Q1 2024 Vaxart Inc Earnings Call
Operator: Greetings and welcome to the Vaxart Business Update and First Quarter 2024 Financial Results Conference Call. The question and answer session will follow management's opening remarks. Individual investors may submit written questions to ir@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.
Greetings and welcome to the Vacs Art business update and first quarter 2024 financial results Conference call. A question and answer session will follow management's opening remarks individuals' investors may submit written questions to I R.
It backs our dotcom.
As a reminder, this conference is being recorded.
Speaker Change: I would now like to turn the webcast over to your host Edberg Senior Vice President and General Counsel.
Speaker Change: Good afternoon, and welcome to today's call.
Edward B. Berg: 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 Phillip 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.
Speaker Change: Joining us from <unk> are Stephen Lowe, Chief Executive Officer, Dr. Sean Tucker founder and Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Philip Lee Chief Financial Officer.
Speaker Change: Before we begin I would like to remind everyone that.
Speaker Change: During this conference call backs art may make forward looking statements.
Speaker Change: 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.
Speaker Change: Actual results could materially differ from those discussed in these forward looking statements.
Speaker Change: Due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process.
Speaker Change: And other risks described in the risk factors section of Vacs are its most recently filed annual report on Form 10-K, and also on other periodic reports filed with the SEC.
Speaker Change: <unk> undertakes no obligation to update any forward looking statements. After the date of this call.
Edward B. Berg: 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 in 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 Stephen Lowe. Stephen?
Speaker Change: I'll now turn the call over to Steven Lo Steve.
Speaker Change: Thanks, Fred and thanks to all of you for joining US today on today's call I'll provide a brief summary of my background discuss our recent accomplishments and shared details of our exciting value proposition.
Stephen Lowe: Thanks, Ed, and thanks to all of you for joining us today. On today's call, I'll provide a brief summary of my background, discuss our recent accomplishments, and share details of our exciting value proposition. I'll then turn the call over to James and Phil to review our recent progress, which includes positive data from our bivalent norovirus vaccine candidate in lactating mothers, upcoming milestones, and a financial update. Since this is my first quarterly results call as Vaxart's CEO, I'd like to begin with a brief introduction.
Steven Lo: I'll, then turn the call over to James and Phil to review, our recent progress which includes positive data from our bivalent norovirus vaccine candidate and lactating mothers upcoming milestones and a financial update.
Speaker Change: Since this is my first quarterly results call as Baxter CEO I'd like to begin with a brief introduction.
Stephen Lowe: I've spent most of my 25-plus-year career in the healthcare, biotech, and pharmaceutical sectors, including more than 12 years as a C-level executive at publicly traded biotech companies. Throughout that time, I have led companies through all phases of drug development, from preclinical to launching and commercializing products. In my previous roles, I have worked firsthand with developing clinical programs and executing commercial strategies, experience that will be crucial as we advance Vaxart's pipeline. I enjoy working in biotech because it provides the opportunity to find the right healthcare solutions to society's most pressing unsolved problems.
James F. Cummings: I've spent most of my 25, plus year career in the health care biotech and pharmaceutical sectors, including more than 12 years as a C level executive at publicly traded biotech companies.
James F. Cummings: Throughout that time I have led companies through all phases of drug development from preclinical to launching and commercializing products.
In my previous roles I have worked firsthand in developing clinical programs and executing commercial strategies.
James F. Cummings: Experience that will be crucial as we advance <unk> pipeline.
James F. Cummings: I enjoy working in biotech because it provides the opportunity to find the right health care solutions to society's most pressing unsolved problems. This is what led me to back start where I believe we have a promising science and a passionate team of scientific experts driven to bring transformer.
Stephen Lowe: This is what led me to Vaxart, where I believe we have promising science and a passionate team of scientific experts driven to bring transformative solutions to benefit public health globally. I am excited to lead Vaxart as we bring our pipeline of cutting-edge vaccine candidates to improve outcomes in public health. A major emphasis of mine will be on execution so that we can deliver on Vaxart's promise more quickly in order to solve major public health issues while generating value for our shareholders. And now, a couple comments on our pipeline progress.
James F. Cummings: Chip solutions to benefit public health globally.
James F. Cummings: I am excited to lead back start as we bring our pipeline of cutting edge vaccine candidates to improve outcomes and public health in.
James F. Cummings: A major emphasis of mine will be on execution. So that we can deliver on vac starts promise more quickly in order to solve major public health issues, while generating value for our shareholders.
James F. Cummings: And now a couple of comments on our pipeline progress.
Stephen Lowe: First, we are very pleased with the recent positive results from the phase one clinical trial evaluating our oral pill bivalent norovirus vaccine candidate in lactating mothers. The top-line analysis from this study showed that our vaccine could significantly increase antibodies against norovirus in breast milk. This is an important first signal for the potential of our vaccine to protect against or reduce disease severity of norovirus in the youngest and most vulnerable population, as this virus carries a tremendous economic burden in the United States and other developed countries around the world.
James F. Cummings: First we are very pleased with the recent positive results from the phase one clinical trial evaluating our oral pill bivalent norovirus vaccine candidate and lactating mothers.
