Vaxcyte, Inc. (PCVX) Q4 2021 Earnings Report, Transcript and Summary

Good afternoon. My name is Josh, and I will be your conference operator today. At this time, I would like to welcome everyone to the Vaxcyte Fourth Quarter and Full-Year Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] I would now turn the call over to Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. Please go ahead, sir.

Thank you, Operator, and good afternoon everyone. I'd like to welcome you to Vaxcyte's earnings conference call to discuss our 2021 results and to provide a business update. I am joined today by our Chief Executive Officer, Grant Pickering; our Chief Operating Officer, Jim Wassil; and our VP of Research, Jeff Fairman. 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. Before we begin, I'd like to remind you that during this call we'll be making certain forward-looking statements about Vaxcyte which are subject to various risks and uncertainties. These includes statements related to the benefits of our vaccine candidates, process and timing of the anticipated future development of our vaccine candidates, including the timing and availability of top line data from the VAX-24 days 1/2 clinical proof-of-concept study, the demand for our vaccine candidates, our expected usage and sufficiency of cash and other funding to support our development programs and other operating expenses and other statements that are not historical facts. Any forward-looking statements are based on facts and assumptions as of today and we undertake no obligation to update them. Our actual results may differ materially from these statements. Investors should read the risk factors set forth in Vaxcyte's Form 10-K for the year ended December 31, 2021, and any subsequent reports filed with the SEC. With that, I will turn the call over to Grant Pickering. Grant?

Thanks, Andrew. And all of you on the call and webcast, thanks for joining us today. The past year was an extremely important one for Vaxcyte. We made significant advancements across our business which remains focused on eradicating bacterial infections such as invasive pneumococcal disease, group A Strep and periodontitis. We advanced our pipeline, demonstrated the potential of our novel vaccine platform and onboard the right expertise to help us transition into the clinic and prepare for manufacturing scale up and late stage development. While we all witness the global impact of vaccine innovation on a scale not seen since the 1950s, bacterial infectious diseases have not historically received adequate attention. As a result, the global incidence of pneumococcal disease continues to climb, driven by emerging serotypes not covered by currently available vaccines. Although the available pneumococcal conjugate vaccines or PCVs for short are effective, the underlying chemistry appears to have reached its limit in terms of its ability to permit addition of serotypes to broaden protection without diminished overall immune responses, jeopardizing their long term protection. Our strategy is to overcome such limitations by applying advanced chemistry and modern synthetic techniques, including the XpressCF, cell-free protein synthesis platform to produce vaccines that are uniquely capable of breaking down bacteria's complex defense mechanisms while preserving immunogenicity across the broader spectrum of coverage. Our site specific conjugation technology allows us to engineer a broader spectrum PCVs designed to avoid carrier suppression in ways that we anticipate will afford our PCV franchise an opportunity to surpass the coverage of other pneumococcal vaccines. With this competitive advantage, we believe VAX-24 our lead 24-valent vaccine candidate has the opportunity to be a best in class PCV in both adults and pediatrics in an already $7 billion global market that is poised to undergo significant further growth. Our recent achievements with VAX-24 have paved the way for a surge in momentum in 2022 as we reached key anticipated milestones, just last week, we announced the dosing of the first participants in the VAX-24 phase 1 portion of our Phase 1/2 clinical study in adults and anticipate announcing the top line results of both the Phase 1 and Phase 2 portions by year end. This study is designed to determine the optimal dose of VAX-24 based on safety and immunogenicity and to inform how