Hi, everyone. This is Ed Berg. I'm General Counsel for Vaxart, and I'm here today with Andrei Floroiu, CEO of the company.
Hello, everybody. I'm glad to be here. Thank you for taking time to listen to us.
Today we're here to answer shareholder questions. Thank you, everyone, for submitting your questions. Before we get started, we'll take care of business as a public company. Of course, I'd like to remind everyone that during this discussion, Vaxart may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations, and its product development and regulatory progress, including statements about its ongoing or planned clinical trials. Actual results could materially differ from those discussed in those forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process, and other risks in the Risk Factors section of Vaxart's most recently filed annual report on Form 10-K and on other periodic reports filed with the SEC. Vaxart undertakes no obligation to update any forward-looking statements after the date of this discussion.
Thank you, Andrei, again for being here, and let's get started. Why don't you tell us a little bit about yourself?
Sure. Thank you, Ed. Andrei Floroiu, I'm originally from Romania. Moved to the U.S. 28 years ago in 1995. I started working in biopharma about 20 years ago. I started working with vaccines about eight years ago and have been CEO of Vaxart for three years now. Let me just tell you a little bit about myself. I was originally trained as a computer engineer, and I specialized partially in artificial intelligence. This was back in Romania. I then moved on to designing microprocessors and network security, and I obtained a Master's of Science in Computer Engineering at the University of Maryland.
I worked a little bit in network security and cryptography at IBM. I decided to switch to finance, so I got an MBA from the Wharton School. That took me a step closer to biotech, actually. I started working for McKinsey & Company in New York. That's when I got introduced to biopharma by advising big pharma, mostly big pharma companies, but also biotech companies. This was a bit over 20 years ago. I then moved on to Wall Street and started the biotech investment strategy at The Invus Group in New York. That was a very interesting time because I started to see a lot of samples of successful and failing biotech companies.
What I observed was that it wasn't necessarily as much because of their science, but it was very often because of decisions. Successful companies made robust, unbiased strategic decisions, while unsuccessful ones didn't. Also, the other major factor was raising and allocating capital. Again, that's what differentiated successful and unsuccessful companies from my perspective. During that time, I started to also help biotech companies as a large institutional investor, and that was very exciting. I started being associated with some great successful drugs, such as TYSABRI from Biogen and Soliris from Alexion. One was in multiple sclerosis, the other one was in PNH.
I wanted to later on to take those lessons, combined with the insights I developed with McKinsey to industry, and that's when I started working on vaccines. First, involved with GSK's SHINGRIX, monetizing a royalty to that vaccine. It turned out to be very successful. I didn't have a hand in making the vaccine successful, but I was just involved in monetizing that royalty. I worked quite a bit on cancer vaccines, neoantigen vaccines, a very exciting but very challenging space. I joined Vaxart. During these three years, we completely transformed the company. When I came here, Vaxart was 11 people, almost entirely outsourced.
As you know, Ed, we became a fully vertically integrated company with over, we peaked at, 170 employees, so a 15 times growth. We raised over a quarter of a billion dollars, which allowed us to do two things. One, we started seven clinical trials, and second, we had the capital to internalize a lot of the capabilities that we thought is going to enable us to be successful in the long term. That brings us to where we are today.
Thanks, Andrej. We're going to get to the shareholder questions now. Let's start with the sort of broadest scientific question, which is on the VAAST platform. In regard to this platform, share where we are with. A shareholder asks, validating the VAAST platform to an FDA standard.
Okay. Not sure what up to FDA standard means, but all the clinical work we do is according to FDA regulations and standards, as many biotech investors probably know by now. We have a platform, we have a few clinical trials. I think the most advanced clinical data set we have is that from flu, where we had a challenge study funded by the US government, by BARDA. In that trial, we've shown that our vaccine, which looks like this, just in case people don't know. This is not an aspirin, it's actually our oral vaccine. We've shown there that an oral pill vaccine can be as protective, as the leading injectable against flu, Fluzone from Sanofi. Which is quite a big deal, right?
It's imagine a pill that you can take just with a glass of water that's as protective for that particular strain used in the challenge as an injectable. What was exciting was that while statistically the two vaccines were similar, Vaxart's vaccine trended superior, and it also was deemed that our vaccine was likely to reduce transmission more than the injectable. That started the process of highlighting advantages of our oral tablet vaccine that go beyond it being a pill and more having to do with triggering immunogenicity. Our other clinical programs, let me tell you a little bit about them. Second one is norovirus. We have run six clinical trials so far generated very exciting data.
