Q2 2025 Vaxart Inc Earnings Call & Business Update
As a reminder, this conference is being recorded.
I'd now like to turn the webcast over to your host at Burke Senior Vice President and General Counsel. Please go ahead.
Good afternoon, and welcome to today's call.
Joining us from <unk> are Steven Lo Chief Executive Officer, Dr. Sean Tucker founder and Chief Scientific Officer.
Dr. James Cummings, Chief Medical Officer, and Jerome Grassman, Chief Financial Officer.
Speaker #3: Greetings and welcome to the Vaxart Business Update and second quarter 2025 financial results conference call. A question-and-answer session will follow management's opening remarks, and individual investors may submit written questions to ir@vaxart.com.
Operator: Welcome.
Ed Berg: Greetings and welcome to the Vaxart Business Update and Second Quarter 2025 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. Please go ahead.
Before we begin I would like to remind everyone that during this conference call <unk> 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.
Speaker #3: As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Edward Berg, Senior Vice President and General Counsel.
Speaker #3: Please go ahead.
About as ongoing or planned clinical trials.
Speaker #4: Good afternoon. And welcome to today's call. 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 Jerome Grassman, Chief Financial Officer.
Ed Berg: Good afternoon and welcome to today's call. 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 Jerome Grassman, Chief Financial Officer. Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations, and its product development and regulatory progress, including statements about its ongoing or planned clinical trials. Actual results could materially differ from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process and other risks described in the risk factors section of Vaxart's most recently filed annual report on Form 10-K and also on other periodic reports filed with the SEC.
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 <unk>.
Speaker #4: 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.
<unk>. Most recently filed annual report on Form 10-K, and also on other periodic reports filed with the SEC.
<unk> 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.
Thanks, Ed and thanks to all of you for joining US. This afternoon I'll begin today's call with an overview of our business then we'll pass the call to James and Sean for the latest developments of our clinical and preclinical programs drone will share an update of our financials and finally I'll have some comments related to our stock listing.
Speaker #4: 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, Vaxart's most recently filed annual report on Form 10-K.
Before we open the call for your questions.
Charting with our COVID-19 clinical program last week, we received a second stop work order notice on our phase <unk> trial from advanced technology International or ATI. The rapid response partnership vehicles consortium management firm funded by BARDA like.
Speaker #4: 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.
Ed Berg: 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.
Speaker #4: I'll now turn the call over to Steven Lo. Steve,
Speaker #5: Thanks, Ed. And thanks to all of you for joining us this afternoon. I'll begin today's call with an overview of our business, then we'll pass the call to James and Sean for the latest developments in our clinical and preclinical programs.
Unlike the first stop work order this came as a surprise to us without any advance notice. Unlike the first stop work order notice when we had not yet enrolled anyone in the 10000 participant cohort. We were glad that this came to us when we had already enrolled approximately 5000 participants and the note.
Steven Lo: Thanks, Ed, and thanks to all of you for joining us this afternoon. I'll begin today's call with an overview of our business. Then we'll pass the call to James and Sean for the latest developments of our clinical and preclinical programs. Jerome will share an update of our financials, and finally, I'll have some comments related to our stock listing before we open the call for your questions. Starting with our COVID-19 clinical program, last week we received a second stop work order notice on our Phase 2B trial from Advanced Technology International, or ATI, the Rapid Response Partnership Vehicles Consortium Management Firm funded by BARDA. Like the first stop work order, this came as a surprise to us without any advance notice.
Speaker #5: Jerome will share an update of our financials, and finally, I'll have some comments related to our stock listing before we open the call for your questions.
This allows us to continue the study for those already enrolled.
Speaker #5: Starting with our COVID-19 clinical program, last week we received a second stop work order notice on our Phase 2B trial from Advanced Technology International, or ATI, the rapid response partnership vehicles consortium management firm funded by BARDA.
We continue to believe there is huge potential for our promising oral pill vaccine candidate for Covid enrollment for this trial was proceeding at a rapid pace since we dose. The first participant in late May These trends highlight the strong public interest of our oral vaccine platform and for a safe and effective vaccine.
Speaker #5: Like the first stop work order, this came as a surprise to us without any advance notice. Unlike the first stop work order notice when we had not yet enrolled anyone in the 10,000 participant cohort, we were glad that this came to us when we had already enrolled approximately 5,000 participants. The notice allows us to continue the study for those already enrolled.
Against the Sars Cov two virus.
Steven Lo: Unlike the first stop work order notice, when we had not yet enrolled anyone in the 10,000 participant cohort, we were glad that this came to us when we had already enrolled approximately 5,000 participants, and the notice allows us to continue the study for those already enrolled. We continue to believe there is huge potential for our promising oral pill vaccine candidate for COVID. Enrollment for this trial was proceeding at a rapid pace since we dosed the first participant in late May. These trends highlight the strong public interest of our oral vaccine platform and for a safe and effective vaccine against the SARS-CoV-2 virus. We agree with Secretary Kennedy's priorities that include the development of safe and effective novel vaccine solutions, such as our oral vaccine platform.
We agree with Secretary <unk> priorities that include the development of safe and effective novel vaccine solutions, such as our oral vaccine platform.
As a reminder, our trial is designed to assess the safety immunogenicity and efficacy profiles of our candidate against an mrna comparator. This trial is specifically designed to provide head to head data with the goal of advancing broader an innovative vaccine technologies.
Speaker #5: We continue to believe there is huge potential for our promising oral pill vaccine candidate for COVID. Enrollment for this trial was preceding at a rapid pace since we dosed the first participant in late May.
Speaker #5: These trends highlight the strong public interest of our oral vaccine platform and for a safe and effective vaccine against a SARS-CoV-2 virus. We agree with Secretary Kennedy's priorities that include the development of safe and effective novel vaccine solutions such as our oral vaccine platform.
Although we were trending towards fully enrolling this trial by mid Q4, as we had projected or even earlier, we remain encouraged about the prospects of the trial and our vaccine candidate since there will be data on about 5000 participants we remain in close touch with our BARDA partners in <unk>.
As they indicated that a follow up notice with further details will come.
Speaker #5: As a reminder, our trial is designed to assess the safety immunogenicity and efficacy profiles of our candidate against an mRNA comparator. This trial is specifically designed to provide head-to-head data with the goal of advancing broader and innovative vaccine technologies.
Steven Lo: As a reminder, our trial is designed to assess the safety, immunogenicity, and efficacy profiles of our candidate against an mRNA comparator. This trial is specifically designed to provide head-to-head data with the goal of advancing broader and innovative vaccine technologies. Although we were trending towards fully rolling this trial by mid-Q4, as we had projected, or even earlier, we remain encouraged about the prospects of the trial and our vaccine candidate since there will be data on about 5,000 participants. We remain in close touch with our BARDA partners and ATI, as they indicated that a follow-up notice with further details will come. I'd like to express my appreciation for the work of our clinical teams and investigators across our sites as they continue the important follow-up work on this trial. We also thank the clinical trial participants whose strong interest is making this key study possible.
I would like to express my appreciation for the work of our clinical teams and investigators across our sites as they continue the important follow up work on this trial. We also think that clinical trial participants whose strong interest is making this key study possible cover remains an endemic infection that.
Speaker #5: Although we were trending towards fully enrolling this trial by mid-Q4, as we had projected, or even earlier, we remain encouraged about the prospects of the trial and our vaccine candidate, since there will be data on about 5,000 participants.
<unk> has a morbidity and mortality profile that is more adverse than flu and while vaccination has waned the market opportunity remains quite significant and of course, we anticipate that our differentiated mechanism of action plus delivery as an oral pill can change the trajectory of vaccine <unk>.
Speaker #5: We remain in close touch with our BARDA partners and ATI, as they indicated that a follow-up notice with further details will come. I'd like to express my appreciation for the work of our clinical teams and investigators across our sites as they continue the important follow-up work on this trial.
<unk> and convenience.
Turning to our Norovirus program in June we were pleased to report positive phase one topline results from our second generation construct which increased norovirus blocking antibodies in both the low and high dose cohort with a difference reaching statistical significance for the high dose.
Speaker #5: We also thank the clinical trial participants whose strong interest is making this key study possible. COVID remains an endemic infection that has a morbidity and mortality profile that is more adverse than flu, and while vaccination has waned, the market opportunity remains quite significant.
Steven Lo: COVID remains an endemic infection that has a morbidity and mortality profile that is more adverse than flu. And while vaccination has waned, the market opportunity remains quite significant. And of course, we anticipate that our differentiated mechanism of action, plus delivery as an oral pill, can change the trajectory of vaccine acceptance and convenience. Turning to our norovirus program, in June, we were pleased to report positive Phase 1 top-line results from our second-generation constructs, which increased norovirus blocking antibodies in both the low and high-dose cohort, with the difference reaching statistical significance for the high-dose cohort. Compared to our first-generation constructs, our new constructs were optimized to generate stronger immune responses.
Short compared to our first generation contracts, our new contracts were optimized to generate stronger immune responses.
We plan to share the complete results of this study in a peer reviewed journal, but it is encouraging that our second generation constructs have shown meaningful improvement on an important marker of protection against norovirus infection and that the data continue to show they are well tolerated with a benign safety profile we.
Speaker #5: And of course, we anticipate that our differentiated mechanism of action, plus delivery as an oral pill, can change the trajectory of vaccine acceptance and convenience.
Speaker #5: Turning to our norovirus program, in June, we were pleased to report positive Phase 1 top-line results from our second-generation constructs, which increased norovirus blocking antibodies in both the low and high-dose cohorts, with a difference reaching statistical significance for the high-dose cohort.
