Q2 2024 Vaxart Inc Earnings Call

August 8, 2024

Speaker Change: and many more. Thank you. Thank you.

Speaker Change: [inaudible]

Operator: Greetings and welcome to the Vaxart Business Update and second quarter 2024 Financial Results Conference call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to ir@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. Good afternoon, everyone.

Operator: Greetings and welcome to the Vaxart business update and second quarter, 2024 financial results conference call. A question and answer session will follow management's opening remarks.

Speaker Change: Greetings and welcome to the Vaxart business update and second quarter 2024 financial results conference call. A question-and-answer session will follow management's opening remarks.

Operator: Individual investors may submit written questions to IR at Vaxart.com. As a reminder, this conference is being recorded.

Speaker Change: Individual investors may submit written questions to IR at vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel.

Edward Berg: I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel.

Ed Berg: Good afternoon, and welcome to today's call. Joining us from Vaxart are our Steven Lo, Chief Executive Officer, Dr. Sean Tucker, Founder and Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Phil Lee, Chief Financial Officer. Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations, its product development, and regulatory progress, including statements about its ongoing or planned clinical trials.

Operator: Good afternoon and welcome to today's call.

Edward Berg: Joining us from Vaxart are Steven Lowe, Chief Executive Officer, Dr. Sean Tucker, Founder and Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Phil Lee, Chief Financial Officer. Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements. Including statements about the company's financial results, financial guidance, its future business strategies and operations, its product development and regulatory progress, including statements about its ongoing or planned clinical trials. Actual results could materially differ from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process, and other risks described in the risk factors section of Vaxart's most recently filed annual report on Form 10-K, and also on other periodic reports filed with the SEC.

Speaker Change: Good afternoon and welcome to today's call.

Speaker Change: Joining us from Vaxart are Steven Lo, Chief Executive Officer, Dr. Sean Tucker, Founder and Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Phil Lee, Chief Financial Officer.

Ed 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 factor section of Vaxart's most recently filed annual report on Form 10K 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 Steven Lo. Steve?

Ed Berg: Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements.

Ed Berg: including statements about the company's financial results, financial guidance, its future business strategies and operations, its product development and regulatory progress, including statements about its ongoing or planned clinical trials.

Ed Berg: Actual results could materially differ from those discussed in these forward-looking statements due to a number of important factors.

Ed Berg: 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.

Edward Berg: Vaxart undertakes no obligation to update any forward-looking statements after the date of this call.

Ed Berg: VaxArt undertakes no obligation to update any forward-looking statements after the date of this call.

Edward Berg: I'll now turn the call over to Steven Lowe. Steve?

Ed Berg: I'll now turn the call over to Steven Lo. Steve?

Steven Lowe: Thanks, Ed, and thanks to all of you for joining us this afternoon. Today, I look forward to sharing updates on the recent progress that we have made for both COVID and norovirus programs and detailing our upcoming milestones.

Steven Lo: Thanks, Ed. And thanks to all of you for joining us this afternoon. Today, I look forward to sharing updates on the recent progress that we have made for both COVID and norovirus programs and detailing our upcoming milestones. I'll then turn the call over to James for a more in-depth discussion of our planned BARDA-funded Phase 2b COVID trial and conversations with FDA for norovirus. Finally, Phil will cover our financial update before we open the call to your questions.

Steven Lo: Thanks, Ed, and thanks to all of you for joining us this afternoon. Today I look forward to sharing updates on the recent progress that we have made for both COVID and norovirus programs and detailing our upcoming milestones.

James Cummings: I'll then turn the call over to James for a more in-depth discussion of our planned Varta-funded Phase 2B COVID trial and conversations with FDA for norvirus.

James: I'll then turn the call over to James for a more in-depth discussion of our planned BARDA-funded Phase 2b COVID trial and conversations with FDA for norovirus. Finally, Phil will cover our financial update before we open the call for your questions.

Steven Lowe: Finally, Phil will cover our financial update before we open the call for your questions. Since I joined Vaxart in March, I've had the opportunity to spend time with all of the functions in our company and can confirm a deep commitment to advancing our science and to focusing on driving execution across the entire organization. It has been a strategic imperative of ours, particularly given the challenges of a biotech company that's innovating groundbreaking technology. This technology is also the reason why I joined Vaxart. I believe in the transformational potential of our oral pill vaccine platform. After five months of CEO, I have great confidence in our team who are hard at work with the goal of bringing solutions to solve some of society's greatest infectious disease threats.

Steven Lo: Since I joined Vaxart in March, I've had the opportunity to spend time with all of the functions in our company and can confirm a deep commitment to advancing our science and to focusing on driving execution across the entire organization. It has been a strategic imperative of ours, particularly given the challenges of a biotech company that's innovating ground-breaking technology. This technology is also the reason why I joined Vaxart.

James: Since I joined Vaxart in March, I've had the opportunity to spend time with all of the functions in our company and can confirm a deep commitment to advancing our science and to focusing on driving execution across the entire organization.

Steven Lo: It has been a strategic imperative of ours, particularly given the challenges of a biotech company that's innovating groundbreaking technology.

Steven Lo: I believe in the transformational potential of our oral pill vaccine platform. After five months as CEO, I have great confidence in our team, who are hard at work with the goal of bringing solutions to solve some of society's greatest infectious disease threats. At the halfway point of 2024, I am quite pleased to report that we have delivered on the goals that we set out to accomplish by mid-year.

James: This technology is also the reason why I joined Vaxart.

Speaker Change: I believe in the transformational potential of our oral pill vaccine platform. After five months as CEO , I have great confidence in our team, who are hard at work with the goal of bringing solutions to solve some of society's greatest infectious disease threats.

Steven Lowe: At the halfway point of 2024, I am quite pleased to report that we have delivered on the goals that we set out to accomplish by mid-year. Starting with our COVID program, as we announced in June, we were thrilled to receive one of the largest Barta contracts to date under Project Next Gen. The award, valued at up to $453 million, is through Project Next Gen's $5 billion initiative by the Department of Health and Human Services to develop new, innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19. Earning this award serves to highlight the promise of our platform.

James: At the halfway point of 2024, I am quite pleased to report that we have delivered on the goals that we set out to accomplish by mid-year.

Steven Lo: Starting with our COVID program, as we announced in June, we were thrilled to receive one of the largest BARDA contracts to date under Project Next Gen. The award, valued at up to $453 million, is through Project Next Gen's $5 billion initiative by the Department of Health and Human Services to develop new, innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19. Earning this award serves to highlight the promise of our platform.

James: Starting with our COVID program, as we announced in June , we were thrilled to receive one of the largest BARDA contracts to date under Project Next Gen.

James: The award, valued at up to $453 million, is through Project Next Gen's $5 billion initiative by the Department of Health and Human Services to develop new, innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19.

Steven Lo: It also underscores the opportunity we have to reimagine how vaccines are manufactured and distributed globally and the urgency of our mission. As James will detail shortly, we continue to have an ongoing and productive dialogue with FDA, and pending their alignment, we will initiate this Phase 2B trial. Turning to our norovirus program, we achieved meaningful progress over the past 12 months and are poised to take the next step in this program. In late April, we announced positive top-line results for our Phase 1 clinical trial focused on lactating mothers, which can potentially help us achieve our long-term goal of protecting infants through passive antibody transfer. As a reminder, this trial was partially funded by the Bill and Belinda Gates Foundation.

Steven Lowe: It also underscores the opportunity we have to reimagine how vaccines are manufactured and distributed globally, and the urgency of our mission. As Genes will detail shortly, we continue to have an ongoing and productive dialogue with the FDA, and pending their alignment, we will initiate this phase 2B trial.

James: Earning this award serves to highlight the promise of our platform. It also underscores the opportunity we have to reimagine how vaccines are manufactured and distributed globally and the urgency of our mission.

James: As James will detail shortly, we continue to have an ongoing and productive dialogue with FDA, and pending their alignment, we will initiate this Phase 2B trial.

Steven Lowe: Paul. Turning to our Norovirus program, we achieved meaningful progress over the past 12 months and are poised to take the next step in this program. In late April, we announced positive top-line results for our Phase 1 clinical trial focused on lactating mothers, which can potentially help us achieve our long-term goal of protecting infants through passive antibody transfer.

Edward Berg: Greetings and welcome to the Vaxart Business Update and second quarter, 2024 Financial Results Conference Call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to IR at Vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel.

