Q3 2023 Vaxart Inc Earnings Call
Speaker 1: Greetings and welcome to the Vaxart Business Update and third quarter 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 vaxart.com. As a reminder this conference is being recorded.
Greetings and welcome to the Zacks Heart business update and third quarter 2023 financial results Conference call. A question and answer session will follow management's opening remarks and.
Individual investors may submit written questions to IR at <unk> Dot com.
As a reminder, this conference is being recorded.
Speaker 1: I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel. Please go ahead, Ed.
I would now like to turn the webcast over to your host Ed Burke Senior Vice President and General Counsel. Please go ahead.
Speaker 2: Good afternoon and welcome to today's call. Joining us from Vaxart are Andre Florio, Chief Executive Officer, Dr. James Cummings, Chief Medical Officer, Philip Lee, Chief Financial Officer, and Brant Bean, Senior Vice President for Business Operations.
Good afternoon, and welcome to today's call joining.
Joining us from <unk> are Andre Florio, Chief Executive Officer, Dr. James Cummings, Chief Medical Officer, Philip Lee, Chief Financial Officer, and Brent being senior Vice President for business operations.
Speaker 2: Before we begin, I would like to remind everyone that during this conference call, Baxart may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business...
Before we begin I would like to remind everyone that during this conference call backs or I may make forward looking statements, including statements about the company's financial results.
Financial guidance.
Its future business strategies and operations.
Speaker 2: and its product development and regulatory progress, including statements about its ongoing or planned clinical trial.
And its product development and regulatory progress, including statements about its ongoing or planned clinical trials.
Speaker 2: 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 vaxarts most recently filed annual report on form 10k 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.
<unk> uncertainty inherent in the clinical development and regulatory process and other risks described in the risk factors section.
Section.
<unk> most recently filed annual report on Form 10-K.
And also on other periodic reports filed with the SEC.
Speaker 2: Baxart undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Andre.
<unk> undertakes no obligation to update any forward looking statements. After the date of this call.
I'll now turn the call over to Andre Florida.
Andre.
Speaker 3: Thank you, Ed. And thank you to all of you for joining us today.
Thank you Anne and thank you for all of you for joining us today.
Speaker 3: On today's call, we'll highlight the recent clinical progress we have made on our coronavirus auto-field vaccine program.
On today's call, we'll highlight the recent clinical progress we have made on our model of ours or.
I'll handle that in program.
Speaker 3: We will also provide a look at our planned milestones and briefly discuss our COVID program before opening the call to your question.
He will also provide a look at our plan milestones and briefly discuss our coffee program before opening the call to your questions.
Speaker 3: During the first quarter, we took important steps to validate our mucosal vaccine plus.
During the first quarter, we took important steps to validate army of course other vaccine platform.
Speaker 3: We released encouraging top line data from two phase two trials of our norovirus program.
Well at least encouraging topline data from two phase two trials, so far the nodal wireless program.
Speaker 3: First, from our phase two dose ranging study for our bivalent norovirus oral vaccine candidate, and then from our phase two...
First put them on a phase two dose ranging study put out by hail a little wireless all vaccine candidates.
And then from a faithful nuttall quite a challenge study.
Speaker 3: The data we generated from both of these trials will drive the next steps for this program, which we believe has the potential to transform both how we think of norovirus and the vaccination paradigm as we know.
So they thought we generated on both of these trials will drive the next steps for this program, which we believe has the potential to transform both how we think that'll bias and the vaccination paradigm I see now.
James will go over the scientific findings from these trials in more detail.
Speaker 3: James will go over the scientific findings from these trials in more detail.
Speaker 3: But beforehand, there are a few key points I'd like to share in terms of what we have learned at this stage of our norovirus work.
Beforehand that out a few key points I'd like to share in terms of what we have learned at this stage of automotive wireless program.
Speaker 3: First, our oral pill vaccine candidate has the potential to reduce the rates of norovirus infection, acute gastroenteritis, and viral shedding. These were key results from our recent challenge.
First all of the people vaccine candidate has the potential to reduce the rate so not a lot of infection.
Acute gastroenteritis and vital.
These are the key results from our recent challenges.
Speaker 3: We believe that when we substantially reduce shedding, we dramatically slow down the rate of transmission.
