Novavax, Inc. (NVAX) Earnings Call Transcript & Summary

Good morning. I'm Eric Joseph, senior biotech analyst at JPMorgan. And our next presenting company this morning is Novavax, and it's my pleasure to welcome and introduce Stan Erck and Greg Glenn, CEO -- CEO, Stan Erck and Head of R&D, Greg Glenn, to tell us a little bit about the company. Just a quick formatting note. There is a Q&A session after the presentation. So to submit a question, just click the blue "Ask a Question" button, and I can submit it or ask it on your behalf, or you can e-mail me at [email protected]. So with that, Stan, let me pass it over to you for the presentation.

Thank you, Eric. And good morning, and thanks for the opportunity to present today. If we can move on to Slide 3, that would be great. And we'll talk about the agenda. So in the next 20 minutes or so, we will discuss where we are today and where we're going this year. I'll take you through our CoV2373 overview, talk a bit about our unique and differentiated vaccine platform, give an update on the clinical development program, including the immunogenicity data from our Phase II trial and outline our manufacturing and commercial plans for 2021. So if you go to the next slide, from many perspectives, and we switch to the next slide, which will be Slide 5. This gives you an idea of what's happened in 2020. It was a very significant year, given the unprecedented nature of the pandemic with its massive scale and demonstration. We're going to focus our presentation today on of our COVID-19 progress. As we always do, when an emerging virus is identified by the CDC or WHO, we begin working on a vaccine construct. When the SARS-CoV-2 sequence became public on the Internet, we began working immediately within a month of that publication. We identified several as many as 30 vaccine constructs and based on early animal data, selected out our vaccine candidate, NVX-CoV2373, and we'll refer to this as 2373 throughout the presentation. So a few weeks later, we received major funding from CEPI, followed by the U.S. Department of Defense and then operational work speed for a total of $2 billion in [indiscernible] financing. During this time, we signed major deals to expand our supply chain and ramp up large-scale manufacturing. And in parallel, we started our Phase I/II clinical trial, announcing positive data from the trial in early August. And then since September, we have launched 3 efficacy trials, a Phase IIb trial in South Africa and 2 Phase III trials, one in the U.K. and our latest in the U.S. and Mexico. And as important as 2020 was, 2020 (sic) [ 2021 ] is going to be even more important. We've got to report on our Phase II efficacy trial in South Africa and our Phase III efficacy data in the U.K. within a few weeks, and we are enrolling our Phase III trial in the U.S. and Mexico at a very fast pace. And in the first quarter, we expect to finalize multiple advanced purchase agreements. And in parallel, we will assemble regulatory packages with global regulatory agencies, such as MHRA in the U.K., EMA in Europe and the FDA in the U.S. And we are building a commercial infrastructure and establishing partnerships that will allow us to get our vaccine approved for use and distributed globally. And with that, let me turn the presentation over to Greg Glenn, our President of R&D.

