. This study was not powered to meet the regulatory non-periodity standard, and as a result, these confidence intervals will be substantially wider. The combined data from both adult phase 2 studies will enable us to perform the statistical powering necessary to T-up to the phase 3 non-periodity study for the next 24 adults. These data, along with the full six month safety data from both studies, will facilitate our end of phase 2 meeting with FDA, which we expect to hold in the second half of this year. To put the US Adult PCD market opportunity in the context.

Speaker 3: Today, it is approximately $2 billion of the $7 billion total annual global market, and is expected to be the fastest growing segment of the market going forward.

Speaker 3: Key growth drivers include an increase in adult vaccination rates outside the U.S. and in the U.S., the potential shift to universal adult vaccination starting at age 50 instead of age 65, which itself would expand the market and open up the adult regimen to a prime-boost schedule, as is the case in the infant market.

Speaker 3: The infant cohort represents the largest portion of the global pneumococcal vaccine market with approximately $5 billion in annual sales. And we are thrilled to be launching our first clinical program in the second quarter of this year. This follows FDA clearance of our own India application, which we announced last week.

Speaker 3: Bringing the broadest PCV to both infants and adults represents an opportunity to significantly reduce invasive disease across the entire population. To maintain a long-term leadership position in this market and to address the serotype replacement phenomenon that we would expect based on the widespread use of the 24-valent PCV gate.

Speaker 3: we continue to invest in our 31-valent Vax31 program. Similar to Vax24, we believe our unique carrier-sparing PCB approach gives us the opportunity to expand the spectrum of coverage to address additional pathogenic serotypes without compromising the ability to continue to vaccinate against previously circulating strains.

Speaker 3: This is critical since previously controlled strains have rebounded in prior instances where vaccine coverage was withdrawn. This puts Baxite in a different position than other sponsors who are applying the conventional PCV approach and are forced to make sacrifices in an attempt to cover newly circulating strains. We have continued to make significant investments in the advancement of Act 31 and expect to submit the adult IND for this program in the second half of this year and deliver top line data next year.

Speaker 3: Beyond our PCV franchise, we continue to progress and bolster our early stage pipeline of novel vaccines, including vaccine one, a vaccine candidate designed to prevent infections in both adults and children caused by group based bacteria and VaxPG, which is designed to treat periodontal disease. We are also introducing a new program called VaxGI, a vaccine designed to prevent Shigella, a dangerous bacterial infection with significant fatality rates among infants in low and middle income settings. Jeff will provide additional details on our earlier stage programs later on today's call. Given the magnitude of the opportunity for our PCV franchise, we continue to invest to further solidify our manufacturing foundation. Our strategic relationship with LONSA remains strong, and we believe we are well positioned to support a potential adult Vax24 launch in the US market out of existing LONSA facilities. Plans to ensure an expanding commercial manufacturing footprint to support the infant indication and ex-US markets are underway. Additionally, we further fortified our extract supply chain via our recent expanded agreement with Sutro BioPharma. gotten Started.

Speaker 3: From a financial perspective, we are in a strong position with over $950 million on the balance sheet as of December 31, aided by two successful follow-on financings last year totaling $805 million in gross proceeds. This financial strength provides us the capital to fund through several important incremental milestones, which Andrew will highlight later. I'll now turn it over to Jim, who will provide more details on our PPP programs. Jim. Thanks, Grant. I'd like to start by reiterating why developing broader coverage vaccines to treat pneumococcal disease matters. Despite widespread administration of effective vaccines, the global impact of disease remains significant and is associated with high case fatality rates, antibiotic resistance, and meningitis. In the US alone, adult and pediatric pneumococcal vaccines only cover approximately 60% and 41% respectively of circulating disease. As a result, the public health community continues to affirm the need for broader spectrum vaccines to prevent invasive disease, and to prevent the spread of COVID-19.

