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spk02: Greetings, and welcome to the VaxArt Business Update and Third Quarter 2023 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, Ed Berg, Senior Vice President and General Counsel. Please go ahead, Ed.
spk04: Good afternoon and welcome to today's call. Joining us from VaxArt are Andre Florio, Chief Executive Officer, Dr. James Cummings, Chief Medical Officer, Philip Lee, Chief Financial Officer, and Brant Bean, Senior Vice President for Business Operations. Before we begin, I would 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 materially differ 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 also on 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 Florio. Andrei?
spk01: Thank you, Ed, and thank you to all of you for joining us today. On today's call, we'll highlight the recent clinical progress we have made on our Norovirus oral field vaccine program. We will also provide a look at our planned milestones and briefly discuss our COVID program before opening the call to your questions. During the third quarter, we took important steps to validate our mucosal vaccine platform. We released encouraging top line data from two phase two trials of our Norovirus program. First, from our phase two dose ranging study for our bivalent Norovirus oral vaccine candidate, and then from our phase two Norovirus challenge study. The data we generated from both of these trials will drive the next steps for this program. which we believe has the potential to transform both how we think of norovirus and the vaccination paradigm, as we know. James will go over the scientific findings from these trials in more detail. But beforehand, there are a few key points I'd like to share in terms of what we have learned at this stage of our norovirus program. First, our oral pill vaccine candidate has the potential to reduce the rates of norovirus infection acute gastroenteritis, and viral shedding. These were key results from our recent challenge study. We believe that when we substantially reduce shedding, we dramatically slow down the rate of transmission. That is an incredible potential benefit of these vaccines. Second, we believe this data validate the potential of our oral tablet norovirus vaccine program. We now have completed eight clinical trials for norovirus all of which showed that our vaccines induce strong immune responses and are safe and well-tolerated with no vaccine-related serious adverse events. We are confident in VaxArts platform and the Norovirus program specifically as we aim towards a registrational phase three study. And third, we believe we have established clinical proof of concept for our oral pill platform via now two human challenge studies, one for norovirus and the other for influenza. In each case, we demonstrated that our oral pill vaccine technology has a clear and consistent impact on a number of important metrics, such as reducing the rate of infection, illness, and shedding. We continue to believe we have the most advanced norovirus vaccine candidate in clinical development that is both formulated for oral administration and designed for delivery to the gastrointestinal system. A pill vaccine could truly change how we vaccinate globally, how we make vaccines, how we distribute them, and how we administer them. Not to mention that polls show that many more people will take vaccines that are not needle-based while the more remote regions of the world could have access to an oral pill that does not have the cold chain and infrastructure requirements of injectables. I want to emphasize the impact of the disease we are fighting against. Norovirus recently was named the leading cause of foodborne illness during the Joint Food and Agriculture Organization and the World Health Organization expert meeting on microbiological risk assessment in Rome, Italy. And norovirus is the leading cause of gastroenteritis. This is a disease with an economic burden in excess of $10 billion annually in the US alone and of over $60 billion globally. Norovirus infections affect young children and the elderly disproportionately. Recently, we dosed the first subject in our previously announced clinical trial to evaluate the ability of our norovirus vaccine candidate to induce antibodies in breast milk and transfer of antibodies to young infants. We are excited about the potential for this study, as Vaxart's oral norovirus vaccine pill may make it possible for mothers to protect their infants against this highly contagious disease that has serious health consequences. And now for a brief update on our COVID-19 program. We continue to make progress on a potential COVID vaccine, and we believe the cross-reactivity of our current construct suggests a pathway for developing a pan-coronavirus vaccine. Several recent forecasts project new COVID variants to continue to appear exacerbating the persistence of this serious threat to public health. Given our prioritization of the Norovirus program, we are assessing next steps for the COVID program, which could include a number of options. We look forward to providing you information once we determine the path forward for this important program. I'll now turn the call over to James to review the recent progress for our Norovirus program.
