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spk08: Greetings and welcome to the VaxArt Business Update and Full Year 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 Burge, Senior Vice President and General Counsel.
spk00: Good afternoon, and welcome to today's call. Joining us from VaxArt are Dr. Michael Finney, Interim Chief Executive Officer, Dr. Shawn Tucker, Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Sel 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 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 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 Dr. Michael Finney. Mike?
spk04: Thanks, Ed, and thanks to all of you for joining us today. It's a pleasure to be speaking with you at this exciting time in the company's development. As this is my first quarterly call with you, I will begin with a brief introduction of myself and my observations of our company, and then I'll transition the call to the rest of the team to move through our recent accomplishments, clinical programs, upcoming planned milestones, and full year performance. First, this is my second installment as VaxArt CEO, having served in a similar capacity from 2009 to 2011. I've been a VaxArt board member since 2007 and board chair since March 2023. Throughout my time with VaxArt, I've seen the company go through many periods of clinical and corporate growth and take on a variety of new challenges. Never have I been more confident in our team and in our trajectory than I am right now. I firmly believe 2023 was a transformational year for this company and our mucosal technology. We made solid progress on our oral vaccine platform, completing two phase two clinical studies for our norovirus oral vaccine candidates, and we have now established proof of concept in two challenge studies for both respiratory and GI viruses. Based on the totality of the data we have produced through these and our other reported clinical trials, I think it's clear what we have our hands on. Our oral pill vaccines hold a very real promise of offering several advantages compared with injectables, including the ability to vaccinate people faster, easier, and painlessly without the need for cold chain storage or trained medical professionals to administer the vaccines, as well as the promise of mucosal immune response. We've already determined in preclinical and clinical trials that our candidates have a favorable immune profile induce serum antibody and serum neutralizing antibody responses, induce potent T cell responses, create mucosal immune responses, and can inhibit virus shedding, which may have an impact on virus transmission. Looking at the current landscape, and particularly given our recent ARDA contract award, we are now poised to make a major stride forward with our COVID-19 program. James will go over the details of the preparations and the study design, but it is clear that the federal government believes we need better vaccines that harness the power of mucosal immunity to more strongly combat the current XBB and future variants of the virus. The first generation of vaccines was a start, but the virus has continued to evolve. We can do much better, and VaxArt is prepared to accept that challenge and demonstrate our technology's promise. At the same time, we're making steady progress on our Norovirus program. We've completed our analyses of the recent challenge study data and have identified a potential correlate of protection, which will inform our upcoming meeting with the FDA to discuss the optimal path forward for this program. We continue to believe we have the most advanced norovirus vaccine candidate in clinical development, and it's both formulated for oral administration and designed for delivery to the gastrointestinal. Norovirus carries a tremendous economic burden in this country and globally, And we look forward to creating an oral vaccine that eases this burden for millions of societies most vulnerable. Finally, I can say with great pleasure that last week we announced the appointment of a permanent president and chief executive officer, Steve Lowe. Steve brings a wealth of biopharma experience to VaxArt, with more than 25 years in healthcare, biotech, and pharmaceuticals, including more than 12 of those years in the C-suite. He's had a particular focus on development and commercialization, having helped two companies bring their first product to market. VaxArt is in a tremendous position to advance its mission. We are excited to add a high-caliber, experienced CEO to elevate this company to greater heights and create value for our shareholders. And currently, I will be stepping down as CEO and retaining my position as chair of the board. Steve joins VaxArt's effective March 18, and we are thrilled to welcome him. I'll now turn over the call to James to review the recent progress for our coronavirus program.