James F. Cummings: The topline analysis from this study showed that our vaccine could significantly increase antibodies against norovirus in breast milk. This is an important first signal for the potential of our vaccine to protect against or reduce disease severity of norovirus and the youngest.
James F. Cummings: And most vulnerable population.
James F. Cummings: This virus carries a tremendous economic burden in the United States and other developed countries around the world.
James F. Cummings: The next step for our Norovirus program will be a meeting with the FDA in mid 2024 to review our clinical findings to date, which include our dose ranging phase two study of our bivalent norovirus vaccine candidate and our phase II Challenge study.
Stephen Lowe: The next step for our norovirus program will be a meeting with the FDA in mid-2024 to review our clinical findings to date, which include our dose-ranging Phase 2 study of our bivalent norovirus vaccine candidate and our Phase 2 challenge study of the G1-1 component of our bivalent norovirus vaccine candidate. We anticipate this meeting will assist us in determining the regulatory pathway and clinical next steps. Second, we expect to initiate our COVID-19 Phase 2b trial, possibly as early as this quarter, once we are able to secure additional funding and gain regulatory alignment.
James F. Cummings: Of the G. One one component of our bivalent norovirus vaccine candidates.
James F. Cummings: We anticipate this meeting will assist us in determining the regulatory pathway and clinical next steps.
James F. Cummings: Second we expect to initiate our COVID-19 phase two b trial, possibly as early as this quarter. Once we are able to secure additional funding and gain regulatory alignment. We have been honored to receive an initial contract from BARDA and look forward to working with them on.
Stephen Lowe: We are honored to receive an initial contract from BARDA and look forward to working with them on Project NextGen as we continue preparations for this trial. This Phase 2B study will evaluate our oral pill XBB COVID-19 vaccine candidate against an improved mRNA comparator. We agree with the federal government that better vaccines are needed and believe these next-generation vaccines will include those that harness the power of mucosal immunity, like our innovative candidate.
James F. Cummings: Project Nextgen as we continue preparations for this trial. This phase <unk> study will evaluate our oral pill X B B COVID-19 vaccine candidate against and improved M. RNA a comparator, we agreed with the federal government that better vaccines are needed and bill.
James F. Cummings: Leave. These next generation vaccines will include those that harness the power of mucosal immunity like our innovative candidates, we look forward to providing an update on funding and our timing as you as events warrant.
Stephen Lowe: We look forward to providing an update on funding and our timing as events warrant. We are proud of the growing body of data that reinforces our confidence in our differentiated technology, and we continue to improve this technology. Recent preclinical data suggest our COVID-19 XBB construct has produced a more robust immunogenic response compared with our previous constructs. With these results, we are exploring whether certain changes we implemented in our XBB vaccine candidate will be beneficial for other indications in our pipeline.
James F. Cummings: We are proud of the growing body of data that reinforces our confidence and our differentiated technology and we continue to improve this technology recent preclinical data suggests our COVID-19 X P. B construct has produced a more robust immunogenic response compared with our previous calls.
James F. Cummings: Strikes with these results we are exploring whether certain changes we implemented in our X P. B vaccine candidate will also be beneficial for other indications in our pipeline.
Stephen Lowe: We believe Vaxart is in an excellent position to seize the opportunity in front of us and advance our oral vaccine platform. Our data to date are compelling across respiratory and enteric programs, and we are determined to press on toward our goal of bringing these solutions to the populations that need them, both in the United States and globally. I'll now turn the call over to James to review the recent progress of our Norovirus and COVID-19 programs.
James F. Cummings: We believe <unk> is in an excellent position to seize the opportunity in front of us and advance our oral vaccine platform. Our data to date are compelling across respiratory and enteric programs and we are determined to press on toward our goal of bringing these solutions to the populations that need them.
James F. Cummings: In the United States and globally.
James F. Cummings: I'll now turn the call over to James to review the recent progress of our norovirus and COVID-19 programs.
James F. Cummings: Thanks, Steve.
James F. Cummings: We're encouraged by our progress in both our norovirus and COVID-19 programs. First, on norovirus. Late last month, we announced positive top-line data from our Phase 1 clinical trial, evaluating the ability of our norovirus vaccine candidate to induce antibodies in lactating mothers' breast milk. Recall that this study was partially supported by the Bill and Melinda Gates Foundation.
James F. Cummings: Encouraged by our progress in both our norovirus and COVID-19 programs first on Norovirus late last month, we announced positive topline data from our phase one clinical trial evaluating the ability of our norovirus vaccine candidate to induce antibodies and lactating mothers breast milk.
James F. Cummings: We found in our initial analyses that antibodies to norovirus rose on average four-fold for the G11 virus strain and six-fold for the G24 virus strain in the breast milk of lactating mothers who received the Vaxart vaccine candidate in the high-dose group. Importantly, there were no vaccine-related serious adverse events and no dose-limiting pharmacotoxicity. These key findings may offer hope for mothers to protect their children against or reduce the effect of this highly contagious virus.
James F. Cummings: Recall that this study was partially supported by the Bill and Melinda Gates Foundation.