Believe this has first in class or best in class potential as currently there are no approved vaccines and other products in development do not have the unique profile as well as delivery advantages of our platform.
Speaker #5: Compared to our first-generation constructs, our new constructs were optimized to generate stronger immune responses. We plan to share the complete results of the study in a peer-reviewed journal but it's encouraging that our second-generation constructs have shown meaningful improvement on an important marker of protection against norovirus infection and that the data continue to show they are well tolerated with a benign safety profile.
With continuing outbreaks in the news and a significant burden on society norovirus represents a significant unmet need.
Steven Lo: We plan to share the complete results of the study in a peer-reviewed journal, but it's encouraging that our second-generation constructs have shown meaningful improvement on an important marker of protection against norovirus infection and that the data continue to show they are well tolerated with a benign safety profile. We believe this has first-in-class or best-in-class potential, as currently there are no approved vaccines and other products in development do not have the unique profile as well as delivery advantages of our platform. With continuing outbreaks in the news and a significant burden on society, norovirus represents a significant unmet need. As we have shared before, norovirus is believed to cause 20% of diarrheal disease globally and is the leading cause of acute gastroenteritis, or AGE, worldwide. This highlights the public health potential of our oral norovirus vaccine.
As we have shared before norovirus is believed to cost 20% of Diarrhoeal disease globally and is the leading cause of acute gastroenteritis or AJ worldwide. This highlights the public health potential of our oral norovirus vaccine the healthcare economic cost of norovirus infection.
Speaker #5: We believe this has first-in-class or best-in-class potential as currently there are no approved vaccines, and other products in development do not have the unique profile as well as delivery advantages of our platform.
And associated AJ are estimated at $60 billion worldwide and $10 billion in the United States.
This underscores why market research estimates the potential of a multibillion dollar U S market for a safe and effective norovirus vaccine.
Speaker #5: With continuing outbreaks in the news and a significant burden on society, norovirus represents a significant unmet need. As we have shared before, norovirus is believed to cause 20% of diarrheal disease globally and is the leading cause of acute gastroenteritis, or AGE, worldwide.
Following the release of Norovirus topline data our leadership team attended the bio International Convention in Boston, We held many productive 101 partnering discussions throughout the conference and while it's too early to share specific details about a potential partnership I am pleased to share that we have meaningful interest from <unk>.
Speaker #5: This highlights the public health potential of our oral norovirus vaccine, the healthcare economic costs of norovirus infection, and associated AGE are estimated at $60 billion worldwide, and $10 billion in the United States.
Many parties, we will share more information of course, if a partnership is achieved.
Steven Lo: The healthcare economic costs of norovirus infection and associated AGE are estimated at $60 billion worldwide and $10 billion in the United States. This underscores why market research estimates the potential of a multi-billion dollar US market for a safe and effective norovirus vaccine. Following the release of norovirus top-line data, our leadership team attended the BioInternational Convention in Boston. We held many productive one-on-one partnering discussions throughout the conference. And while it's too early to share specific details about a potential partnership, I'm pleased to share that we have meaningful interest from many parties. We will share more information, of course, if a partnership is achieved. Finally, we are progressing our preclinical research in avian influenza. As Sean will highlight, our new avian influenza vaccine was 100% protective against death in a robust Ferrite Clade 2344B challenge model compared with 0% survival in placebo-treated animals.
Finally, we are progressing our preclinical research and avian influenza as Sean will highlight our new avian influenza vaccine was 100% protective against the death and a robust ferret clade to 344, B challenge model compared with zero percent survival.
Speaker #5: This underscores why market research estimates the potential of a multi-billion dollar U.S. market for a safe and effective norovirus vaccine. Following the release of norovirus top-line data, our leadership team attended the BioInternational Convention in Boston. We held many productive one-on-one partnering discussions throughout the conference, and while it's too early to share specific details about a potential partnership, I'm pleased to share that we have meaningful interest from many parties.
Civil and placebo treated animals based on our growing body of data. We believe there is potential for our seasonal and avian influenza vaccine candidates and plan to look for funding to continued development of these programs.
Overall, our broad pipeline with programs in norovirus, COVID-19, and influenza have a number of upcoming value, creating milestones with a platform designed to generate both systemic and mucosal immunity. We believe our oral pill vaccine has the potential to transform <unk>.
Speaker #5: We will share more information, of course, if a partnership is achieved. Finally, we are progressing our preclinical research in avian influenza. As Sean will highlight, our new avian influenza vaccine was 100% protective against death in a robust ferret-clade 2, 3, 4, 4B challenge model, compared with 0% survival in placebo-treated animals.
Global public health and revolutionize distribution and administration.
I'll now turn the call over to James for a review of our COVID-19, and norovirus clinical programs James.
Speaker #5: Based on our growing body of data, we believe there is potential for our seasonal and avian influenza vaccine candidates and plan to look for funding to continue development of these programs.
Steven Lo: Based on our growing body of data, we believe there is potential for our seasonal and avian influenza vaccine candidates and plan to look for funding to continue development of these programs. Overall, our broad pipeline with programs in norovirus, COVID-19, and influenza has a number of upcoming value-creating milestones. With a platform designed to generate both systemic and mucosal immunity, we believe our oral pill vaccine has the potential to transform global public health and revolutionize distribution and administration. I'll now turn the call over to James for a review of our COVID-19 and norovirus clinical programs. James.
Thanks, Steve and thanks to everyone for joining today's call.
I'll start with an update of our Covid program.
Speaker #5: Overall, our broad pipeline with programs in norovirus, COVID-19, and influenza has a number of upcoming value-creating milestones. With a platform designed to generate both systemic immucosal immunity, we believe our oral pill vaccine has the potential to transform global public health and revolutionize distribution and administration.
After our initial stop work order was lifted in April we quickly activated our clinical sites resumed participant screening and initiated dosing in the 10000 participant cohort all within about one month's time.
As Steve mentioned, we were well on our way to achieving our enrollment targets with about half of the participants enrolled earlier this month. However.
However, with the latest stop work order, we immediately ceased enrollment it's worth mentioning though that the independent data safety monitoring board or <unk> for this trial cast with assessing the safety of the trial had determined at its meeting in mid July that the study could continue to proceed without <unk>.
Speaker #5: I'll now turn the call over to James Cummings for a review of our COVID-19 and norovirus clinical programs. James.
Speaker #6: Thanks, Steve, and thanks to everyone for joining today's call. I'll start with an update on our COVID program. After our initial stop-work order was lifted in April, we quickly activated our clinical sites, resumed participant screening, and initiated dosing in the 10,000-participant cohort, all within about one month's time.
James Cummings: Thanks, Steve, and thanks to everyone for joining today's call. I'll start with an update of our COVID program. After our initial stop work order was lifted in April, we quickly activated our clinical sites, resumed participant screening, and initiated dosing in the 10,000 participant cohort, all within about one month's time. As Steve mentioned, we were well on our way to achieving our enrollment targets, with about half of the participants enrolled earlier this month. However, with the latest stop work order, we immediately ceased enrollment. It's worth mentioning, though, that the Independent Data Safety Monitoring Board, or DSMB, for this trial, tasked with assessing the safety of the trial, had determined at its meeting in mid-July that the study could continue to proceed without modification, providing further evidence of the safety profile of our vaccine candidate.
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<unk> further evidence of the safety profile of our vaccine candidate.
As a reminder, this fee.
As to the trial is a double blind multicenter randomized comparator controlled study.
Speaker #6: As Steve mentioned, we were well on our way to achieving our enrollment targets, with about half of the participants enrolled earlier this month. However, with the latest stop work order, we immediately ceased enrollment.
It's designed to evaluate the relative efficacy safety and Immunogenicity of our oral COVID-19 vaccine candidate compare to an approved mrna COVID-19 vaccine in adults who had been previously vaccinated against COVID-19.
Speaker #6: It's worth mentioning, though, that the independent data safety monitoring board, or DSMB, for this trial, tasked with assessing the safety of the trial had determined at its meeting in mid-July that the study could continue, to proceed without modification.
Based on the stop work order notification, we will continue to conduct a 12 month follow up for all participants who have already been dosed in the trial, which will be funded by BARDA.
Speaker #6: Providing further evidence of the safety profile of our vaccine candidate. As a reminder, this Phase 2B trial is a double-blind, multi-center, randomized, comparator-controlled study.
As we determine next steps for the trial with approximately 5000 participants enrolled.
James Cummings: As a reminder, this Phase 2B trial is a double-blind, multi-center, randomized, comparator-controlled study. It's designed to evaluate the relative efficacy, safety, and immunogenicity of our oral COVID-19 vaccine candidate compared to an approved mRNA COVID-19 vaccine in adults who have been previously vaccinated against COVID-19. Based on the stop work order notification, we will continue to conduct a 12-month follow-up for all participants who have already been dosed in the trial, which will be funded by BARDA. As we determine next steps for the trial, with approximately 5,000 participants enrolled, we believe we will still produce a very comprehensive data readout that is anticipated in 2026. We're also continuing, per protocol, follow-up work for the 400-person Sentinel cohort, which BARDA will continue to fund. Participants are being monitored for up to 12 months post-vaccination to assess safety, immunogenicity, and efficacy for the Sentinel cohort.
We believe we will still produce a very comprehensive data readout that is anticipated in 2026.
Speaker #6: It's designed to evaluate the relative efficacy, safety, and immunogenicity of our oral COVID-19 vaccine candidate compared to an approved mRNA COVID-19 vaccine in adults who have been previously vaccinated against COVID-19.
