Full Year 2023 Vaxart Inc Earnings Call
Edward B. Berg: Greetings and welcome to the Vaxart business update and full year 2023 financial results. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to IR at vaxart.com. As a reminder, this conference, I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Manager. Good afternoon, and welcome to today's call.
Greetings and welcome to the backs art business update and full year 2023 financial results conference call.
A question and answer session will follow management's opening remarks individual investors may submit written questions to IR at <unk> Dot com.
As a reminder, this conference is being recorded.
Michael J. Finney: Looking at the current landscape, and particularly given our recent ARDA contract award, we are now poised to make some major strides forward with our COVID-19 program. James will go over the details of the preparations and the study design. It is clear that the federal government believes we need better vaccines that harness the power of mucosal immunity to more strongly combat the current XDD and future variants of the virus. The first generation of vaccines was a start, but the viruses continue to evolve. We can do much better, and Vaxart is prepared to accept that challenge and demonstrate our technology. At the same time, we're making steady progress on our norovirus. We've completed our analyses of the recent challenge study data and have identified a potential correlate of protection, which will inform our upcoming meeting with the FDA to discuss the optimal path forward for this program. We continue to believe we have the most advanced norovirus vaccine candidate in clinical development. It's both formulated for oral administration and designed for delivery to the cat.
I would now like to turn the webcast over to your host Ed Burch, Senior Vice President and General Counsel.
Good afternoon, and welcome to today's call.
Unknown Executive: Joining us from Vaxart are Dr. Michael Finney, Interim Chief Executive Officer; Dr. Sean Tucker, Chief Scientific Officer; Dr. James Cummings, Chief Medical Officer; and Phil Lee, Chief Financial Officer. Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations, and its product development and regulatory progress, including statements about its ongoing or planned clinical trials. Actual results could differ materially from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process and other risks described in the risk factors section of Vaxart's most recently filed annual report on Form 10-K and also in other periodic reports filed with the SEC. Vaxart undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Dr. Michael Finney. Mike.
Joining us from back sorry, our Doctor, Michael Finney interim Chief Executive Officer, Dr. Sean Tucker Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and sell Lee Chief Financial Officer.
Before we begin I would like to remind everyone that during this conference call backs aren't may make forward looking statements, including statements about the company's financial results.
Natural guidance.
Its future business strategies and operations.
And its product development and regulatory progress, including statements about its ongoing or planned clinical trials.
Actual results could differ materially from those discussed in these forward looking statements.
Due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process and other risks described in the risk factors section of <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.
Michael J. Finney: Norovirus carries a tremendous economic burden in this country and globally, and we look forward to creating an oral vaccine that eases this burden for millions of society's most vulnerable. Finally, I can say with great pleasure that last week we announced the appointment of a permanent President and Chief Executive Officer, Steve Lowe. He brings a wealth of biopharma experience to Vaxart, with more than 25 years in healthcare, biotech, and pharmaceuticals, and absolutely more than 12 of those years in the CCC.
I'll now turn the call over to Doctor Michael Finney.
Mike.
Unknown Attendee: Thanks, Ed. And thanks to all of you for joining us today. It's a pleasure to be speaking with you at this exciting time in the company. As this is my first quarterly call with you, I will begin with a brief introduction of myself and my observations about our company, and then I'll transition the call to the rest of the team to move through our recent accomplishments, clinical programs, upcoming planned milestones, and full year. First, this is my second time as Vaxart's CEO, having served in a similar capacity from 2009 to 2011. I have been a Vaxart board member since 2007 and board chair since March 2020. Throughout my time with Vaxart, I've seen the company go through many periods of clinical and corporate growth and take on a variety of new challenges. Never have I been more confident in our team and in our trajectory than I am now.
Thanks, Chad and thanks to all of you for joining us today.
It's a pleasure to be speaking with you at this exciting time in the company's development.
As this is my first quarterly call with you I will begin with a brief introduction of myself and my observations of our company and then I'll transition to calls through the rest of the team to move through our recent accomplishments clinical programs upcoming planned milestones and full year.
Yeah.
First this is my second installment of snacks Hart CEO, having served in a similar capacity from 2009 2011.
I've been a <unk> board member since 2007 and board Chair since March 2023.
Throughout my time with Baxter I've seen the company go through many periods in clinical and corporate Roche take on a variety of new challenges.
Michael J. Finney: He's had a particular focus on development and commercialization, having helped two companies bring their first products to market. Vaxart is in a tremendous position to advance its mission. We are excited to add a high-caliber, experienced CEO to elevate this company to greater heights and create value for our shareholders. And currently, I will be stepping down as CEO and retaining my position as Chair of the Board. He joins Vaxart as of March 18, and we are thrilled to welcome him.
Never have I been more cautious in our team and in our trajectory and I am right now.