spk06: Thanks, Andre. We made great clinical strides in our norovirus program during the third quarter, announcing top line data from two separate phase two trials. We believe the data that we've shared today is promising for this vaccine candidate and for our vaccine platform overall. I'd now like to provide you with a high level summary of both studies. I'll start with the data from our phase two dose ranging study of our bivalent norovirus vaccine candidate. Recall that this candidate contains two genotypes, G11 and G24, both of which have caused the majority of norovirus disease in humans over the past 20 or so years. The primary endpoints were safety and immunogenicity in order to determine a dose level for our phase three development. The preliminary results of the trial showed robust serum immune responses across all doses at day 29 relative to day one. Both vaccine doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms. At day 29, increases in serum IgA, serum IgG, and BT50 for both the G24 and G11 strains in the vaccine arms were similar to those seen in previous norovirus studies conducted by Vaxart. These results also demonstrate that the bivalent norovirus vaccine candidate was well tolerated with a favorable safety profile that included no vaccine-related serious adverse events or SAEs. and no dose-limiting toxicity. Adverse event rates for both doses were similar to placebo. Turning to the phase two G11 norovirus challenge study, which measured the safety, immunogenicity, and efficacy of our monovalent norovirus vaccine candidate, the primary objectives were to determine the clinical efficacy of our monovalent norovirus vaccine candidate compared to placebo to protect against norovirus acute gastroenteritis, or AGE, caused by the Norwalk strain challenge inoculum, and to evaluate the VP1-specific IgA antibody secreting cells, or ASCs, the HBGA blocking antibody, and the VP1-specific serum IgA and serum IgG responses to the vaccine. This was a double-blinded, randomized, placebo-controlled study in which healthy volunteers received a single oral dose of our norovirus vaccine candidate that targets the G11 strain of norovirus, or they received placebo on day one. On days 29 and 30, participants were challenged with the G11 strain of norovirus and then assessed for infection, norovirus AGE, and the immune responses through day 57. This study met five of its six primary endpoints. The results show a statistically significant 29% relative reduction in infection, a 21% relative reduction in norovirus AGE that was not statistically significant, and an 85% relative reduction in viral shedding. which was a pre-specified study endpoint in the vaccinated cohort compared with placebo. As we noted in the data announcement, we believe these results support the potential for our norovirus vaccine program to provide significant public health benefits. We also believe these are important findings that support the potential use of our oral pill vaccine technology in enabling a vaccine for norovirus. As I very mentioned, we dosed the first subject in our phase one clinical trial evaluating VaxArt's oral pill bivalent norovirus vaccine candidate focused on safety and immunogenicity in lactating mothers. This is an important step towards VaxArt's goal of developing a vaccine that may reduce the significant global health threat norovirus poses, especially to children under five years of age. Norovirus sickens approximately 21 million people in the United States each year, and 15% of children under age five contract norovirus annually. We believe an oral pill norovirus vaccine may make it possible for mothers to protect their infants against this highly contagious virus. In terms of next steps for the Norovirus program, additional analyses of the data from our previous Norovirus trials are ongoing, and these will help us in determining how we go forward. Next steps for registration would include a Phase 2b dose confirmation study of our bivalent candidate in order to obtain sufficient safety data to inform an end of Phase 2 meeting with the FDA in the United States. We remain on track for the FDA meeting by the end of 2024. I'll now hand the call over to Phil Lee, our Chief Financial Officer, for a brief discussion of our financials. Over to you, Phil.
spk05: Thank you, James. The details of our financial results for the third quarter of 2023 are summarized in today's press release. Revenue for the third quarter of 2023 was $2.1 million compared to no revenue in the third quarter of 2022. Revenue in the third quarter of 2023 was primarily from revenue recognized for work performed under Vaxar's grant from the Bill and Melinda Gates Foundation. Vaxar ended the third quarter of 2023 with cash, cash equivalents, restricted cash, and marketable securities of $53 million compared to $67.9 million as of June 30th, 2023. The decrease was primarily due to cash used in operations as we advanced our programs. The company continues to anticipate current cash runway into the third quarter of 2024. Thank you all for your time today. We will now open the call for your questions.