Now we're in the midst of two more clinical trials, one of which is a challenge study, which, you know, you could see that as a proxy for efficacy when the data is out. Finally, our third clinical trial program is COVID, where we generated exciting data from both phase I and phase II, and two constructs. Our goal is to continue to find ways to progress all these programs.
When you think about the platform, or, what you're saying is essentially that you're developing multiple programs using this platform, and we're talking about progress. Let's go with the first of the program that we, as a company, have said that we are prioritizing, and I'll ask you why. Why are we prioritizing norovirus?
Okay. Yeah, we announced early this year that we are prioritizing norovirus. Part of this narrow focus had to do with limited resources that we have as a company. I want to say that we all believe strongly in all our programs, clinical programs at least, but we have to choose even, given limited resources. We chose to focus on norovirus for multiple reasons that we believe are very compelling. First of all, it's an unaddressed market that also has a very large economic burden here in the U.S., $10 billion alone annually, globally, probably $60 billion. There is very limited competition, so there is only one, at least in the West, only one advanced clinical program, and that's an injectable program.
The data we have generated so far across six clinical trials is very encouraging. We've shown there a strong immunogenicity similar to natural infection, which is kind of what you want to do. We've shown that these responses are long-lasting. Very interestingly, we've shown that the immune responses in elderly adults are very similar to those in younger adults, which is atypical of injectable vaccines. That could be an advantage in this important population. When you put it all together, we believe that our vaccine can have significant advantages, potential advantages to our only competitor, which is an injectable. You know, the responses in elderly is one of them, the potential to reduce transmission is another one.
But also because of our form factor, we have the opportunities to maximize the economic value here because we're going to use two different formulations in elderly adults, which is our typical formulation, versus kids. Kids below the age of five, which is an important segment here, they can't swallow pills. What we're going to do is we're going to use this microtab that we can put in a puree or something like that the kids can ingest. Again, lots of interesting reasons to focus there... Importantly, we've seen a line of sight to creating significant value here by advancing this program. Yeah.
Can you just remind our shareholders where we are on the development and what the upcoming data readouts are and when they're to be expected?
For norovirus?
For norovirus.
We have two very important data readouts that are coming up shortly this year. One of them is the top-line data from our dose ranging bivalent dose ranging study that we said is gonna come out in mid-year, so two weeks from now. The second one is the top-line data from our challenge study, monovalent challenge study, which we said is gonna come out in Q3.
In your opinion, what would success look like for those upcoming readouts?
Success here can come in multiple shapes, if you want. I would say broadly, the success is data that's gonna continue to encourage us to advance these programs towards approval and commercialization. Could also include data that's gonna grow the body of evidence, validating our platform and also showing or continuing to support the potential advantages of mucosal vaccination.
With regard to that data, what data will determine the plan for a phase III trial, and how long could that trial potentially take?
The way biotech works and the way we want to operate as a company is continue to be science-driven and data-driven. We need to see the data from these two trials to then refine our plans for phase III, and then we go and discuss those with the FDA, and that's how we know, you know, how the design is gonna look like, the size of the trial, the length of the trial, the endpoints, all these things. It's hard to tell without turning these two cards face up.
Thank you. There's also another norovirus trial that the company announced that is partially funded by the Gates Foundation. Can you tell us about what's happening with that study?
Yeah. That study, it's actually very interesting. What we want to do there, we want to show that you can vaccinate infants, younger than six months old by basically vaccinating their mothers. You know, their mothers just take a pill with a glass of water, and then through their breast milk, they give the antibodies to the infants, and we're gonna show that that transfer can happen, and that would be, you know, pretty exciting. Also, what's exciting about this, while we do it with the norovirus vaccine, you can potentially extrapolate it to the broader platform.
Can you tell us a little more about the timing of that study?
What we said there is that we're gonna start this trial this year, and we are on track to do so, and we're gonna announce when we know more.
Thank you. Well, let's turn our attention to COVID and coronaviruses. The company announced that it's undertaking an effort to develop an oral pan-coronavirus vaccine. What's the status of that effort? How come this effort on COVID's been in the works for a long time. Where are we with regard to development with regard to COVID and coronaviruses in general?