Unknown Attendee: I firmly believe 2023 was a transformational year for this and our mycosal technology, which made solid progress on our oral vaccines, completing two phase two clinical studies for our norovirus oral vaccine candidate. And we have now established proof of concept, two challenge studies for both respiratory and GI viruses. Based on the totality of the data we have produced through these and our other reported clinical trials, I think it's clear what we have our hands on. Our oral pill vaccine holds a very real promise of offering several advantages compared with injectable vaccines, including the ability to vaccinate people faster, easier, and painlessly. Without the need for cold chain storage or trained medical professionals to administer the vaccine, as well as the promise of New Council and New University.
I firmly believe 2023 was a transformational year for this company and our <unk> technology.
Made solid progress on our oral vaccine platform completing two phase II clinical studies for norovirus oral vaccine candidates.
We have now established proof of concept to challenge studies, both respiratory and Gi viruses.
Based on the totality of the data we have for us through these and our other reporting to clinical trials I think it's clear that what we have our hands on.
Our oral pill vaccines hold a very real promise of offering several advantages compared with injectables, including the ability to vaccinate people faster easier and painlessly without the need for cold chain storage are trained medical professionals to administer the vaccines as well as the promise and cultural immune response.
James F. Cummings: I'll now turn over the call to James to review the recent progress of our coronavirus program. Thanks, Mike. First, I want to thank our clinical, regulatory, CMC, and research teams who've worked tirelessly for nearly four years on our COVID-19 program. Their perseverance and dedication to our cutting-edge research have been crucial in laying the groundwork for this program's recent progress. All of us here at Vaxart were encouraged in January to receive a $9.27 million contract from BARDA to prepare for a 10,000 subject Phase IIb clinical trial evaluating our company's oral pill XBV COVID-19 vaccine candidate against an approved mRNA vaccine comparator. This award is part of the federal government's Project NextGen effort to boost our nation's pandemic preparedness and improve upon our collective ability to combat COVID Vaxart is one of only a handful of companies to receive funding from BARDA to date to prepare for a Phase IIb clinical trial under this very important initiative.
Unknown Attendee: We've already determined in preclinical and clinical trials that our candidates have a favorable immune profile and do serum antibody and serum neutralizing antibody responses, induce potent T cell responses, create mucosal immune responses, and can inhibit virus shedding, which may have an impact on virus transmission. Looking at the current landscape, and particularly given our recent ARDA contract award, we are now poised to make a major stride forward with our COVID-19 program James will go over the details of the preparations and the study design.
We've already determined.
In preclinical and clinical trials that are candidates have a favorable immune profile reduce serum antibody in serum neutralizing antibody responses.
Potent T cell responses create mucosal immune responses and can inhibit viral shedding, which may have an impact on virus transmission.
Looking at the current landscape and particularly given our recent Arctic contract Award. We are now poised to make a major stride forward with our COVID-19 program.
Gainesville go over the details of the preparations and the study design.
Unknown Attendee: But it is clear that the federal government believes we need better vaccines that harness the power of mucosal immunity to more strongly combat the current XDD and future variants of the virus. The first generation of vaccines was a start, but the viruses continue to evolve. We can do much better, and Vaxart is prepared to accept that challenge and demonstrate our technology. At the same time, we're making steady progress on our norovirus. We've completed our analyses of the recent challenge study data and have identified a potential correlate of protection, which will inform our upcoming meeting with the FDA to discuss the optimal path forward for this program. We continue to believe we have the most advanced norovirus vaccine candidate in clinical development. It's both formulated for oral administration and designed for delivery to the cat.
It is clear that the federal government believes we need better vaccines harnessed the power of mucosal immunity more strongly combat the current <unk> and future variants of the virus.
First generation of vaccines was to start with the virus has continued to evolve you can do much better in fact charters prepared to accept that challenge and demonstrate our technologies promise.
At the same time, we're making steady progress on our norovirus program, which completed our analysis of the recent challenge study data and have identified a potential correlate of protection, which will inform our upcoming meeting with the FDA to discuss the optimal path forward for this program.
We continue to believe we have the most advanced norovirus vaccine candidate in clinical development and spokes formulated for oral administration and designed for delivery to the gastrointestinal.
Unknown Attendee: Norovirus carries a tremendous economic burden in this country and globally, and we look forward to creating an oral vaccine that eases this burden for millions of society's most vulnerable. Finally, I can say with great pleasure that last week we announced the appointment of a permanent president and chief executive officer. Hilo brings a wealth of biopharma experience to Vaxart with more than 25 years in healthcare, biotech, and pharmaceutical. Absolutely more than 12 of those years have been in this.
Norovirus carries a tremendous economic burden in this country and globally and we look forward to creating oral vaccine that eases the burden for millions of societies most vulnerable.
James F. Cummings: We're heartened by the government's support, which we think is indicative of the potential of our differentiated approach to the continuing challenge that is COVID-19. This support will empower Vaxart to move forward with our oral COVID-19 program. Currently, we're engaged in preparations to initiate this Phase 2B trial. This trial, which may start as early as Q2 in 2024, is a Phase 2B double-blinded, multicenter, randomized, comparator-controlled clinical trial to determine the relative efficacy, safety, and immunogenicity of Vaxart's investigational oral SARS-CoV-2 XBB vaccine tablet against a currently approved mRNA CO As we continue our clinical trial preparations, we're working to secure additional funding, which would support the initiation and conduct of the Phase IIb study. We will provide the timing and amount of any additional funding as events unfold.
