Q2 2021 Novavax Inc Earnings Call

Thank you.

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Audience: Thank you. Thank you. Thank you. Thank you.

Operator: Good day everyone and welcome to NEVAC's second quarter 2021 financial and operating results. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Starkey, followed by After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press the star, then one. Please note that this event is being recorded. I'd now like to turn the conference over to Sylvia Taylor, senior vice president, corporate affairs, and investor relations. Go ahead.

Sylvia Taylor: Thanks, Cole. Good afternoon, everyone, and thank you to all of you who have joined today's call to discuss our second quarter 2021 operational highlights and financial 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. We've also posted the slides we are using during today's call under events in the investor section of our website.

Good day, everyone and welcome to the Novavax second quarter 2021 financial and operating results all participants will be in a listen only mode.

You need assistance. Please signal conference specialist by pressing the star of Keefe O zero.

After todays presentation, there will be an opportunity to ask questions to ask the question. You May Press Star then 1. Please note. This event is being recorded I would now like to turn the conference over to Silvia Taylor <unk> Senior Vice President Corporate Affairs and Investor Relations. Please go ahead.

Thanks, Carl Good afternoon, everyone and thank you to all of you who have joined today's call to discuss our second quarter 2021 operational highlights and financial results.

Sylvia Taylor: Joining me today is Stan Irk, President and CEO, who will provide an overview of our progress in the second quarter, our supply commitments, our regulatory timelines, as well as updates on manufacturing. Dr. Philip Dubovsky, Chief Medical Officer, will discuss developments in our COVID-19 program, and John Trezino, Chief Commercial Officer, Chief Business Officer, and Interim Chief Financial Officer, will provide an update on our financial results for the quarter Additionally, Dr. Greg Glenn, President of R&D, will be available for the Q&A section at the end of today's call.

The press release announcing our results is currently available on our website at Novavax Dot Com and an audio archive of this conference call will be available on our website. Later today. We've also posted the slides we are using during today's call under events in the investors section of our website.

Joining me today, Stan <unk>, President and CEO, who will provide an overview of our progress in the second quarter, our supply commitments of regulatory timelines as 1 of the updates on manufacturing.

Sylvia Taylor: Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference, which are based on our current projections and beliefs. For example, statements relating to future financial or business performance, conditions, or strategy, including expectations regarding revenue, operating expenses, cash usage, clinical development of our vaccine candidates, timing of future regulatory filings and actions, and other anticipated milestones. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties that could change over time, and actual results could differ materially from what is described in such statements.

Dr. Phillip Dubowski, Chief Medical Officer will discuss developments for our COVID-19 program and John Trevino, Chief Commercial Officer, Chief Business Officer, and interim Chief Financial Officer will provide an update on our financial results for the quarter. Additionally, Dr. Greg Glenn President of R&D will be.

Available for the Q&A section at the end of today's call.

Before we begin with prepared remarks, I need to remind you that we will be making forward looking statements. During the teleconference, which are based on our current projections and beliefs.

For example statements relating to future financial or business performance conditions or strategy, including expectations regarding revenue operating expenses cash usage clinical development of our vaccine candidates.

Sylvia Taylor: We encourage you to consult the risk factors discussed in our SEC filings for additional details. I would now like to hand the call over to Stan. For those of you following the accompanying slides, please turn to slide three.

<unk> of future regulatory filings and actions and other anticipated milestones are forward looking statements.

Stan Irk: And thank you, Sylvia, and thanks to everyone for joining us today. As we start this presentation today, we can note that through the development of vaccines and treatments today, significant progress has been made to combat the COVID-19 pandemic. However, we also note that with the continued circulation of variants and with the inequitable access to vaccines that persists in many parts of the world, Novavax's mission to bring NBX COVID-2373 to market as swiftly as possible has never been more important

Novavax cautions that these forward looking statements are subject to numerous assumptions risks and uncertainties, which change over time and actual results could differ materially from what is described in such statements. We encourage you to consult the risk factors discussed in our SEC filings for additional detail.

I would now like to hand, the call over to Stan for those of you. Following the accompanying slides please turn to slide 3.

And thank you Sylvia and thanks for everyone for joining us today.

We start this presentation today.

Note that through the development of vaccines and treatments to day significant progress has been made to combat the COVID-19 pandemic. However.

Stan Irk: At Novavax, this week, we took a major step forward in advancing this mission. We are announcing the filing of multiple regulatory submissions for 2373 with our partner, Sierra Minister. These regulatory submissions encompass global markets, including filings with the Drugs Controller General of India, as well as with regulatory agencies in Indonesia and the Philippines.

We also note that with the.

The continued circulation of marriage with you in the equitable access to vaccines that persist in many parts of the world the old <unk> mission to bring <unk> Kobe $23.73 to market as swiftly as possible has never been more important.

No. The ex this week, we took a major step forward in advancing this mission.

We are announcing the filing of multiple regulatory submissions for 2073 with our partner serum Institute.

Stan Irk: We view these submissions as the first of many, bringing us one step closer to delivering 2373 to those in need. In addition to these regulatory developments, I'd like to begin today's call by providing an overview of a few of our major achievements in all areas of our business since the beginning of the second quarter. We announced positive data from our Prevent 19 Pivotal Phase 3 trial, demonstrating 90% overall efficacy and 100% protection against moderate and severe disease.

These regulatory submissions encompass global markets, including filings with the drugs controller general of India, as well as with regulatory agencies in Indonesia, and the Philippines.

We view. These submissions is the first of many bringing us 1 step closer to delivering $23.73 to those in need.

In addition to these regulatory developments I'd like to begin today's call by providing an overview of the few of our major achievements in all areas of of our business since the beginning of the second quarter.

We announced positive data from our prevent 19 pivotal phase III trial, demonstrating 90% overall efficacy and 100% protection against moderate and severe disease.

Stan Irk: Philip, we'll talk more about this short, Philip, we took major steps in exploring 2373's boosting capabilities, including positive results announced today from our six-month booster study in our ongoing U.S. and Australia phase two trial. In conjunction with our Prevent 19 trial, these outstanding data make a compelling case for 2373 to become the universal booster of choice. We also continue to explore heterologous boosting alongside other vaccines in the market by participating in two partner-led studies.

Philip will talk more about the shortly.

We took major steps of exploring $23.70, threes boosting capabilities, including positive results announced today from a.

The 6 month booster study and our ongoing U S and Australia phase II trial.

In conjunction with our prevent 19 trial. These outstanding data to make a compelling case for $23.73 to become the universal booster of choice.

Stan Irk: The Comcov 2 study and the Cov Boost Mix and Match study being conducted in the U.K. We furthered the global reach of our vaccine candidate, finalizing advanced purchase agreements with Gavi for 1.1 billion doses and with the European Commission, announced yesterday, for up to 200 million doses of 2373.

We also continue to explore heterologous boosting alongside other vaccines in the market by participating in 2 partner led studies. The <unk> 2 study and the <unk> boost mix and match study being conducted in the U K.

We further the global reach of our vaccine candidate finalizing the advanced purchase agreements with <unk> for $1.1 billion doses and with the European Commission announced yesterday for up to 200 million doses of $23.73 and.

Stan Irk: And on the manufacturing front, we continue to work closely with our global partners to progress toward our anticipated manufacturing capacity. We have made significant progress during the quarter to ready our global supply chain for the delivery of 2373 following anticipated regulatory approvals. And today, we reaffirm our guidance to be at a monthly capacity of 100 million doses by the end of the third quarter and 150 million doses by the end of the fourth.

And on the manufacturing front, we continue to work closely with our global partners to progress toward our anticipated manufacturing capacity.

We have made significant progress during the quarter to ready our global supply chain for the delivery of $23.73, following anticipated regulatory approvals and today, we reaffirm our guidance to be at of monthly capacity of 100 million doses by the end of the third quarter and of 150 million doses by the end of the fourth quarter.

Stan Irk: In parallel with these developments, we have our eye on the future, advancing other candidates in our pipeline that we believe are pivotal in our ability to continuously address the world's most urgent global health needs. We are excited to share with you more about these and our many other Chivas in the second quarter. Today, our management team will discuss clinical developments for 2373 and our financial results for the second quarter. And I will discuss updates on our supply commitments globally, progress toward regulatory approvals for 2373, and the status of our manufacturing global supply chain.

In parallel with these developments, we have our eye on the future advancing other candidates on our pipeline that we believe are pivotal and our ability to continuously address the world's most urgent global health needs.

We're excited to share with you more about these and our many other chivas in the second quarter today, our management team will discuss clinical developments for 'twenty 373, and our financial results for the second quarter net.

I will discuss updates on our supply commitments globally.

Progress toward regulatory approvals of $23.73, and the status of our manufacturing and global supply chain.

Stan Irk: I'll also highlight our key areas of focus moving into the remainder of 2021, as well as 2022 and beyond. With that, I would now like to hand the call over to Phillip to discuss our many clinical developments in the second quarter.

Also highlight the key areas of focus moving into the remainder of 2021 as well as 2022 and beyond.

With that.

I would now like to hand, the call over to Philip to discuss our many clinical developments over the second quarter.

Filip Dubovsky: Thanks, Dan. We achieved a number of milestones in the second quarter across the clinical program, and I'll highlight a few of these in the overall context of our studies. So maybe switch to slide five, please. Oh, here we are.

Thanks, Dan.

We achieved a number of milestones in the second quarter across the clinical program and I'll highlight a few of these in the overall context of our studies so maybe switch to slide 5 please.

Filip Dubovsky: So here are the clinical programs that we've conducted since the beginning of the development. We start off in phase one, phase two in the U.S. and Australia. There, we establish the dose level, the immunologic profile, and the preliminary safety profile of the study. And this is a study that's ongoing, and we've conducted some six-month boosting, which I'll talk about later. We moved on to a phase two study in South Africa, and this was our preliminary efficacy evaluation, as well as defining the overall safety profile and exploring the efficacy and safety in a small group of HIV subjects.

Yes.

So here of the clinical programs.

The we've conducted.

