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spk07: Greetings. Welcome to VaxArt Business Update and Full Year 2022 Financial Results Conference Call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to ir at vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Brant Vian, Senior Vice President, Business Operations. Thank you. You may begin.
spk05: Good afternoon, and welcome to today's call. Joining us from VaxArt are Andre Floriu, our Chief Executive Officer, Dr. Sean Tucker, our Founder and Chief Science Officer, Dr. John James Cummings, our Chief Medical Officer, and Phil Lee, our Chief Financial Officer. Before we get started, I'd like to remind everyone that during this conference call, 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 differ materially from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process and other risks described in the risk factors section of VaxArt's most recently filed annual report. on Form 10-K, and other periodic reports filed with the SEC. VaxArt undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Andre Floriu. Andre.
spk02: Thank you, Brent, and thanks to all of you joining us today. We are pleased to share with you our corporate strategy update and talk about how we'll be progressing our transformational oral vaccine platform. As we said in the press release we issued this afternoon, we are prioritizing the development of our oral pill bivalent norovirus vaccine candidate as we believe this to be the best strategy to position Vaxar for long-term success and maximize shareholder value. Our goal of this strategy is to focus most of our investments on the programs that have the greatest near-term potential to validate and progress our oral pill technology platform. Norovirus represents a very attractive target for VaxArt because of the very compelling risk-reward profile of our program. I will highlight five dimensions here. The disease characteristics, the large commercial opportunity, the attractive competitive context, the compelling data we have generated so far, and our near-term data readouts. The key characteristics of norovirus as an infectious disease have not changed since we started working on our program, and we do not expect them to change. This is unlike COVID, which has been a constant moving target with emerging variants. Norovirus is less challenging for a company like Vaxar to develop a solution again. Second, the norovirus commercial opportunity is huge for a company of any size, an annual $10 billion disease burden in the US alone, with an estimated $60 billion burden globally. Third, competition for a norovirus vaccine is very limited. There is no approved vaccine anywhere in the world, and ours is the only oral programming development that we are aware of. And to our knowledge, there is only one other advanced programming development. Importantly, Our oral enterically delivered mucosal vaccine could have significant advantages for an enteric mucosal infection when compared to potentially injectable alternatives. Additionally, an oral pill vaccine has inherent convenience advantages in both key populations, kids and the elderly. The fourth point is that the data we have generated so far with our Norovirus program is substantial and quite compelling. We have completed six clinical trials and rolling 360 subjects in our Norovirus program. And this does not include the two ongoing phase two trials with top line data expected to read out this year. The immunogenicity data we have seen to date from the completed trials look consistently strong and the safety and tolerability data so far is benign. Additionally, as my colleagues will cover in more detail, our data in one key segment, the elderly, looks much better than what we would expect in this population, which is different than the data that has been seen with injectables. So we have a lot of concrete data points here to make us very excited about the potential for the clinical success of our norovirus program. We'll highlight many of these aspects over the next few months in both scientific and investor events. And fifth, we have two important top-line data readouts over the next six months. The first one is our phase two dose ranging study in mid-2023, and the second is our phase two challenge study in the third quarter. Now, besides that, importantly, we believe that if the data generated from our norovirus program continues to be strong, we'll have a range of value-creating options for taking the program forward. Mid- to late-stage vaccine assets addressing large markets are very attractive to many industry players, and these vaccine assets are quite rare, which is why at J.P. Morgan this year, we've seen that there is a lot of interest in this type of assets. So we believe this industry dynamic will translate into valuable optionality for us later on. Now, let me talk a little bit about our COVID-19 program. We continue to believe that the current injectable COVID-19 vaccines leaves a lot to be desired and that the encouraging data from our program suggests that our platform could fundamentally change how we fight COVID-19 and pandemics in general. That being said, we have had to adjust our strategy to the continuous evolution of the COVID-19 pandemic and the changing perspectives of important stakeholders, such as governments and regulators. Therefore, we decided to play to the strengths suggested by our clinical data and focus on addressing pandemic preparedness by developing a pan-beta coronavirus vaccine. One of the notable weaknesses of injectable COVID-19 vaccines has been their relatively narrow strain-specific activity. while cross-reactivity has been a feature of our mucosal oral pill vaccine. Such cross-reactivity will be essential for providing better protection against a virus that continues to evolve at a rapid rate and may escape the protection afforded by currently approved vaccines. Therefore, our broader focus on this beta coronavirus approach means we will not proceed with the previously