We're also continuing per protocol follow up work for the 400 person Sentinel cohort, which BARDA will continue to fund.
<unk> are being monitored for up to 12 months post vaccination to assess safety immunogenicity and efficacy for the Sentinel cohort.
Speaker #6: Based on the stop work order notification, we will continue to conduct 12-month follow-up for all participants who have already been dosed in the trial, which will be funded by BARDA.
We expect to report data in the first quarter of 2026.
During the second quarter.
We reported positive topline results from the phase one trial, comparing our first and second generation norovirus vaccine constructs.
Speaker #6: As we determine next steps for the trial, with approximately 5,000 participants enrolled, we believe we will still produce a very comprehensive data readout that is anticipated in 2026.
These data showed that our second generation construct stimulated higher levels of norovirus blocking antibodies and.
Speaker #6: We're also continuing per protocol follow-up work for the 400-person Sentinel cohort, which BARDA will continue to fund. Participants are being monitored for up to 12 months post-vaccination to assess safety and immunogenicity and efficacy for the Sentinel cohort.
And then the first generation contracts at both the high and low doses evaluated in the trial.
The difference was statistically significant and the high dose cohort.
As we previously shared these norovirus blocking antibodies correlated with protection against Norovirus infection in a phase II Challenge study of the first generation construct which demonstrated a 30% relative reduction in the risk of infection.
Speaker #6: We expect the report data in the first quarter of 2026. During the second quarter, we reported positive top-line results from the Phase 1 trial comparing our first and second-generation norovirus vaccine constructs.
James Cummings: We expect to report data in the first quarter of 2026. During the second quarter, we reported positive top-line results from the Phase 1 trial comparing our first and second-generation norovirus vaccine constructs. These data showed that our second-generation constructs stimulated higher levels of norovirus blocking antibodies than the first-generation constructs at both the high and low doses evaluated in the trial. The difference was statistically significant in the high-dose cohort. As we previously shared, these norovirus blocking antibodies correlated with protection against norovirus infection in a Phase 2 challenge study of the first-generation constructs, which demonstrated a 30% relative reduction in the risk of infection. We believe that the blocking antibodies raised by the second-generation constructs will also be protective against infection.
We believe that the blocking antibodies raised by the second generation construct will also be protective against infection.
Speaker #6: These data showed that our second-generation constructs stimulated higher levels of norovirus-blocking antibodies than the first-generation constructs at both the high and low doses evaluated in the trial.
Given that the phase one head to head trial showed higher levels of norovirus blocking antibody with the second generation construct we are optimistic that this will translate into a greater reduction in infection and a field study.
Speaker #6: The difference was statistically significant in the high-dose cohort. As we previously shared, these norovirus blocking antibodies correlated with protection against norovirus infection in a Phase 2 challenge study of the first-generation constructs, which demonstrated a 30% relative reduction in the risk of infection.
We believe that the potential of our second generation construct combined with the significant public health need and market opportunity for a safe and effective norovirus vaccine provides us with a meaningful opportunity to attract additional funding that will allow this program to move forward with the.
Speaker #6: We believe that the blocking antibodies raised by the second-generation constructs will also be protective against infection. Given that the Phase 1 head-to-head trial showed higher levels of norovirus blocking antibody, with the second-generation constructs, we're optimistic that this will translate into a greater reduction in infection in a field study.
A potential partnership or other funding this program could advance to a phase <unk> study in the second half of 2025, enabling an end of phase II meeting with the FDA that could support phase III trial initiation as early as 2026.
James Cummings: Given that the Phase 1 head-to-head trial showed higher levels of norovirus blocking antibody with the second-generation constructs, we're optimistic that this will translate into a greater reduction in infection in a field study. We believe that the potential of our second-generation constructs, combined with the significant public health need and market opportunity for a safe and effective norovirus vaccine, provides us with a meaningful opportunity to attract additional funding that will allow this program to move forward. With a potential partnership or other funding, this program could advance to a Phase 2B study in the second half of 2025, enabling an end-of-Phase 2 meeting with the FDA that could support Phase 3 trial initiation as early as 2026. I'll now hand the call over to Dr. Sean Tucker for the latest developments from our avian flu preclinical program. Sean?
I'll now hand, the call over to Dr. Shawn Tucker.
The latest developments from our avian flu preclinical program Sean.
Speaker #6: We believe that the potential of our second-generation constructs, combined with the significant public health need and market opportunity for a safe and effective norovirus vaccine, provides us with a meaningful opportunity to attract additional funding that will allow this program to move forward.
Thank you James as many of you are aware the H five N. One strain of avian influenza is circulating in wild birds around the globe and causing outbreaks in poultry and dairy cows in the United States.
According to the U S centers for disease control and prevention 70 cases of human H, one H five N. One infection have been reported since the outbreak began resulting in one death.
Speaker #6: With the potential partnership or other funding, this program could advance to a Phase 2B study in the second half of 2025, enabling an end-of-Phase 2 meeting with the FDA that could support Phase 3 trial initiation as early as 2026.
This is not just a U S virus with reported cases in southeast Asia and other places.
Getting to the World Health organization.
Speaker #6: I'll now hand the call over to Dr. Sean Tucker, for the latest developments from our avian flu preclinical program. Sean? Thank you, James. As many of you are aware, the H5N1 strain of the avian influenza is circulating in wild birds around the globe and causing outbreaks in poultry and dairy cows in the United States.
We're 15 laboratory confirmed cases of human infection with avian flu in Cambodia This year.
While there is no known evidence of person to person infection. At this time the continued circulation of the virus increases the risk of mutations that could make animal to human transmission easier or result in human to human transmission.
Sean Tucker: Thank you, James. As many of you are aware, the H5N1 strain of avian influenza is circulating in wild birds around the globe and causing outbreaks in poultry and dairy cows in the United States. According to the US Centers for Disease Control and Prevention, 70 cases of human H5N1 infection have been reported since the outbreak began, resulting in one death. This is not just a US virus, with reported cases in Southeast Asia and other places. According to the World Health Organization, there were 15 laboratory-confirmed cases of human infection with avian flu in Cambodia this year. While there is no known evidence of person-to-person infection at this time, the continued circulation of the virus increases the risk of mutations that could make animal-to-human transmission easier or result in human-to-human transmission.
Speaker #6: According to the U.S. Centers for Disease Control and Prevention, 70 cases of human H5N1 infection have been reported since the outbreak began, resulting in one death.
Additionally, individuals currently working with dairy herds at multi farms or have contact with potentially infected animals could benefit from a safe and effective avian flu vaccine.
Speaker #6: This is not just a U.S. virus, with reported cases in Southeast Asia and other places. According to the World Health Organization, there were 15 laboratory-confirmed cases of human infection with avian flu in Cambodia this year.
A key benefit of our vast vaccine platform development is that it allows us to move quickly in formulating and evaluating novel vaccine contracts.
Given the potentially growing threat of avian flu, we were able to develop and commence preclinical evaluation of a new avian flu a construct in just a few months.
Speaker #6: While there is no known evidence of person-to-person infection at this time, the continued circulation of the virus increases the risk of mutations that could make animal-to-human transmission easier or result in human-to-human transmission.
Subsequently, we performed a challenge study of this construct where it demonstrated 100% survival and reduced viral load.
In this study ferrets for vaccine twice with an old Ava H five vaccine, a new H five vaccine or placebo.
Speaker #6: Additionally, individuals currently working with dairy herds at poultry farms or who have contact with potentially infected animals could benefit from a safe and effective avian flu vaccine.
Sean Tucker: Additionally, individuals currently working with dairy herds at poultry farms or have contact with potentially infected animals could benefit from a safe and effective avian flu vaccine. A key benefit of our Vax vaccine platform development is that it allows us to move quickly in formulating and evaluating novel vaccine constructs. Given the potentially growing threat of avian flu, we were able to develop and commence preclinical evaluation of a new avian flu construct in just a few months. Subsequently, we performed a challenge study of this construct where it demonstrated 100% survival and reduced viral load. In this study, ferrets were vaccinated twice with an old H5 vaccine, a new H5 vaccine, or placebo. Eight weeks after the first vaccination, they were challenged intranasally with H5N1. 100% of the ferrets receiving the new H5 vaccine survived, while all the animals who received placebo died by day six post-challenge.
Eight weeks after the first vaccination they were challenged inter nasally with H five N. One.
Speaker #6: A key benefit of our Vax vaccine platform development is that it allows us to move quickly in formulating and evaluating novel vaccine constructs. Given the potentially growing threat of avian flu, we were able to develop and commence preclinical evaluation of a new avian flu construct in just a few months.
100% of the ferrets, receiving the new H five vaccine survive while all the animals received placebo dry died by day six post challenge three.
<unk> three of a animals, receiving the old vaccine was still alive. After 90 days after challenge in.
In addition to the survival benefit observed with the new vaccine study showed a greater than two log reduction in nasal wash viral load in ferrets, receiving the new vaccine and this decrease was statistically significant compared with the old vaccine and placebo.
Speaker #6: Subsequently, we performed a challenge study of this construct, where it demonstrated 100% survival and reduced viral load. In this study, ferrets were vaccinated twice with an old H5 vaccine, a new H5 vaccine, or placebo.
We believe these data are highly compelling and have the potential to support a partnership or business development opportunity. We intend to report the data from these and other studies of our avian flu vaccine candidate in a peer reviewed journal are peer reviewed medical or scientific conference.