James F. Cummings: We found in our initial analyses that antibodies to norovirus rose on average four fold for the G. One one virus strain and six fold for the G. Two for virus strain in the breast milk of lactating mothers, who receives the vacs art vaccine candidate in the high dose group.
James F. Cummings: Importantly, there were no vaccine related serious adverse events and no dose limiting pharmacopeia toxicity.
These key findings may offer hope for mothers to protect their children against or reduce the effect of this highly contagious virus, while mucosal immunization of the youngest children is challenging due to the nature of their developing immune system, our creative approach and the passive transfer.
James F. Cummings: While mucosal immunization of the youngest of children is challenging due to the nature of their developing immune system, our creative approach to the passive transfer of antibodies from mothers to infants could potentially improve infection resistance in infants.
James F. Cummings: Antibodies from mothers to incense.
James F. Cummings: Potentially improve infection resistance and entrance.
James F. Cummings: Globally Norovirus is a very serious illness with an economic burden estimated at more than $60 billion annually.
James F. Cummings: Globally, norovirus is a very serious illness, with an economic burden estimated at more than $60 billion annually. It is particularly prevalent among the youngest age group, children under eight years of age, as norovirus carries a tremendous rate of outbreak incidence compared with other infectious diseases. In the developing world, it carries a much higher mortality rate than in developing nations, especially in countries that already have a rotavirus vaccine program. Norovirus causes an estimated 50,000 child deaths every year, mostly in developing countries.
James F. Cummings: It is particularly prevalent among the youngest age group children under eight years of age as norovirus carries a tremendous rate of outbreak incidents compared with other infectious diseases.
James F. Cummings: In the developing world.
James F. Cummings: It carries a much higher mortality rate than in developing nations.
James F. Cummings: Especially in countries that already have a rotavirus vaccine program.
James F. Cummings: Norovirus causes an estimated 50000 child deaths every year, mostly in developing countries.
James F. Cummings: As a reminder, this was a phase one, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent G11, G24 norovirus vaccine in healthy lactating females of at least 18 years of age. The study enrolled 76 subjects in five sites in South Africa.
As a reminder, this was a phase one multi center randomized double blind placebo controlled dose ranging study designed to evaluate the safety Tolerability and Immunogenicity of orally administered by Zealand G. One one G. Two for norovirus.
Vaccine in healthy lactating females of at least 18 years of age.
James F. Cummings: The study enrolled 76 subjects and five sites in South Africa.
James F. Cummings: Subjects were randomized to high or medium dose vaccine or placebo. Safety Data from this study remains blinded and will become available 12 months after enrollment. We are conducting additional analyses of the study data, and we expect to report more complete results, including other immunogenicity measures, in a future scientific manuscript.
James F. Cummings: Subjects were randomized into high or medium dose vaccine or placebo groups.
James F. Cummings: Safety data from this study remains blinded and will become available 12 months after enrollment.
James F. Cummings: We are conducting additional analyses of this study data and we expect to report more complete results, including other immunogenicity measures in a future scientific manuscript.
James F. Cummings: Looking ahead as Steve mentioned, we are targeting a mid 2020 for meeting with the FDA to discuss our data on potential correlates of protection as well as potential future clinical studies, such as the phase II B dose confirmation study and if required a G. Two four challenge.
James F. Cummings: Looking ahead, as Steve mentioned, we are targeting a mid-2024 meeting with the FDA to discuss our data on potential correlates of protection, as well as potential future clinical studies, such as a Phase 2b dose confirmation study and, if required, a G2-4 challenge study. We are hopeful that supporting safety data from a Phase 2B study could result in a end of phase 2 meeting with the FDA that would focus on the scope and design of a Phase 3 pivotal efficacy study for our norovirus vaccine in adults over 18 years of age.
James F. Cummings: Study.
James F. Cummings: We are hopeful that supporting safety data from our phase II B study could result in an end of phase two meeting with the F. D. A.
James F. Cummings: Focus on the scope and design of a phase III pivotal efficacy study for our norovirus vaccine in adults over 18 years of age.
James F. Cummings: Turning now to our COVID-19 program, we continue to make progress in preparing for 10000 subject phase two b clinical trial evaluating our oral pill X B B COVID-19 vaccine candidate.
James F. Cummings: Turning now to our COVID-19 program, we continue to make progress in preparing for a 10,000 subject Phase 2B clinical trial evaluating our oral pill XBB COVID-19 vaccine candidate against an approved mRNA vaccine comparator. You may recall that preparations for the study were supported by a contract from BARDA and are part of the federal government's Project NextGen effort to enhance the nation's pandemic preparedness and better confront the continuing challenge of COVID-19. We have substantially completed the preparations of our manufacturing processes in advance of the launch of this trial.
James F. Cummings: <unk> and improved mrna vaccine comparator.
James F. Cummings: You may recall the preparations for the study were supported by a contract from BARDA and are part of the federal government's project Nextgen efforts to enhance the nation's pandemic preparedness and better confront the continuing challenge of COVID-19.
James F. Cummings: We have substantially completed the preparations of our manufacturing processes in advance of the launch of this trial.