Finally, I can say with great pleasure that last week, we announced the appointment of a permanent president and Chief Executive Officer, Steve Lo <unk>.
He brings a wealth of biopharma experienced <unk> with more than 25 years in health care biotech and pharmaceuticals, including more than 12 of those years in the C suite here.
Unknown Attendee: He's had a particular focus on development and commercialization, having helped two companies bring their first products to market. Vaxart is in a tremendous position to advance its mission. We are excited to add a high-caliber, experienced CEO to elevate this company to greater heights and create value for our shareholders. And currently, I will be stepping down as CEO and retaining my position as Chair of. He joins Vaxart as of March 18, and we are thrilled to welcome him.
He's had a particular focus on development and commercialization, having helped two companies bring their first product to market.
Sorry.
Tremendous vision to advance its mission, we are excited to add a high caliber experienced CEO calibrate this company to greater heights and create value for our shareholders.
The currently I'll be stepping down as CEO and regaining my position as chair of the board.
He joins <unk> effective March 18, and we are thrilled to welcome him.
James F. Cummings: I'll now turn over the call to James to review the recent progress of our coronavirus. Thanks, Mike. First, I want to thank our clinical, regulatory, CMC, and research teams who've worked tirelessly for nearly four years on our COVID-19 program. Their perseverance and dedication to our cutting-edge research have been crucial in laying the groundwork for this program's recent progress. All of us here at Vaxart were encouraged in January to receive a $9.27 million contract from BARDA to prepare for a 10,000 subject Phase IIb clinical trial evaluating our company's oral pill XBV COVID-19 vaccine candidate against an approved mRNA vaccine comparator. This award is part of the federal government's Project NextGen effort to boost our nation's pandemic preparedness and improve upon our collective ability to combat COVID Vaxart is one of only a handful of companies to receive funding from BARDA to date to prepare for a Phase IIb clinical trial under this very important initiative.
I'll now turn it over the call to James to review the recent progress for our corridor of Iris program.
Thanks, Mike.
First I want to thank our clinical regulatory CMC and research teams who've worked tirelessly for nearly four years on our COVID-19 program.
Their perseverance and dedication to our cutting edge research have been crucial and laying the groundwork for this programs recent progress.
All of US here in fact start we're encouraged in January to receive a 9.2 dollars 7 million dollar contract from BARDA to prepare for a 10000 subject phase <unk> clinical trial evaluating our company's oral pill ex COVID-19.
COVID-19 vaccine candidate against an approved mrna vaccine comparator.
James F. Cummings: Commensurate with additional funding, we hope to be among the first of the Project NextGen recipients to initiate our Phase IIb head-to-head clinical trial. Last month, we continued to demonstrate the cross-protective potential of our COVID-19 vaccine candidates with the publication of previously announced data in the journal Vaccines. This preclinical non-human primate data showed that our vaccine candidates could protect against multiple SARS-CoV-2 variants of concern, as they elicited strong antigen-specific serum IgG and IgA responses with neutralizing activity. Vaccination also reduced SARS-CoV-2 shedding following infectious challenge in both the upper and lower airway of non-human primates.
This award is part of the Federal government's project next Gen efforts to boost our nations pandemic preparedness and improve upon our collective ability to combat COVID-19.
Thanks Art.
One of only a handful of companies to receive funding from BARDA to date to prepare for a phase two b clinical trial under this very important initiatives.
James F. Cummings: We're heartened by the government's support, which we think is indicative of the potential of our differentiated approach to the continuing challenge that is COVID-19. This support will empower Vaxart to move forward with our oral COVID-19 program. Currently, we are engaged in preparations to initiate this phase 2b trial. This trial, which may start as early as Q2 in 2024, is a Phase 2B double-blinded, multicenter, randomized, comparator-controlled clinical trial to determine the relative efficacy, safety, and immunogenicity of Vaxart's investigational oral SARS-CoV-2 XBB vaccine tablet against an approved mRNA COVID-19 needle-injected booster vaccine in adults previously immunized against COVID-19
We're heartened by the government support, which we think is indicative of the potential of our differentiated approach to the continuing challenge that is COVID-19.
This support will empower <unk> to move forward with our oral COVID-19 program.
Currently we are engaged in preparations to initiate this phase two b trial.
This trial, which may start as early as Q2 in 2024.
The phase two b double blinded multi center randomized comparator controlled clinical trial to determine the relative efficacy safety and immunogenicity of <unk> investigational oral Sars koby to SBB vaccine tablets against our currently approved.
James F. Cummings: Publications in highly respected journals, such as Vaccines, are really important because they continue to show that our groundbreaking research is being recognized by the scientific community. These data also serve as the foundation for our current COVID-19 vaccine candidate, which will be evaluated during the upcoming Phase 2b clinical trial. Vaxart's vast platform and technology have great potential.