James: Turning to our norovirus program, we achieved meaningful progress over the past 12 months and are poised to take the next step in this program.

James: In late April, we announced positive top-line results for our Phase 1 clinical trial focused on lactating mothers, which can potentially help us achieve our long-term goal of protecting infants through passive antibody transfer.

Steven Lowe: As a reminder, this trial was partially funded by the Bill and Melinda Gates Foundation. In addition to these recent compelling data, we previously reported encouraging Phase 2 results from our norovirus challenge study. Our Norovirus program remains an essential component of our overall strategy and pipeline, and we continue to be confident that our program will yield positive results that will contribute to global health. Norovirus is a highly contagious virus and is the leading cause of acute gastroenteritis symptoms such as vomiting and diarrhea. It thickens approximately 21 million people in the United States each year, including 15% of children under age five who contract norovirus annually.

James: As a reminder, this trial was partially funded by the Bill and Belinda Gates Foundation.

Steven Lo: In addition to these recent compelling data, we previously reported encouraging phase two results from our norovirus challenge study. Our norovirus program remains an essential component of our overall strategy and pipeline, and we continue to be confident that our program will yield positive results that will contribute to global health. Norovirus is a highly contagious virus and is the leading cause of acute gastroenteritis symptoms such as vomiting and diarrhea. It sickens approximately 21 million people in the United States each year, including 15 percent of children under age five who contract norovirus annually.

Edward Berg: Good afternoon and welcome to today's call.

James: In addition to these recent compelling data, we previously reported encouraging phase 2 results from our norovirus challenge study.

James: Our norovirus program remains an essential component of our overall strategy and pipeline, and we continue to be confident that our program will yield positive results that will contribute to global health.

James: Norovirus is a highly contagious virus and is the leading cause of acute gastroenteritis symptoms such as vomiting and diarrhea. It sickens approximately 21 million people in the United States each year, including 15% of children under age 5 who contract norovirus annually.

Steven Lo: Without an approved vaccine against norovirus, people will continue to miss work to care for their children affected by this disease. Furthermore, according to data from the NIH, adults at least 65 years old are at high risk for severe symptoms and clinical outcomes, including longer disease duration and death.

Steven Lowe: Without an approved vaccine against norovirus, people will continue to miss work to care for their children infected with this disease. Furthermore, according to data from the NIH, adults at least 65 years old are at high risk for severe symptoms and clinical outcomes, including longer disease duration and death. The economic annual disease burden of norovirus is $10.6 billion in the United States alone. At this time, we continue to have an active dialogue with the FDA that includes sharing additional requested information. We look forward to continuing our constructive discussions that will help inform the regulatory pathway and clinical next steps for this program.

James: Without an approved vaccine against norovirus, people will continue to miss work to care for their children affected with this disease.

Edward 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 10K, 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.

James: Furthermore, according to data from the NIH, adults at least 65 years old are at high risk for severe symptoms and clinical outcomes, including longer disease duration and death.

Steven Lo: The economic annual disease burden of norovirus is $10.6 billion in the United States alone. At this time, we continue to have an active dialogue with the FDA that includes sharing additional requested information. We look forward to continuing our constructive discussions that will help inform the regulatory pathway and clinical next steps for this program. Now, I would like to touch briefly on our financial position. As a clinical stage biotech company, it takes significant financial resources to achieve our ultimate goal of commercializing a groundbreaking novel vaccine.

James: The economic annual disease burden of norovirus is 10.6 billion dollars in the United States alone.

Speaker Change: At this time, we continue to have an active dialogue with the FDA that includes sharing additional requested information. We look forward to continuing our constructive discussions that will help inform the regulatory pathway and clinical next steps for this program.

Steven Lowe: I'll now turn the call over to Steven Lowe. Steve? Thanks, Ed, and thanks to all of you for joining us this afternoon.

Steven Lowe: Now, I would like to touch briefly on our financial position. As a clinical stage biotech company, it takes significant financial resources to achieve our ultimate goal of commercializing a groundbreaking novel vaccine. By extending our runway in 2026, we enhanced our capital position, allowing us to invest in innovation and continue to advance towards realizing our corporate goals. As pioneers in the world vaccine space, we believe our differentiated approach that focuses on mucosal immunity will be key to our success. The promise of a mucosal vaccine that is cross-reactive against various strains may be better at preventing disease transmission, especially for mutating viruses than existing vaccines.

Speaker Change: Now I would like to touch briefly on our financial position.

Speaker Change: As a clinical stage biotech company, it takes significant financial resources to achieve our ultimate goal of commercializing a groundbreaking novel vaccine.

Steven Lowe: Today, I look forward to sharing updates on the recent progress that we have made for both COVID and norvirus programs and detailing our upcoming milestones.

Steven Lo: By extending our runway to 2026, we enhanced our capital position, allowing us to invest in innovation and continue to advance towards realizing our corporate goals. As pioneers in the oral vaccine space, we believe our differentiated approach that focuses on mucosal immunity will be key to our success. The promise of a mucosal vaccine that is cross-reactive against various strains may be better at preventing disease transmission, especially for mutating viruses, than existing vaccines. For public health, this is a crucial need in keeping people safe from infectious diseases.

James: By extending our runway in 2026, we enhanced our capital position, allowing us to invest in innovation and continue to advance towards realizing our corporate goals.

James Cummings: I'll then turn the call over to James for a more in-depth discussion of our planned Varta-funded Phase 2B COVID trial and conversations with FDA for norvirus.

James: As pioneers in the oral vaccine space, we believe our differentiated approach that focuses on mucosal immunity will be key to our success.

James: The promise of a mucosal vaccine that is cross-reactive against various strains may be better at preventing disease transmission, especially for mutating viruses, than existing vaccines.

Steven Lowe: For public health, this is a crucial need in keeping people safe from infectious diseases. The science is still being proven, but we remain committed to advancing our programs. We look forward to keeping you posted on our ongoing discussions with the FDA, sharing updates from our part of the funded phase 2b COVID trial, and detailing the next steps in our neurovirus program.

James: For public health, this is a crucial need in keeping people safe from infectious diseases. The science is still being proven, but we remain committed to advancing our programs.

Steven Lo: The science is still being proven, but we remain committed to advancing our program. We look forward to keeping you posted on our ongoing discussions with FDA, sharing updates from our BARDA-funded Phase 2B COVID trial, and detailing the next steps in our norovirus program. I'll now turn the call over to James to provide a further review of the recent progress of our COVID-19 and Norovirus programs.

Steven Lowe: This technology is also the reason why I joined Vaxart. I believe in the transformational potential of our oral pill vaccine platform. After five months of CEO, I have great confidence in our team who are hard at work with the goal of bringing solutions to solve some of society's greatest infectious disease threats.

James: We look forward to keeping you posted on our ongoing discussions with FDA, sharing updates from our Board of Funded Phase 2B COVID trial and detailing the next steps in our Nora virus program.

James Cummings: I'll now turn the call over to James to provide a further review of the recent progress of our COVID-19 and neurovirus programs. Thanks, Steve. Echoing Steve's comments, we appreciate the funding provided by Barta for VaxArt to evaluate our oral PIL-XBV COVID-19 vaccine in a Phase 2b clinical trial. We believe this funding is significant for two key reasons. First, it enables us to further validate our platform and our program in a large clinical trial against an mRNA comparator. And two, it demonstrates strong interest from the U.S. government as part of recognizes the need for next generation COVID vaccine.

James: I'll now turn the call over to James to provide a further review of the recent progress of our COVID-19 and norovirus programs.

Steven Lowe: At the halfway point of 2024, I am quite pleased to report that we have delivered on the goals that we set out to accomplish by mid-year. Starting with our COVID program, as we announced in June, we were thrilled to receive one of the largest Barta contracts to date under Project Next Gen. The award, valued at up to $453 million, is through Project Next Gen's $5 billion initiative by the Department of Health and Human Services to develop new innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19.

James Cummings: Echoing Steve's comments, we appreciate the funding provided by BARDA for Vaxart to evaluate our oral pill XBB COVID-19 vaccine candidate in a Phase 2b clinical trial. We believe this funding is significant for two key reasons. First, it enables us to further validate our platform and our program in a large clinical trial against an mRNA comparator. And two, it demonstrates strong interest from the U.S. government as BARDA recognizes the need for a next-generation COVID vaccine. We're excited to have earned their support.