Over the beginning of the development, we start off on the phase 1 phase 2 in the U S, Australia, where we establish the dose level the margin profile in the preliminary safety profile of the study and the the study that's ongoing and we've conducted some 6 months boosting which I'll talk about later.

Moving on to a phase II study in South Africa, and this is our preliminary efficacy evaluation as well as defining the overall safety profile and exploring the efficacy and safety in a small group of HIV subjects.

Filip Dubovsky: We moved on to our first big phase three study in the UK, and this was a licensure-enabling study that collected licensure-enabling safety as well as efficacy data, and included a small influenza co-administration study. I'll touch base on that data a bit later as well. And finally, we conducted a large phase three study in the US, and this defined safety data and emergency data as well as efficacy data in the US population. Let's move on to slide five.

On to our first big Phase III study in the U K and this is a license for enabling study debt.

The licensure, enabling safety as well as the efficacy data included a small influenza co administration study and I'll touch based on that data a bit later as well and finally, we conducted a large phase III study in the U S and this day.

And the safety.

Safety data in just the data as well of efficacy data in the U S population, let's move onto slide 5 please.

Filip Dubovsky: Here's what to remind you of the design of the Prevent 19 study in the U.S. and Mexico, and this is a study that included 30,000 adults aged greater than 18 years of age, and it was randomized two to one. And as you know, we've gone ahead and crossed these people over in a blinded crossover fashion, and the enrollment in the two-dose crossover is almost complete. Additionally, we expanded this study to include adolescents 12 to 18 years of age, and we enrolled 2,248 of these children. The dosing is complete, and the file for safety, emergency, and efficacy is ongoing. We have a blinded crossover plan, and we should be beginning that next week.

Here's what I remind you of the design of the prevent 19 study in the U S and Mexico and this is the study that included 30000 adults aged.

Aged greater than 18 years of age and it was randomized 2 to 1.

And as you know we've gone ahead and crises people over in a blinded crossover fashion and the enrollment in the 2 dose crossover is almost complete.

Additionally, we expanded the study to include adolescents 12 to 18 years of age and we enrolled 2248 of these children the.

The dosing is complete and the follow up for safety Immunogenicity and efficacy is ongoing.

We have a blinded crossover planned and we should be bidding beginning debt next week.

Filip Dubovsky: So let's move on to slide six, please. Here, what I've displayed is the Kaplan-Meier curve for the primary efficacy endpoint. And overall, as you remember, the overall efficacy was 9% as Stan mentioned. From this graph, you can see a couple of other things.

So let's move on to slide 6 please.

Here, what I've displayed as the Kaplan Meier curve for the primary efficacy.

Endpoint.

And overall as you remember the overall efficacy was 9% of Stan mentioned from the graph you can see a couple of other things you can see the separation of the vaccine or placebo rates began before the day 21 before the second dose was Kevin <unk>.

Filip Dubovsky: You can see the separation of the vaccine and placebo rates began before day 21, before the second dose was given. Additionally, you can see through 90, there's no convergence of the rates suggesting durability of protection for our vaccine. And finally, I want to remind you that all the severe cases occurred in the placebo group. So, let's move onto slide seven.

Additionally, you can see through day 90, Theres no convergence of the rates, suggesting durability of protection for our vaccine.

And finally I want to remind you that all of the severe cases occurred on the placebo group. So.

So let's move on to slide 7.

Filip Dubovsky: Slide 7 contains data which is updated from what we talked about last, and this is because we got additional sequence data from the disease cases in the study. So the way this slide is designed is that the variance of concern is in red, the variance of interest is in yellow, and the variance that is neither of concern nor interest. Those that represent the strains closest to the Wuhan strain, more like match strains, are represented in green.

Sure.

On slide 7 contains data, which is updated from we chatted last and this is because we got additional sequence data from the disease cases in the study.

So the way. This slide is designed is the the variance of concern are in red the variance of interest on yellow and the variants that are neither of concern or interest does that represent the strains closest to the Wuhan strain more of like match Springs are represented in green.

Filip Dubovsky: You can see that overall, we had 14 cases in the vaccine group and 63 cases in the placebo group. And I'll remind you, this was a 2-1 randomized study, so you can consider the placebo group half of what we only were in a 1-to-1 randomized study. And that efficacy, like we talked about, was 90% with a lower bound of 83%. Our key secondary endpoint was against strains that were neither of interest or of concern, those most like the Wuhan strain.

You can see the overall, we had 14 cases in the vaccine group and 63 cases in the placebo group and remind you. This was the 2 to 1 randomized study. So you can consider the placebo group half of what it would have normally been in the 1 to 1 randomized study.

And that efficacy, while we talked about was 9% with the lower bound of 83%.

Our key secondary endpoint was against strains that we're neither buyers of interest or various of concern those most like the Wuhan strain and there we had 100% of efficacy you can see there are no disease, causing strains ingredient under the vaccine arm.

Filip Dubovsky: And there we had 100% efficacy. You can see there are no disease-causing strains in green under the vaccine arm. Against modern severe disease, we had 100% efficacy with a lower bound of 87s, and that's irrespective of variance or non-variants. You can see there were no cases at all in the moderate or disease group under the vaccine column. And finally, we had exploratory analysis against pairs of conservative interest, for which we saw efficacy of 92.6 percent with a lower bound of 80 percent. We had enough cases in this study also to estimate the vaccine efficacy against B117, which is the alpha variant first seen in the UK.

Against modern severe disease, we had a 100% efficacy where the lower bound of 87% and that's irrespective of variance for non variance you can see there were no cases at all in of moderate or disease group under the vaccine column.

And finally, we had exploratory analysis against periods of good sort of interest, which we saw the efficacy of 92, 6% with the lower bound of 80%.

We had enough cases of the study also to estimate the vaccine efficacy against the B 1.7.

Which is the alpha Varian first seen on the U K and there we had a point estimate of 93% with lower bound of 80%.

Filip Dubovsky: And there we had a point estimate of 93% with a lower bound of 80%. What's remarkable across all of these endpoints is really the consistency of the efficacy, as well as the precision and the high, lower bound. So let's turn to slide eight.

What's remarkable across all of these endpoints is really the consistency of the efficacy as well as the precision and the high lower bound so let's turn to slide 8.

Yes.

Filip Dubovsky: Slide 8 outlines the design of the UK study. This is a one-to-one randomized study with 15,000 dollars for people less than 18 years of age. And this also, we cross the subject over and enrollment of all the crossover vaccinations that have been complete. So let's move on to slide nine, which shows the Kaplan-Meier curve of the primary endpoint. As we talked about previously, and it's published now, the primary efficacy was 89% overall. Once again, you can see the separation of the curves beginning right at day 21 or before. And once again, there's no convergence of the curve suggesting durability protection.

Slide 8 outlines of the design of the UK study.

This is the 1 to 1 randomized study with 15000 adults greater than 18 years of age.

And this is also we cross the subjects over and enrollment of all of the crossover reclamation has been complete so let's move on to slide 9.

Which shows the Kaplan Meier curve of the primary endpoint as we've talked about previously and on its published narrow the primary efficacy was 89% overall.

Once again, you can see the separation of the curve at the beginning.

At day 21 of our before and once again, there is no convergence of the curve, suggesting durability of protection.

Filip Dubovsky: There are small red S's that denote severe disease, and they're all in the placebo group. In fact, over all of our programs, we have yet to see a severe case in the vaccinated group. Let's turn to flight 10. Part of this study was an influenza sub study where people received a licensed dose of the influenza vaccine with the first dose of 2373. What I've highlighted here are the local and systemic reactors in sea vents.

There are small red.

The denote severe disease and they're all in the placebo group in fact over all of our programs we have yet to see a severe case in the vaccinated group, let's turn to slide 10.

Part of the study, whereas the influence of sub study where people received a licensed dose of influence of vaccine with the first dose of $23.73.

What I have highlighted here is the local and systemic reactors in the events on the left hand side is local of both placebo flu alone Novavax alone and then a combination of Novavax and flu.

Filip Dubovsky: The left-hand side is a local profile of both placebo, flu alone, Novavax alone, and then a combination of Novavax and flu. And what you can see is that the Raggency profile is quite favorable. There's a small increase in the amount of mild symptoms, but overall, the vaccine is tolerable, and this is mimicked in the systemic side as well. The influenza, HIAI, and serial conversion were preserved with co-administration, and I'll detail these data in a subsequent slide.

And what you can see is that our the residency profile is quite favorable.

As a small increase in the amount of mild symptoms, but overall the vaccine is tolerable and this is mimicking the systemic side as well.

The influence of Hai and Seroconversion were preserved with co administration and I'll detail. This data in the subsequent slide and I'll remind you that the overall efficacy of the study was 89, 7% and when we do the subgroup analysis of those in the <unk> study we saw the the efficacy was preserved at 87, 5%, even though some of the.

Filip Dubovsky: And I'll remind you that the overall efficacy of the study was 89.7%. And when we did a subgroup analysis of those in the flu study, we saw that the efficacy was preserved at 87.5%, even though it was a very small subgroup of only 400 individuals. So let's go to slide 11 and look at the immunome. So what's displayed on slide 11 is the HCI responses of people who received the licensed vaccine alone compared to when given with 2373.

Very small subgroup of only 400 individuals.

So let's go to slide 11, and look at the immuno.

So displayed on slide 11 is the Hai responses of people who received the <unk>.

Licensed vaccine.

Low compared to when given with $23.73 on.

Filip Dubovsky: On the left-hand side, you can see the quadruvalent data, and this is people who were aged 16 to 64 years of age, who, by standards in the UK, received a quadrivalent cell culture influenza vaccine. The older subjects received an adjuvanted vaccine, and they're on the right-hand panel. This was a very small group of older subjects because the public health infrastructure in the UK works very well, and we only had 16 subjects who received our vaccine plus influenza, so the conference intervals are quite wide.

On the left hand side, you can see the quadrivalent of data and this is people who are aged 60% to 64 years of age who buy our standards in the U K received quadrivalent cell culture of influenza vaccine. The older subjects received adjuvant vaccine and they are on the right hand panel.