Mrna COVID-19 needle injected booster vaccine in adults previously immunized against COVID-19 infection.
James F. Cummings: As we continue our clinical trial preparations, we're working to secure additional funding, which would support the initiation and conduct of the Phase IIb study. We will provide the timing and amount of any additional funding as events unfold. Commensurate with additional funding, we hope to be among the first of the Project NextGen recipients to initiate our Phase IIb head-to-head clinical trial. Last month, we continued to demonstrate the cross-protective potential of our COVID-19 vaccine candidates with the publication of previously announced data in the journal Vaccines. This pre-clinical non-human primate data showed that our vaccine candidates could protect against multiple SARS-CoV-2 variants of concern as they elicited strong antigen-specific serum IgG and IgA responses with neutralizing activity. Vaccination also reduced SARS-CoV-2 shedding following infectious challenge in both the upper and lower airway of non-human primates.
As we continue our clinical trial preparations, we're working to secure additional funding, which would support the initiation and conduct of the phase <unk> study.
We will provide the timing and amount of any additional funding as events warrant.
Insert with additional funding we hope to be among the first of the project Nextgen recipients to initiate our phase to be head to head clinical trial.
Sean N. Tucker: We believe this platform could transform the landscape, not only for COVID-19 vaccines, but also for other infectious diseases that present a significant threat to global public health, such as norovirus and Influenza. We're very proud of our entire team as we continue to lead the way in mucosal vaccine science. I'll now hand the call over to Dr. Sean Tucker, our chief science officer and founder, for an update on our norovirus vaccine program
Last month, we continued to demonstrate the cross protective potential of our COVID-19 vaccine candidates with the publication of previously announced data in the journal vaccines.
This preclinical nonhuman primate data show that our vaccine candidates could protect against multiple Sars COVID-19 two variants of concern.
Elicited strong antigen specific CRM, agg, and Iga responses with neutralizing activity.
Vaccination also reduced Sars koby to shedding following infectious challenge in both the upper and lower airway of nonhuman primates.
Sean N. Tucker: Thanks, James. We made significant progress in our norovirus program in 2023, delivering top-line data from two phase two studies, including a challenge study of our G11 monovalent candidate. We have evaluated most of the data, and we believe we are on track to identify potential correlative protection that will aid in the advancement of our bivalent norovirus candidate. We believe the data we have shared to date is promising for this vaccine candidate and for our vaccine platform overall. Late in the fourth quarter, we completed enrollment in our Phase 1 clinical trial to evaluate the ability of our norovirus vaccine candidates to induce antibodies in lactating mothers' breast milk and transfer those antibodies to young infants. Recall that this study is being supported partially by the Bill and Melinda Gates Foundation. This Phase 1 multicenter, randomized, double-blind, placebo-controlled, dose-ranging study is designed to evaluate the safety, tolerability, and immunogenicity of our oral-administered, bivalent G1-1, G2-4 vaccine in healthy, lactating females of at least 18 years of age. The study enrolled 76 subjects at five sites in South Africa.
James Cummings: Publications in highly respected journals such as Vaccines, are really important because they continue to show that our groundbreaking research is being recognized by the scientific community. These data also serve as the foundation for our current COVID-19 vaccine candidate, which will be evaluated during the upcoming Phase 2b clinical trial. Vaxart's vast platform and technology has great potential.
Publications and highly respected journals such as vaccines.
But really important because they continue to shell that our groundbreaking research is being recognized by the scientific community.
These data also serve as the foundation for our current <unk> COVID-19 vaccine candidate, which will be evaluated during the upcoming phase two b clinical trial.
<unk> vast platform and technology has great potential.
We believe this platform could transform the landscape not only for COVID-19 vaccines, but also for other infectious diseases that present significant threats.
The global public health, such as Norovirus and influenza.
We're very proud of our entire team as we continue to lead the way in your coastal vaccine science.
I'll now hand, the call over to Dr. Shawn Tucker, our Chief Science Officer, and founder for an update on our Norovirus vaccine program Sean.
Thanks, James we made significant progress in our norovirus program in 2023, delivering topline data from two phase II studies, including a challenge study of RG. One one monovalent candidate we have evaluated most of the data and we built and we believe we are on track for identify potential correlate.
The protection that will aid in the advancement of our bivalent Norovirus candidate.
We believe the data we have shared to date is promising for this vaccine candidate and for our vaccine platform overall.
Late in the fourth quarter, we completed enrollment of our phase one clinical trial to evaluate the ability of our norovirus vaccine candidate to induce antibodies in lactating mothers breast milk and transfer those antibodies to young infants.
Sean N. Tucker: These subjects were randomized to high or low doses of the vaccine or placebo. The primary endpoints of the study are frequency, duration, and severity of solicited symptoms of COVID-19 for one week following the study drug test. Also, Frequency, Duration, and Severity of Unsolicited Treatment of Adverse Events, Serious Adverse Events, Adverse Events of Special Interest, and New Onset of Clinical Illness through the Active Period
Recall that this study is being supported partially by the Bill and Melinda Gates Foundation.