planned clinical COVID-19 trials. And as we advance new vaccine candidates, we will determine the best development plan going forward. Furthermore, we remain engaged in discussions with regulatory agencies, governments, non-governmental organizations, and other strategic partners to maximize the value of all our vaccine programs. And we will provide updates as warranted. While we very much value every member of the Vaxar team, we have taken the difficult but necessary step to adjust our staffing level with a 27% reduction in workforce to reflect these new priorities and activities. With a change in program prioritization, our cash runway now extends into the second quarter of 2024. And as James will discuss in a moment, we expect to achieve several important milestones within the Norovirus program between now and then. These milestones have the potential to support the continued advancement of the Norovirus program toward the phase three trial, while also providing further validation of the promise of our oral pill vaccine platform. To showcase our differentiated Norovirus program and bivalent candidate, I am pleased to announce that we will be hosting a virtual key opinion leader call on March 28th at 1 p.m. Eastern Time with several leaders in the norovirus vaccine development. Sarah Bartsch, FICOR Project Director at the Research Foundation of the City University of New York, and Jan Vigne, Head of the National CalciVirus Laboratory at the Centers for Disease Control and Prevention in Atlanta. will share their insights and perspectives on the global need for a safe, effective, and readily deployable norovirus vaccine. And with that, I'll turn the call over to James for a review of our norovirus program. Thanks, Andre.
spk06: I'm really excited about the potential of our oral norovirus vaccine program, which could transform the vaccination paradigm globally, providing significant advantages compared to needle-based vaccines. We've already demonstrated robust immunogenicity data from our phase one norovirus clinical trials in both young adult and elderly populations. These data show that our bivalent vaccine candidate induced a robust immune response to include IgA antibody secreting cells, had an ASC response rate of 78% for the G11 strain and 93% for the G24 strain. with no interference observed. This means that the presence of G11 antigens did not interfere with the stimulation of an immune response against the G24 strain and vice versa. Importantly, our norovirus candidate has an attractive safety profile in trials today that's well tolerated with no serious adverse events, and that's consistent with our platform. We believe it has the potential to reduce transmission as well. As stated in this afternoon's press release, a key component of our prioritization of the norovirus vaccine program is the expansion of the ongoing phase two G11 norovirus challenge study to include additional challenge cohorts. We believe that the increased data set generated with these additional cohorts will improve the likelihood of identifying a correlative protection between immune responses to the vaccine and a reduction in risk of norovirus infection or acute gastroenteritis. Identifying a correlative protection may reduce the size and the duration of a phase three trial. With the inclusion of the additional cohorts, we expect to report top line data from the phase two challenge study in the third quarter of 2023. As announced last month, we initiated and dosed the first subject in the phase two dose ranging study of our bivalent norovirus vaccine candidate, a critical next step in advancing this promising candidate to a phase three clinical study. Our bivalent vaccine, is designed to target the prevalent strains of two norovirus genotypes, G11 and G24. They're the ones that cause the majority of norovirus disease in humans. Our oral pill, bivalent norovirus candidate, is differentiated from other norovirus vaccines in development for the reasons Andres already noted. It creates both mucosal and systemic immune responses. We're customizing the presentation for different age courts. There's no need for refrigeration because it's stable at room temperature, and it's much easier to distribute while eliminating the biomedical waste associated with administering injected needle-based vaccines. The phase two dose ranging trial is expected to enroll approximately 135 healthy adults at three sites in the United States. The first 10 subjects received open-label high-dose vaccine, and the remaining subjects will be randomized to high- and low-dose vaccine or placebo. Each of the vaccine arms will have 50 subjects, and the placebo arm will have 25 subjects. The primary endpoints are safety and immunogenicity. in order to determine a dose level for phase three development. We expect to report top line data from the phase two dose ranging study in mid 2023. If successful, the next step would be a phase two B study leading to an end of phase two meeting with the FDA next year. In addition to the ongoing studies of our norovirus vaccine candidates in healthy adults, we expect to initiate a Bill and Melinda Gates Foundation-funded clinical trial to evaluate the ability of our norovirus vaccine candidate to induce breast milk antibodies and transfer of antibodies to breastfeeding infants. If such transfer does occur, it could provide an important route for protecting infants from norovirus infection. This is especially important given the high incidence of norovirus infection in young children. We expect to initiate this study in 2023. Based on our growing body of data and the trials we have currently underway, we believe our bivalent norovirus candidate has a potentially expeditious path towards submission and a potential FDA approval. We look forward to advancing our promising norovirus vaccine candidate that may benefit individuals, communities, and health systems globally. I'll now turn the call over to Sean for an update on our novel COVID-19 constructs. Sean?