spk02: Thank you. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment, please, while we poll for questions. Our first question today is coming from from B. Riley. Your line is now live. Please proceed.
spk03: if I can ask a couple clarifying questions on the correlate of protection additional analysis that is going on just maybe we get if there's any color there you can share and are you looking at both the monovalent and bivalent data sets for the correlate of protection and you need this for the phase 2b dose confirmation study. Thanks.
spk06: Thank you. This is James Cummings. I'll take those. So in terms of the correlative protection, we're continuing that analysis from our challenge study. As you may recall, that challenge study was a monovalent vaccine versus a matched monovalent strain of challenge inoculum. As we mentioned, We're confident we'll have a correlate of protection, and that analysis is ongoing. When it comes to the data sets that are being used, we certainly would look towards the challenge study as finding that correlate of protection. We will certainly look at other studies and analyses from the past as to where that correlate lies, but the determination of the correlate is based on the challenge study at this time. And then, you know, how that might impact a Phase IIb, or more importantly, a Phase III study, would be based on a dialogue with the FDA. What we hope to garner from a Phase II study, a Phase IIb, would be additional safety data to bring us to an end of Phase II meeting with the FDA, which is, as I mentioned, still online for or it's still on schedule for end of 2024. Thank you. Thanks.
spk03: Appreciate it.
spk02: Thank you. As a reminder, that's star one to be placed in the question queue. Our next question is coming from Liang Cheng from Jefferies. Your line is now live.
spk00: Hey, Tim. This is Liang for Roger. A couple questions from us. So I guess the first one is about, you know, the potential Phase 2 or the Phase 2B study. So any color around the study design in terms of, you know, number of enrollment and timing and those?
spk06: This is James. I'll take that question. So the Phase 2B study design may be impacted somewhat by some of our further analyses, but will be used to beef up the overall numbers for an end of phase two meeting with the FDA. That said, it would be, you know, somewhere along the lines of at least 400 or so, maybe more, individuals who would receive a test article, and then moving forward. And that would be a direct look at the safety and immunogenicity of that study.
spk00: Thank you. So maybe another question. I remember, I think I mentioned that you'll potentially do another bivalent challenge study. So what are the current considerations around that?
spk06: Certainly. So currently we've done and reported on the norovirus G11 strain challenge and look forward to reporting that further analysis out to the community. In dialogue with the FDA, we will then make a decision on moving forward with that correlate to impact the phase three study design and if needed, an additional challenge study with G24 could be executed. But at this time, it's not a requirement. If it were to be executed, it could be done in parallel with a Phase IIb study. We'll have more information on that once we have the correlate identified and have had those initial discussions with the FDA.
spk00: Got it. Thank you. Maybe one quick one on the phase one study design. So I know you mentioned that, you know, the measurement of transmission reduction into phase three and the importance of that. So any feedback from the agent around that part for the transmission reduction?
spk06: So what we had reported on was actually a large decrease in viral shedding, which we believe may lead to a decrease in transmission, you know, utilizing standards of public health policies. That said, we only have the data on the viral shedding, which is statistically significant at an 84% relative reduction. That data would then be further gathered in a phase three study.
spk00: Got it. Got it. Thank you. That's all for now.
spk02: Thank you. Thank you. And now let's turn the call back to Brant for further questions.
spk07: Thank you very much, Operator. So we've got a number of questions that have come in through various sources from our shareholders and other interested parties. A number of them are norovirus related. I think we've had some of them answered already. There's certainly a lot of interest in the correlative protection, and also when a phase three trial for norovirus is going to happen. But I think, James, you've already answered those. Here's one that I will ask you, James, a little bit more clarification on norovirus. So the question is, can you provide us with an update in terms of where you are in analyzing the additional neural data? It goes on to a path forward to a phase two B trial, but I think the timeline for additional neural data is most important here.