This phase one multicenter randomized double blind placebo controlled dose ranging study is designed to evaluate the safety tolerability and immunogenicity of our oral administered bivalent G. One one G tube for vaccine in healthy lactating females of at least 18 years of age the study enrolled 76 W.
At five sites in South Africa.
These subjects were randomized into high or low dose vaccine or placebo.
The primary endpoints for the study of frequency duration and severity of solicited symptom Sir.
For one week following the study drug dose frequency.
The duration and severity of unsolicited treatment adverse events serious adverse events adverse events of special interest and new onset of clinical illness through the active period.
Sean N. Tucker: In particular, and what's most exciting, is that this study will look for VP1 specific IgG1 and IgG4 IgA in the serum and in the breast milk. We are currently expecting to announce top-line results from this Phase 1 trial in mid-2024. Going forward, we plan to meet with the FDA during the second quarter of 2024 to discuss our data on potential correlates, a phase 2B dose confirmation study, and potentially a G24 challenge study. We currently believe a phase 2B study would generate sufficient safety data to have an end of phase 2 meeting with the FDA. An end of phase two meeting will allow us to gain agreement with the FDA on the scope and design of a phase three pivotal efficacy study in adults over 18 years of age.
In particular and what's most exciting is that this study will look for DP, one specific I G. G. One and ITG for Iga in the serum and in the breast though.
We are currently expecting to announce topline results from this phase one trial in mid 2024.
Going forward, we plan to meet with the FDA during the second quarter of 2024 to discuss our data on potential correlates.
Phase II dose confirmation study and potentially a G. Two four challenge study with.
Currently believe AG phase II B study would generate sufficient safety data to have an end of phase II meeting with the FDA.
And end of phase two meeting with allow us to gain concurrence with the FDA on the scope and design of our phase III pivotal efficacy study in adults over 18 years of age.
Phillip Eric Lee: That said, the type and timing of our next clinical study will be determined following our meeting with the FDA in Q2. We plan to provide an update on the next steps for this program as soon as we are able to after that meeting. I'll now hand the call over to Phil Lee, our CFO, for a brief discussion of our financials. Phil?
That said the type and timing of our next clinical study will be determined following our meeting with the FDA in Q2.
We plan to provide an update on the next steps for this program as soon as we are able to after that meeting I'll now hand, the call over to Phil Lee our CFO for a brief discussion of our financial Phil.
Phillip Eric Lee: Thank you, Sean. The details of our financial results for the full year 2023 are summarized in today's press release. Revenue for 2023 was $7.4 million, compared to $0.1 million in 2022. Revenue in 2023 was primarily from revenue recognized for work performed under Vaxart's grant from the Bill and Melinda Gates Foundation and non-cash royalty revenue from increased sales of Inovere in Japan. Vaxart ended 2023 with cash, cash equivalents, and investments of $39.7 million. This cash balance does not include approximately $15 million in net proceeds raised in early 2024.
Thank you Sean.
The details of our financial results for the full year 2023 are summarized in today's press release.
Revenue for 2023 or $7.4 million compared to zero point $1 million in 2022.
Revenue in 2023 was primarily from revenue recognized for work performed under our backs are scrap from the Bill and Melinda Gates Foundation, and noncash royalty revenue from increased sales of <unk>, Japan.
That's where it ended 2023 with cash cash equivalents and investments of $39 $7 million.
This cash balance does not include approximately $15 million net proceeds raised in early 2024.
Operator: Vaxart anticipates its current cash runway into the fourth quarter of 2024. Thank you all for your time today. We will now open the call to your questions. Thank you for watching!
<unk> anticipates current cash runway into the fourth quarter of 2024.
Thank you all for your time today, we will now open the call for your questions.
Thank you we will now be conducting a question and answer session.
Operator: We will now be conducting a question and answer session. If you would like to ask a question, please use the Q&A box on your screen. Or, please press star 1 on your telephone.
We would like to ask a question. Please press star one on your telephone keypad.
Operator: A confirmation tone will indicate your line is in the question. You may press star 2 if you would like to remove your question from. For participants using speaker equipment, it may be necessary to pick up your handset before pressing, One moment, please, while we poll for questions. [inaudible] Our first question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question. Hi team, this is Asia on behalf of Charles.
Confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
One moment, please pull for questions.
Thank you.
First question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
Hi team. This is <unk> on for Charles we have a question regarding the lactating mothers study can you talk about.
Sean N. Tucker: We have a question regarding the lactating mother study. Can you talk about possibly what you would like to see from this phase one study that could further differentiate the oral norovirus pills target product profile and possibly support approval in the future? Thank you. Sean, do you want to handle that one? Yeah, I'll start and then let James jump in. Yeah, I mean, the key thing about this experiment, or I should say this clinical study, is that by giving the vaccine to lactating mothers, we hope to see antibodies in the breast milk, and those breast milk antibodies will be transferred to young infants. As you might know, one of the main, I should say, young children are probably the most susceptible to norovirus infection, and by getting the antibodies into kids, whether via breast milk, we think that's going to have a big impact.
