Vaxcyte, Inc. Q4 FY2020 Earnings Call

Good afternoon. My name is Sarah, 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. 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 the financial results for the quarter and full-year ended December 31, 2020, and to provide a business update. I am joined today by our CEO, Grant Pickering; our COO, Jim Wassil; and our VP of Research, Jeff Fairman. Earlier this afternoon, Vaxcyte issued a news release announcing the company's results. Copies of our 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 include statements regarding the anticipated process and timing of the development of our vaccine candidates, the timing of our IND application submission and top-line data from our clinical proof-of-concept study for VAX-24, the potential benefits and market of our vaccine candidates and technology platform, and impact of the COVID-19 pandemic on our business, the payments of milestones, and our expected uses and sufficiency of cash and other funding to support our development programs and other operating expenses. These 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, 2020, and any subsequent reports filed with the SEC.

Thanks, Andrew. And all of you on the call and webcast, thanks for joining us today. The past year has been transformational for Vaxcyte as we have made meaningful progress across all areas of our business. This was highlighted by the progress of our vaccine pipeline, which continues to illustrate what we believe are the unique competitive advantages and scalability of our technology platform to enable us to deliver broader spectrum and/or more immunogenic vaccines. Our lead vaccine candidate is VAX-24, a 24-valent investigational pneumococcal conjugate vaccine, or PCV. For this program, we have achieved several key manufacturing milestones to support our IND application submission to enable the initiation of our clinical proof-of-concept study. VAX-24, along with VAX-XP, forms the basis of our PCV franchise strategy, targeting the existing $7 billion pneumococcal vaccine market. VAX-24 is designed to improve upon the standard of care in this market by covering the additional strains that are responsible for the majority of residual pneumococcal disease currently in circulation. Based on the data we've generated to date, we believe VAX-24 has the potential to protect against the strains collectively covered by the leading PCV, Prevnar 13, and the older less immunogenic form of vaccine, called Pneumovax 23. We believe that VAX-24 has the opportunity to replace both standard of care vaccines with a single broad spectrum PCV. Our site-specific conjugation technology creates a competitive advantage that allows us to engineer broader spectrum PCVs designed to avoid carrier suppression in ways that we believe will afford our PCV franchise an opportunity to surpass the coverage of our competitors, which has been the key adoption determinant in this market. For VAX-XP, we continue to lay the groundwork to support a level of readiness to push the spectrum of coverage even further to address newly emerging strains and expand our competitive advantage. Today, we are announcing compelling new data generated with our latest conjugates produced at larger scale at Lonza, our CMO. We also made significant progress on our prophylactic vaccine candidate VAX-A1, which is designed to prevent Group A Strep infections. This work led to nominating our final vaccine candidate in the first quarter of this year, accomplishing one of our stated 2021 milestones. The global need for a vaccine to treat Group A Strep is clear. Based on our recently published data, we are increasingly excited about the potential to deliver a best-in-class and first-in-class vaccines for multiple age groups. We also continue to advance VAX-PG, our vaccine designed to treat periodontal disease, and anticipate nominating the final candidate in the second-half of this year. Behind the scenes, we are also making progress with earlier-stage vaccine discovery programs that leverage our platform. Aside from our pipeline progress, we executed two successful financings in 2020, raising gross proceeds of $110 million in our Series D financing in March, and $287 million in our IPO in June. As a result, our balance sheet remains strong to fund our programs through the anticipated key VAX-24 clinical proof-of-concept milestone. And finally, we added a number of key leaders and team members to support the advancement of our pipeline, our transition to being a public company, and the overall growth of our business. While we achieved several significant IND enabling milestones over the past year for VAX-24, we are changing our estimate for the timing for our anticipated IND submission from the second half of 2021 to now between January and June of 2022. This change is due primarily to additional time required to complete the ongoing drug substance manufacturing along with capacity constraints at our CMO and the impact from the COVID-19 pandemic. Jim will share additional background on this shortly. With respect to our Phase 1/2 clinical study that will follow the IND submission for VAX-24, we expect to deliver the top line data between late 2022, which is within our prior guidance, and early 2023. Given the magnitude of the market opportunity and the attractive profile of our PCV candidates, we’re committed to taking the necessary steps in time to deliver the 24 conjugated drug substances that we believe will maximize our potential for long-term success. We believe the scalability of our technology platform is unrivaled, allowing us to deliver the broadest spectrum PCVs, while still honoring the key conventions of proven PCVs, which have been tremendously successful to-date. Vaccine developers, particularly those targeting invasive pneumococcal disease, have generally been focused on overcoming two challenges. The first is carrier suppression, and the second is antigenic competition. To date, the preclinical data for VAX-24 has demonstrated the potential for our platform to overcome these challenges. This is further exemplified by VAX-XP, where the latest preclinical data that we are sharing today show robust immunogenicity across the board with an even broader spectrum PCV compared to the standard of care vaccines. The results are available for review in our 10-K and updated corporate overview presentation that’s now available on our website. These data give us further confidence that we have a PCV franchise that has the potential to attain a leadership position and maintain that position in the long run despite spirited competition. I’ll now turn it over to Jim to give you a more detailed update on our pipeline beginning with VAX-24.