Yeah, yeah. Yeah, so we started this program about three years ago. I want to remind everybody that we did a phase I trial with an S+N construct, and then we did a phase II trial with a S only construct. That data came out late last year. Both of these data sets looked quite interesting in that what we realized is that the people who respond to our vaccine, which was Wuhan-based, also showed responses to a wide array of other coronaviruses. That led us to believe that our vaccine has the potential that injectables don't, to be cross-reactive, right?
As the COVID-19 pandemic kind of started to end, we said, okay, well, it doesn't matter because there are gonna be other pandemics, and we believe that a vaccine that is cross-protective has the potential to improve our ability to fight future pandemics and in pandemic preparedness. We changed our focus from just COVID-19 to pandemic preparedness and pan-coronavirus. That's why the next step, the next clinical step in the development program was U.K. challenge study, where we wanted to do something that was very exciting, actually, which is we wanted to vaccinate people with the Wuhan-based vaccine and then challenge them with Omicron. Through that trial, we're very excited in trying to prove that our vaccine can cross-protect, which no other vaccine has been able to show.
As financial markets became a lot more challenging and our access to capital was challenged, like most small biotech companies, we had to press the pause button on that because we couldn't see any more a way to generate return on investment, right? Governments weren't interested in funding and supporting work on COVID. There was no clear way to sell COVID vaccines, right? No available buyer that would return, and also interest from strategic partners doing this, right? We just thought it wouldn't be prudent for us to continue to invest in this program, even though we thought the next step was very interesting.
We had to make a very unpleasant decision to scrap plans for that challenge study and wait to see what other opportunities we have to advance this program. Luckily, just very recently, I think, we started to be very excited about coronavirus, particularly due to the U.S. government new $5 billion effort in this area.
Let's talk about that effort and where Vaxart is with prior to that. Did you submit to BARDA for funding by the deadline? Was it accepted? Where is the company with product?
Did we get the money, and did we get? Of course, of course. No, these are all good questions.
Yeah.
We, as I'll talk a bit later, we are a bit limited in how much information we can provide at this point. What I would say is mostly based on publicly available information. First of all, we have lobbied for over two years, the U.S. government, on the need to fund next-generation vaccines to improve our ability to fight pandemics, because we believe that the current generation vaccines, the mRNA vaccines, that many of us took, have significant shortcomings, and if the next pandemic comes, we're not going to be well prepared. That message seemed to get traction, then not get, and, you know, it got caught up into the political games that all of us can see.
It was very exciting when we realized that finally, the U.S. government sees the need to actually put serious money behind this effort. Then we weren't sure whether this is going to pass the debt ceiling negotiations, and we're very relieved when we saw that it did. This program, NextGen, is a $5 billion effort, and the reason we are very excited about it is because one of the goals there is to support the advancement of mucosal vaccines and the vaccines that can show cross-reactivity, right? This information is available publicly. You can all go and read it. What I can tell you is that many people from outside of the company, some of them our competitors, told us that they felt that that proposal was written somewhat with Vaxart in mind.
I'm not sure that's the case, but I think we believe that we are uniquely positioned for this proposal. One of the things that makes us uniquely positioned is the requirement by BARDA that the vaccine candidates that they want to fund should be ready to enter a phase II-B trial within six months from submission. We're actually not aware of any other mucosal vaccine that can fit that criteria. That's one reason for it, we're excited. The other 1 is that BARDA's stated intention is to fund very large phase II-B trials, so 10,000 people. If you run the numbers, and this is, you know, at this point, highly speculative, this results into a $100 million - $160 million study.
I think such a large study and a large award would generate very, very interesting and new data. I think it's about time that indeed, the U.S. government supports our program.
you're excited about the support, but Vaxart right now, you're saying, isn't ready to make a statement?
No, I mean, you know, we're a known entity to BARDA. We have been known by the scientists there. We have been in interactions with the U.S. government the last three years. We are in interactions now. It's just not proper that we are more specific. When we have something clear and definitive, we will, of course, update investors.
Thanks. Okay, let's turn to flu. How much of a priority is the influenza program going forward?
Right now, it's not a priority because we have to focus our resources, right? I would answer this question a bit differently. The data we generated in flu is clearly very exciting, and everybody in the industry shares that thought. Also, what we believe is that flu is not a properly addressed need, if you want, right? The current crop of flu vaccines, they have okay efficacy. They need to match the strains. They're injectables. You need to go to a pharmacy, get injected. Some people don't like injections, et cetera. We think that there is significant room for innovation here, and we believe that an oral pill vaccine would allow a lot more people to get vaccinated and potentially provide them with better protection.
