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

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax PREVENT-19 Phase III Final Data Announcement Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker today, Silvia Taylor. You may begin.

Good morning, and thank you to everyone who has joined today's call to discuss our PREVENT-19 Phase III final data results. A press release announcing our results is currently available on our website at novavax.com, and an audio archive of this conference call will be available on our website later today. Please also note that we have posted the slides that we are using during this morning's call at novavax.com/events. Joining me today for discussion and a Q&A period are Stan Erck, President and CEO; Dr. Gregory Glenn, President of Research and Development; Dr. Filip Dubovsky, EVP and Chief Medical Officer; and John Trizzino, EVP, Chief Commercial Officer, Chief Business Officer and Interim Chief Financial Officer. Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference that could include financial, clinical or commercial projections. Statements related to future financial or business performance, conditions or strategy and other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage and clinical development and anticipated milestones are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainty, which change over time. I'd now like to hand the call over to Stan. For those of you following on the accompanying slides, please turn to Slide 3. Stan?

Thank you, Silvia. So today is a great day for Novavax. This morning, we are talking about the exciting results of our PREVENT-19 Phase III study in the U.S. and Mexico. But this work follows a successful Phase III trial in the U.K., a successful Phase II trial in South Africa and a successful Phase I/II trial in the U.S. and Australia. These trials taught us a lot about our vaccine and from the early clinical data and even the preclinical work before that, we were encouraged about the potential of NVX-CoV2373 to play a significant role in combating the global COVID pandemic. With each analysis, our trials proved that we are on the right track. And today, with safety and efficacy that are consistent across all studies, our PREVENT-19 results reaffirm our strong belief in 2373. All of this work has been made possible by the participants who volunteered for our trials and the research and clinical staff who conducted the studies. We are grateful for all of these contributions. We are also thankful for the support of the U.S. Government in the study. For more on these results, I'll turn it over to Dr. Filip Dubovsky.