Thanks, Grant. Before I get into our accomplishments for VAX-24 and status update, I think it would be helpful to review the manufacturing process for this program and the remaining activities necessary to enable the IND application submission. As we previously shared, the manufacturing process for VAX-24 included the following four steps. First, we manufacture eCRM, our proprietary protein carrier. Second, we manufacture 24 pneumococcal polysaccharides, one for each of the serotypes included in VAX-24. Third, we manufacture 24 conjugated drug substances, which consist of three discrete stages; first, each of the 24 polysaccharides is sized to a targeted molecular weight, then a linker is attached to each of the 24 sized polysaccharides to generate 24 activated polysaccharides. Finally, the 24 activated polysaccharides are conjugated or covalently linked to the eCRM carrier protein, resulting in the 24 conjugated drug substances. The fourth and final step of the process includes the manufacturing of the drug product by mixing the 24 conjugated drug substances and filling them into vials. To-date, we’ve made significant progress towards our IND filing, including a number of key accomplishments in the past year. We’ve successfully completed the GMP manufacture testing and release of both the eCRM carrier protein and the 24 pneumococcal polysaccharides. For the conjugated drug substance, we’ve now successfully sized and activated each of the 24 polysaccharides and are in the midst of the manufacturing of each of the 24 conjugated drug substances. Earlier this year, we successfully manufactured our initial drug product batches with our 24 conjugate at Lonza. These batches will serve as the source of our lead block stability data for our IND. We also successfully completed manufacturing of drug product batches used in the GLP toxicology studies and initiated the GLP toxicology study in the first quarter of this year. Now, before we submit our IND, we still have a few outstanding items, which include, first, completion of the GMP manufacturing testing and release of the conjugated drug substances and drug product; second, completion of the GLP toxicology study that is currently underway; and third, generation and submission of stability data resulting from the GMP drug product. As Grant mentioned, we’re updating our guidance for the VAX-24 IND submission as a result of a few factors, which I will provide more detail on. First, as we have progressed through the manufacturing of the 24 drug substances, we have experienced some process-related issues as we transitioned into GMP production at Lonza. In and of themselves, these have only caused minor delays across the three stages of production, but taken together, they have resulted in a meaningful cumulative delay to the campaign. While these adjustments are typical for this stage of vaccine development and our initial guidance has accounted for process modifications, we underestimated the cumulative impact of these changes. As I noted, we have progressed successfully through the first two stages of the drug substance production campaign and are in the midst of the final stage of conjugating the 24 drugs substances. Ultimately, before we are able to complete the final conjugation stage, we encountered an interruption of the drug substance manufacturing campaign at Lonza. Now working with a world-class team such as Lonza has many benefits; however, they also have numerous clients with late stage clinical and commercial products. As a result, our GMP conjugate manufacturing campaign was unfortunately interrupted due to Lonza’s prior customer commitments. The good news is that we have resumed our manufacturing campaign, the early data of which are encouraging, and we are working towards completing the 24 conjugated drugs substances. Finally, the COVID-19 pandemic created some operational headwinds, travel restrictions delayed the qualification of key analytical equipment and in-person CMO oversight. We also saw raw material supply chain issues slow down. Fortunately, we do believe these issues have now been resolved. All in all, we have made substantial progress towards delivering the VAX-24 IND and look forward to completing the remaining deliverables for our current guidance. As previously noted, we’re also announcing today new immunogenicity data for our VAX-XP, our PCV candidate with expanded breadth of coverage of at least 30 strains. The strains in VAX-XP cover over 90% of invasive pneumococcal disease currently circulating in the United States. The new data demonstrates the potential scalability and robustness of our technology platform. Importantly, they also demonstrate that during the scale-up and transfer to Lonza, the fidelity of the process was maintained. In this study conducted in rabbits, we compared VAX-XP to more than 30 different pneumococcal serotypes including all those contained in Prevnar 13. The results show that VAX-XP immune responses were at least comparable to Prevnar 13 and superior to polysaccharide-only serotypes like those contained in Pneumovax 23. Before turning it over to Jeff to provide an update on the status of VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections, I want to touch upon the increasing global need for a vaccine to address this serious pathogen. Group A Strep is a ubiquitous disease causing an estimated 700 million cases of disease globally. The majority of these are pharyngitis, or strep throat, which results in significant usage of antibiotic prescriptions and consequently are a source of increased antibiotic resistance. Group A Strep can also have grave outcomes. There are an estimated half a million deaths per year globally due to the combination of rheumatic heart disease and other invasive diseases. Traditionally thought of as a childhood disease, the rate of invasive disease in the elderly has increased substantially over the past decade. In the U.S., the annual rate of invasive disease in adults 65 and over has more than doubled since 2012 and is now more than three times the rate of invasive pneumococcal disease when the CDC recommended Prevnar 13 for the adult population. This creates an opportunity to develop VAX-A1 not only for children, but also for adults. We believe VAX-A1 has first-in-class and best-in-class potential to address this significant need. With that, I'll turn it over to Jeff to provide a program update.