Thanks, Stan, and good morning, Eric. Thank you for having us on. So I'd like to start with the -- I'm going to go through the construct we've made, then go into -- directly into the clinical program. So let's go to Slide 8. So we make a recombinant nanoparticle technology platform, and it really is ideal for addressing these global public health threats and especially emerging infectious diseases. And you can see here what's depicted is a viral infection, virus is infecting cells and budding off from the cell. So the recombinant nanoparticle technology is a technology that mimics the features of a viral infection that are needed to stimulate a strong immune response. So the initial virus binding event and subsequent cell infection is mediated by viral surface proteins. So we make these proteins. And we have exquisite recapitulation of the structure as a full-length recombinant protein. The protein is then formulated in a detergent nanoparticle, which you can see in the second circle there. And it's made to replicate the viral surface protein structure and stimulate a highly specific immune response. Now in a virus, you have a danger signal, have other things that are in there that stimulate the immune response. So our adjuvant Matrix-M, which you can see in the third image there, provides a nonspecific danger signal and amplifies the quantity and quality of B and T cell responses. And together, this leads to effective immunity. This nanoparticle vaccine, the protein as you'll see in a second, is very stable. They're mixed together and stored in standard refrigeration. So if you move to the next slide, just touch on the construct we've made. So as you know, it's recombinant, so we can genetically engineer this to be a very stable and natively configured protein. I would note, one of the distinguishing features of our vaccine is its full length. These proteins have a foot that sticks down into a viral membrane, and that's how it works in our nanoparticle. And it's a full-length protein. And you can see here, it's a spike protein, which I think is important because that's -- target now has been well-validated by 2 efficacy studies. It's formulated with Matrix-M, it's highly immunogenic and it's designed -- was designed to be a very stable protein, which allows us to store it in vials as a liquid and a ready-to-use formulation, and it's stable at 2 to 8 degrees Celsius. And so therefore, as a result, it can be shipped and stored in a typical vaccine distribution network. You can see some of the characterization photomicrographs there, and that's in our publications, which are referenced. So speaking of publications, we are a science-driven company. And our work -- with our work, we drive to peer-review publications and everything we do, and this includes 4 recent publications in Science, Nature Communications, New England Journal and Vaccine on our COVID vaccine. And now -- so I'd like to go to the next slide, Slide 11, and touch on one important milestone -- preclinical milestone, which is a nonhuman primate study. So in this study, we immunized rhesus macaques, nonhuman primates with our vaccine, really using the doses and the schedule we expected to use in the clinic and then the animals were challenged at day 38, which would be after the second immunization. And what you can see here on the left side is the recovery of virus -- replicating virus. And you can see in the placebo group, we could recover virus in the lungs. But in the vaccine group, we see no virus and more, I'd say, even important and maybe stunning really is that on the left -- in the right panel there, you can see, again, placebo virus recovered from the nose, but not in the upper and lower airway. So really good result, upper and airway sterile immunity. This would suggest not only can we protect people from disease, but maybe also disrupt transmission. So let's turn to the next slide. We're going to go through our clinical program, where we're making good progress in the clinic. Overall, we immunized more than 25,000 people vaccinated to date in our COVID vaccine program. And so if you go to Slide 13, this provides an overview. We've launched multiple clinical trials in the last months, including beginning with our Phase I/II trial, which is in the upper left, that enrolled subjects 18 to 59 years old. We published that data in the New England Journal, and I'll review that a little bit. The Phase II trial and the Phase III trials we have here, I want to note that these are trials that are aligned in their endpoint definitions, their statistical success criteria and the safety data requirements. So they, as a body, will give us a very important validation to provide the safety and efficacy to provide to our regulators as part of our package. So the South African study, as you can see, it was 4,400 subjects fully enrolled, we expect data Q1 of '21 very soon obviously. U.K. is around 15,000 subjects. Again, another efficacy study. This again, the data readout should be very soon. The U.S. trial, as you know, we have recently started enrolling. That's a 30,000 subject trial. And then we have trials in India, Japan and Czech Republic that will extend the data we need for licensure or fulfillment of requirements in these different countries. So if you go to the next slide, I'm just going to recapitulate some of the data from our Phase I/II trial done in the U.S. So let's go to Slide 15. Remember this trial was a trial safety immunogenicity trial designed to evaluate the 5 and 25-microgram doses, which we expected from our Ebola program to be the sweet spot for our technology. It was 1 in 2 doses, it was placebo-controlled, and you can see here the study design. So just a kind of the key slide here from that trial. On the left, you have the scatter plot showing the anti-spike IgG responses, you can see at day 35. In the red, we've got the 2 dose groups that are of most interest, the 5-microgram and the 25-microgram you can see. There's no difference between those immune responses after 2 doses. And then aligned to it, we have convalescent sera from clinically ill subjects. You can see, we are exceeding the level of immunity from convalescent sera, together suggesting that we've reached a peak response after 2 doses. And on the right, you see the neutralization, really very much we show in our New England Journal paper in this data, that there's a very strong correlation between spike IgG and the microneuts, which is considered a functional response. And you can see here, just pictorially, that you see a very similar response, and again, well in excess