All right, thanks everybody for joining us again at the Citizens Life Science Conference. Next company we have presenting has a really interesting oral vaccine platform, unique, I believe. It's Vaxart. We have Steve Lo, who's President and CEO, and James Cummings, Chief Medical Officer, and they're going to run you through a presentation. Take it away, Steve. Great, thank you very much. Good afternoon. As Roy mentioned, James Cummings, our Chief Medical Officer, is joining me. I'm Steve Lo. I'm the CEO of Vaxart. Thanks to citizens for the opportunity to present at this week's conference. As a reminder, in this presentation, we have forward-looking statements. I'll start off with just a quick poll of the audience. I don't think I see anyone raising their hands right now. Who likes getting shots? No one's raising their hands here. Certainly, from our perspective in the world of vaccines, what if you didn't need a shot? What if you can take a pill instead of getting the shot? I even think about the fact that there's a lot of time involved in getting your vaccine, right? You have to call your healthcare provider or call the pharmacy, get an appointment, stand in line, check in, all those things that are required to finally get a shot from a healthcare provider. From our standpoint, we have a way that could make it even much easier, right? We are changing the way how vaccines are delivered. The employees of Vaxart are dedicated and passionate about this. It is not just how vaccines are delivered, but even how the immune system responds. From our standpoint, I know that there has been a lot of discussion around vaccines in the general public. If you look at this slide on the left-hand side, our standpoint is vaccines are essential to public health. You can see where there is positive impact, whether it prevents illnesses, prevents hospitalizations and deaths. Certainly, from a public health standpoint, vaccines are important. On the right-hand side, from a business and revenue standpoint, we certainly believe that vaccines are what we would say a nice annuity. As you can see, in an adopted vaccine, over the course of the life cycle of that vaccine, it just generates consistent revenue. From both the business and the public health standpoint, we're excited to be working on vaccines. On top of that, we think we can even make it better. Let's first look at what the limitations are of injectable vaccines and why there is potential for a new approach. You see the cold chain complexity, certainly with the mRNAs, the cold chain, the access, right? You have to, if folks remember back in the days with COVID, you had to be in a line in a football stadium to get your injection. Waiting for a healthcare provider, it's a needle. Let's not forget about that. Certainly, there are other challenges, whether it's side effects, injection site reactions, et cetera. Certainly, there is an opportunity to simplify logistics. Perhaps the vaccine could come directly to you, right? Nowadays, you can call your pharmacy, and it can be delivered straight to your house. Easily deployable, certainly if there's a pandemic. Again, self-administered, so not the needle, the waste. It's a glass of water and a vaccine. On top of that, James will talk about this, right? The broad and durable immunity. It isn't just the convenience, but the scientific reasons why we think we have a great opportunity here. It is a paradigm shift, right? It's not just a pill. We're talking about our oral pill vaccine platform being needle-free, induces mucosal and systemic immunity. Also, the potential to reduce transmission. Again, James will talk a little bit about that. The benign and safety and tolerability profile. Folks do remember when you had your mRNA, how you felt the next day. Thermostable, self-administration, right? These are, I think, the key features and benefits of why we're excited to be working at Vaxart. Speaking of Vaxart, if you're not familiar with our company, just a brief background here. Our founder, Dr. Sean Tucker, has been with the company since day one. He's our Chief Scientific Officer and is an expert in mucosal immunity. We have a very strong IP profile that ultimately supports the oral recombinant pill vaccine. We have a pipeline, which James will review shortly. We are located in the biotech hub of South San Francisco and actually manufacture right down the street in South San Francisco. All U.S. manufacturing. We are also delighted that we have a good team of veterans who have deep vaccine experience. Speaking of which, James Cummings, our CMO, I will turn the podium over to him as he is someone who's been working on vaccines for quite some time. Thanks, Steve. Thank you. Taking a look at our platform for our vaccine, we call it VAST, Vector Adjuvant Antigen Standardization Technology. It consists of a non-replicating Ad5 that's been dried and put into a pill. Along with that is the pathogen-specific antigen and an adjuvant. This adjuvant system tells your GI tract, your small intestine, this isn't food. This is something that you should pay attention to immunologically. It's an oral pill taken with a glass of water. The tablet dissolves. The vaccine is delivered to the lower portion of the small intestine, and it activates the immune system. This activation of the immune system doesn't just provide systemic immunity for serologic IgG and IgA, but also promotes mucosal immunity so that the mucosal immunity, predominantly IgA, provides another layer of defense, usually before the pathogen has time to actually infect