This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk07: Greetings and welcome to the VaxArt Business Update and Third Quarter 2024 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 Byrd, Senior Vice President and General Counsel.
spk06: Good afternoon and welcome to today's call. Joining us from VaxArt are Stephen Lowe, Chief Executive Officer, Dr. Sean Tucker, Founder and Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Phil Lee, Chief Financial Officer. 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 factor section of VACSART's most recently filed annual report on Form 10-K and also on other periodic reports filed with the SEC. VACSART undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Stephen Lowe. Steve?
spk00: Thanks, Ed, and thanks to all of you for joining us this afternoon. On today's call, I'm excited to highlight a number of accomplishments that we have achieved since our last update. I'll then have James and Sean share updates on our COVID, norovirus, and HPV programs prospectively. Then Phil will discuss our financial results before we open the call for your questions. When I joined VaxArt earlier this year, we set out clear objectives with the goal of advancing our oral pill vaccine platform and bringing a potentially transformative solution to improve public health. Not only does our platform show promise in addressing many of the shortcomings of injectable vaccines, such as using mucosal immunity to potentially block infection and transmission, but it also improves delivery convenience and has demonstrated a benign safety and tolerability profile across 19 clinical trials to date. In summary, we continue to see the potential for a truly differentiated and transformational platform. Today, I am pleased to report that we have achieved several milestones in executing on our goals. Starting with our COVID program, through our partnership with BARDA, we have taken a major step forward in finding a new way of confronting pandemics in the future. In September, we started enrollment in our Phase 2B study evaluating our COVID-19 oral pill vaccine candidate against an approved mRNA vaccine comparator. Interest for our trial is strong, and it is our goal to progress this study as rapidly as possible. James will discuss this trial in more detail shortly, but I would like to note that as recipients of one of the largest BARDA-funded Project NextGen awards to date, now valued at up to $456 million, we appreciate this collaboration and look forward to continuing our work with our government partners. As we track vaccination trends this season, we have seen COVID vaccinations increase substantially post-KP2 availability beginning in late August and early September. In fact, data that's tracked by Alcubia suggests that approximately 35 million people will receive a COVID vaccine dose in the US alone. This is comparable to last year's season of approximately 40 million doses. Based on these trends, It is clear that there remains robust demand for a COVID vaccine, and we believe that our solution can address this demand more efficiently and effectively than current injectable methods. Turning to our norovirus program, we have had fruitful communication with FDA and recently received constructive feedback on our data for potential correlates of protection. Sean will share a deeper dive of our assessment and planning. but I will note that we are taking a thoughtful approach in the best way to progress this program. We are meeting with a number of advisors and disease experts as we evaluate the best clinical development path. In addition to our conversations with FDA, we were pleased to have presented promising data of our trials at Infectious Disease Week and the World Vaccine Congress, underscoring our commitment to this significant unmet need. given that there are currently no approved vaccines against norovirus. This is a highly contagious virus and is the leading cause of acute gastroenteritis symptoms, such as vomiting and diarrhea, and sickens approximately 21 million people in the United States each year. It is one of our three pipeline programs with a multi-billion dollar market, and we are determined to advance this program forward. In addition to our two lead clinical programs in COVID and norovirus, we are continuing to look for the opportunity to advance our other programs with careful investment to further advance other indications. As an example, we recently published promising preclinical data on our HPV vaccine constructs in the August publication of vaccines, which suggests that our mucosal vaccine platform represents a possible non-invasive approach to prevent the progression to cervical cancer. We have additional preclinical studies planned to further characterize the immune-stimulating and anti-tumor activity of our HPV vaccine. We look forward to sharing updates from our BARDA-funded Phase 2B COVID trial, detailing the next steps in our norovirus program, and determining the best strategic opportunities for our other programs. I'll now turn the call over to James to provide a further review of the recent progress for our COVID-19 program.