of what you see with convalescent sera. So we have some new data today. We have been following these subjects. It's out for 6 months. Remember that trial was going on in July. So we now have 6-month data on the right here. So you can see this data plot a little bit differently as a kinetic. So you can see the day 0 out through the boost. You can see the really important, much higher logs, higher immune response with a 2 dose regimen, no diffs between 5 and 25. You can see out at 6 months, the immune response with 5-microgram with Matrix-M, which is our chosen dose. It actually matches up very closely with the total immune response in the convalescent sera, which obviously would be acute. So this is very encouraging, these robust responses that are persisting after 6 months. You can also see a little drift in the placebo group. So over time, beginning to accumulate some folks that had some infection. If you go to Slide 18. We had designed the program to have a Phase I/II facet to dose confirm. So again, we saw responses that we needed to confirm at 5 micrograms as our chosen dose, compared to 25 and then we expanded. The FDA asked us to expand our data into the older adult populations and we've done that in this trial. So you can see placebo-controlled trial, 1 versus 2 doses, and the population includes both young and older adults. Again, you can see here, it looks very familiar, I hope, looks very, very similar to the Phase I data. Again, we didn't see improvement in the responses by going up to 25 micrograms and the value of the second dose. We do have also the safety data from that trial, which is important for us to provide that. This is the local reactogenicity. I would say, overall, it's well tolerated. The way the legend works is that the gray hatched area is on no reported local reactogenicity and the gray, of course, is mild, and then you can see moderate and severe. So -- and what we've been able to do here, and we provided this data to the CDC, is to break it out by age. You can see there's a little more local reactogenicity after the second dose and a diminished amount of reactogenicity in the older adults at the 5-microgram group. And again, I'd say a very nice-looking profile where the vast majority of subjects were reporting either nothing or a mild reactogenicity. And then on the next slide, Slide 21, this is a systemic reactogenicity, again very similar picture. A little more with the second dose, less with the older adults. We did have some grade 4s. Thankfully, those are life-threatening events. Those are in the placebo. And so you can see here, when you get out in the trial, you collect data like that. And so we're glad that we do not see it in the active group. And again, the vast majority of subjects in the older adults are reporting mild or moderate -- sorry, nothing or mild symptoms, a little -- a few that are in the moderate and smattering of severe event. So really a very good well-tolerated local and systemic reactogenicity profile for our vaccine. So overall, the Phase II trial and the Phase I trial are consistent. They confirmed a 5-microgram dose, which is very convenient. In the vaccine world, this is a very low dose. The immunogenicity, it's -- the antibody responses are maintained through 6 months. They compare favorably even at 6 months to convalescent sera. And the safety really looks quite good, no SAEs, no adverse events of special interest. There is a balance and mostly mild, moderate when we do record events, and we think the vaccine was well tolerated with symptoms of approximately 2-day duration when we did observe symptoms. Okay. So very active now. Go to the next slide. We're very active in the efficacy setting. As you probably know, we'll be announcing the interim data from the Phase IIb this quarter. So it's coming up quite soon. This trial is going well. The South African trial was a trial designed to enroll 4,400 adults, 18 to 65 years of age. We have HIV-positive subjects embedded in this trial. The sites we engage had special expertise with this area. And you can see it either received the chosen dose of 5 micrograms of the recombinant spike with 50 Matrix or placebo. This trial will read out. Now we had -- the trial allows us to read out between 23 and 50 events. We think we'll be reading out on the upper end of that. And again, as I mentioned earlier, the success criteria, statistical success criteria, the endpoints and the safety criteria for unblinding are really consistent with the other 2 trials. Okay, the next slide. You can see the Union Jack there on Slide 25. So this trial in the U.K. has been going really quite well. And this trial, again, had 5-microgram dose. It's enrolled 15,000 adults, greater than 18 years of age. 25% of them were greater than 65. It's fully enrolled, as the South African trials also fully enrolled, I should have noted. And again, the primary endpoint will be PCR positive symptomatic in the COVID illness. And again, this interim analysis will be done at 50 events with the final analysis of 100 events. And you can imagine, both these trials have been enrolled in extremely intense disease setting, and we expect to unblind these trials shortly. So then I'll just turn to the Phase III U.S.-Mexico trial on Slide 27. As you probably know, we started this trial in the -- and go to Slide 28, please. We started this trial just at the sort of tail end of the New Year's holiday. And that's -- it's going very well. It's a randomized, observer-blinded, placebo-controlled trial to evaluate the efficacy and safety of the Novavax CoV2373. We're going to randomize 30,000 adults in a 2:1 ratio. And our goal is to enroll 25% of the people over 65, 15% black or African Americans, 10% to 20% Latinx and 1% to 2% native Americans. The primary endpoint is identical to the U.K. trial. We planned one interim analysis at 72 events, and that would allow us to analyze the data and file for EUA. We believe we will do a final vaccine analysis at 144 events. And just to note, there is a change in the protocol and -- which is posted on our website and will be updated shortly. So this is going very well. Just go to the next slide. Briefly, you can see recruitment across the United States. We have 115 sites. We've started very shortly time ago, and we're almost 6,000 subjects of the 30,000. So enrollment is going extremely well. And today, we have more than 24% of over 65, 30% African Americans, 12% Latinx and 6% Asian. So we're on track and with our enrollment goals in this trial as well. So with that, I'm going to turn it back to Stan, and thank you very much.