Speaker #6: Eight weeks after the first vaccination, they were challenged intranasally with H5N1. 100% of the ferrets receiving the new H5 vaccine survived, while all the animals received placebo died by day six post-challenge.
I will now now hand, the call over to Jerome for a brief discussion of our financials surround.
Speaker #6: Three of eight animals receiving the old vaccine were still alive after nine days after challenge. In addition to the survival benefit observed with the new vaccine, the study showed a greater than two log reduction in nasal wash viral load in ferrets receiving the new vaccine.
Sean Tucker: Three of eight animals receiving the old vaccine were still alive after nine days after challenge. In addition to the survival benefit observed with the new vaccine, the study showed a greater than two log reduction in nasal wash viral load in ferrets receiving the new vaccine, and this decrease was statistically significant compared with the old vaccine and placebo. We believe these data are highly compelling and have the potential to support a partnership or business development opportunity. We intend to report the data from these and other studies of our avian flu vaccine candidate in a peer-reviewed journal or peer-reviewed medical or scientific conference. I'll now hand the call over to Jerome for a brief discussion of our financials. Jerome?
Thank you Sean the details of our second quarter 2025 financial results are summarized in today's press release.
Revenue for the second quarter of 2025 was $39 7 million.
Speaker #6: And this decrease was statistically significant compared with the old vaccine. And placebo. We believe these data are highly compelling and have the potential to support a partnership or business development opportunity.
Compared to $6 4 million for the second quarter of 2024.
Revenue in the second quarter of 2025 was primarily from the BARDA contract awarded in June 2024.
Speaker #6: We intend to report the data from these and other studies of our avian flu vaccine candidate in a peer-reviewed journal or peer-reviewed medical or scientific conference.
Revenue in the second quarter of 2024 was primarily from a separate BARDA contract awarded in January 2024.
<unk> ended the second quarter with cash cash equivalents and investments of $26 $3 million.
Speaker #6: I'll now now hand the call over to Jerome for a brief discussion of our financials. Jerome?
Speaker #3: Thank you, Sean. The details of our second quarter 2025 financial results are summarized in today's press release. Revenue for the second quarter of 2025 was $39.7 million compared to $6.4 million for the second quarter of 2024.
Based on our current plan Rockstar expected cash runway into the first quarter of 2026.
Jerome Grassman: Thank you, Sean. The details of our second quarter 2025 financial results are summarized in today's press release. Revenue for the second quarter of 2025 was $39.7 million compared to $6.4 million for the second quarter of 2024. Revenue in the second quarter of 2025 was primarily from the BARDA contract awarded in June 2024. Revenue in the second quarter of 2024 was primarily from a separate BARDA contract awarded in January 2024. Vaxart ended the second quarter with cash cash equivalents and investments of $26.3 million. Based on our current plan, Vaxart expects cash runway into the first quarter of 2026. To further extend our cash runway, Vaxart will remain aggressive in seeking strategic partnerships and pursuing other non-dilutive funding options.
To further extend our cash runway.
<unk> will remain aggressive in seeking strategic partnerships and pursuing other non dilutive funding options and.
Speaker #3: Revenue in the second quarter of 2025 was primarily from the BARDA contract awarded in June 2024. Revenue in the second quarter of 2024 was primarily from a separate BARDA contract awarded in January 2024.
In addition, following approximately 10% reduction in workforce during the first quarter of 2025, the company implemented an additional reduction in workforce during the second quarter, reducing its workforce by a further approximately 21% to decrease operating costs and better align its workforce with the needs of its <unk>.
Speaker #3: Vaxart ended the second quarter with cash cash equivalents and investments of $26.3 million. Based on our current plan, Vaxart expects cash runway into the first quarter of 2026.
Business.
I will now turn the call back to Steve for closing remarks.
Thank you Jerome.
I would like to use this time to provide an update on our stock listing before taking your questions as many of our listeners are aware our listing on NASDAQ has been suspended because we are not in compliance with nasdaq's $1 minimum bid price requirement. Since July eight are common shares have been trading on the OTC.
Speaker #3: To further extend our cash runway, Vaxart will remain aggressive in seeking strategic partnerships and pursuing other non-dilutive funding options. In addition, following an approximately 10% reduction in workforce during the first quarter of 2025, the company implemented an additional reduction in workforce during the second quarter, reducing its workforce by a further approximately 21% to decrease operating costs and better align its workforce with the needs of its business.
Jerome Grassman: In addition, following an approximately 10% reduction in workforce during the first quarter of 2025, the company implemented an additional reduction in workforce during the second quarter, reducing its workforce by a further approximately 21% to decrease operating costs and better align its workforce with the needs of its business. I will now turn the call back to Steve for closing remarks.
<unk> best market. While this exchange is the highest tier of the OTC markets group. Our goal is to regain compliance on NASDAQ. So that we can resume trading on that exchange.
While we continue to consider all options in an effort to have NASDAQ list. Its suspension of our common shares and appreciate the continued support from our stockholders. We continue to believe that listing on NASDAQ is the best option for the future of <unk>, we have a meeting with the NASDAQ hearings panel tomorrow.
Speaker #3: I will now turn the call back to Steve for closing remarks.
Speaker #5: Thank you, Jerome. I'd like to use this time to provide an update on our stock listing before taking your questions. As many of our listeners are aware, our listing on NASDAQ has been suspended because we are not in compliance with NASDAQ's $1 minimum bid price requirement.
Steven Lo: Thank you, Jerome. I'd like to use this time to provide an update on our stock listing before taking your questions. As many of our listeners are aware, our listing on NASDAQ has been suspended because we are not in compliance with NASDAQ's $1 minimum bid price requirement. Since July 8th, our common shares have been trading on the OTC QX Best Market. While this exchange is the highest tier of the OTC Markets Group, our goal is to regain compliance on NASDAQ so that we can resume trading on that exchange. While we continue to consider all options in an effort to have NASDAQ lift its suspension of our common shares and appreciate the continued support from our stockholders, we continue to believe that listing on NASDAQ is the best option for the future of Vaxart.
To discuss our plan to regain compliance, which based on our current share price is to effect a reverse stock split we will share an update once a decision has been communicated to US. However, there is no assurance that NASDAQ will support our plan to that end, we have scheduled a special meeting of stock.
Speaker #5: Since July 8, our common shares have been trading on the OTC QX Best Market, which is the highest tier of the OTC Markets Group.
Speaker #5: Our goal is to regain compliance on NASDAQ so that we can resume trading on that exchange. While we continue to consider all options in an effort to have NASDAQ lift its suspension of our common shares and appreciate the continued support from our stockholders, we continue to believe that listing on NASDAQ is the best option for the future of Vaxart.
Holders to be held virtually on September 5th at 830, a M Pacific time, and urge a vote for our reverse stock split proposal.
A similar proposal was not approved during our annual meeting in June as many of our stockholders at that time believed that we're vacs are traded on the OTC that our share price would grow organically for a smoother path to listing on NASDAQ as.
Speaker #5: We have a meeting with the NASDAQ Hearings Panel tomorrow to discuss our plan to regain compliance. Which, based on our current share price, is to affect a reverse stock split.
Steven Lo: We have a meeting with the NASDAQ hearings panel tomorrow to discuss our plan to regain compliance, which, based on our current share price, is to effect a reverse stock split. We will share an update once a decision has been communicated to us. However, there is no assurance that NASDAQ will support our plan. To that end, we have scheduled a special meeting of stockholders to be held virtually on September 5th at 8:30 a.m. Pacific Time and urge a vote for our reverse stock split proposal. A similar proposal was not approved during our annual meeting in June, as many of our stockholders at that time believed that were Vaxart traded on the OTC that our share price would grow organically for a smoother path to listing on NASDAQ.
As we previously stated we do not believe our current stock price reflects anywhere close to where we believe is the full value of our company. However, since our listing on OTC our share price has not appreciated in a meaningful manner trading between 26 and 47.
Speaker #5: We will share an update once a decision has been communicated to us. However, there is no assurance that NASDAQ will support our plan. To that end, we have scheduled a special meeting of stockholders to be held virtually on September 5th at 8:30 AM Pacific Time and urge a vote for our reverse stock split proposal.
We are less attractive to institutional investors and passively managed index funds, who often have mandates against investing in OTC listed companies.
Speaker #5: A similar proposal was not approved during our annual meeting in June as many of our stockholders at that time believed that were Vaxart traded on the OTC, that our share price would grow organically for a smoother path to listing on NASDAQ.
And following BARDA stop work order notification re listing on NASDAQ is now more important than ever NASDAQ listed companies are often viewed more favorably for potential partnerships, making this a critical step for future collaborations.
Speaker #5: As we previously stated, we do not believe our current stock price reflects anywhere close to where we believe is the full value of our company.
Steven Lo: As we previously stated, we do not believe our current stock price reflects anywhere close to where we believe is the full value of our company. However, since our listing on OTC, our share price has not appreciated in a meaningful manner, trading between $0.26 and $0.47. We are less attractive to institutional investors and passively managed index funds, who often have mandates against investing in OTC-listed companies. And following BARDA's stop work order notification, relisting on NASDAQ is now more important than ever. NASDAQ-listed companies are often viewed more favorably for potential partnerships, making this a critical step for future collaborations. It is for these reasons that we strongly believe that voting for the proposal is in the best interest of Vaxart and for you, our stockholders.
It is for these reasons that we strongly believe that voting for the proposal is in the best interest of <unk> and for you our stockholders in an effort to proactively address questions regarding this proposal and other frequently asked stockholder questions. We will host a live fire side chat on <unk>.