We believe that's why do we substantially reduced spending will dramatically slow down the rate of transmission.
Speaker 3: That is an incredible potential benefit of this vaccine.
That'd be something incredible for past so benefit of these vaccines.
Speaker 3: Second, we believe this data validate the potential of our oral tablet norovirus vaccine program.
We believe these data validate the potential of our oral tablet norovirus vaccine program.
Speaker 3: We now have completed eight clinical trials for Norovirus.
We now have completed eight clinical trials for the bottle virus.
Speaker 3: all of which showed that our vaccines induce strong immune responses and are safe and well-tolerated with no vaccine-related serious adverse events.
Wheatstone.
Our vaccines induced strong immune responses.
Safe and well tolerated with no vaccine related serious adverse events.
Speaker 3: We are confident in Jax
We are confident in fact starts platform and Anoro hottest programs specifically.
Aimed towards a registrational phase III study.
Speaker 3: And third, we believe we have established clinical proof of concepts for our oral pill platform via now two human challenge studies, one for neurovirus and the other for influenza.
And third.
We believe we have established clinical proof of concept for our oilfield.
Platform <unk>.
Yeah now towards human challenge patents, one for the novel virus and the other for influenza.
Speaker 3: In each case, we demonstrated that our oral pill vaccine technology
In each case, we demonstrated that's all all TD vaccine technology.
Speaker 3: has a clear and consistent impact on a number of important measures and practices.
A clear and Pos system.
On a number of important metrics such as did you say that April infection illness and shedding.
Speaker 3: such as reducing the rate of infection, illness, and shedding.
Speaker 3: We continue to believe we have the most advanced not-of-virus vaccine candidate in clinical development that is both formulated for oral administration and designs for delivery to the gastrointestinal system.
We continue to believe we have the most advanced norovirus vaccine candidate in clinical development that is both formulated for oral administration and designs for delivery to the gastrointestinal system.
Speaker 3: a pill vaccine could truly change how we vaccinate global, how we make vaccines, how we distribute them, and how we administer.
Appeal vaccine could totally changed how we vaccinate globally.
We make vaccine, how we distribute them and how we administer.
Speaker 3: Not to mention that quotes show that many more people will take vaccines that are not middle-based.
Not to mention the cost so that many more people will take vaccines that are not naval base.
Speaker 3: while the more remote regions of the world could have access on oral appeal, that does not have the coaching and infrastructure requirement was injectable.
While the Mod in most regions of the world could have accessed on all appeal does not have a cold chain and infrastructure requirements of Injectables.
Speaker 3: I want to emphasize the impact of the disease we are fighting this.
I want to emphasize the impact of the.
The disease without fighting against.
Speaker 3: Norovar recently was named the leading cause of football and iron illness during the joint food and agricultural organization and the World Health Organization expert meeting on microbiological risk assessment in Rome, Italy.
Not a lot of it is something he was named the leading cause of food borne illness. During the join food and agriculture organization and the World Health organization expert meeting on microbiological, a risk assessment in Rome, Italy.
Yeah.
Speaker 3: And not a virus is the leading cause of gut
And none of US is the leading cause of gastroenteritis.
This is a disease with an economic burden in excess of $10 billion annually in the U S alone.
Speaker 3: This is a disease with an economic burden in excess of $10 billion annually in the US alone.
Speaker 3: and of over $60 billion global.
Of over $60 billion globally.
Speaker 3: Norovarty factions affect young children and the elderly this proportion.
None of RSV infections affect young children and the elderly disproportionately.
Recently, we dosed the first subject in our previously announced clinical trials to validate the ability of our novel.
Speaker 3: Recently, we do the first subjects in our previously announced clinical trial to evaluate the ability of our neurovirus and candidate to induce antibodies in breast milk and transfer of antibodies to young.
Candidate.
Just anti bodies in breast milk I'm task for anti bodies too young.
Speaker 3: We are excited about the potential for this study. As vectors, or all nor of our vaccine pills, may make it possible for mothers to protect their infants against this highly contagious disease that has serious health problems.
We're excited about the potential for this study.
That's that's all norovirus vaccine Kim may make it possible for mothers to protect.
Against this highly contagious disease that has serious health consequences.
Speaker 3: enough for a brief update on our COVID-19 program.