Thanks, Stan. So maybe we can go to next slide. I'm very pleased to present these results to you today. And I think we're all going to be excited when you see these results. So Slide 4, has the design of the study. As you remember, this study included 30,000 adults greater than 18 years of age and was randomized 2:1. Where we are with the current study is we've crossed over the adults. So the people who received placebo got active vaccine and the people who got active vaccine got placebo. Additionally, we've expanded this study to include adolescents 12 to 17 years of age, and we've completed enrollment of that age group. The data we'll be describing today is data in the adults only, and that's from when they were randomized to when they crossed over to receive their crossover vaccine. And this will include both safety and efficacy data. Next slide, Slide 5. On this slide, what you see is the time course of the variants that have occurred in the U.S. in the color diagram on top. You can see that we gave dose 1 from December 27 to February 18, and dose 2 from January 18 to March 26. The blue box indicates a window when we captured efficacy endpoints. And what you can see in the bright orange is that there was an emergence of B.1.1.7, which was first identified and described in the U.K. as a large portion of the strains in the U.S. There's a very small sliver in bright red in the bottom, which accounts for 1% to 2%, and that includes cases from 351 variant, which was first described in South Africa. So we conducted the study, the efficacy evaluation period during a time when emergence -- variants emerged in the U.S. Next slide. Now we're talking about Slide 6. And so just to remind you that one of the features of the study is we had a big push to enroll high-risk populations. And then we included previously underrepresented ratio and I think subgroups. And you can see in the chart that we did very well in enrolling Latinos, African Americans, Native Americans as well as Asian Americans, and we had a broad location of the trial sites in the U.S. and a handful in Mexico. Next slide. Now we're on Slide 7. Slide 7 highlights the demographics of the population we actually enrolled and you can see the randomization worked well. All of the key categories were well balanced between the vaccine and placebo group. I want to call your attention to the bottom line, which is medical comorbidities of 37%. And these are high-risk medical conditions that we tried to enroll to make sure that we had a population representative include people who would most benefit from the vaccine. Next slide. This slide is a very high-level review of the safety that we saw, and you can see both the serious adverse events and SAEs were infrequent and they were balanced between the 2 age groups. The graph didn't project well of the bottom 3 lines with adverse events of special interest and deaths. Those all had a rate of less than 0.1% and were also balanced. No adverse event was reported more frequently than in 1% of the participants. And this is very consistent with the previous data we've captured in the U.K. as well as South Africa. Next slide. Now we're on Slide 9, and Slide 9 shows the reactogenicity profile of the vaccine. And let me already do to this slide a little bit. On the left-hand side, we have the local reactogenicity symptoms, dose 1 and dose 2. And on the right-hand side, the systemic dose 1 and dose 2. In gray is the placebo group and in blue is the vaccine group. And you can see if we focus first on the local side that we had an increase of local reactogenicity events after dose 2, which was completely expected. And the most common ones were pain and tenderness and these were all short-lived, occurring both median and mean less than 3 days. And you can see the grade 3 response in the gray bar was very, very low indeed. On the right-hand side are the systemic side effects. Once again, a few more after dose 2, once again expected. The terms that were most common were fatigue, headache and muscle pain. And these were also short-lived, less than 2 days median and mean. And the number of grade 3s was low. And this is very consistent with our previous studies. I think it may be important to look at fever rates, which were very low, including grade 3s. And the safety profile we just discussed was reviewed with the NIH DSMB and they agree with our evaluation of this data. So let's turn to the next slide, Slide 10. Slide 10 shows the primary efficacy endpoint. You can see that in the vaccine group, we had 14 cases. In the placebo group, we had 63 cases. And I want to remind you once again this was 2:1 randomization, so this resulted in a vaccine efficacy of over 90% with a lower bound of 82.9%. As a primary efficacy endpoint, this had a statistical success criteria, which we achieved handily because we were [ about ] 3% with a lower bound. It's important to note that 82% of these cases were caused by variants of interest and variants of concern and those are the definitions defined by the U.S. CDC. I think another notable feature is that all the cases in the vaccine group that broke through were in the mild category. And we have a secondary endpoint, which looks in moderate and severe later in the deck, and we can focus on that then. So next slide. Now we're on to Slide 11. So Slide 11 is a detail about the variants that we were able to identify in the study. As you saw previously, we had a total of 77 cases in the per protocol population. We have sequence data available on 54 of those cases. We may give some subsequent -- further sequencing, but these are the ones we had in hand for the primary analysis. What you can see is that as far as variants of concern, 65% of all the cases fell in that category. Vast majority were 1.1.7, which was first identified in the U.K. You can also see 429, which is California, 351, which is South Africa and P.1, which is Japan and Brazil. 17% of the cases were variants of interest. These include, from the top going down, U.S.A., New York. USA, New York, You have the India delta variant, but that's a 617.1, so another more severe one as well Brazil. And finally, in this green category, you can see that 19% of the cases were variants not of concern and interest. And these are cases that have not been identified as worrisome by the CDC. And in this category, things that would be more like prototype, including Wuhan strain, will fall into this group. So let's turn to Slide #12, please. So we identified as a key secondary endpoint, efficacy against variants not considered variants of interest and concern. And the reason we did this is that this most resembles the mild strains that the vaccine was built against. So the prototype will fit in this category as with the virus that was first identified in Wuhan. And as you can see, we had 10 cases in the placebo group and 0 cases in the vaccine group, yielding efficacy of 100%, lower bound greater than 80%. And as a key secondary endpoint, we also preestablished a success criteria in the statistical analysis plan, and we achieved that handily. So there are a number of cases that we were not able to sequence, in fact, 23 and all. Of those 20, 1 were mild, 1 was moderate and 1 was severe. You can see that all the cases in the foot note that occurred in the vaccine group were, in fact, mild. And this makes some scientific sense. The mild disease likely had lower viral loads, so it was harder to get enough virus to sequence the data. So this all holds together from a scientific perspective. So let's move to the next slide, Slide 13. Slide 13 is the flip of that analysis, and that's looking at efficacy against vaccine -- variants of interest and variants of concern. And this is an exploratory endpoint. But you can see that we had a total of 6 cases in the vaccine group, 38 in the placebo group, yielding a vaccine efficacy of 93% with a lower bound of greater than 80%. So this is -- this, I think, is remarkable. It shows that if you generate antibodies of a very high quality, they are actually able to impact both variants of concern and variants of interest. Next slide, please. So one of the predefined secondary endpoints was efficacy against moderate and severe disease. In this analysis, you can see that we had no cases in the vaccine group, 14 cases in placebo group, giving a vaccine efficacy of 100%, lower bound of 87%. We additionally had a post-hoc analysis looking just at severe disease and you can see, once again, we had 100% efficacy against severe disease with a 95% confidence interval starting at 35%. And remember, this is 2:1 randomization, so this is really -- we think it is more like 0 versus 8 cases. I think there were -- additionally, we had 6 hospitalizations with COVID, and this included one patient who succumbed to the COVID disease. And these all occurred in placebo group. These were not included in the efficacy analysis because by the strict rules of the protocol, the PCR had to be done by the central lab and because these patients were hospitalized, they were unable to submit samples. So -- and then we're going to be conducting a post-hoc analysis, which includes all severity, including hospitalizations and that should be coming up in the near future. Next slide, please. Now we're on Slide 15. Another predefined secondary endpoint was efficacy in the high-risk population. And this was defined in the protocol as those who were greater than 65 years of age and those who had medical conditions such as obesity, chronic kidney disease, chronic lung disease, cardiovascular disease and type 2 diabetes or were living under life circumstances, which increased their risk to severe disease or getting COVID. This included things like hard living conditions as well as working in packing plants. And you can see in this analysis, we had 13 cases in the COVID group, 62 in placebo group, yielding a VE of 91%, lower bound once again greater than 80%. So let's go to the last slide, and I can sum up the results. This is now Slide 16. So overall, the primary efficacy evaluation yielded a vaccine efficacy of over 90% and this was in the face of predominance of variants of interest and concern, over 83% were VOIs or VOCs. Additionally, when we just looked at those that were variants of concern and interest, we had a vaccine efficacy of 93%, once again showing if you generate high levels of quality antibody with this vaccine, you're able to impact disease caused by variants. We had 100% protection in this analysis against moderate and severe disease. And furthermore, we had 10% protection against variants not considered variants of concern and interest. And once again, this is where the original prototype strains will fall into. So it's a good benchmark about how this vaccine technology could perform against mild strains. All the hospitalizations occurred in the placebo group and all the severe cases, including a death, occurred in the placebo group. So with this, I'm going to conclude my remarks, and we can go back to Stan.