spk08: Thanks, Steve. The BARDA Phase 2B clinical trial will provide an important readout that could further validate our platform and highlight the possibility of a new alternative to current injected vaccines against COVID-19. It's our belief that the cross-reactivity of our vaccine candidates' mucosal immune responses could have a significant impact against evolving variants with a better safety and tolerability profile versus the mRNA comparator. Based on data generated from prior trials, our vaccine candidates have shown that participants had increased IgA antibodies to SARS-CoV-2, the virus that causes COVID-19. while maintaining immunization protection against current and future COVID-19 variants and a benign tolerability profile. We thank BARDA for their strong leadership, partnership, and funding to make this Phase 2b trial a reality. As a reminder, the Phase 2b clinical trial is a double-blinded, multicenter, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of VaxArt's oral pill COVID-19 vaccine candidate compared to an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The Sentinel cohort comprises of 400 participants, with 200 receiving VaxArt's XBD vaccine and 200 receiving an approved mRNA XBB vaccine comparator. We are making good progress in enrolling these participants and expect a complete dosing for this cohort later this month. Once enrollment is complete, an independent data safety monitoring board, or DSMB, and the US FDA will review the 30-day safety data on the first 400 participants. After a signal to proceed from the reviewers, we will then enroll the remaining 10,000 participants in the second phase of this study. The phase 2B study will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and safety. The primary endpoint is relative efficacy of Vaxart's COVID-19 vaccine candidate compared to an approved mRNA COVID-19 vaccine for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination. We anticipate that it will take about six months to completely enroll this study. I'll now hand the call over to Dr. Sean Tucker, our founder and chief science officer for a brief discussion of our norovirus program and our recent HPV publication. John?
spk01: Thank you, James. As Steve mentioned earlier, we received constructive feedback from the FDA on our data for potential correlates of protection and next steps for our norovirus program. While we believe we have identified a functional antibody response that may be associated with protection from norovirus, the FDA requested new clinical data before proceeding with further review of our potential correlate. We are reviewing the current guidance from the FDA and consulting with disease experts before announcing next steps with our program. Additionally, we have created additional norovirus G11 and G24 constructs that we believe, based on preclinical data, may be more potent than the constructs being evaluated in clinical trials. We are discussing the regulatory feedback from the FDA, the clinical data on current constructs, and the preclinical data generated on our new constructs with our advisors and certain key opinion leaders to assist us in determining the best way to progress our norovirus program. We look forward to progressing the Norovirus program using the best available information and technology as part of our commitment to developing the first approved oral Norovirus vaccine. Last month, I had the honor of presenting data related to our Norovirus challenge study at ID Week. I want to take this time to share a few key takeaways from my presentation. It featured encouraging results from our phase two double-blinded placebo-controlled study evaluating our G11 vaccine candidate against placebo given to healthy subjects infected 29 days plus after vaccination. Our norovirus oral vaccination was shown to induce mucosal and systemic immune responses with our most significant effects against infection and shedding in the face of a vigorous human viral challenge model. Through machine learning, we are able to identify, potentially, immune correlates of protection. Protection against infection most tightly associated with making a functional antibody response to norovirus and fecal IgA. By comparing prediction performance of a range of individual markers and ranking them, we will ascertain whether combining individual immune markers improves prediction for protection against norovirus. Additionally, I'm pleased to share the findings from our colleague, Dr. Lam Nguyen's presentation at ID Week regarding our phase one study evaluating our norovirus vaccine candidate in healthy lactating females and their nursing infants. Our candidate's safety profile aligned with our previous trials with the side effect profile similar to placebo and was well tolerated in postpartum lactating subjects. In terms of mutagenicity, Antibodies to norovirus rose on average fourfold for the G11 virus strain and sixfold for the G24 virus strain in the breast milk of lactating mothers who received a Vaxart vaccine candidate in the high dose group. Further, we found those antibodies could be detected in the fecal samples of breastfeeding infants, showing the potential of passive transfer through breast milk We continue to explore the durability of immune response, nasal and soluble IGA responses, and safety through 365 days. Given the challenges of developing norovirus vaccine in infants, these results in breastfeeding infants represent an important and creative initial step in the development of the norovirus vaccine that is safe and immunogenic with the potential to decrease norovirus severity in infants. Overall, we are highly motivated and committed to further progressing our norovirus oral pill vaccine program, which has demonstrated robust immunogenicity, promising efficacy, and a benign safety and tolerability profile to date. The totality of evidence will help inform our clinical development plan. With regards to our HPV program, I'm pleased to say that we recently published promising preclinical data on our HPV vaccine constructs in the August issue of Vaccines. Our preclinical data showed that the VaxArts HPV vaccine constructs stimulated specific T cell immune responses in an animal model of HPV-related tumorigenesis. These data also suggested that administration of a mucosal vaccine against these proteins in mice with HPV-expressing tumors led to reductions in tumor size and increased survival. These data support the promise of our mucosal vaccine platform as a possible non-invasive approach to prevent the progression to cervical cancer. We have additional preclinical studies planned to further characterize the immune-stimulating and anti-tumor activity of our HPV vaccine. I'll now hand the call over to Phil Lee, our CFO, for a brief discussion on our financials. Phil?