This is the very small group of older subjects because of the public health infrastructure in the UK works very well and we only had 16 of subjects, who received our vaccine plus influenza so of the confidence intervals are quite wide.

Filip Dubovsky: However, on the left-hand side, this was a larger group of individuals, so we can be more precise in our estimates of the immune response to the flu vaccine. And you can see that the H-A-I responses to the flu vaccine were preserved for all four strains. In fact, numerically, the H-I responses, as well as the circumversion responses, were higher in the co-administrated vaccine compared to the vaccine alone. So let's move on to the next slide, slide 12, please.

Over on the left hand side. These were larger group of individuals. So we can be more precise in our estimates of the immune response to the flu vaccine and you can see that the.

Hai responses for the flu vaccine with preserved for all for strains in fact numerically the hai responses as well as the circumvention of responses were higher in the co administrator of vaccine compared to the vaccine alone.

So let's move on to the next slide Slide 12. Please.

Filip Dubovsky: This is a comparison of the efficacy results from our two-phase three studies that were independently conducted and powered. You can see that the efficacy was remarkably consistent, 89% in the UK study and 90% in the U.S. study, less than a single percentage point difference between the two studies, indicating that the vaccine response is very robust. Against match strain efficacy, in the UK, we saw 96% against a prototype, and in the U.S. Mexico, where we had greater variance spreading, we saw 100% efficacy against those that were non-variants of concern or internalities. Efficacy against variance in the UK was 86% against Alpha, and in the U.S., 93% against Alpha.

This is the comparison of the efficacy of results from our 2 phase III studies that are independently conducted empowered.

Can see that the efficacy was remarkably consistent 89% in the UK study and 90% in the U S study less than a single percentage point difference in the.

2 studies, indicating that the vaccine responses very robust.

Against my straight efficacy in the U K, we saw of 96% against the prototype and in the U S. Mexico, where we had greater bearing spreading we saw a 100% of efficacy against those of our non bearings of concern or interest.

Against efficacy against variance in the UK was 86% against Alpha in the U S, 93% against the Alpha and overall in the U S bearings of considering the interest of 92%. So this vaccine works quite well against variance impact and.

Filip Dubovsky: And overall, in the U.S., variance of concern and interest is 92%. So this vaccine works quite well against variance, in fact. And finally, we have this observation that in the U.S., our efficacy against severe disease was 100%. We didn't have enough cases in the UK to estimate efficacy, but all the severe cases were in the placebo group. And I have to say, also in South Africa, all the severe and hospitalized cases were in the placebo group as well.

And finally, we have this observation that in the U S. Our efficacy against severe disease was 100%.

We didn't have enough of cases in the U K to estimate of efficacy, but also of a year of cases were in the placebo group and I would say also in the South Africa all of the severe on Housewives pieces were in the placebo group as well.

Filip Dubovsky: So let's move on to slide 13, please. Slide 13 is a display of the South Africa phase 2B design. And the only point I want to make here is that enrollment for all the crossover and boost vaccinations has started. And this design is a little bit different from the other two in that the people who received placebo initially got two doses of vaccine at six months. However, the people who got two doses initially got a single boost dose at six months.

So let's move onto slide 13 please.

Yes.

Slide 13 is a display of the South Africa phase 2 B design and the only point I want to make here is the enrollment of all of the crossover and boost vaccinations has started and this design is the little bit different from the other 2 in the the people who received placebo initially got 2 doses of vaccine at.

6 months however, the people who've got 2 doses initially that of single boost dose at 6 months and this will allow us to collect additional boost data both from a safety.

Filip Dubovsky: And this will allow us to collect additional boost data, both from a safety and emergency perspective, in this population. So let's move to slide 14. Slide 14 displays the study design of our phase 2B study that we started in the U.S. and Australia over a year ago. Here we enrolled 1,28 adults, 18 to 84, and half of those were adults who were greater than 60 years of age.

Perspective in this population.

Moving to slide 14 please.

Slide 14 displays the study design of our phase <unk> study that we started any of the U S and Australia over a year ago.

Here, we enrolled 1208 adults, aged 18 to 84 and half of those were adults who are greater than 60 years of age.

Filip Dubovsky: After the two-dose primary series, we went back, and we boosted some of these select individuals at six months. We plan an additional boost at one year. And the groups that I've highlighted in red, perhaps click, please.

After the 2 dose primary series, we went back and we boosted some of these select individuals at 6 months of the.

6 months.

On an additional boost at 1 year and the the <unk>.

<unk> that I've highlighted in red perhaps click throughs.

Filip Dubovsky: They have highlighted and read on the printed slides are the group we'll be talking about. These are people who received two doses initially at day 0 and 21, and half of them were boosted at day 189 with a 5-micogram dose of 2373. Let's go to slide 15, please.

So they are highlighted in red on the printed slides are the group will be talking about these are people who receive 2 doses initially of day zero in 'twenty, 1 and half of them were boosted at day 189, with the Pi microgram dose of $23.73, let's go to slide 15. Please.

Filip Dubovsky: So, slide 15 displays the adverse events comparing dose 1 to dose 2, and we've displayed adverse events overall, severe adverse events, medically attended adverse events, SEs, discontinuations, and potentially immune-mediated medical complications. And you can see there's a lot of consistency between dose 1, 2, and 3, and there isn't an excess of adverse events at dose 3. And the rates of severe AEs and SEs are very low indeed.

So slide 15 of our displays of adverse events comparing gross wanted to dose to the dose III and we've displayed adverse events overall severe adverse events medically attended <unk> events.

The discontinuation and.

<unk> immune mediated medical complications and you can see there's a lot of consistency between dose of 1.2 and 3 and there is an excess of adverse events and dose <unk> III and the rates of severe aes in SCS are of very low indeed.

Filip Dubovsky: So this data was reviewed by our external safety monitoring committee, and they expressed no concerns and suggested we proceed with vaccination. Let's move to slide 16. Slide 16 highlights the local systemic reactions after vaccination. And what you can see is that for the local reactions, we had an increase in reactivity for dose two and then additionally for dose three, which is completely expected with additional vaccinations. What you can also see is that more than 90% of the reactions were either none, mild, or moderate with a very low rate of grade three or more. The median duration was short, less than two days on average, with the exception of EAR FEMA, which was 2.5 days. Let's go to slide 17, please.

So this data was reviewed by our external safety monitoring committee and the voice no concerns and so just as we proceed with the vaccination, let's move to slide 16. Please.

Okay.

Slide 16 highlights the local systemic reactions after vaccination.

And what you can see is for the local reactions, we had an increase of reactors for the city.

For those 2 and then additionally for dose III, which is completely expected.

With additional vaccinations, which you can also see is that more than 90% of the reactions were either non mild or moderate with the very low rate of growth we have more events.

The median duration of short plus the 2 days median with exception of erythema, which was $2.5 days, let's go slide 17. Please.

Filip Dubovsky: Slide 7 Genes and Companion Slide, which details the systemic symptoms, and it's very similar to what we saw previously. As expected, the symptoms increased with dosing, and with the exception of fatigue, more than 90% reported either none, mild, or moderate symptoms, and the vent rate was quite low overall. Once again, the median duration was short, plus in one day, with the exception of muscle pain, which was two days.

Slide 17 is the companion slide which details the systemic symptoms and it's very similar to what we saw previously.

Yeah.

As expected the symptoms of increased with dosing with it and with the exception of fatigue more than 90%.

Reported either non mild or moderate symptoms and the event rate was quite low overall once again, the median duration of short clips in 1 day with exception of muscle pain, which was 2 days.

Filip Dubovsky: Let's move to slide 18 and look at some immunodata. What I've detailed here is the immune response, the immunokinetics of the anti-IG response conducted with our validated assay, and this is against a prototype. So you can see the peak response after two doses on day 35 was 41,000 units, which decreased over time. But when we boosted it, it rose up to over 200,000 units. And this represents a 4.6-fold increase compared to the peak seen after primary vaccination. Go to slide 19, please.

Let's move to slide 18, and look at some of immuno data.

Whereas the detailed here is the immune response to the immuno kinetics of anti IGT response conducted with our validated assay and this is against the prototype. So you can see the peak response. After 2 doses on day 35 was 41000, which decreased overtime when we boosted it rose up to over 200000.

Units and this represents a 4.6 fold increase compared to the peak seen after primary vaccination for this.

Filip Dubovsky: This is the same data, but it's displayed by age. And the point here is that in both the younger adults and the older adults, we had a good impact from boosting. In fact, the impact on older adults was even higher than younger adults to the boost, which is likely because they had slightly lower TDs to begin with. Move on to slide 20, please.

<unk> 19 please.

This is the same data, but it's the display by age.

The point here is that in both the younger adults from the older. Adults we had a good impact from boosting in fact, the impact of older adults was even higher than younger adults to the boost which is likely because they had cycle of lower titers to begin with.

Let's move on to slide 20. Please.

Filip Dubovsky: So all the data I've shown you up until now from an emergency perspective was against our validated anti-spike IGG for the prototype strain. We also developed a validated anti-spike IGG for the beta variant, so the one that was first identified in South Africa.

So all of the date of shown you up until now from of emergency perspective was against our validated anti spiked for the prototype strain. We also developed the validated anti spike.

<unk> assay for the beta variant.

So that 1 of the first identified in.

Filip Dubovsky: And you can see we got a really nice boost with that as well. From 4,400 a day at the six-month time period to almost 170,000 a day, 270,000 a day. So, what we have here is some evidence that the vaccine has the potential to cross-react against variance. We know this is true because we have good efficacy against variance. Go to 521, please.

South Africa, and you can see we got a really nice boost with that as well from a 44 for 400 of.

A day the 6.

The 6 month time period to over almost 170000 of day $2.17.

So what we have here is some evidence that the vaccine has.

The potential to cross react against variance, we noticed the true because we have good efficacy against various gross.

Moving on 1 please.