Speaker #5: However, since our listing on OTC, our share price has not appreciated in a meaningful manner, trading between $0.26 and $0.47. We are less attractive to institutional investors and passively manage index funds who often have mandates against investing in OTC-listed companies.
22025 at 430 P. M. Eastern time, we encourage you to either sent questions in advance to IR at <unk> Dot com or live through the webcast player.
Speaker #5: And following BARDA's stop work order notification, relisting on NASDAQ is now more important than ever. NASDAQ-listed companies are often viewed more favorably for potential partnerships making this a critical step for future collaborations.
We will do our best to answer as many questions as possible with the hope that we can secure your votes.
Speaker #5: It is for these reasons that we strongly believe that voting for the proposal is in the best interest of Vaxart and for you, our stockholders.
As a reminder, in the event that we received stockholder approval before proceeding to effect a reverse split we will first evaluate our situation to determine the likelihood of regaining compliance with Nasdaq.
Speaker #5: In an effort to proactively address questions regarding this proposal and other frequently asked stockholder questions, we will host a live fireside chat on August 20, 2025, at 4:30 PM Eastern Time.
Steven Lo: In an effort to proactively address questions regarding this proposal and other frequently asked stockholder questions, we will host a live fireside chat on August 20th, 2025, at 4:30 p.m. Eastern Time. We encourage you to either send questions in advance to ir@vaxart.com or live through the webcast player. We will do our best to answer as many questions as possible with the hope that we can secure your votes. As a reminder, in the event that we receive stockholder approval before proceeding to effect a reverse split, we will first evaluate our situation to determine the likelihood of regaining compliance with NASDAQ. While we work towards regaining compliance on NASDAQ, our clinical, regulatory, and operational teams are executing at a high level that has enabled us to report positive data and hit key milestones within our stated timelines.
While we work towards regaining compliance on NASDAQ, our clinical regulatory and operational teams are executing at a high level that has enabled us to report positive data and hit key milestones within our stated timelines are phase one norovirus data progress with our COVID-19.
Speaker #5: We encourage you to either send questions in advance to ir@vaxart.com or live through the webcast player. We will do our best to answer as many questions as possible with the hope that we can secure your votes.
<unk> phase <unk> trial, and compelling preclinical data all serve as added validation and interest for our revolutionary oral pill vaccine candidates, we look forward to sharing our continued progress.
Speaker #5: As a reminder, in the event that we receive stockholder approval, before proceeding to affect a reverse split, we will first evaluate our situation to determine the likelihood of regaining compliance with NASDAQ.
Thanks, everyone for your time today, we will now take your questions.
Since we have our scheduled fire side chat upcoming we kindly request reserving all questions relating to our proxy for the fireside chat.
Speaker #5: While we work towards regaining compliance on NASDAQ, our clinical, regulatory, and operational teams are executing at a high level that has enabled us to report positive data and hit key milestones within our stated timelines.
Operator, you May open the line for questions.
Thank you.
Ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue.
Speaker #5: Our Phase 1 norovirus data, progress with our COVID-19 Phase 2B trial, and compelling preclinical data all served as added validation and interest for our revolutionary oral pill vaccine candidates.
Steven Lo: Our Phase 1 norovirus data, progress with our COVID-19 Phase 2B trial, and compelling preclinical data all serve as added validation and interest for our revolutionary oral pill vaccine candidates. We look forward to sharing our continued progress. Thanks, everyone, for your time today. We will now take your questions. Since we have our scheduled fireside chat upcoming, we kindly request reserving all questions relating to our proxy for the fireside chat. Operator, you may open the line for questions.
You May press Star two if you would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker #5: We look forward to sharing our continued progress. Thanks, everyone, for your time today. We will now take your questions. Since we have our scheduled fireside chat upcoming, we kindly request reserving all questions relating to our proxy for the fireside chat.
And our first question comes from the line of Cheng with Jefferies. Please proceed.
Hey, Good afternoon. This is Leon channel for Roger So congrats on the fast pace of Colgate the trial enrollment. So I guess my question about the Covid trial.
Speaker #5: Operator, you may open the line for questions.
Speaker #3: Thank you. Ladies and gentlemen, if you would like to ask a question, please press *1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue.
Operator: Thank you. Ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your headset before pressing the star keys. And our first question comes from the line of Liang Cheng with Jefferies. Please proceed.
Now you have a 5000 to enroll at a positive 400, something now cohort does that continue the follow up so.
Let's just assume that you continue to fall off.
Speaker #3: You may press *2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your headset before pressing the * keys.
<unk> already enrolled patients as <unk>.
And our protocol, so what would be the statistical assumption on plan there regarding comparing the immunogenicity and efficacy.
Speaker #3: And our first question comes from the line of Liang Chang with Jefferies. Please proceed.
The vessels are.
Compared to arm and also maybe just quickly confirm.
Currently enrollment about 5000 is about one to one ratio between these two arms. Thank you.
Speaker #7: Hey, good afternoon. This is Liang Chang for Rogers. So, congrats on the fast pace of the COVID trial enrollment. So, I guess my question about the COVID trial, you know, now you have 5,000 enrolled plus 400 Sentinel cohorts that it continues to follow up.
Liang Cheng: Hey, good afternoon. This is Liang Cheng for Rogers. So congrats on the fast pace of the COVID trial enrollment. So I guess my question about the COVID trial, you know, now you have 5,000 enrolled plus the 400 Sentinel cohort that continue to follow up. So let's just assume that you continue to follow up those already enrolled patients as planned in the protocol. So what would be your statistical assumption and plan there regarding comparing the immunogenicity and efficacy versus compared to arm? And also maybe just quickly confirm the current enrollment of 5,000 is about one to one ratio between these two arms. Thank you.
Hi, Thanks for the question. This is Steve Yes, So first of all before I turn it over to James.
We're really pleased with the rapid enrollment since we got this trial started in April so getting to 5000, certainly was not a small feat in and obviously, thanks to the participants as well as our clinical study sites your questions on our stats in the ratio, let me turn that over to James.
Speaker #7: So, let's just assume that you continue to follow up those, you know, already enrolled patients, as planned in the protocol. So what would be the, you know, your statistical assumption and plan there, regarding, you know, comparing the, immunogenicity and efficacy, versus the, comparator arm?
Thanks, Steve and thanks to them. So it's a 5000 or about a 5000 person enrolled studies, so far and thats likely to provide some very useful data from both the scientific and regulatory standpoint.
Speaker #7: And also, could you quickly confirm that the current enrollment of about 5,000 reflects roughly a one-to-one ratio between these two arms? Thank you.
The statistical analysis plan, where we're looking at that right now to ensure the best possible use of these data and to confirm this was.
Speaker #3: Great.
Speaker #8: Hi, Liang. Thanks for the question. This is Steve. Yeah, so first of all, before I turn it over to James, you know, we're really pleased with the rapid enrollment, you know, since we got this trial started in April.
Steven Lo: Great. Hi, Liang. Thanks for the question. This is Steve. Yeah, so first of all, before I turn it over to James, you know, we're really pleased with the rapid enrollment, you know, since we got this trial started in April. So getting to 5,000 certainly was not a small feat. And obviously, thanks to the participants as well as our clinical study sites. Your questions on the stats and the ratio, let me turn that over to James.
Listed as a randomized study so about half of the folks will receive our test construct and the other half will receive a comparator mrna.
Speaker #8: So, getting to 5,000 certainly was not a small feat, and obviously thanks to the participants as well as our clinical study sites. Your questions on the stats and the ratio, let me turn that over to James.
Got it and then maybe a follow up on that question. So.
Alternatively say FTR enrollment.
Speaker #6: Thanks, Steve, and thanks, Liang. So, you know, it's a 5,000 or about a 5,000-person enrolled study so far. And that's likely to provide some very useful data.
James Cummings: Thanks, Steve, and thanks, Liang. So, you know, it's a 5,000 or about a 5,000 person enrolled study so far. And that's likely to provide some very useful data from both the scientific and a regulatory standpoint. The statistical analysis plan, we're relooking at that right now to ensure the best possible use of these data. And to confirm, this was listed as a randomized study. So about half of the folks will receive our test construct, and the other half will receive a comparator mRNA.
Resume to towards that over 10000, Nicole so what's your expectation.
Expectation on the impact for the enrollment pace.
Speaker #6: From both the scientific and regulatory standpoints, we are relooking at the statistical analysis plan to ensure the best possible use of these data.
The second stockholder.
Thank you.
That depends and it depends on on when any changes might occur what I can say in terms of where we would be in terms of enrollment so.
Speaker #6: And to confirm, this was listed as a randomized study, so about half of the folks will receive our test construct, and the other half will receive a comparator mRNA.
We're waiting more information when we have that clarity we'll certainly.
Follow up.
Thanks James.
Thank you.
Sure.
Speaker #7: Got it. And there may be a follow-up on that question. So, you know, alternatively, say if your enrollment in, resume, to, you know, towards the 10,000 to go, so what's your expectation on the impact for the enrollment pace for the second stop order?
Liang Cheng: Got it. And there may be a follow-up on that question. So, you know, alternatively, say if your enrollment resumes towards the 10,000 goal, so what's your expectation on the impact for the enrollment pace for the second stop order?
The next question comes from the line of Chang Lee with Oppenheimer. Please proceed.
Hi, Thanks for taking the questions and provide an update.
Maybe just a first question on the Norovirus program.
Speaker #7: Thank you.
Speaker #6: I, I, I guess that depends, Liang. It depends on when any changes might occur. What I can say in terms of where we would be in terms of enrollment.