James: Thanks, Steve. Echoing, Steve's comments. We appreciate the funding provided by Barta. For Vax Art to evaluate our oral, pill, XBB COVID-19 vaccine candidate in a phase 2B clinical trial.

Speaker Change: We believe this funding is significant for two key reasons.

James: First, it enables us to further validate our platform and our program in a large clinical trial against an mRNA comparator.

James: And two, it demonstrates strong interest from the U.S. government as BARDA recognizes the need for a next-generation COVID vaccine.

Steven Lowe: Earning this award serves to highlight the promise of our platform. It also underscores the opportunity we have to reimagine how vaccines are manufactured and distributed globally and the urgency of our mission. As Genes will detail shortly, we continue to have an ongoing and productive dialogue with FDA and pending their alignment, we will initiate this phase 2B trial.

James Cummings: We're excited to have earned their support. We continue to build a body of compelling data for our COVID vaccine candidate. We believe that this trial will demonstrate that our vaccine candidate improved immune responses at new coastal surfaces, which are the surface linings found inside the nose, inside the mouth, along the eyes, and among other sites in the body for absorption, and are particularly vulnerable to infections. It is our belief that the cross-reactivity of our vaccine candidates' new coastal immune responses could have a significant impact against evolving variants, with a better safety and tolerability profile versus the mRNA comparator.

James Cummings: We continue to build a body of compelling data for our COVID vaccine candidates. We believe that this trial will demonstrate that our vaccine candidate improves immune responses at mucosal surfaces, which are the surface linings found inside the nose, inside the mouth, along the eyes, and among other sites in the body for absorption that are particularly vulnerable to infection. It is our belief that the cross-reactivity of our vaccine candidate's mucosal immune response could have a significant impact against evolving variants with a better safety and tolerability profile versus the mRNA comparator.

James: We're excited to have earned their support.

James: We continue to build a body of compelling data for our COVID vaccine candidates.

James: We believe that this trial will demonstrate that our vaccine candidate improves immune responses at mucosal surfaces, which are the surface linings found inside the nose, inside the mouth, along the eyes, and among other sites in the body for absorption.

James: and are particularly vulnerable to infection.

James: It is our belief that the cross-reactivity of our vaccine candidates' mucosal immune responses

James: could have a significant impact against evolving variants with a better safety and tolerability profile versus the mRNA comparator.

James Cummings: Now, I'll provide details of our trial design and where we currently stand in initiating this study. The phase 2B clinical trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart's oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The study design anticipates enrolling approximately 10,000 healthy adults, 18 years and older in the United States, with 5,000 receiving Vaxart's COVID-19 vaccine candidate, and an additional 5,000 receiving an approved mRNA comparator. As part of the subject baseline characteristics, at least 25% of the participants should be at high risk for disease, and we expect all subjects who have had an mRNA injection in the past, and probably some infection of COVID.

James Cummings: Now, I'll provide details of our trial design and where we currently stand in initiating this study. The Phase 2B clinical trial is a double-blind, multicenter, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart's oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 The study design anticipates enrolling approximately 10,000 healthy adults 18 years and older in the United States, with 5,000 receiving Vaxart's COVID-19 vaccine candidate and an additional 5,000 receiving an approved mRNA comparator.

Steven Lowe: In addition to these recent compelling data, we previously reported encouraging Phase 2 results from our Norovirus Challenge Study. Our Norovirus program remains an essential component of our overall strategy and pipeline, and we continue to be confident that our program will yield positive results that will contribute to global health. Norovirus is a highly contagious virus and is the leading cause of acute gastroenteritis symptoms such as vomiting and diarrhea. It thickens approximately 21 million people in the United States each year, including 15% of children under age five who contract Norovirus annually.

James: Now, I'll provide details of our trial design and where we currently stand in initiating this study.

James Cummings: As part of the subject baseline characteristics, At least 25% of the participants should be at high risk for disease, and we expect all subjects who have had an mRNA injection in the past and probably some infection of code. The study will measure efficacy for symptomatic and asymptomatic disease. It will measure systemic and mucosal immune induction and the incidence of any adverse events. The primary endpoint is the relative efficacy of Vaxart's COVID-19 vaccine kit compared to one approved mRNA comparator for the prevention of symptomatic disease. Primary Efficacy Analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination. We anticipate that it will take about six months to complete enrollment.

James: The Phase 2b clinical trial is a double-blind, multicenter, randomized,

James: compared or controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart's oral pill COVID-19 vaccine candidate.

James: Against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection.

Steven Lowe: Without an approved vaccine against Norovirus, people will continue to miswork to care for their children infected with this disease. Furthermore, according to data from the NIH, adults at least 65 years old are at high risk for severe symptoms and clinical outcomes, including longer disease duration and death. The economic annual disease burden of Norovirus is $10.6 billion in the United States alone. At this time, we continue to have an active dialogue with the FDA that includes sharing additional requested information. We look forward to continuing our constructive discussions that will help inform the regulatory pathway and clinical next steps for this program.

James: The study design anticipates enrolling approximately 10,000 healthy adults 18 years and older in the United States.

James: with 5,000 receiving Vax Arts COVID-19 vaccine candidate, and an additional 5,000 receiving and approved mRNA comparator.

James: As part of the subject baseline characteristics

James: At least 25% of the participants.

James: should be at high risk for disease.

James: And we expect all subjects who have had an mRNA injection in the past and probably some infection of COVID.

James Cummings: The study will measure efficacy for symptomatic and asymptomatic disease. It will measure systemic amucosal immune induction and the incidence of any adverse events. The primary endpoint is relative efficacy of Vaxart's COVID-19 vaccine candidate, compared to one approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination. We anticipate that it will take about six months to complete enrollment. An interim analysis for vaccine efficacy may be performed when 255 clinical COVID-19 cases have been reached. For designed endpoints, we will look for cross-reactivity, including blood, saliva, and nasal responses.

James: The study will measure efficacy for symptomatic and asymptomatic disease.

Steven Lowe: Now, I would like to touch briefly on our financial position. As a clinical stage biotech company, it takes significant financial resources to achieve our ultimate goal of commercializing a groundbreaking novel vaccine. By extending our runway in a 2026, we enhanced our capital position, allowing us to invest in innovation and continue to advance towards realizing our corporate goals. As pioneers in the world vaccine space, we believe our differentiated approach that focuses on mucosal immunity will be key to our success.

James: We will measure systemic and the coastal immune induction and the incidents of any adverse events.

James: The primary endpoint is relative efficacy of Vaxart's COVID-19 vaccine candidate compared to one approved mRNA comparator for the prevention of symptomatic disease.

James: Primary Efficacy Analysis.

James: will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.

James: We anticipate that it will take about six months to complete enrollment.

Steven Lowe: The promise of a mucosal vaccine that is cross-reactive against various strains may be better at preventing disease transmission, especially for mutating viruses than existing vaccines. For public health, this is a crucial need in keeping people safe from infectious diseases.

James Cummings: An interim analysis for vaccine efficacy may be performed. When 255 clinical COVID-19 cases have been re- For designed endpoints, we will look for cross-reactivity, including blood, saliva, and nasal responses. Our study will also analyze safety, tolerability, and immunogenicity, specifically focused on systemic and mucosal responses. Subjects will use electronic diaries to take notes and will take weekly slides. These data points will enable a quick analysis for a study of this large size.

James: and interim analysis for vaccine efficacy may be performed when 255 clinical COVID-19 cases have been reached.

James: For designed endpoints, we will look for cross-reactivity, including blood, saliva, and nasal responses.

Steven Lowe: The science is still being proven, but we remain committed to advancing our programs. We look forward to keeping you posted on our ongoing discussions with FDA, sharing updates from our part of funded phase 2b COVID trial and detailing the next steps in our neurovirus program.

James Cummings: Our study will also analyze safety, tolerability, and immunogenicity, specifically focused on systemic and eucosal response. Subjects will use electronic diaries to take notes and will take weekly swabs. These data points will enable for a quick analysis for study of this large size. And an independent data and safety monitoring board, or DSMB, will review the safety data of all study participants. Funding from Project Next Gen supports trial preparations, worked with the CROs, overhead, and other trial-related costs. We need a part of frequently to ensure that we are aligned on trial execution. Currently, we expect to initiate the Phase 2V clinical trial as early as the second half of 2024, pending alignment with the FDA.