James F. Cummings: We're working to secure additional funding and regulatory alignment, and if successful, we currently anticipate initiating this Phase 2B trial as early as the second quarter. As a reminder, this is a Phase IIb, double-blind, multi-center, randomized, comparator-controlled clinical trial to determine the relative efficacy, safety, and immunogenicity of Vaxart's investigational oral SARS-CoV-2 XBB vaccine tablet against I'll now hand the call over to Phil Lee, our Chief Financial Officer, for a brief discussion of our financials. Thank you, James.
James F. Cummings: We're working to secure additional funding and regulatory alignment and if successful. We currently anticipate initiating this phase two b trial as early as the second quarter.
James F. Cummings: As background. This is a phase two b double blind multicenter randomized comparator controlled clinical trial to determine the relative efficacy.
James F. Cummings: Safety and Immunogenicity of <unk> investigational oral Sars Covid, two X D. B vaccine tablet against a currently approved mrna needle injected booster vaccine in adults previously immunized against COVID-19 infection.
James F. Cummings: I'll now hand, the call over to Phil Lee, Our Chief Financial Officer for a brief discussion of our financials Phil.
James F. Cummings: Phil.
Phillip Eric Lee: Thank you James the details of our financial results for the first quarter of 2024 are summarized in today's press release.
Phillip Eric Lee: The details of our financial results for the first quarter of 2024 are summarized in today's press release. Revenue for the first quarter of 2024 was $2.2 million, compared to $0.7 million in the first quarter of 2023. Revenue in the first quarter of 2024 was primarily from revenue recognized for work performed under Vaxart's contract from BARDA and non-cash World 2 revenue from sales of Inovir in Japan. Vaxart ended the first quarter with cash, cash equivalents, and investments of $36.7 million.
Phillip Eric Lee: Revenue for the first quarter of 2024 was $2 $2 million compared to zero point $7 million in the first quarter of 2023.
Phillip Eric Lee: Revenue in the first quarter of 'twenty 'twenty four what's primarily from revenue recognized for work performed under back such contract from BARDA and noncash royalty revenue from sales.
Phillip Eric Lee: India and Japan.
Phillip Eric Lee: That's sort of ended the first quarter with cash cash equivalents and investments of $36 $7 million.
Phillip Eric Lee: While we did not receive any cash payments from BARDA during the first quarter, we have received approximately $1.6 million subsequent to the end of the quarter. We are in the process of executing on the remaining deliverables and submitting for the remaining $7.67 million portion of our current BARDA contract, and we'll provide an update when we report our second quarter financial results. Based on our current plan, Vaxart anticipates its current cash flow rate into the late fourth quarter of 2024.
Phillip Eric Lee: While we did not receive any cash payments from BARDA. During the first quarter. We have received approximately $1.6 million subsequent to the end of the quarter.
Phillip Eric Lee: We are in the process of executing on the remaining deliverables and for many for the remaining $7.7 million or a car a BARDA contract.
Phillip Eric Lee: And we'll provide an update when we report our second quarter financial results.
Phillip Eric Lee: Based on our car plant that sort of anticipate current cash runway into late fourth quarter of 2024.
Operator: Thank you everyone for your time today. We will now open the call for your questions. And ladies and gentlemen, at this time, we'll conduct our question.
Speaker Change: Thanks, everyone for your time today, we will now open the call for your questions.
Speaker Change: Thank you.
Operator: And ladies and gentlemen, at this time, we'll conduct our 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 that 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 your handset before pressing the start key. One moment, please, while we pull for questions. Thank you. Thank you, and our first question comes from Mayank Mantani with B. Riley Securities. Please state your question.
Speaker Change: And ladies and gentlemen at this time well conduct 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 that your line is in the question queue.
Speaker Change: You May press star two to remove yourself from the queue.
Speaker Change: 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.
Speaker Change: Yeah.
Speaker Change: Thank you and our first question comes from my Ink, Montana with B Riley Securities. Please state your questions.
Speaker Change: Hey, guys. This is Madison on for Matt. Thank you for taking off.
Madison: Hey guys, this is Madison on the phone. Thank you for taking our question. I wanted to ask... Maybe you could speak to what you need to demonstrate to procure this additional funding in order to initiate phase two B of BARDA, and maybe if you could speak to your confidence level regarding where you're at regarding obtaining those funds that are needed.
Speaker Change: Sure.
Madison: I wanted to ask.
Madison: So maybe could you speak to what you need to to.
Madison: Demonstrate to procure this additional funding in order to.
Madison: Initiate the phase II B BARDA and maybe if you could speak to you.
Madison: Your your confidence level on where you're at regarding obtaining those funds that are needed.
Stephen Lowe: Yes, hi. Good afternoon.
Speaker Change: Yes, hi, good afternoon. Thanks for the question. So I'll cover a few things and then I'll turn it over to James on the specifics are you know.