James Cummings: Thank you. I guess that depends, Liang. It depends on when any changes might occur, what I can say in terms of where we would be in terms of enrollment. So, you know, we're waiting for more information. When we have that clarity, we'll certainly follow up.
Congrats again on barrels on the pretty impressive data shown in June.
I'm just wondering I think I mentioned that progression to the phase <unk> trial is contingent.
Speaker #6: So, you know, we're waiting for more information. When we have that clarity, we'll certainly follow up.
Partnership or additional funding. So just wanted to confirm that you need to secure funding where partnerships for <unk>.
Start of the phase to be.
Speaker #7: Thanks, James. Thank you.
Liang Cheng: Thanks, James. Thank you.
And also maybe that's like a related question to what is the.
Speaker #3: Sure. The next question comes from the line of Chang Li with Oppenheimer. Please proceed.
James Cummings: Sure.
Realistic earliest start starting in time for the Phase <unk> study and then have a follow up thanks.
Operator: The next question comes from the line of Chang Li with Oppenheimer. Please proceed.
Alright. Thanks.
Thanks for the question, Yes, I'll turn that over to drone in terms of your question, but yes from our standpoint I'll just say that since we released the data in June we've had some productive conversations with potential partners and drove can speak to just the funding.
Speaker #8: Hi, thanks for taking the questions and providing the update. Maybe just the first question on the norovirus program, and congrats again on the pretty impressive data shared in June.
Chang Li: Hi. Thanks for taking the questions and providing the updates. Maybe just the first question on the norovirus program, and congrats again on the pretty impressive data shared in June. I'm just wondering, I think you mentioned the progression to the Phase 2B trial is contingent on partnership or additional funding. So I just want to confirm that you need to secure funding or partnership before you start the Phase 2B study. And also maybe just like a related question to what is the realistic earliest starting time for the Phase 2B study? And then have a follow-up. Thanks.
Speaker #8: I'm just wondering, I think you mentioned the progression to the Phase 2B trial is contingent on, partnership or additional funding. So I just want to confirm that you need to secure funding or partnership before you start the Phase 2B study.
Yeah. So the funding we've communicated previously as well.
The progression of this study is contingent on funding, whether that's from a partnership or from external.
Speaker #8: and also maybe just like a related question to what is the realistic earliest start, starting time for the Phase 2B study? And then have a follow-up.
Funding sources.
It will be contingent.
Speaker #8: Thanks.
Got it.
Any potential gating factor like besides the funding where.
Speaker #3: Hi, Chang. thanks for the question. yeah, I'll turn that over to Jerome in, in terms of, your question. But yeah, from our standpoint, I'll just say that, since we released the data in June, you know, we've had some productive conversations with, potential, partners and Jerome can speak to just the funding, yeah.
Steven Lo: Hi, Chang. Thanks for the question. Yeah, I'll turn that over to Jerome in terms of your question. But yeah, from our standpoint, I'll just say that since we released the data in June, you know, we've had some productive conversations with potential partners, and Jerome can speak to just the funding.
Yes Chuck.
Not that we're aware of I mean, it really is a funding I mean, you obviously are aware of the data, which we were really happy to do we've really started even the process of lining up.
Speaker #5: As to the funding, Julie, we've communicated previously as well that the progression of this study is contingent on funding, whether that's from a partnership or from external funding sources.
What to do next in terms of.
Jerome Grassman: Yeah, as to the funding, we've communicated previously as well that the progression of this study is contingent on funding, whether that's from a partnership or from external funding sources. It will be contingent.
<unk> et cetera, so it really is primarily a funding.
Our gate got it got it and just like maybe a question on the COVID-19 program.
Can you just maybe share some detail on the rationale behind the second quarter and.
Speaker #5: it will be contingent.
Speaker #6: Got it. And are there any potential gaining factors besides funding? Where?
Chang Li: Got it. And are there any potential gating factors, like beside the funding or?
Whether that you think that the paths to resuming enrollment.
The program. Thank you.
Sure, Yes stated in our opening comments, we haven't received any specific information as to the rationale what we did was of course honor the work order and so we did not enroll any more participants into the trial, we're very happy that we are.
Speaker #3: Yeah, Chang. Not that we're aware of. I mean, it really is, is a funding. I mean, you obviously are aware of the data, which we were really happy to do.
Steven Lo: Yeah, Chang, not that we're aware of. I mean, it really is the funding. I mean, you obviously are aware of the data, which we were really happy to do. We've really started even the process of lining up what to do next in terms of, you know, CROs, etc. So it really is primarily a funding gate.
Speaker #3: We've really started even the process of lining up, what to do next in terms of, you know, CROs, etc. So it really is, primarily a, a, a funding.
Round 5000.
And frankly, I think we're just waiting for more additional information.
Speaker #3: A gate.
Speaker #6: Got it. Got it. And just like, maybe a question on the COVID-19 program. Can you just maybe share some detail on the rationale behind the second stop work order and whether you think there's a path to resuming enrollment for the program?
Chang Li: Got it. Got it. And just like maybe a question on the COVID-19 program, can you just maybe share some detail on the rationale behind the second stop work order and whether you think there's a path to resuming enrollment for the program? Thank you.
From BARDA.
<unk> been in dialogue with them, but we haven't received a specific rationale as of yet.
Okay got it thanks for taking the questions.
Speaker #6: Thank you.
Speaker #3: Sure. Yeah, as stated in our opening comments, we haven't received any specific information as to the rationale. What we did was, of course, honor the work order.
Steven Lo: Sure. Yeah, stated in our opening comments, we haven't received any specific information as to the rationale. What we did was, of course, honor the work order, and so we did not enroll any more participants into the trial. We're very happy that we are around 5,000. And, you know, frankly, I think we're just waiting for more additional information from BARDA. We have been in dialogue with them, but we haven't received a specific rationale as of yet.
And the next question comes from the line of.
My.
Tommy with B Riley Securities. Please proceed.
Yes, good afternoon, and thanks for taking our questions.
Speaker #3: And so we did not enroll any more participants into the trial. We're very happy that we are around 5,000, and frankly, I think we're just waiting for more additional information from BARDA.
Now that you've had some time to digest <unk>.
As phase one data and getting maybe hitting some strategic feedback and bio. Thank you mentioned is there a <unk> structure.
<unk> model that seems the most appealing and Nike feasible and has there been any.
Speaker #3: we have been in dialogue with them, but we haven't received the specific, rationale as of yet.
And <unk> had on the development plan, including the convention correlates of protection that in person and then I have a quick follow up.
Speaker #6: Okay. Got it. Thanks for taking up the questions.
Chang Li: Okay. Got it. Thanks for taking the questions.
Great Hey, Mike Thanks for the question.
Speaker #3: And the next question comes from the line of Mayank Mamtani, with B. Riley Securities. Please proceed.
Operator: And the next question comes from the line of Mayank Mamtani with B Riley Securities. Please proceed.
Ill, let James have Sean answer the second question, but in terms of the first one we've been pretty clear that we're agnostic I think it's important from the science and from the clinical development that we want to move forward with the phase two so we don't put any strict requirements that it has to be structured this way et.
Speaker #8: Yes. Good afternoon, Dean. Thanks for taking the questions. Now that you've had some time to digest the norovirus Phase 1 data, including maybe getting some strategic feedback from Ad Bio, like you mentioned, is there a particular deal structure or economic model that seems most appealing and likely feasible? And has there been any input you've had on the development plan, including the potential correlates of protection that you're pursuing?
Mayank Mamtani: Yes. Good afternoon, team. Thanks for taking our questions. Now that you've had some time to digest the norovirus Phase 1 data, including maybe getting some strategic feedback at Bio, like you mentioned, is there a particular deal structure, economic model that seems most appealing and likely feasible? And has there been any input you've had on the development plan, including, you know, the potential correlates of protection that you're pursuing? And then I have a quick follow-up.
Cetera, and we're certainly open to co development.
Licensing.
Important just to get the science moving forward. So we've been very open minded about that.
Now.
And I'm sorry, Mike if you can ask the second question again, just for Sean and James.
Speaker #8: And then I have a quick follow-up. Great.
Speaker #3: Hey, Mayank. Thanks for the question. I'll let James or Sean answer the second question. But in terms of the first one, you know, we've been pretty clear that we're agnostic.
Steven Lo: Great. Hey, Mayank. Thanks for the question. I'll let James or Sean answer the second question. But in terms of the first one, you know, we've been pretty clear that, you know, we're agnostic. I think it's important from the science and from the clinical development that we want to move forward with the Phase 2, so we don't put any strict requirements that it has to be structured this way, etc. And, you know, we're certainly open to co-development, licensing. It's important just to get the science moving forward. So we've been very open-minded about that. And I'm sorry, Mayank, if you can ask the second question again, just for Sean and James?
Yes, just any input on the development plan.
Have in mind.
And including the potential correlates protection that you have in mind based on tightening their.
Speaker #3: I think it's important from the science and from the clinical development that we want to move forward with the Phase 2. So we don't put any strict requirements that it has to be structured this way, etc.
Feedback any.
Any insight on that.
Yeah, Sean can go ahead, and yes, I think the key thing is obviously from the challenge study we know what the most important carlitz are those are the things you want to monitor.
Speaker #3: And, you know, we're certainly open to co-development and licensing. It's important just to get the science moving forward. So we've been very open-minded about that.
From the standpoint of showing Immunogenicity is good and would be predictive of success, but the key thing from the standpoint of that phase III trial is to get enough numbers for safety to allow us to proceed to an end of phase II meeting with the FDA.