Speaker 4: or IPD. We designed VAX24 to deliver a PCV that includes all of the serotypes covered by the currently marketed vaccine. As confirmed by our strong clinical results from the phase one two proof of concept study, VAX24 has the potential to provide an additional 10 to 28% of protection for adults compared with the standard of care of PCVs. In this study, VAX24 met the approval non-inferiority threshold for all 24 serotypes and exceeded the immune response of PCV24 for 16 of the common 20 serotypes. Four of those demonstrated statistically superior responses. Based on these results, we believe we have the opportunity to set a new bar for the pneumococcal vaccine by delivering broader coverage and higher immune responses relative to the conventional PCVs. Looking ahead, we expect top line data for our second phase two study in adults 65 and older in the second quarter of this year. With the upcoming second quarter data readout, I want to provide a bit more context about our objectives and the expectations for the study. As a reminder, the study design is identical to the first phase two study.

Speaker 4: but for the age and the number of subjects, at 50 subjects per cohort versus nearly 200 in the first phase two study. This smaller study was designed to further inform the powering of the pivotal phase three study while adding to the body of research for VACs 24. As Grant mentioned, it was not powered to demonstrate non-afferoate, so it is most important to focus on the point estimates for the opo geometric mean ratios for each of the serotypes rather than the confidence interval. That's because you can expect these confidence intervals to be wider, and it's very possible that several may cross the 0.5 non-afferoate thresholds. Yet, if the GMRs are between 0.6 to 0.75 or higher for each serotype, prior phase three studies have shown that these ratios are adequate to achieve the non-afferoate threshold.

Speaker 4: We can glean some useful insights when looking at the results of the age stratification analysis of the first phase two study as seen on slide 12. The graph to the left reflects the data we shared in October of last year from the full study population in which the confidence intervals for the OPPA GMRs were relatively narrow. The two additional forest plots show the age stratified OPPA GMRs. In the 60 to 64-year-old cohort shown on the far right of this slide, we had approximately 50 subjects.

Speaker 4: The results show a general improvement in the point estimates, which is encouraging, and as expected, a significant widening of the confidence intervals due to the smaller sample size. These confidence intervals are relevant because we enrolled approximately the same number of subjects per cohort in the 65 and older study. When we announce our top-line data from the older adult study, given precedent phase 3 programs have enrolled subjects both older and younger than 65, we also plan to share pooled data that includes the results from the 60-64 year old cohort in our prior study.

Speaker 4: Based on well-established development pathways, we anticipate the Phase III study design will include the same validated surrogate immune endpoints that have served as the basis for full approval of multiple prior PCVs. These were also the basis for our positive Phase II study. We expect top-line data from that pivotal Phase III non-inferior study in 2025, and we will keep you apprised of other milestones following the planned regulatory interactions in the second half of this year. As our adult program advances, we are also excited to move into the infant population with VAX24 and plan to initiate a Phase II study in the second quarter of this year. This study, outlined on slide 13, includes three doses given to healthy infants in the first six months of life. This is referred to as the primary series. Primary series is followed by a dose administered at 12 to 15 months of age, which is referred to as the booster dose. This study...

Speaker 4: will be conducted in two stages, and we will compare Vax24 to the broadest standard of care, PCV, which today is PCV15. The stage one portion of the study will evaluate the safety and tolerability of a single injection of Vax24 at three dose levels compared to PCV15 in approximately 48 infants at two months of age in a dose escalation manner. Participants will be randomized on a three-to-one basis and will be evaluated for safety at seven days after dosing. A data safety monitoring committee will evaluate these data to which we will remain blinded before making a go-no-go decision to enable us to proceed to a higher dose and ultimately to the second stage of the study. The second stage of the study is significantly larger and will enroll approximately 750 healthy infants. We will evaluate safety, tolerability, and immunogenicity for the same three doses of Vax24 and compare it to PCV15. Participants will be randomized equally into four separate arms with serology drawn for immunogenicity evaluations at seven months and before and after the booster dose. The key pre-specified immunogenicity study endpoints will follow convention, which includes an assessment of the percent of participants with IgG titers above predefined levels.

Speaker 3: VaxA1, our novel conjugate vaccine designed to prevent infections caused by group A strep, remains highly relevant given the recent outbreaks that have captured news headlines. Group A strep is one of the leading infectious disease-related causes of death and disability worldwide and is a significant contributor to the prescription of antibiotics in the very young.