Filip, thank you very much. Great data.

Absolutely.

All right. So we're going to open it up to Q&A. And operator, if you could organize that for us, that would be great.

[Operator Instructions] And the first question comes from Charles Duncan with Cantor Fitzgerald.

Congratulations on these very good data. So a quick question regarding the number of infections. So I think the data speak for themselves. But I'm wondering if you could provide a perspective on how to interpret the data relative to data sets that may have higher numbers? Do you believe that the numbers that you have here, and the stats have clear predictive value for efficacy of the vaccine when more patients -- or more people have taken it?

Well, I'm not 100% sure specifically what you're asking. So let me answer 2 questions. One of them is, if we think about that high numbers in for the mild vaccine strain. That's why we prespecified the variants of the -- efficacy analysis against variants not of concern and interest. So this is a number which would most likely -- which we think will be similar to results we'd get if we were doing this just against Wuhan or the prototype strain. As far as the BARDA analysis, the primary efficacy analysis, that actually included vaccine efficacies against all variants, and 82% of those cases were variants. So I think this very much has been -- represents what we can hope to see when the vaccine gets deployed. I guess I'd like to point out that the overall vaccine efficacy was only differed by about 0.5 percentage point from what we saw in the U.K. So we're getting very consistent results against both variants as well as with nonvariants. Did it answer your question?

Yes, it did. I was just referring to 77 infections versus, say, something like 150. Do you have confidence in this data? And then the second thing is, was there any geographic grouping in the observation of infections?

So we -- for the latter question, we don't have that data yet. As far as the robustness of the data, I think it speaks for itself. Our lower bounds and all this analysis were about 80%. So that actually is a very consistent and very robust response. In the ITT analysis, which we don't have in hand yet, we have well over 250 cases. And as you remember, what happened is the epidemic slowdown just as we were entering the efficacy evaluation period. So where we lost the ability to have many cases what it gave us was the ability to have many variant cases. And I think in the context of what's happening globally, efficacy against variants is going to be a very key feature.

Okay. Last clinical question is regarding the side effect profile, you mentioned fever. And I guess I'm wondering if you can speculate on, call it, the technology platform versus some others that are out there, how do you interpret the fever observation as being fairly low?

I think your notion is right. I mean each technology is going to have a different safety profile. We've tested this obviously with many different antigens, including our NanoFlu product, and it's always been favorable. In this case, we have exceedingly low levels of antigen, 5 micrograms, right? That's just a tiny bit. And it's really in conjunction with the adjuvant that we get such high levels of efficacy, high levels of neutralizing antibody with a very broad spread of epitope identification. So I think those do matter. We are aware that there's going to be some data coming out soon from the U.K., where they're doing some match studies, and that will continue to build our efficacy profile.

Okay. Last question for Stan, probably your favorite question and that is, how do you feel about being able to produce vaccine, and can you provide some, call it, quantification, if that's important or other measures of success that you anticipate in the near term?