Speaker #3: And I'll... I'm sorry, Mayank. If you can ask the second question again just for Sean and James.
Okay. Okay. Thank you and.
Speaker #6: Yeah, just any input on the development plan you had, you have in mind, and, and including the potential correlates of protection that, you know, you have in mind based on prior regulatory feedback.
Mayank Mamtani: Yeah, just any input on the development plan you have in mind and including the potential correlates of protection that you have in mind based on prior regulatory feedback. Any insight on that?
Also on the avian flu data is it a publication plan than what might be the process of <unk>.
Gary maybe a federal funding process, there and lastly.
Speaker #6: Any, any insight on that?
Hey, John.
R&D spend on a go forward basis, how should we think about that then.
Speaker #3: Yep. Sean can go ahead and.
Steven Lo: Yep. Sean can go ahead and.
Speaker #6: Yeah. I, I think the key thing is, you know, obviously from the challenge study, we know what the most important correlates are. Those are the things we want to monitor.
James Cummings: Yeah, I think the key thing is, you know, obviously from the challenge study, we know what the most important correlates are. Those are the things we want to monitor, you know, from the standpoint of showing immunogenicity is good and would be predictive of success. But the key thing from the standpoint of that Phase 2 trial is to get enough numbers for safety to allow us to proceed to an end of Phase 2 meeting with the FDA.
And should we assume the spend profile that you have.
Speaker #6: You know, from the standpoint of showing immunogenicity, it is good and would be predictive of success. But the key thing from the standpoint of that Phase 2 trial is to get enough numbers for safety to allow us to proceed to an End of Phase 2 meeting with the FDA.
Essentially the incentive.
Sunday reimbursed.
So I'm going to get impacted by the staff work on it. Thanks.
Thanks for the Kansas.
Yes.
Mike I think that the.
A key thing from the standpoint that publication is to get the paper written and obviously the data has come out just recently, where you have a little work.
Speaker #3: Okay. Okay. Thank you. And,
Mayank Mamtani: Okay. Okay. Thank you. And also on the avian flu data, is there a publication planned and what might be the process of securing maybe a federal funding process there? And lastly, hey, Jerome, on the R&D spend on a go-forward basis, how should we think about that? And should we assume the spend profile that you have, you know, will essentially be in some way reimbursed and it's not going to get impacted by the stop work order? Thanks for taking our questions.
Speaker #6: also on the avian flu data, is there a publication planned and, what might be the process of, securing maybe a federal funding process there?
In terms of the type of funding I mean again this avian flu theres a lot of need there is a lot of circulating virus in cattle in.
Speaker #6: And lastly, hey, Jerome, on the R&D spend on a go-forward basis, how should we think about that? And, and, and should we assume the, the, the spend profile that you have, you know, will essentially be, in some way reimbursed, and it's not going to get impacted by the stop work order?
Poultry and we think that there's a good opportunity to sort of go after <unk>.
That may be exposed to this so that would be our next bet.
Yeah, and as to the R&D expenses save.
<unk> pro to stop work order, it's our understanding that BARDA will continue to fund the per protocol sort of follow up on both safety and efficacy for the about 5000 participants dosed to date.
Speaker #6: Thanks for taking our questions. Yeah. I, I, Mayank, I think the, the, the key thing from the standpoint of the publication is to get the, the paper written and obviously the data has come out just recently.
James Cummings: Yeah, Mayank, I think the key thing from the standpoint of the publication is to get the paper written. And obviously, the data has come out just recently, so we have a little work to do. In terms of the type of funding, I mean, again, this is avian flu. There's a lot of need. There's a lot of circulating virus in cattle, in, you know, poultry. And we think that, you know, there's a good opportunity to try to go after, you know, people that may be exposed to this. So that would be our next bet.
Since the cost of running a clinical trial includes substantial fixed cost components, we do anticipate greater than 50% of the original contract.
Speaker #6: So we have a little work to do. in terms of the type of funding, I mean, again, this is avian flu. There's a lot of need, there's a lot of circulating, virus in cattle in, you know, poultry and we think that, you know, there's a good opportunity to sort of go after, you know, people that may be exposed to this.
To be collected.
Okay. Thank you.
Thank you.
Speaker #6: So that would be our next bet.
There are no more questions at this time I would now.
Now I'd like to turn the call back over to Ed Burke, who will address written questions from investors.
Speaker #3: Yeah. And as to the R&D expenses, I say per the stop work order, it's our understanding that BARDA will continue to fund the per protocol sort of follow-up on both safety and efficacy for the about 5,000 participants, those to date.
Steven Lo: And as to the R&D expenses, say, per the stop work order, it's our understanding that BARDA will continue to fund the per protocol sort of follow-up on both safety and efficacy for the about 5,000 participants dosed to date. And since the cost of running a clinical trial includes substantial fixed cost components, we do anticipate greater than 50% of the original contract to be collected.
Thank you operator and thank.
Thank you for submitting your questions.
We have a couple of questions on the COVID-19 program.
Speaker #3: And, since the cost of running a clinical trial includes substantial fixed cost components, we do anticipate greater than 50% of the original contract. To be collected.
The first is for James will a 5000 person phase two b clinical trial, assuming essentially that the stop work order stays in place.
Speaker #6: Okay. Thank you.
Mayank Mamtani: Okay. Thank you.
Will that produce useful data in support of the product's development plan.
Speaker #3: Thank you. Jerome, no more questions at this time. I would now like to turn the call back over to Ed Berg, who will address written questions from the investors.
Operator: Thank you. There are no more questions at this time. I would now like to turn the call back over to Ed Berg, who will address written questions from investors.
Thanks, Ed.
And about 5000 person phase II <unk> study, it's very likely to provide some very useful data from both the scientific and a regulatory standpoint.
Speaker #8: Thank you, operator. And, thank you for submitting your questions. we have a couple questions on the COVID-19 program. the first is for James. Will a 5,000-person Phase 2B clinical trial assuming essentially that the stop work order stays in place, will that produce useful data in support of the products development plan?
Ed Berg: Thank you, Operator. And thank you for submitting your questions. We have a couple of questions on the COVID-19 program. The first is for James. Will a 5,000-person Phase 2B clinical trial, assuming essentially that the stop work order stays in place, will that produce useful data in support of the product's development plan?
Again, we are re looking the statistical analysis plan.
Just to ensure that we're making the best possible use of these data to support the product development.
Thanks, and another question on Covid do you believe the stop work order could work in your favor and accelerating your timeline James do you have a sense of the timeline.
Sure so if.
If we are unable to enroll additional patients.
Subjects due to the stop work order we do.
Speaker #6: Thanks, Ed. So, yeah, you know, in an approximately 5,000-person Phase 2B study, it's very likely to provide some very useful data from both the scientific and regulatory standpoints.
James Cummings: Thanks, Ed. So yeah, you know, an about 5,000-person Phase 2B study, it's very likely to provide some very useful data from both a scientific and a regulatory standpoint. Again, we are relooking the statistical analysis plan just to ensure that we're making the best possible use of these data to support the product development.
You have a timeline to report top line data a little earlier than expected.
As a reminder for this study we required a 12 months follow up post vaccination period from the last person dose to assess safety immunogenicity and efficacy.
Speaker #6: again, we are relooking the statistical analysis plan. just to ensure that we're making the best possible use of these data, to support the product development.
Great. Thanks.
Speaker #3: Thanks. Another question on COVID. Do you believe the stop work order could work in your favor in accelerating your timeline? James, do you have a sense of the timeline?
Mayank Mamtani: Thanks. Another question on COVID. Do you believe the stop work order could work in your favor and accelerate your timeline? James, do you have a sense of the timeline?
And our final question for you James on Covid.
In spite of lower uptake from the approved mrna vaccines why do you think that trial was so successful in achieving a rapid enrollment pace.
Speaker #5: Sure. So, you know, if we are unable to enroll additional patients or subjects due to the stop work order, we do have a timeline to report top-line data a little earlier than expected.
James Cummings: Sure. So, you know, if we are unable to enroll additional patients, subjects, due to the stop work order, we do have a timeline to report top-line data a little earlier than expected. You know, as a reminder for this study, we required a 12-month follow-up post-vaccination period from the last person dosed to assess safety, immunogenicity, and efficacy.
Well, yes.
Certainly a robust demand for participating in our Covid clinical study and I want to acknowledge and thank all the participants and all the study sites and really everyone who worked to.
Speaker #5: You know, as a reminder for this study, we required a 12-month follow-up post-vaccination period from the last person dosed to assess safety, immunogenicity, and efficacy.
To rapidly enroll about 5000 participants I believe the robust enrollment paced showcases the demand for a better COVID-19 vaccine.
While Sars Cov two virus continues to mutate remains prevalent around the world. We're looking forward to analyzing the data which may be available as early as late 2026.
Speaker #3: Great. Thanks. And the final question for you, James, on COVID. In spite of lower uptake from the approved mRNA vaccines, why do you think the trial was so successful in achieving a rapid enrollment pace?
Mayank Mamtani: Great. Thanks. And the final question for you, James, on COVID. In spite of lower uptake from the approved mRNA vaccines, why do you think the trial was so successful in achieving a rapid enrollment pace?
So the study participants that have already been dosed.
Speaker #5: Well, you know, there was certainly a robust demand for participating in our COVID clinical study. I want to acknowledge and thank all the participants, all the study sites, and really everyone who worked to rapidly enroll about 5,000 participants.