we power a future pivotal Phase 3 immunogenicity study in adults. The immunogenicity data from the Phase 2 portion of this study should tell us if one or more of the VAX-24 doses can meet or exceed the non inferior immune response threshold on a serotype by serotype basis that is required for regulatory approval. If achieved, this milestone has the potential to represent a major inflection point for the company. We remain excited about the adult pneumococcal vaccine market, given it represents approximately $2 billion in annual sales and has the opportunity to grow significantly based on a number of key factors. First, we've seen premium pricing justified for broader spectrum PCVs, including both of the recently FDA approved products, Pfizer's 20-Valent PCV Prevnar 20 or PCV 20 and Merck's 15 Valent PCV or PCV 15. This validates the value associated with broader disease coverage once again. Second, late last fall, the CDC's Advisory Committee on Immunization Practices or ACIP recommended a PCV for certain risk groups ages 19 to 64, which further expands the adult market given approximately 30% of adults aged 50 to 64 fall into one of these identified risk groups. Third, during the same ACIP meeting, there was a strong desire expressed by several committee members to lower the universal adult vaccination recommendation from 65 years of age down to 50 years of age and up, this move alone would significantly expand the potential size of the adult market. And lastly, by lowering the age recommendation to 50, we may see the door open to a prime boost PCV regimen in adults, which would further grow this market and provide longer term protection to the elderly population. This could be enabled if a broader spectrum PCV such as VAX-24 were approved, which would eclipsed the coverage of the older polysaccharide only vaccine Pneumovax 23 and could lead to its removal from the treatment schedule. So we believe VAX-24 is very well positioned in the current market and will have an opportunity to capitalize on additional growth drivers given its potential spectrum of coverage. Importantly, positive results from the ongoing phase 1/2 study will put us in a position to trigger additional development activities with our PCV franchise. Upon completing the phase 1 portion of this study, we plan to expand the backs 24 program into the 65 and up population and upon positive data from the phase 2 portion into the well established and large pediatric segment. Subject to a pre-IND meeting with the FDA, we would expect to be able to submit a pediatric IND application in the first half of 2023. As part of our PCV franchise strategy, we continue to aggressively invest in VAX-XP. Our PCV candidate with an expanded breadth of coverage of greater than 30 strains. This parallel investment has put us in a position to provide guidance for the anticipated submission of the adult VAX-XP IND application following the announcement of top line results from the VAX-24 phase 1/2 study. Beyond our PCV programs, we continue to make progress with our other pipeline candidates. VAX-A1 our vaccine to prevent group A Strep infections is now an IND enabling activities. We anticipate providing clear guidance on the expected timing for our VA-A1 IND application submission in the second half of this year. The global need for a vaccine to prevent group A Strep is compelling in both children and adults making this an exciting follow on opportunity behind our PCV franchise that would allow us to once again target a large and broad population. And finally, VAX-PG our vaccine designed to treat periodontal disease continues to progress and we intend to nominate the final candidate by the end of this year. To support these programs we strengthened our balance sheet by completing a $115 million follow on offering earlier this quarter. With this incremental capital, we believe we have the resources to fund our operations for at least 12 months past the anticipated announcement of the VAX-24 Phase 1/2 top line results, which is noted is expected by year end. I'm incredibly proud of what we have achieved and look forward to what promises to be the most important year in the company's history thus far. I'll now turn it over to Jim Wassil, who will share additional information about VAX-24, including the Phase 1/2 clinical study design and our VAX-XP and VAX-A1 programs.