Possibly what you would like to see from this phase one study that could further differentiate the oral norovirus pills target product profile and possibly supporting approval in the future. Thank you.
Sean do you want to handle that one.
Yeah, I'll start and then let James.
Jump in Yeah, I mean, the key thing about this experiment.
I'd say this clinical study is by giving the vaccine to lactating mothers, we hope to see antibodies in Nebraska milk and those vast milk antibodies will be transferred to young infants as you might know.
No that one of the main.
I should say young children are probably the most susceptible to norovirus infection and by getting the antibodies into kids, but there will be a vast breast milk. We think that's going to have a big impact we hope that this not only by protecting the mother and the kids. We could also protect essentially by the SEC.
Sean N. Tucker: We hope that this, you know, not only by protecting the mother and the kids, but we could also protect, you know, essentially by, if these antibodies are going to be very good and have great efficacy, we could also have the ability to block transmission to other people in the community. James, do you want to add anything? Thanks, Sean.
If these antibodies are going to be very good and great efficacy. We could also have bought have ability to block transmission to other people in the community James do you want to add anything.
Thanks, Sean you know, there's a rich history.
Maternal immunization to assist with covering children.
James F. Cummings: But I think the interesting thing about our vast platform is that it does such a compelling job on mucosal immunity and on IGA production. So taking a look at those levels in the breast milk in a more formalized way and then taking a look at potentially how the children do with that breast milk laden with maternal antibodies should go a long way to bettering our understanding of how this platform could work to potentially impact that pediatric population. Thank you. Our next question comes from the line of Roger Song with Jeffreys: please proceed with your, Thank you. This is Liang Cheng and Roger Song.
The interesting thing about our vast platform is it does such a compelling job on mucosal immunity and on Iga production. So taking a look at those levels in the breast milk and a more formalized way and then taking a look at.
Potentially how the children.
Do with breast milk laden with maternal antibodies should go a long way to bettering our understanding of how this platform could work to potentially.
Impact that pediatric population.
Thank you.
Our next question comes from the line of Roger song with Jefferies. Please proceed with your question.
Great. Thank you. This is a downturn on Roger song. So we have a couple of questions. So I guess, maybe the first one.
Phillip Eric Lee: So we have a couple of questions. So I guess maybe the first one is, you know, would you remind us about the economics of the BARDA next-gen funding and how that would impact your runway down to the year? Then I have some follow-up questions. Thank you. Well, the BARDA contract we announced in January provides funding to prepare for a Phase 2b COVID-19 trial, but we can't speculate about BARDA's award process or timing. Other companies have announced that they are subject to an option agreement with BARDA where BARDA might provide something in the neighborhood of $400 million to execute on the contract.
Could you remind us of the economics of Nevada, Nextgen funding and how would that impact your runway down to the year.
Then I have some follow up questions. Thank you.
Okay.
Well the BARDA contract, we announced in January provides funding to prepare for a phase II B COVID-19 trial, we can't speculate about BARDA award process or timing.
Other.
Other companies have announced that they are they were subject to an option agreement with BARDA.
We're BARDA might provide something in the neighborhood of $400 million too.
Phillip Eric Lee: We believe that as we execute against the milestones in this contract, we'll be in a position to receive additional funds. Unknown Speaker. The details are not things that we can, that we have any ability to talk about right now. We'll provide an update as we gain additional visibility. Sure, thank you. So my next question is about the protection correlates. So I wonder, you know, how would that protection correlates impact your phase three study plan? Sean, I think you're the expert on that. Yes, I'll start and again I'll let James follow along. I think the key thing about understanding what immune parameters are important is good for a variety of reasons, but one of the things is that if you have an established correlate of protection of your vaccine, so you know that measuring this immune parameter leads to protection, it could lead to a reduction in and out of subjects that you need to test in a phase three efficacy study because that correlate can be used essentially to understand what's protective and you can use it to bridge between different age groups.
To execute on the contract.
We believe that as we execute against the milestones in this contract will be in a position to receive additional funds.
The details.
Are not things that we can do we have any ability to talk about right now will provide an update as we gain additional visibility.
Sure. Thank you.
So my next question, it's part of the protection correlates. So I wonder how how would that protection correlates impact your phase III.
At the plant.
Sean I think you're the expert on that.
Yes, I'm going to I'll start and again I'll, let James follow at all along.
The key thing about understanding what immune parameters are important for our is good for a variety of reasons, but one of the things is that if you have an established correlated protection.
Of your vaccine. So you know that this measure used to mean parameter leads.
It leads to protection it could lead to a reduction in out of subjects that you need to test in our phase III efficacy study because that correlate can be used essentially to understand what is protective and you can use it to bridge between different age groups James.
Sean N. Tucker: James, would you like to add to that? Thanks, Sean. So, you know, we're very excited about the work that Sean and his team are doing there. And, you know, as Sean had mentioned, defining a correlate is an impressive piece of work. With further discussion, there is the potential to consider that as a surrogate for protection. And as Sean mentioned, it would impact both the numbers required for a clinical field study in phase, as well as potentially the duration of time of that study, going on, looking at those immune correlate parameters and not just field efficacy.