Filip Dubovsky: Flight 21 displays wild type neutralization. Once again, this is against the prototype strain. And you can see very similar patterns to what we saw with IGG responses, a peak at day 35, maybe at month 6th, and boosted to over 6,000, with an increased fold rise in the older adults. Let's move on to slide 22.

By 'twenty, 1 displays the wildfire neutralization once against the against the prototype strain and you can see very similar patterns of what we saw with the IGT responses of peak at day 35 midyear at month, 6 and boosted to over 6000.

With the increase fold rise in the older adults.

Let's move on to slide 22.

Filip Dubovsky: So on this slide, what I've displayed is the peak responses that we observed in the UK Phase 3 study. Next to that, in the middle column, are the immune responses that we observed in the Prevent 19 study. And finally, on the right-hand side, I have the boost data we just showed.

So on this slide where of displayed is the peak responses that we.

Observed in the UK Phase III study next of that in the Middle column is the the immune responses that we observed in the prevent 19 study and finally on the right hand side I have the boost data. We just showed additionally, I've put in the vaccine efficacy is the top of the phase III studies.

Filip Dubovsky: Additionally, I've put in the vaccine efficacy as atop the phase three studies. And what you can see is that compared to the two phase three programs, where we showed high-low efficacy not only against variance but also against non-avarians, we had a 4.7 to 4.4-4.4-4.4-fold rise. This gives us a lot of hope that we're going to increase the durability of protection as well as protect overall. Let's go to the next slide. This slide is a companion slide but shows wild-type microneutralization responses.

And what you can see is the compared to.

The 2 phase III programs, where we showed <unk> efficacy not only against our variance, but also against non of variance that we had of 4.7 to $4.4 fold rise.

This gives us a lot of hope that where.

We're going to increase durability of protection as well as protection overall as 1 of the next slide.

The slide the companion slide which shows wildfire micro neutralization of responses and the once again you can see the peak responses in the U K as well as the U S Phase III study and the we had a large boost from these with our phase III program.

Filip Dubovsky: And once again, you can see the peak responses in the UK, as well as the US Phase 3 study, and then we had a large boost from these with our in our Phase 2 program. I guess there are a couple things to point out here. One of them is that the fold rise is greater for microneutralization than for IGG, and this suggests the potential maturation of the immune response with greater spread. I'll show you a bit more data about this in the next couple of slides.

I guess, a couple of things to point out here.

1 of them is the the fold rise is greater for the micro neutralization and for ITG and this suggests the potential maturation of the immune response with greater spread how should we sort of.

A bit more data about this and next couple of slides, we were criterias to understand our immune response to these vaccines for this vaccine because we had such good efficacy against the variance was.

Filip Dubovsky: We were quite curious to understand our immune response to these vaccines, to this vaccine because we had such good efficacy against the variance. Let's move to slide 24. This is a pretty complicated slide, so I'm going to take my time going through this data.

Turning to slide 24.

Slide 24 is a pretty complicated slide some of our taking my time going through this data.

We developed a functional human <unk> 2 inhibition assay. So what we did is we developed our.

Filip Dubovsky: So what we did is we developed spike proteins from the prototype strain, delta, beta, and alpha. And what we did in this assay is we showed that the antibodies that are generated by vaccination can block that interaction. So this is a functional assay. On the left-hand side, you can see the data for day-thirty-five. So the day-a-3-5 data is the peak of response after two doses. And in black, you can see the prototype. In blue, you can see delta, in red, beta, and in green, alpha.

Spike proteins from the prototype strain Delta beta and Alpha and what do we do in this assay as we show that the antibodies that are driven by vaccination can block of that interaction such as the functional assay on.

On the left hand side, you can see the day 35 data. So the de identified data at the peak of response after 2 doses and in Black you can see the prototype.

Blue you can see delta and Red beta and in greenhouse on.

Filip Dubovsky: And I want to remind you that the efficacy against the prototype was between 96 and 100 percent, and against Alpha was between 86 and 94%. And the other variants displayed functional immune responses that were between those two. So we have high hope that the efficacy against those variants will be somewhere between that which we saw for the prototype and that which we saw for alpha. On the right-hand side, you can see the responses after boosting, and we had between a six-fold to 10.8-fold increase over what we saw at 835.

And I want to remind you that the.

Efficacy against the prototype was between 96% to 100% and against Alpha was between 86% to 94%.

And the other variance displayed immune functional immune responses to the lag between those 2 so we have high hopes that the efficacy against those variance will be somewhere between that which we software of the prototype debt free software Alpha.

On the right hand side, you can see the responses after boosting and we had between a 6 fold to 10.8 fold increase over what we saw at day 35 Importantly, Delta is getting a lot of attention you can see that it had a 6.6 fold rise over the peak response after the primary vaccination series another couple of observations.

Filip Dubovsky: Importantly, Delta is getting a lot of attention. You can see that it had a 6.6-fold rise over the peak response after the primary vaccination series. Another couple of observations on this part of the graph. One of them is that we left no one behind.

On this part of the graph.

1 of them is that we love to know on behind you can see that 100% of the people were boosted.

Into high levels, especially when you compared to the levels. We've seen here to those which were shown to be protective on the left hand side of the graph.

Filip Dubovsky: You can see that 100% of the people were boosted to high levels, especially when you compare the levels we've seen here to those which were shown to be protective on the left-hand side of the graph. Another observation is that we really have very consistent responses across the three variants, and this we attribute really to the maturation of the mean response with boost. So let me move on to slide 25, which is a quick clinical summary.

Another observation is that we.

Really have very consistent responses across the 3 variance.

And this we attribute really to the maturation of the immune response with boosting.

So let me move onto slide 25, which is the quick.

Quick clinical summary.

So we have data from 2 independent phase III studies that showed high levels of the vaccine efficacy in.

Filip Dubovsky: So we have data from two independent phase three studies that showed high levels of vaccine efficacy. In the UK, 89.7% overall, in the U.S., over 90%. And both of these studies have shown strong efficacy against variants against both B117, the alpha variant, as well as all variants of concern and interest in the U.S. study. Next slide.

In the U K 89, 7% overall in the U S over 90%.

And both of these studies have shown strong efficacy against variance against both the Bureau of on 70 Alpha variant as well as all of areas of concern of interest in the U S study.

Next slide.

I've shared with you today.

About our single dose boosting at 6 months and the significantly increases immune responses, both wildfire neutralization as well as anti Spike ITG Ubuntu between for 3 to $6 for fall over the peak primary vaccination of response and our functional <unk>.

Filip Dubovsky: I've shared with you today about our single dose boosting at six months, and this significantly increases immune responses; both wild type neutralization as well as anti-spike IGG were boosted between 4.3 to 6.4 fold over the peak primary vaccination risk in our functional ACE2 immune response. We were able to detect this against alpha, beta, and delta, not only in our primary vaccination series but also after we boosted it, and these went from a peak of 2.616 to 10.8 fold increase.

Immune response.

We're able to take this it gives alpha beta and delta not only in our primary vaccination series, but also after we boosted it in these went from a peak of 2.6.

616% to $10.8 fold increase.

We think of this data will support the use of our vaccine and of boosting campaign and Furthermore, we share data with you. The the code ministration with flu doesn't adversely impact the influenza immune response. So we have high hopes of boosting could be incorporated into the annual.

1 of the vaccine in the nation campaign.

So let me turn it back over to Stan.

Thanks, Phillip moving to slide 27.

Filip Dubovsky: We think that this data will support the use of our vaccine in a boosting campaign. And furthermore, we share data with you that code administration with flu doesn't adversely impact the influenza immune response. So we have high hopes that our boosting could be incorporated into the annual influenza vaccine nation. So, let me turn this back over to Stan.

We provide an overview of our supply of commitments to date, there remains significant demand for 2373 globally with vaccination rates vary widely from country to country. We continue to see significant opportunity in ex U S markets to provide supply for initial explanations in high income countries, we believe our technology well positions us to be.

Stan Irk: Moving to slide 27, we provide an overview of our supply commitments to date. There remains significant demand for 2373 globally, with vaccination rates varying widely from country to country. We continue to see significant opportunity in ex-US markets to provide supply for initial vaccinations. In high-income countries, we believe our technology well-positions us to become the booster of choice.

On the booster of choice.

Yesterday, we were pleased to announce the finalization of the advanced purchase agreement with the European Commission for the purchase of up to 200 million doses of $23.73.

We expect to begin delivery of initial doses following anticipated regulatory approval from the European Medicines agency and through this agreement of $23.73 is expected to be the first protein based COVID-19 vaccine available on the European Union.

Stan Irk: Yesterday, we were pleased to announce the finalization of an advanced purchase agreement with the European Commission for the purchase of up to 200 million doses of 2373. We expect to begin delivery of initial doses following the anticipated regulatory approval from the European Medicines Agency, and through this agreement, 2373 is expected to be the first protein-based COVID-19 vaccine available in the European Union. Additionally, we finalized our APA with Gavi, reaffirming our commitment to fair and equitable access to 2373. The cumulative 1.1 billion doses that we, alongside our partner Serum Institute, committed to the COVA facility will be critical in ensuring widespread initial vaccination, particularly in developing markets. Now, let's turn to our regulatory manufacturing updates. Next, I would like to discuss our progress during the second quarter in two key areas.

Additionally, we finalized our API with gobby reaffirming our commitment to fair and equitable access to $23.73, the cumulative of $1.1 billion doses that Lee alongside our partner serum Institute of committed to the Covid facility will be critical in ensuring widespread of initial the explanation, particularly in the developing markets.

So, let's turn to our regulatory manufacturing updates.

Next I'd like to discuss our progress during the second quarter for 2 key areas. The first share progress towards gaining regulatory authorization of $23.73, and anticipated timelines for completion of filings the <unk>.

As our progress towards achieving our anticipated manufacturing capacity and our expectations for the supply of $23.73 globally.

We'll then discuss our key areas of strategic focus for the remainder of 2021 as well as our expectations moving into 2022 and beyond.

Starting with our efforts to gain regulatory authorization of $23.73. This week by submitting its first regulatory filings in multiple countries. Novavax has graduated to a new level. Please.