James: Our study will also analyze safety, tolerability, and immunogenicity, specifically focused on systemic and mucosal response.

James: Subjects will use electronic diaries to take notes and will take weekly swabs.

James Cummings: I'll now turn the call over to James to provide a further review of the recent progress of our COVID-19 and neurovirus programs. Thanks, Steve. Echoing Steve's comments, we appreciate the funding provided by Barta for VaxArt to evaluate our oral PIL-XBV COVID-19 vaccine in a phase 2b clinical trial. We believe this funding is significant for two key reasons. First, it enables us to further validate our platform and our program in a large clinical trial against an mRNA comparator.

James: These data points will enable for a quick analysis for a study of this large size.

James Cummings: And an independent Data and Safety Monitoring Board, or DSMB, will review the safety data of all study participants. Funding from Project NextGen supports trial preparations, work with the CROs, overhead, and other trial-related costs. We meet with BARDA frequently to ensure that we are aligned on trial execution.

James: And an independent Data and Safety Monitoring Board, or DSMB, will review the safety data of all study participants.

James Cummings: And two, it demonstrates strong interest from the U.S, government as part of recognizes the need for next generation COVID vaccine. We're excited to have earned their support. We continue to build a body of compelling data for our COVID vaccine candidate. We believe that this trial will demonstrate that our vaccine candidate improved immune responses at new coastal surfaces, which are the surface linings found inside the nose, inside the mouth, along the eyes, and among other sites in the body for absorption, and are particularly vulnerable to infections. It is our belief that the cross-reactivity of our vaccine candidates' new coastal immune responses could have a significant impact against evolving variants with a better safety and tolerability profile versus the mRNA comparator.

Speaker Change: Funding from Project NextGen supports trial preparations, work with the CROs, overhead, and other trial-related costs.

James: We meet with BARDA frequently to ensure that we are aligned on trial execution.

James Cummings: Currently, we expect to initiate the Phase 2b clinical trial as early as the second half of 2024, pending alignment with the FDA. We've addressed many of the FDA's questions to date and remain engaged with their regulatory team. This process does take some time to complete, but we must ensure that we are aligned with the FDA before we can initiate this study. As previously announced, we completed the preparations of our manufacturing processes before trial launch and now expect to enroll the first patient in the second half of 2024.

James: Currently, we expect to initiate the Phase 2B Clinical trial as early as the second half of 2024, pending alignment with the FDA.

James Cummings: We've addressed many of the FDA's questions to date and remain engaged with their regulatory team. This process does take some time to complete, but we must ensure that we are aligned with the FDA before we can initiate this study. As previously announced, we completed the preparations of our manufacturing processes before trial launch, and now expect to enroll the first patient in the second half of 2024.

James: We've addressed many of the FDA's questions to date and remain engaged with their regulatory team.

James: This process does take some time to complete, but we must ensure that we are aligned with the FDA before we can initiate this study.

James: As previously announced, we completed the preparations of our manufacturing processes before trial launch and now expect to enroll the first patient in the second half of 2024.

James Cummings: Now, I'll share an update on our FDA discussions regarding our Nora virus program. We received constructive feedback from the FDA on our data for potential correlates of protection and next steps for our Nora virus program. Our dialogue with the FDA also reviewed our clinical findings today, which include our dose-ranging Phase 2 study of our bi-valent Nora virus vaccine candidate, and our Phase 2 challenge study of the G11 component of our bi-valent Nora virus vaccine. Presently, the FDA requested additional information that will lead to further discussion and feedback. We're in the process of submitting the information, and that will determine next steps once we've finished our discussions with the FDA.

James Cummings: Now, I'll share an update on our FDA discussions regarding our norovirus program. We received constructive feedback from the FDA on our data for potential correlates of protection and next steps for our norovirus program. Our dialogue with the FDA also reviewed 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.

James: Now, I'll share an update on our FDA discussions regarding our norovirus program.

James: We received constructive feedback from the FDA on our data for potential correlative protection and next steps for our norovirus program.

James: Our dialogue with the FDA also reviewed our clinical findings to date, which include our dose-ranging Phase 2 study of our bivalent norovirus vaccine candidate.

James: and our Phase 2 challenge study of the G1-1 component of our bivalent norovirus vaccine.

James Cummings: As part of the subject baseline characteristics, at least 25% of the participants should be at high risk for disease, and we expect all subjects who have had an mRNA injection in the past, and probably some infection of COVID. The study will measure efficacy for symptomatic and asymptomatic disease. It will measure systemic amucosal immune induction and the incidence of any adverse events. The primary endpoint is relative efficacy of Vaxart's COVID-19 vaccine candidate, compared to one approved mRNA comparator for the prevention of symptomatic disease.

James Cummings: Presently, the FDA requested additional information that will lead to further discussion and feedback. We're in the process of submitting the information, and that will determine next steps once we've finished our discussions with the FDA. I'll now hand the call over to Phil Lee, our chief financial officer, for a brief discussion of our financials.

James: Presently, the FDA requested additional information that will lead to further discussion and feedback.

James: We're in the process of submitting the information, and that will determine next steps once we've finished our discussions with the FDA.

Phillip Lee: I'll now hand a call over to Phil Lee, our Chief Financial Officer, for a brief discussion of our financials. Thank you, James. The details of our financial results for the second quarter of 2024 are summarized in today's press release. Revenue for the second quarter of 2024 was $6.4 million, compared to $1.4 million in the second quarter of 2023. Revenue in the second quarter of 2024 was primarily from revenue recognized or work performed under Vaxort's contract with BARDA awarded in January 2024. Revenue in the second quarter of 2023 was primarily from revenue recognized or work performed under Vaxort's grant from the Bill and Melinda Gates. Vaxart ended the second quarter of 2024 with cash, cash equivalence, and investments of $62.6 million.

James: I'll now hand a call over to Phil Lee, our chief financial officer for a brief discussion of our financials.

Phil Lee: Thank you, James. The details of our financial results for the second quarter of 2024 are summarized in today's press release. Revenue for the second quarter of 2024 was $6.4 million, compared to $1.4 million in the second quarter of 2023. Revenue in the second quarter of 2024 was primarily from revenue recognized for work performed under Vaxart's contract with BARDA, awarded in January 2024. Revenue in the second quarter of 2023 was primarily from revenue recognized or work performed under Vaxart's brand from the Bill and Melinda Gates Foundation.

James: Bill?

Phil Lee: Thank you, James. The details of our financial results for the second quarter of 2024 are summarized in today's press release.

Phil Lee: Revenue for the second quarter of 2024 was $6.4 million, compared to $1.4 million in the second quarter of 2023.

Speaker Change: Revenue in the second quarter of 2024 was primarily from revenue recognized, or work performed under Vaxart's contract, with BARDA awarded in January 2024.

James: Revenue in the second quarter of 2023 was primarily from revenue recognized for work performed under Vaxart's grant from the Bill and Melinda Gates Foundation.

Phil Lee: Vaxart ended the second quarter of 2024 with cash, cash equivalents, and investments of $62.6 million. Subsequent to the close of the quarter, we received a payment of approximately $64.7 million from BARDA. Proceeds from the $64.7 million payment will be used to continue study startup activities for the COVID-19 Phase 2B clinical trial. Based on our current plan, Vaxart continues to anticipate cash runway into 2026. Thanks, everyone, for your time today. We will now open the call to your questions.

James: Vaxart ended the second quarter of 2024 with cash, cash equivalents, and investments of $62.6 million.

Phillip Lee: Subsequent to the close of the quarter, we received a payment of approximately $64.7 million from Barta. Proceeds from the $64.7 million payment will be used to continue study startup activities for the COVID-19 phase to be clinical trial. Based on our current plan, Vaxart continues to anticipate cash runway into 2026.

Speaker Change: Substitute to the clothes of the quarter, we received a payment of approximately 64.7 million dollars from Florida.

Speaker Change: Proceeds from the 64.7-millimeter payment will be used to continue study startup activities for the COVID-19 face-to-be clinical trial.

James Cummings: Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post vaccination. We anticipate that it will take about six months to complete enrollment. An interim analysis for vaccine efficacy may be performed when 255 clinical COVID-19 cases have been reached. For designed endpoints, we will look for cross-reactivity, including blood, saliva, and nasal responses. Our study will also analyze safety, tolerability, and immunogenicity, specifically focused on systemic and eucosal response.