And now for a brief update on our COVID-19 program.
Speaker 3: We continue to make progress on a potential COVID vaccine, and we believe that cross-reactivity of our current construct suggests a pathway for developing a tan coronavariate vaccine.
We continue to make progress on our potential COVID-19 vaccine and we believe the cross reactive with you all.
Our current cost structure.
Yes, a pathway for developing a pan coronavirus vaccine.
Speaker 3: Several recent forecasts project new COVID variants to continue to appear, exacerbating the persistence of this serious threat to public health.
Several recent forecast projects more coffee as bad as the continue to talk to you.
So I'll say debating the persistence of the serious threat to probably.
Probably yes.
Given all the prior authorization, although not a hot program.
We are assessing next steps for the Covid program, which could include a number of options.
Speaker 3: We look forward to providing new information once we determine the task forward for this important program.
We look forward to providing information.
Once we determine the path forward for this important program.
Speaker 3: I'll now turn the call over to James to review the recent progress for our Noro virus program.
I'll now turn the call over to James to review the recent progress toward all of the Norovirus program.
Thanks Andre.
We made great clinical strides and our norovirus program during the third quarter announcing top line data from two separate phase II trials. We believe the data that we've shared today is promising for this vaccine candidates and for our vaccine platform overall.
Speaker 4: We believe the data that we've shared today is promising for this vaccine candidate and for our vaccine platform overall.
Speaker 4: I now like to provide you with a high level summary of both studies.
I'd now like to provide you with a high level summary of both studies.
Speaker 4: First, I'll start with the data from our phase two, dose ranging study of our bivalent, norovirus vaccine can.
First I'll start with the data from our phase two dose ranging study of our bivalent norovirus vaccine candidate <unk>.
Speaker 4: Recall that this candidate contains two genotypes, G11 and G24, both of which have caused the majority of norivirus disease in humans over the past 20 or so years.
Recall that this candidate contains two genotypes G. One one and G. Two for.
Both of which have caused the majority of norovirus disease in humans over the past 20 or so years.
Speaker 4: The primary endpoints for safety and immunogenicity in order to determine a dose level for our phase three development.
Primary endpoints for safety and Immunogenicity in order to determine a dose level for our phase III development.
Speaker 4: The preliminary results of the trial showed robust serum and immune responses across all doses at day 29 relative to day
The preliminary results of the trial.
<unk> robust serum immune responses across all doses at day 29 relative to day one.
Speaker 4: Both vaccine doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose.
Both vaccine doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms.
Speaker 4: At day 29, increases in serum IgA, serum IgG, and BT50 for both the G24 and G11 strains in the vaccine are
At day 29 increases in serum Iga steer them I G. G. N V. T 50 for both the G. Two four and G. One one strains in the vaccine arms were similar to those seen in previous Norovirus studies conducted by Baxter.
Speaker 4: were similar to those seen in previous norovirus studies conducted by Vax.
Speaker 4: These results also demonstrate that the bi-villain norovirus vaccine candidate was well tolerated with a favorable safety profile that included no vaccine-related serious adverse events where SAE's and no dose limiting toxic.
These results also demonstrate that the bivalent norovirus vaccine candidate was well tolerated with a favorable safety profile that included no vaccine related serious adverse events, where I say, yes, and no dose limiting toxicity.
Speaker 4: The adverse event rates for both doses were similar to placebo.
Adverse event rates for both doses were similar to placebo.
Speaker 4: Turning to the Phase 2 G11 Norovirus Challenge Study, which measured the safety, immunogenicity, and efficacy of our monovalent norovirus vaccine.
Turning to the phase two G. One one norovirus challenge study, which measure the safety immunogenicity and efficacy of our monovalent norovirus vaccine candidates.
Speaker 4: The primary objectives were to determine the clinical efficacy of our monovellant, more of our spaxine candidate compared to placebo.
The primary objectives were determined the clinical efficacy of our monovalent tomorrow virus vaccine candidates compared to placebo.
Speaker 4: to protect against norivirus acute gastroenteritis or AGE caused by the norwalk-strain challenge to protect against orivirus acute gastroenteritis or AGE caused by the norwalk-strain challenge
To protect against norovirus acute gastroenteritis or a G E caused by the Norwalk strained challenge inoculum and to evaluate the V. P. One specific iga antibody secreting cells or a S sees the H D G a blocking antibody.