Stan Irk: The first is our progress toward gaining regulatory authorization for 2373 and anticipated timelines for completing our filings. Second is our progress toward achieving our anticipated manufacturing capacity and our expectations for the supply of 2373 Global. I will then discuss our key areas of strategic focus for the remainder of 2021, as well as our expectations moving into 2022 and beyond. Starting with our efforts to gain regulatory authorization at 2373, this week, by submitting its first regulatory filings in multiple countries, Novavax has graduated to a new level. Please turn to slide 28.

Please turn to slide 28.

As I mentioned earlier on today's call, we filed regulatory submissions in multiple markets in partnership with serum Institute.

These regulatory submissions for emergency use authorization will filed with the drug controller general of India, and regulatory agencies in India, Indonesia, and the Philippines.

We expect to file for emergency use listen to the World Health organization in August.

We expect that the granting of emergency use listing by the <unk>, we will open the door for exports to numerous countries many of whom are participating in the COVID-19 ex facility.

These major milestones reflect the strength of our continued partnership with serum Institute and Mark an important first step toward accelerating global equity accessed 20, <unk> III we.

Stan Irk: As I mentioned earlier on today's call, we filed regulatory submissions in multiple markets in partnership with Sierra Minister. These regulatory submissions for emergency use authorization were filed with the Drugs Controller General of India and regulatory agencies in Indonesia and the Philippines. We expect to file for emergency use listing with the World Health Organization in August and expect that the granting of emergency use listing by the WHO will open the door for exports to numerous countries, many of whom are participating in the COVAX facility.

We expect these submissions to be the first of many with additional filing is expected in the coming months.

We are also working on submissions that will eventually cover the rest of the world because we are dealing with regulatory agencies that have different requirements in the countries that have different needs. These regulatory filings in the subsequent approval processes will flow.

Sure will occur over a series of months, let me cover of the ones that we're working on now.

In the U S. We are continuing to work with the FDA in collaboration with our team that we now referred to as the U S government to finalize our filing package for authorization under emergency use authorization.

Stan Irk: These major milestones reflect the strength of our continued partnership with Serum Institute and mark an important first step toward accelerating global equitable access to 2373. We expect these submissions to be the first of many additional filings expected in the coming month. We are also working on submissions that will eventually cover the rest of the world. Because we're dealing with regulatory agencies that have different requirements, and in countries that have different needs, these regulatory filings and subsequent approval processes will occur over a series of months.

The current timeline looks to now be in the fourth quarter hopefully early in the fourth quarter. This.

Of this timeline is based upon a couple of factors first the completion of validation of the analytical methods and Additionally, we have many complex critical activities as part of our <unk>.

Stan Irk: Let me cover the ones that we are working on now. In the U.S., we are continuing to work with the FDA, in collaboration with our team that we now refer to as the U.S. government, to finalize our filing package for authorization under an emergency use authorization. The current timeline looks to now be in the fourth quarter, hopefully early in the fourth quarter. This timeline is based upon a couple of factors.

Stan Irk: First, the completion of validation of analytical methods, and additionally, we have many complex critical activities as part of our finalization of our authorization submission that are being carried out with multiple third parties. Importantly, I believe all the key components are in place to achieve our filing within the fourth quarter. The good news is that the UA pathway remains open. Peter Marks, Director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, was quoted in a Bloomberg interview this week saying that, and I quote, there probably is going to be a point at which we stop giving emergency use authorizations, but right now, one wouldn't want to rule out continuing to give emergency use authorizations.

Stan Irk: We still don't have an approved protein-based vaccine, for instance, and there are some people where that might be a very good alternative. So I think that's good news. So regarding our progress toward completing regulatory filings and other geographies, we continue to advance our program with the MHRA, which is the UK regulatory agency. We are targeting to submit to MHRA in the third quarter, but as with all applications, this may change based on discussions planned for later this month to support our planned application in the third quarter.

The administration and health, Canada and of New Zealand through Med safe as always gaining the regulatory of authorization for 23.73 remains of top priority as we move into the the remainder of 2021 and we continue to work tirelessly with the regulatory authorities to complete our violence review the completion of multiple filings.

<unk>.

Announced today as a significant per step.

But only the first step in gaining authorization of of 23.73 around the world.

So moving the slide 29.

Next I will discuss on anticipate the timeline towards achieving our manufacturing capacity in progress made during the quarter to prepare of global supply chain for commercialization.

Stan Irk: Given that there are many countries who will rely on MHRA authorizations as a basis for their own regulatory approvals, this is another important global filing. In addition to filing with the MHRA, we are preparing to file in additional important markets within weeks of the MHRA filing, including the European Medicines Agency, the Australian Therapeutic Goods Administration in Health Canada, and in New Zealand through MedSafe. As always, gaining regulatory authorization for 2373 remains a top priority as we move into the remainder of 2021, and we continue to work tirelessly with regulatory authorities to complete our filing. The completion of multiple filings, announced today as a significant first step, but only the first step, in gaining approval for 2373 around the world. So moving to slide 29.

Today, we remain on track to achieve manufacturing capacity of 100 million doses per month by the end of the third quarter of 21, and 150 million doses per month by the end of the fourth quarter of 21 of manufacturing and development during the second quarter of reflective of progress toward reaching are anticipated manufacturing capacity as well as our efforts.

The proactively build on for future expansion.

Stan Irk: Next, I will discuss our anticipated timeline toward achieving our manufacturing capacity and progress made during the Corps to prepare a global supply chain for commercialization. Today, we remain on track to achieve manufacturing capacity of 100 million doses per month by the end of the third quarter of 21, and 150 million doses per month by the end of the fourth quarter of 21. Our manufacturing developments during the second quarter reflect our progress toward reaching our anticipated manufacturing capacity, as well as our efforts to proactively build our future expanses.

Stan Irk: Notably, we took additional strides toward producing 2373 in Canada, initiating technology transfer to produce 2373 at the National Research Council's Biologics Manufacturing Center in Canada. We're excited to see such progress at this facility, which completed construction on June 21, and we expect to begin large-scale GMP manufacturing once the facility receives regulatory approval from Health Canada.

Stan Irk: The production of 2373 in Canada will represent the first manufacturing capacity in the country for a COVID-19 vaccine. We expect our global supply change and support expansion of distribution of 2373 beginning the second half of 21, and we anticipate shipping 2373 vaccine upon anticipated regulatory approvals. Initially, our doses may be prioritized for low-income countries where we'll be able to support critical unmet demand for primary vaccinations. We view our partnership with CIRM Institute as a key component in delivering supply to low- and middle-income countries, including CERM Institute's contribution to the COVAX facility.

In the same period in 2020.

This increase was due to increased development activities related to Covid $23.73 under the U S government and set the agreements.

During the quarter, we filed an ATM offering in June 2021, which allowed us to issue and sell up to 500 million of gross proceeds of common stock as of June 32021, no shares have been issued under the new ATM.

We ended the quarter with a strong cash position of $2.1 billion compared to $806 million at year end 2020.

This increase in cash was primarily due to $1.1 billion in payments received under advanced purchase agreements.

Stan Irk: We remain confident in our ability to deliver upon our bilateral supply agreements, including with the European Commission, as well as our commitment to the U.S. government, especially as the need for boosters increases among high-income countries around the world. With that, I'd now like to hand over the call to John to discuss our financial results for the court. Thanks, Dan.

The timing of payments to third parties.

And the $565 million of ATM funding in Q1.

With that I would now like to turn the call back to stand to discuss our strategic focus for the months to come thanks, Jon turning to slide 31, I will lastly highlight of key areas of strategic focus for the remainder of 'twenty..1. These include the following.

John Joseph Trizzino: Moving to slide 30. We issued our second quarter earnings press release, which discusses our financial results for the quarter, and we'll be filing our 10 Q for the second quarter of 2021 today, which includes details on important business and financing events during the second quarter. With that said, I'd like to provide a high-level overview of some of our key financial results for the quarter. Novavac's revenue in the second quarter of 2021 was $298 million compared to $36 million in the same period in 2020.

Cleaning the additional regulatory filings in gaining regulatory authorizations of $23.73 in multiple markets running our global supply chain for commercialization and reaching our anticipated manufacturing capacity of 100, and 150 million doses per month, beginning expansive distribution of $23.73, and finally advancing lifecycle management of <unk>.

373.

We believe these near term priorities are critical and laying the foundation for the commercial success of the coming years.

As we look towards 2022 and beyond we believe that the clinical development of $23.73 to date positions our vaccine to become the universal booster of choice and the preferred vaccine for annual re vaccination.

John Joseph Trizzino: This increase was due to increased development activities related to COVID-2373 under the U.S. government and SEPP agreement. During the quarter, we filed an ATM offering in June 2021, which allowed us to issue and sell up to $500 million in gross proceeds of common stock. As of June 30th, 2021, no shares had been issued under the new ATM.

Our differentiated technology as well as our global supply chain will enable us to support demand and an anticipated booster market in 2022 would be on <unk>.

As we continue to develop other areas of our pipeline both of our variant strain in combination vaccine programs will play a meaningful role in our long term success.

They've been on us to effectively address continue continued evolution of COVID-19.

John Joseph Trizzino: We ended the quarter with a strong cash position of $2.1 billion, compared to $806 million at year-end 2020. This increase in cash was primarily due to $1.1 billion in payments received under advanced purchase agreements, the timing of payments to third parties, and the $565 million of ATM funding in Q1. With that, I would now like to turn the call back to the stand to discuss our strategic focus for the months to come. Thanks, John, turning to slide 31. I will lastly highlight our key areas of strategic focus for the remainder of 21. These include the following.

Alongside seasonal influenza.

Before opening the call the Q&A I wanted to take a moment to acknowledge and thank the novavax clinical trial participants around the world. These individuals made of crucial and lifesaving contribution during an unprecedented global pandemic.

And now they are the reasons that some countries are starting to reopen.

I and my colleagues have heard for many of you about your experiences and we are grateful for your generosity.

I know that in some situations clinical trial participants are being challenged with respect to proof of explanation.