spk03: Thanks, James. The SARS-CoV-2 pandemic seems to be in a transition, perhaps turning into an endemic virus, and yet the virus really is continuing to cause significant mortality or morbidity, as well as to mutate. For these reasons, there is an ongoing risk that new variants will emerge and that the current vaccines will provide limited protection against these viral threats. We know regulatory guidance and the commercial opportunity continue to evolve. We believe that chasing the latest variant is not the best strategy for any company or for our society given how long it takes to develop, manufacture, and of course administer that vaccine. Therefore, We are now developing novel constructs that could provide protection, not only against the strains of SARS-CoV-2 that are most prevalent today, but also against future strain. We believe that this more proactive approach will be essential for getting off the hamster wheel of COVID-19 vaccine development, bringing the pandemic under control and reducing the individual and societal impact of an endemic infectious disease. Moreover, Based on the substantial mucosal cross-reactivity data reported to date from the Phase I and Phase IIa studies of our COVID-19 vaccine candidates, we believe that we may be able to potentially create an oral pan-beta coronavirus vaccine. SARS-CoV-2, the virus that causes COVID-19, is a subspecies of virus within the beta coronavirus genus, as are other coronaviruses. A pan-beta coronavirus vaccine would make it easier to future-proof the vaccine, whether the emerging coronavirus threat was a new SARS-CoV-2 variant, SARS-CoV-1, MERS-CoV, or some other beta coronavirus. Keep in mind, our clinical data for COVID-19 demonstrated it is possible to use antibodies at the entry points for SARS-CoV-2 infection, the nasal and oral mucosa. These mucosal antibodies were cross-reactive to multiple SARS-CoV-2 strains, as well as more distantly related beta coronaviruses, such as SARS-CoV-1 and MERS-CoV. It's important to note that SARS-CoV-1 and MERS-CoV were more deadly than SARS-CoV-2, and future beta coronavirus infections could also be more dangerous. Therefore, we believe that a mucosal antibody-inducing pan-beta coronavirus vaccine may be a valuable tool for pandemic preparedness. I'll now turn the call over to Andre.
spk02: Andre? Thanks, Sean. I want to take a moment now to welcome Phil Lee, Zaxar's new Chief Financial Officer. Phil joined our team in December and brings nearly 15 years of experience in strategy, M&A, and partnering on more than $20 billion in transactions. speaking on behalf of the entire leadership team, we're excited to have him on board. Phil?
spk04: Thanks, Andre. The details of our financial results for the full year 2022 are summarized in today's press release. Backchart ended the year with cash, cash equivalents, restricted cash, and marketable securities of $95.7 million compared to $114.8 million as of September 30th, 2022. The decrease was primarily due to cash used in operations as we advanced our Norovirus program. As Andre noted earlier, these funds provide cash runway into the second quarter of 2024. I'll now turn the call back to Andre for his closing remarks.
