Good afternoon, everyone, and welcome to the HC Wainwright Annual Global Investment Conference. My name is Brandon Foulkes. I'm one of the Biopharma analysts here at HC Wainwright. Next up, we have a company presentation from Vaxart, and from Vaxart, we have CEO Stephen Lo. Stephen, over to you.
Great, thank you very much, Brandon. First, I want to thank the team from HC Wainwright for the opportunity to present at this week's conference. As a reminder, during my presentation, there will be some forward-looking statements. I'm delighted to share with everybody what we're working on here at Vaxart. There's been a lot of discussion in the press around vaccines, and certainly from our standpoint, we like that discussion because we view ourselves as an opportunity to be an alternative to the traditional vaccines that are out there. Our platform is designed to generate both systemic and mucosal immunity. We are working on transforming the approach to vaccines with our oral pill vaccine platform, and we're currently working on norovirus, COVID-19, flu, and hopefully one day we can even share some information on human papillomavirus (HPV).
Our oral pill vaccine platform is thermally stable, and that allows for great opportunities from an administration and distribution standpoint, as well as the fact that our company is based here in the United States, and we do all our manufacturing here in the United States. What I'm going to do next is just talk about why we believe we're a great alternative to the traditional vaccines out there and the scientific background behind it. I know everyone in this audience has probably had a vaccine in the past, and on the left-hand side, this is what you most likely did. You had to stand in line, schedule an appointment, get a traditional vaccine. That vaccine, from a mechanism of protective immunity standpoint, provided systemic immunity.
You may have had some injection site reactions, and how that vaccine got to the pharmacy or to the physician's office may have required some cold chain storage and transport along the way. Our oral pill vaccine platform offers both systemic and mucosal immunity. So far to date, we have a benign safety and tolerability profile. It could be self-administered at home. We think about the oral pill vaccine just being drop-shipped and on your doorstep, and you can take it there. It is because of the thermally stable, easy access, and logistics that we're working on that we think we would be a great alternative to the traditional vaccines that are out there. Not only from a convenience standpoint, but also from a scientific standpoint, we believe we have a unique modular vaccine platform that allows for both systemic and mucosal response. Our pill dissolves in the intestine.
It elicits an immune response against the protein antigen target, and it dissolves in the intestine, activates the immune system. As you can see with our patented technology, you can use it for norovirus, COVID-19, flu, and potentially one day HPV because it's modular. On top of that, unlike the injectable vaccines, which only induce a systemic IgG response, we believe our platform generates both a mucosal and systemic response, which offers greater cross-reactivity and also the potential for high variant coverage. As I stated earlier, here is what we're working on right now. First, we are working on norovirus. I will spend a few minutes shortly talking about our program there and what we've achieved thus far. In terms of respiratory vaccines, we are also working on COVID-19. I'll talk about our progress there.
Also on flu, I'll give you some background information on what we've achieved so far there. Like I said, one day with some of our preclinical work in HPV, we hope to even have a therapeutic vaccine. Let's start with norovirus. I know this is lunchtime here, so I probably will keep it pretty straightforward. Our next generation vaccine builds on compelling data that we've had in a prior challenge model with good efficacy results in phase 2. Norovirus is responsible for $10+ billion of economic burden. We are not aware of any vaccines that are currently approved, and we certainly believe that we would have first-in-class potential for a norovirus vaccine. It has the potential to reduce rates of infection, illness, and shedding, which helps with the spread or combats the spread. We've seen that in a phase 2 challenge study with our first generation vaccine candidate.
Our bivalent vaccine provides protection against the dominant strains, the GII.1 as well as the GII.4. We believe it has potential for improved protection against norovirus. Because we've been working on this for quite some time, we've actually improved upon the first generation construct to have a next generation vaccine candidate, which again I'll talk about now. Again, just as a reminder, you may have had many bouts with norovirus in your lifetime. The typical lifetime risk with norovirus, most adults have had up to eight episodes of norovirus. I'm sure if you've had it, you will recall the last time you've had it. In terms of the disease burden, worldwide, 685 million infections, 20 million here in the United States. It is not just a travel vaccine.
We look at it as there's a huge economic burden from if it's a spread in a daycare center, a nursing home, food workers. There's potential to prevent this from spreading. As a result, think about if it's at a child care center, a parent would have to take time off from work. This is where the economic burden of this disease is quite high. As I talked about earlier, we conducted a challenge study with our first construct. Our first construct, the vaccine candidate, met five of six primary endpoints, including on infection. There were several important secondary and exploratory endpoints that were met as well, which then provided a possible reduction in transmission potential. On the left-hand side there, you will see that the infection was a 30% relative reduction in infections against placebo in our first generation vaccine construct.
It also reduced 21% on the norovirus AGE, which is the acute gastroenteritis symptoms. The infection was statistically significant at a p-value of 0.03. The 21% relative reduction was a p-value of 0.149. It did not meet statistical significance, but certainly trending in the right direction. We saw a potential reduction in transmission potential, as in the virus in the stool, virus in emesis as well. This gave us the opportunity to say we can perfect this. This is also one of the reasons why we decided to work on a newer second generation vaccine candidate. As such, we decided to compare in a recent study, in a recent phase 1 study, our second generation, next generation vaccine construct against our first generation. This was an open label three arm study. It was designed to look at immunological endpoints with serum MBAA titers and fecal IgE.
We compared our next generation in two doses against the first generation. We had 20 participants in each arm, and it was not designed for statistical significance, but interesting enough, we did reach statistical significance. As you can see here in the next slide, we saw significant increases in G11 and G24 neutralizing antibodies with our next generation vaccine candidate. We saw a significant improvement in the geometric fold rise of our MBAA in both G11 and G24 at our high dose vaccine at the same dose level as the first generation. That was statistically significant, even with 20 subjects. We also saw a positive trend in the lower dose as well. This gives us great hope that we are on track for the next phase of our program. Our next generation norovirus vaccine is slated to progress to phase 2B for additional insights into safety and immunogenicity.