your body's cells, keeping the invader outside the gate, if you will. That secreted IgA is a different form in terms of a dimeric IgA. When one thinks of an IgG, one can consider it more of a lock-and-key phenomenon immunologically. It's very specific. It's very good for what it's pointed towards. Should there be any strain variation or movement in terms of what that strain might look like, it's a little confusing to the immune system. We know for most of the injectables, that systemic IgG is the response that you're getting. I'm systemic IgA. For our product, we're also looking at the mucosal IgA. Again, think of an IgG as having two fingers to grab a ping-pong ball. For a dimeric IgA in the mucosa, think of it as multiple sticky fingers. That helps not just grab onto that pathogen before it gets into your cell, but if there's any variation in that pathogen from strain change or whatnot, what we've been able to show is that the IgA response still has some impact. That affinity is minimal. This is a look at our portfolio. We'll talk first about norovirus. I'll pivot over to our respiratory vaccines. We do have a therapeutic vaccine in HPV, which is preclinical. Looking at norovirus, we'll take a look at our first generation and then our current generation of norovirus vaccines. Norovirus is an infection, which many of you have likely had impacted in your life. Many people believe that it's a cruise ship phenomenon. That certainly can run through a cruise ship like wildfire. It only takes 10-100 copies of the virus to cause clinical disease. In an enclosed space or a confined population, that can really take off. Also, when food service handlers have an impact of norovirus, and we can see from, I believe, one of the companies, Chipotle, had to provide a large settlement for people and the impact of that virus on their customers. It is a virus that does not discriminate from a socioeconomic standpoint. I would wager to say that Oprah Winfrey has access to the best healthcare on the planet. Last year, she had to be hospitalized because of norovirus. That's one of the impacts of this disease. A lifetime risk. Generally, everyone's exposed to norovirus by the time they're age five. Three to eight episodes of norovirus throughout your age. From an infectious standpoint, globally, we have over 680 million infections. In the U.S. alone, it's 20 million clinical cases of norovirus. From deaths and hospitalization, globally, we look at over 200,000 deaths per year. In the U.S., we're fortunate. We have a little over 900 cases of deaths, many of them, unfortunately, in our senior population. It's 100,000 hospitalizations within that disease frame. That's a large portion of our healthcare dollar. From an economic cost, it's $60 billion a year globally. In the U.S. alone, it's a $10 billion a year cost annually. Those aren't my numbers. Those numbers were recently published by Bruce Lee, who's now a professor at the City University of New York, formerly at Hopkins. These are detailed numbers looking at the impact, not just to the healthcare costs, but the costs in the pediatric population of the impact on that child and of the parent or caregiver who may have to miss work because you can't send a child with norovirus into daycare or into another enclosed population, not until they're cleared. When we look at the eligible populations, clearly, the elderly population trumps most. Anyone who's 65 years and older is at risk for severe disease, the immunocompromised, and people in stepwise care facilities or hospitals, any enclosed space where the population might not change as much. From an occupational standpoint, there are several populations that are not just at risk, but are of key importance. From a military standpoint, we have 10 million active duty personnel, thereabouts in the United States, where there's active duty, reserves, National Guard, et cetera. We have 11 carrier strike groups in the United States. right now. If you can imagine norovirus going through a carrier strike group, that's about 10% of your combat effectiveness rendered useless for a period of 30-50 days. Healthcare professionals, those supplying care, as I said, it's 10-100 copies of the virus that can transmit disease. That also translates over to the first responders who might transport someone or care for someone who has norovirus infection. Food workers, we've mentioned already the transmission that happens within the food preparation industry. Childcare providers. These are all work populations, occupations at risk. From a situational standpoint, lactating mothers, mothers who exclusively breastfeed their children, are at risk for maternal- to- infant, infant- to- maternal transmission of norovirus. As mentioned in the very first slide of this portion, from the travel industry, people who travel, people who work in the travel industry. I do not know for many of you who may have attended a previous finance conference earlier this year in San Francisco. There were a lot of people who were missing because there was a norovirus outbreak on the East Coast of the United States that was significant to our industry. This is a little bit of a recap on what an ideal norovirus vaccine would look like. You can translate this across the portfolio to most vaccines. We want a vaccine that provides a durable, cross-reactive, and mucosal immunity. Durable, six months to a year at least. Cross-reactive, as I mentioned, that dimeric IgA and mucosa having cross-reactivity that can provide some support against strain change. That mucosal