Speaker 4: and to evaluate the VP1 specific IGA and a bias of treating cells or ASC.
Speaker 4: the HBGA blocking antibody, and the VP1 specific serum IgA and serum IgG responses to the vaccine.
In the V P. One specific serum Iga and serum IGT responses to the vaccine.
This was a double blinded randomized placebo controlled study in which healthy volunteers received a single oral dose of our norovirus vaccine candidate that targets. The G. One one strain of Norovirus War they received placebo.
Speaker 4: This was a double blinded, randomized placebo controlled study in which healthy volunteers received a single oral dose of our Moravirus vaccine candidate that targets the G11 strain of Moravirus, or they received placebo.
On day one.
Speaker 4: On days 29 and 30, participants were challenged with the G11 strain of norovirus and then assessed for infection, norovirus AGE, and the immune responses through day 57.
On day 29, and 30 participants were challenged with the G. One one strain of Norovirus and then assessed for infection Norovirus AG and the immune responses through day 57.
Speaker 4: This study met five of its six primary endpoints. The results show a statistically significant 29%
This study met five of its six primary endpoints.
The results show, a statistically significant 29% relative reduction in infection.
Speaker 4: 21% relative reduction in norovirus AGE that was not statistically.
A 21% relative reduction in norovirus, a J that was not statistically significant and then 85% relative reduction in viral shedding which was a pre specified study endpoint in the vaccinated cohort compared with placebo.
Speaker 4: and an 85% relative reduction in viral shedding, which was a pre-specified study endpoint in the vaccinated cohort compared with placebo.
Speaker 4: As we noted in the data announcement, we believe these results support the potential for our norovirus vaccine program to provide significant public health.
As we noted in the data announcement, we believe these results support the potential for our norovirus vaccine program to provide significant public health benefits.
Speaker 4: We also believe these are important findings that support the potential use of our oral pill vaccine technology in enabling a vaccine for norovirus.
We also believe these are important findings that support the potential use of our oral pill vaccine technology and enabling a vaccine for norovirus.
As I've already mentioned, we dosed the first subject in our phase one clinical trial evaluating <unk> oral pill bivalent norovirus vaccine candidate.
Speaker 4: As I had already mentioned, we dosed the first subject in our phase one clinical trial evaluating Vaxart's oral pill bivalent norovirus vaccine candidate focused on safety and immunogenicity in lactating mothers.
On safety and Immunogenicity and lactating mothers.
Speaker 4: This is an important step towards VaxArt's goal of developing a vaccine that may reduce the significant global health threat norovirus poses, especially to children under five years old.
This is an important step towards vacs are at school or developing a vaccine that may reduce the significant global health threat, nor a virus poses, especially to children under five years of age.
Speaker 4: Norovirus sickens approximately 21 million people in the United States each year.
Norovirus seconds, approximately 21 million people in the United States, each year and 15% of children under age five contract norovirus annually.
Speaker 4: And 15% of children under age 5 contract norovirus.
Speaker 4: We believe an oral pill nor a virus vaccine may make it possible for mothers to protect their infants against this highly contagious.
We believe an oral pill norovirus vaccine may make it possible for mothers to protect their instance against this highly contagious virus.
Speaker 4: In terms of next steps for the norovirus program, additional analyses of the data from our previous norovirus trials are ongoing, and these will help us in determining how we go forward.
In terms of next steps for the Norovirus program additional analyses of the data from our previous norovirus trials are ongoing.
And these will help us in determining how we go forward.
Speaker 4: Next steps for registration would include a phase 2b dose confirmation study of our bivalent candidate in order to obtain sufficient safety data to inform an end of phase 2 meeting with the FDA in the United States.
Next steps for registration would include a phase II dose confirmation study of our bi valent candidate in order to obtain sufficient safety data to inform an end of phase II meeting with the FDA in the United States.
Speaker 4: We remain on track for the FDA meeting by the end of 2020.
We remain on track for the FDA meeting by the end of 2024.
Speaker 4: I'll now hand the call over to Phil Lee, our Chief Financial Officer, for a brief discussion of our financials. Over to you, Phil.