Want these folks to know that we are doing everything we can to advocate for them. This includes working with governments to make the case of those who participate in clinical trials should be considered fully vaccinated from public health perspective, and treated in the same manner of someone who has received deployed vaccine.

Stan Irk: Completing additional regulatory filings and gaining regulatory authorizations for 2373 in multiple markets, getting 2373 ready in our global supply chain for commercialization, and reaching our anticipated manufacturing capacity of 150 million doses per month, beginning, and expanding, distribution of 2373, and finally, advancing lifecycle management of 2373. We believe these near-term priorities are critical to laying a foundation for commercial success in the coming years. As we look towards 2022 and beyond, we believe that the clinical development of 2373, to date, positions our vaccine to become the universal boost of choice and the preferred vaccine for annual re-vaccination.

These are unprecedented questions and we are supporting the efforts to devise solutions, while we can't control of the decisions that the countries in private entities make around vaccine mandates. We will also do our best to keep you informed on our progress on <unk>.

To reiterate that we are working day of 90 to finalize the requirements for the submission process and I want to personally. Thank all of the clinical trial participants for their vital contributions to public health during the pandemic.

For those who have reached out to us directly we appreciate your related in the snow about the situation.

Stan Irk: Our differentiated technology, as well as our global supply chain, will enable us to support demand in an anticipated booster market in 2022 and beyond. As we continue to develop other areas of our pipeline, both our variant strain and combination vaccine programs will play a meaningful role in our long-term success, enabling us to effectively address the continued evolution of COVID-19 alongside seasonal influenza. Before opening the call to Q&A, I wanted to take a moment to acknowledge and thank the Novavax clinical trial participants around the world.

Stan Irk: These individuals made a crucial and life-saving contribution during an unprecedented global pandemic, and now they are the reasons that some countries are starting to reopen. I and my colleagues have heard from many of you about your experiences, and we are grateful for your generosity. We know that in some situations, clinical trial participants are being challenged with respect to proof of vaccination. We want these folks to know that we are doing everything we can to advocate for them.

The I think the risk reduction is is dramatic and I think that it's a matter of now mechanics of getting all the all of the date of the final final day of the assembled and submit it and it's we're talking weeks here, we're not talking months, so I I'm not worried about the the future.

Stan Irk: This includes working with governments to make the case that those who participate in clinical trials should be considered fully vaccinated from a public health perspective and treated in the same manner as someone who has received a deployed vaccine.

The best.

Okay. So you believe it at least the time lines that you've put for if you'll be able to reach those that more of less correct.

I do.

Great for Christmas. This is day. This is a very this is a very big.

Stan Irk: These are unprecedented questions, and we are supporting the efforts to devise solutions. While we can't control the decisions that countries and private entities make around vaccine mandates, we will also do our best to keep you informed on our progress. I want to reiterate that we are working day and night to finalize the requirements for the submission process, and I want to personally thank all of the clinical trial participants for their vital contributions to public health during the pandemic.

Big transformation transition of the company would filed with now filed with the regulatory agencies the 3 countries.

You know we've got a complete file the package for those we are we are finishing the additional requirements and the various countries for that I've mentioned, we've listed dates that we plan on making with a lot of confidence.

Got it got it perfect. Thank you and I guess my last question of what additional day to do you need to generate and [noise].

Stan Irk: For those who have reached out to us directly, we appreciate your letting us know about your situation. I'd also like to thank our entire Novavx team for their continued dedication over an incredibly busy quarter. These tireless efforts, combined with the support of our partners globally, bring us significantly closer to delivering our COVID-19 vaccine.

To file to support for a boost of strategy campaign does it make sense to income art is there even the possibility that you can include some of the date of that we're seeing here and the E Bay filings to the U S E. When U K.

Yeah. So certainly we share this day, where some of those agencies normally I think it initially were planning to file with just the overall primary indication of better than the range for the primary reclamation and the date of would follow on of our subsequent variation hopefully this day there will be.

Operator: And I would now like to turn it over to the operator for Q and A. We will now begin the question and answer session. To ask a question, you may press any star than one on your touchtone phone. If you're using a speaker phone, please pick up your hand on it before pressing the. To withdraw your question, please press Starvin. And at this time, we'll pause momentarily to assemble the rock. And our first question today will come from Kellechi Shakiri with Jeffries. Please go ahead.

And even prior to the professional b L, a or or M. A and I agreed on at the very good.

Okay alright, thank you.

And the next question will come from my Ma'am tawny with the route of the F. B R. Please go ahead.

Kellechi Shakiri: Yes, thank you. Congratulations on all the progress you've made over the quarter, and thank you for the comprehensive update. I guess my first question is, what gives you confidence that you'll be able to file in the U.S., EU, and UK? And I guess how much risk is there associated with addressing some of those last remaining issues that are the gaining steps to those filings? Any color there will be extremely helpful.

Good afternoon, thanks for taking of questions and congrats on a lot of progress being made it. So if they me just ask of quake follow up on on the UK filing that seems to be taking a little longer than maybe maybe that was the anticipated I'm. Just curious if the cough cough do data that is being worked up on.

Also a mix and match vaccine data I'm just curious if you have an update on that and if that data set is playing any of the all of it.

Stan Irk: Yeah, I think the risk reduction is dramatic. I think that it's a matter of now the mechanics of getting all the data, final data, assembled and submitted. And we're talking weeks here; we're not talking months. So I'm not worried about future submissions. Yeah, so you believe that at least the timelines that you've

What is going on and and you can and if you can comment on the CMC side you know the first part of that question would be helpful.

Okay, well I'll tell you the clinical study portion of the question. So there are 2 studies that are being.

Kellechi Shakiri: that you've put forth, you'll be able to reach those goals; is that more or less correct? I do.

Funded by the V T I kind of being done by the University of Oxford, and Southampton 1 of them is the head of August vaccination study that for you referenced Comcast too and the other 1 is a boosting study where people receive 2 doses of are the sponsors vaccines that are being boosted by our vaccine and that's the cost of the study.

Stan Irk: Great. But this is a very, this is a very big transformation and transition of the company.

Stan Irk: We filed. We've now filed with regulatory agencies in three countries, and we've got a complete filing package for those. We are finishing the additional requirements in the various countries that I mentioned. We've listed dates that we plan on meeting with a lot of confidence. Got it. Perfect. Thank you. And my last question, what additional data do you need to generate and file to support your booster strategy campaign? Does it make sense to, or is there even a possibility that you can include some of the data that we're seeing here in the EUA filings to the U.S., EU, and UK?

The data the.

B R sponsored by ourselves are sponsored by the universities and we understand of the day there will be available on published in the September timeframe to look for.

Forward to the data is with yourselves. We've discussed this data where it would be UK regulators and they suggested it would be helpful. But I thought that our fees uhm to boost data in conjunction with our South Africa data would really be desirable to include it in the labeled indication.

Filip Dubovsky: Yeah, so certainly we've shared this data with some of those agencies informally. I think initially we're planning to file with just the overall primary indication of greater than age for the primary vaccination, and this data would follow on for subsequent variation. Hopefully, this data will be in even prior to a beneficial BLA or MAA and can be done as a variant. Okay, all right. Thank you.

Great and maybe if I could ask a specific question on the Booth day Dot here. The you know the headline number for the ex on.

On a board the IGD Spike and also the device type of utilization of.

How how do you see this compare relative to maybe what we have seen with them on the knees and then the idea of decay has in in your kinetic seems quite steep I'm just curious of Phillip how how should we think about that is there.

Operator: And our next question will come from Ma'am Tani, with B. Rale, the FBR. Please go ahead.

The thing with the platform on it just the we should be expecting this out of the Kid at 6 months.

Mayank Mamtani: Good afternoon. Thanks for taking our questions and congrats on a ton of progress being made here. So if I may just ask a quick follow-up on the UK filing that seems to be taking a little longer than maybe it was anticipated. I'm just curious about the Comcov 2 data that is being worked upon, also the mix-and-match vaccine data, and I'm just curious if you have an update on that and if that data set is playing any role with what is going on. on in the UK and if you can comment on the CMC side, you know, the first part of that question would be helpful too.

Respect of a M on any of the other protein based vaccine.

I guess, a couple of thoughts on and Greg can jump in as well I'm not sure of the measuring the absolute value of of either new R. I T. T. At 6 months of the indication of of of course.

The of that time point I think we've seen that for on some of the other sponsors who started or muted and have data in that regard. We certainly haven't seen any of the K and a couple of Meyer curve that I showed you. Although you know clearly that was the only for the first of 90.100 days or so.

I guess the other thing is that athletes matter and different kind of assays measure of different things and finally I would I would say, there's not 1 of the quantity of the antibody we induce the also the quality.

Filip Dubovsky: Okay, well, I'll take the clinical study portion of the question. So there are two studies that are being funded by the VTF and are being done by the University of Oxford and Southampton. One of them is a heterologous vaccination study that you referenced, Comcov 2. And the other one is a boosting study where people receive two doses of other sponsors' vaccines that are being boosted by our vaccine, and that's the COF boost.

I saw from the day, we showed where the functional as 2 inhibition results.

The hour antibodies able to the real across neutralized.

Barium.

Early crush neutralizes on the right word to be able to block the functional interaction between spike in the east too.

Filip Dubovsky: Those studies are not sponsored by ourselves, but are sponsored by the universities, and we understand the data will be available and published in the September timeframe. So we look forward to that data as much as you do. We discussed this data with the UK regulators, and they suggested it would be helpful, but thought that our phase two boost data in conjunction with our South Africa data would really be desirable to include it in the label indicators.

So much like we saw with the influenza study, where we had good.

Cross protection against.

Drifted strength I think we're seeing the same thing so it's a combination of the absolute items to achieve and how good your antibody levels are.

And I guess the other point is that these titers at the <unk> of 200000 on like we demonstrated here that's going to take a very long time for that to decay.

And we have a bunch of a better chance of.

Epitope of spreading and for.

Perhaps the berrien.