spk02: Thank you, Sean. The details of our financial results for the third quarter of 2024 are summarized in today's press release. Revenue for the third quarter of 2024 was $4.9 million, compared to $2.1 million in the third quarter of 2023. Revenue in the third quarter of 2024 was primarily from government contracts related to BARDA. Revenue in the third quarter of 2023 was primarily from revenue recognized for work performed under VaxArt's grant from the Bill and Melinda Gates Foundation and non-cash royalty revenue from the sales of Innoveer in Japan. VaxArt ended the third quarter of 2024 with cash, cash equivalents, and investments of $58.7 million. Based on our current plan, VaxArt continues to anticipate cash runway into 2026. Thanks, everyone, for your time today. We will now open the call for your questions.
spk07: Thank you. We will now be conducting a question and answer session. 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 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star key. One moment please while we call for questions. Our first question comes from the line of Chang Li with Oppenheimer. Please proceed with your question.
spk03: Oh, hi, this is Chang from Oppenheimer. Thanks for providing the updates and taking the questions. Maybe a couple from us. First on the COVID-19 phase two study, I'm curious about, we can talk about the interest level from investigators. And how do you see the current enrollment progress versus your maybe internal projection? And also, I remember before you talk about the potential interim analysis in the Phase IIb study, so Q is if you are still planning to do interim analysis based on certain number of events accrued. And my second question just on norovirus program, just wondering if you can provide some more color on the feedback you received from the FDA, and maybe specifically what kind of new clinical data is required. Thank you so much.
spk00: Great. Thanks. And thanks for your questions. This is Steve. I'll address the first question, and then I'll turn it over to Sean for the other two. Your question related to just interest level from investigators and enrollment. As we were saying in the opening remarks, we're pretty happy to be on track with getting to the 400 participants in the Sentinel study. And we haven't had any problem with enrolling patients. I mean, there's interest. And just from what we're tracking in terms of just vaccines in the marketplace right now, there is still quite a good uptake of the COVID vaccine. So from our perspective, that's going well, and we hope to announce an update shortly when we reach the 400. I'll turn over to Sean on the interim analysis.
spk01: Yeah, in terms of your question on the interim analysis, with our partners at BARDA, we are considering an interim analysis that would evaluate safety and efficacy signals. However, our focus and commitment will be to complete the full study through the 12-month visit post-vaccination for all participants that complete the trial. Preliminary data from our previous clinical Preclinical studies indicates our vaccine triggers a mucosal immune response that may be superior injectables, and that is something we will explore throughout the trial.
spk00: And then the last question was around just specific feedback from the FDA on the norovirus. Chung, I just want to make sure we've captured your last question correctly.
spk03: Yes, I'm curious about any specific feedback you can share with us on the FDA's conversation and also kind of what kind of the specific clinical data is required for next step. Thank you.
spk01: Sure. Well, obviously we had discussions with the FDA. Our goal is to get into a Phase IIb study and an end of Phase II meeting. We did get some clarity and in terms of what the requirements will be. We aren't discussing the details at this time, but we feel like we got a clearer path forward to be successful and get to the end of phase two meeting.
spk03: Okay, thank you so much.
spk07: Thank you. Our next question comes from the line of Mayank Mantani with BYU Security. Please proceed with your question.
spk05: Good afternoon, Dean. Thanks for taking our questions and congrats on the progress. So it seems like the COVID Sentinel cohort enrollment has gone very quickly. We'd love to hear your thoughts on the DSMB 30-day safety analysis. You know, what are you kind of looking for there or DSMB and FDA is looking for there? And also, how are you managing the study blind here? In terms of the mucosal immunity-related endpoints you're assessing, anything you could comment on the expectation for potential separation relative to the mRNA vaccine? It seems like there are a lot of serum, nasal, and T-cell endpoints listed on your clinicalclubs.gov page, you know, if you could provide any color. And then I have a quick follow-up on Norovirus.