I'll now hand, the call over to Phil Lee, Our Chief Financial Officer for a brief discussion of our financials over to you Phil.
Speaker 5: Thank you, James. The details of our financial results for the third quarter of 2023 are summarized in today's press release.
Thank you James the details of our financial results for the third quarter of 2023 are summarized in today's press release.
Speaker 5: Revenue for the third quarter of 2023 was $2.1 million compared to no revenue in the third quarter of 2022.
Revenue for the third quarter of 2023 was $2 $1 million compared to no revenue in the third quarter of 2022.
Revenue in the third quarter of 2023 was primarily from revenue recognized for work performed under back towards grant from the Bill and Melinda Gates Foundation.
Speaker 5: Revenue in the third quarter of 2023 was primarily from Revenue Recognize for work performed under Vaxart's grant from the bill in Melinda Gates County.
Speaker 5: Vaxar ended the third quarter of 2023 with cash, cash equivalents, restricted cash, and marketable securities of $53 million compared to $67.9 million as of June 30, 2023.
That's our ended the third quarter of 2023 with cash cash equivalents restricted cash and marketable securities of $53 million compared to $67 $9 million as of June 32023.
Speaker 5: The decrease was primarily due to cash used in operations as we advanced our program.
The decrease was primarily due to cash used in operations as we advanced our programs.
Speaker 5: The company continues to anticipate current cash runway in due the third quarter of 2024.
The company continues to anticipate current cash runway into the third quarter of 2024.
Speaker 5: Thank you all for your time today. We will now open the call for your question.
Thank you all for your time today, we will now open the call for your questions.
Thank you well now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
Speaker 1: Thank you. We'll now be conducting a question and answer session. If you'd like to be placed into question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue.
You May press star two if you'd like to move your question from the queue.
Speaker 1: For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 1. One moment please while we poll for questions.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one one moment. Please while we poll for questions.
Speaker 1: Our first question today is coming from Mayank Manthami from B. Riley. Your line is now live, please proceed.
Our first question today is coming from my final Tommy from B Riley Goodbye and is now live. Please proceed.
Okay.
If I can ask a couple of clarifying questions on the core of protection Hum additional analysis that is going or just maybe if we can get if theres any color there you could share.
Speaker 6: clarifying questions on the correlate of protection.
Speaker 6: additional analysis that is going on just maybe we get if there's any color there you can share and are you looking at both the monovalent and bivalent
And are you looking at both the monovalent and bivalent.
Speaker 6: data sets for the core of protection. And you can need this for the phase to be dose confirmation study. Thanks.
Data sets for the correlate protection.
And do you need this for the phase II dose confirmation study.
<unk>.
Speaker 4: Thank you. This is James Cummings. I'll take those. So, in terms of the correlate of protection, we're continuing that analysis from our challenge study as you may recall that challenge study was a monovalent vaccine versus a matched monovalent strain of challenge.
Thank you. This is James Cummings I'll take those so in terms of the correlate of protection. We're continuing that analyses from our challenge study as you may recall that challenge study was a monovalent vaccine versus a matched monovalent.
Strain of challenge inoculum.
Speaker 4: as we mentioned, we're confident we'll have a correlative protection, and that analysis is ongoing. When it comes to...
As we mentioned we're confident we'll have a correlated protection and that analysis is ongoing and when it comes to the.
Speaker 4: the data sets that are being used, we certainly would look towards the challenge study as finding that correlate of protection.
The datasets that are being used we certainly would look towards the challenge study.
As finding that correlate a protection.
Speaker 4: We will certainly look at other studies and analyses from the past as to where that correlate lies. But the determination of the correlate is based on the challenge study at hand.
We'll certainly look at other studies and analysis from the past as to where that correlate lives, but the determination of the coil. It is based on the challenge study at this time.
Speaker 4: And then, you know, how that might impact a Phase 2B, or more importantly, a Phase 3 study, would be based on dialogue with the FDA. What we hope to garner from a Phase 2 study, a Phase 2B, would be additional safety data to bring us to an end of Phase 2 meeting with the FDA, which is, as I mentioned,
And then you know how that might impact.
A phase II B more importantly, a phase III study.
It would be based on a dialogue with the FDA.
While we hope to garner from a phase II study a phase two b would be additional safety data to bring us to an end of phase two meeting with the FDA, which is as I mentioned.