Stephen Lowe: Thanks for the question. So, I'll cover a few things, and then I'll turn it over to James for the specifics. You know, in terms of confidence levels, right? So the original award of $9.27 million was to fund the preparation for the 10,000 subject study. And as both James and I have outlined, you know, we made progress there. And I think you can even see in the financial results that we've been reimbursed for some of that work. So, that is why we continue to say that we're prepared to start the trial as early as this quarter. But I will also turn it over to James.
Speaker Change: In terms of confidence level right. So the b.
Speaker Change: The original award of the 9.27 million was to find the preparation for the 10000 subjects study and as both James and I have.
Speaker Change: Outlined you know we've made progress there and I think you can even see in the financial results. We've been reimbursed for some of that work so.
Speaker Change: That is why we continue to say that we're prepared to start the trial as early as this quarter, but let me also turn it over to James.
Speaker Change: Yeah.
James F. Cummings: Thanks, Steve you know.
James F. Cummings: Thanks Steve, you know... In terms of the preparation for the study, I think the team has done an excellent job in putting together the pieces for the evaluation of the XBB construct against an improved mRNA comparator. This is a big study, 10,000 people, right? And so to get all those food groups set up, it takes a team, and we've got a good one. In terms of where we're at, we'll report back when we have those details for you, but we've been in close communication with BARDA on the preparations, and we plan to provide an update on funding and on our timing as applicable.
James F. Cummings: In terms of the preparation for the study I think the team has done an excellent job in putting together the pieces for evaluation of the SCB construct against improved mrna comparator vaccine. This is a big study 10000 people right and so to get all those food groups set up but it takes the team and we.
James F. Cummings: Got it good one in terms of where we're at and we'll report back when we have.
James F. Cummings: Those are those details for you.
James F. Cummings: But we've been in close communication with BARDA on the preparations and we plan to provide an update on funding and or timing as applicable.
Speaker Change: I see thanks, guys.
Operator: Thanks, guys.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: And our next question comes from Charles Duncan with Cantor Fitzgerald. Please state your question.
Acia: And our next question comes from Charles Duncan with Cantor Fitzgerald. Please state your question.
Charles Cliff Duncan: Hi team. This is a yeah on for Charles Thank.
James F. Cummings: Hi team, this is Acia on behalf of Charles. Thank you for taking our question. So we also have a question regarding the Phase 2B study for the COVID-19 vaccine. Can you talk about possible specific endpoints and criteria that will be used to evaluate its efficacy and safety against the mRNA vaccine comparator? Can you also elaborate on what enrollment for this study would look like, such as where you might enroll patients from, and are there any other challenges you might anticipate?
Speaker Change: Thank you for taking our question.
Charles Cliff Duncan: We also have a question regarding the phase two study for the COVID-19 vaccine can you talk about a possible specific endpoint them quite well.
Speaker Change: Well he is to evaluate efficacy and safety against.
R&D investing comparator and can you also elaborate on what enrollment for this study would look like such as where you might in all patients and are there any other challenges you might anticipate.
Speaker Change: Sure I'll turn that over to James since he has the details on that.
James F. Cummings: Sure, I'll turn that over to James since he has the details on that.
James F. Cummings: Sure. So as far as where we're actually executing the clinical trial, it's planned to be executed here in the United States. And in terms of enrollment, it would be healthy individuals and individuals at risk above the age of 18. It's important that we test this vaccine against the comparator mRNA vaccine in a population that's likely to do the most good. So we're moving along those lines. What was the second part of your question, Asiya?
James F. Cummings: Sure so as far as where we're actually executing the clinical trial is planned to be executed here in the United States and in terms of enrollment it would be healthy individuals and in individuals at risk about the age of 18 years. It's important that we we are 10.
James F. Cummings: First this vaccine against the comparator mrna vaccine.
James F. Cummings: In a population that's it's likely to do the most good so we're moving along those lines what was the second part of your question.
Acia: So it was about possible endpoints and criteria that you would be using for the study? Yes.
James F. Cummings: So it was about possible endpoints and criteria.
Speaker Change: I think for the study.
James F. Cummings: Yeah, so the endpoints are safety always, right, and we're very fortunate in that our platform across every article in our pipeline portfolio has been very well received, very safe, and well tolerated. We'll also be looking at efficacy, both for symptomatic COVID-19 infection compared to the comparator vaccine, and we'll be looking at the immunological readouts and mucosal readouts of that vaccine. Okay.
Speaker Change: Yeah. So the endpoints are safety always right in and we're very fortunate in that our platform across every article in our pipeline portfolio.
Speaker Change: Has been very well received very safe and well tolerated.
Speaker Change: We'll also be looking at efficacy both for symptomatic COVID-19 infection compared to the comparator vaccine.
Speaker Change: And we'll be looking at the immunological readouts and mucosal readouts of that vaccine.
Speaker Change: Okay. Thank you so much that makes a lot of sense.
Acia: Okay, thank you so much. That makes a lot of sense.
Speaker Change: Thank you.
Speaker Change: And our next question comes from Roger song with Jefferies. Please state your question.
Operator: And our next question comes from Roger Song with Jeffreys. Please state your question.
Roger Song: Hey, good afternoon, this downturn of all four projects.
Liangchen Lau: Hey, good afternoon. This is Liangchen Lau from Rogers.