James would you like to add to that.
Thanks, Sean so.
Yeah, we're very excited about the work that Sean and his team is doing there and.
As Sean had mentioned.
Defining a correlate.
It's an impressive piece of work.
With further discussion there is a potential to consider that as a surrogate for protection and as Sean mentioned it would.
TAC both at the numbers required for our clinical field study in phase III as.
As well as potentially the duration of time that that study would would go on looking at those immune correlate parameters and not just field efficacy. So more to follow as we have that discussion in the near future. Thank you.
James F. Cummings: So more to follow as we have that discussion in the near future. Got it. Thank you. Maybe my last question is about, you know, the potential Phase 2D to 4 challenge study. So what would be some key considerations or discussions regarding the necessity of this study? James, can you answer that?
Got it. Thank you maybe my last question is about.
The potential to do.
<unk> four challenge study, but what would be some kidney cultivation or discussion.
Guarding the necessity of this study.
Yeah.
Hi, James can you answer that.
James F. Cummings: Certainly. So thanks, Roger. I think that, you know, we'll gain a lot of information in our conversation with the agency. If they require additional information from an additional challenge, G24 would be a challenge study that could be performed. You know, it's something that we've looked into in a just-in-case scenario, if it is required. And if it's not, you know, it's not, right
Certainly so thanks Raj so I think that.
We'll gain a lot of information in our conversation with the agency if they require additional.
Information from an additional challenge.
Two four would be a challenge study that could be performed at Sep is something that we've looked into and adjusting case scenario. If it is required.
And if it's not.
It's all right I think we'll have a lot more clarity.
James F. Cummings: I think we'll have a lot more clarity on if we are required to do an additional challenge study after we have that meeting with the agency. Thank you, James. Okay. Okay. Thank you. I think that's it from us.
If we are required to do an additional challenge study after we have that meeting with the agency.
Thank you James got it got it. Thank you I think that's it from us.
Thank you.
Thank you. Our next question comes from the line of modern young Moms.
Edward B. Berg: Thank you. Thank you. Our next question comes from the line of Mon Young. Mahmantani, with B. Reilly. Please proceed with your Hey, guys, Madison Olin for Mayank.
Johnny with B Riley Securities. Please proceed with your question.
Hey, guys Madison one for Mick.
Congrats on the progress and if I can ask a follow up to the previous question.
James F. Cummings: Congratulations on the progress. And if I can ask a follow-up to the previous question, in the event that you do have a G2-4 challenge study, I'm just wondering how fast you think you'll be able to get that study up and running?
In the event that you do have a.
G. Two four challenge study just.
Just wondering how fast do you think youll be able to get that study up and running and then secondly, an unrelated.
James F. Cummings: And then secondly, unrelated, maybe you mentioned, for BARDA Phase II, will you be using a commercial grade material for your Vax team? Mike, would you like me to go forward on that? Sure. Yes. Yes. Please.
Do you maybe mentioned I'm not sure.
For the BARDA phase two will you be using a commercial grade material.
For Europe.
Yes.
Mike.
Go forward on that sure yes.
James F. Cummings: I sure will. So in terms of your second question, first, I guess this phase two B study that would be executed is just that. It's a clinical trial under the auspices of good clinical practice guidelines and rules and regulations from the FDA. So it requires GMP manufactured material, which is what we use in all of our clinical trials.
Sure well so in terms of your second question first I guess.
This this phase to the study that would be executed.
It's just that it's a clinical trial under the auspices.
The good clinical practice guidelines and rules and regulations from the FDA. So it requires a GMP manufactured material, which is what we use in and all of our clinical trials.
James F. Cummings: So I think that should square that away. The comparator vaccine will be an approved mRNA Needle Injected Vaccine. And we'll be comparing the efficacy of both of those vaccines or candidate vaccines against one another. And we'll also be looking at safety. You know, we in our platform have a very fortunately, very clean safety profile, and we'll be comparing that to, you know, the solicited and unsolicited adverse events both from our product but also from that needle-based injection of an mRNA booster. And we'll be looking at that data as well. What was your second question? And secondly, follow up to the prior question, in the event, after your meeting with the FDA, in the event that you were to run a challenge study, just curious how fast you guys could initiate it. Yes. Well, I think there is, it just depends on what the guidance of the FDA really tells us, right?
So that I think that should square that away the comparator vaccine.
He will be an approved.
<unk>.
Mrna needle injected vaccine and we will be comparing the efficacy.
Both of those vaccines or candidate vaccines against one another.
Also be looking at safety.
We and our platform have a very fortunately very clean safety profile, and we will be comparing that to.
The solicited and unsolicited adverse events, both from our product, but also from that needle based injection of mrna booster and will be.
Looking at that data as well, but what was your second question.
And secondly, a follow up to the prior question in the event. After your meeting with the FDA in the event that you were to run a challenge study just curious how fast you.