Speaker 4: still online for, or it's still on schedule for end of 2024.
Still online for or is it still.
Oh on schedule for end of 2024.
Thank you.
Yeah.
Thanks I appreciate it.
Speaker 1: Thank you. As a reminder, that's star one to be placed in the question queue. Our next question is coming from Liang Cheng from Jeffries. Your line is now live.
Thank you as a reminder, that star one to be placed in the question queue. Our next question is coming from young Chang from Jefferies. Your line is now live.
Speaker 7: Hi, Tim. This is Leon for Roger. A couple of questions from us. So I guess the first one is about, you know, the, um, the potential, uh, phase two or the phase two B study. So, um, any color is on the study design in terms of, you know, um, member of enrollment and timing and those.
Hey, Tim this is the ankle Roger.
A couple of questions from us.
The first one is about you know the.
The potential phase two while the phase <unk> study so any carriers onto the study design in terms of you know.
Remember, all the enrollment and timing and dose.
Speaker 4: This is James, I'll take that question. So the Phase II BE study design may be impacted somewhat by some of our further analyses, but will be used to beef up the overall numbers for an end of Phase II meeting with the FDA. That said, it would be somewhere along the lines that at least
This is James I'll take that question. So the phase II B study design may be impacted somewhat by some of our further analyses, but will be used to beef up the overall numbers for an end of phase two meeting with the FDA that.
Said it would be.
Somewhere along the lines of at least four.
Speaker 4: 400 or so, maybe more, individuals who'd receive test article. And then-
400, or so maybe more individuals who would receive a test article and.
And then moving forward.
Speaker 4: And that would be the direct look at the safety and immunogenicity of that stuff.
And that would be a direct look at the safety and Immunogenicity of <unk>.
That study.
Speaker 7: Thank you. So maybe another question. I remember, I think I mentioned that you'll potentially do another like five-reel and challenge study. So what are the current considerations around that?
Thank you so maybe another question.
I remember I.
I think I mentioned that you'll potentially do another like 5 billion challenge study so what what are the.
Current concentration for wombat.
Certainly.
Speaker 8: So currently we've done and reported on the Noravirus G11Strain Challenge and look forward to reporting in that further analysis.
So currently we've done and reported on the Norovirus G. One one strain challenge and look forward to reporting and that further analysis house.
Speaker 8: to the community. In dialogue with the FDA, we will then make a decision on moving forward with that correlate to impact the phase three.
To the community.
In dialogue with the FDA, we will then make.
Make a decision on moving forward with that correlate to impact the phase three study design.
And if needed an additional challenge study with G. Two four could be executed.
Speaker 4: And if needed, an additional challenge study with G24 could be executed.
But at this time, it's not a requirement.
Speaker 4: If it were to be executed, it could be done in parallel with a phase 2b study.
If it were to be executed it could be done in parallel with a phase <unk> study.
Speaker 8: We'll have more information on that once we have the co-related identified and have had those initial discussions with the F.
We will have more information on that once we have the correlated identified and they've had those initial discussions with the FDA.
Speaker 7: Got it. Thank you. Maybe one quick one on the phase one study design. So I know you mentioned that, you know, the, you know, the measurement of transmission reduction into phase three and the importance of that. So, um, so any, any feedback from the agent around that part.
Got it. Thank you maybe one quick one on the phase one study design. So I know you mentioned that the.
But the measurement of the.
Transmission reduction into phase III and the importance of that so so.
So any any feedback from the agent around.
That's part.
But the transmission reduction.
Speaker 8: But so what we had reported on was actually a large decrease in viral shedding, which we believe may lead to decrease in transmission, utilizing standards of public health.
So what we had reported on was actually a large decrease in viral shedding, which we believe may lead to a decrease in transmission.
Utilizing standards of public health policies.
Speaker 8: That said, we only have the data on the viral shedding, which is statistically significant at an 84% role.
That said, we we only have the data on the viral shedding which is statistically significant at an 84% relative reduction.
Speaker 8: that data would then be further gathered in a phase three study.
That data would then be further gathered in a phase III study.
Got it got it. Thank you that's all from us.
Thank you.
Speaker 1: Thank you, and now let's turn the call back to Brandt for further questions.