Roger Song: For taking our questions I guess, what I'm up.
Operator: Thank you for taking our questions, I guess, from us. So, I understand that you haven't met with the FDA yet, but, you know, regarding the potential Phase 2 challenge study, what would be some considerations around, you know, whether there would be such a study or not? And also, I have a question about the potential immunology correlates. So, could you remind us if you are still continuing with data analysis, and are there any updates or plans on the immunogenicity correlates? Thank you.
Roger Song: No.
Roger Song: I understand that you haven't met with the FDA, yet, but regarding the potential.
Roger Song: Two challenge study, so what would be some consolidations that wrong you know whether.
Speaker Change: They would be such a study or now and also I have a question part of that potential.
In an Aussie correlate so could you remind us if you are still continuing along with our data analysis and Oh there Ana.
Speaker Change: Any updates on plans on the.
Speaker Change: And Oh Gee needs they are correlated.
Speaker Change: Thank you.
Speaker Change: Sure Yeah, I'll turn it over to James Shortly you know my high level is.
Stephen Lowe: Sure, yeah, I'll turn it over to James shortly. My high level is, you know, obviously what we stated in terms of our meeting with the FDA is, you know, we're still targeting the middle of this year. And James can cover a bit more about that.
James F. Cummings: Obviously, what we stated in terms of our meeting with the FDA as you know, we're still targeting a middle of this year.
James F. Cummings: And change.
James F. Cummings: Change can cover a bit more about that.
James F. Cummings: Thanks, Steve So as we mentioned, we'll be planning to air will be dealing with the F. D. A.
James F. Cummings: So, as we mentioned, we'll be meeting with the FDA in mid-2024, and we'll review our clinical findings to date, which includes data on potential correlates of protection.
Change: Mid 'twenty four and we'll review our clinical findings to date that includes stayed at potential correlates protection.
Change: We anticipate this meeting will assist us in determining the proper regulatory pathway and clinical next steps and as I mentioned in my my grief. If some of these steps could include a phase two the dose confirmation study.
James F. Cummings: We anticipate this meeting will assist us in determining the proper regulatory pathway and clinical next steps. And as I mentioned in my brief, some of these steps could include a phase 2b dose confirmation study and, if required, a G2 Ford Challenge Study. But I'd like to get input from the agency. We'll determine the timing of any future norovirus studies after our discussions with you.
Change: And if required a G. Two for Chegg study, but I'd like to to get input from the agency.
Change: <unk> will determine the timing of any future norovirus studies.
Change: After our discussions with the FDA.
Operator: Also, regarding the Phase 1 lactating mothers data, I know detailed data will be published in the future. Would there be any data around measurements in infants?
Speaker Change: Got it that makes sense so.
Speaker Change: Regarding the big one lactating mothers data I know so detailed data will be published in the future.
Speaker Change: Would there be any data around measurements in the infants.
Speaker Change: Jingles Sean.
James F. Cummings: James or Sean, either one of you want to take that? Sure.
Speaker Change: Wherever you want to take that.
James F. Cummings: Sure. You know, the data we have to date, Leung, is some of the top line data, and we continue to perform analyses. Some of those analyses will look at fecal matter, the amount of material in the infant's feces. But that's, again, down the road.
Sean N. Tucker: Sure so.
Sean N. Tucker: You know the data we have to date, a young is that some of the topline data and we continue to perform analyses.
Sean N. Tucker: Some of those analyses will look at sequel.
The amount of material in the infant species.
Sean N. Tucker: But that's again.
Sean N. Tucker: Down the road.
Speaker Change: Got it. Thank you that's all from us.
Liangchen Lau: Got it. Thank you. That's all from us. Thanks again.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Thank you.
Edward B. Berg: I would now like to turn the call back to Ed Berg for further questions.
Speaker Change: I would now like to turn the call back to Edinburg for further questions.
Speaker Change: Okay. Thank you.
Edward B. Berg: Okay, thank you. We have additional questions that came in from investors. So I will start with our Phase 2B COVID study, and this is for James. Do you have enough manufacturing capacity to produce your COVID vaccine for the Phase 2B trial? Sure, thanks for the question.
Edinburg: We have additional questions that came in from investors.
Edinburg: So I will start with our.
Edinburg: Phase two be Covid study and then this is for James do you have enough manufacturing capacity to produce your COVID-19 vaccine for the phase two b trial.
James F. Cummings: Sure. Thanks for the question, yes beef they have sufficient material that's already been produced.
James F. Cummings: Sure, thanks for the question. Yes, we have sufficient material that's already been produced.
James F. Cummings: Thanks.
James F. Cummings:
James F. Cummings: The other question for you James on Covid.
Edward B. Berg: The other question for you, James, on COVID. The question for the COVID trial is, how does the fall COVID-19 booster season affect Vaxart's ability to procure mRNA vaccines for use in the control arm? I said, so this study.
Speaker Change: The Covid trial is how does the fall COVID-19 booster season.
Speaker Change: Fact, max or its ability to procure mrna vaccines for use in the control arm.