Mayank Mamtani: Great. And maybe I could ask a specific question on the boost data here, you know, the headline number of 4X on both IGG spikes and also the wild type neutralization. How does this compare relative to maybe what we have seen with MRIs? And then, you know, the IGG decay here in your kinetic seems quite steep. I'm just curious, Philip, how should we think about that? You know, is there anything with the platform, or should we just be expecting this sort of decay at six months, you know, irrespective of a MRNA or a protein-based vaccine?

Finding and protection because of the boost data and the maturation of immune response, we're doing the same thing.

That's good thank you.

Awesome and the thank you and my final question on manufacturing maybe Stan of.

Able to comment on the side of what might be a monthly then they'd say for July of or anything on the dosage of that you may have stockpiled.

Even like the shelf life because.

Folks are concerned that the bureaucracy of.

Filip Dubovsky: I have a couple of thoughts, and Greg can jump in as well. I'm not sure that measuring the absolute value of either Nutes or ITG at six months is an indication of efficacy at that time point. I think we've seen that from some of the other sponsors who started before we did and have data in that regard. We certainly haven't seen any decay in the Kaplan-Meyer curves that I showed you, although, you know, clearly that I was only for the first 90, 100 days or so.

Filip Dubovsky: I guess the other thing is that assays matter, and different kinds of assays measure different things. And finally, I would say it's not only the quantity of the antibody we induce but also the quality. You saw from the data we showed with the functional H2 inhibition results that our antibodies were able to really cross-neutralize variance, early crust neutralizes in the right way to be able to block the functional interaction between spike and AC2.

Filip Dubovsky: So, much like we saw with the influenza study, where we had good cross-protection against drifted strains, I think we're seeing the same thing. So it's a combination of the absolute titers to achieve and how good your antibody levels are. And I guess the other point is that these titers, if the hit titers of 200,000, like we demonstrated here, that's going to take a very long time for that to decay. And we have a much better chance of, you know, epitope spreading, and cross-barian binding and protection because of the boost data and the maturation of the immune response. Greg, do you know, say anything?

Our questions.

I had kind of the.

A broader question to start with and that is regarding in the annual boosting campaign I guess I'm wondering if you could lay out how you think that would work and what you think the strongest source of competitive advantage is that you may have as it in distribution or is it.

Mayank Mamtani: Awesome, and thank you. And my final question on manufacturing, maybe Stan, are you able to comment on sort of, you know, what might be your monthly run rate, say, for July or anything on the doses that you may have stockpiled or even, like, you know, the shelf life? Because, you know, I think folks are concerned that this bureaucracy of, you know, getting not just into the market might be impacting what doses you may already have sitting on the and not getting to people who can benefit from it.

Efficacy or tolerability or an ability for your vaccine the work nicely in the sandbox, if you will with other vaccines such as influenza.

Well, maybe I can think of it.

Bracket on from the medical side and the like as Dan said pretty much all of the above I think debt.

We will see of additional data emerges whether the exact records of the profile of various vaccines are when they are given either in homologous boosting our head of August booster and I think we'll have an advantage there.

Stan Irk: Yeah, I think we're certainly working to make sure that we don't run into a shelf life problem with product being made. We have been successful in extending dating from six months to nine months on a variety of our in-process work. Our expectation is that it won't be an issue we expect.

We've demonstrated that when we boost book with our vaccine, we get very broad protection against all of the brands we've tested it against.

Stan Irk: We expect fairly rapid licensure, and we expect to be able to use the product we make that we're scaling up right now. We're scaling up globally to this rate of 100 million doses by the end of next month. And so you can figure out how to get to that point, and then from 100 million to 150 million. But until the product is filled, we don't have to worry about dating because the drug substance, the antigen itself, is frozen.

To be clear I mean broadly of Peter response against all of the brands who tested again.

So I think we're in good shape, there as well the.

Sure.

I suspect that as we go forward, we're going to have additional data, which is going to speak to the pathology of our vaccine and how long we can use it and the sulfur.

And so forth.

Yes, I would just add Charles if theres a variety of factors here on I think you heard of the presentation on the day that was presented today that we're confident in the benefit and value of our boost the strategy, but it really remains some additional data to be collected.

Stan Irk: So that's all on the shelf. We've got many tens of millions of doses that are already ready to go. And by the end of August, when we expect to begin shipping, being able to ship, globally, we will probably have probably over 100 million doses that we are able to ship. We're, um, we're, um, cooking on that issue. It's going well.

Globally on what that policy position of global health policy position is going to be on on boost on what the timeframe is for that so we're we're obviously collecting all the information relative to the data we have.

Mayank Mamtani: Fantastic. Thanks for taking my question and congrats on the progress.

Operator: And our next question will come from Charles Duncan of Cantor Fitzgerald. Please go ahead. I don't know.

Charles Duncan: Okay, thanks Stan and the team for a comprehensive update and taking our questions. I had kind of a broader question to start with, and that is regarding an annual boosting campaign. I guess I'm wondering if you could lay out how you think that would look and what you think the strongest source of competitive advantages that you may have.

Stan Irk: Is it in distribution? Or is it efficacy or tolerability or the ability for your vaccine to work nicely in the sandbox, if you will, with other vaccines such as influenza?

Filip Dubovsky: Well, maybe I can take back some of that from the medical side, and like Stan said, pretty much all the above. I think that we'll see as additional data emerges what the exact reactionity profile of various vaccines is when they're given either an homologous boosting or heterologous boosting. And I think we'll have an advantage there. I think we've demonstrated that when we boost with our vaccine, we get very broad protection against all the Berenfoods we tested it against.

Filip Dubovsky: To be clear, I mean, broad immune responses against all the variants we tested against. So I think we're in good shape there as well. I suspect that as we go forward, we're going to have additional data, which is going to speak to the prosology of our vaccine and how long we can use it, its self-life, and so forth. Thank you.

Come up with them and the leading to of filing in September.

Last question regarding the influenza I'm quite interested in seeing that move for it I think it may be interesting to see a combination of vaccine and I guess I'm wondering when you consider the results that you have with the quadrivalent vaccine what do Ya.

Stan Irk: I don't have anything. Yeah, I would just add, Charles, that there are a variety of factors here, and I think you heard in the presentation and the data that was presented today that we're confident in the benefit and value of our boost strategy, but there really remains some additional data to be collected globally on, you know, what that policy position, or global health policy position is going to be on boost, you know, and what the time frame is for that.

Think was the driver of the Ah influenza or the response was it matrix am and could you speculate on what the response might look like when you combine with 2373 with with the Nanoflu.

Stan Irk: So we're obviously collecting all the information relative to the data we had, we're looking at the data from the other manufacturers, and certainly we're in communication in the U.S. and globally about what that health care policy will be to support a boost strategy. And I think the data is suggesting that we're prepared for whatever that might be.

Yeah. This is Greg of beer or just I think we have 2 sets of data now. So 1 is a very of care shoes.

Covid back.

With major assume and you previously as you know we had really good success and the older girls starting out of the flu vaccine in this trial. This is the license vaccine given during the administration and I think the show to us the uke.

Charles Duncan: Could you imagine a six-month boost or a 12-month or annual boost?

Good good for very good flu response, and cope response, sorry will previously so we're looking forward to swear at the group you know.

Stan Irk: Yeah, I think the data that was shown was, you know, six-month homologous boost data. I think Philip has talked about us going to be running a clinical trial in the fall and will be looking at heterologous boost. And so we see significant value in a six-month boost strategy, as confirmed by the data. But we'll have to wait to see what the likes of ACIP and others will say in regard to that.

[noise] day with our expectation of this fall will be starting a combination of flu.

Covid vaccine nature of them and we know matrix 2 of them have some really good for Ya.

Great.

I better.

The quality and quantity of immune response.

I think the Covid has really proven that the the.

The technology can be very powerful for for protection against these.

That's true vaccine flu.

Flu, there's been the gap.

Proving immune response proving the FC with the flu would be our expectations of those combo vaccine. So we're very excited to get that program into the clinic of night you expected that.

Charles Duncan: Okay, and then quickly going on to the MHRA meeting that you mentioned later this month or next month, what is the specific question that you're looking to get out of MHRA, or is it a checkup meeting prior to filing an application for, or finishing the application for approval in the UK?

We've said I think that sometime this fall.

And the first subject from the combo of trial.

Okay. Thanks for that at the color and looking for it to the upcoming of regulatory update.

Stan Irk: Yeah, this is, this, we hope, would be the final meeting where we'd have the submission after that. We're looking at the final, final questions that they come up with leading to a filing in September.

Thank you.

And the next question will come from Vernon for non Anita with H D Wayne right.

Please go ahead.

Hi, everyone. Thanks for thinking of my question and congrats on the tremendous progress and now it's been a long trip and I've been there with you and moving all the way.

Charles Duncan: Last question regarding influenza. I'm quite interested in seeing that move forward. I think it may be interesting to see a combination vaccine. And I guess I'm wondering, when you consider the results that you have with a quadruvalent vaccine, what do you think was the driver of the influenza or the response? Was it Matrix M? And could you speculate on what the response might look like when you combine 2373 with nanofloat?

No you just announced the submission for the way in India.

Indonesia, and the Philippines, but can you give us an idea of how long does a regulatory process takes and those [noise] countries and do you can you provide any insight into how many doses have been already distributed by others.

Greg Glenn: Yeah, this is Greg. I mean, I think we have two sets of data now, so one is a very efficacious COVID vaccine with Matrix-Im, and previously, as you know, we had really good success in older adults with our nanoflu vaccine. In this trial, this is a licensed vaccine given during the administration, and I think it shows us that you could get a very good flu response and COVID response simultaneously. So we're looking forward to it.

You know and other vaccines and those geographies and perhaps by the time 2373 becomes available in India, Indonesia, and the Philippines.

So I can speak to Indonesia, I think that they have had about 70 million doses distributed to date a lot of those vaccine doses are for the the sign of farm, which is the inactivate of vaccine and countries of express the real interest in trying to to have a booster with.

Greg Glenn: I think we're, you know, staying with our expectation that this fall we'll be starting our combination flu vaccine COVID with Matrix-Im. And we know Matrix-M has some really good features.