Yes. Thanks, Greg. So making a vaccine doesn't help unless you couldn't manufacture it and get it out in the world. And so we've got a lot to do, and we've done a lot to get there. And so the -- some of the benefits of our vaccine, potentially ours, so we presented in 10 dose vials. And we want to get these vaccines out. We have an advantage, which is we have great stability of our vaccine and can ship it and store it and refrigerate it at standard refrigerated temperatures, which is the standard way of vaccines get distributed around the globe. And so it makes it easier to ship, store, and distribute 2373. And it's a benefit for hospitals, pharmacies and healthcare settings that can store in standard refrigerators. In addition, we ship it in ready-to-use liquid vials, and it requires no dilution or what's called, bedside mixing. So that makes it easy to apply. And in addition to being easier to distribute, our Matrix-M adjuvant enables dose sparing. And so what this means is we can produce far more doses with less antigen, which is an extremely important benefit for global capacity. So stability, and no mixing and low doses, so we get lots of production. So if we go to Slide 32. And you show this global supply chain established is -- it's -- in my view, it's one of the most important parts of our story. If you look at the slide, you can see that we've got capacity to produce not just the drug substance, the antigen, but the adjuvant that goes along with it and the ability to fill, finish and package in a global capacity. And so we are continuing to stand up large-scale manufacturing. We are in the process of commercial-scale production, tech transfer and engineering runs and are on track to meet time lines for manufacturing sites across 8 countries. When we're fully up and running at all of our facilities, which is expected to be in the second quarter, we expect to be at a production rate of approximately 2 billion doses a year. Our global breadth is a critical enabler to our commitment to fair and equitable access to the vaccine worldwide. As of today, for antigen alone, we have 8 sites across 7 countries. We have begun or will begin in January, GMP production at large scale at all of our facilities. We are stockpiling the active drug substance and will initiate final packaging once we have regulatory approval. Our approach to vaccine developed from the start has been that this is a global problem and that we need to be able to ensure global access to our vaccine. We have announced a number of agreements with governments worldwide, and we're working on more. We have also a collaboration with Serum Institute to provide significant supply to low and middle-income countries. Let me point out just one special aspect of this slide. You can see from the agreements that they're across -- indicated across the globe with all those low assembles that we've assembled a very broad list. To understand the magnitude of the work that has gone into this, at the beginning of last year, there was not one manufacturing or distribution site on this map. This has all been established since 2020. So going to the next slide and summarizing. We're starting 2021 in a very strong financial position. We have critical Phase III efficacy data coming in the next few weeks. We are working closely with global regulatory agencies with the goal of achieving approval for use as soon as possible. We have established a global manufacturing network in an incredibly short period of time. And we are building commercial -- we're building a commercial infrastructure to enable the sale and distribution of our vaccine. And although we focused on our 2373 vaccine, the same platform that enabled the development of this vaccine is being used to develop a pipeline of important respiratory vaccines. We now have 3 respiratory vaccine candidates that have been developed in Phase III clinical trials including for coronavirus, influenza and RSV. They are all based in our platform. We're making recombinant nanoparticles and combining them with our Matrix-M adjuvant, which should make them easily combined. Recently, we formed a working group that is separate from our 2373 development team. This group is charged with identifying and developing the best combination of these vaccines. Our goal is to establish Novavax as the world's leading company in vaccines against respiratory pathogens. We expect to report our progress in the development of this vaccine pipeline later this year. Obviously, for now, our primary focus is to be the key component of the solution in this global pandemic. Thanks, and I believe we now have time for Q&A.