James F. Cummings: So this study is actually a comparator of homologous vaccines, two vaccines that are geared towards the same. We've already procured an XBB mRNA vaccine that is the comparator construct that we need for this trial.
James F. Cummings: So this study is actually a comparator of homologous vaccines to vaccines that are geared towards the same.
James F. Cummings: Yeah strain of the virus, we've already secured.
James F. Cummings: And X P. D mrna vaccine that is the comparator construct that we need for this trial.
Thanks James.
Speaker Change: Mhm on.
Sean N. Tucker: On the 108 study, this is for Sean. In your recent press release announcing the lactating mothers study data, you mentioned antibody increased figures. How do these compare to the other published data?
Speaker Change: On the one way to study this is for Sean in your recent press release announcing the lactating mothers study data you mentioned antibody increased figures how do these compare to the other published data.
Sean N. Tucker: Yes, that's a great question. Well, there haven't been as many studies done where the women postpartum have been vaccinated. Most studies, you know, in mothers have been done in the third trimester, not after the infant is born. Moreover, there haven't really been that many different reactions in no-dorovirus vaccine trials in lactating mothers. Having said that, from the few studies that we've been able to find on vaccination in postpartum mothers, we believe our results compare quite favorably. We get a similar response or better than what's been described.
Sean N. Tucker: Yeah. That's a great question, while there haven't been as many studies are done where the women postpartum had been vaccinated. Most studies you know in bothers them done in the third trimester.
Speaker Change: Not after the infant born Moreover, there haven't really been that many actually didn't know Dora virus vaccine trials.
Speaker Change: Lactating mothers.
Speaker Change: Having said that a few studies that people didn't find an vaccination in postpartum mothers. We believe our results compare quite favorably, we're getting a similar response or better and what's been described.
Speaker Change: Thanks, Sean back to the this is one for Sean but back to COVID-19.
Sean N. Tucker: Thanks. Sean, back to the, this is one for Sean, but back to COVID-19 and the Phase 2B trial. The question is, what differentiates Vaxart's technology from the other next-gen COVID vaccines that received contracts from BARDA?
Speaker Change: In the phase two B trial.
Sean N. Tucker: The question is what differentiates that search technology from the other Nextgen COVID-19 vaccines that received contracts from BARDA.
Sean N. Tucker: Well, first off, we're the only oral pill vaccine that's currently been contracted in the project NextGen Recipients. The benefit that we see is that it's just more convenient to administer our vaccine by injection or, you know, better than a nasal spray. The other advantage we have, of course, is that, as James mentioned before, we actually have our own manufacturing facilities and would have been able to make the vaccine, you know, quickly. And it's a competitive advantage for us because of that.
Sean N. Tucker: Well first off we're the only oral pill vaccine apparently been contracted in the project Nextgen recipient of the.
Sean N. Tucker: <unk> that we see is that it's just more convenient for administering our vaccine by injection or.
Sean N. Tucker: Better than a nasal spray.
Speaker Change: The other advantage. We have of course is that you know as James mentioned before as you know, we actually have our own manufacturing facilities and when they've been able to make vaccine you know quickly and it's a competitive advantage for us.
Speaker Change: Cause of that.
Speaker Change: Thanks.
Sean N. Tucker: Thanks. This one is also for Sean. And I think, Steve, you might want to step in and make some comments. The question is, how do you intend to educate the medical community and consumers on your COVID and norovirus oral vaccine benefits? in order to rapidly drive adoption in the U.S., the U.K., and broadly and broadly, particularly given what has been learned about the shortcomings of existing vaccines and overall vaccine hesitancy. And, of course, as the lawyer, I will state that we don't, we're not going to be promoting our vaccines until they're approved, but there are other methods of communicating information.
Speaker Change: This one is also for Sean.
Speaker Change: And I think Steve you might want to step in and make some comments and the question is how do you intend to educate the medical community and consumers on your Covid and neuro virus oral vaccine benefits.
Sean N. Tucker: In order to rapidly drive adoption in the U S. The U K.
Steve: And broadly and broadly, particularly given what has been learned about the shortcomings of existing vaccines and the overall vaccine hesitancy.
Steve: And of course.
Speaker Change: I will I will as the lawyer I will state that we don't we're not going to be promoting our vaccines until they're approved but there are other methods of communicating information so sean with that.
Sean N. Tucker: So, Sean, with that, feel free to add. Sure. Well, we think our tablet vaccine will do well from the standpoint of overcoming vaccine hesitancy. In fact, we did some previous polling data conducted in 2021 and 2022, and the latest suggested that 8 out of 10 recipients would prefer a pill to a shot or a nasal spray.
Speaker Change: Feel free to sure well, we think our tablet vaccine will do well from the standpoint of overcoming vaccine hesitancy.
Sean N. Tucker: In fact, we did do some previous polling data conducted in 2021 and 2022 and the latest suggest that eight out of 10 recipient would prefer until two a shot or a nasal spray.
Sean N. Tucker: So, you know, further, we have, you know, gone to various medical conferences and conferences, and we have seen lots of positive feedback about our approach, and we think the excitement is indicative of the understanding in the medical community that there may be some pent-up demand for, you know, a new technology that's easier to use.
