Q4 2022 Vaxart Inc Earnings Call
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Speaker 2: 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, Brent Bain, Senior Vice President Business Operations. Thank you. You may begin. Good afternoon and welcome to today's call. This is Brent Bain, Senior Vice President Business Operations.
Speaker 3: Joining us from DocStart are Andre Floryu, our Chief Executive Officer, Dr. Sean Tucker, our Founder and Chief Science Officer, Dr. James Cummings, our Chief Medical Officer, and Phil Lee, our Chief Financial Officer.
Speaker 3: 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.
Speaker 3: and its product development and regulatory progress, including statements about its ongoing or planned clinical trials.
Speaker 3: 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 10K.
Speaker 3: and other periodic reports filed with the FCC.
Speaker 3: Vaxart undertakes no application to update any forward-looking statements after the date of this call. I'll now turn the call over to Andrei Soreyu. Andrei.
Speaker 4: 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 transformation oral vaccine platform.
Speaker 4: As we said in the press release we should this afternoon, we are prioritizing the development of our oral pill by violent norovirus vaccine candidate.
Speaker 4: As we believe, this to be the best strategy to position VaxR for long-term success and maximize shareholder value.
Speaker 4: 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 peel technology platform. Norovirus represents a very attractive target for VaxR.
Speaker 4: because of the very compelling risk-reward profile of our program.
Speaker 4: I will highlight five dimensions here.
Speaker 4: The disease characteristics.
Speaker 4: the large commercial opportunity, the attractive competitive context.
Speaker 4: the compelling data we have generated so far, and our near-term data readouts.
Speaker 4: So first, 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.
Speaker 4: This is unlike COVID which has been a constant moving target with emerging variants.
Speaker 4: Norovirus is less challenging for a company like VaxR to develop a solution again.
Speaker 4: Second, the norovirus commercial opportunity is huge for a company of any size.
Speaker 4: 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.
Speaker 4: There is no approved vaccine anywhere in the world and ours is the only oral programming development that we are aware of.
Speaker 4: And to our knowledge, there is only one other advanced programming development.
Speaker 4: Importantly, our oral and empirically delivered mucosal vaccine could have significant advantages for an enteric mucosal infection when compared to potentially injectable alternatives.
Speaker 4: Additionally, an oral pill vaccine has inherent convenience advantages in both key populations, kids and the elderly.
Speaker 4: The fourth point
Speaker 4: is that the data we have generated so far with our norovirus program is substantial and quite compelling.
Speaker 4: The data we have generated so far with our norovirus program is substantial and quite compelling. We have completed six clinical trials.
Speaker 4: enrolling 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.
Speaker 4: The immunogenicity data we have seen today from the completed trials look consistently strong and the safety and tolerability data so far is benign.
Speaker 4: 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.
Speaker 4: which is different than the data that has been seen with injectables.
Speaker 4: 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.
Speaker 4: We will highlight many of these aspects over the next few months in both scientific and investor events.
Speaker 4: And this we have two important top line data readouts over the next six months.
Speaker 4: 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.
Speaker 4: Now, besides that, importantly, we believe that if the data generated from our norovirus program continues to be strong, we will have a range of value-creating options for taking the program forward.
Speaker 4: Mid to late stage vaccine assets addressing large markets are very attractive to many industry players.
Speaker 4: And these vaccine assets are quite rare.
Speaker 4: which is why at JP Morgan this year we've seen that there is a lot of interest in this type of asset. So we believe this industry dynamic will translate into valuable optionality for us later on.
Speaker 4: Now, let me talk a little bit about our COVID-19 program.
Speaker 4: 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 suggest that our platform could fundamentally change how we fight COVID-19.
Speaker 4: 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.
Speaker 4: Therefore, we decided to play to the strengths suggested by our clinical data and focus on addressing pandemic preparedness by developing a pan-data coronavirus vaccine.
Speaker 4: One of the notable weaknesses of injectable COVID-19 vaccines
Speaker 4: has been their relatively narrow strain specific activity.
Speaker 4: While cross reactivity has been a feature of our mucosal oral pill vaccine.
Speaker 4: 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.
Speaker 4: Therefore, our broader focus on this beta coronavirus
Speaker 4: approach means we will not proceed.
Speaker 4: with a previously planned clinical COVID-19 trials.
Speaker 4: And as we advance new vaccine candidates, we will determine the best development plan going forward.
Speaker 4: 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.
Speaker 4: and we will provide updates as warranty.
Speaker 4: while we very much value every member of the VACFAC team.
Speaker 4: we have taken the difficult but necessary step to adjust our staffing levels with a 27% reduction in workforce.
Speaker 4: to reflect these new priorities and activities.
Speaker 4: With the change in program prioritization, our cash runway now extends into the second quarter of 2024.