immunity, not only impacting infection, but also having an impact on viral shedding or disease shedding. Shedding is the first step in how these illnesses are transmitted to others. If you can impact viral shedding, you can decrease potentially disease transmission. A state-of-the-art recombinant technologies is how we actually manufacture this vaccine in flexible manufacturing. It is entirely scalable. Easy to administer. What could be easier than a pill and a glass of water? It is thermostable at room temperature. We have data going out up to two years at 30 degrees Centigrade. There is no requirement for a complex cold chain, extended freezer access, et cetera. From a logistics standpoint, as well as a storage standpoint, that is a huge benefit. We can be developed rapidly. From the time that we identify what that strain or genetic sequence might look like, we are fully capable of executing a response in a timely fashion and providing global accessibility. For a thermostable pill, it's pretty easy to get it out into underrepresented areas in low to middle-income countries, et cetera. Do not forget what Steven mentioned earlier, that during the pandemic response, it took us over nine months to get people immunized. Just for the people who wanted the vaccine here in the United States, because of the logistics of going to a physician's office or getting into a vaccine-related clinic, we can mail this to you. We can put it in Uber Eats or we can send it by Amazon. I mean, the application for distribution and obtaining herd immunity is phenomenal. Getting back to norovirus, the majority of norovirus that impacts humans is GII.4 strain. The additional strain is GI.1. GI.1 and GII.4 are the two strains that are in our bivalent norovirus vaccine. The GII.4 strain primarily causes extensive disease in the pediatric and the elderly community and is often associated with more severe symptoms and symptoms requiring hospitalization. When we look at the clinical program, the data we've shown to date, we've shown that our norovirus construct provides both a systemic immune response as well as a mucosal immune response. We've shown that it has an impact on shedding. In norovirus alone, after a challenge, we decreased the area under the curve for shedding by 80%. That's statistically significant. We know that doing this, both a functional antibody that our vaccine produces using an MBAA assay, as well as norovirus-specific fecal IgA, a mucosal immune response, are important for protection against disease. From the FDA feedback we've received, we did meet with the FDA on an ongoing basis across the platform of our vaccines. The input we received from them, we asked them to comment on our correlates of protection that we've identified during our challenge study. They have asked for additional information. Again, we've identified from our standpoint the MBAA, which is a functional antibody, as well as the relevance of fecal IgA or mucosal immunity in the protection for individuals from norovirus. Now, people say, "All right, well, you're in phase II. I showed you my portfolio slide, right? What's this about a phase I head-to-head that we'll go over in just a second? We're always looking to improve things. Our Head of Science, Sean Tucker, our founder, was able to make some small tweaks to the existing vaccine structure and platform that provided better immunity and better stability. When we look at the GII.4-specific and GI.1-specific serum IgG responses, in this slide, the orange is the new construct. The black dots represent the legacy construct. This is in preclinical models. The placebo is on the bottom. You can see a several-fold increase in immune responses in the preclinical models for the new or improved construct. We are embarking on a phase I of the legacy construct, which we have a large amount of data against our new construct to show in humans the improvement of immunogenicity from this response, looking at both a low and a high dose of our new construct compared to the 10 to the 11 dose of the traditional or legacy construct. We have concluded enrolling this clinical trial. I am very excited that we should have top-line data by mid-year. This is looking at the functional antibody response in these individuals. Moving on to our respiratory vaccines, we have a COVID-19 vaccine that I would like to talk about. I know there is a lot of COVID-19 vaccine fatigue out there, but it is a relevant portion of our portfolio. It has been funded by BARDA, right? Many of you may know that in February, we were asked to put this large program on pause while it was reviewed at HHS. A few weeks ago, we were given the indication that we are now off pause and moving forward with this clinical program. This is under Project NextGen. Project NextGen for COVID wanted five main areas of performance improvement: vaccines that are easy to administer and reduce the spread of virus. Again, it's a pill and a glass of water. I've mentioned the mucosal immunity showing a decrease in viral shedding. In preclinical models, we've actually showed an impact on disease transmission: better protection, longer-lasting vaccines. Vaccines that provide immunogenicity out 360 days sounds pretty good to me. Solutions for faster, cheaper, more rapidly deployable opportunities. Again, a pill and a glass of water. No red-bag medical waste, no medical professional to have to supply the vaccine. Then the pan-coronavirus protection. I'll mention that in just a minute on our further slide. Four out of the five key pieces of Project NextGen, I