Sean N. Tucker: Okay.
Sean N. Tucker: Eric You know we had you know had gone we've gone to various medical conferences and Congresses, and we haven't seen lots of positive feedback about our approach and we think the exciting thing is indicated the understanding and the medical community that there may be some pent up demand for you know a new technology that's easier to use.
Sean N. Tucker: Keith.
Stephen Lowe: Yeah. Thanks, Sean. And, you know, Sean's being modest.
Keith: Yeah, Thanks, Sean Sean.
Keith: John's being modestly gets invited to a lot of conferences that speak in and I think you know any sort of scientific exchange like that is is an important and I think as we continue releasing more data having that opportunity to do so is important to us as Ed mentioned, we're not FDA approved as of yet so.
Stephen Lowe: He gets invited to a lot of conferences to speak, and I think, you know, any sort of scientific exchange like that is important. And I think as we continue releasing more data, having that opportunity to do so is important to us. As Ed mentioned, we're not FDA-approved as of yet, so we'll stick to the regular medical scientific exchanges to make sure that what we have in our data is out there for everyone to absorb.
Keith: We will stick to the regular medical scientific exchanges to make sure that what we have in our data is out there for everyone to absorb.
Speaker Change: Thank you Steve.
Stephen Lowe: Thank you, Steve. A question directed to you. You mentioned in your prepared remarks having better execution. How do you think that can be accomplished?
Speaker Change: A question directed to you you mentioned in your prepared remarks, having better execution.
Steve: Do you think that can be accomplished.
Steve: Okay.
Stephen Lowe: Yes, thanks for the question. Well, I think, first and foremost, we as a company want to make sure that we have our priorities set. And I'm delighted to see that we have. As you've seen already or heard today, we talked about making sure that we execute on the agreement with BARDA to prepare for this upcoming 10,000 subject trial. And it's already been demonstrated by the fact that, as James mentioned, we have made great progress on the manufacturing front.
Steve: Yes. Thanks for the question well I think first and foremost we as a company want to make sure that we have our priorities and I'm delighted to see that we have as you've seen our radio heard today.
Speaker Change: We've talked about making sure that we execute on the agreement with BARDA to prepare for this upcoming 10000 subject trial.
Speaker Change: It's already been demonstrated with the fact that as James mentioned, we have made great progress on the manufacturing front, we prepared and are preparing for the trial to the extent that you've heard.
Stephen Lowe: We've prepared and are preparing for the trial to the extent that you've heard more details about it. And so, you know, to me, that is to continue to execute. You know, we want to balance that by making sure that we're very rigorous with everything that we do, but also understanding that, you know, we want to help the public out there. So anything we can do to balance that with good speed is also important. And that's certainly how I look at having better execution.
Speaker Change: More details about it and so you know to me that is.
Speaker Change: We need to execute we want to balance that with making sure that we're a very rigorous with everything that we're doing but also understanding that.
We want to help our the public out there. So anything we can do to balance that with good speed is also.
Speaker Change: Certainly how I look at.
Speaker Change: Having better execution.
Speaker Change: Yeah.
Speaker Change: Thanks, a last question for Steve.
Stephen Lowe: Thanks. Last question for Steve. It's been nearly two months since you arrived as CEO. What have you learned in that time?
Steve: It's been nearly two months since you've arrived as CEO what have you learned in that time.
Steve: Great. Thanks for that question first and foremost let me just say I'm delighted to be here, what I have found and learned is that this is what we have heard back started as very promising science in one of the main reasons why I wanted to come here and secondly, now that I've been here for two months.
Stephen Lowe: Great, thanks for that question. First and foremost, let me just say I'm delighted to be here. What I have found and learned is that this is what we have here at Vaxart, very promising science and one of the main reasons why I wanted to come here. And secondly, now that I've been here for two months, getting a chance to work side by side with the employees, our scientists, everybody, I can say that we are very passionate about our work and our mission.
I'm getting a chance to work side by side would be employees. Our scientists everybody I can say that we are very passionate about our work and our mission and if you combine the promising science with dedicated employees.
Stephen Lowe: And if you combine the promising science with dedicated employees here at Vaxart, we are very focused on wanting to advance our vaccine candidates forward and get them out there as soon as we can with the approvals that we need and with the trials that we need to execute and conduct. But we are also very focused on execution and also delivering value to our stakeholders.
Steve: At <unk>, we are very focused on wanting to.
Steve: Advance our.
Steve: Vaccine candidates forward and get it out there as soon as we can with the approvals that we need and with the trials that we need to execute and conduct but we are very focused on execution and are also delivering value to our stakeholders.
Speaker Change: Thanks, Steve.
Operator: Thank you, everyone, for tuning in. I will turn it back over to our operator to close out the...
Steve: Thank you everyone for tuning in and I will.
Speaker Change: I will turn it back over to our operator to closeout P.
Speaker Change: Carl.
Operator: Thank you.
Operator: This concludes this conference. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.
Speaker Change: This concludes this conference you may disconnect your lines at this time and have a wonderful day.
Speaker Change: Thank you for your participation today.