James Cummings: Well, you know, there was certainly a robust demand for participating in our COVID clinical study. And I want to acknowledge and thank all the participants and all the study sites and really everyone who worked to rapidly enroll about 5,000 participants. I believe the robust enrollment pace showcases the demand for a better COVID vaccine. While, you know, SARS-CoV-2 virus continues to mutate and remains prevalent around the world, we're looking forward to analyzing the data, which may be available, you know, as early as late 2026 to study participants that have already been dosed.
Thanks.
Now we have some questions on norovirus.
James I'm going to call on you again.
Weather.
Were there any surprises in the top line phase <unk> data from June.
Speaker #5: I believe the robust enrollment pace showcases the demand for a better COVID vaccine. While the SARS-CoV-2 virus continues to mutate and remains prevalent around the world, we're looking forward to analyzing the data, which may be available as early as late 2026.
The show worst statistical significance right.
Although the study wasn't powered to determine superiority by statistical methods.
The increase in the MBIA titers with the second generation construct we're sufficiently large 141% for the G. One one construct and 94% for the GE two four construct this demonstrates statistical significance at the higher dose, which is why we pivoted over to the new construct high dose.
Speaker #5: So, the study participants that have already been dosed.
Speaker #3: Thanks. now we have some questions on norovirus. James, I'm going to call on you again. were there were there any surprises in the top-line Phase 1 norovirus data from June?
Mayank Mamtani: Thanks. Now we have some questions on norovirus. James, I'm going to call on you again. Were there any surprises in the top-line Phase 1 norovirus data from June?
Thanks.
On the neuro front.
I'll give you a break for a second James.
We'll go to Steve.
How close is the company to a partnership for neuro and <unk>.
Speaker #6: There sure were. Statistical significance, right? although the study wasn't powered to determine superiority by statistical methods, you know, the increase in the MBAA titers with the second-generation constructs, were sufficiently large 141% for the G11 construct and 94% for the G24 construct.
James Cummings: There sure were. Statistical significance, right? Although the study wasn't powered to determine superiority by statistical methods, you know, the increase in the MBAA titers with the second-generation constructs were sufficiently large, 141% for the G11 construct and 94% for the G24 construct. This demonstrates statistical significance at the higher dose, which is why we pivoted over to the new construct high dose.
I know you talked about structure, but.
Where are we on timing yeah. Thanks for the question.
As I stated earlier, we had some really good one on one meetings at Bayou back in June and since then we continue our conversations with these potential partners.
Because these are confidential discussions.
Speaker #6: This demonstrates statistical significance at the higher dose, which is why we pivoted over to the new construct high dose.
It's hard for us to comment on timing, but certainly when we get to a point of an announcement will put that out there, but I want to just say that we remain in conversations with folks and they seem to certainly be productive and.
Speaker #3: Thanks. On the norofronto, I'll give you a break. For a second, James. we'll go to Steve. how close is the company to a partnership for noro?
Mayank Mamtani: Thanks. On the neuro front, I'll give you a break for a second, James. We'll go to Steve. How close is the company to a partnership for neuro? And I know you talked about structure, but where are we on timing?
Lot of times it's.
Wanting to see some of the data behind the trial et cetera.
Speaker #3: And I know you talked about structure, but where are we on timing?
Okay.
Thanks.
Speaker #5: Yeah. Thanks for the question. As I stated earlier, we, we had some really good one-on-one meetings at bio back in June and since then we continue our conversations with, these potential partners.
Steven Lo: Yeah, thanks for the question. As I stated earlier, we had some really good one-on-one meetings at Bio back in June. And since then, we continue our conversations with these potential partners. Because these are confidential discussions, it's hard for us to comment on timing. But certainly, when we get to a point of an announcement, we'll put that out there. But I want to just say that, you know, we remain in conversations with folks, and they seem to certainly be productive. And a lot of times, it's, you know, wanting to see additional, you know, some of the data behind the trial, etc.
A question for Sean.
The breast milk study showed promising results.
Have there been any discussions about another trial to further the understanding of whether there can be passive.
Transfer.
Speaker #5: because these are confidential discussions, it's hard for us to comment on timing, but certainly when we get to a point of, an announcement, we'll, we'll put that out there.
Yeah, obviously, we got some great results from the study and continue to evaluate our next steps are.
As soon as we have a decision we will make an announcement. However, much of this is funding a patent in this underscores just how important is for us to be able to access funding from a wide range of sources. The next study is likely to be funded by non dilutive funding sources for our partnership.
Speaker #5: But I, I want to just say that, you know, we remain in conversations with folks and they seem to certainly be, productive and a lot of times it's, you know, wanting to see additional, you know, some of the data behind the trial, etc.
Great and another question for you Sean.
Speaker #3: Thanks. question for Sean. The, the breast milk study showed promising results. Have there been any discussions about another trial to further the understanding of whether there can be passive immune transfer?
Mayank Mamtani: Thanks. Question for Sean. The breast milk study showed promising results. Have there been any discussions about another trial to further the understanding of whether there can be passive immune transfer?
This one is there are a whole inactivated virus vaccines have been mentioned in the news and how is that search results and <unk> construct compared to whole inactivated viruses things well.
<unk> haul inactivated viruses to Sars Kobe do have not done so well in clinical studies compared to mrna, we havent directly compared against these but if we do as well or better than the mrna and the BARDA supported study, we would expect to do better than haul inactivated viruses as well.
Speaker #6: Yeah, obviously we got some great results from the study and continue to evaluate our next steps. As soon as we have a decision, we will make an announcement.
James Cummings: Yeah, obviously, we got some great results from the study and continue to evaluate our next steps. As soon as we have a decision, we will make an announcement. However, much of this is funding dependent and underscores just how important it is for us to be able to access funding from a wide range of sources. The next study is likely to be funded by non-dilutive funding sources or a partnership.
Speaker #6: However, much of this is funding-dependent and underscores just how important it is for us to be able to access funding from a wide range of sources.
Speaker #6: The next study is likely to be funded by non-dilutive funding sources or a partnership.
Thanks, one more question.
Yes.
Speaker #3: Great. Another question for you, Sean. This one is, yeah, whole inactivated virus vaccines have been mentioned in the news. How do Vaxart's results and Vaxart's construct compare to whole inactivated virus vaccines?
It could be Steve or Jerome.
Mayank Mamtani: Great. Another question for you, Sean. This one is a whole inactivated virus.Vaccines
With cash runway into 2026, where capital raising strategies are you exploring.
Operator: have been mentioned in the news, and how does Vaxart's results and Vaxart's construct compare to whole inactivated virus vaccines?
Yeah, we're actively engaged in discussions as Steve has mentioned with several prospective partners regarding our vaccine platform and programs, including clearly Covid norovirus and flu.
Speaker #6: Well, whole inactivated viruses, the SARS-CoV-2, have not done so well in clinical studies compared to mRNA. we haven't directly compared against these, but if we do as well or better as the mRNA and the BARDA-supported study, we would expect to do better than whole inactivated viruses as well.
Operator: Well, whole inactivated viruses to SARS-CoV-2 have not done so well in clinical studies compared to mRNA. We haven't directly compared against these, but if we do as well or better as mRNA in the BARDA-supported study, we would expect to do better than whole inactivated viruses as well.
Prospective partners include both regional and global pharma companies.
At the same time I also want to emphasize that we maintain a highly disciplined approach to managing our expenses and ensuring that optimal resource allocation.
In order to extend our cash flows.
Speaker #3: Thanks. One more question; this could be Steve or Jerome. With cash runway into 2026, what capital raising strategies are you exploring?
Operator: Thanks. One more question. This could be Steve or Jerome. With cash runway into 2026, what capital raising strategies are you exploring?
Yeah, I'll just add that.
We really appreciate all the hard work of our employees and as Jerome mentioned in the opening comments right, where you had to reduce some of our workforce expenses and so that's always difficult.
Speaker #5: Yeah. We've actively engaged in discussions as Steve has mentioned with several prospective partners regarding our vaccine platform and programs, including clearly COVID, norovirus, and flu.
Operator: Yeah, we're actively engaged in discussions, as Steve has mentioned, with several prospective partners regarding our vaccine platform and programs, including clearly COVID, norovirus, and flu. Prospective partners include both regional and global pharma companies. At the same time, I also want to emphasize that we maintain a highly disciplined approach to managing our expenses and ensuring that optimal resource allocation in order to extend our cash flows.
For us.
And as John said, we look at a variety of ways to raise capital, but also control our spend.
And I will certainly say and will continue to beat on the drove that we believe that a listing on Nasdaq.
We're definitely strengthened our position in both the partnership discussions in future financings.
And again, we do encourage our shareholders to vote for the reverse stock split.
Operator: Yeah, I'll just add that we really appreciate all the hard work of our employees. And as Jerome mentioned in the opening comments, right, we had to reduce some of our workforce expenses. And so, you know, that's always difficult for us. And as Jerome said, we look at a variety of ways to raise capital, but also control our spend. And I'll certainly say, and we'll continue to beat on the drum, that, you know, we believe that a listing on NASDAQ would definitely strengthen our position in both the partnership discussions and future financings. And again, we do encourage our shareholders to vote for the reverse stock split. We are going to be happy to take questions. The whole entire management team will be there at the fireside chat next week.
We are going to be happy to take questions.
The whole entire management team will be there at the Fireside chat next week.
Okay. There are no more questions I will turn it back over to operator, Thank you to close the sale.
Thank you Sir.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
Operator: Okay, there are no more questions. We'll turn it back over to Operator. Thank you to close us out.
Operator: Thank you, sir. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.