We talked about the fact that our vaccine has the potential to cut transmission, so we still remain very excited about the prospects of this program.
Thank you. Let's turn our attention to potential value creation through strategic partnerships. What are your plans for future business partnerships?
Our plans may be somewhat different than some other small companies, at least the many that I have met as an investor. I think you see many CEOs who want to turn their company into the next Pfizer, and that usually, you know, more often than not, doesn't end well. I believe, and I think our board shares my belief, that each asset has a natural owner. In the case of vaccines, particularly vaccines that address very large markets, such as flu, such as norovirus, such as COVID, there is a strong argument that Big Pharma is better able to create more value, particularly in the late-stage development, say, phase III and commercialization.
That being said, also Big Pharma has a lot of cash, but as with many small companies during COVID, they focused on COVID. Now fast-forward three years later, some of them don't have much in their pipeline. There is a lot of interest in late-stage vaccine assets, and there aren't that many of them out there. Of course, we are having conversations and as do, you know, other companies in our space, that's something that's usual, and we're open to finding those opportunities that we believe will create or maximize shareholder value. Again, when we have something to say, we'll say it.
Okay.
Yeah.
Thanks. Let's talk about. We talked a little bit about the headwind of having limited resources and many potential creators of values. Let's talk about another headwind, supply chain issues. Last year, you mentioned that there were supply chain issues. Are those issues still a concern for the company? If so, what are we doing to overcome that better?
Yeah. I would say that largely most of those issues went away. Some still remain, but most of them went away. Also over the past three years, as I said, we have been able to build, internalize lots of capabilities that made us a bit less dependent on outside factors, outside providers, and so forth. You put these two together, and I think today we are much more able to be in charge of our destiny, which also allowed us, for example, for these two ongoing norovirus trials, to stay on track with the timelines.
That's great. That's great. We are not finished this fireside chat, but there was a question about increased communication with our shareholders, and someone asked: "Can you commit to doing more of these fireside chats to keep the investors in the loop?
I think that also depends on the reaction to this fireside chat. If it's good and if there is demand for it, we are open to doing more of them. I think the right way to continue is to perhaps do this with some of our other colleagues, Sean or James, talk about other topics and help investors understand the company better, get to know us better, understand how we're thinking, that kind of stuff. Yeah, we are open to it. I wanna just draw the attention and make the point that fireside chats are not meant to disseminate timely material, potentially stock moving information, right?
This is an area where I feel there has been, there's been a few misconceptions, particularly from institutional investors, so I'd like to take the opportunity to address some of them here, right? The way publicly traded companies update investors and disseminate information is, as you know, as a lawyer, right, quite heavily regulated, right? Information flows aren't as fluid as we would like it to be. Even us answering these questions, right, we have to, you know, be careful what we can say, how we can say, there are disclaimers, et cetera. I'd like to give you a bit of a sense of some of the restrictions here, and the things that we can do and the things that we cannot do.
You know, as I mentioned before, I was an investor before, I totally understand that as an investor, you want more and more information all the time. It's never too much, right? I also got to understand the limitations that companies have in providing information, what kind of information they can and cannot provide. More specifically, let's talk about clinical stage biotech, right? Here, value is driven by data, right? Most of the communication that you see from biotech companies like Vaxart is around clinical data and around clinical trials. When you start one, what's the status, and when you have clinical data, right? We have made those announcements, when we don't say anything, it's often because there is nothing that we have to say, right? That's worth saying.
I think we get lots of questions all the time, weekly. You know, people like to get weekly updates, but there aren't weekly updates to make. The other thing I want to make sure everybody understands, we have obligations as a publicly traded company. We can't just sit on information, right? We can't just sit on clinical trial data or a partnership and not update investors, right? We have an obligation to disclose. Again, when we don't say something, we don't have an update, is because we don't have anything to update on. The other important concept is that you have to disseminate the information and disseminate at the same time to everybody, right? You cannot do selective disclosure.
Even if I'm talking to a large investment fund or hedge fund, it's not like we can be on the phone with them and tell them something that we cannot tell individual investors. I want all of you that listen to this to know that you are getting the same information that everybody else is getting. Now, let me talk to you a little bit about some of the information we either cannot communicate or that is not wise to communicate, right? One of them is interactions with governments, right? I'll give you an interesting example here, sometimes you are bound by confidentiality, right? You are limited in what you can say.