Thanks, Jim. VAX-A1 leverages one of the key applications of our cell-free protein synthesis platform, the ability to produce site-specific polysaccharide protein conjugates. The resulting conjugate is designed to ensure optimal exposure of both the B and T cell epitopes on the protein carrier to confer robust, boostable, and durable protective immune responses. VAX-A1 was designed to confer broad protection against subtypes of Group A Strep. It includes a conserved polysaccharide polyrhamnose conjugated to a Group A Strep-specific immunogenic protein carrier using our site-specific conjugation technology, along with two highly conserved protein virulence factors that, when left unchecked, interfere with the body's ability to respond to the infection. By using these conserved antigens, we believe that our investigational vaccine could address the full range of pathogenic serotypes of Group A Strep. We continue to make solid progress with this program. Earlier this year, we nominated our final vaccine candidate consistent with our target timeline. In connection with this nomination, we recently completed the first phase of our award under our agreement with CARB-X. In addition, at the beginning of this year, we announced the publication of preclinical data from our program in infectious microbes and diseases. In the published study, which was carried out in collaboration with researchers at the University of California, San Diego, VAX-A1 showed broad and significant protection against systemic and soft tissue infection after animals were challenged with near lethal amounts of Group A Strep bacteria. Broad-based cross-reactivity with multiple serotypes of Group A Strep was observed in the serum of vaccinated animals. No cross-reactivity was detected with human heart or brain proteins, which is a key leading indicator of vaccine safety. Looking ahead, we expect to initiate IND enabling activities in the second half of this year and are currently working with CARB-X to finalize the next potential phase of our cost reimbursement research award with them. VAX-PG, our novel therapeutic vaccine designed to treat periodontal disease, leverages another key application of our cell-free protein synthesis platform, the ability to produce and test protein antigens. Periodontal disease affects an estimated 65 million adults in the United States. Globally, severe periodontal disease afflicts 10% to 15% of the adult population, resulting in productivity loss estimated at nearly $54 billion. Periodontitis has also been shown to be associated with an increased risk of heart attack, stroke, cardiovascular disease, and Alzheimer's disease. VAX-PG targets porphyromonas gingivalis, the keystone 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 factors either at all or at sufficient yields to permit commercial scale supply. We have established preclinical proof-of-concept for this program based on the data published in the Journal of Clinical Periodontology. In the study, VAX-PG demonstrated robust protein-specific IgG responses following immunization and protected mice from P. gingivalis-elicited oral bone loss, which is a clinical manifestation of periodontitis. We are advancing the program toward our corporate target to nominate our final vaccine candidate, which we expect to occur in the second half of this year. The third novel dimension of our platform technology is the ability to conjugate immunomodulatory molecules to candidate antigens. Earlier this month, we and our collaborators published a paper in Scientific Reports where we demonstrated an enhanced CD8-positive T cell response by directly conjugating an adjunct to the candidate antigen. This expansion of our site-specific technology platform has the potential application in viral vaccines when enhanced CD8 T cell responses are required. I will now turn it over to Andrew for a financial update.