Speaker 4: And as James will discuss in a moment, we expect to achieve several important milestones within the norovirus program between now and then.
Speaker 4: These milestones have the potential to support the continued advancement of the norovirus program.
Speaker 4: toward the phase 3 trial while also providing further validation of the promise of our oral pill vaccine platform. To showcase our differentiated norovirus program.
Speaker 4: and by valent candidate.
Speaker 4: I am pleased to announce that we will be hosting a virtual Key Opinion Leader call on March 28th at 1pm Eastern Time.
Speaker 4: with several leaders in the norovirus vaccine development.
Speaker 5: Sara Barge.
Speaker 4: FICOR project director at the Research Foundation of the City University of New York, and Jan Wiene, 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.
Speaker 3: globally, providing significant advantages compared to needle-based vaccines.
Speaker 6: We've already demonstrated robust immunogenicity data from our phase 1 norovirus clinical trials.
Speaker 6: in both young adult and elderly populations.
Speaker 6: These data show that our bivalent vaccine candidate induced a robust immune response to include IgA antibody-subcreting cells.
Speaker 6: had an ASC response rate of 78% for the G11 strain and 93% for the G24 strain with no interference observed.
Speaker 6: 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.
Speaker 6: Importantly, our norovirus candidate has an attractive safety profile in trials today that's well tolerated with no serious adverse events.
Speaker 6: and that's consistent with our platform.
Speaker 6: We believe it has the potential to reduce transmission as well.
Speaker 6: As stated in this afternoon's press release, a key component of our prioritization of the Norovirus vaccine program.
Speaker 6: is the expansion of the ongoing Phase II G11 Norovirus Challenge Study.
Speaker 6: expansion of the ongoing phase 2 G11 norovirus challenge study to include additional challenge cohorts.
Speaker 6: 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.
Speaker 6: and a reduction in risk of norovirus infection.
Speaker 6: or acute gastroenteritis.
Speaker 6: Identifying a correlative protection may reduce the size and the duration of a Phase III trial.
Speaker 6: With the inclusion of the additional cohorts, we expect to report top-line data from the Phase II Challenge Study in the third quarter of 2023.
Speaker 6: As announced last month, we initiated and dosed the first subject in the phase 2 dose ranging study of our bivalent norovirus vaccine candidate.
Speaker 6: critical next step in advancing this promising candidate to a phase 3 clinical study.
Speaker 6: Our bivalent vaccine is designed to target the prevalent strains of two norovirus genotypes.
Speaker 6: G11, and G24. They're the ones that cause the majority of norovirus disease in humans.
Speaker 6: 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.
Speaker 6: for customizing the presentation for different age courts.
Speaker 6: There's no need for refrigeration because it's stable at room temperature.
Speaker 6: And it's much easier to distribute while eliminating the biomedical waste associated with administering injected needle-based vaccines.
Speaker 6: The Phase II dose ranging trial is expected to enroll approximately 135 healthy adults at three sites in the United States.
Speaker 6: The first 10 subjects received open label high-dose vaccine.
Speaker 6: 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.
Speaker 6: The primary endpoints are safety and immunogenicity.
Speaker 6: in order to determine a dose level for phase 3 development.
Speaker 6: We expect to report top-line data from the Phase II dose ranging study in mid-2023.
Speaker 6: If successful, the next step would be a Phase IIb study, leading to an end of Phase II meeting with the FDA next year.
Speaker 6: In addition to the ongoing studies of our norovirus vaccine candidates in healthy adults.
Speaker 6: 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.
Speaker 6: If such transfer does occur, it could provide an important route for protecting infants.
Speaker 6: from norovirus infection. This is especially important given the high incidence of norovirus infection in young children.
Speaker 6: We expect to initiate this study in 2023.
Speaker 6: 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 toward submission and a potential FDA approval.
Speaker 6: We look forward to advancing our promising norovirus vaccine candidate that may benefit individuals.
Speaker 6: communities, and health systems globally. I'll now turn the call over to Sean.
Speaker 6: for an update on our novel COVID-19 constructs.
Speaker 6: novel COVID-19 constructs. Sean?
Speaker 6: 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...
Speaker 6: to develop, manufacture, and of course, administer that vaccine.
Speaker 6: 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 strains.
Speaker 6: 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.
Speaker 3: Moreover...
Speaker 6: Based on the substantial recostle cross reactivity data reported to date from the phase one and phase two A studies of our COVID-19 vaccine candidate, we believe that we may be able to repentially, potentially create an oral pan beta coronavirus vaccine.
Speaker 6: SARS-CoV-2, the virus that causes COVID-19, is a subspecies of virus within the beta coronavirus genus, as are other coronaviruses.