spk01: Sure. In terms of the first question, when you're asking about the DSMB feedback and our expectations, well, we're still blinded. So the DSMB will, you know, put together a summary, and our expectation is that there'll be no safety concerns and we'll continue to enroll at the end of it. I mean, that would be our expectations. And your second question again, Maya, oh, it was about the samples. Yeah, we're taking saliva, nasal swabs, and obviously some PBMCs from the standpoint of the 10,000 subjects. And we'll get some analysis in terms of how each vaccine will do or in terms of making those mucosal as well as you know, systemic responses. Again, we're still blinded, so we won't see that data for a while, but the goal is to definitely compare the two vaccines for systemic and mucosal immune induction.
spk05: Understood. And maybe just to clarify the interim analysis, you intend to have that definitely at a 12-month Maybe could we add a lesser sample size than 10,000? Is that what I heard you could consider?
spk01: Yeah, so what was in the protocol as of now is that we were planning to do an interim analysis once there was 225 cases, if I'm not mistaken. Sorry, I was just corrected. And at that point, there would be an interim analysis to look at the differences between the two vaccine. And again, it's relative efficacy. So essentially, it would ask the question, how many people in each group had been infected with SARS-CoV-2? And that's part of, again, as part of the protocol to date. Again, we are under discussions with our partners, you know, and what their intentions are and But the key thing from our standpoint is, you know, we want to look at 12 months of data at the end of this because that will be very informative, I believe, particularly as new variants pop up over that 12-month period.
spk05: Very helpful. Thank you. And then on the next 10 norovirus G11 and G24 constructs, anything, Sean, you could comment on? the construct design, and if you intend to publish preclinical data that you probably have been accumulating at this point. And to the extent you can, you know, put the picture together on, you know, the correlates that you're working with the FDA and how, you know, learnings from there could be helpful in expediting these next generation candidates.
spk01: Yeah, very good question. So we have shared a little bit of that data in mice, and what we have seen is that both the G11 and G24, what we call them next generation constructs, seem to be much more potent in terms of listening antibody responses to either G11 or G24. I think the key thing is that what we have found and we've applied throughout our platform is that if we made small changes to the way the backbone is set up and some of the structures, we've seen substantial improvements in immunogenicity in preclinical models. Obviously, we plan on testing at some point these things clinically. You asked another question about the correlates and yes we've had identified a couple things that are very important from the standpoint of predicting protection from norovirus from the G11 challenge and that those learnings can be make it a lot easier to apply to doing your process optimization or clinical development because if you know what to look for, it makes it a lot easier to get to the finish line and potentially when you look at the new constructs to know whether you're substantially going to improve the efficacy for the study. So yes, all our learnings in the original G11 challenge and the things we have been discussing with the FDA are applicable to either new or next generation constructs.
spk05: Did you say the timing for these constructs from an IND standpoint? I know manufacturing can go very quickly for you guys, but are you guiding for an IND filing timeline?
spk01: Yeah, we haven't provided any guidance at this time, and as we develop our constructs further, we'll let people know.
spk05: Great. Thanks for taking our questions.
spk07: Thank you. Our next question comes from the line of Liang Cheng with Jefferies. Please proceed with your question.
spk04: Hey guys, thank you for taking our questions. This is Liang Cheng for Roger from Jefferies. I guess my first question is about the COVID program. So just wondering, do you expect any impact on the enrollment given, you know, thinking about the finality of the COVID and also, you know, do you think there would be any impact on the infection rate, considering now it's in November and you're considering six months enrollment, six months to complete your enrollment?
spk00: Yeah, thanks for the question. In terms of enrollment, I can tell you what we're seeing right now is we haven't seen any slowdown of enrollment with the Sentinel cohort based on our projections, and we work very closely with study sites and our CRO. There hasn't been any feedback that says that we should be generally concerned about enrollment. So, from our standpoint, it's all systems go. And I'll turn it over to Sean for his comments.
spk01: Yeah. I mean, I guess you asked the question about infection rate and new variants. Well, obviously, things are keep, as with all COVID vaccine developments, the strains that are circulating change quite rapidly. And over three or four months, there'll be new know strains i think right now it's kp3 if is circulating most prevalently but i mean this is just the way it works with covid you know again one of the things that we like about our platform is that we create these cross-reactive mucosal iga responses and we think that they'll be beneficial in the long term you know as the variants show up uh thanks for uh for the answer uh so
spk04: Also about the NOAA virus program. So just wondering what data FDA requested can provide any color on that?