Speaker 3: IND enabling activities continue as back they want advances to the clinic. These include analytical assay method development, immunological assays, and scaling up the process towards the production of GMP-grade drug substance and drug product. We will give updates as to the anticipated timing of the IND submission as the program advances. I'm also pleased to share that we have achieved our goal last year to name a final candidate for Bax PG. Our therapeutic vaccine candidate designed to treat periodontal disease.

Speaker 3: Periodontal disease impacts approximately 65 million adults in the U.S., resulting in productivity losses that are estimated at more than $50 billion per year. As we await the readout of our final preclinical studies, we have begun the scale-up of the production of our candidate vaccine proteins, analytical assay development, and clinical serology assay development necessary to support eventual early-stage clinical studies. FACS-PG leverages a key application of our cell-free platform, which is the ability to make tough to make protein antigens.

Speaker 3: This also has a bearing on the nomination of our new vaccine program. Backs, g. I. is designed to prevent dysentery caused by she got a bacteria. Which is commonly referred to as. She goes, this is a bacterial illness with no available preventative treatment. It affects an estimated 188M people worldwide each year. And results in approximately 164,000 deaths annually. Mostly among children under 5 years of age in low and middle income areas. With the aim of reducing morbidity and mortality due to this disease. The W. H. O. lists she gala vaccine development as a priority goal. More information can be seen on slide 17. The central antigen and backs g. I. is. While this is a well appreciated antigen, others have been unable to produce it, but be at an amount sufficient to enable a commercial product. Yet with our cell free technology, we believe we can produce this antigen. At substantially improved yield, allowing for commercial scale production. More information on this unique application of the cell free technology is available.

Speaker 3: The increase in G&A expenses was driven principally by higher personnel related and corporate costs as we invested in our team and infrastructure to support our overall growth. I will note the 23 million dollar charge we incurred in the fourth quarter related to the agreement we entered into with Sutro BioPharma during that period. This amount reflects the upfront cash and stock consideration for the experience of the agreement.

Speaker 3: $23 million sutro charge, particularly in R&D. The expected significant increase in R&D expenses is primarily a function of our investment to make the required clinical trial materials for our planned Vax24 Phase 3 program, which will consist of multiple trials. And to a much lesser degree, expenses related to executing our Vax24 Infant Phase 2 study, preparing for our planned Vax31 Adult Phase 1-2 study, activities to support a future BLA for Vax24, and an increase in employee headcount to support our anticipated growth. Turning to the balance sheet and cash runway, as Grant noted, we continue to maintain a strong financial position, ending 2022 with $957.9 million in cash, cash equivalents, and investments. Going forward, we expect that our balance sheet will be sufficient to fund our operating expenses.

Speaker 3: and capital expenditure requirements through a number of important milestones over the next few years, including the top-line pivotal Vax24 Phase III non-inferiority study in adults, for which data is expected in 2025. As we've noted before, our cash runway outlook does not reflect the potential costs associated with securing additional manufacturing capacity to support, for certain components of our vaccine, expected increased commercial quantities upon the potential approval and launch of Vax24 in the infant population and to expand into other markets outside of the United States. We continue to evaluate our alternatives to bring on such additional capacity. I will now turn it over to Grant for closing remarks. Thanks, Andrew. It was an extraordinary year of validation for Vax24 at our pipeline, and we are in a position to maintain our strong momentum in 2023. We expect this to be a milestone-rich year across our pipeline with a focus on Vax24 and Vax31. We look forward to sharing further updates as the year progresses and appreciate your interest by joining us today. With that, let's take some questions. Operator. Thank you. As a reminder, if you would like to ask a question, please hit star 11 on your telephone keypad. One moment while we compile for the Q&A roster. As well, please limit yourself to one question and one follow-up.

Speaker 3: And as you referenced, that was the subject of the discussion at last week's ACIP meeting, where the conclusion of the working group was, on the one hand, you have the improved coverage of PCV20, but on the other hand, you have higher immune responses with the 15 valent for Merck. So that's the trade-off that's being required with the conventional technology. And that's what has us so excited about the data that we generated last fall.