spk03: Thanks, Mike. First, I want to thank our clinical regulatory CMC and research teams who've worked tirelessly for nearly four years on our COVID-19 program. Their perseverance and dedication to our cutting edge research have been crucial in laying the groundwork for this program's recent progress. All of us here at FACTSART were encouraged in January to receive a $9.27 million contract from BARDA to prepare for a 10,000 subject phase 2B clinical trial, evaluating our company's oral pill XBV COVID-19 vaccine candidate against an approved mRNA vaccine comparator. This award is part of the federal government's Project NextGen effort to boost our nation's pandemic preparedness and improve upon our collective ability to combat COVID-19. VaxArt is one of only a handful of companies to receive funding from BARDA to date to prepare for a Phase 2B clinical trial under this very important initiative. We're heartened by the government's support, which we think is indicative of the potential of our differentiated approach to the continuing challenge that is COVID-19. This support will empower VaxArt to move forward with our oral COVID-19 program. Currently, we're engaged in preparations to initiate this Phase 2b trial. This trial, which may start as early as Q2 in 2024, is a Phase 2b double-blinded, multicenter, randomized, comparator-controlled clinical trial to determine the relative efficacy, safety, and immunogenicity of VaxArts' investigational oral SARS-CoV-2 XBB vaccine tablet against a currently approved mRNA COVID-19 needle-injected booster vaccine in adults previously immunized against COVID-19 infection. As we continue our clinical trial preparations, we're working to secure additional funding which would support the initiation and conduct of the Phase 2b study. We will provide the timing and amount of any additional funding as events warrant. Commensurate with additional funding, we hope to be among the first of the project next-gen recipients to initiate our Phase 2b head-to-head clinical trial. Last month, we continued to demonstrate the cross-protective potential of our COVID-19 vaccine candidates with the publication of previously announced data in the journal Vaccines. This preclinical non-human primate data showed that our vaccine candidates could protect against multiple SARS-CoV-2 variants of concern, as they elicited strong antigen-specific serum IgG and IgA responses with neutralizing activity. Vaccination also reduced SARS-CoV-2 shedding following infectious challenge in both the upper and lower airway of non-human primates. Publications in highly respected journals such as Vaccines are really important because they continue to show that our groundbreaking research is being recognized by the scientific community. These data also serve as the foundation for our current COVID-19 vaccine candidate, which will be evaluated during the upcoming Phase 2B clinical trial. VaxArt's vast platform and technology has great potential. We believe this platform could transform the landscape not only for COVID-19 vaccines, but also for other infectious diseases that present significant threats to global public health, such as norovirus and influenza. We're very proud of our entire team as we continue to lead the way in mucosal vaccine science. I'll now hand the call over to Dr. Sean Tucker, our chief science officer and founder, for an update on our norovirus vaccine program. Sean?
spk02: Thanks, James. We made significant progress in our norovirus program in 2023, delivering top line data from two phase two studies, including a challenge study of our G11 monovalent candidate. We have evaluated most of the data, and we believe we are on track for identifying potential correlates of protection that will aid in the advancement of our bivalent norovirus candidate. We believe the data we have shared to date is promising for this vaccine candidate and for our vaccine platform overall. Late in the fourth quarter, we completed enrollment in our phase one clinical trial to evaluate the ability of our norovirus vaccine candidate to induce antibodies in lactating mother's breast milk and transfer those antibodies to young infants. Recall that this study is being supported partially by the Bill and Melinda Gates Foundation. This phase one multicenter randomized double blind placebo controlled dose ranging study is designed to evaluate the safety, tolerability, and immunogenicity of our oral administered bivalent G11, G24 vaccine in healthy lactating females of at least 18 years of age. The study enrolled 76 subjects at five sites in South Africa. These subjects were randomized into high or low dose vaccine or placebo. The primary endpoints to the study is frequency, duration, and severity of solicited symptoms for one week following the study drug dose. The frequency, duration, and severity of unsolicited treatment adverse events, serious adverse events, adverse events of special interest, and new onset of clinical illness through the active period. In particular, and what's most exciting, is that this study will look for VP1-specific IgG1 and IgG4 IgA in the serum and in the breast milk. We are currently expecting to announce top-line results in this Phase 1 trial in mid-2024. Going forward, we plan to meet with the FDA during the second quarter of 2024 to discuss our data on potential correlates, a Phase 2b dose confirmation study, and potentially a G2-4 challenge study. We currently believe a phase 2B study would generate sufficient safety data to have an end of phase 2 meeting with the FDA. An end of phase 2 meeting would allow us to gain concurrence with the FDA on the scope and design of a phase 3 pivotal efficacy study in adults over 18 years of age. That said, the type and timing of our next clinical study will be determined following our meeting with the FDA in Q2. We plan to provide an update on the next steps for this program as soon as we are able to after that meeting. I'll now hand the call over to Phil Lee, our CFO, for a brief discussion of our financial. Phil?