Speaker 6: a pan-beta coronavirus vaccine would make it easier to future proof the vaccine, whether the emerging coronavirus threat with a new SARS-CoV-2 variant, SARS-CoV-1, MERS-CoV, or some other beta coronavirus.
Speaker 6: Keep in mind our clinical data for COVID-19 demonstrated that 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 cars SARS-CoV-2 strains, as well as more distantly related data coronavirus such as
Speaker 6: 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.
Speaker 6: Therefore, we believe that a new coastal antibody inducing BIT, PAN, they've beta coronavirus vaccine, may be a valuable tool for pandemic preparedness.
Speaker 6: I'll now turn the call over to Andre.
Speaker 6: the call over to Andre. Andre?
Speaker 4: Thanks, Cian. 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 transactions.
Speaker 4: Speaking on behalf of the entire leadership team, we're excited to have him on board. See you!
Speaker 3: Thanks Andre. The details of our financial results for the full year 2022 are summarized in today's press release. VACTR ended the year with cash, cash equivalents, restricted cash, and marketable securities of $95.7 million compared to $114.8 million as of September 30, 2022.
Speaker 3: The decrease was primarily due to cache use in operations as we advanced our norovirus program.
Speaker 3: As Andre noted earlier, these funds provide cash runway into the second quarter of 2024.
Speaker 3: I'll now turn the call back to Andre for his closing remarks.
Speaker 4: Thanks, Phil. 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.
Speaker 4: 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.
Speaker 4: The prioritization of our Norovirus program will also provide us with several important milestones against which our investors can measure our progress.
Speaker 4: These milestones include reporting top line data from the ongoing phase 2 dose ranging study of our bivalent norovirus vaccine candidate in mid 2023.
Speaker 4: Reporting top data from our ongoing Phase II challenge studies.
Speaker 4: for our G1 monovalent norovirus vaccine candidate in Q3 2023.
Speaker 4: and initiating in 2023 the Bill and Melinda Gates Foundation funded clinical trial.
Speaker 4: to evaluate the ability of our norovirus vaccine candidates to induce antibodies in breast milk and transfer of antibodies to young infants.
Speaker 4: 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 bi-valent vaccine candidate.
Speaker 4: We hope you'll join us for this exciting and informative virtual event.
Speaker 4: On behalf of the AXAARTS leadership team, I'd like to thank you for your time today and we are now happy to take your questions.
Speaker 2: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation to whom 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. And for a participant using speaker equipment, maybe necessary to pick up your handset.
Speaker 6: liking the focus on neurovirus. I have 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, maybe not so quantitatively, but.
Speaker 6: what would you what would you be encouraged by in terms of taking that data set to the agency and would you anticipate that end of phase two 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 three by roughly this
Speaker 7: James, do you want to take this? Sure. Thanks, Charles. Thanks for the question. So, in terms of the top-line data from our phase two dose confirmation, dose ranging study, the top-line data we'll have in mid-23 is the top-line data that we'll have in mid-23.
Speaker 7: is based on 135 people, right? Either receiving placebo or a high 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.
Speaker 7: Again, in our platform, we've seen a very consistent, clean safety profile. 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-to-study
Speaker 7: would occur. 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
Speaker 7: It would be a larger sized study based on the dose selected. And I would see that potentially taking place in 2024.
Speaker 6: Does that answer your question Charles? Yeah I think it does. We'll look forward to that data. The second question that I had was either for Andre or Phil and Phil recently joined the firm. I guess I'm wondering if you could provide more color on
Speaker 6: 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? Noro kind of sticking with that same order of operation.
Speaker 3: and COVID.
Speaker 3: But in terms of what's going forward, obviously I think there has been a significant focus on norovirus and the trials, the clinical trials that were 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.
Speaker 6: Okay that's helpful. Last question on partnering. I guess my question is strategy and I mean so it's probably going to be an imperfect question or certainly answer takes two to tango but with regard to moving into a longer larger
Speaker 4: 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...
Speaker 4: challenge data, the Norovar 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.
Speaker 2: Thanks for taking my questions. Thank you so much. Our next question is from Mayank Mantani with B. Riley Securities. Please proceed.
Speaker 8: 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 could you talk a little bit more for the challenge study the rational for expanded cohorts and I think it would be helpful for investors to understand. I think it would be helpful for investors to understand.
Speaker 8: what levels of protection, you know, be it GI symptomatic efficacy or even transmission, you are 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.
Speaker 7: So, James, do you want to take this question? Sure. So, Mike, thanks for the question. In terms of the type of data to drill down into what we're looking at for the challenge study, we have two rounds of research done for theseSTATMan, the scientific 57 study.
Speaker 7: Essentially, we're looking at protective efficacy, so looking at a reduction in symptomatic acute gastroenteritis secondary to a 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.