Speaker 3: where Vax24 was able to show broader coverage, but in fact, better immune responses against the common strains of the less-valent vaccine. So, you know, that's the existential choice that they're being forced to make. And, you know, the working group basically, you know, didn't really indicate how they were gonna act, but that's the trade-off that they're going to have to consider if the April PDUFA date comes when the FDA approves PREV-R20.

Speaker 3: before I was able to show broader coverage, but in fact, better immune responses against the common strains of the less-valent vaccine. So, you know, that's the existential choice that they're being forced to make. And, you know, the working group basically, you know, didn't really indicate how they were gonna act, but that's the trade-off that they're going to have to consider if the April Padoopa Day comes in the FDA approves webinar 20. All right, thanks Vince.

Speaker 3: has been about the minimum amount you need to show to make room for the point for the competence intervals on either side. So yeah, as we're approaching that 65 plus readout, you know, those are the sort of point estimates we'll be looking to exceed. And, you know, as we saw from the larger study.

Speaker 3: week, you know, the pediatric data for PCV 20 was released. And once again, we saw that they could go down as low as 0.6, which they are at for a few strains. I know one in particular, they got to 0.6 and the number that were closed. And again, that was adequate to exceed the non-period threshold. So I think we're seeing that sort of consistency across adults and pediatrics that has been a bit of a hallmark in this space. And.

Speaker 4: Oh, and then Jim, why don't you take the second part about security already? Sure. I think that if what you've seen with our data for the 60 to 64, if that's reproducible in the 65 plus, we feel comfortable with the phase three size that we can repeat the statistical security per and a four that we've seen in the 50 to 64. But we could in fact, if we again repeat what we've seen in the 50 to 64 in the phase three, go as high as many as eight or nine depending upon what the FDA says would be the requirement for the lower bound demonstrates security. If it's lower bound of 1.0 or greater, we think that we can hit, you know, seven or eight of those. That's great. King. Thanks, Roger. Thank you. One moment while we prepare for the next question.

Speaker 5: in adults.

Speaker 5: I think you had said, you know, if the lower bound was 1.0 or greater, you might be able to hit seven to eight of those or something. I just wanted to understand that a little bit better. Thank you. Hey, David, thank you for the question. Yeah, so, you know, the ACIP.

Speaker 3: conversation last week would suggest that PCV 20 is on on a path toward approval. We'll find out soon enough when the FDA decides in April , but looking forward to our own phase 2 clinical study that we've already guided to beginning in the second quarter of this year. You know we have two different stages for that study. The first stage is a safety look for which we have been planning to compare to PCV 15 and as you say if they give a joint recommendation.

Speaker 5: And that would be in accord we'd strike with each of the investigators who'd be participating in the study. But given the interactions that we've had with the FDA, we're not going to be able to

Speaker 5: Although we could theoretically have the alternative, I think the preference would be that the FDA would want us to compare to the broadest spectrum one and we'll be doing what we can to potentially alter that original plan. But that will be a bit of a work in progress as things unfold with the FDA and then the ACIP. And then you had a second question with regard to the lower bound. I hope that wasn't something that I confused the issue around the technical.

Speaker 4: lower bound threshold in order to show the non-imperiality standard is still to exceed 0.5, but that's where the lower limit of the 95th confidence interval needs to exceed. And what we were saying was the point estimate, if it's at 0.6, that's usually enough for that lower limit to exceed 0.5. But was that more related to the superiority? Okay, yes. Do you want me to take it from there? Yes. So for the superiority, what I see in the past is that sometimes the FGAT wants to take into account some nasty variability because if they're going to put a statistical superiority claim in your label, they want to make sure that you're absolutely sure that it's superior. So it wouldn't be materially higher than 1.0, but it might be slightly higher to give some degree of leeway in case there's some nasty variability. So we don't expect it not to be 1.0, but even if it's even higher. I think we can achieve at least four and more. And then the last thing I'll say on that is that even if we aren't able to get a superiority claim in the label.

Speaker 4: that absolute immunogenicity value will then reset the bar for others to demonstrate non-inferiority again. So even if it's not in the label, we'll raise the bar for others who want to follow to demonstrate non-inferiority. That's very helpful. Thank you very much. Thank you. One moment while we prepare for the next question. One moment, please.