We are currently in discussions with potential partners, as well as looking at funding to move this to the next phase. The next phase would be a phase 2B safety study that could be started as early as the second half of this year, followed by an end of phase two meeting with the U.S. FDA. A phase three trial could potentially begin as early as 2026. Now I'll move on to COVID-19. We are conducting a head-to-head study against an approved mRNA injectable vaccine, currently one that's been approved in the marketplace. As I stated earlier, we believe that we would be a nice alternative to the mRNAs that are out there. We currently have 5,000 subjects enrolled. This is a BARDA-funded, U.S. government-funded phase 2B clinical trial that we were funded up to 10,000 subjects. We're currently at approximately 5,000 subjects when we received the U.S.
stop work order from the U.S. government. At this point, the study will continue, and we will establish safety and tolerability in this indication and ultimately support the safety profile of our whole entire platform. This study also includes the next generation vaccine construct, which is what we're working on now for COVID. We expect to have 12 months relative efficacy endpoint about in the second half of next year. Just a little more detail on a head-to-head study of our oral pill vaccine versus an mRNA injectable. This was funded by BARDA and the U.S. government with a Project NextGen award of up to $460 million. We started this trial in the second half of 2024, where we dosed 400 participants in a sentinel cohort. That included 200 with our oral XBB oral vaccine candidate versus 200 in an XBB mRNA currently approved vaccine.
We actually expect to have a 12-month readout sometime in the first part of 2026, which is an important milestone for us. On top of that, we have the main participant cohort of up to 10,000 participants. We enrolled really quickly early this year, and we have approximately 5,000 subjects in that trial. We did receive a U.S. government stop work order about the same time that a lot of the other mRNA programs were canceled by the U.S. government. From our standpoint, we're really pleased that we were able to enroll 5,000 subjects. Those subjects, per the stop work order, will continue to be followed through the trial. From that standpoint, we may have a 12-month data readout in the second half of towards the end of 2026 as well. Finally, another program that we've been working on for quite some time is our flu program.
We actually had conducted a phase 2 challenge study in flu many years ago. It was against a market-leading injectable vaccine. We believe we have a differentiated mechanism of action, again from both mucosal and serum antibodies. It could potentially reduce shedding, which reduces disease transmission, and finally, a good favorable safety profile. On top of that, with a lot of news around avian flu, we also started a program with our H5N1 construct in avian flu, and we have some animal model results, which I'll share with you shortly here. Getting back to the flu challenge study, this was also funded by BARDA many years ago. It was our first generation oral vaccine candidate. As you can see here, it protected as well as the market-leading injectable vaccine against influenza infection. It was a single dose administration.
It was either our oral vaccine versus the currently approved injectable vaccine, Fluzone to be specific, versus placebo. As you can see in the graph there, we had a 49% reduction of influenza infection versus placebo compared to Fluzone, which had a 38% reduction in the infection rate compared to placebo in this challenge study. It gives us certainly some hope that we can transform how we approach even flu vaccines for the future. From a pandemic standpoint, we also looked at avian flu, H5N1, in a challenge study with ferrets. This is an animal study that we had put together. The ferrets either received placebo or they received our vaccine candidate. At the end of this, those ferrets who did not receive our vaccine did not survive. Those who received our vaccine, 100% of them survived.
This is preclinical animal data, but from our standpoint, it gives us hope that we are certainly looking at multiple vaccines that could work on our platform. In terms of upcoming milestones, as I talked about in our cash runway, we have multiple value creating milestones. Our cash runway is to the first quarter of next year. Let's recap for norovirus. We are in discussions right now with potential partners once the phase 1 data came out, and there's certainly been some interest. Our hope is with funding that we can start the phase 2B study very shortly towards the end or second half of 2025, which will then keep us on our important timelines for this vaccine, which again is an unmet medical need. There are no current competitors that are FDA approved right now. We believe a great market opportunity.
With COVID-19, we continue to conduct our head-to-head study, and we expect enrollment to be completed. If we continue on, we would complete the enrollment towards the second half of this year, but we've already reached 5,000 subjects. If the enrollment stops, we should have some 12-month data approximately a year later. We continue to monitor the 400 participants in our sentinel cohort. From that standpoint, we expect that data to be available in the first quarter of 2026. Of course, continued development of our influenza vaccine with the proper funding. I'll close with the fact that we have a very strong management and leadership team here at Vaxart Inc. Dr. Sean Tucker is our Founder and Chief Scientific Officer. He's been working on this for quite some time and is certainly a recognized expert in this field. Dr. James Cummings, who's our Chief Medical Officer, has worked on many vaccine programs in his career. Dr. Ray Stapleton, who's our Chief Technology Officer, has managed a lot of manufacturing programs. As a reminder, we do all our manufacturing here in the United States. We're also supported by Jerome Grassman, our Chief Financial Officer, Ed Berg, our General Counsel, and Lori Hastings, our Head of Human Resources. In closing, we're really excited about the opportunity of what we can do with vaccines. I know vaccines are in the news, but there's also a lot of talk about alternatives to the mRNA in the news. We believe we're a good opportunity for that. We are pioneering a transformative approach, and our platform is designed to generate both systemic and mucosal immunity.
We have quite a few programs, as I explained, that we're working on in norovirus, COVID-19, as well as flu, and potentially one day with human papillomavirus (HPV). As a reminder, we have a thermally stable oral pill format that allows for easier distribution, easier administration, and we manufacture here in the United States. Thank you to the HC Wainwright team for the opportunity to present today.