Speaker Change: Based on our current plan, Vaxart continues to anticipate cash runway into 2026.

Phillip Lee: Thanks, everyone, for your time today.

Operator: We will now open the call for your questions. Thank you. Ladies and gentlemen, the floor is now open for questions. If you do have a question, please press star 1 on your telephone keypad at this time. Again, that star 1. If you do have a question or comment.

Speaker Change: Thanks everyone for your time today. We will now open the call for your questions.

Operator: Thank you. Ladies and gentlemen, the floor is now open to questions. If you do have a question, please press star 1 on your telephone keypad at this time. Again, that's star 1 if you have a question or comment. And we'll take our first question from Charles Duncan from Cantor Fitzgerald. Please go ahead, Charles.

Speaker Change: Thank you. Ladies and gentlemen, the floor is now open for questions. If you do have a question, please press star 1 on your telephone keypad at this time. Again, that star 1 if you do have a question or comment.

Elaine Kim: And we'll take our first question from Charles Duncan from Cantor Fitzgerald. Please go ahead, Charles. Hi, this is Elaine Kim on for Charles. Thank you for taking our questions.

Speaker Change: And we'll take our first question from Charles Duncan from Cantor Fitzgerald. Please go ahead, Charles.

Elaine Kim: Hi, this is Elaine Kim on behalf of a child. Thank you for taking our questions. For the role of the virus program, can you provide more color on the additional details that were requested by the FDA and how you anticipate the design of the disease to be trialed will be in comparison to prior phase two studies that were conducted.

Speaker Change: Hi, this is Elaine Kim on for Charles. Thank you for taking our questions.

Elaine Kim: For the newer virus program, can you provide more color on the additional details that was requested by the FDA and how to anticipate the design of disease to be trial will be in comparison to prior phase two studies that you've conducted? Hi, Elaine.

James Cummings: Subjects will use electronic diaries to take notes and will take weekly swabs. These data points will enable for a quick analysis for study of this large size. And an independent data and safety monitoring board, or DSMB, will review the safety data of all study participants. Funding from Project Next Gen supports trial preparations worked with the CROs, overhead, and other trial-related costs. We need a part of frequently to ensure that we are aligned on trial execution.

Elaine Kim: For the norovirus program, can you provide more color on the additional details that was requested by the FDA, and how do you anticipate the design of the Phase IIb trial will be in comparison to prior Phase II studies that you've conducted?

Steven Lo: Hi Elaine, thanks for the question. I'm going to go ahead and turn that over to James since he has provided some comments.

James Cummings: Thanks for the question.

James Cummings: I'm going to go ahead and turn that over to James since he had provided some of the comments. Thanks, Dave. So, as you'd expect, the FDA is reviewing our preclinical and clinical discussion as to the nature of FDA discussion. That's ongoing. And that's consistent with practices, I think, of most companies, which don't disclose specific details when there are ongoing discussions with the agency.

Speaker Change: Hi, Elaine. Thanks for the question. I'm going to go ahead and turn that over to James and see how he had provided some of the comments.

James Cummings: Thanks, Steve. So, you know, as you'd expect. The FDA is reviewing our preclinical and clinical norovirus data. At this time, we're not providing detailed information as to the nature of FDA discussions. You know, that's ongoing. And that's consistent with the practices, I think, of most companies, which don't disclose specific details when there are ongoing discussions with the agency. When, you know, when we can share next steps for the Norovirus program after those discussions have finished, we'll certainly put that out. And you asked, I think, the second portion, which was what impact that would have on the Phase 2B trial. And that, again, depends on the details around those discussions. Thank you.

Elaine Kim: Thank you for answering our questions.

James: Thanks, Steve. So, you know, as you'd expect.

James: The FDA is reviewing our preclinical and clinical norovirus data.

James Cummings: Currently, we expect to initiate the phase 2V clinical trial as early as the second half of 2024, pending alignment with the FDA. We've addressed many of the FDA's questions to date and remain engaged with their regulatory team. This process does take some time to complete, but we must ensure that we are aligned with the FDA before we can initiate this study. As previously announced, we completed the preparations of our manufacturing processes before trial launch, and now expect to enroll the first patient in the second half of 2024.

Speaker Change: At this time, we're not providing detailed information as to the nature of FDA discussions.

James: You know, that's ongoing, and that's consistent with practices, I think, of most companies.

Speaker Change: which sounds as close to specific details when they're ongoing discussions with the agency. When we can't share the next steps for the Norvice Program after those discussions are finished.

James Cummings: When we can share next steps for the newer virus program, after those discussions have finished, we'll certainly put that out. And you asked the second portion that was what impact that would have on the phase to be trial. And that again depends on the details around those discussions.

James: We'll certainly put that out. And you asked, I think, the second portion of that was what impact that would have on the Phase IIb trial, and that, again, depends on the details around those discussions.

Elaine Kim: Thank you. Thank you for answering your questions.

Speaker Change: Thank you.

Speaker Change: Thank you for answering our questions.

Operator: Thank you. Once again, it's star one. If you do have a question or comment.

Operator: Thank you. Once again, it's star one if you do have a question or comment. Okay, and there are no further questions at this time on the phone. I'd like to turn the floor to Mr. Berg to address the written questions.

Speaker Change: i

Speaker Change: Thank you. Once again, it's star one if you do have a question or comment.

Speaker Change: [inaudible]

Operator: Okay, and there are no further questions at this time over the phone.

Speaker Change: i

Operator: I'd like to turn the floor to Mr. Burke to address the written questions. Thank you. We have questions that have been submitted. The first is what steps remain in order to initiate the phase two B COVID study, and related to that, what additional information is needed from the FDA before getting their approval to start the study.

Speaker Change: Okay and there are no further questions at this time over the phone. I'd like to turn the floor to Mr. Berg to address the written questions.

Ed Berg: Thank you. We have questions that have been submitted. The first is, what steps remain in order to initiate the Phase 2B COVID study? And related to that, what additional information is needed from the FDA before getting their approval to start the study? And I think, Dr. Cummings, if you could address this one.

Mr. Berg: Thank you. We have questions that have been submitted.

Mr. Berg: The first is what steps remain in order to initiate the phase 2b COVID study and related to that what additional information is needed from the FDA before getting their approval to start the study.

James Cummings: And I think Dr. Cummings, if you can address this one. Thank you. You know, we continue to have ongoing and very productive dialogue with the FDA. We have addressed some of the comments and look forward to resolving the remaining ones soon. However, as I said before, like most companies, we will not be providing detailed information as to the nature of these ongoing discussions. We have substantially completed the preparations of our manufacturing processes in advance of the launch of this trial, and we have sufficient vaccine supply produced in order to go forward. Other key activities in the startup of the trial would include trial site activation and subcontracting with various vendors.

Phillip Lee: I'll now hand a call over to Phil Lee, our chief financial officer, for a brief discussion of our financials. Thank you, James. The details of our financial results for the second quarter of 2024 are summarized in today's press release. Revenue for the second quarter of 2024 was $6.4 million, compared to $1.4 million in the second quarter of 2023. Revenue in the second quarter of 2024 was primarily from revenue recognized or work performed under Vaxort's contract with Barda awarded in January 2024.

Mr. Berg: I think Dr. Cummings, if you can address this one.

James Cummings: Thank you. You know, we continue to have ongoing and very productive dialogue with the FDA. We have addressed some of the comments and look forward to resolving the remaining ones. However, as I said before, like most companies, we will not be providing detailed information as to the nature of these ongoing discussions.

Speaker Change: Thank you.

Dr. Cummings: You know, we continue to have ongoing and very productive dialogue with the FDA.

Speaker Change: We have addressed some of the comments and look forward to resolving the remaining ones soon. However, as I said before, like most companies, we will not be providing detailed information as to the nature of these ongoing discussions.

James Cummings: We have substantially completed the preparations of our manufacturing processes in advance of the launch of this trial, and we have sufficient vaccine supply produced in order to go forward. Other key activities in the startup of the trial would include trial site activation and subcontracting with various vendors. We plan to provide an update as warranted. Thank you. Thanks. I follow up question again on our Phase 2B COVID trial for Dr. Cummings: once the Phase 2B COVID trial initiates, describe the subject enrollment process, and whether the challenge is that you might face in recruiting 10,000 adults for the study.

Speaker Change: We have substantially completed the preparations of our manufacturing processes in advance of the launch of this trial, and we have sufficient vaccine supply produced in order to go forward.