Speaker 3: targets. And then separately, I was just hoping you might help us understand where you see the real differentiation opportunity for VAX31. My impression was that the team was really thinking about some unique opportunities, particularly in otitis media, as an opportunity there.

Speaker 5: Just love to touch on Vax 31. Thanks. Yeah, thanks for the question, Chamis. So as it relates to the Vax 31 program, we've guided to an IND going into the second half of this year. And like we saw with Vax 24 last year, these adult studies accrue and read out quickly. So we have guided to being in receipt of the data from that study, top line data next year in 2024. So in order for us to be able to guide to an IND in the second half, it means we're well on our way from a manufacturing perspective. We've said publicly that we made a surplus of the 24 drug subs.

Speaker 5: Uh, really excited about that and we believe we'll be able to leverage the same lawns infrastructure for the production of acts 31 that we've been budgeting for for that's 24 as a result as it relates to the differentiation. Maybe Jim and I can tag team this 1, but, you know, in the adult space.

Speaker 5: Once you get up to 31 strains, you're effectively covering the evidence pathogenic serotypes for pneumococci. So in the US, those 31 conjugates will cover 95% of the circulating disease in Europe and gets as high as 98%. So you really feel like you've covered the gamut once you get to these 31 conjugates. And what we think we can do with the carrier sparing technology that we...

Speaker 5: we certainly need strains, they have to no longer include those strains that have been taken out of circulation. So, as we mentioned in the prepared remarks, there's historical precedent where vaccination that's been withdrawn for currently covered controlled strains can result in rebound. So, it's more than just the coverage advantage, it's also the maintenance.

Speaker 5: of the no longer circulating strains. So that is a big opportunity for us in the adult space. And then your reference to the otitis media is another aspect of the potential advantage as it relates to the infant indication. So Jim, maybe you can talk a little bit about that. Yeah, and I'll say first in the infant, FACS 31 will increase coverage against IPD by about 25% or more from what would be the standard of care if PCV 20 makes it through the new thing.

Speaker 4: even more so if it's referenced against PCV15. So there is still a substantial impact on invasive disease. But in terms of otitis media, especially 35B stereotypes, there's a lot more contribution to otitis media in these incremental strains that are in VAX31. And you get 48% increase in coverage of otitis media. And when you think about it, you know, the incident rate is almost to the point where every kid gets at least one ear infection. So and if about 35, 40% of those are strep pneumonia, you can see that that's a ubiquitous disease. So this incremental 48% could have a substantial impact obviously on medical expenses, but also on antimicrobial resistance because it's one of the main drivers for...

Speaker 3: US, but what would it take to do a much larger manufacturing footprint? Is this something that you could do in-house? Would this be a larger, long deal? And maybe if you could put some bookends on how much a full-size manufacturing footprint might cost in various scenarios.

Speaker 5: Yeah, hey, John . Thank you for the question. We'll talk team this one as well. I'll have you in through. Bring it home, but just just in terms of order and magnitude. I think the way people should be thinking about that US adult launch related capacity and the tens of millions of doses, whereas we ultimately get into the full wedge adult and infant and sort of global reach capacity. P thingy demand does get into the greater than 100 million doses per year sort of territory. So we're talking.

Speaker 3: magnitude will depend on the route we take and when we pull the trigger, I think something over the next 12 to 18 months we're likely to do so we can ensure we have the necessary capacity to meet the demand subsequent to the launch. Probably premature at this time to kind of range the options, but we're hoping to be in a position to do that in the not too distant future as we get further down this evaluation. Okay, that makes sense. Is this the sort of thing that you expect LONSA would have the capacity to do already if you ask them tomorrow to do it?

Speaker 3: Well, as Grant noted, we can satisfy the expected demand in the adult population in the U.S. out of the existing facilities. As to whether Monza today, that's one of the evaluations that's likely, they have basically built custom dedicated space for their clients, so it's likely we would need to work and partner with them to develop, build that capacity. So that's something that we're looking into, but it would likely be.