Sometimes it's just not wise to say certain things because we are creating expectations that we need to manage, and then it gets very complicated. For example, about 15 months ago, we were invited to 10 Downing Street, the U.K. Prime Minister's residence, to talk to his special advisor for health, and we're also invited to the U.K. Parliament to talk to PMs and so on. As you can imagine, this was a big honor, and we all felt that it was a validation of the potential of our platform. I would have loved to be able to tell people about it, but it was something that we decided is not wise to do. Why? Because politicians don't like to have attention drawn onto them, right?
We kind of would have upset the people that were looking for support for them. The other one is that you never know if these discussions end up with anything concrete, right? We run the risk of creating some expectations that then don't materialize. In this case, Boris Johnson quit as the U.K. Prime Minister. The people that we talked to were not in their seats anymore, and that was the end of that, right? This is just one example of conversations that we just couldn't comment on, and we've had many of these across, you know, five continents over the last years in COVID. The other one is discussions with strategic partners, right? These discussions in our industry happen all the time, and most of them don't lead to anything.
They take a lot of our time, we prepare for them and so on. Sometimes they take years. You just don't update on progress or status, and very often because you are limited by NDAs and such. Unfortunately, we are bound by lots of rules and regulations as far as what we can disclose and not. We're trying our best to keep investors informed, but I'd like everybody to understand that they're having the same access to information as everybody else, and we are doing our best to try to update you as much as we can.
Thank you. Well stated and very clear along the way.
It was a long answer, and I hope.
It was a long answer.
clear enough.
Important for our shareholders.
You know, keep the questions coming, and we're going to try to answer them, but I think we're not doing anything different than most other biotech companies. In fact, I think this fire chat and other efforts we've had, I think they are things that most biotech companies don't do. You know, it's proof of the fact that we're trying.
Thanks. Well, let's turn to one of the most recent events. Earlier this month, there was a press release issued by the company indicating the sale of more stock. Can you give us the reasoning behind that raise of funds?
Yeah. So, it wasn't an easy decision because the financial markets are very tough. Our stock price is not where we would like it to be. Because of that, it wasn't an easy decision to make. However, as you know from our latest quarterly filing and filings, and if you followed us, you can tell that we are getting close to having 12 months of cash only, and going below that is really not a great place to be. Yeah. Our board felt very strongly that we should raise money. You know, there's a saying in biotech, if you raise money when you can, not when you need it, so that we should raise money when we can, not when we need it.
Financial markets this year have been very unpredictable, hard to predict. Sorry for that. Our stock price was as low as $0.59. It had recovered to $1.40. We have been presented with an opportunity to raise some money, and we don't have a crystal ball, so our stock could be $2 in a month, or it could be back to $0.60, right? We don't know. We decided to take that opportunity, and we feel that that's in the best interest of the company, and we hope that we can, you know. Not we hope. It clearly puts us in a better place to progress the platform on our products.
Thank you. Well, we'll end on one last question. This one probably couldn't be much more broad. Can Vaxart provide a business plan with a schedule? Essentially, someone's asking you for the company's strategic plan.
Well, okay, let's see how we answer that. We have a vision, and that's the reason most of us are here and are excited about the work we do. That vision is to really transform the vaccine segment by progressing our revolutionary platform and changing how people are vaccinated globally, right? We hope that through oral tablet vaccine, we could enable a lot more people to get vaccinated a lot faster, potentially being better protected, right? That's a big vision. We are a small biotech company, right? There are a couple of things that contribute to translating this vision into a strategy. One of them is we are science-based, we are data-driven, right? That dictates your next step in all these programs.
The other one are the external opportunities, both for funding and for value creation, right? You take these two factors along with the vision, and that's what determines the strategy. Right now, our strategy is to focus on the norovirus program, which is, we believe, the shortest path we have to significant value creation, while at the same time looking for opportunities to advance our other programs. As I said, you know, the recent government effort, for example, is one such opportunity for continuing to advance our coronavirus program.
Andre, I want to thank you for your time today, and to our shareholders, I want to thank all of you for all the questions that you've submitted. We look forward to communicating with you, as events progress and as the company progresses.
Yeah, thank you so much for your time. This is our first time doing this. Hopefully, we're going to get better at it, over time, and hopefully more relaxed doing it, right?
Yes.
Thank you for your attention, and keep the questions coming, and we're gonna try to answer as many of them as we can.