Thanks, Grant. Before I get into the key accomplishments for VAX-24 and our anticipated milestones as we advanced our clinical program, I want to reiterate what Grant shared with you about the significance of the PCV opportunity in front of us. The public health community continues to affirm the need for broader spectrum pneumococcal vaccines to prevent pneumococcal disease. Infection caused by Streptococcus pneumoniae bacteria that can lead to basic disease such as meningitis and bacteremia and non invasive disease, including pneumonia. Our PCV franchise is intended to improve upon existing vaccines by covering the serotypes responsible for most of the remaining pneumococcal disease currently in circulation, while maintaining an immunogenicity profile comparable to if not better than Prevnar. With our novel technology, we believe we can go beyond traditional vaccine approaches, as well as some new technologies like mRNA when it comes to addressing bacterial diseases. As a result, our objective is for VAX-24 to replace the collection of standard of care vaccines with a single broad spectrum PCV that includes all of the serotypes covered by the currently marketed vaccine. Now let's turn to the significant progress we've made with VAX-24 and what's to come. In the fourth quarter of 2021 we complete the manufacturing process for the VAX-24 GMP drug product, submitted our IND application to the FDA. With the VAX-24 Phase 1/2 clinical study now underway, we expect to announce the top line safety, tolerability and immunogenicity results by the end of the year. Upon receipt of these top line data will have a good indication of the probability of success of VAX-24 for the adult in patient. Now I'm going to walk you through the Phase 1/2 key study objectives, design and success criteria. This is a randomized observer blind dose findings controlled study designed to evaluate the safety, tolerability and immunogenicity of VAX-24 in healthy adults. Phase one portion will enroll approximately 64 healthy adults aged 18 to 49 to assess the safety and tolerability of each of three VAX-24 doses and compare it to PCV 20 the standard of care selected for our study. Participants will be randomized equally into four separate arms and will be evaluated for safety 8 and 29 days after dosing. The DMC will evaluate these data to which we will remain blinded before making a-go-no-go decision to enable us to proceed to Phase 2. Based on our preclinical data and product profile, we anticipate the safety and tolerability of VAX-24 will be generally consistent with that of Prevnar a vaccine with more than 1 billion doses administered worldwide. The Phase 2 portion is significantly larger and will enroll about 800 healthy adults aged 50 to 64. We will evaluate immunogenicity, along with safety and tolerability for the same three doses of VAX-24 in compared to PCV 20. Immunogenicity will be assessed based on the antibody response using IgG and OPA for the 20 serotypes in common with PCV 20. For the additional four serotypes contained in VAX-24 and Pneumovax 23 ubt not in PCV 20 immunogenicity will be measured based on a fourfold rise in antibody titers. Participants will be randomized equally into four separate arms and approximately 28 days after participants are dosed. Samples are collected to assess immunogenicity. Our top line data will be based on the results as of this one month assessment, as well as the safety and tolerability observations throughout this period. For immunogenicity our goal is to show not a theory versus PCV 20 on a serotype by serotype basis which is the regulatory approval requirement for a Phase 3 study. We may see some serotypes in VAX-24 outperform PCV 20 instead of a new bar for providing protection. It's important to remember that this is a proof of concept study. So there are a range of potential and accessible outcomes as we have seen with other FDA approved PCV. All participants in the Phase 1/2 study will be followed for a total of six months after dosing to assess safety and tolerability. Ultimately, this study will help determine the optimal dose of VAX-24 relative to PCV 20 and how we power the pivotal Phase 3 immunogenicity study. In the Phase 3 study a primary endpoint will assess non inferiority versus the standard of care based on OPA; the measure of functional antibody responses against pneumococcus on a serotype by serotype basis. Non inferiority is defined as greater than or equal to 50% of the OPA responses to the lower limit of the confidence interval relative to PCV 20. This is the same endpoint that served as the basis for the recent FDA approval of PCV 15 and PCV 20 in the adult population. For these approvals, as well as the prior approval of PCV 13 in infant field efficacy studies were not required. We plan to pursue the same path for VAX-24 with regulators. This study is just the beginning of multiple milestones for VAX-24 as we continue to build momentum. To add to our body of data in adults, we plan to conduct a second Phase 2 study. This is in adults 65 and older upon the successful completion of the phase 1 portion of the ongoing trial. The top line data from this study is anticipated in the first half of 2023. As Grant noted, we also plan to move into the pediatric segment with an IND application submissions in the first half of 2023 adding positive top line data from our ongoing clinical study and a pre-IND meeting with the FDA. VAX-XP is also an important part of our strategy as it includes strains that cover over 90% of pneumococcal disease currently circulating in the U.S. Preclinical data presented last fall during it weeks showed VAX-XP exhibited conjugate like immune responses for all 31 serotypes, as demonstrated by IgG immune responses that were superior to polysaccharide based vaccines and comparable to Prevnar 13. Additionally, all serotypes and VAX-60 elicited a T-cell dependent immune response as demonstrated by the increase in IgG titers post boost. As Grant noted, we continue to invest in this program towards an IND filing. Beyond our PCV franchise our VAX-A1 program also leverages unique features of our platform technology. VAX-A1 our novel conjugate vaccine candidates designed to prevent infection caused by group A Strep targets a whitespace, where we have an opportunity to break new ground and address substantial disease in both adults and children. Group A Strep is a pervasive disease that results in 700 million cases of illness each year. It's one of the leading infectious disease related causes of death and disability worldwide, with an estimated 500,000 deaths globally. Yet the majority of group A strep infection flee to pharyngitis, commonly known as strep throat, which is highly prevalent in school aged kids. Case have indicated that antibiotic resistance to Group A strep has significantly increased over the past decades, leaving the CDC categorized group A Strep as a concerning threat. VAX-A1 leverages a proprietary conserved polysaccharide antigen conjugated to a Group A Strep specific protein carrier. Our site specific conjugation technology allows us to precisely bond the polysaccharide to the protein carrier, avoiding both the T-cell and B-cell epitope to optimally present both the polysaccharide and protein to the immune system. We look forward to providing guidance on the anticipated IND submission timing in the second half of 2022. With that, I'll turn it over to Jeff to provide VAX-PG program updates.