spk06: Sure, James. So currently we're evaluating more immune responses and data on an individual subject level within that study. We look forward to sharing those details of the analysis once completed.
spk07: Thank you, James. Andre, here's one for you, really talking about the future of the organization. The question is specifically, do you have plans in 2024 to introduce any new product candidates? Andre.
spk01: Thank you, Brent. So as we look into 2024, our focus will remain on identifying the best ways to progress our existing clinical pipeline, which is now composed, as many of you know, of the norovirus, the pan-coronavirus, and the flu programs. And we believe that doing this would create more than enough catalysts and opportunities for value creation for a company of our size.
spk07: Thank you, Andre. Okay, we've got a number of questions about how much money we have. Phil, this one's going to come to you. Specifically, the question is, do you intend to initiate the Phase 2B trial with existing cash, or will you need to raise additional capital to fund this trial? Phil?
spk05: So, just to recap, we are currently conducting additional analyses of the data for our norovirus trials. And once we have determined the path forward for the program, we will provide an update on next steps. And in that we may include update on cash runway guidance if appropriate.
spk07: Thank you, Phil. Okay. Back to clinical and James, this one is on the lactating mother study. So it's the question for the lactating mother study. What is your timeline to top line data?
spk06: Thanks. We'll have a better sense of timing for data from this study as we move closer to full enrollment. To date, we've enrolled seven subjects into that study.
spk07: Perfect. And there's an add-on question to that as well, James. Please remind us how the data from the lactating mother study fits into the overall development program for the norovirus candidate.
spk06: Immunizing lactating mothers may provide increases in the norovirus immunoglobulins in the breast milk, and that could help protect the nursing infant. And that's really part of our strategy to protect this vulnerable population.
spk07: Fantastic. Thank you, James. Lots of questions about this one. So, Andre, this one's coming to you about additional funding from outside sources, specifically BARDA or other U.S. governments. I'll give you the question, and there's a lot of ways that this has been asked, but do you have an update on Project NextGen funding, and could you still receive funding from BARDA or NIH for this program? Andre?
spk01: Yeah, so if we were to have a concrete update, we would have share that with you, so we don't. But we remain optimistic. We remain of the opinion, as we have said multiple times in the past, that the US government should support our pan-coronavirus program. Looking at the programs that have received funding as part of the NextGen program, We continue to believe that our pan-coronavirus program should be supported because it does provide several potential advantages, distinct advantages over those programs. Again, we remain of this belief that if the U.S. wants to significantly improve its ability to fight future pandemics, our program should be supported And we will update you when we have any specific updates to share.
spk07: Great. Thank you, Andre. James, another one for you. Back to the World Vaccine Congress. So the question is, are there any updates from the World Vaccine Congress that you can share? James.
spk06: Sure. Thanks. So, you know, our data from the norovirus challenge was very well received. when it was contrasted to what the impact of our candidate vaccine might be, went up against natural infection. And the key part here is natural infection generally results from exposure to 10 to 100 virus particles. Don't forget the challenge in oculum was a million virus particles. So we think it's likely that the overall protection level in a natural infection will be enhanced because there's far less virus to protect against.
spk07: Excellent. Thank you very much. Phil, there's another financial question regarding the GATE study. So, the question to you, Phil, is how much revenue is left to be recognized from the GATE study and over what time span?
spk05: Phil? Sure. Thanks, Brent. So, we recognize grant revenue in the period of which the related costs are incurred and services are rendered. So at this point, we really have recognized the vast majority of the current grant from the Bill and Melinda Gates Foundation as revenue. I currently expect to recognize the remaining $79,000 in the fourth quarter of 2023. Excellent.
spk07: Thank you, Phil. Okay. And, Operator, that closes our Q&A.
spk02: Thank you. With that, does that close today's conference? If so, then you may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.
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