spk02: Thanks, Gil. We are starting 2023 with significant momentum. With the expansion of the Phase 2 G11 norovirus trial and the initiation of our Phase 2 bivalent norovirus trial, we are very well positioned to generate the data we believe we will need to inform the design of a Phase 3 clinical trial that can support approval of our bivalent norovirus vaccine candidate. Moreover, with the updates to our portfolio prioritization that we announced today, We believe we have the optimal strategy and resources to set ourselves on a course for success and future sustainability. The prioritization of our Norovirus program will also provide us with several important milestones against which our investors can measure our progress. These milestones include reporting top line data from the ongoing phase two dose ranging study of our bivalent Norovirus vaccine candidate in mid 2023. reporting top data from our ongoing Phase II challenge study for our G11 monovalent norovirus vaccine candidate in Q3 2023, and initiating in 2023 the Bill and Melinda Gates Foundation-funded clinical trial to evaluate the ability of our norovirus vaccine candidate to induce antibodies in breast milk and transfer of antibodies to young infants. Finally, as I mentioned earlier, we will host a virtual key opinion leader call on March 28th at 1 p.m. Eastern Time that will illustrate the differentiated nature of our norovirus program and our bivalent vaccine candidates. We hope you will join us for this exciting and informative virtual event. On behalf of Vaxart's leadership team, I'd like to thank you for your time today, and we are now happy to take your questions.
spk07: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. And for a participant using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Charles Duncan with Cantor Fitzgerald. Please proceed. Hey. Hi.
spk08: Good afternoon, Andre and team. Thanks for taking our question. Liking the focus on norovirus. Had a couple of questions there. With regard to the top line data, mid-23, I guess I'm wondering if you could lay out maybe what you would like to see, you know, maybe not so quantitatively, but what would you be encouraged by in terms of taking that data set to the agency? And would you anticipate that end of Phase 2 meeting by the end of 23 or in 24? I think you said early 24. But could you be in a position to operationalize, depending on funding, for a Phase 3 by roughly this time next year?
spk02: James, do you want to take this?
spk06: Sure. Thanks, Charles. Thanks for the question. So in terms of the top line data from our phase two dose confirmation, dose ranging study, you know, the top line data we'll have in mid-23 is based on 135 people, right, either receiving placebo or higher or low dose of our bivalent construct. I would say that what we're looking for with those reports are the immunogenicity as well as the safety profiles of the product. Again, you know, in our, you know, platform, we've seen a very consistent clean safety profile. And we'll see what that data looks like come mid-year. In terms of our approach with the agency and when an end of phase two study would occur, you know, after we have the results of that top line data, we'll be building the follow-on study, Part B of that study, which will give us the numbers needed to go before the FDA. That would be probably, well, I won't go into the details of how big, but it would be a larger size study based on the dose selected. And I would see that potentially taking place in 2024. Does that answer your question, Charles?
spk08: Yeah, I think. I think it does. We'll look forward to that data. The second question that I had was either for Andre or Phil. Phil recently joined the firm. I guess I'm wondering if you could provide more color on the R&D spend. I think it was about $81 million in the year. How much of that was COVID versus Noro? And then in terms of R&D spend that you anticipate for this year, What percentage of it is COVID versus Noro kind of sticking with that same order of operations?
spk02: Phil, do you want to take a stab at this?
spk04: Sure. So I think the best way to get you the numbers is actually in the 10K that we filed. What we disclosed there is the external spend for Norovirus and COVID. But in terms of what's going forward, obviously I think there has been a significant focus on norovirus and the clinical trials that we're running there. So you could largely think that the majority of our spend will be on norovirus, although we are continuing with other assets in our platform as well.
spk08: Okay, that's helpful. Last question on partnering. I guess my question is strategy, and so it's probably going to be an imperfect question. question or certainly answer takes two to tango, but with regard to moving into a longer, larger study of Phase 3 in Noro, would you anticipate the data yet this year to be able to enable you to progress with partnering discussions, or would you rather take the candidate into Phase 3 yourselves? Thanks.