Thanks Jim. VAX-PG is our novel therapeutic vaccine candidate designed to treat periodontal disease. It leverages a key application of our cell free protein synthesis platform, which has the ability to make tough to make protein antigens. Periodontal disease impacts approximately 65 million adults in the United States globally severe periodontal disease affects 10% to 15% of the adult population, resulting in productivity losses that are estimated at nearly $54 billion per year. VAX-PG porphyromonas gingivalis, the key pathogen responsible for periodontitis. VAX-PG incorporates protein antigens that we believe are uniquely enabled with our technology, due to their inability to be produced in conventional production vectors either at all or at sufficient yield to permit commercial scale supply. We continue to make progress on our early stage work for this program, and as Grant shared are planning to nominate a final VAX-PG candidate by the end of 2022. Beyond our named programs, we continue to leverage our novel platform to develop new vaccine candidates to prevent or treat bacterial infections. XpressCF cell free protein synthesis platform and strain promoted quick chemistry allow us to produce vaccines that are uniquely capable of breaking down bacteria's complex defense mechanisms while preserving immunogenicity. Numerous papers republished in 2021, which have validated our platform approach. I would now like to turn the call over to Andrew who will provide a financial update.

Great, thanks, Jeff. I'll briefly cover a few financial points before turning it over to Grant for our closing remarks. With respect to the income statement, the details of our fourth quarter and year end 2021 results and the reasons for the variances to the comparable 2020 periods are reflected in our 10-K filing and summarized in our press release. In summary, the year-over-year increase in R&D expenses was primarily the result of an increase in costs related to our VAX-XP program and headcount growth, partially offset by a decrease in VAX-24 related costs. The increase in G&A expenses was driven primarily by costs associated with our headcount growth and our first full year of operations as a public company. As we look forward, we expect a substantial increase in 2022 expenses over a full year and Q4, 2021 annualized levels, particularly in R&D. We expect a significant increase in R&D expenses is primarily a function of advancing VAX-24 into the clinic, scaling up our manufacturing activities in anticipation of a VAX-24 Phase 3 program, and IND enabling activities for VAX-XP. Turning to the balance sheet and cash runway. We continue to maintain a strong balance sheet. We ended 2021 with $273.1 million in cash, cash equivalents and investments and earlier this year, we completed a follow on offering in which we raised an estimated $107.6 million in net proceeds. Going forward, we expect that our balance sheet will be sufficient to fund our operating expenses and capital expenditure requirements through at least 12 Months pass the announcement of the top line data from our phase 1/2 clinical study of VAX-24 in adults. We will continue to remain disciplined in our allocation of capital based on our priorities and progress. With that, I'll now turn the call back over to Grant for some closing remarks before we open up the line for Q&A. Grant?

Thanks, Andrew. What we have achieved over the past year has been remarkable, given the level of complexity associated with manufacturing a 24-valent PCV and I would like to recognize the entire Vaxcyte team and our partners at Lonza for their many contributions. The coming year is an important one for the company and we will remain focused on executing the phase 1/2 VAX-24 clinical study to announce the anticipated top line data by year end, expanding the VAX-24 clinical program into additional populations and preparing for manufacturing scale up and late stage development, investing in VAX-XP to ensure optionality with our PCV franchise and continue to make progress with VAX-A1 and VAX-PG. 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. [Operator Instructions] Our first question comes from Komal Patel with Bank of America. You may proceed with your question.

Hi, everyone, thanks for taking my questions. So my first question is, what would management view as a highly positive outcome from its Phase 1 adult vaccine study? And what are the key parameters why -- with which management will judge the success of the trial? And then for the multi valent pneumococcal vaccine development? What are your latest thoughts on the sort of product profile needed to facilitate [indiscernible] like winner takes all market scenario?

Thanks for that question Komal. Was that it?

Yes.

Yes. Okay. Very good. So two parts to that one. I'll let Jim Wassil, our Chief Operating Officer answer the question with regard to what we would consider a success out of the phase ½ study. Jim, do you want to go ahead?