I would now like to turn the call back to Brent for further questions.
Speaker 9: Thank you very much, operators. So we've got a number of questions that have come in through various sources from our...
Thank you very much operator, so we've got a number of questions that have come in through various sources from our.
Speaker 9: shareholders and other infested parties. A number of the menoravars, we later I think we've had some of them answered already. There was certainly a lot of interest in how the corridor protection and also went up day three trial for neurovirus, which is gonna happen, but I think James you've already answered those.
Shareholders and other interested parties a number of the menorah virus related I think we've had some of them answered already there was certainly a lot of interest in.
The core a little protection and also win a phase III trial for norovirus is going to happen, but I think James you've already I suppose.
Speaker 9: Here's one that I will ask you, James, a little bit more clarification on Norovirus. The question is, can you provide us with an update in terms of where you are in analyzing the additional Norovirus data?
Oh, Here's one that I will ask you James a little bit more clarification on norovirus. So the question is can you provide us with an update in terms of where you are in analyzing the additional neuro data.
Speaker 9: and it goes on in a path forward to a face to be trial, but I think it's the timeline for additional normal data.
In the past and it goes on them a path forward to a phase two b trial, but I think the timeline for additional normal data that's most important here.
Speaker 4: So currently we're evaluating more immune responses and data on an individual subject level within that study. We look forward to sharing those details of the analysis once completed.
Sure James So currently we're evaluating more immune responses and data on an individual subject level within that study we look forward to sharing those details of the analysis once completed.
Thank you James Andre Here's one for you really talking about the future of the organization. The question specifically do you have plans in 2024 to introduce any new product candidate Andrzej.
Speaker 9: James Andre. Here's one for you. We're really talking about the future of the organization. The question is specifically, do you have plans in 2024 to introduce any new product candidates?
Speaker 3: Thank you, Brand. So as we look into 2024, our focus will remain on identifying the best ways to progress our existing clinical pipeline, which is now composed as many of you know of the notovirus, the pan-coronavirus, and the flu-trograph.
Thank you Brian.
So as we look into 'twenty 'twenty four our focus will.
He will remain on identifying the best ways to progress our existing clinical pipeline.
Which is now composed as many of you know of the novel virus, the coronavirus and the slow programs.
Speaker 3: And we believe that doing this would create more than enough capital and opportunities for value creation for a company of our size.
And we believe that doing this will create more than enough carefully.
Opportunities for value creation for a company of our size.
Thank you Andre.
Speaker 9: Okay, we've got a number of questions about how much money we have. Phil, this one's going to come huge. Specifically, the question is, do you intend to initiate the phase to be trial with existing cash? Or will you need to raise additional capital upon this trial?
Okay. We've got a number of questions about how much money, we have fill this one's going to come to you. So specifically the question is do you intend to initiate the phase two b trial with existing cash or will you need to raise additional capital to fund this trial Phil.
Speaker 5: So just to recap, we are currently conducting additional analyses of the data for our NOVARs trials. And once we have determined the path forward for the program, we will provide an update on next steps. And in that, we may include update on cash while we guide it. So it's appropriate.
So just to recap we are currently conducting additional analyses of the data off our novartis trials and once we have determined the path forward for the program. We will provide an update on next steps and in that we may include updated cash runway guidance if appropriate.
Thank you Phil Okay back to clinical.
Speaker 9: Thank you Phil. Okay, back to clinical. And James, this one is on the lactating mother study. So it's the question for the lactating mother study. What is your timeline to top slime data?
And James This one is on the lactating mothers study. So the question for the Lactating mothers study what is your timeline to top line data.
Speaker 8: Thanks. We'll have a better sense of timing for data from this study as we move closer to full enrollment. Today, we've enrolled seven subjects into that study.
We'll have a better sense of timing for data from this study as we move closer to full enrollment today.
Today, we've enrolled seven subjects into that study.
Speaker 9: Perfect and there's an add on question to that as well James. Please remind us how the data from the lactating mother study fits into the overall development program for the norivars.
Perfect and then as an add on.
Question to that as well James It's please remind us how the data from the lactating mothers studies fits into the overall development program for the Norovirus candidate.
Speaker 4: So immunizing lactating mothers may provide increases in the neurovirus and the agobulums in the breast milk, and that could help protect the nursing infant.