Sure. And I think that we're not changing guidance that we gave a few weeks ago at the end of the first quarter earnings report. We are filing this on a global basis, and we will be filing all of the data now. The rest of the -- the remaining CMC data, which is the long pole in the tent is being put together now, and we expect to file with the U.S. FDA, with the U.K. MHRA with EU EMA and also importantly, I think in India and Korea. And all of these filings are -- we intend to have those filings done and in the end in the third quarter. And the different agencies will take different times to evaluate it, but a lot of them are working on it right now because we've had growing solutions. And our goal is to manufacture all of the plants -- we have been successful with all the plants globally, these 8 manufacturing sites, to produce product at commercial scale. We haven't had the raw materials to produce at the commercial scale consistently throughout the first half of this year, but we expect to be able to do that starting in the third quarter. So our goal is to have -- to be up at a capacity of around 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter.

The next question comes from Kelechi Chikere with Jefferies.

Congratulations on the much anticipated data here. These data clearly position Novavax and 2373 as one of the premier players in the space. I guess my first question is, where are you at in the process of completing your CMC requirements versus where you were in early May? And I guess more importantly, how much risk would you say is there with you actually completing those CMC requirements before your Q3 filing. And I guess my second question is just similar to Charles. Just if you could help us put into context your level of confidence in reaching your vaccine production goals in Q3. Is there a particular supplier coming online with the Biden administration lifting the embargoes? Any data points that you can cite to have basis of your confidence would be extremely helpful.

Yes. So it's a process. And the process involves developing assays for products. So we make products in 8 different plants in 8 different countries. And we have to make sure that the process allows us to have -- make the same product. When we make a batch in the Czech Republic that looks exactly the same as Korea or the United States. So to do that, you have to develop a set of comparability assays, potency assays, purity assays to make sure the product is the same. And that's what takes time. And we're in the middle of that validation process. We've taken one of the most important assays and qualified it, and now validated it. And that basically just you have to run it in every -- just a ton of times with every variant condition and show that it works the same way. So we're doing that, and it takes time. But we're -- I think we're going to be successful in meeting our time lines. With respect to the -- one of my concerns about being able to scale up that requires raw materials, I think that the -- one of the things that's constrained us in the past was not being able to ship materials across certain borders. And now that the borders are opening up and all the manufacturers have been trying to increase their capacity, whether it's for filters, whether it's for 2,000-liter bags or media, they're all trying to -- they've been working with -- this is an industry-wide problem, and we're gaining better availability of product. It's still tight if you -- in normal times, you'd want 6 months' worth of raw material inventory in the production plant, and we don't have that. But we have weeks at least, and before we had a week and so it's getting better.

The next question comes from Mayank Mamtani with B. Riley FBR.

Congrats on the stellar data here. So 2 quick ones on the data. So Filip, on the dropout rate, just please comment on what you had -- what you sort of reported here relative to what you had expected? And then in terms of follow-up, how much you have in terms -- from a safety standpoint, And what more you think you need to -- if you had to file for an EUA putting the assay requirements aside, like how much safety follow-up you have at this point?

Yes, so maybe the second question first. So we timed the closing of the database and the efficacy evaluation to match what's required by the FDA to EUA. And that was a median of safety data for 2 months after the second dose. So that's captured. And that is the data that you got a brief glimpse of now. This is an ongoing process. You just have top line results, but we'll be giving rest of the safety data, which we will be summarizing, writing it up into a clinical study report and submitting it to all the global regulatory agencies, including the U.S. IND. As far as dropouts, we had, at the end, approximately 5,000 people drop out of the study and they dropped out at different rates, slightly higher in the older people who had easier access to EUA vaccine early on and slightly less so in the younger folks. So these are as of May. As you saw, we obviously had adequate cases to evaluate the efficacy of the vaccine, and we're going to have more enough cases in the database as well.

Great. And then on the sequenced 23 cases, is there a reason to believe that there's a higher proportion of delta and beta variants in there, just given the relatively -- again, everything is relative, a lot VE number there.

Yes. It's -- that would be really speculative. I think one thing you can feel confident of is if there are some hiding in the vaccine group, they're mild disease. So when we -- one of the primary analysis included even those we couldn't sequence and all the diseases in breakthrough was mild. Now we hope to have some additional sequencing based on that. We're taking different approaches to sequence it and that will be cooked into post-hoc analysis where we could evaluate that as well. So we may be getting some more information. We just don't have it in hand right now.