Great. Thanks, Jeff. Before turning it over to Grant for some closing remarks, a few financial highlights. First, with respect to the income statement, the details of our fourth quarter and year-end 2020 results are reflected in our press release and 10-K filing along with the key variance drivers. In summary, the year-over-year increase in R&D expenses was primarily a function of the advancement of our VAX-24 program. While the increase in G&A expenses was driven primarily by our transition to public company status and our overall growth. As we look forward, based on our plans to advance our pipeline programs led by VAX-24 and to increase the size of our organization to support these efforts, we expect R&D and G&A expenses to increase substantially over 2020 levels. Secondly, regarding the balance sheet and cash runway, we ended 2020 with a strong balance sheet with $386.2 million in cash and cash equivalents compared to $397 million as of the prior quarter end, and up substantially from the prior year-end due to the Series D and IPO financings during the year. Going forward, we expect our balance sheet will be sufficient to fund our operating expenses and capital expenditure requirements through at least the completion and announcement of the top line data from our Phase 1/2 clinical proof-of-concept study of VAX-24 in adults, which, as noted, we expect between late 2022 and early 2023, and to continue to advance our pipeline of other vaccine candidates. 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.

Thanks, Andrew. Our mission at Vaxcyte is to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. In light of all the external headwinds in 2020, our progress last year, and the continued momentum this year represent substantial strides toward achieving our mission. I want to thank all of our employees and collaborators, including the team at Lonza, for persevering through a tremendously challenging moment in history. For the remainder of 2021, our primary areas of focus would be to deliver on our remaining VAX-24 IND-enabling milestone, invest in VAX-XP to maximize our PCV franchise optionality and value, advance VAX-A1 into IND-enabling activities, nominate the final vaccine candidate for VAX-PG, and advance our earlier-stage discovery programs. With that, I want to thank you all again for joining us today, and your continued interest in Vaxcyte. Before we close our prepared remarks, I'd like to thank Kurt von Emster, who previously held the position of our Board Chair, for agreeing to serve in this role on an interim basis as we initiate a search for a permanent Board Chair. We look forward to your questions today and to speaking with you in the weeks and months ahead.

Thank you. Our first question comes from the line of Jason Gerberry with Bank of America. Your line is now open.

Hi, guys. Thank you for taking my questions. Can you remind us and apologies if I missed this, but how many of the conjugated drug substances have Lonza successfully completed? Just trying to get a sense of where you're at in that process. And, ultimately, the range of outcomes for timing of IND submission is like six months. Can you give us a sense of what are the key variables that drive that range ultimately? I assume it's not the GLP tox study; I assume that's pretty straightforward once you complete some of the other steps along the process. And if you can also just remind us how long the stability testing is? Thanks.

Yes. Hey, Jason, thank you for that question. So, as we mentioned in the prepared remarks, this DS campaign consists of three different stages. So, we've completed those first two stages. As you say, we're now in the process of making the 24 conjugates themselves. We're going to stay away from getting into full specificity as to the number that we made. But I could characterize it as being well on our way to having made the 24. Ultimately, we'll only be able to declare victory once we have made all 24 of those and they pass all of the analytical tests required to meet our critical quality attributes. You got it exactly right, that the GLP tox study is already underway. We don’t expect that to be rate limiting. So, the deliverables that are going to actually result in the ultimate IND submission timing are this completion of the DS conjugates and then being formally released. We have to make them and then complete that battery of analytical tests. Once we complete that, that will allow us to follow through with the drug product campaign to make each of the three different doses that we'll take into the clinical study. And then, of course, there will be an analytical series of tests that are run on those in order to declare victory there. Regarding stability, we've already put the tox lots of the drug substances and the DP on stability. So, these lead lot stability studies have already started. We will need to deliver a month of stability data ultimately to permit the IND filing.