think we have at this point. We received that BARDA award. That's up to $460 million. There's $240 million currently available for payment. This is a milestone, a pay-as-you-go contract with BARDA and an OTA. We started the 400-participant sentinel study. That is 200 folks receiving our vaccine candidate and 200 folks receiving a comparative-approved mRNA vaccine. We completed enrollment in November of 2024. We look to conclude that portion of the study by December of 2025. This is a very interesting study in that we're looking specifically in the sentinel cohort as well as a larger study at efficacy over a 12-month period of time. That's important because we know that the coronavirus that causes COVID-19, it mutates. There's strain variation about three to four times a year, depending on which modelers you talk about. The vaccine construct that you chose and then developed and had approved, by the time you're fielding it, it may or may not be as relevant as when it was identified. Now you have 12 months of additional time elapsing where the strains have a chance to mutate, to disguise themselves, if you will, and to evade your immune system. The 10,000-person study, again, the stop work order was lifted on 24 April of this year. We've reactivated our field sites and are currently screening for this study. We continue with discussions with BARDA regarding the dosing of those participants. I mentioned cross-reactivity being an important feature of our construct, right? For our COVID-19 vaccine, we looked at the cross-reactivity of our immune responses, not only to SARS-CoV-2, which is the virus that causes COVID-19, but we looked at SARS-CoV-1. We looked at MERS-CoV. These are all things that have been in the lexicon of pandemic preparedness over the last 10 or 15 years. We looked at other beta coronaviruses. We have shown cross-reactivity across all of them. We have generated some promising COVID results to date. Our first construct was expressing the S+N antigens. That completed a phase I where it was highly immunogenic, had very robust T-cell responses, as our platform is meant to induce. It was cross-reactive from a mucosal IgA standpoint and durable responses, again, out 360 days. When we looked at it, we thought, again, we can make this better. We would like to improve our serum or systemic responses. We developed a new construct, which expresses the S antigen only. It had a 72% immune response post-vaccination, better serum responses than our prior construct. We showed that we were able to boost folks who had received previously an mRNA vaccine. It was, again, a very highly cross-reactive mucosal immune response, mucosal IgA. We have maintained our benign tolerability profile to date. Let's pivot down to flu. Before COVID, we were working very diligently on a flu vaccine. We have currently both a seasonal vaccine program as well as a pandemic H5 program underway. In 2017, we executed a human challenge study that was funded by BARDA. We went head-to-head with Fluzone, which was at the time the most popular flu vaccine in the United States, known for the robust immunity and protection. Participants who enrolled in this study had to have a baseline hemagglutination inhibition of less than 10. We wanted everyone to have an even playing field because 60 people in each arm, that's a little small. We challenged after day 90, but up to day 120 after immunization with wild-type influenza A. The primary endpoint was the number of folks who were and the percentage that were infected from the challenge. Here we look at the controlled challenge of our vaccine versus Fluzone. On the right-hand side, the gray 71% are the number of people who received placebo who were infected. There is a 38% decrease in infection when Fluzone was used. There was a 49% decrease in infection when our Vaxart candidate vaccine was used, with a p-value of 0.001. A strong p-value, good protection. We showed an impact on viral shedding, which is another hallmark of this mucosal immunity, so that even if you had a breakthrough infection, you'd be less likely to spread this disease to others. We have some key milestones coming up in 2025 for our norovirus vaccine. We have some top-line data from that phase I trial that I mentioned, comparing our legacy construct, of which we have a lot of data, compared to our new construct, which we feel will be better. On our COVID-19 vaccine program, we have our BARDA study for the 10,000-person cohort moving forward and screening for enrollment. We have also been moving forward consistently with our 400-person sentinel study, which concluded enrollment in November of this past year. We should have that study conclude from the clinical standpoint in December of this year. From our influenza vaccine, we've demonstrated protective efficacy in a phase II study already. We continue development of both our seasonal as well as our pandemic influenza program. From an ex-sum standpoint, our vaccine platform is designed to generate substantial systemic and mucosal immune responses. Mucosal immune responses are the sweet spot of this platform. It supports a broad pipeline of programs in norovirus, influenza, COVID-19, and really others. Think of the mucosal surfaces in the body, any wet surface in the body, whether it's the respiratory tract, the GI tract, the genitourinary tract. That's where these vaccines can really show a difference if that's how the pathogen gets in. I'll mention lastly that all of our manufacturing is done right here in the United States. With that, we'll take any questions.