Awesome. And then you obviously have had a lot of other publications come out since Friday, the 3 preclinical studies and then also the co-administration study with flu a substudy part of your U.K. cohort. Maybe just -- kind of just touch on like what -- how you're thinking about variant-specific vaccine versus a single booster given that you're seeing such strong efficacy here against the VOCs. And also just maybe comment on what we should be watching out for the Com-COV study data coming out later this -- I guess, in July at some point?

Yes. So first of all, as far as the variant work, the real question I believe you're asking is do we really need a variant specific vaccine? Or if we give just this vaccine or this vaccine as a booster, would that be adequate to achieve very high levels of protection against the variants. And right now the data we have from the study are apart reassuring. As you know, in our Phase II study, we are giving 6-month boost dose. So we'll be able to quantify the level of immunity and we can try to, in the lab, see if those can neutralize whatever variant emerges at that time, including delta. So that's one feature. And of course, we're also working on constructing our variants vaccines. And maybe Greg can touch base on what they just published.

Yes. Mayank, as you know, this Friday, we put out a manuscript on the beta variant we made, and we tested that in 3 different animal models. It was very effective at preventing matched virus as well as drifted virus B.1.1.7, the original prototype strain. So I think Filip is right. This data is really encouraging, suggesting that our vaccine against the variants we're seeing in the U.S. works extremely well. We're still on track to evaluate the South African variant strain in the trial because we want to be ready. Also in that paper, you saw we boosted our nonhuman primates who have been primed with original strain with our South African variant strain got extremely high immunity. So reaching back and reaching forward. So our goal right now is to generate the data. We're watching the very ominous third wave, for example, in South Africa. And we want to be ready if there's a decision made or need to go to the variant. Right now, I think this data speaks for itself, very strong against the variants we've seen certainly in the U.S.

And just back to the Com-COV data. That reactogenicity data will be available at a later date. But as you know, for the Com-COV, the initial -- on their study where we did not participate, they published their reactogenicity profile as a letter, and we're hopeful that we're going to have a similar treatment to Com-COV2 where we do participate. So perhaps that data will be available in the near future as well. And just to touch base on the study that perhaps you were referring to in your question, I mean we have a manuscript, which is available on that archive now, which included an influenza substudy in the U.K. study. And there, we demonstrated that we had accessible reactogenicity when we co-administered our vaccine with influenza. We did not impact the immune response to flu at all 4 strains in the main group. And most importantly, we maintained a trend toward efficacy of 87.5% in the people who received flu vaccine at the same time as our vaccine. And this really compares favorably with the overall endpoint was at 89.8%. So I think we at least have a path forward now. We're thinking about vaccinating people in the wintertime when they need both influenza as well as COVID vaccines.

[Operator Instructions] The next question comes from Eric Joseph with David Weiss.

Eric Joseph form JPMorgan. Just one on sort of the timing of the data release this morning. And congrats on achieving the efficacy rate. Just given that you basically had excluded all the events by the end of April, can you just sort of help us understand sort of the lag in timing between having those -- essentially those cases in hand and the fuller data set detail today. And then on the regulatory front, if I remember correctly, the demonstration of comparability with large-scale manufacturing of 2373 was -- was needed to start this Phase III trial? Can you just clarify how the CMC requirements for submission you different from those to start PREVENT-19 and should we -- or can we anticipate a relatively more strict process with respect to EUA package here in the U.S.?

I'm not 100% sure I understood the first part of your question, but I'll take a crack at it anyway. So yes, we finished accruing cases at the end of April. And I think your question was why did it take so long to get the results? And in that regard, we had many steps we had to take, including cleaning all data for 30,000 people since we need to have a clean safety database as well as the efficacy database. We also need to sequence those strains. And finally, all the severe cases were adjudicated by external adjudication committee. So they had a lot of work to do to make sure that they all aligned up with all the classifications of mild, moderate and severe disease line. So essentially, that's the process we undertook and we just have the results now. Did that answer your question? I wasn't sure [indiscernible]

Maybe there's 1 piece also. So now we have strong efficacy data with a scaled up manufacturing process. So during comparability of our other processes, we will anchor a lot of our work to this -- to the comparability for this lot. It provides a very good anchor for the CMC to have a lot that's gone through efficacy. So I think that's what you were referring to.

Yes. Eric, this is Stan. I apologize, but could you redo your question about CMC issues?