No, that's correct. And Jason, this is Jim. Let me address your question regarding the range of guidance we've provided. As we mentioned, these process-related adjustments are expected and standard in drug development. At this stage, if we see fewer adjustments than anticipated, it would allow us to submit the IND at the early end of the range, which would be early 2022. Conversely, if we encounter more adjustments than expected, we would be pushed to the later end of the range. This explains the time frame we have outlined.

Yes, hi, guys. Thanks for taking my question, maybe just one on VAX-24. Clearly, if you're at the back end of the range, in June 2022, for IND, and your guidance for top line data at late 2022-early 2023, how feasible is that early 2023 timeframe?

Yes, I think

Yes, go ahead, Andrew.

Yes, I was going to say that the top line data range, Biren, generally corresponds with the IND application submission range. So, if we're in a position to deliver the IND application submission in the early part of '22, we believe that would put in a position of having the top line data by the end of the year. If, alternatively, we're at the back end of the application submission range in, call it, Q2, up to June '22, in that scenario we're more likely to have data in the early part of 2023.

Okay. And then I guess a question on VAX-XP, so congrats on the progress there, can you just maybe talk about the read-throughs that you can take on VAX-24 manufacturing to the XP program? And whether manufacturing can be expedited as a result of the key learnings that you've made on VAX-24?

Yes, thanks, Biren. Yes, we're really excited about the VAX-XP data. This just shows the scalability that the platform can deliver in terms of coverage. So we're very encouraged with this immunogenicity data. To put a slightly finer point on it, the incremental conjugates that are on top of VAX-24 that were included in this study, these are conjugates that were made at Lonza at a substantially larger scale than we had produced previously here at Vaxcyte. So this is a 15-fold scale-up akin to what we had done with VAX-24. It's encouraging to see the consistency of the immunogenicity across those incremental strains. The 24 conjugates that were included in VAX-XP that are also in VAX-24 were made in the tox batch that we made at Lonza. We believe that VAX-24 is the fastest path to market for the most important strains, which we need to get solutions for as soon as practicable.

And when can we expect the IND for XP?

It's too early to say what that timing is going to look like for that, Biren. It's going to pivot off the ultimate timing for the VAX-24 IND. We're also going to key off the epidemiological data and the demand for some of these incremental strains that are already becoming more and more important. As that data evolves, that's also going to guide us. To a lesser extent, we're obviously going to be monitoring the competition as well. But for us, VAX-24 is the fastest path to the market. We believe that this would put VAX-24 in a position to not only be the broadest spectrum PCV but also open the door for a prime boost in adults where it would really be valuable for older adults to receive a second, significantly higher boost to create longer lasting protection.

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Shall we move on to the next question?

Hi, congratulations on all the progress during the quarter and thanks for taking my questions. Quite a few, first question I had is how do you think ACIP will update its guidelines as new PCVs get introduced? There are going to be two new ones likely in the near term, and then newer ones to follow with broader coverage. Do you think pricing is going to be a factor here? The second thing I want to ask you is, do you think COVID changes the importance of PCVs for patients? How do doctors feel about that? And the last question I had for you is just on OpEx for 2021. You talked about a substantial increase, and I know you gave some guidance on how long your cash runway goes out, but maybe if you could just give us a little bit more color on what substantial, what qualifies for substantial in your mind and then that breakup between R&D and SG&A, how should we think about that? Thank you.

Yes, great. Thanks, Louise. I heard three questions essentially I'll take one, I'll pass the other to Jim, and then Andrew will comment on the financials. I can start with the COVID-related question before Jim, who is our resident ACIP expert comments on how we expect some of these other PCVs to impact the market. But certainly, as we think about greater risk associated with circulating COVID, especially with the variants in older adults, it shows the importance of having more broad vaccination with the pneumococcal vaccines out there. We saw that early on as the pandemic took hold last year, that the rate of vaccination in Europe and the U.S. was up substantially. This is only going to increase the rate of vaccination in adults with pneumococcal vaccines and will put additional pressure on the spectrum of coverage that's available to create protection for what’s a preventable infection. Jim?