Speaker Change: Other key activities in the startup of the trial would include trial site activation and subcontracting with various vendors. We plan to provide an update as warranted. Thank you.

James Cummings: We plan to provide an update as warranted.

Phillip Lee: Revenue in the second quarter of 2023 was primarily from revenue recognized or work performed under Vaxort's grant from the Bill and Melinda Gates Vaxart ended the second quarter of 2024 with cash, cash equivalence and investments of $62.6 million. Subsequent to the close of the quarter, we received a payment of approximately $64.7 million from Barta. Proceeds from the $64.7 million payment will be used to continue study startup activities for the COVID-19 phase to be clinical trial. Based on our current plan, Vaxart continues to anticipate cash runway into 2026.

James Cummings: Thank you.

James Cummings: Thanks.

James Cummings: I follow-up question, again on our phase 2B COVID trial for Dr. Cummings. Once the phase 2B COVID trial initiates, describe the subject enrollment process.

Speaker Change: Thanks. A follow-up question, again on our Phase 2B COVID trial for Dr. Cummings. Once the Phase 2B COVID trial initiates, describe the subject enrollment process. What are the challenges that you might face in recruiting 10,000 adults?

James Cummings: What are the challenges that you might face in recruiting 10,000 adults for the study?

James Cummings: I thanks. You know, we review this is really an opportunity for our very experienced clinical trial management team to demonstrate our ability to recruit. And in enrolling 10,000 subjects for this trial, we expect the demographics of this site to be representative of the population of the United States, with 25% of the participants considered at high risk of severe COVID-19 disease. And some of those factors would be things like diabetes, coronary artery disease, asthma, obesity with a BMI of greater than 30, increased age, and chronic kidney or lung diseases.

James Cummings: Thanks. You know, we view this as really an opportunity for our very experienced clinical trial management team to demonstrate our ability to recruit. In enrolling 10,000 subjects for this trial, we expected the demographics of this study to be representative of the population of the United States, with 25% of the participants considered at high risk of severe COVID-19 disease. And some of those factors would be things like diabetes, coronary artery disease, asthma, obesity with a BMI of greater than 30, increased age, and chronic kidney or lung diseases.

Speaker Change: for the study.

Dr. Cummings: Thanks. You know, we review this as really an opportunity for our very experienced clinical trial management team to demonstrate our ability to recruit. In enrolling 10,000 subjects for this trial, we expected demographics of this study to be representative of the population of the United States.

Edward Berg: Thanks, everyone, for your time today. We will now open the call for your questions. Thank you. Ladies and gentlemen, the floor is now open for questions. If you do have a question, please press star 1 on your telephone keypad at this time. Again, that star 1, if you do have a question or comment.

Elaine Kim: And we'll take our first question from Charles Duncan from Cantor Fitzgerald, please go ahead, Charles.

Speaker Change: with 25% of the participants considered at high risk of severe COVID-19 disease.

Speaker Change: And some of those factors would be things like diabetes.

Operator: Thanks.

Phillip Lee: Next question is, again, on the COVID trial and the contract. This is the contract with ATI, for Phil. What was the $64.7 million payment for and what milestones do you need to achieve for the COVID Phase 2B study in order to earn the additional funds from BARDA or through ATI? So the $64.7 million payment that we had received was because we had actually already achieved the single milestone in that ATI contract. You're referring to the up to 453 million dollar contract because we executed a contract with the CRO. The remaining contract funding is actually not tied to specific milestones, but rather, we will be reimbursed for costs and earn a fee as we continue to prepare, initiate, and really execute this COVID-19 Phase 2B trial.

James Cummings: Thanks. Next question is again on the COVID trial and the contract. This is the contract with ATI, for Phil. What was the $64.7 million payment for, and what milestones do you need to achieve for the COVID Phase 2B study in order to earn the additional funds from BARDA or through ATI?

Dr. Cummings: Thanks!

Elaine Kim: Hi, this is Elaine Kim on for Charles. Thank you for taking our questions. For the newer virus program, can you provide more color on the additional details that was requested by the FDA and how to anticipate the design of disease to be trial will be in comparison to prior phase two studies that you've conducted?

Dr. Cummings: Next question is again on the COVID trial and the contract, this is the contract with ATI.

Speaker Change: What was the $64.7 million payment for and what milestones do you need to achieve for the COVID Phase 2B study in order to earn the additional funds?

James Cummings: Hi, Elaine. Thanks for the question.

Dr. Cummings: from...

Dr. Cummings: Sparta, or through ATI.

Phil Lee: So the $64.7 million payment that we had received was because we had actually already achieved a single milestone in that ATI contract you're referring to, the up to $453 million contract, because we had executed a contract with the CRO. The remaining contract funding is actually not tied to specific milestones, but rather, we will be reimbursed for a cost and earn a fee as we continue to prepare, initiate, and really execute this COVID-19 face-to-face trial.

Speaker Change: So the $64.7 million payment that we had received was because we had actually already achieved a single milestone.

Dr. Cummings: and that H.I. contract you're referring to the up to 453 million dollar contract because we executed a contract with the C.R.L.

Dr. Cummings: The remaining contract funding is actually not tied to specific milestones, but rather we will be re-aversed for a cost and earn a fee as we continue to prepare initiative and really execute this COVID-19 face-to-face trial.

Phillip Lee: Thanks, Phil.

Phil Lee: Thanks, Phil. Our questions, the questions submitted on the NeuroVirus program mirror the analysts' questions, so we'll skip that for the moment and go to other questions. We have one on RSV. RSV is no longer included in your development pipeline. Can you please elaborate on that decision? And I think that, Steve, if I can ask you to answer.

Operator: Our questions submitted on the Neurovirus program, merely the analyst's questions, so we'll skip that for the moment and go to other questions. We have one on RSV.

Phil Lee: Thanks, Phil.

Speaker Change: Our questions, the questions submitted on the Neurovirus Program mirror the analyst questions so we'll skip that for the moment and go to other questions. We have one on RSV. RSV is no longer included in your development pipeline.

Operator: RSV is no longer including your development pipeline. Can you please elaborate on that decision?

Steven Lowe: And I think that Steve, if I can ask you to answer. Yes, so the company always continually reviews our candidate pipeline to determine what are the best strategic opportunities out there and will make decisions based on various factors, including what the market and competitive dynamics are, our resources, and timing. For now, we're focused on some of the more important opportunities that can advance our science while generating data in the near term and therefore, as an example, being highly focused on our COVID-19 program because of our contracts with BARDA that gives us potentially up to $453 million in funding is certainly a reason why we would shift the priority towards COVID.

Phil Lee: Can you please elaborate on that decision and I think that Steve if I can ask you to answer

Steven Lo: Yes, so the company always continually reviews our candidate pipeline to determine what's the, you know, what are the best strategic opportunities out there, and we'll make decisions based on various factors including, you know, what the market and competitive dynamics are, our resources, and timing. For now, we're focused on some of the more important opportunities that can advance our science while generating data in the near term, and therefore, as an example, being highly focused on our COVID-19 program because of our contract with BARDA that, you know, gives us potentially up to 453 million dollars in funding is certainly a reason why we would shift the priority toward COVID.

Steve: Yes, so the company always continually reviews our candidate pipeline to determine what are the best strategic opportunities out there and we'll make decisions based on various factors.

Edward Berg: Okay, and there are no further questions at this time over the phone.

Steve: including, you know, what the market and competitive dynamics are, our resources and timing.

Edward Berg: I'd like to turn the floor to Mr. Burke to address the written questions. Thank you. We have questions that have been submitted.

Speaker Change: For now, we're focused on some of the more important opportunities that can advance our science while generating data in the near term, and therefore, as an example, being highly focused on our COVID-19 program because of our contract with BARDA that gives us potentially up to 453

James Cummings: The first is what steps remain in order to initiate the phase two B COVID study and related to that, what additional information is needed from the FDA before getting their approval to start the study. And I think Dr. Cummings, if you can address this one. Thank you. You know, we continue to have ongoing and very productive dialogue with the FDA. We have addressed some of the comments and look forward to resolving the remaining ones soon.

Phil Lee: A million dollars in funding is certainly a reason why we would shift the priority towards COVID.

Steven Lowe: Thanks, Steve.

Steven Lo: Thanks, Steve. Another question for you: how has your experience with Vaxart in the past five months supported your initial decision to join the company back in March? Yes, so...