spk01: Yeah, we're not commenting on specific requests or requirements, you know, right now. We're trying to assess, you know, what the guidance we did get, which we do think we got additional clarity about what it takes to get to have a successful end of phase two meeting.
spk04: Got it. Makes sense. Thank you.
spk07: Thank you. And we have reached the end of this portion of the Q&A session. Now I'll hand the call back over to Ed Berg.
spk06: Thank you. We have some questions from our retail investors that's been sent in. I'll start with one that we partially answered, but I'll ask Sean to elucidate a little more. How quickly can you start the 10,000 participant phase of the trial? I think some of this gets to the timing and the review by FDA and DSMB.
spk01: Yeah. Well, the company's goal is to rapidly enroll in the Sentinel cohort. I think things are going well. And as we mentioned in previous remarks, we expect it to be completed pretty soon, this month, actually. After enrollment completion and upon a favorable review by the independent DSMB and FDA of that 30-day safety data, our plan is to immediately start enrollment the second phase of the trial, which we currently anticipate in early 2025. Thanks.
spk06: Another question about the trial that was sent in, is the infrastructure prepped for the trial to begin, including recruiting?
spk01: Yeah. Well, thanks to the hard work of our dedicated team, we are well prepared to initiate the second part of the trial upon favorable review of the 30-day safety data from the independent DSMB as well as the FDA. We are really confident in our ability to deliver both investigational and comparator vaccine to sites and have worked very closely with our CRO to ensure site readiness. And of course, we already have a number of active sites that have randomized participants for our Sentinel cohort, with many additional sites ready to participate in the next phase.
spk06: Thank you. One more question. Neurovirus program, you may have fully covered it, but I'll Put it out there. On your neurovirus program, what's your most logical next step?
spk01: Again, our goal is to have an end-of-Phase II meeting with the FDA and discuss requirements for Phase III and licensure. But to get there, we do need to add more data to our overall package. We will continue to be thoughtful and deliberate in this approach and ensure that we can build the most compelling data package for the FDA.
spk06: Thank you. A question for Steve, would you consider conducting a trial outside of the U.S. potentially with a partner?
spk00: Yes, we're always open to collaboration with companies to co-develop our platform and also non-dilutive funding opportunities with entities outside the United States, if it makes good business sense. So our vaccines and development have the potential to have an impact not only in the United States, but also around the world. So we're definitely open to broader partnerships. And as an example, you know, Sean mentioned earlier, we had conducted our phase one norovirus trial in lactating mothers in South Africa, which was funded by the Bill and Belinda Gates Foundation.
spk06: Thanks. Another question. This is for Sean. Do you have additional updates regarding your earlier stage programs, such as seasonal flu, HPV, or avian flu? Can we anticipate any preclinical data And are you prioritizing one program?
spk01: Yeah, well, we are currently conducting preclinical work on avian flu, seasonal flu, and HPV. As for bird flu, our previous data showed our platform may potentially be effective for various strains of bird flu, although we have not conducted any studies of the current circulating strains, the ones that are in the U.S. Additionally, we've published a paper in vaccines, which I mentioned before, about our HPV constructs. and we regularly review our candidate pipeline to determine the best strategic opportunities. The company makes these decisions based on a variety of factors, including market and competitive dynamics, resources, and timing. In addition to these programs, we will continue to conduct preclinical development of novel constructs to grant both current and emerging infectious disease threats for pandemic preparedness.
spk06: Thank you. That's all the questions we have at this time. I'd like to turn the floor over to Steve Lowe for some closing remarks.
spk00: Yes. Thank you, everyone, for joining us on today's call. At VaxArt, we are working with great effort in pursuit of revolutionizing how we think about global public health. Supporting vaccine development is not only an investment in health, but in the resilience and prosperity of our global community. We are proud to be introducing innovation in the vaccine space as pioneers in oral vaccines. We believe our differentiated approach that focuses on mucosal immunity will be key to our success. So we continue to be optimistic about our promising future and look forward to updating you all on our progress. Operator, you may close the call.
spk07: Thank you. This concludes today's conference. You may disconnect your line at this time. Thank you for your participation.
Disclaimer