spk01: Thank you, Sean. The details of our financial results for the full year 2023 are summarized in today's press release. Revenue for 2023 was $7.4 million compared to $0.1 million in 2022. Revenue in 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 increased sales of Innoveer in Japan. Vaxart ended 2023 with cash, cash equivalents, and investments of $39.7 million. This cash balance does not include approximately $15 million net proceeds raised in early 2024. Baxar anticipates current cash runway into the fourth quarter of 2024. Thank you all for your time today. We will now open the call for your questions.
spk08: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, 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 would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Thank you. Our first question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
spk07: Hi, team. This is Asiya on for Charles. We have a question regarding the lactating mother study. Can you talk about possibly what you would like to see from this phase one study that could further differentiate the oral norovirus pills target product profile? and possibly supporting approval in the future. Thank you.
spk04: Sean, do you want to handle that one?
spk02: Yeah, I'll start and then let James jump in. Yeah, I mean, the key thing about this experiment, or I should say this clinical study, is by giving the vaccine to lactating mothers, we hope to see antibodies in the breast milk And those breast milk antibodies will be transferred to young infants. As you might know that, you know, one of the main, I should say, young children are probably the most susceptible to norovirus infection. And by getting the antibodies into kids, whether via breast milk, we think that's going to have a big impact. We hope that this, you know, not only by protecting the mother and the kids, we could also protect, you know, essentially by if these antibodies are going to be very good and create efficacy, we could also have ability to block transmission to other people in the community. James, do you want to add anything?
spk03: Thanks, Sean. You know, there's a rich history of maternal immunization to assist with covering children, but I think the interesting thing about our vast platform is it does such a compelling job on mucosal immunity and on IgA production. So, Taking a look at those levels in the breast milk in a more formalized way and then taking a look at potentially how the children do with that breast milk laden with maternal antibodies should go a long way to bettering our understanding of how this platform could work to potentially impact that pediatric population.
spk08: Thank you. Our next question comes from the line of Roger Song with Jefferies. Please proceed with your question.
spk05: Great, thank you. This is Liang Cheng on Roger Song. So we have a couple of questions. So I guess maybe the first one is, you know, would you remind us of the economics of the BARDA NextGen funding and how would that impact your runway down to the year? Then I have some follow-up questions. Thank you.
spk04: Well, the BARDA contract we announced in January provides funding to prepare for a Phase 2b COVID-19 trial. We can't speculate about BARDA's award process or timing. Other companies have announced that they were subject to an option agreement with BARDA, where BARDA might provide something in the neighborhood of $400 million to execute on the contract. We believe that as we execute against the milestones in this contract, we'll be in a position to receive additional funds. The details are not things that we have any ability to talk about right now. We'll provide an update as we gain additional visibility.
spk05: Sure. Thank you. So my next question is about the protection correlates. So I wonder, you know, how would that protection correlates impact your Phase III study plan?
spk04: Sean, I think you're the expert on that.
spk02: Yes, I'll start, and again, I'll let James follow along. I think the key thing about understanding what immune parameters are important is good for a variety of reasons, but one of the things is that if you have an established correlate of protection of your vaccine, so you know that measuring this immune parameter leads to protection, it could lead to a reduction in and out of subjects that you need to test in a phase three efficacy study, because that correlate can be used essentially to understand what's protective and you can use it to bridge between different age groups. James, would you like to add to that?
spk03: Thanks, Sean. So, you know, we're very excited about the work that Sean and his team is doing there. And, you know, as Sean had mentioned, you know, defining a correlate is an impressive piece of work, With further discussion, there is a potential to consider that as a surrogate for protection. And as Sean mentioned, it would impact both the numbers required for a clinical field study in phase three, as well as potentially the duration of time that that study would go on, looking at those immune correlate parameters and not just field efficacy. So more to follow as we have that discussion. in the near future. Thank you.
spk05: Got it. Thank you. Maybe my last question is about, you know, the potential safe 2D tool for challenge study. So, what would be some key considerations or discussions regarding the necessity of this study?
spk04: James, can you answer that?
spk03: Certainly. So, thanks, Roger. you know, we'll gain a lot of information in our conversation with the agency. If they require additional information from an additional challenge, G24 would be a challenge study that could be performed. You know, it's something that we've looked into in a just-in-case scenario if it is required. And if it's not, you know, it's not, right? I think we'll have a lot more clarity on if we are required to do an additional challenge study after we have that meeting with the agency.