spk02: Hi, Charles. So I'll try to answer this question, even though, as you can appreciate, it's a bit premature. So I think the data that is going to come out in the third quarter, particularly the challenge data, the norovirus challenge data, is seen as very important by investors and potential strategic partners, too. So I think After that, data will be a key decision point for us in terms of how we proceed forward.
spk08: Got it. That's helpful. Thanks for taking my questions. Thank you so much.
spk07: Our next question is from Mayank Mantani with B. Reilly Securities. Please proceed.
spk01: Good afternoon, team. Thanks for taking our questions. And I also appreciate the timely pivot focus on our virus. So maybe just piggybacking on the prior comment, Andre, could you talk a little bit more for the challenge study, the rationale for expanded cohorts? And I think it would be helpful for investors to understand what levels of protection, you know, be it symptomatic efficacy or even transmission you're looking to target in this data set. And if you are able to go a bit deeper on the types of immune correlates you're looking at, that also would be very helpful.
spk02: So James, do you want to take this question?
spk06: Sure. So, Mike, thanks for the question. the type of data to drill down into what we're looking at for the challenge study. Essentially, we're looking at protective efficacy. So, looking at a reduction in symptomatic acute gastroenteritis secondary to norovirus. We're also looking at the potential for decrease in shedding, viral shedding of norovirus. We all know it doesn't take a lot of norovirus to cause an infection. But if you can decrease shedding, you should decrease potential transmission. So those are two of the things we're looking at. And then another facet of that study in particular is looking at a correlate of protection. We feel that a correlate of protection could be key in sizing up our phase three endeavors and looking at the potential to decrease numbers and or timelines for a phase three study. looking at a correlative protection. This challenge is a G11 challenge. And, you know, our bivalent vaccine that we're going to dose ranging study has G11 and G24. So we're keenly interested in what that correlative protection may look like. And then sharing that with the FDA in discussions to get a read on how that might impact our phase three study. Does that answer your question?
spk01: Yes, it does. And maybe if I can ask you to be a little more specific on the dose ranging study for the bivalent, the dose levels that you're looking at, how do they compare against the monovalent work that you've done before? And, you know, what sort of answers that you're looking from there that you think would be very helpful with the regulators? And if there is a need for you to do a bivalent specific challenge study also, you know, before you start a phase three, if you could clarify that. Thanks again for the question.
spk06: Sure, thanks. So in terms of the dosage levels of that study, and it's available on clintrials.gov, we're looking at a bivalent of G1.1 and G2.4. At 5, E to the 10, which a total dose is 1e to the 11th dose, right? In terms of the high dose, that's G24 and G11. That's a 1e to the 11th per strain for a total dose of 2e to the 11th. Now, in our previous studies, we've had doses as high as 1e to the 11th. So this is a higher dose. And as I said, we'll be looking to maintain what we've already seen across our doses in this and other vaccines, which would be a clean safety profile. In terms of other diarrheal diseases or diarrheal disease presentation while performing studies until we go into our phase three, certainly we would collect any data in a phase two if someone were to have, you know, acute gastroenteritis, but that would be exploratory only. These studies aren't really geared for that. that's where a phase three study would come in. So I think the best way to look at this is leveraging what could be the benefit of our challenge study. As you know, in the adult populations, you know, there's not a consistent transmission annually. It's more selected by population. And so we would look forward to garnering a lot of knowledge from that challenge study in terms of potentially protective efficacy. Does that answer that question, Ryan?
spk01: That does. And maybe just one more question that just came in. Could you also touch on the requirement for you to initiate the breastfeeding mothers and infant study? And if you can comment quantitatively on how much funding you have or will receive from the Gates Foundation?
spk06: Well, I'll leave the funding questions to those people who who dabble in those arts. But from my standpoint, you know, that look at a study in lactating postpartum women, where we would give our oral tableted vaccine to women who've already delivered babies, so they have a breastfeeding infant, to measure a couple things. One, looking, of course, to ensure that we're safe, but looking at the amount of antibody that we find in the breast milk. I think that's very important and that's part of this study. And then the second piece is looking at the amount of antibodies against norovirus we find in the infant's feces or stool. So looking at passage or transfer of those antibodies in breast milk, I think is very important. And from our standpoint, this may be a way to protect some of the most vulnerable populations by implementing a vaccination strategy on the lactating mom. I'll leave the question of dollar amounts, et cetera, to others on the call. Andre, Sean, Phil, would you like to comment?