Yes. Yes. Thanks, Greg; thanks, Stan, for that presentation and overview and for hanging back for a couple of questions.

A couple coming in here from investors. The first is really to have you guys contrast the Matrix-M adjuvant, your Matrix-M adjuvant with that of GSK's adjuvant technology that's incorporated into their vaccine Canada program? Greg, do you want to?

Yes. I can take a stab at that. So the adjuvant we have is a saponin, which is a derivative of a tree bark. It sounds a little crazy, but it's been worked on in labs for decades, and it's gone into many products. So our adjuvant -- what I like about the adjuvant is the company we bought maybe 8 years ago now, which is working on this, had put it into a nanoparticle. And the nanoparticles, frankly, it's been my career to be focused on nanoparticles. They look like danger signals. They look like what, antigen-present cells and the immune system are ready to see. They are small. And this particular configuration allows it to be taken up by a phagocytic cell, if you will, which is the first prow of the ship of the immune response. And by doing that, it becomes stimulated. And it's nonspecific, we call it a danger signal. And so by being a particle, it really targets the phagocytic cells. And that makes for a very localized reaction. So for safety, you get, as you can see, I think, really quite a good level of safety and you get a very targeted immune stimulation. And so we get the -- I think, the very best of what an adjuvant can do. So really close to what you'd get without an adjuvant in terms of the adverse event profiles and then a very strong immune stimulation. So I'd say the secret sauce when we bought the company what we really were enamored with was the fact that it was a particle targeted and we needed to develop the kind of data that allows you then to deploy it, which is much more clinical data. So I think what we've done in addition to industrializing the process and you can see from Stan's slides is pretty widespread. We've also created now a really pretty extensive safety in immunogenicity and soon-to-be efficacy data set using the adjuvant. That has existed for GSK's adjuvant. So there's some merits in that. We've had a few places where we've done some comparative work. Our -- I think our -- I believe our profile is very good. I can't -- I wouldn't want to dismiss the AsO3 work. But our adjuvant, I think, is now looking very attractive in terms of having a good, beneficial medium stimulation and a pretty modest adverse event profile.

Okay. Got it. Got it. I guess, a very topical question, right? As we're hearing and learning more about the more transmissional variant of COVID-19 or SARS-CoV-2, I should say, the natural question is whether there is -- whether there might be any impacts to the anticipated vaccine efficacy rates, particularly for the PREVENT-19 trial? I guess, we're hearing from CDC and the mRNA manufacturers that there really is no anticipated impacts on vaccine efficacy. How do you kind of read sort of any new, I guess, any potential impact on the efficaciousness of your vaccine in Canada as a result of the transmissible strength?

No, it's a really -- yes, really good question. So I haven't seen all of the data that's being talked about, but I think most of the manufacturers have run out, got antisera and looked to see if it's neutralizing, which is -- can be reassuring. We happen to be in 2 trial settings with different drift, if you will, variants or these mutants. And so we're doing -- the really critical experiment is to see whether our vaccines are working in these settings where there's been mutation. We -- actually because this is the same topic for flu, and as you probably know, last year, we announced our Phase III pivotal trial data. Specifically, to -- with the technology specifically meant to address this type of problem with flu, we're feeling very comfortable that our vaccine should work and work well. We expected that these viruses will drift. They have high mutation rates, they're under immune pressure. We already know there's been quite a bit of mutation. So it's going to be very interesting. We are able to -- we will be able to -- we're sequencing them, the viruses. We are going to be able to see what exactly is being transmitted and picked up in our PCR. So extremely interesting piece of -- and I would say, unexpected in one sense, as specifically, we didn't know exactly what might pop up as we did the trials, but we are expecting some antigenic drift with this virus. It's just how it goes with flu and RSV. And these viruses have related behaviors when they get out. So we're very optimistic that our vaccine similar to what we showed with flu where we have really a very broad -- the virus that was H3N2 with a lot of antigenic drift. We started a trial and by the fall, the virus, the H3N2, especially was very different. Yet, we showed that it had no impact on our -- the immunogenicity. In other words, we have these broad responses, see multiple epitopes on the spike protein we expect here. And we really fully expect our vaccine to work well. So that will be something to see with our trial. The mutants in South Africa and the U.K. are a little bit different as well. So that's going to be another, I'd say, robustness to having multiple trials to be able to demonstrate that.

Another question on PREVENT-19. You provided a bit of a progress update in terms of enrollment. Are you able to guide at this point when you might be at full enrollment of PREVENT-19? And to what extent does having the MR -- the availability of mRNA vaccines prevent -- or presents any challenges to either accrual or, I guess, compliance within the trial itself, ensuring that participants don't go out and decide to get, I don't know, double PREVENT basically and get exposed to both vaccines?