spk04: Thank you, James.
spk05: Got it. Got it. Thank you. I think that's it from us. Thank you.
spk08: Thank you. Our next question comes from the line of Manyank Mantani with B Reilly Securities. Please proceed with your question.
spk06: Hey, guys. Madison Owen from MAIC. Congrats on the progress. And if I can ask a follow-up to the previous question. In the event that you do have a G24 challenge study, I'm just wondering how fast do you think you'll be able to get that study up and running? And then secondly, an unrelated Could you maybe mention, I'm not sure, for the BARDA phase two, will you be using commercial grade material for your vaccine?
spk03: Mike, would you like me to go forward on that? Sure.
spk04: Yes.
spk03: I sure will. So in terms of your second question, first, I guess, Um, this, uh, this phase two B study that would be, uh, executed, uh, is just that it's a clinical trial under the auspices of the, the good clinical practice guidelines and rules and regulations from the FDA. So it requires, uh, GMP manufactured material, which is what we use in, in all of our clinical trials. Um, so that, I think that should square that away, the comparator vaccine. will be an approved mRNA needle-injected vaccine. And we'll be comparing the efficacy of both of those vaccines or candidate vaccines against one another. We'll also be looking at safety. You know, we in our platform have a very fortunately very clean safety profile. And we'll be comparing that to, you know, the solicited and unsolicited adverse events both from our product but also from that needle-based injection of an mRNA booster. And we'll be looking at that data as well. What was your second question?
spk06: Secondly, a follow-up to the prior question, in the event, after your meeting with the FDA, in the event that you were to run a challenge study, just curious how fast you guys could initiate, yeah,
spk03: Well, I think it just depends on what the guidance of the FDA really tells us, right? So I don't want to speak for the agency or make any assumptions until after we have that meeting. That said, the good news is that there are groups that have been refining what is that challenge model in the United States. So I think we could, in relatively short order, move forward with a challenge study. I can't be more specific than that until we have the dialogue with the agency.
spk06: Understood. Thanks.
spk08: Thank you. I would now like to turn the call back over to Ed Burge for further questions.
spk00: Thank you, operator. We'll now turn to questions submitted by our shareholders. So the first question is from Mike Finney. Incoming CEO Steve Lowe has had success in first product commercialization. Was that the primary factor in your search? What other attributes did you consider and how did you make the selection?
spk04: Well, regulatory and commercialization experience are of course important, but the board was looking for an all-around performer and I think we found that with Steve.
spk00: Thanks, Mike. Our next question, what is the timing for next steps for neurovirus? This is on timing, following your FDA meeting in Q2. And James, I think you've answered some portion of this, but I'll turn to you. Sure.
spk03: So timing and next steps will, as I mentioned, be dependent on the dialogue with the FDA, right? We'll assess at that time and look forward to providing an update to anyone really who's interested after we have that meeting. You know, the nice thing is there's a couple of ways we see looking at the impact of how a next step would be, whether it's, you know, with the Phase 2b dose confirmation study for more safety data, whether it's for a challenge study that may be required or may not be required to give more information of the correlates to protection, and then with the whole idea of looking downrange to, to a potential phase three study. That's the goal.
spk00: Thanks, James. Another question on neurovirus. Will you be disclosing the results of your neurovirus data analysis and the correlate of protection? Sean, I think this is yours.
spk02: Yeah, I'd be obviously very excited about the work we've done. And, you know, of course, we will share our findings with the EA after we gather its input. We'll assess the next steps for the program. And once all that's done, we also plan to submit a peer-reviewed manuscript. And again, the timing of that will be determined at a future date.
spk00: Thanks, Sean. Next question. Please elaborate on the preparations for the Phase 2B COVID trial. When do you expect to complete preparations? James, I believe this is yours.
spk03: Sure. So, you know, we've been coordinating with our colleagues at BARDA, and we've done, I think, a great job in terms of moving forward, progressing with preparation for what is a really significant endeavor, a Phase 2b study of 10,000 enrollees. Once we have that completed, we will update you.
spk00: Okay, thanks. That is all the questions we have at this time, so I want to thank everyone today for joining us, and this concludes today's call. Thank you.
spk04: Thank you, Ed.
spk08: You may disconnect your lines at this time and have a wonderful day. We thank you for your participation.
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