Thanks, Grant. Louise, when you looked at the February ACIP presentations on pneumococcal vaccines, they outlined basically what they think they're going to do; with the June ACIP, they're going to review cost-effectiveness and make their evidence recommendations. They think that if the products are licensed, they could potentially have a vote in October. When you try to figure out what they will recommend, they made a list of policy questions that are under consideration by the working group as well as questions with regard to what they need to evaluate from a health economic perspective. They made inquiries about whether PCV-15 or 20 should be given at age 50 and above or 65 years of age and above. So, they’re potentially considering lowering the age of recommendation down to 50. They also asked if PCV 15 or 20 should be recommended in younger adults with underlying medical conditions. I do think that they will recommend PCVs for the 18 to 49 or 18 to 65 age group that has certain pre-existing conditions. All indications are pointing towards they will continue with giving the PCVs first and then a year later with Pneumovax 23 to ensure that they get the breadth of coverage. We're hoping that ultimately we can reduce the number of shots and not have to do that series going forward.

Yes, sure. Thanks, Jim. You're correct. We did not provide point estimates or range estimates for 2021 operating expenses other than to say, as you noted, we expect both G&A and R&D expenses to increase substantially. I guess a couple of data points I would offer as you think about that hopefully will be helpful. Our G&A expenses over the course of 2020 increased quarter-over-quarter as we built our organization upon the transition to a public company last June, where we saw the effect of things like D&O insurance expenses and higher stock-based compensation levels. We expect year-over-year ‘21, compared to ‘20, to see a substantial increase in G&A. That increase will be more modest compared to annualized Q4 of 2020, because we've largely built out what is required to support a public company status. On the other hand, R&D expenses will fluctuate due to the nature of the underlying activities. Year-over-year, again expecting a substantial increase. If you look at 2020, our peak R&D quarter was actually the first quarter of 2020, given the nature of activities at that time. We still expect a substantial increase in 2021 compared to the annualized R&D number in Q1, but we expect that to fluctuate more just given the nature of the underlying activities over the course of the year.

Hi, everyone. Thanks for taking our question. Just a few quick ones on VAX-A1 and VAX-PG. You laid out some highlights for IND enabling studies; could it be possible that both of those into the clinic preference for advancing either one of those programs at a faster pace or I guess prioritization on one program over the other, or would they be sort of in a parallel fashion? Thank you.

Great, Joe. This is Andrew. I'll take the first part, and then maybe take a crack at the second one, and my colleagues can follow. I would say for each of the programs, VAX-A1 and VAX-PG, we are at this moment not providing guidance as you heard on the prepared remarks for VAX-A1 having nominated the final candidate in Q1, which was on our timeline. We expect to initiate IND enabling activities in the second half of this year among the activities included for VAX-A1 are the selection of a CMO partner and the determination of the CMC path forward. It wouldn’t be until that point where it would be prudent for us to set forth IND guidance, but you should expect us to do that once we have a clear path with respect to the CMO partner. For VAX-PG, it's a little further behind at the moment. We have just nominated our final candidate consistent with our previous timelines. We now expect to do so in the second half of this year, again, consistent with what we outlined. At that point, much like for VAX-A1, we would expect to select the CMO partner and establish a path forward. At which time we likely will be in a position to offer our IND guidance. Overall, vis-à-vis timeline, VAX-A1 is ahead at this point.

Yes. Hey Joe, this is Grant Pickering. I would chime in and just say that A1 is ahead. It also has the benefit of a substantial offset from CARB-X. We’re really excited about the data that we’re seeing from that program where we’re buoyed by the notion that there’s an opportunity to develop this vaccine not only for pediatric regimens but also for adult vaccination. So, we’re moving both programs forward based on the significant potential they each bring to the company. Yes, thanks, Joe.

Thank you. There are no further questions at this time. I would now like to turn the call back over to Grant Pickering for closing remarks.

Yes. Thanks, Sarah. I just like to thank you all for your support of the company. We really appreciate you dialing in. Obviously, we’re disappointed that we’re not going to be able to hit the original IND guidance. We made huge strides last year. We don’t feel that there’s anything in particular that is now going to get in our way. There’s a lot of operational activity required to deliver on a vaccine like VAX-24 with the level of complexity we’re looking at. So, we’re confident in the guidance that we provided today. We really appreciate all of your support and the work that the team has put into this, as well as our colleagues at Lonza. Thank you all very much for your attention today and take care.

Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.