Steven Lowe: Another question for you: how has your experience with Vaxart in the past five months supported your initial decision to join the company back in March? Yeah, so I'm delighted to be here. As I stated in some of the comments, I'm impressed with the opportunities that we have to advance our science, and frankly, we've already been able to accomplish some near-term goals in the first half of 2024. As mentioned, our agreement with Barda, as well as having some opportunities as we continue to work with the FDA on neurovirus, and our plan right now is to continue and execute for the second half of the year.

Speaker Change: Thanks Steve. Another question for you. How has your experience with Vaxart in the past five months supported your initial decision to join the company back in March?

Steven Lo: Yes, so I'm delighted to be here. As I stated in some of the comments, I'm impressed with the opportunities that we have to advance our science. And, you know, frankly, we've already been able to accomplish some near-term goals in the first half of 2024. As I mentioned, our agreement with BARDA, as well as having some opportunities as we continue to work with the FDA on norovirus, and, you know, our plan right now is to continue to do so for the second half of the year. So it's going to be an exciting but important time for the company.

James Cummings: However, as I said before, like most companies, we will not be providing detailed information as to the nature of these ongoing discussions. We have substantially completed the preparations of our manufacturing processes in advance of the launch of this trial, and we have sufficient vaccine supply produced in order to go forward. Other key activities in the startup of the trial would include trial site activation and subcontracting with various vendors. We plan to provide an update as warranted. Thank you. Thanks.

Speaker Change: Yeah, so I'm delighted to be here. As I stated in some of the comments, I'm impressed with the opportunities that we have to advance.

Speaker Change: our science. And, you know, frankly, we've already been able to accomplish some near term goals in the first half of 2024. As mentioned, you know, our agreement with BARDA,

Speaker Change: as well as having some opportunities as we continue to work with the FDA on norovirus and You know our plan right now is to continue to execute for the second half of the year So it's going to be an exciting but important time for the company

Steven Lowe: So it's going to be an exciting but an important time for the company. Thanks.

James Cummings: I follow-up question, again on our phase 2B COVID trial for Dr. Cummings, once the phase 2B COVID trial initiates, describe the subject enrollment process. What are the challenges that you might face in recruiting 10,000 adults for the study? I thanks. You know, we review this is really an opportunity for our very experienced clinical trial management team to demonstrate our ability to recruit. And in enrolling 10,000 subjects for this trial, we expect the demographics of this site to be representative of the population of the United States, with 25% of the participants considered at high risk of severe COVID-19 disease. And some of those factors would be things like diabetes, coronary artery disease, asthma, obesity with a BMI of greater than 30, increased age, and chronic kidney or or lung diseases. Thanks.

Sean Tucker: A question for Sean. Dr. Tucker, this is with all the news about avian flu. Are you planning to progress that program, and are you planning to or aiming to secure funding to make such progress? Yes, obviously we're working on making improvements to all of our vaccine constructs and testing these preclinically, and we will be optimistic, or opportunistic, I should say, in the pursuit of funding for these vaccine candidates, including avian influenza.

Sean Tucker: A question for Sean, Dr. Tucker, this is, with all the news about avian flu, are you planning to progress that program, and are you planning to, or aiming to secure funding to make such progress? All right, uh, yeah, obviously you're working on

Speaker Change: [inaudible]

Speaker Change: Thanks!

Dr. Tucker: A question for Sean, Dr. Tucker, this is with all the news about avian flu, are you planning to progress that program and are you planning to or aiming to secure funding?

Sean Tucker: Hi. Yes, obviously, we're working on making improvements to all of our vaccine constructs and testing these preclinically. And we will be optimistic or opportunistic, I should say, in the pursuit of funding for these vaccine candidates, including avian influenza.

Speaker Change: to make such progress.

Sean: Hi, yes, obviously you're working on making improvements to all of our vaccine constructs and testing these preclinically and we will be optimistic for our opportunistic, I should say, in the pursuit of funding for these vaccine class candidates including AD and influenza.

Operator: Great. One last question for Steve.

Steven Lo: One last question for Steve. How do you see Vaxart's platform fitting into the government's vision for next-gen vaccines and pandemic preparedness?

Speaker Change: One last question for Steve.

Steven Lowe: How do you see Vaxxar's platform fitting into the government's vision for next-gen vaccines and pandemic preparedness? Yes, so we always believe that our oral pill, Mikrocell technology, is going to be the key differentiator from some of the currently approved COVID-19 vaccines, and I think it's evident in the fact that we were awarded the project Next-Gen award to proceed with this COVID-19 trial. So, you know, we're of course very optimistic, and I think as long as we continue to execute as well as move forward with this trial, you know, it's going to be very transformative for the company. So again, I think we are feeling that we're very aligned with the government in terms of what their goals are, and you know, we're delighted to proceed.

Steve: How do you see Vaxart's platform fitting into the government's vision for next-gen vaccines and pandemic preparedness?

Phillip Lee: Next question is, again, on the COVID trial and the contract, this is the contract with ATI, for Phil. What was the $64.7 million payment for and what milestones do you need to achieve for the COVID phase 2B study in order to earn the additional funds from Barda or through ATI? So the $64.7 million payment that we had received was because we had actually already achieved the single milestone in that ATI contract, you're referring to the up to 453 million dollar contract because we executed a contract with the CRO. The remaining contract funding is actually not tied to specific milestones, but rather, we will be reimbursed for costs and earn a fee as we continue to prepare, initiate, and really execute this COVID-19 phase 2B trial.

Steven Lo: Yeah, so we always believe that our oral pill mucosal technology is going to be the key differentiator from some of the currently approved COVID-19 vaccines. And I think it's evident in the fact that we were awarded the project, NextGen, if we were to proceed with this COVID-19 trial. So, you know, we're, of course, very optimistic, and I think as long as we continue to execute, as well as move forward with this trial, it's going to be very transformative for the company. So, again, I think we feel like we're very aligned with the government in terms of what their goals are, and, you know, we're delighted to proceed.

Steve: Yes, so we always believe that our oral pill mucosal technology is going to be the key differentiator from some of the currently approved COVID-19 vaccines.

Phillip Lee: Thanks, Phil.

Speaker Change: And I think it's evident in the fact that we were awarded the project NextGen.

Speaker Change: You know, war to proceed with

Sean: We are very optimistic and I think as long as we continue to execute, as well as move forward with this trial, it's going to be very transformative for the company.

Edward Berg: Our questions submitted on the Neurovirus program, merely the analyst's questions, so we'll skip that for the moment and go to other questions.

Speaker Change: are feeling that we're very aligned with the government in terms of what their goals are and we're delighted to proceed.

Operator: G. Great.

Operator: Great. Okay, I'd like to turn the call back over to the operator.

Operator: Okay, I'd like to turn the call back over to the operator. Certainly, and we do have an additional phone question, and it comes from Mayank Mamtani from B. Riley, please go ahead.

Speaker Change: Great. Okay, I'd like to turn the call back over to the operator.

Operator: Certainly, and we do have an additional phone question, and it comes from Mayank Mamtani from B Riley. Please go ahead.

Speaker Change: Certainly, and we do have an additional phone question, and it comes from Maiank Mampani from B Riley, please go ahead.

Mayank Mamtani: Hi. Hi, how are you? This is Ali from Mayank Mamtani.

Ali: Hi, how are you?

Ali: This is Ali for Mayank Mamtani, so thanks for taking our question, and congrats for the progress. So I just had a couple of quick questions.

Speaker Change: Hi. Hi, how are you? This is Ali for Mayank Mamtani. So thanks for taking our question.

Ali: So thanks for taking our question and congratulations on the progress. So I just had a couple of quick questions. Is there a reason to believe, you know, your norovirus vaccine is more robust against emerging norovirus strains? And I was wondering, you know, if you could comment on the recent failure by HILVAC's Phase 2B trial and how you position yourself in the neurovirus landscape. Thank you.

Ali: and congrats for the progress. So I just had a couple of quick questions. Is there reason to believe, you know, your no-row virus vaccine is more robust against the emerging no-row virus strains?

Ali: Is the reason to believe, you know, your neurovirus vaccine is more robust against emerging neurovirus strains? And I was wondering, you know, if you could comment on, you know, the recent failure by heel wax, you know, face to be trial, and how do you position yourself, you know, in the neurovirus landscape? Thank you.