No, it's actually -- it's a reality we're dealing with. I would say it's our expectation that we can not only complete enrollment, but we can complete efficacy. The -- when you look at the number of cases, and the disease burden we're seeing in the setting of the U.S., we really are requiring a very small proportion of that. So -- and if you think -- I was talking to someone, I went to college in Walla Walla, Washington, that population is about 30,000 people. So we need one Walla Walla for our trial. So look, I think we're seeing already really good enrollment. We're taking advantage of a well-oiled recruitment and trial structure. We're collaborating with the NIH on that. So they're a big part of that. And great advice. So execution-wise, I think we're seeing that we can do this and do this well. We are paying a lot of attention to this. As you can imagine, subjects do have the ability to do what they want for their own benefit. We -- it is a 2:1 randomization, so that provides additional benefit -- potential benefit of 2 and 3 chance of getting the vaccine. So that comes into play as well. I think we're going to see enrollment in weeks. And then, there we are. I mean, we -- as you know, the surveillance begins at day 28, that will be shortly. I mean, we started, I think it was the 28th of December. So we're very quickly going to be in a period where we're collecting cases. For some reason, if the distribution becomes so widespread and it becomes difficult to get to an efficacy result, this data is still very, very important to us. We have 2 trials where we are really aligning the primary endpoint, the success criteria. And we believe that the -- especially the U.K. trial can be submitted as the basis for efficacy. There was not -- this would not be unprecedented. There's good guidance for -- the FDA is always ahead of the game, provides guidance on how to utilize that type of data. So if that becomes the case, the U.S. safety and immunogenicity will really be important because we're in the populations that are highest risk in the U.S. that will provide assurance and safety to these at-risk populations. So it does make us feel like we made a good decision to go out into multiple efficacy studies. But we're pretty confident that we can get to a point where we can evaluate the efficacy in the U.S. as well.

Assuming positive pivotal data, can you just speak to the amount of vaccine that you would have available, sort of, call it, midyear? Yes. I'll leave the question there.

Yes. So I'll take this. In the U.S. -- so in the U.S., we have an agreement with OWS Operation Works, we deliver them 100 million doses -- 110 million doses actually, we expect to have those delivered during the second quarter of this year. Globally, production capacity is coming up at 3 different facilities, controlled by us plus Serum Institute that has its massive capacity, and they're our partner in this. So as I think we mentioned in my slideshow that the expectation is that we would be able to be at the range of production by midyear of over 150 million doses or above.

Okay. Okay. Another question here, investor question here, asking about the longevity and immunity and immunization with the COVID vaccine -- or sorry, with 2373? You have a slide here that sort of speaks to the tighter curves going at 6 months. This is looking at anti-Spike IG. I guess, is it fair to assume that you expect a similar trend when it comes to neutralizing titer? And how does -- I mean, how does that trend line sort of compare with some of the other vaccine candidates...

We haven't -- good question. We haven't seen a lot. Look, I think what you're seeing is normal immunity. So you get a peak response. And then depending on how high it was, you're going to see decay over 6 months or to 1 year. We actually have experience with this with our Ebola vaccine. We published that out at one year. We're kind of right on the edge of what we would have considered protective. I think that boosting here with this virus is going to be -- it's not going to go away. You're going to see waning natural immunity and people are going to get reinfected. And so we have already begun to embark on -- we've got a protocol to look at boosting with our vaccine. And one of the strengths of our technology is recombinant spike protein is we can boost. And we know that the boosting will be very strong. So when you have the vectors, you develop a vector response, it's much more difficult to boost. And we don't know so much about the status of mRNA. I believe that boosting at least at 1 year or maybe even a 6 months might be advisable, especially in at-risk populations. We haven't been into this pandemic long enough to see how much breakthrough infection is, it's sort of the sporadic reports becoming more consistently obvious that people have these waning immunity. So what I would say is encouraging about our data is, we have been able to anchor it to convalescent sera. And out at 6 months, frankly, we look right like convalescent sera that we have in our trial is gathered fairly acutely. You can see the details of that, by the way, in the New England Journal supplemental section. But at 6 months, we look like convalescent sera. I would have expect -- I expect convalescent sera, those folks who have convalescent antibodies like that to be quite robustly protected. And so we're there, it looks like 6 months we're there, but it's waning. And I think that there will be a lot of discussion about boosting. And I believe the manifestation of that will be a need for a lot of vaccine for that. Our technology, it's very much amenable to a boosting regimen.

Are you able to look at boosting in any of the Phase III trials or the Phase IIb trial that's ongoing? Or is that is something specific...

Yes. it's going to be -- we're going to do this with our Phase II trial where we have subjects getting to 6 months, so we're going to explore boosting it 6 months and 1 year. And you'll see more information coming out on that shortly.

Okay. Great. Given then -- getting the hook here on the presentation. So I come to the end of things. I want to thank you all for joining us this morning, and thanks, everybody, for tuning in, and have a great day.

Great. Thank you. Take care.

Yes. Take care. Bye-bye.