spk02: Yeah, so we're not going to provide details on the dollar amounts here. We just said that this trial was co-founded by the Gates Foundation and us, and we're just going to leave it there.
spk07: We have reached the end of the phone questions and answers. We now turn the conference back over to Brant for any online questions.
spk05: Fabulous. Yes, we've got a number of online questions. I'm going to start off. Andre, this one's going to be for you. The question is, why prioritize norovirus? Why make that decision now, and why didn't we make the decision earlier? Andre.
spk02: Yeah. Thank you, Brant. We really believe that we have one of the leading norovirus vaccine candidates, and it's important to emphasize that. And our decision to focus on the norovirus program followed an extensive strategic review of our business and a review of our entire pipeline candidates, including looking at what would be the fastest path to commercial product for us. as well as the most efficient way for us to maximize our current resources. So the reason we prioritized norovirus is because, overall, it presents the best risk-reward profile for us in the near term. As we mentioned, we have two very important data readouts this year, one mid-year and one in the third quarter. And we do see progressing or advancing the Norovirus program as being the best way for us to validate our program, our platform, and to position us for long-term success. And importantly, the updated cash runway extends well beyond those two data readouts. So I think that's important for investors to know.
spk05: Excellent. Thanks, Andre. Focusing on the cash runway, there's a number of questions on norovirus. Phil, this is going to be for you. And they all relate to norovirus. I'm going to try and summarize the scope of all the questions that we're getting. So can you complete a Phase III study in norovirus without additional funding? What's the projected cost and duration of a Phase III study? And does your cash runway include a Phase III study? Phil, passing that over to you.
spk04: Sure. Thanks, Brent. So the guidance of our cash runway is into Q2 2024, and that does include a cost associated with all our existing norovirus phase 2 studies, as well as the Gates Foundation-funded study planned for later this year. What it doesn't include is the projected cost to conduct a phase 3 trial, and we aren't really providing guidance on the cost of a potential phase 3 trial at this time.
spk05: Excellent. Thanks, Phil. Back to you, Brent. James, this one's on norovirus for you on the clinical study. So the question is in norovirus again. Presuming you obtain positive data from phase two studies, when would the end of phase two FDA meeting take place? And what's your timeline to design and initiate a phase three trial? James.
spk06: Thanks. Presuming we have positive data from the phase two studies, we expect an end of phase two meeting would be next year, 2024. The phase three trial, could begin as early as next year as well, and that will be in concert with guidance from the agency. Over.
spk05: Excellent. Thank you, James. Andre, this one's going to be for you, and it really is talking about funding. What's the prospect for U.S. or international government funding, whether it's from the U.K., BARDA, et cetera? Andre, over to you.
spk02: Well, this is a difficult question to answer, particularly now as – we perceive the interest and the tension of various governments and governmental agencies have shifted. So it's hard to predict what governments are going to do. We remain in contact with important agencies both here in the U.S. and abroad, and we continue to believe that our oral pill vaccine platform could play a transformational role in fighting the pandemics in general. So, again, we continue to have those communications, but it's hard to predict the outcome.
spk05: Thank you, Andre. Phil, this is another question on share price for you. And there's a number of them. I'll just answer one, but there's a lot of questions about the same thing. Will there be a reverse split to get the shares over $1? If so, what's the ratio? Phil, hand that over to you.
spk04: Sure, Brent. So, we believe we have key catalysts that would really drive the potential interest in our stock price in the next two quarters. You know, as we mentioned earlier on this call, those catalysts do include a top line data readout for our phase two dose ranging study, as well as the top line data for our phase two challenge study for norovirus. In terms of a reverse split, you know, we don't believe we need one at this time.
spk05: Excellent. Thank you, Phil. Well, that wraps up our questions for today. Sherry, I hand it back to you.
spk07: Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.
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