Sure. So in the phase 1/2 as I said on the call, we are going to be starting with a phase 1 safety analysis and then we're going to be shifting quickly in the phase 2. For the Phase 2, we will be doing a comparison of the immunogenicity between our VAX-24 and PCV 20. I think what we are expecting is because of our platform, because of our site specific conjugation that we're going to be able to achieve a geometric mean ratio that is at least as good if not better than PCV 20 on a serotype by serotype basis. And that's where we'll be looking at. Obviously, we'll be doing a dose choice to move into Phase 3. So we'll be making the choice of which dos to move forward. But just to mention that even if we aren't able to demonstrate superiority on a stereotype by serotype basis, the FDA has set a requirement of having at least half the serotype response as the standard of care to be able to move forward to a Phase 3 and ultimately to licensure. So even if we're not able to achieve superiority, we believe we've got a large room where we can make a sufficient immune response and move forward.

Great. And then with regard to your second part as it relates to potentially getting VAX-24 on track for a preferred recommendation [indiscernible] recommendation relative to [indiscernible], yes I mean, I think, there are two key aspects of why we think that VAX-24 is well-positioned to potentially obtain a preferred recommendation. And that is the relative incremental coverage that VAX-24 could provide over and above PCV 20. So the 10% to 15% advantage that Prevnar 20 had relative to the 15-valent vaccine for Merck which allowed it to be recommended as a standalone vaccine is similar to the amount of coverage that we would expect to have over and above the 20. So that's one aspect of the reason why we have a level of confidence. But then there's an important additional dimension, which is the current standard of care recommendation in adults from the ACIP is either PCV 20 or PCV 15 plus Pneumovax. So the reality is that the current coverage of either the PCVs are not adequate to fully cover the 23 strains that are in Pneumovax and that older polysaccharide only vaccine continues to be part of the regimen and with a 24 valent PCV like VAX-24, it would entirely eclipse the coverage of Pneumovax 23 in a way that could allow the ACIP to remove that vaccine altogether which would obviously simplify the regimen to a single vaccine altogether and would open the door to a prime boost for PCVs in the adult population, which of course is the same approach that we use in children. And that's been a key sticking point that's prevented a lowering of the universal recommendation age below 65. Now, there were discussions at the last October ACIP meeting where they discussed lowering the age down to 50. But there was real anxiety about having Pneumovax used in a way that could interfere with the boost with the PCV later on. So if we can deliver that kind of incremental coverage which we believe we will and be able to remove Pneumovax from the regimen, we think that could be a compelling argument that could justify a preferred recommendation in the adult market.

Thank you, so much.

Yes, thanks Patel.

Thank you. Our next question comes from Louise Chen with Cantor. You may proceed with your question.

Hi, congratulations on all the progress this quarter. And thanks for taking my question. So first question I have for you is ACIP recommendation aside, how do you think you will effectively compete with some of these larger companies in this space. And then secondly, how do you see the market playing out if both your VAX-24 and VAX-XP make it to the market. How do you plan to market two of them together? And then, last question I have for you is so how did you think about that fourfold rise in antibody titer corresponding to good efficacy in the Phase II portion of your VAX-24 study. Thank you.