Speaker 7: 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 is, it could be key in sizing up our phase three endeavors.
Speaker 7: and looking at the potential to decrease numbers and or timelines for a phase three study looking at a cordless protection. This challenge is a G11 challenge and you know our bio-analysis vaccine that we're going to do a strange study has G11 and G24.
Speaker 7: 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? Yes, it does. And maybe if I can ask you to be a little more specific on the...
Speaker 8: 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, you could clarify that. Thanks again for the question.
Speaker 7: Sure, thanks. So in terms of the dosage levels of that study, it's available on www.quintrials.gov.
Speaker 7: we're looking at a bivalent of G11 and G24 at 5 e to the 10, which the total dose is 1 e to the 11 dose, right? In terms of the high dose, that's G24 and G11. That's a 1 e to the 11 per strain for a total dose of 2 e to the 11.
Speaker 7: Now, in our previous studies, we've had doses as high as one E to the 11. 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,
Speaker 7: or a 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 a acute gastroenteritis, but that would be exploratory only. These studies aren't really geared for that.
Speaker 7: 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, there's not a consistent transmission annually. It's more selected by population. And so we would.
Speaker 7: We would look forward to garnering a lot of knowledge from that challenge study in terms of potentially protective efficacy.
Speaker 8: Does that answer that question, Ryan? 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.
Speaker 7: and lactating postpartum women.
Speaker 7: where we would give our oral tablet vaccine to women who've already delivered a baby, so they have a breastfeeding infant, to measure a couple of 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.
Speaker 7: 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.
Speaker 7: From our standpoint, this may be a way to protect some of the most vulnerable populations by implementing a vaccination strategy on the lactating model.
Speaker 7: I'll leave the question of dollar amounts, et cetera, to others on the call. Andre, Sean, Phil, would you like to comment? Yeah. So, Mike, we're not going to provide details on the dollar amounts here. We just said that this trial is not going to be a good idea.
Speaker 6: was co-founded by the Gates Foundation and us. And we're just going to leave it there. We have reached the end of the phone questions and answers. I'll turn the conference back over to Brant for any online questions.
Speaker 9: 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.
Speaker 9: The question is why prioritize norovirus? Why make that decision now and why didn't we make the decision?
Speaker 9: Norovirus, why make that decision now and why didn't we make the decision earlier?
Speaker 4: Thank you, Brent. We really believe that we have one of the leading norovirus vaccine candidates and it is important to emphasize that. Our decision to focus on the norovirus program followed an extensive strategic review of our business.
Speaker 4: 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 prioritize norovirus.
Speaker 4: is because overall it presents the best risky work profile for us in the near term. As we mentioned, we have two very important data readouts this year, one media and one in the third quarter.
Speaker 4: 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.
Speaker 4: So I think that's important for investors to know.
Speaker 9: Excellent. Thanks, Andre. So, focusing on the cash runway, there's a number of questions on Norovirus. Phil, this is going to be for you.
Speaker 9: And they all relate to Norovod. I'll try and summarize the scope of...
Speaker 9: All the questions that we're getting. So can you complete a phase 3 study of the norovirus without additional funding? What's the projected cost and duration of a phase 3 study and does your cash runway include a phase 3 study? Phil, passing that over to you.
Speaker 3: 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 two 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 three trial, and we aren't really providing guidance on the cost of a potential phase three trial at this time.
Speaker 9: Excellent. Thanks, Phil.
Speaker 9: James, this one's on Norovirus for you in the clinical study. So, the question is, Norovirus again. Presuming you obtained positive data from Phase 2 studies, when would the end of Phase 2 FDA meeting take place? And what's your timeline to design and initiate a Phase 3 trial? James.
Speaker 7: Thanks. Presuming we have positive data from the Phase 2 studies, we expect an end of Phase 2 meeting would be next year, 2024. The Phase 3 trial could begin as early as next year as well, and that will be in concert with guidance from the agency.
Speaker 9: Over. Excellent. Thank you, James. Andre, this one's going to be for you and really talk about funding. What's the prospect for US or international government funding, whether it's from the UK, BARDA, etc. Andre, over to you.
Speaker 4: Well, this is a difficult question to answer, particularly now as we perceive the interest and attention of various governments and governmental agencies have shifted. So you're going to talk about various focuses.
Speaker 4: 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 pandemic in general.
Speaker 4: So again, we continue to have those communications, but it's hard to predict the outcome. Thank you, Andrei. Phil, this is another question on share price for you.
Speaker 9: 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.
Speaker 3: 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. 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.
Speaker 3: In terms of a reverse split, we don't believe we need one at this time. Excellent. Thank you, Phil. Well, that wraps up our questions for today. Terry, I'll hand it back to you.
Speaker 2: Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.
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