Speaker 2: You know, I'm under taking. Understood. Thanks so much. Thanks John . Thank you. One moment while we prepare for the next question. The next question is coming from Luis Chin. A picture of your line is open. Hi, congratulations on the quarter and thanks for taking my questions here. So one question we are asking get that is, since we've already shown a Christmas concept for VAC 24 and because the market for PCD is getting crowded, why not just move forward with VAC 31. And then second question I had for you was on the market opportunities, PreVAC's A1, PG and GI. You know, what do you think of those? How do you think about potential peak sales first, what you might see for your PCD? And when you plan to start studying for these opportunities or these?

Speaker 5: Within the next several years or after you kind of move through the pivotal stuff with your PCD. Thank you Thanks for the question Louise Yeah, I mean certainly back 31 is going to be I mean, I'm on record for calling it a category killer But the reality is that 24 has a best-in-class profile in both the adult and infant market and It is on the fastest track to introduction to the market And so it's our primary focus to deliver that vaccine to the market We believe that that's 24 is going to be a trend tremendous introduction for our carriers bearing PCVs to the market and We know that upon widespread use of X 24. It's only going to enhance

Speaker 5: the rate of circulating disease for this strains over and above those that are in Vax 24. So we know Vax 31 is going to be important and we have it moving as fast as it can. And with what we know today, this is the right strategy for the company. If there was something to change either from a competitive dynamics perspective or from an epidemiology perspective, we would be in a position to revisit that. But we believe this is the right way to maximize value for Vax site. And we think it's the right thing to do, so finally, as a global health solution.

Speaker 5: And then as it relates to the pipeline, yeah, we think that what we can do with this cell-free protein synthesis platform is going to continue to pay dividends. VaxA1 is our broad spectrum group-based strep vaccine. We've all been hearing about increasing rates of the circulation of group-based strep infections. And like PCVs, group-based strep afflicts adults and infants. So this is an important and what could be valuable intervention on both ends of the age spectrum. So we're moving that program forward aggressively. And because of that widespread usage, we do think it has blockbuster potential given the magnitude of morbidity and mortality that it can address. And then as it relates to the other programs, you know, VaxPG, we've nominated the lead candidate that we want to advance to address this therapeutics.

Speaker 6: Hi, thanks for taking our question. Just given that there's a competitor, 24-valent pneumococcal vaccine program out there in mid-stage development, can you explain the relative importance of potentially being first to market? And do you think that your current timelines for Vax24 phase 3 data readouts put you in a good position, relative to that 24-valent competitor? Yeah, thanks for the question, Joey. Indeed, there is another 24-valent.

Speaker 5: And non-covalent approaches haven't been able to assure that. So this is a non-covalent-bound approach that they're moving forward. And what they've said in their own public filings is that they don't expect to be able to launch that program until the back end of this decade. So it does put VAX24 in a position to find its way to the market potentially significantly earlier. And that's why VAX24 is a non-covalent approach. And the reason why is because it's a non-covalent approach. So it's a non-covalent approach. And it's a non-covalent approach. And it's a non-covalent approach.

Speaker 5: than that particular program. And as it relates to first mover advantages, usually that's valuable unless the second or third market have a material advantage. And when we look objectively about what we're doing, the data we've generated, we feel like we've got the more tried-and-true approach. We think we've got extremely compelling immunogenicity data and a safety profile that looks remarkably similar to the already approved pneumococcal conjugate vaccines. And the hallmark of these covalent-bound PCBs is the ability to boost because that protein carrier and its T cell epitopes being...

presented to the immune system simultaneously are what deliver that key boost effect. And that's what is often lost when it's not presented simultaneously is that ability to deliver a boost. And certainly in the infant market, that's the price of admission has to be able to boost in a material way. And we think the adult market is going in that direction also. So, we're always vigilant about the competition, but we think we're in an extremely enviable position in this moment as it relates to that particular program.

Great. Thanks so much for taking our questions. Thanks, Joy. Thank you. This concludes today's conference call. You may all disconnect. Everyone have a great day. Thanks, everybody. The conference will begin shortly. To raise and lower your hand during Q&A, dial star 1 1.