Great, thank you, Louise. I think that was a three-part question. So how are we going to compete with the oligopolists, how would we think about VAX-24 and VAX-XP potentially coexisting and then the fourfold rise piece. Maybe I can take the first two parts of that and then ask Jim to comment on the rationale for the fourfold rise piece. So yes, I think obviously Pfizer and Merck are extremely formidable competitors who have a very vested interest in maintaining their stake. But I think the way that we view this is there has been substantial precedent over the years for broader spectrum vaccines usurping lesser valent vaccines and we've seen that time-and-time again whether it was tri valent to quarter valent flu vaccine, whether it was Gardasil versus Cervarix in the HPV market which led to the greater coverage from Gardasil eventually resulting in a withdrawal of use of Cervarix in the U.S. altogether. So the path that we're on is one where we are able to leverage the same basic components that have resulted in such an effective approach to prevent these types of bacterial infections. But we found a way to put us on a path to produce broader spectrum versions. And so for us, if we're able to deliver along the lines of what I just described in terms of what would justify a preferred recommendation, it should put us in a position to have a compelling case to the key decision makers both from a regulatory perspective and then a conduct perspective through the ACIP. So if we can deliver that kind of profile and if we can deliver the sort of volume that would allow for a supply of a universal recommendation sort of magnitude, I think it'll put us into a really strong position and this is not a market where you need to deploy 1000s of sales reps to drive adoption. It's really critical singular bodies in each sober nation that are making these decisions about coverage. So I think we're well-positioned that we've been well-capitalized and we're not going to sell ourselves short but that’s kind of how we're thinking about it in this moment. Obviously we've got a long way to go. As it relates to VAX-24 and VAX-XP, we've realized that we do have this unique ability to add incremental coverage without facing the same immunological diminution that the conventional chemistry has resulted in. And so, we do have VAX-XP waiting in the wings if you will but in terms of actually bringing the products to market, you do have this cascade that occurs by virtue of initially developing these vaccines in the adult population. It's a shorter path, it’s a single dose in this moment as opposed to the pediatric indication where they receive four vaccines over a 15 month timeframe. So it naturally puts adult pace of development ahead of infants. So you could imagine a scenario where everything goes as we hope where VAX-24 could obtain initially an adult approval and recommendation followed by an infant approval and recommendation. And then, VAX-XP could come in thereafter in adults and then again cascade into infants. So, there is a natural progression to how these work and that's why we want to keep VAX-XP within striking distance because these vaccines have been so effective historically when that when you vaccinate with them, those included strains or effectively taken out of circulation and it only makes those incremental strains more in epidemiologically relevant. And that's the rationale behind VAX-XP as a fast forward. And that's how we see them cascading into the market. But to have both in the same indication, would be unlikely, it would be more of a replacement sort of strategy. So, if that answers the first two parts, I'll ask Jim to comment on the fourfold rise. Jim, approach.

Sure, thanks Grant. With the fourfold rise, it's sort of a two part answer. The first is we looked at the recent approvals of PCV20 and PCV15. PCV20 use a comparison of non-inferiority versus Pneumovax to determine whether or not they too get license here. However, PCV15 looked at fourfold rise, so they looked at a statistically superior fourfold rise versus PCV13. So we had two options available to us based on precedent to be able to we felt to get an approval for VAX-24. Now with the ACIP in October making a recommendation, we were going to do the comparison and we still are doing a comparison against PCV20 where the recommendation is to use PCV15 and Pneumovax or PCV20. Since PCV20 is our competitor, we decided to use that and to go with the fourfold rise and we believe that that's based on the regulatory precedent as well as the recommendation by the ACIP will give us good indication of success for Phase 2.

Okay. Thanks Louise.

Thank you.

Thank you. [Operator Instructions] Our next question comes from Joseph Stringer with Needham & Company. You may proceed with your question.

Hi, this is Ben Ricardo on for Joseph Stringer. Thanks for taking our question. Just one about sort of the COVID related impacts. So could we just talk about any potential impacts on the upcoming VAX-24 trial based on having a larger-than-anticipated winter, COVID season, or a smaller one coming up? Thanks a lot.

So this is Jim Wassil on for Jim Wassil. And we're seeing the clinical program as well. We don’t expect COVID to have an impact. Our initial study is in 18-year-old to 49-year-olds. And that healthy 18-year-old to 49-year-old cohort is sufficiently large that we don’t foresee that will have any issues with enrollment. The Phase 2 is age 50 to 64, same thing; sufficient cohort there. Our main exclusion criteria for enrollment is actually not having an experimental vaccine either before, during, or six-months after. Given the majority of the individuals have already received all their COVID shot. We are able to enroll sufficient subjects without having any exclusion. So we feel -- will be able to move along just as fast as we originally anticipated.

Yes. and then maybe worth pointing out, Ben, that there isn’t a seasonal component to executing these trials, that one of the nice aspects of developing a follow-on pneumococcal conjugate vaccine is that these are just studies focused on safety and immunogenicity. So, there isn’t an infection rate component to this. We don’t have to follow the subjects who've been vaccinated to confirm that they don’t contract a Strep pneumonia infection. These are just immunizing the subjects and following them for 30 days in this Phase ½ study, the Phase 2 study in particular where we're looking at immunogenicity. So we don’t need to run those big field efficacy studies that are the convention when you have to show efficacy. These are validated surrogate immuno endpoints. So that's not an aspect of executing these particular trials.

Great, thank you.

Thanks, Ben.

Thank you. And I'm not showing any further questions at this time. I would now like to turn the call back over to Grant Pickering for any further remarks.

Well, I just want to thank you all for your interest and for participating in the call today. And have a good rest of your week. Thank you, very much.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.