Charles Duncan: It creates a better, you know, quality and quantity immune response. I think that COVID has really proven the technology can be very powerful for protection against these respiratory vaccines. And I think, you know, flu, there's been a gap in proving the immune response, proving the efficacy of flu vaccines, which would be our expectation with this combo vaccine. So we're very excited to get that program into the clinic, and I expect that, as we said, I think that sometime this fall we will enroll our first subjects in the combo trial. Okay, thanks for that.

A vaccine my car so.

We did we have been approached by the government or at least for partner serum Institute was approached by Indonesia because of their extraordinary.

Greenlee difficult situations are happy with the Delta virus vaccine named Meg and I guess when I looked at the data we had the day with boosting the was very encouraging to see how good our immune response.

It was the Delta and we can't predict the timing of.

These regulatory interactions for easily we're hoping that that something.

Fairly soon it happened, but but right now we just don't have the prediction for the timing of of their actions.

Charles Duncan: Okay, thanks for that, Ed, and color me. Looking forward to the upcoming regulatory updates.

Okay, and as a follow up to that I know that.

Operator: And our next question will come from Vernon Bernardito with H.C. Wainwright. Please go ahead.

You're gonna manufacturing at the end of 50 million doses.

Vernon Tolentino Bernardino: Hi, everyone. Thanks for taking my question, and congrats on the tremendous progress. I know it's been a long trip, and I've been there with you and reading all the way. I know you just announced the submission for EOA in India, Indonesia, and the Philippines, but can you give us an idea how long the regulatory process takes in those countries, and can you provide any insight into people? to how many doses have already been distributed by others, you know, and other vaccines in those geographies, and perhaps by the time, you know, 2,373 becomes available in India, Indonesia, and the Philippines.

Oh of manufacture the balance of the 1.1 billion how much of of those total sense will be going to.

The the on countries.

Yeah. So we don't show of the Kovacs control the agave controls that Navi and UNICEF. So we don't have the.

Currently we don't know the the order in which day once you Bud dosage for physical ex facility.

Okay.

That's all I have thanks for taking my question and congrats on the tremendous progress.

Yeah. Thanks for.

And the next question will come from Eric Joseph J P. Morgan. Please go ahead.

Hi, good evening, Thank you for taking the questions Uhm.

I guess with respect to the equity funds with EMEA, sorry for you I'm, sorry, if I missed it but can you speak to what extent the submission.

Greg Glenn: So I can speak to Indonesia. I think that they have had about 70 million doses distributed to date. A lot of those vaccine doses are for the Sino Farm, which is the inactivated vaccine, and countries have expressed a real interest in trying to have a booster with a vaccine like ours. So, um, we have been approached by their government, or at least our partner's serum institute was approached by Indonesia because of their, you know, extremely difficult situation they're having with the Delta virus vaccine.

Due to the requirements differ from those already submitted with the survey for 2 for India, Indonesia, and the Philippines.

<unk> R.

Just curious to know whether you see European regular his new move the the goalposts at all.

Even that.

Kind of taken this long to complete those submissions.

And then Stan.

You sound very proud of fairly confident on the the authorization that.

Greg Glenn: And I guess when I looked at the data we had today with boosting, it was very encouraging to see how good our immune response, you know, was to Delta. And we can't predict the timing of, you know, these regulatory interactions very easily. We're hoping that something, you know, fairly soon will happen, but right now we just don't have a prediction for the timing of their actions.

For meeting opening in the U S. Following the approval sensual to the loyalty of our mrna vaccines.

I'm curious the other thing of of feedback specifically for the agency that if you're comfortable with the windows to the opening 3 or fourth quarter, and whether or not it does.

I'll be curious to get a sense of how to think about.

Online too of BLA filing the 23.73.

Yeah.

Yeah. So so there's a couple of questions here, but my confidence in my statement is generated by of news article Peter.

Vernon Tolentino Bernardino: Okay, and as a follow-up to that, I know that you're going to manufacture 350 million doses, and SIAI will manufacture the balance of the $1.1 billion. How much of those doses will be going to those three countries?

Peter March quote and before that before I read that quote I would've said, we can't predict whether the U S. It's been a question mark for much whether the he was going to remain open and when Peter Mark showed that it will.

Stan Irk: Yeah, so we don't, so Kovacs controls it, Gavi controls it, Gavi and Unicep, so we don't have... Currently, we don't know the order in which they want to provide doses for the Covex facility.

It will remain open in particular, because we want to get a.

Protein base.

Covid Covid vaccine through the system I my.

Vernon Tolentino Bernardino: Okay. That's all I have. Thanks for taking my question, and congrats on the tremendous progress.

Confidence went up a lot so.

Operator: And our next question will come from Eric Joseph with J.P. Morgan. Please go ahead.

So that's what I base it on on.

On the regulatory issues. So everybody every so we have.

Eric William Joseph: Hi, good evening. Thanks for taking the question. I guess with respect to the upcoming negotiations with EMA and MHRA, can you, I'm sorry if I missed it, but can you speak to what extent the submission will cover?

We have made products and the different plants and usually the different clinical trials and what is the only difference between what we're filing with everybody else and for attending to file with the M. H R. Atma.

Eric William Joseph: packages or requirements differ from those already submitted with the Serv Institute for India, Indonesia, and the Philippines. I'm just curious to know whether you're seeing European regulars move

Finish up from comparability work between loss that needs to be done on those I think I think the actual studies are done and David Ash, we put together and that's what you're gonna take gaze of the state of put together and submitted to the M. H R a and.

Eric William Joseph: the goalposts at all, given that, you know, it's kind of taking this long to complete those submissions. And then Stan, you sound very, fairly confident about the authorization path remaining open in the U.S. following the approval, or potential approval, of the MRNA vaccines. I'm curious to know if there's any other feedback specifically from the agency that makes you comfortable with that window fitting.

So it's it's.

I.

I have a great deal of confidence that the package will go into them on the timetable will just talked about.

How are you planning to update the investors I guess as it relates to those.

Pack of submissions.

Stan Irk: three or fourth quarter, and whether or not it does, we'll be curious to get a sense of how to think about timelines for a BLA filing with 2373. Yeah, so there's a couple questions there, but my confidence in my statement is generated by a news article. Peter Mark's quote, and before I read that quote, I would have said, you know, we can't predict whether the EUA's, it's been a question mark for a lot, whether the EUA is going to remain open.

Stan Irk: And when Peter Mark said that it would remain open, in particular because we want to get a protein-based COVID vaccine through the system, my confidence went up a lot. And so that's what I based my confidence on the regulatory issues. So every every, every, so we have made the product in different plants and used it in different clinical trials.

Stan Irk: And the only difference between what we're filing with everybody else and what we're intending to file with the MHRA and EMA is that we're finishing up some comparatability work between lots that need to be done. And I think the actual studies are done, but data has to be put together, and that's what it's going to take. We've given those data put together and submitted it to the MHRA. And so it's, it's, uh, Um.

Stan Irk: I have a great deal of confidence that a package will go into them on the timetable we just talked about. How are you planning to update investors, I guess, as a result of those package submissions? Yeah, both. Well, I think when we get an approval, you'll get a press release. And I think when we file with major agencies like MHRA and email, we'll announce that in a press release. Okay, and maybe just one follow-up question if I could. I'm just trying to understand, better understand some of the language in the most recent filing here.

No the year originally.

Yes.

Sure Josh because of the times of the original timetable of called for the starting to deliver those doses in the fourth quarter and through the second quarter of next year and I think that probably we won't get many doses shipped in the fourth quarter.

Eric William Joseph: as it relates to

Eric William Joseph: Your agreement with the US government saying that it would like to see FDA alignment on your analytical methods.

Eric William Joseph: manufacturing, how to understand that, is that suggesting some kind of authorization or approval before continued U.S. production? And would it have been very... Yeah. Yeah, that's sort of...

And it will just push it back to the first and second quarter.

Okay great.

Stan Irk: Yeah, that's sort of the source of some of the delay with the FDA is we have this USG, the U.S. government, that is our partner in developing this vaccine, and they are the gate to our submitting it to the FDA. So there has to be some negotiation with the US government, and does the validation activities meet their standards, and then we take it to the FDA. and there's always a time lag with the FDA these days, and so it is, but we need what they want us to get. FTA to concur that our assay is fully validated, and that's what the time difference is.

Great stockpile of those doses so.

They will come.

In a rush once we get the FDA approval.

Okay, great. Okay. Thanks for taking the questions guys. Thank you.

And this will conclude our question and answer session I would like to turn the conference back over to Stan for any closing remarks.

Okay.

Yeah. This has been a huge transition quarter for the company I mean getting the regulatory submissions.

Is huge.

We're on the verge of product approval, we believe we have additional we've demonstrated additional.

Eric William Joseph: the originally planned delivery of the 100 million doses under the original Warspeed Agreement. I know that you originally expected delivery to the top of the point there. Sure, it does because the original timetable called for starting to deliver those doses in the fourth quarter and through the second quarter of next year, and I think that probably we won't get many doses shipped in the fourth quarter, and it will just push it back to the first and second quarter. We have stockpiles.

Demand for the product.

And with the with the EU filing.

And we've got great data that shows our vaccine.

The effective against the various strains and so we're very optimistic of quarter reported to the next quarter. Thank you.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.

Stan Irk: in a rush once we get FDA approval. Okay, great. Thank you.

[music].

Eric William Joseph: Okay, great. Thank you for taking the questions, guys. Thank you.

Operator: And this will conclude our question and answer session. I'd like to turn the conference back over to the floor for any closing remarks.

Stan Irk: Yeah, this has been a huge transition quarter for the company. I mean, getting regulatory submissions in is huge. We're on the verge of product approval, we believe. We have additional, we've demonstrated additional demand for the product and with the EU filing. And we've got great data that shows our vaccine is effective against the varied strains. And so we're very optimistic. We'll look forward to reporting to you next quarter. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time. Thank you.

Operator: and the Thank you.