Yes, sure. It is my understanding that comparability at this large-scale manufacturing, there aren't still a lot was what you need administrator satisfied with OWS to start PREVENT-19. Is the other requirements for CMC meaningfully different to satisfy new regulators compared to what was required to start the Phase III trial here. I guess given that you essentially use large-scale -- use products manufactured under large-scale process here for PREVENT-19, so you can anticipate a relatively sort of more swift. Do you basically have this -- the validation assay is already in hand to support the CMC requirements for EUA and the U.S.

Yes. I think the answer to this is that we -- the process of getting these assays in place requires qualification, developing them and then qualifying them and validating them. And so we have gone through the qualification process in particular in our -- in the middle of -- or hopefully, the tail end of validating, which is a time-consuming process. And when you run all the assays in various lots and show comparability. So it's just a time-consuming process. We've got lots of people working on. We've got 8 different plants, so we're trying to get -- demonstrate comparability of them. And so -- but having said that, the work is going on, and we'll get there.

Okay. Maybe just a final question, if I could. A lot of questions from investors on how you're thinking about pricing particularly sort of whether the pricing -- you just see that pricing model differs for a vaccine that is new sort of in this pandemic period versus one that's used more as a booster in an endemic setting, looking next years following.

Yes. And that's a great question. And the answer in the short run is the pandemic, we have a pricing SKU. It's got a tier for the low-income, upper middle income and high-income countries. And it's pretty much in line with some of the other manufacturers. And in fact, it should be noted and I think this is a good thing. It should be noted that given that we've got a commitment of 1.1 billion doses with COVAX, along with our partners Serum Institute, a lot of our first doses are going to go into low- and middle-income countries as they should. And then -- but in parallel, We have advanced purchase agreements with 4 or 5 high-income countries that we will be supplying those as well. And so -- but in the very early days, it's going to be low and middle income countries. And throughout 2020, too, I think it's going to transition from satisfying the 1.1 billion dose commitment, all of our APIs. And eventually, it's going to transition into a booster. And we haven't determined what the new pricing scheme for that would be, but I wouldn't be surprised if it didn't follow a tiered pricing again by country that we sell it to. So I think, particularly in the United States, our vaccine is going to be probably most importantly used as a booster, but that's going to be true. We've got a lot of -- actually in United States, we've got a lot of prime boost doses to get out there. There's a lot of people who haven't been vaccinated yet. But even as we work our way through those, there's going to be a need for booster reload. There's a need for boosting, and I think that's pretty well accepted in the industry. And the studies that are going on right now are going to show how our vaccine is effective at boosting and has a safety profile that's favorable.

This concludes our question-and-answer session. I would like to turn the conference back over to management for any closing remarks.

I'm sorry, was there 1 more question? There appears to be one more question.

Yes. We actually had somebody just joined in, as I was saying that. We have Vernon Bernardino with H.C. Wainwright.

Congratulations on the whole process and the successful positive results. It had a been long journey and glad to have been there with you. Thanks for squeezing this question. The comments you just had brought a question that I didn't think of until then. And that is, what have you looked at so far as far as like a market study that you could perhaps expect in the future? And how are you looking at it as far as market share when you get to the vaccine being participant or having a role in a market where it's all booster shots in the U.S.?

Yes. So we have been looking at it. And I think that what we see is not a pandemic vaccine that just goes away once we get everybody vaccinated. I think we look at this as an ongoing large market much like characterized maybe by flu where you have changing virus and have to have a booster whether the booster has to be an annual shot or something different from an annual shot time will tell, but we see this as an ongoing market. So when you transition from pandemic to the more commercial aspects of the market, then you have to look at product advantages more carefully. And market share and pricing will probably follow those characteristics. We're confident in our vaccine with the characteristics we have and the safety profile, the stability and ability to ship it at standard refrigerated temperatures is going to be an advantage of ours. And so that's how we see that play out. There's going to be also an opportunity to combine our vaccine with our NanoFlu vaccine. We know the results that we have from our Phase III pivotal study earlier last year. And we've already -- we just published actually a paper showing that -- in animals now that our combination of NanoFlu with COVID vaccine does very well that the combination doesn't -- adding COVID to flu or flu to COVID doesn't change the immune response that you get to either. And we actually challenged the animals with COVID and got 100% protection against COVID challenge. So we're optimistic that we can bring this along as well.

Terrific. That's an environment I'm looking forward to and congratulations again.

You're welcome. Okay. So now I think we're done. And I'd like to thank everybody for listening in. We've -- this is a huge milestone for the company and hopefully, for the world of vaccination. And so we expect to bring our platform forward into people's arms around the globe as soon as we can.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.