Guys could initiate.
Well I think there is it just depends on what the guidance of the FDA really tells US right. So I don't want to speak for the agency or make any assumptions until after we have that meeting and that said the good news is that.
James F. Cummings: So I don't want to speak for the agency or make any assumptions until after we have that meeting. That said, the good news is that there are groups that have been refining what that challenge model is in the United States. So I think we could, in relatively short order, move forward with a challenge study. I can't be more specific than that until we have the dialogue with the agency. Okay. Thanks.
There are groups that have been refining what is that challenge model.
In the United States. So I think we could in relatively short order and move forward with a challenge study.
Can't be more specific than that until we have the dialogue with the agency.
Understood. Thanks.
Mhm.
James F. Cummings: Thank you. I would now like to turn the call back over to Ed Berg for further questions. Thank you, operator. We'll now turn to questions submitted by our shareholders. So the first question is for Mike Finney. Since incoming CEO Steve Lowe has had success in the first product commercialization, was that the primary factor in your search? What other attributes?
Thank you.
I would now like to turn the call back over to Ed Baird for further questions.
Thank you operator.
We'll now turn to questions submitted by our shareholders.
So the first question is.
For Mike Finney.
Incoming CEO, Steve Lo has had success in the first product commercialization was that the primary factor in your search.
What other attributes did you consider and how did you make the selection.
Michael J. Finney: What did you consider and how did you make the selection? Well, regulatory and commercialization experience are, of course, important, but the board was looking for an all-around performer, and I think we found that with Steve. Thanks, Mike. Our next question is: What is the timing for the next steps for Neurovirus? This is on timing.
Regulatory and commercialization experience are of course important but the board was looking for an all round performer and I think we found that with Steve.
Thanks, Mike.
Our next question.
What is the timing for next steps for norovirus.
James F. Cummings: Following your FDA meeting in Q2, and James, I think you've answered some portion of this, but I'll turn to you. Sure. So timing and next steps will, as I mentioned, be dependent on the dialogue with the FDA, right? We'll assess at that time and look forward to providing an update to anyone really who's interested after we have that meeting. The nice thing is there's a couple of ways we see looking at the impact of how a next step would be, whether it's with the phase 2b dose confirmation study for more safety data, whether it's for a challenge study that may be required or may not be required to give more information on quality protection, and then with the whole idea of looking down range to a potential phase 3 study. Thanks, James. Another question on the neurovirus.
On timing following your FDA meeting in Q2, and James I think you've answered some portion of this but I'll turn to you.
Sure so.
Timing and next steps rule as I mentioned be dependent.
The dialogue with the FDA right, we'll assess at that time and look forward to providing an update too many of them really as interested after we have that meeting.
The nice thing is theirs.
A couple of ways, we see.
Looking at the impact us our next step would be whether it's.
The phase II dose confirmation study from our safety data, whether it's for US a challenge study.
May be you required it may not be required to give more information of quality protection and then with the whole idea of looking down range to two.
Potential phase III study.
That's the goal.
Thanks, James and the other question on Norovirus.
Will you be disclosing the results of your norovirus data analysis and the correlate of protection, Sean I think this is yours.
Yeah, I mean, obviously very excited about the work we've done and of course, we will share our findings at the AE. After we gathered input and then we'll next assess the next steps for the program and once all that's done we also plan to submit a peer reviewed manuscript and again the timing of that will be determined at a future date.
Sean N. Tucker: Will you be disclosing the results of your Neurovirus Data Analysis and the Correlation of Protection? Sean, I think this is yours. Yeah, obviously, very excited about the work we've done, and you know, of course, we will share our findings with you after we gather its input, and then we'll next assess the next steps for the program. And once all that's done, we also plan to submit a peer-reviewed manuscript. And again, the timing of that will be determined at a future date. Thanks, Sean. Next question. Please elaborate on the preparations for the Phase 2B COVID trial. When do you expect to complete the preparations? James, I believe this is your... Sure. So, you know, we've been coordinating with our colleagues at BARDA, and we've done, I think, a great job in terms of moving forward, progressing with preparation for what is a really significant endeavor, a Phase IIb study of 10,000 enrollees. Once we have that completed, we will update you. Okay, thanks. That is all the questions we have at this time.
Thanks, Sean.
Next question.
Please elaborate on the preparations for the phase two B Covid trial, when do you expect to complete preparations James I believe this is yours.
Sure.
So we've been coordinating with our colleagues at BARDA.
And we've done I think a great job in terms of moving forward progressing with preparation for what is a really significant endeavor.
Phase II study of 10000 enrollees.
Once we have that completed we will update you.
Okay. Thanks.
That is all the questions. We have at this time, so I want to thank everyone today for joining us and this concludes today's call.
Thank you.
Thank you Ed.
You may disconnect your lines at this time and have a wonderful day, we thank you for your participation.
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James F. Cummings: So I want to thank everyone today for joining us. And this concludes today's call. Thank you. Thank you, Ed. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation.
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