So immunizing lactating mothers may provide increases and the norovirus immunoglobulins in the breast milk and that could help protect the nursing infant and that's.
Speaker 4: That's really part of our strategy to protect this vulnerable population.
That's really part of our strategy to protect this vulnerable population.
Speaker 9: Fantastic. Thank you, James. Lots of questions about this one. So, Andre, this one's coming to you about additional funding from outside sources, specifically Barta or other cover US government. So, I'll give you the question. And there's a lot of ways this has been...
Fantastic. Thank you James.
Lots of questions about this one so I'd, rather just not coming to you about additional funding from outside sources, specifically BARDA or other covered U S government, but I'll give you the questions and there's a lot of ways that this is Ben.
Speaker 9: But do you have an update on projects next year on funding and can could you still receive funding from Barta or NIH for this program?
Asked but do you have an update on project Nextgen funding and could.
Could you still receive funding from BARDA or NIH for this program Andre.
Speaker 3: Yeah, so if we were to have a concrete update, we would share that with you, so we don't. But we remain optimistic, we remain of the opinion as we have said multiple times in the past that the US government should support our pan-coronavirus program.
Yeah. So.
If we wanted to have a concrete update.
The share that with you so so we'd done but what.
We remain optimistic we remain.
As we have said multiple times in the past that.
Government should support our phone call on us.
And Corona virus program.
Speaker 3: You know, looking at the programs that have received funding as part of the next-gen program, we continue to believe that our pan-coronavirus program still be supported because it does provide several potential advantages.
You know looking at the programs that have received funding as part of the Nextgen program. We continue to believe that our and Corona virus program still be supported because it does provide.
Several potential advantages distinct advantages over those programs. So again, we remain of the belief that that.
If the U S wants to significantly in Peru.
Its ability to fight future Pandemics.
The program should be supportive.
And we will update you when we have.
Any specific updates to share.
Great. Thank you Andre.
Speaker 9: James, another one for you back to the World Vaccine Congress. So the question is, are there any updates from the World Vaccine Congress that you can share?
James another one for you.
Back to the World vaccine Congress. So the question is are there any updates from the world vaccine Congress that you can sure James.
Sure. Thanks so.
You know our data from the Norovirus challenge was very well received.
Speaker 8: when it was contracted to what the impact of our candidate vaccine might be, went up against natural infection. And the key part here is natural infection generally results from exposure to 10 to 100 virus.
When it was contrast, it to what the impact of our candidate vaccine might be went up against natural infection and the key part here is natural infection generally results from an exposure to 10 to 100 virus particles.
Speaker 8: Don't forget that challenge in oculum was a million virus particles. So we think it's likely that the overall...
I forget the challenge inoculum was a million virus particles. So we think it's likely that the overall protection level and.
Speaker 8: and the natural infection will be enhanced because there's far less virus to protect against.
A natural infection will be enhanced because there's far less virus to protect against.
Excellent. Thank you very much.
Speaker 9: Phil, there's another financial question regarding the gate study. So the question to you, Phil, is how much revenue is left to be recognized from the gate study and over what time span? Phil.
Bill there's another financial question regarding the gates study. So the question for you Phil is how much revenue is left to be recognized from the <unk> study and over what time span Phil.
Speaker 5: Sure, thanks, Grant. So we recognize Grant revenue in the period of which the related costs are incurred and services are rendered. So at this point, we really have recognized the vast majority of the current grant from the Bill and the Linda Gates Foundation. That's right.
Sure. Thanks, Brian So we recognize grant revenue in the period of which the related costs are incurred and services are rendered.
At this point, we really have recognized the vast majority of the current grant from the Bill and Melinda Gates Foundation that's revenue.
Speaker 5: I currently expect to recognize the remaining 79,000 in the fourth quarter of 2023.
I currently expect to recognize the remaining $79000 in the fourth quarter of 2023.
Speaker 9: Excellent, thank you Phil. Okay, and operator that closes our Q&A.
Excellent. Thank you, Phil Okay, and operators that closes our Q&A.
Thank you with that does that close todays conference. If so then you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.
Speaker 1: Thank you with that. Does that close today's conference? If so, then we just characterize at this time and have a wonderful day. We thank you for your participation today.