Edward Berg: We have one on RSV. RSV is no longer including your development pipeline.

Speaker Change: And I was wondering if you could comment on the recent failure by Hilwax face to be trial and how do you position yourself in the neuro virus landscape?

Steven Lowe: Can you please elaborate on that decision? And I think that Steve, if I can ask you to answer. Yes, so the company always continually reviews our candidate pipeline to determine what are the best strategic opportunities out there and will make decisions based on various factors including what the market and competitive dynamics are, our resources and timing. For now, we're focused on some of the more important opportunities that can advance our science while generating data in the near term and therefore, as an example, being highly focused on our COVID-19 program because of our contracts with Barda that gives us potentially up to $453 million in funding is certainly a reason why we would shift the priority towards COVID. Thanks, Steve.

Steven Lo: Great. Well, thanks again for that question. And yeah, we've been thinking through what happened with pill vacs quite a bit. And what I'll do is I'll turn it over to Sean to provide some comments there. Sure. Yeah, I mean, again, you know, we believe that the Hillelvack

Ali: Great. Well, thanks again for that question.

Sean Tucker: And yeah, we've been thinking through what's happened with heel wax quite a bit, and what I'll do is I'll turn it over to Sean to provide some comments there.

Ali: Great. Well, thanks again for that question. And yeah, we've been thinking through what's happened with pill vacs quite a bit. And what I'll do is I'll turn it over to Sean to provide some comments there.

Sean Tucker: Sure. Yeah, I mean, again, you know, we believe that the hella back data, which, you know, in their vaccine can be produced a strong serum response, really underscores our plant that generating eucosal response to the critical developed and affected vaccine for neurovirus.

Sean Tucker: I mean, again, you know, we believe that the HILOVAC data, which, you know, in their vaccine candidate, produced a strong serum response, really underscores our point that generating mucosal responses may be critical to develop an effective vaccine for norovirus. Remember that injected vaccines do not typically elicit these sort of responses. Our existing data demonstrates our cancer has both a serum and a mucosal response, and we believe this is going to allow us to be much more successful.

Sean Tucker: Sure. Yeah.

Sean: Sure, yeah, I mean, again, you know, we believe that the HILVAC data, which, you know, in their vaccine candidate produced a strong serum response, really underscores our point that generating mucosal response may be critical to develop an effective vaccine for norovirus. Remember that injected vaccines do not typically elicit these sort of responses.

Sean Tucker: Remember that injected vaccines do not typically elicit these sorts of responses. Our existing data demonstrates our cancer list both of serum and eucosal response, and we believe this is going to allow us to be much more successful. Also, keep in mind that our program is right now so it's unhealthy adults and not on hints, and which renders the comparison between the two programs maybe a little bit less relevant.

Ali: Our existing data demonstrates our cancer with both a serum and a mucosal response, and we believe this is going to allow us to be much more successful. Also keep in mind that our program is right now focused on healthy adults and not on infants, which renders the comparison between the two programs maybe a little bit less relevant.

Sean Tucker: Also, keep in mind that our program is right now focused on healthy adults and not on infants, which renders the comparison between the two programs maybe a little bit less relevant. The other question you asked is about cross-reactivity, and I can tell you, you know, one of the things that I think is important about having an IGA response is that we have shown, and others have shown, that these can be much more cross-reactive, and we think that gives them a better potential to address things that happen when new strains or new outbreaks occur.

Steven Lowe: Another question for you, how has your experience with Vaxart in the past five months supported your initial decision to join the company back in March? Yeah, so I'm delighted to be here. As I stated in some of the comments, I'm impressed with the opportunities that we have to advance our science and frankly, we've already been able to accomplish some near-term goals in the first half of 2024.

Sean Tucker: The other question you asked is about cross-reactivity, and I can tell you, you know, one of the things that I think is important about having an IgA response is that we have shown that others have shown these can be much more cross-reactive. And we think that gives it better potential to address things that happen when they're new strains or new outbreaks occur.

Ali: The other question you asked is about cross-reactivity, and I can tell you, you know, one of the things that I think is important about having an IGA response is that we have shown and others have shown these can be much more cross-reactive. We think that gives it better potential to address things that happen when new strains or new outbreaks occur.

Ali: Thank you so much.

Steven Lowe: As mentioned, our agreement with Barda as well as having some opportunities as we continue to work with the FDA on neurovirus and our plan right now is to continue and execute for the second half of the year. So it's going to be an exciting but an important time for the company. Thanks.

Speaker Change: Thank you so much.

Ali: Excellent, thank you.

Operator: Excellent, thank you. Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time and have a great day. Thank you for watching this Chris Orr video. If you want to check out my other videos, click on the list above.

Sean Tucker: Thank you so much. It's excellent. Thank you. Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time and have a great time. Thank you very much for watching, and don't forget to subscribe to the channel and click on the bell icon to get notified of new videos. Thank you very much for watching, and don't forget to subscribe to the channel and don't forget to subscribe to the YouTube channel and don't forget to click on the bell icon to get notified of new videos.

Operator: Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation.

Speaker Change: Excellent. Thank you. Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time and have a great day.

Operator: You may disconnect your lines at this time, and have a great day.

Sean Tucker: A question for Sean. Dr. Tucker, this is with all the news about avian flu. Are you planning to progress that program and are you planning to or aiming to secure funding to make such progress? Yes, obviously we're working on making improvements to all of our vaccine constructs and testing these preclinically and we will be optimistic or opportunistic, I should say, in the pursuit of funding for these vaccine candidates including avian influenza.

Speaker Change: [inaudible]

Sean Tucker: Great.

Speaker Change: you

Speaker Change: www.globalonenessproject.org

Steven Lowe: One last question for Steve. How do you see Vaxxar's platform fitting into the government's vision for next-gen vaccines and pandemic preparedness? Yes, so we always believe that our oral pill, Mikrocell technology is going to be the key differentiator from some of the currently approved COVID-19 vaccines and I think it's evident in the fact that we were awarded the project next-gen award to proceed with this COVID-19 trial so you know we're of course very optimistic and I think as long as we continue to execute as well as move forward with this trial you know it's going to be very transformative for the company so again I think we are feeling that we're very aligned with the government in terms of what their goals are and you know we're delighted to proceed.

Edward Berg: G. Great.

James Cummings: [inaudible] Cummings, James Cummings

Edward Berg: Okay, I'd like to turn the call back over the operator.

Ali: Certainly, and we do have an additional phone question, and it comes from Mayank Mamtani from B. Riley, please go ahead. Hi, how are you? This is Ali for Mayank Mamtani, so thanks for taking our question and congrats for the progress. So I just had a couple of quick questions. Is the reason to believe, you know, your neurovirus vaccine is more robust against emerging neurovirus strains?

Operator: Question 3: What was the best meal or HOTMEAL? [music]

Ali: And I was wondering, you know, if you could comment on, you know, the recent failure by heel wax, you know, face to be trial, and how do you position yourself, you know, in the neurovirus landscape? Thank you. Great. Well, thanks again for that question.

Sean Tucker: And yeah, we've been thinking through what's happened with heel wax quite a bit, and what I'll do is I'll turn it over to Sean to provide some comments there. Sure. Yeah, I mean, again, you know, we believe that the hella back data, which, you know, in their vaccine can be produced a strong serum response, really underscores our plant that generating eucosal response to the critical developed and affected vaccine for neurovirus. Remember that injected vaccines do not typically elicit these sort of responses.

Operator: Andrei Floroiu, James Cummings, Paul Andrei Floroiu, James Cummings, Paul

Sean Tucker: Our existing data demonstrates our cancer list both of serum and eucosal response, and we believe this is going to allow us to be much more successful. Also, keep in mind that our program is right now so it's unhealthy adults and not on hints, and which renders the comparison between the two programs, maybe a little bit less relevant. The other question you asked is about cross-reactivity, and I can tell you, you know, one of the things that I think is important about having an IgA response is that we have shown that others have shown these can be much more cross-reactive. And we think that gives it better potential to address things that happen when they're new strains or new outbreaks occur.

Ali: Thank you so much. Excellent, thank you.

Edward Berg: Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time, and have a great day.

Speaker Change: ?? ?? ?? ??

Speaker Change: [inaudible] James Cummings

Andrei Floroiu: Andrei Floroiu, James Cummings, Paul Andrei Floroiu, James Cummings, Paul

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